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

merz australia pty ltd - incobotulinumtoxina, quantity: 50 u - injection, powder for - excipient ingredients: albumin; sucrose - xeomin is indicated in adults for the treatment of:,? cervical dystonia (spasmodic torticollis),? blepharospasm,? spasticity of the upper limb,? chronic sialorrhea due to neurological disorders,? upper facial lines,- glabellar frown lines,- lateral periorbital lines (crow?s feet),- horizontal forehead lines,xeomin is indicated in children and adolescents aged 2 years to 17 years for the symptomatic treatment of:,? chronic sialorrhea due to neurological/neurodevelopmental disorders,? spasticity of the lower and/or upper limbs

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

merz australia pty ltd - incobotulinumtoxina, quantity: 100 u - injection, powder for - excipient ingredients: albumin; sucrose - xeomin is indicated in adults for the treatment of:,? cervical dystonia (spasmodic torticollis),? blepharospasm,? spasticity of the upper limb,? chronic sialorrhea due to neurological disorders,? upper facial lines,- glabellar frown lines,- lateral periorbital lines (crow?s feet),- horizontal forehead lines,xeomin is indicated in children and adolescents aged 2 years to 17 years for the symptomatic treatment of:,? chronic sialorrhea due to neurological/neurodevelopmental disorders,? spasticity of the lower and/or upper limbs

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

allergan, inc. - botulinum toxin type a (unii: e211kpy694) (botulinum toxin type a - unii:e211kpy694) - botulinum toxin type a 50 [usp'u] - botox cosmetic (onabotulinumtoxina) is indicated in adult patients for the temporary improvement in the appearance of: - moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity - moderate to severe lateral canthal lines  associated with orbicularis oculi activity - moderate to severe forehead lines associated with frontalis muscle activity botox cosmetic 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 )] . botox cosmetic is contraindicated in the presence of infection at the proposed injection site(s). risk summary there are no studies or adequate data from postmarketing surveillance on the developmental risk associated with use of botox cosmetic in pregnant women.   in animal studies, administrations of botox cosmetic during pregnancy resulted in adverse effects on fetal growth (decreased fetal body weight and skeletal ossification) at clinically relevant doses, which were associated with maternal toxicity [see data]. 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. the background risk of major birth defects and miscarriage for the indicated populations is unknown. data animal data when botox cosmetic (4, 8, or 16 units/kg) was administered intramuscularly to pregnant mice or rats two times during the period of organogenesis (on gestation days 5 and 13), reductions in fetal body weight and decreased fetal skeletal ossification were observed at the two highest doses. the no-effect dose for developmental toxicity in these studies (4 units/kg) is approximately 4 times the average high human dose for glabellar lines, lateral canthal lines, and forehead lines of 64 units on a body weight basis (units/kg). when botox cosmetic was administered intramuscularly to pregnant rats (0.125, 0.25, 0.5, 1, 4, or 8 units/kg) or rabbits (0.063, 0.125, 0.25, or 0.5 units/kg) daily during the period of organogenesis (total of 12 doses in rats, 13 doses in rabbits), reduced fetal body weights and decreased fetal skeletal ossification were observed at the two highest doses in rats and at the highest dose in rabbits. these doses were also associated with significant maternal toxicity, including abortions, early deliveries, and maternal death. the developmental no-effect doses in these studies of 1 unit/kg in rats is approximately equal the average high human dose of 64 units based on units/kg, and the developmental no-effect dose of 0.25 units/kg in rabbits is less than the average high human dose based on units/kg. when pregnant rats received single intramuscular injections (1, 4, or 16 units/kg) at three different periods of development (prior to implantation, implantation, or organogenesis), no adverse effects on fetal development were observed. the developmental no-effect level for a single maternal dose in rats (16 units/kg) is approximately 16 times the average high human dose of 64 units based on units/kg. risk summary there are no data on the presence of botox cosmetic in human or animal milk, the effects on the breastfed child, or the effects on milk production.   the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for botox cosmetic and any potential adverse effects on the breastfed infant from botox cosmetic or from the underlying maternal conditions. safety and effectiveness in patients below the age of 18 years have not been established. glabellar lines in the two initial glabellar lines clinical studies of botox cosmetic, the responder rates appeared to be higher for subjects younger than age 65 than for subjects 65 years or older [see clinical studies ( 14 )] . lateral canthal lines in the two lateral canthal lines clinical studies of botox cosmetic, the responder rates appeared to be higher for subjects younger than age 65 than for subjects 65 years or older. forehead lines in the two forehead lines clinical studies of botox cosmetic, the responder rates appeared to be higher for subjects younger than age 65 than for subjects 65 years or older.

Canada - English - Health Canada

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

Canada - English - Health Canada

merz pharmaceuticals gmbh - incobotulinumtoxina - powder for solution - 50unit - incobotulinumtoxina 50unit - other miscellaneous therapeutic agents

Japan - English - すりの適正使用協議会 RAD-AR Council, Japan

teijin pharma limited - incobotulinumtoxina - injection

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - botulinum toxin type a 100 units equivalent to incobotulinumtoxina (usan), purified botulinum toxin type a - powder for injection - 100 units - active: botulinum toxin type a 100 units equivalent to incobotulinumtoxina (usan), purified botulinum toxin type a excipient: albumin sucrose - xeomin is indicated in adults for the treatment of: · cervical dystonia · blepharospasm · spasticity of the upper limb · upper facial lines -glabellar frown lines -lateral periorbital lines (crow's feet) - horizontal forehead lines

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - botulinum toxin type a 50 units equivalent to incobotulinumtoxina (usan), purified botulinum toxin type a - powder for injection - 50 units - active: botulinum toxin type a 50 units equivalent to incobotulinumtoxina (usan), purified botulinum toxin type a excipient: albumin sucrose - xeomin is indicated in adults for the treatment of: · cervical dystonia · blepharospasm · spasticity of the upper limb · upper facial lines -glabellar frown lines -lateral periorbital lines (crow's feet) - horizontal forehead lines

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)

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