Australien - engelsk - Department of Health (Therapeutic Goods Administration)

medsurge pharma pty ltd - rocuronium bromide, quantity: 50 mg - injection, solution - excipient ingredients: sodium hydroxide; glacial acetic acid; sodium acetate; water for injections; sodium chloride - rocuronium is indicated as an adjunct to general anaesthesia to facilitate endotracheal intubation during routine induction, to provide muscle relaxation and to facilitate mechanical ventilation in adults, and paediatric patients from term newborn infants to adolescents. ,in adults, rocuronium is also indicated as an adjunct to general anaesthesia to facilitate endotracheal intubation during rapid sequence induction when suxamethonium is contraindicated. ,in adults, rocuronium is also indicated as an adjunct in the intensive care unit (icu) to facilitate mechanical ventilation.

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

juno pharmaceuticals pty ltd - icatibant acetate, quantity: 31.38 mg (equivalent: icatibant, qty 30 mg) - injection, solution - excipient ingredients: glacial acetic acid; sodium chloride; water for injections; sodium hydroxide - fyzant is indicated for symptomatic treatment of acute attacks of hereditary angioedema (hae) in adults, adolescents and children aged 2 years and older with c1-esterase-inhibitor deficiency.

Australien - engelsk - 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).

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

swedish orphan biovitrum pty ltd - pegcetacoplan, quantity: 1080 mg - injection, solution - excipient ingredients: water for injections; sodium hydroxide; sodium acetate trihydrate; glacial acetic acid; sorbitol - empaveli is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (pnh) who have an inadequate response to, or are intolerant of, a c5 inhibitor.

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

amdipharm mercury australia pty ltd - lanreotide acetate, quantity: 66.67 mg (equivalent: lanreotide, qty 60 mg) - injection, solution - excipient ingredients: glacial acetic acid; water for injections - mytolac is indicated for:,- the treatment of acromegaly when the circulating levels of growth hormone and igf-1 remain abnormal after surgery and/or radiotherapy or in patients who are dopamine agonist treatment refractory,- the treatment of symptoms of carcinoid syndrome associated with carcinoid tumours,- the treatment of gastroenteropancreatic neuroendocrine tumours (gep-nets) in adult patients with unresectable locally advanced or metastatic disease.

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

amdipharm mercury australia pty ltd - lanreotide acetate, quantity: 133.33 mg (equivalent: lanreotide, qty 120 mg) - injection, solution - excipient ingredients: water for injections; glacial acetic acid - mytolac is indicated for:,- the treatment of acromegaly when the circulating levels of growth hormone and igf-1 remain abnormal after surgery and/or radiotherapy or in patients who are dopamine agonist treatment refractory,- the treatment of symptoms of carcinoid syndrome associated with carcinoid tumours,- the treatment of gastroenteropancreatic neuroendocrine tumours (gep-nets) in adult patients with unresectable locally advanced or metastatic disease.

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

amdipharm mercury australia pty ltd - lanreotide acetate, quantity: 100 mg (equivalent: lanreotide, qty 90 mg) - injection, solution - excipient ingredients: water for injections; glacial acetic acid - mytolac is indicated for:,- the treatment of acromegaly when the circulating levels of growth hormone and igf-1 remain abnormal after surgery and/or radiotherapy or in patients who are dopamine agonist treatment refractory,- the treatment of symptoms of carcinoid syndrome associated with carcinoid tumours,- the treatment of gastroenteropancreatic neuroendocrine tumours (gep-nets) in adult patients with unresectable locally advanced or metastatic disease.

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

cipla australia pty ltd - icatibant acetate, quantity: 31.38 mg (equivalent: icatibant, qty 30 mg) - injection, solution - excipient ingredients: sodium chloride; glacial acetic acid; sodium hydroxide; water for injections - cipla icatibant is indicated for symptomatic treatment of acute attacks of hereditary angioedema (hae) in adults, adolescents and children aged 2 years and older with c1-esterase-inhibitor deficiency.

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

theramex australia pty ltd - ganirelix, quantity: 0.25 mg - injection, solution - excipient ingredients: glacial acetic acid; water for injections; mannitol; sodium hydroxide - for the prevention of premature luteinisation and ovulation in patients undergoing controlled ovarian stimulation, followed by oocyte pick up and assisted reproductive techniques

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

juno pharmaceuticals pty ltd - esmolol hydrochloride, quantity: 10 mg/ml - injection, solution - excipient ingredients: water for injections; hydrochloric acid; sodium hydroxide; sodium chloride; glacial acetic acid; sodium acetate trihydrate - supraventricular tachycardia,esmolol juno is indicated for the rapid control of ventricular rate in patients with atrial fibrillation or atrial flutter in perioperative, postoperative, or other emergent circumstances where short term control of ventricular rate with a short-acting agent is desirable. esmolol juno is also indicated in non compensatory sinus tachycardia where, in the physician's judgement, the rapid heart rate requires specific intervention. esmolol juno is not intended for use in chronic settings where transfer to another agent is anticipated or for treatment periods greater than 24 hours duration.