Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - acetylcysteine, quantity: 2 g - injection, concentrated - excipient ingredients: water for injections; disodium edetate; sodium hydroxide - as an antidote for paracetamol poisoning: acetylcysteine injection concentrate is indicated in the treatment of paracetamol overdose to protect against hepatotoxicity.

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

fresenius kabi australia pty ltd - ropivacaine hydrochloride, quantity: 200 mg - injection, solution - excipient ingredients: sodium chloride; hydrochloric acid; sodium hydroxide; water for injections - surgical anaesthesia (adults and children over 12 years of age); epidural block for surgery including caesarean section; intrathecal anaesthesia; field block (minor nerve block and infiltration); major nerve block. analgesia (adults and children over 12 years of age); continuous epidural infusion or intermittent bolus epidural administration for analgesia in postoperative pain or labour pain; field block (minor nerve block and infiltration); continuous peripheral nerve block infusion or intermittent injections for post operative pain management; continuous wound infusion for postoperative pain management (adults only). analgesia (children aged 0 - 12 years); caudal epidural block in neonates (> 37 weeks gestation and over 2500 g weight), infants and children up to and including 12 years. continous epidural infusion in infants (> 30 days and over 2500 g weight) and children up to and including 12 years; peripheral nerve block in children aged 1 up to and including 12 years. for peri- and postoperative pain management. there are no safety or efficacy data to support the use of ropivacaine hydrochloride for analgesia for longer than 72 hours. (data for peripheral nerve block administered as a continuous peripheral infusion or intermittent injections and for continuous wound infusion support the use for up to 48 hours only).

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

fresenius kabi australia pty ltd - ropivacaine hydrochloride, quantity: 100 mg - injection, solution - excipient ingredients: sodium chloride; hydrochloric acid; sodium hydroxide; water for injections - surgical anaesthesia (adults and children over 12 years of age); epidural block for surgery including caesarean section; intrathecal anaesthesia; field block (minor nerve block and infiltration); major nerve block. analgesia (adults and children over 12 years of age); continuous epidural infusion or intermittent bolus epidural administration for analgesia in postoperative pain or labour pain; field block (minor nerve block and infiltration); continuous peripheral nerve block infusion or intermittent injections for post operative pain management; continuous wound infusion for postoperative pain management (adults only). analgesia (children aged 0 - 12 years); caudal epidural block in neonates (> 37 weeks gestation and over 2500 g weight), infants and children up to and including 12 years. continous epidural infusion in infants (> 30 days and over 2500 g weight) and children up to and including 12 years; peripheral nerve block in children aged 1 up to and including 12 years. for peri- and postoperative pain management. there are no safety or efficacy data to support the use of ropivacaine hydrochloride for analgesia for longer than 72 hours. (data for peripheral nerve block administered as a continuous peripheral infusion or intermittent injections and for continuous wound infusion support the use for up to 48 hours only).

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

fresenius kabi australia pty ltd - ropivacaine hydrochloride, quantity: 150 mg - injection, solution - excipient ingredients: sodium chloride; hydrochloric acid; sodium hydroxide; water for injections - surgical anaesthesia (adults and children over 12 years of age); epidural block for surgery including caesarean section; intrathecal anaesthesia; field block (minor nerve block and infiltration); major nerve block. analgesia (adults and children over 12 years of age); continuous epidural infusion or intermittent bolus epidural administration for analgesia in postoperative pain or labour pain; field block (minor nerve block and infiltration); continuous peripheral nerve block infusion or intermittent injections for post operative pain management; continuous wound infusion for postoperative pain management (adults only). analgesia (children aged 0 - 12 years); caudal epidural block in neonates (> 37 weeks gestation and over 2500 g weight), infants and children up to and including 12 years. continous epidural infusion in infants (> 30 days and over 2500 g weight) and children up to and including 12 years; peripheral nerve block in children aged 1 up to and including 12 years. for peri- and postoperative pain management. there are no safety or efficacy data to support the use of ropivacaine hydrochloride for analgesia for longer than 72 hours. (data for peripheral nerve block administered as a continuous peripheral infusion or intermittent injections and for continuous wound infusion support the use for up to 48 hours only).

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

fresenius kabi australia pty ltd - ropivacaine hydrochloride, quantity: 75 mg - injection, solution - excipient ingredients: sodium chloride; hydrochloric acid; sodium hydroxide; water for injections - surgical anaesthesia (adults and children over 12 years of age); epidural block for surgery including caesarean section; intrathecal anaesthesia; field block (minor nerve block and infiltration); major nerve block. analgesia (adults and children over 12 years of age); continuous epidural infusion or intermittent bolus epidural administration for analgesia in postoperative pain or labour pain; field block (minor nerve block and infiltration); continuous peripheral nerve block infusion or intermittent injections for post operative pain management; continuous wound infusion for postoperative pain management (adults only). analgesia (children aged 0 - 12 years); caudal epidural block in neonates (> 37 weeks gestation and over 2500 g weight), infants and children up to and including 12 years. continous epidural infusion in infants (> 30 days and over 2500 g weight) and children up to and including 12 years; peripheral nerve block in children aged 1 up to and including 12 years. for peri- and postoperative pain management. there are no safety or efficacy data to support the use of ropivacaine hydrochloride for analgesia for longer than 72 hours. (data for peripheral nerve block administered as a continuous peripheral infusion or intermittent injections and for continuous wound infusion support the use for up to 48 hours only).

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

fresenius kabi australia pty ltd - ropivacaine hydrochloride, quantity: 50 mg - injection, solution - excipient ingredients: sodium chloride; hydrochloric acid; sodium hydroxide; water for injections - surgical anaesthesia (adults and children over 12 years of age); epidural block for surgery including caesarean section; intrathecal anaesthesia; field block (minor nerve block and infiltration); major nerve block. analgesia (adults and children over 12 years of age); continuous epidural infusion or intermittent bolus epidural administration for analgesia in postoperative pain or labour pain; field block (minor nerve block and infiltration); continuous peripheral nerve block infusion or intermittent injections for post operative pain management; continuous wound infusion for postoperative pain management (adults only). analgesia (children aged 0 - 12 years); caudal epidural block in neonates (> 37 weeks gestation and over 2500 g weight), infants and children up to and including 12 years. continous epidural infusion in infants (> 30 days and over 2500 g weight) and children up to and including 12 years; peripheral nerve block in children aged 1 up to and including 12 years. for peri- and postoperative pain management. there are no safety or efficacy data to support the use of ropivacaine hydrochloride for analgesia for longer than 72 hours. (data for peripheral nerve block administered as a continuous peripheral infusion or intermittent injections and for continuous wound infusion support the use for up to 48 hours only).

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

fresenius kabi australia pty ltd - ropivacaine hydrochloride, quantity: 40 mg - injection, solution - excipient ingredients: sodium chloride; hydrochloric acid; sodium hydroxide; water for injections - surgical anaesthesia (adults and children over 12 years of age); epidural block for surgery including caesarean section; intrathecal anaesthesia; field block (minor nerve block and infiltration); major nerve block. analgesia (adults and children over 12 years of age); continuous epidural infusion or intermittent bolus epidural administration for analgesia in postoperative pain or labour pain; field block (minor nerve block and infiltration); continuous peripheral nerve block infusion or intermittent injections for post operative pain management; continuous wound infusion for postoperative pain management (adults only). analgesia (children aged 0 - 12 years); caudal epidural block in neonates (> 37 weeks gestation and over 2500 g weight), infants and children up to and including 12 years. continous epidural infusion in infants (> 30 days and over 2500 g weight) and children up to and including 12 years; peripheral nerve block in children aged 1 up to and including 12 years. for peri- and postoperative pain management. there are no safety or efficacy data to support the use of ropivacaine hydrochloride for analgesia for longer than 72 hours. (data for peripheral nerve block administered as a continuous peripheral infusion or intermittent injections and for continuous wound infusion support the use for up to 48 hours only).

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

fresenius kabi australia pty ltd - ropivacaine hydrochloride, quantity: 20 mg - injection, solution - excipient ingredients: sodium chloride; hydrochloric acid; sodium hydroxide; water for injections - surgical anaesthesia (adults and children over 12 years of age); epidural block for surgery including caesarean section; intrathecal anaesthesia; field block (minor nerve block and infiltration); major nerve block. analgesia (adults and children over 12 years of age); continuous epidural infusion or intermittent bolus epidural administration for analgesia in postoperative pain or labour pain; field block (minor nerve block and infiltration); continuous peripheral nerve block infusion or intermittent injections for post operative pain management; continuous wound infusion for postoperative pain management (adults only). analgesia (children aged 0 - 12 years); caudal epidural block in neonates (> 37 weeks gestation and over 2500 g weight), infants and children up to and including 12 years. continous epidural infusion in infants (> 30 days and over 2500 g weight) and children up to and including 12 years; peripheral nerve block in children aged 1 up to and including 12 years. for peri- and postoperative pain management. there are no safety or efficacy data to support the use of ropivacaine hydrochloride for analgesia for longer than 72 hours. (data for peripheral nerve block administered as a continuous peripheral infusion or intermittent injections and for continuous wound infusion support the use for up to 48 hours only).

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

phebra pty ltd - acetylcysteine, quantity: 6 g - injection - excipient ingredients: sodium hydroxide; water for injections - as an antidote for paracetamol poisoning: acetadote injection is indicated in the treatment of paracetamol overdose to protect against hepatoxicity.

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - dexamethasone sodium phosphate, quantity: 4.37 mg/ml (equivalent: dexamethasone phosphate, qty 4 mg/ml) - injection, solution - excipient ingredients: sodium hydroxide; sodium citrate dihydrate; water for injections; sodium sulfite; disodium edetate; hydrochloric acid - replacement therapy - adrenocortical insufficiency dexamethasone has predominantly glucocorticoid activity and therefore is not a complete replacement therapy in cases of adrenocortical insufficiency. dexamethasone should be supplemented with salt and/or a mineralocorticoid, such as deoxycorticosterone. when so supplemented, dexamethasone is indicated in: acute adrenocortical insufficiency - addison's disease, bilateral adrenalectomy; relative adrenocortical insufficiency - prolonged administration of adrenocortical steroids can produce dormancy of the adrenal cortex. the reduced secretory capacity gives rise to a state of relative adrenocortical insufficiency which persists for a varying length of time after therapy is discontinued. should a patient be subjected to sudden stress during this period of reduced secretion (for up to two years after therapy has ceased) the steroid output may not be adequate. steroid therapy should therefore be reinstituted to help cope with stress such as that associated with surgery, trauma, burns, or severe infections where specific antibiotic therapy is available; primary and secondary adrenocortical insufficiency. disease therapy dexamethasone is indicated for therapy of the following diseases: collagen diseases: systemic lupus erythematosus, polyarteritis nodosa, dermatomyositis, giant cell arteritis, adjunctive therapy for short term administration during an acute episode or exacerbation, acute rheumatic carditis ? during an exacerbation or as maintenance therapy. pulmonary disorders: status asthmaticus, chronic asthma, sarcoidosis, respiratory insufficiency. blood disorders: leukaemia, idiopathic thrombocytopaenic purpura in adults, acquired (autoimmune) haemolytic anaemia. rheumatic diseases: rheumatoid arthritis, osteoarthritis, adjunctive therapy for short term administration during an acute episode or exacerbation of rheumatoid arthritis or osteoarthritis. skin diseases: psoriasis, erythema multiforme, pemphigus, neutrophilic dermatitis, localised neurodermatitis, exfoliative dermatitis, sarcoidosis of skin, severe seborrhoeic dermatitis, contact dermatitis. gastrointestinal disorders: ulcerative colitis, regional enteritis. oedema: cerebral oedema associated with primary or metastatic brain tumours, neurosurgery or stroke, oedema associated with acute non-infectious laryngospasm (or laryngitis). eye disorders: allergic conjunctivitis, keratitis, allergic corneal marginal ulcers, chorioretinitis, optic neuritis, anterior ischaemic optic neuropathy. neoplastic states: cerebral neoplasms, hypercalcaemia associated with cancer, leukaemias and lymphomas in adults, acute leukaemia in children. endocrine disorders: adrenal insufficiency. preoperative and postoperative support dexamethasone may be used in any surgical procedure when the adrenocortical reserve is doubtful. this includes the treatment of shock due to excessive blood loss during surgery. shock dexamethasone may be used as an adjunct in the treatment of shock. dexamethasone should not be used as a substitute for normal shock therapy.