Carbaglu
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
19-07-2023
Charakterystyka produktu
(SPC)
19-07-2023
Sprawozdanie z oceny publicznego
(PAR)
19-07-2011
Składnik aktywny:
carglumic acid
Dostępny od:
Recordati Rare Diseases
Kod ATC:
A16AA05
INN (International Nazwa):
carglumic acid
Grupa terapeutyczna:
Other alimentary tract and metabolism products,
Dziedzina terapeutyczna:
Amino Acid Metabolism, Inborn Errors; Propionic Acidemia
Wskazania:
Carbaglu is indicated in treatment of:hyperammonaemia due to N-acetylglutamate-synthase primary deficiency;hyperammonaemia due to isovaleric acidaemia;hyperammonaemia due to methymalonic acidaemia;hyperammonaemia due to propionic acidaemia.
Podsumowanie produktu:
Revision: 19
Status autoryzacji:
Authorised
Data autoryzacji:
2003-01-24
Ulotka dla pacjenta
19
B. PACKAGE LEAFLET
20
PACKAGE LEAFLET: INFORMATION FOR THE USER
CARBAGLU 200 MG DISPESIBLE TABLETS
carglumic acid
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 or pharmacist.
-
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Carbaglu is and what it is used for
2.
What you need to know before you take Carbaglu
3.
How to take Carbaglu
4.
Possible side effects
5
How to store Carbaglu
6.
Contents of the pack and other information
1.
WHAT CARBAGLU IS AND WHAT IT IS USED FOR
Carbaglu can help eliminating excessive ammonia plasma levels
(elevated ammonia level in the
blood). Ammonia is especially toxic for the brain and leads, in severe
cases, to reduced levels of
consciousness and to coma.
Hyperammonaemia may be due to
•
the lack of a specific liver enzyme N- acetylglutamate synthase.
Patients with this rare disorder
are not able to eliminate nitrogen waste, which builds up after eating
protein.
This disorder persists during the entire life of the affected patient
and therefore the need for this
treatment is lifelong.
•
isovaleric acidaemia, methylmalonic acidaemia or propionic acidaemia.
Patients suffering from
one of these disorders need treatment during the hyperammonaemia
crisis.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CARBAGLU
DO NOT TAKE CARBAGLU
if you are allergic to carglumic acid or any of the other ingredients
of Carbaglu (listed in section 6).
Do not take Carbaglu during breast-feeding
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Carbaglu.
Carbaglu treatment should be initiated under the supervision of a
physician
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Charakterystyka produktu
1
ANNEX
I
SUMMARY OF PRODUCT CHARACTERISTICS
_ _
2
1.
NAME OF THE MEDICINAL PRODUCT
Carbaglu 200 mg dispersible tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200 mg of carglumic acid.
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Dispersible tablet
The tablets are white and elongated with three score marks and
engraved on one side.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Carbaglu is indicated in treatment of
•
hyperammonaemia due to N-acetylglutamate synthase primary deficiency.
•
hyperammonaemia due to isovaleric acidaemia.
•
hyperammonaemia due to methylmalonic acidaemia.
•
hyperammonaemia due to propionic acidaemia.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Carbaglu treatment should be initiated under the supervision of a
physician experienced in the
treatment of metabolic disorders.
Posology:
•
For N-acetylglutamate synthase deficiency:
Based on clinical experience, the treatment may be started as early as
the first day of life.
The initial daily dose should be 100 mg/kg, up to 250 mg/kg if
necessary.
It should then be adjusted individually in order to maintain normal
ammonia plasma levels (see
section 4.4).
In the long term, it may not be necessary to increase the dose
according to body weight as long as
adequate metabolic control is achieved; daily doses range from 10
mg/kg to 100 mg/kg.
_Carglumic acid responsiveness test _
It is recommended to test individual responsiveness to carglumic acid
before initiating any long term
treatment. As examples
-
In a comatose child, start with a dose of 100 to 250 mg/kg/day and
measure ammonia plasma
concentration at least before each administration; it should normalise
within a few hours after
starting Carbaglu.
-
In a patient with moderate hyperammonaemia, administer a test dose of
100 to 200 mg/kg/day
for 3 days with a constant protein intake and perform repeated
determinations of ammonia
plasma concentration (before and 1 hour after a meal); adjust th
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