natgillin/translations-raw huggingface dataset:
You should also take calcium and vitamin D supplements while being treated with XGEVA unless you have an excess of calcium in the blood. 
D tijekom liječenja lijekom XGEVA osim ako imate višak kalcija u krvi.
The solution may contain trace amounts of translucent to white proteinaceous particles. 
Otopina može sadržavati tragove prozirnih do bijelih proteinskih čestica.
The recommended dose of XGEVA is 120 mg administered once every 4 weeks, as a single injection under the skin (subcutaneous). 
Preporučena doza lijeka XGEVA je 120 mg primijenjeno svaka 4 tjedna u obliku jedne injekcije pod kožu (potkožno).
A dental examination with preventive dentistry and an individual benefit-risk assessment is recommended prior to treatment with denosumab. 
Prije liječenja denosumabom preporuča se obaviti stomatološki pregled s preventivnim stomatološkim liječenjem i individualnu procjenu koristi i rizika.
The patient-year adjusted overall incidence (number of events per 100 patient years) of confirmed ONJ was 1.1% during the first year of treatment, 3.7% in the second year and 4.6% per year thereafter. 
Sveukupna prilagođena incidencija prema bolesnik-godini (broj događaja na 100 bolesnik-godina) za potvrđenu ONČ iznosila je 1,1% tijekom prve godine liječenja, 3,7% u drugoj godini i 4,6% po godini nakon toga.
XGEVA is not recommended in paediatric patients (age < 18) other than skeletally mature adolescents with giant cell tumour of bone (see section 4.4). 
Ne preporučuje se primjena lijeka XGEVA u pedijatrijskih bolesnika (u dobi < 18) osim kod koštano sazrelih adolescenata s gigantocelularnim tumorom kosti (vidjeti dio 4.4).
In two phase II single-arm clinical trials in patients with giant cell tumour of bone, ONJ occurred in 2.3% (12 of 523) of patients treated with XGEVA (median overall exposure of 20.3 months; range: 0 - 83.4). 
U dva klinička ispitivanja faze II na jednoj skupini bolesnika s gigantocelularnim tumorom kosti, ONČ se pojavila u 2,3% (12 od 523) bolesnika liječenih lijekom XGEVA (medijan ukupne izloženosti od 20,3 mjeseca, raspon: 0 - 83,4).
Unusual thigh bone fractures 
Neuobičajeni prijelomi bedrene kosti
In subjects with giant cell tumour of bone who received 120 mg every 4 weeks with a loading dose on days 8 and 15, steady-state levels were achieved within the first month of treatment. 
U ispitanika s gigantocelularnim tumorom kosti koji su primali 120 mg svaka 4 tjedna, s udarnom dozom 8. i 15. dana, razine stanja dinamičke ravnoteže postignute su unutar prvog mjeseca liječenja.
It may contain trace amounts of clear to white particles. 
Može sadržavati prozirne do bijele čestice u tragovima.
Adverse reactions reported in patients with advanced malignancies involving bone, multiple myeloma, or with giant cell tumour of bone MedDRA system organ class Frequency category 
Tablica 1. Nuspojave zabilježene u bolesnika s uznapredovalim malignim bolestima koje zahvaćaju kosti, s multiplim mijelomom ili s gigantocelularnim tumorom kosti MedDRA klasifikacija organskih sustava
Clinical efficacy and safety in patients with bone metastases from solid tumours 
Klinička djelotvornost i sigurnost u bolesnika s koštanim metastazama solidnih tumora
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1.7 mL 
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA
Hypocalcaemia was reported in 16.9% of patients treated with XGEVA and 12.4% of patients treated with zoledronic acid. 
Hipokalcijemija je prijavljena u 16,9% bolesnika koji su primali lijek XGEVA i u 12,4% bolesnika koji su primali zoledronatnu kiselinu.
71.6% (95% CI: 64.6, 77.9) of patients (table 4) assessed by any of the modalities, with the majority of responses defined by a reduction in fluorodeoxyglucose PET activity or increase in density measured in CT/HU, only 25.1% of the patients had a response per RECIST. 
Sveukupno, lijek XGEVA je postigao objektivni odgovor u liječenju tumora kod 71,6% (95% CI: 64,6; 77,9) bolesnika (tablica 4) procijenjen na jedan od nekoliko načina, a najviše odgovora je definirano kroz smanjenje aktivnosti fluorodeoksiglukoze mjerene PET-om ili kroz povećanje izmjerene gustoće na CT/HU, a samo je 25,1% bolesnika imalo odgovor prema Kriterijima za procjenu terapijskog odgovora kod solidnih tumora (engl.
The pharmacokinetics of denosumab is not expected to be affected by hepatic impairment. 
Ne očekuje se da bi oštećenje jetre utjecalo na farmakokinetiku denosumaba.
Hypercalcaemia following treatment discontinuation in patients with giant cell tumour of bone and in patients with growing skeletons 
Hiperkalcijemija nakon prekida liječenja u bolesnika s gigantocelularnim tumorom kosti i bolesnika sa skeletom u razdoblju rasta
Accompanying increases in parathyroid hormone have also been observed in patients receiving XGEVA with severe renal impairment or receiving dialysis. 
Također je primijećen porast razine paratiroidnog hormona kod bolesnika s teškim oštećenjem funkcije bubrega ili koji su na dijalizi i koji su primali lijek XGEVA.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION XGEVA 120 mg injection denosumab 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA XGEVA 120 mg injekcija denosumab s.c.
Giant cell tumour of bone 
Gigantocelularni tumor kosti
Osteonecrosis of the jaw (ONJ) 
Osteonekroza čeljusti (ONČ)
In Study 6, XGEVA has been evaluated in a subset of 18 adolescent patients (aged 13-17 years) with giant cell tumour of bone who had reached skeletal maturity defined by at least 1 mature long bone (e.g. closed epiphyseal growth plate of the humerus) and body weight ≥ 45 kg. An objective response was observed for four of six evaluable adolescents in an interim analysis of Study 6. 
6 na podskupini od 18 adolescentnih bolesnika (13-17 godina starosti) s gigantocelularnim tumorom kosti, a koji su dosegli zrelost koštanog sustava što je definirano s barem jednom zrelom dugom kosti (primjerice zatvorena epifizna ploča rasta humerusa) i tjelesnom težinom ≥ 45 kg.
There is no need for renal monitoring with XGEVA dosing. 
Nije potrebno pratiti funkciju bubrega prilikom doziranja lijeka XGEVA.
In the double-blind treatment phase of this trial, ONJ was confirmed in 5.9% of patients treated with XGEVA (median exposure of 19.4 months; range 1 52) and in 3.2% of patients treated with zoledronic acid. 
U dvostruko slijepoj fazi liječenja u ovom ispitivanju, ONČ je potvrđena u 5,9% bolesnika liječenih lijekom XGEVA (medijan izloženosti od 19,4 mjeseci; raspon: 1 - 52) i u 3,2% bolesnika liječenih zoledronatnom kiselinom.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 120 mg of denosumab in 1.7 mL of solution (70 mg/mL). 
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna bočica sadrži 120 mg denosumaba u 1,7 ml otopine (70 mg/ml).
In a clinical study of patients without advanced cancer with severe renal impairment (creatinine clearance < 30 mL/min) or receiving dialysis, there was a greater risk of developing hypocalcaemia in the absence of calcium supplementation. 
U kliničkom ispitivanju kod bolesnika koji nisu bolovali od uznapredovalog raka, a imali su teško oštećenje bubrega (klirens kreatinina < 30 ml/min) ili su bili na dijalizi, postojao je povećan rizik za razvoj hipokalcijemije ako nije primijenjen nadomjestak kalcija.
The safety and efficacy of XGEVA was studied in two phase II open-label, single-arm trials (studies 5 and 6) that enrolled 529 patients with giant cell tumour of bone that was either unresectable or for which surgery would be associated with severe morbidity. 
Sigurnost i djelotvornost lijeka XGEVA ispitana je u dva otvorena klinička ispitivanja faze II na jednoj skupini bolesnika (ispitivanja 5 i 6) koja su uključila 529 bolesnika s gigantocelularnim
XGEVA was studied in an open-label trial that enrolled 18 skeletally mature adolescents with giant cell tumour of bone. 
Provedeno je otvoreno ispitivanje lijeka XGEVA na 18 koštano sazrelih adolescenata s gigantocelularnim tumorom kosti.
What XGEVA contains 
XGEVA sadrži natrij
Patients with prior history of ONJ or osteomyelitis of the jaw, an active dental or jaw condition requiring oral surgery, non-healed dental/oral surgery, or any planned invasive dental procedure, were not eligible for inclusion in these studies. 
Bolesnici s anamnezom ONČ-a ili osteomijelitisa čeljusti, s aktivnom bolešću zubi ili čeljusti koja zahtijeva oralnu operaciju, oni s nezacijeljenom stomatološkom/oralnom operacijom ili koji planiraju invazivne stomatološke zahvate nisu bili prikladni za uključivanje u ova ispitivanja.
In the primary double blind treatment phases of four phase III active-controlled clinical trials in patients with advanced malignancies involving bone, new primary malignancy was reported in 54/3691 (1.5%) of patients treated with XGEVA (median exposure of 13.8 months; range: 1.0-51.7) and 33/3688 (0.9%) of patients treated with zoledronic acid (median exposure of 12.9 months; range: 
U primarnim dvostruko slijepim fazama liječenja u četiri aktivno kontrolirana klinička ispitivanja faze III u bolesnika s uznapredovalim malignim bolestima koje zahvaćaju kosti nova primarna maligna bolest prijavljena je u 54 od 3691 (1,5%) bolesnika koji su primali lijek XGEVA (medijan izloženosti od 13,8 mjeseci, raspon: 1,0 - 51,7) i u 33 od 3688 (0,9%) bolesnika koji su primali zoledronatnu kiselinu (medijan izloženosti od 12,9 mjeseci, raspon: 1,0 - 50,8).
You may have low levels of calcium in your blood. 
Možda Vam je razina kalcija u krvi snižena.
The use of XGEVA has not been studied in children and adolescents with other cancers that have spread to bone. 
Primjena lijeka XGEVA u djece i adolescenata koji boluju od drugih oblika raka koji su se proširili na kosti nije ispitana.
First SRE Median time (months) 
Prvi SRE Medijan vremena (mjeseci)
Each vial contains 120 mg of denosumab in 1.7 mL of solution (corresponding to 70 mg/mL). 
Jedna bočica sadrži 120 mg denosumaba u 1,7 ml otopine (što odgovara 70 mg/ml).
MARKETING AUTHORISATION NUMBER(S) EU/1/11/703/001 1 single use vial EU/1/11/703/002 4 single use vials EU/1/11/703/003 3 single use vials 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/11/703/001 1 bočica za jednokratnu upotrebu
Lichenoid drug eruptions (e.g. lichen planus-like reactions), have been reported in patients in the postmarketing setting. 
Izbijanje lihenoidnih kožnih promjena uzrokovano lijekom Izbijanje lihenoidnih kožnih promjena uzrokovano lijekom (npr. reakcije nalik na lihen planus) prijavljeno je u bolesnika nakon stavljanja lijeka u promet.
The highest incidence of ONJ was observed in a phase III trial in patients with multiple myeloma. 
Najveća incidencija ONČ opažena je u kliničkom ispitivanju faze III u bolesnika s multiplim mijelomom.
NAME OF THE MEDICINAL PRODUCT XGEVA 120 mg solution for injection 
NAZIV LIJEKA XGEVA 120 mg otopina za injekciju
In the primary treatment phases of three phase III active-controlled clinical trials in patients with advanced malignancies involving bone, ONJ was confirmed in 1.8% of patients treated with XGEVA (median exposure of 12.0 months; range: 0.1 - 40.5) and 1.3% of patients treated with zoledronic acid. 
U primarnim fazama liječenja u tri aktivno kontrolirana klinička ispitivanja faze III u bolesnika s uznapredovanim malignim bolestima koje zahvaćaju kosti, ONČ je potvrđena u 1,8% bolesnika koji su primali lijek XGEVA (medijan izloženosti od 12,0 mjeseci, raspon: 0,1 - 40,5) i u 1,3% bolesnika koji su primali zoledronatnu kiselinu.
Hypercalcaemia following treatment discontinuation in patients with giant cell tumour of bone3 
Hiperkalcijemija nakon prekida liječenja u bolesnika s gigantocelularnim tumorom kosti3
High calcium levels in the blood after stopping treatment with XGEVA Some patients with giant cell tumour of the bone have developed high calcium levels in the blood weeks to months after stopping treatment. 
Kod nekih bolesnika s gigantocelularnim tumorom kosti dolazi do razvoja visokih razina kalcija u krvi tjednima do mjesecima nakon prekida liječenja.
In studies 1, 2 and 3, overall survival was balanced between XGEVA and zoledronic acid in patients with advanced malignancies involving bone: patients with breast cancer (hazard ratio and 95% CI was 0.95 [0.81, 1.11]), patients with prostate cancer (hazard ratio and 95% CI was 1.03 [0.91, 1.17]), and patients with other solid tumours or multiple myeloma (hazard ratio and 95% CI was 0.95 [0.83, 1.08]). 
U ispitivanjima 1, 2 i 3 ukupno preživljenje bilo je podjednako kod lijeka XGEVA i zoledronatne kiseline u bolesnika s uznapredovalim malignim bolestima koje zahvaćaju kosti: bolesnika s rakom dojke (omjer hazarda i 95% CI je bio 0,95 [0,81; 1,11]), bolesnika s rakom prostate (omjer hazarda i 95% CI je bio 1,03 [0,91; 1,17]), i bolesnika s drugim solidnim tumorima ili multiplim mijelomom (omjer hazarda i 95% CI je bio 0,95 [0,83; 1,08]).
A grade 4 decrease in serum calcium levels was experienced in 0.6% of patients treated with XGEVA and 0.2% of patients treated with zoledronic acid (see section 4.4). 
Smanjenje razina kalcija u serumu stupnja 4 primijećeno je u 0,6% bolesnika liječenih lijekom XGEVA i u 0,2% bolesnika liječenih zoledronatnom kiselinom (vidjeti dio 4.4).
Supplementation with calcium and vitamin D is required in all patients unless hypercalcaemia is present (see section 4.2). 
D potrebni su u svih bolesnika osim u slučajevima hiperkalcijemije (vidjeti dio 4.2).
There are no or limited amount of data from the use of denosumab in pregnant women. 
Nema podataka o primjeni denosumaba u trudnica ili su podaci ograničeni.
Rare side effects (may affect up to 1 in 1,000 people): 
Rijetke nuspojave (mogu se pojaviti u do 1 na 1000 osoba):
It is important to tell your doctor if you are breast-feeding or plan to do so. 
Obavijestite svog liječnika ako dojite ili planirate dojiti.
New primary malignancy1 
Nova primarna maligna bolest1
Patients with prior history of ONJ or osteomyelitis of the jaw, an active dental or jaw condition requiring oral surgery, non-healed dental/oral surgery, or any planned invasive dental procedure were excluded from the clinical trials. 
Bolesnici s anamnezom ONČ-a ili osteomijelitisa čeljusti, s aktivnom bolešću zubi ili čeljusti koja zahtjeva operaciju, koji se nisu oporavili nakon operacije zubi ili u usnoj šupljini ili s planiranim invazivnim zahvatima na zubima, bili su izuzeti iz kliničkih ispitivanja.
First and subsequent SRE* Mean number/patient Rate ratio (95% CI) / 
Prvi i sljedeći SRE* Prosječan broj/bolesnik Omjer stopa (95% CI) / RRR (%) p-vrijednost za superiornost SSM po godini
A higher incidence of hypocalcaemia among subjects treated with denosumab compared to zoledronic acid has been observed in SRE prevention clinical trials. 
Opažena je veća incidencija hipokalcijemije u skupini ispitanika koji su primali denosumab nego u ispitanika koji su primali zoledronatnu kiselinu u kliničkim ispitivanjima prevencije koštanih događaja.
STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 120 mg of denosumab in 1.7 mL of solution (70 mg/mL). 
NAVOĐENJE DJELATNE(IH) TVARI Jedna bočica sadrži 120 mg denosumaba u 1,7 ml otopine (70 mg/ml).
Denosumab 120 mg Q4W Zoledronic Acid 4 mg Q4W 
Denosumab 120 mg svaka 4 tjedna Zoledronatna kiselina 4 mg svaka 4 tjedna
• To avoid discomfort at the site of injection, allow the vial to reach room temperature (up to 
• Kako bi se izbjegao neugodan osjećaj na mjestu injekcije, ostavite bočicu da postigne sobnu temperaturu (do 25°C) prije injiciranja te injicirajte polagano.
Based on duration of exposure, there are insufficient data in giant cell tumour of bone patients to assess risk of ONJ beyond 2 years. 
Nema dovoljno podataka za procjenu rizika od ONČ kod bolesnika s gigantocelularnim tumorom kosti nakon 2 godine na temelju trajanja izloženosti.
- if you are allergic to denosumab or any of the other ingredients of this medicine (listed in section 6). 
Što morate znati prije nego počnete primjenjivati lijek XGEVA Nemojte primjenjivati lijek XGEVA: - ako ste alergični na denosumab ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
XGEVA is not recommended for use if you are pregnant. 
Ne preporučuje se korištenje lijeka XGEVA u trudnoći.
A grade 3 decrease in serum calcium levels was experienced in 2.5% of patients treated with XGEVA and 1.2% of patients treated with zoledronic acid. 
Smanjenje razina kalcija u serumu stupnja 3 primijećeno je u 2,5% bolesnika liječenih lijekom XGEVA i u 1,2% bolesnika liječenih zoledronatnom kiselinom.
• persistent pain in the mouth and/or jaw, and/or swelling or non-healing of sores in the mouth or jaw, discharge, numbness or feeling of heaviness in the jaw, or loosening of a tooth could be signs of bone damage in the jaw (osteonecrosis). 
• trajna bol u ustima i/ili čeljusti, i/ili oticanje ili nezarastanje rana u ustima ili čeljusti, iscjedak,
Supplementation of at least 500 mg calcium and 400 IU vitamin D daily is required in all patients, unless hypercalcaemia is present (see section 4.4). 
D dnevno nužan je u svih bolesnika, osim u slučaju prisutne hiperkalcijemije (vidjeti dio 4.4).
Objective treatment response in patients with giant cell tumour of bone 
Tablica 4. Objektivni terapijski odgovor u bolesnika s gigantocelularnim tumorom kosti Broj bolesnika procjenjivih na odgovor
Density/Size4 
Gustoća/veličina4
A higher incidence of ONJ among subjects treated with denosumab compared to zoledronic acid has been observed in SRE prevention clinical trials. 
Opažena je veća incidencija ONČ u skupini ispitanika koji su primali denosumab nego u ispitanika koji su primali zoledronatnu kiselinu u kliničkim ispitivanjima prevencije koštanih događaja.
In the post-marketing setting, events of hypersensitivity, including rare events of anaphylactic reactions, have been reported in patients receiving XGEVA. 
Nakon stavljanja lijeka u promet u bolesnika koji primaju lijek XGEVA zabilježeni su slučajevi preosjetljivosti, uključujući rijetke slučajeve anafilaktičkih reakcija.
• diarrhoea. 
• proljev.
A grade 3 decrease in serum calcium levels was experienced in 1.4% of patients treated with XGEVA and 0.6% of patients treated with zoledronic acid. 
Smanjenje razina kalcija u serumu stupnja 3 primijećeno je u 1,4% bolesnika liječenih lijekom XGEVA i u 0,6% bolesnika liječenih zoledronatnom kiselinom.
A grade 4 decrease in serum calcium levels was experienced in 0.4% of patients treated with XGEVA and 0.1% of patients treated with zoledronic acid. 
Smanjenje razina kalcija u serumu stupnja 4 primijećeno je u 0,4% bolesnika liječenih lijekom XGEVA i u 0,1% bolesnika liječenih zoledronatnom kiselinom.
Efficacy results in patients with advanced malignancies involving bone Study 1 breast cancer 
Tablica 2. Rezultati djelotvornosti u bolesnika s uznapredovalim malignim bolestima koje zahvaćaju kosti
Efficacy and safety of 120 mg XGEVA SC every 4 weeks or 4 mg zoledronic acid (dose-adjusted for reduced renal function) IV every 4 weeks were compared in three randomised, double-blind, 
Dmab = Denosumab 120 mg svaka 4 tjedna ZA = Zoledronatna kiselina 4 mg svaka 4 tjedna N = Broj randomiziranih ispitanika * = Statistički značajno za superiornost, ** = Statistički značajno za ne-inferiornost
Drug hypersensitivity1 
Preosjetljivost na lijek1
active-controlled studies, in IV-bisphosphonate naïve patients with advanced malignancies involving bone: adults with breast cancer (study 1), other solid tumours or multiple myeloma (study 2), and castrate-resistant prostate cancer (study 3). 
Djelotvornost i sigurnost 120 mg lijeka XGEVA primijenjenog s.c. svaka 4 tjedna ili 4 mg zoledronatne kiseline (doza prilagođena za smanjenu funkciju bubrega) primijenjene i.v. svaka 4 tjedna uspoređene su u tri randomizirana, dvostruko slijepa, aktivno kontrolirana ispitivanja u bolesnika koji do tada nisu primali intravenski bisfosfonat, s uznapredovalim malignim bolestima koje zahvaćaju kosti: odrasli s rakom dojke (ispitivanje 1), drugim solidnim tumorima ili multiplim mijelomom (ispitivanje 2) i rakom prostate rezistentnim na kastraciju (ispitivanje 3).
NR NR NR NR NR 28.6 
NP NP NP NP NP 28,6
Water for injections * Acetate buffer is formed by mixing acetic acid with sodium hydroxide 
6.1 Popis pomoćnih tvari acetatna kiselina, ledena* natrijev hidroksid (za podešavanje pH)* sorbitol (E420) polisorbat 20 voda za injekcije * acetatni pufer dobiva se miješanjem acetatne kiseline s natrijevim hidroksidom
Protect from light. 
Zaštićeno od svjetlosti.
Date of last renewal: 10/06/2015 
Datum zadnjeg produženja: 10/06/2015
The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) 470/2009. 
Djelatne tvari kao načelo biološkog podrijetla namijenjene za proizvodnju aktivnog imuniteta nisu u okviru regulativa (EC) 470/2009.
PACKAGE SIZE 10 x 1 dose 
VELIČINA PAKOVANJA 10 x 1 doza
CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES 
SADRŽAJ: TEŽINA, VOLUMEN ILI BROJ DOZA
Interaction with other medicinal products and other forms of interaction: 
Interakcija sa drugim medicinskim proizvodima i drugi oblici interakcije:
Store in a refrigerator. 
Čuvati u hladnjaku
Thereafter a maximum interval of two years is recommended (see scheme). 
Nakon toga preporuča se maksimalno period od 2 godine do sljedećeg cijepljenja (vidi skicu).
Keep out of the sight and reach of children. 
Čuvati izvan pogleda i dosega i djece.
The excipients (including adjuvants) 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 navedene u dijelu 6.1 SPC su ili dozvoljene tvari za koje je u tablici 1, Dodatka 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.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 08/07/2005 
Datum prvog odobrenja za stavljanje u promet: 08/07/2005
Incompatibilities: Do not mix with any other veterinary medicinal product. 
Inkompatibilnost: Ne miješati sa drugim veterinarsko-medicinskim proizvodima.
Store in a refrigerator (2 °C - 8 °C). 
Čuvati u hladnjaku (2°C-8 °C),
In very rare cases a local reaction exceeding 5 cm and possibly persisting longer than 2 days may occur. 
U vrlo rijetkim slučajevima može se javiti lokalna reakcija koja prelazi 5 cm i može trajati duže od 2 dana.
THE WORDS "FOR ANIMAL TREATMENT ONLY" AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE 
13. RIJEČI “SAMO ZA LIJEČENJE ŽIVOTINJA” I UVETI ILI OGRANIČENJA U POGLEDU OPSKRBE I PRIMJENE, AKO JE PRIMJENJIVO
Equilis Te [a clear pictogram of a horse] 
Equilis Te [piktogram konja]
This will lead to a passive protection against tetanus for at least 21 days after concurrent administration. 
To će dovesti do pasivne zaštite protiv tetanusa kroz najmanje 21 dana nakon pravilne upotrebe.
Ask your veterinary surgeon how to dispose of medicines no longer required. 
Pitajkte vašeg veterinara kako odlagati lijekove koji više nisu u upotrebi.
Following the administration of a double dose of vaccine, no side effects other than those described under section 4.6 have been observed except for some depression at the day of vaccination. 
Nakon administracije dvostrukih doza cjepiva, nema nikakvih drugih nuspojava osim onih koje su opisane u poglavlju 4.6., osim moguće utučenosti do kojih dođe na dan cijepljenja.
24 months after the first revaccination 
24 mjeseca nakon prvog docjepljivanja
To stimulate active immunity against tetanus. 
Poticanje aktivnog imuniteta protiv tetanusa
Only healthy animals should be vaccinated. 
Samo zdrave životinje mogu biti cijepljenje.
Package size: 
Veličina pakiranja:
Administer 1 ml of vaccine intramuscularly. 
Upotrijebiti 1ml cjepiva intramuskularno.
Do not use this veterinary medicinal product after the expiry date which is stated on the label. 
Ne koristiti ovaj veterinarsko medicinski proizvod poslije isteka roka valjanosti naznačenog na etiketi.