Description: Larifer-XT Injection is an intravenous (IV) iron supplement containing iron sucrose, designed to rapidly elevate and restore hemoglobin levels in patients with severe iron deficiency anemia, including pregnant women.

Key Benefits:

1. Rapid hemoglobin elevation
2. Safety and effectiveness
3. Prevention of anemia-related complications

Indications:

1. Severe iron deficiency anemia
2. Anemia during pregnancy
3. Nephrology:

– Chronic kidney disease (CKD) patients on dialysis

– Iron deficiency anemia in patients with kidney transplant

4. Gastroenterology:

– Inflammatory bowel disease (IBD) patients with iron deficiency anemia

– Gastrectomy or gastric bypass patients with iron deficiency

5. Oncology: Cancer patients with chemotherapy-induced anemia

Precautions:

1. Hypersensitivity to iron sucrose or other ingredients
2. Iron overload or hemochromatosis
3. Cardiac history (heart failure, myocardial infarction)
4. Infections (monitor for signs of infection)
5. Renal impairment (dosage adjustment may be necessary)
6. Pregnancy and breastfeeding (discuss risks and benefits with healthcare provider)
7. Drug interactions (inform doctor about all medications)

Dosage and Administration:

1. Administer IV injection over 5-10 minutes
2. Dose: 100-200 mg elemental iron per dose
3. Frequency: As prescribed by healthcare provider

Contraindications:

1. Hypersensitivity to iron sucrose or other ingredients
2. Iron overload or hemochromatosis

Nephrology Considerations:

1. Monitor iron levels and adjust dosage accordingly
2. Use with caution in patients with kidney transplant
3. Avoid using Larifer-XT Injection in patients with severe kidney impairment

Gastroenterology Considerations:

1. Monitor for gastrointestinal side effects
2. Use with caution in patients with inflammatory bowel disease (IBD)

Oncology Considerations:

1. Monitor for chemotherapy-induced anemia
2. Use Larifer-XT Injection in combination with chemotherapy

Storage and Handling:

1. Store at room temperature (20-25°C)
2. Protect from light and moisture
3. Use within expiration date

Packaging:

1. Vials of 100 mg/5 mL elemental iron
2. Cartons of 10 vials

Label Claims:

1. Rapidly elevates hemoglobin levels
2. Safe and effective treatment for iron deficiency anemia
3. Prevents anemia-related complications

Regulatory Compliance:

1. Compliant with GMP and DCGI guidelines.
2. Meets IP standards.

References:

1. “Iron deficiency anemia during pregnancy” (American College of Obstetricians and Gynecologists, 2020)
2. “Intravenous iron supplementation in CKD patients” (National Kidney Foundation, 2020)
3. “Iron deficiency anemia in cancer patients” (American Society of Clinical Oncology, 2020)