FrancophonIA/ELRC3.0 huggingface dataset:
English: Administration-related reactions (ARRs)/hypersensitivity reactions such as chills and/or fever, dyspnoea, hypotension, wheezing, bronchospasm, tachycardia, reduced oxygen saturation, respiratory distress, rash, nausea, vomiting and headache were seen in Herceptin clinical trials (see section 4.4).
Croatian: U kliničkim ispitivanjima lijeka Herceptin primijećene su reakcije povezane s primjenom lijeka/reakcije preosjetljivosti, poput zimice i/ili vrućice, dispneje, hipotenzije, piskanja pri disanju, bronhospazma, tahikardije, smanjene zasićenosti kisikom, respiratornog distresa, osipa, mučnine, povraćanja i glavobolje (vidjeti dio 4.4).
English: In study BCIRG 006, 213/1075 patients in the DCarbH (TCH) arm, 221/1074 patients in the AC→DH
Croatian: U ispitivanju BCIRG 006 je 213/1075 bolesnica u skupini DCarbH (TCH), 221/1074 bolesnica u skupini AC→DH (AC→TH) i 217/1073 bolesnica u skupini AC→D (AC→T) imalo Karnofsky status ≤ 90 (bilo 80 ili 90).
English: +Dyspnoea
Croatian: + Herceptin
English: Common side effects of Herceptin: may affect up to 1 in 10 people
Croatian: Česte nuspojave lijeka Herceptin: mogu se javiti u do 1 na 10 osoba
English: MARKETING AUTHORISATION NUMBER(S) EU/1/00/145/002
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/00/145/002
English: Trastuzumab may persist in the circulation for up to 7 months after stopping Herceptin treatment based on population pharmacokinetic analysis of all available data (see section 5.2).
Croatian: Na temelju populacijske farmakokinetičke analize svih dostupnih podataka (vidjeti dio 5.2), trastuzumab može biti prisutan u cirkulaciji do 7 mjeseci nakon prestanka liječenja lijekom Herceptin.
English: FP +H N = 294
Croatian: FP +H
English: Table 7: Final Overall Survival Analysis from the joint analysis of trials NSABP B-31 and NCCTG N9831
Croatian: Tablica 7 Konačna analiza ukupnog preživljenja iz skupne analize ispitivanja NSABP B-31 i NCCTG N9831
English: which was followed by • CMF on day 1 and 8 every 4 weeks for 3 cycles which was followed after surgery by • additional cycles of adjuvant Herceptin (to complete 1 year of treatment)
Croatian: • CMF 1. i 8. dana svaka 4 tjedna u 3 ciklusa a zatim nakon kirurškog zahvata
English: - following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable) (see section 5.1).
Croatian: Herceptin je indiciran u liječenju odraslih bolesnika s HER2 pozitivnim ranim rakom dojke: - nakon kirurškog zahvata, kemoterapije (neoadjuvantne ili adjuvantne) i radioterapije (ako su provedeni) (vidjeti dio 5.1)
English: Hazard ratios (95 % CI) A: doxorubicin; C: cyclophosphamide; P: paclitaxel; D: docetaxel; Carb: carboplatin; H: trastuzumab CI = confidence interval
Croatian: Post-hoc eksplorativna analiza s preživljenjem bez bolesti i simptomatskim srčanim događajima Dugoročno praćenje Omjeri hazarda (95% CI) A: doksorubicin, C: ciklofosfamid, P: paklitaksel, D: docetaksel, Carb: karboplatin, H: trastuzumab CI = interval pouzdanosti * U trenutku konačne analize preživljenja bez bolesti.
English: No staining is observed or membrane staining is observed in < 10 % of the tumour cells
Croatian: Nema vidljive obojenosti ili se obojenost membrane primjećuje u < 10% tumorskih stanica.
English: which was followed by - Paclitaxel 175 mg/m2 administered 3-weekly for 4 cycles,
Croatian: - paklitaksel 175 mg/m2, svaka 3 tjedna u 4 ciklusa,
English: The recommended maintenance dose of Herceptin at three-weekly intervals is 6 mg/kg body weight, beginning three weeks after the loading dose.
Croatian: Preporučena doza održavanja lijeka Herceptin koja se primjenjuje u trotjednim intervalima iznosi 6 mg/kg tjelesne težine, a počinje se primjenjivati 3 tjedna nakon udarne doze.
English: Median follow-up 12 months*
Croatian: 12 mjeseci*
English: The median overall survival for the high HER2 expressing group was 11.8 months versus 16 months, HR 0.65 (95 % CI 0.51-0.83) and the median progression free survival was 5.5 months versus 7.6 months, HR 0.64 (95 % CI 0.51-0.79) for FP versus FP + H, respectively.
Croatian: Medijan ukupnog preživljenja u skupini s visokom ekspresijom HER2 koja nije primala Herceptin iznosio je 11,8 mjeseci u usporedbi sa 16 mjeseci u skupini koja je primala Herceptin, omjer hazarda (HR) 0,65 (95% CI 0,51-0,83).
English: Severe pulmonary adverse reactions occur in association with the use of Herceptin and have been associated with a fatal outcome.
Croatian: Pri primjeni lijeka Herceptin uočene su teške plućne nuspojave koje su završavale smrtnim ishodom.
English: Disease-free survival No. patients with event p=0.0003
Croatian: Smrt (događaj ukupnog preživljenja): broj bolesnica s događajem p=0,014
English: These symptoms can be treated with an analgesic/antipyretic such as meperidine or paracetamol, or an antihistamine such as diphenhydramine.
Croatian: Ovi se simptomi mogu liječiti analgeticima/antipireticima, poput meperidina ili paracetamola, ili antihistaminicima, poput difenhidramina.U većine bolesnika dolazi do povlačenja simptoma, nakon čega se nastavlja s daljnjim infuzijama lijeka Herceptin.
English: A weak to moderate complete membrane staining is detected in > 10 % of the tumour cells.
Croatian: Slaba do umjerena obojenost cijele membrane u > 10 % tumorskih stanica.
English: AC→P
Croatian: p-vrijednost naspram AC→P
English: • sleepiness (somnolence)
Croatian: • pospanost (izrazita pospanost)
English: Trastuzumab
Croatian: Nuspojava
English: Herceptin and anthracyclines should not be given concurrently in the adjuvant treatment setting.
Croatian: Kod adjuvantnog liječenja ne smiju se istodobno davati Herceptin i antraciklini.
English: Patients with MBC should be treated with Herceptin until progression of disease.
Croatian: U bolesnika s metastatskim rakom dojke liječenje lijekom Herceptin traje do progresije bolesti.
English: Parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration.
Croatian: Prije primjene, parenteralne lijekove treba pregledati zbog mogućih zaostalih čestica ili promjene boje.
English: Patients experiencing dyspnoea at rest due to complications of advanced malignancy and comorbidities may be at increased risk of pulmonary events.
Croatian: Bolesnici s dispnejom u mirovanju uslijed komplikacija uznapredovale zloćudne bolesti i popratnih komorbiditeta mogu imati povećan rizik od plućnih reakcija.
English: In the BCIRG 006 study Herceptin was administered either in combination with docetaxel, following
Croatian: U sklopu ispitivanja BCIRG 006 Herceptin je primjenjivan u kombinaciji s docetakselom nakon AC kemoterapije (AC→DH) ili u kombinaciji s docetakselom i karboplatinom (DCarbH).
English: ADCC has been shown to be preferentially exerted on HER2 overexpressing cancer cells compared with cancer cells that do not overexpress HER2.
Croatian: In vitro je pokazano da se trastuzumabom posredovana stanična citotoksičnost ovisna o protutijelima odvija s većim afinitetom na tumorskim stanicama koje imaju povećanu ekspresiju HER2 u usporedbi s tumorskim stanicama koje nemaju povećanu ekspresiju HER2.
English: Hazard Ratio versus Observation *Co-primary endpoint of DFS of 1 year versus observation met the pre-defined statistical boundary **Final analysis (including crossover of 52 % of patients from the observation arm to Herceptin) *** There is a discrepancy in the overall sample size due to a small number of patients who were randomized after the cut-off date for the 12-month median follow-up analysis
Croatian: ***Postoji nesrazmjer u ukupnoj veličini uzorka zbog malog broja bolesnika koji su randomizirani nakon završnog datuma za analizu medijana praćenja od 12 mjeseci.
English: L-histidine hydrochloride monohydrate L-histidine α,α-trehalose dihydrate polysorbate 20
Croatian: L-histidin α,α-trehaloza dihidrat polisorbat 20
English: which was followed by - CMF on day 1 and 8 every 4 weeks for 3 cycles which was followed after surgery by - additional cycles of adjuvant Herceptin (to complete 1 year of treatment)
Croatian: - CMF 1. i 8. dana, svaka 4 tjedna u 3 ciklusa a zatim nakon kirurškog zahvata
English: Weekly dosing in metastatic breast cancer
Croatian: Rak dojke Metastatski rak dojke
English: How Herceptin is given
Croatian: Kako ćete primati Herceptin
English: Cycle
Croatian: 1. ciklus
English: The efficacy results from the joint analysis of the NSABP B-31 and NCCTG 9831 trials at the time of the definitive analysis of DFS* are summarized in Table 6.
Croatian: Rezultati djelotvornosti iz skupne analize ispitivanja NSABP B-31 i NCCTG 9831 u trenutku konačne analize preživljenja bez bolesti prikazani su sažeto u Tablici
English: +Pleural effusion
Croatian: +dispneja kašalj epistaksa rinoreja
English: • jaundice
Croatian: • svrbež
English: HER2.
Croatian: Herceptin2
English: Do not use Herceptin if:
Croatian: Nemojte primati Herceptin
English: pCR (absence ofinvasive neoplastic cells in breast Non-responders Exact 95% CI for pCR Rate*
Croatian: pCR (nema invazivnih neoplastičnih stanica u dojci)
English: Biopsy specimenstaining pattern
Croatian: Tablični prikaz nuspojava
English: NAME OF THE MEDICINAL PRODUCT Herceptin 150 mg powder for concentrate for solution for infusion
Croatian: Herceptin 150 mg prašak za koncentrat za otopinu za infuziju
English: Pneumonitis
Croatian: Kemoterapija
English: NAME OF THE MEDICINAL PRODUCT Herceptin 600 mg solution for injection in vial Trastuzumab
Croatian: Herceptin 600 mg otopina za injekciju trastuzumab
English: Paclitaxel2 N=77
Croatian: N=77
English: • haemorrhoids
Croatian: • upala dojke
English: • itchiness
Croatian: • tjeskoba
English: Nervous system disorders 1Tremor
Croatian: Poremećaji živčanog sustava
English: Herceptin intravenous formulation is not for subcutaneous use and should be given as an intravenous infusion only.
Croatian: Herceptin u intravenskoj formulaciji nije namijenjen za supkutanu primjenu i smije se primijeniti isključivo intravenskom infuzijom.
English: Signs and symptoms of cardiac dysfunction such as dyspnoea, orthopnoea, increased cough, pulmonary oedema, S3 gallop, or reduced ventricular ejection fraction, have been observed in patients treated with Herceptin (see section 4.4).
Croatian: U bolesnika liječenih lijekom Herceptin primijećeni su znakovi i simptomi disfunkcije srca, poput dispneje, ortopneje, pojačanog kašlja, plućnog edema, trećeg srčanog zvuka ili smanjene ejekcijske frakcije klijetke (vidjeti dio 4.4).
English: Administration-related reactions (ARRs) are known to occur with Herceptin subcutaneous formulation.
Croatian: Kod primjene lijeka Herceptin u supkutanoj formulaciji znale su se pojaviti reakcije povezane s primjenom.
English: 80.9 %) in favour of the AC→DH (Herceptin) arm and 4.6 percentage points (85.5 % versus 80.9 %) in favour of the DCarbH (Herceptin) arm compared to AC→D.
Croatian: Za primarnu mjeru ishoda ispitivanja BCIRG 006, preživljenje bez bolesti, omjer hazarda apsolutno je povoljan u smislu trogodišnjeg preživljenja bez bolesti s razlikom od 5,8 postotnih bodova (86,7 % naspram 80,9 %) u korist AC→DH skupine (Herceptin) i 4,6 postotnih bodova (85,5 % naspram na 80,9 %) u korist DCarbH skupine (Herceptin) u usporedbi s AC→D skupinom.
English: Three-weekly and weekly schedule
Croatian: Rani rak dojke Trotjedni i tjedni ciklusi
English: Neutralizing antitrastuzumab antibodies were detected in post-baseline samples in 2 of 30 patients in the Herceptin intravenous arm and 3 of 47 in the Herceptin subcutaneous arm. 21.0 % of patients treated with Herceptin subcutaneous formulation developed antibodies against the excipient hyaluronidase (rHuPH20).
Croatian: Neutralizirajuća protutijela na trastuzumab pronađena su u uzorcima prikupljenima nakon početka ispitivanja u 2 od 30 bolesnika u skupini liječenoj lijekom Herceptin za intravensku primjenu te 3 od 47 bolesnika u skupini liječenoj lijekom Herceptin za supkutanu primjenu.
English: 4mg/kg + 2mg/kg qw
Croatian: 4 mg/kg + 2 mg/kg jedanput na tjedan metastatski rak dojke rani rak dojke
English: +Acute pulmonary oedema
Croatian: +akutni plućni edem nepoznato
English: weekly) and docetaxel (60 mg/m2 IV) in Japanese women with HER2- positive MBC, suggested that concomitant administration of Herceptin had no effect on the single dose pharmacokinetics of docetaxel.
Croatian: Podaci iz ispitivanja JP16003, ispitivanja lijeka Herceptin (intravenska udarna doza od 4 mg/kg, nakon koje slijedi intravenska doza od 2 mg/kg jedanput tjedno) i docetaksela (60 mg/m2 intravenski) s jednom skupinom žena japanskog podrijetla s HER2-pozitivnim metastatskim rakom dojke, ukazali su da istodobna primjena lijeka Herceptin ne utječe na farmakokinetiku jednokratne doze docetaksela.
English: Herceptin subcutaneous fixed dose formulation is not for intravenous use and should be given as a subcutaneous injection only.
Croatian: Herceptin u supkutanoj formulaciji nije namijenjen za intravensku primjenu i smije se primijeniti isključivo supkutanom injekcijom.
English: It may take up to 7 months for Herceptin to be removed from the body.
Croatian: Da bi se Herceptin uklonio iz tijela, potrebno je i do 7 mjeseci.
English: Uncommon side effects of Herceptin: may affect up to 1 in 100 people
Croatian: • grčevi u nogama Manje česte nuspojave lijeka Herceptin: mogu se javiti u do 1 na 100 osoba
English: • diarrhoea
Croatian: • hemoroidi
English: (N=2032)
Croatian: AC→P (N=2032)
English: STATEMENT OF ACTIVE SUBSTANCE(S) The vial contains 150 mg trastuzumab.
Croatian: Bočica sadrži 150 mg trastuzumaba.
English: Distant Recurrence
Croatian: Stopa odgovora
English: Glomerulonephropathy
Croatian: L-histidinklorid hidrat
English: +Acute respiratory distress syndrome
Croatian: +pneumonija astma plućni poremećaji
English: Table 4 Efficacy Results from the Monotherapy and Combination Therapy Studies
Croatian: Tablica 4 Rezultati djelotvornosti iz ispitivanja monoterapije i kombinirane terapije Parametar
English: The rate of ARRs of all grades varied between studies depending on the indication, the data collection methodology, and whether trastuzumab was given concurrently with chemotherapy or as monotherapy.
Croatian: metodologiji prikupljanja podataka te o tome je li se trastuzumab primjenjivao u kombinaciji s kemoterapijom ili kao monoterapija.
English: Paclitaxel, in combination with Herceptin, was administered as follows: - intravenous paclitaxel - 80 mg/m2 as a continuous intravenous infusion, given every week for 12 weeks.
Croatian: - intravenski paklitaksel - 80 mg/m u kontinuiranoj intravenskoj infuziji, jednom tjedno tijekom 12 tjedana ili
English: Herceptin IV (N = 263)
Croatian: (N = 263)
English: • chest pain
Croatian: • upala jetre
English: Gastrointestinal disorders Diarrhoea
Croatian: +dispneja kašalj epistaksa rinoreja pneumonija astma plućni poremećaj
English: Three-weekly schedule
Croatian: 3 tjedna
English: Upper respiratory tract infection
Croatian: • uzdignuti osip • infekcija krvi
English: • blood infection.
Croatian: • krvarenje iz nosa
English: Other infusion-related symptoms are: feeling sick (nausea), vomiting, pain, increased muscle tension and shaking, headache, dizziness, breathing difficulties, wheezing, high or low blood pressure, heart rhythm disturbances (palpitations, heart fluttering or irregular heart beat), swelling of the face and lips, rash and feeling tired.
Croatian: Ostale nuspojave povezane s infuzijom su: mučnina, povraćanje, bol, povećana napetost mišića i drhtanje, glavobolja, omaglica, otežano disanje,
English: Pregnancy, puerperium and perinatal conditions
Croatian: Žene reproduktivne dobi / kontracepcija
English: Herceptin1 N=172
Croatian: N=172
English: (hazard ratio = 1.16, 95 % CI [0.73, 1.83] for DCarbH (TCH) versus AC→D (AC→T); hazard ratio
Croatian: Nije primijećena prednost u pogledu preživljenja bez bolesti u toj podskupini bolesnica (omjer hazarda = 1,16; 95% CI [0,73; 1,83] za skupinu DCarbH (TCH), naspram AC→D (AC→T); omjer hazarda od 0,97; 95% CI [0,60; 1,55] za AC→DH (AC→TH) naspram AC→D).
English: Paresis
Croatian: SAD
English: Parenteral solutions should be inspected visually for particulates and discoloration prior to administration.
Croatian: Parenteralnu otopinu prije davanja treba pregledati zbog mogućih zaostalih čestica ili promjene boje.
English: Malignant neoplasm progression
Croatian: progresija zloćudnih neoplazmi nepoznato progresija neoplazme nepoznato
English: Each vial contains 150 mg trastuzumab that has to be dissolved in 7.2 mL of water for injection.
Croatian: Jedna bočica sadrži 150 mg trastuzumaba koji treba otopiti u
English: Three -weekly dosing in metastatic breast cancer
Croatian: tjedna metastatski rak dojke rani rak dojke 390
English: Post-hoc exploratory analysis with DFS and symptomatic cardiac events Long term follow-up** Hazard ratios (95 % CI)
Croatian: Analiza djelotvornosti tijekom dugoročnog praćenja Omjeri hazarda za preživljenje bez bolesti (95% CI) p-vrijednost p<0,0001
English: • Medicines should not be disposed of via wastewater or household waste.
Croatian: • Nikada nemojte nikakve lijekove bacati u otpadne vode.
English: Herceptin SC (N=260)
Croatian: DCarbH (n=1074)
English: Early breast cancer
Croatian: uznapredovali rak želuca
English: Herceptin1 N=105
Croatian: N=105
English: PHARMACEUTICAL FORM AND CONTENTS Powder for concentrate for solution for infusion 1 vial
Croatian: Prašak za koncentrat za otopinu za infuziju
English: L-methionine
Croatian: • proljev
English: barely perceptible membranous reactivity irrespective of percentage of tumour cells stained
Croatian: Nakupina tumorskih stanica s vrlo slabom/jedva primjetnom membranskom reaktivnošću bez obzira na postotak obojenih tumorskih stanica
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Herceptin 600 mg solution for injection
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA
English: Invented name StrengthPharmaceutical form
Croatian: Doza Farmaceutski oblik
English: MA (EU) number
Croatian: Broj (EU) odobrenja (Novoizumljen o) ime
English: Further information on Nobivac LeuFel can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Croatian: Više informacija o VMP-u Nobivac LeuFel možete naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: This overview was last updated in June 2018.
Croatian: Ovaj pregled informacija posljednji je put ažuriran u 06. 2018.
English: This medicine is the same as Leucogen, which is already authorised in the European Union (EU).
Croatian: Ovaj VMP isti je kao i Leucogen, koji je već odobren u Europskoj uniji (EU).
English: The vaccine is given to cats as an injection under the skin.
Croatian: Cjepivo se daje mačkama ubrizgavanjem injekcije pod kožu.
English: Nobivac LeuFel must not be used in pregnant cats.
Croatian: Nobivac LeuFel ne smije se primjenjivati u gravidnih mačaka.
English: Signs of the disease can include loss of appetite, weight loss, poor fur condition, fever, pale gums and diarrhoea; cats persistently infected with the virus may spread it to other cats.
Croatian: Znakovi bolesti uključuju gubitak apetita, gubitak težine, loše stanje krzna, vrućicu, blijede desni i proljev, a mačke koje su stalno zaražene virusom mogu ga prenijeti na druge mačke.
English: The vaccine is used to prevent the disease signs and persistent viraemia (the presence of FeLV in the blood).
Croatian: Cjepivo se primjenjuje radi sprečavanja znakova bolesti i stalne viremije (prisutnost virusa FeLV u krvi).
English: This authorisation was based on the authorisation granted to Leucogen in 2009 (‘informed consent').
Croatian: Odobrenje se temeljilo na odobrenju koje je 2009. izdano za VMP Leucogen („informirani pristanak”).
English: The FeLV protein used in the vaccine is not extracted from viruses but is made in a bacterium using ‘recombinant technology'.
Croatian: Protein FeLV koji se koristi u cjepivu nije izvađen iz virusa, nego se dobiva iz bakterije primjenom „rekombinantne tehnologije”.
English: Protection starts 3 weeks after the primary course of vaccination and lasts one year.
Croatian: Zaštita počinje tri tjedna nakon početne primjene cjepiva i traje jednu godinu.
English: In cases where the kitten may have antibodies passed from the mother, a third injection can be given from 15 weeks of age.
Croatian: U slučajevima kada je mačić od majke stekao protutijela može se ubrizgati treća injekcija pri uzrastu od 15 tjedana.
English: When a cat is given the vaccine, the cat's immune system recognises the protein as ‘foreign' and makes antibodies against it.
Croatian: Kada mačka primi cjepivo, imunosni sustav mačke prepoznaje protein kao „strano tijelo” i proizvodi protutijela za njega.
English: Following the first booster vaccination, protection lasts 3 years.
Croatian: Nakon prvog docjepljivanja, zaštita traje tri godine.
English: The most common side effects with Nobivac LeuFel (which may affect up to 1 in 10 cats) are a moderate and short-lived local reaction (≤2 cm) after the first injection which resolves without treatment within 3 to 4 weeks, raised body temperature (lasting 1 to 4 days), apathy (listlessness) and digestive disturbances.
Croatian: Najčešće nuspojave VMP-a Nobivac LeuFel (koje se mogu javiti u 1 na 10 mačaka) jesu umjerena i kratkotrajna lokalna reakcija (≤2 cm) nakon prve injekcije koja spontano nestane nakon tri do četiri tjedna, povišena tjelesna temperatura (koja traje od 1 do 4 dana), apatija (ravnodušnost) i probavne smetnje.
English: A laboratory study in which cats were exposed to feline leukaemia virus confirmed that following the first annual booster vaccination cats were protected for a three year period against leukaemia.
Croatian: Laboratorijsko ispitivanje u kojem su mačke bile izložene virusu mačje leukemije potvrdilo je da su nakon prvog godišnjeg docjepljivanja mačke bile zaštićene protiv leukemije u razdoblju od tri godine.
English: Nobivac LeuFel also contains aluminium hydroxide gel and extract of Quillaja saponaria as adjuvants (ingredients that strengthen the immune response).
Croatian: Nobivac LeuFel sadržava i gel aluminijeva hidroksida te ekstrakt Quillaja saponaria kao adjuvanse (sastojci koji pojačavaju imunosni odgovor).
English: What is Nobivac LeuFel and what is it used for?
Croatian: Što je Nobivac LeuFel i za što se koristi?
English: Other information about Nobivac LeuFel
Croatian: Ostale informacije o VMP-u Nobivac LeuFel
English: Feline leukaemia is an infectious disease of cats which affects the immune system and is caused by the feline leukaemia virus (FeLV).
Croatian: Mačja leukemija zarazna je bolest mačaka koja utječe na imunosni sustav, a uzrokuje ju virus mačje leukemije (FeLV).
English: In the future, the immune system will be able to produce antibodies more quickly when it is exposed to FeLV, which will help to protect against the disease caused by the virus.
Croatian: Kada imunosni sustav životinje ubuduće bude izložen virusu FeLV, moći će brže proizvesti protutijela za zaštitu od bolesti koju uzrokuje virus.
English: A booster vaccination of a single injection is necessary one year after the initial vaccination course.
Croatian: Potrebno je izvršiti docjepljivanje jednom injekcijom godinu dana nakon početnog ciklusa cijepljenja.
English: Nobivac LeuFel is available as a suspension for injection and can only be obtained with a prescription.
Croatian: Nobivac LeuFel je dostupan kao suspenzija za injekciju i izdaje se samo na veterinarski recept.
English: After the first injection 69% of the kittens had antibodies to FeLV and this increased to 100% after the second injection.
Croatian: Nakon prve injekcije, 69 % mačića imalo je protutijela za FeLV, a ta je razina nakon druge injekcije porasla na 100 %.
English: The company that makes Leucogen has agreed that its scientific data can be used for Nobivac LeuFel (‘informed consent').
Croatian: Proizvođač cjepiva Leucogen pristao je na to da se njegovi znanstveni podatci upotrebljavaju za VMP Nobivac LeuFel (tzv. „informirani pristanak”).
English: Nobivac LeuFel received a marketing authorisation valid throughout the EU for Nobivac LeuFel on 6 November 2017.
Croatian: VMP Nobivac LeuFel dobio je odobrenje za stavljanje u promet koje je na snazi u Europskoj uniji od 6. studenog 2017.