البلد: المملكة المتحدة
اللغة: الإنجليزية
المصدر: MHRA (Medicines & Healthcare Products Regulatory Agency)
Nitisinone
Swedish Orphan Biovitrum Ltd
A16AX04
Nitisinone
5mg
Capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 09080100; GTIN: 7350031440126
PACKAGE LEAFLET: INFORMATION FOR THE USER ORFADIN 2 MG HARD CAPSULES ORFADIN 5 MG HARD CAPSULES ORFADIN 10 MG HARD CAPSULES ORFADIN 20 MG HARD CAPSULES nitisinone 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, pharmacist or nurse. - This medicine has been prescribed for you. 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Orfadin is and what it is used for 2. What you need to know before you take Orfadin 3. How to take Orfadin 4. Possible side effects 5. How to store Orfadin 6. Contents of the pack and other information 1. WHAT ORFADIN IS AND WHAT IT IS USED FOR The active ingredient of Orfadin is nitisinone. This medicine is used for treatment of a rare disease called hereditary tyrosinemia type 1 in adults, adolescents and children (in any age range). In this disease your body is unable to completely break down the amino acid tyrosine (amino acids are building blocks of our proteins), forming harmful substances. These substances are accumulated in your body. Orfadin blocks the breakdown of tyrosine and the harmful substances are not formed. You must follow a special diet while you are taking this medicine, because tyrosine will remain in your body. This special diet is based on low tyrosine and phenylalanine (another amino acid) content. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ORFADIN DO NOT TAKE ORFADIN - if you are allergic to nitisinone or any of the other ingredients of this medicine (listed in section 6). Do not breast-feed while taking this medicine, see section “Pregnancy and breast-feeding”. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Orfadin. - if you g اقرأ الوثيقة كاملة
OBJECT 1 ORFADIN 2MG 5MG 10MG AND 20 MG HARD CAPSULES Summary of Product Characteristics Updated 06-Mar-2017 | Swedish Orphan Biovitrum Ltd 1. Name of the medicinal product Orfadin 2 mg hard capsules Orfadin 5 mg hard capsules Orfadin 10 mg hard capsules Orfadin 20 mg hard capsules 2. Qualitative and quantitative composition Each capsule contains 2 mg nitisinone. Each capsule contains 5 mg nitisinone. Each capsule contains 10 mg nitisinone. Each capsule contains 20 mg nitisinone. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Hard capsule. White, opaque capsules (6x16 mm) imprinted “NTBC 2mg” in black on the body of the capsule. White, opaque capsules (6x16 mm) imprinted “NTBC 5mg” in black on the body of the capsule. White, opaque capsules (6x16 mm) imprinted “NTBC 10mg” in black on the body of the capsule. White, opaque capsules (6x16 mm) imprinted “NTBC 20mg” in black on the body of the capsule. The capsules contain a white to off white powder. 4. Clinical particulars 4.1 Therapeutic indications Treatment of adult and paediatric (in any age range) patients with confirmed diagnosis of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine. 4.2 Posology and method of administration Nitisinone treatment should be initiated and supervised by a physician experienced in the treatment of HT-1 patients. Posology Treatment of all genotypes of the disease should be initiated as early as possible to increase overall survival and avoid complications such as liver failure, liver cancer and renal disease. Adjunct to the nitisinone treatment, a diet deficient in phenylalanine and tyrosine is required and should be followed by monitoring of plasma amino acids (see sections 4.4 and 4.8). The recommended initial daily dose in the paediatric and adult population is 1 mg/kg body weight administered orally. The dose of nitisinone should be adjusted individually. It is recommended to administer the dose once daily. However, due to the limi اقرأ الوثيقة كاملة