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

janssen-cilag pty ltd - teclistamab, quantity: 30 mg - injection, solution - excipient ingredients: glacial acetic acid; sucrose; disodium edetate; sodium acetate trihydrate; polysorbate 20; water for injections - tecvayli as monotherapy has provisional approval in australia and is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-cd38 monoclonal antibody.,the decision to approve this indication has been made on the basis of the overall response rate in a single arm study. continued approval of this indication depends on verification and description of benefit in confirmatory trials.

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

janssen-cilag pty ltd - teclistamab, quantity: 153 mg - injection, solution - excipient ingredients: polysorbate 20; sodium acetate trihydrate; glacial acetic acid; sucrose; water for injections; disodium edetate - tecvayli as monotherapy has provisional approval in australia and is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-cd38 monoclonal antibody.,the decision to approve this indication has been made on the basis of the overall response rate in a single arm study. continued approval of this indication depends on verification and description of benefit in confirmatory trials.

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

southern cross pharma pty ltd - droperidol, quantity: 5 mg - injection, solution - excipient ingredients: mannitol; tartaric acid; sodium hydroxide; water for injections - anaesthesia droperidol droperidol lupin is indicated to produce tranquillisation and to reduce the incidence of nausea and vomiting in surgical and diagnostic procedures for premedication, induction, and as an adjunct in the maintenance of general and regional anaesthesia in neuroleptanalgesia in which droperidol lupin injection is given concurrently with a narcotic analgesic, to aid in producing tranquillity and decreasing anxiety and pain.,psychiatry the management of severe agitation, hyperactivity, or aggressiveness in psychotic disorders, including schizophrenic reaction and the manic type of manic depressive illness, or in disturbed states, such as some types of acute brain syndrome and in nonpsychotic acute excitation states.

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

southern cross pharma pty ltd - droperidol, quantity: 2.5 mg - injection, solution - excipient ingredients: mannitol; tartaric acid; sodium hydroxide; water for injections - anaesthesia droperidol lupin injection is indicated to produce tranquillisation and to reduce the incidence of nausea and vomiting in surgical and diagnostic procedures for premedication, induction, and as an adjunct in the maintenance of general and regional anaesthesia in neuroleptanalgesia in which droperidol lupin injection is given concurrently with a narcotic analgesic, to aid in producing tranquillity and decreasing anxiety and pain.,psychiatry the management of severe agitation, hyperactivity, or aggressiveness in psychotic disorders, including schizophrenic reaction and the manic type of manic depressive illness, or in disturbed states, such as some types of acute brain syndrome and in nonpsychotic acute excitation states.

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

baxter healthcare pty ltd - lidocaine hydrochloride monohydrate, quantity: 53.3 mg (equivalent: lidocaine hydrochloride, qty 50 mg) - injection, solution - excipient ingredients: hydrochloric acid; water for injections; sodium chloride; sodium hydroxide - for production of local or regional anaesthesia by nerve block, infiltration injection, caudal or other epidural blocks. treatment or prophylaxis of life-threatening ventricular arrhythmias, including those associated with myocardial infarction, general anaesthesia in patients predisposed to ventricular arrhythmias, digitalis intoxication, or following resuscitation from cardiac arrest.

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

baxter healthcare pty ltd - lidocaine hydrochloride monohydrate, quantity: 213.2 mg (equivalent: lidocaine hydrochloride, qty 200 mg) - injection, solution - excipient ingredients: water for injections; sodium chloride; hydrochloric acid; sodium hydroxide - for production of local or regional anaesthesia by nerve block, infiltration injection, caudal or other epidural blocks. treatment or prophylaxis of life-threatening ventricular arrhythmias, including those associated with myocardial infarction, general anaesthesia in patients predisposed to ventricular arrhythmias, digitalis intoxication, or following resuscitation from cardiac arrest.

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

baxter healthcare pty ltd - lidocaine hydrochloride monohydrate, quantity: 42.66 mg (equivalent: lidocaine hydrochloride, qty 40 mg) - injection, solution - excipient ingredients: sodium hydroxide; water for injections; sodium chloride; hydrochloric acid - for production of local or regional anaesthesia by nerve block, infiltration injection, caudal or other epidural blocks. treatment or prophylaxis of life-threatening ventricular arrhythmias, including those associated with myocardial infarction, general anaesthesia in patients predisposed to ventricular arrhythmias, digitalis intoxication, or following resuscitation from cardiac arrest.

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

baxter healthcare pty ltd - lidocaine hydrochloride monohydrate, quantity: 21.32 mg (equivalent: lidocaine hydrochloride, qty 20 mg) - injection, solution - excipient ingredients: sodium hydroxide; sodium chloride; hydrochloric acid; water for injections - for production of local or regional anaesthesia by nerve block, infiltration injection, caudal or other epidural blocks. treatment or prophylaxis of life-threatening ventricular arrhythmias, including those associated with myocardial infarction, general anaesthesia in patients predisposed to ventricular arrhythmias, digitalis intoxication, or following resuscitation from cardiac arrest.

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

baxter healthcare pty ltd - lidocaine hydrochloride monohydrate, quantity: 426.6 mg (equivalent: lidocaine hydrochloride, qty 400 mg) - injection, solution - excipient ingredients: sodium chloride; hydrochloric acid; water for injections; sodium hydroxide - for production of local or regional anaesthesia by nerve block, infiltration injection, caudal or other epidural blocks. treatment or prophylaxis of life-threatening ventricular arrhythmias, including those associated with myocardial infarction, general anaesthesia in patients predisposed to ventricular arrhythmias, digitalis intoxication, or following resuscitation from cardiac arrest.

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

baxter healthcare pty ltd - lidocaine hydrochloride monohydrate, quantity: 106.65 mg (equivalent: lidocaine hydrochloride, qty 100 mg) - injection, solution - excipient ingredients: sodium chloride; sodium hydroxide; hydrochloric acid; water for injections - for production of local or regional anaesthesia by nerve block, infiltration injection, caudal or other epidural blocks. treatment or prophylaxis of life-threatening ventricular arrhythmias, including those associated with myocardial infarction, general anaesthesia in patients predisposed to ventricular arrhythmias, digitalis intoxication, or following resuscitation from cardiac arrest.