Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

amgen australia pty ltd - denosumab, quantity: 60 mg/ml - injection, solution - excipient ingredients: acetate; water for injections; polysorbate 20; sodium hydroxide; sorbitol - the treatment of osteoporosis in postmenopausal women. prolia significantly reduces the risk of vertebral, non-vertebral and hip fractures.,treatment to increase bone mass in men with osteopaenia receiving androgen deprivation therapy for non-metastatic prostate cancer (see clinical trials).,treatment to increase bone mass in men with osteoporosis at increased risk of fracture.,treatment to increase bone mass in women and men at increased risk of fracture due to long-term systemic glucocorticoid therapy.

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

atnahs pharma australia pty ltd - granisetron hydrochloride, quantity: 1.12 mg/ml (equivalent: granisetron, qty 1 mg/ml) - injection, solution - excipient ingredients: water for injections; citric acid monohydrate; sodium hydroxide; sodium chloride; hydrochloric acid - adults:,kytril (tablets and injection) is indicated for use in adults for:,the prevention of nausea and vomiting induced by cytotoxic chemotherapy; the prevention of nausea and vomiting induced by radiotherapy. kytril (injection) is also indicated for use in the treatment of nausea and vomiting induced by cytotoxic chemotherapy; and prevention and treatment of post-operative nausea and vomiting.,paediatric:,kytril injection is indicated for the prevention of nausea and vomiting induced by cytotoxic chemotherapy.

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

mundipharma pty ltd - oxycodone hydrochloride, quantity: 10 mg/ml - injection, solution - excipient ingredients: sodium citrate dihydrate; sodium chloride; sodium hydroxide; citric acid monohydrate; water for injections; hydrochloric acid - oxynorm solution for injection or infusion is indicated for the short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain.

Velika Britanija - angleščina - MHRA (Medicines & Healthcare Products Regulatory Agency)

base) 3.8mg/1ml solution for injection vials (aspen pharma trading ltd - dexamethasone sodium phosphate - solution for injection - 3.8mg/1ml

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

seqirus pty ltd - tramadol hydrochloride, quantity: 50 mg/ml - injection, solution - excipient ingredients: sodium acetate; water for injections - tramal solution for injection is indicated for the short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain.

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

teva pharma australia pty ltd - glatiramer acetate, quantity: 40 mg - injection, solution - excipient ingredients: mannitol; water for injections - copaxone is indicated for the: 1- reduction of the frequency of relapses in patients with relapsing remitting multiple sclerosis. 2-treatment of patients with a single clinical event suggestive of multiple sclerosis and at least two clinically silent mri lesions characteristic of multiple sclerosis, if alternative diagnoses have been excluded.

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

australasian medical & scientific ltd - sodium tetradecyl sulfate, quantity: 30 mg/ml - injection, solution - excipient ingredients: benzyl alcohol; water for injections; dibasic sodium phosphate dodecahydrate; monobasic potassium phosphate; sodium hydroxide - indications as at 09 june 2005 : the solution is designed for injection directly into the lumen of the varicose vein and is used as a sclerosant in the treatment of uncomplicated varicose veins of the leg by compression sclerotherapy. the strength of fibrovein selected depends on the size of the veins to be treated. fibrovein 3% is for the treatment of large superficial varicose veins. fibrovein 1% is for the treatment of small varicose veins and the larger venules. minor venules and spider veins (venous flares) should be treated with fibrovein 0.5% or 0.2%. the selection of the incorrect strength particularly in the case of minor venules and spider veins is liable to give rise to adverse reactions.

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

samsung bioepis au pty ltd - adalimumab, quantity: 40 mg - injection, solution - excipient ingredients: sodium citrate dihydrate; citric acid monohydrate; sorbitol; polysorbate 20; water for injections; histidine; histidine hydrochloride monohydrate - rheumatoid arthritis: hadlima 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. hadlima can be used alone or in combination with methotrexate.,juvenile idiopathic arthritis polyarticular juvenile idiopathic arthritis hadlima 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 antirheumatic drugs (dmards). hadlima can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.,enthesitis-related arthritis hadlima 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 hadlima 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 hadlima is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.,crohn?s disease in adults and children (6 years and older) hadlima 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 hadlima 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 section 5.1 pharmacodynamic properties- clinical trials for ulcerative colitis).,psoriasis in adults and children hadlima is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.,hadlima 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),hadlima is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in patients with an inadequate response to conventional systemic hidradenitis suppurativatherapy.,uveitis hadlima 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.

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - hyoscine hydrobromide, quantity: 400 microgram/ml - injection, solution - excipient ingredients: water for injections - hyoscine injection bp is indicated as a pre-operative medication to produce sedation and amnesia. it is also used pre-operatively to inhibit salivation and excessive secretions of the respiratory tract. hyoscine hydrobromide is also indicated for the treatment of selected cases of nausea and vomiting resulting from motion sickness, although oral or transdermal administration is more frequently used for this indication.

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

medsurge pharma pty ltd - oxycodone hydrochloride, quantity: 10 mg/ml - injection, solution - excipient ingredients: sodium citrate dihydrate; hydrochloric acid; citric acid monohydrate; sodium chloride; sodium hydroxide; water for injections - oxycodone hcl medsurge solution for injection or infusion is indicated for the short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain.