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

aspen pharmacare australia pty ltd - lidocaine hydrochloride, quantity: 5 mg/ml; adrenaline (epinephrine) acid tartrate, quantity: 9.1 microgram/ml (equivalent: adrenaline (epinephrine), qty 5 microgram/ml) - injection, solution - excipient ingredients: water for injections; sodium chloride; sodium metabisulfite; hydrochloric acid; sodium hydroxide - xylocaine solutions are indicated for the production of local or regional anaesthesia by the following techniques: infiltration, intravenous regional anaesthesia - excluding solutions with adrenaline, peripheral nerve block such as intercostal block, major plexus block such as brachial plexus block, epidural block, subarachnoid block.

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

aspen pharmacare australia pty ltd - bupivacaine hydrochloride, quantity: 5 mg/ml (equivalent: bupivacaine hydrochloride monohydrate, qty 5.28 mg/ml) - injection, solution - excipient ingredients: sodium hydroxide; water for injections; dilute hydrochloric acid; sodium chloride - indications as at 4 april 2000: marcain solutions are 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 - continuous epidural infusion or intermittent bolus epidural administration for analgesia in postoperative pain or labour pain. - field block (minor nerve block and infiltration). the choice of 4 strengths, 0.125%, 0.25%, 0.375% and 0.5%, makes it possible to vary the degree of motor blockade.

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

viatris pty ltd - procaine benzylpenicillin, quantity: 1.5 g - injection, suspension - excipient ingredients: sodium citrate dihydrate; water for injections; polysorbate 80 - indications as at 18 february 2002: treatment of moderately severe infections due to penicillin sensitive organisms. therapy should be guided by bacteriological studies, including sensitivity tests and also by clinical response. infections which usually respond to adequate dosage are: group a streptococcal infections including upper respiratory tract infections, skin and skin structure infections and scarlet fever; pneumococcal infections of the respiratory tract; susceptible staphylococcal infections, most gonococcal infections, syphilis, fusospirochaetosis (vincent's gingivitis and pharyngitis). cilicaine syringe 1.5 must be administered by the intramuscular route only (see section 4.2 dose and method of administration).

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

ucb australia pty ltd t/a ucb pharma division of ucb australia - certolizumab pegol, quantity: 200 mg - injection, solution - excipient ingredients: sodium acetate; sodium chloride; water for injections - rheumatoid arthritis cimzia is indicated for the treatment of moderate to severe active rheumatoid arthritis (ra) in adult patients. ? combined with mtx in case of either an inadequate response or intolerance to previous therapy with one or more disease modifying antirheumatic drugs (dmards) or ? as monotherapy in case of a contraindication or intolerance to mtx (see section 4.2 dose and method of administration). cimzia has been shown to reduce the rate of progression of joint damage as measured by x-ray, when given in combination with mtx. cimzia in combination with mtx is indicated for the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with mtx or other dmards.,psoriatic arthritis cimzia is indicated for the treatment of adult patients with active psoriatic arthritis where response to previous disease modifying antirheumatic drug therapy (dmards) has been inadequate. cimzia has been shown to improve physical function.,ankylosing spondylitis cimzia is indicated for the treatment of adult patients with active, ankylosing spondylitis who have been intolerant to or have had inadequate response to at least one nonsteroidal anti-inflammatory drug (nsaid).,non-radiographic axial spondyloarthritis cimzia is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axspa) with objective signs of inflammation as indicated by elevated c reactive protein (crp) and /or magnetic resonance imaging (mri) change, who have had an inadequate response to, or are intolerant to, nonsteroidal anti-inflammatory drugs (nsaids).,plaque psoriasis cimzia is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.

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

dentsply sirona pty ltd - prilocaine hydrochloride, quantity: 30 mg/ml; felypressin, quantity: 0.54 microgram/ml - injection, solution - excipient ingredients: sodium chloride; water for injections; hydrochloric acid; sodium hydroxide - citanest is indicated for the production of local anaesthesia in routine dental procedures and oral surgery by means of infiltration and nerve block techniques.

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

dentsply sirona pty ltd - prilocaine hydrochloride, quantity: 30 mg/ml; felypressin, quantity: 0.54 microgram/ml - injection, solution - excipient ingredients: sodium chloride; water for injections; hydrochloric acid; sodium hydroxide - indications as at 23 july 2003 : citanest is indicated for the production of local anaesthesia in routine dental procedures and oral surgery by means of infiltration and nerve block tecniques.

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

strides pharma science pty ltd - ceftazidime pentahydrate, quantity: 1175 mg (equivalent: ceftazidime, qty 1000 mg) - injection, powder for - excipient ingredients: sodium carbonate - ceftazidime for injection is indicated for the treatment of single and mixed infections caused by susceptible aerobic organisms with suspected or documented resistance to other antimicrobials, but not to ceftazidime, and as an alternative to aminoglycosides in pseudomonal infection in patients in whom aminoglycoside toxicity is a cause for concern and other pseudomonal antibiotics cannot be used. ,indications include the following:,severe infections in general: ,for example: septicaemia including neonatal sepsis, bacteraemia; and in patients in intensive care units with specific problems, e.g., infected burns.,respiratory tract infections: ,for example: pneumonia, broncho-pneumonia, infected pleurisy, infected bronchiectasis and bronchitis.,severe ear, nose and throat infections: ,for example: otitis media, mastoiditis.,urinary tract infections: ,for example: acute and chronic pyelonephritis, pyelitis, cystitis, urethritis (bacterial only), and infections associated with bladder and renal stones.,skin and soft tissue infections: ,for example, erysipelas, abscesses, cellulitis, infected burns and wounds, mastitis.,gastrointestinal and abdominal infections: ,for example: intra-abdominal abscesses, enterocolitis.,bone and joint infections: ,for example: osteitis, osteomyelitis, septic arthritis, infected bursitis.

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

strides pharma science pty ltd - ceftazidime pentahydrate, quantity: 2349 mg (equivalent: ceftazidime, qty 2000 mg) - injection, powder for - excipient ingredients: sodium carbonate - ceftazidime for injection is indicated for the treatment of single and mixed infections caused by susceptible aerobic organisms with suspected or documented resistance to other antimicrobials, but not to ceftazidime, and as an alternative to aminoglycosides in pseudomonal infection in patients in whom aminoglycoside toxicity is a cause for concern and other pseudomonal antibiotics cannot be used. ,indications include the following:,severe infections in general: ,for example: septicaemia including neonatal sepsis, bacteraemia; and in patients in intensive care units with specific problems, e.g., infected burns.,respiratory tract infections: ,for example: pneumonia, broncho-pneumonia, infected pleurisy, infected bronchiectasis and bronchitis.,severe ear, nose and throat infections: ,for example: otitis media, mastoiditis.,urinary tract infections: ,for example: acute and chronic pyelonephritis, pyelitis, cystitis, urethritis (bacterial only), and infections associated with bladder and renal stones.,skin and soft tissue infections: ,for example, erysipelas, abscesses, cellulitis, infected burns and wounds, mastitis.,gastrointestinal and abdominal infections: ,for example: intra-abdominal abscesses, enterocolitis.,bone and joint infections: ,for example: osteitis, osteomyelitis, septic arthritis, infected bursitis.

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

sandoz pty ltd - fluorouracil, quantity: 5000 mg - injection, solution - excipient ingredients: sodium hydroxide; water for injections - alone or in combination, for the palliative treatment of malignant tumours, particularly of the breast, colon or rectum; and in the treatment of gastric, primary hepatic, pancreatic, uterine (cervical particularly), ovarian and bladder carcinomas. fluorouracil should only be used when other proven measures have failed or are considered impractical.

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

phebra pty ltd - magnesium sulfate heptahydrate, quantity: 500 mg/ml - injection, concentrated - excipient ingredients: water for injections - parenteral administration of magnesium is indicated in the treatment of acute hypomagnesaemia. magnesium salts are also indicated to prevent hypomagnesaemia in patients receiving total parenteral nutrition. magnesium sulphate is also indicated in the prevention and treatment of life-threatening seizures in the treatment of toxemias of pregnancy (pre-eclampsia and eclampsia). for emegency treatment of some arrhythmias such as torsade de pointes and those associated with hypokalemia.