Australia - English - 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.

Australia - English - 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.

Australia - English - 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.

Australia - English - 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.

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

fresenius kabi australia pty ltd - dexmedetomidine hydrochloride, quantity: 1180 microgram (equivalent: dexmedetomidine, qty 1000 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.

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

orion pharma (aus) pty limited - dexmedetomidine hydrochloride, quantity: 1180 microgram (equivalent: dexmedetomidine, qty 1000 microgram) - injection, concentrated - excipient ingredients: water for injections; sodium chloride - 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.

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

janssen-cilag pty ltd - amivantamab, quantity: 350 mg - injection, concentrated - excipient ingredients: methionine; disodium edetate; histidine; polysorbate 80; histidine hydrochloride monohydrate; water for injections; sucrose - rybrevant has provisional approval for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (nsclc) that has an activating epidermal-growth factor receptor (egfr) exon 20 insertion mutation, whose disease has progressed on or after platinum-based chemotherapy.,the decision to approve this indication has been made on the basis of objective response rate and duration of response in a single arm study. continued approval of this indication depends on verification and description of benefit in a confirmatory study.

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

baxter healthcare pty ltd - sodium nitroprusside, quantity: 50 mg - injection, concentrated - excipient ingredients: water for injections - sodium nitroprusside baxter 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.

Malta - English - Medicines Authority

venus pharma gmbh am bahnhof 1-3, werne, d 59368, germany - concentrate for solution for infusion - docetaxel 20 mg/ml - antineoplastic agents

Malta - English - Medicines Authority

venus pharma gmbh am bahnhof 1-3, werne, d 59368, germany - concentrate for solution for infusion - docetaxel 20 mg/ml - antineoplastic agents