Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

california department of public health - human botulinum neurotoxin a/b immune globulin (unii: x641y30oa7) (human botulinum neurotoxin a/b immune globulin - unii:x641y30oa7) - human botulinum neurotoxin a/b immune globulin 50 mg in 1 ml - babybig® , botulism immune globulin intravenous (human), is indicated for the treatment of infant botulism caused by toxin type a or b in patients below one year of age. - as with other immunoglobulin preparations, babybig should not be used in individuals with a prior history of severe reaction to other human immunoglobulin preparations.[1-4] - individuals with selective immunoglobulin a deficiency have the potential for developing antibodies to immunoglobulin a and could have anaphylactic reactions to the subsequent administration of blood products that contain immunoglobulin a. babybig has been studied for safety and efficacy only in patients below one year of age [see adverse reactions (6) and clinical studies (14) ]. it has not been tested in other populations. ndc 68403-1100-7 rx only 100 mg igg, 100 mg sucrose 20 mg albumin (human) lyophilized solvent detergent treated botulism immune globulin intravenous (human) (big-iv) babybig® store between 2°c and 8°c (35.6°f and 46.4°f).

Úc - Tiếng Anh - 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

Úc - Tiếng Anh - 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

Úc - Tiếng Anh - APVMA (Australian Pesticides and Veterinary Medicines Authority)

zoetis australia pty ltd - clostridium botulinum type d toxoid; clostridium botulinum type c; thiomersal - misc. vaccines or anti sera - clostridium botulinum type d toxoid vaccine-toxoid active 0.0 p; clostridium botulinum type c vaccine-toxoid active 0.0 p; thiomersal mercury other 0.1 mg/ml - immunotherapy - cattle | sheep | beef | bos indicus | bos taurus | bovine | buffalo | bull | bullock | calf | cow | dairy cow | ewe | heifer | h - botulism

Úc - Tiếng Anh - APVMA (Australian Pesticides and Veterinary Medicines Authority)

csl limited - clostridium botulinum type c - immunotherapy - cattle | sheep | beef | bos indicus | bos taurus | bovine | buffalo | bull | bullock | calf | cow | dairy cow | ewe | heifer | h - vaccines and antisera | brown snake bite | cheesy gland | enterotoxaemia | tetanus

Ai-len - Tiếng Anh - HPRA (Health Products Regulatory Authority)

ipsen pharma - clostridium botulinum toxin type a haemagglutinin complex - powder for solution for injection - 125 speywood - other muscle relaxants, peripherally acting agents; botulinum toxin

Hoa Kỳ - Tiếng Anh - 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.

Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

emergent biosolutions canada inc. - equine botulinum neurotoxin a immune fab2 (unii: le3j6i6dxp) (equine botulinum neurotoxin a immune fab2 - unii:le3j6i6dxp), equine botulinum neurotoxin b immune fab2 (unii: vsk09vp4hl) (equine botulinum neurotoxin b immune fab2 - unii:vsk09vp4hl), equine botulinum neurotoxin c immune fab2 (unii: x5i2p7e9ty) (equine botulinum neurotoxin c immune fab2 - unii:x5i2p7e9ty), equine botulinum neurotoxin d immune fab2 (unii: 30y9n0sebe) (equine botulinum neurotoxin d immune fab2 - unii:30y9n0sebe), equine botul - equine botulinum neurotoxin a immune fab2 4500 [iu] in 10 ml - bat [botulism antitoxin heptavalent (a, b, c, d, e, f, g) – (equine)] is a mixture of immune globulin fragments indicated for the treatment of symptomatic botulism following documented or suspected exposure to botulinum neurotoxin serotypes a, b, c, d, e, f, or g in adults and pediatric patients. the effectiveness of bat is based on efficacy studies conducted in animal models of botulism. none. risk summary there are no human or animal data to establish the presence or absence of bat associated risk. risk summary there are no data to assess the presence or absence of bat in human milk, the effects on the breastfed child or the effects on milk production/excretion. consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for bat and any potential adverse effects on the breastfed child from bat or from the underlying maternal condition. the effectiveness of bat has not been established in pediatric patients. limited pediatric safety data are available. fifteen pediat

Úc - Tiếng Anh - APVMA (Australian Pesticides and Veterinary Medicines Authority)

zoetis australia pty ltd - clostridium botulinum type d toxoid - unknown - clostridium botulinum type d toxoid vaccine-toxoid active 0.0 - active constituent

Úc - Tiếng Anh - APVMA (Australian Pesticides and Veterinary Medicines Authority)

zoetis australia pty ltd - clostridium botulinum type c toxoid - unknown - clostridium botulinum type c toxoid vaccine-toxoid active 0.0 - active constituent