Kolbam
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
15-07-2020
Karatteristiċi tal-prodott
(SPC)
15-07-2020
Rapport ta 'Valutazzjoni Pubblika
(PAR)
15-02-2016
Ingredjent attiv:
cholic acid
Disponibbli minn:
Retrophin Europe Ltd
Kodiċi ATC:
A05AA03
INN (Isem Internazzjonali):
cholic acid
Grupp terapewtiku:
Bile and liver therapy
Żona terapewtika:
Metabolism, Inborn Errors
Indikazzjonijiet terapewtiċi:
Cholic Acid FGK is indicated for the treatment of inborn errors of primary bile acid synthesis, in infants from one month of age for continuous lifelong treatment through adulthood, encompassing the following single enzyme defects:sterol 27-hydroxylase (presenting as cerebrotendinous xanthomatosis, CTX) deficiency;2- (or alpha-) methylacyl-CoA racemase (AMACR) deficiency;cholesterol 7 alpha-hydroxylase (CYP7A1) deficiency.
Sommarju tal-prodott:
Revision: 14
L-istatus ta 'awtorizzazzjoni:
Withdrawn
Data ta 'l-awtorizzazzjoni:
2015-11-20
Fuljett ta 'informazzjoni
Medicinal product no longer authorised
35
B. PACKAGE LEAFLET
Medicinal product no longer authorised
36
PACKAGE LEAFLET: INFORMATION FOR THE USER
KOLBAM 50 MG HARD CAPSULES
KOLBAM 250 MG HARD CAPSULES
cholic acid
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Kolbam is and what it is used for
2.
What you need to know before you use Kolbam
3.
How to use Kolbam
4.
Possible side effects
5.
How to store Kolbam
6.
Contents of the pack and other information
1.
WHAT KOLBAM IS AND WHAT IT IS USED FOR
Kolbam contains a substance called cholic acid.
In the body cholic acid is naturally produced in the liver and is part
of the bile, a fluid that helps
digestion and absorbs fat and vitamins from the food. Cholic acid also
promotes normal growth of
children. Patients with certain types of conditions known as inborn
errors of bile synthesis cannot
produce cholic acid and bile normally, which leads to the production
and build-up of abnormal
substances that are potentially damaging to the liver.
Kolbam is used to treat these ‘inborn errors of bile acid
synthesis’. By replacing the missing cholic
acid it stimulates the production of normal bile and helps prevent the
build-up of the abnormal
substances in the liver. In growing infants, treatment with cholic
acid helps wit
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Karatteristiċi tal-prodott
Medicinal product no longer authorised
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Kolbam 50 mg hard capsules.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 50 mg of cholic acid.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
50 mg capsule: Size number 2 capsule with a Swedish orange cap (black
imprint “ASK001”) and
body (black imprint “50mg”). The capsules contain a white powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Kolbam 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
α
-) methylacyl-
CoA racemase (AMACR) deficiency or Cholesterol 7
α
-hydroxylase (CYP7A1) deficiency in infants,
children and adolescents aged 1 month to 18 years and adults.
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 15 mg/kg/day.
Where the dose calculated is not a multiple of 50, the nearest dose
below the maximum of
15 mg/kg/day should be selected, provided that is sufficient to
suppress urinary bile acids. If not, the
next higher dose should be selected.
Patients should be monitored initially every 3 months during the first
year then 6 mo
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