EVRYSDI

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

RISDIPLAM

متاح من:

ROCHE PHARMACEUTICALS (ISRAEL) LTD

ATC رمز:

M09AX10

الشكل الصيدلاني:

POWDER FOR SOLUTION

تركيب:

RISDIPLAM 60 MG/BOTTLE

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

Required

المصنعة من قبل:

HOFFMANN LA ROCHE LTD, SWITZERLAND

المجال العلاجي:

RISDIPLAM

الخصائص العلاجية:

Evrysdi is indicated for the treatment of spinal muscular atrophy (SMA) types 1,2 and 3 in patients 2 months of age and older.

تاريخ الترخيص:

2021-06-29

نشرة المعلومات

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

خصائص المنتج

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