Canada - English - Health Canada

ipsen biopharmaceuticals canada inc - abobotulinumtoxina - powder for solution - 500unit - abobotulinumtoxina 500unit - other miscellaneous therapeutic agents

Canada - English - Health Canada

ipsen biopharmaceuticals canada inc - abobotulinumtoxina - powder for solution - 300unit - abobotulinumtoxina 300unit - other miscellaneous therapeutic agents

Canada - English - Health Canada

ipsen biopharmaceuticals canada inc - abobotulinumtoxina - powder for solution - 300unit - abobotulinumtoxina 300unit - other miscellaneous therapeutic agents

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

galderma laboratories, l.p. - botulinum toxin type a (unii: e211kpy694) (botulinum toxin type a - unii:e211kpy694) - botulinum toxin type a 300 u - dysport is indicated for the treatment of cervical dystonia in adults. dysport is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with procerus and corrugator muscle activity in adults less than 65 years of age. dysport is indicated for the treatment of spasticity in patients 2 years of age and older. dysport is contraindicated in patients with: - known hypersensitivity to any botulinum toxin products, cow's milk protein, or to any of the components in the formulation [see warnings and precautions (5.3)] .  this product may contain trace amounts of cow's milk protein [see description (11)] . - infection at the proposed injection site(s). risk summary there are no adequate and well-controlled clinical studies with dysport in pregnant women. dysport should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus. dysport produced embryo-fetal toxicity in relation to maternal toxicity when given to pregn

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

ipsen biopharmaceuticals, inc. - botulinum toxin type a (unii: e211kpy694) (botulinum toxin type a - unii:e211kpy694) - botulinum toxin type a 500 u - dysport is indicated for the treatment of cervical dystonia in adults. dysport is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with procerus and corrugator muscle activity in adults less than 65 years of age. dysport is indicated for the treatment of spasticity in patients 2 years of age and older. dysport is contraindicated in patients with: - known hypersensitivity to any botulinum toxin products, cow's milk protein, or to any of the components in the formulation [see warnings and precautions (5.3)]. this product may contain trace amounts of cow's milk protein [see description (11)] . - infection at the proposed injection site(s). risk summary there are no adequate and well-controlled clinical studies with dysport in pregnant women. dysport should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus. dysport produced embryo-fetal toxicity in relation to maternal toxicity when given to pregnant rats and

Canada - English - Health Canada

merz pharmaceuticals gmbh - incobotulinumtoxina - powder for solution - 100unit - incobotulinumtoxina 100unit - other miscellaneous therapeutic agents

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

solstice neurosciences, llc - rimabotulinumtoxinb (unii: 0y70779m1f) (rimabotulinumtoxinb - unii:0y70779m1f) - rimabotulinumtoxinb 2500 [usp'u] in 0.5 ml - myobloc is indicated for the treatment of cervical dystonia to reduce the severity of abnormal head position and neck pain associated with cervical dystonia in adults. myobloc is indicated for the treatment of chronic sialorrhea in adults. myobloc is contraindicated in patients with: - a known hypersensitivity to any botulinum toxin product or to any of the components in the formulation [see warnings and precautions (5.3), description (11)] - infection at the proposed injection site(s) risk summary there are no adequate data on the developmental risks associated with the use of myobloc in pregnant women. no developmental toxicity was observed in pregnant rats administered myobloc by intramuscular injection during gestation and lactation, at doses producing maternal toxicity. in the u.s. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. the background risk of major birth defects and miscarriage for the indicated population is unknown. data animal data when myobloc was administered by intramuscular injection to pregnant rats (0, 300, 1000, or 3000 units/kg/day) or rabbits (0, 0.03, 0.1, 0.3, or 1.0 units/kg/day) throughout gestation, no adverse effects on embryofetal development were observed. the highest dose tested in rat, which was associated with maternal toxicity, was 36 times the maximum recommended human dose (mrhd) for cervical dystonia (5000 units) on a body weight (units/kg) basis. the highest dose tested in rabbit was substantially less than the mrhd for cervical dystonia on a units/kg basis; maternal toxicity was observed at all but the lowest dose tested. risk summary there are no data on the presence of myobloc in human 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 myobloc and any potential adverse effects on the breastfed infant from myobloc or from the underlying maternal condition. safety and effectiveness in pediatric patients have not been established. cervical dystonia in the controlled studies for myobloc in patients with cervical dystonia, 152 (75%) were under the age of 65, and 52 (26%) were 65 years of age or older [see clinical studies (14.1)] . for these age groups, the most frequently reported adverse reactions occurred at similar rates in both age groups. efficacy results did not suggest any large differences between these age groups. very few patients age 75 or older were enrolled; therefore, no conclusions regarding the safety and efficacy of myobloc within this age group can be determined. chronic sialorrhea of the 166 myobloc-treated patients in the placebo-controlled studies for treatment of chronic sialorrhea [see clinical studies (14.2)] , 105 (63%) were 65 years of age or older, and 43 (26%) were 75 years of age or older. no overall differences in safety or effectiveness were observed between patients over 65 years of age and younger patients, but greater sensitivity of some older patients cannot be ruled out.

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

merz north america, inc. - botulinum toxin type a (unii: e211kpy694) (botulinum toxin type a - unii:e211kpy694) - botulinum toxin type a 50 [usp'u] - xeomin is indicated for the treatment of chronic sialorrhea in patients 2 years of age and older. upper limb spasticity in adult patients xeomin is indicated for the treatment of upper limb spasticity in adult patients. upper limb spasticity in pediatric patients, excluding spasticity caused by cerebral palsy xeomin is indicated for the treatment of upper limb spasticity in pediatric patients 2 to 17 years of age, excluding spasticity caused by cerebral palsy. xeomin is indicated for the treatment of cervical dystonia in adult patients. xeomin is indicated for the treatment of blepharospasm in adult patients. xeomin 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. xeomin is contraindicated in patients with: - known hypersensitivity to any botulinum toxin product or to any of the components in the formulation [see warnings and precautions (5.3) and description (11)] . - infection at t

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

merz pharmaceuticals, llc - botulinum toxin type a (unii: e211kpy694) (botulinum toxin type a - unii:e211kpy694) - botulinum toxin type a 50 [usp'u] - xeomin is indicated for the treatment of chronic sialorrhea in patients 2 years of age and older. upper limb spasticity in adult patients xeomin is indicated for the treatment of upper limb spasticity in adult patients. upper limb spasticity in pediatric patients, excluding spasticity caused by cerebral palsy xeomin is indicated for the treatment of upper limb spasticity in pediatric patients 2 to 17 years of age, excluding spasticity caused by cerebral palsy. xeomin is indicated for the treatment of cervical dystonia in adult patients. xeomin is indicated for the treatment of blepharospasm in adult patients. xeomin 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. xeomin is contraindicated in patients with: - known hypersensitivity to any botulinum toxin product or to any of the components in the formulation [see warnings and precautions (5.3) and description (11)] . - infection at t

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.