Ország: Izrael
Nyelv: angol
Forrás: Ministry of Health
SOMATROPIN
PFIZER PHARMACEUTICALS ISRAEL LTD
H01AC01
POWDER FOR SOLUTION FOR INJECTION
SOMATROPIN 5.3 MG
S.C
Required
PFIZER MANUFACTURING BELGIUM NV/SA
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 (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. Adults: For adults who have suffered from growth-hormone deficiency since childhood. For adults who have aquired growth hormone deficiency due to a pituitary pathology causing hypopituitarism.
2021-02-28
Genotropin GQ 5.3mg, Israel, PIL CC 04 July 2022 2021-0068728 1 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only GENOTROPIN ® 5.3 MG POWDER AND SOLVENT FOR RECONSTITUTION OF SOLUTION FOR SUBCUTANEOUS INJECTION A GENOTROPIN 5.3 MG INJECTION PEN CONTAINS: SOMATROPIN RECOMBINANT 5.3 MG/ML For a list of inactive ingredients and allergens, see section 6 ‘Further information’. READ THE ENTIRE LEAFLET CAREFULLY BEFORE 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. WHAT SHOULD I KNOW ABOUT GENOTROPIN? • Before using this medicine you must be trained by a qualified healthcare professional about preparing the medicine and injecting it. 1. WHAT IS THIS MEDICINE INTENDED FOR? In children: • Treatment of growth problems in children due to failed or insufficient secretion of growth hormone by the pituitary. • Growth problems due to Turner syndrome. • Retarded growth in children due to renal insufficiency. • Prader-Willi syndrome. • Children born small for gestational age (SGA). In adults: • Adults who have had growth hormone deficiency since childhood. • Adults who have growth hormone deficiency due to a problem in their pituitary. THERAPEUTIC GROUP: growth hormone. 2. BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE: • If you are sensitive (allergic) to the active ingredient or to any of the other ingredients that this medicine contains (see section 6). • If you have an active tumor (cancer). Tumors must be inactive and you must have finished your anti-tumor treatment before you start your treatment with GENOTROPIN. • If you are seriously ill (for example, complications following open heart surgery, abdominal surgery, acute respirato Olvassa el a teljes dokumentumot
Genotropin 5.3mg and 12mg, Israel CC 12 July 2022 Page 1 of 12 2021-0068728 _ _ 1. NAME OF THE MEDICINAL PRODUCT GENOTROPIN 5.3 mg, GENOTROPIN 12 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION GENOTROPIN 5.3 mg powder and solvent for solution for injection, with preservative. One cartridge contains 5.3 mg somatropin*. After reconstitution the concentration of somatropin is 5.3 mg/ml. GENOTROPIN 12 mg powder and solvent for solution for injection, with preservative. One cartridge contains 12 mg somatropin*. After reconstitution the concentration of somatropin is 12 mg/ml. * produced in _Escherichia coli _ cells by recombinant DNA technology For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for solution for injection. In the two-chamber cartridge there is a white powder in the front compartment and a clear solution in the rear compartment. 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 chronic renal insufficiency. Growth disturbance (height SDS< -2.5 and parental 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. In Prader-Willi syndrome (PWS) to improve growth and body composition. The diagnosis of PWS should be confirmed by genetic analysis. 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 The dosage and administration schedule should be individualized. The injection should be given subcutaneously and the site varied to prevent lipoatrophy. Genotropin 5.3mg and 12mg, Israel CC 12 July 2022 Page 2 of 12 Olvassa el a teljes dokumentumot