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.

New Zealand - English - Medsafe (Medicines Safety Authority)

abbvie limited - botulinum toxin type a 50 u - powder for injection - 50 u - active: botulinum toxin type a 50 u excipient: albumin sodium chloride - · 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)

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.

Malta - English - Medicines Authority

allergan pharmaceuticals ireland castlebar road, westport, county mayo, ireland - botulinum toxin, type a - powder for solution for injection - botulinum toxin type a 50 allergan units/0.1 millilitre - muscle relaxants

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)

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

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 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.

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 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. botox (botulinum toxin type a) purified neurotoxin complex in indicated for the following therapeutic indications: 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. this does not include idiopathic overactive bladder. 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 vii 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 equinas foot deformity, due to juvenile cerebral palsy in patients two years of age 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. botox (botulinum toxin type a) purified neurotoxin complex in indicated for the following therapeutic indications: - prophylaxis of headaches in adults with chronic migraine (headache 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 vii nerve disorders (specifically hemifacial spasm) in patients twelve years and over; - 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 of age 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 in indicated for the following cosmotic indications: temporary improvement in the appearance of upper facial rhytides (glabellar lines, crow-s feet and forehead lines) in adults.