Israel - English - Ministry of Health

tzamal bio-pharma ltd - dalbavancin - powder for concentrate for solution for infusion - dalbavancin 500 mg - dalbavancin - xydalba is indicated for the treatment of acute bacterial skin and skin structure infections (absssi) in adults

European Union - English - EMA (European Medicines Agency)

abbvie deutschland gmbh & co. kg - dalbavancin hydrochloride - soft tissue infections; skin diseases, bacterial - antibacterials for systemic use, - treatment of acute bacterial skin and skin structure infections (absssi) in adults.

Canada - English - Health Canada

endo ventures ltd. - dalbavancin (dalbavancin hydrochloride) - powder for solution - 500mg - dalbavancin (dalbavancin hydrochloride) 500mg - glycopeptides

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

allergan, inc. - dalbavancin hydrochloride (unii: 33wdq7t81e) (dalbavancin - unii:808ui9ms5k) - dalbavancin 500 mg in 25 ml - dalvance is contraindicated in patients with known hypersensitivity to dalbavancin.  risk summary there are no adequate and well-controlled studies with dalvance use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse developmental outcomes. no treatment-related malformations or embryo-fetal toxicity were observed in pregnant rats or rabbits at clinically relevant exposures of dalbavancin. treatment of pregnant rats with dalbavancin at 3.5 times the human dose on an exposure basis during early embryonic development and from implantation to the end of lactation resulted in delayed fetal maturation and increased fetal loss, respectively [ see data ] . the estimated 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. data animal data no evidence of embryo or fetal toxicity was found in the rat or rabbit at a dose of 15 mg/kg/day (1.2 and 0.7 times the human dose on an exposure basis, respectively). delayed fetal maturation was observed in the rat at a dose of 45 mg/kg/day (3.5 times the human dose on an exposure basis).   in a rat prenatal and postnatal development study, increased embryo lethality and increased offspring deaths during the first week post-partum were observed at a dose of 45 mg/kg/day (3.5 times the human dose on an exposure basis). risk summary there are no data on the presence of dalbavancin or its metabolite in human milk, the effects on the breast-fed child, or the effects on milk production. dalbavancin is excreted in the milk of lactating rats. when a drug is present in animal milk, it is likely that the drug will be present in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for dalvance and any potential adverse effects on the breast-fed child from dalvance or from the underlying maternal condition. the safety and effectiveness of dalvance for the treatment of absssi has been established in pediatric patients aged birth to less than 18 years. use of dalvance for this indication is supported by evidence from adequate and well-controlled studies in adults with additional pharmacokinetic and safety data in pediatric patients aged birth to less than 18 years [see adverse reactions ( 6.1 ), clinical pharmacology ( 12.3 ), and clinical studies (14.1)] . there is insufficient information to recommend dosage adjustment for pediatric patients with absssi and clcr less than 30 ml/min/1.73m2  [see dosage and administration ( 2.2 )]. of the 2473 patients treated with dalvance in phase 2 and 3 clinical trials, 403 patients (16.3%) were 65 years of age or older. the efficacy and tolerability of dalvance were similar to comparator regardless of age. the pharmacokinetics of dalvance was not significantly altered with age; therefore, no dosage adjustment is necessary based on age alone.  dalvance is substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection in this age group. in patients with renal impairment whose known clcr is less than 30 ml/min and who are not receiving regularly scheduled hemodialysis, the recommended regimen for dalvance is 1125 mg, administered as a single dose, or 750 mg followed one week later by 375 mg. no dosage adjustment is recommended for patients receiving regularly scheduled hemodialysis, and dalvance can be administered without regard to the timing of hemodialysis. there is insufficient information to recommend dosage adjustment for pediatric patients younger than 18 years with clcr less than 30 ml/min/1.73m2 [see dosage and administration ( 2.3 ) , clinical pharmacology ( 12.3 )] . no dosage adjustment of dalvance is recommended for patients with mild hepatic impairment (child-pugh class a). caution should be exercised when prescribing dalvance to patients with moderate or severe hepatic impairment (child-pugh class b or c) as no data are available to determine the appropriate dosing in these patients [ see clinical pharmacology   ( 12.3 ) ] .

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

correvio uk ltd - dalbavancin hydrochloride - powder for solution for infusion - 500mg

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

wfm private label, lp - bryonia alba root (unii: t7j046yi2b) (bryonia alba root - unii:t7j046yi2b), protortonia cacti (unii: lzb7tfx1lt) (protortonia cacti - unii:lzb7tfx1lt), drosera rotundifolia (unii: qr44n9xpjq) (drosera rotundifolia - unii:qr44n9xpjq), ipecac (unii: 62i3c8233l) (ipecac - unii:62i3c8233l), pulsatilla vulgaris (unii: i76kb35jev) (pulsatilla vulgaris - unii:i76kb35jev), rumex crispus root (unii: 9n1rm2s62c) (rumex crispus root - unii:9n1rm2s62c), spongia officinalis skeleton, roasted (unii: 1pip394iid) (s - bryonia alba root 3 [hp_c] in 1 ml - temporary relieves cough due to minor throat and bronchial irritation as may occur with a cold. helps loosen phlegms (mucus) and thin bronchial secretions to make coughs more productive. do not use if seal at base of cap is broken or missing. antimonium tartaricum 6c  helps loosen thick mucus bryonia alba 3c  relieves dry and painful cough coccus cacti 3c  relieves cough associated with a tickling in the throat drosera rotundifolia 3c  relieves barking cough worse at night ipecacuanha 3c relieves cough associated with nausea pulsatilla 6c  relieves wet cough during the day becoming worse at night rumex crispus 6c relieves dry cough triggered by cold air spongia tosta 3c relieves dry, croupy and barking cough sticta pulmonaria 3c relieves nighttime hacking cough stop use and ask a doctor if cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or a persistent headache. these

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

wfm private label, lp - bryonia alba root (unii: t7j046yi2b) (bryonia alba root - unii:t7j046yi2b), protortonia cacti (unii: lzb7tfx1lt) (protortonia cacti - unii:lzb7tfx1lt), drosera rotundifolia (unii: qr44n9xpjq) (drosera rotundifolia - unii:qr44n9xpjq), ipecac (unii: 62i3c8233l) (ipecac - unii:62i3c8233l), pulsatilla vulgaris (unii: i76kb35jev) (pulsatilla vulgaris - unii:i76kb35jev), rumex crispus root (unii: 9n1rm2s62c) (rumex crispus root - unii:9n1rm2s62c), spongia officinalis skeleton, roasted (unii: 1pip394iid) (s - bryonia alba root 3 [hp_c] in 1 ml - antimonium tartaricum ... 6c helps loosen thick mucus* bryonia alba 3c ... relieves dry and painful cough* coccus cacti 3c ... relieves cough associated with a tickling in the throat* drosera rotundifolia 3c ... relieves barking cough worse at night* ipecacuanha 3c ... relieves cough associated with nausea* pulsatilla 6c ... relieves wet cough during the day becoming worse at night* rumex crispus 6c ... relieves dry cough triggered by cold air* spongia tosta 3c ... relieves dry, croupy and barking cough* sticta pulmonaria 3c ... relieves nighttime hacking cough* uses* - temporary relieves cough due to minor throat and bronchial irritation as may occur with a cold - helps relieve chest congestion due to common colds by loosening phlegm (mucus) and thinning bronchial secretions to make coughs more productive do not use if you are allergic to any of this product's ingredients. stop use and ask a doctor if cough lasts for more than 7 days, comes ba

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

seroyal usa - bryonia alba root (unii: t7j046yi2b) (bryonia alba root - unii:t7j046yi2b) - bryonia alba root 3 [hp_x] - indications for the temporary relief of cough and aching muscle indications for the temporary relief of cough and aching muscle directions adults: take five granules three times daily or as recommended by your healthcare practitioner. children: take three granules and follow adult directions.

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

rxhomeo private limited d.b.a. rxhomeo, inc - bryonia alba root (unii: t7j046yi2b) (bryonia alba root - unii:t7j046yi2b) - bryonia alba root 3 [hp_x] - flu, rheumatism condition listed above or as directed by the physician

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

celletech ltd. - bryonia alba root (unii: t7j046yi2b) (bryonia alba root - unii:t7j046yi2b) - bryonia alba root 30 [hp_c]