What is it and how is it used?
Carbaglu can help eliminating excess of hyperammonaemia (elevated ammonia level in the blood), 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. Nitrogen waste is in the form of ammonia, which is especially toxic for the brain and leads, in severe cases, to reduced levels of consciousness and to coma.
This disorder will persist during the entire life time of the patient and therefore the need for this treatment is lifelong.
What do you have to consider before using it?
Do not take Carbaglu:
Do not take Carbaglu if you are hypersensitive (allergic) to carglumic acid or any of the other ingredients of Carbaglu.
Do not take Carbaglu during breast-feeding
Take special care with Carbaglu:
Carbaglu treatment should be initiated under the supervision of a physician experienced in the treatment of metabolic disorders.
Your doctor will test your individual responsiveness to carglumic acid before initiating any long term treatment.
The dose should be adjusted individually in order to maintain normal ammonia plasma levels.
Your doctor may prescribe supplemental arginine or restrict your protein intake.
In order to follow-up your condition and your treatment, your doctor may examine your liver, your kidneys, your heart and your blood on a regular basis.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription
Taking Carbaglu with food and drink
Carbaglu must be taken orally before meals or feedings.
The tablets must be dispersed in a minimum of 5 to 10 ml of water and taken immediately. The suspension has a slightly acidic taste.
Pregnancy and Breast-feeding
The effects of Carbaglu on pregnancy and the unborn child are not known. Please consult your doctor for advice if you are pregnant or planning to become pregnant.
The excretion of carglumic acid into breast milk has not been studied in women. Nevertheless, as carglumic acid has been shown to be present in the milk of lactating rats with potential toxic effects for their fed pups, you should not breast feed your baby if you are taking Carbaglu.
Driving and using machines
Effects on the ability to drive and use machines are not known.
How is it used?
Always take Carbaglu exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.
The usual dose:
When the patient is in hyperammonaemic coma, Carbaglu is administered by fast push through a syringe via the tube set up and used to feed you..
If you take more Carbaglu than you should:
Ask your doctor or pharmacist for advice.
If you forget to take Carbaglu:
Do not take a double dose to make up for forgotten individual doses.
What are possible side effects?
Like all medicines, Carbaglu can have side effects.
The following side effects were reported as follows: very common (occurring in at least one in 10 patients), common (occurring in at least one in 100 patients), uncommon (occurring in at least one in1,000 patients), rare (occurring in at least one in 10,000 patients), very rare (occurring in at least one in 100,000 patients).
If you notice any side effects, please inform your doctor or pharmacist.
How should it be stored?
Keep out of the reach and sight of children.
Do not use after the expiry date stated on the tablet container.
Store in a refrigerator (2°C – 8°C)
After first opening of the container: do not refrigerate, do not store above 30°C.
Keep the container tightly closed in order to protect from moisture.
Write the date of opening on the tablet container. Discard 1 month after first opening.
