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)

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)

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)

ranbaxy pharmaceuticals inc. - ganciclovir (unii: p9g3ckz4p5) (ganciclovir - unii:p9g3ckz4p5) - ganciclovir 250 mg - ganciclovir capsules are indicated for the prevention of cmv disease in solid organ transplant recipients and in individuals with advanced hiv infection at risk for developing cmv disease. ganciclovir capsules are also indicated as an alternative to the intravenous formulation for maintenance treatment of cmv retinitis in immunocompromised patients, including patients with aids, in whom retinitis is stable following appropriate induction therapy and for whom the risk of more rapid progression is balanced by the benefit associated with avoiding daily iv infusions (see clinical trials ). safety and efficacy of ganciclovir have not been established for congenital or neonatal cmv disease; not for the treatment of established cmv disease other than retinitis; nor for use in non-immunocompromised individuals. the safety and efficacy of ganciclovir capsules have not been established for treating any manifestation of cmv disease other than maintenance treatment of cmv retinitis. ganciclovir is contraindicated in pati

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

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 hhh (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 hhh (ganciclovir) is not indicated for congenital or neonatal cmv disease; nor for the treatment of cmv infection in non-immunocompromised individuals.

Israel - English - Ministry of Health

a.l. medi-market ltd. - ganciclovir as sodium - powder for concentrate for solution for infusion - ganciclovir as sodium 500 mg/vial - ganciclovir - ganciclovir medi-market 500 mg is indicated for the treatment of cmv retinitis in immunocompromised patiens, including patients with acquired immunodeficiency syndrome (aids). ganciclovir medi-market 500 mg is also indicated for the prevention of cmv disease in transplant recipients at risk for cmv disease.

Canada - English - Health Canada

fresenius kabi canada ltd - ganciclovir (ganciclovir sodium) - powder for solution - 500mg - ganciclovir (ganciclovir sodium) 500mg - nucleosides and nucleotides

Canada - English - Health Canada

sterimax inc - ganciclovir (ganciclovir sodium) - powder for solution - 500mg - ganciclovir (ganciclovir sodium) 500mg - nucleosides and nucleotides