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This is indicated as irrigating fluid of choice in:

• Transurethral resection of prostate.
• Endoscopic procedures within the urinary tract.
• Urinary bladder surgery etc.

Irrigation Solution used in Urological Surgery

Glycine irrigation solution contains glycine which is an amino acid and a non-electrolyte. It is therefore non-conductive and suitable for irrigation purpose. Glycine Irrigation Solution minimizes the risk of intravascular haemolysis which can occur from absorption of plain water. Glycine Irrigation Solution is rapidly degraded in the liver by glycine oxidase.

The total volume of solution used for irrigation depends on the judgment of the attending surgeon. Height from the operating table of 60 cm (approx. 2ft) is likely to cause increased intravascular absorption of glycine.

Administration Procedure:

• Check infusion set and infusion solution prior to use
• Pull moderately to tear off the protective cover of the Eurohead
• Hold lightly the Eurohead but not the bag
• Open the flow regulator fully and hold the giving set on the top white area, but not the membrane venting region
• Insert the spike of the administration set to the Eurohead and fit the connector of the administration set firmly to the needle
• Gradually allow the fluid to flow down to the needle tip and close
• Remove the protective cover of the needle
• Locate the veinpuncture site and clean the site with an antiseptic solution, and then insert the needle
• Securely tape the puncture site
• Securely tape the wings and tubing
• Start infusion while adjusting drip speed

Large intravenous doses of glycine are known to cause nausea and salivation. Other consequences of systemic absorption of glycine include electrolyte loss, diuresis, edaema, thirst, dehydration, cardiovascular and pulmonary disorders.

Glycine Irrigation Solution is not for injection in any route. It is contraindicated in patients with anuria.

Patients with cardiovascular disease should be evaluated after transurethral resection of prostate using glycine. Care should be exercised if the liver or kidney is impaired. Aseptic technique is essential while using glycine. Unused portion should be discarded. Do not use if the bottle is leaking, solution is cloudy, contains particles or after expiry date.

Additives may be incompatible. When introducing additives, use aseptic technique, mix thoroughly and do not store.

Store at controlled room temperature, protect from light and heat

This is indicated as irrigating fluid of choice in:

• Transurethral resection of prostate.
• Endoscopic procedures within the urinary tract.
• Urinary bladder surgery etc.

Irrigation Solution used in Urological Surgery

Glycine irrigation solution contains glycine which is an amino acid and a non-electrolyte. It is therefore non-conductive and suitable for irrigation purpose. Glycine Irrigation Solution minimizes the risk of intravascular haemolysis which can occur from absorption of plain water. Glycine Irrigation Solution is rapidly degraded in the liver by glycine oxidase.

The total volume of solution used for irrigation depends on the judgment of the attending surgeon. Height from the operating table of 60 cm (approx. 2ft) is likely to cause increased intravascular absorption of glycine.

Administration Procedure:

• Check infusion set and infusion solution prior to use
• Pull moderately to tear off the protective cover of the Eurohead
• Hold lightly the Eurohead but not the bag
• Open the flow regulator fully and hold the giving set on the top white area, but not the membrane venting region
• Insert the spike of the administration set to the Eurohead and fit the connector of the administration set firmly to the needle
• Gradually allow the fluid to flow down to the needle tip and close
• Remove the protective cover of the needle
• Locate the veinpuncture site and clean the site with an antiseptic solution, and then insert the needle
• Securely tape the puncture site
• Securely tape the wings and tubing
• Start infusion while adjusting drip speed

Large intravenous doses of glycine are known to cause nausea and salivation. Other consequences of systemic absorption of glycine include electrolyte loss, diuresis, edaema, thirst, dehydration, cardiovascular and pulmonary disorders.

Glycine Irrigation Solution is not for injection in any route. It is contraindicated in patients with anuria.

Patients with cardiovascular disease should be evaluated after transurethral resection of prostate using glycine. Care should be exercised if the liver or kidney is impaired. Aseptic technique is essential while using glycine. Unused portion should be discarded. Do not use if the bottle is leaking, solution is cloudy, contains particles or after expiry date.

Additives may be incompatible. When introducing additives, use aseptic technique, mix thoroughly and do not store.

Store at controlled room temperature, protect from light and heat

Irinotecan Injection is indicated as a component of first-line therapy in combination with 5-fluorouracil (5-FU) and leucovorin (LV) for patients with metastatic carcinoma of the colon or rectum.

Irinotecan is indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy.

Cytotoxic Chemotherapy

Irinotecan inhibits the action of topoisomerase I. Irinotecan prevents religation of the DNA strand by binding to topoisomerase I-DNA complex. The formation of this ternary complex interferes with the moving replication fork, which induces replication arrest and lethal double-stranded breaks in DNA. As a result, DNA damage is not efficiently repaired and apoptosis (programmed cell death) occurs.

Administer as a 90-minute intravenous infusion followed by LV and 5-FU. A reduction in the starting dose by one dose level may be considered for patients with any of the following conditions: prior pelvic/abdominal radiotherapy, performance status of 2, or increased bilirubin levels.

Refractory colorectal malignancies: 125 mg/m² once wkly for 4 wk, followed by a 2 wk rest period.

Metastatic colorectal cancer: As 1st  line treatment: 125 mg/m² on days 1,8,15 and 22 of a 6-wk cycle.

Anemia, Leukopenia, Neutropenia,Thrombocytopenia, Elevated bilirubin, Diarrhea, Nausea, Asthenia, Abdominal pain, Vomiting , Alopecia, Fever, Constipation, Anorexia, Mucositis, Pain, Dyspnea, Cough, Dizziness, Infection, Rash, Abdominal fullness, AST increased , Dyspepsia, Edema, Ascites/jaundice, Vasodilation, Thromboembolism, Hypotension, Neutropenic fever, Headache, Insomnia, Orthostatic hypotension

Patients with a known hypersensitivity to the drug or its excitements.

Early diarrhea is usually transient and infrequently severe. It may be accompanied by cholinergic symptoms of rhinitis, increased salivation, miosis, lacrimation, diaphoresis, flushing, and intestinal hyperperistalsis that can cause abdominal cramping. Bradycardia may also occur.

Late diarrhea can be life threatening since it may be prolonged and may lead to dehydration, electrolyte imbalance, or sepsis.Late diarrhea can be complicated by colitis, ulceration, bleeding, ileus, obstruction, and infection. Cases of megacolon and intestinal perforation have been reported.

Diuretics increase risks of dehydration secondary to vomiting/diarrhoea; prophylactic dexamethasone as an antiemetic may enhance lymphocytopenia; prochlorperazine may increase incidence of akathisia; antineoplastic agents (myelosuppression and diarrhoea). St John's wort, ketoconazole may reduce irinotecan exposure.

Pregnancy Category D. There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Store at controlled room temperature 15° to 30°C. Protect from light. Keep the vial in the carton until the time of use.

Irinotecan Injection is indicated as a component of first-line therapy in combination with 5-fluorouracil (5-FU) and leucovorin (LV) for patients with metastatic carcinoma of the colon or rectum.

Irinotecan is indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy.

Cytotoxic Chemotherapy

Irinotecan inhibits the action of topoisomerase I. Irinotecan prevents religation of the DNA strand by binding to topoisomerase I-DNA complex. The formation of this ternary complex interferes with the moving replication fork, which induces replication arrest and lethal double-stranded breaks in DNA. As a result, DNA damage is not efficiently repaired and apoptosis (programmed cell death) occurs.

Administer as a 90-minute intravenous infusion followed by LV and 5-FU. A reduction in the starting dose by one dose level may be considered for patients with any of the following conditions: prior pelvic/abdominal radiotherapy, performance status of 2, or increased bilirubin levels.

Refractory colorectal malignancies: 125 mg/m² once wkly for 4 wk, followed by a 2 wk rest period.

Metastatic colorectal cancer: As 1st  line treatment: 125 mg/m² on days 1,8,15 and 22 of a 6-wk cycle.

Anemia, Leukopenia, Neutropenia,Thrombocytopenia, Elevated bilirubin, Diarrhea, Nausea, Asthenia, Abdominal pain, Vomiting , Alopecia, Fever, Constipation, Anorexia, Mucositis, Pain, Dyspnea, Cough, Dizziness, Infection, Rash, Abdominal fullness, AST increased , Dyspepsia, Edema, Ascites/jaundice, Vasodilation, Thromboembolism, Hypotension, Neutropenic fever, Headache, Insomnia, Orthostatic hypotension

Patients with a known hypersensitivity to the drug or its excitements.

Early diarrhea is usually transient and infrequently severe. It may be accompanied by cholinergic symptoms of rhinitis, increased salivation, miosis, lacrimation, diaphoresis, flushing, and intestinal hyperperistalsis that can cause abdominal cramping. Bradycardia may also occur.

Late diarrhea can be life threatening since it may be prolonged and may lead to dehydration, electrolyte imbalance, or sepsis.Late diarrhea can be complicated by colitis, ulceration, bleeding, ileus, obstruction, and infection. Cases of megacolon and intestinal perforation have been reported.

Diuretics increase risks of dehydration secondary to vomiting/diarrhoea; prophylactic dexamethasone as an antiemetic may enhance lymphocytopenia; prochlorperazine may increase incidence of akathisia; antineoplastic agents (myelosuppression and diarrhoea). St John's wort, ketoconazole may reduce irinotecan exposure.

Pregnancy Category D. There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Store at controlled room temperature 15° to 30°C. Protect from light. Keep the vial in the carton until the time of use.

Irinotecan Injection is indicated as a component of first-line therapy in combination with 5-fluorouracil (5-FU) and leucovorin (LV) for patients with metastatic carcinoma of the colon or rectum.

Irinotecan is indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy.

Cytotoxic Chemotherapy

Irinotecan inhibits the action of topoisomerase I. Irinotecan prevents religation of the DNA strand by binding to topoisomerase I-DNA complex. The formation of this ternary complex interferes with the moving replication fork, which induces replication arrest and lethal double-stranded breaks in DNA. As a result, DNA damage is not efficiently repaired and apoptosis (programmed cell death) occurs.

Administer as a 90-minute intravenous infusion followed by LV and 5-FU. A reduction in the starting dose by one dose level may be considered for patients with any of the following conditions: prior pelvic/abdominal radiotherapy, performance status of 2, or increased bilirubin levels.

Refractory colorectal malignancies: 125 mg/m² once wkly for 4 wk, followed by a 2 wk rest period.

Metastatic colorectal cancer: As 1st  line treatment: 125 mg/m² on days 1,8,15 and 22 of a 6-wk cycle.

Anemia, Leukopenia, Neutropenia,Thrombocytopenia, Elevated bilirubin, Diarrhea, Nausea, Asthenia, Abdominal pain, Vomiting , Alopecia, Fever, Constipation, Anorexia, Mucositis, Pain, Dyspnea, Cough, Dizziness, Infection, Rash, Abdominal fullness, AST increased , Dyspepsia, Edema, Ascites/jaundice, Vasodilation, Thromboembolism, Hypotension, Neutropenic fever, Headache, Insomnia, Orthostatic hypotension

Patients with a known hypersensitivity to the drug or its excitements.

Early diarrhea is usually transient and infrequently severe. It may be accompanied by cholinergic symptoms of rhinitis, increased salivation, miosis, lacrimation, diaphoresis, flushing, and intestinal hyperperistalsis that can cause abdominal cramping. Bradycardia may also occur.

Late diarrhea can be life threatening since it may be prolonged and may lead to dehydration, electrolyte imbalance, or sepsis.Late diarrhea can be complicated by colitis, ulceration, bleeding, ileus, obstruction, and infection. Cases of megacolon and intestinal perforation have been reported.

Diuretics increase risks of dehydration secondary to vomiting/diarrhoea; prophylactic dexamethasone as an antiemetic may enhance lymphocytopenia; prochlorperazine may increase incidence of akathisia; antineoplastic agents (myelosuppression and diarrhoea). St John's wort, ketoconazole may reduce irinotecan exposure.

Pregnancy Category D. There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Store at controlled room temperature 15° to 30°C. Protect from light. Keep the vial in the carton until the time of use.

Pumpkin is a plant. The seed and its oil are used to make medicine. Pumpkin is commonly used by mouth for symptoms of benign prostatic hyperplasia (BPH).

Herbal and Nutraceuticals

The chemicals in pumpkin seed cause an increase in urination (diuretic effect), which helps relieve bladder and prostate discomfort. Some chemicals might also reduce swelling (inflammation) in the prostate.

For benign prostatic hyperplasia (BPH): 5 grams pumpkin seed twice daily. 1-2 tablets or capsules of pumpkin seed oil or extracts daily. 160 mg pumpkin seed oil 1-3 times daily in combination with saw palmetto and other ingredients.

Pumpkin is LIKELY SAFE in food amounts. It is POSSIBLY SAFE to take pumpkin seed or pumpkin seed oil in medicinal amounts. Side effects from pumpkin products are rare.

There isn't enough reliable information to know if pumpkin is safe to use in medicinal amounts when pregnant or breastfeeding. Stay on the safe side and stick with usual food amounts.

Store below 25ºC, dry place and away from direct sunlight. Keep out of reach of children.

Mebeverine is indicated for the:

• Symptomatic treatment of irritable bowel syndrome (IBS)
• Chronic irritable colon
• Spastic constipation
• Mucous colitis
• Colicky abdominal pain
• Persistent non-specific diarrhoea

Anticholinergics

For adults, elderly and children over 10 years:

• Mebeverine Hydrochloride 135 mg tablet: 1 tablet 03 times daily.
• Mebeverine Hydrochloride 200 mg capsule: 1 capsule 02 times daily.

This is most effective when taken 20 minutes before meals. After several weeks when the desired effect has been obtained, the dosage may be gradually reduced.

Missed dose: If a dose of this medicine is missed, that should be taken as soon as possible. However, if it is almost time for the next dose, then skip the missed dose and the regular dosing schedule should be maintained. Dose should not be doubled at the same time to compensate the missed dose.

Use in children: Mebeverine is not recommended for children under 10 years.

Generally Mebeverine is well tolerated. However, few side-effects like skin rash, urticaria and angioedema may appear

Hypersensitivity to the drug or any other ingredients.

Caution should be exercised in porphyria or allergic reaction to this or any other medicine of this group.

No teratogenicity has been shown in animal experiments. However, the usual precautions concerning the administration of any drug during pregnancy should be exercised. Mebeverine does not excrete in the breast milk after administering at therapeutic dose.

On theoretical grounds it may be predicted that CNS excitability will occur in case of overdosage. No specific antidote is known: gastric lavage and symptomatic treatment is recommended

Do not store above 30°C. Keep away from light and out of the reach of children.

Irinotecan Injection is indicated as a component of first-line therapy in combination with 5-fluorouracil (5-FU) and leucovorin (LV) for patients with metastatic carcinoma of the colon or rectum.

Irinotecan is indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy.

Cytotoxic Chemotherapy

Irinotecan inhibits the action of topoisomerase I. Irinotecan prevents religation of the DNA strand by binding to topoisomerase I-DNA complex. The formation of this ternary complex interferes with the moving replication fork, which induces replication arrest and lethal double-stranded breaks in DNA. As a result, DNA damage is not efficiently repaired and apoptosis (programmed cell death) occurs.

Administer as a 90-minute intravenous infusion followed by LV and 5-FU. A reduction in the starting dose by one dose level may be considered for patients with any of the following conditions: prior pelvic/abdominal radiotherapy, performance status of 2, or increased bilirubin levels.

Refractory colorectal malignancies: 125 mg/m² once wkly for 4 wk, followed by a 2 wk rest period.

Metastatic colorectal cancer: As 1st  line treatment: 125 mg/m² on days 1,8,15 and 22 of a 6-wk cycle.

Anemia, Leukopenia, Neutropenia,Thrombocytopenia, Elevated bilirubin, Diarrhea, Nausea, Asthenia, Abdominal pain, Vomiting , Alopecia, Fever, Constipation, Anorexia, Mucositis, Pain, Dyspnea, Cough, Dizziness, Infection, Rash, Abdominal fullness, AST increased , Dyspepsia, Edema, Ascites/jaundice, Vasodilation, Thromboembolism, Hypotension, Neutropenic fever, Headache, Insomnia, Orthostatic hypotension

Patients with a known hypersensitivity to the drug or its excitements.

Early diarrhea is usually transient and infrequently severe. It may be accompanied by cholinergic symptoms of rhinitis, increased salivation, miosis, lacrimation, diaphoresis, flushing, and intestinal hyperperistalsis that can cause abdominal cramping. Bradycardia may also occur.

Late diarrhea can be life threatening since it may be prolonged and may lead to dehydration, electrolyte imbalance, or sepsis.Late diarrhea can be complicated by colitis, ulceration, bleeding, ileus, obstruction, and infection. Cases of megacolon and intestinal perforation have been reported.

Diuretics increase risks of dehydration secondary to vomiting/diarrhoea; prophylactic dexamethasone as an antiemetic may enhance lymphocytopenia; prochlorperazine may increase incidence of akathisia; antineoplastic agents (myelosuppression and diarrhoea). St John's wort, ketoconazole may reduce irinotecan exposure.

Pregnancy Category D. There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Store at controlled room temperature 15° to 30°C. Protect from light. Keep the vial in the carton until the time of use.

Osimertinib is indicated for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy.

Cytotoxic Chemotherapy

Osimertinib is an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) that binds to certain mutant forms of EGFR (T790M, L858R, and exon 19 deletion) that predominate in non-small cell lung cancer (NSCLC) tumours following treatment with first-line EGFR-TKIs. As a third-generation tyrosine kinase inhibitor, osimertinib is specific for the gate-keeper T790M mutation which increases ATP binding activity to EGFR and results in poor prognosis for late-stage disease. Furthermore, osimertinib has been shown to spare wild-type EGFR during therapy, thereby reducing non-specific binding and limiting toxicity.

The recommended dose of Osimertinib is 80 mg once a day until disease progression or unacceptable toxicity. Osimertinib can be taken with or without food. If a dose of Osimertinib is missed, do not make up the missed dose and take the next dose as scheduled.

Administration To Patients Who Have Difficulty Swallowing Solids: Disperse tablet in 60 ml (2 ounces) of non-carbonated water only. Stir until tablet is dispersed into small pieces (the tablet will not completely dissolve) and swallow immediately. Do not crush, heat, or ultrasonicate during preparation. Rinse the container with 120 ml to 240 ml (4 to 8 ounces of) water and immediately drink.

If administration via nasogastric tube is required, disperse the tablet as above in 15 ml of non-carbonated water, and then use an additional 15 ml of water to transfer any residues to the syringe. The resulting 30 ml liquid should be administered as per the nasogastric tube instructions with appropriate water flushes (approximately 30 ml).

Common side effects are Interstitial Lung Disease or Pneumonitis, QTc Interval Prolongation, Cardiomyopathy, Keratitis

Strong CYP3A4 Inducers: If concurrent use is unavoidable, increase Osimertinib dosage to 160 mg daily when coadministering with a strong CYP3A inducer. Resume Osimertinib at 80 mg 3 weeks after discontinuation of the strong CYP3A4 inducer

Use in Pregnancy: There are no or limited amount of data from the use of Osimertinib in pregnant women. Studies in animals have shown reproductive toxicity. Based on its mechanism of action and preclinical data, Osimertinib may cause foetal harm when administered to a pregnant woman. Administration of osimertinib to pregnant rats was associated with embryolethality, reduced foetal growth and neonatal death at exposures similar to what is expected in humans. Osimertinib is not recommended during pregnancy and in women of childbearing potential not using contraception.

Use in Lactation: It is not known whether osimertinib or its metabolites are excreted in human milk. Administration to rats during gestation and early lactation was associated with adverse effects, including reduced growth rates and neonatal death. There is insufficient information on the excretion of osimertinib or its metabolites in animal milk. A risk to the suckling child cannot be excluded. Breast-feeding should discontinue during treatment with Osimertinib.

Fertility: There are no data on the effect of Osimertinib on human fertility. Results from animal studies have shown that Osimertinib has effects on male and female reproductive organs and could impair fertility

Store Osimertinib at room temperature between 20°C to 25°C. Safely throw away medicine that is out of date or that you no longer need. Keep Osimertinib and all medicines out of the reach of children.

This tablet is indicated for the treatment and prevention of Iron, Folic Acid and Zinc deficiencies.

Iron, Vitamin & Mineral Combined preparation

This tablet is the preparation of Iron, Folic Acid and Zinc. In this preparation, Iron is present as Iron (III) Hydroxide Polymaltose Complex, a noble Iron preparation. It contains non-ionic Ferric Iron and Polymaltose in a stable complex. This complex facilitates a controlled absorption of the Iron when it comes in contact with the mucosal cell surface. Due to non-ionic nature, Iron (III) Hydroxide Polymaltose Complex is more stable than conventional Iron form. Folic Acid helps in the proper development of the fetus. Zinc keeps enzymes working and helps to metabolize proteins.

One tablet daily. Two tablets may be required a day in severe cases or as directed by the physician.

This tablet is generally well tolerated. However, a few side effects of oral Iron preparations, including nausea, vomiting, constipation or diarrhoea may occur rarely.

This tablet is contraindicated in patients with a known hypersensitivity to any of the ingredients of this product.

As with all Iron preparations, dark coloration of the stool may occur which is without clinical significance.

Since Iron is complex bound, ionic interaction with foodstuff components (phytates, oxalates, tannin etc.) and concomitant administration of medicaments (tetracyclines, antacids) are unlikely to occur.

Use of any drug during the first trimester of pregnancy should be avoided if possible. Thus administration of Iron in the first trimester requires definite evidence of Iron deficiency.

No intoxication or Iron overloaded has been reported in case of overdose.

Keep in a cool & dry place away from light and moisture. Keep out of the reach of children.

Ferric Carboxymaltose is indicated for the treatment of iron deficiency anemia in adult patients-

• Who have intolerance to oral iron or have had unsatisfactory response to oral iron
• Who have non-dialysis dependent chronic kidney disease.

Parenteral Iron Preparations

Non-dextran, IV is a colloidal iron hydroxide in complex with carboxymaltose, a carbohydrate polymer that releases iron; replaces iron stores found in hemoglobin, myoglobin, and enzymes; works to transport oxygen via hemoglobin Macrophage engulf FCM from blood and control iron release. Transferrin saturates and, Iron into the liver, spleen and Bone marrow.

For patients weighing 50 kg or more: Give Ferric Carboxymaltose in two doses separated by at least 7 days. Give each dose as 750 mg for a total cumulative dose not to exceed 1500 mg of iron per course.

For patients weighing less than 50 kg: Give Ferric Carboxymaltose in two doses separated by at least 7 days. Give each dose as 15 mg/kg body weight for a total cumulative dose not to exceed 1500 mg of iron per course.

The dosage of Ferric Carboxymaltose is expressed in mg of elemental iron. Each mL of Ferric Carboxymaltose contains 50 mg of elemental iron. Ferric Carboxymaltose treatment may be repeated if iron deficiency anemia reoccurs.

Administer Ferric Carboxymaltose intravenously, either as an undiluted slow intravenous push or by infusion. When administering as a slow intravenous push, give at the rate of approximately 100 mg (2 mL) per minute. When administered via infusion, dilute up to 750 mg of iron in no more than 250 mL of sterile 0.9% sodium chloride injection, USP, such that the concentration of the infusion is not less than 2 mg of iron per mL and administer over at least 15 minutes.

When added to an infusion bag containing 0.9% Sodium Chloride Injection, USP, at concentrations ranging from 2 mg to 4 mg of iron per mL, Ferric Carboxymaltose solution is physically and chemically stable for 72 hours when stored at room temperature. To maintain stability, do not dilute to concentrations less than 2 mg iron/mL.

Inspect parenteral drug products visually for the absence of particulate matter and discoloration prior to administration. The product contains no preservatives. Each vial of Ferric Carboxymaltose is intended for single use only. Any unused drug remaining after injection must be discarded.

Avoid extravasation of Ferric Carboxymaltose since brown discoloration of the extravasation site may be long lasting. Monitor for extravasation. If extravasation occurs, discontinue the Ferric Carboxymaltose administration at that site.

Nausea, Hypertension, Flushing, Decreased blood phosphorus, Dizziness, Vomiting, Pruritus, Rash, Urticaria, Wheezing, Injection site discoloration, Headache, Increased alanine aminotransferase), Dysgeusia, Hypotension, Constipation, Serious anaphylactic/anaphylactoid reactions

Hypersensitivity to any of its components.

Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Ferric carboxymaltose. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. Monitor patients for signs and symptoms of hypersensitivity during and after Ferric carboxymaltose administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Ferric carboxymaltose when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. Other serious or severe adverse reactions potentially associated with hypersensitivity which included, but not limited to, pruritus, rash, urticaria, wheezing, or hypotension may occur.

Hypertension: Transient elevations in systolic blood pressure, sometimes occurring with facial flushing, dizziness, or nausea were observed. These elevations generally occurred immediately after dosing and resolved within 30 minutes. Monitor patients for signs and symptoms of hypertension following each Ferric carboxymaltose administration.

There are no known drug interactions and none well documented.

Pregnancy Category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks

Do not store above 30°C. Do not freeze.

For treatment of iron deficiency and prevention of concomitant Folic acid deficiency in adults. For maintenance of maternal haematopoiesis during pregnancy particularly when diet is abnormal or substandard.

Iron & Vitamin Combined preparations

Iron is an essential constituent of the body being necessary for haemoglobin formation and for the oxidative processes of living tissues. Iron salts should only be given for the treatment and as prophylaxis of Iron deficiency anaemia. Iron deficiency anaemias are most often the result of chronic haemorrhage, nutritional deficiency, pregnancy or parasite infestation or malabsorption of iron.

A deficiency of Folic acid typically during pregnancy has long been known to cause a megaloblastic anaemia. The vitamin is not storable in the body and the combination of fetal demand during pregnancy and malnutrition can lead to a deficiency, hence anaemia. It has been observed that the rapid production of red blood cells following treatment with iron may deplete body folate if there is inadequate intake; combination of folic acid and ferrous fumerate avoids the complication. Iron and Folic acid are absorbed in the proximal small intestine particularly the duodenum. Ferrous Fumerate & Folic acid supplements replenish iron deficiency. Thereby arresting the anaemia process. Absorbed iron is taken upto the bone marrow's tissues that form blood cells where it is used to synthesize haemoglobin.

In anaemia: The usual dose is one tablet or capsule daily.

In severe or refractory iron deficiency anaemia: The usual dose is one tablet or capsule twice daily may be given.

In Pregnancy, it is recommended that the dose should be started at the first antenatal consultation and continued until 3 months after delivery.

Gastric distress, abdominal cramps, diarrhoea, allergic reaction.

This is contraindicated in patients with pernicious anaemia and anaemia other than those due to iron deficiency. The nature and causes of anaemia should be established. Absorption of Ferrous Fumerate & Folic acid is inhibited by Magnesium trisillicate and Antacid containing carbonate.

Administration of Ferrous Fumerate & Folic acid during the first trimester of pregnancy may be undesirable. Very few pregnant women are not protected by physiological doses of Folic acid. If anaemia is developed despite prophylaxis with Ferrous Fumerate & Folic acid, patients should be investigated further. Some postgastrectomy patients show poor absorption of iron. Care is needed when treating patients with peptic ulcer.

When Ferrous Fumerate & Folic acid combination and Tetracycline are taken concomitantly, absorption of both drugs are reduced. Concurrent administration of antacid may reduce absorption of iron. Serum anticonvulsant levels may be reduced by administration of folate.

There is no contraindication in pregnancy and lactation.

Oral Iron preparations

Iron Polymaltose Complex is a polysaccharide-iron complex, which is a novel iron preparation used in the treatment of iron deficiency anaemia. Iron, an essential constituent of the body, is necessary for haemoglobin formation and for the oxidative process of living tissue. This preparation contains non-ionic ferric iron and polymaltose in a stable complex. This facilitates a controlled absorption of the ferric iron when it comes in contact with the mucosal cell surface. Being non-ionic, it does not release any free radicals and thus takes care of all the toxic effects found due to the release of free radicals by the traditional ionized iron salt preparations. It does not interact with the food components and other medications and so, unlike ferrous salts, there is no decrease in bioavailability of Iron Polymaltose Complex. This makes sure that with the consumption of this complex, iron gets utilized at a faster rate in the haemoglobin and myoglobin synthesis.

Dosage and duration of therapy are dependent upon the extent of iron deficiency and should be taken as directed by the physician.

• Adults: 10 ml once or twice daily
• Children (6-12 years): 10 ml daily
• Children (2-6 years): 5 ml daily
• Premature infants & Infants: 3.33 mg of elemental iron/kg body weight.

This preparation is well tolerated. However, a few side effects of oral iron preparations, including nausea, vomiting, constipation or diarrhoea may occur.

Initially epigastric pain, diarrhea and vomiting; and may include metabolic acidosis, convulsions, and coma after apparent recovery. Speed is essential for effective treatment which is dependent upon removing excess iron from the alimentary tract prior to absorption. Initially an emetic should be given, followed by gastric lavage with 1% sodium bicarbonate, and oral administration of desferrioxamine to complex with residue.

Generally no interactions have been observed. Since, the iron is complex bound, ionic interactions with foodstuff components (phytates, oxalates, tannin, etc.) and concomitantly administered medicaments (tetracycline, antacids) are unlikely to occur.

Administration of drugs during first trimester of pregnancy requires careful assessment of potential risk versus benefits to be gained and should not be administered unless clearly indicated. For the remainder of the pregnancy, iron therapy may be indicated but only on advice of a physician. Iron is excreted in breast milk but not in clinically significant concentrations.

In case of overdosage, initially epigastric pain, diarrhoea and vomiting can occur and may include metabolic acidosis, convulsions and coma after apparent recovery. Should seek emergency medical attention in case of overdose. Initially an emetic should be given and then gastric lavage and general supportive measures should be employed.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

This is indicated for the treatment and prophylaxis of Iron, Folic Acid and Zinc deficiency especially during pregnancy and lactation.

Iron, Vitamin & Mineral Combined preparation

Adult or Elderly: 1 capsule daily. In more severe cases, 2 capsules daily may be required.

Children: Aged over 1 year: 1 capsule daily. The capsule may be opened and the pellets to be mixed with soft cool food, but they must not be chewed.

Dark stools are usual during iron therapy and nausea and other symptoms of gastrointestinal irritation such as anorexia, vomiting, discomfort, constipation and diarrhoea are sometimes encountered. Zinc may also produce a gastrointestinal upset. These timed-release capsules are designed to reduce the possibility of gastrointestinal irritation. There have been rare reports of allergic reactions

Do not use in patients hypersensitive to the components of the product or those with iron overload.

Care should be taken in patients who may develop Iron overloads, such as those with haemochromatosis, haemolytic anaemia or red cell aplasia. Failure to respond to treatment may indicate other causes of anaemia and should be further investigated. Iron & Zinc chelate with tetracycline and absorption of all three agents may be impaired. The absorption of Zinc may be reduced in the presence of Iron. Absorption of Iron may be impaired by penicillamine and by antacids. Such potential interactions can be reduced by separating the administration of each product by several hours. In patients with renal failure a risk of Zinc accumulation could exist.

Use of any drug during the first trimester of pregnancy should be avoided if possible. Thus administration of Iron during the first trimester requires definite evidence of Iron deficiency where inadequate diet calls for supplementary Zinc and Folic acid is justified during the remainder of the pregnancy.

Iron overdosage is dangerous, particularly in children and requires immediate attention. Gastric lavage should be carried out in the early stages, or if this is not possible vomiting should be induced. These procedures should not be undertaken where signs of the corrosive effects of zinc are present. Give oral desferrioxamine (2 gm for a child or 5 gm for an adult) and demulcent. If serum Iron levels at 4 hours or more post-ingestion are over 5mg/l in a child or 8 mg/l in adults, or if the patient is in shock of coma, intravenous desferrioxamine should be used. Zinc Sulphate in gross over dosage is corrosive. Symptoms are those of gastrointestinal irritation leading in severe cases to haemorrhage, corrosion of the mucosa and possible later stricture formation. Gastric lavage or emesis should be avoided. Demulcents such as milk should be given. Chelating agents such as Dimercaprol, Penicillamine or Edetic Acid have been recommended.

Symptomatic and supportive measures should be given as required. The timed-release capsule presentation may delay excessive absorption of Iron and Zinc and allow more time for initiation of appropriate counter-measure.

Protected from light and moisture, store below 30˚C. Keep out of reach of children.

Other beta-lactam Antibiotics

Imipenem acts as an antimicrobial through the inhibition of cell wall synthesis of various gram-positive and gram-negative bacteria. This inhibition of cell wall synthesis in gram-negative bateria is attained by binding to pencillin binding proteins (PBPs). In E. coli and selected strains of P. aeruginosa, imipenem has shown to have the highest affinity to PBP-2, PBP-1a, and PBP-1b. This preferential binding to PBP-2 and PBP-1b results in the direct conversion of the individual cell to a spheroblast, which leads to rapid cell lysis and death without filament formation.

Cilastatin is a specific and reversible renal dehydropeptidase-I inhibitor. Since the antibiotic, imipenem, is hydrolyzed by dehydropeptidase-I, which resides in the brush border of the renal tubule, cilastatin is administered with imipenem to block the metabolism and thus the inactivation of imipenem so that antibacterial levels of imipenem can be attained in the urine. The drug also prevents the metabolism of leukotriene D4 to leukotriene E4 through the inhibition of leukotriene D4 dipeptidase.

The total daily dosage of Imipenem should be based on the type or severity of infection and given in equally divided doses based on consideration of degree of susceptibility of the pathogens, renal function and body-weight.

Imipenem & Cilastatin IV: Up to 500 mg dose should be given over 20 to 30 minutes; > 500 mg dose should be infused over 40 to 60 minutes. In patients who develop nausea during the infusion, the rate of infusion may be slowed.

Adult: Normal daily dose is 1-2 g administered in 3-4 divided doses. For the treatment of moderate infection, a 1 g b.i.d. dosage regimen may also be used. In infections due to less susceptible organisms, the daily dosage may be increased to a maximum of 4 g/day or 50 mg/kg/day, whichever is lower.

• Mild infection: 250 mg 6 hourly (1 gm/day)
• Moderate infection: 500 mg 8 hourly or 1 gm 12 hourly (1.5-2 gm/day)
• Severe infection with fully susceptible microorganism: 500 mg 6 hourly (2gm/day)
• Severe infection with less susceptible organisms (primarily some strains of P. aeruginosa): 1 gm 3-4 times daily (3-4 gm/day)

Paediatric Dosing Schedule:

• ≥ 3 months of age: the recommended dose for non-CNS infections is 15-25 mg/kg/dose administered every six hours. The maximum daily dose for treatment of infections with fully susceptible organisms is 2.0 g per day, and of infections with moderately susceptible organisms is 4.0 g/day. Higher doses (up to 90 mg/kg/day in older children) have been used in patients with cystic fibrosis.
• ≤3 months of age: Following dosage schedule is recommended for non-CNS infections:
• <1 week of age: 25 mg/kg every 12 hrs
• 1-4 weeks of age: 25 mg/kg every 8 hrs
• 4 weeks-3 months of age: 25 mg/kg every 6 hrs.

Imipenem is not recommended for the therapy of meningitis. If meningitis is suspected, an appropriate antibiotic should be used. Imipenem and cilastatin for injection is not recommended in pediatric patients <30 kg with impaired renal function, as no data are available.

Most common side effects with imipenem are nausea and vomiting. Other side effects reported with this drug are diarrhea, rash, thrombophlebitis, thrombocytosis, neutro-penia, eosinophilia and derangements of liver and renal functions. Use of imipenem is not recommended for patient with history of anaphylactic reaction with penicillin.

Contraindicated in patients who have demonstrated hypersensitivity to this product.

Caution when used in patients with known hypersensitivity to other β-lactams due to possibility of cross-sensitivity. CNS disorders such as epilepsy; renal, hepatic impairment; pregnancy, lactation.

Concurrent admin with probenecid may increase the half-life of cilastatin. Increased risk of generalised seizures when used concurrently with ganciclovir.

Pregnancy: Category C. There are no adequate and well controlled studies in pregnant women. Cispenam should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Lactation: Imipenem has been detected in human milk. If the use of Cispenam is deemed essential, the patient should stop nursing.

Dosage adjustment in renal impairment:

• CrCl >71: No changes.
• CrCl 41-70: Max 37.5 mg/kg/day or 3 g/day. (Range: 9.4 - 37.5 mg/kg/day) divided q6-8h.
• CrCl 21-40: Max 25 mg/kg/day or 2 g/day. (Range: 6.25 - 25 mg/kg/day) divided q6-12h.
• CrCl 6-20: Max 12.5 mg/kg/day (max dose 1 g/day). Range: 6.25 - 12.5 mg/kg/day) divided q12h. (Usual: 250mg q12h)
• Dialysis Hemodialysis: 125 - 500 mg q12h. (Max 12.5 mg/kg/day). Give dose after dialysis.
• Peritonial Dialysis: 125 - 250 mg q12h

In the case of overdosage, discontinue Imipenem/Cilastatin, treat symptomatically, and institute supportive measures as required. Imipenem/Cilastatin Sodium is hemodialyzable.

Parenteral Iron Preparations

The therapeutic class of Iron Sucrose is haematinic. Iron Sucrose Injection USP is a brown, sterile, aqueous, complex of Polynuclear Iron (III) Hydroxide in Sucrose for Intravenous use. The drug product contains approximately 30% Sucrose w/v (300 mg/ml) and has a pH of 10.5-11.1. Following intravenous administration, Iron Sucrose Injection is dissociated into Iron and Sucrose by the reticuloendothelial system, and Iron is transferred from the blood to a pool of Iron in the liver and bone marrow. Ferritin, an Iron storage protein, binds and sequesters Iron in a nontoxic form, from which Iron is easily available. Iron binds to plasma transferrin, which carries Iron within the plasma and the extracellular fluid to supply the tissues. The transferrin receptor, located in the cell, and the transferrin-receptor complex is returned to the cell membrane. Transferrin without Iron (apotransferrin) is then released to the plasma. The intracellular Iron becomes (mostly) haemoglobin in circulating red blood cells (RBCs). Transferrin synthesis is increased and ferritin production reduced in Iron deficiency. The converse is true when Iron is plentiful. Its elimination halflife is 6 h, total clearance is 1.2 L/h, non-steady state apparent volume of distribution is 10.0 L and steady state apparent volume of distribution is 7.9 L. In Iron Sucrose, its Iron component appears to distribute mainly in blood and to some extent in extravascular fluid. A significant amount of the administered Iron distributes in the liver, spleen and bone marrow and that the bone marrow is an Iron trapping compartment and not a reversible volume distribution. The sucrose component is eliminated mainly through urinary excretion.

Adults and Elderly: 5-10 ml Iron Sucrose Injection (100-200 mg Iron) once to three times a week depending on the hemoglobin level.

Children: There is limited data on children under study conditions. If there is a clinical need, it is recommended not to exceed 0.15 ml Iron Sucrose Injection (3 mg Iron) per kg body weight once to three times per week depending on the haemoglobin level.

Intravenous injection: Iron Sucrose Injection can also be administered undiluted by slow intravenous injection at the (normal) recommended rate of 1 ml Iron Sucrose Injection (20 mg Iron) per minute [5 ml Iron Sucrose Injection (100 mg Iron) in 2 to 5 minutes]. A maximum of 10 ml Iron Sucrose Injection (200 mg Iron) can be injected per injection. Before administration of the therapeutic dose in a new patient, a test dose of 1 ml Iron Sucrose Injection (20 mg Iron) in adults and in children with a body weight greater than 14 kg and half the daily dose (1.5 mg Iron/kg) in children with a body weight less than 14 kg should be injected over 1 to 2 minutes. If no adverse reactions occur within a waiting period of 15 minutes, the remaining portion of the injection can be administered at recommended speed. After an injection the arm of the patient should be extended.

Infusion: Iron Sucrose Injection should preferably be administered by drip infusion (in order to reduce the risk of hypotensive episodes and paravenous injection) in a dilution of 1 ml Iron Sucrose Injection (20 mg Iron) in max. 20 ml 0.9% w/v Sodium Chloride [5 ml (100 mg Iron) in max. 100 ml 0.9% w/v NaCI etc. up to 25 ml (500 mg Iron) in max. 500 ml 0.9% w/v NaCI]. Dilution must take place immediately prior to infusion and the solution should be administered as follows: 100 mg Iron in at least 15 minutes; 200 mg Iron in at least 30 minutes; 400 mg Iron In at least 1.5 hours, and 500 mg Iron in at least 3.5 hours. Further of the maximum tolerated single dose of 7 mg Iron/kg body weight, an Infusion time of at least 3.5 hours has to be respected, independently of the total dose.

Before administration of the therapeutic dose in a new patient the first 20 mg Iron in adults and in children with a body weight greater than 14 kg and half the daily dose (1.5 mg lron/kg) in children with a body weight less than 14 kg should be infused over 15 minutes as a test dose. If no adverse reactions occur, the remaining portion of the infusion can be administered at recommended speed.

The use of Iron Sucrose is contraindicated in patients with evidence of Iron overload, in patients with known hypersensitivity to Iron Sucrose or any of its inactive components, and in patients with anaemia not caused by Iron deficiency. It is also contraindicated in patients with history of allergic disorders including asthma, eczema and anaphylaxis, liver disease and infections.

General: Because body Iron excretion is limited and excess tissue Iron can be hazardous, caution should be exercised to withhold Iron administration in the presence of evidence of tissue Iron overload. Patients receiving Iron Sucrose require periodic monitoring of hematologic and haematinic parameters (hemoglobin, hematocrit, serum ferritin and transferrin saturation). Iron therapy should be withheld in patients with evidence of Iron overload. Transferrin saturation values increase rapidly after IV administration of Iron Sucrose; thus, serum Iron values may be reliably obtained 48 hours after IV dosing.

Hypersensitivity Reactions: Serious hypersensitivity reactions have been rarely reported in patients receiving Iron Sucrose. Several cases of mild or moderate hypersensitivity reactions were observed in these studies.

Hypotension: Hypotension has been reported frequently in hemodialysis patients receiving intravenous Iron. Hypotension following administration of Iron Sucrose may be related to rate of administration and total dose administered. Caution should be taken to administer Iron Sucrose according to recommended guidelines.

Drug-drug interactions involving Iron Sucrose have not been studied. Iron Sucrose Injection should not be administered concomitantly with oral iron preparations since the absorption of oral Iron is reduced. Even oral Iron therapy should not be given until 5 days after last injection.

Pregnancy Category-B. No adequate and well controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Iron Sucrose is administered to a nursing woman.

Pediatric Use: Safety and effectiveness of Iron Sucrose in pediatric patients have not been established.

Geriatric Use: No overall differences in safety were observed between the elder subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Injection into dialyser: Iron Sucrose Injection may be administered directly into the venous limb of the dialyser under the same conditions as for intravenous injection.

Hemodialysis Dependent-Chronic Kidney Disease Patients (HDD-CKD): Iron Sucrose Injection may be administered undiluted as a 100 mg slow intravenous injection over 2 to 5 minutes or as an infusion of 100 mg, diluted in a maximum of 100 ml of 0.9% NaCI over a period of at least 15 minutes per consecutive hemodialysis session for a total cumulative dose of 1,000 mg.

Non-Dialysis Dependent-Chronic Kidney Disease Patient (NDD-CKD): Iron Sucrose Injection is administered as a total cumulative dose 1000 mg over a 14 day period as a 200 mg slow IV injection undiluted over 2 to 5 minutes on 5 different occasions within the 14 day period.

Dosages of Iron Sucrose Injection in excess of Iron needs may lead to accumulation of Iron in storage sites leading to hemosiderosis. Periodic monitoring of Iron parameters such as serum ferritin and transferrin saturation may assist in recognizing Iron accumulation. Iron Sucrose should not be administered to patients with Iron overload and should be discontinued when serum ferritin levels equal or exceed established guidelines. Particular caution should be exercised to avoid Iron overload where anaemia unresponsive to treatment has been incorrectly diagnosed as Iron deficiency anaemia. Symptoms associated with overdosage or infusing Iron Sucrose too rapidly included hypotension, headache, vomiting, nausea, dizziness, joint aches, paresthesia, abdominal and muscle pain, edema. and cardiovascular collapse. Most symptoms have been successfully treated with IV fluids, hydrocortisone, and/or antihistamines. Infusing the solution as recommended or at a slower rate may also alleviate symptoms.

Store in a cool (15°C- 30°C) & dry place, protected from light. Keep out of the reach of children. Do not freeze.

Irinotecan Injection is indicated as a component of first-line therapy in combination with 5-fluorouracil (5-FU) and leucovorin (LV) for patients with metastatic carcinoma of the colon or rectum.

Irinotecan is indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy.

Cytotoxic Chemotherapy

Irinotecan inhibits the action of topoisomerase I. Irinotecan prevents religation of the DNA strand by binding to topoisomerase I-DNA complex. The formation of this ternary complex interferes with the moving replication fork, which induces replication arrest and lethal double-stranded breaks in DNA. As a result, DNA damage is not efficiently repaired and apoptosis (programmed cell death) occurs.

Administer as a 90-minute intravenous infusion followed by LV and 5-FU. A reduction in the starting dose by one dose level may be considered for patients with any of the following conditions: prior pelvic/abdominal radiotherapy, performance status of 2, or increased bilirubin levels.

Refractory colorectal malignancies: 125 mg/m² once wkly for 4 wk, followed by a 2 wk rest period.

Metastatic colorectal cancer: As 1st  line treatment: 125 mg/m² on days 1,8,15 and 22 of a 6-wk cycle.

Anemia, Leukopenia, Neutropenia,Thrombocytopenia, Elevated bilirubin, Diarrhea, Nausea, Asthenia, Abdominal pain, Vomiting , Alopecia, Fever, Constipation, Anorexia, Mucositis, Pain, Dyspnea, Cough, Dizziness, Infection, Rash, Abdominal fullness, AST increased , Dyspepsia, Edema, Ascites/jaundice, Vasodilation, Thromboembolism, Hypotension, Neutropenic fever, Headache, Insomnia, Orthostatic hypotension

Patients with a known hypersensitivity to the drug or its excitements.

Early diarrhea is usually transient and infrequently severe. It may be accompanied by cholinergic symptoms of rhinitis, increased salivation, miosis, lacrimation, diaphoresis, flushing, and intestinal hyperperistalsis that can cause abdominal cramping. Bradycardia may also occur.

Late diarrhea can be life threatening since it may be prolonged and may lead to dehydration, electrolyte imbalance, or sepsis.Late diarrhea can be complicated by colitis, ulceration, bleeding, ileus, obstruction, and infection. Cases of megacolon and intestinal perforation have been reported.

Diuretics increase risks of dehydration secondary to vomiting/diarrhoea; prophylactic dexamethasone as an antiemetic may enhance lymphocytopenia; prochlorperazine may increase incidence of akathisia; antineoplastic agents (myelosuppression and diarrhoea). St John's wort, ketoconazole may reduce irinotecan exposure.

Pregnancy Category D. There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Store at controlled room temperature 15° to 30°C. Protect from light. Keep the vial in the carton until the time of use.

This is indicated for the treatment and prophylaxis of Iron, Folic acid, Vitamin B complex and Vitamin C deficiency, or to meet extra need of these vitamins and minerals especially in pregnancy or when planning for pregnancy.

Iron & Vitamin Combined preparations

Iron is an essential mineral, with several important roles in the body. For example, it helps to make red blood cells, which carry oxygen around the body. A lack of iron can lead to iron deficiency anaemia. Liver is a good source of iron, don't eat it if you are pregnant. This is because it is also rich in vitamin A which, in large amounts, can harm your unborn baby.

Folic acid is essential for the production of certain coenzymes in many metabolic systems such as purine and pyrimidine synthesis. It is also essential in the synthesis and maintenance of nucleoprotein in erythropoesis. It also promotes WBC and platelet production in folate-deficiency anaemia.

Vitamin C is necessary for collagen formation and tissue repair; plays a role in oxidation/reduction reactions as well as other metabolic pathways including synthesis of catecholamines, carnitine, and steroids; also plays a role in conversion of folic acid to folinic acid.

Vitamin B complex: The building blocks for good health come from a variety of foods, even if they are from the same family of nutrients. Such is the case with vitamin B, a key player in maintaining cell health and keeping you energized.

Not all types of vitamin B do the same thing. Additionally, the different types of vitamin B all come from different types of foods.

Vitamin B deficiencies can lead to health problems. Sometimes a doctor will prescribe a supplement when they think you’re not getting enough.

Recommended adult dose is one capsule daily. In more severe deficiency states, 2 capsules a day may be required or as directed by the physician.

Generally well tolerated. However, a few allergic reactions may be seen.

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. Iron therapy is contraindicated in haemachromatosis and haemosiderosis, and in patients receiving repeated blood transfusion or with anaemia not due to by iron deficiency. It should be given cautiously to patients taking Levodopa as one of the ingredients (Pyridoxine) reduces the effect of Levodopa.

Care should be taken in patients who may develop iron overload, such as those with hemochromatosis, haemolytic anaemia or red cell aplasia. Iron chelates with tetracycline and absorption may be impaired.

Care should be taken when given to patients with Iron storage or Iron absorption disease. Iron form chelates with antacids and Tetracycline and absorption of all these may be impaired if taken concurrently

It is recommended during pregnancy and lactation.

Accidental overdose of iron containing products is a leading cause of fatal poisoning in children fewer than 6. Avoid higher doses if you have liver disease or hemochromatosis; excess can cause bloody diarrhea, vomiting, acidosis, darkened stools, abdominal pain. Symptoms may clear in a few hours. Riboflavin is reported to be completely safe and no toxic symptoms have been reported so far. Higher doses of Nicotinamide may cause vomiting, diarrhea. Sensory neuropathy was observed in individuals consuming more than 200 mg Pyridoxine for very long periods. No cases of Folic acid overdosages have been reported. Acute ingestion of Ascorbic acid, even of massive doses, is unlikely to cause significant effects.

Store in a dry place below 25° C. Protect from light.

This syrup is indicated for the treatment and prevention of Iron, Vitamin B complex and Zinc deficiencies, specially during pregnancy and lactation.

Iron & Vitamin Combined preparations

This syrup is the preparation of Iron, Vitamin B complex and Zinc. In this preparation, Iron is present as Iron (III) Hydroxide Polymaltose Complex. Iron (III) Hydroxide Polymaltose Complex facilitates a controlled absorption of the iron when it comes in contact with the mucosal cell surface. Due to non-ionic nature, this Iron (III) Hydroxide Polymaltose Complex is more stable than conventional Iron form.

Adults: 5 ml-10 ml (1-2 teaspoonful) 3 times daily or as recommended by the physician.

Children: 5 ml (1 teaspoonful) 3 times daily or as recommended by the physician.

Infants: 0.33 ml/kg body weight daily or as recommended by the physician.

This syrup is generally well tolerated. However, a few side effects of oral Iron preparations, including nausea, vomiting, constipation or diarrhoea may occur.

It is contraindicated in patients with a known hypersensitivity to any of the ingredients of this product.

Caution should be taken in the conditions where there is a risk of Iron overload, such as hemochromatosis, thalassemia, hemosiderosis or hemolytic anemia.

Since Iron is complex bound, ionic interaction with foodstuff components (phytates, oxalates, tannin etc.) and concomitant administrations of medicaments (tetracyclines, antacids) are unlikely to occur.

Recommended in pregnancy & lactation

Recommended in children

In case of overdose, epigastric pain, diarrhoea, vomiting, metabolic acidosis and convulsion may occur. Should seek emergency medical attention in case of overdose. Initially an emetic should be given and then gastric lavage & general supportive measures should be employed.

Keep in a dry place away from light and heat. Keep out of the reach of children.

This is indicated in Constipation, Intestinal inflammation, IBS Ulcerative colitis & Piles.

Bulk-forming laxatives, Herbal and Nutraceuticals

This is the formulation of Isabgul Spicy which is very effective herbal formulation of two mostly laxative medicinal herbs Plantago ovata & Cassia angustifolia. Ispaghula is capable of absorbing up to 40 times of water and Sonapata act as a inhibitor of water & electrolyte absorption from the large intestine that increase the volume and pressure of the intestinal contents. As a result it stimulates the peristaltic movement of the gut. In this way Isabgul Plus helps regular bowel movement and relieves constipation. Ispaghula has the ability to bind with bile acid; an important component of fat digestion found in our body from cholesterol. This process lowers circulating blood cholesterol level by excretion of those fats. Regular intake of Isabgul plus also helps to regularizes the function of GIT, cures constipation, intestinal irritation, intestinal inflammation, IBS & ulcerative colitis bulk forming of stool & ease evacuation, reduce hyperacidity, increase digestion & improves the function of digestive system as well as helps to normalize the gut health.

Adult: 1 sachet or 4 gm powder with 150-200 ml water 1-2 times daily.

Children:

• 6-12 years: 1/2 to 1 sachet or 2-4 gm powder with 150-200 ml water 1-2 times daily.
• Under 6 years: As directed by the physician. 1/2 sachet or 2 gm powder with 150-200 ml water 1-2 times daily.

In few cases it may occurs flatulence, stomach irritation & intestinal obstruction.

When dried husk intake orally without water may cause problems.

Plenty of water should take during this preparation intake. Should not use in the presence of intestinal obstruction acute inflammatory intestinal diseases or appendicitis.

This should not be used during pregnancy. It does not pass into breast milk. Therefore, it can be used safely lactation

Store in a cool & dry place, protect from light. Keep out of the reach of the children.