Country: ইস্রায়েল
ভাষা: ইংরেজি
সূত্র: Ministry of Health
RISDIPLAM
ROCHE PHARMACEUTICALS (ISRAEL) LTD
M09AX10
POWDER FOR SOLUTION
RISDIPLAM 60 MG/BOTTLE
ORAL
Required
HOFFMANN LA ROCHE LTD, SWITZERLAND
RISDIPLAM
Evrysdi is indicated for the treatment of spinal muscular atrophy (SMA) types 1,2 and 3 in patients 2 months of age and older.
2021-06-29
INSTRUCTIONS FOR CONSTITUTION (FOR HCP) EVRYSDI 0.75 MG/ML POWDER FOR ORAL SOLUTION Risdiplam Instructions for Constitution (FOR PHARMACISTS ONLY) 1 EACH EVRYSDI CARTON CONTAINS (SEE FIGURE A): 1 1 Cap 2 1 Evrysdi bottle 3 2 Oral syringes 12 mL (in pouches) 4 2 Oral syringes 6 mL (in pouches) 5 1 Press-in bottle adapter 6 1 Package Leaflet (not shown) 7 1 Instructions for Constitution (not shown) 8 1 Instructions for Use (not shown) Figure A 2 IMPORTANT INFORMATION ABOUT EVRYSDI • AVOID INHALING Evrysdi powder. • USE GLOVES. • DO NOT use if the powder expiry date has passed. The powder expiration date is printed on the bottle label. • DO NOT dispense the constituted solution if the solution’s Discard After date exceeds the original powder expiration date. • AVOID GETTING CONTACT with the medicine on your skin. If the medicine gets on your skin, wash the area with soap and water. • DO NOT use the medicine if any of the supplies are damaged or missing. • Use Purified Water or Water for Injection to constitute the medicine. • Do not add oral syringes other than the ones provided in the carton. 3 HOW TO STORE EVRYSDI • Do not store the powder (unconstituted medicine) above 25°C and keep it in the carton. Do not freeze. • Store the solution (constituted medicine) in a refrigerator (2 to 8°C) and keep it in the carton upright. • Keep the oral solution in the original bottle and always keep the bottle in an upright position with the cap tightly closed. 4 CONSTITUTION Figure B STEP 1 Gently tap the bottom of the bottle to loosen the powder (See Figure B). 5 Figure C STEP 2 Remove the cap by pushing it down and then twisting to the left (counter- clockwise) (See Figure C). Do not throw away the cap. 6 Figure D STEP 3 Carefully pour 79 mL of Purified Water or Water for Injection into the medicine bottle (See Figure D). 7 Figure E STEP 4 Hold the medicine bottle on a table with one hand. Insert the press-in bottle adapter into the opening by pushing it down with the other hand. Ensure it is complet সম্পূর্ণ নথি পড়ুন
1 Evrysdi_PI_ver 4 EVRYSDI ® RISDIPLAM Powder for oral Solution 1. NAME OF THE MEDICINAL PRODUCT Evrysdi 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each bottle contains 60 mg risdiplam in 2 g powder for oral solution. Each mL of the constituted solution contains 0.75 mg risdiplam. Excipients with known effects Each mL contains 0.38 mg of sodium benzoate and 2.97 mg of isomalt. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for oral solution. Light yellow, yellow, greyish yellow, greenish yellow, or light green powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS EVRYSDI is indicated for the treatment of spinal muscular atrophy (SMA) types 1, 2 and 3 in patients 2 months of age and older 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with Evrysdi should be initiated by a physician with experience in the management of SMA. Posology The recommended once daily dose of Evrysdi is determined by age and body weight (see Table 1). Evrysdi is taken orally once a day after a meal at approximately the same time each day. TABLE 1. Dosing regimen by age and body weight _AGE AND BODY WEIGHT_ _RECOMMENDED DAILY DOSE_ 2 months to < 2 years of age 0.20 mg/kg ≥ 2 years of age (< 20 kg) 0.25 mg/kg ≥ 2 years of age ( ≥ 20 kg) 5 mg 2 Treatment with a daily dose above 5 mg has not been studied. _Delayed or missed doses_ If a planned dose is missed, it should be administered as soon as possible if still within 6 hours of the scheduled dose. Otherwise, the missed dose should be skipped and the next dose should be administered at the regularly scheduled time the next day. If a dose is not fully swallowed or vomiting occurs after taking a dose of Evrysdi, another dose should not be administered to make up for the incomplete dose. The next dose should be administered at the regularly scheduled time. _Elderly_ No dose adjustment is required in elderly patients based on limited data in subjects aged 65 years and older (see section 5.2). _Renal impairment_ Risdiplam has not been s সম্পূর্ণ নথি পড়ুন