Country: Холандија
Језик: Холандски
Извор: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
SAPROPTERINEDIHYDROCHLORIDE 100 mg/stuk SAMENSTELLING overeenkomend met ; SAPROPTERINE 76,8 mg/stuk
SAPROPTERINEDIHYDROCHLORIDE 100 mg/stuk SAMENSTELLING overeenkomend met ; SAPROPTERINE 76,8 mg/stuk
Oplosbare tablet
ASCORBINEZUUR (L-) (E 300) ; CROSPOVIDON (E 1202) ; MANNITOL (D-) (E 421) ; MAÏSZETMEEL, GEPREGELATINEERD ; NATRIUMSTEARYLFUMARAAT ; RIBOFLAVINE (E 101), ASCORBINEZUUR (L-) (E 300) ; CROSPOVIDON (E 1202) ; MANNITOL (D-) (E 421) ; MAÏSZETMEEL, GEPREGELATINEERD ; NATRIUMSTEARYLFUMARAAT ; RIBOFLAVINE
Oraal gebruik
2022-04-04
1 BIJSLUITER: INFORMATIE VOOR DE GEBRUIKER SAPROPTERINE DZ 100 MG OPLOSBARE TABLETTEN Sapropterin dihydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What [Product name] is and what it is used for 2. What do you need to know before you take [Product name] 3. How to take [Product name] 4. Possible side effects 5. How to store [Product name] 6. Contents of the pack and other information 1. WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR [Product name] contains the active substance sapropterin which is a synthetic copy of a body’s own substance called tetrahydrobiopterin (BH4). BH4 is required by the body to use an amino acid called phenylalanine in order to build another amino acid called tyrosine. [Product name] is used to treat hyperphenylalaninaemia (HPA) or phenylketonuria (PKU) in patients of all ages. HPA and PKU are due to abnormally high levels of phenylalanine in the blood which can be harmful. [Product name] reduces these levels in some patients who respond to BH4 and can help increase the amount of phenylalanine that can be included in the diet. This medicine is also used to treat an inherited disease called BH4 deficiency in patients of all ages, in which the body cannot produce enough BH4. Because of very low BH4 levels phenylalanine is not used properly and its levels rise, resulting in harmful effects. By replacing the BH4 that the body cannot produce, [Product name] reduces the harmful excess of phenylalanine in the blood and increases the dietary tolerance to phenylalanine. Прочитајте комплетан документ
1 SAMENVATTING VAN DE PRODUCTKENMERKEN 1. NAAM VAN HET GENEESMIDDEL Sapropterine DZ 100 mg oplosbare tabletten 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, round (of diameter about 9.5 mm) tablet, with “L71” imprinted on one side and “T” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS [Product name] 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). [Product name] 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 [Product name] 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 this medicinal product 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, [Product name] is intended for long-term use (see section 5.1). Posology _PKU _ The starting dose of [Product name] 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 as defined by the physician. _BH4 deficiency _ The starting dose of [Product name] in adult and paediatric patients with BH4 deficiency is 2 to 5 mg/kg body weight total daily dose. Doses may be adjusted up to a total of 20 mg/kg per day. 2 [Product Прочитајте комплетан документ