Australija - engleski - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - valganciclovir hydrochloride, quantity: 496.3 mg (equivalent: valganciclovir, qty 450 mg) - tablet, film coated - excipient ingredients: stearic acid; microcrystalline cellulose; crospovidone; titanium dioxide; sunset yellow fcf aluminium lake; purified talc; xanthan gum; allura red ac aluminium lake; polyvinyl alcohol; lecithin; indigo carmine aluminium lake - the treatment of cytomegalovirus (cmv) retinitis in patients with acquired immunodeficiency syndrome (aids). ,the prophylaxis of cmv infection and disease following solid organ transplantation in patients at risk of cmv disease.

Australija - engleski - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - valganciclovir hydrochloride, quantity: 496.3 mg (equivalent: valganciclovir, qty 450 mg) - tablet, film coated - excipient ingredients: crospovidone; microcrystalline cellulose; stearic acid; titanium dioxide; sunset yellow fcf aluminium lake; purified talc; xanthan gum; allura red ac aluminium lake; polyvinyl alcohol; lecithin; indigo carmine aluminium lake - the treatment of cytomegalovirus (cmv) retinitis in patients with acquired immunodeficiency syndrome (aids). ,the prophylaxis of cmv infection and disease following solid organ transplantation in patients at risk of cmv disease.

Sjedinjene Američke Države - engleski - 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.

Velika Britanija - engleski - MHRA (Medicines & Healthcare Products Regulatory Agency)

kensington pharma ltd - ganciclovir sodium - powder for solution for infusion - 500mg

Velika Britanija - engleski - MHRA (Medicines & Healthcare Products Regulatory Agency)

a a h pharmaceuticals ltd - ganciclovir sodium - powder for solution for infusion - 500mg

Velika Britanija - engleski - MHRA (Medicines & Healthcare Products Regulatory Agency)

reig jofre uk ltd - ganciclovir sodium - powder for solution for infusion - 500mg

Belgija - engleski - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

sandoz sa-nv - valganciclovir hydrochloride 496,3 mg - eq. valganciclovir 450 mg - film-coated tablet - 450 mg - valganciclovir hydrochloride 496.3 mg - valganciclovir

Armenija - engleski - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

f. hoffmann-la roche ltd - valganciclovir (valganciclovir hydrochloride) - tablets film-coated - 450mg

Singapur - engleski - HSA (Health Sciences Authority)

dksh singapore pte. ltd. - ganciclovir sodium eqv ganciclovir - injection, powder, for solution - 500 mg - ganciclovir sodium eqv ganciclovir 500 mg

Irska - engleski - HPRA (Health Products Regulatory Authority)

roche products limited - ganciclovir sodium - pdr/conc/soln for infus - 500 mg milligram - nucleosides and nucleotides excl. reverse transcriptase inhibitors