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

novartis pharmaceuticals australia pty ltd - omalizumab, quantity: 150 mg - injection, solution - excipient ingredients: water for injections - allergic asthma,children 6 to < 12 years of age - in children aged 6 to <12 years, xolair is indicated as add-on therapy to improve asthma control in patients with severe allergic asthma who have documented exacerbations despite daily high dose inhaled corticosteroids, and who have immunoglobulin e levels corresponding to the recommended dose range (see table 1 in section 4.2 dose and method of administration).,adults and adolescents 12 years of age and above -xolair is indicated for the management of adult and adolescent patients with moderate to severe allergic asthma, who are already being treated with inhaled steroids, and who have serum immunoglobulin e levels corresponding to the recommended dose range (see table 1 in section 4.2 dose and method of administration).,chronic rhinosinusitis with nasal polyps (crswnp),xolair is indicated as add-on treatment in adult patients (18 years of age and above) for the treatment of severe crswnp with inadequate response to intranasal corticosteroids. recommended dosing is determined by serum immunoglobulin e levels and body weight corresponding to the recommended dose range in the product information (see section 4.2 dose and method of administration).,chronic spontaneous urticaria (csu),xolair is indicated for adults and adolescents (12 years of age and above) with chronic spontaneous urticaria who remain symptomatic despite h1 antihistamine treatment.

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

bayer australia ltd - octocog alfa, quantity: 2000 iu - injection, diluent for - excipient ingredients: water for injections - kogenate fs is indicated for the treatment and prophylaxis of bleeding in patients with haemophilia a (congenital factor viii deficiency). it may also be used in patients with factor viii inhibitors (neutralising antibodies) who continue to respond to infused factor viii. kogenate fs does not contain von willebrand factor and hence is not indicated in von willebrands disease.

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

bayer australia ltd - octocog alfa, quantity: 3000 iu - injection, diluent for - excipient ingredients: water for injections - kogenate fs is indicated for the treatment and prophylaxis of bleeding in patients with haemophilia a (congenital factor viii deficiency). it may also be used in patients with factor viii inhibitors (neutralising antibodies) who continue to respond to infused factor viii. kogenate fs does not contain von willebrand factor and hence is not indicated in von willebrands disease.

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

juno pharmaceuticals pty ltd - cefoxitin sodium, quantity: 2.103 g - injection, powder for - excipient ingredients: - cefoxitin sodium for injection is indicated for the treatment of the following infections when due to susceptible organisms (see microbiology): peritonitis and other intra-abdominal and intra-pelvic infections, female genital tract infections, septicaemia, endocarditis, urinary tract infections, respiratory tract infections, bone and joint infections, and skin and skin structure infections. cefoxitin sodium for injection has a high degree of stability against beta-lactamase and therefore effective against beta-lactamase producing organisms resistant to penicillins or cephalosporins. it can also be used in mixed infections provided that the organisms are sensitive to it. cefoxitin sodium can be used as adjunctive therapy in the surgical treatment of infections including abscesses, infection complicating hollow viscus perforations, cutaneous infections and infections of serous surfaces whether caused by aerobes, mixed aerobes and anaerobes or anaerobes. cefoxitin sodium for injection is also indicated for the prevention of post-operative infections associated with certain surgical procedures of the gastrointestinal, biliary and genital tracts.

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

juno pharmaceuticals pty ltd - cefoxitin sodium, quantity: 1.051 g - injection, powder for - excipient ingredients: - cefoxitin sodium for injection is indicated for the treatment of the following infections when due to susceptible organisms (see microbiology): peritonitis and other intra-abdominal and intra-pelvic infections, female genital tract infections, septicaemia, endocarditis, urinary tract infections, respiratory tract infections, bone and joint infections, and skin and skin structure infections. cefoxitin sodium for injection has a high degree of stability against beta-lactamase and therefore effective against beta-lactamase producing organisms resistant to penicillins or cephalosporins. it can also be used in mixed infections provided that the organisms are sensitive to it. cefoxitin sodium can be used as adjunctive therapy in the surgical treatment of infections including abscesses, infection complicating hollow viscus perforations, cutaneous infections and infections of serous surfaces whether caused by aerobes, mixed aerobes and anaerobes or anaerobes. cefoxitin sodium for injection is also indicated for the prevention of post-operative infections associated with certain surgical procedures of the gastrointestinal, biliary and genital tracts.

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

juno pharmaceuticals pty ltd - flucloxacillin, quantity: 1 g - injection, powder for - excipient ingredients: - treatment of confirmed or suspected staphylococcal infections and other gram-positive coccal infections including pneumonia, skin and skin structure and wound infections, infected burns and cellulitis.

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

juno pharmaceuticals pty ltd - flucloxacillin, quantity: 500 mg - injection, powder for - excipient ingredients: - treatment of confirmed or suspected staphylococcal infections and other gram-positive coccal infections including pneumonia, skin and skin structure and wound infections, infected burns and cellulitis.

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

bayer australia ltd - interferon beta-1b, quantity: 0.25 mg/ml - injection, powder for - excipient ingredients: albumin; mannitol - betaferon is indicated for the treatment of: - ambulatory patients with relapsing-remitting multiple sclerosis (ms) characterised by at least two attacks of neurologic dysfunction over a two year period followed by complete or incomplete recovery. - betaferon is also indicated for the reduction of frequency and severity of clinical relapses, and for the slowing of progression of disease in patients with secondary progressive multiple sclerosis. - the treatment of patients with a single clinical event suggestive of multiple sclerosis and at least two clinically silent magnetic resonance imaging (mri) lesions characteristic of multiple sclerosis, if alternative diagnoses have been excluded.

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

seqirus pty ltd - benzylpenicillin sodium, quantity: 600 mg - injection, powder for - excipient ingredients: - benzylpenicillin is bactericidal and is active against most gram-positive organisms. it is also active against spirochaetes such as treponema pallidum. benzylpenicillin may also be used for the prevention of bacterial endocarditis in dental and upper respiratory tract procedures and prevention of wound infections and sepsis in surgical procedures where the likely pathogens are streptococci.

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

juno pharmaceuticals pty ltd - flucloxacillin sodium monohydrate, quantity: 2176 mg (equivalent: flucloxacillin, qty 2000 mg) - injection, powder for - excipient ingredients: - treatment of confirmed or suspected staphylococcal infections and other gram-positive coccal infections including pneumonia, skin and skin structure and wound infections, infected burns and cellulitis.