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Rx Item-Entecavir 0.5Mg Tab 30 By Cipla Pharma Gen Baraclude

NDC 49884-0104-11 UPC/GTIN No.3-49884-10411-5 Mfg.Part No.10411BRAND: ENTECAVIR NDC: 49884-0104-11,49884010411 UPC: 3-49884-10411-5,349884104115 Par Pharma IncOnly Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

Rx Item-Entecavir 0.5Mg Tab 30 By Cipla Pharma Gen Baraclude

$1333.05$299.99

Item No.:RX611269 NDC No.49884010411 UPC No.:349884104115 NDC No. 69097-0426-02 UPC/GTIN No. MPN 84130 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,ResearchCo.,Uni.,VA,Vet & Wholesalers in scope of practice can order this RX Item. Rx Item No. Rx611269 Entecavir 0.5mg Tab 30 by Cipla Pharma Item No. 611269 NDC No. 69097-0426-02 UPC No. Other Name Entecavir,Baraclude Therapeutic Code 081832

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ENTECAVIR - entecavir anhydrous tablet
Camber Pharmaceuticals, Inc.

BOXED WARNING

WARNING: SEVERE ACUTE EXACERBATIONS OF HEPATITIS B, PATIENTS CO-INFECTED WITH HIV AND HBV, AND LACTIC ACIDOSIS AND HEPATOMEGALY
Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy, including entecavir. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy. If appropriate, initiation of anti-hepatitis B therapy may be warranted [see Warnings and Precautions (5.1)].
Limited clinical experience suggests there is a potential for the development of resistance to HIV (human immunodeficiency virus) nucleoside reverse transcriptase inhibitors if entecavir tablets are used to treat chronic hepatitis B virus (HBV) infection in patients with HIV infection that is not being treated. Therapy with entecavir tablets is not recommended for HIV/HBV co-infected patients who are not also receiving highly active antiretroviral therapy (HAART) [see Warnings and Precautions (5.2)].Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogue inhibitors alone or in combination with antiretrovirals [see Warnings and Precautions (5.3)].



1 INDICATIONS & USAGE

Entecavir tablet is indicated for the treatment of chronic hepatitis B virus infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.
The following points should be considered when initiating therapy with entecavir tablets:
� In adult patients, this indication is based on clinical trial data in nucleoside-inhibitor-treatment-na�ve and lamivudine-resistant subjects with HBeAg-positive and HBeAg-negative HBV infection and compensated liver disease and a more limited number of subjects with decompensated liver disease. [see Clinical Studies ( 14.1)]. Pediatric use information is approved for Bristol-Myers Squibb Company's Baraclude� (entecavir) tablets. However, due to Bristol-Myers Squibb Company's marketing exclusivity rights, this drug product is not labeled with that information.

2 DOSAGE & ADMINISTRATION

2.1 Timing of Administration
Entecavir tablets should be administered on an empty stomach (at least 2 hours after a meal and 2 hours before the next meal).

2.2 Recommended Dosage in Adults
Compensated Liver Disease
The recommended dose of entecavir tablets for chronic hepatitis B virus infection in nucleoside�inhibitor-treatment-na�ve adults and adolescents 16 years of age and older is 0.5 mg once daily.
The recommended dose of entecavir tablets in adults and adolescents (at least 16 years of age) with a history of hepatitis B viremia while receiving lamivudine or known lamivudine or telbivudine resistance substitutions rtM204I/V with or without rtL180M, rtL80I/V, or rtV173L is 1 mg once daily.
Decompensated Liver Disease The recommended dose of entecavir tablets for chronic hepatitis B virus infection in adults with decompensated liver disease is 1 mg once daily.

2.3 Recommended Dosage in Pediatric Patients
Pediatric use information is approved for Bristol-Myers Squibb Company's Baraclude� (entecavir) tablets. However, due to Bristol-Myers Squibb Company's marketing exclusivity rights, this drug product is not labeled with that information.

NDC 49884-0104-11 UPC/GTIN No.3-49884-10411-5 Mfg.Part No.10411
RX ITEM-Entecavir 0.5Mg Tab 30 By Cipla
NDC 49884-0104-11 UPC/GTIN No.3-49884-10411-5 Mfg.Part No.10411

BRAND: ENTECAVIR NDC: 49884-0104-11,49884010411 UPC: 3-49884-10411-5,349884104115 Par Pharma Inc
Entecavir 0.5Mg Tab 30 By Cipla Pharma
BRAND: ENTECAVIR NDC: 49884-0104-11,49884010411 UPC: 3-49884-10411-5,349884104115 Par Pharma Inc

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
ENTECAVIR ORAL TABLET 0.5
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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