FrancophonIA/ELRC3.0 huggingface dataset:
English: In dogs, at doses up to 100 mg/kg bodyweight per day for 10 days, the only clinical symptom of overdose was vomiting, which occurred usually within 2.5 hours of dosing.
Croatian: Kod pasa, u dozama do 100 mg/kg tjelesne težine dnevno tokom 10 dana, jedini klinički simptom predoziranja bilo je povraćanje koje se uobičajeno javljalo unutar 2,5 sata od primjene.
English: In cats, at doses of 75 to 100 mg/kg bodyweight per day for 5 days, given monthly for a period of six months, the most commonly observed clinical sign was vomiting.
Croatian: Kod mačaka, pri dozama od 75 do 100 mg/kg tjelesne težine dnevno tokom 5 dana, primijenjenim u mjesečnim intervalima u trajanju od 6 mjeseci, najčešće primijećeni klinički znak bio je povraćanje.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Oral use.
Croatian: METODE I NAČIN(I) PRIMJENE
English: The primary faecal and urinary metabolites in both the rat and the cat were identified as the glutathione conjugates of the parent compounds and N-demethylated spinosyns A and D. Excretion is primarily via the faeces, and also to a lesser extent in the urine.
Croatian: Primarni bilijarni, fekalni i urinarni metaboliti u štakora i mačaka identificirani su kao konjugati glutationa izvornih spojeva i N-demetiliranih spinosina A i D.
English: Comfortis 665 mg 665 mg spinosad Comfortis 1040 mg 1040 mg spinosad Comfortis 1620 mg 1620 mg spinosad
Croatian: Comfortis 425 mg 425 mg spinosada Comfortis 665 mg 665 mg spinosada Comfortis 1040 mg 1040 mg spinosada Comfortis 1620 mg 1620 mg spinosada
English: In dogs, a commonly observed adverse reaction is vomiting, which occurs in the first 48 hours after dosing and is most likely caused by a local effect on the small intestines.
Croatian: Povraćanje je često primijećena nuspojava kod pasa i događa se unutar prvih 48 sati nakon primjene što je vjerojatno uzrokovano lokalnim utjecajem na tanko crijevo.
English: The veterinary medicinal product should be administered in accordance with the following table to ensure a dose of 50-75 mg/kg bodyweight for cats:
Croatian: Veterinarsko-medicinski proizvod mora se primijeniti u skladu sa sljedećom tablicom kako bi se osigurala doza od 50-75 mg/kg tjelesne težine kod mačaka:
English: In cats, a commonly observed adverse reaction is vomiting, which occurs in the first 48 hours after dosing and is most likely caused by a local effect on the small intestines.
Croatian: Povraćanje je često primijećena nuspojava kod mačaka i događa se unutar prvih 48 sati nakon primjene što je vjerojatno uzrokovano lokalnim utjecajem na tanko crijevo.
English: Tan to brown, or speckled, round, flat, bevelled edge tablets, plain on one side and debossed with a number as listed below on the other:
Croatian: Svijetlosmeđe do smeđe boje ili pjegave, okrugle, plosnate tablete, s ukošenim rubovima, ravne na jednoj strani i s jednim od sljedećih utisnutih brojeva na drugoj:
English: The veterinary medicinal product should be administered in accordance with the following table to ensure a dose of 45-70 mg/kg bodyweight in dogs:
Croatian: Veterinarsko-medicinski proizvod mora se primijeniti u skladu sa sljedećom tablicom kako bi se osigurala doza od 45-70 mg/kg tjelesne težine kod pasa:
English: Comfortis 90 mg spinosad 90 mg Comfortis 140 mg spinosad 140 mg Comfortis 180 mg spinosad 180 mg Comfortis 270 mg spinosad 270 mg Comfortis 425 mg spinosad 425 mg Comfortis 665 mg spinosad 665 mg Comfortis 1040 mg spinosad 1040 mg Comfortis 1620 mg spinosad 1620 mg
Croatian: Comfortis 140 mg spinosad 140 mg Comfortis 180 mg spinosad 180 mg Comfortis 270 mg spinosad 270 mg Comfortis 425 mg spinosad 425 mg Comfortis 665 mg spinosad 665 mg Comfortis 1040 mg spinosad 1040 mg Comfortis 1620 mg spinosad 1620 mg
English: Tan to brown, or speckled, round, flat, bevelled edge tablets, plain on one side and debossed with a number underlined as listed below on the other:
Croatian: Svijetlosmeđe do smeđe boje ili pjegave, okrugle, plosnate tablete, s ukošenim rubovima, ravne na jednoj strani i s jednim od sljedećih podvučenih utisnutih brojeva na drugoj:
English: − common (more than 1 but less than 10 animals in 100 animals)
Croatian: - česte (više od 1 ali manje od 10 životinja na 100 životinja) - manje česte (više od 1 ali manje od 10 životinja na 1.000 životinja)
English: Comfortis 1040 mg chewable tablets for dogs
Croatian: Comfortis 270 mg tablete za žvakanje za pse i mačke
English: Number of tablets and strength (mg spinosad) 1 x 90 mg tablet 1 x 140 mg tablet 1 x 180 mg tablet 1 x 270 mg tablet 1 x 425 mg tablet 1 x 665 mg tablet 1 x 1040 mg tablet 1 x 1620 mg tablet 1 x 1620 mg tablet + 1 x 665 mg tablet 2 x 1620 mg tablets
Croatian: Broj tableta i jačina tableta (mg spinosada) 1 tableta od 90 mg 1 tableta od 140 mg 1 tableta od 180 mg 1 tableta od 270 mg 1 tableta od 425 mg 1 tableta od 665 mg 1 tableta od 1040 mg 1 tableta od 1620 mg 1 tableta od 1620 mg + 1 tableta od 665 mg 2 tablete od 1620 mg
English: Comfortis 90 mg chewable tablets for dogs and cats Comfortis 140 mg chewable tablets for dogs and cats Comfortis 180 mg chewable tablets for dogs and cats Comfortis 270 mg chewable tablets for dogs and cats Comfortis 425 mg chewable tablets for dogs and cats Comfortis 665 mg chewable tablets for dogs
Croatian: Comfortis 90 mg tablete za žvakanje za pse i mačke Comfortis 140 mg tablete za žvakanje za pse i mačke Comfortis 180 mg tablete za žvakanje za pse i mačke Comfortis 270 mg tablete za žvakanje za pse i mačke Comfortis 425 mg tablete za žvakanje za pse i mačke
English: Comfortis 90 mg 90 mg spinosad Comfortis 140 mg 140 mg spinosad Comfortis 180 mg 180 mg spinosad Comfortis 270 mg 270 mg spinosad Comfortis 425 mg 425 mg spinosad
Croatian: Comfortis 140 mg 140 mg spinosada Comfortis 180 mg 180 mg spinosada Comfortis 270 mg 270 mg spinosada
English: Faecal excretion accounted for the vast majority of metabolites in cats.
Croatian: Velika većina metabolita kod mačaka izlučuje se fekalnim putem.
English: Comfortis 1620 mg chewable tablets for dogs spinosad
Croatian: Comfortis 180 mg tablete za žvakanje za pse i mačke
English: Tan to brown, or speckled with embedded darker particles, round, flat, bevelled edge tablets plain on one side and debossed with a number and a line above on the other side:
Croatian: Svijetlosmeđe do smeđe boje ili pjegave s ugrađenim tamnijim česticama, okrugle, plosnate tablete, s ukošenim rubovima, ravne na jednoj strani podvučenih utisnutih s brojem i crtom iznad brojeva na drugoj strani: 180 mg: 4228
English: Faecal excretion accounted for the vast majority of metabolites in dogs.
Croatian: Velika većina metabolita kod pasa izlučuje se fekalnim putem.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV DJELATNE(IH) TVARI I DRUGIH
English: This effect was also maintained in the long-term.
Croatian: Ovo se djelovanje zadržalo i dugoročno.
English: Another study showed maintenance of this effect for 24 months.
Croatian: Drugim ispitivanjem utvrđeno je održavanje djelovanja za razdoblje od 24 mjeseca.
English: Treatment should be started at a dose of 50 mg a day and the doctor may increase the dose up to 100 mg a day based on patient's need.
Croatian: Terapiju treba započeti s dozom od 50 mg svaki dan,a liječnik može povećati dozu na 100 mg na dan ovisno o potrebi bolesnika.
English: The full EPAR and risk management plan summary for Xadago can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR kao i plan upravljanja rizikom za lijek Xadago nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What is Xadago and what is it used for?
Croatian: Što je Xadago i za što se koristi?
English: Xadago safinamide
Croatian: Xadago safinamid
English: Regarding safety, in overall it was considered acceptable.
Croatian: Vezano uz sigurnu primjenu, načelno je zaključeno da se ista smatra prihvatljivom.
English: Why is Xadago approved?
Croatian: Zašto je Xadago odobren?
English: In both studies, 6 months treatment with Xadago increased the time during the day during which patients were ‘on' and able to move by 30-60 minutes when compared with placebo.
Croatian: U oba ispitivanja, 6-mjesečna terapija s lijekom Xadago povećala je vrijeme tijekom dana tijekom kojeg su bolesnici bili "uključeni" i mogli su se kretati 30-60 minuta u usporedbi s placebom.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Xadago on 24 February 2015.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Xadago na snazi u Europskoj uniji od 24. veljače 2015.
English: It is not intended to provide practical advice on how to use Xadago.
Croatian: Svrha sažetka nije davati praktične savjete o načinu korištenja lijeka Xadago.
English: What measures are being taken to ensure the safe and effective use of Xadago?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Xadago?
English: Xadago is available as tablets (50 and 100 mg) and can only be obtained with a prescription.
Croatian: Lijek Xadago dostupan je u tabletama (50 i 100 mg), a izdaje se samo na recept.
English: This is a summary of the European public assessment report (EPAR) for Xadago.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Xadago.
English: The active substance in Xadago, safinamide, is a ‘monoamine oxidase-B (MAO-B) inhibitor'.
Croatian: Djelatna tvar lijeka Xadago, safinamid, je "inhibitor monoamin oksidaze-B (MAO-B)".
English: What are the risks associated with Xadago?
Croatian: Koji su rizici povezani s lijekom Xadago?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Xadago's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je da koristi od lijeka Xadago nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za korištenje u Europskoj uniji.
English: Other information about Xadago
Croatian: Ostale informacije o lijeku Xadago
English: It blocks the enzyme monoamine oxidase type B (which breaks down dopamine), thereby helping to restore dopamine levels in the brain and improving the patient's symptoms.
Croatian: Inhibira enzim monoamin oksidaze tipa B (koji razgrađuje dopamin), stoga pomaže pri uspostavljanju razina dopamina u mozgu i poboljšava simptome bolesnika.
English: The Committee concluded that the effect of Xadago on the daily time that patients lived without motor symptoms was of clinical relevance, also taking into account the response reported in the literature for other Parkinson's medicines.
Croatian: Odbor je zaključio da je djelovanje lijeka Xadago na dnevno razdoblje tijekom kojeg su bolesnici živjeli bez motoričkih simptoma bilo od kliničkog značaja, ako se uzme u obzir odgovor prijavljen u literaturi za Parkinsonovu bolest.
English: In patients with Parkinson's disease, certain cells in the brain that produce dopamine die, and as dopamine is involved in controlling movement, the patient's movement worsens over time.
Croatian: U bolesnika s Parkinsonovom bolesti, određene stanice u mozgu koje proizvode dopamin umiru, a budući da je dopamin uključen u kontrolu pokreta, tijekom vremena pogoršava se kretanje bolesnika.
English: The most common side effects with Xadago (which may affect up to 1 in 10 people) are insomnia (difficulty sleeping), dyskinesia (difficulty controlling movement), somnolence (sleepiness), dizziness, headache, worsening of existing Parkinson's disease, cataract (clouding of the lens), orthostatic hypotension (drop in blood pressure when standing up), nausea (feeling sick) and falls.
Croatian: Najčešće nuspojave lijeka Xadago (mogu se javiti u više od 1 na 10 osoba) su insomnija (poteškoće sa spavanjem), diskinezija (poteškoće s kontroliranjem pokreta), somnolencija (pospanost), omaglica, glavobolje, pogoršanje postojeće Parkinsonove bolesti, katarakt (magljenje leća), ortostatska hipotenzija (pad u krvnom tlaku prilikom stajanja), mučnina (osjećaj slabosti) i padovi.
English: Xadago must not be used in patients with severe liver problems, in patients treated with pethidine or other MAO inhibiting medicines, or in patients with certain conditions affecting the eyes.
Croatian: Xadago se ne smije primjenjivati u bolesnika s ozbiljnim problemima jetre, u bolesnika s liječenim petidinom ili drugim lijekovima koji inhibiraju MAO, ili u bolesnika s određenim stanjima koja zahvaćaju oči.
English: These fluctuations occur when the effect of levodopa wears off and the patient suddenly switches from being ‘on' and able to move about to being ‘off' and having difficulty moving about.
Croatian: Ove fluktuacije nastupaju kada djelovanje lijeka levodopa oslabi, a bolesnik iznenada prelazi iz stanja "uključenosti" i može se kretati u stanje "isključenosti" te ima poteškoća s kretanjem.
English: Xadago was also investigated as an add-on to treatment in 2 studies in patients with early Parkinson's disease without fluctuations, but these studies did not show a clear benefit and the company did not pursue this use as part of the application.
Croatian: Xadago je također ispitan kao dodatna terapija u 2 ispitivanja u bolesnika s ranom Parkinsonovom bolesti bez fluktuacija, no ovim ispitivanjima nije utvrđena jasna korist,a tvrtka nije zatražila odobrenje za ovu primjenu u sklopu prijave.
English: A risk management plan has been developed to ensure that Xadago is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Xadago.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Xadago, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek Xadago nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: Xadago is a medicine used to treat Parkinson's disease, a progressive brain disorder that causes shaking, slow movement and muscular stiffness.
Croatian: Xadago se koristi za liječenje Parkinsonove bolesti, progresivnog moždanog poremećaja koji uzrokuje drhtanje, usporene pokrete i krutost mišića.
English: For more information about treatment with Xadago, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Xadago pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: Xadago contains the active substance safinamide.
Croatian: Xadago sadrži djelatnu tvar safinamid.
English: Xadago, as an add-on treatment to levodopa with or without other medicines for Parkinson's disease, has been compared with placebo (a dummy treatment) in two main studies involving 1,218 patients with late stage Parkinson's disease who experienced fluctuations.
Croatian: Xadago, kao dodatna terapija uz levodop s ili bez drugih lijekova za Parkinsonovu bolest, uspoređen je s placebom (lažnim liječenjem) u dva glavna ispitivanja koja su obuhvatila 1218 bolesnika s Parkinsonovom bolesti u kasnoj fazi, a koji su imali fluktuacije.
English: It is used in addition to levodopa (a medicine commonly used to treat the symptoms of Parkinson's disease) either alone or in combination with other medicines for Parkinson's, in patients with mid- to late-stage Parkinson's disease who are having ‘motor fluctuations'.
Croatian: Koristi se kao dodatak levodopanu (lijeku koji se najčešće koristi za liječenje simptoma Parkinsonove bolesti) bilo kao monoterapija ili u kombinaciji s drugim lijekovima za Parkinsonovu bolest, te u bolesnika s srednjim do kasnim stadijem Parkinsonove bolesti, koji imaju "motoričke fluktuacije".
English: For practical information about using Xadago, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Xadago bolesnici trebaju pročitati u uputi o lijeku ili se obratiti svom liječniku ili ljekarniku.
English: How is Xadago used?
Croatian: Kako se Xadago koristi?
English: What benefits of Xadago have been shown in studies?
Croatian: Koje su koristi lijeka Xadago utvrđene u ispitivanjima?
English: For the full list of all side effects reported with Xadago, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih pri primjeni lijeka Xadago potražite u uputi o lijeku.
English: How does Xadago work?
Croatian: Kako djeluje Xadago?
English: This overview was last updated in March 2018.
Croatian: Ovaj pregled posljednji je put ažuriran u 3. 2018.
English: Together, these combined actions result in loss of consciousness.
Croatian: Ta kombinirana djelovanja zajedno dovode do gubitka svijesti.
English: SevoFlo (sevoflurane)
Croatian: SevoFlo (sevofluran)
English: SevoFlo (sevoflurane) EMA/CVMP/92087/2007
Croatian: SevoFlo (sevofluran) EMA/CVMP/92087/2007
English: Further information on SevoFlo can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Croatian: Više informacija o VMP-u SevoFlo nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: SevoFlo must not be given to animals with a genetic susceptibility to malignant hyperthermia.
Croatian: SevoFlo se ne smije davati životinjama s genetskom osjetljivošću na malignu hipertermiju.
English: When a dog or cat is given a mixture of oxygen and sevoflurane to breathe, the sevoflurane is inhaled into its lungs and is carried by the blood into the brain.
Croatian: Kada pas ili mačka dobiju smjesu kisika i sevoflurana da je udahnu, sevofluran udahnu u pluća i on se krvlju prenosi u mozak.
English: What is SevoFlo and what is it used for?
Croatian: Što je SevoFlo i za što se koristi?
English: In case of accidental contact with the skin or eyes, or for more information, the package leaflet should be consulted.
Croatian: U slučaju slučajnog kontakta s kožom ili očima, odnosno za više informacija, potrebno je pročitati uputu o VMP-u.
English: The effectiveness of SevoFlo was comparable to isoflurane.
Croatian: Djelotvornost VMP-a SevoFlo bila je usporediva s isofluranom.
English: SevoFlo is given using specialised anaesthetic equipment, usually in a carefully controlled gas mixture including oxygen.
Croatian: SevoFlo se primjenjuje s pomoću specijalizirane opreme za anesteziju, obično u pažljivo kontroliranoj smjesi plinova koja sadržava kisik.
English: In addition, SevoFlo has been commonly used off-label (use that is not officially authorised) as an anaesthetic for cats for more than 10 years and therefore its use in cats is considered to be ‘well-established'.
Croatian: Osim toga, SevoFlo se uobičajeno primjenjuje bez službenog odobrenja kao anestetik za mačke već više od 10 godina i stoga se smatra da je njegova primjena kod mačaka „provjerena”.
English: SevoFlo produced a relatively rapid and smooth start of anaesthesia in dogs, followed by a good recovery.
Croatian: SevoFlo je proizveo relativno brz i neometan početak anestezije u pasa te naknadno dobar oporavak.
English: SevoFlo is used to bring about and maintain general anaesthesia (loss of consciousness).
Croatian: SevoFlo se koristi za davanje i održavanje opće anestezije (gubitka svijesti).
English: Other information about SevoFlo
Croatian: Ostale informacije o VMP-u SevoFlo
English: Why is SevoFlo authorised in the EU?
Croatian: Zašto je SevoFlo odobren u EU-u?
English: This is a rare life-threatening condition usually triggered by exposure to certain general anaesthetics that is associated with muscle spasm and very high body temperatures.
Croatian: To je rijetko, ali za život opasno stanje, koje obično nastaje zbog izloženosti određenim općim anesteticima i koje je povezano s grčenjem mišića i vrlo visokim tjelesnim temperaturama.
English: Sevoflurane mimics the action of GABA, a substance that naturally reduces brain activity, and blocks the action of glutamate, which stimulates the activity of the brain.
Croatian: Sevofluran oponaša djelovanje tvari GABA koja prirodno smanjuje aktivnost mozga i blokira djelovanje glutamata koji potiče aktivnost mozga.
English: If a person accidentally inhales sevoflurane vapour, this may cause symptoms such as shivering, nausea, headache, low blood pressure, decreased heart rate and even reduced breathing.
Croatian: Ako osoba slučajno udahne paru sevoflurana, to može izazvati simptome kao što su drhtanje, mučnina, glavobolja, nizak krvni tlak, snižen broj otkucaja srca pa čak i ograničeno disanje.
English: SevoFlo is a general anaesthetic for dogs and cats.
Croatian: SevoFlo je opći anestetik za pse i mačke.
English: The most common side effects with SevoFlo, which may affect more than 1 in 10 animals, are low blood pressure, rapid breathing, muscle tenseness, excitation, a temporary inability to breathe, small muscle twitches and vomiting.
Croatian: Najčešće nuspojave povezane s primjenom VMP-a SevoFlo, koje se mogu pojaviti u 1 na 10 životinja, jesu nizak krvni tlak, brzo disanje, napetost mišića, ekscitacija, privremena nesposobnost disanja, mali mišićni trzaji i povraćanje.
English: Care must therefore be taken when handling SevoFlo: any spillage must be removed immediately, the vapour must not be inhaled, and any contact with the product by mouth must be avoided.
Croatian: Stoga se mora pozorno rukovati VMP-om SevoFlo: ako se prolije, mora se odmah ukloniti, para se ne smije udahnuti te se mora izbjegavati bilo kakav kontakt s ustima.
English: The European Medicine's Agency decided that SevoFlo's benefits are greater that its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od VMP-a SevoFlo nadmašuju s njim povezane rizike te da se može izdati odobrenje za njegovu primjenu u EU-u.
English: The dog or cat breathes in the gas mixture, which causes it to become unconscious.
Croatian: Pas ili mačka udišu smjesu plinova koja uzrokuje njihovu nesvijest.
English: What are the risks associated with SevoFlo?
Croatian: Koji su rizici povezani s VMP-om SevoFlo?
English: Studies in dogs found that SevoFlo was as effective at starting and maintaining anaesthesia as other anaesthetic agents, such as isoflurane (another anaesthetic gas), thiopental, propofol, and ketamine plus diazepam.
Croatian: U ispitivanjima provedenima na psima utvrđeno je da je VMP SevoFlo bio jednako djelotvoran na početku anestezije i u njezinu održavanju kao ostala sredstva za anesteziju, kao što je isofluran (još jedan anestetski plin), tiopental, propofol i ketamin s diazepamom.
English: Pregnant and breast-feeding women must not come into contact with the product and they should also avoid operating rooms and animal recovery areas where the product is being used or has recently been used.
Croatian: Trudnice i dojilje ne smiju doći u dodir s VMP-om te moraju izbjegavati operacijske dvorane i prostore za oporavak životinja u kojima se VMP primjenjuje ili je nedavno primjenjivan.
English: It contains the active substance sevoflurane, a chemical which is a liquid at room temperature, but when heated becomes a gas (vaporises).
Croatian: Sadržava djelatnu tvar sevofluran, kemikaliju koja je tekuća pri sobnoj temperaturi, ali zagrijana prelazi u plinovito stanje (isparava).
English: An overview of SevoFlo and why it is authorised in the EU
Croatian: Pregled VMP-a SevoFlo i zašto je odobren u EU-u
English: SevoFlo received a marketing authorisation valid throughout the EU for SevoFlo on 11 December
Croatian: SevoFlo je dobio odobrenje za stavljanje u promet koje je na snazi u Europskoj uniji od 11. prosinca