natgillin/translations-raw huggingface dataset:
In a 52-week double-blind controlled trial, vildagliptin (50 mg twice daily) reduced baseline HbA1c by -1% compared to -1.6% for metformin (titrated to 2 g/day) statistical non-inferiority was not achieved. 
U dvostruko slijepom kontroliranom ispitivanju u trajanju od 52 tjedna, vildagliptin (50 mg dvaput na dan) je smanjio početnu HbA1c vrijednost za -1% u usporedbi s -1,6% kod metformina (titriranog do 2 g/dan), pri čemu statistička ne-inferiornost nije postignuta.
2,682 patients were treated with vildagliptin 100 mg daily (either 50 mg twice daily or 100 mg once daily) and 1,102 patients were treated with vildagliptin 50 mg once daily. 
2682 bolesnika liječena su vildagliptinom u dozi od 100 mg na dan (ili 50 mg dvaput na dan ili 100 mg jedanput na dan), a 1102 bolesnika liječena su vildagliptinom u dozi od 50 mg jedanput na dan.
Table 7 Post-marketing adverse reactions 
Tablica 7 Nuspojave nakon stavljanja lijeka u promet
In another 24-week study in patients with more advanced type 2 diabetes not adequately controlled on insulin (short and longer acting, average insulin dose 80 IU/day), the mean reduction in HbA1c when vildagliptin (50 mg twice daily) was added to insulin was statistically significantly greater than with placebo plus insulin (0.5% vs. 0.2%). 
U drugom 24-tjednom ispitivanju s bolesnicima s uznapredovalom šećernom bolešću tipa 2 u kojih terapijom inzulinom nije postignuta odgovarajuća kontrola (prosječna doza inzulina kratkog ili dugog djelovanja 80 IU/dan), srednje sniženje HbA1c kad je vildagliptin (50 mg dvaput na dan) bio pridodan inzulinu bilo je statistički značajno veće nego kad je inzulinu bio pridodan placebo (0,5% u odnosu na 0,2%).
In data from controlled monotherapy and add-on therapy trials of up to 24 weeks in duration, the incidence of ALT or AST elevations  3x ULN (classified as present on at least 2 consecutive measurements or at the final on-treatment visit) was 0.2%, 0.3% and 0.2% for vildagliptin 50 mg once daily, vildagliptin 50 mg twice daily and all comparators, respectively. 
U podacima iz kontroliranih ispitivanja monoterapije i ispitivanja lijeka kao dodatne terapije u trajanju do 24 tjedna incidencija povećanja ALT-a ili AST-a 3x GGN (klasificirano kao prisutnost u najmanje 2 uzastopna mjerenja ili na završnoj posjeti tijekom liječenja) bila je 0,2% za 50 mg vildagliptina jedanput dnevno, 0,3% za 50 mg vildagliptina dvaput dnevno i 0,2% za sve lijekove usporedbe.
In controlled clinical trials with the combination of vildagliptin 50 mg + a sulphonylurea, the overall incidence of withdrawals due to adverse reactions was 0.6% in the vildagliptin 50 mg + sulphonylurea vs 0% in the placebo + sulphonylurea treatment group. 
U kontroliranim kliničkim ispitivanjima s kombinacijom 50 mg vildagliptina i sulfonilureje, ukupna incidencija povlačenja iz ispitivanja zbog nuspojava je bila 0,6% u skupini liječenoj sa 50 mg vildagliptina uz sulfonilureju, u odnosu na 0% u skupini placeba uz sulfonilureju.
Reporting suspected adverse reactions after authorisation of the medicinal product is important. 
Nakon dobivanja odobrenja lijeka, važno je za prijavljivanje sumnji na njegove nuspojave.
Combination with a thiazolidinedione 
Kombinacija s tiazolidindionom
Vildagliptin AUC increased on average 1.4, 1.7 and 2-fold in patients with mild, moderate and severe renal impairment, respectively, compared to normal healthy subjects. 
AUC vildagliptina povećao se u prosjeku 1,4; 1,7 odnosno 2 puta u bolesnika s blagim, umjerenim odnosno teškim oštećenjem bubrega, u usporedbi s normalnim zdravim ispitanicima.
In addition, in controlled monotherapy trials with vildagliptin the overall incidence of withdrawals due to adverse reactions was no greater for patients treated with vildagliptin at doses of 100 mg daily (0.3%) than for placebo (0.6%) or comparators (0.5%). 
Osim toga, u kontroliranim kliničkim ispitivanjima monoterapije vildagliptinom ukupna incidencija povlačenja iz ispitivanja zbog nuspojava nije bila veća u bolesnika koji su liječeni vildagliptinom u dozama od 100 mg na dan (0,3%), u odnosu na bolesnike koji su primali placebo (0,6%) ili lijekove usporedbe (0,5%).
In a 24-week double-blind controlled trial, vildagliptin (50 mg twice daily) was compared to rosiglitazone (8 mg once daily). 
U dvostruko slijepom kontroliranom ispitivanju u trajanju od 24 tjedna, vildagliptin (50 mg dvaput na dan) je uspoređivan s roziglitazonom (8 mg jedanput na dan).
Mean change from baseline in HbA1c (%) at week 24 
Srednja promjena od početne vrijednosti za HbA1c (%) u 24. tjednu
No dose adjustment is required in patients with mild renal impairment (creatinine clearance ≥ 50 ml/min). 
U bolesnika s blagim oštećenjem bubrega (klirens kreatinina ≥50 ml/min) nije potrebno prilagođavati dozu.
Vildagliptin significantly decreased HbA1c compared with placebo (difference of 0.6%) from a mean baseline of 7.8% at week 16. 
Vildagliptin je značajno smanjio HbA1c u usporedbi s placebom (razlika 0,6%) od srednje početne vrijednosti od 7,8% nakon 16 tjedana.
Patients receiving rosiglitazone experienced a mean increase in weight (+1.6 kg) while those receiving vildagliptin experienced no weight gain (-0.3 kg). 
U bolesnika koji su primali roziglitazon došlo je do povećanja srednje vrijednosti tjelesne težine (+1,6 kg), dok oni koji su primali vildagliptin nisu dobili na tjelesnoj težini (-0,3 kg).
After two years, mean reduction in HbA1c was -0.5% for vildagliptin and -0.6% for gliclazide, from a mean baseline HBA1c of 8.6%. 
Nakon dvije godine, srednje sniženje HbA1c bilo je -0,5% za vildagliptin i -0,6% za gliklazid, uz srednju početnu vrijednost HbA1c od 8,6%.
A test to determine your liver function will be performed before the start of Jalra treatment, at threemonth intervals for the first year and periodically thereafter. 
Testovi jetrene funkcije će se napraviti prije početka liječenja Jalrom, potom tijekom prve godine u razmacima od tri mjeseca te poslije toga periodički.
The incidence of peripheral oedema when vildagliptin 100 mg daily was added to a maximum dose of background pioglitazone (45 mg once daily) was 7.0%, compared to 2.5% for background pioglitazone alone. 
Incidencija perifernog edema bila je 7,0% kada je 100 mg vildagliptina na dan dodavano maksimalnoj dozi osnovne terapije pioglitazonom (45 mg jedanput na dan), u odnosu na 2,5% za samo osnovnu terapiju pioglitazonom.
In clinical trials, the incidence of hypoglycaemia was uncommon in patients receiving vildagliptin + pioglitazone (0.6%) but common in patients receiving placebo + pioglitazone (1.9%). 
U kliničkim je ispitivanjima incidencija hipoglikemije bila manje česta u bolesnika koji su primali vildagliptin + pioglitazon (0,6%), ali je bila česta u bolesnika koji su primali placebo + pioglitazon (1,9%).
Combination with metformin and a sulphonylurea 
Kombinacija s metforminom i sulfonilurejom
A 52-week multi-centre, randomised, double-blind trial was conducted in patients with type 2 diabetes and congestive heart failure (NYHA functional class I-III) to evaluate the effect of vildagliptin 50 mg twice daily (N=128) compared to placebo (N=126) on left-ventricular ejection fraction (LVEF). 
Multicentrično, randomizirano, dvostruko slijepo ispitivanje u trajanju od 52 tjedna provedeno je u bolesnika sa šećernom bolešću tipa 2 i kongestivnim zatajenjem srca (NYHA funkcionalna klasa I-III) da bi se ocijenio učinak vildagliptina 50 mg dvaput na dan (N=128) u usporedbi s placebom (N=126) na ejekcijsku frakciju lijeve klijetke (eng. left-ventricular ejection fraction, LVEF).
Jalra is used to treat adult patients with type 2 diabetes. 
Jalra se primjenjuje za liječenje bolesnika sa šećernom bolešću tipa
Jalra should not be used in patients with hepatic impairment, including patients with pre-treatment ALT or AST > 3x ULN (see also sections 4.2 and 5.2). 
Jalra se ne smije primjenjivati u bolesnika s oštećenjem funkcije jetre, uključujući bolesnike u kojih su ALT ili AST prije početka liječenja bili >3x vrijednosti GGN (vidjeti također dijelove 4.2 i 5.2).
DPP-4 inhibition by vildagliptin is not affected by age. 
Dob ne utječe na inhibiciju DPP-4 vildagliptinom.
The incidence of peripheral oedema was lower in the vildagliptin group than in the rosiglitazone group (2.1% vs. 4.1% respectively). 
Incidencija perifernog edema bila je niža u skupini koja je primala vildagliptin, nego u skupini koja je primala roziglitazon (2,1%, u odnosu na 4,1%).
Aluminium/Aluminium (PA/Al/PVC//Al) blister Available in packs containing 7, 14, 28, 30, 56, 60, 90, 112, 180 or 336 tablets and in multipacks containing 336 (3 packs of 112) tablets. 
Dostupno u pakiranjima koja sadrže 7, 14, 28, 30, 56, 60, 90, 112, 180 ili 336 tableta i u višestrukim pakiranjima koja sadrže 336 (3 pakiranja od 112) tableta.
A 24-week, multi-centre, randomised, double-blind, placebo-controlled trial was conducted to evaluate the treatment effect of vildagliptin 50 mg once daily compared to placebo in 515 patients with type 2 diabetes and moderate renal impairment (N=294) or severe renal impairment (N=221). 
24-tjedno multicentrično, randomizirano, dvostruko slijepo, placebo kontrolirano ispitivanje bilo je provedeno kako bi se ocijenio učinak terapije vildagliptinom od 50 mg jedanput na dan u usporedbi s placebom, u 515 bolesnika sa šećernom bolesti tipa 2 i umjerenim oštećenjem bubrega (N=294) ili teškim oštećenjem bubrega (N=221).
In the overall population, the placebo-adjusted mean reduction from a mean baseline HbA1c 8.8% was -0.72%. 
U sveukupnoj populaciji srednje sniženje, prilagođeno s obzirom na placebo, u odnosu na srednju početnu vrijednost HbA1c 8,8% bilo je -0,72%.
Following withdrawal of treatment with Jalra and LFT normalisation, treatment with Jalra should not be reinitiated. 
Nakon prekida liječenja Jalrom i normalizacije testova jetrene funkcije ne smije se ponovno započeti primjena Jalre.
Table 5 Adverse reactions reported in patients who received Jalra 50 mg twice daily in combination with metformin and a sulphonylurea (N=157) 
Tablica 5 Nuspojave zabilježene u bolesnika koji su primali Jalru 50 mg dva puta na dan u kombinaciji s metforminom i sulfonilurejom (N=157)
The incidence of hypoglycaemia in the overall population was 4.7% and 5.6% in the vildagliptin and placebo groups, respectively. 
Incidencija hipoglikemije u cjelokupnoj populaciji bila je 4,7% u skupini koja je primala vildagliptin i 5,6% u skupini koja je primala placebo.
Lactose, anhydrous Cellulose, microcrystalline Sodium starch glycolate (type A) Magnesium stearate 
6.1 Popis pomoćnih tvari laktoza, bezvodna celuloza, mikrokristalična natrijev škroboglikolat (vrste A) magnezijev stearat
In clinical trials, the incidence of hypoglycaemia was common in patients receiving vildagliptin 100 mg daily in combination with metformin (1%) and uncommon in patients receiving placebo + metformin (0.4%). 
U kliničkim je ispitivanjima incidencija hipoglikemije bila česta u bolesnika koji su primali 100 mg vildagliptina na dan u kombinaciji s metforminom (1%) te manje česta u bolesnika koji su primali placebo uz metformin (0,4%).
In a clinical trial of 2 years' duration, vildagliptin (50 mg twice daily) was compared to gliclazide (up to 320 mg/day). 
U kliničkom ispitivanju koje je trajalo 2 godine, uspoređivan je vildagliptin (50 mg dva puta na dan) s gliklazidom (do 320 mg/dan).
More than 15,000 patients with type 2 diabetes participated in double-blind placebo- or activecontrolled clinical trials of up to more than 2 years' treatment duration. 
U dvostruko slijepim placebo ili aktivno kontroliranim kliničkim ispitivanjima u trajanju više od 2 godine sudjelovalo je više od 15 000 bolesnika sa šećernom bolešću tipa 2.
• The other ingredients are lactose anhydrous, microcrystalline cellulose, sodium starch glycolate 
• Drugi sastojci su bezvodna laktoza, mikrokristalična celuloza, natrijev škroboglikolat (vrste A)
In clinical trials, the incidence of hypoglycaemia when vildagliptin 50 mg once daily was added to glimepiride was 1.2% versus 0.6% for placebo + glimepiride. 
U kliničkim je ispitivanjima incidencija hipoglikemije bila 1,2% kada je 50 mg vildagliptina jedanput na dan dodano glimepiridu, u odnosu na 0,6% za placebo uz glimepirid.
In patients with moderate renal impairment vildagliptin significantly decreased HbA1c compared with placebo (difference of -0.53%) from a mean baseline of 7.9%. 
U bolesnika s umjerenim oštećenjem bubrega vildagliptin je značajno smanjio HbA1c u usporedbi s placebom (razlika od -0,53%) u odnosu na srednju početnu vrijednost od 7,9%.
Table 6 Adverse reactions reported in patients who received Jalra 100 mg daily in combination with insulin (with or without metformin) in double-blind studies (N=371) 
Tablica 6 Nuspojave zabilježene u bolesnika koji su primali Jalru 100 mg na dan u kombinaciji s inzulinom (s ili bez metformina) u dvostruko slijepim ispitivanjima (N=371)
How to take Jalra 
Kako uzimati Jalru
Some patients have had the following side effects while taking Jalra alone: 
Neki su bolesnici imali sljedeće nuspojave kada su uzimali samo Jalru:
Cardiac failure 
Zatajivanje srca
In patients with severe renal impairment, vildagliptin significantly decreased HbA1c compared with placebo (difference of -0.56%) from a mean baseline of 7.7%. 
U bolesnika s teškim oštećenjem bubrega, vildagliptin je značajno smanjio HbA1c u usporedbi s placebom (razlika od -0,56%) u odnosu na srednju početnu vrijednost od 7,7%.
There is limited experience in patients with ESRD on haemodialysis. 
Postoji ograničeno iskustvo u bolesnika u završnoj fazi bubrežne bolesti na hemodijalizi.
• Common: Dizziness 
• Često: omaglica
• Common: Trembling, headache, dizziness, weakness, low blood glucose 
• Često: drhtanje, glavobolja, omaglica, slabost, niska razina glukoze u krvi
Other side effects Some patients have had the following side effects while taking Jalra and metformin: 
Neki su bolesnici imali sljedeće nuspojave kada su uzimali Jalru i metformin:
Skin lesions, including blistering and ulceration have been reported in extremities of monkeys in nonclinical toxicology studies (see section 5.3). 
U nekliničkim toksikološkim ispitivanjima (vidjeti dio 5.3) zabilježene su kožne lezije, uključujući pojavu mjehurića i ulceracija na ekstremitetima majmuna.
Table 2 Adverse reactions reported in patients who received Jalra 50 mg in combination with a sulphonylurea in double-blind studies (N=170) 
Tablica 2 Nuspojave zabilježene u bolesnika koji su primali 50 mg Jalre u kombinaciji sa sulfonilurejom u dvostruko slijepim ispitivanjima (N=170)
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
11.NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
More than 1,900 patients receiving vildagliptin 50 mg once daily or 100 mg daily were ≥ 65 years. 
Broj bolesnika koji su primali vildagliptin u dozi od 50 mg jedanput na dan ili 100 mg na dan, a koji su bili u dobi ≥65 godina, iznosio je više od 1900.
Table 1 Adverse reactions reported in patients who received Jalra 100 mg daily in combination with metformin in double-blind studies (N=208) 
Tablica 1 Nuspojave zabilježene u bolesnika koji su primali 100 mg Jalre na dan u kombinaciji s metforminom u dvostruko slijepim ispitivanjima (N=208)
In the pioglitazone add-on study, the absolute weight increases with placebo, Jalra 100 mg daily were 1.4 and 2.7 kg, respectively. 
U kliničkom ispitivanju kao dodatne terapije uz pioglitazon, apsolutno povećanje tjelesne težine s placebom bilo je 1,4 kg, odnosno 2,7 kg sa 100 mg Jalre na dan.
Nasopharyngitis Metabolism and nutrition disorders Common 
Nazofaringitis Poremećaji metabolizma i prehrane Često
As triple oral therapy in combination with - a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. 
Kao trojna oralna terapija u kombinaciji sa - sulfonilurejom i metforminom u bolesnika u kojih je kontrola glikemije nedostatna usprkos dijeti i tjelovježbi uz dvojnu terapiju ovim lijekovima.
In controlled clinical trials with the combination of vildagliptin 100 mg daily + metformin, no withdrawal due to adverse reactions was reported in either the vildagliptin 100 mg daily + metformin or the placebo + metformin treatment groups. 
U kontroliranim kliničkim ispitivanjima kombinacije 100 mg vildagliptina na dan uz metformin, nije zabilježeno povlačenje iz ispitivanja zbog nuspojava niti u skupini liječenoj sa 100 mg vildagliptina na dan uz metformin, niti u skupini na placebu uz metformin.
In controlled clinical trials with the combination of vildagliptin 100 mg daily+ a thiazolidinedione, no withdrawal due to adverse reactions was reported in either the vildagliptin 100 mg daily + thiazolidinedione or the placebo + thiazolidinedione treatment groups. 
U kontroliranim kliničkim ispitivanjima kombinacije 100 mg vildagliptina na dan i tiazolidindiona, nije zabilježeno povlačenje iz ispitivanja zbog nuspojava niti u skupini liječenoj sa 100 mg vildagliptina na dan uz tiazolidindion, niti u skupini koja je primala placebo uz tiazolidindion.
• Uncommon: Headache, weakness, low blood glucose 
• Manje često: glavobolja, slabost, niska razina glukoze u krvi
In clinical trials, weight did not change from baseline when vildagliptin 50 mg daily was added to glimepiride (-0.1 kg and -0.4 kg for vildagliptin and placebo, respectively). 
U kliničkim se ispitivanjima tjelesna težina nije mijenjala od početne vrijednosti kada je 50 mg vildagliptina na dan dodano glimepiridu (-0,1 kg za vildagliptin odnosno -0,4 kg za placebo).
Table 3 Adverse reactions reported in patients who received Jalra 100 mg daily in combination with a thiazolidinedione in double-blind studies (N=158) 
Tablica 3 Nuspojave zabilježene u bolesnika koji su primali 100 mg Jalre na dan u kombinaciji s tiazolidindionom u dvostruko slijepim ispitivanjima (N=158)
More than 5,000 male and more than 4,000 female patients received vildagliptin 50 mg once daily or 100 mg daily. 
Broj muškaraca i žena koji su dobivali vildagliptin u dozi od 50 mg jedanput na dan ili 100 mg na dan iznosio je više od 5000, odnosno više od 4000.
• Common: Headache, chills, nausea (feeling sick), low blood glucose, heartburn 
• Često: glavobolja, zimica, mučnina, niska razina glukoze u krvi, žgaravica
Table 4 Adverse reactions reported in patients who received Jalra 100 mg daily as monotherapy in double-blind studies (N=1,855) 
Tablica 4 Nuspojave zabilježene u bolesnika koji su primali 100 mg Jalre na dan kao monoterapiju u dvostruko slijepim ispitivanjima (N=1855)
Nervous system disorders Uncommon 
Poremećaj probavnog sustava Nepoznato
• Uncommon : Diarrhoea, flatulence 
• Manje često: proljev, nadutost
No severe hypoglycaemic events were reported in the vildagliptin arms. 
U skupini bolesnika koji su primali vildagliptin nisu zabilježeni teški hipoglikemijski događaji.
• Uncommon: Headache, constipation, swollen hands, ankle or feet (oedema), joint pain, low blood glucose 
• Manje često: glavobolja, zatvor, otečene šake, gležnjevi ili stopala (edem), bol u zglobovima,
Vildagliptin in combination with metformin and glimepiride significantly decreased HbA1c compared with placebo.The placebo-adjusted mean reduction from a mean baseline HbA1c of 8.8% was -0.76%. 
Srednja vrijednost sniženja, prilagođena s obzirom na placebo, od početne srednje vrijednosti HbA1c od 8,8% bilo je -0,76%.
• Uncommon: Constipation 
• Manje često: zatvor
In case of such reactions, appropriate treatment is recommended. 
U slučaju pojave ovakvih reakcija, preporuča se odgovarajuće liječenje.
White homogenous emulsion. 
Bijela homogena emulzija.
Zoetis WHC 2 LLC 2000 Rockford Road, Charles City IA 50616 USA 
Zoetis WHC 2 LLC 2000 Rockford Road, Charles City IA 50616 SAD
ATCvet code: QI09AA07 
ATCvet kod: QI09AL
Upon shaking, the black deposit disappears and the emulsion becomes homogenous again. 
Nakon protresanja, crni talog nestaje, a emulzija ponovno postaje homogena.
The use of a multi-dosing syringe is recommended. 
Preporučuje se korištenje štrcaljke s više doza.
Vaccination schedule: One injection from 3 weeks of age. 
Raspored cijepljenja: Jedna injekcija u dobi od 3 tjedna.
Use vaccination devices according to the manufacturer's instructions. 
Koristite uređaj za cijepljenje u skladu s uputama proizvođača.
CONTENTS BY WEIGHT, VOLUME OR BY NUMBER OF DOSES 25 doses 
SADRŽAJ PO TEŽINI, VOLUMENU ILI BROJU DOZA
Shelf life of the veterinary medicinal product as package for sale: 18 months. 
Rok valjanosti veterinarsko-medicinskog proizvoda kad je zapakiran za prodaju: 18 mjeseci.
If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon. 
Ako zamijetite bilo koju nuspojavu,uključujući one koje nisu opisane u ovoj uputi o VMP, ili smatrate da VMP nije djelovao, molimo obavijestite svog veterinara.
Major incompatibilities: Do not mix with any other vaccine or immunological product. 
Glavne inkompatibilnosti: Ne miješati s bilo kojim drugim cjepivom ili imunološkim proizvodom.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorization: 07/02/2018. 
Datum prvog odobrenja: 07/02/2018.
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 navedeno 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.
These clinical signs normally resolve without treatment. 
Ovi klinički znakovi se obično povuku bez liječenja.
The vaccine is to be administered aseptically. 
Cjepivo treba primijeniti aseptično.
0.2 mg *Relative potency unit determined by ELISA antigen quantification (in vitro potency test) compared to a reference vaccine. 
0,2 mg *Jedinica relativne potencije određena pomoću ELISA kvantifikacije antigena (in vitro ispitivanje potencije) uspoređena s referentnim cjepivom.
It is intended to stimulate active immunity against PCV2 in pigs. 
Namjenjen je za poticanje aktivnog imuniteta protiv PCV2 u svinja.
MARKETING AUTHORISATION NUMBERS EU/2/17/223/001-006 
EU/2/17/223/001-006
The safety of the veterinary medicinal product has not been established during pregnancy or lactation. 
Neškodljivost veterinarsko-medicinskog proizvoda nije utvrđena za vrijeme graviditeta ili laktacije.
This resolves spontaneously within 48 hours without treatment. 
Ono se spontano povlači unutar 48 sati bez liječenja.
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 koja se sastoji od tvari biološkog podrijetla, namijenjenih za stvaranje aktivne imunosti na koje se ne primjenjuju odredbe Uredbe (EK) br 470/2009.
During storage, a slight black deposit may appear and the emulsion may separate into two distinct phases. 
Tijekom čuvanja može nastati malo crnog taloga, a emulzija se može razdvojiti na dvije zasebne faze.
In individual pigs the temperature increase compared to pre-treatment may commonly exceed 2 °C. 
U pojedinih svinja povećanje temperature u odnosu na onu prije tretmana obično može prijeći 2°C.
Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the vial after EXP. 
Ne koristite veterinarsko-medicinski proizvod poslije isteka roka valjanosti naznačenog na kutiji i bočici poslije EXP.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with the local requirements. 
Svi neupotrijebljeni veterinarsko-medicinski proizvod ili otpadni materijali dobiveni primjenom tih veterinarsko-medicinskih proizvoda trebaju se odlagati u skladu s lokalnim propisima.
Administer one dose of 2 ml to pigs in the neck behind the ear. 
Svinjama primijenite jednu dozu od 2 ml u vrat iza uha.