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

pfizer australia pty ltd - nonacog alfa, quantity: 500 iu - injection, powder for - excipient ingredients: sucrose; histidine; polysorbate 80; glycine - benefix is indicated for the control and prevention of haemorrhagic episodes in patients with haemophilia b (congenital factor ix deficiency or christmas disease), including control and prevention of bleeding in surgical settings. benefix is not indicated for the treatment of other factor deficiencies (e.g. factors ii, vii and x), nor for the treatment of haemophilia a patients with inhibitors to factor viii, nor for the reversal of coumarin induced anti-coagulation, nor for the treatment of bleeding due to low levels of liver-dependent coagulation factors.

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

pfizer australia pty ltd - nonacog alfa, quantity: 250 iu - injection, powder for - excipient ingredients: polysorbate 80; histidine; glycine; sucrose - benefix is indicated for the control and prevention of haemorrhagic episodes in patients with haemophilia b (congenital factor ix deficiency or christmas disease), including control and prevention of bleeding in surgical settings. benefix is not indicated for the treatment of other factor deficiencies (e.g. factors ii, vii and x), nor for the treatment of haemophilia a patients with inhibitors to factor viii, nor for the reversal of coumarin induced anti-coagulation, nor for the treatment of bleeding due to low levels of liver-dependent coagulation factors.

European Union - English - EMA (European Medicines Agency)

laboratorios hipra, s.a. - recombinant verotoxin 2e of e. coli - inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia) escherichia + clostridium, immunologicals for suidae - pigs - active immunisation of piglets from 2 days of age to prevent mortality and reduce clinical signs of oedema disease (caused by verotoxin 2e produced by e. coli) and to reduce the loss of daily weight gain during the finishing period in the face of infections with verotoxin 2e producing e. coli until slaughter from 164 days of age.

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

a-s medication solutions - hyaluronidase (human recombinant) (unii: 743quy4vd8) (hyaluronidase (human recombinant) - unii:743quy4vd8) - hylenex recombinant is indicated as an adjuvant in subcutaneous fluid administration for achieving hydration. hylenex recombinant is indicated as an adjuvant to increase the dispersion and absorption of other injected drugs. hylenex recombinant is indicated as an adjunct in subcutaneous urography for improving resorption of radiopaque agents. hylenex recombinant is contraindicated in patients with known hypersensitivity to hyaluronidase or any of the excipients in hylenex recombinant. a preliminary skin test for hypersensitivity to hylenex recombinant can be performed. the skin test is made by an intradermal injection of approximately 0.02 ml (3 units) of a 150 unit/ml solution. a positive reaction consists of a wheal with pseudopods appearing within 5 minutes and persisting for 20 to 30 minutes and accompanied by localized itching. transient vasodilation at the site of the test, i.e., erythema, is not a positive reaction. discontinue hylenex recombinant if sensitization occurs. pregnancy category c. in an em

European Union - English - EMA (European Medicines Agency)

janssen-cilag international n.v.    - recombinant adenovirus type 26 (ad26) encoding the glycoprotein (gp) of the ebola virus zaire (zebov) mayinga strain - hemorrhagic fever, ebola - vaccines - active immunization for prevention of disease caused by ebola virus (zaire ebolavirus species) in individuals ≥ 1 year of age.,

European Union - English - EMA (European Medicines Agency)

janssen-cilag international n.v.    - recombinant modified vaccinia ankara bavarian nordic virus encoding the: ebola virus zaire (zebov) mayinga strain glycoprotein (gp); ebola virus sudan gulu strain gp; ebola virus taï forest strain nucleoprotein and the marburg virus musoke strain gp - hemorrhagic fever, ebola - vaccines - active immunization for prevention of disease caused by ebola virus (zaire ebolavirus species) in individuals ≥ 1 year of age.,

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

sanofi-aventis australia pty ltd - influenza haemagglutinin recombinant, quantity: 45 microgram - injection, solution - excipient ingredients: dibasic sodium phosphate; sodium chloride; polysorbate 20; monobasic sodium phosphate; water for injections - flublok quadrivalent is indicated for active immunisation for the prevention of influenza disease caused by influenza virus types a and b contained in the vaccine. flublok quadrivalent is approved for use in persons 18 years of age and older.

European Union - English - EMA (European Medicines Agency)

ceva-phylaxia co. ltd. - recombinant fowlpox virus expressing the membrane fusion protein and the encapsidation protein of avian infectious laryngotracheitis virus, live - chicken - for active immunisation of chickens from 8 weeks of age in order to reduce the skin lesions due to fowlpox and to reduce the clinical signs and tracheal lesions due to avian infectious laryngotracheitis. 

European Union - English - EMA (European Medicines Agency)

intervacc ab - recombinant streptococcus equi protein cce, recombinant streptococcus equi protein eq85, recombinant streptococcus equi protein idee - immunologicals for equidae - horses - for the active immunisation to reduce clinical signs and the number of abscesses in acute stage of infection with s. equi.

Philippines - English - FDA (Food And Drug Administration)

hipra philippines, inc.; distributor: hipra philippines, inc. - inactivated recombinant escherichia coli verotoxin vaccine (vet.) - suspension for injection (im) - formulation: each i ml (dose) of vaccine contains: recombinant verotoxin 2e rp 21.50 *