Valley Medical Pharmacy 
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Brawley, CA 92227 
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Valganciclovir Generic Valcyte 450 Mg Tabs 60 By Qualitest Product

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Valganciclovir Generic Valcyte 450 Mg Tabs 60 By Qualitest Product

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Valganciclovir Generic Valcyte 450 Mg Tabs 60 By Qualitest Product This Item Requires A Valid Order From A Physician Licensed in USA. Item Number.:RXB10146029/RXD5040514
Size : 60
Selling UoM : EA
NDC: 00603-6330-20
UPC Barcode : 306036330204
Supplier: 0050000059 GENERICS BIDCO I, LLC
Supplier Material : 633020
Generic Code : 047797 VALGANCICLOVIR HCL ORAL TABLET 450 MG
Fine Line Class : 850085008510 All Rx Products
Product Category : RX Pharmaceuticals
Product Type : G

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Product Description.:

E 114
tablet , film-coated , pink , oval oblong
Convex

Valcyte contains valganciclovir hydrochloride (valganciclovir HCl), a hydrochloride salt of the L-valyl ester of ganciclovir that exists as a mixture of two diastereomers. Ganciclovir is a synthetic guanine derivative active against cytomegalovirus (CMV).

Valcyte is available as a 450 mg tablet for oral administration. Each tablet contains 496.3 mg of valganciclovir HCl (corresponding to 450 mg of valganciclovir), and the inactive ingredients microcrystalline cellulose, povidone K-30, crospovidone and stearic acid. The film-coat applied to the tablets contains Opadry Pink? .

Valcyte is also available as a powder for oral solution, which when constituted with water as directed contains 50 mg/mL valganciclovir free base. The inactive ingredients of Valcyte for oral solution are sodium benzoate, fumaric acid, povidone K-30, sodium saccharin, mannitol and tutti-frutti flavoring.

Valganciclovir HCl is a white to off-white crystalline powder with a molecular formula of C14H22N6O5?HCl and a molecular weight of 390.83. The chemical name for valganciclovir HCl is L-Valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]-3-hydroxypropyl ester, monohydrochloride. Valganciclovir HCl is a polar hydrophilic compound with a solubility of 70 mg/mL in water at 25?C at a pH of 7.0 and an n-octanol/water partition coefficient of 0.0095 at pH 7.0. The pKa for valganciclovir HCl is 7.6.

INDICATIONS
Adult Patients

Treatment of Cytomegalovirus (CMV) Retinitis: Valcyte tablets are indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS) [see Clinical Studies].

Prevention of CMV Disease: Valcyte tablets are indicated for the prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-]) [see Clinical Studies].
Pediatric Patients

Prevention of CMV Disease: Valcyte for oral solution and tablets are indicated for the prevention of CMV disease in kidney and heart transplant patients (4 months to 16 years of age) at high risk [see Clinical Studies].
Limitations of Use

Valcyte is not indicated for use in either adult or pediatric liver transplant patients [see Clinical Studies]

The safety and efficacy of Valcyte have not been established for:

* Prevention of CMV disease in solid organ transplants other than those indicated [see Clinical Studies]
* Prevention of CMV disease in pediatric solid organ transplant patients < 4 months of age [see Clinical Studies]
* Treatment of congenital CMV disease [see Use in Specific Populations]