Carbaglu carglumic acid 200 mg dispersible tablets tube
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
22-05-2020
Summary of Product characteristics
(SPC)
24-08-2020
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
carglumic acid, Quantity: 200 mg
Available from:
Recordati Rare Diseases Australia Pty Ltd
INN (International Name):
carglumic acid
Pharmaceutical form:
Tablet, dispersible
Composition:
Excipient Ingredients: colloidal anhydrous silica; microcrystalline cellulose; sodium lauryl sulfate; croscarmellose sodium; hypromellose; sodium stearylfumarate
Administration route:
Oral
Units in package:
60 Tablets, 5 Tablets
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
Carbaglu is indicated in treatment of,? Hyperammonaemia due to N-acetylglutamate synthase primary deficiency,? Hyperammonaemia due to Organic Acidaemias such as:,-Hyperammonaemia due to isovaleric acidaemia -Hyperammonaemia due to methylmalonic acidaemia -Hyperammonaemia due to propionic acidaemia
Product summary:
Visual Identification: A bar-shaped tablet, with 4 punches on one side ('c c c c'), size 18.0 x 6.0 mm, with 3 break-marks both sides; Container Type: Tube; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Child resistant closure
Authorization status:
Registered
Authorization date:
2015-02-12
Patient Information leaflet
Carbaglu AU CMI 2.00
1
CARBAGLU
®
_Carglumic acid, 200 mg Dispersible Tablets _
Consumer Medicine Information
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
more common questions about
Carbaglu.
It does not contain all of the
available information. It does
not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you taking
Carbaglu against the benefits
he/she expects it will have for
you.
IF YOU HAVE ANY CONCERNS
ABOUT TAKING THIS MEDICINE,
ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read this again.
WHAT CARBAGLU
IS USED FOR
Carbaglu is used to eliminate
excessive levels of ammonia,
referred to as
hyperammonaemia. The high
levels of ammonia in the blood
may be caused by the lack of a
specific liver enzyme called N-
acetyl glutamate synthase
(NAGS) or due to isovaleric
acidaemia, methylmalonic
acidaemia or propionic
acidaemia.
High levels of ammonia in the
blood are toxic for the brain and
leads in severe cases, to reduced
levels of consciousness and
coma.
Some people are born with
inherited diseases that cause
some of the body’s enzymes to
be missing or defective. The
deficiency of NAGS is a rare
disorder and results in patients
not being able to eliminate
nitrogen waste from the body
which builds up after eating
protein. This disorder persists
for life and therefore the need
for this treatment is lifelong.
Isovaleric acidaemia,
methylmalonic acidaemia and
propionic acidaemias are rare
disorders that can inhibit NAGS
and cause episodes of
hyperammonaemia. The
treatment of elevated ammonia
in these disorders is required
during these episodes.
Carbaglu helps the body’s
natural process to eliminate
ammonia by triggering the
enzymes required to convert this
to urea. This is eliminated from
the body in urine.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY
CARBAGLU HAS BEEN PRESCRIBED
FOR YOU.
This medicine is available only
with a doctor’s prescription.
BEFORE YOUR DOCTOR
GIVES
Read the complete document
Summary of Product characteristics
AUSTRALIAN PRODUCT INFORMATION - CARBAGLU
®
(CARGLUMIC ACID)
1
NAME OF THE MEDICINE
Carglumic acid
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Carglumic acid is a white crystalline powder, soluble in boiling
water, slightly soluble in cold
water, practically insoluble in organic solvents (cyclohexane,
dichloromethane, ether).
CARBAGLU contains 200 mg of carglumic acid as the active ingredient.
For the list of excipients,
see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
CARBAGLU is a dispersible tablet containing 200 mg of carglumic acid.
The tablets are white and
elongated and 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 Organic Acidaemias such as:
o
Hyperammonaemia due to isovaleric acidaemia
o
Hyperammonaemia due to methymalonic acidaemia
o
Hyperammonaemia due to propionic acidaemia
4.2
DOSE AND METHOD OF ADMINISTRATION
CARBAGLU treatment should be initiated under the supervision of a
physician experienced in the
treatment of metabolic disorders.
Any episode of acute symptomatic hyperammonaemia should be treated as
a life-threatening
emergency and may be started as early as the first day of life.
Treatment of hyperammonaemia may
require dialysis, preferably hemodialysis, to remove a large burden of
ammonia. Uncontrolled
hyperammonaemia can rapidly result in brain injury/damage or death,
and prompt use of all
therapies necessary to reduce plasma ammonia levels is essential.
Plasma levels of ammonia and amino acids should be maintained within
normal limits. Ongoing
monitoring of neurological and cardiac status, laboratory tests
(renal, hepatic, haematological) and
clinical responses in patients receiving carglumic acid is crucial to
assess patient response.
CARBAGLU tablets should not be swallowed whole or crushed. Disperse
CARBAGLU tablets in
water immediately before use. CARBAGLU is for oral administration
only.
ADULT DOSAGE
Th
Read the complete document
