Special Import - Devit-3 300,000 Iu 1 Ampul

Devit-3 300,000 Iu 1 Ampul

Description:

Devit-3 300,000 iu ampul is a high‑dose vitamin D3 (cholecalciferol) medicinal preparation used under medical supervision to correct severe vitamin D deficiency and related bone and mineral disorders. Each ampoule contains 300,000 iu cholecalciferol in an oil solution, designed for intramuscular or oral administration as a single or intermittent therapeutic dose. Vitamin D3 plays a key role in calcium and phosphate homeostasis, bone mineralization, and proper functioning of the musculoskeletal system. This product is classified as a medicine, not a daily supplement, and is typically used in hospitals or by physicians for loading doses in deficiency states.

Indications:

• Treatment of vitamin D deficiency or insufficiency confirmed by laboratory testing (e.g., low serum 25‑hydroxyvitamin D levels).
• Management of refractory rickets (vitamin D–resistant rickets) as part of a comprehensive treatment plan.
• Treatment of familial hypophosphatemia, in combination with other therapies as directed by a specialist.
• Adjunctive therapy in hypoparathyroidism to help normalize calcium and phosphate levels.
• Management of hypocalcemia and renal osteodystrophy in patients with chronic renal failure, especially those undergoing dialysis, as prescribed by a nephrologist.
• Prevention and management of osteoporosis (including primary and corticosteroid‑induced osteoporosis) when used together with adequate calcium intake, under medical supervision.
• Support of bone health, reduction of fracture risk, and improvement of bone mineral density in patients with documented vitamin D deficiency.

Active Ingredients / Key Components:

• Cholecalciferol (Vitamin D3) – 300,000 iu per ampoule (concentration: 300,000 iu/ml).
• Excipients: Oil-based solvent and other inactive ingredients – exact composition and concentrations are not available in the provided information. Refer to the official package leaflet for full excipient list.

Dosage & Administration / How to Use:

• Route of administration: Intramuscular (i.m.) injection or oral use, strictly as directed by a physician.
• Adults and elderly: Typical regimens may include a single 300,000 iu dose or repeated doses at intervals (e.g., every 3 months) depending on severity of deficiency and clinical judgment. Exact dosage schedule must be determined by the treating doctor.
• Children: Use only under specialist supervision. Dosing must be carefully adjusted by body weight, age, and laboratory values to avoid overdose.
• Intramuscular use: The ampoule is administered deeply into a large muscle (e.g., gluteal muscle) by a healthcare professional using aseptic technique. Do not self‑inject.
• Oral use: When prescribed orally, the contents of the ampoule may be swallowed directly or mixed with a small amount of liquid or soft food. Take with or after food if advised by your doctor to improve absorption and tolerance.
• Duration of therapy: Depends on indication, baseline vitamin D level, and response to treatment. Follow‑up blood tests (vitamin D, calcium, phosphate, parathyroid hormone) are usually required to adjust therapy.
• Concomitant calcium: Often used together with calcium supplements in osteoporosis and severe deficiency, as recommended by the physician.
• Do not exceed the prescribed dose. High‑dose vitamin D can cause serious toxicity if misused.

Clinical Benefits:

• Helps rapidly correct severe vitamin D deficiency, restoring adequate serum vitamin D levels.
• Supports proper calcium and phosphate absorption from the intestine, contributing to normal bone mineralization.
• Assists in the management of rickets and osteomalacia, improving bone strength and reducing bone pain when used as part of a comprehensive treatment plan.
• Contributes to the prevention and management of osteoporosis (including corticosteroid‑induced osteoporosis) when combined with calcium and lifestyle measures.
• Helps reduce the risk of hypocalcemia in patients with hypoparathyroidism or chronic kidney disease when used under specialist supervision.
• Supports musculoskeletal function, potentially reducing muscle weakness and fall risk associated with severe vitamin D deficiency.

Warnings & Contraindications:

• Use only under medical supervision. This is a high‑dose vitamin D3 medicine and is not intended for routine self‑supplementation.
• Contraindicated in patients with hypercalcemia, hypervitaminosis D, or known hypersensitivity to cholecalciferol or any component of the formulation.
• Use with extreme caution in patients with renal impairment, nephrolithiasis (kidney stones), sarcoidosis, or other granulomatous diseases, as they may be more sensitive to vitamin D.
• Monitor serum calcium, phosphate, creatinine, and vitamin D levels regularly during treatment, especially with repeated dosing.
• Avoid concomitant high‑dose vitamin D supplements or multivitamins containing vitamin D unless specifically approved by your doctor.
• Certain medicines (e.g., thiazide diuretics, digoxin, anticonvulsants, glucocorticoids, cholestyramine, orlistat) may interact with vitamin D3. Inform your doctor about all medications and supplements you are taking.
• Consult your doctor before use if pregnant or breastfeeding; dosing must be carefully individualized to avoid fetal or neonatal hypercalcemia.
• Consult your doctor before use if you have liver disease, kidney disease, heart disease, a history of kidney stones, or endocrine disorders such as hyperparathyroidism.
• Not intended to diagnose, treat, cure, or prevent any disease without proper medical evaluation and prescription.
• Keep out of reach of children. Accidental ingestion of high‑dose vitamin D can be dangerous.

Side Effects:

• When used at prescribed doses with monitoring, Devit-3 is generally well tolerated. However, excessive dosing or individual sensitivity can lead to vitamin D toxicity and hypercalcemia.
• Common or possible side effects of hypercalcemia: nausea, vomiting, constipation, loss of appetite, abdominal pain, excessive thirst, increased urination, muscle weakness, fatigue, headache.
• Serious side effects (seek immediate medical attention): severe or persistent vomiting, confusion, drowsiness, irregular heartbeat, severe muscle weakness, bone pain, kidney pain or flank pain, signs of kidney stones (e.g., blood in urine), or sudden changes in mental status.
• Local reactions after intramuscular injection may include pain, redness, or swelling at the injection site.
• If you experience any unusual symptoms or suspect overdose, stop use and contact your doctor or emergency services immediately.

Storage Instructions:

Store in a cool, dry place away from direct sunlight and sources of heat. Keep the ampoule in its original packaging to protect from light. Do not freeze. Keep container tightly closed and out of reach of children. Do not use after the expiry date printed on the pack. Dispose of unused medicine according to local regulations; do not throw into wastewater or household waste.

Specifications:

• Product type: High‑dose vitamin D3 medicinal preparation.
• Active ingredient strength: 300,000 iu cholecalciferol per 1 ml ampoule (300,000 iu/ml).
• Form: Sterile oil solution in glass ampoule for intramuscular or oral use.
• Pack size: 1 ampoule.
• Intended use: Short‑term high‑dose therapy for vitamin D deficiency and related conditions under medical supervision.

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.