Καναδάς - Αγγλικά - Health Canada

formative pharma inc. - ganciclovir (ganciclovir sodium) - powder for solution - 500mg - ganciclovir (ganciclovir sodium) 500mg

Καναδάς - Αγγλικά - Health Canada

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

Ισραήλ - Αγγλικά - Ministry of Health

teva israel ltd - valganciclovir as hydrochloride - film coated tablets - valganciclovir as hydrochloride 450 mg - valganciclovir - valganciclovir teva is indicated for the induction and maintenance treatment of cytomegalovirus (cmv) retinitis in patients with acquired immunodeficiency syndrome (aids). valganciclovir teva is indicated for the prevention of cmv disease in cmv-negative patients who have received a solid organ transplant from a cmv-positive donor.

Ηνωμένες Πολιτείες - Αγγλικά - 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

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

exela pharma sciences, llc - ganciclovir (unii: p9g3ckz4p5) (ganciclovir - unii:p9g3ckz4p5) - ganciclovir 2 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)] .  ganciclovir injection is indicated for the prevention of cmv disease in adult transplant recipients at risk for cmv disease [see clinical studies (14 )] . ganciclovir injection is contraindicated in patients who have experienced a clinically significant hypersensitivity reaction (e.g., anaphylaxis) to ganciclovir, valganciclovir or acyclovir. risk summary inanimal 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 on at least one case report in a pregnant woman, no adequate human data are a

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

bausch & lomb incorporated - ganciclovir (unii: p9g3ckz4p5) (ganciclovir - unii:p9g3ckz4p5) - ganciclovir 1.5 mg in 1 g - zirgan ® (ganciclovir ophthalmic gel) 0.15% is indicated for the treatment of acute herpetic keratitis (dendritic ulcers). none. teratogenic effects ganciclovir has been shown to be embryotoxic in rabbits and mice following intravenous administration and teratogenic in rabbits. fetal resorptions were present in at least 85% of rabbits and mice administered 60 mg/kg/day and 108 mg/kg/day (approximately 10,000x and 17,000x the human ocular dose of 6.25 mcg/kg/day), respectively, assuming complete absorption. effects observed in rabbits included: fetal growth retardation, embryolethality, teratogenicity, and/or maternal toxicity. teratogenic changes included cleft palate, anophthalmia/microphthalmia, aplastic organs (kidney and pancreas), hydrocephaly, and brachygnathia. in mice, effects observed were maternal/fetal toxicity and embryolethality. daily intravenous doses of 90 mg/kg/day (14,000x the human ocular dose) administered to female mice prior to mating, during gestation, and during lactation caused hypoplasia of the testes and seminal vesicles in the month-old male offspring, as well as pathologic changes in the nonglandular region of the stomach [see carcinogenesis, mutagenesis, impairment of fertility (13.1)]. there are no adequate and well-controlled studies in pregnant women. zirgan should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. it is not known whether topical ophthalmic ganciclovir administration could result in sufficient systemic absorption to produce detectable quantities in breast milk. caution should be exercised when zirgan is administered to nursing mothers. safety and efficacy in pediatric patients below the age of 2 years have not been established. no overall differences in safety or effectiveness have been observed between elderly and younger patients.

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

amici pharmaceuticals llc - ganciclovir (unii: p9g3ckz4p5) (ganciclovir - unii:p9g3ckz4p5) - ganciclovir 1.5 mg in 1 g

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

hainan poly pharm. co., ltd. - 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

Ηνωμένες Πολιτείες - Αγγλικά - 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

Ηνωμένες Πολιτείες - Αγγλικά - 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