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

abbvie pty ltd - adalimumab, quantity: 50 mg/ml - injection, solution - excipient ingredients: sodium citrate dihydrate; monobasic sodium phosphate dihydrate; dibasic sodium phosphate dihydrate; citric acid monohydrate; water for injections; polysorbate 80; mannitol; sodium chloride - rheumatoid arthritis: humira 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. humira can be used alone or in combination with methotrexate.,juvenile idiopathic arthritis: - polyarticular juvenile idiopathic arthritis: humira 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). humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. - enthesitis-related arthritis: humira 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: humira 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: humira is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.,crohn's disease in adults and children (6 years and older): humira 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 of infliximab.,ulcerative colitis: humira 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 clinical trials).,psoriasis in adults and children: humira is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. humira 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): humira 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: humira 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.

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

abbvie pty ltd - lopinavir, quantity: 100 mg; ritonavir, quantity: 25 mg - tablet, film coated - excipient ingredients: titanium dioxide; polyvinyl alcohol; macrogol 3350; purified talc; colloidal anhydrous silica; iron oxide yellow; copovidone; sorbitan monolaurate; sodium stearylfumarate - kaletra is indicated for the treatment of hiv-1 infection, in combination with other antiretroviral agents in adults and children aged 2 years and older. this indication is based on the analyses of plasma hiv-1 rna levels and cd4 cell counts from controlled clinical studies (see clinical trials).

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

abbvie pty ltd - lopinavir, quantity: 200 mg; ritonavir, quantity: 50 mg - tablet, film coated - excipient ingredients: sodium stearylfumarate; macrogol 3350; hyprolose; macrogol 400; colloidal anhydrous silica; polysorbate 80; purified talc; copovidone; titanium dioxide; iron oxide yellow; hypromellose; sorbitan monolaurate - kaletra is indicated for the treatment of hiv-1 infection, in combination with other antiretroviral agents in adults and children aged 2 years and older. this indication is based on the analyses of plasma hiv-1 rna levels and cd4 cell counts from controlled clinical studies (see clinical trials).

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

abbvie pty ltd - leuprorelin acetate, quantity: 30 mg - injection, modified release - excipient ingredients: mannitol; polylactic acid - in the palliative treatment of metastatic or locally extensive prostate cancer (stage c and d).

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

abbvie pty ltd - leuprorelin acetate, quantity: 22.5 mg - injection, modified release - excipient ingredients: mannitol; polylactic acid - in the palliative treatment of metastatic or locally extensive prostatic cancer. (stage c and d).

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

abbvie pty ltd - leuprorelin acetate, quantity: 7.5 mg - injection, modified release - excipient ingredients: gelatin; mannitol; polyglactin - lucrin depot 7.5 mg injection and lucrin depot 3 month 22.5mg injection and lucrin depot 4 month 30mg injection are indicated in the palliative treatment of metastatic or locally extensive prostatic cancer (stage c and d).

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

abbvie pty ltd - levobupivacaine hydrochloride, quantity: 1.436 mg; levobupivacine, quantity: 1.25 mg - injection, solution - excipient ingredients: water for injections; hydrochloric acid; sodium chloride; sodium hydroxide - adults - pain management. continuous epidural infusion, for post operative and labour analgesia.

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

abbvie pty ltd - lopinavir, quantity: 80 mg/ml; ritonavir, quantity: 20 mg/ml - oral liquid, solution - excipient ingredients: ethanol absolute; glycerol; acesulfame potassium; sodium chloride; menthol; high fructose maize syrup; saccharin sodium; purified water; povidone; peg-40 hydrogenated castor oil; peppermint oil; propylene glycol; citric acid; sodium citrate dihydrate; flavour - kaletra is indicated for the treatment of hiv-1 infection, in combination with other antiretroviral agents in adults and children aged 2 years and older. this indication is based on the analyses of plasma hiv-1 rna levels and cd4 cell counts from controlled clinical studies (see clinical trials).

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

abbvie pty ltd - levobupivacaine hydrochloride, quantity: 8.449 mg/ml (equivalent: levobupivacine, qty 7.5 mg/ml) - injection, solution - excipient ingredients: sodium hydroxide; sodium chloride; water for injections; hydrochloric acid - adults levobupivacaine is indicated in adults for: surgical anaesthesia: major: epidural (including for caesarean section), intrathecal, peripheral nerve block minor: local infiltration, oral, peribulbar block in ophthalmic surgery. pain management: continuous epidural infusion, single or multiple bolus administration for post-operative, labour or chronic pain. for continuous epidural analgesia, levobupivacaine may be administered in combination with epidural fentanyl, morphine or clonidine. children levobupivacaine is indicated in children greater than 6 months of age, for infiltration analgesia (ilioinguinal/iliohypogastric blocks). after careful consideration to alternative concentrations, the 7.5mg/ml concentration of levobupivacine may be considered for those procedures requiring a dense block with low volume. the 7.5mg/ml concentration should not be considered for paediatric use.

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

abbvie pty ltd - levobupivacaine hydrochloride, quantity: 5.633 mg/ml (equivalent: levobupivacine, qty 5 mg/ml) - injection, solution - excipient ingredients: water for injections; sodium hydroxide; sodium chloride; hydrochloric acid - adults levobupivacaine is indicated in adults for: surgical anaesthesia: major: epidural (including for caesarean section), intrathecal, peripheral nerve block minor: local infiltration, oral, peribulbar block in ophthalmic surgery. pain management: continuous epidural infusion, single or multiple bolus administration for post-operative, labour or chronic pain. for continuous epidural analgesia, levobupivacaine may be administered in combination with epidural fentanyl, morphine or clonidine. children levobupivacaine is indicated in children greater than 6 months of age, for infiltration analgesia (ilioinguinal/iliohypogastric blocks). after careful consideration to alternative concentrations, the 7.5mg/ml concentration of levobupivacine may be considered for those procedures requiring a dense block with low volume. the 7.5mg/ml concentration should not be considered for paediatric use.