natgillin/translations-raw huggingface dataset:
It is able to multiply locally at the submucosal injection site during a short period and is shed into the oro-nasal cavity during a few days, but the vaccine strain does not survive on the oro-nasal mucosa and does not disseminate systemically at the recommended dose. 
Na mestu submukoznega injiciranja se lahko krajši čas lokalno razmnožuje in nekaj dni širi v ustno in nosno votlino, vendar na sluznici ustne in nosne votline ne preživi in se pri uporabi priporočenega odmerka ne širi v organizem.
Restrain the animal's head, lift the upper lip and insert the needle into the inside of the upper lip until the applicator rests on the lip. Administer the whole contents of the syringe into the inside of the upper lip (see Figure 3). 
Konju zadržite glavo, dvignite zgornjo ustnico in iglo vbodite na notranji strani zgornje ustnice tako globoko, da se aplikator dotakne njene površine.
Lyophilisate: Store in a refrigerator (2 °C - 8 °C). 
Liofilizat: Shranjujte v hladilniku (2 °C-8 °C).
Vaccination scheme: 
Revakcinacija:
Basic vaccination: Horses from 4 months of age onwards receive two vaccinations of one dose with a 4 week interval. 
Shema cepljenja: Osnovno cepljenje: konje od 4 mesecev starosti dalje cepimo dvakrat s po enim odmerkom s 4
PHARMACEUTICAL FORM Lyophilisate and solvent for suspension for injection Lyophilisate: off-white or cream-coloured pellet Solvent: clear colourless solution 
Liofilizat in vehikel za suspenzijo za injiciranje Liofilizat: peleta belkaste ali krem barve Vehikel: bistra brezbarvna raztopina
Onset of immunity: 2 weeks after basic vaccination. 
Imunost se razvije dva tedna po osnovnem cepljenju.
QUALITATIVE AND QUANTITATIVE COMPOSITION Per dose of 0.2 ml vaccine: 
V odmerku po 0,2 ml cepiva:
The vaccine strain is a deletion mutant with a limited growth potential in mammalian tissue. 
Cepni sev je delecijski mutant z omejeno potencialno rastjo v tkivu sesalcev.
Anti-inflammatory therapy is indicated even if only a very small amount of the product in injected. 
Čeprav je bila injicirana le zelo majhna količina proizvoda, je indicirana protivnetna terapija.
The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009. 
C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN ZAOSTANKOV ZDRAVILA (MRL) Učinkovina biološkega izvora, namenjena vzbujanju imunosti, ni vključena v Uredbo(ES) št.
Therefore only a single dose of vaccine is needed to restore immunity. 
Imunski odziv na osnovno cepljenje se ohrani do šest mesecev, zato je za obnovitev imunosti potreben samo en odmerek cepiva.
DOSAGE FOR EACH SPECIES, ROUTES AND METHOD OF ADMINISTRATION Submucosal vaccination of 0.2 ml of reconstituted product. 
4.9 Odmerjanje in pot uporabe Submukozno cepljenje z 0,2 ml rekonstituiranega cepiva.
Furthermore, an increase in rectal temperature up to 2.5 °C may occur on the day of vaccination. 
Na dan cepljenja se lahko za največ 2,5 °C poveča rektalna temperatura.
Aseptically reconstitute the freezedried vaccine with 0.3 ml of the sterile solvent provided. 
Aseptično rekonstituirajte liofilizirano cepivo z 0,3 ml priloženega sterilnega vehikla.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY MEDICINAL PRODUCTS OR WASTE MATERIALS 
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEPORABLJENEGA ZDRAVILA ALI ODPADNIH SNOVI
MARKETING AUTHORISATION HOLDER 
DATUM PRIDOBITVE DOVOLJENJA ZA PROMET
Aseptically reconstitute the lyophilisate with 0.3 ml of the sterile solvent provided. 
Liofilizat aseptično rekonstituirajte z 0,3 ml priloženega sterilnega vehikla.
THE WORDS "KEEP OUT OF THE SIGHT AND REACH OF CHILDREN" 
BESEDILO ''ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM''
ROUTE OF ADMINISTRATION See package leaflet. 
POT UPORABE ZDRAVILA Glejte priloženo navodilo.
After vaccination a diffusely swollen reaction, which may be warm or painful, develops at the injection site within 4 hours. 
Po cepljenju se na mestu vboda v 4 urah pojavi reakcija v obliki difuzne otekline, ki je lahko topla ali boleča.
Use during pregnancy, lactation or lay: Do not use in pregnant or lactating mares. 
4.7 Uporaba v obdobju brejosti, laktacije ali nesnosti Ne uporabite pri brejih kobilah ali kobilah v obdobju laktacije.
Further, an increase in rectal temperature up to 2 °C may occur on the day of vaccination. 
Na dan cepljenja se lahko za največ 2 °C poveča rektalna temperatura.
QUANTITY OF THE ACTIVE SUBSTANCE Live Streptococcus equi. 
Živi Streptococcus equi
STATEMENT OF ACTIVE AND OTHER SUBSTANCE 0.2 ml dose: 
V odmerku po 0,2 ml:
NAME OF THE VETERINARY MEDICINAL PRODUCT Equilis StrepE, lyophilisate for suspension for injection, for horses 
Equilis StrepE, liofilizat za suspenzijo za injiciranje, za konje
THE WORDS "KEEP OUT OF THE SIGHT AND REACH OF CHILDREN" Keep out of the sight and reach of children. 
BESEDILO ''ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM'' Zdravilo shranjujte nedosegljivo otrokom.
PARTICULARS TO APPEAR ON THE INNER BOX WITH LYOPHILISATE 
Za dajanje submukozno na notranjo stran zgornje ustnice
Lyophilisate: off-white or cream coloured pellet Solvent: clear colourless solution 
1 Colony forming units - kolonijske enote Liofilizat: peleta belkaste ali krem barve Vehikel: bistra brezbarvna raztopina
PACKAGE LEAFLET FOR: Equilis StrepE, lyophilisate and solvent for suspension for injection, for horses 
Equilis StrepE, liofilizat in vehikel za suspenzijo za injiciranje, za konje
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST REVISED Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/). 
Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani
ROUTE OF ADMINISTRATION For submucosal use. 
Za submukozno uporabo
Marketing authorization holder and manufacturer responsible for batch release: Intervet International B.V. 
Imetnik dovoljenja za promet z zdravilom in izdelovalec, odgovoren za sprostitev serije Intervet International B.V.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS 
6.6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi
Slight enlargements, which may be transient painful, of the retropharyngeal and mandibular lymph nodes may occur for a few days after vaccination. 
Nekaj dni po cepljenju so lahko blago povečani retrofaringealni in mandibularni limfni vozli, kar lahko spremlja prehodna bolečina.
− rare (more than 1 but less than 10 animals in 10,000 animals) 
- občasni (pojavijo se pri več kot1živali toda pri manj kot 10 živalih od 1.000 živali) - redki (pojavijo se pri več kot1živali toda pri manj kot 10 živalih od 10.000 živali) - zelo redki (pojavijo se pri manj kot 1 živali od 10.000 živali, vključujoč posamezne primere).
For animal treatment only. 
Samo na veterinarski recept.
Name and address of the manufacturer of the biological active substance Intervet International B.V. 
Ime in naslov izdelovalca biološke aktivne učinkovine
BATCH NUMBER Lot {number} 
IZDELOVALČEVA ŠTEVILKA SERIJE Lot {številka}
EXPIRY DATE EXP: {month/year} 
DATUM IZTEKA ROKA UPORABNOSTI EXP: {mesec/leto}
A slight cloudy discharge commonly occurs from the mucosal injection site at 3 or 4 days post vaccination. 
Običajno se 3 do 4 dni po cepljenju na mestu vboda pojavi blag moten izcedek.
In addition to the clinical signs given under section 6, vaccination with a ten times overdose may induce an abscess in one of the submandibular lymph nodes. 
Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno) Poleg kliničnih znakov, ki so opisani v poglavju 6, lahko cepljenje z 10-krat prevelikim odmerkom povzroči tudi absces na katerem od submandibularnih limfnih vozlov.
NAME OF THE DILUENT 
Viala z vehikom
SPECIAL STORAGE CONDITIONS Keep out of the sight and reach of children. 
Zdravilo shranjujte nedosegljivo otrokom.
EXPIRY DATE EXP {month/year} 
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA Exp {mesec/leto}
EXPIRY DATE Exp {month/year} 
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP{mesec/leto}
6.1 List of excipients 
6.5 Vrsta ovojnine in vsebina
Fimbriae Types 2 and 3 (FIM) 
fimbrije tipa 2 in 3 (FIM)
3 micrograms Conjugated to meningococcal protein2 50 micrograms adsorbed on aluminium phosphate (0.17 mg Al adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.15 mg Al 3 produced in yeast (Saccharomyces cerevisiae) cells by recombinant DNA technology 4 produced in Vero cells or equivalent antigenic quantity determined by a suitable immunochemical method. 
adsorbiran na aluminijev fosfat (0,17 mg Al adsorbiran na amorfni aluminijev hidroksifosfat sulfat (0,15 mg Al 3 pridobljen v celicah kvasovke (Saccharomyces cerevisiae) s tehnologijo rekombinantne DNA 4 pridobljen v celicah Vero ali enakovredna količina antigenov, določena z ustrezno imunokemijsko metodo.
Poliovirus (Inactivated)4: Type 1 (Mahoney) 
poliovirus (inaktiviran)4 tip 1 (sev Mahoney)
Hepatitis B surface antigen2,3: 
površinski antigen hepatitisa B2,3
50 (5x10) pre-filled syringes (multipack) 
50 (5 x 10) napolnjenih injekcijskih brizg (združeno pakiranje)
--1 One dose (0.5 ml) contains: Diphtheria Toxoid1: 
--1 En odmerek (0,5 ml) vsebuje: toksoid davice1
Tetanus Toxoid1: 
toksoid tetanusa1
Bordetella pertussis antigens1: Pertussis Toxoid (PT) 
antigene Bordetella pertussis1 toksoid bakterije oslovskega kašlja (PT)
Filamentous Haemagglutinin (FHA) 20 micrograms Pertactin (PRN) 
pertaktin (PRN)
The European Commission granted a marketing authorisation valid throughout the European Union for Entyvio on 22 May 2014. 
Evropska komisija je dovoljenje za promet z zdravilom Entyvio, veljavno po vsej Evropski uniji, izdala 22. maja 2014.
What measures are being taken to ensure the safe and effective use of Entyvio? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Entyvio?
What is Entyvio and what is it used for? 
Kaj je zdravilo Entyvio in za kaj se uporablja?
Furthermore, the risks are considered manageable, despite the lack of long-term safety data, if recommendations in place are followed. 
Poleg tega so bila tveganja kljub pomanjkanju podatkov o dolgoročni varnosti ocenjena kot obvladljiva, če se upoštevajo sprejeta priporočila.
The full EPAR and risk management plan summary for Entyvio 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 Entyvio sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The recommended dose is 300 mg given at weeks zero, two and six, and then every eight weeks after that in patients who respond. 
Priporočeni odmerek je 300 mg, ki se daje na ničti, drugi in šesti teden ter nato pri bolnikih z odzivom na vsakih osem tednov.
This is a summary of the European public assessment report (EPAR) for Entyvio. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Entyvio.
It is not intended to provide practical advice on how to use Entyvio. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Entyvio was also shown to be more effective than placebo at improving symptoms of Crohn's disease. 
Prav tako se je zdravilo Entyvio izkazalo za učinkovitejše od placeba pri izboljšanju simptomov Crohnove bolezni.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Entyvio's benefits are greater than its risks and recommended that it be approved for use in the EU. 
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Entyvio večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
Entyvio is given as an infusion that lasts 30 minutes. 
Zdravilo Entyvio se daje z infuzijo, ki traja najmanj 30 minut.
Patients who receive Entyvio must be given a special alert card that summarises the safety information about the medicine. 
Bolniki, ki prejemajo zdravilo Entyvio, morajo prejeti posebno opozorilno kartico, na kateri so povzete informacije o varnosti zdravila.
The company will also provide educational material to all healthcare professionals expected to prescribe Entyvio to remind them of the need to monitor patients for signs of neurological disease or PML, in particular those treated with certain biological medicines which may potentially cause PML. 
Poleg tega bo družba zagotovila izobraževalno gradivo za vse zdravstvene delavce, ki naj bi predpisovali zdravilo Entyvio, da jih bo opozorila na potrebo po spremljanju bolnikov glede znakov nevroloških bolezni in PML, zlasti tistih, ki se zdravijo z določenimi biološkimi zdravili, ki lahko povzročijo PML.
Why is Entyvio approved? 
Zakaj je bilo zdravilo Entyvio odobreno?
A risk management plan has been developed to ensure that Entyvio is used as safely as possible. 
Za zagotovitev čim varnejše uporabe zdravila Entyvio je bil pripravljen načrt obvladovanja tveganj.
Other information about Entyvio 
Druge informacije o zdravilu Entyvio
In ulcerative colitis and Crohn's disease these cells are involved in causing inflammation in the gut. 
Pri ulceroznem kolitisu in Crohnovi bolezni te celice sodelujejo pri povzročanju vnetja v črevesju.
Vedolizumab has been designed to attach to ‘alfa-4-beta-7 integrin', a protein mostly found on the surface of certain white blood cells in the gut. 
Vedolizumab je bil zasnovan tako, da se veže na „integrin alfa-4beta-7“, beljakovino, ki je najpogosteje prisotna na površini določenih belih krvnih celic v črevesju.
Entyvio must not be used in people with active serious infections such as tuberculosis, sepsis (infection in the blood), listeriosis (infection with bacteria called Listeria) or opportunistic infections (those seen in patients with a weakened immune system) such as progressive multifocal leukoencephalopathy (PML, a rare brain infection that usually leads to severe disability or death). 
Zdravilo Entyvio se ne sme uporabljati pri osebah z aktivnimi resnimi okužbami, kot so tuberkuloza, sepsa (okužba krvi), listerioza (okužba z bakterijo, imenovano Listeria) ali oportunistične okužbe (takšne, ki se pojavijo pri bolnikih z oslabljenim imunskim sistemom), kot je progresivna multifokalna levkoencefalopatija (PML, tj. redka okužba možganov, ki običajno povzroči hudo invalidnost ali smrt).
What are the risks associated with Entyvio? 
Kakšna tveganja so povezana z zdravilom Entyvio?
For more information about treatment with Entyvio, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Entyvio preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Patients received either Entyvio or placebo (a dummy treatment) and the main measure of effectiveness was the proportion of patients whose symptoms improved after 6 weeks of treatment. 
Bolniki so prejemali bodisi zdravilo Entyvio bodisi placebo (zdravilo brez zdravilne učinkovine), glavno merilo učinkovitosti pa je bilo delež bolnikov, pri katerih so se po 6 tednih zdravljenja simptomi izboljšali.
Entyvio is produced by a method known as ‘recombinant DNA technology'; it is made by cells into which a gene (DNA) has been introduced that makes them able to produce vedolizumab. 
Zdravilo Entyvio se pridobiva z metodo, imenovano „tehnologija rekombinantne DNA“: izdelajo ga celice, v katere so vstavili gen (DNA), s pomočjo katerega lahko tvorijo vedolizumab.
Entyvio was shown to be more effective than placebo: 47% (106 out of 225) of patients who received Entyvio showed an improvement in symptoms, compared with 26% (38 out of 149) of patients who received placebo. 
Zdravilo Entyvio se je izkazalo za učinkovitejše od placeba: izboljšanje simptomov so opazili pri 47 % (106 od 225) bolnikov, ki so prejemali zdravilo Entyvio, v primerjavi s 26 % (38 od 149) bolnikov, ki so prejemali placebo.
It can only be obtained with a prescription and treatment should be started and supervised by a specialist who has experience in the diagnosis and treatment of ulcerative colitis or Crohn's disease. 
Izdaja zdravila je le na recept, zdravljenje z njim pa mora uvesti in nadzorovati zdravnik specialist, ki ima izkušnje z diagnosticiranjem in zdravljenjem ulceroznega kolitisa ali Crohnove bolezni.
What benefits of Entyvio have been shown in studies? 
Kakšne koristi je zdravilo Entyvio izkazalo v študijah?
The most common side effects with Entyvio (which may affect more than 1 in 10 people) are nasopharyngitis (inflammation of the nose and throat such as a cold), headache and arthralgia (joint pain). 
Najpogostejši neželeni učinki zdravila Entyvio (ki se lahko pojavijo pri več kot 1 osebi od 10) so nazofaringitis (vnetje nosu in žrela, kot je na primer prehlad), glavobol in artralgija (bolečine v sklepih).
By blocking alfa-4-beta-7 integrin, vedolizumab reduces the inflammation in the gut and the symptoms of these diseases. 
Vedolizumab z zaviranjem integrina alfa-4-beta-7 zmanjša vnetje v črevesju in simptome teh bolezni.
In Crohn's disease, the CHMP considered that although the time required for improvement of symptoms may be longer and the size of the effect limited when compared with anti-TNF-alfa therapy, Entyvio still offers a benefit for patients because of its different mechanism of action and safety profile. 
Glede Crohnove bolezni je odbor CHMP menil, da je sicer čas, potreben za izboljšanje simptomov, lahko daljši, obseg učinka pa omejen v primerjavi z zdravljenjem z zaviralci TNF-alfa, vendar ima zdravilo Entyvio zaradi drugačnega mehanizma delovanja ter varnostnega profila kljub temu koristi za bolnike.
It is used to treat adult patients with ulcerative colitis (a disease causing inflammation and ulcers in the lining of the gut) or Crohn's disease (a disease causing inflammation of the digestive tract). 
Uporablja se za zdravljenje odraslih bolnikov z ulceroznim kolitisom (boleznijo, ki povzroča vnetje in razjede na črevesni sluznici) ali Crohnovo boleznijo (boleznijo, ki povzroča vnetje prebavnega trakta).
Entyvio is a medicine that contains the active substance vedolizumab. 
Entyvio je zdravilo, ki vsebuje zdravilno učinkovino vedolizumab.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Entyvio, including the appropriate precautions to be followed by healthcare professionals and patients. 
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Entyvio in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
In one main study in adult patients with moderate to severe active Crohn's disease in whom conventional therapy or TNF-alfa antagonists were ineffective or could not be tolerated, 15% (32 out of 220) of patients receiving Entyvio showed improved symptoms after 6 weeks of treatment, compared with 7% (10 out of 148) of patients on placebo. 
V eni glavni študiji pri odraslih bolnikih z zmerno do močno aktivno Crohnovo boleznijo, pri katerih konvencionalno zdravljenje ali zdravljenje z zaviralci TNF-alfa ni bilo učinkovito ali pa ga niso prenašali, so izboljšanje simptomov po 6 tednih opazili pri 15 % (32 od 220) bolnikov, ki so prejemali zdravilo Entyvio, v primerjavi s 7 % (10 od 148) bolnikov, ki so prejemali placebo.
Similarly, in this study the maintenance of the effect up to 52 weeks with Entyvio was more effective than with placebo. 
Podobno je bilo v tej študiji vzdrževanje učinka zdravila Entyvio v obdobju 52 tednov uspešnejše kot pri placebu.
In ulcerative colitis, the Committee considered that the benefit of Entyvio has been clearly demonstrated, which is relevant for patients who do not respond to TNF-alfa therapy. 
Odbor je menil, da je bila pri ulceroznem kolitisu korist zdravila Entyvio nedvomno dokazana, kar je pomembno za bolnike, ki se ne odzivajo na zdravljenje z zaviralci TNF-alfa.
For practical information about using Entyvio, patients should read the package leaflet or contact their doctor or pharmacist. 
Za praktične informacije o uporabi zdravila Entyvio naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
In addition, the study also showed that Entyvio maintained the effect up to 52 weeks more effectively than placebo. 
Poleg tega je študija pokazala, da je zdravilo Entyvio uspešneje vzdrževalo učinek v obdobju 52 tednov kot placebo.
Vedolizumab is used to treat moderate to severe active disease when conventional therapy or medicines called TNF-alfa antagonists are ineffective, no longer effective, or cannot be tolerated by the patient. 
Vedolizumab se uporablja za zdravljenje zmerno do močno aktivne bolezni, kadar konvencionalno zdravljenje ali zdravljenje z zdravili, imenovanimi zaviralci tumorje nekrotizirajočega faktorja alfa (TNF-alfa), ni učinkovito, ni več učinkovito ali pa ga bolnik ne prenaša.
For the full list of all side effects reported with Entyvio, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Entyvio, glejte navodilo za uporabo.
In ulcerative colitis, Entyvio has been investigated in a main study in patients with moderate to severe active disease in whom conventional therapy or TNF-alfa antagonists were ineffective or could not be tolerated. 
Zdravilo Entyvio so pri ulceroznem kolitisu proučili v glavni študiji pri bolnikih z zmerno do močno aktivno boleznijo, pri katerih konvencionalno zdravljenje ali zdravljenje z zaviralci TNF-alfa ni bilo učinkovito ali pa ga niso prenašali.
All patients are monitored for any reactions during the infusion and for at least one to two hours after the end of the infusion. 
Med infundiranjem in še najmanj eno do dve uri po njem je treba preverjati, ali so se pri bolniku pojavile kakršne koli reakcije.
The active substance in Entyvio, vedolizumab, is a monoclonal antibody. 
Zdravilna učinkovina v zdravilu Entyvio, vedolizumab, je monoklonsko protitelo.
Entyvio is available as a powder to be made up into a solution for infusion (drip) into a vein. 
Zdravilo Entyvio je na voljo v obliki praška za pripravo raztopine za infundiranje (kapalno infuzijo) v veno.
How is Entyvio used? 
Kako se zdravilo Entyvio uporablja?
How does Entyvio work? 
Kako zdravilo Entyvio deluje?
The European Commission issued a decision on 2 September 2011. 
Evropska komisija je odločbo izdala 2. septembra 2011.
The use in children was further clarified. 
Natančneje je bila pojasnjena tudi uporaba pri otrocih.
Diflucan is authorised in the EU via national procedures. 
Zdravilo Diflucan je v EU odobreno z nacionalnimi postopki.
Why was Diflucan reviewed? 
Zakaj je bilo zdravilo Diflucan pregledano?
The CHMP harmonised the dosing recommendations for the various indications to be in line with international guidelines. 
CHMP je uskladil priporočila za odmerjanje za različne indikacije, tako da so usklajena z mednarodnimi smernicami.
The European Medicines Agency has completed a review of Diflucan. 
Evropska agencija za zdravila je zaključila pregled zdravila Diflucan.
The Committee harmonised the wording on the use of the medicine for these conditions, specifying when it is to be used for treatment and prophylaxis (prevention) and introducing restrictions for certain indications. 
Odbor je uskladil besedilo za uporabo zdravila pri teh boleznih in opredelil, kdaj je treba zdravilo uporabljati za zdravljenje in profilakso (preprečevanje), ter uvedel omejitve za nekatere indikacije.
On 18 February 2010, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Diflucan in the EU. 
Evropska komisija je 18. februarja 2010 zadevo napotila na CHMP, da bi uskladila dovoljenja za promet z zdravilom Diflucan v EU.
Diflucan is an antifungal medicine that belongs to the triazoles group. 
Diflucan je protiglivično zdravilo, ki spada v skupino triazolov.
It contains the active substance fluconazole. 
Vsebuje zdravilno učinkovino flukonazol.
Diflucan is also available in the EU under other trade names: Fluconazole, Fungustatin, Fungata, Triflucan. 
Zdravilo Diflucan je v EU na voljo tudi pod drugimi tržnimi imeni: Fluconazole, Fungustatin, Fungata, Triflucan.