سعر ايوجيسبوف 400 مجم 28 قرص 2022

Tablets containing sofosbuvir 400 mg (AUG Pharma, Egypt), a nucleotide-analogue HCV NS5B polymerase inhibitor used in combination regimens for chronic hepatitis C; 28 tablets per pack.

• Chronic hepatitis C, in combination with other medicinal products (adults and paediatric patients aged 3 years and above)Population: Adults and children aged 3 years and aboveEuropean Medicines Agency (EMA)
• Chronic HCV genotype 1, 2, 3 or 4 infection in adults without cirrhosis or with compensated cirrhosis, as a component of a combination antiviral regimenPopulation: AdultsDailyMed (U.S. National Library of Medicine)

• With ribavirin with or without peginterferon alfa, the most common adverse reactions were fatigue, headache, nausea and insomnia; no adverse reactions specific to sofosbuvir were identified.International label, same formulation · European Medicines Agency (EMA)

• Hypersensitivity to sofosbuvir or to any of the excipients.International label, same formulation · European Medicines Agency (EMA)
• Co-administration with strong intestinal P-gp inducers (carbamazepine, phenobarbital, phenytoin, rifampicin, St John's wort), which markedly lower sofosbuvir levels and may cause loss of efficacy.International label, same formulation · European Medicines Agency (EMA)

• Not recommended as monotherapy; if the other medicines of the combination are permanently discontinued, sofosbuvir should also be stopped.International label, same formulation · European Medicines Agency (EMA)
• Life-threatening severe bradycardia and heart block with amiodarone; use amiodarone only if alternatives are not tolerated or contraindicated, with in-patient cardiac monitoring for the first 48 hours and daily heart-rate monitoring for at least 2 weeks.International label, same formulation · European Medicines Agency (EMA)
• Hepatitis B virus reactivation, some cases fatal, reported with direct-acting antivirals; screen all patients for HBV before treatment and monitor co-infected patients.International label, same formulation · European Medicines Agency (EMA)

• AmiodaroneSevere bradycardia and heart block; use only when alternatives are not tolerated or contraindicated, with close cardiac monitoring.European Medicines Agency (EMA)
• Strong intestinal P-gp inducers (carbamazepine, phenobarbital, phenytoin, rifampicin, St John's wort)Contraindicated: markedly decreased sofosbuvir exposure and possible loss of efficacy.European Medicines Agency (EMA)

• Limited human pregnancy data; animal studies do not indicate harmful reproductive effects. As a precaution, avoid use during pregnancy; if combined with ribavirin, the ribavirin pregnancy contraindications apply.International label, same formulation · European Medicines Agency (EMA)
• Unknown whether sofosbuvir and its metabolites are excreted in human milk; metabolites are excreted in animal milk. Should not be used during breast-feeding.International label, same formulation · European Medicines Agency (EMA)

• Sofosbuvir: Pan-genotypic inhibitor of the HCV NS5B RNA-dependent RNA polymerase; a nucleotide prodrug converted intracellularly to the active uridine analogue triphosphate (GS-461203), which is incorporated into HCV RNA and acts as a chain terminator (EU SmPC).