Israel - English - Ministry of Health

lapidot medical import and marketing ltd - metronidazole - solution for infusion - metronidazole 500 mg / 100 ml - metronidazole - metronidazole - treatment and prophylaxis of infection which are or may be due to anerobic bacteria,especially bacteriodes species,including bacteriodes fragilis, fusobacterium,eurobacterium and clostridium species.

Malta - English - Medicines Authority

b braun melsungen ag carl-braun-strasse 1, d34212 melsungen, germany - metronidazole - solution for infusion - metronidazole 5 mg/ml - antibacterials for systemic use

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

b. braun melsungen ag - metronidazole 5 mg/ml - solution for infusion - 5 mg/ml - metronidazole 5 mg/ml - metronidazole

Israel - English - Ministry of Health

lapidot medical import and marketing ltd - metronidazole - solution for infusion - metronidazole 500 mg / 100 ml - metronidazole - metronidazole - treatment and prophylaxis of infection which are or may be due to anerobic bacteria,especially bacteriodes species,including bacteriodes fragilis, fusobacterium,eurobacterium and clostridium species.

Ireland - English - HPRA (Health Products Regulatory Authority)

b. braun melsungen ag - metronidazole - solution for infusion - 5 milligram(s)/millilitre - imidazole derivatives; metronidazole

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

b. braun, germany - metronidazole - solution for infusion - 5 mg/ml

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

b. braun medical inc. - metronidazole (unii: 140qmo216e) (metronidazole - unii:140qmo216e) - metronidazole 500 mg in 100 ml - to reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole injection usp and other antibacterial drugs, metronidazole injection usp should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. metronidazole injection usp is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. indicated surgical procedures should be performed in conjunction with metronidazole injection usp therapy. in a mixed aerobic and anaerobic infection, antibiotics appropriate for the treatment of the aerobic infection should be used in addition to metronidazole injection usp. metronidazole injection usp is effective in bacteroides fragil

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

prasco laboratories - metronidazole (unii: 140qmo216e) (metronidazole - unii:140qmo216e) - metronidazole 7.5 mg in 1 g - metronidazole topical lotion is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea. metronidazole topical lotion is contraindicated in individuals with a history of hypersensitivity to metronidazole or to other ingredients of the formulation.

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

sandoz inc. - metronidazole (unii: 140qmo216e) (metronidazole - unii:140qmo216e) - metronidazole 10 mg in 1 g - metronidazole gel usp, 1% is indicated for the topical treatment of inflammatory lesions of rosacea. metronidazole gel usp, 1% is contraindicated in patients with a history of  hypersensitivity to metronidazole or to any other ingredient in the formulation. risk summary available data have not established an association with metronidazole use during pregnancy and major birth defects, miscarriage or other adverse maternal or fetal outcomes. no fetotoxicity was observed after oral administration of metronidazole in pregnant rats or mice. the available data do not allow the calculation of relevant comparisons between the systemic exposures of metronidazole observed in animal studies to the systemic exposures that would be expected in humans after topical use of metronidazole gel usp, 1%. the background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. risk summary it is not known whether metronidazole is present in human milk after topical administration. published literature reports the presence of metronidazole in human milk after oral administration. there are reports of diarrhea and candida infection in breastfed infants of mothers receiving oral treatment with metronidazole. there are no data on the effects of metronidazole on milk production. because of the potential for serious adverse reactions, advise patients that breastfeeding is not recommended during treatment with  metronidazole gel usp, 1%. safety and effectiveness in pediatric patients have not been established. sixty-six subjects aged 65 years and older were treated with metronidazole gel usp, 1% in the clinical study.   no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

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

taro pharmaceuticals u.s.a., inc. - metronidazole (unii: 140qmo216e) (metronidazole - unii:140qmo216e) - metronidazole 10 mg in 1 g - metronidazole gel usp, 1% is indicated for the topical treatment of inflammatory lesions of rosacea. metronidazole gel usp, 1% is contraindicated in patients with a history of hypersensitivity to metronidazole or to any other ingredient in the formulation. teratogenic effects: pregnancy category b. there are no adequate and well-controlled studies with the use of metronidazole in pregnant women. metronidazole crosses the placental barrier and enters the fetal circulation rapidly. no fetotoxicity was observed after oral administration of metronidazole in rats or mice at 200 and 20 times, respectively, the expected clinical dose. however, oral metronidazole has shown carcinogenic activity in rodents. because animal reproduction studies are not always predictive of human response, metronidazole should be used during pregnancy only if clearly needed. after oral administration, metronidazole is secreted in breast milk in concentrations similar to those found in the plasma. even though blood levels taken after top