Ireland - English - HPRA (Health Products Regulatory Authority)

pharmaq as - aeromonas salmonicida subspecies salmonicida; al 2017; listonella anguillarum serotype o1; al 112; listonella anguillarum serotype o2a; al 104 - emulsion for injection - . - aeromonas + vibrio - atlantic salmon - immunological - inactivated vaccine

New Zealand - English - Medsafe (Medicines Safety Authority)

takeda new zealand limited - octocog alfa 3000 [iu];   - injection with diluent - 3000 iu - active: octocog alfa 3000 [iu]   excipient: calcium chloride dihydrate glutathione histidine mannitol polysorbate 80 sodium chloride trehalose dihydrate trometamol water for injection - advate is indicated for use in haemophilia a for prevention and control of haemorrhagic episodes. patients with haemophilia a may be treated with advate as perioperative management. advate is not indicated in von willebrand's disease.

Ireland - English - HPRA (Health Products Regulatory Authority)

pharmaq as - aeromonas salmonicida subsp. salmonicida, al 2017, listonella anguillarum serotype o1; al 112, listonella anguillarum serotype o2a; al 104 - emulsion for injection - unknown - aeromonas vaccine + vibrio vaccine - fish - (atlantic) salmon - immunological - inactivated vaccine

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

csl behring australia pty ltd - c1 esterase inhibitor, quantity: 3000 iu - injection, diluent for - excipient ingredients: - berinert? sc for subcutaneous injection is indicated for prevention of recurrent hereditary angioedema (hae) attacks in patients aged 8 years and older with c1 esterase inhibitor deficiency.

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

adama australia pty limited - alpha-cypermethrin; liquid hydrocarbon - emulsifiable concentrate - alpha-cypermethrin pyrethroid active 100.0 g/l; liquid hydrocarbon solvent other 760.0 g/l - insecticide - apple | apricot | asparagus - except white asparagus | banksia | broccoli | brussels sprouts | cabbage | canola | cauliflower | - aphids - rhopalosiphum spp. | apple dimpling bug - c. liebknechti | apple weevil | autumn gum moth | banksia moth - danima banksiae | blackheaded pasture cockchafer | blue oat or pea mite | bronzed field beetle | brown pasture looper | cabbage moth | cabbage white butterfly | cadmus spp. | cluster caterpillar | common armyworm - mythimna convecta | corn earworm | cotton budworm or bollworm | cutworm - agrotis spp. | eucalyptus weevil | garden or south african vine weevil | green mirid bug | grey cluster bug | helicoverpa armigera | helicoverpa spp. | liparetrus spp. - adults | native budworm or bollworm | pasture webworm - hednota spp. | pea weevil | pink or brown cutworm | plague thrips | redlegged earth mite | rice bloodworm | rough bollworm | rutherglen bug | sorghum midge | southern or barley armyworm | tasmanian eucalyptus leaf beetle | tobacco budworm | tobacco looper or looper caterpillar | tomato grub | vegetable weevil | wingless grasshopper | acrossidius tasmaniae | barley armyworm | barley grub | b

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

takeda pharmaceuticals australia pty ltd - octocog alfa, quantity: 3000 iu - injection, diluent for - excipient ingredients: water for injections - advate is indicated for use in haemophilia a for prevention and control of haemorrhagic episodes. patients with haemophilia a may be treated with advate as perioperative management. advate is not indicated in von willebrands disease.

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

alphapharm pty ltd - piperacillin sodium, quantity: 4.2 g (equivalent: piperacillin, qty 4 g); tazobactam sodium, quantity: 0.54 g (equivalent: tazobactam, qty 0.5 g) - injection, powder for - excipient ingredients: - tazopip is indicated in the treatment of serious bacterial infections caused by susceptible strains of beta -lactamase producing organisms in the conditions as listed: 1. lower respiratory tract infections 2. urinary tract infections (complicated and uncomplicated). 3.intra- abdominal infections. 4. skin and skin structure infections. 5. bacterial septicaemia. 6. gynaecological infections. children under the age of 12 years: in hospitalised children aged 2 to 12 years, tazopip is indicated for the treatment of serious intra-abdominal infections. it has not been evaluated in this indication for paediatric patients below the age of 2 years. while tazopip is indicated only for the conditions listed above, it may be used as a single agent in the treatment of mixed infections caused by piperacillin susceptible and beta -lactamase producing piperacillin-resistant organisms. appropriate culture and susceptibility tests should be performed before treatment in order to identify organisms causing infection to determine

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

alphapharm pty ltd - piperacillin sodium, quantity: 2.1 g (equivalent: piperacillin, qty 2 g); tazobactam sodium, quantity: 0.27 g (equivalent: tazobactam, qty 0.25 g) - injection, powder for - excipient ingredients: - tazopip is indicated in the treatment of serious bacterial infections caused by susceptible strains of beta -lactamase producing organisms in the conditions as listed: 1. lower respiratory tract infections 2. urinary tract infections (complicated and uncomplicated). 3.intra- abdominal infections. 4. skin and skin structure infections. 5. bacterial septicaemia. 6. gynaecological infections. children under the age of 12 years: in hospitalised children aged 2 to 12 years, tazopip is indicated for the treatment of serious intra-abdominal infections. it has not been evaluated in this indication for paediatric patients below the age of 2 years. while tazopip is indicated only for the conditions listed above, it may be used as a single agent in the treatment of mixed infections caused by piperacillin susceptible and beta -lactamase producing piperacillin-resistant organisms. appropriate culture and susceptibility tests should be performed before treatment in order to identify organisms causing infection to determine

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

emcure pharmaceuticals pty ltd - melphalan hydrochloride, quantity: 55.97 mg (equivalent: melphalan, qty 50 mg) - injection, diluent for - excipient ingredients: sodium citrate dihydrate; ethanol; water for injections; propylene glycol - for?the?treatment?of?patients?with?multiple?myeloma?for?whom?oral therapy?is?not?appropriate

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

fresenius kabi australia pty ltd - adalimumab, quantity: 40 mg - injection, solution - excipient ingredients: mannitol; monobasic sodium phosphate dihydrate; water for injections; sodium chloride; sodium hydroxide; citric acid monohydrate; sodium citrate dihydrate; dibasic sodium phosphate dihydrate; polysorbate 80 - rheumatoid arthritis idacio is indicated for reducing signs and symptoms, as well as inhibiting the progression of structural damage in adult patients with moderate to severely active rheumatoid arthritis. this includes the treatment of patients with recently diagnosed moderate to severely active disease who have not received methotrexate.,idacio can be used alone or in combination with methotrexate.,juvenile idiopathic arthritis polyarticular juvenile idiopathic arthritis idacio in combination with methotrexate is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to one or more disease modifying anti-rheumatic drugs (dmards). idacio can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.,enthesitis-related arthritis idacio is indicated for the treatment of enthesitis-related arthritis in children, who have had an inadequate response to, or who are intolerant to, conventional therapy.,psoriatic arthritis idacio is indicated for the treatment of signs and symptoms, as well as inhibiting the progression of structural damage, of moderate to severely active psoriatic arthritis in adult patients where response to previous dmards has been inadequate.,ankylosing spondylitis idacio is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.,crohn?s disease in adults and children (? 6 years) idacio is indicated for the treatment of moderate to severe crohn?s disease, to reduce the signs and symptoms of the disease and to induce and maintain clinical remission in patients;,? who have had an inadequate response to conventional therapies or, ? who have lost response to or are intolerant to infliximab,ulcerative colitis idacio is indicated for the treatment of moderate to severe ulcerative colitis in adult patients who have had an inadequate response to conventional therapy or who are intolerant to or have medical contraindications for such therapies. patients should show a clinical response within 8 weeks of treatment to continue treatment beyond that time. (see 5.1 pharmacodynamic properties-clinical trials).,psoriasis in adults and children idacio is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.,idacio is indicated for the treatment of severe chronic plaque psoriasis in children and adolescent patients from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy.,hidradenitis suppurativa in adults and adolescents (from 12 years of age) idacio is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.,uveitis idacio is indicated for the treatment of non-infectious intermediate, posterior and pan-uveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid sparing, or in whom corticosteroid treatment is inappropriate.