מדינה: אוגנדה
שפה: אנגלית
מקור: National Drug Authority
ARTESUNATE+AMODIAQUINE
GUILIN PHARMACEUTICALS CO.LTD
ARTESUNATE+AMODIAQUINE
50MG+135MG
ORAL SOLID ORDINARY TABLETS
1.0X1.0X3.0X20.0 TABLET BLISTER,1.0X25.0X3.0 TABLET BLISTER,1.0X25.0X6.0 TABLET BLISTER
2011-07-01
Amodiaquine (as hydrochloride)/Artesunate 135mg/50mg Tablets (Guilin Pharmaceutical Co. Ltd), MA084 WHOPAR part 3 April 2014 Updated: February 2018 1 of 6 PATIENT INFORMATION LEAFLET Amodiaquine (as hydrochloride)/Artesunate 135mg/50mg Tablets (Guilin Pharmaceutical Co. Ltd), MA084 WHOPAR part 3 April 2014 Updated: February 2018 2 of 6 PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER ASAQ GPSC™ (50MG/135MG) * artesunate/amodiaquine (as hydrochloride) 50mg/135 mg tablets 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 health care provider • 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 health care provider. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET 1. What ASAQ GPSC™(50mg/135mg) is and what it is used for 2. What you need to know before you take ASAQ GPSC™(50mg/135mg) 3. How to take ASAQ GPSC™(50mg/135mg) 4. Possible side effects 5. How to store ASAQ GPSC™(50mg/135mg) 6. Contents of the pack and other information 1. WHAT ASAQ GPSC™ (50MG/135MG) IS AND WHAT IT IS USED FOR This medicine is an antimalarial, i.e, a drug used to treat a certain type of malaria infection. ASAQ GPSC™ (50mg/135mg) contains two antimalarial medicines, artesunate and amodiaquine, which work together to kill the malaria parasite (tiny organism that is found inside the red blood cells). Your health care provider has found that you have malaria and so has prescribed ASAQ GPSC™ (50mg/135mg). It is indicated only for the treatment of so called uncomplicated malarial attacks due to _Plasmodium _ _falciparum_ (a particular type of malaria parasite) against which the medicine is active. For complete cure it is important that you complete the prescribed dos קרא את המסמך השלם
ML ASAQ winthrop – August 2010-V1 Page 1 of 11 ARTESUNATE AMODIAQUINE WINTHROP 25 MG/67.5 MG, TABLET ARTESUNATE AMODIAQUINE WINTHROP 50 MG/135 MG, TABLET ARTESUNATE AMODIAQUINE WINTHROP 100 MG/270 MG, TABLET NAME OF THE MEDICINAL PRODUCT _ARTESUNATE AMODIAQUINE WINTHROP_ ® 25MG/67.5MG TABLETS Artesunate, amodiaquine _ARTESUNATE AMODIAQUINE WINTHROP_ ® 50MG/135MG TABLETS Artesunate, amodiaquine _ _ _ARTESUNATE AMODIAQUINE WINTHROP_ ® 100MG/270MG TABLETS Artesunate, amodiaquine QUALITATIVE AND QUANTITATIVE COMPOSITION _ARTESUNATE AMODIAQUINE WINTHROP _ is a fixed dose combination of amodiaquine and artesunate. Each ARTESUNATE AMODIAQUINE WINTHROP 25mg/67.5mg tablet contains 25 milligrams of artesunate 67.5 milligrams of amodiaquine _ (as hydrochloride)_ Each ARTESUNATE AMODIAQUINE WINTHROP 50mg/135mg tablet contains 50 milligrams of artesunate and 135 milligrams of amodiaquine _ (as hydrochloride)_ . Each ARTESUNATE AMODIAQUINE WINTHROP 100mg/270mg tablet contains 100 milligrams of artesunate and 270 milligrams of amodiaquine _ (as hydrochloride)_ . PHARMACEUTICAL FORM Tablets : ARTESUNATE AMODIAQUINE WINTHROP 25mg/67.5mg is a round bilayer tablet : one layer is yellow coloured, the other one is white to slightly yellow, with score line, engraved on one side “AS” and on the other side “25”. ARTESUNATE AMODIAQUINE WINTHROP 50mg/135mg is a round bilayer tablet : one layer is yellow coloured, the other one is white to slightly yellow, with score line, engraved on one side “AS” and on the other side “50”. ARTESUNATE AMODIAQUINE WINTHROP 100mg/270mg is a round bilayer tablet : one layer is yellow coloured, the other one is white to slightly yellow, with score line, engraved on one side “AS” and on the other side “100”. The tablets may be mottled but it does not alter the safety and effectiveness of the product. The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses. ML ASAQ winthrop – August 2010-V1 Page 2 of 11 CLINICAL PARTICULARS THERAPEUT קרא את המסמך השלם