国: イスラエル
言語: 英語
ソース: Ministry of Health
SAPROPTERIN DIHYDROCHLORIDE
MEDISON PHARMA LTD
A16AX07
TABLETS SOLUBLE
SAPROPTERIN DIHYDROCHLORIDE 100 MG
PER OS
Required
BIOMARIN INTERNATIONAL LIMITED, IRELAND
SAPROPTERIN
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.Kuvan is also indicated for the 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.
2016-09-21
1 The format of this leaflet was determined by the Ministry of Health and its contents were inspected and approved in 12/2015 and updated in accordance with the instructions of the Ministry of Health in 02/2019. PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATION) - 1986 This medicine requires a doctor’s prescription KUVAN ® SOLUBLE TABLETS Active ingredient: Each soluble TABLET CONTAINS 100 MG OF Sapropterin dihydrochloride (EQUIVALENT TO 77 MG SAPROPTERIN) Inactive ingredients - See Section 6. PLEASE READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. THIS LEAFLET CONTAINS INFORMATION THAT IS IMPORTANT FOR YOU. • Keep this leaflet. You may want to read it again. • This leaflet contains concise information about the medicine. If you have any further queries, contact a doctor or pharmacist. • This medicine has been prescribed for your treatment. Do not pass it on to others. It may cause them harm, even if it seems to you that their medical condition is similar to yours. In this leaflet: 1. What is the intended use of the medicine? 2. Before using the medicine 3. How should this medicine be used? 4. Side-effects 5. How to store the medicine 6. Additional information 1. WHAT IS THE INTENDED USE OF THE MEDICINE? KUVAN ® is intended for the treatment of high blood levels of the amino acid phenylalanine in adults and children of all ages. High blood levels of phenylalanine can be harmful. These conditions are called hyperphenylalaninaemia (HPA) or phenylketonuria (PKU). KUVAN decreases these levels in patients who respond to BH4. This makes it possible for these patients to increase the amount of phenylalanine in their diet. KUVAN can also treat a genetic disease known as BH4 deficiency in adults and children of all ages, where the body is unable to produce enough BH4. Because of the low BH4 level, the phenylalanine consumption is abnormal, its level rises, and the phenylalanine accumulation is harmful. Administering KUVAN, which is a substitute for the BH4 that th 完全なドキュメントを読む
1 PRESCRIBING INFORMATION KUVAN ® 1. NAME OF THE MEDICINAL PRODUCT Kuvan ® 100 mg soluble tablets. 2. 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. 3. PHARMACEUTICAL FORM Soluble tablet. Off-white to light yellow soluble tablet with “177” imprinted on one face. 4. CLINICAL PARTICULARS 4.1 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 section 4.2). Kuvan is also indicated for the 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 (see section 4.2). 4.2 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 taking Kuvan is required to ensure adequate control of blood phenylalanine levels and nutritional balance._ _ As HPA due to either PKU or BH4 deficiency is a chronic condition, once responsiveness is demonstrated, Kuvan is intended for long-term use. However, there are limited data regarding the long-term use of Kuvan. _ _ _Posology _ Kuvan is provided as 100 mg tablets. The calculated daily dose based on body weight should be rounded to the nearest multiple of 100. For instance, a calculated dose of 401 to 450 mg should be rounded down to 400 mg corresponding to 4 tablets. A calculated dose of 451 mg to 499 mg should be rounded up to 500 mg corresponding to 5 tablets. 2 _PKU _ The starting dose of Kuvan 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 adequat 完全なドキュメントを読む