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Omnitrope 1.5ml cartridges & vials

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Description

Omnitrope 1.5ml cartridges & vials

Omnitrope 1.5ml cartridges & vials  is a recombinant human growth hormone indicated for:
• Pediatric: Treatment of children with growth failure due to growth hormone deficiency GHD
• Adult: Treatment of adults with either adult onset or childhood onset GHD

OMNITROPE should be administered subcutaneously

• Pediatric GHD: 0.16 to 0.24 mg/kg//week, divided into 6 – 7 daily injections,
• Adult GHD: not more than 0.04 mg/kg/week (divided into daily injections) to be increased as tolerated to not more than 0.08 mg/kg/week); to be increased gradually every 1 – 2 months
• OMNITROPE Cartridges 5 mg/1.5 mL and 10 mg/1.5 mL must be used with the corresponding OMNITROPE® Pen 5 and Pen 10 delivery system, respectively
• Injection sites should always be rotated to avoid lipoatrophy

CONTRAINDICATIONS

• Acute Critical Illness
• Children with Prader-Willi syndrome who are severely obese or have severe respiratory impairment – reports of sudden death (4.2)
• Active Malignancy
• Active Proliferative or Severe Non-Proliferative Diabetic Retinopathy
• Children with closed epiphyses
• Known hypersensitivity to somatropin or excipients

DOSAGE FORMS AND STRENGTHS

• 5 mg/1.5 mL Cartridge is a prefilled sterile somatropin solution containing benzyl alcohol in a glass cartridge ready to be administered with the Omnitrope Pen 5.
• 10 mg/1.5 mL Cartridge is a prefilled sterile somatropin solution in a glass cartridge ready to be administered with the Omnitrope® Pen 10.
• 1.5 mg/vial is supplied with two vials, one containing somatropin as a powder and the other vial containing the diluent (Sterile Water for Injection)

 

Additional information

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cartridges (1.5ml), 1 kit (8 vials)

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