Australie - anglais - Department of Health (Therapeutic Goods Administration)

ferring pharmaceuticals pty ltd - triptorelin acetate, quantity: 100 microgram (equivalent: triptorelin, qty 95.6 microgram/ml) - injection, solution - excipient ingredients: glacial acetic acid; water for injections; sodium chloride - decapeptyl 100 micrograms/1 ml is indicated for down-regulation and prevention of premature luteinising hormone (lh) surges in women undergoing controlled ovarian hyperstimulation for assisted reproductive technologies (art).,in clinical trials decapeptyl 100 micrograms/1 ml has been used in cycles where urinary and recombinant human follicle stimulating hormone (fsh) as well as human menopausal gonadotrophin (hmg) were used for stimulation.

Australie - anglais - Department of Health (Therapeutic Goods Administration)

phebra pty ltd - bupivacaine hydrochloride monohydrate, quantity: 105.54 mg (equivalent: bupivacaine hydrochloride, qty 100 mg); adrenaline (epinephrine) acid tartrate, quantity: 182 microgram (equivalent: adrenaline (epinephrine), qty 100 microgram) - injection, solution - excipient ingredients: sodium metabisulfite; hydrochloric acid; sodium chloride; water for injections - bupivacaine 0.5% with adrenaline 1:200,000 phebra is indicated for the production of local or regional anaesthesia and analgesia in individuals as follows:,surgical anaesthesia ? epidural block for surgery ? field block (minor and major nerve blocks and infiltration) analgesia ? intermittent bolus epidural administration for analgesia in postoperative pain or labour pain ? field block (minor nerve block and infiltration)

Australie - anglais - Department of Health (Therapeutic Goods Administration)

boucher & muir pty ltd - bupivacaine hydrochloride monohydrate, quantity: 5.28 mg/ml (equivalent: bupivacaine hydrochloride, qty 5 mg/ml) - injection, solution - excipient ingredients: glucose; water for injections; sodium hydroxide - bupivacaine spinal heavy bnm is indicated for the production of spinal anaesthesia.,bupivacaine spinal heavy bnm is suitable for abdominal surgery lasting 45 - 60 minutes and urological and lower limb surgery lasting 2 - 3 hours.

Australie - anglais - Department of Health (Therapeutic Goods Administration)

grifols australia pty ltd - alpha-1-proteinase inhibitor, quantity: 1000 mg - solution - excipient ingredients: monobasic sodium phosphate; alanine; water for injections - prolastin? c liquid is an alpha-1-proteinase inhibitor indicated to increase serum alpha-1-proteinase inhibitor levels in adults with congenital deficiency of alpha-1-antitrypsin and with clinically significant emphysema (fev1 <80%).,the data for clinical efficacy of prolastin? c liquid is derived from changes in the biomarkers alpha-1 anti-protease level and ct lung density. efficacy on fev1 or patient relevant endpoints such as quality of life or pulmonary exacerbations has not been established in randomised clinical trials.,clinical trials have only included patients who were not smoking.

Australie - anglais - 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.

Australie - anglais - Department of Health (Therapeutic Goods Administration)

specialites septodont pty ltd - articaine hydrochloride, quantity: 88 mg; adrenaline (epinephrine) acid tartrate, quantity: 0.02 mg (equivalent: adrenaline (epinephrine), qty 0.011 mg) - injection, solution - excipient ingredients: sodium chloride; sodium metabisulfite; sodium hydroxide; water for injections - ? septanest 1:200,000 is indicated for local anaesthesia for simple dental procedures in adults, adolescents and children 4 years of age and older. ? septanest 1:200,000 is indicated only for dental procedures

Australie - anglais - Department of Health (Therapeutic Goods Administration)

specialites septodont pty ltd - articaine hydrochloride, quantity: 68 mg; adrenaline (epinephrine) acid tartrate, quantity: 0.0155 mg (equivalent: adrenaline (epinephrine), qty 0.0085 mg) - injection, solution - excipient ingredients: sodium chloride; sodium metabisulfite; sodium hydroxide; water for injections - ? septanest 1:200,000 is indicated for local anaesthesia for simple dental procedures in adults, adolescents and children 4 years of age and older. ? septanest 1:200,000 is indicated only for dental procedures

Australie - anglais - Department of Health (Therapeutic Goods Administration)

merck healthcare pty ltd - somatropin, quantity: 8 mg/ml - injection, solution - excipient ingredients: phenol; sucrose; citric acid; poloxamer; water for injections; sodium hydroxide - saizen is indicated for:,1. treatment of growth failure in children due to human growth hormone deficiency.,2. treatment of growth failure in girls with gonadal dysgenesis (turner syndrome), confirmed by chromosomal analysis.,3. replacement therapy in adults with pronounced growth hormone deficiency as diagnosed in 2 different dynamic tests for growth hormone deficiency and defind by peak gh concentrations of less than 2.5 nanogram/ml. adults must also fulfill the following criteria: childhood onset: patients who were diagnosed as growth hormone deficient during childhood, must be retested and their growth hormone deficiency confirmed before replacement therapy with saizen is started. adult onset: patients must have growth hormone deficiency as a result of hypothalamic or pituitary disease and at least one other hormone deficiency diagnosed (except for prolactin) and adequate replacement therapy instituted, before replacement therapy using growth hormone may begin.,4. treatment of growth disturbance (growth retardation) in pre-pubertal children due to chronic renal insufficiency (cri).

Australie - anglais - Department of Health (Therapeutic Goods Administration)

merck healthcare pty ltd - somatropin, quantity: 8 mg/ml - injection, solution - excipient ingredients: sucrose; poloxamer; sodium hydroxide; water for injections; citric acid; phenol - saizen is indicated for:,1. treatment of growth failure in children due to human growth hormone deficiency.,2. treatment of growth failure in girls with gonadal dysgenesis (turner syndrome), confirmed by chromosomal analysis.,3. replacement therapy in adults with pronounced growth hormone deficiency as diagnosed in 2 different dynamic tests for growth hormone deficiency and defind by peak gh concentrations of less than 2.5 nanogram/ml. adults must also fulfill the following criteria: childhood onset: patients who were diagnosed as growth hormone deficient during childhood, must be retested and their growth hormone deficiency confirmed before replacement therapy with saizen is started. adult onset: patients must have growth hormone deficiency as a result of hypothalamic or pituitary disease and at least one other hormone deficiency diagnosed (except for prolactin) and adequate replacement therapy instituted, before replacement therapy using growth hormone may begin.,4. treatment of growth disturbance (growth retardation) in pre-pubertal children due to chronic renal insufficiency (cri).

Australie - anglais - Department of Health (Therapeutic Goods Administration)

merck healthcare pty ltd - somatropin, quantity: 5.83 mg/ml - injection, solution - excipient ingredients: poloxamer; sodium hydroxide; sucrose; citric acid; phenol; water for injections - saizen is indicated for:,1. treatment of growth failure in children due to human growth hormone deficiency.,2. treatment of growth failure in girls with gonadal dysgenesis (turner syndrome), confirmed by chromosomal analysis.,3. replacement therapy in adults with pronounced growth hormone deficiency as diagnosed in 2 different dynamic tests for growth hormone deficiency and defind by peak gh concentrations of less than 2.5 nanogram/ml. adults must also fulfill the following criteria: childhood onset: patients who were diagnosed as growth hormone deficient during childhood, must be retested and their growth hormone deficiency confirmed before replacement therapy with saizen is started. adult onset: patients must have growth hormone deficiency as a result of hypothalamic or pituitary disease and at least one other hormone deficiency diagnosed (except for prolactin) and adequate replacement therapy instituted, before replacement therapy using growth hormone may begin.,4. treatment of growth disturbance (growth retardation) in pre-pubertal children due to chronic renal insufficiency (cri).