natgillin/translations-raw huggingface dataset:
There have been reports of bronchospasm or exacerbation of asthma associated with the use of ketorolac ophthalmic solution in patients who either have a known hypersensitivity to aspirin/NSAIDs, or a past medical history of asthma. 
V povezavi z uporabo raztopine za oko, ki vsebuje ketorolak, so poročali o bronhospazmih in eksacerbacijah astme pri bolnikih, ki so bili bodisi dokazano preobčutljivi za acetilsalicilno kislino/nesteroidna protivnetna zdravila bodisi so imeli astmo v anamnezi.
Omidria should not be used during breast-feeding. 
Zdravilo Omidria se ne sme uporabljati med dojenjem.
Use within 6 hours of dilution. 
Razredčeno raztopino porabite v 6 urah po redčenju.
Clear, colourless to slightly yellow, solution with a pH: 6.3 ±0.3. 
FARMACEVTSKA OBLIKA koncentrat za raztopino za intraokularno izpiranje Bistra, brezbarvna do rahlo rumenkasta raztopina s pH: 6,3 ± 0,3.
In case of accidental intracameral injection of the concentrated solution, the anterior chamber should be evacuated immediately and irrigated with standard ophthalmological irrigation solution. 
V primeru nenamernega injiciranja koncentrirane raztopine v očesni prekat je treba tekočino takoj odstraniti in sprednji očesni prekat izprati s standardno raztopino za izpiranje očesa.
Supplied in a single-use vial designed to deliver 4.0 mL of concentrate for dilution into 500 mL of irrigation solution for ocular use. 
Na voljo je v viali za enkratno uporabo, oblikovani tako, da je mogoče 4,0 ml koncentrata za redčenje dovesti v 500 ml raztopine za izpiranje za okularno uporabo.
Omidria must be administered in a controlled surgical setting by a qualified ophthalmological surgeon experienced in intraocular lens replacement surgery. 
Zdravilo Omidria mora dati usposobljen kirurg oftalmolog, ki ima izkušnje s kirurško vstavitvijo umetne intraokularne leče, v nadzorovanem kirurškem okolju.
The solution should be used within 6 hours of preparation. 
Raztopino uporabite v 6 urah po pripravi;
− 4.0 mL of concentrate solution should be injected into a 500 mL bag /bottle of irrigation solution. 
− 4,0 ml koncentrirane raztopine vbrizgajte v 500 mililitrsko vrečko/stekleničko z raztopino za izpiranje;
− Using aseptic technique, withdraw 4.0 mL of concentrate solution using an appropriate sterile needle. 
− z ustrezno sterilno iglo odvzemite 4,0 ml koncentrirane raztopine in pri tem uporabite aseptično tehniko;
The following warnings and precautions related to topical ophthalmic use of phenylephrine and ketorolac should be considered with the use of Omidria: 
Pri uporabi zdravila Omidria je treba upoštevati naslednja opozorila in previdnostne ukrepe, povezane z lokalno očesno uporabo fenilefrina in ketorolaka:
After dilution in 500 mL of irrigation solution, the solution contains 0.081 mg/mL of phenylephrine and of 0.023 mg/mL ketorolac. 
Po redčenju v 500 ml raztopine za izpiranje raztopina vsebuje 0,081 mg/ml fenilefrina in 0,023 mg/ml ketorolaka.
Omidria is indicated for addition to irrigation solution used during intraocular lens replacement procedures only. 
Zdravilo Omidria je indicirano samo za dodajanje raztopini za izpiranje, ki se uporablja med vstavljanjem umetne intraokularne leče.
− No other medicinal products should be added to the prepared irrigation solution. 
− v pripravljeno raztopino za izpiranje ne dodajajte nobenih drugih zdravil.
METHOD OF ADMINISTRATION Intraocular use after dilution. 
POSTOPEK UPORABE Intraokularna uporaba po redčenju.
In Study 2, only 4% of patients in the Omidria group compared to 23% of patients in the placebo group had a pupil diameter < 6 mm at cortical clean-up, and 1% of patients in the Omidria group compared to 27% of patients in the placebo group had a pupil constriction ≥ 2.5 mm (P < 0.0001, Chi-Square test). 
V študiji 2 so imeli med čiščenjem lečne skorje premer zenice < 6 mm samo 4 % bolnikov v skupini z zdravilom Omidria, medtem ko je bilo v skupini s placebom takih bolnikov 23 %, zoženje zenice za ≥ 2,5 mm pa so opazili pri 1 % bolnikov v skupini z zdravilom Omidria in 27 % bolnikov v
This is known as intraocular lens replacement. 
Poseg se imenuje vstavitev umetne intraokularne leče.
No drug-related adverse events or pathological findings were observed, with combinations of phenylephrine and ketorolac in irrigation solution administered at concentrations up to 7200 µM phenylephrine and 900 µM ketorolac. 
Pri uporabi raztopine za izpiranje, ki je vsebovala kombinacijo fenilefrina in ketorolaka v koncentracijah do 7200 µM fenilefrina in 900 µM ketorolaka, niso opazili nobenih z zdravilom povezanih neželenih učinkov ali patoloških sprememb.
Each 4.0 mL vial of solution contains 40.6 mg (10.2 mg/mL) of phenylephrine and 11.5 mg (2.88 mg/mL) of ketorolac. 
Ena 4,0-mililitrska viala z raztopino vsebuje 40,6 mg (10,2 mg/ml) fenilefrina in 11,5 mg (2,88 mg/ml) ketorolaka.
Vasoconstriction occurs in the conjunctival circulation and in other ocular vessels to the extent that they are exposed to drug. 
V ožilju očesne veznice in drugih očesnih žilah pride do vazokonstrikcije, katere obseg je odvisen od stopnje izpostavljenosti žil zdravilu.
In Study 1, the CMH weighted mean difference (Omidria - placebo) in the mean AUC was -5.20 mm [95% confidence interval: -7.31, -3.09] (P < 0.001). 
V študiji 1 je tehtana sredina (Omidria-placebo) povprečne AUC po CMH znašala -5,20 mm [95-odstotni interval zaupanja: -7,31, -3,09] (p < 0,001).
Intraocular use after dilution. 
Intraokularna uporaba po redčenju.
In Study 2, the CMH weighted mean difference (Omidria - placebo) in the mean AUC was -4.58 mm [95% confidence interval: -6.92, -2.24] (P < 0.001). 
V študiji 2 je tehtana sredina (Omidria-placebo) povprečne AUC po CMH znašala -4,58 mm [95-odstotni interval zaupanja: -6,92, -2,24] (p < 0,001).
In Study 1, the CMH weighted mean difference (Omidria - placebo) in the mean area-under-the curve (AUC) was 0.58 mm [95% confidence interval: 0.48, 0.68] (P < 0.0001). 
V študiji 1 je tehtana sredina (Omidria-placebo) povprečne površine pod krivuljo (AUC) po CMH znašala 0,58 mm [95-odstotni interval zaupanja: 0,48, 0,68] (p < 0,0001).
NAME OF THE MEDICINAL PRODUCT Omidria 10 mg/mL + 3 mg/mL concentrate for solution for intraocular irrigation 
IME ZDRAVILA Omidria 10 mg/ml + 3 mg/ml koncentrat za raztopino za intraokularno izpiranje
- if you are allergic to phenylephrine or ketorolac or any of the other ingredients of this medicine 
- če ste alergični na fenilefrin ali ketorolak ali katero koli sestavino tega zdravila (navedeno v poglavju 6); - če imate očesno bolezen, imenovano glavkom z zaprtim zakotjem.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON 
PODATKI NA ZUNANJI OVOJNINI NOTRANJA ŠKATLA
In Study 2, the CMH weighted mean difference (Omidria - placebo) in the mean AUC was 0.59 mm [95% confidence interval: 0.49, 0.69] (P < 0.0001). 
V študiji 2 je tehtana sredina (Omidria-placebo) povprečne AUC po CMH znašala 0,59 mm [95-odstotni interval zaupanja: 0,49, 0,69] (p < 0,0001).
The following information is intended for healthcare professionals only: To prepare Omidria for intraocular irrigation, dilute 4.0 mL of Omidria concentrate in 500 mL of standard ophthalmological irrigation solution. 
Zdravilo Omidria pripravite za intraokularno izpiranje tako, da 4,0 ml koncentrata zdravila Omidria razredčite v 500 ml standardne oftalmološke raztopine za izpiranje.
There have been reports of serious cardiovascular reactions, including ventricular arrhythmias and myocardial infarctions, in patients using ophthalmic phenylephrine. 
Pri bolnikih, ki so uporabljali fenilefrin za oko so poročali o resnih srčno-žilnih neželenih učinkih, med katerimi so bile tudi ventrikularne aritmije in srčni infarkti.
6.6 Special precautions for disposal and other handling To prepare Omidria for intraocular irrigation, dilute 4.0 mL of concentrate in 500 mL of standard ophthalmological irrigation solution. 
Zdravilo Omidria pripravite za intraokularno izpiranje, tako da 4,0 ml koncentrata razredčite v 500 ml standardne oftalmološke raztopine za izpiranje.
General disorders and administration site conditions 
Splošne težave in spremembe na mestu aplikacije vnetje bolečine
Each 4 mL of solution in the vial contains phenylephrine hydrochloride equivalent to 40.6 mg (10.2 mg/mL) of phenylephrine and ketorolac trometamol equivalent to 11.5 mg (2.88 mg/mL) of ketorolac. 
Ena viala s 4 ml raztopine vsebuje fenilefrinijev klorid, ki ustreza 40,6 mg (10,2 mg/ml) fenilefrina, in trometamolijev ketorolakat, ki ustreza 11,5 mg (2,88 mg/ml) ketorolaka.
How Omidria is stored 
Shranjevanje zdravila Omidria
AUC 12 hour ocular pain VAS score (Co-primary endpoint) [Mean±SD] 
AUC rezultatov za bolečino v očesu 12 ur po operaciji na VAS (soprimarni opazovani dogodek) [povprečna ± standardni odklon]
The use of Omidria during intraocular lens replacement surgery may cause vision to be temporarily affected. 
Uporaba zdravila Omidria med kirurško vstavitvijo umetne intraokularne leče lahko začasno poslabša vid (glejte poglavje 4.7).
- Especially, tell your doctor if you are taking atropine, a medicine used to dilate (widen) the pupil of the eye.Taking atropine at the same time as Omidria may increase blood pressure and cause the heart to beat faster in some patients. 
- Predvsem morate zdravnika obvestiti, če jemljete atropin, zdravilo, ki se uporablja za širjenje očesne zenice.
Significant elevations in blood pressure have been reported following instillation of topical ocular phenylephrine. 
Po vkapavanju lokalnega fenilefrina za oko so poročali o pomembnem zvišanju krvnega tlaka.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Omidria 10 mg/mL + 3 mg/mL concentrate for solution for intraocular irrigation phenylephrine/ketorolac 
IME ZDRAVILA IN POT(I) UPORABE Omidria 10 mg/ml + 3 mg/ml koncentrat za raztopino za intraokularno izpiranje fenilefrin/ketorolak
One 4 mL vial contains phenylephrine hydrochloride equal to 40.6 mg phenylephrine and ketorolac trometamol equal to 11.5 mg ketorolac. 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena 4-mililitrska viala vsebuje fenilefrinijev klorid, ki ustreza 40,6 mg fenilefrina, in trometamolijev ketorolakat, ki ustreza 11,5 mg ketorolaka.
Package leaflet: Information for the user Omidria 10 mg/mL + 3 mg/mL concentrate for solution for intraocular irrigation phenylephrine/ketorolac 
Navodilo za uporabo Omidria 10 mg/ml + 3 mg/ml koncentrat za raztopino za intraokularno izpiranje fenilefrin/ketorolak
NAME OF THE MEDICINAL PRODUCT Omidria 10 mg/mL + 3 mg/mL concentrate for solution for intraocular irrigation phenylephrine/ketorolac 
Omidria 10 mg/ml + 3 mg/ml koncentrat za raztopino za intraokularno izpiranje fenilefrin/ketorolak
Pupil diameter was measured throughout the surgical procedure. 
Med kirurškim posegom so merili premer zenice.
Omidria is not recommended during pregnancy. 
Uporaba med nosečnostjo ni priporočljiva.
Following dilution do not store above 25 ˚C 
Po redčenju shranjujte pri temperaturi do 25 ˚C.
Omidria is used as a solution to rinse the eye (irrigation solution) during surgery to replace the lens. 
Zdravilo Omidria se uporablja v obliki raztopine za izpiranje očesa med kirurško vstavitvijo umetne intraokularne leče.
The European Commission granted a marketing authorisation valid throughout the European Union for Ikervis on 19 March 2015. 
Evropska komisija je dovoljenje za promet z zdravilom Ikervis, veljavno po vsej Evropski uniji, izdala 19. marca 2015.
The doctor should confirm the need for continuing treatment at least every 6 months. 
Zdravnik mora najmanj vsakih šest mesecev potrditi, da obstaja potreba po nadaljevanju zdravljenja.
What measures are being taken to ensure the safe and effective use of Ikervis? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Ikervis?
It is used when treatment with artificial tears (tear substitutes) is insufficient to improve the condition. 
Zdravilo se uporablja, kadar zdravljenje z umetnimi solzami (nadomestki solz) ne zadostuje za izboljšanje stanja.
About 29% (44 of 154) of those given Ikervis responded, compared with 23% (21 of 91) given the vehicle. 
Odzvalo se je približno 29 % (44 od 154) bolnikov, ki so prejemali zdravilo Ikervis, v primerjavi s 23 % (21 od 91) bolnikov, ki so prejemali vehikel.
The full EPAR and risk management plan summary for Ikervis 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 Ikervis sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
If other eye drops are used, the different medicines must be given at least 15 minutes apart. 
Če se uporabljajo tudi druge kapljice za oko, je treba zdravili dati v razmiku najmanj 15 minut.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Ikervis'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 Ikervis večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
Other information about Ikervis 
Druge informacije o zdravilu Ikervis
Ikervis should be given last. 
Zdravilo Ikervis je treba dati nazadnje.
This is a summary of the European public assessment report (EPAR) for Ikervis. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Ikervis.
A risk management plan has been developed to ensure that Ikervis is used as safely as possible. 
Za zagotovitev čim varnejše uporabe zdravila Ikervis je bil pripravljen načrt obvladovanja tveganj.
The CHMP considered that this was clinically meaningful, since none of the available medicines for the condition have been shown to reduce damage to the surface of the eye, which might help prevent the progression of the disease. 
Odbor CHMP je menil, da je to zmanjšanje klinično pomembno, saj za nobeno razpoložljivo zdravilo za to bolezen ni bilo dokazano, da bi zmanjšalo poškodbo površine očesa, kar lahko pomaga preprečiti napredovanje bolezni.
These symptoms are usually short lasting and occur at the time the eye drops are used. 
Simptomi so običajno kratkotrajni in se pojavijo v času uporabe kapljic za oko.
It is not intended to provide practical advice on how to use Ikervis. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
What is Ikervis and what is it used for? 
Kaj je zdravilo Ikervis in za kaj se uporablja?
The active substance in Ikervis, ciclosporin, acts on cells of the immune system (the body's natural defences) that are involved in the processes that cause inflammation. 
Zdravilna učinkovina v zdravilu Ikervis, ciklosporin, deluje na celice imunskega sistema (naravnega obrambnega mehanizma telesa), ki sodelujejo pri procesih, ki povzročajo vnetje.
What are the risks associated with Ikervis? 
Kakšna tveganja so povezana z zdravilom Ikervis?
Regarding safety, the medicine was well tolerated, with mainly short-lasting effects on the eye at the time the eye drops are used; the risk of effects on the body as a whole was considered to be low. 
Z vidika varnosti so bolniki zdravilo dobro prenašali, saj so v glavnem opažali samo kratkotrajne neželene učinke na oko v času uporabe kapljic, tveganje za učinke na celotno telo pa je bilo ocenjeno kot majhno.
Although Ikervis had not been shown to be any better than the vehicle in improving symptoms such as discomfort and pain, there was evidence that it could reduce the inflammation and damage to the cornea associated with keratitis. 
Čeprav se zdravilo Ikervis ni izkazalo za učinkovitejše od vehikla pri izboljšanju simptomov, kot sta neugodje in bolečina, je bilo dokazano, da lahko zmanjša vnetje in poškodbo roženice, povezana s keratitisom.
Why is Ikervis approved? 
Zakaj je bilo zdravilo Ikervis odobreno?
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Ikervis, 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.
What benefits of Ikervis have been shown in studies? 
Kakšne koristi je zdravilo Ikervis izkazalo v študijah?
For more information about treatment with Ikervis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Ikervis preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The medicine is available as single-dose eye drops and the recommended dose is one drop in each affected eye daily at bedtime. 
Zdravilo je na voljo v obliki enoodmernih kapljic za oko, priporočeni odmerek pa je ena kapljica v vsako prizadeto oko enkrat na dan pred spanjem.
The most common side effects with Ikervis (which may affect more than 1 in 10 people) are pain and irritation in the eye; other common side effects are lacrimation (excessive tears), ocular hyperaemia (red eye), and erythema (redness) of the eyelid. 
Najpogostejša neželena učinka zdravila Ikervis (ki lahko prizadeneta več kot 1 osebo od 10) sta bolečina v očesu in draženje očesa, drugi pogosti neželeni učinki pa so solzenje (čezmerna količina solz), očesna hiperemija (rdeče oko) in eritem (rdečina) veke.
Without sufficient protection from the tear fluid, the cornea can get damaged and become inflamed (keratitis), which can eventually lead to ulceration, infection and reduced vision. 
Če solzna tekočina ne nudi zadostne zaščite, se roženica lahko poškoduje in se vname (keratitis), kar lahko sčasoma privede do nastanka razjede, okužbe in poslabšanega vida.
In patients with dry eye disease, either not enough tear fluid is produced to create the protective film of moisture that normally coats the surface of the eye, or abnormalities in the tear fluid cause it to dry out too quickly. 
Pri bolnikih s sindromom suhega očesa bodisi ne nastaja dovolj solzne tekočine, da bi se ustvaril zaščitni sloj vlage, ki običajno prekriva površino očesa, bodisi se zaradi nepravilnosti v solzni tekočini ta prehitro posuši.
The main measure of effectiveness was the proportion of patients whose condition responded to treatment after six months, as measured by a combination of damage to the cornea and a score for the level of symptoms, including discomfort and pain. 
Glavno merilo učinkovitosti je bil delež bolnikov, katerih bolezen se je po šestih mesecih odzvala na zdravljenje, kar so ocenili na podlagi poškodbe roženice in rezultatov ocene stopnje izraženosti simptomov, ki so vključevali neugodje in bolečino.
Applying it directly to the eye reduces inflammation and damage there but limits its effects elsewhere in the body. 
Nanos zdravila neposredno v oko zmanjša vnetje in poškodbo na tem delu, medtem ko omeji učinke zdravila drugje v telesu.
For practical information about using Ikervis, patients should read the package leaflet or contact their doctor or pharmacist. 
Za praktične informacije o uporabi zdravila Ikervis naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Ikervis contains the active substance ciclosporin. 
Zdravilo Ikervis vsebuje zdravilno učinkovino ciklosporin.
Ikervis can only be obtained with a prescription and treatment should only be started by a healthcare professional trained in ophthalmology (eye medicine). 
Izdaja zdravila Ikervis je le na recept, zdravljenje z njim pa sme uvesti samo zdravstveni delavec, usposobljen na področju oftalmologije (očesne medicine).
The benefits of Ikervis have been shown in one main study involving 246 patients with severe dry eye disease, where Ikervis was compared with the vehicle (the same eye drop formula but without any active substance). 
Koristi zdravila Ikervis so dokazali v eni glavni študiji z 246 bolniki s hudim sindromom suhega očesa, v kateri so zdravilo Ikervis primerjali z vehiklom (enakim pripravkom v obliki kapljic za oko, ki pa ni vseboval nobene zdravilne učinkovine).
For the full list of all side effects reported with Ikervis, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Ikervis, glejte navodilo za uporabo.
How does Ikervis work? 
Kako zdravilo Ikervis deluje?
Ikervis is a medicine used to treat severe keratitis, an inflammation of the cornea (the transparent layer covering the front of the eye) in adult patients with dry eye disease. 
Ikervis je zdravilo, ki se uporablja za zdravljenje hudega keratitisa, tj. vnetja roženice (prozorne plasti, ki prekriva sprednji del očesa), pri odraslih bolnikih s sindromom suhega očesa.
The proportion of patients who responded to treatment was therefore similar in the two groups, but when only the damage to the cornea was considered, Ikervis was significantly better than the vehicle at reducing it. Levels of HLADR (a measure of inflammation in eye cells) were also reduced in patients using Ikervis compared with the dummy treatment. 
Delež bolnikov, ki so se odzvali na zdravljenje, je bil torej v obeh skupinah podoben, ko so primerjali samo poškodbo roženice, pa je bilo zdravilo Ikervis pri zmanjšanju poškodbe znatno učinkovitejše od vehikla.
How is Ikervis used? 
Kako se zdravilo Ikervis uporablja?
The medicine must not be used in patients who have or are suspected to have an infection of the eye or the tissues around the eye. For the full list of restrictions, see the package leaflet. 
Zdravilo se ne sme uporabljati pri bolnikih, ki imajo ali ki bi lahko imeli okužbo očesa ali tkiv okoli očesa.
Some animals may also have hypersensitivity (allergic) reactions. 
Pri nekaterih živalih se lahko pojavijo preobčutljivostne (alergijske) reakcije.
In all studies the vaccinated cattle and sheep were compared with animals that were not immunised (controls). 
V vseh študijah so cepljene ovce in govedo primerjali z živalmi, ki niso bile imunizirane (kontrolnimi skupinami).
After vaccination, animals may have a slightly raised temperature (usually not more than 0.5°C, but in individual cases up to about 2°C) for up to three days after vaccination. 
Do treh dni po cepljenju je možno rahlo povišanje telesne temperature (navadno ne za več kot 0,5 °C, v posameznih primerih do približno 2 °C).
The vaccine also contains ‘adjuvants' (aluminium hydroxide and saponin) to enhance the immune response. 
Cepivo vsebuje tudi „adjuvanse“ (aluminijev hidroksid in saponin) za povečanje imunskega odziva.
In the future, if the animals are exposed to the same type of bluetongue virus, the immune system will be able to produce antibodies more quickly. 
Če bo žival v prihodnosti ponovno izpostavljena virusu modrega jezika istega tipa, bo imunski sistem protitelesa izdelal hitreje.
The main measure of effectiveness was the level of the bluetongue virus in the blood (viraemia) of animals. 
Glavni merilo učinkovitosti je bila raven virusa modrega jezika v krvi (viremija) živali.
Bovilis BTV8 was initially authorised under ‘exceptional circumstances'. 
Zdravilo Bovilis BTV8 je bilo prvotno izdano v „izjemnih okoliščinah“.
When it is given to cattle and sheep, the animals' immune system recognises the virus as ‘foreign' and produce antibodies against it. 
Ko govedo ali ovco cepimo, imunski sistem živali prepozna virus kot „tujek“ in proti njemu izdela protitelesa.
Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease. 
Cepiva delujejo tako, da imunski sistem (naravni obrambni mehanizem telesa) naučijo, kako naj se brani pred boleznijo.
One injection is enough to vaccinate sheep, but cattle will need a second injection approximately three weeks later. 
Za cepljenje ovac zadostuje ena injekcija, govedo pa potrebuje drugo injekcijo tri do štiri tedne kasneje.
This means that it was not possible at the time of the initial authorisation to obtain complete information about Bovilis BTV8. 
To pomeni, da ob prvotni izdaji ni bilo mogoče pridobiti vseh podatkov o cepivu Bovilis BTV8.