FrancophonIA/ELRC3.0 huggingface dataset:
English: For longer term treatment, once a clinical response has been observed (after ≥ 4 days), the dose of the product can be adjusted to the lowest effective individual dose reflecting that the degree of pain and inflammation associated with chronic musculo-skeletal disorders may vary over time.
Slovenian: Pri dolgotrajnejšem zdravljenju lahko, ko opazite klinični odziv (po 4 dneh ali več), odmerek zdravila prilagodite na najmanjši še učinkoviti individualni odmerek, pri čemer upoštevajte, da se lahko stopnja bolečine in vnetja, povezana s kroničnimi mišično-skeletnimi obolenji, s časom spreminja.
English: Shake gently before use.
Slovenian: Pred uporabo nežno pretresite.
English: In the case of overdose symptomatic treatment should be initiated.
Slovenian: V primeru prevelikega odmerjanja je treba uvesti simptomatsko zdravljenje.
English: RevitaCAM must not be administered in conjunction with other NSAIDs or glucocorticosteroids.
Slovenian: Zdravila RevitaCAM se ne sme dati v kombinaciji z drugimi NSAID ali glukokortikosteroidi.
English: Meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas urine contains only traces of the parent compound.
Slovenian: Meloksikam je najti pretežno v plazmi in je hkrati glavni produkt biliarnega izločanja, medtem ko vsebuje urin le sledove starševske spojine.
English: Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of increased renal toxicity.
Slovenian: Izogibajte se uporabi pri dehidriranih, hipovolemičnih ali hipotenzivnih živalih, saj obstaja možnost tveganja za povečano toksičnost za ledvice.
English: Approximately 75 % of the administered dose is eliminated via faeces and the remainder via urine.
Slovenian: Približno 75 % uporabljenega odmerka se izloči v blatu, preostanek pa v urinu.
English: Meloxicam is completely absorbed following oromucosal administration and maximal plasma concentrations are obtained after approximately 4.5 hours.
Slovenian: Meloksikam se povsem absorbira po oralnem dajanju, in doseže maksimalne koncentracije v plazmi po približno 4,5 urah.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals ) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).
Slovenian: Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (pri več kot 1 živali od 10 živali med enim ciklom zdravljenja) - pogosti (pri več kot 1 a manj kot 10 živali od 100 živali) - občasni (pri več kot 1 a manj kot 10 živali od 1.000 živali) - redki (pri več kot 1 a manj kot 10 živali od 10.000 živali) - zelo redki (pri manj kot 1 živali od 10.000 živali, vključujoč posamezne primere).
English: Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein binding may compete for binding and thus lead to toxic effects.
Slovenian: Drugi NSAID, diuretiki, antikoagulanti, aminoglikozidni antibiotiki in snovi, ki se močno vežejo na beljakovine, lahko tekmujejo za vezavo in tako povzročijo toksične učinke.
English: The MAH must ensure that the system of pharmacovigilance as described in Part 1 of the marketing authorisation application, is in place and functioning before and whilst the product is on the market.
Slovenian: Imetnik dovoljenja za promet mora zagotoviti, da je sistem farmakovigilance, predložen kot je opisan v delu I vloge za pridobitev dovoljenja za promet, vzpostavljen in deluje, preden da zdravilo v promet in ves čas trženja zdravila.
English: Overdose (symptoms, emergency procedures, antidotes): In case of overdose symptomatic treatment should be initiated.
Slovenian: Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi): V primeru prevelikega odmerjanja je treba uvesti simptomatsko zdravljenje.
English: EU/2/12/138/001 6 ml/10 ml vial EU/2/12/138/002 11 ml/20 ml vial EU/2/12/138/003 33 ml/50 ml vial EU/2/12/138/004 3 ml/10 ml vial EU/2/12/138/005 3 ml/20 ml vial EU/2/12/138/006 8 ml/50 ml vial
Slovenian: EU/2/12/138/001 6 ml/10 ml stekleni viali EU/2/12/138/002 11 ml/20 ml stekleni viali EU/2/12/138/003 33 ml/50 ml stekleni viali EU/2/12/138/004 3 ml/10 ml stekleni viali EU/2/12/138/005 3 ml/20 ml stekleni viali EU/2/12/138/006 8 ml/50 ml stekleni viali
English: Maintenance dosage range meloxicam delivered (mg/kg)*
Slovenian: Razpon dostavljenega vzdrževalnega odmerka meloksikama (mg/kg)*
English: Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the vial.
Slovenian: Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na škatli in viali.
English: Oromucosal spray Yellow colloidal dispersion
Slovenian: Oralno pršilo rumena koloidna disperzija
English: When the product is used according to the recommended dosage regime, steady state concentrations of meloxicam in plasma are reached on the second day of treatment.
Slovenian: Če se zdravilo uporablja po priporočenem režimu odmerjanja, so koncentracije meloksikama v stanju dinamičnega ravnotežja v plazmi dosežene drugi dan zdravljenja.
English: Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects and accordingly a treatment-free period with such veterinary medicinal products should be observed for at least 24 hours before commencement of treatment.
Slovenian: Predhodno zdravljenje s protivnetnimi učinkovinami lahko povzroči dodatne neželene učinke ali jih okrepi, zato morate upoštevati vsaj 24-urno obdobje brez uporabe takih zdravil za uporabo v veterinarski medicini, preden začnete zdravljenje.
English: In case of pump failure, wipe nozzle and then re-prime the pump as described above.
Slovenian: Če razpršilnik ne deluje, obrišite šobo in nato razpršilnik pripravite, kot je opisano zgoraj.
English: Spray RevitaCAM into dog's mouth
Slovenian: Zdravilo RevitaCAM razpršite v gobec psa
English: Store the vial in an upright position.
Slovenian: Vialo shranjujte v pokončnem položaju.
English: Meloxicam is metabolised to an alcohol, an acid derivative and to several polar metabolites.
Slovenian: Meloksikam se presnovi v alkohol, derivat kisline in v številne polarne presnovke.
English: In some dogs sneezing, coughing/gagging or drooling may be observed immediately after treatment administration.
Slovenian: Pri nekaterih psih so takoj po dajanju zdravila opazili kihanje, kašljanje/davljenje ali slinjenje.
English: People with known hypersensitivity to Non Steriodal Anti-inflammatory Drugs (NSAIDs) should avoid contact with the veterinary medicinal product.
Slovenian: Osebe z znano preobčutljivostjo na nesteroidna protivnetna zdravila (NSAID) naj se izogibajo stiku z zdravilom.
English: If RevitaCAM is not used for two days or more, re-prime with one or more sprays or until a fine spray appears.
Slovenian: Če zdravila RevitaCAM dva ali več dni ne uporabljate, ponovite postopek priprave z enim ali več pritiski ali dokler se ne pojavijo drobne razpršene kapljice.
English: * For the initial treatment of a single dose of 0.2 mg meloxicam/kg body weight, the above maintenance doses should be doubled.
Slovenian: * Pri začetnem zdravljenju z enkratnim odmerkom 0,2 mg meloksikama/kg telesne mase podvojite zgornje vzdrževalne odmerke.
English: Avoid direct contact between the product and skin, if accidental exposure occurs wash hands immediately with soap and water.
Slovenian: Preprečite nenamerni neposredni stik med zdravilom in kožo, ob nenamerni izpostavitvi roke takoj umijte z milom in vodo.
English: To prime the pump depress at least 10 times prior to first use or until a fine spray appears.
Slovenian: Za pripravo razpršilnika pred prvo uporabo nanj pritisnite vsaj 10-krat ali dokler se ne prikažejo drobno razpršene kapljice.
English: Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders.
Slovenian: Ublažitev vnetja in bolečine pri akutnih in kroničnih mišično-skeletnih obolenjih.
English: To administer RevitaCAM, the dog's top lip should be grasped and gently pulled away exposing the gums.
Slovenian: Za dajanje zdravila RevitaCAM primite zgornjo ustnico psa in jo nežno povlecite stran, da se prikaže dlesen.
English: The treatment-free period, however, should take into account the pharmacological properties of the products used previously.
Slovenian: Pri določanju obdobja brez zdravljenja upoštevajte farmakološke lastnosti predhodno uporabljenih zdravil.
English: Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, non-steroids (oxicams) ATCvet Code:
Slovenian: Farmakoterapevtska skupina: protivnetna in protirevmatična zdravila, nesteroidna (oksikami) Oznaka ATCvet:
English: There is a linear relationship between the dose administered and plasma concentration observed in the therapeutic dose range.
Slovenian: V terapevtskem razponu odmerjanja obstaja linearno razmerje med danim odmerkom in opazovano koncentracijo v plazmi .
English: Ethyl alcohol Polycarbophil Boric acid Potassium chloride Hydrochloric acid Sodium hydroxide Water, purified
Slovenian: 6.1 Seznam pomožnih snovi etanol polikarbofil borova kislina kalijev klorid klorovodikova kislina natrijev hidroksid voda, prečiščena
English: Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs.
Slovenian: Ublažitev vnetja in bolečine pri akutnih in kroničnih mišično-skeletnih obolenjih pri psih.
English: Particular care should be taken with regard to the accuracy of dosing.
Slovenian: Bodite posebno pozorni na pravilno odmerjanje.
English: Manufacturer for the batch release: Abbott Logistics B.V., Minervum 7201, Breda 4817 ZJ, THE NETHERLANDS
Slovenian: Izdelovalec, odgovoren za sprostitev serije: Abbott Logistics B.V., Minervum 7201, Breda 4817 ZJ, NIZOZEMSKA
English: Immediately after administration of the spray use a moist paper towel or tissue to clean the tip of the pump.
Slovenian: Takoj po dajanju pršila očistite konico razpršilnika z vlažno papirnato brisačo ali robčkom.
English: EXP {month/year} Shelf-life of opened vial: 6 months
Slovenian: EXP {mesec/leto} Odprto vialo porabite v roku: 6 mesecev
English: Do not use in pregnant or lactating animals.
Slovenian: Ne uporabite pri brejih živalih ali živalih v laktaciji.
English: Do not use in animals suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.
Slovenian: Ne uporabite pri živalih z boleznimi prebavil, kot so draženje in krvavitve, okvarjenim delovanjem jeter, srca ali ledvic in hemoragičnimi obolenji.
English: D. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Slovenian: D. DRUGI POGOJI IN ZAHTEVE KI JIH MORA IZPOLNITI IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: The mist should be directed to the back and towards the gums and/or inner cheek, mucosal surfaces.
Slovenian: Pršenje usmerite nazaj in proti sluznicam dlesni in/ali notranjih ličnic.
English: The mouth should not be opened any wider than necessary to facilitate application.
Slovenian: Gobca ne razpirajte bolj, kot je potrebno za nanos pršila.
English: Marketing authorisation holder: Zoetis Belgium SA, Rue Laid Burniat 1, 1348 Louvain-la-Neuve, BELGIUM
Slovenian: Imetnik dovoljenja za promet z zdravilom: Zoetis Belgium SA, Rue Laid Burniat 1, 1348 Louvain-la-Neuve, BELGIJA
English: Allow the pump to fully reflate before administering consecutive sprays.
Slovenian: Razpršilnik naj se do konca napolni z zrakom, preden ponovite pršenje.
English: Medicines should not be disposed of via wastewater or household waste but in accordance with local requirements.
Slovenian: Ne odvrzite zdravila v odpadno vodo ali v gospodinjske odpadke.
English: If adverse reactions occur, treatment should be discontinued and the advice of the veterinarian should be sought.
Slovenian: Posebni previdnostni ukrepi za uporabo pri živalih Če se pojavijo neželeni učinki, je treba zdravljenje prekiniti in se posvetovati z veterinarjem.
English: The pump should be depressed fully, ensuring no mist escapes from the mouth.
Slovenian: Na razpršilnik pritisnite do konca in ne dovolite, da bi razpršene kapljice uhajale iz gobca.
English: Wipe pump with tissue to prevent clogging
Slovenian: Razpršilnik obrišite z robčkom, da se ne zamaši
English: Active substance: Meloxicam 5 mg
Slovenian: Zdravilna učinkovina: meloksikam 5 mg
English: Name and address of the manufacturer(s) responsible for batch release
Slovenian: Ime in naslov izdelovalca (izdelovalcev) zdravila, odgovornega (odgovornih) za sprostitev serije
English: Treatment is to be continued once daily by oromucosal administration (at 24-hour intervals) at a maintenance dose of 0.1 mg meloxicam/kg body weight (see dosing table).
Slovenian: Zdravljenje začnite z enim odmerkom 0,2 mg meloksikama/kg telesne mase prvi dan. Nadaljujte zdravljenje z vzdrževalnim odmerkom 0,1 mg meloksikama/kg telesne mase z dajanjem pršila na ustno sluznico enkrat na dan (v 24-urnih presledkih) (glejte preglednico odmerjanja).
English: Excipients: Ethyl alcohol 150 mg
Slovenian: Pomožna snov: etanol 150 mg
English: Typical adverse drug reactions of Non Sterioidal Anit-Inflammatory Drugs (NSAIDs) such as loss of appetite, vomiting, diarrhoea, faecal occult blood, apathy and renal failure have occasionally been reported.
Slovenian: Občasno so poročali o običajnih neželenih učinkih nesteroidnih protivnetnih zdravil (NSAID), kot so izguba apetita, bruhanje, driska, prikrita kri v blatu, apatija in ledvična odpoved.
English: A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IMETNIK(I) DOVOLJENJ(A) ZA IZDELAVO ZDRAVILA, ODGOVOREN(ODGOVORNI) ZA SPROSTITEV SERIJE
English: Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and antipyretic effects.
Slovenian: Njegovo delovanje temelji na zaviranju sinteze prostaglandinov, kar ima protivnetne, analgetične, antieksudativne in antipiretične učinke.
English: Typical adverse drug reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood, apathy and renal failure have occasionally been reported.
Slovenian: Občasno so poročali o običajnih neželeni učinki na NSAID, kot so izguba apetita, bruhanje, driska, prikrita kri v blatu, apatija in ledvična odpoved.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals
Slovenian: Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo Po dajanju zdravila si umijte roke.
English: Abbott Logistics B.V., Minervum 7201, Breda 4817 ZJ, THE NETHERLANDS
Slovenian: Abbott Logistics B.V, Minervum 7201
English: OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
Slovenian: DRUGI POGOJI IN ZAHTEVE KI JIH MORA IZPOLNITI IMETNIK
English: 10 ml glass vial containing either 3ml or 6 ml 20 ml glass vial containing either 3ml or 11ml 50 ml glass vial containing either 8 ml or 33 ml Not all pack sizes may be marketed.
Slovenian: 20-mililitrska steklena viala vsebuje 3 ml ali 11 ml razpršilnik za 100 µl 50-mililitrska steklena viala vsebuje 8 ml ali 33 ml razpršilnik za 215 µl Ni nujno, da so v prometu vsa navedena pakiranja.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Slovenian: Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo: Po dajanju zdravila si umijte roke.
English: Prime pump by spraying into tissue
Slovenian: Črpalko pripravite s pršenjem v robček
English: RevitaCAM 5 mg/ml oromucosal spray for Dogs Meloxicam
Slovenian: RevitaCAM 5 mg/ml oralno pršilo za pse meloksikam
English: RevitaCAM 5 mg/ml oromucosal spray for Dogs
Slovenian: RevitaCAM 5 mg/ml oralno pršilo za pse
English: Shelf-life of the veterinary medicinal product as packaged for sale: 30 months Shelf-life after first opening the immediate packaging: 6 months
Slovenian: Rok uporabnosti zdravila v pakiranju za prodajo: 30 mesecev.
English: EXP {month/year}> Shelf-life of opened vial: 6 months Once broached, use by …
Slovenian: Odprto vialo porabite v roku: 6 mesecev Načeto zdravilo porabite do …
English: 50 ml glass vial containing either 8 ml or 33 ml
Slovenian: 50-mililitrski stekleni viali vsebuje 8 ml ali 33 ml razpršilnik za 215 µl
English: Oromucosal Spray
Slovenian: Meloksikam
English: Insert pump into vial
Slovenian: Vstavite razpršilnik v vialo Vialo nežno pretresite
English: 20 ml glass vial containing either 3ml or 11ml
Slovenian: 20-mililitrski stekleni viali vsebuje 3 ml ali 11 ml razpršilnik za 100 µl
English: PACKAGE LEAFLET FOR: RevitaCAM 5mg/ml oromucosal spray for Dogs
Slovenian: NAVODILO ZA UPORABO RevitaCAMcam 5 mg/ml oralno pršilo za pse
English: 10 ml glass vial containing either 3ml or 6 ml
Slovenian: 10-mililitrska steklena viala vsebuje 3 ml ali 6 ml razpršilnik za 50 µl
English: Veterinary medicinal product subject to prescription
Slovenian: POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE
English: CARTON
Slovenian: Presnova
English: 90 (3 x 30) tablets (multipack)
Slovenian: 90 (3 × 30) filmsko obloženih tablet (skupno pakiranje)
English: 30 x 1 tablets (unit dose)
Slovenian: 30 x 1 tableta (enojno pakiranje)
English: Invented name Strength Pharmaceutical Form Route of Administration
Slovenian: Farmacevtska oblika
English: It contains inactivated (killed) whole virus of two equine influenza (flu) strains (‘A/equine-2/South Africa/4/03' and ‘A/equine-2/Newmarket/2/93').
Slovenian: Vsebuje inaktivirana (uničena) cela virusa dveh sevov influence (gripe) konj („A/konjski-2/Južna Afrika/4/03“ in „A/konjski-2/Newmarket/2/93“).
English: The swelling is expected to decrease within two days.
Slovenian: Oteklina naj bi izginila v dveh dneh.
English: In very rare cases fever may occur for one day, and up to three days in exceptional circumstances.
Slovenian: V zelo redkih primerih se lahko pojavi povišana telesna temperatura, ki traja en dan, oziroma izjemoma do tri dni.
English: Equine influenza is a highly contagious disease that is very common in horses but that rarely causes death.
Slovenian: Influenca konj je zelo nalezljiva bolezen, ki je pri konjih zelo pogosta, vendar redko povzroči pogin.
English: These equine influenza viruses have been inactivated so that they can no longer cause disease.
Slovenian: Ti virusi so bili inaktivirani, tako da ne morejo povzročiti bolezni.
English: This should be followed by a third vaccination five months later, and afterwards by yearly revaccinations.
Slovenian: Temu sledi tretje cepljenje pet mesecev kasneje, nato pa obnovitveno cepljenje vsako leto.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Equilis Prequenza on 8 July 2005.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Equilis Prequenza, veljavno po vsej Evropski uniji, odobrila dne 8. julija 2005.
English: The duration of protection was five months after primary vaccination and 12 months after the first revaccination.
Slovenian: Zaščita je trajala pet mesecev po osnovnem cepljenju in 12 mesecev po prvem ponovnem cepljenju.
English: 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.
Slovenian: Njegov namen je pojasniti, kako je Odbor za zdravila za uporabo v veterinarski medicini (CVMP) ocenil predloženo dokumentacijo, na podlagi katere je oblikoval priporočila glede uporabe zdravila.
English: Vaccines work by ‘teaching' the immune system how to defend itself against diseases.
Slovenian: Cepiva delujejo tako, da imunski sistem „naučijo“, kako naj se brani pred boleznimi.
English: The effectiveness of the current formulation of the vaccine has been assessed in additional laboratory studies.
Slovenian: Učinkovitost trenutne formulacije je bila raziskana v dodatnih laboratorijskih študijah.
English: The studies also compared the clinical signs and virus excretion of a group of vaccinated animals with those of a control group, i.e. which did not receive the vaccine.
Slovenian: V študijah so primerjali tudi klinične znake in izločanje virusa pri cepljenih živalih in živalih iz kontrolne skupin, tj. tistih, ki niso prejele cepiva.
English: Pain at the injection site can occur rarely.
Slovenian: Na mestu injiciranja se lahko redko pojavi bolečina.
English: A hard or soft swelling may occur at the injection site.
Slovenian: Na mestu injiciranja se lahko pojavi trda ali mehka oteklina.
English: When a horse is given the vaccine, the immune system recognises the virus as ‘foreign' and makes antibodies against them.
Slovenian: Ko konj prejme cepivo, imunski sistem prepozna virus kot „tujek“ in proti njim tvori protitelesa.
English: The main measure of effectiveness was the production of protective levels of antibodies against the influenza components.
Slovenian: Glavno merilo učinkovitosti tvorjenje zaščitnih ravni protiteles proti sestavinam influence.
English: Other information about Equilis Prequenza:
Slovenian: Druge informacije o zdravilu Equilis Prequenza:
English: The vaccine is given as an injection into a muscle.
Slovenian: Cepivo se daje z injiciranjem v mišico.
English: Horses should receive a primary vaccination, consisting of two injections given four weeks apart.
Slovenian: Konji potrebujejo osnovno cepljenje, ki vključuje dve injiciranji, ki se izvedeta v razmiku štirih tednov.
English: The vaccine is available as a suspension for injection.
Slovenian: Cepivo je na voljo v obliki suspenzije za injiciranje.
English: The withdrawal period is the time allowed after administration of the medicine before the animal can be slaughtered and the meat used for human consumption or before the milk can be used for human consumption.
Slovenian: Obdobje karence je čas, ki mora preteči po uporabi zdravila, preden se lahko žival zakolje, meso ali mleko pa uporabi za prehrano ljudi.
English: The vaccine also contains an ‘adjuvant' to enhance the immune response.
Slovenian: Cepivo vsebuje tudi adjuvans za povečanje imunskega odziva.
English: Horses developed protection two weeks after primary vaccination.
Slovenian: Pri konjih so se zaščitne ravni razvile dva tedna po osnovnem cepljenju.
English: Equilis Prequenza is a vaccine for use in horses.
Slovenian: Equilis Prequenza je cepivo, ki se uporablja pri konjih.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Equilis Prequenza exceed the risks for the approved indications and recommended that Equilis Prequenza be given a marketing authorisation.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi cepiva Equilis Prequenza večje od z njim povezanih tveganj, kadar se zdravilo uporablja za odobrene indikacije, in priporočil, da se zanj odobri dovoljenje za promet.
English: The current formulation of Equine Prequenza has been shown to produce similar results to those shown in the initial studies.
Slovenian: Za trenutno formulacijo cepiva Equilis Prequenza je bilo dokazano, da ima podobne rezultate, kot so bili doseženi v prvotnih študijah.
English: The effectiveness of Equilis Prequenza was initially studied in several trials under laboratory and field conditions.
Slovenian: Učinkovitost zdravila Equilis Prequenza so prvotno raziskali v več preskušanjih, izvedenih v laboratorijskih in terenskih pogojih.
English: The safety of the initial formulation of Equilis Prequenza was studied in several studies under laboratory and field conditions in a large number of horses, from 2 months of age.
Slovenian: Varnost zdravila prvotne formulacije cepiva Equilis Prequenza so raziskovali v več študijah, izvedenih v laboratorijskih in terenskih pogojih na številnih konjih, starejših od dveh mesecev.