ERGOCALCIFEROL Solution for injection Ref.[8405] Active ingredients: Vitamin D2

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2015  Publisher: RPH Pharmaceuticals AB, Lagervรคgen 7, 136 50, Haninge, Sweden

Therapeutic indications

Intramuscular therapy with Ergocalciferol Injection is used in patients with gastrointestinal, liver or biliary disease associated with malabsorption of Vitamin D, resulting in hypophosphataemia, rickets, and osteomalacia.

Posology and method of administration

Route of Administration

IM injection.

Adults, Children and Elderly

Dosage should be individualised by the clinician for each patient. Serum and urinary calcium concentrations, phosphate and BUN should be monitored at regular intervals, initially weekly, in order to achieve optimum clinical response and to avoid hypercalcaemia.

Doses should not normally exceed 40,000 units/day (1.0mg/day) for adults and 10,000 units/day (0.25mg/day) for children.

Ergocalciferol Injection may be administered as a single dose or repeated daily, dependent upon clinical response and requirements. Calcium and phosphorous supplements should be administered where necessary.

Overdose

Administration to patients in excess of their daily requirement can cause hypercalcaemia (see Section 4.8 Undesirable Effects), hypercalciuria and hyperphosphataemia. Concomitant high intake of calcium and phosphate may lead to similar abnormalities.

Treatment of chronic overdose with resulting hypercalcaemia consists of immediate withdrawal of the vitamin, a low calcium diet and generous fluid intake. Severe cases may require hydration with intravenous saline together with symptomatic and supportive treatment as indicated by the patient’s clinical condition. Plasma calcium U & E’s should be monitored.

Shelf life

Shelf life: 36 months.

Special precautions for storage

Store below 25ยฐC.

Protect from light.

Nature and contents of container

1ml clear, one-point cut (OPC) glass Type 1 Ph Eur ampoules packed in cartons of 10 ampoules

Special precautions for disposal and other handling

Plastic syringes should not be used to administer Ergocalciferol Injection.

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