אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

orion laboratories pty ltd t/a perrigo australia - chloral hydrate, quantity: 100 mg/ml - oral liquid, solution - excipient ingredients: sucrose; citric acid; sodium citrate dihydrate; saccharin sodium; glycerol; methyl hydroxybenzoate; ethanol; propylene glycol; purified water; flavour - indications as at 19 september 2003: chloral hydrate mixture is indicated pre-operatively to produce sedation. it is also indicated for short term (not more than 2 weeks) use as a hypnotic to assist in sleep disorders.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - ciclosporin, quantity: 100 mg/ml - oral liquid, solution - excipient ingredients: dl-alpha-tocopherol; ethanol; corn glycerides; propylene glycol; peg-40 hydrogenated castor oil - as an immunosuppressive agent for the prevention of graft rejection following kidney, liver and heart allogeneic transplantation. for induction and/or maintenance of remission in the nephrotic syndrome. cyclosporin is not a first-line agent. its use should be restricted to occasions when steroids and cystostatic drugs have failed, or are not tolerated, or are considered inappropriate, and when renal function is unimpaired (see warnings). for the treatment of severe, active rheumatoid arthritis in patients for whom classical slow-acting antirheumatic agents (including methotrexate) are inappropriate or ineffective. in patients with severe psoriasis in whom conventional therapy is ineffective or inappropriate and the disease has caused a significant interference with quality of life. additional indication from 11 june 1997: for the treatment of severe atopic dermatitis when other treatment is ineffective or inappropriate.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

pharmaco australia ltd - clonazepam, quantity: 2.5 mg/ml - oral liquid, solution - excipient ingredients: saccharin sodium; propylene glycol; brilliant blue fcf; glacial acetic acid; flavour - tablets. most types of epilepsy in infants and children, especially absences (petit mal), myoclonic seizures and tonic-clonic fits, whether due to primary generalised epilepsy, or to secondary generalisation of partial epilepsy. in adults all varieties of generalised epilepsy, (including myoclonic, akinetic, tonic and tonic-clonic seizures), and in partial epilepsy (including psychomotor seizures). injection. intravenous use for status epilepticus only. note. efficacy by the intramuscular route has not need demonstrated.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

aft pharmaceuticals pty ltd - phenoxymethylpenicillin potassium, quantity: 56.568 mg/ml (equivalent: phenoxymethylpenicillin, qty 50 mg/ml) - oral liquid, powder for - excipient ingredients: sucrose; sodium benzoate; saccharin sodium; flavour; colour - when oral therapy is required in the treatment of mild to moderately severe infections due to penicillin sensitive organisms such as penicillin sensitive staphylococci, pneumococci, gonococci and haemolytic streptococci. therapy should be guided by bacteriological studies, including sensitivity tests, and by clinical response. for prophylactic use in recurrent streptococcal infections including the prevention of recurrence following rheumatic fever and/or sydenham's chorea. for the prevention of bacterial endocarditis in patients with rheumatic fever and/or congenital heart disease who are about to undergo dental or upper respiratory surgery or instrumentation. oral penicillin should not be used as adjunctive prophylaxis for genitourinary instrumentation or surgery, lower intestinal tract surgery, sigmoidoscopy or complications of childbirth.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

aft pharmaceuticals pty ltd - phenoxymethylpenicillin potassium, quantity: 28.284 mg/ml (equivalent: phenoxymethylpenicillin, qty 25 mg/ml) - oral liquid, powder for - excipient ingredients: sucrose; sodium benzoate; saccharin sodium; colour; flavour - when oral therapy is required in the treatment of mild to moderately severe infections due to penicillin sensitive organisms such as penicillin sensitive staphylococci, pneumococci, gonococci and haemolytic streptococci. therapy should be guided by bacteriological studies, including sensitivity tests, and by clinical response. for prophylactic use in recurrent streptococcal infections including the prevention of recurrence following rheumatic fever and/or sydenham's chorea. for the prevention of bacterial endocarditis in patients with rheumatic fever and/or congenital heart disease who are about to undergo dental or upper respiratory surgery or instrumentation. oral penicillin should not be used as adjunctive prophylaxis for genitourinary instrumentation or surgery, lower intestinal tract surgery, sigmoidoscopy or complications of childbirth.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - furosemide, quantity: 10 mg/ml - oral liquid, solution - excipient ingredients: glycerol; purified water; sodium hydroxide; sorbitol solution (70 per cent) (non-crystallising); methyl hydroxybenzoate; ethanol; propyl hydroxybenzoate; sunset yellow fcf; quinoline yellow; flavour - oedema: lasix is indicated in adults, infants and children for the treatment of oedema associated with congestive heart failure, cirrhosis of the liver and renal disease, including the nephrotic syndrome. lasix is particularly useful when an agent with greater diuretic potential than that of those commonly employed is desired. parenteral therapy should be reserved for patients unable to take oral medication or for patients in emergency clinical situations. lasix injection is also indicated as adjunctive therapy in acute pulmonary oedema and cerebral oedema where intense and rapid onset of diuresis is desired. if gastrointestinal absorption is impaired or oral medication is not practical for any reason, lasix is indicated by the intravenous route. parenteral use should be replaced with oral lasix as soon as practical.hypertension. oral lasix may be used in adults for the treatment of hypertension alone or in combination with other antihypertensive agents. hypertensive patients who cannot be adequately controlled with thiazides will probably also not be adequately controlled with lasix alone.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

aspen pharmacare australia pty ltd - haloperidol, quantity: 2 mg/ml - oral liquid, solution - excipient ingredients: methyl hydroxybenzoate; purified water; propyl hydroxybenzoate; lactic acid - chronic therapy: the management of manifestations of psychotic disorders such as schizophrenia, psychosis due to organic brain damage or mental deficiency, the manic phase of manic depressive illness, gilles de la tourette syndrome. short term therapy: the treatment of acute alcoholism for the relief of delusions, hallucinations and confused states, and for the control of accompanying tremulousness and aggressive behaviour. in the treatment of intractable nausea and vomiting associated with radiation or malignancy and not responding to other therapy. neuroleptanalgesia

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

seqirus pty ltd - tramadol hydrochloride, quantity: 100 mg/ml - oral liquid, solution - excipient ingredients: sucrose; propylene glycol; sodium cyclamate; saccharin sodium; purified water; glycerol; ethoxylated hydrogenated castor oil; mint oil dementholised; potassium sorbate; flavour - tramal oral drops are indicated for the short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - itraconazole, quantity: 10 mg/ml - oral liquid, solution - excipient ingredients: propylene glycol; hydroxypropylbetadex; saccharin sodium; purified water; caramel; sorbitol solution (70 per cent) (non-crystallising); sodium hydroxide; hydrochloric acid; flavour - sporanox oral solution is indicated for: * the treatment of oral and/or oesophageal candidiasis in hiv-positive or other immunocompromised patients. * prophylaxis of fungal infections in neutropenic patients.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

viatris pty ltd - cefaclor monohydrate, quantity: 26.86 mg/ml (equivalent: cefaclor, qty 25 mg/ml) - oral liquid, powder for - excipient ingredients: methylcellulose; sodium lauryl sulfate; dimeticone 350; xanthan gum; tapioca starch; erythrosine; sucrose; flavour - aclor is indicated for the treatment of the following types of infections caused by or likely to be caused by susceptible organisms: lower respiratory infections, including pneumonia, bronchitis and exacerbations of chronic bronchitis. upper respiratory tract infections, including pharyngitis, tonsillitis and otitis media. skin and skin structure infections. urinary tract infections including pyelonephritis and cystitis. note: 1. penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. aclor appears to be as effective as phenoxymethyl penicillin in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of aclor in the subsequent prevention of rheumatic fever are not available at present. 2. appropriate culture and susceptibility studies should be performed to determine susceptibility of the causative organism to cefaclor.