Country: Малезија
Језик: Енглески
Извор: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
GALSULFASE
PHARM-D SDN. BHD.
GALSULFASE
5ml mL
BioMarin International Limited
NAGLAZYME ® _ _ Concentrated Solution for Intravenous Infusion Galsulfase (1mg/1 ml) 1 _Consumer Medication Information Leaflet (RiMUP)_ WHAT IS IN THIS LEAFLET 1. What Naglazyme is used for 2. How Naglazyme works 3. Before you use Naglazyme 4. How to use Naglazyme 5. While you are using Naglazyme 6. Side effects 7. Storage and disposal of Naglazyme 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT NAGLAZYME IS USED FOR Naglazyme is used to treat patients with Mucopolysaccharidosis VI (MPS VI, Maroteaux-Lamy syndrome), a rare lysosomal storage disease (LSD). People with MPS VI disease have either a low level or no level of activity of an enzyme called _N-acetylgalactosamine 4-_ _sulfatase_, which breaks down specific substances (glycosaminoglycans) in the body. As a result, these substances do not get broken down and processed by the body as they should. They accumulate in many tissues in the body, leading to a progressive disorder with multiple organ and tissue involvement. HOW NAGLAZYME WORKS This medicine contains a recombinant enzyme called galsulfase. This can replace the natural enzyme which is lacking in MPS VI patients. Treatment has been shown to improve walking and stair-climbing ability, and to reduce the levels of glycosaminoglycans in the body. BEFORE YOU USE NAGLAZYME - _When you must not use it_ Your doctor will tell you if you should not be treated with Naglazyme. _ _ - _Before you start to use it _ Tell your doctor if you have or have had any medical conditions, especially if you: Have ever had an allergic reaction to galsulfase or any other ingredients of Naglazyme. Have sleep apnea (a condition in which breathing stops for a short time or becomes shallow during sleep) Have heart disease Have lung disease or breathing problems Have a fever, cough, or cold Are pregnant or planning to become pregnant. Are breast-feeding or planning to breast-feed - _Taking other medicines_ Tell your doctor or nurse if you or your child are Прочитајте комплетан документ
FULL PRESCRIBING INFORMATION INDICATIONS AND USAGE NAGLAZYME® (galsulfase) is indicated for patients with Mucopolysaccharidosis VI (MPS VI, Maroteaux-Lamy syndrome). NAGLAZYME has been shown to improve walking and stair-climbing capacity. DOSAGE AND ADMINISTRATION RECOMMENDED DOSE The recommended dosage regimen of NAGLAZYME is 1 mg per kg of body weight administered once weekly as an intravenous infusion. Pretreatment with antihistamines with or without antipyretics is recommended 30 to 60 minutes prior to the start of the infusion _ [see _ _Warnings and Precautions]._ The total volume of the infusion should be delivered over a period of time of no less than 4 hours. NAGLAZYME should be diluted with 0.9% Sodium Chloride Injection, USP, to a final volume of 250 mL and delivered by controlled intravenous infusion using an infusion pump. The initial infusion rate should be 6 mL per hour for the first hour. If the infusion is well tolerated, the rate of infusion may be increased to 80 mL per hour for the remaining 3 hours. The infusion time can be extended up to 20 hours if infusion reactions occur. For patients 20 kg and under or those who are susceptible to fluid volume overload, physicians may consider diluting NAGLAZYME in a volume of 100 mL [_see Warnings and Precautions and Adverse Reactions_]. The infusion rate (mL per hour) should be decreased so that the total infusion duration remains no less than 4 hours. Each vial of NAGLAZYME provides 5 mg of galsulfase (expressed as protein content) in 5 mL of solution and is intended for single use only. Do not use the vial more than one time. The concentrated solution for infusion must be diluted with 0.9% Sodium Chloride Injection, USP, using aseptic techniques. Prepare NAGLAZYME using low-protein-binding containers and administer the diluted NAGLAZYME solution to patients using a low-protein-binding infusion set equipped with a low-protein-binding 0.2 μm in-line filter. There is no information on the compatibility of diluted NAGLAZYME with glass containers. INSTRU Прочитајте комплетан документ