natgillin/translations-raw huggingface dataset:
Dose adjustment recommendations for adverse reactions Verzenios dose combination therapy 
Doza lijeka Verzenios u kombiniranoj terapiji
You should not breast-feed while taking Verzenios. 
Tijekom liječenja lijekom Verzenios ne smijete dojiti.
Tablet core croscarmellose sodium lactose monohydrate microcrystalline cellulose colloidal hydrated silica sodium stearyl fumarate 
Jezgra tablete karmelozanatrij, umrežena laktoza hidrat celuloza, mikrokristalična silicijev dioksid, koloidni, hidratizirani natrijev stearilfumarat
Concomitant use of strong CYP3A4 inhibitors should be avoided. 
Inhibitori CYP3A4 Istodobnu primjenu snažnih inhibitora CYP3A4 treba izbjegavati.
Suspend dose until toxicity resolves to Grade 1 or less. 
Odgoditi primjenu doze dok se toksičnost ne ublaži do 1. ili nižeg stupnja.
17% of patients were pre/perimenopausal on ovarian suppression with a GnRH agonist. 
17% bolesnica bile su žene u predmenopauzi/perimenopauzi koje su primale agonist hormona koji oslobađa gonadotropin (engl. gonadotropine-releasing hormone, GnRH) radi supresije funkcije jajnika.
CYP3A4 inducers 
Induktori CYP3A4
Serious infections such as lung infections can be life-threatening; - cause blood clots in the veins; - affect the way your liver works; - cause diarrhoea. 
- uzrokovati stvaranje krvnih ugrušaka u venama - utjecati na rad jetre
MONARCH 2: Summary of efficacy data (Investigator assessment, intent-to-treat population) 
Tablica 8. MONARCH 2: Sažetak podataka o djelotvornosti (ocjena ispitivača, populacija predviđena za liječenje)
Verzenios 50 mg film-coated tablets Verzenios 100 mg film-coated tablets Verzenios 150 mg film-coated tablets 
Verzenios 50 mg filmom obložene tablete Verzenios 100 mg filmom obložene tablete Verzenios 150 mg filmom obložene tablete
Metabolism and nutrition disorders 
Poremećaji metabolizma i prehrane vrlo često smanjen tek
• Tiredness 
• omaglica
Each film-coated tablet contains 14 mg of lactose (as monohydrate). 
Jedna filmom obložena tableta sadrži 14 mg laktoze (u obliku hidrata).
- Verzenios 150 mg film-coated tablets are yellow, oval tablets debossed with “Lilly” on one side and “150” on the other. 
- Verzenios 150 mg filmom obložene tablete su žute, ovalne tablete s utisnutom oznakom “Lilly” na jednoj strani i “150” na drugoj strani.
Age, gender, and body weight had no effect on the exposure of abemaciclib in a population pharmacokinetic analysis in patients with cancer (135 males and 859 females; age range 24-91 years; and body weight range 36-175 kg). 
U populacijskoj farmakokinetičkoj analizi bolesnika s rakom (135 muškaraca i 859 žena; raspon dobi:
o Itraconazole, ketoconazole, posaconazole, voriconazole (used to treat fungal infections) o Lopinavir/ritonavir (used to treat HIV/AIDS) o Digoxin (used to treat heart disorders) o Dabigatran etexilate (used to reduce the risk of stroke and blood clots) 
o itrakonazol, ketokonazol, posakonazol, vorikonazol (koriste se za liječenje gljivičnih infekcija)
Very common Infectionsb 
Infekcije i infestacije vrlo često infekcijeb
Verzenios 100 mg film-coated tablets polyvinyl alcohol (E1203) titanium dioxide (E171) macrogol (E1521) talc (E553b) 
Verzenios 100 mg filmom obložene tablete poli(vinilni alkohol) (E1203) titanijev dioksid (E171) makrogol (E1521) talk (E553b)
EU/1/18/1307/001 EU/1/18/1307/002 EU/1/18/1307/003 EU/1/18/1307/004 EU/1/18/1307/005 EU/1/18/1307/006 EU/1/18/1307/007 EU/1/18/1307/008 EU/1/18/1307/009 EU/1/18/1307/010 EU/1/18/1307/011 EU/1/18/1307/012 EU/1/18/1307/013 EU/1/18/1307/014 EU/1/18/1307/015 
EU/1/18/1307/001 EU/1/18/1307/002 EU/1/18/1307/003 EU/1/18/1307/004 EU/1/18/1307/005 EU/1/18/1307/006 EU/1/18/1307/007 EU/1/18/1307/008 EU/1/18/1307/009
In patients with advanced and/or metastatic cancer, co-administration of the CYP3A4 inhibitor clarithromycin resulted in a 3.4-fold increase in the plasma exposure of abemaciclib and a 2.5-fold increase in the combined unbound potency adjusted plasma exposure of abemaciclib and its active metabolites. 
CYP3A4 klaritromicina povećala je plazmatsku izloženost abemaciklibu 3,4 puta, dok je kombiniranu plazmatsku izloženost abemaciklibu i njegovim aktivnim metabolitima prilagođenu za potentnost nevezane frakcije povećala 2,5 puta.
EU/1/18/1307/016 EU/1/18/1307/017 EU/1/18/1307/018 EU/1/18/1307/019 EU/1/18/1307/020 EU/1/18/1307/021 
EU/1/18/1307/010 EU/1/18/1307/011 EU/1/18/1307/012 EU/1/18/1307/013 EU/1/18/1307/014 EU/1/18/1307/015 EU/1/18/1307/016 EU/1/18/1307/017 EU/1/18/1307/018 EU/1/18/1307/019 EU/1/18/1307/020 EU/1/18/1307/021
Contact your doctor immediately for any of the following: - Symptoms such as chills or fever. 
Odmah se obratite svom liječniku ako primijetite bilo koju od sljedećih nuspojava:
A reduction in the risk of disease progression or death was observed in patients with visceral disease, (HR of 0.481 [95% CI: 0.369, 0.627]), median PFS 14.7 months versus 6.5 months; in patients with bone-only disease (HR of 0.543 [95% CI: 0.355, 0.833]); patients with measurable disease (HR of 0.523 [95% CI: 0.412, 0.644]). 
Opaženo je smanjenje rizika od progresije bolesti ili smrti u bolesnica s visceralnom bolešću (HR: 0,481 [95% CI: 0,369; 0,627], medijan PFS-a od 14,7 mjeseci naspram 6,5 mjeseci), u bolesnica samo s koštanom bolešću (HR: 0,543 [95% CI:
- Verzenios 50 mg film-coated tablets are beige, oval tablets debossed with “Lilly” on one side and “50” on the other. 
- Verzenios 50 mg filmom obložene tablete su bež, ovalne tablete s utisnutom oznakom “Lilly” na jednoj strani i “50” na drugoj strani.
You must tell your doctor if you become pregnant. 
Ako zatrudnite, morate o tome obavijestiti svog liječnika.
- Verzenios 100 mg film-coated tablets are white, oval tablets debossed with “Lilly” on one side and “100” on the other. 
- Verzenios 100 mg filmom obložene tablete su bijele, ovalne tablete s utisnutom oznakom “Lilly” na jednoj strani i “100” na drugoj strani.
de la Industria 30, 28108 Alcobendas, Madrid, Spain For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: 
Za sve informacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje lijeka u promet:
- If you get any side effects, talk to your doctor, pharmacist or nurse. 
Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, ljekarnika ili medicinsku sestru.
Each film-coated tablet contains 100 mg abemaciclib. 
Jedna filmom obložena tableta sadrži 100 mg abemacikliba.
Nervous system disorders 
Poremećaji živčanog sustava vrlo često disgeuzija omaglica
Suspend dose until toxicity resolves to baseline or Grade 1. 
Odgoditi primjenu doze dok se toksičnost ne ublaži do 1. stupnja ili početne razine.
Eli Lilly Polska Sp. z o.o. 
Eli Lilly Italia S.p.A.
Each film-coated tablet contains 50 mg abemaciclib. 
Jedna filmom obložena tableta sadrži 50 mg abemacikliba.
Excipients: lactose. 
- uzrokovati proljev.
• Verzenios 100 mg film-coated tablet: each tablet contains 100 mg abemaciclib. 
• Verzenios 100 mg filmom obložena tableta: jedna tableta sadrži 100 mg abemacikliba.
Each film-coated tablet contains 150 mg abemaciclib. 
Jedna filmom obložena tableta sadrži 150 mg abemacikliba.
• Verzenios 150 mg film-coated tablet: each tablet contains 150 mg abemaciclib. 
• Verzenios 150 mg filmom obložena tableta: jedna tableta sadrži 150 mg abemacikliba.
You should avoid becoming pregnant while taking Verzenios. 
Tijekom liječenja lijekom Verzenios morate izbjegavati trudnoću.
In clinical studies, increases in serum creatinine occurred within the first month of abemaciclib dosing, remained elevated but stable through the treatment period, were reversible upon treatment discontinuation, and were not accompanied by changes in markers of renal function, such as blood urea nitrogen (BUN), cystatin C, or calculated glomerular filtration rate based on cystatin C. 
U kliničkim su se ispitivanjima povišenja serumskih vrijednosti kreatinina javljala unutar prvog mjeseca primjene abemacikliba te su se tijekom cijelog razdoblja liječenja održavale na povišenoj, ali stabilnoj razini, da bi se nakon prekida liječenja vratile u normalu.
Verzenios 150 mg film-coated tablets Each film-coated tablet contains 150 mg abemaciclib. 
Verzenios 150 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 150 mg abemacikliba.
• Verzenios 50 mg film-coated tablet: each tablet contains 50 mg abemaciclib. 
• Verzenios 50 mg filmom obložena tableta: jedna tableta sadrži 50 mg abemacikliba.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR 150 MG FILM-COATED TABLETS 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA FILMOM OBLOŽENE TABLETE OD 150 MG
Verzenios 150 mg film-coated tablets 
Verzenios 150 mg filmom obložene tablete
Mild (Child Pugh A) and moderate (Child Pugh B) hepatic impairment had no effect on the exposure of abemaciclib. 
Blago (Child Pugh stadij A) i umjereno (Child Pugh stadij B)
Neutropenia was reported in patients receiving abemaciclib. 
U bolesnica koje su primale abemaciklib prijavljeni su slučajevi neutropenije.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR 100 MG FILM-COATED TABLETS 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA FILMOM OBLOŽENE TABLETE OD 100 MG
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR 50 MG FILM-COATED TABLETS 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA FILMOM OBLOŽENE TABLETE OD 50 MG
Verzenios 150 mg film-coated tablets polyvinyl alcohol (E1203) titanium dioxide (E171) macrogol (E1521) talc (E553b) iron oxide yellow (E172) 
Verzenios 150 mg filmom obložene tablete poli(vinilni alkohol) (E1203) titanijev dioksid (E171) makrogol (E1521) talk (E553b) željezov oksid, žuti (E172)
Verzenios 100 mg film-coated tablets Each film-coated tablet contains 100 mg abemaciclib. 
Verzenios 100 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 100 mg abemacikliba.
0.246, 0.698); in patients who were progesterone receptor negative, the HR was 0.509 (95% CI: 0.325, 
Omjer hazarda u bolesnica u predmenopauzi/perimenopauzi iznosio je 0,415 (95% CI: 0,246; 0,698), dok je u bolesnica negativnih na progesteronske receptore HR iznosio 0,509 (95% CI: 0,325; 0,797).
Alanine aminotransferase increased Aspartate aminotransferase increased a 
Tablica 4. Preporuke za zbrinjavanje povišenih vrijednosti aminotransferaza Potrebno je kontrolirati vrijednosti alanin aminotransferaze (ALT) i aspartat aminotransferaze (AST)
Grade 2 
2. stupanj
Verzenios 100 mg 
16. PODACI NA BRAILLEOVOM PISMU Verzenios 100 mg
Verzenios 50 mg film-coated tablets 
Verzenios 50 mg filmom obložene tablete
In patients who were pre/perimenopausal, the hazard ratio was 0.415 (95% CI: 
Hazard Ratio, HR]: 0,540 [95% CI:
Verzenios 50 mg film-coated tablets polyvinyl alcohol (E1203) titanium dioxide (E171) macrogol (E1521) talc (E553b) iron oxide yellow (E172) iron oxide red (E172) 
Verzenios 50 mg filmom obložene tablete poli(vinilni alkohol) (E1203) titanijev dioksid (E171) makrogol (E1521) talk (E553b) željezov oksid, žuti (E172)
• Dizziness 
• svrbež
Grade 1 
1. stupanj
EU/1/18/1307/007 (14 film-coated tablets) EU/1/18/1307/008 (168 film-coated tablets) EU/1/18/1307/009 (28 x 1 film-coated tablets) EU/1/18/1307/014 (28 film-coated tablets) EU/1/18/1307/015 (56 film-coated tablets) EU/1/18/1307/020 (42 film-coated tablets) EU/1/18/1307/021 (70 film-coated tablets) 
EU/1/18/1307/007 (14 filmom obloženih tableta) EU/1/18/1307/008 (168 filmom obloženih tableta) EU/1/18/1307/009 (28 x 1 filmom obložena tableta) EU/1/18/1307/014 (28 filmom obloženih tableta) EU/1/18/1307/015 (56 filmom obloženih tableta) EU/1/18/1307/020 (42 filmom obložene tablete) EU/1/18/1307/021 (70 filmom obloženih tableta)
Verzenios 150 mg 
TABLETE OD 150 MG
EU/1/18/1307/001 (14 film-coated tablets) EU/1/18/1307/002 (168 film-coated tablets) EU/1/18/1307/003 (28 x 1 film-coated tablets) EU/1/18/1307/010 (28 film-coated tablets) EU/1/18/1307/011 (56 film-coated tablets) EU/1/18/1307/016 (42 film-coated tablets) EU/1/18/1307/017 (70 film-coated tablets) 
EU/1/18/1307/001 (14 filmom obloženih tableta) EU/1/18/1307/002 (168 filmom obloženih tableta) EU/1/18/1307/003 (28 x 1 filmom obložena tableta) EU/1/18/1307/010 (28 filmom obloženih tableta) EU/1/18/1307/011 (56 filmom obloženih tableta) EU/1/18/1307/016 (42 filmom obložene tablete) EU/1/18/1307/017 (70 filmom obloženih tableta)
EU/1/18/1307/004 (14 film-coated tablets) EU/1/18/1307/005 (168 film-coated tablets) EU/1/18/1307/006 (28 x 1 film-coated tablets) EU/1/18/1307/012 (28 film-coated tablets) EU/1/18/1307/013 (56 film-coated tablets) EU/1/18/1307/018 (42 film-coated tablets) EU/1/18/1307/019 (70 film-coated tablets) 
EU/1/18/1307/004 (14 filmom obloženih tableta) EU/1/18/1307/005 (168 filmom obloženih tableta) EU/1/18/1307/006 (28 x 1 filmom obložena tableta) EU/1/18/1307/012 (28 filmom obloženih tableta) EU/1/18/1307/013 (56 filmom obloženih tableta) EU/1/18/1307/018 (42 filmom obložene tablete) EU/1/18/1307/019 (70 filmom obloženih tableta)
Neutropenia 
Doziranje
Verzenios 50 mg film-coated tablets abemaciclib 
Verzenios 50 mg filmom obložene tablete abemaciklib
Verzenios 100 mg film-coated tablets 
Verzenios 100 mg filmom obložene tablete
Warnings and precautions 
Preporuke za zbrinjavanje
Verzenios 50 mg tablets abemaciclib 
NAZIV LIJEKA Verzenios 50 mg tablete abemaciklib
Verzenios 150 mg tablets abemaciclib 
NAZIV LIJEKA Verzenios 150 mg tablete abemaciklib
Verzenios 150 mg film-coated tablets abemaciclib 
Verzenios 150 mg filmom obložene tablete abemaciklib
The primary endpoint was investigator-assessed progression-free survival (PFS) evaluated according to RECIST 1.1; key secondary efficacy endpoints included objective response rate (ORR), clinical benefit rate (CBR) and overall survival (OS). 
Primarna mjera ishoda bilo je preživljenje bez progresije bolesti (engl. progression-free survival, PFS) prema ocjeni ispitivača na temelju verzije 1.1 Kriterija za ocjenu odgovora kod solidnih tumora (engl.
Verzenios 100 mg film-coated tablets abemaciclib 
Verzenios 100 mg filmom obložene tablete abemaciklib
Verzenios 150 mg abemaciclib 
NAZIV LIJEKA Verzenios 150 mg abemaciklib
Verzenios 100 mg tablets abemaciclib 
NAZIV LIJEKA Verzenios 100 mg tablete abemaciklib
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS CALENDAR BLISTER CARD FOR 150 MG FILM-COATED TABLETS 
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP KALENDARSKA BLISTER KARTICA ZA FILMOM OBLOŽENE TABLETE OD 150 MG
Eli Lilly Italia S.p.A. Tel: + 39- 055 42571 
Eli Lilly Hrvatska d.o.o. Tel: +385 1 2350 999
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS CALENDAR BLISTER CARD FOR 50 MG FILM-COATED TABLETS 
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP KALENDARSKA BLISTER KARTICA ZA FILMOM OBLOŽENE TABLETE OD 50 MG
Verzenios 50 mg 
16. PODACI NA BRAILLEOVOM PISMU Verzenios 50 mg
Eli Lilly Nederland B.V. Tel: + 31-(0) 30 60 25 800 
Eli Lilly Ges.m.b.H. Tel: + 43-(0) 1 711 780
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS CALENDAR BLISTER CARD FOR 100 MG FILM-COATED TABLETS 
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP KALENDARSKA BLISTER KARTICA ZA FILMOM OBLOŽENE TABLETE OD 100 MG
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER TO BE USED INSIDE THE CALENDAR BLISTER CARD FOR 150 MG FILMCOATED TABLETS 
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER ULOŽEN U KALENDARSKU BLISTER KARTICU ZA FILMOM OBLOŽENE TABLETE OD 150 MG
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER TO BE USED INSIDE THE CALENDAR BLISTER CARD FOR 50 MG FILMCOATED TABLETS 
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER ULOŽEN U KALENDARSKU BLISTER KARTICU ZA FILMOM OBLOŽENE TABLETE OD 50 MG
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER TO BE USED INSIDE THE CALENDAR BLISTER CARD FOR 100 MG FILMCOATED TABLETS 
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER ULOŽEN U KALENDARSKU BLISTER KARTICU ZA FILMOM OBLOŽENE TABLETE OD 100 MG
Progression-free survival (PFS) was significantly prolonged in the Verzenios plus aromatase inhibitor (AI) arm, (Hazard Ratio [HR] of 0.540 [95% CI, 0.418 to 0.698]); median PFS was 28.18 months in the Verzenios plus AI arm and was 14.76 months in the placebo plus AI arm. 
0,418 - 0,698]); medijan PFS-a iznosio je 28,18 mjeseci u skupini koja je primala Verzenios plus inhibitor aromataze te 14,76 mjeseci u skupini koja je primala placebo plus inhibitor aromataze.
Verzenios 100 mg abemaciclib 
NAZIV LIJEKA Verzenios 100 mg abemaciklib
Very common 
I DOHVATA
Verzenios 50 mg film-coated tablets Each film-coated tablet contains 50 mg abemaciclib. 
KVALITATIVNI I KVANTITATIVNI SASTAV Verzenios 50 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 50 mg abemacikliba.
Please refer to the Summary of Product Characteristics of the endocrine therapy combination partner for the recommended posology. 
Za preporučeno doziranje endokrine terapije koja se primjenjuje u kombinaciji s abemaciklibom vidjeti sažetak opisa svojstava lijeka za tu endokrinu terapiju.
- The active substance is abemaciclib. 
Što Verzenios sadrži - Djelatna tvar je abemaciklib.
Verzenios 50 mg abemaciclib 
NAZIV LIJEKA Verzenios 50 mg abemaciklib
Management recommendations for diarrhoea 
Preporuke za zbrinjavanje proljeva
• Dry mouth 
• suha usta
Package leaflet: Information for the patient Verzenios 50 mg film-coated tablets Verzenios 100 mg film-coated tablets Verzenios 150 mg film-coated tablets abemaciclib This medicine is subject to additional monitoring. 
Verzenios 50 mg filmom obložene tablete Verzenios 100 mg filmom obložene tablete Verzenios 150 mg filmom obložene tablete abemaciklib
Overall survival was not mature at the final PFS analysis (133 events observed across the two arms). 
(133 događaja opažena u obje skupine).
Protect from light. 
Zaštititi od svjetla.
In case of such reactions, appropriate treatment is recommended. 
U slučaju takvih reakcija preporuča se prikladna terapija.
Lot: {number} 
Lot: {broj}
CONTENTS BY WEIGHT, VOLUME OR BY NUMBER OF DOSES 
SADRŽAJ PO TEŽINI, VOLUMENU ILI BROJU DOZA
ATC Vet Code: QI09AA07 
ATCvet kôd: QI09AA07
1348 Louvain-la-Neuve BELGIUM 
1348 Louvain-la-Neuve BELGIJA
10 doses (20 ml) 
10 doza (20 ml)
Sulfolipo-cyclodextrin (SLCD) 
Sulfolipo-ciklodekstrin (SLCD)
Local tissue reactions in the form of swelling at the injection site are very common and may last for up to 26 days. 
Lokalna reakcija tkiva u obliku otekline na mjestu aplikacije je vrlo česta i može trajati do 26 dana.
Interactions with other medicinal products and other forms of interaction: 
Interakcije s drugim medicinskim proizvodima i drugi oblici interakcija:
Overdose (symptoms, emergency procedures, antidotes): 
Predoziranje (simptomi, hitni postupci, antidoti):
a) The administration of the veterinary medicinal product to animals will interfere with the implementation of a national programme for the diagnosis, control or eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals. 
a) će primjena veterinarsko-medicinskog proizvoda na životinjama interferirati s provedbom nacionalnih programa za otkrivanje, kontrolu i iskorjenjivanje bolesti životinja ili će prouzročiti poteškoće u certificiranju odsutnosti zaraze u živih životinja ili hrani ili drugim proizvodima dobivenim od tretiranih životinja.
Avoid stress in the animals before and after the time of vaccination. 
Treba izbjegavati stres u životinja prije i nakon vakcinacije.
Vaccination schedule: 
Program vakcinacije:
Hepes acid 
Hepes kiselina
SPECIAL WARNING(S), IF NECESSARY 
POSEBNA UPOZORENJA, UKOLIKO JE POTREBNO
Pigs (piglets) 
Svinje (prasad)
50 doses 125 doses 
125 doza
Zero days. 
Nula dana.
Pigs (piglets) from 3 weeks of age. 
Svinje (prasad) starije od 3 tjedna života.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. 
Nema dostupnih podataka o neškodljivosti i učinkovitosti ovog cjepiva kada se koristi zajedno sa bilo kojim drugim veterinarsko-medicinskim proizvodom.
Any person intending to manufacture, import, possess, sell, supply and use this veterinary medicinal product must first consult the relevant Member State's competent authority on the current vaccination policies, as these activities may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation. 
Svaka osoba koja namjerava proizvoditi, uvoziti, posjedovati, prodavati, opskrbljivati i koristiti ovaj veterinarsko-medicinski proizvod mora prethodno konzultirati nadležno tijelo odnosne države članice u pogledu važećih odredbi o cijepljenju, jer te aktivnosti mogu biti zabranjene u državi članici, u cijelosti ili samo na djelu njezinog teritorija, u skladu s nacionalnim zakonodavstvom.
EU/2/09/099/001-006 
ODOBRENJA ZA STAVLJANJE U PROMET EU/2/09/099/001-006
Store and transport refrigerated (2 °C - 8 °C). 
Čuvati i prevoziti na hladnom (2 ⁰C - 8 ⁰C).
Shelf life after first opening the immediate packaging: use immediately. 
Rok valjanosti nakon prvog otvaranja unutarnjeg pakiranja: iskoristiti odmah.
Zoetis Manufacturing & Research Spain, S.L. 
Zoetis Manufacturing & Research Spain, S.L. Ctra.
According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of its territory if it is established that: 
Sukladno članku 71. Direktive 2001/82/EK i Europskog Parlamenta i Vijeća koja je dopunjena, države članice zabranjuju ili mogu zabraniti uvoz, prodaju, opskrbu i/ili primjenu veterinarsko-medicinskog proizvoda na cijelom ili na dijelu svog teritorija ako je utvrđeno da:
The area of local tissue reactions is in general below 5 cm in diameter, but in some cases a larger swelling may occur. 
Površina reakcije je uglavnom do 5 cm u promjeru iako u nekim slučajevima može biti i veća.
Vaccinate only healthy animals. 
Cijepiti samo zdrave životinje.
Use vaccination devices according to the manufacturer's instructions. 
Koristite automatske aplikatore u skladu s uputama proizvođača.
Date of first authorisation: 24/07/2009 Date of last renewal: 06/06/2014 
Datum zadnje obnove: 06/06/2014
EXP {month/year} Once broached use immediately. 
ROK VALJANOSTI EXP {mjesec/godina} Jednom otvorenu bočicu odmah upotrijebiti.
These clinical signs normally resolve without treatment. 
Navedeni klinički znaci najčešće prolaze bez dodatne terapije.
Minimum Essential Medium without phenol red Sodium bicarbonate 
Minimalni esencijalni medij bez fenol crvene
The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product. 
Pomoćne tvari (uključujući adjuvanse), navedene u dijelu 6.1 SPC su ili dozvoljene tvari za koje je u tablici 1. Dodataka Uredbe Komisije (EU) br. 37/2010 naznačeno da određivanje MRL nije nužno, ili se smatra da se na njih ne primjenjuju odredbe Uredbe (EK) br. 470/2009 kada se primjenjuju u tim veterinarsko-medicinskim proizvodima.
0.1 mg * Relative Potency unit determined by ELISA antigen quantification (in vitro potency test) compared to a reference vaccine. 
*Jedinica relativne potencije određena ELISA određivanjem količine antigena (in vitro test potencije)
Do not mix with any other veterinary medicinal product. 
Ne miješati s bilo kojim drugim veterinarsko-medicinskim proizvodom.
Special warnings for each target species: 
Posebna upozorenja za svaku od ciljnih vrsta životinja:
The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009. 
Djelatna tvar se sastoji od tvari biološkog podrijetla, koje su namijenjene za stvaranje aktivne imunosti i na koje se ne primjenjuju odredbe Uredbe (EK) br. 470/2009.