Euroopan unioni - suomi - EMA (European Medicines Agency)

nabriva therapeutics ireland dac - lefamulin acetate - pneumonia, bacterial; community-acquired infections - systeemiset bakteerilääkkeet, - xenleta is indicated for the treatment of community-acquired pneumonia (cap) in adults when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of cap or when these have failed. on otettava huomioon viralliset ohjeet antibioottien tarkoituksenmukaisesta käytöstä.

Euroopan unioni - suomi - EMA (European Medicines Agency)

elanco gmbh - tulatromysiini - systeemiseen käyttöön tarkoitetut antibakteerit - cattle; pigs; sheep - cattle: treatment and metaphylaxis of bovine respiratory disease (brd) associated with mannheimia haemolytica, pasteurella multocida, histophilus somni and mycoplasma bovis susceptible to tulathromycin. taudin läsnäolo karjassa olisi perustettava ennen metafylaktista hoitoa. treatment of infectious bovine keratoconjunctivitis (ibk) associated with moraxella bovis susceptible to tulathromycin. pigs: treatment and metaphylaxis of swine respiratory disease (srd) associated with actinobacillus pleuropneumoniae, pasteurella multocida, mycoplasma hyopneumoniae, haemophilus parasuis and bordetella bronchiseptica susceptible to tulathromycin. taudin läsnäolo karjassa olisi perustettava ennen metafylaktista hoitoa. the product should only be used if pigs are expected to develop the disease within 2–3 days. lampaat: tarttuvan pododermatiitin (jalkajuhla) alkuvaiheen hoito, johon liittyy virulentti dichelobacter nodosus, joka vaatii systeemistä hoitoa.

Euroopan unioni - suomi - EMA (European Medicines Agency)

vmd n.v. - tulatromysiini - antibacterials for systemic use, macrolides - cattle; pigs; sheep - cattle: treatment and metaphylaxis of bovine respiratory disease (brd) associated with mannheimia haemolytica, pasteurella multocida, histophilus somni and mycoplasma bovis susceptible to tulathromycin. taudin läsnäolo karjassa olisi perustettava ennen metafylaktista hoitoa. treatment of infectious bovine keratoconjunctivitis (ibk) associated with moraxella bovis susceptible to tulathromycin. pigs: treatment and metaphylaxis of swine respiratory disease (srd) associated with actinobacillus pleuropneumoniae, pasteurella multocida, mycoplasma hyopneumoniae, haemophilus parasuis and bordetella bronchiseptica susceptible to tulathromycin. taudin läsnäolo karjassa olisi perustettava ennen metafylaktista hoitoa. the product should only be used if pigs are expected to develop the disease within 2–3 days. lampaat: tarttuvan pododermatiitin (jalkajuhla) alkuvaiheen hoito, johon liittyy virulentti dichelobacter nodosus, joka vaatii systeemistä hoitoa.

Euroopan unioni - suomi - EMA (European Medicines Agency)

dechra regulatory b.v. - tulatromysiini - systeemiseen käyttöön tarkoitetut antibakteerit - cattle; pigs; sheep - cattle: treatment and metaphylaxis of bovine respiratory disease (brd) associated with mannheimia haemolytica, pasteurella multocida, histophilus somni and mycoplasma bovis susceptible to tulathromycin. taudin läsnäolo karjassa olisi perustettava ennen metafylaktista hoitoa. treatment of infectious bovine keratoconjunctivitis (ibk) associated with moraxella bovis susceptible to tulathromycin. pigs: treatment and metaphylaxis of swine respiratory disease (srd) associated with actinobacillus pleuropneumoniae, pasteurella multocida, mycoplasma hyopneumoniae, haemophilus parasuis and bordetella bronchiseptica susceptible to tulathromycin. taudin läsnäolo karjassa olisi perustettava ennen metafylaktista hoitoa. the product should only be used if pigs are expected to develop the disease within 2–3 days. lampaat: tarttuvan pododermatiitin (jalkajuhla) alkuvaiheen hoito, johon liittyy virulentti dichelobacter nodosus, joka vaatii systeemistä hoitoa.

Euroopan unioni - suomi - EMA (European Medicines Agency)

nova laboratories ireland limited - azathioprine - graft hylkääminen - immunosuppressantit - jayempi is indicated in combination with other immunosuppressive agents for the prophylaxis of transplant rejection in patients receiving allogenic kidney, liver, heart, lung or pancreas transplants. azathioprine is indicated in immunosuppressive regimens as an adjunct to immunosuppressive agents that form the mainstay of treatment (basis immunosuppression). jayempi is used as an immunosuppressant antimetabolite either alone or, more commonly, in combination with other agents (usually corticosteroids) and/ or procedures which influence the immune response. jayempi is indicated in patients who are intolerant to glucocorticosteroids or if the therapeutic response is inadequate despite treatment with high doses of glucocorticosteroids, in the following diseases:severe active rheumatoid arthritis (chronic polyarthritis) that cannot be kept under control by less toxic agents (disease-modifying anti-rheumatic -medicinal products – dmards)auto-immune hepatitis systemic lupus erythematosusdermatomyositispolyarteritis nodosapemphigus vulgaris and bullous pemphigoidbehçet’s diseaserefractory auto-immune haemolytic anaemia, caused by warm igg antibodieschronic refractory idiopathic thrombocytopenic purpurajayempi is used for the treatment of moderately severe to severe forms of chronic inflammatory bowel disease (ibd) (crohn’s disease or ulcerative colitis) in patients in whom glucocorticosteroid therapy is necessary, but where glucocorticosteroids are not tolerated, or in whom the disease is untreatable with other common means of first choice. it is also indicated in adult patients in relapsing multiple sclerosis, if an immunomodulatory therapy is indicated but beta interferon therapy is not possible, or a stable course has been achieved with previous treatment with azathioprine. 3jayempi is indicated for the treatment of generalised myasthenia gravis. depending on the severity of the disease, jayempi should be given in combination with glucocorticosteroids because of slow onset of action at the beginning of treatment and the glucocorticosteroid dose should be gradually reduced after several months of treatment.

Euroopan unioni - suomi - EMA (European Medicines Agency)

mylan ireland limited - sugammadex sodium - neuromuskulaarinen estäminen - kaikki muut terapeuttiset tuotteet - reversal of neuromuscular blockade induced by   rocuronium or vecuronium in adults. for the paediatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in children and adolescents aged 2 to 17 years.

Euroopan unioni - suomi - EMA (European Medicines Agency)

fresenius kabi deutschland gmbh - sugammadex sodium - neuromuskulaarinen estäminen - kaikki muut terapeuttiset tuotteet - reversal of neuromuscular blockade induced by rocuronium or vecuronium in adults. for the paediatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in children and adolescents aged 2 to 17 years.

Euroopan unioni - suomi - EMA (European Medicines Agency)

billev pharma aps - lutetium (177lu) chloride - radionuklidien kuvantaminen - terapeuttiset radiofarmaseuttiset valmisteet - lutetium (177lu) chloride billev is a radiopharmaceutical precursor, and it is not intended for direct use in patients. it is to be used only for the radiolabelling of carrier molecules that have been specifically developed and authorised for radiolabelling with lutetium (177lu) chloride.

Euroopan unioni - suomi - EMA (European Medicines Agency)

aop orphan pharmaceuticals gmbh - sugammadex sodium - neuromuskulaarinen estäminen - kaikki muut terapeuttiset tuotteet - neuromuskulaarisen salpauksen aiheuttama rokuronin tai vekuronin. for the paediatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in children and adolescents aged 2 to 17 years.

Euroopan unioni - suomi - EMA (European Medicines Agency)

nova laboratories ireland limited - spironolaktoni - edema; heart failure; liver cirrhosis; ascites; nephrotic syndrome; hyperaldosteronism; essential hypertension - antihypertensives and diuretics in combination - in the management of refractory oedema associated with congestive cardiac failure; hepatic cirrhosis with ascites and oedema, malignant ascites, nephrotic syndrome, diagnosis and treatment of primary aldosteronism, essential hypertension. neonates, children and adolescents should only be treated under guidance of a paediatric specialist (see sections 5. 1 ja 5.