国: マレーシア
言語: 英語
ソース: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Somatropin , recombinant DNA derived human growth hormone
MERCK SDN. BHD.
Somatropin , recombinant DNA derived human growth hormone
1units Units; 5units Units
Merck Serono S.p.A.
_Consumer Medication Information Leaflet (RiMUP) _ 1 SAIZEN LIQUID Somatrapin (6mg, 12mg, 20mg) WHAT IS IN THIS LEAFLET 1. What Saizen is used for 2. How Saizen works 3. Before you use Saizen 4. How to take 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: In the treatment of children with short stature who have failed to grow because their body produces no growth hormone or insufficient levels of growth hormone. In the 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. In the 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: In the 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 take it _ If you or your child are allergic (hypersensitive) to somatropin or any of the other ingredients of Saizen. If you have been told that your child’s bones have stopped growing and that he/she has therefore reached his/her 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, s 完全なドキュメントを読む
1. NAME OF THE MEDICIN AL PRODUCT 6 mg (5.83 mg/ml), 12 mg (8 mg/ml), 20 mg (8 mg/ml) solution for injection 2. QUALITATIV E AN D QUAN TITATIVE COMPOSITION Saizen Liquid 6 mg solution for injection. Each cartridge contains 1.03 ml solution (6 mg somatropin*) Saizen Liquid 12 mg & 20 mg for injection: Each cartridge contains 1.50 ml solution (12 mg somatrop rin*) or 2.50 ml solution (20 mg somatropin*). *recombinant human growth hormone, pro duced by recombinant DNA technology in mammalian cells For a full list of excipients, see sectio n 6.1. 3. PHARMACEUTICAL FORM Solutio n for injection. Clear to slightly opalescent solution with pH of 5.6 -6.6 and osmolality 250 -450 mOsm/k g. 4. CLINICA L PARTICULARS 4.1 Therapeutic indications Saizen® is indicated in the treatment of: • growth failure in children caused by decreased or absent secretion of endogenous growth hormone. • growt h failur e in girls wit h gonada l dysgenesi s (Turne r Syndrome) , confirme d by chromosomal analysis. • growth disturbance (current height 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 (HV SD S < 0 during the last year) by 4 years of age or later. • replacemen t therap y in adult s with pronounce d growt h hormon e deficienc y as diagnose d by a single dynami c test for growt h hormon e deficiency . 完全なドキュメントを読む