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

emergent biosolutions canada inc. - anthrax immune globulin human (unii: vkz83s945z) (anthrax immune globulin human - unii:vkz83s945z) - anthrax immune globulin human 60 [iu] in 35 ml - anthrasil is an anthrax immune globulin intravenous (human) indicated for the treatment of inhalational anthrax in adult and pediatric patients in combination with appropriate antibacterial drugs. the effectiveness of anthrasil is based solely on efficacy studies conducted in animal models of inhalational anthrax [see 13.2 animal toxicology and/or pharmacology]. limitations: risk summary there are no human data to establish the presence or absence of anthrasil associated risk. risk summary there are no data to assess the presence or absence of anthrasil in human milk, the effects on the breastfed child or the effects on milk production/excretion. safety and effectiveness of anthrasil in the pediatric population (≤16 yrs of age) have not been studied. allometric scaling was used to derive dosing regimens to provide pediatric patients with exposure comparable to the observed exposure in adults receiving 420 units and 840 units. the dose for pediatric patients is based on body weight. safety and effectiveness of

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

emergent biodefense operations lansing, llc - bacillus anthracis strain v770-np1-r antigens (unii: 873oi62848) (bacillus anthracis strain v770-np1-r antigens - unii:873oi62848) - bacillus anthracis strain v770-np1-r antigens 100 ug in 1 ml - biothrax is a vaccine indicated for the active immunization for the prevention of disease caused by bacillus anthracis in persons 18 through 65 years of age. the efficacy of biothrax for post-exposure prophylaxis is based solely on studies in animal models of inhalational anthrax. do not administer biothrax to individuals with a history of anaphylactic or anaphylactic-like reaction following a previous dose of biothrax or any component of the vaccine, including aluminum, benzethonium chloride, and formaldehyde. [see description (11).] pregnancy category d. [see warnings and precautions (5.3)] healthcare practitioners are encouraged to register women who receive biothrax during pregnancy in emergent’s vaccination pregnancy registry by calling 1-619-553-9255. male fertility: a retrospective study was performed at an in-vitro fertilization clinic to evaluate whether biothrax may impact reproductive function in men. this study compared semen parameters, embryo quality, and pregnancy outcomes in 254 male cli

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

virbac (australia) pty ltd - bacillus anthracis (sterne 34f2 strain) - parenteral liquid/solution/suspension - bacillus anthracis (sterne 34f2 strain) vaccine-microbial active 0.0 ml - immunotherapy - cattle | pigs | sheep | beef | boar | bos indicus | bos taurus | bovine | buffalo | bull | bullock | calf | cow | dairy cow | ew - bacillus anthracis | anthrax

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

zoetis - anthrax spores(5m/ml) - parenteral liquid/solution/suspension - vaccine - cattle | pigs | sheep | beef | boar | bos indicus | bos taurus | bovine | buffalo | bull | bullock | calf | cow | dairy cow | ew - bacillus anthracis | anthrax

Canada - English - Health Canada

emergent biosolutions canada inc - anthrax immunoglobulin (human) - solution - 60unit - anthrax immunoglobulin (human) 60unit - serums

Canada - English - Health Canada

emergent biodefense operations lansing llc - anthrax antigen filtrate - suspension - 50mcg - anthrax antigen filtrate 50mcg - vaccines

New Zealand - English - Ministry for Primary Industries

ministry for primary industries - bacillus anthracis (sterne 34f2 strain) live spores - bacillus anthracis (sterne 34f2 strain) live spores 0 vaccine - vaccine

Singapore - English - HSA (Health Sciences Authority)

emergent sales and marketing singapore pte. ltd. - anthrax antigen protein - injection, suspension - 50μg/dose (nominal) - anthrax antigen protein 50μg/dose (nominal)

European Union - English - EMA (European Medicines Agency)

hra pharma rare diseases - ketoconazole - cushing syndrome - antimycotics for systemic use - ketoconazole hra is indicated for the treatment of endogenous cushing’s syndrome in adults and adolescents above the age of 12 years.

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

organon pharma pty ltd - betamethasone dipropionate, quantity: 0.64 mg/g (equivalent: betamethasone, qty 0.5 mg/g) - ointment - excipient ingredients: white soft paraffin; liquid paraffin - topical treatment of corticosteroid-responsive dermatoses. these include atopic eczema, infantile eczema, nummular eczema, contact dermatitis, neurodermatitis, anogenital and senile pruritus, lechen planus, intertrigo and psoriasis. indications as at 26 august 1992: eleuphrat is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. these include atopic eczema, infantile eczema, nummular eczema, contact dermatitis, neurodermatitis, anogenital and senile pruritus, lichen planus, intertrigo and psoriasis.