Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
SOMATROPIN, BIOSYNTHETIC
MERCK SDN. BHD.
SOMATROPIN, BIOSYNTHETIC
5Units Units; 1Units Units
Merck Serono S.p.A.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ 1 SAIZEN ® CLICK.EASY INJECTION Somatropin (8mg) 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, abdomin Baca dokumen lengkap
1 1. NAME OF THE MEDICINAL PRODU CT Saizen® 8 mg click. easy®, powder and solvent for solution for injection 2. QUA LITATIVE AND QU ANTITATIVE COMPO SITION Each vial of Saizen 8 mg click.easy contains 8 mg somatropin* (recombinant human growth hormone). *produced by recombinant DNA technology in mammalian cells Reconstitution with the contents of the bacteriostatic solvent cartridge gives a concentration of 5.83 mg/ml. For the full list of excipients, see section List of excipients 3. PHA RMACEUTICAL 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 6.5 -8.5. 4. CLINICAL PARTICULARS 4.1 Therapeu tic indi cations Saizen® is indicated in the trea tment of: • growth failure in children caused by decrea sed or absent secretion of endogenous growth hormone. • growth failure in girls with gonadal dysgenesis (Tur ner Syn drome), confirmed by chromosomal analysis. • growth disturbance (cur rent height SDS < -2.5 and pare ntal adjusted height SDS < -1) in sho rt children born small for gestational age (SG A) 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 later. 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: Font: (Default) Calibri, (Asian) Calibri Formatted: Font: (Default) Calibri, (Asian) Calibri, Bold Formatted ... Formatted: Font: (Default) Calibri, (Asian) Calibri Formatted: Font: (Default) Calibri, (Asian) Calibri, Bold For Baca dokumen lengkap