Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
somatropin
BioPartners GmbH
H01AC01
somatropin
Pituitary and hypothalamic hormones and analogues
Turner Syndrome; Dwarfism, Pituitary
Paediatric poulationLong-term treatment of children (2 to 11 years old) and adolescents (12 to 18 years old) with growth failure due to an inadequate secretion of normal endogenous growth hormone.Treatment of short stature in children with Turner syndrome, confirmed by chromosome analysis.Treatment of growth retardation in pre-pubertal children with chronic renal insufficiency.Adult patientsReplacement therapy in adults with pronounced growth hormone deficiency of either childhood- or adult-onset aetiology.Patients with severe growth hormone deficiency in adulthood are defined as patients with known hypothalamic-pituitary pathology and at least one additional 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 growth hormone 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-1 (IGF-1) concentrations (< 2 standard deviation score (SDS)), who may be considered for one test. The cut-off point of the dynamic test should be strict.
Revision: 5
Withdrawn
2006-04-24
B. PACKAGE LEAFLET 20 Medicinal product no longer authorised PACKAGE LEAFLET: INFORMATION FOR THE USER VALTROPIN 5 MG/1.5 ML POWDER AND SOLVENT FOR SOLUTION FOR INJECTION Somatropin READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Valtropin is and what it is used for 2. Before you use Valtropin 3. How to use Valtropin 4. Possible side effects 5. How to store Valtropin 6. Further information 1. WHAT VALTROPIN IS AND WHAT IT IS USED FOR Your medicine is called Valtropin. It is a human growth hormone, also called somatropin. It has the same structure as the growth hormone that the body produces in the pituitary glands (glands located at the base of the brain). Growth hormone regulates the growth and development of cells. When it stimulates growth of cells in the long bones of the legs and spine, it causes an increase in height. VALTROPIN IS USED - to treat children (2 to 11 years old) and teenagers (12 to 18 years old) who do not develop to their normal height because of poor bone growth caused by growth hormone deficiency (relative lack of growth hormone), Turner syndrome, or ‘chronic renal insufficiency’ (a condition in which the kidneys gradually lose their ability to perform their normal functions, such as the removal of wastes and extra fluid from the body). - to treat adults with severe growth hormone deficiency who already had growth hormone deficiency when they were children or who do not have enough growth hormone during their adult years for some other reason. In this leaflet the patient is addressed as ‘you’. Caregivers administering Valtropin to their ch Lesen Sie das vollständige Dokument
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 Medicinal product no longer authorised 1. NAME OF THE MEDICINAL PRODUCT Valtropin 5 mg/1.5 ml powder and solvent for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One vial of powder contains 5 mg somatropin (corresponding to 15 IU). After reconstitution with 1.5 ml solvent, 1 ml contains: somatropin* 3.33 mg (corresponding to 10 IU) _* _ produced in _Saccharomyces cerevisiae_ 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. White or almost white powder. The solvent is a clear solution. After reconstitution with the solvent provided, Valtropin has a pH of approximately 7.5 and an osmolality of approximately 320 mOsm/kg. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Paediatric population - Long-term treatment of children (2 to 11 years old) and adolescents (12 to 18 years old) with growth failure due to an inadequate secretion of normal endogenous growth hormone. - Treatment of short stature in children with Turner syndrome, confirmed by chromosome analysis. - Treatment of growth retardation in pre-pubertal children with chronic renal insufficiency. Adult patients - Replacement therapy in adults with pronounced growth hormone deficiency of either childhood- or adult-onset aetiology. Patients with severe growth hormone deficiency in adulthood are defined as patients with known hypothalamic-pituitary pathology and at least one additional 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 growth hormone 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-1 (IGF-1) concentrations (< 2 standard deviation score (SDS)), who may be considered for one test. T Lesen Sie das vollständige Dokument