FrancophonIA/ELRC3.0 huggingface dataset:
English: The study met its primary endpoint and showed a statistically significant improvement in PFS in the pemetrexed arm over the placebo arm (n= 581, independently reviewed population; median of 4.0 months and 2.0 months, respectively) (hazard ratio= 0.60, 95% CI= 0.49-0.73, p < 0.00001).
Slovenian: Študija je dosegla svojo primarno končno točko in pokazala statistično značilno izboljšanje preživetja brez napredovanja v skupini s pemetreksedom glede na skupino s placebom (n = 581, neodvisno pregledana populacija; mediana 4,0 mesece in 2,0 meseca) (razmerje tveganja = 0,60, 95 % CI: 0,490,73, p < 0,00001).
English: The study met its primary endpoint and showed a statistically significant improvement in PFS in the pemetrexed arm over the placebo arm (n = 472, independently reviewed population; median of 3.9 months and 2.6 months, respectively) (hazard ratio = 0.64, 95 % CI = 0.51-0.81, p = 0.0002).
Slovenian: Študija je dosegla svoj primarni ciljni učinek in dokazala statistično pomembno izboljšanje preživetja brez napredovanja bolezni v skupini, ki je prejemala pemetreksed, v primerjavi s skupino, ki je prejemala placebo (n = 472, neodvisno pregledana populacija; mediano 3,9 meseca in 2,6 meseca) (razmerje tveganja=0,64, 95 % CI = 0,51-0,81, p = 0,0002).
English: - If you get any side effects, talk to your doctor or pharmacist or nurse.
Slovenian: - Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Pemetrexed Accord in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.
Slovenian: Zdravilo Pemetreksed Accord je v kombinaciji s cisplatinom indicirano za zdravljenje bolnikov z neresektabilnim malignim plevralnim mezoteliomom, ki jih še nismo zdravili s kemoterapijo.
English: Clinically relevant CTC toxicity of any grade that was reported in ≥ 1 % and  5 % of the patients that were randomly assigned to pemetrexed include: febrile neutropenia, infection, decreased platelets, diarrhoea, constipation, alopecia, pruritis/itching, fever (in the absence of neutropenia), ocular surface disease (including conjunctivitis), increased lacrimation, dizziness and motor neuropathy.
Slovenian: Klinično pomembne toksičnosti, o katerih so poročali pri > 1 % in  5 % bolnikov, ki so jih naključno dodelili v skupino, ki je prejemala pemetreksed, vključujejo: febrilno nevtropenijo, infekcijo, znižane trombocite, diarejo, zaprtje, alopecijo, srbenje, vročino (v odsotnosti nevtropenije), bolezni površine očesa (vključno s konjunktivitisom), povečano solzenje, omotico in motorično nevropatijo.
English: *P-values < 0.05 comparing pemetrexed/cisplatin to gemcitabine/cisplatin, using Fisher Exact test. **Refer to National Cancer Institute CTC (v2.0; NCI 1998) for each Grade of Toxicity.
Slovenian: *P-vrednosti < 0,05 v primerjavi pemetreksed/cisplatin proti gemcitabin/cisplatin, z uporabo Fisherjevega Exact testa.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Pemetrexed Accord 500 mg powder for concentrate for solution for infusion pemetrexed STATEMENT OF ACTIVE SUBSTANCE(S) LIST OF EXCIPIENTS PHARMACEUTICAL FORM AND CONTENTS METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use after reconstitution and dilution.
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH VIALA IME ZDRAVILA IN POT(I) UPORABE Pemetreksed Accord 500 mg prašek za koncentrat za raztopino za infundiranje pemetreksed NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN SEZNAM POMOŽNIH SNOVI FARMACEVTSKA OBLIKA IN VSEBINA POSTOPEK IN POT(I) UPORABE ZDRAVILA Za intravensko uporabo po rekonstituciji in redčenju.
English: Pemetrexed Accord 500 mg powder for concentrate for solution for infusion Type I glass vial with a grey bromobutyl rubber stopper with royal blue flip-off seal containing 500 mg of pemetrexed.
Slovenian: Pemetreksed Accord 500 mg prašek za koncentrat za raztopino za infundiranje Steklena viala tipa I s sivim zamaškom iz bromobutilne gume in kraljevsko modro "flip-off" zaporko, ki vsebuje 500 mg pemetrekseda.
English: Pemetrexed Accord 1000 mg powder for concentrate for solution for infusion Type I glass vial with a grey bromobutyl rubber stopper with royal blue flip-off seal containing 1000 mg of pemetrexed.
Slovenian: Pemetreksed Accord 1000 mg prašek za koncentrat za raztopino za infundiranje Steklena viala tipa I s sivim zamaškom iz bromobutilne gume in kraljevsko modro "flip-off" zaporko, ki vsebuje 1000 mg pemetrekseda.
English: Alkaline phosphatase, AST and ALT  5 times upper limit of normal is acceptable if liver has tumour involvement.
Slovenian: Če so jetra tumorsko prizadeta, so sprejemljive vrednosti alkalne fosfataze, AST in ALT  5-kratnik zgornje meje normalnih vrednosti.
English: Pemetrexed Accord is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section 5.1).
Slovenian: Zdravilo Pemetreksed Accord je indicirano kot monoterapija za zdravljenje drugega izbora bolnikov z lokalno napredovalim ali metastatskim nedrobnoceličnim pljučnim karcinomom, ki nima pretežno ploščatocelične histologije (glejte poglavje 5.1).
English: Median time to tumour progression (months) (95 % CI)
Slovenian: Log Rank p-vrednost* Mediana časa do napredovanja tumorja (meseci) (95 % IZ)
English: Alopecia Common Rash/ desquamation
Slovenian: Alopecija Izpuščaj/ luščenje
English: Stomatitis/ Pharyngitis Nausea
Slovenian: Mukozitis/S tomatitis
English: *** According to National Cancer Institute CTC (v2.0; NCI 1998), taste disturbance and alopecia should only be reported as Grade 1 or 2.
Slovenian: ***V skladu z CTC Nacionalnega inštituta za rakava obolenja (v2.0; NCI 1998), motnje okusa in alopecija morata biti poročana kot stopnja 1 ali 2.
English: From the start of pemetrexed plus cisplatin first line induction treatment, the median OS of patients was 16.9 months for the pemetrexed arm and 14.0 months for the placebo arm (hazard ratio= 0.78, 95 % CI= 0.64-0.96).
Slovenian: Od začetka indukcijskega zdravljenja prve izbire s pemetreksedom skupaj s cisplatinom je bilo mediano skupno preživetje bolnikov 16,9 meseca v kraku s pemetreksedom in 14,0 mesecev v kraku s placebom (razmerje tveganja = 0,78, 95% % CI = 0,64-0,96).
English: For patients with NSCLC other than predominantly squamous cell histology (n= 430, independently reviewed population) median PFS was 4.4 months for the pemetrexed arm and 1.8 months for the placebo arm, hazard ratio= 0.47 (95% CI= 0.37-0.60, p= 0.00001).
Slovenian: Za bolnike z NSCLC , ki nima pretežno ploščatocelične histologije (n = 430, neodvisno pregledana populacija) je bila mediana preživetja brez napredovanja 4,4 mesece za skupino s pemetreksedom in 1,8 meseca za skupino s placebom, razmerje tveganja = 0,47, 95% CI: 0,37-0,60, p = 0,00001).
English: Granulocytes decreased
Slovenian: Znižani trombociti
English: Cisplatin lymphatic system disorders common Granulocytes decreased Leukocytes decreased Haemoglobin decreased Platelets decreased
Slovenian: Znižan hemoglobin Znižani nevtrofilci/ granulociti Znižani levkociti Znižani trombociti
English: Pemetrexed / cisplatin
Slovenian: Pemetreksed/ cisplatin
English: Progression free survival (months) Median
Slovenian: Prednostna p-vrednost (RT) Preživetje brez napredovanja (meseci) Mediana
English: What Pemetrexed Accord contains
Slovenian: Kaj vsebuje zdravilo Pemetreksed Accord
English: If you get any side effects, talk to your doctor or pharmacist or nurse.
Slovenian: Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: treatment with pemetrexed and 3.5 cycles of placebo.
Slovenian: Bolniki so dobili povprečno 5 ciklov vzdrževalnega zdravljenja s pemetreksedom in 3,5 cikle placeba.
English: Cisplatin Pemetrexed / cisplatin
Slovenian: Cisplatin Pemetreksed/ cisplatin
English: Clinically relevant toxicity that was reported in ≥ 1 % and ≤ 5 % of the patients that were randomly assigned to receive cisplatin and pemetrexed include: AST increase, ALT increase, infection, febrile neutropenia, renal failure, pyrexia, dehydration, conjunctivitis, and creatinine clearance decrease.
Slovenian: Klinično pomembne toksičnosti, o katerih so poročali pri > 1 % in ≤ 5 % bolnikov, ki so jih naključno dodelili v skupino, ki je prejemala pemetreksed, vključujejo: povišanje AST, povišanje ALT, okužbo, febrilno nevtropenijo, odpoved ledvic, pireksijo, dehidracijo, konjuktivitis in znižanje očistka kreatinina.
English: Pemetrexed Accord 100 mg powder for concentrate for solution for infusion Type I glass vial with a grey bromobutyl rubber stopper with lavender flip-off seal containing 100 mg of pemetrexed.
Slovenian: Pemetreksed Accord 100 mg prašek za koncentrat za raztopino za infundiranje Steklena viala tipa I s sivim zamaškom iz bromobutilne gume in "flip-off" zaporko v barvi sivke, ki vsebuje 100 mg pemetrekseda.
English: Pemetrexed/ cisplatin (N= 839)
Slovenian: Pemetreksed/cisplatin N = 839
English: Including the induction phase the median OS for patients with NSCLC other than predominantly squamous cell histology was 18.6 months for the pemetrexed arm and 13.6 months for the placebo arm, hazard ratio = 0.71 (95 % CI = 0.56-0.88, p = 0.002).
Slovenian: Vključno z indukcijsko fazo je bila mediana skupnega preživetja za bolnike z NSCLC, ki nima pretežno ploščatocelične histologije 18,6 mesecev za skupino s pemetreksedom in 13,6 mesecev za skupino s placebom (razmerje tveganja = 0,71, 95% CI: 0,56-0,88, p = 0,002).
English: PARAMOUNT:Kaplan Meier plot of progression-free survival (PFS) and Overall Survival (OS) for continuation pemetrexed maintenance versus placebo in patients with NSCLC other than predominantly squamous cell histology (measured from randomisation)
Slovenian: Kaplan Meier-jev graf preživetja brez napredovanja in skupnega preživetja za nadaljevanje vzdrževalnega zdravljenja s pemetreksedom v primerjavi s placebom pri bolnikih z nedrobnoceličnim karcinomom pljuč, ki nima pretežno ploščatocelične histologije (merjeno od randomizacije)
English: The independent review of patient scans confirmed the findings of the investigator assessment of PFS. For randomised patients, as measured from the start of pemetrexed plus cisplatin first line induction treatment, the median investigator-assessed PFS was 6.9 months for the pemetrexed arm and 5.6 months for the placebo arm (hazard ratio = 0.59 95 % CI = 0.47-0.74).
Slovenian: Za naključno izbrane bolnike, merjeno od začetka zdravljenja s pemetreksedom in indukcijskim zdravljenjem prve izbire s cisplatinom, je bilo mediano preživetje brez napredovanja bolezni po oceni raziskovalca 6,9 meseca za skupino, ki je prejemala pemetreksed, in 5,6 meseca za skupino, ki je prejemala placebo (razmerje tveganja = 0,59 95 % CI = 0,47-0,74).
English: Skin rash
Slovenian: North Harrow
English: Other medicines and Pemetrexed Accord
Slovenian: Shranjevanje zdravila Pemetreksed Accord
English: Clinically relevant toxicity that was reported in < 1 % of the patients that were randomly assigned to receive cisplatin and pemetrexed include: GGT increase, chest pain, arrhythmia, and motor neuropathy.
Slovenian: Klinično pomembne toksičnosti, o katerih so poročali pri < 1 % bolnikov, ki so jih naključno dodelili v skupino, ki je prejemala pemetreksed, vključujejo: povišanje GGT, bolečino v prsnem košu, aritmijo in motorično nevropatijo.
English: The median OS for patients with NSCLC other than predominantly squamous cell histology (n = 481) was 15.5 months for the pemetrexed arm and 10.3 months for the placebo arm, hazard ratio = 0.70 (95% CI= 0.56-0.88, p = 0.002).
Slovenian: Mediana skupnega preživetja za bolnike z NSCLC, ki nima pretežno ploščatocelične histologije (n = 481) je bila 15,5 mesecev za skupino s pemetreksedom in 10,3 mesecev za skupino s placebom (razmerje tveganja = 0,70, 95% CI: 0,56-0,88, p = 0,002).
English: Uncommon (may affect up to 1 in 100 people)
Slovenian: Občasno (pojavijo se lahko pri do 1 od 100 bolnikov)
English: Pemetrexed Accord 500 mg powder for concentrate for solution for infusion Each vial contains 500 mg of pemetrexed (as pemetrexed disodium hemipentahydrate).
Slovenian: Pemetreksed Accord 500 mg prašek za koncentrat za raztopino za infundiranje Ena viala vsebuje 500 mg pemetrekseda (v obliki dinatrijevega pemetrekseda hemipentahidrata).
English: A white to either light yellow or greenish-yellow lyophilised powder.
Slovenian: Bel do svetlorumen ali zelenkasto-rumen liofilizirani prašek.
English: Pemetrexed Accord as single agent
Slovenian: Zdravilo Pemetreksed Accord kot samostojno zdravilo
English: Stomatitis/ Pharyngitis Diarrhoea without colostomy
Slovenian: Diareja brez kolostomije
English: Pemetrexed at a dose of 500 mg/m2 was studied as a single-agent in 64 chemonaive patients with malignant pleural mesothelioma.
Slovenian: S pemetreksed kot edino učinkovino so preučevali v odmerku 500 mg/m2 pri 64
English: Common (may affect up to 1 in 10 people)
Slovenian: Pogosto (pojavijo se lahko pri do 1 od 10 bolnikov)
English: Pemetrexed Accord 1000 mg powder for concentrate for solution for infusion pemetrexed
Slovenian: Pemetreksed Accord 1000 mg prašek za koncentrat za raztopino za infundiranje pemetreksed
English: Pemetrexed Accord 500 mg: Each vial contains 500 milligrams of pemetrexed (as pemetrexed disodium hemipentahydrate).
Slovenian: Pemetreksed Accord 500 mg: Ena viala vsebuje 500 miligramov pemetrekseda (v obliki dinatrijevega pemetrekseda hemipentahidrata).
English: Pemetrexed Accord 100 mg: Each vial contains 100 milligrams of pemetrexed (as pemetrexed disodium hemipentahydrate).
Slovenian: Pemetreksed Accord 100 mg: Ena viala vsebuje 100 miligramov pemetrekseda (v obliki dinatrijevega pemetrekseda hemipentahidrata).
English: Pemetrexed Accord 500 mg powder for concentrate for solution for infusion pemetrexed
Slovenian: Pemetreksed Accord 500 mg prašek za koncentrat za raztopino za infundiranje pemetreksed
English: Pemetrexed Accord 1000 mg: Each vial contains 1000 milligrams of pemetrexed (as pemetrexed disodium hemipentahydrate).
Slovenian: Pemetreksed Accord 1000 mg: Ena viala vsebuje 1000 miligramov pemetrekseda (v obliki dinatrijevega pemetrekseda hemipentahidrata).
English: Reconstitute each 500 mg vial with 20 ml of 9 mg/ml (0.9%) sodium chloride solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.
Slovenian: 500 mg viale rekonstituirajte z 20 ml 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje brez konzervansa, tako dobite raztopino, ki vsebuje 25 mg/ml pemetrekseda.
English: Common Pain
Slovenian: Bolečina Edem
English: Reconstitute each 100 mg vial with 4.2 ml of 9 mg/ml (0.9%) sodium chloride solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.
Slovenian: 100 mg viale rekonstituirajte s 4,2 ml 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje brez konzervansa, tako dobite raztopino, ki vsebuje 25 mg/ml pemetrekseda.
English: Pemetrexed Accord 1000 mg powder for concentrate for solution for infusion Each vial contains 1000 mg of pemetrexed (as pemetrexed disodium hemipentahydrate).
Slovenian: Pemetreksed Accord 1000 mg prašek za koncentrat za raztopino za infundiranje Ena viala vsebuje 1000 mg pemetrekseda (v obliki dinatrijevega pemetrekseda hemipentahidrata).
English: Reconstitute 1000-mg vials with 40 ml of sodium chloride 9 mg/ml (0.9 %) solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.
Slovenian: 1000 mg viale rekonstituirajte s 40 ml 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje brez konzervansa, tako dobite raztopino, ki vsebuje 25 mg/ml pemetrekseda.
English: For precautions to be taken before handling or administering Pemetrexed Accord, see section 6.6.
Slovenian: Za previdnostne varnostne ukrepe pri pripravi in dajanju zdravila Pemetreksed Accord glejte poglavje
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Pemetrexed Accord 100 mg powder for concentrate for solution for infusion Each vial contains 100 mg of pemetrexed (as pemetrexed disodium hemipentahydrate).
Slovenian: Pemetreksed Accord 100 mg prašek za koncentrat za raztopino za infundiranje Ena viala vsebuje 100 mg pemetrekseda (v obliki dinatrijevega pemetrekseda hemipentahidrata).
English: Fertility
Slovenian: Faringitis
English: OUTER CARTON NAME OF THE MEDICINAL PRODUCT Pemetrexed Accord 1000 mg powder for concentrate for solution for infusion pemetrexed STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 1000 mg of pemetrexed (as pemetrexed disodium hemipentahydrate).
Slovenian: IME ZDRAVILA Pemetreksed Accord 100 mg prašek za koncentrat za raztopino za infundiranje pemetreksed NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena viala vsebuje 100 mg pemetrekseda (v obliki dinatrijevega pemetrekseda hemipentahidrata).
English: Talk to your doctor or hospital pharmacist or nurse before using Pemetrexed Accord.
Slovenian: Pred začetkom uporabe zdravila Pemetreksed Accord se posvetujte z zdravnikom, bolnišničnim farmacevtom ali medicinsko sestro.
English: Inflammation of the lining of the oesophagus (gullet) has been experienced with Pemetrexed Accord/ radiation therapy.
Slovenian: V kliničnih preskušanjih s pemetreksedom so občasno poročali o ezofagitisu/radiacijskem ezofagitisu.
English: Hepatobiliary disorders
Slovenian: pemetreksed placebo
English: - Keep this leaflet.
Slovenian: Neodprta viala.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 500 mg of pemetrexed (as pemetrexed disodium hemipentahydrate).
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena viala vsebuje 500 mg pemetrekseda (v obliki dinatrijevega pemetreksed hemipentahidrata).
English: definition of ≥ CTC Grade 2 bleeding
Slovenian: Znižan hemoglobin 26,2 Znižani trombociti
English: Not applicable
Slovenian: uporaba
English: Pemetrexed Accord 100 mg powder for concentrate for solution for infusion pemetrexed
Slovenian: Pemetreksed Accord 100 mg prašek za koncentrat za raztopino za infundiranje pemetreksed i.v.
English: Constipation
Slovenian: Konjunktivitis
English: Strength Pharmaceutical Form Route of Administration Packaging
Slovenian: Številka EU ime jakost farmacevtska oblika pot uporabe ovojnina velikost pakiranja
English: This will help protect the pigs against E. coli infection and disease.
Slovenian: To bo pomagalo zaščititi prašiče proti okužbi z E. coli in bolezni.
English: The vaccine starts to be effective 7 days after vaccination and protection lasts for 21 days after vaccination.
Slovenian: Cepivo začne učinkovati 7 dni po cepljenju, zaščita pa traja 21 dni po cepljenju.
English: The effectiveness of the vaccine was first studied in a number of laboratory studies in pigs.
Slovenian: Učinkovitost cepiva so najprej preučevali v več laboratorijskih študijah na prašičih.
English: This is a summary of the European public assessment report.
Slovenian: Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR).
English: It contains live Escherichia coli (E.coli) bacteria of a strain (O8:K87) that does not produce toxins that cause disease.
Slovenian: Vsebuje žive bakterije Escherichia coli (E.coli) seva (O8:K87), ki ne tvori toksinov, ki povzročajo bolezen.
English: The strain of bacteria in the vaccine have this protein but do not produce the toxin that causes the disease.
Slovenian: Tudi sev bakterije v cepivu ima to beljakovino, vendar pa ne tvori toksina, ki povzroča bolezen.
English: In case of accidental ingestion and/or spillage onto skin, medical advice should be sought immediately and the package leaflet or the label shown to the doctor.
Slovenian: V primeru nenamernega zaužitja in/ali razlitja po koži je treba nemudoma poiskati zdravniško pomoč in zdravniku pokazati navodilo za uporabo ali nalepko.
English: Although E.coli is naturally found in the gut, some strains (known as enterotoxigenic strains) produce a toxin that causes diarrhoea, and can result in dehydration, weight loss and occasionally death of the animal.
Slovenian: Čeprav je E. coli naravno prisotna v črevesju, pa nekateri sevi (imenovani enterotoksigeni sevi) proizvajajo toksin, ki povzroča drisko, kar lahko privede do dehidracije, izgube telesne mase in včasih tudi smrti živali.
English: In each study 350 pigs were vaccinated with Coliprotec F4 and 350 pigs remained unvaccinated.
Slovenian: V vsaki študiji so 350 prašičev cepili z zdravilom Coliprotec F4, 350 prašičev pa je ostalo necepljenih.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Coliprotec F4 on 16 March 2015.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Coliprotec F4, veljavno po vsej Evropski uniji, odobrila dne 16/03/2015.
English: The purpose of these studies was to establish how long it took for pigs to be fully protected and the length of time protection lasts against E. coli.
Slovenian: Namen teh študij je bil ugotoviti, po kolikem času je nastopila popolna zaščita prašičev pred E. coli in kako dolgo je ta zaščita trajala.
English: The withdrawal period is the time allowed after administration of the medicine and before the animal can be slaughtered and the meat used for human consumption.
Slovenian: Karenca je časovno obdobje, ki mora preteči po uporabi zdravila, preden se lahko žival zakolje ter se meso uporabi za prehrano ljudi.
English: The benefit-risk balance may be found in the scientific discussion module of this EPAR.
Slovenian: Razmerje med koristmi in tveganji najdete v modulu znanstvene razprave tega evropskega javnega poročila o oceni zdravila (EPAR).
English: Both field studies showed that vaccination with Coliprotec F4 reduced the number of pigs with moderate to severe diarrhoea.
Slovenian: Obe terenski študiji sta pokazali, da je cepljenje z zdravilom Coliprotec F4 zmanjšalo število prašičev z zmerno do hudo drisko.
English: The main measure of effectiveness was the number of pigs developing diarrhoea.
Slovenian: Glavno merilo učinkovitosti je bilo število prašičev, pri katerih se je pojavila driska.
English: The effectiveness of Coliprotec F4 was investigated in two field studies involving pigs where the farms had a history of post-weaning diarrhoea.
Slovenian: Učinkovitost zdravila Coliprotec F4 so preučevali v dveh terenskih študijah, v katere so bili vključeni prašiči s kmetij, na katerih so v preteklosti beležili drisko po odstavitvi.
English: In the future, if the animals are exposed to disease-causing bacteria with the F4 protein, the immune system will be able to respond more quickly.
Slovenian: Ob morebitni ponovni izpostavitvi bakterijam z beljakovino F4, ki povzročajo bolezen, se bo imunski sistem lahko odzval hitreje.
English: Coliprotec F4 is a vaccine.
Slovenian: Zdravilo Coliprotec F4 je cepivo.
English: Coliprotec F4 is a vaccine that is available as a lyophilisate (a freeze-dried pellet) which is made up into an oral suspension with water.
Slovenian: Zdravilo Coliprotec F4 je cepivo, ki je na voljo v obliki liofilizata (pelet, posušenih v zamrznjenem stanju) za pripravo peroralne suspenzije z vodo.
English: Vaccines work by ‘teaching' the immune system (the body's natural
Slovenian: Cepiva delujejo tako, da imunski sistem (naravni obrambni mehanizem telesa) „naučijo“, kako naj se brani pred boleznijo.
English: Personal protective equipment consisting of protective disposable gloves and safety glasses should be worn when handling the vaccine.
Slovenian: Pri rokovanju s cepivom je treba nositi osebno zaščitno opremo, ki jo sestavljajo zaščitne rokavice za enkratno uporabo in zaščitna očala.
English: The CVMP concluded that the benefits of Coliprotec F4 exceed the risks for the approved indication and recommended that Coliprotec F4 be given a marketing authorisation.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Coliprotec F4 večje od z njim povezanih tveganj, kadar se zdravilo uporablja za odobreno indikacijo, in priporočil, da se zanj odobri dovoljenje za promet.