OMNITROPE 10 MG / 1.5 ML

What is OMNITROPE?

OMNITROPE 10 MG / 1.5 ML contains SOMATROPIN : 10 MG / 1.5 ML. It is listed in the Health Canada Drug Product Database under DIN 02325071, held by SANDOZ CANADA INCORPORATED, supplied as SOLUTION for SUBCUTANEOUS administration. Health Canada currently lists it as marketed, status dated 20-Apr-2009. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is OMNITROPE used for?

Omnitrope (somatropin for injection) is indicated for: Children: The long-term treatment of children, who have growth failure due to an inadequate secretion of endogenous growth hormone (growth hormone deficiency [GHD]). Omnitrope is indicated for the treatment of growth failure (current height standard deviation score [SDS] < -2) in short children born SGA (birth weight and/or length below -2 SD) and who fail to achieve catch -up growth (height velocity SDS < 0 during the last year ) by 2 to 4 years or later. The treatment of short stature associated with Turner syndrome in patients whose epiphyses are not closed. The long-term treatment of idiopathic short stature (ISS), also called non-growth hormone-deficient short stature, defined by height standard deviation score (SDS) < -2.25, and associated with growth rates unlikely to permit attainment of adult height in the normal range, in pediatric patients for whom diagnostic evaluation excludes other causes associated with short stature that should be observed or treated by other means. Omnitrope treatment for ISS should be prescribed only for those patients whose epiphyses are not closed. Adults: Omnitrope (somatropin [rDNA origin] for injection) is indicated for replacement of endogenous growth hormone in adults with growth hormone deficiency who meet either of the following two criteria: Adult Onset (AO): Patients who have growth hormone deficiency, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma; or Childhood Onset (CO): Patients who were growth hormone deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes. Patients who were treated with somatropin for growth hormone deficiency in childhood and whose epiphyses are closed should be re-evaluated before continuation of somatropin therapy at the reduced dose level recommended for growth hormone deficient adults. According to current standards, confirmation of the diagnosis of adult growth hormone deficiency in both groups involves an appropriate growth hormone provocative test with two exceptions: (1) patients with multiple other pituitary hormone deficiencies due to organic disease; and (2) patients with congenital/genetic growth hormone deficiency.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

Product details and regulatory record

How is it stored and handled?

After the first injection, the content of the cartridge must be used within 28 days. The cartridge should remain in the pen and be refrigerated between 2 and 8°C. Do not freeze. Protect from light

How is it supplied?

Omnitrope 5.0 mg/1.5 mL is supplied in the following pack sizes: • One cartridge per carton • Five cartridges per carton • Ten cartridges per carton Omnitrope 10.0 mg/1.5 mL is supplied in the following pack sizes: • One cartridge per carton • Five cartridges per carton • Ten cartridges per carton Omnitrope 15.0 mg/1.5 mL is supplied in the following pack sizes: • One cartridge per carton • Five cartridges per carton

What can be used instead?

Other Canadian products sharing ATC code H01AC01 SOMATROPIN. 21 of 49 DINs in this group are currently marketed — marketed products are listed first, because that is what can actually be bought. These tables describe supply, not clinical equivalence: substitution rests with the prescriber or pharmacist, and interchangeability is determined provincially.

Who else supplies SOMATROPIN worldwide?

Nexara tracks national medicine registries and published price lists across multiple markets. SOMATROPIN appears in 1520 registered pack listings across 11 markets, published on 9 different national price bases. Where a Canadian route is closed, that is where an alternative route of supply starts — subject to the import rules in both countries.

Registered listings are not stock. Ask us to confirm what can actually be sourced for your order.