USA - engelsk - 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

USA - engelsk - 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.

Australia - engelsk - Department of Health (Therapeutic Goods Administration)

juno pharmaceuticals pty ltd - metronidazole, quantity: 500 mg - injection, solution - excipient ingredients: water for injections; citric acid; sodium chloride; dibasic sodium phosphate - metronidazole juno is indicated for:treatment of severe anaerobic infection when oral medication is not possible or is contraindicated, when immediate anti-anaerobic therapy is required. metronidazole may be used prophylactically to prevent infection of the surgical site which may have been contaminated or potentially contaminated with anaerobic organisms. procedures in which this may be assumed to have happened include appendectomy, colonic surgery, vaginal hysterectomy, abdominal surgery in the presence of anaerobes in the peritoneal cavity and surgery performed in the presence of anaerobic septicaemia.

USA - engelsk - NLM (National Library of Medicine)

prasco laboratories - metronidazole (unii: 140qmo216e) (metronidazole - unii:140qmo216e) - metronidazole 10 mg in 1 g - metronidazole gel, 1% is indicated for the topical treatment of inflammatory lesions of rosacea. metronidazole gel, 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, 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 2-4% and 15-20%, 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 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, 1%. safety and effectiveness of metronidazole gel, 1% have not been established in pediatric patients. sixty-six subjects aged 65 years and older were treated with metronidazole gel, 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.

Frankrike - fransk - ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Santé)

biogaran - spiramycine 750 000 u.i.; métronidazole 125 mg - comprimé - 750 000 u.i. - pour un comprimé > spiramycine 750 000 u.i. > métronidazole 125 mg - associations d'antibacteriens spiramycine et metronidazole - classe pharmacothérapeutique : associations d'antibactériens spiramycine et métronidazole - code atc : j01ra04.ce médicament est une association de deux antibiotiques, un appartenant à la famille des macrolides et l’autre à la famille des imidazolés. les principes actifs sont respectivement la spiramycine et le métronidazole.ce médicament est indiqué chez l’adulte et chez l’enfant dans le traitement d’infections buccales et dentaires (tels que certains abcès dentaires).

Frankrike - fransk - ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Santé)

arrow generiques - spiramycine 750 000 u.i.; métronidazole 125 mg - comprimé - 750 000 u.i. - pour un comprimé > spiramycine 750 000 u.i. > métronidazole 125 mg - associations d’antibactériens spiramycine et métronidazole - classe pharmacothérapeutique : associations d’antibactériens, spiramycine et métronidazole – code atc : j01ra04.ce médicament est une association de deux antibiotiques, un appartenant à la famille des macrolides et l’autre à la famille des imidazolés. les principes actifs sont respectivement la spiramycine et le métronidazole.ce médicament est indiqué chez l’adulte et chez l’enfant dans le traitement d’infections buccales et dentaires telles que certains abcès dentaires.

Frankrike - fransk - ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Santé)

arrow generiques - spiramycine 1; métronidazole 250 mg - comprimé - 1,5 m.u.i. - pour un comprimé > spiramycine 1,5 m.u.i. > métronidazole 250 mg - associations d’antibactériens spiramycine et métronidazole - classe pharmacothérapeutique : associations d’antibactériens, spiramycine et métronidazole – code atc : j01ra04.ce médicament est une association de deux antibiotiques, un appartenant à la famille des macrolides et l’autre à la famille des imidazolés. les principes actifs sont respectivement la spiramycine et le métronidazole.ce médicament est indiqué chez l’adulte et chez l’enfant dans le traitement d’infections buccales et dentaires telles que certains abcès dentaires.

Frankrike - fransk - ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Santé)

biogaran - spiramycine 1; métronidazole 250 mg - comprimé - 1,5 m.u.i. - pour un comprimé > spiramycine 1,5 m.u.i. > métronidazole 250 mg - associations d'antibacteriens spiramycine et metronidazole - classe pharmacothérapeutique : associations d'antibactériens spiramycine et métronidazole - code atc : j01ra04.ce médicament est une association de deux antibiotiques, un appartenant à la famille des macrolides et l’autre à la famille des imidazolés. les principes actifs sont respectivement la spiramycine et le métronidazole. ce médicament est indiqué chez l’adulte et chez l’enfant dans le traitement d’infections buccales et dentaires tels que certains abcès dentaires.

Frankrike - fransk - ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Santé)

substipharm - spiramycine 1; métronidazole 250 mg - comprimé - 1,5 m.u.i. - pour un comprimé > spiramycine 1,5 m.u.i. > métronidazole 250 mg - associations d’antibactériens spiramycine et métronidazole - classe pharmacothérapeutique : associations d’antibactériens spiramycine et métronidazole - code atc : j01ra04ce médicament est une association de deux antibiotiques, un appartenant à la famille des macrolides et l’autre à la famille des imidazolés. les principes actifs sont respectivement la spiramycine et le métronidazole.ce médicament est indiqué chez l’adulte et chez l’enfant dans le traitement des infections buccales et dentaires (tels que certains abcès dentaires).

Frankrike - fransk - ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Santé)

sun pharma france - spiramycine 1; métronidazole 250 mg - comprimé - 1,5 m.u.i. - pour un comprimé > spiramycine 1,5 m.u.i. > métronidazole 250 mg - associations d’antibactériens spiramycine+metronidazole - classe pharmacothérapeutique : associations d’antibactériens spiramycine et métronidazole – code atc : j01ra04ce médicament est une association de deux antibiotiques, un appartenant à la famille des macrolides et l’autre à la famille des imidazolés. les principes actifs sont respectivement la spiramycine et le métronidazole.ce médicament est indiqué chez l’adulte et chez l’enfant dans le traitement d’infections buccales et dentaires telles que certains abcès dentaires.