Products

MPIVIROPACK

Sofosbuvir
 

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Active ingredient

Sofosbuvir 400 mg.
 

Indications

MPIviropack is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults.

Dosage and Administration

• The recommended dose is one 400 mg tablet, taken orally, once daily with food.
• MPIviropack should be used in combination with other medicinal products. Monotherapy of MPIviropack is not recommended.

Contraindication

Hypersensitivity to the active substance or to any of the excipients.

Side effects

During treatment with sofosbuvir in combination with ribavirin or with peginterferon alfa and ribavirin, the most frequently reported adverse drug reactions were consistent with the expected safety profile of ribavirin and peginterferon alfa treatment, without increasing the frequency or severity of the expected adverse drug reactions.

Drug Interaction

  • Medicinal products that are potent P-gp inducers in the intestine (e.g. rifampicin, St. John's wort, carbamazepine and phenytoin) may decrease sofosbuvir plasma concentration leading to reduced therapeutic effect of MPIviropack and thus should not be used with MPIviropack.
  • Co-administration of MPIviropack with medicinal products that inhibit P-gp and/or BCRP may increase sofosbuvir plasma concentration without increasing GS-331007 plasma concentration, thus MPIviropack may be co-administered with P-gp and/or BCRP inhibitors.
  • Sofosbuvir and GS-331007 are not inhibitors of P-gp and BCRP and thus are not expected to increase exposures of medicinal products that are substrates of these transporters.

Pregnancy and Lactation

• There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of sofosbuvir in pregnant women.
As a precautionary measure, it is preferable to avoid the use of MPIviropack during pregnancy.
• It is unknown whether sofosbuvir and its metabolites are excreted in human milk.
Therefore, MPIviropack should not be used during breast-feeding.

Warning and Precaution

• MPIviropack is always taken with other medicines. Talk to your doctor or pharmacist before taking this medicine if you:
- Have liver problems other than hepatitis C, e.g. if you are awaiting a liver transplantation.
- Have hepatitis B, since your doctor may want to monitor you more closely.
- Have kidney problems. Talk to your doctor or pharmacist if you have severe kidney problems or if you are on kidney dialysis as the effects of Sofosbuvir on patients with severe kidney problems have not been fully tested.
​• Do not give this medicine to children and adolescents under 18 years of age. The use of MPIviropack in children and adolescents has not yet been studied.

Package and Storage

  • Carton box contains White HDPE Bottle of 28 F.C tablets with white HDPE desicant Cap and an insert leaflet.
  • Store at temperature not exceeding 30⁰C in a dry place.

Mother Company

Manufactured by Marcyrl