Australija - engleski - Department of Health (Therapeutic Goods Administration)

baxter healthcare pty ltd - ketorolac trometamol, quantity: 30 mg/ml - injection, solution - excipient ingredients: ethanol; sodium hydroxide; hydrochloric acid; nitrogen; water for injections; sodium chloride - ketorolac-baxter is indicated for the short-term management of moderately severe, acute pain following surgical procedures. the total duration of ketorolac use should not exceed five days.,it is recommended that ketorolac parenteral be used in the immediate post-operative period. patients can then be converted to the oral formulation (dependent on their analgesic needs), as outlined in section 4.2 dose and method of administration (refer to "conversion from intramuscular to oral therapy"). the total period of treatment utilising the oral and/or intramuscular route of administration is not to exceed five days.,general,ketorolac-baxter is not recommended for use as an obstetrical pre-operative medication or for obstetrical analgesia because it has not been adequately studied for use in these circumstances and because the known effects of drugs that inhibit prostaglandin biosynthesis on uterine contraction and foetal circulation.,there is no satisfactory evidence for the use of ketorolac-baxter in acute exacerbations of chronic painful inflammatory conditions (e.g. rheumatoid or osteoarthritis).

Australija - engleski - Department of Health (Therapeutic Goods Administration)

baxter healthcare pty ltd - ketorolac trometamol, quantity: 10 mg/ml - injection, solution - excipient ingredients: sodium chloride; ethanol; nitrogen; water for injections; hydrochloric acid; sodium hydroxide - ketorolac-baxter is indicated for the short-term management of moderately severe, acute pain following surgical procedures. the total duration of ketorolac use should not exceed five days.,it is recommended that ketorolac parenteral be used in the immediate post-operative period. patients can then be converted to the oral formulation (dependent on their analgesic needs), as outlined in section 4.2 dose and method of administration (refer to "conversion from intramuscular to oral therapy"). the total period of treatment utilising the oral and/or intramuscular route of administration is not to exceed five days.,general,ketorolac-baxter is not recommended for use as an obstetrical pre-operative medication or for obstetrical analgesia because it has not been adequately studied for use in these circumstances and because the known effects of drugs that inhibit prostaglandin biosynthesis on uterine contraction and foetal circulation.,there is no satisfactory evidence for the use of ketorolac-baxter in acute exacerbations of chronic painful inflammatory conditions (e.g. rheumatoid or osteoarthritis).

Australija - engleski - Department of Health (Therapeutic Goods Administration)

juno pharmaceuticals pty ltd - ketorolac trometamol, quantity: 30 mg - injection, solution - excipient ingredients: sodium hydroxide; sodium chloride; water for injections; ethanol - ketorolac trometamol solution for injection is indicated for the short-term management of moderately severe, acute pain following surgical procedures. the total duration of ketorolac use should not exceed five days.,it is recommended that ketorolac parenteral be used in the immediate post-operative period.,patients can then be converted to the oral formulation (dependent on their analgesic needs), as outlined in the "dosage and administration" section (refer to "conversion from parenteral to oral therapy"). the total period of treatment utilising the oral and/or intramuscular route of administration is not to exceed five days. note that oral dosage form can be available from other brand/s.,general,ketorolac trometamol solution for injection is not recommended for use as an obstetrical pre-operative medication or for obstetrical analgesia because it has not been adequately studied for use in these circumstances and because the known effects of drugs that inhibit prostaglandin biosynthesis on uterine contraction and foetal circulation.,there is no satisfactory evidence for the use of ketorolac trometamol solution for injection in acute exacerbations of chronic painful inflammatory conditions (e.g. rheumatoid or osteoarthritis).

Australija - engleski - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - ustekinumab, quantity: 90 mg - injection, solution - excipient ingredients: histidine hydrochloride monohydrate; sucrose; water for injections; polysorbate 80; histidine - plaque psoriasis,adults - stelara is indicated for the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.,paediatric population, 6 years and older - stelara is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from 6 years of age who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.,psoriatic arthritis (psa),stelara, alone or in combination with methotrexate, is indicated for the treatment of signs and symptoms of active psoriatic arthritis in adult patients (18 years and older) where response to previous non-biological dmard therapy has been inadequate.,crohn?s disease,stelara is indicated for the treatment of adult patients with moderately to severely active crohn?s disease who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a tnf alpha antagonist or have medical contraindications to such therapies.,ulcerative colitis,stelara is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis.

Australija - engleski - Department of Health (Therapeutic Goods Administration)

viatris pty ltd - oxytocin, quantity: 5 iu - injection, solution - excipient ingredients: glacial acetic acid; sodium acetate trihydrate; water for injections; sodium hydroxide - oxytocin is indicated for the induction of labour; inadequate uterine effort; management of third stage of labour; post-partum haemorrhage.

Australija - engleski - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - dexamethasone sodium phosphate, quantity: 4.4 mg (equivalent: dexamethasone phosphate, qty 4 mg) - injection - excipient ingredients: sodium citrate; creatinine; water for injections - replacement therapy:,adrenocortical insufficiency - dexamethasone has predominantly glucocorticoid activity and, therefore is not a complete replacement therapy in cases of adrenocortical insufficiency. dexamethasone should be supplemented with salt and/or a mineralocorticoid, such as deoxycorticosterone. when so supplemented, dexamethasone is indicated in the following: ? acute adrenocortical insufficiency - addison's disease; bilateral adrenalectomy ? relative adrenocortical insufficiency prolonged administration of adrenocortical steroids can produce dormancy of the adrenal cortex. the reduced secretory capacity gives rise to a state of relative adrenocortical insufficiency which persists for a varying length of time after therapy is discontinued. should a patient be subjected to sudden stress during this period of reduced secretion (for up to two years after therapy has ceased) the steroid output may not be adequate. steroid therapy should, therefore be reinstituted to help cope with stress such as that associated with surgery, trauma, burns or severe infections where specific antibiotic therapy is available. ? primary and secondary adrenocortical insufficiency.,disease therapy: dexamethasone is indicated for therapy of the following diseases - 1. collagen diseases. systemic lupus erythematosus, polyarteritis nodosa, dermatomyositis, giant cell arteritis, adjunctive therapy for short-term administration during an acute episode or exacerbation, acute rheumatic carditis -during an exacerbation or as maintenance therapy. 2. pulmonary disorders. status asthmaticus, chronic asthma, sarcoidosis, respiratory insufficiency. 3. blood disorders. leukaemia, idiopathic thrombocytopaenic purpura in adults, acquired (autoimmune) haemolytic anaemia. 4. rheumatic diseases. rheumatoid arthritis, osteoarthritis, adjunctive therapy for short-term administration during an acute episode or exacerbation of rheumatoid arthritis or osteoarthritis. 5. skin diseases. psoriasis, erythema multiforme, pemphigus, neutrophilic dermatitis, localised neurodermatitis, exfoliative dermatitis, sarcoidosis of skin, severe seborrhoeic dermatitis, contact dermatitis. 6. gastrointestinal disorders. ulcerative colitis, regional enteritis. 7. oedema. cerebral oedema associated with primary or metastatic brain tumours, neurosurgery or stroke, oedema associated with acute non-infectious laryngospasm (or laryngitis). 8. eye disorders. allergic conjunctivitis, keratitis, allergic corneal marginal ulcers, chorioretinitis, optic neuritis, anterior ischaemic optic neuropathy. 9. neoplastic states. cerebral neoplasms, hypercalcaemia associated with cancer, leukaemias and lymphomas in adults, acute leukaemia in children. 10. endocrine disorders. adrenal insufficiency.,preoperative and postoperative support: dexamethasone may be used in any surgical procedure when the adrenocortical reserve is doubtful. this includes the treatment of shock due to excessive blood loss during surgery.,shock: dexamethasone may be used as an adjunct in the treatment of shock. refer to section 4.2 dose and method of administration. dexamethasone should not be used as a substitute for normal shock therapy.

Australija - engleski - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - hepatitis b surface antigen recombinant, quantity: 20 microgram/ml; hepatitis a virus antigen, quantity: 720 elisa unit/ml - injection, suspension - excipient ingredients: trometamol; aluminium hydroxide hydrate; sodium chloride; polysorbate 20; neomycin sulfate; water for injections; formaldehyde solution; aluminium phosphate; dibasic sodium phosphate heptahydrate; monobasic sodium phosphate; acetic acid; leucine; phenylalanine; methionine; lysine hydrochloride; isoleucine; valine; histidine; threonine; tryptophan; alanine; arginine; proline; tyrosine; serine; sodium acetate; dibasic potassium phosphate; magnesium chloride hexahydrate; glycine - twinrix (720/20) is indicated for active immunisation against hepatitis a and hepatitis b virus infection in adults and children from 1 year of age. twinrix junior (360/10) is indicated for use in children aged 1 to 15 years. twinrix (720/20) is indicated for active immunisation against hepatitis a and hepatitis b virus infection in adults and children from 1 year of age. twinrix junior (360/10) is indicated for use in children aged 1 to 15 years.

Australija - engleski - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - vinorelbine tartrate, quantity: 13.85 mg/ml - injection, concentrated - excipient ingredients: nitrogen; water for injections - treatment of advanced breast cancer after failure of standard therapy, as a single agent or in combination; and as first line treatment for advanced non-small cell lung cancer, as a single agent or in combination.

Australija - engleski - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - hepatitis b surface antigen recombinant, quantity: 20 microgram/ml - injection, suspension - excipient ingredients: monobasic sodium phosphate; water for injections; sodium chloride; dibasic sodium phosphate dihydrate; aluminium hydroxide hydrate - engerix-b is indicated for active immunisation against hepatitis b virus infection. the nh&mrc* recommend all infants, young children and unvaccinated adolescents receive a primary course of immunisation against hepatitis b. the nh&mrc also recommends immunisation for persons who are at substantial risk and have been demonstrated or judged to be susceptible to the hepatitis b virus. groups identified at increased risk of acquiring hbv infection include: infants born to carrier (hbsag-positive) mothers; individuals for whom post-exposure prophylaxis for hepatitis b is indicated; household contacts (other than sexual partners) of acute and chronic hepatitis b cases and carriers; susceptible sexual contacts. risk occurs in susceptible (anti-hbs negative) partners of hbv carriers and patients with acute hepatitis b; susceptible clients of std (sexually transmitted disease) clinics, and sexually active men who have sex with men are also at increased risk of infection; injecting drug users; haemodialysis patients, hiv-positive individuals and other immunosuppressed adults; patients receiving certain blood products especially patients with clotting disorders receiving blood product concentrates; individuals with chronic liver disease and / or hepatitis c; staff and residents of facilities for the intellectually disabled, including both residential and non-residential care of this group; liver transplant recipients. such individuals should be vaccinated prior to transplantation if seronegative for hepatitis b, as they may be at increased risk of infection from the transplanted organ; staff and inmates of long term correctional facilities; health care workers, dentists, embalmers, tattooists and body-piercers. all staff directly involved in patient care, embalming, or in the handling of human blood or tissue should be vaccinated; individuals adopting children from overseas. these children should be tested for hepatitis b, and if hbsag positive, members of the adoptive family should be vaccinated; others in whom vaccination may be justified include police, members of the armed forces and emergency services staff, depending on the risks of exposure associated with assigned duties. long term travellers to regions of high endemicity, and those residing for some time in such regions who may anticipate close personal contact with local residents, should be vaccinated. short-term tourists or business travellers are at very little risk of hepatitis b, provided they avoid exposure through sexual contact, injecting drug use, tattooing or body piercing. although the risk of hepatitis b infection in contact sports is low, immunisation of those involved should not be discouraged. as the risk in australian schools is very low, vaccination of classroom contacts is seldom indicated. nevertheless, vaccination of school children and adolescents should be encouraged; as hepatitis d (caused by the delta agent) does not occur in the absence of hepatitis b infection, it can be expected that hepatitis d will also be prevented by vaccination with engerix-b. the vaccine will not protect against infection caused by hepatitis a, hepatitis c and hepatitis e viruses, and other pathogens known to infect the liver.

Australija - engleski - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - hydroxocobalamin chloride, quantity: 1.027 mg - injection, solution - excipient ingredients: water for injections; acetic acid; sodium chloride - the approved indications for hydroxocobalamin injection are for prophylaxis and treatment of pernicious (addisonian) anaemia and other macrocytic anaemias associated with vitamin b12 deficiency. treatment of optic neuropathies such as tobacco amblyopia and leber's optic atrophy.