FrancophonIA/ELRC3.0 huggingface dataset:
English: The vaccine, which is for use in broiler chickens (reared for meat), future layers or breeders (reared for egg production) and turkeys, helps reduce injuries and deaths caused by the infection.
Slovenian: Cepivo, ki se uporablja pri pitovnih piščancih (ki se vzrejajo za meso) in bodočih kokoših nesnicah ali piščancih za vzrejo matične jate (ki se vzrejajo za proizvodnjo jajc) ter puranih, pomaga zmanjšati poškodbe in smrtnost zaradi okužbe.
English: Personnel involved in attending vaccinated animals should follow general hygiene principles and take particular care in handling litter from vaccinated animals.
Slovenian: Osebje, ki skrbi za cepljene živali, mora upoštevati splošna higienska načela in še zlasti previdno ravnati s steljo, ki so jo uporabljale cepljene živali.
English: The field study with over 200,000 commercial broilers showed a significant reduction in colibacillosis lesions and deaths in vaccinated animals.
Slovenian: V terenski študiji z več kot 200 000 pitovnimi piščanci za prodajo so ugotovili znatno zmanjšanje pojava kolibaciloznih lezij in števila poginov pri cepljenih živalih.
English: Poulvac E. coli, like all vaccines, works by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Slovenian: Cepivo Poulvac E. coli deluje kot vsa cepiva tako, da imunski sistem (naravni obrambni mehanizem telesa) „nauči“, kako naj se brani pred boleznijo.
English: The vaccine may spread to in-contact birds.
Slovenian: Cepivo se lahko razširi na ptice, ki so v stiku s cepljenimi živalmi.
English: Colibacillosis can cause injuries to the sac that surrounds the heart (pericarditis), the sac surrounding the liver (perihepatitis) and the ‘air sacs', the specialised bags within the bird's body where air is stored during breathing (airsacculitis), and can lead to death of the bird.
Slovenian: Kolibaciloza lahko povzroči poškodbe srčne ovojnice (perikarditis), jetrne ovojnice (perihepatitis) in „zračnih mešičkov“, tj. posebnih vrečk v ptičjem telesu, v katerih se zrak zadržuje med dihanjem (vnetje zračnih mešičkov), kar lahko povzroči smrt.
English: Poulvac E. coli contains small amounts of the bacterium E. coli serotype O78.
Slovenian: Cepivo Poulvac E. coli vsebuje majhne količine bakterije E. coli, serotip O78.
English: Laboratory studies showed that the vaccine is safe and that protection against colibacillosis lesions starts two weeks after vaccination in chickens and three weeks after vaccination in turkeys.
Slovenian: Laboratorijske študije so pokazale, da je cepivo varno in da zaščita pred kolibaciloznimi lezijami nastopi dva tedna po cepljenju pri piščancih in tri tedne po cepljenju pri puranih.
English: It may also be present in faeces for up to five weeks post vaccination in chickens or seven days post vaccination in turkeys, and remain present in the environment until the end of the finishing (time to slaughter) or rearing period for chickens or for seven days for turkeys.
Slovenian: V blatu je lahko pri piščancih prisoten tudi do pet tednov po cepljenju in sedem dni po cepljenju pri puranih, v okolju pa se lahko pri piščancih obdrži do zakola živali ali do konca obdobja reje oziroma do sedem dni pri puranih.
English: When giving by coarse spray vaccination the reconstituted vaccine should be diluted and sprayed onto the birds so that each bird receives enough for one dose.
Slovenian: Kadar se cepivo daje kot grobo pršenje, je treba pripravljeno cepivo razredčiti in razpršiti po ptičih tako, da vsaka ptica prejme dovolj za en odmerek cepiva.
English: Antibiotic treatment should not be given within one week before or after vaccination.
Slovenian: V enem tednu pred cepljenjem ali po njem ni dovoljeno zdravljenje z antibiotiki.
English: Poulvac E. coli is available as a freeze dried powder (lyophilisate) which can be made into a suspension.
Slovenian: Cepivo Poulvac E. coli je na voljo kot prašek, posušen z zamrzovanjem (liofilizat), s katerim se pripravi suspenzija.
English: The birds consume the vaccine when preening their feathers.
Slovenian: Ptice cepivo zaužijejo, ko si s kljunom čistijo perje.
English: The vaccine strain can be detected in tissues (liver and heart) for up to six days after vaccination in chickens or in tissues (air sacs) for up to four days after vaccination in turkeys.
Slovenian: Sev cepiva je mogoče v tkivu (jetrih in srcu) piščancev zaznati do šest dni po cepljenju, v tkivu (zračnih mešičkih) puranov pa do štiri dni po cepljenju.
English: The studies also demonstrated that the vaccine provides chickens with eight weeks protection against colibacillosis lesions and 12 weeks protection against mortality from colibacillosis with spray vaccination and 12 weeks protection against lesions and mortality with drinking water vaccination.
Slovenian: V študijah se je izkazalo tudi, da cepivo zagotavlja osemtedensko zaščito pred kolibaciloznimi lezijami in 12-tedensko zaščito pred poginom zaradi kolibaciloznih lezij, če se uporabi s pršenjem, in 12-tedensko zaščito pred lezijami in poginom, če se uporabi s pitno vodo.
English: The withdrawal period for meat and eggs from chickens and turkeys treated with Poulvac E. coli is ‘zero' days, which means that there is no mandatory waiting time.
Slovenian: Karenca za meso in jajca piščancev in puranov, cepljenih s cepivom Poulvac E. coli, je nič dni, kar pomeni, da ni obvezne čakalne dobe.
English: In the future, if the animals are exposed to the bacteria, the immune system will be able to make antibodies more quickly.
Slovenian: Ob ponovni izpostavitvi živali bakterijam v prihodnosti bo imunski sistem tako hitreje tvoril protitelesa, kar bo pripomoglo k obrambi pred boleznijo.
English: In chickens it is given as a single dose either by coarse spray vaccination from one day of age or by adding to drinking water from five days of age.
Slovenian: Pri piščancih se daje z enkratnim odmerkom bodisi s cepljenjem z grobim pršenjem od enega dneva starosti dalje bodisi z dodajanjem v pitno vodo od petega dneva starosti dalje.
English: Poulvac E. coli avian colibacillosis vaccine (live)
Slovenian: Poulvac E. coli cepivo proti aviarni kolibacilozi (živo)
English: In turkeys it is given by coarse spray vaccination from one day of age with a second dose three weeks later.
Slovenian: Pri puranih se cepivo daje z grobim pršenjem od enega dneva starosti dalje, drugi odmerek pa tri tedne pozneje.
English: What benefits of Poulvac E. coli have been shown in the studies?
Slovenian: Kakšne koristi je zdravilo Poulvac E. coli izkazalo v študijah?
English: What are the risks associated with Poulvac E. coli?
Slovenian: Kakšna tveganja so povezana z zdravilom Poulvac E. coli?
English: For more information about treatment with Poulvac E. coli, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Poulvac E. coli naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
English: What is Poulvac E. coli and what is it used for?
Slovenian: Kaj je zdravilo Poulvac E. coli in za kaj se uporablja?
English: The use of eye-protection, gloves and a nose-mouth mask by the operator is recommended during administration.
Slovenian: Med dajanjem cepiva se priporoča uporaba zaščite za oči, rokavic ter maske, ki pokriva nos in usta.
English: Poulvac E. coli is a vaccine that is used in chickens and turkeys for active immunisation against an infection caused by Escherichia coli serotype O78 called colibacillosis.
Slovenian: Cepivo Poulvac E. coli se uporablja pri piščancih in puranih za aktivno imunizacijo proti okužbi, ki jo povzroča bakterija Escherichia coli, serotip O78, in se imenuje kolibaciloza.
English: For practical information about using Poulvac E. coli animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Poulvac E. coli naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
English: When Poulvac E. coli is given to a chicken or turkey, the animal's immune system recognises the parts of the bacterium contained in the vaccine as ‘foreign' and makes antibodies against it.
Slovenian: Ko se s cepivom Poulvac E. coli cepijo piščanci ali purani, njihov imunski sistem prepozna dele bakterije, ki jih vsebuje cepivo, kot tujke in proti njim tvori protitelesa.
English: Therefore, it is recommended to clean and disinfect bird houses where the vaccine was administered after completion of the finishing or rearing period.
Slovenian: Zato se po zakolu živali ali po koncu reje priporoča čiščenje in razkuževanje ptičjih hiš, v katerih je bilo cepivo razpršeno.
English: When adding Poulvac E. coli to drinking water a sufficient amount to supply one dose of reconstituted vaccine for every chicken should be added to as much water as is consumed by the chickens in three hours.
Slovenian: Kadar se cepivo Poulvac E. coli daje s pitno vodo, mora biti količini vode, ki jo piščanci popijejo v treh urah, dodana takšna količina, da se zagotovi en odmerek pripravljenega cepiva na vsako ptico.
English: Other information about Poulvac E. coli:
Slovenian: Druge informacije o zdravilu Poulvac E. coli
English: Why is Poulvac E. coli approved?
Slovenian: Zakaj je bilo zdravilo Poulvac E. coli odobreno?
English: How does Poulvac E. coli work?
Slovenian: Kako zdravilo Poulvac E. coli deluje?
English: How is Poulvac E. coli used?
Slovenian: Za kaj se zdravilo Poulvac E. coli uporablja?
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration Immediate Packaging Pack size EU/1/16/1139/001 OCALIVA
Slovenian: Številka EU Zaščiteno ime
English: Meropenem has been authorised in the EU since the 1990s.
Slovenian: Meropenem je v EU odobren od devetdesetih let prejšnjega stoletja.
English: Further information on Vabomere can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Vabomere.
Slovenian: Več informacij o zdravilu Vabomere je na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/Vabomere.
English: Vabomere (meropenem / vaborbactam)
Slovenian: Vabomere (meropenem/vaborbaktam)
English: What measures are being taken to ensure the safe and effective use of Vabomere?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Vabomere?
English: The Agency decided that Vabomere's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Zaključila je, da so koristi zdravila Vabomere večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: As for all medicines, data on the use of Vabomere are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Vabomere stalno spremljajo.
English: Other information about Vabomere
Slovenian: Druge informacije o zdravilu Vabomere
English: Vabomere was found effective at treating infections in two studies.
Slovenian: Zdravilo Vabomere se je izkazalo za učinkovito pri zdravljenju okužb v dveh študijah.
English: Why is Vabomere authorised in the EU?
Slovenian: Zakaj je zdravilo Vabomere odobreno v EU?
English: Side effects reported with Vabomere are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Vabomere, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: What is Vabomere and what is it used for?
Slovenian: Kaj je zdravilo Vabomere in za kaj se uporablja?
English: It can also be used for infections caused by Gram-negative bacteria when other treatments might not work.
Slovenian: Uporablja se lahko tudi za zdravljenje okužb, ki jih povzročijo gramnegativne bakterije, kadar druge oblike zdravljenja niso učinkovite.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Vabomere have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Vabomere upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: Tests for bacteria in the urine found that 67% (128 out of 192) of patients treated with Vabomere were cured, compared with 58% (105 out of 182) of patients treated with piperacillin and tazobactam.
Slovenian: Pri testiranju na bakterije v urinu je bilo ugotovljeno, da je bilo ozdravljenih 67 % (128 od 192) bolnikov, ki so bili zdravljeni z zdravilom Vabomere, v primerjavi z 58 % (105 od 182) bolnikov, ki so se zdravili s piperacilinom in tazobaktamom.
English: What are the risks associated with Vabomere?
Slovenian: Kakšna tveganja so povezana z zdravilom Vabomere?
English: What benefits of Vabomere have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Vabomere izkazalo v študijah?
English: The European Medicines Agency noted that there were limited options for treating infections with bacteria that carry beta-lactamases.
Slovenian: Evropska agencija za zdravila je ugotovila, da obstajajo omejene možnosti za zdravljenje okužb z bakterijami, ki prenašajo beta-laktamaze.
English: An overview of Vabomere and why it is authorised in the EU
Slovenian: Pregled zdravila Vabomere in zakaj je odobreno v EU
English: It works by interfering with the activity of certain proteins that bacteria need to build their cell walls.
Slovenian: Deluje tako, da ovira delovanje določenih beljakovin, ki jih bakterije potrebujejo za gradnjo svojih celičnih sten.
English: Fewer patients treated with Vabomere (14%) died within 4 weeks compared with those receiving best available antibiotic treatment (26%).
Slovenian: V štirih tednih je umrlo manj bolnikov, ki so bili zdravljeni z zdravilom Vabomere (14 %), v primerjavi z bolniki, ki so prejeli najboljše razpoložljivo zdravljenje z antibiotiki (26 %).
English: Vabomere is an antibiotic used in adults to treat the following infections, including when they have spread into the blood (bacteraemia):
Slovenian: Zdravilo Vabomere je antibiotik, ki se uporablja pri odraslih za zdravljenje naslednjih okužb, tudi če so se baterije razširile v kri (bakteriemija):
English: • complicated abdominal infections of the tissues and organs in the belly (intra-abdominal infections);
Slovenian: • zapletenih okužb tkiv in organov v trebuhu (intraabdominalnih okužb);
English: This action weakens the bacterial cell walls which can then collapse, ultimately causing the bacteria to die.
Slovenian: S tem oslabi bakterijske celične stene, ki lahko zato propadejo, zaradi česar bakterije sčasoma odmrejo.
English: The active substances in Vabomere, meropenem and vaborbactam, work in different ways.
Slovenian: Učinkovini zdravila Vabomere, meropenem in vaborbaktam, delujeta na različna načina.
English: However, the Agency recognised that Vabomere cannot deal with all types of bacteria resistant to meropenem.
Slovenian: Vendar je agencija prepoznala, da zdravilo Vabomere ne more uničiti vseh vrst bakterij, odpornih na meropenem.
English: Of those treated with Vabomere, overall 60% (21 out of 35) of patients were cured, compared with 32% (6 out of 19) of patients receiving best available antibiotic treatment.
Slovenian: Med bolniki, ki so bili zdravljeni z zdravilom Vabomere, jih je ozdravilo skupno 60 % (21 od 35), v primerjavi z 32 % (6 od 19) bolnikov, ki so prejemali najboljše razpoložljivo zdravljenje z antibiotikom.
English: Vabomere was compared with the doctor's choice of the best available antibiotic treatment.
Slovenian: Zdravilo Vabomere so primerjali z najboljšim razpoložljivim zdravljenjem z antibiotikom po izbiri zdravnika.
English: The most common side effects with Vabomere (which may affect up to 1 in 10 people) are headache, diarrhoea, inflammation of the vein around the infusion site and nausea (feeling sick).
Slovenian: Najpogostejši neželeni učinki zdravila Vabomere (ki lahko prizadenejo več kot 1 osebo od 10) so glavobol, driska, vnetje vene okoli mesta infundiranja in navzeja (slabost).
English: These enzymes break down beta-lactam antibiotics such as meropenem and stop them from working.
Slovenian: Ti encimi razgrajujejo betalaktamske antibiotike, kot je meropenem, in jim preprečijo delovanje.
English: Vabomere must not be used in patients who are hypersensitive (allergic) to any carbapenem antibiotic or in patients who have had a severe allergic reaction to the broader class of beta-lactam antibiotics (such as penicillins and cephalosporins).
Slovenian: Zdravilo Vabomere se ne sme uporabljati pri bolnikih, ki so preobčutljivi za (alergični na) kateri koli karbapenemski antibiotik ali pri bolnikih, ki so imeli hudo alergijsko reakcijo na širši razred betalaktamskih antibiotikov (kot so penicilini in cefalosporini).
English: Meropenem belongs to the carbapenem class of antibiotics, which belongs to the wider group of antibiotics known as beta-lactams.
Slovenian: Meropenem spada v skupino karbapenemskih antibiotikov, ki so uvrščeni v širšo skupino antibiotikov, znanih kot beta-laktami.
English: By blocking the action of these enzymes, vaborbactam allows meropenem to act against bacteria that would otherwise be resistant to it.
Slovenian: Vaborbaktam z zaviranjem delovanja teh encimov omogoča meropenemu, da deluje proti bakterijam, ki bi sicer bile nanj odporne.
English: The second study involved patients with complicated urinary tract infection (including kidney infection), complicated intra-abdominal infections, lung infections caught in hospital and bacteraemia.
Slovenian: V drugo študijo so bili vključeni bolniki z zapletenimi okužbami sečil (vključno z okužbo ledvic), zapletenimi intraabdominalnimi okužbami, okužbami pljuč, pridobljenimi v bolnišnici, in bakteriemijo.
English: The first study, involving patients with complicated urinary tract infection (including kidney infection), compared Vabomere with a combination of piperacillin (another beta-lactam antibiotic) and tazobactam (a beta-lactamase inhibitor).
Slovenian: V prvi študiji, v katero so bili vključeni bolniki z zapletenimi okužbami sečil (vključno z okužbo ledvic), so primerjali zdravilo Vabomere s kombinacijo piperacilina (drugega betalaktamskega antibiotika) in tazobaktama (zaviralca beta-laktamaze).
English: How is Vabomere used?
Slovenian: Kako se zdravilo Vabomere uporablja?
English: It is given every 8 hours and the duration of treatment depends on the type of infection and its severity.
Slovenian: Injicira se vsakih osem ur, trajanje zdravljenja pa je odvisno od vrste in resnosti okužbe Za več informacij glede uporabe zdravila Vabomere glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: No special concerns about side effects have been raised by the addition of vaborbactam to meropenem.
Slovenian: Zaradi neželenih učinkov, ki bi jih povzročilo dodajanje vaborbaktama meropenemu, ni izrazila nobenega posebnega pomisleka.
English: Vaborbactam allows meropenem to work in many such infections by blocking certain beta-lactamases.
Slovenian: Vaborbaktam omogoča meropenemu, da v številnih takih okužbah deluje z zaviranjem določenih beta-laktamaz.
English: Vabomere contains the active substances meropenem and vaborbactam.
Slovenian: Zdravilo Vabomere vsebuje učinkovini meropenem in vaborbaktam.
English: Vaborbactam is a beta-lactamase inhibitor, which means that it blocks the action of bacterial enzymes called beta-lactamases.
Slovenian: Vaborbaktam je zaviralec beta-laktamaze, kar pomeni, da v telesu zavira delovanje bakterijskih encimov, imenovanih beta-laktamaze.
English: • complicated (difficult-to-treat) infections of the urinary tract, including kidneys;
Slovenian: • zapletenih (težko ozdravljivih) okužb sečil, vključno z ledvicami;
English: For the full list of side effects of Vabomere, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Vabomere, glejte navodilo za uporabo.
English: Vabomere can only be obtained with a prescription.
Slovenian: Predpisovanje in izdaja zdravila je le na recept.
English: Vabomere is given by infusion (drip) into a vein over 3 hours.
Slovenian: Zdravilo Vabomere se daje kot triurna (kapalna) infuzija v veno.
English: • lung infections caught in hospital (hospital-acquired pneumonia), including ventilator-associated pneumonia (pneumonia caught from a ventilator, which is a machine that helps a patient to breathe).
Slovenian: • okužb pljuč, pridobljenih v bolnišnici (bolnišnična pljučnica), vključno z ventilatorsko pljučnico
English: How does Vabomere work?
Slovenian: Kako zdravilo Vabomere deluje?
English: A risk to newborns/infants cannot be excluded.
Slovenian: Tveganja za novorojenčke/otroke ni mogoče izključiti.
English: • Swallow the tablet whole with at least a half glass of water.
Slovenian: • Tableto pogoltnite celo, z najmanj pol kozarca vode.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23 April 2014
Slovenian: Datum prve odobritve: 23. april 2014
English: • Try to take it at the same times each day.
Slovenian: • Poskušajte jemati tableto vsak dan ob istem času.
English: Multiple dose study: Data are restricted to one study.
Slovenian: Študija večkratnih odmerkov: Podatki se nanašajo na eno študijo.
English: • medicines that contain alcohol.
Slovenian: • zdravila, ki vsebujejo alkohol.
English: • The dose of Vokanamet is one tablet twice a day.
Slovenian: • Odmerek zdravila Vokanamet je ena tableta dvakrat na dan.
English: Consumption of alcohol and medicinal products containing alcohol should be avoided.
Slovenian: Uživanju alkohola in zdravil, ki vsebujejo alkohol, se je treba izogibati.
English: It is important that you follow your doctor's instructions carefully.
Slovenian: Zelo pomembno je, da se skrbno držite navodil svojega zdravnika.
English: ATC code: A10BD16.
Slovenian: Oznaka ATC: A10BD16.
English: • It is best to take your tablet with a meal.
Slovenian: • Tableto je najbolje vzeti ob obroku.
English: In both cases, treatment with Vokanamet may be restarted once the patient's condition has stabilised.
Slovenian: V obeh primerih se lahko zdravljenje z zdravilom Vokanamet ponovno uvede, ko je stanje bolnikov stabilizirano.
English: Tablets are to be swallowed whole.
Slovenian: Tablete je treba pogoltniti cele.
English: See section “Warning and precautions”.
Slovenian: Glejte poglavje “Opozorila in previdnostni ukrepi”.
English: As an underlying mechanism has not been established, risk factors, apart from general risk factors, for amputation are unknown.
Slovenian: Osnovnega mehanizma niso ugotovili, zato razen splošnih dejavnikov tveganja dejavniki tveganja za amputacije niso znani.
English: The red blood cells most likely represent a secondary compartment of distribution.
Slovenian: Eritrociti najverjetneje predstavljajo sekundarni predelek porazdelitve.
English: How much to take
Slovenian: Koliko zdravila je potrebno vzeti
English: 16% of patients were Hispanic.
Slovenian: 16% bolnikov je bilo latinskoameriškega izvora.
English: • difficulty in breathing
Slovenian: • težave z dihanjem
English: More information is given below in "Other medicines and Vokanamet".
Slovenian: Več podatkov lahko najdete spodaj pod naslovom "Druga zdravila in zdravilo Vokanamet".
English: After an oral dose, the non-absorbed fraction recovered in faeces was 20-30%.
Slovenian: Po peroralnem odmerjanju je neabsorbirani delež v blatu znašal 20-30%.
English: • if you are allergic to canagliflozin, metformin or any of the other ingredients of this medicine (listed in section 6)
Slovenian: • če ste alergični na kanagliflozin, metformin ali katero koli sestavino tega zdravila (navedeno v poglavju 6)
English: Do not use this medicine after the expiry date which is stated on the bottle and carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na plastenki in na škatli poleg oznake "EXP".
English: For the list of excipients, see section 6.1.
Slovenian: Za celoten seznam pomožnih snovi glejte poglavje 6.1.