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.

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

abbvie pty ltd - botulinim toxin type a, quantity: 100 u - injection, powder for - excipient ingredients: albumin; sodium chloride - botox (botulinum toxin type a) purified neurotoxin complex is indicated for the following therapeutic indications: treatment of overactive bladder with symptoms of urinary incontinence, urgency, and frequency, in adult patients who have an inadequate response to or are intolerant of an anticholinergic medication. treatment of urinary incontinence due to neurogenic detrusor overactivity resulting from a defined neurological illness (such as spinal cord injury or multiple sclerosis) and not controlled adequately by anticholinergic agents. prophylaxis of headaches in adults with chronic migraine (headaches on at least 15 days per month of which at least 8 days are with migraine). treatment of strabismus in children and adults.treatment of blepharospasm associated with dystonia, including benign blepharospasm and viith nerve disorders (specifically hemifacial spasm) in patients twelve years and older. treatment of cervical dystonia (spasmodic torticollis). treatment of focal spasticity of the upper and lower limb

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

abbvie pty ltd - botulinim toxin type a, quantity: 200 u - injection, powder for - excipient ingredients: albumin; sodium chloride - botox (botulinum toxin type a) purified neurotoxin complex is indicated for the following therapeutic indications: treatment of overactive bladder with symptoms of urinary incontinence, urgency, and frequency, in adult patients who have an inadequate response to or are intolerant of an anticholinergic medication.,treatment of urinary incontinence due to neurogenic detrusor overactivity resulting from a defined neurological illness (such as spinal cord injury or multiple sclerosis) and not controlled adequately by anticholinergic agents.,prophylaxis of headaches in adults with chronic migraine (headaches on at least 15 days per month of which at least 8 days are with migraine).,treatment of strabismus in children and adults.,treatment of blepharospasm associated with dystonia, including benign blepharospasm and viith nerve disorders (specifically hemifacial spasm) in patients twelve years and older.,treatment of cervical dystonia (spasmodic torticollis).,treatment of focal spasticity of the upper and lower lim

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

abbvie pty ltd - botulinim toxin type a, quantity: 50 u - injection, powder for - excipient ingredients: albumin; sodium chloride - botox (botulinum toxin type a) purified neurotoxin complex is indicated for the following therapeutic indications: treatment of overactive bladder with symptoms of urinary incontinence, urgency, and frequency, in adult patients who have an inadequate response to or are intolerant of an anticholinergic medication. treatment of urinary incontinence due to neurogenic detrusor overactivity resulting from a defined neurological illness (such as spinal cord injury or multiple sclerosis) and not controlled adequately by anticholinergic agents. prophylaxis of headaches in adults with chronic migraine (headaches on at least 15 days per month of which at least 8 days are with migraine). treatment of strabismus in children and adults.treatment of blepharospasm associated with dystonia, including benign blepharospasm and viith nerve disorders (specifically hemifacial spasm) in patients twelve years and older. treatment of cervical dystonia (spasmodic torticollis). treatment of focal spasticity of the upper and lower limbs, including dynamic equinus foot deformity, due to juvenile cerebral palsy in patients two years and older. treatment of severe primary hyperhidrosis of the axillae. treatment of focal spasticity in adults. treatment of spasmodic dysphonia. botox (botulinum toxin type a) purified neurotoxin complex is indicated for the following cosmetic indications: temporary improvement in the appearance of upper facial rhytides (glabellar lines, crow's feet and forehead lines) in adults.

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 100 [usp'u] - overactive bladder botox  for injection is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication. detrusor overactivity associated with a neurologic condition botox  is indicated for the treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition (e.g., sci, ms) in adults who have an inadequate response to or are intolerant of an anticholinergic medication. botox is indicated for the treatment of neurogenic detrusor overactivity (ndo) in pediatric patients 5 years of age and older who have an inadequate response to or are intolerant of anticholinergic medication. botox is indicated for the prophylaxis of headaches in adult patients with chronic migraine (≥15 days per month with headache lasting 4 hours a day or longer). limitations of use safety and effectiveness have not been established for the prophylaxis of episodic migraine (14 headache days or fewer per month) in seven placebo-controlled studies. botox is indicated for the treatment of spasticity in patients 2 years of age and older. limitations of use   botox has not been shown to improve upper extremity functional abilities, or range of motion at a joint affected by a fixed contracture. botox is indicated for the treatment of adults with cervical dystonia, to reduce the severity of abnormal head position and neck pain associated with cervical dystonia. botox is indicated for the treatment of severe primary axillary hyperhidrosis that is inadequately managed with topical agents. limitations of use the safety and effectiveness of botox for hyperhidrosis in other body areas have not been established. weakness of hand muscles and blepharoptosis may occur in patients who receive botox for palmar hyperhidrosis and facial hyperhidrosis, respectively. patients should be evaluated for potential causes of secondary hyperhidrosis (e.g., hyperthyroidism) to avoid symptomatic treatment of hyperhidrosis without the diagnosis and/or treatment of the underlying disease. safety and effectiveness of botox have not been established for the treatment of axillary hyperhidrosis in pediatric patients under age 18. botox is indicated for the treatment of strabismus and blepharospasm associated with dystonia, including benign essential blepharospasm or vii nerve disorders in patients 12 years of age and older. botox is contraindicated: - in patients who are hypersensitive to any botulinum toxin product or to any of the components in the formulation [see warnings and precautions ( 5.4 )] .  - in the presence of infection at the proposed injection site(s). - for intradetrusor injection in patients with a urinary tract infection; or in patients with urinary retention or post-void residual (pvr) urine volume >200 ml who are not routinely performing clean intermittent self-catheterization (cic) [see warnings and precautions ( 5.12 , 5.13 )] . risk summary there are no studies or adequate data from postmarketing surveillance on the developmental risk associated with use of botox in pregnant women. in animal studies, administration of botox during pregnancy resulted in adverse effects on fetal growth (decreased fetal 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 (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 equal to the human dose of 400 units, on a body weight basis (units/kg). when botox 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 and 0.25 units/kg in rabbits are less than the human dose of 400 units, 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 2 times the human dose of 400 units, based on units/kg. risk summary there are no data on the presence of botox 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 botox and any potential adverse effects on the breastfed infant from botox or from the underlying maternal conditions. detrusor overactivity associated with a neurologic condition the safety and effectiveness of botox for detrusor overactivity associated with a neurologic condition have been established in pediatric patients 5 years of age and older who have an inadequate response to or are intolerant of anticholinergic medication. use of botox in this patient population is based on the results of a randomized, double-blind, parallel group trial in 113 pediatric patients 5 to 17 years of age (inclusive) with detrusor overactivity associated with a neurologic condition (study 191622-120) and a long-term, multicenter, double-blind, long-term extension trial (study 191622-121) [see clinical studies ( 14.3 )]. the most common adverse reactions in this population were urinary tract infection, bacteriuria, hematuria, and leukocyturia [see adverse reactions   ( 6.1 ) ] . the safety and effectiveness of botox have not been established in patients with ndo younger than 5 years of age. overactive bladder the safety and effectiveness of botox for the treatment of overactive bladder have not been established in pediatric patients. efficacy was not demonstrated in a multicenter, randomized, double-blind, parallel-group, multiple-dose clinical study which was conducted to evaluate the efficacy and safety of botox in pediatric patients aged 12 to 17 years with overactive bladder. fifty-five patients who had an inadequate response to or were intolerant of at least one anticholinergic medication were treated with botox. there was not a statistically significant difference in the mean change from baseline in the daily average frequency of daytime urinary incontinence episodes (primary efficacy endpoint) at week 12 post-treatment when a medium and high dose were each compared to a low dose of botox. the adverse reactions in pediatric patients treated with botox were comparable with the known safety profile in adults with overactive bladder.  prophylaxis of headaches in chronic migraine safety and effectiveness in patients below the age of 18 years have not been established. in a 12-week, multicenter, double-blind, placebo-controlled clinical trial, 123 adolescent patients (ages 12 to below 18 years) with chronic migraine were randomized to receive botox 74 units, botox 155 units, or placebo, for one injection cycle. this trial did not establish the efficacy of botox, compared with placebo, for the prophylaxis of headaches in adolescents with chronic migraine. spasticity safety and effectiveness have been established in pediatric patients 2 to 17 years of age [see warnings and precautions ( 5.1 ), adverse reactions ( 6.1 ) , and clinical studies ( 14.6 )] . the safety and effectiveness of botox have been established by evidence from adequate and well-controlled studies of botox in patients 2 to 17 years of age with upper and lower limb spasticity. safety and effectiveness in pediatric patients below the age of 2 years have not been established [see boxed warning and warnings and precautions ( 5.1 )]. axillary hyperhidrosis safety and effectiveness in patients below the age of 18 years have not been established. cervical dystonia safety and effectiveness in pediatric patients below the age of 16 years have not been established. blepharospasm and strabismus safety and effectiveness in pediatric patients below the age of 12 years have not been established. juvenile animal data in a study in which juvenile rats received intramuscular injection of botox (0, 8, 16, or 24 units/kg) every other week from postnatal day 21 for 12 weeks, changes in bone size/geometry associated with decreased bone density and bone mass were observed at all doses, in association with limb disuse, decreased muscle contraction, and decreased body weight gain. impairment of fertility and male reproductive organ histopathology (degeneration of seminiferous tubules of the testis) were observed at the mid and high doses. bone and male reproductive organ effects showed evidence of reversibility after dosing cessation. the no-effect dose for adverse developmental effects in juvenile animals (8 units/kg) is similar to the human dose (400 units) on a body weight (kg) basis. of the 2145 adult patients in placebo-controlled clinical studies of botox for the treatment of spasticity, 33.5% were 65 or older, and 7.7% were 75 years of age or older. no overall differences in safety were observed between elderly patients and adult patients younger than 65 years of age.  in clinical studies of botox across other indications, no overall differences in safety were observed between elderly patients and younger adult patients, with the exception of overactive bladder (see below). other reported clinical experience has not identified differences in responses between the elderly and younger adult patients, but greater sensitivity of some older individuals cannot be ruled out. overactive bladder of 1242 overactive bladder patients in placebo-controlled clinical studies of botox, 41.4% were 65 years of age or older, and 14.7% were 75 years of age or older. adverse reactions of uti and urinary retention were more common in patients 65 years of age or older in both placebo and botox groups compared to younger patients (see table 24). otherwise, there were no overall differences in the safety profile following botox treatment between patients aged 65 years and older compared to adult patients younger than 65 years of age in these studies. observed effectiveness was comparable between these age groups in placebo-controlled clinical studies.

New Zealand - English - Medsafe (Medicines Safety Authority)

abbvie limited - botulinum toxin type a 100 u - powder for injection - 100 u - active: botulinum toxin type a 100 u excipient: albumin sodium chloride - botox® (botulinum toxin type a) purified neurotoxin complex is indicated: · for the prophylaxis of headaches in adults with chronic migraine (headaches on at least 15 days per month with headache lasting 4 hours a day or longer, of which at least 8 days are with migraine)

Singapore - English - HSA (Health Sciences Authority)

abbvie pte. ltd. - clostridium botulinum toxin type a - injection, powder, for solution - 100 units/vial - clostridium botulinum toxin type a 100 units/vial

Israel - English - Ministry of Health

abbvie biopharmaceuticals ltd, israel - botulinum toxin type a - powder for solution for injection - botulinum toxin type a 100 u/vial - botulinum toxin - botulinum toxin - neurologic disorders:• •focal spasticity associated with dynamic equinus foot deformity due to spasticity in ambulant paediatric cerebral palsy patients two years of age or older. • • focal spasticity of the wrist and hand in adult • focal spasticity of the lower limb, including ankle and foot in adult. • •blepharospasm or vii nerve disorders in patients over 12 years, hemifacial spasm and associated focal dystonias as well as the correction of strabismus in patients 12 years of age and above. • •reduction of the signs and symptoms of cervical dystonia (spasmodic torticollis) in adults. • •symptom relief in adults fulfilling criteria for chronic migraine (headaches on ≥15 days per month of which at least 8 days with migraine) in patients who have responded inadequately or are intolerant of prophylactic migraine medications. bladder disorders: •management of overactive bladder with symptoms of urinary incontinence, urgency and frequency in adult patients who have an inadequate response to, or are intolerant of, anticholinergic medication. •urinary incontinence in adults with neurogenic detrusor overactivity resulting from neurogenic bladder due to stable sub-cervical spinal cord injury, or multiple sclerosis. skin and skin appendage disorder: •management of primary axillary hyperhidrosis in patients who failed other medical symptomatic treatment. •for the temporary improvement in the appearance of: - moderate to severe vertical lines between the eyebrows seen at maximum frown (glabellar lines) and/or, - moderate to severe lateral canthal lines (crow’s feet lines) seen at maximum smile and/or, - moderate to severe forehead lines seen at maximum eyebrow elevation when the severity of the facial lines has an important psychological impact in adult patients.

Israel - English - Ministry of Health

abbvie biopharmaceuticals ltd, israel - botulinum toxin type a - powder for solution for injection - botulinum toxin type a 50 u/vial - botulinum toxin - botulinum toxin - neurologic disorders:• •focal spasticity associated with dynamic equinus foot deformity due to spasticity in ambulant paediatric cerebral palsy patients two years of age or older. • • focal spasticity of the wrist and hand in adult • focal spasticity of the lower limb, including ankle and foot in adult. • •blepharospasm or vii nerve disorders in patients over 12 years, hemifacial spasm and associated focal dystonias as well as the correction of strabismus in patients 12 years of age and above. • •reduction of the signs and symptoms of cervical dystonia (spasmodic torticollis) in adults. • •symptom relief in adults fulfilling criteria for chronic migraine (headaches on ≥15 days per month of which at least 8 days with migraine) in patients who have responded inadequately or are intolerant of prophylactic migraine medications. bladder disorders: •management of overactive bladder with symptoms of urinary incontinence, urgency and frequency in adult patients who have an inadequate response to, or are intolerant of, anticholinergic medication. •urinary incontinence in adults with neurogenic detrusor overactivity resulting from neurogenic bladder due to stable sub-cervical spinal cord injury, or multiple sclerosis. skin and skin appendage disorder: •management of primary axillary hyperhidrosis in patients who failed other medical symptomatic treatment. •for the temporary improvement in the appearance of: - moderate to severe vertical lines between the eyebrows seen at maximum frown (glabellar lines) and/or, - moderate to severe lateral canthal lines (crow’s feet lines) seen at maximum smile and/or, - moderate to severe forehead lines seen at maximum eyebrow elevation when the severity of the facial lines has an important psychological impact in adult patients.

Israel - English - Ministry of Health

abbvie biopharmaceuticals ltd, israel - botulinum toxin type a - powder for solution for injection - botulinum toxin type a 200 u/vial - botulinum toxin - botulinum toxin - neurologic disorders:• •focal spasticity associated with dynamic equinus foot deformity due to spasticity in ambulant paediatric cerebral palsy patients two years of age or older. • • focal spasticity of the wrist and hand in adult • focal spasticity of the lower limb, including ankle and foot in adult. • •blepharospasm or vii nerve disorders in patients over 12 years, hemifacial spasm and associated focal dystonias as well as the correction of strabismus in patients 12 years of age and above. • •reduction of the signs and symptoms of cervical dystonia (spasmodic torticollis) in adults. • •symptom relief in adults fulfilling criteria for chronic migraine (headaches on ≥15 days per month of which at least 8 days with migraine) in patients who have responded inadequately or are intolerant of prophylactic migraine medications. bladder disorders: •management of overactive bladder with symptoms of urinary incontinence, urgency and frequency in adult patients who have an inadequate response to, or are intolerant of, anticholinergic medication. •urinary incontinence in adults with neurogenic detrusor overactivity resulting from neurogenic bladder due to stable sub-cervical spinal cord injury, or multiple sclerosis. skin and skin appendage disorder: •management of primary axillary hyperhidrosis in patients who failed other medical symptomatic treatment. •for the temporary improvement in the appearance of: - moderate to severe vertical lines between the eyebrows seen at maximum frown (glabellar lines) and/or, - moderate to severe lateral canthal lines (crow’s feet lines) seen at maximum smile and/or, - moderate to severe forehead lines seen at maximum eyebrow elevation when the severity of the facial lines has an important psychological impact in adult patients.