MyHep-LVIR Ledipasvir Sofosbuvir Tablets Specification:
Brand Name: MyHep-LVIR Tablets
Contents: Ledipasvir and Sofosbuvir
Manufactured by: MyLan
Strength: 90 mg Ledipasvir and
400 mg Sofosbuvir
Packing: Pack of 28 Tablets
MyHep LVIR is a fixed-dose combination tablet containing ledipasvir and sofosbuvir for oral administration.Each film, coated tablet contains 90 mg ledipasvir and 400 mg sofosbuvir.
INDICATIONS AND USAGE
MyHep LVIR is indicated for the treatment of choronic hepatitis C (CHC) genotype 1 infection in adults.
DOSAGES AND ADMINISTRATION
Recommended Dosage in Adults
MyHepLVIR is two-drug fixed-dose combination product that contained 90 mg of ledipasvir and 400 mg of sofosbuvir in a single tablet.The recommended dosages of MyHepLVIR is one tablet taken orally once daily with or without food.
Duration of treatment
Relapse rates are affected by baseline host and viral factors and differ between treatment durations for certain subgroups. Below provides the recommended LVIR treatment durations for treatment-naive and treatment-experienced patients and those with and without cirrhosis.
Recommended Treatment Duration for MyHepLVIR in Patients with CHC Genotype 1
Patient Population Recommended Treatment Duration
Treatment-naive with or without cirrhosis 12 weeks*
Treatment-experienced** without cirrhosis 12 weeks
Treatment-experienced** with cirrhosis 24 weeks
MyHep LVIR for 8 weeks can be considered in treatment-naÃ¯ve patients without cirrhosis who have pre-treatment HCV RNA less than 6 million IU/ mL .
Treatment-experienced patients who have failed treatment with either peginterferon alfa+ribavirin or an HCV protease inhibitor + peginterferon alfa + ribavirin
DOSAGES FORMS AND STERENGTHS
MyHep LVIR is available as Green colored, oval shaped, film coated tablet debossed with on one side and plain on other side of the tablet.Each tablet contains 90 mg ledipasvir and 400 mg sofosbuvir.
Serious Symptomatic Bradycardia When Coadministered with Amiodarone
Postmarketing cases of symptomatic bradycardia, as well as fetal cardiac arrest and cases requiring pacemaker intervention, have been reported when amiodarone is coadministered with Ledipasvir + Sofosbuvir.Bradycardia has generally occurred within hours to days,btus cases have been observed up to 2 weeks after initiating HCV treatment.Patients also taking beta blockers, or those with underlying cardiac comorbidities and/or advanced liver disease may be at increased risk for symptomatic bradycardia with coadministration of amiodarone.Bradycardia generally resolved after discontinuation of HCV treatment.The mechanism for this effect is unknown.
Clinical Trials Experience
The most common adverse reactions (>=10%) were fatigue and headache Nausea, Diarrhea, Insomnia in subjects treated with 8, 12, or 24 weeks of Ledipasvir + Sofodbuvir.
My father has ordered the MyHep LVIR treatment after he was denied to receive Daclinza by NHS. We read fantastic reviews about this product and decided that it was good and cost effective treatment and with no or few noted side effects. Two weeks after completing his treatment, my father's blood tests came out negative for Hep C. That was the best news we could possibly get. Costumer service was very helpful and guided us through the entire treatment. I definitely recommend this treatment for anybody who is eligble for a non-interferon treatment.
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