Indications
Sovaldi is indicated for use in combination with other medicinal products for the treatment of chronic hepatitis C in adult patients.
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Add to wishlistSovaldi is indicated for use in combination with other medicinal products for the treatment of chronic hepatitis C in adult patients.
Hypersensitivity to sofosbuvir or any other component of the drug;
Pregnancy;
Children under 18 years of age (efficacy and safety have not been established in this population);
Severe renal insufficiency (creatinine clearance<30 ml / min) or end-stage renal failure when hemodialysis is required (safety has not been established in this patient population);
Co-infection with hepatitis C and B viruses (HCV/HBV) (there are no data on the use of Sovaldi in this patient population);
Decompensated cirrhosis of the liver (efficacy and safety have not been established in this patient population);
In patients receiving potent P-glycoprotein inducers (e. g. rifampicin, Hypericum perforatum, carbamazepine and phenytoin, phenobarbital, oxcarbazepine).
1 tablet contains:
active substance:
sofosbuvir 400.0 mg;
excipients:
Pill Core:
mannitol 360.0 mg,
microcrystalline cellulose 356.0 mg,
croscarmellose sodium 60.0 mg,
colloidal silicon dioxide 6.0 mg,
magnesium stearate 18.0 mg;
Tablet shell:
Opadray II yellow 36.0 mg, containing:
polyvinyl alcohol (40.0%),
titanium dioxide (23.33%).
macrogol (20.20%),
talc (14.8%),
iron oxide yellow dye (1.67%).
1 tablet contains: Active ingredient: sofosbuvir 400.0 mg; excipients: Pill Core: mannitol 360.0 mg, microcrystalline cellulose 356.0 mg, croscarmellose sodium 60.0 mg, colloidal silicon dioxide 6.0 mg, magnesium stearate 18.0 mg; Tablet shell: Opadray II yellow 36.0 mg, containing: polyvinyl alcohol (40.0%), titanium dioxide (23.33%). macrogol (20.20%), talc (14.8%), iron oxide yellow dye (1.67%).
SOVALDI (SOFOSBUVIR) is an inhibitor of hepatitis C virus (HCV) NS5B polymerase and is used for the treatment of chronic hepatitis C (CHC) as a component of a combined antiviral therapy regimen in adult patients in combination with other medications. Clinical data on the use of sofosbuvir in patients with genotype 5 or 6 are limited. There are no data on the effectiveness of the drug in patients with co-infection with hepatitis and HIV.
Sovaldi is indicated for use in combination with other medicinal products for the treatment of chronic hepatitis C in adult patients.
Hypersensitivity to sofosbuvir or any other component of the drug; Pregnancy; Children under 18 years of age (efficacy and safety have not been established in this population);Severe renal insufficiency (CC
Since Sovaldi containing Sofosbuvir should only be used in combination with other drugs for the treatment of hepatitis C, the following are the side effects for combinations of these drugs. 1. Combination: sofosbuvir + ribavirin. Infectious and parasitic diseases: often-nasopharyngitis. From the blood and lymphatic system: very often – a decrease in the concentration of Hb; often-anemia. Mental disorders: very often – insomnia; often-depression. From the nervous system: very often – headache, often-impaired attention. From the respiratory system, chest and mediastinal organs: often-shortness of breath, shortness of breath during exercise, cough. From the gastrointestinal tract: very often-nausea; often-abdominal discomfort, constipation, dyspepsia. 2. A combination of sofosbuvir + peginterferon alfa + ribavirin. From the blood and lymphatic system: very often – anemia, neutropenia, a decrease in the number of lymphocytes, a decrease in the number of platelets. From the side of metabolism and nutrition: very often – decreased appetite; often-weight loss. Mental disorders: very often – insomnia; often-depression, anxiety, agitation. From the nervous system: very often-dizziness, headache; often-migraine, memory loss, impaired attention. From the side of the organ of vision: often-unclear vision. From the respiratory system, chest and mediastinal organs: very often – shortness of breath, cough; often – shortness of breath during physical exertion. From the gastrointestinal tract: very often – diarrhea, nausea, vomiting; often-constipation, dry mouth, gastroesophageal reflux.
Powerful inducers of intestinal P-gp (e. g. rifampicin, St. John’s wort, carbamazepine, and phenytoin) may reduce the plasma concentration of sofosbuvir, leading to a decrease in therapeutic efficacy, so they should not be used simultaneously with sofosbuvir.
Treatment with Sovaldi should be initiated and supervised by a doctor with experience in the treatment of chronic hepatitis C. One tablet,400 mg, of Sovaldi is recommended to be taken once a day, with meals. The tablet should be swallowed whole, washed down with water. Tablets should not be chewed or broken. If the delay in taking Sovaldi is less than 18 hours, the patient should take the next dose as soon as possible, and then continue with the usual intake of the drug. If the delay in taking Sovaldi is more than 18 hours, the patient should wait and take the next tablet at the usual time. If the patient experiences vomiting within 2 hours of taking Sovaldi, another dose of the drug should be taken. If the patient vomits 2 hours after taking Sovaldi, there is no need to take another dose of the drug (most of the dose of the drug is absorbed within 2 hours). Sovaldi should be used in combination with other medicinal products.
The highest documented dose of sofosbuvir was a single, supertherapeutic dose of sofosbuvir 1200 mg administered in 59 healthy volunteers. While taking this dose of the drug, there were no unexpected NLRs, all identified NLRs were similar in frequency and severity to those in the placebo group and the sofosbuvir group (400 mg). There is no specific antidote for Sovaldi. In case of overdose, the patient should be monitored for timely detection of signs of toxicity. Treatment of overdose with Sovaldi includes general supportive measures, including monitoring of vital signs and the patient’s clinical condition. Hemodialysis can effectively remove (clearance 53%) the main inactive metabolite (GS-331007) from the blood. A 4-hour hemodialysis session removed 18% of the drug dose.
The drug is not recommended for use as monotherapy, it should be prescribed in combination with other medications for the treatment of chronic hepatitis C. If you stop taking other medications prescribed in combination with this drug, Sovaldi should also be discontinued. Before starting use, you should carefully read the instructions for medical use for co-prescribed medications.
Store at a temperature not exceeding 30°C. Keep out of reach of children.
3 years
Sofosbuvir
Prescription
Out of stock
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