Valsts: Jaunzēlande
Valoda: angļu
Klimata pārmaiņas: Medsafe (Medicines Safety Authority)
Pyrazinamide 500mg;
AFT Pharmaceuticals Ltd
Pyrazinamide 500 mg
500 mg
Tablet
Active: Pyrazinamide 500mg Excipient: Colloidal silicon dioxide Microcrystalline cellulose Pregelatinised maize starch Starch Stearic acid
Bottle, plastic, White HDPE with white PP cap, 100 tablets
Prescription
Prescription
Calyx Chemicals and Pharmaceuticals Limited
pdp-PYRAZINAMIDE is indicated in patients with active tuberculosis caused by Mycobacterium tuberculosis. pdp-PYRAZINAMIDE is not active against the atypical mycobacteria. pdp-PYRAZINAMIDE should be given only in combination with other effective anti-tuberculous agents.
Package - Contents - Shelf Life: Bottle, plastic, White HDPE with white PP cap - 100 tablets - 36 months from date of manufacture stored at or below 25°C
2004-02-18
PDP-PYRAZINAMIDE Pyrazinamide 500 mg Tablet WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Pdp-Pyrazinamide. 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 Pdp- Pyrazinamide 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 THE MEDICINE IS USED FOR Your medicine is used in combination with other medicines to treat tuberculosis, also known as TB. Tuberculosis is a bacterial infection that mainly affects the lungs, but it can also spread to other organs in the body._ _ It belongs to a group of medicines called anti-infectives. 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. This medicine is not addictive. pdp-Pyrazinamide is available only with a doctor’s prescription. This medicine is not expected to affect your ability to drive a car or operate machinery. BEFORE YOU TAKE THIS MEDICINE _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE PDP-PYRAZINAMIDE IF: • You have an allergy to any medicine containing Pyrazinamide • You have an allergy to any of the ingredients listed at the end of this leaflet. • You are breast-feeding. Like most medicines, Pdp-Pyrazinamide is not recommended for use while breast-feeding. • You have liver disease • You have gout or gouty arthritis You have too much uric acid in your blood (also called hyperuricaemia) which may or may not cause gout or gouty arthritis. DO NOT GIVE PDP-PYRAZINAMIDE TO A CHILD. The safety of this medicine has not been established in children. Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pha Izlasiet visu dokumentu
NEW ZEALAND DATA SHEET Page 1 of 5 1 PDP-PYRAZINAMIDE pdp-Pyrazinamide 500mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 500mg of pyrazinamide 3 PHARMACEUTICAL FORM pdp-PYRAZINAMIDE is available as white round tablets, scored on one side with “PMS” on the other side. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications pdp-PYRAZINAMIDE is indicated in patients with active tuberculosis caused by Mycobacterium tuberculosis. pdp-PYRAZINAMIDE is not active against the atypical mycobacteria. pdp-PYRAZINAMIDE should be given only in combination with other effective anti-tuberculous agents. 4.2 Dose and method of administration Usual dose: Pyrazinamide is administered orally, 15 to 30 mg/kg once daily. Older regimens employed 3 or 4 divided doses daily, but most current recommendations are for once a day. Three grams per day should not be exceeded. The CDC recommendations do not exceed 2 g per day when given as a daily regimen. Alternatively, a twice weekly dosing regimen (50 to 75 mg/kg twice weekly based on lean body weight) has been developed to promote patient compliance with a regimen on an outpatient basis. In studies evaluation the twice weekly regimen, doses of Pyrazinamide in excess of 3 g twice weekly have been administered. This exceeds the recommended maximum 3 g/daily dose. However, an increased incidence of adverse reactions has not been reported. pdp-PYRAZINAMIDE should be administered with at least one other effective anti- tuberculous medicine. The use of pdp-PYRAZINAMIDE in combination therapy does not modify the accepted dosages of other anti-tuberculous agents. The tablet should not be divided. 4.3 Contraindications • Patients who are hypersensitive to any component of this product; • Patients with hepatic disease • Patients with hyperuricaemia and/or gouty arthritis. • Safety for use in children has not been established • Nursing mothers. If use of this medicine is deemed essential, the patient should stop nursing. NEW ZEALAND DATA SHEET Page 2 of 5 4.4 Specia Izlasiet visu dokumentu