New Zealand - English - Medsafe (Medicines Safety Authority)

southern cross pharma nz ltd - ganciclovir sodium 543mg equivalent to 500 mg ganciclovir - powder for injection - 500 mg - active: ganciclovir sodium 543mg equivalent to 500 mg ganciclovir - 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.

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmaco (nz) ltd - ganciclovir sodium 543mg equivalent to 500 mg ganciclovir - powder for infusion - 500 mg - active: ganciclovir sodium 543mg equivalent to 500 mg ganciclovir - iindicated for the prophylaxis of cmv infection and disease following bone marrow and solid organ transplantation in patients at risk of cmv disease.

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)

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 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)

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)

par pharmaceutical, inc. - ganciclovir sodium (unii: 02l083w284) (ganciclovir - unii:p9g3ckz4p5) - ganciclovir 500 mg in 10 ml - ganciclovir 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 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, usp 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 adequate human

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

slate run pharmaceuticals, llc - 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, usp 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 placental transfer of ganciclovir has been shown to occur based on ex vivo experiments wit

United States - English - 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