Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
ATOVAQUONE ; PROGUANIL HYDROCHLORIDE
Generics (UK) Limited
P01BB51
ATOVAQUONE ; PROGUANIL HYDROCHLORIDE
250/100 Milligram
Film Coated Tablet
Product subject to prescription which may not be renewed (A)
proguanil, combinations
Marketed
2013-05-31
Colours Non-Print Colours Date: Time: Equate CMYK with Dimensions Main Font Body Text Size Min Text Size used Page Count No. of colours Pharma Code SAP No. Vendor Job No. Trackwise Proof No. Client Market Keyline/Drawing No. Barcode Info Description Component Type Affiliate Item Code Superceded Affiliate Item Code TrackWise PR No. MA No. Packing Site/Printer Supplier Code Sign-offs v2/Oct 2016 1/2 1 Myriad pro 9 pt 9 pt 170 x 360mm Atovaquone Proguanil Hydrochloride 250 mg / 100 mg 12 Leaflet 1184432 877487 1184432 PL 04569/1271 PA0405/062/001 Komarom 50063246 5233 NA 310051 4 United Kingdom, Ireland NA NA Black 13 Jun 2017 19:23 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ATOVAQUONE/PROGUANIL HYDROCHLORIDE 250 MG/100 MG FILM-COATED TABLETS atovaquone/proguanil hydrochloride 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 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. See section 4. WHAT IS IN THIS LEAFLET: 1. What Atovaquone/Proguanil hydrochloride is and what it is used for 2. What you need to know before you take Atovaquone/ Proguanil hydrochloride 3. How to take Atovaquone/Proguanil hydrochloride 4. Possible side effects 5. How to store Atovaquone/Proguanil hydrochloride 6. Contents of the pack and other information 1. WHAT ATOVAQUONE/PROGUANIL HYDROCHLORIDE IS AND WHAT IT IS USED FOR Atovaquone/Proguanil hydrochloride belongs to a group of medicines called antimalarials. It contains two active substances, atovaquone and proguanil hydrochloride. Atovaquone/Proguanil hydrochloride is used to: • Prevent malaria • Treat malaria Malaria is spread by the bite of an infected m Lugege kogu dokumenti
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Atovaquone/Proguanil Hydrochloride 250 mg/100 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 250 mg atovaquone and 100 mg proguanil hydrochloride. Excipient with known effect: Each film-coated tablet also contains 3.82 mg of lactose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet (tablet) Buff coloured, round, biconvex, film-coated tablets debossed with ‘A-P’ over ‘2’ on one side and ‘M’ on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Atovaquone/Proguanil Hydrochloride is a fixed dose combination of atovaquone and proguanil hydrochloride which acts as a blood schizonticide and also has activity against hepatic schizonts of_ Plasmodium falciparum_. It is indicated for: Prophylaxis of_ Plasmodium falciparum_ malaria. Treatment of acute, uncomplicated_ Plasmodium falciparum_ malaria. Because Atovaquone/Proguanil Hydrochloride is effective against drug sensitive and drug resistant_ P. falciparum_ it is especially recommended for prophylaxis and treatment of_ P. falciparum_ malaria where the pathogen may be resistant to other antimalarials. Official guidelines and local information on the prevalence of resistance to antimalarial medicinal products should be taken into consideration. Official guidelines will normally include WHO and public health authorities_'_ guidelines. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Prophylaxis Prophylaxis should • commence 24 or 48 hours prior to entering a malaria-endemic area, • continue during the period of the stay • continue for 7 days after leaving the area. In residents (semi-immune subjects) of endemic areas, the safety and effectiveness of atovaquone/proguanil has been established in studies of up to 12 weeks. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Lugege kogu dokumenti