FrancophonIA/ELRC3.0 huggingface dataset:
English: • The Committee concluded, in view of the available data including the detailed grounds submitted by MAHs during the re-examination phase, that the risk for serious hepatic injury following an overdose with MR paracetamol containing products, could not be adequately minimised such as this risk could be outweighed by the benefits of these products in the treatment of pain and fever.
Slovenian: je odbor PRAC glede na razpoložljive podatke, vključno s podrobno opisanimi razlogi, ki sta jih imetnika dovoljenj za promet z zdravilom predložila med ponovno proučitvijo, zaključil, da tveganja za resno poškodbo jeter po prevelikem odmerjanju zdravil, ki vsebujejo paracetamol s prirejenim sproščanjem, ni mogoče ustrezno zmanjšati v obsegu, da bi koristi teh zdravil pri zdravljenju bolečine in povišane telesne temperature to tveganje odtehtali.
English: It is not considered that this safety concern of serious and potentially fatal hepatic injury in case of overdose with paracetamol MR formulations is sufficiently minimised by effective risk minimisation measures to prevent this risk and to manage it once it occurs.
Slovenian: Ta pomislek glede varnosti za resno in možno smrtno okvaro jeter pri prevelikem odmerjanju formulacij paracetamola s prirejenim sproščanjem ni dovolj zmanjšan z učinkovitimi ukrepi za zmanjšanje tveganja, ki bi to tveganje preprečili in obvladali, kadar bi se pojavilo.
English: The MAH submitted a literature review to justify the clinical benefit of the tramadol/paracetamol MR combination in pain management.
Slovenian: Imetnik dovoljenja za promet z zdravilom je za utemeljitev klinične koristi kombinacije tramadola/paracetamola s prirejenim sproščanjem pri obvladovanju bolečine predložil pregled literature.
English: In view of the above, the safety concern identified is not outweighed by the benefits of these products for the treatment of the approved indications.
Slovenian: Glede na navedeno koristi teh zdravil za zdravljenje odobrenih indikacij ne odtehtajo ugotovljenega pomisleka glede varnosti.
English: This uncertainty is not acceptable by the PRAC in view of the severity of liver toxicity associated with paracetamol overdose.
Slovenian: Ta negotovost zaradi resnosti toksičnosti za jetra, povezane s prevelikim odmerjanjem paracetamola, za odbor PRAC ni sprejemljiva.
English: To lift the suspension, the PRAC recommended that the MAHs should provide evidence of proportionate, feasible and effective measures to minimise the risk for hepatic injury following intentional or accidental overdoses with modified release paracetamol containing products.
Slovenian: Za preklic začasnega umika je odbor PRAC priporočil, naj imetniki dovoljenj za promet z zdravilom predložijo sorazmerne, izvedljive in učinkovite ukrepe za zmanjšanje tveganja za poškodbo jeter po namernem ali nenamernem prevelikem odmerjanju zdravil, ki vsebujejo paracetamol s prirejenim sproščanjem.
English: In addition, the MAH proposed to conduct a Post-authorisation safety study (PASS) to collect details of cases of overdose with MR paracetamol and to optimise the management of overdose.
Slovenian: Poleg tega je imetnik dovoljenja za promet z zdravilom predlagal izvedbo študije varnosti po pridobitvi dovoljenja za promet (PASS), s katero bi zbrali podrobnosti o primerih prevelikega odmerjanja paracetamola s prirejenim sproščanjem in optimizirali zdravljenje prevelikega odmerjanja.
English: The PRAC discussed the available clinical studies during the re-examination phase in view of the grounds submitted by the MAH.
Slovenian: Odbor PRAC je glede na razloge, ki jih je predložil imetnik dovoljenja za promet z zdravilom med ponovno proučitvijo, obravnaval razpoložljive klinične študije.
English: Delayed absorption or double peaks observed both with IR and MR paracetamol formulation depending on the dose ingested have been described up to date.
Slovenian: Do zdaj so opisali zapoznelo absorpcijo ali dvojne vrhove, ki so jih opazili pri formulacijah paracetamola s takojšnjim in prirejenim sproščanje ter so bili odvisni od zaužitega odmerka.
English: The PRAC as a consequence considers that the benefit-risk balance of with modified release paracetamol containing products is no longer favourable.
Slovenian: Posledično odbor PRAC meni, da razmerje med tveganji in koristmi zdravil, ki vsebujejo paracetamol s prirejenim sproščanjem, ni več ugodno.
English: The claimed specific benefits of the MR formulations relate to a reduction of daily tablet intake (from 4 to 3 times daily dosing for the single ingredient products, and the simplified regimen of 2 from 4
Slovenian: Navedene posebne koristi formulacij s prirejenim sproščanjem se nanašajo na zmanjšanje dnevnega vnosa tablet (s štirikrat na trikrat dnevno odmerjanje pri zdravilih z eno učinkovino in poenostavljeni režim z dvema namesto štirih tablet pri kombiniranih zdravilih) ne odtehtajo tveganj za toksičnost za jetra v primeru prevelikega odmerjanja.
English: These risk minimisation measures intended to reduce the risk for hepatic injury following an overdose with an MR formulation of paracetamol or the combination of paracetamol and tramadol were not considered by the PRAC to be sufficiently effective and reliable.
Slovenian: Odbor PRAC je menil, da ti ukrepi za zmanjšanje tveganja za poškodbe jeter po prevelikem odmerjanju formulacije paracetamola s prirejenim sproščanjem ali kombinacije paracetamola in tramadola niso dovolj učinkoviti in zanesljivi, zlasti kar zadeva namerno preveliko odmerjanje.
English: In addition to the concerns expressed in relation to MR formulations containing paracetamol as a single ingredient, the experts concluded that the treatment of overdose with paracetamol/tramadol combination products raises further concerns.
Slovenian: Poleg pomislekov, ki so jih izrazili v povezavi s formulacijami, ki vsebujejo paracetamol s prirejenim sproščanjem kot edino učinkovino, so strokovnjaki zaključili, da zdravljenje prevelikega odmerjanja kombiniranih zdravil s paracetamolom/tramadolom vzbuja dodatne pomisleke To je posledica varnostnega profila tramadola (npr. konvulzije, bruhanje), za katerega je skupina menila, da zelo verjetno pomeni dodatne izzive pri obravnavi prevelikega odmerjanja kombiniranega zdravila s paracetamolom in tramadolom s podaljšanim sproščanjem.
English: In particular with regards to the intentional overdose.
Slovenian: Zelo malo verjetno je, da bi preprečila preveliko odmerjanje, zlasti namerno.
English: Yellow/green suspension.
Slovenian: Rumeno-zelena suspenzija.
English: Anise aroma
Slovenian: Aroma janeža
English: Do not use in pregnant or lactating animals (See section 4.3).
Slovenian: Ne uporabite v obdobju brejosti ali laktacije (glejte poglavje 4.3).
English: 4.4 Special warnings for each target species None.
Slovenian: 4.4 Posebna opozorila za vsako ciljno živalsko vrsto Jih ni.
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Slovenian: DATUM ZADNJE ODOBRITVE NAVODIL ZA UPORABO Podrobne informacije o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) http://www.ema.europa.eu/.
English: Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, non-steroids (oxicams) ATC vet code: QM01AC06
Slovenian: Farmakoterapevtska skupina: protivnetna in protirevmatična zdravila, nesteroidna (oksikami) Oznaka ATC vet: QM01AC06
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21/02/2011
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 21/02/2011
English: Manufacturer responsible for batch release: Produlab Pharma B.V.
Slovenian: Izdelovalec, odgovoren za sproščanje serij: Produlab Pharma B.V.
English: Due to the loading dose, steady state is reached after 2 days (48h).
Slovenian: Zaradi udarnega odmerka se stanje dinamičnega ravnovesja vzpostavi po dveh dneh (48 urah).
English: Use a small container (e.g. a teaspoon) and drop Melosus oral suspension into the container (it is advised to dispense a few drops more than required into the small container).
Slovenian: Uporabite majhen vsebnik (npr. čajno žličko) in nakapljajte peroralno suspenzijo zdravila Melosus v vsebnik (priporočamo, da odmerite nekoliko več kapljic, kot je potrebno).
English: PACKAGE SIZE 125 ml
Slovenian: VELIKOST PAKIRANJA 125 ml
English: For longer term treatment, once clinical response has been observed (after ≥ 4 days), the dose of Melosus 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: Za dolgotrajnejše zdravljenje lahko, ko se pokaže klinični odziv (po ≥ 4 dneh), odmerek Melosusa prilagodimo, tako da določimo najmanjši učinkoviti individualni odmerek ob upoštevanju, da se lahko jakost bolečine in vnetja pri kroničnih mišično-skeletnih obolenjih s časom spreminjata.
English: In very rare cases elevated liver enzymes have been reported.
Slovenian: V zelo redkih primerih so poročali o povišanih vrednostih jetrnih encimov.
English: These adverse reactions are in most cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal.
Slovenian: Našteti neželeni učinki so večinoma prehodni in po končanem zdravljenju minejo, vendar so lahko v zelo redkih primerih tudi resni ali smrtno nevarni.
English: Chronic musculoskeletal disorders in cats: Response to long-term therapy should be monitored at regular intervals by a veterinarian.
Slovenian: Kronična mišično-skeletna obolenja pri mačkah: Odzivanje na dolgotrajno zdravljenje mora v rednih razmikih spremljati veterinar.
English: CONTENTS BY WEIGHT; BY VOLUME OR BY NUMBER OF DOSES
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV
English: MARKETING AUTHORISATION NUMBERS
Slovenian: ŠTEVILKE DOVOLJENJ( ZA PROMET
English: TARGET SPECIES Cats and guinea pigs
Slovenian: CILJNE ŽIVALSKE VRSTE Mačke in morski prašički
English: Pregnancy and Lactation: Do not use in pregnant or lactating animals.
Slovenian: Brejost in laktacija: Ne uporabite v obdobju brejosti ali laktacije.
English: Use a standard 1 ml syringe to draw up Melosus according to the bodyweight of the guinea pig.
Slovenian: Uporabite standardno 1 ml injekcijsko brizgo za zdravilo Melosus glede na telesno maso morskega prašička.
English: In guinea pigs, an overdose of 0.6 mg/kg body weight administered during 3 days followed by a dose of 0.3 mg/kg during 6 additional days did not cause adverse events typical for meloxicam.
Slovenian: Pri morskih prašičkih prevelik odmerek 0,6 mg/kg telesne mase, ki je bil dan v treh dneh po po odmerku 0,3 mg/kg med dodatnimi 6 dnevi ni povzročil neželenih stranskih dogodkov, značilnih za meloksikam.
English: This veterinary medicinal product for dogs should not be used in cats as it is not suitable for use in this species.
Slovenian: Tega zdravila za pse ni dovoljeno uporabljati pri mačkah, ker ni primerno za uporabo pri tej vrsti.
English: Disodium phosphate dodecahydrate Silica, colloidal anhydrous Hydroxyethylcellulose Citric acid monohydrate Sodium cyclamate Sucralose
Slovenian: Natrijev hidrogefosfat dodekahidrat Silicijev dioksid, koloidni, brezvodni Hidroksietilceluloza Citronska kislina monohidrat Natrijev ciklamat
English: Melosus 0.5 mg/ml oral suspension for cats should not be used following parenteral injection of meloxicam or any other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) as appropriate dosage regimens for such follow-up treatments have not been established in cats.
Slovenian: Melosus 0,5 mg/ml peroralna suspenzija za mačke se ne sme uporabljati po parenteralnem injiciranju meloksikama ali katerega koli drugega nesteroidnega protivnetnega zdravila (NSAID), saj ustrezni režimi odmerjanja za tako nadaljnje zdravljenje za mačke niso bili določeni.
English: Cats and guinea pigs
Slovenian: Mačke in morski prašičke
English: Shelf-life of the veterinary medicinal product as packaged for sale: 3 years Shelf-life after first opening the immediate packaging: 6 months
Slovenian: Rok uporabnosti zdravila v pakiranju za prodajo: 3 leta Rok uporabnosti po prvem odpiranju stične ovojnine: 6 mesecev
English: Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Slovenian: Ne uporabite v primeru preobčutljivosti na zdravilno učinkovino ali na katero koli pomožno snov.
English: Dose of 0.2 mg meloxicam/kg body weight: 0.4 ml/kg body weight Dose of 0.1 mg meloxicam/kg body weight: 0.2 ml/kg body weight
Slovenian: Odmerek 0,2 mg meloksikama/kg telesne mase: 0,4 ml/kg telesne mase Odmerek 0,1 mg meloksikama/kg telesne mase: 0,2 ml/kg telesne mase
English: In very rare cases haemorrhagic diarrhoea, haematemesis, gastrointestinal ulceration and elevated liver enzymes have been reported.
Slovenian: V zelo redkih primerih so poročali o hemoragični driski, hematemezi, gastrointestinalnih razjedah in povečanih vrednostih jetrnih encimov.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER CP-Pharma Handelsgesellschaft mbH, Germany
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM CP-Pharma Handelsgesellschaft mbH, Nemčija
English: EXPIRY DATE EXP {month/year} Once opened, use within 6 months.
Slovenian: EXP {mesec/leto} Odprto plastenko uporabite v 6 mesecih.
English: Administer Melosus with the syringe directly into the mouth of the guinea pig.
Slovenian: Zdravilo Melosus dajte neposredno v gobec morskega prašička.
English: Melosus must not be administered in conjunction with other NSAIDs or glucocorticosteroids.
Slovenian: Melosusa ne smemo dajati hkrati z drugimi nesteroidnimi protivnetnimi zdravili ali glukokortikosteroidi.
English: Melosus should not be used following parenteral injection of meloxicam or any other NSAIDs as appropriate dosage regimens for such follow-up treatments have not been established in cats.
Slovenian: Melosus se ne sme uporabljati po parenteralnem injiciranju meloksikama ali katerega drugega nesteroidnega protivnetnega zdravila (NSAID), saj ustrezni režimi odmerjanja za tako nadaljnje zdravljenje za mačke niso bili določeni.
English: Alleviation of mild to moderate post-operative pain associated with soft tissue surgery such as male castration.
Slovenian: Ublažitev blage do zmerne pooperativne bolečine, povezane z operacijo mehkega tkiva, kot je kastracija pri samcih
English: EXPIRY DATE EXP {month/year} Use by …
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP {mesec/leto}
English: To be administered orally either mixed with food or directly into the mouth.
Slovenian: Zdravilo dajemo peroralno, pomešano s hrano, ali neposredno v gobec.
English: The suspension should be given directly into the mouth using a standard 1 ml syringe graduated with ml scale and 0.01 ml increments.
Slovenian: Odmerjanje in pot uporabe Suspenzijo je mogoče dajati z uporabo standardne 1 ml brizge, ki ima ml lestvico in 0,01 ml porasta.
English: Sodium benzoate 1.75 mg
Slovenian: Natrijev benzoat 1,75 mg
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
Slovenian: NAVEDBA UČINKOVIN(E) IN DRUGE(IH) SESTAVIN Zdravilna učinkovina:
English: 4.2 Indications for use, specifying the target species
Slovenian: 4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Mačke:
English: OTHER INFORMATION 10, 25, 50 or 125 ml bottle.
Slovenian: DRUGE INFORMACIJE Plastenke po 10, 25, 50 ali 125 ml.
English: Polyethylene bottle containing 10 ml, 25 ml, 50 ml or 125 ml with a tamper proof child resistant closure and a polypropylene measuring syringe.
Slovenian: Polietilenska plastenka po 10 ml, 25 ml, 50 ml ali 125 ml z varnostnim, za otroke varnim zapiralom in s polipropilensko merilno brizgo.
English: Polyethylene bottle containing 5 ml, 10 ml or 25 ml with a tamper proof child resistant closure and a polypropylene measuring syringe
Slovenian: Polietilenska plastenka po 5 ml, 10 ml ali 25 ml z varnostnim, za otroke varnim zapiralom in polipropilensko merilno brizgo.
English: Post-operative pain and inflammation following surgical procedures: After initial treatment with meloxicam solution for injection for cats, continue treatment 24 hours later with Melosus 0.5 mg/ml oral suspension for cats at a dosage of 0.05 mg meloxicam/kg body weight.
Slovenian: Po začetnem zdravljenju z raztopino meloksikama za injiciranje za mačke nadaljujte zdravljenje 24 ur pozneje z zdravilom Melosus 0,5 mg/ml peroralna suspenzija za mačke v odmerku 0,05 mg meloksikama/kg telesne mase.
English: Meloxicam 1.5 mg
Slovenian: Meloksikam 1,5 mg
English: 15 OTHER INFORMATION 5, 10 or 25 ml bottle.
Slovenian: DRUGE INFORMACIJE Plastenka po 5, 10 ali 25 ml.
English: Do not use the cat syringe with the kg-body weight scale for guinea pigs.
Slovenian: Brizge z lestvico telesne mase v kg za mačke ne uporabljajte za morske prašičke.
English: Marketing authorisation holder: CP-Pharma Handelsgesellschaft mbH Ostlandring 13
Slovenian: Imetnik dovoljenja za promet z zdravilom: CP-Pharma Handelsgesellschaft mbH Ostlandring 13
English: Do not use this veterinary medicinal product after the expiry date which is stated on the carton and bottle after EXP.
Slovenian: Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na zunanji ovojnini in plastenki po EXP. Rok uporabnosti zdravila se nanaša na zadnji dan v navedenem mesecu.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/10/116/003 125 ml
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/10/116/003 125 ml
English: In cats, Melosus 0.5 mg/ml oral suspension for cats should be used.
Slovenian: Pri mačkah je treba uporabiti zdravilo Melosus 0,5 mg/ml peroralna suspenzija za mačke.
English: Do not use in pregnant or lactating animals.
Slovenian: Ne uporabite v obdobju brejosti in laktacije.
English: The suspension can be given using the Melosus measuring syringe provided in the package.
Slovenian: Odmerjanje in pot uporabe Suspenzijo lahko dajemo s priloženo merilno brizgo Melosus.
English: MARKETING AUTHORISATION NUMBERS EU/2/10/116/007 5 ml
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/10/116/007 5 ml
English: In cats, typical adverse reactions of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as loss of appetite, vomiting, diarrhoea, faecal occult blood, apathy and renal failure have occasionally been reported.
Slovenian: Pri mačkah so občasno so poročali o značilnih neželenih učinkih nesteroidnih protivnetnih zdravil (NSAID), kot so izguba teka, bruhanje, driska, kri v blatu (okultna krvavitev), apatija in ledvična odpoved.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Meloxicam 0.5 mg/ml
Slovenian: KOLIČINA UČINKOVIN(E) Meloksikam 0,5 mg/ml
English: Typical adverse reactions of Non-Steroidal Anti-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 značilnih neželenih učinkih nesteroidnih protivnetnih zdravil, kot so izguba teka, bruhanje, driska, kri v blatu (okultna krvavitev), apatija in ledvična odpoved.
English: ROUTE OF ADMINISTRATION Oral use.
Slovenian: POT UPORABE ZDRAVILA Peroralna uporaba.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Melosus 1.5 mg/ml oral suspension for dogs
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Melosus 1,5 mg/ml peroralna suspenzija za pse
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Meloxicam 1.5 mg/ml
Slovenian: KOLIČINA UČINKOVIN(E) Meloksikam 1,5 mg/ml
English: People with known hypersensitivity to NSAIDs should avoid contact with the veterinary medicinal product.
Slovenian: Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo Osebe z znano preobčutljivostjo za nesteroidna protivnetna zdravila (NSAID) naj se izogibajo stiku z zdravilom.
English: PACKAGE LEAFLET: Melosus 1.5 mg/ml oral suspension for dogs
Slovenian: NAVODILO ZA UPORABO Melosus 1,5 mg/ml peroralna suspenzija za pse
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Melosus 0.5 mg/ml oral suspension for cats and guinea pigs
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Melosus 0,5 mg/ml peroralna suspenzija za mačke in morske prašičke
English: STATEMENT OF ACTIVE SUBSTANCES Meloxicam 1.5 mg/ml
Slovenian: NAVEDBA UČINKOVIN(E) Meloksikam 1,5 mg/ml
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Melosus 1.5 mg/ml oral suspension for dogs meloxicam
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Melosus 1,5 mg/ml peroralna suspenzija za pse meloksikam
English: PACKAGE LEAFLET: Melosus 0.5 mg/ml oral suspension for cats and guinea pigs
Slovenian: NAVODILO ZA UPORABO Melosus 0,5 mg/ml peroralna suspenzija za mačke in morske prašičke
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Melosus 0.5 mg/ml oral suspension for cats and guinea pigs Meloxicam
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Melosus 0,5 mg/ml peroralna suspenzija za mačke in morske prašičke Meloksikam
English: Metabolism
Slovenian: Sukraloza
English: Meloxicam 0.5 mg
Slovenian: Meloksikam 0,5 mg Pomožna snov:
English: Dosage
Slovenian: KARENCA
English: Initial treatment is a single oral dose of 0.2 mg meloxicam/kg body weight on the first day.
Slovenian: Začetni peroralni odmerek prvi dan zdravljenja je 0,2 mg meloksikama na kilogram telesne mase.
English: Porcine influenza vaccine (inactivated)
Slovenian: cepivo proti prašičji influenci (inaktivirano)
English: It is given as two injections into the muscle three weeks apart.
Slovenian: Daje se v obliki dveh injekcij v mišico v razmiku treh tednov.
English: The vaccine starts to be effective one week after the second injection and protection lasts for three months.
Slovenian: Cepivo začne učinkovati en teden po drugi injekciji, zaščita pa traja tri mesece.
English: In case of accidental self-injection only a minor injection site reaction is expected.
Slovenian: V primeru nenamernega samo-injiciranja je pričakovati le manjšo reakcijo na mestu injiciranja.
English: The full EPAR for Respiporc FLUpan H1N1 can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila Respiporc FLUpan H1N1 je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: Signs can include fever, depression, coughing, sneezing, difficulty breathing and loss of appetite.
Slovenian: Njeni znaki lahko vključujejo povišano telesno temperaturo, izčrpanost, kašelj, kihanje, težave z dihanjem in izgubo teka.
English: This active immune response will help to protect the pig against the disease caused by this virus.
Slovenian: Aktivni imunski odziv bo pripomogel k zaščiti prašiča pred boleznijo, ki jo ta virus povzroča.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Respiporc FLUpan H1N1's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da so koristi zdravila Respiporc FLUpan H1N1 večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: The effectiveness of Respiporc FLUpan H1N1 was shown in three laboratory studies and one combined field/laboratory study.
Slovenian: Učinkovitost cepiva Respiporc FLUpan H1N1 so dokazali v treh laboratorijskih študijah in eni kombinirani terensko-laboratorijski študiji.
English: The most common side effects with Respiporc FLUpan H1N1 (which may affect up to 1 in 10 animals) are a short-lived increase in rectal temperature, not exceeding 2 °C, which does not last for more than one day and a transient swelling up to 2 cm3 at the site of injection which usually resolves within
Slovenian: Najpogostejša neželena učinka cepiva Respiporc FLUpan H1N1 (ki se lahko pojavita pri največ 1 živali od 10) sta kratkotrajno povišanje rektalne temperature, ki ne presega 2°C in ne traja dlje kot en dan, ter prehodno otekanje do 2 cm3 na mestu injiciranja, ki običajno mine v 5 dneh.