Wielka Brytania - angielski - MHRA (Medicines & Healthcare Products Regulatory Agency)

wockhardt uk ltd - sodium alginate; potassium bicarbonate - oral suspension - 100mg/1ml ; 20mg/1ml

Wielka Brytania - angielski - MHRA (Medicines & Healthcare Products Regulatory Agency)

wockhardt uk ltd - sodium alginate; potassium bicarbonate - oral suspension - 100mg/1ml ; 20mg/1ml

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

alphapharm pty ltd - cefalexin monohydrate, quantity: 52.6 mg/ml (equivalent: cefalexin, qty 50 mg/ml) - oral liquid, powder for - excipient ingredients: sodium lauryl sulfate; allura red ac; methylcellulose; dimeticone 350; xanthan gum; pregelatinised maize starch; sucrose; flavour - indications as at 24 february 2004: ibilex is indicated in the treatment of the following infections when caused by susceptible strains of the designated microorganisms: respiratory tract infections caused by s. pneumoniae and group a beta-haemolytic streptococci (penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. ibilex is generally effective in the eradication of streptococci from nasopharynx; however, substantial data establishing the efficacy of ibilex in the subsequent prevention of rheumatic fever are not available at present.) bacterial sinusitis caused by streptococci, s. pneumoniae and s. aureus (methicillin-sensitive only) otitis media due to s. pneumoniae, staphylococci; skin and soft tissue infections caused by staphlococci anr/or streptococci; genitourinary tract infections, including acute prostatic caused by e. coli, p. mirabilis, and klebsiella sp. the effectiveness of ibilex in the treatment of bacterial infections of the brain and spinal column has not been established and ibilex is not indicated in these conditions. note: appropriate culture and susceptibility test should be initiated prior to and during therapy to determine susceptibility of the causative organism to ibilex. renal function studies should be performed when indicated

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

alphapharm pty ltd - cefalexin monohydrate, quantity: 26.3 mg/ml (equivalent: cefalexin, qty 25 mg/ml) - oral liquid, powder for - excipient ingredients: sodium lauryl sulfate; allura red ac; methylcellulose; dimeticone 350; xanthan gum; pregelatinised maize starch; sucrose; flavour - indications as at 24 february 2004: ibilex is indicated in the treatment of the following infections when caused by susceptible strains of the designated microorganisms: respiratory tract infections caused by s. pneumoniae and group a beta-haemolytic streptococci (penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. ibilex is generally effective in the eradication of streptococci from nasopharynx; however, substantial data establishing the efficacy of ibilex in the subsequent prevention of rheumatic fever are not available at present.) bacterial sinusitis caused by streptococci, s. pneumoniae and s. aureus (methicillin-sensitive only) otitis media due to s. pneumoniae, staphylococci; skin and soft tissue infections caused by staphlococci anr/or streptococci; genitourinary tract infections, including acute prostatic caused by e. coli, p. mirabilis, and klebsiella sp. the effectiveness of ibilex in the treatment of bacterial infections of the brain and spinal column has not been established and ibilex is not indicated in these conditions. note: appropriate culture and susceptibility test should be initiated prior to and during therapy to determine susceptibility of the causative organism to ibilex. renal function studies should be performed when indicated

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

pfizer australia pty ltd - sirolimus, quantity: 1 mg/ml - oral liquid, solution - excipient ingredients: polysorbate 80; propylene glycol; ethanol; ascorbyl palmitate; phosphatidyl choline; mono- and di- glycerides; soy fatty acids - indications as at 9 february 2004: rapamune is indicated for the prophylaxis of organ rejection in patients at mild to moderate immunological risk receiving renal transplants. therapeutic drug monitoring of sirolimus is required.

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

inova pharmaceuticals (australia) pty ltd - dihydrocodeine tartrate, quantity: 1.9 mg/ml - oral liquid - excipient ingredients: purified water; sucrose; citric acid; methyl hydroxybenzoate; amaranth; sorbitol; flavour - for relief of stubborn, unproductive cough.

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

inova pharmaceuticals (australia) pty ltd - codeine phosphate hemihydrate, quantity: 5 mg/ml - oral liquid - excipient ingredients: glycerol; propylene glycol; purified water; sucrose; methyl hydroxybenzoate - relief of unproductive, dry and intractable coughs associated with colds and flu relief of unproductive, dry and intractable coughs associated with colds and flu.

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

clinect pty ltd - chlorpromazine hydrochloride, quantity: 5 mg/ml - oral liquid - excipient ingredients: sucrose; caramel; peppermint oil; spearmint oil; polysorbate 20; purified water; citric acid; sodium citrate dihydrate; ascorbic acid; sodium sulfite; sodium metabisulfite; sodium benzoate; flavour - 1. treatment of acute functional psychosis (eg schizophrenia, mania or psychotic depression). 2. long-term treatment of schizophrenia. 3. short-term treatment of agitation and severe depression. 4. severe behavioural disturbances, as can be found in some children with mental retardation or autism, including the treatment of self-injurious and aggressive behaviour or overactivity. use of chlorpromazine should be in conjunction with an appropriate non-pharmacological management program and long-term use should only be carried out under the supervision of a physician experienced in the management of psychotic disorders in children. 5. in the management of terminal illness to enhance the effect of analgesics and to control nausea and vomiting. 6. control of intractable hiccough.

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

roche products pty ltd - oseltamivir phosphate, quantity: 7.88 mg/ml (equivalent: oseltamivir, qty 6 mg/ml) - oral liquid, powder for - excipient ingredients: saccharin sodium; sodium benzoate; sodium dihydrogen citrate; sorbitol; titanium dioxide; xanthan gum; flavour - tamiflu is indicated for the treatment of infections due to influenza a and b viruses in adults and children including full-term neonates. treatment should commence as soon as possible, but no later than 48 hours after the onset of the initial symptoms of infection.,tamiflu is indicated for the prevention of influenza in adults and children aged 1 year and older. vaccination is the preferred method of routine prophylaxis against infection with influenza virus.

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

sanofi-aventis australia pty ltd - amisulpride, quantity: 100 mg/ml - oral liquid, solution - excipient ingredients: methyl hydroxybenzoate; hydrochloric acid; propyl hydroxybenzoate; purified water; potassium sorbate; saccharin sodium; gluconolactone; sodium gluconate; flavour - amisulpride is indicated for the treatment of acute and chronic schizophrenic disorders, in which positive symptoms (such as delusions, hallucinations, thought disorders) and/or negative symptoms (such as blunted affect, emotional and social withdrawal) are prominent, including patients characterised by predominant negative symptoms.