New Zealand - English - Medsafe (Medicines Safety Authority)

csl behring (nz) ltd - factor ix 500 [iu] (human coagulation 100iu/ml when reconstituted with 5ml water for injections) - injection with diluent - 500 iu - active: factor ix 500 [iu] (human coagulation 100iu/ml when reconstituted with 5ml water for injections) excipient: antithrombin iii chloride citric acid monohydrate heparin phosphorus plasma protein fraction sodium water for injection - monofix®-vf is indicated for the treatment of haemorrhages, for use in surgery, and as prophylaxis in patients with haemophilia b. monofix®-vf is not indicated for the treatment of factor ii, vii or x deficiencies because it does not contain therapeutic levels of these coagulation factors. monofix®-vf is not indicated for the treatment of haemophilia a patients with factor viii inhibitors.

New Zealand - English - Medsafe (Medicines Safety Authority)

csl behring (nz) ltd - factor ix 500 [iu] (50 iu/ml when reconstituted with 10 ml water for injections) - injection with diluent - 50 iu/ml - active: factor ix 500 [iu] (50 iu/ml when reconstituted with 10 ml water for injections) excipient: antithrombin iii chloride citric acid monohydrate heparin phosphorus plasma protein fraction sodium water for injection - monofix®-vf is indicated for the treatment of haemorrhages, for use in surgery, and as prophylaxis in patients with haemophilia b. monofix®-vf is not indicated for the treatment of factor ii, vii or x deficiencies because it does not contain therapeutic levels of these coagulation factors. monofix®-vf is not indicated for the treatment of haemophilia a patients with factor viii inhibitors.

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

southern xp ip pty ltd - amikacin, quantity: 500 mg (equivalent: amikacin sulfate, qty 667.5 mg) - injection, solution - excipient ingredients: sulfuric acid; sodium metabisulfite; sodium citrate dihydrate; water for injections - amikacin sxp injection is indicated in the short-term treatment of serious infections caused by susceptible strains of gram negative bacteria (see microbiology).,staphylococcus aureus, including methicillin resistant strains, is the principal gram positive organism sensitive to amikacin.,the use of amikacin in the treatment of staphylococcal infections should be restricted to second line therapy, and should be confined to patients suffering from severe infections caused by susceptible strains of staphylococcus who have failed to respond or are allergic to other available antibiotics.,amikacin sxp injection is indicated in the treatment of neonatal sepsis when sensitivity testing indicates that other aminoglycosides cannot be used.,in certain severe infections such as neonatal sepsis, concomitant therapy with a penicillin type drug maybe indicated because of the possibility of infections due to gram positive organisms such as streptococci or pneumococci. if concomitant treatment with a penicillin type drug is indicated, then the drugs should be administered separately because in vitro mixing of the two drugs causes inactivation of amikacin.,clinical studies have shown amikacin to be effective in treating bacteraemia, septicaemia including neonatal sepsis and serious infections of the respiratory tract, bones and joints, central nervous system, skin and skin structures (including those resulting from burns), intra-abdominal organs, postoperative infections and complicated and recurrent urinary tract infections, when caused by susceptible organisms.

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)

ucb australia pty ltd t/a ucb pharma division of ucb australia - brivaracetam, quantity: 10 mg/ml - injection, solution - excipient ingredients: sodium chloride; sodium acetate trihydrate; glacial acetic acid; water for injections - briviact solution for injection is indicated as add-on therapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 4 years of age with epilepsy.

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

panpharma australia pty ltd - droperidol, quantity: 2.5 mg/ml - injection, solution - excipient ingredients: mannitol; tartaric acid; sodium hydroxide; nitrogen; water for injections - anaesthesia droperidol panpharma 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 panpharma 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)

panpharma australia pty ltd - droperidol, quantity: 0.5 mg/ml - injection, solution - excipient ingredients: mannitol; tartaric acid; sodium hydroxide; nitrogen; water for injections - anaesthesia droperidol panpharma 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 panpharma 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)

panpharma australia pty ltd - droperidol, quantity: 2.5 mg/ml - injection, solution - excipient ingredients: mannitol; tartaric acid; sodium hydroxide; nitrogen; water for injections - anaesthesia droperidol panpharma 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 panpharma 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)

takeda pharmaceuticals australia pty ltd - susoctocog alfa, quantity: 500 u/ml - injection - excipient ingredients: - for the treatment of bleeding episodes in adults with acquired haemophilia a.,safety and efficacy of obizur have not been established in patients with baseline anti- porcine factor viii inhibitor titre greater than 20 bu.,obizur is not indicated for the treatment of congenital haemophilia a or von willebrand disease.