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CARBAGLU Dispersible tablet (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Carbaglu 200 mg dispersible tablets.

Qualitative and quantitative composition

Each tablet contains 200 mg of carglumic acid. For a full list of excipients, see section 6.1.

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 halves.

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. ...

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, ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients. Breast-feeding during the use of carglumic acid is contraindicated (see sections 4.6 and 5.3).

Special warnings and precautions for use

Therapeutic monitoring Plasma levels of ammonia and amino acids should be maintained within normal limits. As very few data on the safety of carglumic acid are available, systematic surveillance of liver, ...

Interaction with other medicinal products and other forms of interaction

No specific interaction studies have been performed.

Fertility, pregnancy and lactation

Pregnancy For carglumic acid no clinical data on exposed pregnancies are available. Animal studies have revealed minimal developmental toxicity (see section 5.3). Caution should be exercised when prescribing ...

Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed.

Undesirable effects

Reported adverse reactions are listed below, by system organ class and by frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 to 1/10), uncommon (≥1/1,000 to 1/100), rare (≥1/10,000 ...

Overdose

In one patient treated with carglumic acid, where the dose was increased up to 750 mg/kg/day, symptoms of intoxication occurred which can be characterised as a sympathomimetic reaction: tachycardia, profuse ...

Pharmacodynamic properties

Pharmacotherapeutic group: Amino acids and derivatives ATC code: A16AA05 Mechanism of action Carglumic acid is a structural analogue of N-acetylglutamate, which is the naturally occurring activator of ...

Pharmacokinetic properties

The pharmacokinetics of carglumic acid has been studied in healthy male volunteers using both radiolabelled and unlabelled product. Absorption After a single oral dose of 100 mg/kg body weight, approximately ...

Preclinical safety data

Safety pharmacology studies have shown that Carbaglu administered orally at doses of 250, 500, 1000 mg/kg had no statistically significant effect on respiration, central nervous system and cardiovascular ...

List of excipients

Microcrystalline cellulose sodium laurilsulfate hypromellose croscarmellose sodium silica colloidal anhydrous sodium stearyl fumarate

Incompatibilities

Not applicable.

Shelf life

Shelf life: 36 months. After first opening of the tablet container: 3 months.

Special precautions for storage

Store in a refrigerator (2°C–8°C) After first opening of the tablet container: Do not refrigerate. Do not store above 30°C. Keep the container tightly closed in order to protect from moisture.

Nature and contents of container

5-, 15- or 60- high density polyethylene tablet containers closed by a child resistant polypropylene cap with a desiccant unit. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Recordati Rare Diseases, Immeuble Le Wilson, 70, avenue du Général de Gaulle, F-92800, Puteaux, France

Marketing authorization number(s)

EU/1/02/246/001 (15 dispersible tablets) EU/1/02/246/002 (60 dispersible tablets) EU/1/02/246/003 (5 dispersible tablets)

Date of first authorization / renewal of the authorization

Date of first authorisation: 24 January 2003 Date of renewal: 20 May 2008

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