Ország: Egyesült Királyság
Nyelv: angol
Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)
Protionamide
Imported (Germany)
Protionamide
250mg
Oral tablet
No Controlled Drug Status
Valid as a prescribable product
BNF:
PACKAGE LEAFLET: INFORMATION FOR THE USER PETEHA®, 250 mg, film-coated tablets Active substance: prothionamide WHAT IS IN THIS LEAFLET 1. What PETEHA® is and what it is used for 2. What you need to know before you take PETEHA® 3. How to take PETEHA® 4. Possible side effects 5. How to store PETEHA® 6. Further information 1. WHAT PETEHA® IS AND WHAT IT IS USED FOR PETEHA® is medicine used to treat tuberculosis, diseases caused by atypical mycobacteria and leprosy. PETEHA® IS TAKEN - in the treatment of all forms and stages of pulmonary and extrapulmonary tuberculosis as a second line medicine in cases of proven multidrug- resistance of pathogens toward primary medicines, - in the treatment of diseases which are caused by so-called nontuberculous mycobacteria, - in the treatment of leprosy in the scope of modified therapy regimes. PETEHA® is always applied in combination with other medicines effective against the pathogen and only if the pathogen's sensitivity to prothionamide has been proven. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PETEHA® DO NOT TAKE PETEHA® 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, please 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 of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. See section 4. - if you are hypersensitive (allergic) against prothionamide, yellow orange S or one of the other excipients of PETEHA® - if you have a severe liver disease or an acute inflammation of the liver (hepatitis), - if you are known to suffer from cerebral seizures (cerebral seizures) or psychoses, - during pregnancy and lactation (see Section “Pregnancy and Lactation”). TAKE SPECIAL CARE WITH PETEHA® - because of the liver-damaging action of prothionamide and Olvassa el a teljes dokumentumot
PETEHA ® 1 SUMMARY OF PRODUCT CHARACTERISTICS (SPC) 1. NAME OF THE MEDICINAL PRODUCT PETEHA ® 250 mg, film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: prothionamide One film-coated tablet contains 250 mg prothionamide (PTH). Other excipients: Contains lactose monohydrate (see Section 4.4) and Orange Yellow S (see section 4.3 and 4.8) For the full list of excipients, see Section 6.1. 3. PHARMACEUTICAL FORM Orange, round, biconvex film-coated tablets with a breaking notch on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS - Treatment of all forms and stages of pulmonary and extrapulmonary tuberculosis as second line drug in the case of proven multidrug resistance of the pathogens against first line drugs - Treatment of diseases caused by so-called ubiquitous (atypical) mycobacteria - Treatment of leprosy in the context of modified therapy regimens PETEHA ® is always used in combination with other anti-mycobacterial chemotherapeutics and only if susceptibility of the pathogen against prothionamide has been proven. The official guidelines for the proper use of anti-microbial agents need to be taken into account when using PETEHA ® . PETEHA ® 2 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Prothionamide is a second line drug (reserve drug) for the treatment of tuberculosis and of diseases caused by so-called ubiquitous (atypical) mycobacteria. It is always part of a combination therapy with other anti-mycobacterial chemotherapeutics if the susceptibility of the pathogen to prothionamide has been proven. The choice of the therapy regimen is based on the results of the susceptibility test of the specific patient isolate. For the treatment of leprosy, prothionamide is used in the context of modified therapy regimens. DOSAGE FOR TUBERCULOSIS AND DISEASES CAUSED BY ATYPICAL MYCOBACTERIA Adults Prothionamide is dosed according to body weight. Adults are given 15 mg/kg body weight per day. A maximum daily dose of 1,000 mg should not be exceeded. The table below shows the number Olvassa el a teljes dokumentumot