STEROGYL 15H 600 000 UI/1,5 ml S inj IM Amp/1,5ml

For 1 ampoule of 1,5 ml :

Ergocalciferol: 600 000 IU

Excipient with known effect: Peanut oil.

Treatment and/or prophylaxis of vitamin D deficiency states.

Dosage

RESERVED FOR ADULTS.

This presentation, due to the high vitamin D content, is not suitable for children.

½ to 1 ampoule (i.e. 300 000 to 600 000 IU of vitamin D2), in a single dose, once a year.

Method of administration

IM route.

The ampoule may also be administered orally.

This medicine must not be used in cases of:

• Hypersensitivity to peanut or soya, or to any of the other constituents mentioned in the section Composition ;

• Hypercalcaemia, hypercalciuria, calcium lithiasis.

This medicine contains peanut oil and may cause hypersensitivity reactions (urticaria, anaphylactic shock).

This specialty contains a very high dose of vitamin D. To avoid any overdose, do not administer more than once a year and avoid combination with other treatments containing this vitamin.

Monitor calciuria and calcemia and stop vitamin D intake if calcemia exceeds 105 mg/ml (2,62 mmol/l) or if calciuria exceeds 4 mg/kg/day in adults.

In cases of high calcium intake, regular monitoring of urinary calcium excretion is essential.

Associations to be taken into account

Orlistat

Decrease in vitamin D absorption.

At a dose of 600 000 IU of vitamin D per ampoule, the vitamin D concentration of this specialty is high and does not correspond to the doses usually recommended during pregnancy. Consequently, this specialty must be administered neither during pregnancy nor during breastfeeding.

Skin and subcutaneous tissue disorders: Pruritus, skin rash, erythema, oedema.

Due to the presence of peanut oil, risk of hypersensitivity reactions (anaphylactic shock, urticaria).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Centres of Pharmacovigilance - Website: https://signalement.social-sante.gouv.fr/.

Signs resulting from administration of excessive doses of vitamin D or its metabolites:

• Clinical signs: headache, asthenia, anorexia, weight loss, growth arrest, nausea, vomiting, polyuria, polydipsia, dehydration, arterial hypertension, calcium lithiasis, tissue calcifications (in particular renal and vascular), renal insufficiency.

• Biological signs: hypercalcemia, hypercalciuria, hyperphosphatemia, hyperphosphaturia.

• Management: Stop administration of vitamin D, reduce calcium intake, increase diuresis, abundant drinks.

Pharmacotherapeutic class: VITAMIN D, ATC code: A11CC01

(A: Alimentary tract and metabolism)

The essential role of vitamin D is exerted on the intestine, whose capacity to absorb calcium and phosphates it increases, and on the skeleton, whose mineralization it promotes (through its direct actions on bone being formed and its indirect actions involving the intestine, the parathyroids, and already mineralized bone).

After absorption, it binds to a specific carrier protein and is transported to the liver to be converted into 25-hydroxyvitamin D. The latter in turn binds to the same carrier protein and is transported to the kidneys where it is transformed into its active form, 1,25-dihydroxyvitamin D.

Its essential storage sites are adipose tissue, muscles, but also blood. The 1,25-hydroxyvitamin D bound to its carrier protein is the major form of circulating reserve of vitamin D. Its half-life in blood is 15 to 40 days.

Vitamin D and its metabolites are eliminated via the faeces, in unchanged form or in water-soluble form (calcitroic acid, glucuroconjugated derivatives).

5 years.

 Store protected from light.

No special requirements.