Australija - engleski - APVMA (Australian Pesticides and Veterinary Medicines Authority)

jurox pty limited - gentamicin sulfate - misc. aural, ophthalmic, oro/naso pharyngeal - gentamicin sulfate antibiotic active 5.0 mg/ml - ophthalmic preparations - cat | dog | horse | bitch | castrate | cat - queen | cat - tom | colt | donkey | endurance horse | filly | foal | gelding | high - infection - ocular | eye infections | ocular infections

Australija - engleski - APVMA (Australian Pesticides and Veterinary Medicines Authority)

avet health limited - ampicillin as the sodium salt; cloxacillin as the sodium salt - misc. intra mammary - ampicillin as the sodium salt antibiotic active 75.0 mg/3gsy; cloxacillin as the sodium salt antibiotic active 200.0 mg/3gsy - antibiotic & related - cattle lactating | bovine - corynebacterium pyogenes | escherichia coli (e. coli) | staphylococci | streptococci | including b-lactamase producin

Izrael - engleski - Ministry of Health

rafa laboratories ltd - hyperici herba extractum siccum - film coated tablets - hyperici herba extractum siccum 250 mg - other antidepressants - symptoms of mild to moderate depression including: dejected mood, mood lability, inner restlessness, anxiety, states of tension and the difficulty in falling asleep and sleeping through the night which is associated with these conditions. treatment is recommended for up to 24 weeks.

Izrael - engleski - Ministry of Health

rafa laboratories ltd - hyperici herba extractum siccum - film coated tablets - hyperici herba extractum siccum 500 mg - other antidepressants - symptoms of mild to moderate depression including: dejected mood, mood lability, inner restlessness, anxiety, states of tension and the difficulty in falling asleep and sleeping through the night which is associated with these conditions.treatment is recommended for up to 24 weeks.

Novi Zeland - engleski - Ministry for Primary Industries

elanco australasia pty ltd - tilmicosin - tilmicosin 300 g/litre - antibiotic

Australija - engleski - Department of Health (Therapeutic Goods Administration)

biocelect pty ltd - salmonella typhi -

Australija - engleski - Department of Health (Therapeutic Goods Administration)

inova pharmaceuticals (australia) pty ltd - flucytosine, quantity: 10 mg/ml - injection, solution - excipient ingredients: sodium chloride; hydrochloric acid; trometamol; water for injections - indications as at 15 march 1996: antocil is indicated in the treatment of generalised candidiasis, cryptococcosis and chromoblastomycosis.

Izrael - engleski - Ministry of Health

medison pharma ltd - defibrotide - concentrate for solution for infusion - defibrotide 80 mg / 1 ml - defibrotide - defitelio is indicated for the treatment of severe hepatic veno-occlusive disease (vod) also known as sinusoidal obstructive syndrome (sos) in haematopoietic stem-cell transplantation (hsct) therapy.it is indicated in adults and in adolescents, children and infants over 1 month of age .

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

emd serono, inc. - tepotinib hydrochloride (unii: vy5yx2tq1f) (tepotinib - unii:1ijv77ei07) - tepmetko is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (nsclc) harboring mesenchymal-epithelial transition (met ) exon 14 skipping alterations. none. risk summary based on findings in animal studies and the mechanism of action [see clinical pharmacology (12.1)], tepmetko can cause fetal harm when administered to a pregnant woman. there are no available data on the use of tepmetko in pregnant women. oral administration of tepotinib to pregnant rabbits during the period of organogenesis resulted in malformations (teratogenicity) and anomalies at maternal exposures less than the human exposure based on area under the curve (auc) at the 450 mg daily clinical dose (see data) . advise pregnant women of the potential risk to a fetus. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data animal data in embryo-fetal development studies, pregnant rabbits received oral doses of 0.5, 5, 25, 50, 150, or 450 mg/kg tepotinib hydrochloride hydrate daily during organogenesis. severe maternal toxicity occurred at the 450 mg/kg dose (approximately 0.75 times the human exposure at the 450 mg clinical dose). at 150 mg/kg (approximately 0.5 times the human exposure by auc at the 450 mg clinical dose), two animals aborted and one animal died prematurely; mean fetal body weight was also decreased. a dose-dependent increase of skeletal malformations, including malrotations of fore and/or hind paws with concomitant misshapen scapula and/or malpositioned clavicle and/or calcaneous and/or talus, occurred at doses ≥ 5 mg/kg (approximately 0.003 times the human exposure by auc at the 450 mg clinical dose); there was also an incidence of spina bifida at the 5 mg/kg dose level. risk summary there are no data regarding the secretion of tepotinib or its metabolites in human milk or its effects on the breastfed infant or milk production. advise women not to breastfeed during treatment with tepmetko and for one week after the last dose. based on animal data, tepmetko can cause malformations at doses less than the human exposure based on auc at the 450 mg clinical dose [see use in specific populations (8.1)] . pregnancy testing verify pregnancy status in females of reproductive potential prior to initiating tepmetko [see use in specific populations (8.1)] . contraception females advise females of reproductive potential to use effective contraception during tepmetko treatment and for one week after the last dose. males advise male patients with female partners of reproductive potential to use effective contraception during tepmetko treatment and for one week after the last dose. the safety and efficacy of tepmetko in pediatric patients have not been established. of 313 patients with nsclc positive for met ex14 skipping alterations in vision who received 450 mg tepmetko once daily, 79% were 65 years or older, and 41% were 75 years or older. no clinically important differences in safety or efficacy were observed between patients aged 65 years or older and younger patients. no dosage modification is recommended in patients with mild or moderate renal impairment (creatinine clearance [clcr] 30 to 89 ml/min, estimated by cockcroft-gault). the recommended dosage has not been established for patients with severe renal impairment (clcr < 30 ml/min) [see clinical pharmacology (12.3)]. no dosage modification is recommended in patients with mild (child pugh class a) or moderate (child pugh class b) hepatic impairment. the pharmacokinetics and safety of tepotinib in patients with severe hepatic impairment (child pugh class c) have not been studied [see clinical pharmacology (12.3)] .

Izrael - engleski - Ministry of Health

kamada ltd, israel - viable salmonella typhi ty21a cells - gastro resistant hard capsule - viable salmonella typhi ty21a cells - vivotif is indicated for active oral immunisation against typhoid fever, caused by salmonella enterica serovar typhi, (s. typhi), in adults and children aged five years and older.this vaccine should be used in accordance with official recommendations