Country: Israel
Language: English
Source: Ministry of Health
SOMATROPIN
NOVO NORDISK LTD., ISRAEL
H01AC01
SOLUTION FOR INJECTION
SOMATROPIN 10 MG / 1 ML
S.C
Required
NOVO NORDISK A/S, DENMARK
SOMATROPIN
SOMATROPIN
Children: * Short stature due to inadequate or failed secretion of pituitary growth hormone or Turner`s syndrome. * Short stature in children with renal insufficiency. * Growth disturbance (current height SDS < - 2.5 and parental adjusted height SDS < - 1) in short children born small for gestational age (SGA) with a birth weight and/or length below - 2 SD who failed to show catch-up growth (HV SDS < during the last year) by 4 years of age or later.* Children with short stature associated with Noonan syndrome.Adults: Treatment of adults with Hypothalamic-pituitary disease resulting from organic disease or pituitary tumors treated medically surgically or radiotherapy or patients with childhood onset of G.H. deficiency.
2020-05-31
Patient leaflet in accordance with the Pharmacists' Regulations (Preparations) – 1986 This medicine is dispensed with a doctor's prescription only Norditropin ® 15 mg NordiFlex ® Solution for injection in pre-filled pen Active ingredient somatropin 15 mg/1.5 ml Inactive ingredients and allergens in the preparation: see section 6 - Further information. Read the entire leaflet carefully before you start using this medicine. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar to yours. This leaflet contains instructions for using your Norditropin NordiFlex pen. 1. What is this medicine intended for? In children: to treat children with short stature due to failed or inadequate secretion of growth hormone by the pituitary to treat children with short stature due to Turner syndrome to treat children with short stature due to renal insufficiency to treat children with short stature associated with Noonan syndrome growth disturbance in short children born small for gestational age (SGA) who failed to show catch-up growth by 4 years of age. In adults: To treat adults with hypothalamic-pituitary disease due to an organic problem or pituitary tumours, treated medicinally, surgically or by radiotherapy or patients with childhood onset of growth hormone deficiency. Therapeutic group: somatropin and somatropin agonists Norditropin contains a biosynthetic human growth hormone called somatropin which is identical to the growth hormone produced naturally in the body. Children need growth hormone to help them grow; However, adults also need it for their normal health. 2. Before using the medicine Do not use this medicine if: • you are sensitive (allergic) to somatropin, to phenol, or to any of the other ingredients in this medicine (see section 6) • you have had a Read the complete document
1 NOR NOR SPC July21-Notification 1. NAME OF THE MEDICINAL PRODUCT NORDITROPIN ® 10 MG NORDITROPIN ® 15 MG NORDIFLEX ® 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Norditropin NordiFlex: 10 mg/1.5 ml One ml of solution contains 6.7 mg somatropin Norditropin NordiFlex: 15 mg/1.5 ml One ml of solution contains 10 mg somatropin Somatropin (recombinant DNA origin produced in E-coli) 1 mg of somatropin corresponds to 3 IU (International Unit) of somatropin For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Solution for injection in pre-filled pen Clear, colourless solution 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Children: • Short stature due to inadequate or failed secretion of pituitary growth hormone or Turner`s syndrome. • Short stature in children with renal insufficiency. • Growth disturbance (current height SDS < -2.5 and parental adjusted height SDS < -1) in short children born small for gestational age (SGA) with a birth weight and/or length below -2 SD who failed to show catch-up growth (HV SDS < 0 during the last year) by 4 years of age or later. • Children with short stature associated with Noonan syndrome. Adults: • Treatment of adults with Hypothalamic-pituitary disease resulting from organic disease or pituitary tumors treated medically surgically or radiotherapy or patients with childhood onset of G.H. deficiency. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Norditropin should only be prescribed by doctors with special knowledge of the therapeutic indication of use. 2 NOR NOR API JUL21-Notification Posology The dosage is individual and must always be adjusted in accordance with the individual's clinical and biochemical response to therapy. _Generally recommended dosages: _ _Paediatric population_: Growth hormone insufficiency 0.025-0.035 mg/kg/day or 0.7-1.0 mg/m 2 /day When GHD persists after growth completion, growth hormone treatment should be continued to achieve full somatic adult development including lean body mass and bone mineral accrual (for guidance o Read the complete document