natgillin/translations-raw huggingface dataset:
Problems with your hormone producing glands (including the pituitary, the thyroid, the parathyroid and adrenal glands) that may affect how these glands work. 
Znakovi i simptomi mogu uključivati odstupanja u nalazima testova bubrežne funkcije ili smanjen volumen mokraće. tegobe sa žlijezdama koje proizvode hormone (uključujući hipofizu, štitnjaču, doštitne i nadbubrežne žlijezde), koje mogu utjecati na rad tih žlijezda.
Patients with a baseline performance score ≥ 2, active brain metastases or leptomeningeal metastases, autoimmune disease, and patients who had been receiving systemic immunosuppressants prior to study entry were excluded from the pivotal clinical trials of nivolumab or nivolumab in combination with ipilimumab (see sections 4.5 and 5.1). 
U pivotalna klinička ispitivanja nivolumaba ili nivolumaba u kombinaciji s ipilimumabom nisu bili uključeni bolesnici s početnim funkcionalnim statusom od ≥ 2, aktivnim metastazama u mozgu, ili leptomeningealnim metastazama, autoimunom bolešću, kao ni bolesnici koji su prije uključivanja u ispitivanje primali sistemske imunosupresive (vidjeti dijelove 4.5 i 5.1).
The primary efficacy outcome measure was OS. Key secondary efficacy outcome measures were investigator-assessed ORR and PFS. 
Ključne sekundarne mjere ishoda za djelotvornost bile su ORR i PFS prema ocjeni ispitivača.
• Adverse Reaction Management Guide 
• Vodič za zbrinjavanje nuspojava
ECOG PS 2 CNS Metastasis 
Sveukupno Funkcionalni ECOG status 2
Bristol-Myers Squibb Kft. Tel: +371 67708347 
Bristol-Myers Squibb spol. s r.o. Tel: +385 1 2078 508
Skin and subcutaneous tissue disorders Very common rashe, pruritus rashe, pruritus 
Poremećaji kože i potkožnog tkiva Vrlo često osipe, svrbež
Grade 4 rash 
Osip 4. stupnja
Bristol-Myers Squibb B.V. Tel: + 31 (0)30 300 2222 
Bristol-Myers Squibb spol. s r.o. Tel: + 386 1 2355 100
How to use OPDIVO 4. 
3. Kako primjenjivati OPDIVO
Gastrointestinal disorders Very common diarrhoea, nausea Common colitisa, stomatitis, vomiting, abdominal pain, constipation, dry mouth Uncommon pancreatitis, gastritis Rare duodenal ulcer 
Manje često perforacija crijevaa, gastritis, duodenitis gastritis Poremećaji kože i potkožnog tkiva Vrlo često osipe, svrbež osipe, svrbež
Uncommon vasculitis Respiratory, thoracic and mediastinal disorders Common pneumonitisa,c, dyspnoeaa, cough Uncommon pleural effusion Rare lung infiltration 
Poremećaji dišnog sustava, prsišta i sredoprsja Često pneumonitisa,c, dispnejaa, kašalj
Overall survival Events Hazard ratioa (95% CI) p-valueb Median (95% CI) (months) Rate (95% CI) at 6 months Rate (95% CI) at 12 months Rate (95% CI) at 18 months Progression-free survival Events Hazard ratio 95% CI p-value Median (95% CI) (months) Rate (95% CI) at 6 months Rate (95% CI) at 12 months Confirmed objective responsec (95% CI) Odds ratio (95% CI) Complete response (CR) Partial response (PR) Stable disease (SD) Median time to response Months (range) Median duration of response Months (range) 
Raspon Trajanje odgovora kod djelomične remisije (mjeseci) Medijan (95% CI) Raspon Medijan vremena do odgovora Mjeseci (raspon) Medijan trajanja praćenja Mjeseci (raspon) Preživljenje bez progresije bolesti Stopa (95% CI) u 12. mjesecu Stopa (95% CI) u 18. mjesecu
For Grade 4 diarrhoea or colitis, nivolumab or nivolumab in combination with ipilimumab must be permanently discontinued, and corticosteroids should be initiated at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents. 
U slučaju proljeva ili kolitisa 4. stupnja, liječenje nivolumabom ili nivolumabom u kombinaciji s ipilimumabom mora se trajno prekinuti i treba uvesti liječenje kortikosteroidima u dozi ekvivalentnoj 1 do 2 mg/kg/dan metilprednizolona.
Decreased function of the parathyroid gland 
Oštećenje funkcije bubrega
Patients with any history of or concurrent brain metastases, active autoimmune disease, or medical conditions requiring systemic immunosuppression were excluded from the clinical trials of nivolumab or nivolumab in combination with ipilimumab (see sections 4.5 and 5.1). 
U klinička ispitivanja nivolumaba ili nivolumaba u kombinaciji s ipilimumabom nisu bili uključeni bolesnici s prethodnim ili postojećim metastazama u mozgu, aktivnom autoimunom bolešću ili medicinskim stanjima koja su zahtijevala primjenu sistemskih imunosupresiva (vidjeti dijelove 4.5 i 5.1).
Hazard ratioa 99.8% CI p-valueb, c 
99,1% CI p-vrijednostb,h
Not known tumour lysis syndromei Hepatobiliary disorders Common hepatitisc hepatitisc 
Nepoznato sindrom tumorske lizei
Bristol-Myers Squibb Kft. Tel: + 40 (0)21 272 16 00 
Bristol-Myers Squibb Polska Sp. z o.o. Tel.: + 48 22 2606400
n ipilimumab Median OS (95% CI) 
n ipilimumab Medijan OS-a (95% CI)
Progression-free survival Events 
Preživljenje bez progresije bolesti
Diabetes (symptoms include excessive thirst, the passing of a greatly increased amount of urine, increase in appetite with a loss of weight, feeling tired, drowsy, weak, depressed, irritable and generally unwell) or diabetic ketoacidosis (acid in the blood produced from diabetes). 
Znakovi i simptomi koji pokazuju da te žlijezde ne rade pravilno mogu uključivati izrazit umor, promjenu tjelesne težine ili glavobolju, snižene razine kalcija u krvi te smetnje vida. šećernu bolest (simptomi uključuju prekomjernu žeđ, mokrenje uvelike povećane količine mokraće, pojačan tek praćen gubitkom tjelesne težine, osjećaj umora, omamljenost, slabost, depresiju, razdražljivost i opće loše osjećanje) ili dijabetičku ketoacidozu (kiselinu u krvi koja nastaje kao posljedica šećerne bolesti). upalu kože, koja može uzrokovati tešku kožnu reakciju (poznatu pod nazivom toksična epidermalna nekroliza i Stevens-Johnsonov sindrom).
Not known pericardial disordersj Vascular disorders Common hypertension hypertension 
Nepoznato perikardijalni poremećajij Krvožilni poremećaji
Overall survivald 
Ukupno preživljenje Medijan
Nivolumab monotherapy should be withheld for Grade 3 diarrhoea or colitis, and corticosteroids initiated at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents. 
U slučaju proljeva ili kolitisa 3. stupnja, potrebno je odgoditi primjenu nivolumaba u monoterapiji i uvesti liječenje kortikosteroidima u dozi ekvivalentnoj 1 do 2 mg/kg/dan metilprednizolona.
Skin and subcutaneous tissue disorders Very common rashe, pruritus Common vitiligo, dry skin, erythema, alopecia Uncommon erythema multiforme, psoriasis, rosacea, urticaria Rare toxic epidermal necrolysisa,f, Stevens-Johnson syndromea,f Musculoskeletal and connective tissue disorders Common musculoskeletal paing, arthralgia Uncommon polymyalgia rheumatica, arthritis Rare 
Rijetko toksična epidermalna nekrolizaa,f, Stevens-Johnsonov sindroma,f Poremećaji mišićno-koštanog sustava i vezivnog tkiva Često mišićno-koštana bolg, artralgija
Progression Free Survival per Investigator (Months) Number of Subjects at Risk Nivolumab + Ipilimumab 
Preživljenje bez progresije bolesti prema ispitivaču (mjeseci) Broj ispitanika pod rizikom
Everolimus 10 mg (events: 215/411), median and 95% CI: 19.55 (17.64, 23.06) 
Ipilimumab (događaji: 103/164), medijan i 95% CI: 21,49 mjeseci (16,85; 29,08)
OTHER 
Primjena
Ulcer of the small intestines 
Rijetko ulkus dvanaesnika
Immune-related adverse reaction leading to permanent discontinuation Pneumonitis 
Imunološki uzrokovan nefritis i bubrežna disfunkcija
Allergic reaction, reactions related to the infusion of the medicine Decreased secretion of hormones produced by adrenal glands (glands situated above the kidneys), underactive function (hypopituitarism) or inflammation (hypophysitis) of the pituitary gland situated at the base of the brain, swelling of the thyroid gland, diabetes Dehydration 
Imunološki uzrokovana nuspojava koja je dovela do trajnog prekida liječenja Pneumonitis Kolitis Hepatitis Nefritis i bubrežna disfunkcija Endokrinopatije Kožne reakcije Preosjetljivost/reakcija na infuziju Imunološki uzrokovana nuspojava koja je zahtijevala visoke doze kortikosteroidaa,b
Progression- free survival Rate (95% CI) at 12 months Rate (95% CI) at 18 months Overall survival 
Stopa (95% CI) u 12. mjesecu Stopa (95% CI) u 18. mjesecu
Nivolumab + ipilimumab (events: 166/425), median and 95.0% CI: NA (32.49, NA) 
Ipilimumab (događaji: 129/164), medijan i 95% CI: 3,91 (2,83; 4,17)
This overview was last updated in February 2019. 
Pregled informacija posljednji je put ažuriran u veljači 2019.
The medicine is available as a spot-on solution in 2 different concentrations (6% and 12%) and in tubes of various strengths (15, 30, 45, 60, 120, 240 and 360 mg). 
VMP je dostupan u obliku otopine za nakapavanje u dvije različite koncentracije (6 % i 12 %) i u kapaljkama različitih jačina (15, 30, 45, 60, 120, 240 i 360 mg).
Chanhold (selamectin) 
Chanhold (selamektin)
Further information on Chanhold can be found on the Agency's website: ema.europa.eu/Find medicines/veterinary/EPAR/chanhold. 
Više informacija o VMP-u Chanhold nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicines/veterinary/EPAR/chanhold.
The package leaflet contains detailed information on dosage and duration of treatment. 
Uputa o VMP-u sadržava detaljne informacije o doziranju i trajanju liječenja.
Information on the reference medicine can also be found on the Agency's website. 
Informacije o referentnom VMP-u također se nalaze na internetskim stranicama Agencije.
Selamectin activates special proteins called ‘chloride channels' on the surface of nerve and muscle cells of the parasite, allowing charged chloride particles to enter nerve cells and disrupting their normal electrical activity. 
Selamektin aktivira posebne bjelančevine pod nazivom „kloridni kanali” na površini živčanih i mišićnih stanica parazita, omogućujući nabijenim česticama klorida da uđu u živčane stanice i ometaju njihovu normalnu električnu aktivnost.
The strength used and the number of administrations depend on the weight and species of the animal being treated, and the type of parasite. 
Primijenjena jačina i broj primjena ovisi o težini i vrsti životinje koja se liječi te o vrsti parazita.
Chanhold received a marketing authorisation valid throughout the EU on 17 April 2019. 
VMP Chanhold dobio je odobrenje za stavljanje u promet koje je na snazi u EU-u od 17/04/2019.
As for every medicine, the company provided studies on the quality of Chanhold. 
Kao i za svaki VMP, tvrtka je dostavila ispitivanja o kvaliteti VMP-a Chanhold.
This means that Chanhold contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Stronghold. 
To znači da Chanhold sadrži istu djelatnu tvar i djeluje na isti način kao i „referentni VMP” koji je već odobren u Europskoj uniji (EU) pod nazivom Stronghold.
There was no need for ‘bioequivalence' studies to investigate whether Chanhold is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood. 
Nisu bila potrebna ispitivanja „bioekvivalencije” kako bi se istražilo apsorbira li se VMP Chanhold slično referentnom lijeku da bi se postigla ista razina djelatne tvari u krvi.
What is Chanhold and what is it used for? 
Što je Chanhold i za što se primjenjuje?
Other information about Chanhold 
Ostale informacije o VMP-u Chanhold
What are the benefits and risks of Chanhold? 
Koje su koristi i rizici od VMP-a Chanhold?
The European Medicines Agency concluded that, in accordance with EU requirements, Chanhold has been shown to be comparable to Stronghold. 
Europska agencija za lijekove zaključila je kako je, u skladu sa zahtjevima EU-a, utvrđeno da je VMP Chanhold usporediv s VMP-om Stronghold.
This is because the composition of Chanhold is comparable to the reference medicine and when applied to the skin, the active substance in both products is expected to be absorbed in the same way. 
To je zbog toga što je sastav VMP-a Chanhold sličan sastavu referentnog lijeka i kada se primjenjuje na kožu, očekuje se da se djelatna tvar kod oba lijeka apsorbira na isti način.
Chanhold contains selamectin, which is an antiparasitic medicine that belongs to the ‘avermectin' class. 
Chanhold sadrži selamektin, lijek protiv parazita koji pripada razredu avermektina.
An overview of Chanhold and why it is authorised in the EU 
Pregled informacija o VMP-u Chanhold i zašto je odobren u EU-u
Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Stronghold, and do not need to be repeated for Chanhold. 
Ispitivanja koristi i rizika od djelatne tvari u odobrenim primjenama već su provedena s referentnim VMP-om Stronghold i stoga ih nije potrebno ponavljati za VMP Chanhold.
It can also be used as part of a treatment for flea allergy dermatitis (skin inflammation), to prevent heartworm disease in cats and dogs, to treat ear mites in cats and dogs, to treat adult intestinal roundworms and intestinal hookworms in cats, to treat adult intestinal roundworms in dogs, to treat biting lice infestations in cats and dogs, to treat sarcoptic mange (scabies) in dogs. 
Može se primjenjivati i kao dio liječenja alergijskog dermatitisa (upale kože) uzrokovanog buhama, za sprječavanje bolesti srčanog crva u pasa i mačaka, za liječenje infestacije ušnim šugarcem u pasa i mačaka, za liječenje infestacije odraslim crijevnim oblićima i invazije crijevnim udičastim crvima u mačaka, za liječenje infestacije odraslim crijevnim oblićima u pasa, za liječenje infestacije paušima u pasa i mačaka, za liječenje sarkoptoze (šuge) u pasa.
Why is Chanhold authorised in the EU? 
Zašto je VMP Chanhold odobren u EU-u?
Chanhold is an antiparasitic medicine used to treat and prevent infestations with parasites that live on the skin or in the fur of cats and dogs, such as fleas and mites, as well as treating worm parasites that live inside the body. 
Chanhold je antiparazitski VMP koji se primjenjuje za liječenje i sprječavanje infestacija parazitima koji žive na koži ili u dlaci pasa i mačaka, kao što su buhe i šugarci, te oblićima koji žive unutar tijela.
Because Chanhold is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's. 
Budući da je Chanhold generički VMP, smatra se da su njegove koristi i rizici isti kao i oni referentnog VMP-a.
Therefore, the Agency's view was that, as for Stronghold, the benefit of Chanhold outweighs the identified risk and it can be authorised for use in the EU. 
Stoga je mišljenje Agencije da korist od VMP-a Chanhold, kao i kod VMP-a Stronghold, nadmašuje utvrđeni rizik te da može biti odobren za primjenu u EU-u.
How does Chanhold work? 
Kako djeluje Chanhold?
Chanhold contains the active substance selamectin and is a ‘generic medicine'. 
Chanhold sadrži djelatnu tvar selamektin te je „generički lijek”.
Safety information has been included in the summary of product characteristics and the package leaflet for Chanhold, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers. 
U sažetku opisa svojstava kao i u uputi o VMP-u Chanhold nalaze se informacije o sigurnosti primjene, uključujući odgovarajuće mjere opreza kojih se veterinari te vlasnici životinja ili uzgajivači trebaju pridržavati.
EMA/152732/2019 
Chanhold (selamectin) EMA/254992/2019
For more information about using Chanhold, see the package leaflet or contact your veterinarian or pharmacist. 
Za dodatne informacije o primjeni VMP-a Chanhold pogledajte uputu o VMP-u odnosno obratite se veterinaru ili ljekarniku.
How has Chanhold been studied? 
Kako se Chanhold primjenjuje?
Date of first authorisation: 23/02/2005 Date of last renewal: 15/01/2010 
Datum prvog odobrenja: 23/02/2005 Datum posljednje obnove: 15/01/2010
ATCvet code: QI06AH08. 
ATCvet kod: QI06AH08
Do not use in pregnant animals. 
Ne primjenjivati na gravidnim životinjama.
In exceptional circumstances a hypersensitivity reaction may occur, which may require appropriate symptomatic treatment. 
U izuzetnim okolnostima može se javiti hipersenzibilna reakcija, koja može zahtijevati odgovarajuće simptomatsko liječenje.
EXP (mm/yyyy) 
EXP (mm/gggg)
Store and transport refrigerated (2 °C - 8 °C). 
Čuvati i prevoziti rashlađeno (2°C - 8°C).
Use immediately after reconstitution. 
Primijeniti odmah nakon rekonstitucije.
69800 SAINT-PRIEST FRANCE 
69800 SAINT-PRIEST FRANCUSKA
Primary vaccination course: - first injection: from 8 weeks of age, - second injection: 3 to 4 weeks later. 
Prvo cijepljenje: - prva injekcija: od 8. tjedna starosti, - druga injekcija: 3 do 4 tjedna kasnije.
Use in healthy animals only. 
Primijeniti samo na zdravim životinjama.
EU/2/04/051/001 Lyophilisate (10 bottles of 1 dose) + solvent (10 bottles of 1 ml) EU/2/04/051/002 Lyophilisate (50 bottles of 1 dose) + solvent (50 bottles of 1 ml) 
EU/2/04/051/001 Liofilizat (10 bočica s po 1 dozom) + otapalo (10 bočica od 1 ml) EU/2/04/051/002 Liofilizat (50 bočica s po 1 dozom) + otapalo (50 bočica od 1 ml)
In normal conditions of use, transient apathy and anorexia may occasionally occur, as well as hyperthermia (lasting usually for 1 or 2 days). 
U normalnim uvjetima upotrebe, povremeno se mogu javiti apatija i anoreksija, kao i hipertermija (u trajanju obično 1 ili 2 dana).
Per dose of 1 ml: 
Svaka doza od 1 ml sadrži:
A local reaction may occur (slight pain at palpation, itching or limited oedema) that disappears within 1 or 2 weeks at most. 
Može se javiti i lokalna reakcija (lagana bol pri palpaciji, svrbež ili ograničen otok) koja nestaje za najviše 1 ili 2 tjedna.
The product was shown to reduce excretion of feline calicivirus at onset of immunity and for one year after vaccination. 
Proizvod smanjuje ekskreciju mačjeg kalicivirusa na početku imunosti i tijekom 1 godine nakon vakcinacije.
FHV (F2 strain) ................................................................................................................. ≥ 104.9 CCID50 FCV (431 and G1 strains) ............................................................................................... ≥ 2.0 ELISA U. 
FHV (soj F2) ..................................................................................................................... ≥ 104,.9 CCID50 FCV (soj 431 i G1) .......................................................................................................... ≥ 2,0 ELISA U.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. 
U slučaju nehotičnog samoinjiciranja, odmah potražiti pomoć liječnika i pokazati mu uputu o VMP ili etiketu.
Casein hydrolysate Collagen hydrolysate Dipotassium phosphate Potassium dihydrogen phosphate Potassium hydroxide Sodium chloride 
Kazein hidrolizat Kolagen hidrolizat Dikalijev fosfat Kalijev dihidrogenfosfat Kalijev hidroksid Natrijev klorid
The use is not recommended during lactation 
Ne preporučuje se primjena tijekom laktacije
No effect other than those already mentioned in section 4.6 “Adverse reactions” have been observed, except hyperthermia that may exceptionally last 5 days. 
Nisu primijećene nikakve druge nuspojave osim onih spomenutih u odjeljku 4.6 “Nuspojave”, osim hipertermije koja može izuzetno trajati 5 dana.
Shelf life after reconstitution according to directions: use immediately. 
Rok valjanosti nakon rekonstitucije prema uputama: primijeniti odmah .
EXP (mm/yyyy) Once reconstituted use immediately. 
EXP (mm/gggg) Nakon restitucije odmah primijeniti.
No effect other than those already mentioned in section “Adverse reactions” have been observed after the administration of several doses, except hyperthermia that may exceptionally last 5 days. 
Nisu primijećene nikakve druge nuspojave osim onih spomenutih u odjeljku “Nuspojave” nakon primjene nekoliko doza, osim hipertermije koja iznimno može trajati 5 dana.
1 cell culture infective dose 50% 
1 količina virusa koja zarazi 50 % stanica kulture u koju je dodan virus
Active immunisation of cats aged 8 weeks and older: - against feline viral rhinotracheitis to reduce clinical signs, - against calicivirus infection to reduce clinical signs. 
Aktivna imunizacija mačaka starijih od 8 tjedana: - protiv virusnog rinotraheitisa mačaka za smanjenje kliničkih znakova,
Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with Merial non-adjuvanted vaccine against feline leukaemia and/or administered the same day but not mixed with Merial adjuvanted vaccine against rabies. 
Dostupni su podaci o sigurnosti i učinkovitosti koji pokazuju da se ova vakcina može miješati i primijeniti s Merialovomvakcinom protiv mačje leukemije i/ili primijeniti isti dan, ali se ne smije miješati s Merialovom vakcinom protiv bjesnoće.
Where high levels of maternal antibodies against rhinotracheitis or calicivirosis components are expected to be present (e.g. in kittens of 9-12 weeks of age borne from queens which were vaccinated before pregnancy and/or with known or suspected previous exposure to the pathogen(s)), the primary vaccination course should be delayed until 12 weeks of age. 
Kada se očekuje prisutnost visoke razine majčinih protutijela protiv komponenti rinotraheitisa ili kalicivirusa (npr. kod mačića u dobi od 9-12 tjedana od mačaka koje su bile cijepljene prije trudnoće i/ili s poznatim ili suspektnim prethodnim izlaganjem patogenima), prvo cijepljenje treba odgoditi do dobi od 12 tjedana.
Lyophilisate (10x1 dose) + solvent (10x1 ml) Lyophilisate (50x1 dose) + solvent (50x1 ml) 
Liofilizat (10 x 1 doza) + otapalo (10 x 1 ml) Liofilizat (50 x 1 doza) + otapalo (50 x 1 ml)
Store and transport refrigerated. 
11. POSEBNI UVJETI ČUVANJA Čuvati i prevoziti rashlađeno.
Water for injections ..................................................................................................................... q.s. 
Voda za injekcije .......................................................................................................................... q.s. 1 ml
Do not mix with Merial adjuvanted vaccine against rabies. 
Ne miješati s Merialovom vakcinom protiv bjesnoće.
Safety and efficacy data are available which demonstrate that this vaccine can be mixed with Merial non-adjuvanted vaccine against feline leukaemia and/or administered the same day but not mixed with Merial adjuvanted vaccine against rabies. 
Podaci o neškodljivosti i djelotvornosti su dostupni, što je dokaz da ovo cjepivo smije biti pomiješano s cjepivom protiv mačje leukemije tvrtke Merial i/ili primijenjeno istog dana, ali ne pomiješano s cjepivom protiv bjesnoće tvrtke Merial.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Solvent bottle 
OSNOVNI PODACI NAPISANI NA MALIM JEDINICAMA UNUTARNJIH PAKOVANJA
Revaccination: - the first revaccination must be carried out one year after the primary vaccination course, - subsequent revaccinations must be carried out at intervals of up to three years for the rhinotracheitis and calicivirosis components. 
Revakcinacija: - prva revakcinacija mora biti provedena jednu godinu nakon prvog cijepljanja, - naknadne revakcinacije moraju biti provedene u intervalima od najviše tri godine za komponente rinotraheitisa i kalicivirusa.
The duration of immunity after the last re-vaccination is 3 years for the rhinotracheitis and calicivirosis components. 
Trajnost imuniteta nakon zadnje re-vakcinacije je 3 godine za komponente rinotraheitisa i kalicivirusa.
Type I glass bottle containing 1 dose of lyophilisate and type I glass bottle containing 1 ml of solvent, both closed with a butyl elastomer closure and sealed with an aluminium or plastic cap. 
I staklena bočica s 1 ml otapala, obje zatvorene gumenim čepom i zapečaćene aluminijskom ili plastičnom kapicom.
Lyophilisate and solvent for suspension for injection. 
Liofilizat i otapalo za suspenziju za injekcije.
Inject by subcutaneous route one dose (1 ml) of vaccine after reconstitution of the lyophilisate with the solvent, according to the following vaccination scheme: 
Nakon rekonstitucije liofilizata otapalom injicirajte subkutano jednu dozu (1 ml) cjepiva, prema sljedećem rasporedu cijepljenja:
Disodium hydrogen orthophosphate Monopotassium phosphate anhydrous 
Dinatrijev hidrogenortofosfat Monokalijev fosfatanhidrid