CHOLBAM 50 MG

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

CHOLIC ACID

متاح من:

MEGAPHARM LTD

ATC رمز:

A05AA03

الشكل الصيدلاني:

HARD CAPSULE

تركيب:

CHOLIC ACID 50 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

PATHEON PHARMACEUTICALS INC.

المجال العلاجي:

CHOLIC ACID

الخصائص العلاجية:

•Cholbam is indicated for the treatment of inborn errors in primary bile acid synthesis due to Sterol 27-hydroxylase (presenting as cerebrotendinous xanthomatosis, CTX) deficiency, • 2- (or alfa - ) methylacyl-CoA racemase (AMACR) deficiency in infants, children and adolescents aged 1 month to 18 years and adults• Cholesterol 7 alfa - hydroxylase (CYP7A1) deficiency in infants, children and adolescents aged 1 month to 18 years and adults• 3β-hydroxy-5-C27-steroid oxidoreductase deficiency (also known as 3β-hydroxy-5-C27-steroid dehydrogenase/isomerase or 3β-HSD or HSD3β7.

تاريخ الترخيص:

2021-04-30

نشرة المعلومات

PATIENT PACKAGE INSERT IN ACCORDANCE WITH
THE PHARMACISTS’ REGULATIONS - 1986
This medicine is dispensed with a physician’s prescription only
CHOLBAM 50 MG
CHOLBAM 250 MG
HARD CAPSULES
ACTIVE INGREDIENT:
Cholic acid 50, 250 mg
FOR THE LIST OF INACTIVE INGREDIENTS AND ALLERGENS IN THE
PREPARATION, SEE SECTION 6 - “ADDITIONAL INFORMATION”.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE
MEDICINE. This leaflet contains concise information about the
medicine. If you have any further questions, consult your physician
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.
1. WHAT IS THIS MEDICINE INTENDED FOR?
CHOLBAM is intended for the treatment of infants from one month
old, children and adolescents up to 18 years old, and adults who
have an inborn error in bile acid synthesis due to a deficiency of
one of the following enzymes:
•
Sterol 27-hydroxylase
(presenting as cerebrotendinous xanthomatosis, CTX(
•
2- (or alpha-( methylacyl-CoA racemase (AMACR(
•
Cholesterol 7alpha-hydroxylase (CYP7A1(
•
3β-hydroxy-5-C27-steroid oxidoreductase (3β-hydroxy-5-C27-
steroid dehydrogenase/isomerase or 3β-HSD or HSD3β7(
THERAPEUTIC GROUP: Bile acids.
CHOLBAM contains cholic acid.
Your liver makes cholic acid in your body naturally when it makes
bile, which is a fluid that helps with digesting and absorbing fats
and vitamins from your food. Cholic acid also helps in the process
of children’s growth and normal development.
CHOLBAM is intended for use in cases where there is an inborn
problem of cholic acid production. CHOLBAM replaces the cholic
acid which the body does not make; this helps produce bile acids
in the body and prevents the accumulation of harmful substances
in the liver.
In infants, cholic acid treatment helps in the normal development
of the liver and the blood-bile circulation.
CHOLBAM can be used from the age of one month. Patients who
have been diagnosed with a con

خصائص المنتج

1.
NAME OF THE MEDICINAL PRODUCT
CHOLBAM 50 mg
CHOLBAM 250 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 50 mg of cholic acid.
Each hard capsule contains 250 mg of cholic acid.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
CHOLBAM is available in two capsule strengths:
•50 mg capsule: Swedish Orange size 2 hard gelatin capsule with cap
imprinted with “50mg” and body
imprinted with “ASK001”. The capsules contain a white to off-white
powder.
•250 mg capsule: White opaque size 0 hard gelatin capsule with a cap
imprinted with “250mg” and body
imprinted with “ASK002”. The capsules contain a white to off-white
powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Cholbam is indicated for the treatment in infants, children,
adolescents aged 1 month to 18
years and adults of inborn errors in primary bile acid synthesis due
to Sterol 27-hydroxylase
(presenting as cerebrotendinous xanthomatosis, CTX) deficiency,
•
2- (or α-) methylacyl-CoA racemase (AMACR) deficiency
•
Cholesterol 7α -hydroxylase (CYP7A1) deficiency
•
3β-hydroxy-5-C27-steroid oxidoreductase deficiency (also known as
3β-hydroxy-5-C27-steroid
dehydrogenase/isomerase or 3β-HSD or HSD3β7.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
Treatment must be initiated and monitored by physicians, including
paediatricians, experienced in the
management of the specific deficiencies.
Posology
The recommended dosage for cholic acid in the treatment of inborn
errors of primary bile acid synthesis
is 10-15 mg/kg per day, either as a single daily dose or in divided
doses, for both adult and paediatric
patients. The dose should be subsequently titrated to the desired
effect but should not exceed a
maximum of 15mg/kg/day.
Where the dose calculated is not a multiple of 50, the nearest dose
below the maximum of 15mg/kg/day
should be selected, provided that is sufficient to suppress urinary
bile acids. If not, the next higher dose
should be selected.
The recommended dos