|Minimum Order Quantity||1.00||Unit of Measure||Piece/Pieces|
|Payment Terms||Paypal, Others||Delivery Time||7-15 Days|
|Packaging Details||Carton Boxes Packaging||Main Export Market(s)||Asia, Australia, Central America, North America, South America, Eastern Europe, Western Europe, Africa|
|Main Domestic Market||All India||Certifications||Certified Products.|
Banking upon in-depth domain knowledge and years of vast experience, we are engaged in offering Daclatasvir Dihydrochloride 60mg Tablets. These tablets are used for the treatment of patient with chronic hepatitis C virus (HCV) genotype 3 infection. Our expert agents procure these tablets from the trusted vendors of the market. The tablets are tested on defined quality parameters before packing in medical grade materials. We offer Daclatasvir Dihydrochloride 60mg Tablets at reasonable prices.
- Accurate composition
- Low indication of side effects
- Inhibitor of non-structural protein 5A
Mydekla 60 is an inhibitor of non-structural protein 5A (NS5A).
Each film-coated tablet contains Daclatasvir equivalent to Daclatasvir 30 mg or 60 mg.
INDICATIONS AND USAGE
Mydekla 60 is indicated in combination with Sofosbuvir for the treatment of patient with chronic hepatitis C virus (HCV) genotype 3 infection.
DOSAGE AND ADMINISTRATION
Treatment with Mydekla 60 should be initiated and monitored by physician experienced in the management of chronic hepatitis C. The recommended dose of Mydekla 60 is 60 mg once daily to be taken orally with or without meals. Mydekla 60 must be administered in combination with other medical products.The Packeges inserts of the medicinal products in the regimen should also be consulated before initiation of therapy with Mydekla 60.Recommended reginmens and treatment duration are provided below.
Recommended regimens and treatment duration for Mydekla 60 combination therapy
|HCV genotype and patient population||Treatment||Duration|
|Genotype 3 without cirrhosis||Daclatasvir + sofosbuvir||12 weeks|
|Genotype 3 with cirrhosis||Daclatasvir + sofosbuvir||24 weeks|
Dose modification, interruption and discontinuation
Dose modification of Mydekla 60 to manage adverse reactions is not recommended.There is no virologic treatment stopping rules that apply to the combination of Mydekla 60 with sofosbuvir.
Hypersensitivity to the active substance or to any of the excipients Coadministration with medicinal products that strongly induce cytochrome P450 3A4 (CYP3A4) and P-glycoprotein transporter (P-gp) and thus may lead to lower exposure and loss of efficacy of Daclatasvir. These active substances include but are not limited to phenytoin, carbamazepine, oxcarbazepine, rifampicin, rifapentine, systemic dexamethasone, and the herbal product St Johnâ€™s wort (Hypericum perforatum).
WARNINGS AND PRECAUTIONS
MyDacla 60 must not be administered as monotherapy.DeciHeptm must be administered in combination with other medicinal products for the the treatment of chronic HCV infection.
The safety and efficacy of the combination of Daclatasvir and sofosbuvir have been evaluated in a limited number of patients with cirrhosis in clinical studies.
Decompensates liver disease
The safety and efficacy of MyDacla 60 in the treatment of HCV infection in patients with decompensated liver disease have not been established.
Retreatment with MyDacla 60
The efficacy of MyDacla 60 as part of a retreatment regimen in patients with prior exposure to a NS5A inhibitor has not been established.
Pregnancy and contraception requirements
MyDacla 60 should not be used during pregnancy or in women of childbearing potential not using contraception.Use of highly effective contraception should be continued for 5 weeks after completion of Daclatasvir therapy.
Adverse reactions in clinical trials.
The most common adverse reactions(>=10%) were fatigue and headache, aneamia,hot flush,nausea in subjects treated with 8, 12, or 24 weeks of Ledipasvir + Sofosbuvir.
Contraindications of concomitant use
MyDacla 60 is contraindication in combination with medicinal products that strongly induce CYP3A4 and P-gp,e.g. phenytoin,carbamazepine,oxcarbazepine,rifampicin,rifabutin,rifapen-tine,systemic dexamethasone, and the herbal product St Johnâ€™s wort (Hypericum perforatum), and thus may lead to lower exposure and loss of efficacy of Daclatasvir.