United States - English - 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

Australia - English - Department of Health (Therapeutic Goods Administration)

southern cross pharma pty ltd - ganciclovir sodium, quantity: 546 mg (equivalent: ganciclovir, qty 500 mg) - injection, powder for - excipient ingredients: - ganciclovir sxp (ganciclovir) administered as the iv infusion is indicated for the palliative treatment of confirmed sight-threatening cytomegalovirus (cmv) disease in aids and other severely immunocompromised individuals. it is indicated for the treatment of confirmed cmv pneumonitis in bone marrow transplant patients. it is also indicated for the prophylaxis of cmv infection and disease following bone marrow and solid organ transplantation in patients at risk of cmv disease.,note: ganciclovir sxp (ganciclovir) is not indicated for congenital or neonatal cmv disease; nor for the treatment of cmv infection in non-immunocompromised individuals.

United States - English - 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

United States - English - NLM (National Library of Medicine)

sagent pharmaceuticals - ganciclovir sodium (unii: 02l083w284) (ganciclovir - unii:p9g3ckz4p5) - ganciclovir 50 mg in 1 ml - ganciclovir injection 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 injection is indicated for the prevention of cmv disease in adult transplant recipients at risk for cmv disease [see clinical studies (14.2)]. ganciclovir 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 pregnant woman, no ad

United States - English - NLM (National Library of Medicine)

pharmascience inc. - ganciclovir sodium (unii: 02l083w284) (ganciclovir - unii:p9g3ckz4p5) - ganciclovir 500 mg in 10 ml - ganciclovir injection 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 injection is indicated for the prevention of cmv disease in adult transplant recipients at risk for cmv disease [see clinical studies (14.2)]. ganciclovir injection ganciclovir 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. 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 pl

United States - English - NLM (National Library of Medicine)

fresenius kabi usa, llc - ganciclovir sodium (unii: 02l083w284) (ganciclovir - unii:p9g3ckz4p5) - ganciclovir 500 mg in 10 ml - ganciclovir for injection 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 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 pregnant w

United States - English - NLM (National Library of Medicine)

fresenius kabi usa, llc - ganciclovir sodium (unii: 02l083w284) (ganciclovir - unii:p9g3ckz4p5) - ganciclovir sodium 500 mg in 10 ml - ganciclovir for injection 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 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

United States - English - 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

Australia - English - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - valganciclovir hydrochloride, quantity: 496.3 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; crospovidone; stearic acid; titanium dioxide; hypromellose; polysorbate 80; iron oxide red; macrogol 400 - valganciclovir viatris is indicated for the treatment of cytomegalovirus (cmv) retinitis in adult patients with acquired immunodeficiency syndrome (aids). valganciclovir viatris is indicated for the prophylaxis of cmv disease in adult and paediatric solid organ transplantation (sot) patients who are at risk.

Australia - English - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - valganciclovir, quantity: 450 mg - tablet, film coated - excipient ingredients: povidone; stearic acid; microcrystalline cellulose; crospovidone; titanium dioxide; hypromellose; polysorbate 80; iron oxide red; macrogol 400 - valganciclovir is indicated for the treatment of cytomegalovirus (cmv) retinitis in patients with acquired immunodeficiency syndrome (aids). valganciclovir is indicated for the prophylaxis of cmv infection and disease following solid organ transplantation in patients at risk of cmv disease.