CARBAGLU TABLET

Riik: Lõuna-Aafrika Vabariik

keel: inglise

Allikas: South African Health Products Regulatory Authority (SAHPRA)

Saadav alates:

Equity Pharmaceutical (Pty) Ltd

Annus:

Not Indicated

Ravimvorm:

TABLET

Koostis:

None

Volitamisolek:

Registered

Infovoldik

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PROFESSIONAL INFORMATION
SCHEDULING STATUS
S4
1. NAME OF THE MEDICINE
CARBAGLU 200 mg (dispersible tablets)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
CARBAGLU: Each dispersible tablet contains 200 mg of carglumic acid.
For the full list of excipients, see section 6.1.
Sugar free.
3. PHARMACEUTICAL FORM
Dispersible tablets.
A white, bar-shaped tablet, scored on both sides and engraved on one
side (4 punches with the letter c), size
18,0 x 6,0 mm.
The tablet can be divided into equal halves.
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 methymalonic acidaemia.
•
Hyperammonaemia due to propionic acidaemia.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
CARBAGLU treatment should be initiated under the supervision of a
medical practitioner experienced in the
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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 (refer to 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 an

Toote omadused

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PATIENT INFORMATION LEAFLET
SCHEDULING STATUS: S4
CARBAGLU 200 MG (DISPERSIBLE TABLET)
CARGLUMIC ACID
SUGAR FREE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING CARBAGLU
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor, pharmacist, nurse
or other healthcare provider.
•
CARBAGLU has been prescribed for you personally and you should not
share your medicine with other
people. It may harm them, even if their symptoms are the same as
yours.
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 eliminate excessive ammonia plasma levels (this is
elevated ammonia levels 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:
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•
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 hypersensitive (allergic) to carglumic acid or any of the
other ingredients of CARBAGLU.
•
if you are breastfeeding your baby.
WARNINGS AND PRECAUTIONS
CARBAGLU treatment should be initiated under the supervision of a
doctor experienced in the treatment of
metabolic disorders.
Your doctor will initiate and monitor your therapy.
Your doctor may prescribe supplemental arginine or restrict your
protein int