CARGLUMIC ACID WAYMADE 200 MG

Pays: Israël

Langue: anglais

Source: Ministry of Health

Ingrédients actifs:

CARGLUMIC ACID

Disponible depuis:

MBI PHARMA LTD., ISRAEL

Code ATC:

A16AA05

forme pharmaceutique:

DISPERSIBLE TABLETS

Composition:

CARGLUMIC ACID 200 MG

Mode d'administration:

PER OS

Type d'ordonnance:

Required

Fabriqué par:

WAYMADE PLC., UK

Domaine thérapeutique:

CARGLUMIC ACID

indications thérapeutiques:

CARGLUMIC - ACID WAYMADE 200 MG is indicated for- Hyperammonaemia due to N - acetylglutamate synthase primary deficiency. - Hyperammonaemia due to isovaleric acidaemia. - Hyperammonaemia due to methymalonic acidaemia.- Hyperammonaemia due to propionic acidaemia.

Date de l'autorisation:

2023-06-04

Notice patient

1
Patient leaflet in accordance with the Pharmacists' Regulations
(Preparations) – 1986
This medicine is dispensed with a doctor’s prescription only
Carglumic Acid Waymade 200 mg
Dispersible tablets
Active ingredient
Each tablet contains 200 mg carglumic acid.
Inactive ingredients and allergens in this medicine: see section 2
under ‘Important
information about some of this medicine’s ingredients’, and
section 6 ‘Additional information’.
Read the entire leaflet carefully before you start using this
medicine. This leaflet
contains concise information about this medicine. If you have any
further questions, consult
your doctor or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may
harm them, even if it seems to you that their illness is similar to
yours.
1. What is this medicine intended for?
Carglumic Acid Waymade 200 mg is used to treat hyperammonaemia (high
levels of
ammonia in the plasma) due to:
•
the lack of a liver enzyme called N-acetylglutamate synthase. Patients
with this rare
disease are not able to eliminate nitrogen, a waste substance that
builds up in their body
after eating protein. This medical condition persists throughout the
life of the affected
patient, and therefore requires lifelong treatment.
•
certain acidosis conditions (propionic acidaemia, isovaleric
acidaemia, methylmalonic
acidaemia); patients with any of these disorders must be treated
during the
hyperammonaemia stages of their disease.
Therapeutic group: CPS (carbamoyl phosphate synthase) activator
Carglumic Acid Waymade 200 mg can help to eliminate excess ammonia
from the blood.
When ammonia builds up in the blood it is especially toxic for the
brain. In severe cases,
build-up can lead to reduced consciousness and to coma.
2. Before using this medicine
Do not use this medicine if:
•
you are sensitive (allergic) to the active ingredient carglumic acid
or to any of the
other ingredients in this medicine (see section 6)
•
you are breast-feeding
Special warnings abo