Ergotropin 10 IU (3.3 mg)

Ergotropin 10 IU (3.3 mg) (Somatropin) · ATC H01AC01

Growth hormone · somatropin (rDNA origin)

Each vial contains Somatropin 10 IU (3.3 mg) as a lyophilised powder. The kit contains 10 vials (total 100 IU / 33.3 mg) and 1 × 10 ml bacteriostatic water for reconstitution.

For the full list of excipients, see section 6.1.

Lyophilised powder for solution for injection, supplied with bacteriostatic water for reconstitution, for subcutaneous use.

Therapeutic indications

Growth-hormone replacement and other indications for recombinant somatropin, as determined by a physician.

Posology and method of administration

Reconstitute the powder with the bacteriostatic water supplied and give by subcutaneous injection as directed by a physician. Rotate injection sites. Not for intravenous use. Dose and interval are individualised by the prescriber.

Contraindications

Known hypersensitivity to somatropin or to any component of the kit, including the bacteriostatic water. Active malignancy. Acute critical illness after open-heart or abdominal surgery, multiple trauma or acute respiratory failure. Closed epiphyses when used to promote growth. Not for use in pregnancy unless a physician has specifically directed otherwise.

Special warnings and precautions for use

Keep out of the reach and sight of children. Contains a substance prohibited in sport (WADA).

Interaction with other medicinal products

Glucocorticoids

Pharmacological doses of glucocorticoids blunt the growth-promoting effect of somatropin. Replacement doses in ACTH deficiency should be kept as low as practicable.

Insulin and other antidiabetic agents

Somatropin reduces insulin sensitivity. Doses of insulin or oral antidiabetics may need to rise, and glucose should be monitored when treatment starts or the dose changes.

Oral oestrogens

Oral oestrogen increases growth-hormone-binding protein and can raise the somatropin dose required to achieve a target IGF-1. Transdermal oestrogen has less effect.

Medicines metabolised by CYP3A4 — for example sex steroids, anticonvulsants and ciclosporin

Growth hormone may increase the clearance of drugs metabolised by CYP3A4. Clinical effect should be reviewed when somatropin is started or stopped.

Thyroid hormone

Somatropin can increase peripheral conversion of T4 to T3 and unmask central hypothyroidism. Thyroid function should be checked and replacement adjusted if needed.

Use in special populations

Pregnancy and breastfeeding

Not recommended unless a physician has specifically directed use. Somatropin is a large peptide and is not expected to cross the placenta in meaningful amounts, but there are insufficient controlled data. It is not known whether it passes into human milk in clinically relevant amounts; endogenous growth hormone is present in milk.

Paediatric population

Used for growth promotion only while the epiphyses are open and only for indications a physician has established. Monitor growth velocity, IGF-1, thyroid function and glucose. Watch for limp or hip or knee pain (slipped capital femoral epiphysis) and for headache with visual change (intracranial hypertension). The bacteriostatic water contains a preservative and must not be used in neonates.

Elderly

Adults over 60 are more sensitive to fluid retention and to effects on glucose. Start at the low end of the adult replacement range and titrate on IGF-1 and tolerability.

Diabetes and impaired glucose tolerance

Somatropin antagonises insulin. Patients with diabetes need closer glucose monitoring and may need a higher antidiabetic dose. New hyperglycaemia is a reason to review treatment.

Active malignancy and critical illness

Contraindicated in active malignancy and in acute critical illness after major surgery, trauma or acute respiratory failure, where increased mortality has been reported with pharmacological doses of growth hormone. Treatment of residual tumour or recurrence must be excluded before starting, and stopped if malignancy recurs.

Athletes

Somatropin is prohibited at all times under the WADA Prohibited List (section S2, peptide hormones). A therapeutic use exemption is required before an athlete competes while prescribed it. Detection does not depend on the brand name on the carton.

Undesirable effects

General and administration site

Injection-site pain, redness, itching or lipoatrophy if sites are not rotated; peripheral oedema, especially early in treatment

Musculoskeletal

Arthralgia, myalgia, stiffness and, with excess dosing in adults, carpal-tunnel symptoms from fluid retention

Nervous system

Headache; rarely benign intracranial hypertension (papilloedema, visual change, nausea) — more often reported in children

Metabolism and endocrine

Insulin resistance and hyperglycaemia, unmasking of latent hypothyroidism, gynaecomastia rarely

Immune system

Hypersensitivity to somatropin or to the benzyl alcohol in bacteriostatic water; anti-growth-hormone antibodies are uncommon and rarely neutralising

Paediatric skeletal

Slipped capital femoral epiphysis and progression of scoliosis have been reported during growth promotion

Overdose

Acute overdose produces fluid retention, headache, nausea, hyperglycaemia and, occasionally, hypoglycaemia as insulin rises in response. Long-term overdosage reproduces the features of growth-hormone excess: acral enlargement, arthralgia, oedema, carpal-tunnel symptoms and impaired glucose tolerance. There is no specific antidote. Stop the medicine, monitor glucose and fluid status, and treat supportively. Because the half-life is short, acute effects settle once administration stops; IGF-1 declines over the following days.

Pharmacodynamic properties

Somatropin is recombinant human growth hormone of rDNA origin, identical to the native 191-amino-acid pituitary sequence (ATC H01AC01). It binds the growth-hormone receptor and activates JAK2–STAT signalling, stimulating hepatic and local production of insulin-like growth factor-1 (IGF-1). The resulting effects are linear growth in children with open epiphyses, nitrogen retention and lean-tissue accrual, lipolysis, and effects on bone turnover, fluid balance and carbohydrate metabolism. Ergotropin is presented as a sterile lyophilised powder; after reconstitution with the bacteriostatic water supplied it is given by subcutaneous injection.

Pharmacokinetic properties

After subcutaneous injection somatropin is absorbed with a bioavailability of roughly 70–80 %, and peak serum concentrations are typically reached in 3 to 6 hours. Circulating growth hormone is bound in part to growth-hormone-binding protein. Elimination is by receptor-mediated clearance and proteolysis, with a terminal half-life after subcutaneous administration of about 2 to 4 hours — substantially longer than the minutes-long half-life of intravenous growth hormone, because absorption from the injection site is rate-limiting. The biological effect outlasts the hormone itself: IGF-1 rises over 12 to 24 hours and is the marker used to titrate replacement. The lyophilised powder is stable in the refrigerator until the labelled expiry; once reconstituted with bacteriostatic water the solution is a multi-dose preparation and must be kept at 2–8 °C, protected from light, and discarded at the end of its in-use period or if it becomes cloudy.

List of excipients

Lyophilised vial: somatropin 10 IU (3.3 mg), with the bulking and stabilising excipients stated on the vial label. Diluent: bacteriostatic water for injection, 10 ml, containing a preservative so that the reconstituted solution can be used for more than one dose. The powder contains no antimicrobial preservative of its own until the diluent is added.

Excipient warnings

The diluent is bacteriostatic water and contains a preservative (commonly benzyl alcohol). Benzyl alcohol must not be given to neonates or premature infants and may cause allergic reactions. Patients who are pregnant, or who have hepatic or renal impairment, should be assessed before a preserved diluent is used.

Incompatibilities

Do not mix somatropin with other medicinal products in the same syringe, other than the bacteriostatic water supplied for reconstitution. Do not use a diluent that has not been specified for this kit.

Shelf life

36 months from the date of manufacture when stored refrigerated at 2–8 °C in the unopened carton. Do not use after the expiry date stated on the carton and vial (06 / 2029 on lot ERG2800A), which refers to the last day of that month.

After first opening

After reconstitution with the bacteriostatic water supplied, store the vial at 2–8 °C, protected from light, and do not freeze. Use within the in-use period printed on the approved leaflet for this kit, and discard the solution if it is cloudy, coloured or contains particles. Do not store reconstituted vials at room temperature.

Storage

Store refrigerated at 2–8 °C. Do not freeze. Protect from light. Keep the vials in the outer carton until use.

Container

Carton containing 10 vials of lyophilised somatropin 10 IU (3.3 mg) and 1 vial of 10 ml bacteriostatic water (100 IU / 33.3 mg total), in a tamper-evident, GS1-serialised outer carton with the patient leaflet. GTIN 06012346678800. Not all pack sizes may be marketed.

Disposal

Needles, syringes and empty vials are sharps and must not go into household waste. Any unused product, residual solution and the outer carton should be disposed of in accordance with local requirements.

Pack

10 Vials × 10 IU + 10 ml Bacteriostatic Water

GTIN

06012346678800

Serial

2800 4667 8900 28

LOT

ERG2800A

MFG

06 / 2026

EXP

06 / 2029

Every carton carries a GS1 DataMatrix and a verification code; a pack can be checked at ergopharm.net/verify.

Ergopharm Advanced Research Centre, Tandalja, Vadodara, Gujarat 390012, India. For Export Only.

Report a suspected adverse reaction or quality defect to pv@ergopharm.net.