Israel - English - Ministry of Health

life science research israel ltd - botulinum antitoxin type b >5000 iu / 10 ml - solution for injection - botulinum antitoxin - botulinum b intoxication.

Canada - English - Health Canada

sanofi pasteur limited - botulinum antitoxin - solution - 5000unit - botulinum antitoxin 5000unit - serums

Canada - English - Health Canada

aventis pasteur limited - botulinum antitoxin; botulinum antitoxin; botulinum antitoxin - solution - 7500unit; 5500unit; 8500unit - botulinum antitoxin 7500unit; botulinum antitoxin 5500unit; botulinum antitoxin 8500unit - serums

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

evolus, inc. - botulinum toxin type a (unii: e211kpy694) (botulinum toxin type a - unii:e211kpy694) - jeuveau is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients. jeuveau is contraindicated in individuals with known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation [see warnings and precautions (5.4) ]. jeuveau is contraindicated in the presence of infection at the proposed injection site(s). the limited available data on jeuveau use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. an embryofetal developmental study conducted with jeuveau in pregnant rats revealed no treatment-related effects to the developing fetus when jeuveau was administered intramuscularly during organogenesis at doses up to 12 times the maximum recommended human dose (mrhd) (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. animal data in an embryofetal developmental study, intramuscular doses up to 4 unit/kg jeuveau were administered to pregnant rats once daily during organogenesis (gestation days 6 to 16). no maternal or embryofetal toxicities were observed at doses up to 4 unit/kg (12 times the mrhd of 20 units, based on unit/kg comparison). there is no information regarding the presence of prabotulinumtoxina-xvfs in human or animal milk, its effects on the breastfed infant, or on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for jeuveau and any potential adverse effects on the breastfed infant from jeuveau or from the underlying maternal condition safety and effectiveness in pediatric patients have not been established. the two clinical trials of jeuveau included 68 subjects age 65 and greater. although no differences in safety or efficacy were observed between older and younger subjects, clinical studies of jeuveau did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

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

croma australia pty ltd - letibotulinumtoxina, quantity: 50 u - injection, powder for - excipient ingredients: sodium chloride; albumin - letybo is indicated for the temporary improvement in the appearance of moderate to severe glabellar frown lines in adults.

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

croma australia pty ltd - letibotulinumtoxina, quantity: 100 u - injection, powder for - excipient ingredients: sodium chloride; albumin - letybo is indicated for the temporary improvement in the appearance of moderate to severe glabellar frown lines in adults.

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

revance therapeutics, inc. - botulinum toxin type a (unii: e211kpy694) (botulinum toxin type a - unii:e211kpy694) - daxxify is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients. daxxify is indicated for the treatment of cervical dystonia in adult patients. daxxify is contraindicated in: - patients with known hypersensitivity to any botulinum toxin preparation, daxxify, or any of the components in the daxxify formulation [see warnings and precautions (5.4)]. - the presence of infection at the proposed injection sites. risk summary there are no available data on daxxify use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal reproduction studies, intramuscular administration of daxxify during pregnancy resulted in adverse effects on fetal growth (decreased fetal body weight and skeletal ossification) at maternally toxic doses approximately equivalent to 40 times the maximum recommended human dose (mrhd) (see data ). the background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2-4% and 15-20%, respectively. data animal data embryofetal development studies were conducted in rats and rabbits with daxxify. for comparison of animal to human doses based on a body weight comparison, the mrhd is set at 40 units/subject (0.67 units/kg for an average 60 kg subject). intramuscular administration of daxxify (3, 10, or 30 units/kg) to pregnant rats four times during the period of organogenesis (on gestation days 7, 10, 13, and 16) caused decreased fetal body weight and decreased fetal skeletal ossification at the highest dose, which was associated with maternal toxicity. no embryofetal developmental toxicity was noted at doses up to 10 units/kg, which is 15 times the mrhd. intramuscular administration of daxxify (0.02, 0.1, 0.48, or 2.4 units/kg/day) to pregnant rabbits during the period of organogenesis (total of 13 doses) resulted in maternal lethality at 2.4 units/kg/day and significant decreased maternal body weight at 0.48 units/kg/day. no embryofetal developmental toxicity was noted at doses up to 0.48 units/kg/day, which is approximately equivalent to the mrhd. risk summary there are no data on the presence of daxxify in human or animal milk, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered, along with the mother's clinical need for daxxify and any potential adverse effects on the breastfed infant from daxxify or from the underlying maternal condition. safety and effectiveness of daxxify in patients less than 18 years of age have not been established. glabellar lines among the 406 subjects treated with daxxify in the placebo-controlled clinical trials, 36 subjects were 65 years or older. there was no increase in the incidence of treatment-related adverse events in patients over 65 years treated with daxxify. clinical studies of daxxify did not include sufficient numbers of subjects aged 65 and older to determine whether they responded differently from younger subjects [see clinical studies (14)]. cervical dystonia among the 255 patients treated with daxxify in the placebo-controlled clinical trial, 83 patients were 65 years or older. there was no increase in the incidence of treatment-related adverse events in patients over 65 years treated with daxxify. clinical studies of daxxify did not include sufficient numbers of patients aged 65 and older to determine whether they responded differently from younger patients [see clinical studies (14)].

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

evolus australia pty ltd - prabotulinumtoxina, quantity: 100 u - solution, powder for - excipient ingredients: sodium chloride; albumin - nuceiva is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines in adult patients.

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

ipsen pty ltd - clostridium botulinum type a toxin haemagglutinin complex, quantity: 500 u - injection, powder for - excipient ingredients: albumin; lactose monohydrate - dysport is indicated for symptomatic treatment of focal spasticity of: ? upper limbs in adults ? lower limbs in adults ? upper limbs in children aged 2 years and older ? lower limbs in children aged 2 years and older,dysport is indicated in adults for the treatment of: ? spasmodic torticollis ? blepharospasm ? hemifacial spasm ? moderate to severe glabellar lines and / or lateral canthal lines (crow?s feet)

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

ipsen pty ltd - clostridium botulinum type a toxin haemagglutinin complex, quantity: 125 u - injection, powder for - excipient ingredients: albumin; lactose monohydrate - dysport is indicated for symptomatic treatment of focal spasticity of: ? upper limbs in adults ? lower limbs in adults ? upper limbs in children aged 2 years and older ? lower limbs in children aged 2 years and older,dysport is indicated in adults for the treatment of: ? spasmodic torticollis ? blepharospasm ? hemifacial spasm ? moderate to severe glabellar lines and / or lateral canthal lines (crow?s feet)