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

pfizer australia pty ltd - infliximab, quantity: 100 mg - injection, powder for - excipient ingredients: sucrose; dibasic sodium phosphate dihydrate; monobasic sodium phosphate monohydrate; polysorbate 80 - rheumatoid arthritis in adults,inflectra in combination with methotrexate, is indicated for the reduction of signs and symptoms and prevention of structural joint damage (erosions and joint space narrowing) in:,- patients with active disease despite treatment with methotrexate,- patients with active disease who have not previously received methotrexate.,inflectra should be given in combination with methotrexate. efficacy and safety in rheumatoid arthritis have been demonstrated only in combination with methotrexate.,ankylosing spondylitis,inflectra is indicated for the reduction of signs and symptoms and improvement in physical function in patients with active disease.,psoriatic arthritis,inflectra is indicated for the treatment of the signs and symptoms, as well as for the improvement in physical function in adult patients with active and progressive psoriatic arthritis who have responded inadequately to disease-modifying anti-rheumatic drug (dmard) therapy. inflectra may be administered in combination with methotrexate.,psoriasis,inflectra is indicated for the treatment of adult patients with moderate to severe plaque psoriasis for whom phototherapy or conventional systemic treatments have been inadequate or are inappropriate. safety and efficacy beyond 12 months have not been established.,crohn?s disease in adults and in children and adolescents (6 to 17 years),inflectra is indicated for the treatment of moderate to severe crohn?s disease, to reduce the signs and symptoms and to induce and maintain clinical remission in patients who have an inadequate response to conventional therapies.,refractory fistulising crohn?s disease,inflectra is indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients.,ulcerative colitis in adults and in children and adolescents (6 to 17 years),inflectra is indicated for the treatment of moderately severe to severe active ulcerative colitis in patients who have had an inadequate response to conventional therapy.

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

sun pharma anz pty ltd - levetiracetam, quantity: 100 mg/ml - injection, concentrated - excipient ingredients: glacial acetic acid; water for injections; sodium chloride; sodium acetate trihydrate - levetiracetam (film-coated tablets and oral solution) is indicated for:,? use in epileptic patients aged 4 years and older, initially as add on therapy, in the treatment of partial onset seizures with or without secondary generalisation, ? monotherapy in the treatment of partial onset seizures, with or without secondary generalisation, in patients from 16 years of age with newly diagnosed epilepsy. ? add on therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy (jme),and ? add on therapy in the treatment of primary generalized tonic-clonic seizures in adults and children from 4 years of age with idiopathic generalized epilepsy (ige).,levetiracetam sun concentrated injection after dilution is an alternative for patients when oral administration is temporarily not feasible.

Canada - English - Health Canada

sandoz canada incorporated - methotrexate (methotrexate sodium) - solution - 25mg - methotrexate (methotrexate sodium) 25mg - antineoplastic agents

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

fresenius kabi australia pty ltd - gemcitabine hydrochloride, quantity: 2277.2 mg (equivalent: gemcitabine, qty 2000 mg) - injection, powder for - excipient ingredients: sodium hydroxide; mannitol; hydrochloric acid; sodium acetate - gemcitabine kabi is indicated for, the treatment of patients with locally advanced or metastatic non-small cell lung cancer. treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas. gemcitabine is also indicated for patients with 5-fu refractory pancreatic cancer. alone or in combination with cisplatin, for the treatment of patients with bladder cancer. in combination with paclitaxel, is indicated for the treatment of patients with unresectable, locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy. prior chemotherapy should have included an anthracycline unless clinically contraindicated. in combination with carboplatin, for the treatment of patients with recurrent epithelial ovarian carcinoma, who have relapsed > 6 months following platinum-based therapy.

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

fresenius kabi australia pty ltd - gemcitabine hydrochloride, quantity: 1138.6 mg (equivalent: gemcitabine, qty 1000 mg) - injection, powder for - excipient ingredients: hydrochloric acid; sodium acetate; sodium hydroxide; mannitol - gemcitabine kabi is indicated for, the treatment of patients with locally advanced or metastatic non-small cell lung cancer. treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas. gemcitabine is also indicated for patients with 5-fu refractory pancreatic cancer. alone or in combination with cisplatin, for the treatment of patients with bladder cancer. in combination with paclitaxel, is indicated for the treatment of patients with unresectable, locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy. prior chemotherapy should have included an anthracycline unless clinically contraindicated. in combination with carboplatin, for the treatment of patients with recurrent epithelial ovarian carcinoma, who have relapsed > 6 months following platinum-based therapy.

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

fresenius kabi australia pty ltd - gemcitabine hydrochloride, quantity: 227.72 mg (equivalent: gemcitabine, qty 200 mg) - injection, powder for - excipient ingredients: mannitol; sodium acetate; hydrochloric acid; sodium hydroxide - gemcitabine kabi is indicated for, the treatment of patients with locally advanced or metastatic non-small cell lung cancer. treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas. gemcitabine is also indicated for patients with 5-fu refractory pancreatic cancer. alone or in combination with cisplatin, for the treatment of patients with bladder cancer. in combination with paclitaxel, is indicated for the treatment of patients with unresectable, locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy. prior chemotherapy should have included an anthracycline unless clinically contraindicated. in combination with carboplatin, for the treatment of patients with recurrent epithelial ovarian carcinoma, who have relapsed > 6 months following platinum-based therapy.

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

medtas pty ltd - methylprednisolone sodium succinate, quantity: 1326 mg (equivalent: methylprednisolone, qty 1000 mg) - injection, powder for - excipient ingredients: dibasic sodium phosphate; monobasic sodium phosphate dihydrate - when oral therapy is not feasible & strength, dosage form & route of administration of drug reasonably lend preparation to treatment of following conditions. intravenous or intramuscular use only.,endocrine disorders: primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is drug of choice; synthetic analogues may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance). acute adrenocortical insufficiency (hydrocortisone or cortisone is drug of choice; mineralocorticoid supplementation may be necessary particularly when synthetic analogues are used). preoperatively & in event of serious trauma or illness in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful. shock unresponsive to conventional therapy if adrenocortical insufficiency exists or suspected, congenital adrenal hyperplasia, nonsuppurative thyroiditis, hypercalcaemia associated with cancer. congenital adrenal hy

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

accord healthcare pty ltd - gemcitabine hydrochloride (equivalent: gemcitabine, qty 1 g) - injection, powder for - excipient ingredients: hydrochloric acid; mannitol; sodium hydroxide; sodium acetate trihydrate - treatment of patients with locally advanced or metastatic non-small cell lung cancer (nsclc). treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas. treatment of patients with 5-fu refractory pancreatic cancer. treatment of patients with bladder cancer, alone or in combination with cisplatin. treatment, in combination with paclitaxel, of patients with unresectable locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy. prior chemotherapy should have included an anthracycline unless clinically contraindicated. treatment, in combination with carboplatin, of patients with recurrent epithelial ovarian carcinoma, who have relapsed > six months following platinum based therapy.

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

accord healthcare pty ltd - gemcitabine hydrochloride, quantity: 228 mg (equivalent: gemcitabine, qty 200 mg) - injection, powder for - excipient ingredients: mannitol; sodium acetate trihydrate; sodium hydroxide; hydrochloric acid - treatment of patients with locally advanced or metastatic non-small cell lung cancer (nsclc). treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas. treatment of patients with 5-fu refractory pancreatic cancer. treatment of patients with bladder cancer, alone or in combination with cisplatin. treatment, in combination with paclitaxel, of patients with unresectable locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy. prior chemotherapy should have included an anthracycline unless clinically contraindicated. treatment, in combination with carboplatin, of patients with recurrent epithelial ovarian carcinoma, who have relapsed > six months following platinum based therapy.

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

sandoz pty ltd - pantoprazole sodium sesquihydrate, quantity: 45.12 mg (equivalent: pantoprazole, qty 40 mg) - injection, powder for - excipient ingredients: nitrogen - pantoprazole sandoz is indicated for short-term use where oral therapy is not appropriate for the following conditions: 1. symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion, e.g. duodenal ulcer, gastric ulcer, reflux oesophagitis, gastrointestinal lesions refractory to h2 blockers, zollinger-ellison syndrome. 2. maintenance of healed reflux oesophagitis in patients previously treated for moderate to severe reflux oesophagitis. note: patients who gastric or duodenal ulceration is not associated with ingestion of non-steroidal anti-inflammatory drugs require treatment with anti-microbial agents in addition to anti-secretory medicines, whether on first presentation or recurrence.