natgillin/translations-raw huggingface dataset:
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL WITH 2.5 mL or 5 mL WATER FOR INJECTIONS
FARMACEVTSKA OBLIKA IN VSEBINA 1 viala s praškom za raztopino za injiciranje 1 viala, ki vsebuje 2,5 ml vode za injekcije 1 viala, ki vsebuje 5 ml vode za injekcije
• One mL Helixate NexGen 250 IU contains approximately 100 IU (250 IU / 2.5 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution with water for injections.
• 1 ml zdravila Helixate NexGen 250 i.e. vsebuje približno 100 i.e. (250 i.e./ 2,5 ml) rekombinantnega humanega koagulacijskega faktorja VIII (INN: oktokog alfa) po rekonstituciji z vodo za injekcije.
• One mL Helixate NexGen 500 IU contains approximately 200 IU (500 IU / 2.5 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution with water for injections.
• 1 ml zdravila Helixate NexGen 500 i.e. vsebuje približno 200 i.e. (500 i.e./ 2,5 ml) rekombinantnega humanega koagulacijskega faktorja VIII (INN: oktokog alfa) po rekonstituciji z vodo za injekcije.
What Helixate NexGen contains
Kaj vsebuje zdravilo Helixate NexGen
• One mL Helixate NexGen 3000 IU contains approximately 600 IU (3000 IU / 5 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution with water for injections.
• 1 ml zdravila Helixate NexGen 3000 i.e. vsebuje približno 600 i.e. (3000 i.e./ 5 ml) rekombinantnega humanega koagulacijskega faktorja VIII (INN: oktokog alfa) po rekonstituciji z vodo za injekcije.
• One mL Helixate NexGen 1000 IU contains approximately 400 IU (1000 IU / 2.5 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution with water for injections.
• 1 ml zdravila Helixate NexGen 1000 i.e. vsebuje približno 400 i.e. (1000 i.e./ 2,5 ml) rekombinantnega humanega koagulacijskega faktorja VIII (INN: oktokog alfa) po rekonstituciji z vodo za injekcije.
• One mL Helixate NexGen 2000 IU contains approximately 400 IU (2000 IU / 5 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution with water for injections.
• 1 ml zdravila Helixate NexGen 2000 i.e. vsebuje približno 400 i.e. (2000 i.e./ 5 ml) rekombinantnega humanega koagulacijskega faktorja VIII (INN: oktokog alfa) po rekonstituciji z vodo za injekcije.
Helixate NexGen 250 IU powder for solution for injection Helixate NexGen 500 IU powder for solution for injection Helixate NexGen 1000 IU powder for solution for injection Helixate NexGen 2000 IU powder for solution for injection Helixate NexGen 3000 IU powder for solution for injection
Helixate NexGen 250 i.e. prašek za raztopino za injiciranje Helixate NexGen 500 i.e. prašek za raztopino za injiciranje Helixate NexGen 1000 i.e. prašek za raztopino za injiciranje Helixate NexGen 2000 i.e. prašek za raztopino za injiciranje Helixate NexGen 3000 i.e. prašek za raztopino za injiciranje rekombinantni koagulacijski faktor VIII (oktokog alfa)
METHOD OF ADMINISTRATION For reconstitution of Helixate NexGen, see package leaflet.
Navodila za rekonstitucijo zdravila Helixate NexGen so navedena v navodilu za uporabo.
The vial contains a dry white to slightly yellow powder or cake, as well as water for injections to be used to reconstitute the contents of the vial.
FARMACEVTSKA OBLIKA prašek in vehikel za raztopino za injiciranje (sistem Bio-Set) Prašek: suh bel do rahlo rumen prašek ali pogača Vehikel: voda za injekcije, bistra, brezbarvna raztopina
It is available as tablets (0.5, 1 and 2 mg).
Na voljo je v obliki tablet (0,5, 1 in 2 mg).
The full EPAR for Enyglid 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 Enyglid je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Enyglid is taken before meals, normally up to 15 minutes before each main meal.
Zdravilo Enyglid se jemlje pred obroki, po navadi največ 15 minut pred vsakim glavnim obrokom.
The European Commission granted a marketing authorisation valid throughout the European Union for Enyglid on 14 October 2009.
Evropska komisija je dovoljenje za promet z zdravilom Enyglid, veljavno po vsej Evropski uniji, izdala 14. oktobra 2009.
What are the benefits and risks of Enyglid?
Kakšne so koristi in tveganja, povezani z zdravilom Enyglid?
This means that Enyglid is similar to a ‘reference medicine' already authorised in the European Union (EU) called NovoNorm.
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu NovoNorm.
For more information about treatment with Enyglid, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Enyglid preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
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 Enyglid.
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.
This is a summary of the European public assessment report (EPAR) for Enyglid.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Enyglid.
If patients are transferred from another diabetes medicine, the recommended starting dose is 1 mg.
Pri bolnikih, ki preidejo z drugega zdravila za sladkorno bolezen, je priporočeni začetni odmerek 1 mg.
Enyglid is a ‘generic medicine'.
Zdravilo Enyglid je „generično zdravilo“.
Because Enyglid is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicine's.
Ker je zdravilo Enyglid generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so koristi in tveganja enaki kot pri referenčnem zdravilu.
The CHMP concluded that, in accordance with EU requirements, Enyglid has been shown to have comparable quality and to be bioequivalent to NovoNorm.
CHMP je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Enyglid primerljivo raven kakovosti kot zdravilo NovoNorm ter da mu je biološko enakovredno.
Enyglid is a diabetes medicine that contains the active substance repaglinide.
Enyglid je zdravilo za sladkorno bolezen, ki vsebuje zdravilno učinkovino repaglinid.
Because Enyglid is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, NovoNorm.
Ker je zdravilo Enyglid generično zdravilo, so bile študije pri ljudeh omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu NovoNorm.
The Committee recommended that Enyglid be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Enyglid izda dovoljenje za promet.
Other information about Enyglid
Druge informacije o zdravilu Enyglid
It is used together with diet and exercise to lower blood glucose (sugar) levels in patients whose hyperglycaemia (high blood glucose levels) is not adequately controlled by diet, weight reduction and exercise.
Uporablja se skupaj z dieto in telesno dejavnostjo za znižanje glukoze (sladkorja) v krvi pri bolnikih, pri katerih hiperglikemije (visoke koncentracije glukoze v krvi) ni mogoče nadzorovati z dieto, zmanjšanjem telesne mase in telesno dejavnostjo.
Why has Enyglid been approved?
Zakaj je bilo zdravilo Enyglid odobreno?
This dose may need to be increased after one or two weeks.
Priporočeni začetni odmerek je 0,5 mg, ki se po enem ali dveh tednih lahko poveča.
Enyglid may also be used with metformin (another diabetes medicine) in type 2 diabetes patients whose blood glucose levels are not satisfactorily controlled on metformin alone.
Zdravilo Enyglid se lahko uporabi tudi z metforminom (drugim zdravilom za sladkorno bolezen) pri bolnikih s sladkorno boleznijo tipa 2, pri katerih samo z metforminom ni mogoče zadovoljivo nadzorovati ravni glukoze v krvi.
Enyglid is used in adults who have type 2 diabetes.
Zdravilo Enyglid se uporablja pri odraslih s sladkorno boleznijo tipa 2.
Enyglid helps the pancreas to produce more insulin at mealtimes and is used to control type 2 diabetes.
Zdravilo Enyglid spodbuja trebušno slinavko, da med obroki tvori več insulina, zato se uporablja za nadzor sladkorne bolezni tipa 2.
How has Enyglid been studied?
Kako je bilo zdravilo Enyglid raziskano?
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom tudi pri bolnikih s sladkorno boleznijo tipa 2, pri katerih so ravni glukoze v krvi po navadi dobro nadzorovane z dieto, vendar doživljajo obdobja prehodne izgube nadzora.
What is Enyglid used for?
Za kaj se zdravilo Enyglid uporablja?
How is Enyglid used?
Kako se zdravilo Enyglid uporablja?
The marketing authorisation was renewed on 13 June 2005.
Dovoljenje za promet z zdravilom je bilo podaljšano 13. junija 2005.
These effects are mild and temporary.
Ti neželeni učinki so bili blagi in prehodni.
The standard dose is 15 mg per kilogram body weight once a day for the length of time determined by your veterinarian.
Običajen odmerek znaša 15 mg na kilogram telesne mase enkrat dnevno, ki ga je treba dajati tako dolgo, kot to določi veterinar.
Ibaflin is available as tablets (30, 150, 300 and 900 mg) and as oral gels (3 and 7.5%).
Na voljo je v obliki tablet (30, 150, 300 in 900 mg) in v obliki peroralnih gelov (3 % in 7,5 %).
This enzyme is only found in bacterial cells, and does not have a similar function in animal cells.
Ta encim je mogoče najti samo v celicah bakterij, v celicah živali pa nima podobne vloge.
For more information, see the Package Leaflet.
Za več informacij glejte
Other information about Ibaflin:
Druge informacije o zdravilu Ibaflin:
It works by blocking an enzyme called ‘DNA gyrase', which is important in allowing bacteria to make copies of their DNA.
Deluje tako, da zavre encim imenovan „DNA-giraza“, ki je pomemben zato, ker bakterijam omogoča, da izdelujejo kopije svoje DNA.
People who are hypersensitive (allergic) to quinolones should avoid any contact with Ibaflin.
Ljudje, ki so preobčutljivi za (alergični na) kinolone, se morajo izogibati vsakršnega stika z zdravilom Ibaflin.
Cats are treated using the 3% oral gel.
Za zdravljenje mačk se uporablja 3 % peroralni gel.
The European Commission granted a marketing authorisation valid throughout the European Union for Ibaflin to Intervet International B.V. on 13 June 2000.
Evropska komisija je dovoljenje za promet z zdravilom Ibaflin, veljavno po vsej Evropski uniji, odobrila družbi Intervet International B.V.
The use of ibafloxacin may result in an increase in the prevalence of resistant strains in the target species although this risk is likely to be less of a concern due to the treatment of individual animals with this product.
Uporaba ibafloksacina ima lahko za posledico povečanje pogostnosti pojavljanja odpornih sevov pri ciljnih vrstah, vendar pa je takšno tveganje zaradi tega, ker se s tem zdravilom zdravi le posamezne živali, manj zaskrbljujoče.
A strain which is resistant to one type of fluoroquinolone will also be resistant to other members of the class of fluoroquinolones.
Sev, ki je odporen na eno vrsto fluorokinolonov, bo odporen tudi na druge pripadnike iz skupine fluorokinolonov.
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) IBAFLIN EPAR summary for the public
IBAFLIN Povzetek EPAR za javnost
In these studies, the effects of Ibaflin were compared with those of other antibiotics (marbofloxacin, enrofloxacin or amoxicillin/clavulanic acid).
V teh študijah so učinke zdravila Ibaflin primerjali z učinki drugih antibiotikov (marbofloksacina, enrofloksacina ali amoksicilina/klavulanske kisline).
The dose and duration of treatment depend on the nature and severity of the infection, the weight and species of the animal being treated, and the animal's response to treatment.
Odmerek zdravila in trajanje zdravljenja sta odvisna od narave in resnosti okužbe, telesne mase in vrste živali, ki jo zdravimo, ter od tega,
By blocking DNA gyrase, ibafloxacin prevents the bacteria from making DNA and stops them making proteins and growing, resulting in their death.
Z zavrtjem DNA-giraze ibafloksacin bakterijam prepreči tvorbo DNA, s čimer pri njih zaustavi tvorbo beljakovin in rast, kar ima za posledico njihovo odmrtje.
However, the results were insufficient to support the use of Ibaflin in the treatment of urinary tract infections in cats.
Kljub temu pa rezultati niso zadostovali za podporo uporabe zdravila Ibaflin pri zdravljenju okužb sečil pri mačkah.
Why has Ibaflin been approved?
Zakaj je bilo zdravilo Ibaflin odobreno?
Ibaflin is used to treat the infections in dogs and cats:
Zdravilo Ibaflin se uporablja za zdravljenje okužb pri psih in mačkah:
Dogs are treated using the tablets, except for skin infection, where in addition to the tablets either strengths of the oral gel may be used.
Za zdravljenje psov se uporabljajo tablete, razen pri okužbah kože, pri katerih se poleg tablet lahko uporablja tudi peroralni gel manjše ali večje jakosti.
• skin infections, including shallow and deep ‘pyoderma', infected wounds and abscesses caused by bacteria such as Staphylococci, E. coli, Proteus species and Pasteurella species,
• okužb kože, vključno s površinsko in globoko „piodermijo“, okuženih ran in abscesov, ki jih povzročajo bakterije, kot so na primer Staphylococci, E. coli, Proteus vrste in Pasteurella vrste,
• upper respiratory tract infections caused by Staphylococci, E. coli and Klebsiella species.
• okužb zgornjih dihalnih poti, ki jih povzročajo Staphylococci, E. coli in Klebsiella vrste.
Ibaflin contains ibafloxacin, which belongs to a class of medicines having an antibiotic action.
Ibaflin vsebuje ibafloksacin, ki spada v skupino zdravil z antibiotičnim delovanjem.
What benefit has Ibaflin shown during the studies?
Kakšne koristi je zdravilo Ibaflin izkazalo v raziskavah?
The benefit-risk balance may be found in module 6 of this EPAR.
Razmerje med koristmi in tveganji najdete v modulu 6 tega Evropskega javnega poročila o oceni zdravila
Ibafloxacin, is an antibiotic belonging to the class ‘fluoroquinolones'.
Ibafloksacin je antibiotik, ki spada v skupino „fluorokinolonov“.
From data of two different clinical trials, comparable efficacy was shown between the Ibaflin gel formulations and a positive control to support the claims for skin (soft tissue infections - wounds, abscesses) and upper respiratory tract infections in cats for the oral gel formulations.
Na podlagi podatkov, pridobljenih v dveh različnih kliničnih preskušanjih, so ugotovili primerljivo učinkovitost obeh pripravkov zdravila Ibaflin v obliki gela in pozitivno kontrolo v podporo trditvam, ki zadevajo okužbe kože (okužbe mehkih tkiv - rane, abscesi) in okužbe zgornjih dihalnih poti pri mačkah ob uporabi pripravkov gela za peroralno uporabo.
Ibaflin oral gel is indicated in dogs for the treatment of skin infections (pyoderma - superficial and deep, wounds, abscesses).
Ibaflin peroralni gel je indiciran pri psih za zdravljenje okužb kože (piodermija - površinska in globoka, rane, abscesi).
The indication for treatment of urinary infections in cats was not accepted.
Indikacija za zdravljenje okužb sečil pri mačkah ni bila sprejeta.
It is also used in dogs to treat acute (short-lived), uncomplicated infections of the urinary tract caused by Staphylococci, Proteus species, Enterobacter species, E. coli and Klebsiella species.
Pri psih se uporablja tudi za zdravljenje akutnih (kratkotrajnih) nezapletenih okužb sečil, ki jih povzročajo Staphylococci, Proteus vrste, Enterobacter vrste, E. coli in Klebsiella vrste.
Medical advice should be sought if the tablets are swallowed accidentally, particularly by a child.
Če pride do nenamernega zaužitja tablet, se je treba, še posebej kadar gre za otroka, takoj posvetovati z zdravnikom.
Diarrhoea, soft faeces, vomiting, dullness (lack of responsiveness) and anorexia (loss of appetite) occur with low frequency in dogs and cats given Ibaflin.
mehkega blata, otopelosti (pomanjkanja odzivnosti) in anoreksije (izgube apetita).
How does Ibaflin work?
Kako zdravilo Ibaflin deluje?
Salivation can also occur with the oral gel.
Pri uporabi peroralnega gela lahko pride tudi do pojava slinjenja.
Ibaflin tablets have been studied in dogs, looking at their effectiveness in treating skin, urinary tract and respiratory tract infections.
Ibaflin tablete so preučevali pri psih, spremljali pa so njihovo učinkovitost pri zdravljenju okužb kože, sečil in dihalnih poti.
Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.
ocenil predloženo dokumentacijo, na podlagi česar je oblikoval priporočila glede uporabe zdravila.
How has Ibaflin been studied?
Kako je bilo zdravilo Ibaflin raziskano?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Ibaflin exceed the risks for the treatment of skin infections, and respiratory tract infections (upper tract) in dogs and cats, and acute, uncomplicated urinary tract infections in dogs, and recommended that Ibaflin be given a marketing authorisation.
Ibaflin pri zdravljenju okužb kože in okužb dihalnih poti (zgornjih dihalnih poti) pri psih in mačkah ter akutnih nezapletenih okužb sečil pri psih, večje od z njim povezanih tveganj, zato je priporočil, da se za zdravilo Ibaflin odobri dovoljenje za promet z zdravilom.
What is Ibaflin?
Kaj je zdravilo Ibaflin?
Ibaflin tablets were at least as effective as the comparator antibiotics in treating skin, urinary tract and upper tract respiratory infections in dogs.
Ibaflin tablete so bile pri zdravljenju okužb kože, sečil in zgornjih dihalnih poti pri psih najmanj tako učinkovite kot antibiotiki, uporabljeni za primerjavo.
What is Ibaflin used for?
Za kaj se zdravilo Ibaflin uporablja?
The oral gel has been studied in cats looking at skin, respiratory tract and urinary tract infections.
Peroralni gel so preučevali pri mačkah, spremljali pa so okužbe kože, dihalnih poti in sečil.
The oral gel was also at least as effective as the comparator antibiotic (amoxicillin/clavulanic acid) in treating skin and upper respiratory tract infections in cats.
Prav tako je bil peroralni gel pri zdravljenju okužb kože in zgornjih dihalnih poti pri mačkah najmanj tako učinkovit kot za primerjavo uporabljen antibiotik (amoksicilin/klavulanska kislina).
The tablets and oral gel were of comparable effectiveness in treating skin infections in dogs.
Pri zdravljenju okužb kože pri psih je bila učinkovitost tablet primerljiva z učinkovitostjo peroralnega gela.
What are the side-effects associated with Ibaflin?
Kakšni so neželeni učinki zdravila Ibaflin?
Comparable efficacy of the gel formulation to the tablet formulation was shown for dogs in a clinical trial.
V kliničnih preskušanjih so pri psih ugotovili primerljivo učinkovitost zdravila v obliki gela in v obliki tablet.
Ibaflin is given by mouth.
Zdravilo Ibaflin se daje peroralno.
EMEA 2007
(EPAR).
This summary was last updated in November 2018.
Pregled je bil nazadnje posodobljen novembra 2018.
Revaccination is required every six months.
Cepljenje je treba ponoviti vsakih šest mesecev.
Sufficient justification for extrapolation of these data to other strains was provided.
Predlagatelj je zadovoljivo utemeljil ekstrapolacijo teh podatkov na druge seve.
This will help protect them against the disease.
To pomaga zaščititi živali pred boleznijo.
These strains belong to four different serotypes (groups) of the virus known as O, A, Asia 1 and SAT2, and are selected, depending on the epidemiological need, from the following eight strains: O1 Manisa, O1 BFS, O Taiwan 3/97, A22 Iraq, A24 Cruzeiro, A Turkey 14/98, Asia 1 Shamir and SAT2 Saudi Arabia.
Sevi spadajo v štiri različne serotipe (skupine) virusa, imenovane O, A, Asia 1 in SAT2, izberejo pa jih glede na epidemiološke potrebe izmed naslednjih osmih sevov: O1 Manisa, O1 BFS, O Taiwan 3/97, A22 Iraq, A24 Cruzeiro, A Turkey 14/98, Asia 1 Shamir in SAT2 Saudi Arabia.
When animals are vaccinated at 2 weeks of age, revaccination is recommended at 8 to 10 weeks.
Če se živali cepijo pri dveh tednih starosti, se priporoča ponovno cepljenje pri osmih do desetih tednih.
This was considered acceptable, given the laboratory data and taking into account that vaccination against foot-and-mouth disease is currently not permitted in the EU under legal controls on foot-and-mouth disease.
To velja za sprejemljivo ob upoštevanju laboratorijskih podatkov in dejstva, da cepljenje proti slinavki in parkljevki v EU trenutno ni dovoljeno v skladu s pravnim nadzorom slinavke in parkljevke.
The measure of effectiveness was the reduction in clinical signs of foot-and-mouth disease.
Merilo učinkovitosti je bilo zmanjšanje kliničnih znakov slinavke in parkljevke.
Further information can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/aftovaxpur-doe.
Nadaljnje informacije o zdravilu Aftovaxpur DOE so na voljo na spletni strani agencije: ema.europa.eu/medicines/veterinary/EPAR/aftovaxpur-doe.
The start of protection is 1 week after vaccination in cattle and sheep and 4 weeks after vaccination in pigs.
Zaščita se začne en teden po cepljenju goveda in ovac ter štiri tedne po cepljenju prašičev.
Accidental injection of liquid paraffin may cause severe pain and swelling, particularly if injected into a joint or finger - this could result in the loss of the finger if prompt medical attention is not given.
Nenamerno injiciranje tekočega parafina lahko povzroči hude bolečine in otekline, zlasti ob injiciranju v sklep ali prst; brez takojšnje zdravniške oskrbe lahko pride do izgube prsta.
Vaccine containing O1 Manisa antigen reduces clinical signs of foot-and-mouth disease in cattle, sheep and pigs.
Cepivo, ki vsebuje antigen O1 Manisa, zmanjša klinične znake slinavke in parkljevke pri govedu, ovcah in prašičih.
The range of antibodies produced following vaccination with Aftovaxpur DOE was different from that produced by natural infection; this makes it possible to distinguish vaccinated from infected animals, which is important for disease control.
Razpon protiteles, ki so se tvorila po cepljenju s cepivom Aftovaxpur DOE; je bil drugačen kot pri naravni okužbi; to omogoča razlikovanje med cepljenimi in okuženimi živalmi, kar je pomembno za nadziranje bolezni.
The withdrawal period for meat and milk from cattle and sheep and for meat from pigs treated with Aftovaxpur DOE is ‘zero' days which means that there is no mandatory waiting time.
Karenca za meso in mleko goveda in ovac ter meso prašičev, zdravljenih z zdravilom Aftovaxpur DOE, je nič dni, kar pomeni, da ni obvezne čakalne dobe.
The European Medicines Agency decided that Aftovaxpur DOE's benefits are greater than its risks and it be approved for use in the EU.
Evropska agencija za zdravila je zaključila, da so koristi zdravila Aftovaxpur DOE večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
Aftovaxpur DOE received a marketing authorisation valid throughout the EU on 15 July 2013.
Zdravilo Aftovaxpur DOE je pridobilo dovoljenje za promet, veljavno po vsej Evropski uniji, 15. julija 2013.
For more information about using Aftovaxpur DOE, see the package leaflet or contact your veterinarian or pharmacist.
Za več informacij glede uporabe zdravila Aftovaxpur DOE glejte navodilo za uporabo ali se posvetujte z veterinarjem ali farmacevtom.
Some studies also looked at the levels of antibodies in cattle, sheep and pigs after single and repeated doses of the vaccine.
V nekaterih študijah so spremljali tudi ravni protiteles pri govedu, ovcah in prašičih po enem samem odmerku in ponavljajočih se odmerkih cepiva.
In the future, if the animals are exposed to foot-and-mouth disease virus, the immune system will be able to produce antibodies more quickly.
Če so živali kasneje izpostavljene virusu slinavke in parkljevke, lahko imunski sistem hitreje tvori protitelesa proti njej.