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  • Sapropterin Teva
    / Teva Israel LTD, Israel


    Active Ingredient
    Sapropterin 100 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Soluble Tablets

    30 X 100 mg

    partial basket chart 24397 6996

    Related information


    Dosage

    PKU (Phenylketonuria): The starting dose in adult and paediatric patients with PKU is 10 mg/kg body weight once daily. The dose is adjusted, usually between 5 and 20 mg/kg/day, to achieve and maintain adequate blood phenylalanine levels.
    BH4 deficiency: The starting dose in adult and paediatric patients with BH4 deficiency is 2 to5 mg/kg body weight total daily dose. Doses may be adjusted up to 20 mg/kg per day.
    Please refer to the license holder for further details


    Indications

    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.
    Treatment of hyperphenylalaninaemia (HPA) in adults and paediatric patients of all ages with tetrahydrobiopterin (BH4) deficiency who have been shown to be responsive to such treatment.


    Contra-Indications

    Hypersensitivity to the active substance or to any of the excipients.


    Special Precautions

    Please refer to the license holder for further details.


    Side Effects

    Please refer to the license holder for further details.


    Drug interactions

    Please refer to the license holder for further details.


    Pregnancy and Lactation

    Please refer to the license holder for further details.


    Manufacturer
    Teva Israel LTD, Israel
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