Country: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
Isoniazid; Pyrazinamide; Rifampicin
Sanofi-Aventis Ireland Limited T/A SANOFI
J04AM; J04AM05
Isoniazid; Pyrazinamide; Rifampicin
50 /300 /120 milligram(s)
Tablet
Product subject to prescription which may not be renewed (A)
Combinations of drugs for treatment of tuberculosis; rifampicin, pyrazinamide and isoniazid
Marketed
1987-02-09
Internal RIFATER ® 50MG/300MG/120MG TABLETS _ _ _Isoniazid 50mg - Pyrazinamide 300mg -Rifampicin 120mg _ _Sanofi Logo _ IS THIS LEAFLET HARD TO SEE OR READ? PHONE 01 403 5600 FOR HELP. Read all of this leaflet carefully before you start taking this medicine. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Rifater is and what it is used for 2. What you need to know before you take Rifater 3. How to take Rifater 4. Possible side effects 5. How to store Rifater 6. Contents of the pack and other information 1. W 1. WHAT RIFATER IS AND WHAT IT IS USED FOR AT RIFATER IS AND WHAT IT ISED FOR Rifater is one of a group of medicines used to treat tuberculosis (also known as TB) of the lung. 2. WHAT YOU NEED TO KNOW BEFOREYOU TAKE RIFATER 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RIFATER DO NOT TAKE RIFATER IF: • You are allergic (hypersensitive) to: - isoniazid - rifampicin - pyrazinamide - any of the other ingredients (see Section 6 Further information). Signs of an allergic reaction include: rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue. • You have yellowing of the skin and eyes (jaundice). • You are taking saquinavir or ritonavir for HIV infection (see ‘Taking other medicines’ section below). Severe skin reactions such as severe extensive skin damage (separation of the epidermis and superficial mucous membranes) (toxic epidermal necrolysis, TEN,), skin blistering, red/purple rash, fever headache, cough and joint pain (Stevens-Johnson syndrome, SJS) or large areas of red, swollen skin with small pus-filled elevations (acute generalized exanthematous pustulosis, AGEP) may occur. Treatment must be immediately Прочитајте комплетан документ
Health Products Regulatory Authority 14 March 2024 CRN00DR74 Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Rifater 50 mg/300 mg/120 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains : Isoniazid. 50 mg Pyrazinamide 300 mg Rifampicin 120 mg Excipient: Contains 104.99 mg sucrose _For a full list of excipients, see section 6.1. _ 3 PHARMACEUTICAL FORM Coated tablet. Smooth, circular, pink-beige sugar-coated tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Indications for use In the treatment of pulmonary tuberculosis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Recommended Dosage For oral administration. Adults: Rifater is recommended in the initial intensive phase of the short-course treatment of pulmonary tuberculosis. During this phase, which lasts for 2 months, Rifater should be administered on a daily continuous basis. The concomitant administration of ethambutol or intramuscular streptomycin over the same period of time is advised. Rifater should only used under the supervision of specialists having the appropriate facilities for clinical and laboratory monitoring of effects. Each Rifater tablet contains isoniazid (INH), pyrazinamide (Z) and rifampicin (RAMP) in such a ratio that the administration of 9-12 mg/kg RAMP, 4-5mg/kg INH and 23-30mg/kg Z can be achieved by giving 3 tablets daily to patients weighing less than 40kg, 4 tablets to patients weighing 40-49kg, 5 tablets to patients weighing 50-64kg and 6 tablets to patients weighing 65kg or more. Health Products Regulatory Authority 14 March 2024 CRN00DR74 Page 2 of 15 Rifater should be given as a single dose 1-2 hours before a meal to ensure rapid and complete absorption. Once the initial intensive phase of treatment has been completed the treatment can be continued with the combination rifampicin-isoniazid (Rifinah) always on a daily basis. Children: There is insufficient experience of use in children. Use in the elderly: Caution should be exercised in such patients, in view of the possib Прочитајте комплетан документ