Bandaríkin - enska - NLM (National Library of Medicine)

par pharmaceutical - valganciclovir hydrochloride (unii: 4p3t9qf9nz) (ganciclovir - unii:p9g3ckz4p5) - valganciclovir 450 mg - treatment of cytomegalovirus (cmv) retinitis : valganciclovir tablets, usp are indicated for the treatment of cmv retinitis in patients with acquired immunodeficiency syndrome (aids) [see clinical studies (14.1) ]. prevention of cmv disease : valganciclovir tablets, usp 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 (14.1) ]. prevention of cmv disease : valganciclovir tablets, usp are indicated for the prevention of cmv disease in kidney transplant patients (4 months to 16 years of age) and heart transplant patients (1 month to 16 years of age) at high risk [see clinical studies (14.2) ]. valganciclovir is contraindicated in patients who have had a demonstrated clinically significant hypersensitivity reaction (eg, anaphylaxis) to valganciclovir, ganciclovir, or any component of the formulation [see adverse reactions (6.1)]. risk summary after oral administra

Bandaríkin - enska - NLM (National Library of Medicine)

avkare - valganciclovir hydrochloride (unii: 4p3t9qf9nz) (ganciclovir - unii:p9g3ckz4p5) - valganciclovir 450 mg - treatment of cytomegalovirus (cmv) retinitis:  valganciclovir tablets, usp are indicated for the treatment of cmv retinitis in patients with acquired immunodeficiency syndrome (aids) [see clinical studies (14.1)] . prevention of cmv disease: valganciclovir tablets, usp 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 (14.1)] . prevention of cmv disease: valganciclovir tablets, usp are indicated for the prevention of cmv disease in heart transplant patients (4 months to 16 years of age) at high risk [see clinical studies (14.2)] . pediatric use information for pediatric kidney transplant patients ages 4 months to 16 years and for pediatric heart transplant patients ages 1 to less than 4 months is approved for ro

Bandaríkin - enska - NLM (National Library of Medicine)

american health packaging - valganciclovir hydrochloride (unii: 4p3t9qf9nz) (ganciclovir - unii:p9g3ckz4p5) - valganciclovir 450 mg - treatment of cytomegalovirus (cmv) retinitis: valganciclovir tablets are indicated for the treatment of cmv retinitis in patients with acquired immunodeficiency syndrome (aids) [see clinical studies (14.1)]. prevention of cmv disease: valganciclovir 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 (14.1)]. prevention of cmv disease : valganciclovir tablets are indicated for the prevention of cmv disease in kidney transplant patients (4 months to 16 years of age) and heart transplant patients (1 month to 16 years of age) at high risk [see clinical studies (14.2)]. valganciclovir is contraindicated in patients who have had a demonstrated clinically significant hypersensitivity reaction (e.g., anaphylaxis) to valganciclovir, ganciclovir, or any component o

Bandaríkin - enska - NLM (National Library of Medicine)

dr. reddy's laboratories limited - valganciclovir hydrochloride (unii: 4p3t9qf9nz) (ganciclovir - unii:p9g3ckz4p5) - valganciclovir 450 mg - treatment of cytomegalovirus (cmv) retinitis: valganciclovir tablets are indicated for the treatment of cmv retinitis in patients with acquired immunodeficiency syndrome (aids) [see clinical studies (14.1) ]. prevention of cmv disease: valganciclovir 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 (14.1) ]. prevention of cmv disease : valganciclovir tablets are indicated for the prevention of cmv disease in kidney transplant patients (4 months to 16 years of age) and heart transplant patients (1 month to 16 years of age) at high risk  [see clinical studies (14.2) ]. valganciclovir is contraindicated in patients who have had a demonstrated clinically significant hypersensitivity reaction (e.g., anaphylaxis) to valganciclovir, ganciclovir, or any component of the formulation [see adverse reactions (6.1) ]. risk summary after oral administration, va

Bandaríkin - enska - NLM (National Library of Medicine)

northstar rx llc - valganciclovir hydrochloride (unii: 4p3t9qf9nz) (ganciclovir - unii:p9g3ckz4p5) - valganciclovir 450 mg - treatment of cytomegalovirus (cmv) retinitis: valganciclovir tablets are indicated for the treatment of cmv retinitis in patients with acquired immunodeficiency syndrome (aids) [see clinical studies (14.1) ]. prevention of cmv disease: valganciclovir 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 (14.1) ]. prevention of cmv disease : valganciclovir tablets are indicated for the prevention of cmv disease in kidney transplant patients (4 months to 16 years of age) and heart transplant patients (1 month to 16 years of age) at high risk [see clinical studies (14.2) ]. valganciclovir is contraindicated in patients who have had a demonstrated clinically significant hypersensitivity reaction (e.g., anaphylaxis) to valganciclovir, ganciclovir, or any component of the formulation [see adverse reactions (6.1) ]. risk summary after oral administration, val

Bandaríkin - enska - NLM (National Library of Medicine)

aurobindo pharma limited - valganciclovir hydrochloride (unii: 4p3t9qf9nz) (ganciclovir - unii:p9g3ckz4p5) - valganciclovir 450 mg - treatment of cytomegalovirus (cmv) retinitis:   valganciclovir tablets are indicated for the treatment of cmv retinitis in patients with acquired immunodeficiency syndrome (aids) [see clinical studies (14.1)] . prevention of cmv disease:   valganciclovir 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 (14.1)] . prevention of cmv disease: valganciclovir tablets are indicated for the prevention of cmv disease in kidney transplant patients (4 months to 16 years of age) and heart transplant patients (1 month to 16 years of age) at high risk [see clinical studies (14.2)] . valganciclovir tablets are contraindicated in patients who have had a demonstrated clinically significant hypersensitivity reaction (e.g., anaphylaxis) to valganciclovir, ganciclovir, or any component of the formulation [see adverse reactions (6.1)].  risk summary after oral

Bandaríkin - enska - NLM (National Library of Medicine)

camber pharmaceuticals, inc. - valganciclovir hydrochloride (unii: 4p3t9qf9nz) (ganciclovir - unii:p9g3ckz4p5) - valganciclovir 450 mg - treatment of cytomegalovirus (cmv) retinitis: valganciclovir tablets are indicated for the treatment of cmv retinitis in patients with acquired immunodeficiency syndrome (aids) [see clinical studies (14.1)]. prevention of cmv disease: valganciclovir 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 (14.1)]. prevention of cmv disease: valganciclovir tablets are indicated for the prevention of cmv disease in kidney transplant patients (4 months to 16 years of age) and heart transplant patients (1 month to 16 years of age) at high risk [see clinical studies (14.2)]. valganciclovir tablets are contraindicated in patients who have had a demonstrated clinically significant hypersensitivity reaction (e.g., anaphylaxis) to valganciclovir, ganciclovir, or any component of the formulation [see adverse reactions (6.1)]. risk summary after oral administr

Bandaríkin - enska - NLM (National Library of Medicine)

actavis pharma, inc. - valganciclovir hydrochloride (unii: 4p3t9qf9nz) (ganciclovir - unii:p9g3ckz4p5) - valganciclovir 50 mg in 1 ml - prevention of cmv disease: valganciclovir is indicated for the prevention of cmv disease in kidney transplant patients (4 months to 16 years of age) and heart transplant patients (1 month to 16 years of age) at high risk [see clinical studies (14.2)] . valganciclovir for oral solution is contraindicated in patients who have had a demonstrated clinically significant hypersensitivity reaction (e.g., anaphylaxis) to valganciclovir, ganciclovir, or any component of the formulation [see adverse reactions (6.1)]. risk summary after oral administration, valganciclovir (prodrug) is converted to ganciclovir (active drug) and, therefore, valganciclovir is expected to have reproductive toxicity effects similar to ganciclovir. in animal studies, ganciclovir caused maternal and fetal toxicity and embryo-fetal mortality in pregnant mice and rabbits as well as teratogenicity in rabbits at exposures two-times the human exposure. there are no available human data on use of valganciclovir or ganciclovir in pregnant women to e

Bandaríkin - enska - NLM (National Library of Medicine)

dr. reddy's laboratories inc - valganciclovir hydrochloride (unii: 4p3t9qf9nz) (ganciclovir - unii:p9g3ckz4p5) - valganciclovir 450 mg - treatment of cytomegalovirus (cmv) retinitis : valganciclovir tablets are indicated for the treatment of cmv retinitis in patients with acquired immunodeficiency syndrome (aids) [see clinical studies (14.1) ]. prevention of cmv disease : valganciclovir 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 (14.1) ].  prevention of cmv disease :valganciclovir tablets are indicated for the prevention of cmv disease in kidney transplant patients (4 months to 16 years of age) and heart transplant patients (1 month to 16 years of age) at high risk [see clinical studies (14.2) ]. valganciclovir tablets are contraindicated in patients who have had a demonstrated clinically significant hypersensitivity reaction (e.g., anaphylaxis) to valganciclovir, ganciclovir, or any component of the formulation [see adverse reactions (6.1) ].  risk summary after oral administrati

Bandaríkin - enska - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - ganciclovir sodium (unii: 02l083w284) (ganciclovir - unii:p9g3ckz4p5) - ganciclovir for injection, usp is indicated for the treatment of cytomegalovirus (cmv) retinitis in immunocompromised adult patients, including patients with acquired immunodeficiency syndrome (aids) [see clinical studies (14.1)] . ganciclovir for injection, usp is indicated for the prevention of cmv disease in adult transplant recipients at risk for cmv disease [see clinical studies (14.2)]. ganciclovir for injection is contraindicated in patients who have experienced a clinically significant hypersensitivity reaction (e.g., anaphylaxis) to ganciclovir, valganciclovir, or any component of the formulation. risk summary in animal studies, ganciclovir caused maternal and fetal toxicity and embryo-fetal mortality in pregnant mice and rabbits as well as teratogenicity in rabbits at exposures two times the exposure at the recommended human dose (rhd) [see data] . although placental transfer of ganciclovir has been shown to occur based on ex vivo experiments with human placenta and in at least one case report in a