FrancophonIA/ELRC3.0 huggingface dataset:
English: Nausea, constipation, vomiting, abdominal pain, diarrhoea, dyspepsia
Croatian: Poremećaji probavnog sustava Vrlo često Mučnina, konstipacija, povraćanje, abdominalna bol, proljev, dispepsija
English: The median time to onset of anaemia of any grade was 42 days, and 85 days for Grade 3/4 events.
Croatian: Medijan vremena do nastupa anemije bilo kojeg stupnja bio je 42 dana, a 85 dana za anemiju 3./4. stupnja.
English: If adverse reactions persist beyond a 28-day dose interruption, it is recommended that Zejula be discontinued.
Croatian: Ako su nuspojave i dalje prisutne i nakon prekida od 28 dana, preporučuje se ukidanje lijeka Zejula.
English: Approximately 60 % of patients receiving Zejula experienced thrombocytopenia of any grade, and 34 % of patients experienced Grade 3/4 thrombocytopenia.
Croatian: U otprilike 60 % bolesnika koji su primali lijek Zejula došlo je do trombocitopenije bilo kojeg stupnja, a u 34 % bolesnika došlo je do trombocitopenije 3./4. stupnja.
English: Overall, the PRAC considered that the preferred term febrile neutropenia was adequate to describe the cases reviewed within this PSUSA.
Croatian: Dakle, PRAC smatra da za opis slučajeva razmotrenih u okviru ovog PSUSA postupka „febrilna neutropenija“ predstavlja prikladan preporučeni pojam.
English: The median duration of thrombocytopenia events of any grade was 23 days, and the median duration of Grade 3/4 thrombocytopenia was 10 days.
Croatian: Medijan trajanja događaja trombocitopenije bez obzira na stupanj bio je 23 dana, a medijan trajanja trombocitopenije 3./4. stupnja bio je 10 dana.
English: • 84 × 1 hard capsules
Croatian: • 84 × 1 tvrda kapsula
English: • Discontinue Zejula if neutrophils and/or haemoglobin have not returned to acceptable levels within 28 days of the dose interruption period, or if the patient has already undergone dose reduction to 100 mg QD.
Croatian: Prekinite primjenu lijeka Zejula ako se broj neutrofila i/ili hemoglobin ne vrati na prihvatljive razine unutar 28 dana prekida liječenja ili ako je bolesniku već smanjena doza na 100 mg jednom dnevno.
English: Confirmed diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukaemia
Croatian: Potvrđena dijagnoza mijelodisplastičnog sindroma (MDS) ili akutne mijeloične leukemije (AML)
English: Approximately 30 % of patients receiving Zejula experienced neutropenia of any grade, and 20 % of patients experienced Grade 3/4 neutropenia.
Croatian: U otprilike 30 % bolesnika koji su primali lijek Zejula došlo je do neutropenije bilo kojeg stupnja, a u 20 % bolesnika došlo je do neutropenije 3./4. stupnja.
English: TESARO Bio Spain S.L.U
Croatian: España TESARO Bio Spain S.L.U
English: • 28 × 1 hard capsules
Croatian: • 28 × 1 tvrda kapsula
English: In patients with baseline platelet count less than 180 × 109/L, thrombocytopenia of any grade and Grade 3/4 occurred in 76 % and 45 % of the patients, respectively.
Croatian: U bolesnika s početnim brojem trombocita manjim od 180 × 109/L, javila se trombocitopenija bilo kojeg stupnja u njih 76 %, a 3./4. stupnja u 45 %.
English: No dose adjustment for Zejula is required when administered concomitantly with medicinal products known to inhibit OATP1B1 or 1B3 (e.g. gemfibrozil, ritonavir), or OCT1 (e.g. dolutegravir) uptake transporters.
Croatian: Nije potrebna prilagodba doze lijeka Zejula kad se primjenjuje istodobno s lijekovima za koje je poznato da inhibiraju prijenosnike za unos tvari OATP1B1 ili 1B3 (npr. gemfibrozil, ritonavir) ili OCT1 (npr. dolutegravir).
English: • Resume Zejula at a reduced dose.
Croatian: Zejula sa smanjenom dozom.
English: Pancytopenia has been observed in < 1 % of patients receiving niraparib.
Croatian: U < 1 % bolesnika koji su primali niraparib uočena je pancitopenija.
English: Hypokalemia
Croatian: Hipokalijemija
English: The median duration of neutropenia of any grade was 26 days, and 13 days for Grade 3/4 events.
Croatian: Medijan trajanja neutropenije bilo kojeg stupnja bio je 26 dana, a za slučajeve 3./4. stupnja 13 dana.
English: • Discontinue Zejula if the platelet count has not returned to acceptable levels within 28 days of the dose interruption period, or if the patient has already undergone dose reduction to 100 mg QD.
Croatian: Prekinite primjenu lijeka Zejula ako se broj trombocita ne vrati na prihvatljive razine unutar 28 dana prekida liječenja ili ako je bolesniku već smanjena doza na 100 mg jednom dnevno.
English: Hazard ratio (95 % CI) Time to first subsequent treatment
Croatian: p-vrijednost omjer hazarda (95 % CI) vrijeme do prvog sljedećeg liječenja medijan (95 % CI) - mo
English: Zejula 100 mg hard capsules
Croatian: NAZIV LIJEKA Zejula 100 mg tvrde kapsule
English: Recommendations for the management of adverse reactions are provided in Table 1.
Croatian: Preporuke za zbrinjavanje nuspojava nalaze se u Tablici
English: Zejula has moderate influence on the ability to drive or use machines.
Croatian: 4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima Zejula umjereno utječe na sposobnost upravljanja vozilima ili rada sa strojevima.
English: The major primary metabolite M1 does not appear to be an inhibitor of P-gp, BCRP, BSEP, or MATE1/2.
Croatian: M1 nije inhibitor P-gp-a, BCRP-a, BSEP-a ili MATE1/2.
English: The following adverse reactions have been identified in the ENGOT-OV16 study in patients receiving Zejula monotherapy (see Table 3).
Croatian: U bolesnika koji su primali lijek Zejula kao monoterapiju u ispitivanju ENGOT-OV16 zabilježene su sljedeće nuspojave (vidjeti Tablicu 3).
English: • If platelet count is < 75,000/μL at any time, resume at a reduced dose.
Croatian: Tablica 2: Modifikacije doza zbog hematoloških nuspojava Ako u bilo kojem trenutku broj trombocita bude < 75 000/μl, nastavite sa smanjenom dozom.
English: The major primary metabolite M1 is not a substrate of P-gp, BCRP, or BSEP.
Croatian: M1 nije supstrat P-gp-a, BCRP-a ili BSEP-a.
English: The pharmacokinetics of niraparib have not been assessed in patients with severe hepatic impairment (see section 4.2).
Croatian: U bolesnika s teškim oštećenjem funkcije jetre farmakokinetika nirapariba nije bila procijenjena (vidjeti dio 4.2).
English: Niraparib as a substrate of efflux transporters (P-gp, BCRP, and MATE1/2) Niraparib is a substrate of P-glycoprotein (P-gp) and Breast Cancer Resistance Protein (BCRP).
Croatian: Niraparib je supstrat P-glikoproteina (P-gp-a) i proteina rezistencije raka dojke (BCRP-a).
English: Niraparib as a substrate of hepatic uptake transporters (OATP1B1, OATP1B3, and OCT1)
Croatian: Niraparib kao supstrat jetrenih prijenosnika za unos tvari (OATP1B1, OATP1B3 i OCT1)
English: No dose adjustment for Zejula is required when administered concomitantly with medicinal products known to inhibit OAT1 (e.g. probenecid) or OAT3 (e.g. probenecid, diclofenac), or OCT2 (e.g. cimetidine, quinidine) uptake transporters.
Croatian: Nije potrebna prilagodba doze lijeka Zejula kad se primjenjuje istodobno s lijekovima za koje je poznato da inhibiraju prijenosnike za unos tvari OAT1 (npr. probenecid) ili OAT3 (npr. probenecid, diklofenak) ili OCT2 (npr. cimetidin, kinidin).
English: Photosensitivity, rash
Croatian: Često Fotosenzibilnost, osip
English: Back pain, arthralgia, myalgia
Croatian: Manje često Bol u leđima, artralgija, mialgija
English: In the clinical programme, thrombocytopenia was managed with laboratory monitoring, dose modification and platelet transfusion where appropriate (see section 4.2).
Croatian: U kliničkom programu trombocitopenija je bila zbrinuta praćenjem laboratorijskih nalaza, modifikacijom doze i transfuzijom trombocita kada je bilo primjereno (vidjeti dio 4.2).
English: Each hard capsule contains niraparib tosylate monohydrate equivalent to 100 mg of niraparib.
Croatian: Jedna tvrda kapsula sadrži niraparibtozilat hidrat u količini koja odgovara 100 mg nirapariba.
English: No patients with pre-existing severe renal impairment or end-stage renal disease undergoing hemodialysis were identified in clinical studies (see section 4.2).
Croatian: U kliničkim ispitivanjima nije bilo bolesnika s prethodno postojećim teškim oštećenjem funkcije bubrega ili u završnom stadiju bubrežne bolesti koji se podvrgavaju hemodijalizi (vidjeti dio 4.2).
English: • Urinary tract infection
Croatian: • infekciju mokraćnog sustava
English: Niraparib is metabolised primarily by carboxylesterases (CEs) to form a major inactive metabolite, M1.
Croatian: Niraparib se metabolizira primarno karboksilesterazama u glavni inaktivni metabolit, M1. U ispitivanju masene bilance glavni metaboliti u cirkulaciji bili su M1 i M10 (glukuronidi M1 koji nastaju kasnije).
English: The median duration of anaemia of any grade was 63 days, and 8 days for Grade 3/4 events.
Croatian: Medijan trajanja anemije bilo kojeg stupnja bio je 63 dana, a anemije 3./4. stupnja 8 dana.
English: There are no or limited amount of data from the use of niraparib in pregnant women.
Croatian: Podaci o primjeni nirapariba u trudnica su ograničeni ili ih nema.
English: Haematologic adverse reactions have been observed during the treatment with Zejula especially during the initial phase of the treatment.
Croatian: Tablica 2: Modifikacije doza zbog hematoloških nuspojava Tijekom liječenja lijekom Zejula uočene su hematološke nuspojave, posebice tijekom početne faze liječenja.
English: Dose adjustments for adverse reactions
Croatian: Prilagodba doze zbog nuspojava
English: • Stomach pain
Croatian: • nadutost trbuha
English: Myelodysplastic syndrome/acute myeloid leukaemia (MDS/AML), including cases with fatal outcome, have been reported in a small number of patients who received Zejula or placebo.
Croatian: U malog broja bolesnika koji su primali lijek Zejula ili placebo zabilježeni su mijelodisplastični sindrom / akutna mijeloična leukemija (MDS/AML), uključujući i slučajeve sa smrtnim ishodom.
English: Insomnia, anxiety, depression
Croatian: Manje često Nesanica, anksioznost, depresija
English: • Withhold Zejula for a maximum of 28 days and monitor blood counts weekly until platelet counts return to ≥ 100,000/µL.
Croatian: Prekinite primjenu lijeka Zejula na najviše 28 dana i tjedno pratite krvnu sliku dok se broj trombocita ne vrati na ≤ 100 000/µl.
English: Zejula 100 mg capsules niraparib
Croatian: NAZIV LIJEKA Zejula 100 mg kapsule niraparib
English: Dyspnea, cough, nasopharyngitis
Croatian: Dispneja, kašalj, nazofaringitis Često
English: Niraparib is eliminated primarily through the hepatobiliary and renal routes.
Croatian: Niraparib se uglavnom eliminira putem jetre i žuči te bubrega.
English: Neither niraparib nor M1 is a substrate of organic anion transport polypeptide 1B1 (OATP1B1), 1B3 (OATP1B3), or organic cation transporter 1 (OCT1).
Croatian: Ni niraparib ni M1 nisu supstrati polipeptidnog prijenosnika organskih aniona 1B1 (OATP1B1), 1B3 (OATP1B3) niti prijenosnika organskih kationa 1 (OCT1).
English: Common (may affect up to 1 in 10 people) Reduction in the number of white cells in the blood (leukopenia) Talk to your doctor if you get any other side effects.
Croatian: Često (mogu se javiti u do 1 od 10 osoba) • Smanjenje broja bijelih krvnih stanica (leukopenija).
English: The median time to onset of thrombocytopenia regardless of grade and Grade 3/4 thrombocytopenia was 22 and 23 days, respectively.
Croatian: Medijan vremena do nastupa trombocitopenije bez obzira na stupanj bio je 22 dana, a do nastupa trombocitopenije 3./4. stupnja bio je 23 dana.
English: • Feeling sick
Croatian: • osjećaj mučnine
English: Lactose monohydrate
Croatian: Hematološke nuspojave
English: Hypertension, including hypertensive crisis, has been reported with Zejula therapy.
Croatian: Uz liječenje lijekom Zejula zabilježena je hipertenzija, uključujući i hipertenzivnu krizu.
English: Each hard capsule contains niraparib tosylate monohydrate equivalent to 100 mg niraparib.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna tvrda kapsula sadrži niraparibtozilat hidrat u količini koja odgovara 100 mg nirapariba.
English: In the NOVA study, 48 of 367 (13 %) of patients experienced bleeding with concurrent thrombocytopenia; all bleeding events concurrent with thrombocytopenia were Grade 1 or 2 in severity except for one event of Grade 3 petechiae and haematoma observed concurrently with a serious adverse event of pancytopenia.
Croatian: Svi slučajevi krvarenja uz istodobnu trombocitopeniju bili su 1. ili 2. stupnja težine osim jednog slučaja petehija i hematoma 3. stupnja zabilježenog istodobno s ozbiljnom nuspojavom pancitopenije.
English: Inhibition of efflux transporters (P-gp, BCRP, BSEP, and MATE1/2) Niraparib is not an inhibitor of BSEP.
Croatian: Inhibicija efluksnih prijenosnika (P-gp-a, BCRP-a, BSEP-a i MATE1/2)
English: Low blood-cell counts
Croatian: Nizak broj krvnih stanica
English: Therefore, no dose adjustment for Zejula is required when administered concomitantly with medicinal products known to inhibit P-gp (e.g. amiodarone, verapamil) or BCRP (e.g. osimertinib, velpatasvir, and eltrombopag).
Croatian: Stoga nije potrebna prilagodba doze lijeka Zejula kad se primjenjuje istodobno s lijekovima za koje je poznato da inhibiraju P-gp (npr. amiodaron, verapamil)
English: Hypertension, including hypertensive crisis, has been reported with the use of Zejula.
Croatian: Uz primjenu lijeka Zejula zabilježena je hipertenzija, uključujući i hipertenzivnu krizu.
English: Haematologic adverse reactions (thrombocytopenia, anaemia, neutropenia) have been reported in patients treated with Zejula.
Croatian: U bolesnika liječenih lijekom Zejula zabilježene su hematološke nuspojave (trombocitopenija, anemija, neutropenija).
English: Back pain, arthralgia
Croatian: Bol u leđima, artralgija Često
English: • Headache
Croatian: • glavobolju
English: Contact your doctor straightaway if you become pregnant while you are taking Zejula.
Croatian: Ako zatrudnite tijekom uzimanja lijeka Zejula odmah se obratite liječniku.
English: Inhibition of renal uptake transporters (OAT1, OAT3, and OCT2) Neither niraparib nor M1 inhibits organic anion transporter 1 (OAT1), 3 (OAT3), and organic cation transporter 2 (OCT2).
Croatian: Ni niraparib ni M1 ne inhibiraju prijenosnik organskih aniona 1 (OAT1), 3 (OAT3) niti prijenosnik organskih kationa 2 (OCT2).
English: Inhibition of hepatic uptake transporters (OATP1B1, OATP1B3, and OCT1) Neither niraparib nor M1 is an inhibitor of organic anion transport polypeptide 1B1 (OATP1B1) or 1B3 (OATP1B3).
Croatian: Ni niraparib ni M1 nisu inhibitori polipeptidnog prijenosnika organskih aniona 1B1 (OATP1B1) ni 1B3 (OATP1B3).
English: INFORMATION IN BRAILLE
Croatian: 16. PODACI NA BRAILLEOVOM PISMU ZEJULA
English: Niraparib as a substrate of renal uptake transporters (OAT1, OAT3, and OCT2) Neither niraparib nor M1 is a substrate of organic anion transporter 1 (OAT1), 3 (OAT3), and organic cation transporter 2 (OCT2).
Croatian: Ni niraparib ni M1 nisu supstrati prijenosnika organskih aniona 1 (OAT1), 3 (OAT3) niti prijenosnika organskih kationa 2 (OCT2).
English: Estimated Survival Function
Croatian: Oštećenje funkcije jetre
English: • Muscle pain
Croatian: • omaglicu
English: • Back pain
Croatian: • bol u leđima
English: bronchitis
Croatian: FARMACEUTSKI
English: • Dizziness
Croatian: • nesanicu
English: • Abnormal blood tests
Croatian: • odstupanja u nalazima krvi
English: MA (EU) number (Invented) name
Croatian: Broj rješenja (EU)
English: Immediate Packaging Pack size
Croatian: Naziv lijeka Jačina Farmaceutski oblik Način primjene Primarno pakiranje Veličina pakiranja blister (PVC/PVDC/Al) 168 (2 x 84) tableta (multipack)
English: The company requested the authorisation to be recognised in Bulgaria, Croatia, France, Germany, Ireland, Italy, the Netherlands, Poland, Portugal, Romania, Slovenia, Spain and the United Kingdom (the ‘concerned Member States').
Croatian: Tvrtka je željela da odobrenje budu priznato u Bugarskoj, Hrvatskoj, Francuskoj, Njemačkoj, Irskoj, Italiji, Nizozemskoj, Poljskoj, Portugalu, Rumunjskoj, Sloveniji, Španjolskoj i Ujedinjenoj Kraljevini („države članice sudionice u postupku”).
English: 10 June 2016
Croatian: 10. lipnja 2016.
English: The European Commission issued a decision on 10 June 2016.
Croatian: Europska komisija objavila je odluku dana 10. lipnja 2016.
English: However, the Member States could not reach an agreement and the Belgian Federal Agency for Medicines and Health Products referred the matter to the CVMP for arbitration on 29 September 2015.
Croatian: Međutim, države članice nisu uspjele postići dogovor i stoga je Belgijska savezna agencija za lijekove i zdravstvene proizvode uputila predmet CVMP-u na arbitražu 29. rujna 2015.
English: On 17 March 2016, the European Medicines Agency (the Agency) completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine CattleMarker IBR Inactivated emulsion for injection for cattle (thereafter called CattleMarker IBR Inactivated).
Croatian: Europska agencija za lijekove (Agencija) završila je 17. ožujka 2016. arbitražni postupak koji je pokrenut zbog neslaganja među državama članicama Europske unije (EU) u pogledu odobrenja veterinarsko-medicinskog proizvoda CattleMarker inaktivirane emulzije protiv ZRG-a za injekciju za goveda (odatle naziv CattleMarker inaktivirano cjepivo protiv ZRG-a).
English: Zoetis Belgium SA submitted an application for CattleMarker IBR Inactivated for mutual recognition on the basis of the initial authorisation granted by Belgium.
Croatian: Tvrtka Zoetis Belgium SA podnijela je VMP CattleMarker inaktivirano cjepivo protiv ZRG-a za postupak međusobnog priznavanja na temelju početnog odobrenja koje je izdala Belgija.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that, subject to conditions relating to risk mitigation and surveillance measures, the marketing authorisation granted in Belgium for CattleMarker IBR Inactivated can be recognised in other Member States of the EU.
Croatian: Odbor za veterinarsko-medicinske proizvode (CVMP) pri Agenciji zaključio je da, u skladu s uvjetima koji se odnose na mjere ublažavanja rizika i nadzora, odobrenje za stavljanje u promet za VMP CattleMarker inaktivirano cjepivo protiv ZRG-a može biti priznato u drugim državama članicama EU-a.
English: Questions and answers on CattleMarker IBR Inactivated emulsion for injection for cattle (inactivated gE Bovine Herpes Virus type 1 (BoHv-1), strain Difivac) EMA/290855/2016
Croatian: Pitanja i odgovori o CattleMarker inaktiviranoj emulziji protiv ZRG-a za injekciju za goveda (inaktivirani gE goveđi herpes virus tip 1 (GHV-1), soj Difivac) EMA/290855/2016
English: The potential risk of recurrence of Bovine Neonatal Pancytopenia linked to the use of this vaccine in pregnant cows had been addressed by Zoetis; however Germany considered that the proposed handling of the risks was inadequate and that a large scale post authorisation study should be initiated by Zoetis.
Croatian: Tvrtka Zoetis riješila je mogući rizik od pojave goveđe neonatalne pancitopenije povezane s primjenom cjepiva na steonim kravama; međutim, Njemačka je smatrala da predloženo rješenje rizika nije odgovarajuće te da bi tvrtka Zoetis trebala pokrenuti opsežno ispitivanje nakon dobivanja odobrenja za stavljanje u promet.
English: The grounds for the referral were concerns raised by Germany regarding the immunological safety of CattleMarker IBR Inactivated, as the composition and manufacture of this product are similar to PregSure BVD, a vaccine from Zoetis which has been shown to induce a long-lasting allogeneic antibody response that has been associated with Bovine Neonatal Pancytopenia, a neonatal alloimmune disease, in the progeny of vaccinated dams.
Croatian: Razlog za upućivanje na arbitražu bila je zabrinutost koju je izrazila Njemačka u pogledu imunološke sigurnosti VMP-a CattleMarker inaktivirano cjepivo protiv ZRG-a jer su njegov sastav i proizvodnja slični VMP-u PregSure BVD, cjepivu tvrtke Zoetis koje dokazano izaziva dugotrajnu alogeničnu reakciju protutijela koja je povezana s goveđom neonatalnom pancitopenijom, neonatalnom aloimunološkom bolešću, u potomstvu cijepljenih ženki.
English: CattleMarker IBR Inactivated is produced on the same bovine cell line and is adjuvanted with the same highly potent adjuvant as PregSure BVD.
Croatian: VMP CattleMarker inaktivirano cjepivo protiv ZRG-a proizvodi se na istim staničnim linijama goveda i dodaje mu se isti visokopotentni dodatak kao i VMP-u PregSure BVD.
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CVMP concluded that subject to the conduct of additional studies and the implementation of further measures specified in a Risk Management Plan the marketing authorisation for CattleMarker IBR Inactivated should be granted in all concerned Member States.
Croatian: Na osnovi procjene trenutačno dostupnih podataka i provedene znanstvene rasprave u okviru Odbora, CVMP je donio zaključak o izdavanju odobrenja za stavljanje u promet VMP-a CattleMarker inaktivirano cjepivo protiv ZRG-a u svim dotičnim državama članicama, podložno provedbi dodatnih ispitivanja te primjeni dodatnih mjera navedenih u planu upravljanja rizikom.
English: Active immunisation of female cattle from 6 months of age is also indicated to reduce the clinical signs (pyrexia and duration of dyspnoea) of IBR and virus shedding caused by BoHV-1 infection and to reduce the incidence of abortions associated with BoHV-1 infections as demonstrated during the second trimester of gestation following challenge.
Croatian: VMP je također indiciran za aktivnu imunizaciju ženki stoke od 6 mjeseci starosti radi smanjenja kliničkih znakova (pireksija i trajanje dispneje) ZRG-a i izlučivanja virusa kao posljedice infekcije virusom GHV-1, i radi smanjenja pojave pobačaja povezanih s infekcijama virusom GHV-1 kao što je dokazano tijekom drugog tromjesečja gestacije nakon infekcije.
English: Why was CattleMarker IBR Inactivated reviewed?
Croatian: Zašto je VMP CattleMarker inaktivirano cjepivo protiv ZRG-a preispitan?
English: CattleMarker IBR Inactivated is an inactivated infectious bovine rhinotracheitis (IBR) vaccine which contains inactivated glycoprotein E (gE) negative bovine herpes virus 1 (BoHV-1), strain Difivac.
Croatian: CattleMarker inaktivirano cjepivo protiv ZRG-a) inaktivirano je cjepivo protiv zaraznog rinotraheitisa goveda (ZRG) koje sadrži goveđi herpes virus tipa 1 s inaktiviranim glikoproteinom E (gE) (GHV-1) soja Difivac.
English: What is CattleMarker IBR Inactivated?
Croatian: Što je CattleMarker inaktivirano cjepivo protiv ZRG-a?
English: Questions and answers on CattleMarker IBR Inactivated emulsion for injection for cattle (inactivated gE Bovine Herpes Virus type 1 (BoHv-1), strain Difivac)
Croatian: Pitanja i odgovori o CattleMarker inaktiviranoj emulziji protiv ZRG-a za injekciju za goveda (inaktivirani gE
English: (* equivalent to titre prior to inactivation)
Croatian: (*jednako titru prije inaktivacije)
English: Packaging Content Package size
Croatian: Veličina pakovanja
English: EMA Number
Croatian: EU broj
English: These reactions can sometimes be serious.
Croatian: Te reakcije katkada mogu biti ozbiljne.
English: You may need it again.
Croatian: Možda ćete je trebati ponovno.
English: • It is important that your hands and the items you use be as clean as possible.
Croatian: • Važno je da Vaše ruke i predmeti koje koristite budu što čišći.
English: The larger the dose, the longer it will take to inject.
Croatian: Što je veća doza, to treba više vremena da se ubrizga.
English: • A good place is a clean table or kitchen surface.
Croatian: • Dobro mjesto je čist stol ili kuhinjska površina.
English: For immediate and single use following first opening and reconstitution.
Croatian: Za neposrednu i jednokratnu uporabu nakon prvog otvaranja i rekonstitucije.
English: Need to increase the dose (%)
Croatian: Potreba za povećanjem doze (%)
English: Follow the procedure exactly, as it may differ from your past experience.
Croatian: Strogo slijedite opisani postupak, jer može biti različit od Vašeg prethodnog iskustva.
English: E - 28760 Tres Cantos (Madrid) Spain
Croatian: E - 28760 Tres Cantos (Madrid) Španjolska