natgillin/translations-raw huggingface dataset:
The benefits of Zontivity were clearest in a group of 16,897 patients who had had a heart attack, but had no history of stroke or transient ischaemic attack (so-called ‘mini stroke').
Koristi zdravila Zontivity so bile najbolj opazne v podskupini 16 897 bolnikov, ki so doživeli srčni infarkt, vendar v anamnezi niso imeli možganske kapi ali prehodne pretočne motnje (ali tranzitorne ishemične atake, tako imenovane „mini kapi“).
Zontivity was compared with placebo (a dummy treatment) in a main study involving over 26,000 adults who had had a heart attack or other atherothrombotic event or who had peripheral arterial disease.
Zdravilo Zontivity so primerjali s placebom (zdravilom brez zdravilne učinkovine) v glavni študiji, v kateri je sodelovalo več kot 26 000 odraslih, ki so doživeli srčni infarkt ali drug aterotrombotični dogodek ali imajo periferno arterijsko bolezen.
It is given in combination with aspirin and where appropriate, clopidogrel.
Daje se v kombinaciji z aspirinom in, kjer je primerno, s klopidogrelom.
For the full list of all side effects, see the package leaflet.
Za celoten seznam neželenih učinkov glejte navodilo za uporabo.
The active substance in Zontivity, vorapaxar, is an inhibitor of platelet aggregation.
Zdravilna učinkovina zdravila Zontivity, vorapaksar, je zaviralec agregacije trombocitov.
It is given in combination with either aspirin or, where appropriate, with clopidogrel.
Daje se v kombinaciji bodisi z aspirinom bodisi, kjer je primerno, s klopidogrelom.
Zontivity contains the active substance vorapaxar.
Zdravilo Zontivity vsebuje zdravilno učinkovino vorapaksar.
How does Zontivity work?
Kako zdravilo Zontivity deluje?
How is Zontivity used?
Kako se zdravilo Zontivity uporablja?
Thrombin is one of the substances involved in the clotting process, and when it attaches to the PAR-1 receptor it causes the platelets to become ‘sticky', helping the blood clot to form.
Kadar se veže na receptor PAR1, povzroči „lepljivost“ trombocitov in tako pripomore k nastajanju krvnih strdkov.
EMEA Number (Invented) name
Številka EMA (Lastniško ime)
1 bottle + 1 bottle adaptor + 2 oral syringes
1 steklenička + 1 nastavek za stekleničko + 2 peroralni brizgi
Oral suspension Oral use bottle (glass); syringe (PET)
20 mg/ml peroralna suspenzija peroralna uporaba steklenička (steklo); brizga (PET)
This will help protect against coccidiosis.
To ji bo pomagalo pri zaščiti pred kokcidiozo.
Hands and equipment should be washed and disinfected after use.
Po uporabi je treba roke in opremo oprati in razkužiti.
Protection starts at 3 weeks after vaccination and lasts until 60 weeks after vaccination.
Zaščita se začne 3 tedne po cepljenju in traja do 60 tednov po cepljenju.
The full EPAR for Evalon can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila Evalon je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
This is a summary of the European public assessment report (EPAR) for Evalon.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Evalon.
The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Evalon's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da so koristi zdravila Evalon večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
The vaccine suspension should be diluted with the solvent and water according to dosing instructions and sprayed onto the birds so that each bird receives one dose.
Suspenzijo cepiva je treba razredčiti z vehiklom in vodo po navodilih za odmerjanje in jo razpršiti na ptiče, tako da vsak ptič prejme en odmerek.
Evalon is a vaccine.
Zdravilo Evalon je cepivo.
The withdrawal period for meat and eggs from chickens treated with Evalon is ‘zero' days, which means there is no mandatory waiting time.
Karenca za meso in jajca piščancev, zdravljenih z zdravilom Evalon, je „nič“ dni, kar pomeni, da ni obvezne čakalne dobe.
In the future if the animals are exposed to the same Eimeria species the immune system will be able to respond more quickly.
Ob ponovni izpostavitvi živali virusu v prihodnosti se bo imunski sistem tako hitreje odzval.
Coccidiosis is a disease of the gut which results in reduced growth, severe diarrhoea, reduced egg production and a high death rate.
Kokcidioza je črevesna bolezen, za katero so značilni zastoj rasti, huda diareja, zmanjšana tvorba jajc in visoka smrtnost.
It is not intended to provide practical advice on how to use Evalon.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
The results with Evalon and the comparator vaccine were similar for 3 out 4 farms; on 1 farm Evalon vaccinated chickens showed better protection than those given the comparator.
Rezultati cepljenja z zdravilom Evalon in s primerjalnim cepivom so bili pri 3 od 4 farm podobni; na 1 od farm so z zdravilom Evalon cepljeni piščanci izkazali boljšo zaščito kot tisti, ki so bili cepljeni s primerjalnim cepivom.
The vaccine contains the oocysts of Eimeria species that have been weakened so that they cannot cause disease.
To cepivo vsebuje oociste vrste Eimeria, ki so oslabljene in zato ne morejo povzročiti bolezni.
Evalon is available as a suspension and solvent and can only be obtained with a prescription.
Zdravilo Evalon je na voljo v obliki suspenzije in vehikla ter se izdaja le na recept.
The vaccine solvent contains the adjuvant montanide IMS to enhance the immune response.
Cepivo v obliki vehikla vsebuje tudi dodatek montanid IMS za povečanje imunskega odziva.
In a field study involving 4 farms, shedding of oocysts in the faeces was reduced within 3 weeks of vaccination both in Evalon vaccinated chicks and those vaccinated with another vaccine against Eimeria.
Pri terenski študiji, ki je vključevala 4 farme, se je izločanje oocist z iztrebki v 3 tednih po cepljenju zmanjšalo tako pri piščancih, cepljenih z zdravilom Evalon, kot pri tistih, ki so bili cepljeni z drugim cepivom proti vrsti Eimeria.
What is Evalon and what is it used for?
Kaj je zdravilo Evalon in za kaj se uporablja?
The vaccine contains live attenuated (weakened) oocysts of Eimeria acervulina, Eimeria brunetti, Eimeria maxima, Eimeria necatrix and Eimeria tenella.
Cepivo vsebuje žive atenuirane (oslabljene) oociste parazitov vrst Eimeria acervulina, Eimeria brunetti, Eimeria maxima, Eimeria necatrix in Eimeria tenella.
The European Commission granted a marketing authorisation valid throughout the EU for Evalon on
Evropska komisija je dovoljenje za promet z zdravilom Evalon, veljavno po vsej Evropski uniji, izdala
When Evalon is given to chickens, the animals' immune system recognises the Eimeria oocysts as foreign and makes defences against them.
Ko piščanci prejmejo zdravilo Evalon, imunski sistem živali prepozna oociste vrste Eimeria kot „tujek“ ter začne proti njim tvoriti protitelesa.
What are the risks associated with Evalon?
Kakšna tveganja so povezana z zdravilom Evalon?
The birds consume the vaccine when preening their feathers.
Ptiči cepivo zaužijejo pri čiščenju perja.
What benefits of Evalon have been shown in studies?
Kakšne koristi je zdravilo Evalon izkazalo v študijah?
Why is Evalon approved?
Zakaj je bilo zdravilo Evalon odobreno?
Infected birds shed disease spores (oocysts) in their faeces that can spread the infection.
Okuženi ptiči z iztrebki izločajo bolezenske spore (oociste), ki lahko širijo okužbo.
Evalon is a veterinary vaccine to protect chickens against coccidiosis caused by the coccidia parasites Eimeria acervulina, Eimeria brunetti, Eimeria maxima, Eimeria necatrix and Eimeria tenella.
Zdravilo Evalon je cepivo za uporabo v veterinarski medicini, ki se uporablja za zaščito piščancev pred kokcidiozo, ki jo povzročajo paraziti Eimeria acervulina, Eimeria brunetti, Eimeria maxima, Eimeria necatrix in Eimeria tenella.
Other information about Evalon?
Druge informacije o zdravilu Evalon
Evalon avian coccidiosis vaccine (live)
Cepivo (živo) proti aviarni kokcidiozi
Safety information has been included in the summary of product characteristics and the package leaflet for Evalon, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
V povzetek glavnih značilnosti zdravila Evalon in navodilo za njegovo uporabo so bile vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in lastniki ali skrbniki živali.
The vaccine is given to one-day-old chicks by coarse spray vaccination.
Cepivo se daje en dan starim piščancem s pršenjem z večjimi kapljicami.
For more information about treatment with Evalon, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Za več informacij o zdravljenju z zdravilom Evalon naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
For practical information about using Evalon, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Za praktične informacije o uporabi zdravila Evalon naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
How does Evalon work?
Kako zdravilo Evalon deluje?
How is Evalon used?
Kako se zdravilo Evalon uporablja?
For the full list of restrictions, see the package leaflet.
Znanih neželenih učinkov zdravila Evalon ni. Za celoten seznam omejitev glejte navodilo za uporabo.
MA (EU) Numbers (Invented) name Strength
(Izmišljeno) ime Jakost
Immediate Packaging Pack size blister (PVC/PVDC-Alu); wallet blister (PVC/PVDC-AluAlu); carton
Pretisni omot (PVC/PVDC-Alu); zgibanka
It is given once a day by slow infusion lasting about one hour.
Zdravilo se daje enkrat dnevno v obliki počasne infuzije, ki traja približno eno uro.
In patients between 12 months and 17 years of age, the dose depends on body surface area (calculated using the patient's height and weight).
Pri bolnikih, starih od 12 mesecev do 17 let, je odmerek odvisen od telesne površine (ki se izračuna na podlagi bolnikove višine in telesne mase).
In adults, treatment begins with a 70mg starting dose, followed by a daily dose of 50 mg, or of 70 mg if the patient weighs more than 80 kg. A lower dose is given to adults who have moderate problems with their liver.
Pri odraslih se zdravljenje začne s 70-miligramskim uvajalnim odmerkom, ki mu sledi dnevni odmerek 50 mg oziroma 70 mg, če bolnik tehta več kot 80 kg.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Caspofungin Accord has been shown to be comparable to Cancidas.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo v skladu z zahtevami EU dokazano, da je zdravilo Caspofungin Accord primerljivo z zdravilom Cancidas.
The full EPAR and risk management plan summary for Caspofungin Accord can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Caspofungin Accord sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
This is a summary of the European public assessment report (EPAR) for Caspofungin Accord.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Caspofungin Accord.
Caspofungin Accord should be used with caution in children below 12 months of age, because it has not been studied sufficiently in this age group.
Pri otrocih, mlajših od 12 mesecev, je treba zdravilo Caspofungin Accord uporabljati previdno, ker v tej starostni skupini še ni bilo dovolj proučeno.
The Committee recommended that Caspofungin Accord be approved for use in the EU.
Priporočil je, da se zdravilo Caspofungin Accord odobri za uporabo v EU.
Because Caspofungin Accord is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Ker je zdravilo Caspofungin Accord generično zdravilo, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
Caspofungin Accord is an antifungal medicine used to treat adults, adolescents and children with:
Caspofungin Accord je protiglivno zdravilo, ki se uporablja za zdravljenje odraslih, mladostnikov in otrok z:
This means that Caspofungin Accord is similar to a ‘reference medicine' already authorised in the European Union (EU) called Cancidas.
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Cancidas.
(feverish) and neutropenic (has low levels of white blood cells).
(ima povišano telesno temperaturo) in nevtropeničen (mu primanjkuje belih krvničk).
• invasive aspergillosis (another type of fungal infection due to Aspergillus) when the infection does not respond to or the patient does not tolerate amphotericin B or itraconazole (other antifungal medicines);
• invazivno aspergilozo (drugo vrsto glivn okužbe, ki jo povzroča Aspergillus), če se okužba ne odziva na amfotericin B ali itrakonazol (drugi protigliv zdravili) ali ju bolnik ne prenaša;
What measures are being taken to ensure the safe and effective use of Caspofungin Accord?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Caspofungin Accord?
It works by interfering with the production of a component of the fungal cell wall called ‘glucan polysaccharide', which is necessary for the fungus to survive and grow.
Deluje tako, da zavira tvorbo ene od sestavin celične stene glive, imenovane glukanski polisaharid, ki je nujna za to, da bi gliva lahko živela in rasla.
• invasive candidiasis (a type of fungal infection due to Candida);
• invazivno kandidiazo (vrsto glivne okužbe, ki jo povzroča Candida);
Fungal cells treated with Caspofungin Accord have incomplete or defective cell walls, making them fragile, unable to grow and causing their death.
Glivne celice, zdravljene z zdravilom Caspofungin Accord, imajo nepopolne ali okvarjene celične stene, zato so krhke, nezmožne rasti in odmrejo.
The company provided data from the published literature on caspofungin.
Družba je predstavila podatke o kaspofunginu iz objavljene literature.
• suspected fungal infections (such as due to Candida or Aspergillus) when the patient is febrile
• domnevnimi glivnimi okužbami (ki ju npr. povzročata Candida ali Aspergillus), če je bolnik febrilen
A risk management plan has been developed to ensure that Caspofungin Accord is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Caspofungin Accord je bil pripravljen načrt obvladovanja tveganj.
What are the benefits and risks of Caspofungin Accord?
Kakšne so koristi in tveganja, povezani z zdravilom Caspofungin Accord?
Caspofungin Accord is a ‘generic medicine'.
Zdravilo Caspofungin Accord je „generično zdravilo“.
Other information about Caspofungin Accord
Druge informacije o zdravilu Caspofungin Accord
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Caspofungin Accord, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
For more information about treatment with Caspofungin Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Caspofungin Accord preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Caspofungin Accord can only be obtained with a prescription and treatment should be started by a doctor who has experience in the management of invasive fungal infections.
Izdaja zdravila Caspofungin Accord je le na recept, zdravljenje z njim pa mora uvesti zdravnik, ki ima izkušnje z zdravljenjem invazivnih glivnih okužb.
For practical information about using Caspofungin Accord, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Caspofungin Accord naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
It contains the active substance caspofungin.
Vsebuje zdravilno učinkovino kaspofungin.
The list of fungi against which Caspofungin Accord is active can be found in the summary of product characteristics (also part of the EPAR).
Za seznam gliv, proti katerim deluje zdravilo Caspofungin Accord, glejte povzetek glavnih značilnosti zdravila (ki je prav tako del EPAR).
It is not intended to provide practical advice on how to use Caspofungin Accord.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
What is Caspofungin Accord and what is it used for?
Kaj je zdravilo Caspofungin Accord in za kaj se uporablja?
Therefore, the CHMP's view was that, as for Cancidas, the benefit outweighs the identified risk.
Zato je menil, da njegove koristi enako kot pri zdravilu Cancidas odtehtajo znana tveganja.
The active substance in Caspofungin Accord, caspofungin, belongs to a group of antifungal medicines known as ‘echinocandins'.
Zdravilna učinkovina zdravila Caspofungin Accord, kaspofungin, spada v skupino protiglivnih zdravil, znanih kot ehinokandini.
Caspofungin Accord is a powder that is made up into a solution for infusion (drip) into a vein.
Zdravilo Caspofungin Accord je prašek za pripravo raztopine za infundiranje (kapalne infuzije) v veno.
Why is Caspofungin Accord approved?
Zakaj je bilo zdravilo Caspofungin Accord odobreno?
Caspofungin Accord must be made up into a concentrated solution and then diluted before use, using a diluent that does not contain glucose.
Pred uporabo je treba s pomočjo vehikla, ki ne vsebuje glukoze, pripraviti koncentrirano raztopino zdravila Caspofungin Accord in jo nato razredčiti.
How has Caspofungin Accord been studied?
Kako je bilo zdravilo Caspofungin Accord raziskano?
No additional studies in humans were needed as Caspofungin Accord is a generic medicine that is given by infusion and contains the same active substance as Cancidas.
Ker je zdravilo Caspofungin Accord generično zdravilo, ki se daje z infundiranjem in vsebuje isto zdravilno učinkovino kot zdravilo Cancidas, niso bile potrebne nobene dodatne študije pri ljudeh.
How does Caspofungin Accord work?
Kako zdravilo Caspofungin Accord deluje?
How is Caspofungin Accord used?
Kako se zdravilo Caspofungin Accord uporablja?
l t o r
Jakos t
Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmith Kline
Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals
Intramuscular use suspension (H5N1): vial (glass) emulsion (adjuvant): vial (glass)
Intramuskularna uporaba suspenzija (H5N1): viala (steklo) emulzija (adjuvans): viala (steklo)
3.75 µg HA Suspension and Emulsion for emulsion for injection
Suspenzija in emulzija za emulzijo za injiciranje
This is of particular concern, as these patients and patients with renal impaired are already particularly prone to developing hyperkalaemia.
To je zlasti zaskrbljujoče, saj so ti bolniki in bolniki z ledvično okvaro še posebej nagnjeni k razvoju hiperkaliemije.
RAS-acting agents include angiotensinconverting enzyme inhibitors (ACE-inhibitors) such as benazepril, captopril, cilazapril, delapril, enalapril, fosinopril, imidapril, lisinopril, moexipril, perindopril, quinapril, ramipril, spirapril, trandolapril and zofenopril), angiotensin receptor blockers (ARBs) such as candesartan, telmisartan, valsartan, irbesartan, eprosartan, olmesartan, losartan and azilsartan and direct renin inhibitors such as aliskiren.
Med snovi, ki delujejo na renin-angiotenzinski sistem, spadajo zaviralci angiotenzin konvertirajočega encima (zaviralci ACE), kot so benazepril, kaptopril, cilazapril, delapril, enalapril, fosinopril, imidapril, lisinopril, moeksipril, perindopril, kvinapril, ramipril, spirapril, trandolapril in zofenopril, zaviralci angiotenzinskih receptorjev (ARB-ji), kot so kandesartan, telmisartan, valsartan, irbesartan, eprosartan, olmesartan, losartan in azilsartan, in neposredni zaviralci renina, kot je aliskiren.
In addition, the metaanalysis suggested that using multiple RAS-acting agents may not be more beneficial than using a single RAS-acting agent in terms of reducing overall mortality.
Poleg tega je metaanaliza pokazala, da uporaba več snovi, ki delujejo na reninangiotenzinski sistem, morda ni koristnejša od uporabe ene snovi, ki deluje na renin-angiotenzinski sistem, kar zadeva zmanjšanje celokupne smrtnosti.
Having considered the new available evidence from the scientific literature and given the seriousness of the identified safety concerns, the Italian Medicines Agency (AIFA) decided to initiate a review under Article 31 of Council Directive 2001/83/EC on 17 April 2013, referring the matter to the Pharmacovigilance Risk Assessment Committee (PRAC) and requesting the PRAC to issue a recommendation on the benefit-risk of dual RAS blockade therapy through the combined use of ACE-inhibitors, ARBs or aliskiren and whether any regulatory measures should be taken on the marketing authorisations of the products involved in this procedure.
Po preučitvi novih razpoložljivih dokazov iz znanstvene literature in glede na resnost ugotovljenih zadržkov v zvezi z varnostjo je italijanska agencija za zdravila (AIFA) 17. aprila 2013 sprožila pregled v skladu s členom 31 Direktive Sveta 2001/83/ES in zadevo napotila na Odbor za oceno tveganja na področju farmakovigilance (PRAC) ter od njega zahtevala, da izda priporočilo o razmerju med tveganji in koristmi zdravljenja z dvojnim zaviranjem renin-angiotenzinskega sistema s kombinirano uporabo zaviralcev ACE, zaviralcev angiotenzinskih receptorjev ali aliskirena in navede, ali bi bilo treba sprejeti kakršne koli regulativne ukrepe za dovoljenja za promet z zdravili, ki so predmet tega postopka.
In particular, a number of trials in heart failure patients have shown that the addition of a second RAS-acting agent may reduce hospital admissions for heart failure in patients with heart failure, which is considered a meaningful clinical endpoint.
Zlasti številna preskušanja pri bolnikih s srčnim popuščanjem so pokazala, da lahko dodatek druge snovi, ki deluje na renin-angiotenzinski sistem, zmanjša število sprejemov v bolnišnico zaradi srčnega popuščanja pri bolnikih s srčnim popuščanjem, kar velja za pomembno klinično končno točko.
The PRAC was also of the opinion that the contraindication based on the ALTITUDE5 study data regarding the concomitant use of ACEinhibitors or ARBs with aliskiren-containing products in patients with diabetes mellitus or renal impairment (glomerular filtration rate (GFR) < 60 ml/min/1.73 m2) was confirmed by the additional data reviewed and that it should also be implemented in the product information of ARBs and ACE-inhibitors.
Prav tako je menil, da dodatni pregledani podatki potrjujejo kontraindikacijo na podlagi podatkov iz študije ALTITUDE5 glede sočasne uporabe zaviralcev ACE ali zaviralcev angiotenzinskih receptorjev z zdravili, ki vsebujejo aliskiren, pri bolnikih s sladkorno boleznijo ali ledvično okvaro (stopnja glomerularne filtracije < 60 ml/min/1,73 m2) in da je treba to kontraindikacijo prav tako vključiti v informacije o zdravilu za zaviralce angiotenzinskih receptorjev in zaviralce ACE.