Evrysdi Powder for oral solution 0.75 mgmL

Quốc gia: Malaysia

Ngôn ngữ: Tiếng Anh

Nguồn: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Thành phần hoạt chất:

RISDIPLAM

Sẵn có từ:

ROCHE (MALAYSIA) SDN. BHD.

INN (Tên quốc tế):

RISDIPLAM

Các đơn vị trong gói:

100 ml

Sản xuất bởi:

F.HOFFMANN-LA ROCHE LTD

Tờ rơi thông tin

_ _
_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

Đặc tính sản phẩm

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