Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
nitisinone
MendeliKABS Europe Ltd
A16AX04
nitisinone
Other alimentary tract and metabolism products,
Tyrosinemias
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.
Revision: 6
Withdrawn
2017-08-24
27 B. PACKAGE LEAFLET Medicinal product no longer authorised 28 PACKAGE LEAFLET: INFORMATION FOR THE USER NITISINONE MDK 2 MG HARD CAPSULES NITISINONE MDK 5 MG HARD CAPSULES NITISINONE MDK 10 MG HARD CAPSULES NITISINONE MDK 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 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 Nitisinone MDK is and what it is used for 2. What you need to know before you take Nitisinone MDK 3. How to take Nitisinone MDK 4. Possible side effects 5. How to store Nitisinone MDK 6. Contents of the pack and other information 1. WHAT NITISINONE MDK IS AND WHAT IT IS USED FOR Nitisinone MDK contains the active substance 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. Nitisinone MDK 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 NITISINONE MDK DO NOT TAKE NITISINONE MDK: - if you are allergic to nitisinone or any of the other ingredients of this medicine (listed in section 6). ˗ Do not breast-feed while tak Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Nitisinone MDK 2 mg hard capsules Nitisinone MDK 5 mg hard capsules Nitisinone MDK 10 mg hard capsules Nitisinone MDK 20 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Nitisinone MDK 2 mg hard capsule Each hard capsule contains 2 mg nitisinone. Nitisinone MDK 5 mg hard capsule Each hard capsule contains 5 mg nitisinone. Nitisinone MDK 10 mg hard capsule Each hard capsule contains 10 mg nitisinone. Nitisinone MDK 20 mg hard capsule Each hard capsule contains 20 mg nitisinone. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule. The capsules contain a white to off white powder. Nitisinone MDK 2 mg hard capsule White, opaque capsules of 15.7 mm imprinted with black ink “2 mg” on the cap and “Nitisinone” on the body. Nitisinone MDK 5 mg hard capsule White, opaque capsules of 15.7 mm imprinted with black ink “5 mg” on the cap and “Nitisinone” on the body. Nitisinone MDK 10 mg hard capsule White, opaque capsules of 15.7 mm imprinted with black ink “10 mg” on the cap and “Nitisinone” on the body. Nitisinone MDK 20 mg hard capsule White, opaque capsules of 15.7 mm imprinted with black ink “20 mg” on the cap and “Nitisinone” on the body. Medicinal product no longer authorised 3 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 deficie Pročitajte cijeli dokument