Ország: Malajzia
Nyelv: angol
Forrás: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
RISDIPLAM
ROCHE (MALAYSIA) SDN. BHD.
RISDIPLAM
100 ml
F.HOFFMANN-LA ROCHE LTD
_ _ _Consumer Medication Information Leaflet (RiMUP) _ EVRYSDI POWDER FOR ORAL SOLUTION 0.75MG/ML Risdiplam _ _ 1 WHAT IS IN THIS LEAFLET 1. What EVRYSDI is used for 2. How EVRYSDI works 3. Before you use EVRYSDI 4. How to use EVRYSDI 5. While you are using EVRYSDI 6. Side effects 7. Storage and disposal of EVRYSDI 8. Product Description 9. Manufacturer 10. Product Registration Holder 11. Date of Revision 12. Serial Number WHAT EVRYSDI IS USED FOR EVRYSDI is a prescription medicine used to treat spinal muscular atrophy (SMA) in children and adults. HOW EVRYSDI WORKS EVRYSDI works by helping the body make more SMN protein and maintain SMN protein levels throughout the body with continued use. This reduces the loss of nerve cells and may improve muscle strength and function in a broad range of ages and SMA types. In infants with SMA, EVRYSDI improves survival, preserves swallowing, improves likelihood of achieving milestones, and reduces the need for hospitalization and ventilator supported breathing. In children (infants to adolescents) and adults, EVRYSDI may maintain or improve motor function over time. BEFORE YOU USE EVRYSDI - _WHEN YOU MUST NOT USE IT _ Do not take EVRYSDI if: 1. you are allergic to risdiplam or any of the ingredients in EVRYSDI. See the end of this leaflet for a complete list of ingredients in EVRYSDI. 2. the package is torn or shows signs of tampering 3. the expiry date (EXP) printed on the pack has passed. If you take this medicine after the expiry date has passed, it may not work as well. - _BEFORE YOU START TO USE IT_ Before taking EVRYSDI, tell your healthcare provider about all of your medical conditions. - _TAKING OTHER MEDICINES _ Tell your healthcare provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, or herbal supplements. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. HOW TO USE EVRYSDI See the detailed Instructions for Use that comes with EVRYSDI for information on how Olvassa el a teljes dokumentumot
PACK INSERT FOR MALAYSIA EVRYSDI 0.75MG/ML Powder for Oral Solution Risdiplam 1. INDICATIONS AND USAGE EVRYSDI is indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients. 2. DOSAGE AND ADMINISTRATION 2.1 IMPORTANT ADMINISTRATION INSTRUCTIONS Dose Preparation It is recommended that a healthcare provider discuss with the patient or caregiver how to prepare the prescribed daily dose prior to administration of the first dose _[see Instructions for Use]._ Instruct patients or caregivers to prepare the dose using the reusable oral syringe provided. EVRYSDI must be taken immediately after it is drawn up into the oral syringe. If EVRYSDI is not taken within 5 minutes, EVRYSDI should be discarded from the oral syringe, and a new dose should be prepared._ _ Dose Administration EVRYSDI is taken orally once daily after a meal at approximately the same time each day. In infants who are breastfed, EVRYSDI should be administered after breastfeeding. EVRYSDI cannot be mixed with formula or milk. Instruct patients to drink water after taking EVRYSDI to ensure the drug has been completely swallowed. If the patient is unable to swallow and has a nasogastric or gastrostomy tube, EVRYSDI can be administered via the tube. The tube should be flushed with water after delivering EVRYSDI _[see _ _Instructions for Use]. _ 2.2 DOSING INFORMATION EVRYSDI is administered orally once daily. The recommended dosage is determined by age and body weight (see Table 1). TABLE 1 ADULT AND PEDIATRIC DOSING REGIMEN BY AGE AND BODY WEIGHT AGE AND BODY WEIGHT RECOMMENDED DAILY DOSAGE Less than 2 months of age 0.15mg/kg 2 months to less than 2 years of age 0.2 mg/kg 2 years of age and older weighing less than 20 kg 0.25 mg/kg 2 years of age and older weighing 20 kg or more 5 mg 2.3 MISSED DOSE If a dose of EVRYSDI is missed, EVRYSDI should be administered as soon as possible if still within 6 hours of the missed dose, and the usual dosing schedule can be resumed on the next day. Otherwise, the missed dose should be ski Olvassa el a teljes dokumentumot