Valsts: Izraēla
Valoda: angļu
Klimata pārmaiņas: Ministry of Health
SOMATROPIN RECOMBINANT
NOVARTIS ISRAEL LTD
H01AC01
SOLUTION FOR INJECTION
SOMATROPIN RECOMBINANT 15 MG / 1.5 ML
S.C
Required
SANDOZ GmbH, AUSTRIA
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 (height SDS<2.5 and parenteral adjusted height SDS < -1) in short children born SGA (SGA - small for gestational age i.e. born small in relation to the length of the fetus development) with a birth weight and/or length < 2 SD who failed to show catch up growth (HV SDS < 0 during the last year) by 4 years of age or later. Prader willi syndrome (PWS) for improvement of growth and body composition. Adults: For adults who have suffered from growth-hormone deficiency since childhood. For adults who have acquired growth hormone deficiency due to a pituitary pathology causing hypopituitarism.
2017-02-14
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed with a doctor’s prescription only OMNITROPE 5 MG/1.5 ML OMNITROPE 10 MG/1.5 ML OMNITROPE 15 MG/1.5 ML SOLUTION FOR SUBCUTANEOUS INJECTION The active ingredient: SOMATROPIN For use with the SurePal TM pen injector OMNITROPE 5 MG/1.5 ML: A cartridge which contains 5 mg somatropin (15 international units) in 1.5 ml solution for injection. OMNITROPE 10 MG/1.5 ML: A cartridge which contains 10 mg somatropin (30 international units) in 1.5 ml solution for injection. OMNITROPE 15 MG/1.5 ML: A cartridge which contains 15 mg somatropin (45 international units) in 1.5 ml solution for injection. Inactive ingredients - see section “Further Information” in the leaflet. READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE: This leaflet contains concise information about the medicine; if you have further questions, refer to the 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. WHAT SHOULD YOU KNOW BEFORE USING OMNITROPE? Before using this medicine, you should be trained by a certified medical team regarding how to prepare and inject the medicine. For information about side effects, please refer to section 4. 1. WHAT IS THE MEDICINE INTENDED FOR? IN CHILDREN: Treatment of growth problems in children caused by inadequate or complete lack of secretion of growth hormone from the pituitary gland (hypophysis). ∙ Growth problems due to Turner syndrome ∙ Growth delay in children due to kidney failure ∙ Children born small for gestational age (SGA) ∙ Prader-Willi Syndrome IN ADULTS: 1. For adults suffering from growth hormone deficiency from childhood. 2. For adults suffering from growth hormone deficiency due to a problem with the pituitary gland. THERAPEUTIC GROUP: Growth hormone Omnitrope is a recombinant growth hormone (also called SOMATROPIN) 2. BEFORE USING Izlasiet visu dokumentu
1 OMNITROPE 1. NAME OF THE MEDICINAL PRODUCT Omnitrope 5mg/1.5m l, 10mg/1.5m l, 15mg/1.5ml solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Omnitrope 5mg/1.5m Each ml of solution contains 3.33mg of somatropin* (corresponding to 6.67IU). One cartridge contains 1.5ml corresponding to 5m somatropin* (15IU) Omnitrope 10mg/1.5m Each ml of solution contains 6.67mg of somatropin* (corresponding to 20IU) One cartridge contains 1.5ml corresponding to 10mg somatropin* (30IU) Omnitrope 15mg/1.5m Each ml of solution contains 10mg of somatropin* (corresponding to 30IU) One cartridge contains 1.5ml corresponding to 15mg somatropin* (45IU) * produced in Escherichia coli by recombinant DNA technology. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection in a cartridge for SurePal 5, 10 & 15 The solution is clear and colourless 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Infants, children and adolescents Growth disturbance due to insufficient secretion of growth hormone (growth hormone deficiency, GHD). 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 (height SDS<2.5 and parenteral adjusted height SDS < -1) in short children born SGA (SGA - small for gestational age i.e. born small in relation to the length of the fetus development) with a birth weight and/or length < 2 SD who failed to show catch up growth (HV SDS < 0 during the last year) by 4 years of age or later. Prader Willi syndrome for improvement of growth and body composition The diagnosis of PWS should be confirmed by genetic analysis. 2 Adults For adults who have suffered from growth-hormone deficiency since childhood. For adults who have acquired growth hormone deficiency due to a pituitary pathology causing hypopituitarism. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Diagnosis and therapy with somatropin should be initiated and monitored by Izlasiet visu dokumentu