Egyesült Királyság - angol - myHealthbox

milpharm limited - efavirenz. - film-coated tablets - 600mg - non-nucleoside reverse transcriptase inhibitors - it is indicated in antiviral combination treatment of human immunodeficiency virus-1 (hiv-1) infected adults, adolescents and children 3 years of age and older.

Írország - angol - HPRA (Health Products Regulatory Authority)

milpharm limited - cefuroxime axetil (amorphous) - film coated tablet - 250 milligram - cephalosporins and related substances - antibacterials for systemic use, second-generation cephalosporins - cefuroxime milpharm is indicated for the treatment of the infections listed below in adults and children from the age of 3 months • acute streptococcal tonsillitis and pharyngitis. • acute bacterial sinusitis. • acute otitis media. • acute exacerbations of chronic bronchitis. • cystitis. • pyelonephritis. • uncomplicated skin and soft tissue infections. • treatment of early lyme disease.

Írország - angol - HPRA (Health Products Regulatory Authority)

accord healthcare limited - linezolid (form iii) - film coated tablet - 600 milligram - linezolid - antibacterials for systemic use; other antibacterials - linezolid is indicated in adults for the treatment of community acquired pneumonia and nosocomial pneumonia when known or suspected to be caused by susceptible gram positive bacteria. in determining whether linezolid is an appropriate treatment, the results of microbiological tests or information on the prevalence of resistance to antibacterial agents among gram positive bacteria should be taken into consideration. (see section 5.1 for the appropriate organisms).

Európai Unió - angol - EMA (European Medicines Agency)

cangene europe limited - human hepatitis b immunoglobulin - immunization, passive; hepatitis b - specific immunoglobulins - immunoprophylaxis of hepatitis b - in case of accidental exposure in non-immunised subjects (including persons whose vaccination isincomplete or status unknown).- in haemodialysed patients, until vaccination has become effective.- in the newborn of a hepatitis b virus carrier-mother.- in subjects who did not show an immune response (no measurable hepatitis b antibodies) after vaccination and for whom a continuous prevention is necessary due to the continuous risk of being infected with hepatitis b.consideration should also be given to other official guidance on the appropriate use of human hepatitis b immunoglobulin for intramuscular use.

Európai Unió - angol - EMA (European Medicines Agency)

mylan pharmaceuticals limited - tenofovir disoproxil - hiv infections - antivirals for systemic use - hiv-1 infectiontenofovir disoproxil 245 mg film-coated tablets are indicated in combination with other antiretroviral medicinal products for the treatment of hiv-1 infected adults.in adults, the demonstration of the benefit of tenofovir disoproxil in hiv-1 infection is based on results of one study in treatment-naïve patients, including patients with a high viral load (> 100,000 copies/ml) and studies in which tenofovir disoproxil was added to stable background therapy (mainly tritherapy) in antiretroviral pre-treated patients experiencing early virological failure (< 10,000 copies/ml, with the majority of patients having < 5,000 copies/ml).tenofovir disoproxil 245 mg film-coated tablets are also indicated for the treatment of hiv-1 infected adolescents, with nrti resistance or toxicities precluding the use of first line agents, aged 12 to < 18 years.the choice of tenofovir disoproxil to treat antiretroviral-experienced patients with hiv-1 infection should be based on individual viral resistance testing and/or treatment history of patients.hepatitis b infectiontenofovir disoproxil 245 mg film-coated tablets are indicated for the treatment of chronic hepatitis b in adults with:compensated liver disease, with evidence of active viral replication, persistently elevated serum alanine aminotransferase (alt) levels and histological evidence of active inflammation and/or fibrosis.evidence of lamivudine-resistant hepatitis b virus.decompensated liver disease.tenofovir disoproxil 245 mg film-coated tablets are indicated for the treatment of chronic hepatitis b in adolescents 12 to < 18 years of age with:compensated liver disease and evidence of immune active disease, i.e. active viral replication, persistently elevated serum alt levels and histological evidence of active inflammation and/or fibrosis.

Európai Unió - angol - EMA (European Medicines Agency)

pfizer limited - pneumococcal oligosaccharide serotype 18c, pneumococcal polysaccharide serotype 19f, pneumococcal polysaccharide serotype 23f, pneumococcal polysaccharide serotype 4, pneumococcal polysaccharide serotype 6b, pneumococcal polysaccharide serotype 9v, pneumococcal polysaccharide serotype 14 - pneumococcal infections; immunization - vaccines - active immunisation against disease caused by streptococcus pneumoniae serotypes 4, 6b, 9v, 14, 18c, 19f and 23f (including sepsis, meningitis, pneumonia, bacteraemia and acute otitis media) in infants and children from two months up to five years of age.the use of prevenar should be determined on the basis of official recommendations taking into consideration the impact of invasive disease in different age groups as well as variability of serotype epidemiology in different geographical areas.

Ausztrália - angol - APVMA (Australian Pesticides and Veterinary Medicines Authority)

adama australia pty limited - fluensulfone; liquid hydrocarbon - emulsifiable concentrate - fluensulfone thiazole active 480.0 g/l; liquid hydrocarbon solvent other 428.0 g/l - nematicide

Ausztrália - angol - APVMA (Australian Pesticides and Veterinary Medicines Authority)

nufarm australia limited - imazamox as the ammonium salt - soluble concentrate - imazamox as the ammonium salt imidazolinone active 350.0 g/l - herbicide

Új-Zéland - angol - Medsafe (Medicines Safety Authority)

teva pharma (new zealand) limited - ciprofloxacin hydrochloride 3.5 mg/ml equivalent to ciprofloxacin 3.0 mg/ml;   - eye drops, solution - 3 mg/ml - active: ciprofloxacin hydrochloride 3.5 mg/ml equivalent to ciprofloxacin 3.0 mg/ml   excipient: benzalkonium chloride disodium edetate glacial acetic acid hydrochloric acid mannitol sodium acetate sodium hydroxide water for injection - treatment of corneal ulcers, conjunctivitis and blepharitis caused by susceptible strains of bacteria in adults and children 12 months of age and older.

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

global medical solutions australia pty limited t/a radpharm scientific - aggregated albumin, quantity: 2.5 mg; stannous chloride dihydrate, quantity: 0.1 mg; sodium chloride, quantity: 1.2 mg; albumin, quantity: 5 mg - powder - excipient ingredients: nitrogen; water for injections - technetium tc 99m albumin aggregated injection is a lung imaging agent which may be used as an adjunct in the evaluation of pulmonary perfusion in adults and paediatric patients. technetium tc 99m albumin aggregated injection may be used in adults as an imaging agent to aid in the evaluation of peritoneovenous (leveen) shunt patency.