BYLVAY 1200 MICROGRAMS

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

ODEVIXIBAT AS SESQUIHYDRATE

متاح من:

MEDISON PHARMA LTD

ATC رمز:

A05AX05

الشكل الصيدلاني:

HARD CAPSULE

تركيب:

ODEVIXIBAT AS SESQUIHYDRATE 1200 MCG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

ALBIREO AB, SWEDEN

المجال العلاجي:

ODEVIXIBAT

الخصائص العلاجية:

Bylvay is indicated for the treatment of progressive familial intrahepatic cholestasis (PFIC) in patients aged 6 months or olderBylvay is indicated for the treatment of cholestatic pruritus in patients 12 months of age and older with Alagille syndrome (ALGS).

تاريخ الترخيص:

2023-01-05

نشرة المعلومات

1
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
BYLVAY 200 MICROGRAMS HARD CAPSULES
BYLVAY 400 MICROGRAMS HARD CAPSULES
BYLVAY 600 MICROGRAMS HARD CAPSULES
BYLVAY 1,200 MICROGRAMS HARD CAPSULES
ACTIVE INGREDIENT AND ITS QUANTITY:
BYLVAY 200 MCG HARD CAPSULES:
Each hard capsule contains 200 micrograms odevixibat (as
sesquihydrate)._ _
_ _
BYLVAY 400 MCG HARD CAPSULES:
Each hard capsule contains 400 micrograms odevixibat (as
sesquihydrate)._ _
_ _
BYLVAY 600 MCG HARD CAPSULES:
Each hard capsule contains 600 micrograms odevixibat (as
sesquihydrate)._ _
_ _
BYLVAY 1,200 MCG HARD CAPSULES:
Each hard capsule contains 1,200 micrograms odevixibat (as
sesquihydrate)._ _
Inactive ingredients and allergens - see section 6 "Additional
information".
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
This leaflet contains concise information about this medicine. If you
have any further
questions, consult your doctor or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may
harm them, even if it seems to you that their illness is similar to
yours.
1.
WHAT IS THE MEDICINE INTENDED FOR?
Bylvay is indicated for the treatment of progressive familial
intrahepatic cholestasis (PFIC) in
patients aged 6 months or older. PFIC is a liver disease caused by
build-up of bile acids
(cholestasis) that gets worse over time and is often accompanied with
severe itching.
This medicine increases the excretion of bile acids from the body.
Bile acids are components
of the digestive fluid called bile, which is produced by the liver and
secreted into the
intestines. The active ingredient, odevixibat, blocks the mechanism
that normally reabsorbs
the bile acids from the intestines after they have done their job.
This allows them to pass out
of the body in the stool.
THERAPEUTIC GROUP: other drugs for bile therapy
2.
BEFORE USING THE MEDICINE
X DO NOT USE THIS MEDICINE IF:
•
You ar

خصائص المنتج

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Bylvay 200 micrograms
hard capsules
Bylvay 400 micrograms
hard capsules
Bylvay 600 micrograms
hard capsules
Bylvay 1,200 micrograms
hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Bylvay 200 mcg hard capsules
Each hard capsule contains odevixibat sesquihydrate equivalent to 200
micrograms odevixibat_ _
_ _
Bylvay 400 mcg hard capsules
Each hard capsule contains odevixibat sesquihydrate equivalent to 400
micrograms odevixibat_ _
_ _
Bylvay 600 mcg hard capsules
Each hard capsule contains odevixibat sesquihydrate equivalent to 600
micrograms odevixibat_ _
_ _
Bylvay 1,200 mcg hard capsules
Each hard capsule contains odevixibat sesquihydrate equivalent to
1,200 micrograms odevixibat_ _
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule
Bylvay 200 mcg hard capsules
S
ize 0 capsule with ivory opaque cap and white opaque body; imprinted
“A200”
with black ink.
Bylvay 400 mcg hard capsules
S
ize 3 capsule with orange opaque cap and white opaque body; imprinted
“A400”
with black ink.
Bylvay 600 mcg hard capsules
Size 0 capsule
with ivory opaque cap and body; imprinted “A600”
with black ink.
Bylvay 1,200 mcg hard capsules
S
ize 3 capsule with orange opaque cap and body; imprinted “A1200”
with black ink.
4.
CLINICAL PARTICULARS
2
4.1
THERAPEUTIC INDICATIONS
Progressive Familial Intrahepatic Cholestasis (PFIC)
Bylvay is indicated for the treatment of progressive familial
intrahepatic cholestasis (PFIC) in patients
aged 6 months or older (see sections 4.4 and 5.1).
Alagille Syndrome (ALGS)
Bylvay is indicated for the treatment of cholestatic pruritus in
patients 12 months of age and older with
ALGS.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment must be initiated and supervised by physicians experienced
in the management of PFIC.
Posology
RECOMMENDED DOSAGE FOR PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS
(PFIC) IN PATIENTS
AGED 6 MONTHS OR OLDER
The recommended dose of odevixibat is 40 mcg/