natgillin/translations-raw huggingface dataset:
In this analysis, the percentage of opioid negative urines in the sublingual buprenorphine group was very similar to the results in the Sixmo group (33% versus 31%), and non-inferiority of Sixmo to sublingual buprenorphine was shown. 
Sixmo (33 % proti 31 %) in dokazana je bila neinferiornost zdravila Sixmo v primerjavi z buprenorfinom.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton (kit) 
PODATKI NA ZUNANJI OVOJNINI Zunanja škatla (komplet)
• latex, talc-free sterile gloves 
• sterilne rokavice iz lateksa brez smukca,
Retreatment with Sixmo implants 
Ponovno zdravljenje z implantati Sixmo
NAME OF THE MEDICINAL PRODUCT Sixmo 74.2 mg implant 
IME ZDRAVILA Sixmo 74,2 mg implantat
In many cases the presence of pre-existing hepatic impairment (genetic disease, liver enzyme abnormalities, infection with hepatitis B or hepatitis C virus, alcohol abuse, anorexia, concomitant use of other potentially hepatotoxic medicines) and ongoing injecting drug use may have a causative or contributory role. 
V mnogih primerih so lahko vzrok ali lahko k temu prispevajo že obstoječe okvare jeter (genetska bolezen, nenormalnosti jetrnih encimov, okužba z virusom hepatitisa B ali C,
The manifestations of acute buprenorphine overdose include pinpoint pupils, sedation, hypotension, respiratory depression and death. 
Manifestacije akutnega prevelikega odmerjanja buprenorfina vključujejo zožene zenice, sedacijo,
Clean removal site with alcohol pad prior to marking the skin. 
Preden kožo označite, mesto odstranjevanja očistite z alkoholno blazinico.
Sixmo should be used with caution in patients with asthma or other breathing problems. 
Pri astmatičnih bolnikih ali bolnikih, ki imajo druge težave z dihanjem, je treba zdravilo Sixmo uporabljati previdno.
• nefazodone: a medicine to treat depression 
določena zdravila za zdravljenje depresije,
Furthermore, after establishment of non-inferiority, superiority of Sixmo over sublingual buprenorphine was tested and established (p=0.034). 
Poleg tega so po ugotovitvi neiferiornosti testirali in potrdili superiornost zdravila Sixmo v primerjavi podjezičnim buprenorfinom
Properly placed implants are those placed just under the skin, using the implant applicator, about 80 to 100 mm (8 to 10 cm) above the medial epicondyle, in the sulcus between the biceps and triceps muscle of the inner side of the upper arm. 
100 mm (8 do 10 cm) nad medialnim epikondilom v sulkus med dvoglavo in triglavo mišico na notranji strani nadlakti.
Therefore, use these medicines during Sixmo treatment only on doctor's advice and at the prescribed dosage. 
ta kombinacija lahko povzroči smrt zaradi depresije dihanja, zato taka zdravila v času uporabe zdravila Sixmo vzemite le po nasvetu zdravnika in v predpisanem odmerku;
Sublingual buprenorphine should be discontinued 12 to 24 hours prior to subcutaneous insertion of Sixmo implants. 
Jemanje podjezičnega buprenorfina je treba prekiniti 12 do 24 ur pred subkutano vstavitvijo implantatov Sixmo.
• sterile fenestrated drapes 
• sterilne fenestrirane prevleke,
Weeks 17 to 24 
IZ mediane Mediana (razpon) 17. do 24. teden
• rash, rash pustular, skin lesion 
• izpuščaj, pustularni izpuščaj, kožna lezija,
NAME OF THE MEDICINAL PRODUCT Sixmo 74.2 mg implant (buprenorphine) 
IME ZDRAVILA Sixmo 74,2 mg implantat (buprenorfin)
Cardiac disorders common palpitations** uncommon atrial flutter, bradycardia 
občasni atrijsko plapolanje, bradikardija
• dizziness, drowsiness 
• omotica, zaspanost,
The administration of additional buprenorphine sublingual doses should be considered by the treating physician if: 
Lečeči zdravnik lahko o dajanju dodatnih odmerkov podjezičnega buprenorfina razmisli v naslednjih primerih:
Injury, poisoning and procedural complications common procedural pain*, procedural site reaction* uncommon post procedural complication (*), contusion (*), wound dehiscence*, migration of implanted drug***, device breakage*** 
občasni zapleti po postopku (*), kontuzija (*), dehiscenca rane*, migracija implantiranega zdravila***,
• CYP3A4 inhibitors and inducers: Buprenorphine is metabolized to norbuprenorphine primarily by CYP3A4; therefore, potential interactions may occur when Sixmo is given concurrently with medicinal products that affect CYP3A4 activity. 
• zaviralci in induktorji CYP3A4: Buprenorfin se v norbuprenorfin presnavlja predvsem preko
• Similarly, inducers of CYP3A4 (e.g. phenobarbital, carbamazepine, phenytoin, rifampin) may have the potential to reduce buprenorphine plasma concentrations because of increased metabolism of buprenorphine to norbuprenorphine. 
• Podobno imajo lahko induktorji encima CAP3A4 (npr. fenobarbiral, karbamazepin, fenitoin,
• increased sweating, feeling unwell 
• povečano potenje, slabo počutje,
• Liver damage, including liver failure, has been reported when using buprenorphine. 
• Med jemanjem buprenorfina so poročali o poškodbi jeter, vključno z odpovedjo jeter.
Talk to your doctor before using Sixmo if you have: 
Pred začetkom jemanja zdravila Sixmo se posvetujte z zdravnikom, če imate katerega od naslednjih stanj:
Before administering Sixmo implants 
Preden vam dajo implantate Sixmo
Identify the insertion site, which is at the inner side of the upper arm, about 80 to 100 mm (8 to 10 cm) above the medial epicondyle, in the sulcus between the biceps and triceps muscle. 
Določite mesto vstavitve, ki je na notranji strani nadlakti, približno 80 do 100 mm (8
Table 3: Percentage of Opioid-Negative Urine Samples for Weeks 1 to 16 and Weeks 17 to 24, 
Preglednica 3: Odstotek urinskih vzorcev, negativnih na opioide, od 1. do 16. tedna in od
Instructions for removal of Sixmo 
Navodila za odstranjevanje implantatov Sixmo
• constipation, nausea, vomiting, diarrhoea 
• zaprtost, slabost, bruhanje, driska,
Cases of acute hepatic injury (including fatal cases) have been reported with the active substance buprenorphine in opioid-dependent addicts both in clinical trials and in post marketing adverse reaction reports. 
Pri osebah, zasvojenih z opioidi, so tako v kliničnih preskušanjih kot v poročilih o neželenih učinkih po začetku trženja v povezavi z uporabo učinkovine buprenorfin poročali o primerih akutne okvare jeter (tudi s smrtnim izidom).
Nervous system disorders common headache, dizziness, somnolence, hypertonia**, syncope** uncommon hypoaesthesia, migraine, depressed level of consciousness, hypersomnia, paraesthesia, tremor 
Bolezni živčevja pogosti glavobol, omotica, zaspanost, hipertonija**, sinkopa**
• Monoamine oxidase inhibitors (MAOI): Possible exacerbation of the effects of opioids, based on experience with morphine. 
• zaviralci MAO: izkušnje z morfinom kažejo, da sočasna uporaba zaviralcev MAO lahko poudari učinke opioidov.
Sublingual buprenorphine should be discontinued 12 to 24 hours prior to insertion of four Sixmo implants. 
Jemanje podjezičnega buprenorfina je treba prekiniti 12 do 24 ur pred vstavitvijo implantatov Sixmo.
Step 13: The patient should lie on their back, with the implant arm flexed at the elbow and externally rotated, so that the hand is positioned next to the head. 
Roka, v kateri je implantat, naj bo v komolcu upognjena in obrnjena navzven, tako da je dlan poleg glave.
Insert one implant into the cannula (Figure 9), re-insert the obturator, and gently push the obturator forward (mild resistance should be felt) until the obturator stop line is level with the bevel-up stop marking, which indicates the implant is positioned at the tip of the cannula (Figure 10). 
dokler se črta za ustavitev na mandrenu ne poravna z oznako za ustavitev pri navzgor obrnjeni poševnini konice, kar pomeni, da se implantat nahaja na konici kanile (slika 10).
Table 4: Percentage of Opioid-Negative Urine Samples for Weeks 1 to 24, Study PRO-806 
Preglednica 4: Odstotek urinskih vzorcev, negativnih na opioide, od 1. do 24. tedna, študija
Frequency Adverse reactions Infections and infestations common viral infection, bronchitis**, infection**, influenza**, pharyngitis**, rhinitis** uncommon cellulitis, skin infection, peritonsillar abscess, rash pustular, urinary tract infection, vulvovaginal mycotic infection, implant site infection*, implant site abscess* 
Infekcijske in parazitske bolezni pogosti virusna okužba, bronhitis**, okužba**, influenca**, faringitis**, rinitis**
• migraine, tremor 
• migrena, tresavica,
Equipment for removal of Sixmo 
Oprema za odstranjevanje implantatov Sixmo
• enlarged prostate or narrowed urethra 
• povečano prostato ali zoženo sečnico, • zmanjšano delovanje ščitnice,
• Adson single tooth tissue forceps 
• kirurška pinceta Adson,
NAME OF THE MEDICINAL PRODUCT Sixmo 74.2 mg implant buprenorphine 
IME ZDRAVILA Sixmo 74,2 mg implantat buprenorfin
Metabolism and nutrition disorders common decreased appetite uncommon abnormal weight gain, dehydration, increased appetite 
apatija, evforično razpoloženje, zmanjšano občutenje orgazma, nemirnost, razdražljivost,
Musculoskeletal and connective disorders common bone pain**, myalgia** uncommon muscle spasms, limb discomfort, musculoskeletal pain, neck pain, pain in extremity, temporomandibular joint syndrome, arthralgia*** Renal and urinary disorders uncommon urinary hesitation, micturition urgency, pollakisuria 
občasni mišični krči, nelagodje v okončinah, bolečina v mišicah in kosteh, bolečina v vratu, bolečina v okončinah, sindrom temporomandibularnega sklepa, artralgija***
Close the incision with sutures. 
Rez zaprite s šivanjem.
These risks and the patient's stability in treatment for opioid dependence should be considered when determining whether Sixmo is appropriate for the patient. 
Pri odločanju, ali je zdravljenje z zdravilom Sixmo primerno za določenega bolnika, je treba razmisliti o tveganjih in stabilnosti bolnika pri zdravljenju odvisnosti od opioidov.
Modification of the Sixmo dose is not required in patients with renal impairment. 
Pri bolnikih z okvaro ledvic spreminjanje odmerka zdravila Sixmo ni potrebno.
Mark the channel tracks where each implant will be inserted by drawing 4 lines - with each line 40 mm long. 
Implantati se vstavijo skozi majhen subkutani rez velikosti 2,5 do 3 mm. Označite sledi kanalov, kjer bodo vstavljeni implantati, in sicer narišite 4 črte, vsaka naj bo dolga 40 mm. Implantati bodo razporejeni v pahljačasti obliki od 4 do 6 mm narazen, pri čemer se pahljača odpira proti rami
Only a healthcare professional who is trained in the insertion of Sixmo should perform the procedure, using only the implant applicator, with the recommended local anaesthetic available. 
pri tem postopku pa mora uporabljati aplikator za implantate in imeti na voljo priporočeni lokalni anestetik.
• #15 blade scalpel 
• skalpel, rezilo št. 15,
• abnormal function of the bile duct 
• nenormalno delovanje žolčevoda,
Eye disorders common mydriasis** uncommon eye discharge, lacrimal disorder, vision blurred 
občasni izcedek iz očesa, motnje solznih žlez, zamegljen vid
• high blood pressure, feeling heartbeat 
• duševna bolezen, za katero so značilne blodnje in nerazumnost, • visok krvni tlak, zaznaven srčni utrip,
• Please note that an ultrasound and MRI facilities need to be available to the clinical site at which the insertion and removal of Sixmo occurs. 
• Upoštevajte, da mora biti v bolnišnici, kjer se izvaja vstavljanje in odstranjevanje zdravila
Sixmo 74.2 mg implant buprenorphine 
Navodilo za uporabo Sixmo 74,2 mg implantat buprenorfin
General disorders and administration site conditions common fatigue, chills, asthenia, pain, implant site haematoma*, implant site pain*, implant site pruritus*, implant site haemorrhage*, implant site erythema*, implant site scar*, chest pain**, malaise***, drug withdrawal syndrome*** uncommon oedema peripheral, discomfort, face oedema, feeling cold, pyrexia, swelling, implant site oedema*, implant site reaction*, device expulsion*, impaired healing*, implant site 
Neželeni učinki občasni periferni edem, nelagodje, obrazni edem, občutek mrazenja, pireksija, otekanje, edem na mestu implantata*, reakcija na mestu implantata*, iztis pripomočka*, slabše celjenje*, parestezija na mestu implantata*, izpuščaj na mestu implantata*, brazgotinjenje*
• inflammation of the airways in the lungs, throat or inner lining of the nose 
• kašelj, zasoplost, • vnetje spodnjih dihalnih poti, grla ali nosne sluznice,
Treatment discontinuation criteria 
Prekinitev zdravljenja
Psychiatric disorders common insomnia, anxiety, hostility**, nervousness**, paranoia** uncommon depression, libido decreased, sleep disorder, apathy, euphoric mood, orgasmic sensation decreased, restlessness, irritability, drug dependence***, agitation***, thinking abnormal*** 
Psihiatrične motnje pogosti nespečnost, anksioznost, sovražnost**, živčnost**, paranoja**
No Sixmo dose adjustment is therefore considered necessary for patients with renal impairment. 
Zato pri bolnikih z okvaro ledvic prilagoditev odmerka zdravila Sixmo ni potrebna.
Medicinal product subject to special and restricted medical prescription. 
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le na poseben recept in le s posebnim režimom.
Breast-feeding 
SL BPN
Mean (SE) 
zlom pripomočka***
This should be stopped 12 to 24 hours before insertion of the next set of Sixmo implants. 
Z uporabo podjezičnih odmerkov je treba prenehati 12 do 24 ur pred vstavitvijo novega kompleta implantatov Simxo.
• Other CNS depressants: Other opioid derivatives (e.g. methadone, analgesics and antitussives), certain antidepressants, sedative H1-receptor antagonists, barbiturates, anxiolytics other than benzodiazepines, neuroleptics, clonidine and related substances: these combinations increase CNS depression. 
barbiturati, anksiolitiki, ki niso benzodiazepini, nevroleptiki, klonidinom in podobnimi učinkovinami, saj te kombinacije povečajo depresijo centralnega živčnega sistema.
• pressure bandage around 8 cm wide 
• kompresijski povoj, širok pribl.
• abnormal sensation such as prickling, “pins and needles”, tingling and itchiness 
• nenormalni občutki, kot so ščemenje, zbadanje, mravljinčenje, srbenje,
Driving and using machines 
Trenutna tehnika in usposabljanje
• reduced kidney function 
• slabše delovanje ledvic,
• other medicines that depress the brain or spinal cord, as these reduce alertness, making driving and using machines hazardous other opioid derivatives such as methadone, strong painkillers and cough suppressants certain medicines to treat depressions medicines called antihistamines used to treat allergic reactions, sleep disturbances, cold; or prevent and treat nausea and vomiting medicines to treat epilepsy or to sedate, with active substance names mostly ending with “tal” medicines to treat anxiety, other than those described in the first bullet point medicines to treat mental or anxiety disorders, with sedative effects, called neuroleptics clonidine: a medicine to treat high blood pressure and high eye pressure 
zdravila za zdravljenje dušenih bolezni ali anksioznih motenj, ki imajo učinke sedacije in se jim reče nevroleptiki, klonidin: zdravilo za zdravljenje visokega krvnega tlaka in visokega očesnega tlaka;
OTHER 
Sixmo
• sedation 
• sedacijo,
• a history of fits 
• vodilo za iglo,
(ITT) 
(MRI).
• migration of implant(s), device breakage or expulsion 
• zapleti po postopku, • premik implantata/implantatov, zlom ali iztis implantata,
• latex, talc-free, sterile gloves 
• meter, sterilen,
Respiratory, thoracic and mediastinal disorders common cough**, dyspnoea** uncommon respiratory depression, yawning Gastrointestinal disorders common constipation, nausea, vomiting, diarrhoea, abdominal pain, gastrointestinal disorder**, tooth disorder** uncommon dry mouth, dyspepsia, flatulence, haematochezia 
Bolezni prebavil pogosti zaprtost, navzea, bruhanje, diareja, bolečina v trebuhu, bolezni prebavil**, bolezni zob**
• muscle spasms, limb discomfort 
• mišični krči, nelagodje v okončinah,
Mean plasma buprenorphine concentrations up to day 28 are based on data from the relative bioavailability study PRO-810 (which had intensive PK sampling), while concentrations after day 28 are based on pooled data from studies PRO-805, PRO-806, PRO-807 and PRO-811. 
Povprečne koncentracije buprenorfina v plazmi do 28. dneva temeljijo na podatkih študije o relativni biološki uporabnosti PRO-810 (z intenzivnim farmakokinetičnim vzorčenjem), medtem ko so koncentracije po
Non-Caucasian population 
Populacija nebelcev
This summary was last updated on 03/09/2012. 
Povzetek je bil nazadnje posodobljen 3. 9. 2012.
Every year, the European Medicines Agency reviewed additional information according to an agreed timetable on the quality, safety and efficacy of the vaccine. 
Evropska agencija za zdravila bo vsako leto po dogovorjenem časovnem razporedu ponovno pregledala vse nove podatke o kakovosti, varnosti in učinkovitosti cepiva.
Both sheep and cattle will need a second injection three to four weeks later. 
Ovce in govedo morajo tri do štiri tedne pozneje prejeti drugo injekcijo.
After vaccination, there can be a small swelling at the injection site lasting up to two weeks. 
Po cepljenju lahko se lahko na mestu injiciranja pojavi manjša oteklina, ki traja do največ dva tedna.
The first injection is given at one month of age in animals that have never been exposed to the disease, and at two-and-a-half months if the animal's mother is already immune to the disease. 
Prva injekcija se da mesec starim živalim, ki še nikoli niso bile izpostavljene bolezni, in dva meseca in pol starim mladičem mater, ki so že imune na bolezen.
The duration of protection was also investigated in studies using sheep and cattle and was found to be 12 months for both species. 
Trajanje zaščite so proučevali tudi v študijah na ovcah in govedu, ugotovljeno pa je bilo, da traja ta za obe vrsti 12 mesecev.
The withdrawal period is the time allowed after administration of the medicine and before the animal can be slaughtered and the meat or milk used for human consumption. 
Obdobje karence je čas, ki mora preteči po uporabi zdravila, preden se lahko žival zakolje in meso ali mleko uporabi za prehrano ljudi.
Results from a series of laboratory safety trials performed with vaccines of similar composition but of different bluetongue serotypes were also presented in order to extrapolate safety conclusions, as the vaccine was initially intended for use in an emergency situation. 
Predloženi so bili tudi rezultati niza laboratorijskih preiskav varnosti s cepivi s podobno sestavo, vendar drugimi serotipi virusa modrega jezika, da bi ekstrapolirali zaključke o varnosti, saj je bilo cepivo prvotno namenjeno uporabi v nujnih primerih.
The studies also demonstrated that the vaccine can be used in pregnant sheep and cows. 
Študije so pokazale tudi, da se cepivo lahko uporablja pri brejih ovcah in kravah.
The European Commission granted a marketing authorisation valid throughout the European Union for BTVPUR AlSap 8 on 17 March 2009. 
Evropska komisija je dovoljenje za promet z zdravilom BTVPUR AlSap 8, veljavno po vsej Evropski uniji, odobrila dne 17. marca 2009.
Animals may show a temporary increase in body temperature, usually of no more than 1°C, in the 24 hours after vaccination. 
Do 24 ur po cepljenju se lahko pri živalih pojavi prehodno povišanje telesne temperature, ki običajno ne presega 1°C.
Another laboratory study looked at the use of the vaccine in sheep aged three to four months. 
V drugi laboratorijski študiji so proučevali uporabo cepiva na ovcah, starih od treh do štirih mesecev.
The CVMP considered that the benefits of BTVPUR AlSap 8 are greater than the risks and recommended that it be given a marketing authorisation. 
CVMP je zaključil, da so koristi zdravila BTVPUR AlSap 8 večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
When it is given to sheep and cattle, the animals' immune system recognises the viruses as ‘foreign' and makes antibodies against them. 
Ko ovce in govedo cepimo, njihov imunski sistem viruse prepozna kot „tujke“ in proti njim razvije protitelesa.
In 2012 the CVMP considered that the submitted data were adequate for the authorisation of BTVPUR AlSap 8 to convert to normal. 
Leta 2012 je CVMP menil, da predloženi podatki zadostujejo, da se dovoljenje za promet z zdravilom BTVPUR AlSap 8 spremeni v običajno.
The studies showed that the vaccine is safe for sheep and cattle and that it prevents viraemia and reduces the signs of the disease in animals from one month of age that are infected with bluetongue virus serotype 8. 
Študije so pokazale, da je cepivo varno za uporabo pri ovcah in govedu ter da preprečuje viremijo in zmanjšuje simptome bolezni pri živalih, starejših od enega meseca, ki so okužene s serotipom 8 virusa bolezni modrikastega jezika.
In the future, if the animals are exposed to the bluetongue virus their immune systems will be able to produce antibodies more quickly. 
Ob ponovni izpostavitvi virusu bolezni modrikastega jezika v prihodnosti bo imunski sistem tako hitreje tvoril protitelesa.
The safety of the vaccine was studied in a number of laboratory safety studies carried out with BTVPUR AlSap in sheep and cattle using a high dose of the vaccine in animals of the minimum age. 
Varnost cepiva so proučili v številnih laboratorijskih študijah varnosti, ki so jih opravili z uporabo cepiva BTVPUR AlSap 8 na govedu in ovcah, pri čemer so uporabili najvišji odmerek cepiva pri najmlajših živalih.
The efficacy of the vaccine in cattle was studied in a laboratory study using the vaccine in cattle from one month of age. 
Učinkovitost cepiva pri govedu so proučili v laboratorijski preiskavi uporabe cepiva na govedu, starejšemu od enega meseca.
BTVPUR AlSap 8 was initially authorised under ‘exceptional circumstances'. 
Zdravilo BTVPUR AlSap 8 je prvotno pridobilo dovoljenje za promet v „izjemnih okoliščinah“.
The vaccine is used to prevent viraemia (the presence of viruses in the blood) and reduce the signs of the disease caused by bluetongue virus serotype 8. 
Cepivo se uporablja za preprečitev viremije (prisotnosti virusa v krvi) in zmanjšanje znakov bolezni, ki jo povzroča serotip 8 virusa modrega jezika.
Inactivated vaccine against bluetongue disease virus, serotype 8 
inaktivirano cepivo proti virusu modrega jezika, serotip 8
The effects of maternally derived antibodies were investigated and the vaccine was shown to be effective in animals from 2.5 months of age. 
Raziskali so tudi učinke maternalnih protiteles in ugotovljeno je bilo, da je cepivo učinkovito za živali, starejše od dveh mesecev in pol.
BTVPUR AlSap 8 contains bluetongue virus of one type (‘serotype 8'). 
Zdravilo BTVPUR AlSap 8 vsebuje en tip virusov modrega jezika („serotip 8“).
BTVPUR AlSap 8 is a vaccinethat is available as a suspension for injection. 
Zdravilo BTVPUR AlSap 8 je cepivo, ki je na voljo v obliki suspenzije za injiciranje.
This means that it was not possible to obtain complete information about BTVPUR AlSap 8 at the time of the initial authorisation. 
To pomeni, da ob prvotni odobritvi ni bilo mogoče pridobiti vseh podatkov o zdravilu BTVPUR AlSap 8.
No withdrawal period for meat and milk with BTVPUR AlSap 8 is necessary (zero days withdrawal period). 
Karenca za meso in mleko po jemanju zdravila BTVPUR AlSap 8 ni potrebna (karenca nič dni).
BTVPUR AlSap 8 is used in sheep and cattle to protect them against bluetongue disease, an infection caused by the bluetongue virus which is transmitted by midges. 
Zdravilo BTVPUR AlSap 8 se uporablja pri ovcah in govedu za zaščito pred boleznijo modrega jezika, tj. okužbo, ki jo prenašajo trzače, povzroča pa jo virus modrega jezika.
BTVPUR AlSap 8 is a vaccine. 
Zdravilo BTVPUR AlSap 8 je cepivo.
BTVPUR AlSap 8 contains bluetongue viruses that have been inactivated so that they cannot cause the disease. 
Zdravilo BTVPUR AlSap 8 vsebuje viruse modrega jezika, ki so inaktivirani in ne morejo povzročiti bolezni.
What benefit has BTVPUR AlSap 8 shown during the studies? 
Kakšne koristi je zdravilo BTVPUR AlSap 8 izkazalo med študijami?
Other information about BTVPUR AlSap 8: 
Druge informacije o zdravilu BTVPUR Alsap 8:
It contains inactivated (killed) bluetongue serotype 8 virus. 
Vsebuje inaktivirane (uničene) viruse modrega jezika, serotip 8.
What is the risk associated with BTVPUR AlSap 8? 
Kakšna tveganja so povezana z zdravilom BTVPUR AlSap 8?
Why has BTVPUR AlSap 8 been approved? 
Zakaj je bilo zdravilo BTVPUR AlSap 8 odobreno?