Țară: Malaezia
Limbă: engleză
Sursă: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
somatropin
PFIZER (MALAYSIA) SDN. BHD.
somatropin
5 Units; 1 Units
Pfizer Manufacturing Belgium NV
Pfizer Confidential _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ GENOTROPIN _®_ Somatropin (5.3 mg, 12 mg) 1 WHAT IS IN THIS LEAFLET 1. What GENOTROPIN is used for 2. How GENOTROPIN works 3. Before you use GENOTROPIN 4. How to use GENOTROPIN 5. While you are using it 6. Side Effects 7. Storage and Disposal of GENOTROPIN 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number WHAT GENOTROPIN IS USED FOR In children, GENOTROPIN is used to treat growth disturbances: - If you do not have enough of your own growth hormone. - If you have Turner syndrome (chromosomal error in girls that can affect growth). - If you have chronic renal (kidney) insufficiency. As kidneys lose their ability to function normally, this can affect growth. - If you have Prader-Willi syndrome (a chromosomal disorder). Growth hormone will help you grow taller if you are still growing, and will also improve your body composition. - If you were small or too light at birth or if you have not been able to catch up or maintain normal growth by four years of age or later. In adults, GENOTROPIN is used to treat persons with pronounced growth hormone deficiency. This can start during adult life, or it can continue from childhood. If you have been treated with GENOTROPIN for growth hormone deficiency during childhood, your growth hormone status will be retested after completion of growth. HOW GENOTROPIN WORKS GENOTROPIN 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 a recombinant DNA-derived protein, meaning it is not made from human or animal tissue. BEFORE YOU USE GENOTROPIN - _When you must not use it_ Do not take GENOTROPIN if - You are allergic (hypersensitive) to somatropin or any of the other ingredients of GENOTROPIN (listed under Product Description). - You have an active tumour (cancer) Citiți documentul complet
1. NAME OF THE MEDICINAL PRODUCT GENOTROPIN 5.3 mg, or 12 mg, powder and solvent for solution for injection. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Somatropin (INN) recombinant DNA-derived human growth hormone produced in _E. coli_. 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 Two-chamber cartridge: 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. The two-chamber cartridge is supplied for use in a sealed disposable multidose pre-filled pen (GoQuick). 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS CHILDREN Growth disturbance due to insufficient secretion of growth hormone (growth hormone deficiency, GHD) and growth disturbance associated with Turner syndrome or chronic renal insufficiency. Growth disturbance [current height standard deviation score (SDS) < - 2.5 and parental adjusted height SDS < - 1] in short children born small for gestational age (SGA), with a birth weight and/or length below - 2 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 w Citiți documentul complet