Šalis: Europos Sąjunga
kalba: anglų
Šaltinis: EMA (European Medicines Agency)
somatropin
BioPartners GmbH
H01AC01
somatropin
Pituitary and hypothalamic hormones and analogues, Somatropin and somatropin agonists
Growth
Somatropin Biopartners is indicated for the replacement therapy of endogenous growth hormone in adults with childhood- or adult-onset growth-hormone deficiency (GHD).Adult-onset: Patients with GHD in adulthood are defined as patients with known hypothalamic-pituitary pathology and at least one additional known deficiency of a pituitary hormone excluding prolactin. These patients should undergo a single dynamic test in order to diagnose or exclude a GHD.Childhood-onset: In patients with childhood-onset isolated GHD (no evidence of hypothalamic-pituitary disease or cranial irradiation), two dynamic tests should be performed after completion of growth, except for those having low insulin-like-growth-factor-I (IGF-I) 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: 3
Withdrawn
2013-08-05
81 B. PACKAGE LEAFLET Medicinal product no longer authorised 82 PACKAGE LEAFLET: INFORMATION FOR THE USER SOMATROPIN BIOPARTNERS 2 MG POWDER AND SOLVENT FOR PROLONGED-RELEASE SUSPENSION FOR INJECTION SOMATROPIN BIOPARTNERS 4 MG POWDER AND SOLVENT FOR PROLONGED-RELEASE SUSPENSION FOR INJECTION SOMATROPIN BIOPARTNERS 7 MG POWDER AND SOLVENT FOR PROLONGED-RELEASE SUSPENSION FOR INJECTION FOR ADULTS Somatropin This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. 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 Somatropin Biopartners is and what it is used for 2. What you need to know before you use Somatropin Biopartners 3. How to use Somatropin Biopartners 4. Possible side effects 5. How to store Somatropin Biopartners 6. Contents of the pack and other information 1. WHAT SOMATROPIN BIOPARTNERS IS AND WHAT IT IS USED FOR Somatropin Biopartners contains human growth hormone, also called somatropin. Growth hormone regulates the growth and development of cells. This medicine is used to treat adults with a lack (deficiency) of growth hormone who - already had growth hormone deficiency when they were children or - do not have enough growth hormone during adulthood. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE SOMATROPIN BIOPARTNERS DO NOT USE SOMATROPIN BIOPARTNERS - if you are allergic to somatropin or any of the other ingr Perskaitykite visą dokumentą
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Somatropin Biopartners 2 mg powder and solvent for prolonged-release suspension for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One vial delivers 2 mg of somatropin* (corresponding to 6 IU). _ _ After reconstitution, 0.2 mL of suspension contains 2 mg somatropin (10 mg/mL). _ _ *produced in Saccharomyces cerevisiae by recombinant DNA technology For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for prolonged-release suspension for injection. White or almost white powder. The solvent is a clear, oily liquid. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Somatropin Biopartners is indicated for the replacement therapy of endogenous growth hormone in adults with childhood- or adult-onset growth hormone deficiency (GHD). Adult-onset: Patients with GHD in adulthood are defined as patients with known hypothalamic-pituitary pathology and at least one additional known deficiency of a pituitary hormone excluding prolactin. These patients should undergo a single dynamic test in order to diagnose or exclude a GHD. Childhood-onset: In patients with childhood-onset isolated GHD (no evidence of hypothalamic-pituitary disease or cranial irradiation), two dynamic tests should be performed after completion of growth, except for those having low insulin-like growth factor-I (IGF-I) concentrations (< -2 standard deviation score (SDS)), who may be considered for one test. The cut-off point of the dynamic test should be strict. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Diagnosis and therapy with this medicinal product should be initiated and monitored by physicians adequately experienced in the diagnosis and man Perskaitykite visą dokumentą