Kraj: Malezja
Język: angielski
Źródło: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Ravidasvir hydrochloride
PHARMANIAGA MANUFACTURING BERHAD
Ravidasvir hydrochloride
28 Tablets
DOPPEL FARMACEUTICI S.R.L.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ RAVIDA ® TABLET 200MG Ravidasvir (200 mg) CONFIDENTIAL Page No. 1 of 3 WHAT IS IN THIS LEAFLET 1. What Ravida is used for 2. How Ravida works 3. Before you use Ravida 4. How to use Ravida 5. While you are using it 6. Side effects 7. Storage and Disposal of Ravida 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number WHAT RAVIDA IS USED FOR Ravida is an antiviral medicine used to treat adults with long- term (‘chronic’) hepatitis C (an infectious disease that affects the liver, caused by the hepatitis C virus). It must always be used together with other medicines against hepatitis C infection and must never be used by itself, since it will not work on its own. Ravida contains the active substance ravidasvir (as ravidasvir hydrochloride). HOW RAVIDA WORKS Ravida works by stopping the hepatitis C virus from multiplying and infecting new cells in the body. This allows the infection to be eliminated from the body. BEFORE YOU USE RAVIDA _When you must not use it _ • If you are allergic to ravidasvir or any of the other ingredients in this medicine (see section Product Description) • If you are currently taking any of the following medicines: o rifampicin or rifabutin (antibiotics used to treat infections, including tuberculosis) o St. John’s wort (herbal medicine traditionally used for insomnia) o carbamazepine, phenobarbital and phenytoin (medicines used to treat epilepsy and prevent seizures) If you are not sure, talk to your doctor or pharmacist before taking Ravida. _Before you start to use it _ Talk to your doctor before taking Ravida. Tell your doctor if any of the following applies: • you have a current or previous infection with hepatitis B virus • you have been previously treated for hepatitis C • you have had liver organ transplant • your liver is damaged and not functioning properly • you have kidney problems • you have diabetes • you suspect or have been diagnosed with HIV _Blo Przeczytaj cały dokument
FRONTE 10 mm XX MM 110 MM 10 mm 10 mm 34 mm 10 mm 10 mm 12 mm 10 mm 12 mm 34 mm PATIENT POPULATION Patients without cirrhosis Patients with compensated cirrhosis REGIMEN AND DURATION Ravida + sofosbuvir for 12 weeks Ravida + sofosbuvir for 24 weeks ANTIARRHYTHMICS Interaction not studied. Expected: No dose adjustment of Ravida or digoxin is required. Digoxin Interaction not studied. Expected: ↔ Ravidasvir ↔ Proton pump inhibitor Same class as omeprazole and similar interactions predicted. Esomeprasole Lansoprazole Pantoprazole Rabeprazole (Increase in gastric pH) Proton pump inhibitors Interaction not studied. Expected: ↓ Ravidasvir ↔ Famotidine It is recommended that H2-receptor antagonists should be administered 4 hours after Ravida. Famotidine (Increase in gastric pH) Interaction not studied. Expected: ↓ Ravidasvir ↔ H2-receptor antagonist Interaction studied. Observed: ↔ Ravidasvir ↔ Omeprazole Same class as famotidine and similar interactions predicted. Cimetidine Nizatidine Ranitidine (Increase in gastric pH) No dose adjustment of Ravida or omeprazole is required. Omeprazole (Increase in gastric pH) H2-receptor antagonists ANTICOAGULANTS ↔ Ravidasvir ↔ Digoxin Caution is warranted because of the narrow therapeutic window of digoxin. Interaction not studied. Expected: ↔ Ravidasvir ↔ Dabigatran etexilate No dose adjustment of Ravida or dabigatran etexilate is required. Caution is warranted because of the narrow therapeutic window of dabigatran etexilate. Dabigatran etexilate Interaction not studied. Close monitoring of INR is recommended with all vitamin K antagonists. This is due to liver function changes during treatment with Ravida. Vitamin K antagonists Losartan ACID REDUCING AGENTS Antacids Interaction not studied. Expected: ↔ Ravidasvir ↔ Losartan No dose adjustment of Ravida or losartan is required. Interaction not studied. Expected: ↓ Ravidasvir ↔ Antacid It is recommended to separate antacid use and Ravida administration by 4 hours. Solubility of ravidasvir decreases a Przeczytaj cały dokument