natgillin/translations-raw huggingface dataset:
Cattle (calves and adult cows). 
Govedo (teleta in odrasle krave).
Recommended vaccination programme: 
Priporočeni program cepljenja:
This slight swelling lasts for less than 24 hours in most cases. 
Ta rahla oteklina traja v večini primerov manj kot 24 ur.
ATCvet code QI02AD01. 
oznaka ATC vet QI02AD01.
This transient rise in temperature is spontaneously resolved within 48 hours without treatment and it is not related to a febrile process. 
Ta prehoden porast temperature samodejno izzveni v 48 urah brez zdravljenja in ni povezan s febrilnim procesom.
In such cases, an appropriate symptomatic treatment should be administered. 
V takem primeru je potrebno ustrezno zdravljenje simptomov.
Vaccination might very rarely cause hypersensitivity reactions. 
Cepljenje lahko zelo redko povzroči preobčutljivostne reakcije.
Date of first authorisation: 27/01/2011 Date of last renewal: 06/11/2015 
Datum pridobitve dovoljenja za promet: 27/01/2011 Datum podaljšanja dovoljenja za promet: 06/11/2015
Diagnostic tools designed to detect gE antibodies should be suitable for this purpose. 
Diagnostične metode za zaznavo protiteles gE naj bi bile primerne za ta namen.
A slight increase in body temperature up to 1 °C is common within 4 days following vaccination. 
Rahel porast telesne temperature do 1°C je v obdobju 4 dni po cepljenju običajen.
The animal should be revaccinated 3 weeks later with the same dose. 
Žival je treba ponovno cepiti z enakim odmerkom čez 3 tedne.
Commonly, an increase in rectal temperature up to 1.63 ºC in adult cows and up to 2.18 ºC in calves may be observed. 
Pogosto je mogoče opaziti zvišanje rektalne temperature do 1,63 ºC pri odraslih kravah in do 2,18 ºC pri teletih.
A transient inflammation at the inoculation site is common in cattle within 72 hours post-vaccination. 
Prehodno vnetje na mestu inokulacije je običajno pri govedu v roku 72 ur po cepljenju.
The excipients listed in section 6.1 of the SPC are either allowed substances for which Table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this product. 
Za pomožne snovi, navedene v poglavju 6.1 SPC , tabela 1 (dovoljene snovi) priloge Uredbe Komisije (EU) št.37/2010 določa, da MRL ni potreben ali pa, kot so uporabljene v tem zdravilu za uporabo v veterinarski medicini, niso vključene v Uredbo(ES) št. 470/2009..
The tk deletion is related to reduced viral neurotropism and reduced establishment of latency. 
Izbris tk je povezan z zmanjšanjem virusnega nevrotropizma in zmanjšanim nastopom latence.
Cattle from the age of 3 months onwards. 
Govedo od 3 mesecev starosti naprej.
Cattle: from the age of 3 months onwards. 
Govedo: od 3 mesecev starosti naprej.
Laboratorios Hipra, S.A. Carretera C-63, km 48.300, Polígono Industrial El Rieral 17170 Amer (Girona) SPAIN 
Laboratorios Hipra, S.A. Carretera C-63, km 48.300, Polígono Industrial El Rieral 17170 Amer (Girona) ŠPANIJA
Each dose of 2 ml contains: Lyophilisate: 
Vsak odmerek po 2 ml vsebuje: Liofilizat:
The recommended initial dose is 1 injection of 2 ml of the reconstituted vaccine per animal. 
Priporočeni začetni odmerek je 1 injiciranje 2 ml rekonstituiranega cepiva na žival.
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports). 
- Zelo pogosti (pojavijo se pri več kot 1 živali od 10 živali) - Pogosti (pojavijo se pri 1 od 10 živali od 100 živali) - Občasni (pojavijo se pri 1 od 10 živali od 1.000 živali) - Redki (pojavijo se pri 1 od 10 živali od 10.000 živali) - Zelo redki (pojavijo se pri manj kot 1 živali od 10.000 živali, vključujoč posamezne primere).
Duration of immunity: 6 months after completion of the basic vaccination. 
Trajanje imunosti: 6 mesecev po zaključku osnovnega cepljenja.
Pregnancy and lactation: Can be used during pregnancy and lactation. 
Uporaba v obdobju brejosti in laktacije: Lahko se uporablja v obdobju brejosti in laktacije.
The active substance being a principle of biological origin intended to produce active immunity is not in the scope of Regulation (EC) 470/2009. 
Učinkovina biološkega izvora namenjena vzbujanju aktivne imunosti, ni vključena v Uredbo(ES) št.
Do not use after the expiry date (EXP) stated on the box and the label. 
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in na nalepki.
Solvent: Colourless type I glass bottle (10 ml) or Type II glass bottle (50 ml or 100 ml containing 60 ml of solvent) or PET bottles (10, 50 or 100 ml containing 60 ml of solvent) closed with a bromobutyl rubber closure and an aluminium cap. 
Vehikel: Brezbarvna steklenica iz stekla tipa I (10 ml) ali steklenica iz stekla tipa II (50 ml ali 100 ml, ki vsebuje 60 ml vehikla) ali PET steklenice (10, 50 ali 100 ml, ki vsebuje 60 ml vehikla), zaprta z bromobutilnim gumijastim zamaškom in aluminijasto zaporko.
The vaccine contains a BoHV-1 strain (CEDDEL strain) that is double deleted within the genes coding for the gE surface protein and the tk enzyme. 
Cepivo vsebuje sev BoHV-1 (sev CEDDEL) z dvojno delecijo v genih, ki kodirata za površinski protein gE in za encim tk.
5 doses 25 doses 30 doses 
5 odmerkov 25 odmerkov 30 odmerkov
Keep the bottles in the box in order to protect from light. 
Stekleničke zaradi zaščite pred svetlobo shranjujte v zunanji ovojnini - škatli.
EXP {month/year} Once reconstituted, use by 6 hours. 
EXP {mesec/leto} Rekonstituirano cepivo uporabite v 6 urah.
Lyophilisate: Colourless type I glass bottle closed with a bromobutyl rubber closure and an aluminium cap. 
Liofilizat: Brezbarvna steklenička iz stekla Tipa I, zaprta z zapiralom iz brombutilne gume in z aluminijasto zaporko.
Reconstitute the lyophilisate with the entire contents of the supplied solvent to obtain a suspension for injection. 
Rekonstituirajte liofilizat s celotno vsebino dobavljenega vehikla, da dobite suspenzijo za injiciranje.
Shelf-life after reconstitution according to directions: 6 hours. 
Rok uporabnosti po rekonstituciji v skladu z navodili: 6 ur.
The absence of the gene coding for the gE surface protein entails that the vaccine does not elicit antibodies to glycoprotein E of BoHV-1 (marker vaccine). 
Odsotnost genetske kode za površinski protein gE ima za posledico, da cepivo ne sproža nastajanja protiteles za glikoprotein E virusa BoHV-1 (marker cepivo).
Solvent: transparent homogenous liquid. 
Vehikel: prozorna homogena tekočina
Use only sterile needles and syringes for administration. 
Za injiciranje uporabljajte samo sterilne igle in brizge.
Do not mix with any other veterinary medicinal product, except the solvent supplied for use with the veterinary medicinal product. 
Ne mešajte z nobenim drugim zdravilom za uporabo v veterinarski medicini razen z vehiklom, namenjenim za uporabo s tem zdravilom.
Solvent of 30 doses: Do not store and transport above 25 ºC. 
Vehikel za 30 odmerkov:: Ne shranjujte in prevažajte pri temperaturi nad 25 °C.
Lyophilisate: white to yellowish powder. 
Liofilizat: bela do rumenkasta prašek
Special precautions for use in animals: Vaccinate healthy animals only. 
POSEBNO(A) OPOZORILO(A) Posebni previdnostni ukrepi za uporabo pri živalih: Cepite le zdrave živali.
This enables discrimination between cattle vaccinated with this vaccine and cattle infected with BoHV-1 field virus or vaccinated with conventional non-marker BoHV-1 vaccines. 
To omogoča razlikovati med govedom, cepljenim s tem cepivom, in govedom, ki je okuženo z virusom BoHV-1 virusa ali cepljeno z običajnim cepivom za BoHV-1 brez markerja.
To stimulate active immunity against bovine herpesvirus type 1 (BoHV-1) in cattle. 
Za stimulacijo aktivne imunosti proti govejemu herpes virusu vrste 1 (BoHV-1) pri govedu.
Onset of immunity: 21 days after completion of the basic vaccination scheme. 
Nastop imunosti: 21 dni po zaključku osnovnega cepljenja.
Administer one dose of 2 ml by intramuscular injection in the neck muscles. 
En 2 ml odmerek dajte z intramuskularno injekcijo v vratno mišičevje.
Animals exposed to gE surface protein will test positive (i.e. cattle infected with BoHV-1 field virus or vaccinated with conventional non-marker BoHV-1 vaccines) but unexposed animals will test negative (i.e. non-infected animals, including those vaccinated with HIPRABOVIS IBR MARKER LIVE). 
Pri živalih, ki so bile izpostavljene površinski beljakovini gE, bo test pozitiven (tj. govedo okuženo z BoHV-1 virusom ali cepljeno z običajnim cepivom za BoHV-1 brez markerja), za neizpostavljene živali pa bo test negativen (tj. za neokužene živali, vključno s tistimi, ki so bile cepljene s Hiprabovis IBR Marker Live).
+34 972 430661 E-mail: hipra@hipra.com 
Faks +34 972 430661 E-pošta: hipra@hipra.com
The method of administration is by intramuscular route, in the neck muscles. 
Pot uporabe je intramuskularna, v vratne mišice.
Suspension after reconstitution: transparent pinkish liquid. 
Suspenzija po rekonsituciji: Rožnata prozorna tekočina.
Any person intending to manufacture, import, possess, sell, supply and/or use of HIPRABOVIS IBR MARKER LIVE must consult the relevant Member State's competent authority on the current vaccination policies prior to the manufacture, import, possession, sale, supply and/or use. 
prodajati, oskrbovati in/ali uporabljati HIPRABOVIS IBR MARKER LIVE, se mora posvetovati s pristojnim organom posamezne države članice o veljavnih programih cepljenja še pred izdelavo,
Potassium chloride Water for injections 
Natrijev klorid Kalijev klorid Voda za injekcije
Pharmacotherapeutic group: Live viral vaccines, bovine rhinotracheitis virus (IBR). 
Farmakoterapevtska skupina Živa virusna cepiva za govedo, virus infekcioznega bovinega rinotraheitisa (IBR).
PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARDBOARD BOX: 5 AND 25 DOSES 
PODATKI NA ZUNANJI OVOJNINI ŠKATLA: 5 IN 25 ODMERKOV
Abbreviations: gE-: deleted glycoprotein E; tk-: deleted thymidine kinase; CCID: cell culture infectious dose 
Okrajšave: gE-: izbrisan glikoprotein E; tk-: izbrisana timidin kinaza; CCID: odmerek za infekcije celične kulture
Avda la Selva, 135 
La Selva, 135
Animals vaccinated with HIPRABOVIS IBR MARKER LIVE will test positive (alongside cattle infected with BoHV-1 field virus or vaccinated with conventional non-marker BoHV-1 vaccines) when samples are analysed in tests based on the identification of antibodies to any other BoHV-1 antigens. 
Pri živalih, ki so bile cepljene s cepivom Hiprabovis IBR Marker Live, bo test pozitiven (kot pri govedu, ki je okuženo z divjim virusom BoHV-1 ali je bilo cepljeno s cepivom za BoHV-1 brez markerja), kadar se vzorce analizira s testi, ki temeljijo na identifikaciji protiteles na katerega koli od drugih protiteles za BoHV-1.
Do not store and transport above 25°C). 
POSEBNA NAVODILA ZA SHRANJEVANJE Ne shranjujte in prevažajte pri temperaturi nad 25 °C.
Lyophilisate of 5, 25 and 30 doses: Store and transport refrigerated (2 °C - 8 °C). 
Liofilizat za 5, 25 in 30 odmerkov: Shranjujte in prevažajte v hladilniku (2 ºC - 8 ºC) Vehikel za 5 in 25 odmerkov:: Shranjujte in prevažajte v hladilniku (2 ºC - 8 ºC)
Solvent for HIPRABOVIS IBR MARKER LIVE 
Vehikel za HIPRABOVIS IBR MARKER LIVE
la Selva, 135 17170 Amer (Girona) SPAIN 
La Selva, 135 17170 Amer (Girona) ŠPANIJA
Phosphate buffer solution. 
Raztopina fosfatnega pufra.
Thereafter a single booster dose of 2 ml should be administered every six months. 
Pot zaključenem osnovnem cepljenju je vsakih šest mesecev potreben spodbujevalen odmerek po 2 ml.
Disodium phosphate dodecahydrate Potassium dihydrogen phosphate Sodium chloride 
Natrijev hidrogenfosfat dodekahidrat Kalijev dihidrogen fosfat
Vaccinate healthy animals only. 
Posebni previdnostni ukrepi za uporabo pri živalih Cepite le zdrave živali.
Vaccinated animals can be differentiated from field virus infected animals due to the marker deletion (gE-) by means of commercial diagnostic kits, unless the animals were previously vaccinated with a conventional vaccine or infected with field virus. 
1) za zmanjšanje kliničnih znakov Infekcioznega bovinega rinotraheitisa in izločanje divjega virusa Cepljene živali je mogoče razlikovati od živali, ki so okužene z divjim virusom, na osnovi izbrisa markerja (gE-) s pomočjo komercialnih diagnostičnih kompletov, razen v primeru, ko so živali predhodno cepili z običajnim cepivom ali pa so okužene z divjim virusom.
Live gE- tk- double-gene deleted bovine herpes virus type 1 (BoHV-1), strain CEDDEL: 106.3 - 107.3 
Živ gE- tk- Goveji Herpes Virus vrste 1 (BoHV-1) z dvojno delecijo genov, sev CEDDEL: 106.3 - 107.3
Each dose of 2 ml contains: Live gE- tk- double-gene deleted bovine herpes virus type 1 (BoHV-1), strain CEDDEL: 106.3 - 107.3 CCID50. 
Vsak odmerek po 2 ml vsebuje: Živ gE- tk- Goveji Herpes Virus vrste 1 (BoHV-1) z dvojno delecijo genov, sev CEDDEL: 106.3 - 107.3 CCID50
PACKAGE LEAFLET: HIPRABOVIS IBR MARKER LIVE 
NAVODILO ZA UPORABO HIPRABOVIS IBR MARKER LIVE
The solvent should be allowed to warm to a temperature between 15 and 20 ºC before reconstitution of the lyophilisate. 
Preden liofilizat rekonstituirate, je treba vehikel pustiti, da se segreje na 15 ºC in 20 ºC.
lyophilisate and solvent for suspension for injection for cattle. 
liofilizat in vehikel za suspenzijo za injiciranje za govedo.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS BOTTLE FOR THE LYOPHILISATE 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Shelf life of the lyophilisate as packaged for sale: 2 years. 
Rok uporabnosti liofilizata v pakiranju za prodajo: 2 leti Rok uporabnosti vehikla v pakiranju za prodajo: 5 leti Rok uporabnosti po rekonstituciji v skladu z navodili: 6 ur.
Cardboard box containing 1 bottle with 5 doses of lyophilisate and 1 bottle with 10 ml of solvent. 
Kartonska škatla z 1 stekleničko z liofilizatom s 5 odmerki in 1 stekleničko z 10 ml vehikla.
The manufacture, import, possession, sale, supply and/or use of HIPRABOVIS IBR MARKER LIVE may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation. 
Izdelava,uvoz/vnos, posedovanje, prodaja, oskrba in/ali uporaba HIPRABOVIS IBR MARKER LIVE
PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARDBOARD BOX: 30 DOSES LYOPHILISATE 
PODATKI NA ZUNANJI OVOJNINI ŠKATLA: 30 ODMERKOV LIOFILIZATA
Store and transport refrigerated. 
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte in prevažajte hladilniku.
Solvent: Phosphate buffer solution. 
Vehikel: Raztopina fosfatnega pufra
No adverse reactions except those mentioned in section 6 “Adverse reactions” were observed after the administration of a 10-fold vaccine dose. 
Po dajanju 10-kratnega odmerka cepiva ni bilo opaziti neželenih učinkov razen tistih, ki so navedeni v točki "Neželeni učinki".
Name and address of the manufacturer of the biological active substances Laboratorios Hipra, S.A. 
Ime in naslov izdelovalca(izdelovalcev) biološke zdravilne učinkovine (zdravilnih učinkovin).
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary 
4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi), (če je potrebno) Po dajanju 10-kratnega odmerka cepiva ni bilo opaziti neželenih učinkov razen tistih, ki so navedeni v poglavju 4.6.
Avoid the introduction of contamination during reconstitution and use. 
Med rekonstitucijo in uporabo pazite, da ne vnesete kontaminantov.
Cardboard box containing 1 bottle with 25 doses lyophilisate and 1 bottle with 50 ml of solvent. 
Kartonska škatla z 1 stekleničko z liofilizatom s 25 odmerki in 1 stekleničko s 50 ml vehikla.. Kartonska škatla z 1 stekleničko z liofilizatom s 30 odmerki Kartonska škatla z 1 stekleničko s 60 ml vehikla.
Each dose of 2 ml: Live gE- tk- double-gene deleted bovine herpes virus type 1 (BoHV-1), strain CEDDEL: 106.3 - 107.3 CCID50. 
Goveji Herpes Virus vrste 1 (BoHV-1) z dvojno delecijo genov, sev CEDDEL: 106.3 - 107.3 CCID50 Okrajšave:
HIPRABOVIS IBR MARKER LIVE lyophilisate for suspension for injection. 
HIPRABOVIS IBR MARKER LIVE liofilizat za suspenzijo za injiciranje.
HIPRABOVIS IBR MARKER LIVE lyophilisate for suspension for injection for cattle. 
HIPRABOVIS IBR MARKER LIVE liofilizat za suspenzijo za injiciranje za govedo.
Monosodium glutamate Sodium chloride 
Natrijev glutamat Natrijev klorid Kalijev klorid Saharoza Voda za injekcije
For the active immunisation of cattle from 3 months of age against bovine herpes virus type 1 (BoHV-1) to reduce the clinical signs of Infectious bovine rhinotracheitis (IBR) and field virus excretion. 
Za aktivno imunizacijo goveda nad 3 mesece starosti proti Govejemu Herpes Virusu vrste 1 (BoHV
HIPRABOVIS IBR MARKER LIVE lyophilisate and solvent for suspension for injection for cattle. 
HIPRABOVIS IBR MARKER LIVE liofilizat in vehikel za suspenzijo za injiciranje za govedo.
Marketing authorisation holder and manufacturer responsible for batch release: LABORATORIOS HIPRA, S.A. 
Imetnik dovoljenja za promet z zdravilom in izdelovalec odgovoren za sproščanje serij:
Name and address of the manufacturer responsible for batch release Laboratorios Hipra, S.A. 
Ime in naslov izdelovalca(izdelovalcev) zdravila, odgovornega (odgovornih) za sprostitev serije
HIPRABOVIS IBR MARKER LIVE lyophilisate and solvent for suspension for injection. 
HIPRABOVIS IBR MARKER LIVE liofilizat in vehikel za suspenzijo za injiciranje.
Lyophilisate: Store and transport refrigerated (2 °C - 8 °C). 
Posebna navodila za shranjevanje Liofilizat: Shranjujte in prevažajte v hladilniku (2 ºC - 8 ºC) Vehikel za 5 in 25 odmerkov: Shranjujte in prevažajte v hladilniku (2 ºC - 8 ºC) Vehikel za 30 odmerkov:: Ne shranjujte in prevažajte pri temperaturi nad 25 °C..
For the active immunisation of cattle from 3 months of age against bovine herpes virus type 1 (BoHV1) to reduce the clinical signs of Infectious bovine rhinotracheitis (IBR) and field virus excretion. 
za zmanjšanje kliničnih znakov Infekcioznega bovinega rinotraheitisa in izločanje divjega virusa Nastop imunosti: 21 dni po zaključku osnovnega cepljenja.
The patients were followed up for an average of 14.5 months. 
V povprečju so bolnike spremljali do 14,5 meseca.
It is available as tablets (5 and 10 mg). 
Na voljo je v obliki tablet (5 in 10 mg).
It is recommended that treatment with Efient and aspirin continue for up to a year. 
Priporoča se, da se zdravljenje z zdravilom Efient in aspirinom nadaljuje do enega leta.
The European Commission granted a marketing authorisation valid throughout the European Union for Efient on 25 February 2009. 
Evropska komisija je dovoljenje za promet z zdravilom Efient, veljavno po vsej Evropski uniji, izdala 25. februarja 2009.
What measures are being taken to ensure the safe and effective use of Efient? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Efient?
The full EPAR for Efient 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) za zdravilo Efient je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Other information about Efient 
Druge informacije o zdravilu Efient
The use of Efient is not recommended in patients over 75 years of age, unless the doctor has carefully considered its benefits and risks, and regards treatment with Efient as necessary. 
Uporaba zdravila Efient ni priporočena pri bolnikih, starejših od 75 let, razen če je zdravnik skrbno proučil njegove koristi in tveganja in je ocenil, da je zdravljenje z zdravilom Efient potrebno.
In addition, the company that markets Efient will make sure that educational materials are available in all Member States for doctors who will treat patients with the medicine. 
Poleg tega bo družba, ki trži zdravilo Efient, poskrbela, da bo v vseh državah članicah zdravnikom, ki bodo bolnike zdravili s tem zdravilom, na voljo izobraževalno gradivo.
A risk management plan has been developed to ensure that Efient is used as safely as possible. 
Za zagotovitev čim varnejše uporabe zdravila Efient je bil pripravljen načrt obvladovanja tveganj.
This is a summary of the European public assessment report (EPAR) for Efient. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Efient.
The materials will include information on how to prescribe the medicine safely and to remind doctors that the medicine is not recommended for patients over the age of 75 years. 
To bo vključevalo informacije o varnem predpisovanju zdravila in opozorilo zdravnikom, da uporaba zdravila pri bolnikih, starejših od 75 let, ni priporočena.
What benefit has Efient shown during the studies? 
Kakšne koristi je zdravilo Efient izkazalo med študijami?
For more information about treatment with Efient, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Efient preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The study involved almost 14,000 adults with acute coronary syndrome who were about to undergo percutaneous coronary intervention. 
Študija je vključevala skoraj 14 000 odraslih z akutnim koronarnim sindromom, ki so bili tik pred perkutano koronarno intervencijo.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Efient. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
At the end of the study, 9% of the patients taking Efient had died from cardiovascular causes or had a heart attack or stroke (643 out of 6,813) compared with 11% of the patients taking clopidogrel (781 out of 6,795). 
Ob koncu študije je 9 % (643 od 6 813) bolnikov, ki so jemali zdravilo Efient, umrlo zaradi srčnožilnih vzrokov ali doživelo srčni infarkt ali kap v primerjavi z 11 % (781 od 6 795) bolnikov, ki so jemali klopidogrel.
Efient treatment starts with one 60-mg dose. 
Zdravljenje z zdravilom Efient se začne z enim 60-miligramskim odmerkom.
What is the risk associated with Efient? 
Kakšna tveganja so povezana z zdravilom Efient?
The Committee recommended that Efient be given marketing authorisation. 
Odbor je priporočil, da se za zdravilo Efient izda dovoljenje za promet.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Efient, 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.
Efient is a medicine that contains the active substance prasugrel. 
Efient je zdravilo, ki vsebuje zdravilno učinkovino prasugrel.
Why has Efient been approved? 
Zakaj je bilo zdravilo Efient odobreno?
The most common side effects with Efient (seen in between 1 and 10 patients in 100) are anaemia (low red blood cell counts), haematoma (a collection of blood under the skin or in a muscle), epistaxis (nosebleeds), gastrointestinal haemorrhage (bleeding in the stomach or gut), rash, haematuria (blood in the urine), bleeding from needle puncture sites, haematoma at puncture sites and bruising. 
Najpogostejši neželeni učinki zdravila Efient (opaženi pri 1 do 10 bolnikih od 100) so anemija (nizko število rdečih krvnih celic), hematom (skupek krvi pod kožo ali v mišici), epistaksa (krvavitev iz nosu), gastrointestinalna krvavitev (krvavitev v želodcu ali črevesju), izpuščaj, hematurija (kri v urinu), krvavitev iz mest vboda igle, hematom na mestih vboda in modrice.