Država: Armenija
Jezik: engleski
Izvor: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
pyrazinamide
Macleods Pharmaceuticals Ltd.
J04AK01
pyrazinamide
400mg
tablets
(100/10x10/) and (672/24x28/) in blister
Prescription
Registered
2016-10-06
1.3.3 PATIENT INFORMATION LEAFLET MACLEODS PHARMACEUTICALS LTD._ _ _ _ PYRAZINAMIDE TABLETS BP 400 MG 1.3.3 PATIENT INFORMATION LEAFLET The Patient Information Leaflet for PYRAZINAMIDE TABLETS BP 400 MG as approved by WHO under TB Prequalification Programme is enclosed overleaf Pyrazinamide 400 mg Tablets (Macleods), TB159 WHOPAR Part 3 September 2011 Section 6 updated: August 2015 Page 1 of 8 PATIENT INFORMATION LEAFLET Pyrazinamide 400 mg Tablets (Macleods), TB159 WHOPAR Part 3 September 2011 Section 6 updated: August 2015 Page 2 of 8 PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER PYRAZINAMIDE 400 MG TABLETS * Pyrazinamide 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, health care provider or pharmacist. - 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. WHAT IS IN THIS LEAFLET : 1. What Pyrazinamide 400 mg Tablets is and what it is used for 2. What you need to know before you take Pyrazinamide 400 mg Tablets 3. How to take Pyrazinamide 400 mg Tablets 4. Possible side effects 5. How to store Pyrazinamide 400 mg Tablets 6. Contents of the pack and other information 1. WHAT PYRAZINAMIDE 400 MG TABLETS IS AND WHAT IT IS USED FOR Pyrazinamide 400 mg Tablets is used in combination with other antituberculosis agents for the treatment of all forms of tuberculosis caused by _Mycobacterium tuberculosis._ 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PYRAZINAMIDE 400 MG TABLETS DO NOT TAKE PYRAZINAMIDE 400 MG TABLETS - if you are hypersensitive (allergic) to pyrazinamide or any of the other ingredients of Pyrazinamide 400 mg Tablets (see section 6, What Pyrazinamide 400 mg Tablets contains). - if you have seve Pročitajte cijeli dokument
1.3.1 SUMMARY OF PRODUCT CHARACTERISTICS MACLEODS PHARMACEUTICALS LTD._ _ _ _ PYRAZINAMIDE TABLETS BP 400 MG 1.3.1 SUMMARY OF PRODUCT CHARACTERISTICS The Summary of Product Characteristics for PYRAZINAMIDE TABLETS BP 400 MG as approved by WHO under TB Prequalification Programme is enclosed overleaf Pyrazinamide 400 mg Tablets WHOPAR Part 4 September 2011 (Macleods), TB159 Section 6 updated: February 2014 _ _ _ _ _PAGE 1 OF 8 _ SUMMARY OF PRODUCT CHARACTERISTICS Pyrazinamide 400 mg Tablets WHOPAR Part 4 September 2011 (Macleods), TB159 Section 6 updated: February 2014 _ _ _ _ _PAGE 2 OF 8 _ 1. NAME OF THE MEDICINAL PRODUCT Pyrazinamide 400 mg Tablets * 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: Pyrazinamide 400 mg _ _ For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablets White, circular, convex, bevelled-edge tablets, plain on both sides. The tablets should not be divided. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS: Pyrazinamide 400 mg Tablets is indicated in combination with other antituberculosis agents for the treatment of all forms of tuberculosis caused by _Mycobacterium tuberculosis._ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oral use Pyrazinamide 400 mg Tablets must always been given in combination with other antituberculosis agents. DAILY REGIMEN 25 mg/kg (20-30 mg/kg) body weight as a single daily dose. 35 mg/kg (30-40 mg/kg) body weight for children weighing less than 30 kg, as a single daily dose. _ _ _NUMBER OF PYRAZINAMIDE 400 MG TABLETS FOR TREATMENT ACCORDING TO WEIGHT BANDS _ Daily regimen (adults and children) Weight in kg 11-20 21-39 40-54 55-70 >70 Number of tablets per day 1 2 3 4 5 INTERMITTENT REGIMEN 35 mg/kg (30-40 mg/kg) body weight 3 times a week as a single dose or 50 mg/kg (40-60 mg/kg) body weight 2 times a week as a single dose (The latter 50 mg twice weekly regimen, however, is not recommended by WHO). Pyrazinamide 400 mg Tablets should preferably be taken without food _(1)_ . Tablets should be swallowed whole with drinking wat Pročitajte cijeli dokument