Страна: Австралия
Язык: английский
Источник: Department of Health (Therapeutic Goods Administration)
nitisinone, Quantity: 4 mg
A Menarini Australia Pty Ltd
Oral Liquid, suspension
Excipient Ingredients: hypromellose; glycerol; polysorbate 80; sodium benzoate; citric acid monohydrate; sodium citrate; purified water; Flavour
Oral
90 mL
(S4) Prescription Only Medicine
Orfadin (nitisinone) is indicated for the treatment of patients with hereditary tyrosinaemia type 1 in combination with dietary restriction of tyrosine and phenylalanine.
Visual Identification: White slightly viscous opaque suspension with child resistant cap; Container Type: Bottle; Container Material: Glass Type III Coloured; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Child resistant closure
Registered
2019-02-26
ORFADIN ® ORAL SUSPENSION _Nitisinone_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about ORFADIN oral suspension. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking ORFADIN against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT ORFADIN IS USED FOR ORFADIN contains a medicine called nitisinone which is used for the treatment of a disease called hereditary tyrosinaemia type 1 (HT-1). In this disease the body is unable to completely break down the amino acid tyrosine. Harmful substances can form and accumulate in the body. ORFADIN blocks the breakdown of tyrosine and by doing so the harmful substances are not formed. However, tyrosine will remain in the body and therefore a special diet that is low in tyrosine and phenylalanine content must be followed when taking ORFADIN. Nitisinone belongs to a group of medicines called 'other alimentary and metabolism products'. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. ORFADIN is not addictive. ORFADIN is available only with a doctor's prescription. BEFORE YOU TAKE ORFADIN _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE ORFADIN IF YOU HAVE AN ALLERGY TO: • any medicine containing nitisinone. • any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin DO NOT BREAST-FEED IF YOU ARE TAKING THIS MEDICINE. DO NOT TAKE THIS MEDICINE AFTER THE EXPIRY DATE PRINTED ON THE PACK OR IF THE PACKAGING IS TORN OR Прочитать полный документ
AUSTRALIAN PRODUCT INFORMATION – ORFADIN ® NITISINONE CAPSULE AND ORAL SUSPENSION ORFADIN ® PI vA08-0 Page 1 of 16 1. NAME OF THE MEDICINE Nitisinone 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _Capsules_: Each capsule contains 2 mg, 5 mg, 10 mg or 20 mg nitisinone. _Oral suspension_: 1 mL contains 4 mg of nitisinone. Excipients with known effect: The oral suspension contains glycerol and sodium benzoate (see section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE). For the full list of excipients, see section 6.1 List of excipients. 3. PHARMACEUTICAL FORM _Capsules_: white, opaque, hard gelatin capsules imprinted with “NTBC 2 mg”, “NTBC 5 mg”, “NTBC 10 mg” or “NTBC 20 mg” in black ink; and contain a white to off white powder. _Oral suspension_: white, slightly viscous, opaque suspension. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ORFADIN (nitisinone) is indicated for the treatment of patients with hereditary tyrosinaemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine. 4.2 DOSE AND METHOD OF ADMINISTRATION ORFADIN treatment should be initiated and supervised by a physician experienced in the treatment of HT-1 patients. Treatment of HT-1 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 ORFADIN treatment, a diet deficient in phenylalanine and tyrosine is mandatory. The patient should be provided with clear instructions on the restricted diet and on the importance of adherence to the restricted diet. The patient’s compliance to the diet should be checked regularly by monitoring of phenylalanine and plasma tyrosine levels. _Starting dose _ The recommended initial dose is 1 mg/kg body weight /day divided in 2 doses administered orally. The dose of ORFADIN should be adjusted individually. ________________________________________________________________________ ORFADIN ® PI vA08-0 Page 2 of 16 _Dose adjustment _ Regular monitoring, should inc Прочитать полный документ