Land: Malaysia
Språk: engelska
Källa: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
RECOMBINANT HUMAN SOMATROPIN
UNITED ITALIAN TRADING (M) SDN BHD
RECOMBINANT HUMAN SOMATROPIN
01.5ml mL
Sandoz GmbH, Biochemiestrasse
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ _ _ SCITROPIN A TM CARTRIDGE SOLUTION FOR INJECTION Somatropin (5mg/1.5mL (15IU), 10mg/1.5mL (30IU)) 1 WHAT IS IN THIS LEAFLET 1. What SciTropin A TM is used for 2. How SciTropin A TM works 3. Before you use SciTropin A TM 4. How to use SciTropin A TM 5. While you are using SciTropin A TM 6. Side effects 7. Storage and Disposal of SciTropin A TM 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number WHAT SCITROPIN A™ IS USED FOR The name of your medicine is SciTropin A™. It contains a biosynthetic human growth hormone known as Somatropin, which is a protein molecule occurring naturally in humans. SciTropin A™ is identical to the body’s own growth hormone. It is used to treat children who grow too slowly because of a deficiency of growth hormone, chronic renal failure, Prader ‐ Willi syndrome, Turner syndrome, children born small for gestational age and as a replacement therapy in adults with pronounced growth hormone deficiency. Your doctor, however, may have prescribed SciTropin A™ for another purpose. Ask your doctor if you have any questions about why SciTropin A™ has been prescribed for you. This medicine is available only with a doctor’s prescription. SciTropin A™ is not addictive. HOW SCITROPIN A™ WORKS SciTropin A™ is produced using recombinant DNA technology. The active substance Somatropin (biosynthetic human growth hormone, rDNA ‐ derived human growth hormone [r ‐ hGH]) is produced in cell culture by Escherichia coli cells bearing the gene for human growth hormone BEFORE YOU USE SCITROPIN A™ _- When you must not use it _ Do not use SciTropin A if: 1. You are allergic to Somatropin or to any of the excipients (benzyl alcohol). Some of the symptoms of an allergic reaction may include skin rash, itching, difficulty breathing or swelling of the face or lips. 2. You have evidence of cancer or tumour. 3. You have a serious injury or illness. 4. The child being treated has closed Läs hela dokumentet
SCITROPIN A ™ Somatropin (rbe) (recombinant human growth hormone, r-hGH) Solution for Injection in cartridge 5 mg/1.5 mL (15 IU) and 10 mg/1.5 mL (30 IU) DESCRIPTION SciTropin A ™ is produced using recombinant DNA technology. The active substance somatropin (biosynthetic human growth hormone, rDNA-derived human growth hormone [r-hGH]) is produced in cell culture by Escherichia coli cells bearing the gene for human growth hormone. SciTropin A ™ Solution for Injection is a clear, colourless solution. SciTropin A ™ is a biosimilar product of Genotropin ®. SciTropin A™ has been shown to have a comparable quality, safety and efficacy profile to Genotropin ®. COMPOSITION _SciTropin A_ _TM_ _ 5 mg/1.5mL (15 IU) Solution for Injection _ Each cartridge (1.5 mL) contains 10 mg recombinant somatropin. Other ingredients: sodium phosphate dibasic heptahydrate 1.34 mg, sodium phosphate monobasic dihydrate 1.56 mg, poloxamer 188 3.0 mg, phenol 4.50 mg, glycine 27.75 mg and water for injection ad 1.5 mL. _SciTropin A_ _TM_ _ 10 mg/1.5mL (30 IU) Solution for Injection_ Each cartridge (1.5 mL) contains 10 mg recombinant somatropin. Other ingredients: sodium phosphate dibasic heptahydrate 1.34 mg, sodium phosphate monobasic dihydrate 1.56 mg, poloxamer 188 3.0 mg, phenol 4.50 mg, glycine 27.75 mg and water for injection ad 1.5 mL. CLINICAL TRIAL DATA FOR THE BIOSIMILAR DESCRIBING CLINICAL SIMILARITY TO THE REFERENCE PRODUCT In three sequential clinical trials, involving a total of previously untreated 89 GHD children the efficacy and safety of SciTropin A™ were compared with another somatropin (Genotropin ®) product approved for growth hormone deficiency (GHD) in pediatric patients. 44 patients received SciTropin A ™ powder for solution for injection (p.f.s.f.i.) 5.8 mg/ vial and 45 patients received Genotropin ® for 9 months. After 9 months of treatment patients who had received Genotropin ® product were switched to SciTropin A ™ solution for injection (s.f.i.) 5 mg/1.5 mL. After 15 months of treatment, all pa Läs hela dokumentet