Davalindi 200 000 Lu/ml
Description:
Davalindi 200 000 lu/ml is a high‑potency injectable vitamin D3 (cholecalciferol) medicinal product used under medical supervision to correct and prevent severe vitamin D deficiency. It is supplied as an intramuscular ampoule and is intended for patients who require rapid restoration of vitamin D levels or who cannot take oral vitamin D. By providing a concentrated dose of cholecalciferol, Davalindi supports calcium and phosphate balance, bone mineralization, and overall musculoskeletal health, and is commonly used in the management of complex metabolic bone disorders.
Indications:
- Treatment of vitamin D deficiency or insufficiency confirmed or suspected by a healthcare professional.
- Refractory (vitamin D–resistant) rickets requiring high‑dose vitamin D therapy.
- Familial hypophosphatemia as part of a comprehensive treatment plan.
- Hypoparathyroidism to help maintain normal calcium and phosphate levels.
- Management of hypocalcemia in patients with chronic renal failure.
- Renal osteodystrophy in patients with chronic renal failure undergoing dialysis.
- Used in conjunction with calcium supplements in the management and prevention of primary osteoporosis.
- Used in conjunction with calcium in the prevention and management of corticosteroid‑induced osteoporosis.
Active Ingredients / Key Components:
- Cholecalciferol (Vitamin D3) – 200 000 international units (iu) per ml (exact concentration per ampoule volume is not specified in the available information (For full ingredient information, please check the product leaflet or the manufacturer’s official website.)).
- Excipients: Not specified in the available information (For full ingredient information, please check the product leaflet or the manufacturer’s official website.). For full list of excipients, refer to the official package leaflet.
Dosage & Administration / How to Use:
- Davalindi 200 000 lu/ml is for intramuscular (i.m.) injection only and must be administered by a healthcare professional.
- Recommended dose, dosing interval, and duration of treatment must be individualized by the prescribing physician based on age, body weight, indication, baseline vitamin D status, calcium and phosphate levels, and renal function.
- Common clinical practice for high‑dose vitamin D3 injections involves intermittent dosing (e.g., single or repeated doses at weekly or monthly intervals), but exact regimens must follow the physician’s instructions and local guidelines.
- Patients should have serum calcium, phosphate, and vitamin D levels monitored regularly during high‑dose therapy to avoid toxicity.
- May be used together with oral calcium supplements and, when indicated, other medications (e.g., phosphate binders, active vitamin D analogues) as prescribed.
- Do not self‑inject. Do not use more frequently or at higher doses than prescribed.
Clinical Benefits:
- Rapid correction of severe vitamin D deficiency, especially in patients who cannot tolerate or absorb oral vitamin D.
- Supports proper calcium and phosphate homeostasis, contributing to healthy bone mineralization and skeletal strength.
- Helps manage metabolic bone disorders such as rickets, osteomalacia, renal osteodystrophy, and osteoporosis when used as part of a comprehensive treatment plan.
- Assists in reducing the risk of fractures related to osteoporosis when combined with adequate calcium intake and other medical measures.
- Supports neuromuscular function and may help reduce symptoms related to hypocalcemia such as muscle cramps and tetany, under medical supervision.
Warnings & Contraindications:
- Contraindicated in patients with hypersensitivity to cholecalciferol (vitamin D3) or any component of the formulation (excipients not specified in the available information (For full ingredient information, please check the product leaflet or the manufacturer’s official website.)).
- Contraindicated in hypercalcemia, hypervitaminosis D, and most cases of severe hyperparathyroidism unless specifically directed by a specialist.
- Use with extreme caution in patients with renal impairment, nephrolithiasis (kidney stones), sarcoidosis, or other granulomatous diseases due to increased risk of hypercalcemia.
- Regular monitoring of serum calcium, phosphate, creatinine, and vitamin D levels is recommended during high‑dose therapy.
- Consult your doctor before use if pregnant or breastfeeding; dosing in pregnancy and lactation must be carefully controlled to avoid vitamin D overdose in mother or baby.
- Consult your doctor before use if you are taking cardiac glycosides (e.g., digoxin), thiazide diuretics, other vitamin D products, calcium supplements, or magnesium‑containing antacids, due to risk of interactions and hypercalcemia.
- Not intended for routine self‑supplementation; this is a prescription‑strength medicinal product.
- Keep out of reach of children.
- This product information does not replace the official patient leaflet or medical advice. Always follow your doctor’s instructions.
Side Effects:
- Commonly related to excessive dosing or prolonged use: hypercalcemia and hypercalciuria, which may present with nausea, vomiting, constipation, abdominal pain, loss of appetite, excessive thirst, increased urination, muscle weakness, fatigue, confusion, or bone pain.
- Very high or prolonged overdose may lead to kidney damage, nephrolithiasis (kidney stones), calcification of soft tissues, and cardiac rhythm disturbances.
- Local injection‑site reactions such as pain, redness, or swelling may occur.
- Allergic reactions (rash, itching, swelling, severe dizziness, difficulty breathing) are rare but require immediate medical attention.
- Stop treatment and seek medical advice immediately if signs of hypercalcemia or any severe or unusual symptoms appear.
Storage Instructions:
Store in a cool, dry place away from direct sunlight. Keep container tightly closed. Keep out of reach of children. Do not use after the expiry date stated on the packaging. Do not freeze. Store at the temperature conditions specified on the outer carton or leaflet (exact temperature range is not provided in the available information (For full ingredient information, please check the product leaflet or the manufacturer’s official website.)).
Specifications:
- Product form: intramuscular ampoule containing solution for injection.
- Strength: 200 000 iu vitamin D3 (cholecalciferol) per ml.
- Pack size and exact ampoule volume: not specified in the available information (For full ingredient information, please check the product leaflet or the manufacturer’s official website.).
- Intended use: prescription‑strength vitamin D3 medicine for intramuscular administration by healthcare professionals.
Disclaimer: All pharmacy products are intended for general use only and do not replace professional medical advice, diagnosis, or treatment. Always consult a healthcare provider before use. Results may vary, and no specific outcomes are guaranteed. Products are not intended to diagnose, treat, cure, or prevent any disease unless stated. Follow label instructions carefully, as misuse may cause adverse effects. Compliance with local laws is the customer’s responsibility.
