natgillin/translations-raw huggingface dataset:
Patients with HER2+ tumours were randomised to receive either neoadjuvant chemotherapy concurrently with neoadjuvant-adjuvant Herceptin, or neoadjuvant chemotherapy alone. 
Bolniki s HER2-pozitivnimi tumorji so bili randomizirani v skupino, ki je prejemala neoadjuvantno kemoterapijo sočasno z neoadjuvantnim zdravilom Herceptin najprej, nato pa še adjuvantno, ali v skupino, ki je prejemala le neoadjuvantno kemoterapijo.
The final OS results from the joint analysis of studies NSABP B-31 and NCCTG N9831 are summarized in Table 7: 
Končni rezultati za celokupno preživetje iz skupne analize študij NSABP B-31 in NCCTG N9831 so povzeti v spodnji preglednici 7.
How to store Herceptin 
Shranjevanje zdravila Herceptin
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 7. 
Rezultati učinkovitosti iz skupne analize preskušanj NSABP B-31 in NCCTG N9831 v času končne analize preživetja brez bolezni* so povzeti v preglednici 7.
- Studies NSABP B-31 and NCCTG N9831 that comprise the joint analysis were designed to investigate the clinical utility of combining Herceptin treatment with paclitaxel following AC chemotherapy, additionally the NCCTG N9831 study also investigated adding Herceptin sequentially to AC→P chemotherapy in patients with HER2 positive EBC following surgery. 
- Preskušanji NSABP B-31 in NCCTG N9831, ki imata skupno analizo, sta bili zasnovani za proučevanje klinične koristi kombinacije zdravljenja z zdravilom Herceptin in paklitakselom po kemoterapiji z doksorubicinom in ciklofosfamidom (kemoterapiji AC).
Reproduction studies have been conducted in Cynomolgus monkeys at doses up to 25 times that of the weekly human maintenance dose of 2 mg/kg Herceptin intravenous formulation and have revealed no evidence of impaired fertility or harm to the fetus. 
Študije o vplivu na sposobnost za razmnoževanje so opravili pri opicah Cynomolgus z odmerki, ki so bili do 25-krat večji od tedenskega vzdrževalnega odmerka intravenske oblike zdravila Herceptin pri ljudeh (2 mg/kg).
• Keep this medicine out of the sight and reach of children. 
· Zdravilo shranjujte nedosegljivo otrokom!
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. 
Odmerjanje paklitaksela v kombinaciji z zdravilom Herceptin je bilo naslednje: paklitaksel intravensko - 80 mg/m2 v obliki kontinuirane intravenske infuzije, vsak teden, skupaj 12 tednov ali paklitaksel intravensko - 175 mg/m2 v obliki kontinuirane intravenske infuzije, vsake 3
which was followed by - Paclitaxel 175 mg/m2 administered 3-weekly for 4 cycles, 
· paklitaksel 175 mg/m2, dan enkrat na tri tedne, 4 cikle; sledili so
No. patients with event p=0.0008 
Pojav oddaljenih metastaz: število bolnikov z dogodkom p = 0,0008
• failure of the lungs of the baby to develop in the womb 
· okvara pri razvoju pljuč otroka v maternici · nenormalen razvoj ledvic otroka v maternici
The recommended maintenance dose of Herceptin at three-weekly intervals is 6 mg/kg body weight, beginning three weeks after the loading dose. 
Priporočen vzdrževalni odmerek zdravila Herceptin je 6 mg/kg telesne mase po 3 tednih od prejema uvajalnega odmerka, in nato v tritedenskih razmakih.
Herceptin treatment should only be initiated by a physician experienced in the administration of cytotoxic chemotherapy (see section 4.4), and should be administered by a healthcare professional only. 
Zdravljenje z zdravilom Herceptin mora vpeljati zdravnik z izkušnjami s citotoksično kemoterapijo (glejte poglavje
• The other ingredient(s) are L-histidine hydrochloride monohydrate, L-histidine, α,α-trehalose dihydrate, polysorbate 20. 
· Pomožne snovi so L-histidinijev klorid monohidrat, L-histidin, α,α-trehaloza dihidrat in polisorbat 20.
• itchiness 
· tesnoba
Patients with MBC or MGC should be treated with Herceptin until progression of disease. 
Bolnike z metastatskim rakom dojk ali metastatskim rakom želodca je treba z zdravilom Herceptin zdraviti do napredovanja bolezni.
Table 4 Efficacy Results from the Monotherapy and Combination Therapy Studies 
Rezultati učinkovitosti iz študij monoterapije in kombiniranega zdravljenja
Study MO22982 investigated switching between the Herceptin intravenous and Herceptin subcutaneous formulation with a primary objective to evaluate patient preference for either the intravenous or the subcutaneous route of trastuzumab administration. 
V študiji MO22982 so proučevali prehajanje med zdravljenjem z zdravilom Herceptin v intravenski in subkutani obliki.
• pain, swelling, redness or tingling of hands and/or feet 
· rdečina, oteklina ali ranice v ustih in/ali žrelu · bolečina, oteklina, rdečina ali zbadanje v rokah in/ali nogah
+Acute respiratory distress syndrome 
+pljučnica astma motnje delovanja pljuč
Table 15 Population Predicted Steady State PK Exposure Values (median with 5th - 95th Percentiles) 
Farmakokinetične vrednosti izpostavljenosti, predvidene za populacijo (mediana s 5.-95.
Herceptin and anthracyclines should not be given concurrently in the adjuvant treatment setting. 
Pri adjuvantnem zdravljenju raka dojk zdravila Herceptin in antraciklinov ne smemo dajati sočasno.
Do not administer as an intravenous push or bolus. 
Zdravila ne smemo dajati kot hitro intravensko infuzijo ali bolus.
As Herceptin does not contain any antimicrobial-preservative, from a microbiological point of view, the medicine should be used immediately. 
Z mikrobiološkega stališča je zdravilo Herceptin treba uporabiti takoj, saj ne vsebuje konzervansov.
Disease-free survival No. patients with event p<0.0001 
Preživetje brez bolezni: število bolnikov z dogodkom p < 0,0001
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Herceptin 150 mg powder for concentrate 
IME ZDRAVILA IN POT(I) UPORABE Herceptin 150 mg prašek za koncentrat trastuzumab le za intravensko uporabo
In this trial, 2 cohorts (one using subcutaneous formulation in vial and one using subcutaneous formulation in administration system) were investigated using a 2-arm, cross-over design with 488 patients being randomized to one of two different three-weekly Herceptin treatment sequences (IV [Cycles 1-4]→ SC [Cycles 5-8], or SC [Cycles 1-4]→ IV [Cycles 5-8]). 
Šlo je za navzkrižno zasnovano preskušanje z dvema skupinama, v katerem so 488 bolnikov randomizirali v prejemanje enega od dveh različnih 3-tedenskih zaporedij zdravljenja z zdravilom Herceptin (iv. [1. do
• respiratory distress 
· okužba pljuč
MBC 
AGC
(57.8 µg/mL) of the study. 
(5. do 8. cikel).
In patients with lower body weights (<59 kg, the lowest body weight quartile) the fixed dose used in the Herceptin subcutaneous arm was not associated with an increased risk of cardiac events or significant drop in LVEF. 
Herceptin, ni bil povezan z višjim tveganjem za neželene učinke, povezane s srcem, ali pomembnim padcem v LVEF.
Distant disease-free survival 
Preživetje brez bolezni
- following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel. 
se zdravilo Herceptin daje sočasno s paklitakselom po kemoterapiji z doksorubicinom in ciklofosfamidom.
No staining is observed or membrane staining is observed in < 10 % of the tumour cells 
Obarvanje ni prisotno ali pa so obarvane membrane pri < 10 % vseh tumorskih celic v preparatu.
The recommended maintenance dose at three-weekly intervals is 6 mg/kg body weight, beginning three weeks after the loading dose. 
Priporočen vzdrževalni odmerek je 6 mg/kg telesne mase po 3 tednih od prejema uvajalnega odmerka, in nato v tritedenskih razmakih.
No. patients with event p=0.0182 
Smrt (dogodek celokupnega preživetja): število bolnikov z dogodkom p = 0,0182
• headache 
· hemoroidi
In addition a post-hoc exploratory analysis was performed on the data sets from the joint analysis (JA) NSABP B-31/NCCTG N9831* and BCIRG006 clinical studies combining DFS events and symptomatic cardiac events and summarised in Table 10: Table 10: Post-hoc exploratory analysis results from the joint analysis NSABP B-31/NCCTG N9831* 
Dodatno so izvedli post-hoc eksplorativno analizo podatkov iz skupne analize kliničnih študij NSABP B-31/NCCTG N9831 in BCIRG006, ki vključujejo dogodke preživetja brez bolezni in simptomatske srčne dogodke.
Table 5 Efficacy Results from the Non-Comparative Monotherapy and Combination Therapy Studies Parameter 
Preglednica 5 navaja rezultate učinkovitosti monoterapije in kombiniranega zdravljenja iz študij brez primerjalne skupine.
A weak to moderate complete membrane staining is detected in > 10 % of the tumour cells. 
Šibko do srednje močno obarvane celotne membrane pri > 10 % tumorskih celic.
1Cardiac flutter 
1nereden srčni utrip
Herceptin intravenous formulation is not for subcutaneous use and should be given as an intravenous infusion only. 
Intravenska oblika zdravila Herceptin ni namenjena subkutani aplikaciji in se lahko daje le z intravensko infuzijo.
Herceptin subcutaneous fixed dose formulation is not for intravenous use and should be given as a subcutaneous injection only. 
Subkutana oblika zdravila Herceptin ni namenjena intravenski aplikaciji in se lahko daje le s subkutano injekcijo.
In the neoadjuvant-adjuvant treatment setting, study MO16432, a multicentre randomised trial, was designed to investigate the clinical efficacy of concurrent administration of Herceptin with neoadjuvant chemotherapy including both an anthracycline and a taxane, followed by adjuvant Herceptin, up to a total treatment duration of 1 year. 
Pri adjuvantnem zdravljenju so zdravilo Herceptin proučevali v 4 obsežnih, multicentričnih, randomiziranih preskušanjih: - Študija BO16348 je bila zasnovana za primerjavo enoletnega in dvoletnega zdravljenja z zdravilom Herceptin (odmerjanjem na 3 tedne) z opazovanjem bolnikov z zgodnjo obliko HER2-pozitivnega raka dojk po operaciji, standardni kemoterapiji in radioterapiji (kar so uporabili).
STATEMENT OF ACTIVE SUBSTANCE(S) The vial contains 150 mg trastuzumab. 
Viala vsebuje 150 mg trastuzumaba.
The difference in serious adverse event rates between formulations was mainly due to infections with or without neutropenia (4.4 % versus 8.1 %) and cardiac disorders (0.7 % versus 1.7 %); 
Razlika v pogostnosti resnih neželenih učinkov med oblikama je bila v glavnem zaradi okužb z nevtropenijo ali brez nje (4,4 % v primerjavi z 8,1 %) in srčnimi dogodki (0,7 % v primerjavi z 1,7 %); · pooperativne okužbe rane (hude in/ali resne): 1,7 % za intravensko obliko v primerjavi s 3,0 % za subkutano obliko; · z aplikacijo povezane reakcije med obdobjem zdravljenja: 37,2 % za intravensko obliko v primerjavi s 47,8 % za subkutano obliko; · hipertenzija: 4,7 % za intravensko obliko v primerjavi z 9,8 % za subkutano obliko.
Uncommon side effects of Herceptin: may affect up to 1 in 100 people 
Občasni neželeni učinki zdravila Herceptin, ki se lahko pojavijo pri največ 1 od 100 bolnikov, so: · gluhost
L-histidine hydrochloride monohydrate L-histidine α,α-trehalose dihydrate polysorbate 20 
L-histidin a,a-trehaloza dihidrat polisorbat 20
Switching treatment between Herceptin intravenous and Herceptin subcutaneous formulations and vice versa, using the three-weekly (q3w) dosing regimen, was investigated in study MO22982 (see section 4.8). 
V študiji MO22982 so proučevali prehod z zdravljenja z zdravilom Herceptin v intravenski obliki na subkutani obliki in obratno s 3-tedenskim režimom odmerjanja (glejte poglavje 4.8).
AC→D = doxorubicin plus cyclophosphamide, followed by docetaxel; AC→DH = doxorubicin plus cyclophosphamide, followed by docetaxel plus trastuzumab; CI = confidence interval Table 9: Overview of efficacy analyses BCIRG 006 AC→D versus DCarbH 
AC → D = doksorubicin in ciklofosfamid, ki jima sledi docetaksel; DCarbH = docetaksel, karboplatin in trastuzumab; IZ = interval zaupanja V študiji BCIRG 006 se razmerje ogroženosti za primarni cilj, preživetje brez bolezni, izraža kot absolutna korist skupine AC → DH (zdravilo Herceptin) v smislu 3-letnega preživetja brez bolezni za
The addition of Herceptin to paclitaxel chemotherapy also resulted in a 37 % decrease in the risk of death. 
Hkrati je zmanjšal tudi tveganje za smrt za 37 %.
In the BCIRG 006 study Herceptin was administered either in combination with docetaxel, following 
V študiji BCIRG 006 so zdravilo Herceptin dajali v kombinaciji z docetakselom po kemoterapiji z doksorubicinom in ciklofosfamidom (AC → DH) ali v kombinaciji z docetakselom in karboplatinom
- intravenous docetaxel - 75 mg/m2 as an intravenous infusion over 1 hour, given every 3 weeks for 6 cycles (day 2 of cycle 1, then day 1 of each subsequent cycle) which was followed by: - carboplatin - at target AUC = 6 mg/mL/min administered by intravenous infusion over 3060 minutes repeated every 3 weeks for a total of six cycles 
Odmerjanje paklitaksela v kombinaciji z zdravilom Herceptin je bilo naslednje: paklitaksel intravensko - 80 mg/m2 v obliki kontinuirane intravenske infuzije, vsak teden, skupaj 12 tednov ali paklitaksel intravensko - 175 mg/m2 v obliki kontinuirane intravenske infuzije, vsake 3 tedne, skupaj 4 cikle (na 1. dan vsakega cikla).
• chest pain 
· vnetje jeter
Malignant neoplasm progression 
napredovanje maligne neoplazme neznano napredovanje neoplazme neznano
Herceptin and anthracyclines should not be given concurrently in combination in the adjuvant treatment setting. 
Metastatski rak dojk Pri zdravljenju metastatskega raka dojk kombinacije zdravila Herceptin in antraciklinov ne smemo dajati sočasno.
Uncommon side effects of Herceptin: may affect up to 1 in 100 people: 
Pogosti neželeni učinki zdravila Herceptin, ki se lahko pojavijo pri največ 1 od 10 bolnikov, so:
Table 10 Overview of Efficacy Analyses BCIRG 006 AC→D versus DCarbH Parameter 
Preglednica 10: Pregled analiz učinkovitosti za preskušanje BCIRG 006; AC → D v primerjavi
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 
***V celokupni velikosti vzorca je neskladje zaradi majhnega števila bolnikov, ki so jih randomizirali po preteku datuma, do katerega so upoštevali podatke za analizo po mediano 12-mesečnem spremljanju.
• hair loss 
· kožni izpuščaj
At the time of the definitive analysis of DFS. 
* V času končne analize preživetja brez bolezni.
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). 
Pri 21,0 % bolnikov, zdravljenih s subkutano obliko zdravila Herceptin, so se pojavila protitelesa proti pomožni snovi hialuronidazi (rHuPH20).
• abnormal or impaired blood clotting • anaphylactic reactions 
· okužbe · driska · zaprtje · zgaga (dispepsija) · utrujenost
Therefore, no constant value for half-life of trastuzumab can be deduced. 
očitnega vpliva na očistek trastuzumaba niso opazili.
A: doxorubicin; C: cyclophosphamide; P: paclitaxel; H: trastuzumab DFS analysis was also performed at the final analysis of OS from the joint analysis of studies 
A: doksorubicin; C: ciklofosfamid; P: paklitaksel; D: docetaksel; Carb: karboplatin; H: trastuzumab IZ = interval zaupanja * V času končne analize preživetja brez bolezni.
For intravenous use only 
Za intravensko uporabo le po rekonstituciji in razredčitvi
Rhinitis 
SERIJ
• respiratory failure 
· motnje delovanja pljuč
No. patients with event p=0.0024 
Smrt (dogodek celokupnega preživetja): število bolnikov z dogodkom p = 0,0024
Refer to the Summary of Product Characteristics (SmPC) for paclitaxel, docetaxel or aromatase inhibitor for information on dose reduction or delays. 
Za zmanjšanje odmerka ali odlog dajanja paklitaksela, docetaksela ali zaviralca aromataze glejte njihove Povzetke glavnih značilnosti zdravila.
or 
dan
The results of this substudy suggested that the exposure to the bioactive metabolites (e.g. 5-FU) of capecitabine was not affected by concurrent use of cisplatin or by concurrent use of cisplatin plus Herceptin. 
Herceptin ni vplivala na izpostavljenost biološko aktivnim metabolitom kapecitabina (npr. 5-FU).
Table 8 Final Overall Survival Analysis from the joint analysis of trials NSABP B-31 and NCCTG N9831 
Končna analiza celokupnega preživetja iz skupne analize preskušanj NSABP B-31 in
The recommended scoring system to evaluate the IHC staining patterns is as stated in Table 2: Table 2 Recommended Scoring System to Evaluate the IHC Staining Patterns in Breast Cancer Score Staining pattern 
Priporočeno točkovanje za vrednotenje obarvanja preparatov po metodi IHC pri raku dojk Rezultat
Rare side effects of Herceptin: may affect up to 1 in 1,000 people 
Redki neželeni učinki zdravila Herceptin, ki se lahko pojavijo pri največ 1 od 1000 bolnikov, so: · mišična šibkost · zlatenica
Roche Pharma AG Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen Germany 
Roche Pharma AG Emil-Barell-Strasse-1
• Hypertension: 4.7 % versus 9.8 % for the intravenous formulation versus subcutaneous formulation respectively. 
14,1 % za intravensko obliko v primerjavi z 21,5 % za subkutano obliko.
Table 4: Efficacy results from the non-comparative monotherapy and combination therapy studies Parameter 
Preglednica 4 navaja rezultate učinkovitosti monoterapije in kombiniranega zdravljenja iz študij brez primerjalne skupine.
* At median duration of follow up of 1.8 years for the patients in the AC→P arm and 2.0 years for patients in the AC→PH arm ** p value for OS did not cross the pre-specified statistical boundary for comparison of AC→PH vs. AC→P 
** Vrednost p za celokupno preživetje ni presegla vnaprej določene statistične meje za primerjavo AC → PH z
• dizziness 
· pasasti izpuščaj
If you receive Herceptin with any other medicine to treat cancer, such as paclitaxel, docetaxel, an aromatase inhibitor, carboplatin or cisplatin you should also read the patient information leaflets for these products. 
zaviralec aromataze, karboplatin ali cisplatin, preberite tudi navodila za uporabo teh zdravil.
- The NSABP B-31 and NCCTG N9831 studies that comprise the joint analysis were designed to investigate the clinical utility of combining Herceptin treatment with paclitaxel following AC chemotherapy, additionally the NCCTG N9831 study also investigated adding Herceptin sequentially to AC→P chemotherapy in patients with HER2 positive EBC following surgery. 
Dodatno so v preskušanju NCCTG N9831 pri bolnikih z zgodnjo obliko HER2-pozitivnega raka dojk po operaciji proučevali zaporedno dajanje zdravila Herceptin po kemoterapiji z doksorubicinom in ciklofosfamidom, ki jima je sledil paklitaksel (kemoterapiji AC → P).
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. 
Mediana celokupnega preživetja v skupini, ki je imela visoko izražen HER2, je bila 11,8 meseca za skupino, ki ni prejemala zdravila Herceptin, v primerjavi s 16 meseci za skupino, ki je prejemala tudi zdravilo Herceptin - razmerje ogroženosti 0,65 (95-% interval zaupanja; 0,51-0,83).
Renal failure 
Neželeni učinek
Ear and labyrinth disorders Deafness 
Ušesne bolezni, vključno z motnjami labirinta gluhost občasno
Back pain 
· bolečina v hrbtu
As a weekly regimen (initial loading dose of 4 mg/kg followed by 2 mg/kg every week) concomitantly with paclitaxel following chemotherapy with doxorubicin and cyclophosphamide. 
Pri tedenskem režimu (uvajalni odmerek 4 mg/kg telesne mase, nato 2 mg/kg telesne mase vsak teden)
• hot flush 
· vročinski oblivi
The recommended scoring system to evaluate the IHC staining patterns is as stated in Table 2: Table 2: Recommended scoring system to evaluate the IHC staining patterns Score Staining pattern 
Priporočeni način vrednotenja rezultatov obarvanja preparatov po metodi IHC je naveden v preglednici 2.
No reactivity or membranous reactivity in < 10 % of tumour cells 
bazolateralne ali lateralne membrane pri > 10 % tumorskih celic.
barely perceptible membranous reactivity irrespective of percentage of tumour cells stained 
Klaster tumorskih celic ima bledo, komaj zaznavno obarvanje membrane, neglede na odstotek obarvanih tumorskih celic.
- intravenous docetaxel - 100 mg/m2 as an intravenous infusion over 1 hour, given every 3 weeks for 4 cycles (day 2 of first docetaxel cycle, then day 1 of each subsequent cycle) 
Odmerjanje docetaksela je bilo naslednje: - docetaksel intravensko - 100 mg/m2 v obliki intravenske infuzije v 1 uri, vsake 3 tedne, skupaj 4
- as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. 
Zdravilo Herceptin je indicirano za zdravljenje odraslih bolnikov s HER2-pozitivno metastatsko obliko raka dojk: - kot monoterapija za zdravljenje tistih bolnikov, ki so za svojo metastatsko bolezen predhodno že prejemali najmanj dve liniji kemoterapije.
weeks for 6 cycles (day 2 of cycle 1, then day 1 of each subsequent cycle) which was followed by: - carboplatin - at target AUC = 6 mg/mL/min administered by intravenous infusion over 3060 minutes repeated every 3 weeks for a total of six cycles 
Odmerjanje doksorubicina in ciklofosfamida, ki so ju dajali sočasno, je bilo naslednje: doksorubicin v obliki intravenskega bolusa - 60 mg/m2, vsake 3 tedne, 4 cikle; ciklofosfamid intravensko - 600 mg/m2 v 30 minutah, vsake 3 tedne, 4 cikle.
Glomerulonephritis membranous 
L-histidinijev klorid monohidrat
Herceptin Subcutaneous 
zdravilo Herceptin2
In this leaflet: 
so:
If the patient misses a dose of Herceptin subcutaneous formulation, it is recommended to administer the next 600 mg dose (i.e. the missed dose) as soon as possible. 
Če je bolnik izpustil odmerek zdravila Herceptin v subkutani obliki, mu je treba dati naslednji
Time to Disease Progression, 
Motnje v času nosečnosti,
Polysorbate 20 
L-metionin polisorbat 20 voda za injekcije
Herceptin Intravenous 
Intravenska oblika zdravila Herceptin
Some adverse events / reactions were reported with a higher frequency for the subcutaneous formulation: 
O nekaterih neželenih učinkih so poročali pogosteje pri subkutani obliki: · resni neželeni učinki (večino od teh so odkrili zaradi hospitalizacije ali njenega podaljšanja):
Invented name StrengthPharmaceutical form 
Izmišljeno ime Jakost Farmacevtska oblika
This overview was last updated in June 2018. 
Pregled je bil nazadnje posodobljen junija 2018.
Further information on Nobivac LeuFel can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports. 
Nadaljnje informacije o zdravilu Nobivac LeuFel so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
This medicine is the same as Leucogen, which is already authorised in the European Union (EU). 
To zdravilo je enako zdravilu Leucogen, ki je že odobreno v Evropski uniji (EU).
The FeLV protein used in the vaccine is not extracted from viruses but is made in a bacterium using ‘recombinant technology'. 
Beljakovina FeLV, uporabljena v cepivu, ni pridobljena iz virusov, pač pa je bila narejena v bakteriji s pomočjo „rekombinantne tehnologije“.
The vaccine is used to prevent the disease signs and persistent viraemia (the presence of FeLV in the blood). 
Cepivo se uporablja za preprečevanje znakov bolezni in trajne viremije (prisotnosti virusa FeLV v krvi).
The European Medicines Agency decided that Nobivac LeuFel's benefits are greater than its risks and it can be authorised for use in the EU. 
Evropska agencija za zdravila je odločila, da so koristi zdravila Nobivac LeuFel večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
The vaccine is given to cats as an injection under the skin. 
Cepivo se mačkam daje z injiciranjem pod kožo.