אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

medsurge pharma pty ltd - levetiracetam, quantity: 500 mg - injection, concentrated - excipient ingredients: sodium chloride; sodium acetate trihydrate; glacial acetic acid; water for injections - levetiracetam concentrate solution for iv infusion after dilution is an alternative for patients when oral administration is temporarily not feasible.,levetiracetam concentrate solution for iv infusion 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).,? add on therapy in the treatment of primary generalised tonic-clonic (pgtc) seizures in adults and children from 4 years of age with idiopathic generalised epilepsy (ige).

ישראל - אנגלית - Ministry of Health

eldan electronic instruments co ltd, israel - dextrose anhydrous - solution for infusion - dextrose anhydrous 5 % - vehicle solution for supplementary medication. energy supply, hypertonic dehydration

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

astrazeneca pty ltd - durvalumab, quantity: 500 mg - injection, concentrated - excipient ingredients: histidine hydrochloride monohydrate; trehalose dihydrate; water for injections; polysorbate 80; histidine - locally advanced non-small cell lung cancer (nsclc),imfinzi is indicated for the treatment of patients with locally advanced, unresectable nsclc whose disease has not progressed following platinum-based chemoradiation therapy.,small cell lung cancer (sclc),imfinzi in combination with etoposide and either carboplatin or cisplatin is indicated for the first-line treatment of patients with extensive-stage small cell lung cancer (es-sclc).,biliary tract cancer (btc),imfinzi in combination with gemcitabine and cisplatin is indicated for the treatment of patients with locally advanced or metastatic biliary tract cancer (btc).,hepatocellular carcinoma (hcc),imfinzi in combination with tremelimumab is indicated for the treatment of adult patients with unresectable hepatocellular carcinoma (uhcc) who have not received prior treatment with a pd-1/pd-l1 inhibitor. malignant pleural mesothelioma (mpm),imfinzi in combination with pemetrexed and either cisplatin or carboplatin has provisional approval for the first-line treatment of patients with unresectable mpm with epithelioid histology.,the decision to approve this indication has been made on the basis of two phase 2 single arm studies. continued approval of this indication depends on verification and description of clinical benefit in a confirmatory trial.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

astrazeneca pty ltd - durvalumab, quantity: 120 mg - injection, concentrated - excipient ingredients: histidine; water for injections; trehalose dihydrate; histidine hydrochloride monohydrate; polysorbate 80 - locally advanced non-small cell lung cancer (nsclc),imfinzi is indicated for the treatment of patients with locally advanced, unresectable nsclc whose disease has not progressed following platinum-based chemoradiation therapy.,small cell lung cancer (sclc),imfinzi in combination with etoposide and either carboplatin or cisplatin is indicated for the first-line treatment of patients with extensive-stage small cell lung cancer (es-sclc).,biliary tract cancer (btc),imfinzi in combination with gemcitabine and cisplatin is indicated for the treatment of patients with locally advanced or metastatic biliary tract cancer (btc).,hepatocellular carcinoma (hcc),imfinzi in combination with tremelimumab is indicated for the treatment of adult patients with unresectable hepatocellular carcinoma (uhcc) who have not received prior treatment with a pd-1/pd-l1 inhibitor. malignant pleural mesothelioma (mpm),imfinzi in combination with pemetrexed and either cisplatin or carboplatin has provisional approval for the first-line treatment of patients with unresectable mpm with epithelioid histology.,the decision to approve this indication has been made on the basis of two phase 2 single arm studies. continued approval of this indication depends on verification and description of clinical benefit in a confirmatory trial.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

southern xp ip pty ltd - sodium nitroprusside, quantity: 25 mg/ml - injection, concentrated - excipient ingredients: water for injections - nitroprusside sxp concentrated injection is indicated for:,1. immediate reduction of blood pressure in patients with hypertensive crises. concomitant oral antihypertensive medication should be started while the hypertensive emergency is being brought under control with sodium nitroprusside.,2. producing controlled hypotension during anaesthesia in order to reduce bleeding in surgical procedures where surgeon and anaesthetist deem it appropriate.,3. short term therapy of cardiac failure, to enhance cardiac output and lower myocardial oxygen requirements. patients should be commenced on oral therapy as soon as possible.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

alnylam australia pty ltd - patisiran, quantity: 10 mg - injection, concentrated - excipient ingredients: peg2000-c-dmg; sodium chloride; dlin-mc3-dma; water for injections; monobasic potassium phosphate; dibasic sodium phosphate heptahydrate; cholesterol; distearoylphosphatidylcholine - onpattro is indicated for the treatment of hereditary transthyretin-mediated amyloidosis (hattr amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

fresenius kabi australia pty ltd - dexmedetomidine hydrochloride, quantity: 472 microgram (equivalent: dexmedetomidine, qty 400 microgram) - injection, concentrated - excipient ingredients: sodium chloride; water for injections - intensive care unit (icu) sedation,for sedation of initially intubated patients during treatment in an intensive care setting. the use of dexmedetomidine kabi by continuous infusion in these patients should not exceed 24 hours.,procedural sedation,for sedation of non-intubated patients prior to and/or during surgical and other procedures.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

orion pharma (aus) pty limited - dexmedetomidine hydrochloride, quantity: 472 microgram (equivalent: dexmedetomidine, qty 400 microgram) - injection, concentrated - excipient ingredients: sodium chloride; water for injections - intensive care unit (icu) sedation:,for sedation of initially intubated adult patients during treatment in an intensive care setting. the use of dexdor by continuous infusion in these patients should not exceed 24 hours.,procedural sedation:,for sedation of non-intubated adult patients prior to and/or during surgical and other procedures.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

fresenius kabi australia pty ltd - dexmedetomidine hydrochloride, quantity: 236 microgram (equivalent: dexmedetomidine, qty 200 microgram) - injection, concentrated - excipient ingredients: sodium chloride; water for injections - intensive care unit (icu) sedation,for sedation of initially intubated patients during treatment in an intensive care setting. the use of dexmedetomidine kabi by continuous infusion in these patients should not exceed 24 hours.,procedural sedation,for sedation of non-intubated patients prior to and/or during surgical and other procedures.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

orion pharma (aus) pty limited - dexmedetomidine hydrochloride, quantity: 236 microgram (equivalent: dexmedetomidine, qty 200 microgram) - injection, concentrated - excipient ingredients: sodium chloride; water for injections - intensive care unit (icu) sedation:,for sedation of initially intubated adult patients during treatment in an intensive care setting. the use of dexdor by continuous infusion in these patients should not exceed 24 hours.,procedural sedation:,for sedation of non-intubated adult patients prior to and/or during surgical and other procedures.