Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
somatropin
Sandoz GmbH
H01AC01
somatropin
Pituitary and hypothalamic hormones and analogues
Turner Syndrome; Prader-Willi Syndrome; Dwarfism, Pituitary
Infants, children and adolescentsGrowth disturbance due to insufficient secretion of growth hormone (GH).Growth disturbance associated with Turner syndrome.Growth disturbance associated with chronic renal insufficiency.Growth disturbance (current height standard-deviation score (SDS) < -2.5 and parental adjusted SDS < -1) in short children / adolescents born small for gestational age (SGA), with a birth weight and / or length below -2 standard deviations (SDs), who failed to show catch-up growth (height velocity (HV) SDS < 0 during the last year) by four years of age or later.Prader-Willi syndrome (PWS), for improvement of growth and body composition. The diagnosis of PWS should be confirmed by appropriate genetic testing.AdultsReplacement therapy in adults with pronounced growth hormone deficiency. Patients with severe growth hormone deficiency in adulthood are defined as patients with known hypothalamic pituitary pathology and at least one known deficiency of a pituitary hormone not being prolactin. These patients should undergo a single dynamic test in order to diagnose or exclude a growth hormone deficiency. In patients with childhood-onset isolated GH deficiency (no evidence of hypothalamic-pituitary disease or cranial irradiation), two dynamic tests should be recommended, except for those having low insulin-like-growth-factor-I (IGF-I) concentrations (SDS < -2) who may be considered for one test. The cut-off point of the dynamic test should be strict.
Revision: 22
Authorised
2006-04-12
87 B. PACKAGE LEAFLET 88 PACKAGE LEAFLET: INFORMATION FOR THE USER OMNITROPE 1.3 MG/ML POWDER AND SOLVENT FOR SOLUTION FOR INJECTION somatropin READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Omnitrope is and what it is used for 2. What you need to know before you use Omnitrope 3. How to use Omnitrope 4. Possible side effects 5. How to store Omnitrope 6. Contents of the pack and other information 1. WHAT OMNITROPE IS AND WHAT IT IS USED FOR Omnitrope is a recombinant human growth hormone (also called somatropin). It has the same structure as natural human growth hormone which is needed for bones and muscles to grow. It also helps your fat and muscle tissues to develop in the right amounts. It is recombinant meaning it is not made from human or animal tissue. IN CHILDREN OMNITROPE IS USED TO TREAT THE FOLLOWING GROWTH DISTURBANCES: • If you are not growing properly and you do not have enough of your own growth hormone. • If you have Turner syndrome. Turner syndrome is a genetic disorder in girls that can affect growth – your doctor will have told you if you have this. • If you have chronic renal (kidney) insufficiency. As kidneys lose their ability to function normally, this can affect growth. • If you were small or too light at birth. Growth hormone can help you grow taller if you have not been able to catch up or maintain normal growth by 4 years of age or later. • If you have Prader-Willi syndrome (a chromosomal disorder). Growth hormone will help you grow taller if y Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Omnitrope 1.3 mg/ml powder and solvent for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION After reconstitution, one vial contains 1.3 mg somatropin* (corresponding to 4 IU) per ml. * produced in _Escherichia coli_ by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for solution for injection. The powder is white. The solvent 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). - Growth disturbance associated with Turner syndrome. - Growth disturbance associated with chronic renal insufficiency. - Growth disturbance (current height standard deviation score (SDS) < -2.5 and parental adjusted height SDS < -1) in short children/adolescents born small for gestational age (SGA), with a birth weight and/or length below -2 standard deviation (SD), who failed to show catch-up growth (height velocity (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. The diagnosis of PWS should be confirmed by appropriate genetic testing. Adults - Replacement therapy in adults with pronounced growth hormone deficiency. - _Adult onset:_ Patients who have severe growth hormone deficiency associated with multiple hormone deficiencies as a result of known hypothalamic or pituitary pathology, and who have at least one known deficiency of a pituitary hormone not being prolactin. These patients should undergo an appropriate dynamic test in order to diagnose or exclude a growth hormone deficiency. - _Childhood onset:_ Patients who were growth hormone deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes. Patients with childhood onset GHD should be re-evaluated for growth hormone secretory capa Aqra d-dokument sħiħ