KUVAN Soluble tablet (2020)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Kuvan 100 mg soluble tablets.
Qualitative and quantitative composition
Each soluble tablet contains 100 mg of sapropterin dihydrochloride (equivalent to 77 mg of sapropterin). For the full list of excipients, see section 6.1.
Pharmaceutical form
Soluble tablet. Off-white to light yellow soluble tablet with 177 imprinted on one face.
Therapeutic indications
Kuvan is indicated for the treatment of hyperphenylalaninaemia (HPA) in adults and paediatric patients of all ages with phenylketonuria (PKU) who have been shown to be responsive to such treatment (see ...
Posology and method of administration
Treatment with Kuvan must be initiated and supervised by a physician experienced in the treatment of PKU and BH4 deficiency. Active management of dietary phenylalanine and overall protein intake while ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Dietary intake Patients treated with Kuvan must continue a restricted phenylalanine diet and undergo regular clinical assessment (such as monitoring of blood phenylalanine and tyrosine levels, nutrient ...
Interaction with other medicinal products and other forms of interaction
Although concomitant administration of inhibitors of dihydrofolate reductase (e.g. methotrexate, trimethoprim) has not been studied, such medicinal products may interfere with BH4 metabolism. Caution is ...
Fertility, pregnancy and lactation
Pregnancy There are limited amount of data from the use of Kuvan in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, ...
Effects on ability to drive and use machines
Kuvan has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Summary of the safety profile Approximately 35% of the 579 patients aged 4 years and over who received treatment with sapropterin dihydrochloride (5 to 20 mg/kg/day) in the clinical trials for Kuvan experienced ...
Overdose
Headache and dizziness have been reported after the administration of sapropterin dihydrochloride above the recommended maximum dose of 20 mg/kg/day. Treatment of overdose should be directed to symptoms. ...
Pharmacodynamic properties
Pharmacotherapeutic group: Other alimentary tract and metabolism products, Various alimentary tract and metabolism products ATC code: A16AX07 Mechanism of action Hyperphenylalaninaemia (HPA) is diagnosed ...
Pharmacokinetic properties
Absorption Sapropterin is absorbed after oral administration of the dissolved tablet, and the maximum blood concentration (C<sub>max</sub>) is achieved 3 to 4 hours after dosing in the fasted state. The ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology (CNS, respiratory, cardiovascular, genitourinary), and toxicity to reproduction. An increased ...
List of excipients
Mannitol (E421) Calcium hydrogen phosphate, anhydrous Crospovidone type A Ascorbic acid (E300) Sodium stearyl fumarate Riboflavin (E101)
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years.
Special precautions for storage
Store below 25°C. Keep the bottle tightly closed in order to protect from moisture.
Nature and contents of container
High-density polyethylene (HDPE) bottle with child-resistant closure. The bottles are sealed with an aluminium seal. Each bottle contains a small plastic tube of desiccant (silica gel). Each bottle contains ...
Special precautions for disposal and other handling
Disposal: Any unused medicinal product or waste material should be disposed of in accordance with local requirements. Handling: Patients should be advised not to swallow the desiccant capsule found in ...
Marketing authorization holder
BioMarin International Limited, Shanbally, Ringaskiddy, County Cork, Ireland
Marketing authorization number(s)
EU/1/08/481/001 EU/1/08/481/002 EU/1/08/481/003
Date of first authorization / renewal of the authorization
Date of the first authorisation: 02 December 2008 Date of latest renewal: 02 December 2013
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