Ergocalciferol 300,000 IU Injection (10 x 1 ml ampoules)

Ergocalciferol

Pharmaceutical Product

Vitamin D2 (ergocalciferol) 300,000 IU/1 ml solution for intramuscular injection

Licensed in the UK as Ergocalciferol 300,000 IU Solution for Injection with a Marketing Authorisation regulated by the MHRA.
Manufactured in accordance with Good Manufacturing Practice (GMP) for sterile injectable medicinal products.
SmPC and PIL available via the electronic Medicines Compendium (emc) for product 9133.

Licensed in the UK as Ergocalciferol 300,000 IU Solution for Injection with a Marketing Authorisation regulated by the MHRA.
Manufactured in accordance with Good Manufacturing Practice (GMP) for sterile injectable medicinal products.
SmPC and PIL available via the electronic Medicines Compendium (emc) for product 9133.

Vitamin D2 (ergocalciferol) 300,000 IU/1 ml solution for intramuscular injection

Description

Ergocalciferol 300,000 IU Injection is a high-strength vitamin D2 (ergocalciferol) solution for intramuscular injection, supplied in 1 ml clear Type I glass ampoules containing 300,000 IU (7.5 mg) ergocalciferol per ml. It is indicated for intramuscular therapy in patients with gastrointestinal, liver or biliary disease associated with malabsorption of vitamin D, resulting in hypophosphataemia, rickets and osteomalacia, and for other situations requiring parenteral vitamin D2 replacement under specialist supervision. Each pack from Teleta contains 10 x 1 ml ampoules and is a prescription-only medicine that must be used according to the Summary of Product Characteristics and local protocols.

Bnefits

Provides a very high-strength dose of vitamin D2 (300,000 IU per 1 ml ampoule) for patients who require parenteral vitamin D replacement.
Intramuscular administration bypasses gastrointestinal absorption, making it suitable for patients with malabsorption due to gastrointestinal, hepatic or biliary disease.
Indicated for correction of hypophosphataemia, rickets and osteomalacia associated with vitamin D deficiency.
Clear, colourless to pale yellow solution in Type I glass ampoules with a simple formulation (ergocalciferol in ethyl oleate).
Supplied in a convenient pack of 10 single-use 1 ml ampoules for use in hospital or specialist clinical settings.
Licensed product with a UK Marketing Authorisation and full MHRA-regulated SmPC and PIL.

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.
Treatment of vitamin D deficiency states where oral administration is not possible or not effective due to malabsorption.
Use in other conditions requiring parenteral vitamin D2 replacement as directed by a specialist (e.g. certain bone metabolism disorders), in line with the SmPC and local guidelines.

Composition

Active substance: Ergocalciferol (vitamin D2) 300,000 IU per 1 ml (equivalent to 7.5 mg ergocalciferol).
Excipient: Ethyl oleate (the only listed excipient in the PIL/SmPC).

Formulation

Pharmaceutical form: Solution for injection.
Colourless to pale yellow oily solution for intramuscular injection.
Each 1 ml Type I glass ampoule contains 300,000 IU ergocalciferol in ethyl oleate.

Packaging

Pack of 10 x 1 ml clear Type I glass ampoules containing ergocalciferol 300,000 IU/ml solution for injection.
Ampoules supplied in a carton with approved labelling, batch number and expiry date.
Accompanied by a Patient Information Leaflet (PIL) and/or professional information in line with the SmPC.

Usage

For intramuscular injection only; not for intravenous use.
Dose and frequency must be determined by a physician, based on the patient’s vitamin D status, severity of deficiency, clinical condition, age, and current guidelines.
Typical use is intramuscular injection into a large muscle (e.g. gluteal muscle), observing standard IM injection technique and aseptic precautions.
Inspect the ampoule visually before use; the solution should be colourless to pale yellow and free from visible particles. Do not use if the solution is discoloured or contains particulate matter, or if the ampoule is damaged.
Warm the ampoule to room/body temperature if stored cold to reduce injection discomfort and viscosity, in accordance with local practice.
Administer slowly into the muscle to minimise local irritation; rotate injection sites if repeated doses are required.
Monitor the patient’s calcium, phosphate and vitamin D levels regularly during therapy and adjust dosing accordingly in line with the SmPC and local protocols.
Use each ampoule once only; discard any unused solution after opening in accordance with local requirements for disposal of parenteral medicinal products.
Only clinicians experienced in the management of vitamin D deficiency and its complications should prescribe and administer this product.

Contraindications

Hypercalcaemia.
Hypervitaminosis D.
Metastatic calcification.
Known hypersensitivity to ergocalciferol (vitamin D2) or to any of the excipients (e.g. ethyl oleate).
Conditions associated with hypercalcaemia such as primary hyperparathyroidism or malignant bone disease, unless under specialist supervision.
Severe renal impairment or renal failure with risk of hyperphosphataemia and ectopic calcification, unless carefully monitored by a specialist.

Adverse Effects

Hypercalcaemia and hypercalciuria with prolonged or excessive dosing, which may present with nausea, vomiting, constipation, anorexia, abdominal pain, polyuria, polydipsia, weakness, headache, muscle or bone pain and, in severe cases, confusion or cardiac arrhythmias.
Soft tissue and vascular calcification with chronic overdose or prolonged hypercalcaemia.
Reversible elevations in serum phosphate or changes in renal function in susceptible patients.
Injection site reactions such as pain, redness, swelling or induration.
Rare hypersensitivity reactions, including rash, pruritus or more severe allergic responses in sensitised individuals.
Very prolonged use at high doses may contribute to nephrocalcinosis or kidney stones, particularly in patients with pre-existing renal impairment.

Storage Conditions

Store below 25°C.
Do not refrigerate or freeze unless specifically stated otherwise in the SmPC; protect from excessive heat and direct sunlight.
Keep ampoules in the outer carton to protect from light.
Do not use after the expiry date printed on the packaging.
Keep out of the sight and reach of children.
Dispose of used ampoules, needles and syringes in accordance with local requirements for clinical waste and sharps.

Duration

The treatment regimen, including single-dose or repeated dosing, is individualised according to the severity of deficiency, underlying condition and response. Protocols may use single or intermittent high-dose injections (e.g. at intervals of several weeks or months) with ongoing monitoring of calcium, phosphate and vitamin D status; duration is determined by the prescribing clinician and local guidelines.

Onset

Biochemical response (rise in vitamin D and associated calcium/phosphate changes) generally occurs over days to weeks following intramuscular injection of ergocalciferol, with maximal effects often seen within several weeks; clinical improvements in bone symptoms may take longer and require sustained correction of deficiency.