البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
GLECAPREVIR; PIBRENTASVIR
ABBVIE BIOPHARMACEUTICALS LTD, ISRAEL
J05AP57
FILM COATED TABLETS
PIBRENTASVIR 40 MG; GLECAPREVIR 100 MG
PER OS
Required
ABBVIE DEUTSCHLAND GMBH & CO. KG, GERMANY
GLECAPREVIR AND PIBRENTASVIR
Maviret is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults and in adolescents aged 12 to <18 years
2023-01-31
WEAR GLASSES IF YOU NEED THEM. IF YOU HAVE ANY FURTHER QUESTIONS REGARDING THE USE OF THE MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. 4. SIDE EFFECTS As with any medicine, use of Maviret may cause side effects in some users. Do not be alarmed when reading the list of side effects. You may not suffer from any of them. • IN PEOPLE WHO HAD OR HAVE ADVANCED LIVER PROBLEMS BEFORE STARTING TREATMENT WITH MAVIRET: RARE RISK OF WORSENING LIVER PROBLEMS, LIVER FAILURE AND DEATH. Your doctor will check you for signs and symptoms of worsening liver problems during treatment with Maviret. Tell your doctor right away if you have any of the following signs and symptoms: nausea, tiredness, yellowing of your skin or white part of your eyes, bleeding or bruising more easily than normal, confusion, dark or black or bloody stool, loss of appetite, diarrhea, dark or brown (tea-colored) urine, swelling or pain on the upper right side of your stomach area (abdomen), sleepiness, vomiting of blood, lightheadedness. TELL YOUR DOCTOR OR PHARMACIST IF YOU NOTICE ANY OF THE FOLLOWING SIDE EFFECTS: VERY COMMON SIDE EFFECTS - effects that occur in more than 1 user in 10: • feeling very tired (fatigue) • headache COMMON SIDE EFFECTS - effects that occur in 1-10 users in 100: • feeling sick (nausea) • diarrhoea • feeling weak or lack of energy (asthenia) • increase in bilirubin levels (a laboratory test for liver function) UNCOMMON SIDE EFFECTS - effects that occur in 1-10 users in 1,000: • swelling of the face, lips, tongue, throat, abdomen, arms or legs SIDE EFFECTS OF UNKNOWN FREQUENCY - effects whose frequency has not been determined yet: • itching IF A SIDE EFFECT HAS OCCURRED, IF ANY OF THE SIDE EFFECTS WORSEN OR IF YOU SUFFER FROM A SIDE EFFECT NOT MENTIONED IN THE LEAFLET, CONSULT THE DOCTOR. REPORTING SIDE EFFECTS Side effects can be reported to the Ministry of Health by clicking on the link “Report Side Effects due to Drug Treatment” found on the Ministry of Health homepage (www.health.gov.il) that directs to the on اقرأ الوثيقة كاملة
MAV API APR 22 _ CL Page 1 of 25 1. NAME OF THE MEDICINAL PRODUCT Maviret 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 100 mg glecaprevir and 40 mg pibrentasvir. Excipient with known effect Each film-coated tablet contains 7.48 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Pink, oblong, biconvex, film-coated tablet of dimensions 18.8 mm x 10.0 mm, debossed on one side with ‘NXT’', plain on the other. 4. CLINICAL PARTICULARS WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV TEST ALL PATIENTS FOR EVIDENCE OF CURRENT OR PRIOR HEPATITIS B VIRUS (HBV) INFECTION BEFORE INITIATING TREATMENT WITH MAVIRET. HBV REACTIVATION HAS BEEN REPORTED IN HCV/HBV COINFECTED PATIENTS WHO WERE UNDERGOING OR HAD COMPLETED TREATMENT WITH HCV DIRECT ACTING ANTIVIRALS AND WERE NOT RECEIVING HBV ANTIVIRAL THERAPY. SOME CASES HAVE RESULTED IN FULMINANT HEPATITIS, HEPATIC FAILURE, AND DEATH. MONITOR HCV/HBV COINFECTED PATIENTS FOR HEPATITIS FLARE OR HBV REACTIVATION DURING HCV TREATMENT AND POST-TREATMENT FOLLOW-UP. INITIATE APPROPRIATE PATIENT MANAGEMENT FOR HBV INFECTION AS CLINICALLY INDICATED . 4.1. THERAPEUTIC INDICATIONS Maviret is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults and in adolescents aged 12 to <18 years (see sections 4.2, 4.4. and 5.1). 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Maviret treatment should be initiated and monitored by a physician experienced in the management of patients with HCV infection. Posology _Adults and adolescents aged 12 to <18 years _ The recommended dose of Maviret is 300 mg/120 mg (three 100 mg/40 mg tablets), taken orally, once daily at the same time with food (see section 5.2). MAV API APR 22 _ CL Page 2 of 25 The recommended Maviret treatment durations for HCV genotype 1, 2, 3, 4, 5, or 6 infected patients with compensated liver disease (with or without cirrhosis) are provided in Table 1 and Table 2. اقرأ الوثيقة كاملة