Krajina: Spojené kráľovstvo
Jazyk: angličtina
Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)
Nitisinone
Swedish Orphan Biovitrum Ltd
A16AX04
Nitisinone
4mg/1ml
Oral suspension
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF:
PACKAGE LEAFLET: INFORMATION FOR THE USER ORFADIN 4 MG/ML ORAL SUSPENSION 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 get red eyes or any other signs of effects on the eyes. Contact your doctor imm Prečítajte si celý dokument
OBJECT 1 ORFADIN 4MG/ML ORAL SUSPENSION Summary of Product Characteristics Updated 06-Mar-2017 | Swedish Orphan Biovitrum Ltd 1. Name of the medicinal product Orfadin 4 mg/ml oral suspension 2. Qualitative and quantitative composition 1 ml contains 4 mg of nitisinone. Excipients with known effect: Each ml contains: sodium 0.7 mg (0.03 mmol) glycerol 500 mg sodium benzoate 1 mg For the full list of excipients, see section 6.1. 3. Pharmaceutical form Oral suspension. White, slightly viscous opaque suspension. 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 limited data in patients with body weight <20 kg, it is recommended to divide the total daily dose into two daily administrations in this patient population. _Dose adjustment_ During regular monitoring, it is appropriate to follow urine succinylacetone, liver function test values and alpha-fetoprotein levels (see section 4.4). If urine succinylacetone is still detectable one month after the start of nitisinone treatment, the nitisinone dose should be increased to 1.5 mg/kg body weight/day.A Prečítajte si celý dokument