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)].

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

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.

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

lundbeck australia pty ltd - eptinezumab, quantity: 100 mg/ml - injection, concentrated - excipient ingredients: polysorbate 80; histidine; sorbitol; water for injections; histidine hydrochloride monohydrate - vyepti is indicated for the preventive treatment of migraine in adults.

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

teva pharma australia pty ltd - fremanezumab, quantity: 225 mg - injection, solution - excipient ingredients: histidine hydrochloride monohydrate; histidine; polysorbate 80; disodium edetate; sucrose; water for injections - ajovy is indicated for the preventive treatment of migraine in adults.

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

teva pharma australia pty ltd - fremanezumab, quantity: 225 mg - injection, solution - excipient ingredients: histidine; disodium edetate; histidine hydrochloride monohydrate; polysorbate 80; sucrose; water for injections - ajovy is indicated for the preventive treatment of migraine in adults.

Israel - English - Ministry of Health

alphamedix ltd, israel - botulinum toxin type a - powder for solution for injection - botulinum toxin type a 0.8 ng 100 ld50 units / vial - botulinum toxin - xeomin is indicated for the symptomatic treatment of blepharospasm, cervical dystonia of a predominantly rotational form (spasmodic torticollis) and of post-stroke spasticity of the upper limb presenting with flexed wrist and clenched fist in adult. xeomin is indicated for the temporary improvement in the appearance of moderate to severe vertical lines between eyebrows seen at frown (glabellar frown lines) in adults below 65 years when the severity of these lines has an important psychological impact for the patient

New Zealand - English - Medsafe (Medicines Safety Authority)

douglas pharmaceuticals limited - botulinum toxin type a 100 units (prabotulinumtoxina (usan)) - powder for injection - 100 units - active: botulinum toxin type a 100 units (prabotulinumtoxina (usan)) excipient: albumin sodium chloride - the temporary improvement in the appearance of moderate to severe glabellar lines in adult patients below 65 years of age.