Basic growth hormone pen, replaceable-cartridge

Intended purpose

This device is intended for subcutaneous injection of a daily dose of Omnitrope (rhGH drug). It is intended for patients (paediatric patients and adults) treated for growth disturbances and growth hormone deficiencies. The injection can be performed by the patient him/herself or also by a trained caregiver in case of small children or patients unable to perform the injection themselves. The device is a multi-dose, semi-reusable needle-based injection system with automated functions to be used with the liquid formulation Omnitrope in a standard 1.5mL disposable pre-assembled cartridge.