UCEDANE Dispersible tablet (2021)
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Περιεχόμενα
1. Name of the medicinal product
Ucedane 200 mg dispersible tablets.
2. Qualitative and quantitative composition
Each tablet contains 200 mg of carglumic acid. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Dispersible tablet. The tablets are rod-shaped, white and biconvex with three score lines on both sides and engraving L/L/L/L on one side. The tablet can be divided into four equal doses.
4.1. Therapeutic indications
Ucedane is indicated in treatment of: hyperammonaemia due to N-acetylglutamate synthase primary deficiency. hyperammonaemia due to isovaleric acidaemia. hyperammonaemia due to methymalonic acidaemia. ...
4.2. Posology and method of administration
Ucedane 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, ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Breast-feeding during the use of carglumic acid is contraindicated (see sections 4.6 and 5.3).
4.4. 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, ...
4.5. Interaction with other medicinal products and other forms of interaction
No specific interaction studies have been performed.
4.6. 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 ...
4.7. Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.
4.8. 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) and uncommon (≥1/1,000 to <1/100) 100), rare ...
4.9. 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 ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Amino acids and derivatives <b>ATC code:</b> A16AA05 Mechanism of action Carglumic acid is a structural analogue of N-acetylglutamate, which is the naturally occurring ...
5.2. 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 ...
5.3. Preclinical safety data
Safety pharmacology studies have shown that carglumic acid administered orally at doses of 250, 500, 1000 mg/kg had no statistically significant effect on respiration, central nervous system and cardiovascular ...
6.1. List of excipients
Microcrystalline cellulose Mannitol Colloidal anhydrous silica Sodium stearyl fumarate Crospovidone type B Copovidone K 28
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
36 months.
6.4. Special precautions for storage
Not applicable.
6.5. Nature and contents of container
Blister (ALU/ALU) packed in cartons. Pack size of 12 or 60 dispersible tablets.
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Eurocept International BV, Trapgans 5, 1244 RL Ankeveen, The Netherlands
8. Marketing authorization number(s)
EU/1/17/1202/001 EU/1/17/1202/002
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 23 June 2017
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