Country: Малезија
Језик: Енглески
Извор: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
SOMATOTROPIN,RECOMBINANT HUMAN
MERCK SDN. BHD.
SOMATOTROPIN,RECOMBINANT HUMAN
5ml1Units mL; 5ml5Units mL
Merck Serono S.A. (Aubonne)
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ 1 SAIZEN ® INJECTION Somatropin (3.33mg) WHAT IS IN THIS LEAFLET 1. What Saizen is used for 2. How Saizen works 3. Before you use Saizen 4. How to use Saizen 5. While you are using Saizen 6. Side Effects 7. Storage and Disposal of Saizen 8. Product Description 9. Manufacturer and Product Registration holder 10. Date of revision WHAT SAIZEN IS USED FOR Saizen is a growth hormone. In children and adolescents: • Treatment of children with short stature who have failed to grow because their body produces no growth hormone or insufficient levels of growth hormone. • Treatment of girls who have failed to grow due to gonadal dysgenesis (also referred to as Turner Syndrome), confirmed by a test on the chromosomes. • Treatment of growth problems in children who were born small and who have not reached normal height by the age of 4 years or later. In adults: • Treatment of adults with a marked lack of growth hormone (growth hormone deficiency). This therapy is given to adults who have a serious growth hormone deficiency that has been medically diagnosed by a test. HOW SAIZEN WORKS Saizen's main action is to increase growth in children and adolescents and to treat adults with growth hormone deficiency. The growth hormone (somatropin) contained in Saizen is almost the same as human’s natural growth hormone except that it is made outside the body by a process called “recombinant DNA technology” (genetic engineering). BEFORE YOU USE SAIZEN _- When you must not use it _ • If you or your child are allergic (hypersensitive) to somatropin or any of the other ingredients of Saizen. • If you or your child’s bones have stopped growing and therefore reached the final height. • If you have an active tumour (cancer). Tumours must be inactive and you must have finished your anti - tumour treatment before you start your treatment with Saizen. • If you or your child have an acute critical illness, suffering complications following open heart surgery, abdominal surg Прочитајте комплетан документ
1 1. NA ME OF THE MEDICINA L PRODU CT Saizen® 3.33 mg powder and solvent for solution for injecti on 2. QU ALITATIVE AN D QU ANTITATIVE COM POSI TION Each vial of Saizen 3.33 mg contains somatropin* (recombinant human growth hormone). *produced by recombinant DNA technology in mammalian cells After reconstitution with the enclosed solvent, each vial shall contain ≥ 0.67 mg of Saizen/ml. For the full list of excipients, see section List o f excipients . 3. PHARMACEUTICAL FORM Powder and solvent for solution for injection Appearance of the powder: white lyophilised powder. Appearance of the solvent: clear colourless solution. The pH of the reconstituted solution is 7.4 –8.5. 4. CLINICAL PARTICULARS 4.1 Therapeu tic indi cations Saizen® is indicated in t he treatme nt of: • growth fail ure in children caused by decreased or absent secretion of endogenous growth hormone. • growth fail ure in girls with gonadal dysgenesis (Turner Syndrome ), confirmed by chromosomal analysis. • growth disturbance (current height SDS < -2.5 and parental adjusted height SDS < -1) in short children born small for gestati onal age (SGA) with a birth weight and/ or length below – 2 SD, who failed to show catch -up growth (HV SDS < 0 during the last year) by 4 years of age or la ter. • replaceme nt therapy in adults with pronounced growth hormone deficiency as diagnosed by a single dynamic test for growth hormone deficiency. Patients must also fulfill the following crit eria: Formatted: Font: (Default) Calibri, (Asian) Calibri, Bold Formatted: List Paragraph, Outline numbered + Level: 1 + Numbering Style: 1, 2, 3, … + Start at: 1 + Alignment: Left + Aligned at: 0.2 cm + Indent at: 0.84 cm Formatted: Font: (Default) Calibri, (Asian) Calibri Formatted: Font: (Default) Calibri, (Asian) Calibri, Bold Formatted: List Paragraph, Outline numbered + Level: 1 + Numbering Style: 1, 2, 3, … + Start at: 1 + Alignment: Left + Aligned at: 0.2 cm + Indent at: 0.84 cm Formatted ... Formatted: Font: (Default) Calibri, (Asian) Calibri, Bo Прочитајте комплетан документ