FrancophonIA/ELRC3.0 huggingface dataset:
English: Pain in extremities, arthralgia, musculoskeletal pain General disorders and administration site conditions Very common:
Croatian: bolovi u kostima, mialgija, artralgija, generalizirani bolovi manje često:
English: Table 3: Efficacy results (prostate cancer patients receiving hormonal therapy)
Croatian: Tablica 3: Rezultati djelotvornosti (bolesnici s rakom prostate koji primaju hormonsku terapiju) Bilo koji koštani događaj (+ hiperkalcijemija izazvana tumorom)
English: • Hypersensitivity to the active substance, to other bisphosphonates or to any of the excipients listed in section 6.1
Croatian: - Preosjetljivost na djelatnu tvar, druge bisfosfonate ili neku od pomoćnih tvari navedenih u dijelu
English: The rate of atrial fibrillation serious adverse events was 1.3% (51 out of 3,862) and 0.6% (22 out of 3,852) in patients receiving zoledronic acid 5 mg and placebo, respectively.
Croatian: Stopa fibrilacije atrija kao ozbiljnog štetnog događaja bila je 1,3% (51 od 3862) u bolesnica koje su primale zoledronatnu kiselinu u dozi od 5 mg, odnosno 0,6% (22 od 3852) bolesnica koje su primale placebo.
English: Swelling, redness, pain and itching to the eyes or eye sensitivity to light.
Croatian: Manje često (može se javiti u do 1 na 100 osoba) Oticanje, crvenilo, bol i svrbež očiju i osjetljivost očiju na svjetlost.
English: Zoledronic Acid Hospira 4 mg/100 ml (to appear in roundel) solution for infusion Zoledronic acid
Croatian: Zoledronatna kiselina Hospira 4 mg/100 ml (pojavljuje se u krugu) otopina za infuziju zoledronatna kiselina primjena u venu
English: Fractures are often bilateral; therefore the contralateral femur should be examined in bisphosphonate-treated patients who have sustained a femoral shaft fracture.
Croatian: Budući da su prijelomi često obostrani, u bolesnika liječenih bisfosfonatima s dijafiznim prijelomom bedrene kosti potrebno je pregledati bedrenu kost na suprotnoj strani.
English: 7 MARKETING AUTHORISATION HOLDER
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: Zoledronic acid is contraindicated in breast-feeding women (see section 4.3).
Croatian: Zoledronatna kiselina je kontraindicirana tijekom dojenja (vidjeti dio 4.3).
English: Zoledronic Acid Hospira 5 mg/100 ml (to appear in roundel) solution for infusion Zoledronic acid
Croatian: Zoledronatna kiselina Hospira 5 mg/100 ml (pojavljuje se u krugu) otopina za infuziju zoledronatna kiselina primjena u venu
English: Zoledronic Acid Hospira recommended dose* 4.0 mg zoledronic acid 3.5 mg* zoledronic acid 3.3 mg* zoledronic acid 3.0 mg* zoledronic acid * Doses have been calculated assuming target AUC of 0.66 (mg•hr/l) (CLcr = 75 ml/min).
Croatian: 3,0 mg* zoledronatne kiseline *Doze su izračunate uz pretpostavku da je ciljni AUC od 0,66 (mg•hr/l) (CLcr = 75 ml/min).
English: Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Croatian: Drugi lijekovi i Zoledronatna kiselina Hospira Molimo obavijestite svog liječnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: Hypotension (some of the patients had underlying risk factors)
Croatian: Krvožilni poremećaji manje često hipertenzija, naleti crvenila nepoznato** hipotenzija (neki od bolesnika imali su podležeće faktore rizika)
English: Uncommon Blood creatinine increased, pollakiuria, proteinuria
Croatian: Poremećaji bubrega i mokraćnog sustava manje često povišeni kreatinin u krvi, polakisurija, proteinurija nepoznato** oštećenje bubrega.
English: Zoledronic Acid Hospira 4 mg/100 ml solution for infusion Zoledronic acid
Croatian: Zoledronatna kiselina Hospira 4 mg/100 ml otopina za infuziju zoledronatna kiselina
English: Zoledronic Acid Hospira 4 mg/100 ml solution for infusion
Croatian: Zoledronatna kiselina Hospira 4 mg/100 ml otopina za infuziju
English: Table 5: Efficacy results (breast cancer and multiple myeloma patients)
Croatian: Tablica 5: Rezultati djelotvornosti (u bolesnika s rakom dojke i multiplim mijelomom) Bilo koji koštani događaj (+ hiperkalcijemija izazvana tumorom)
English: s r.o.
Croatian: D na dan.
English: Zoledronic Acid Hospira 5 mg/100 ml solution for infusion Zoledronic acid
Croatian: Zoledronatna kiselina Hospira 5 mg/100 ml otopina za infuziju zoledronatna kiselina
English: Placebo zoledronic acid
Croatian: placebo zoledronatna kiselina 4 mg
English: This medicinal product contains less than 1 mmol sodium (23 mg) per 100 ml dose of Zoledronic Acid Hospira, i.e. essentially “sodium free”.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po dozi, tj. zanemarive količine natrija.
English: 5 PHARMACOLOGICAL PROPERTIES
Croatian: FARMAKOLOŠKA SVOJSTVA
English: How Zoledronic Acid Hospira is used
Croatian: Koliko se Zoledronatne kiseline Hospira primjenjuje
English: Zoledronic Acid Hospira 5 mg/100 ml solution for infusion
Croatian: Zoledronatna kiselina Hospira 5 mg/100 ml otopina za infuziju
English: Common Nausea, vomiting, diarrhoea Uncommon Dyspepsia, abdominal pain upper, abdominal pain, gastroesophageal reflux disease, constipation, dry mouth, oesophagitis, toothache, gastritis Skin and subcutaneous tissue disorders Uncommon Rash, hyperhidrosis, pruritus, erythema Musculoskeletal and connective tissue Common Myalgia, arthralgia, bone pain, back pain,
Croatian: Poremećaji probavnog sustava često mučnina, povraćanje, proljev manje često dispepsija, bol u gomjem abdomenu, bol u abdomenu, bolest gastroezofagealnog refluksa, konstipacija, suhoća usta, ezofagitis, zubobolja, gastritis Poremećaji kože i potkožnog tkiva manje često osip, hiperhidroza, pruritus, eritem Poremećaji mišićno-koštanog sustava i vezivnog tkiva često bolovi u mišićima, zglobovima, kostima, bol u kralježnici, bol u ekstremitetima manje često bol u vratu, mišićno-koštana ukočenost, oticanje zgloba, spazam mišića, bol u ramenu, mišićno-koštana bol u prsima, mišićno-koštana bol, ukočenost zgloba, artritis, slabost mišića rijetko atipični dijafizni prijelomi i suptrohanterni prijelomi† (nuspojava bisfosfonata) vrlo rijetko osteonekroza vanjskog slušnog kanala (nuspojava skupine bisfosfonata) i drugih anatomskih mjesta uključujući bedrenu kost i kuk nepoznato** osteonekroza čeljusti (vidjeti dijelove 4.4 i 4.8 učinci skupine)
English: Cases of ONJ have been reported in the postmarketing setting for zoledronic acid.
Croatian: Slučajevi ONČ zabilježeni su nakon stavljanja lijeka u promet u bolesnika koji su se liječili zoledronatnom kiselinom.
English: Tachycardia Respiratory, thoracic and mediastinal disorders Common:
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja često:
English: − The active substance of Zoledronic Acid Hospira 4 mg/100 ml solution for infusion is zoledronic acid.
Croatian: Što Zoledronatna kiselina Hospira sadrži - Djelatna tvar Zoledronatne kiseline Hospira 4 mg/100 ml otopina za infuziju je zoledronatna kiselina.
English: Nausea, vomiting, decreased appetite Uncommon: Diarrhoea, constipation, abdominal pain, dyspepsia, stomatitis, dry mouth Skin and subcutaneous tissue disorders Uncommon: Pruritus, rash (including erythematous and macular rash), increased sweating Musculoskeletal and connective tissue disorders Common:
Croatian: pruritus, osip (uključujući eritematozni i makularni osip), pojačano znojenje Poremećaji mišićno-koštanog sustava i vezivnog tkiva često:
English: somnolence
Croatian: Dojenje
English: One ml solution contains 0.05 mg zoledronic acid (as monohydrate).
Croatian: Jedan ml otopine sadrži 0,05 mg zoledronatne kiseline (u obliku hidrata).
English: Uveitis
Croatian: Doziranje
English: 3 PHARMACEUTICAL FORM
Croatian: FARMACEUTSKI PODACI
English: One bag with 100 ml contains 4 mg zoledronic acid (as monohydrate).
Croatian: Jedna vrećica sa 100 ml sadrži 4 mg zoledronatne kiseline (u obliku hidrata).
English: Adequate calcium and vitamin D intake are recommended in association with Zoledronic Acid Hospira administration.
Croatian: Uz primjenu Zoledronatne kiseline Hospira, preporučuje se odgovarajući unos kalcija i vitamina D.
English: Uncommon: Acute renal failure, haematuria, proteinuria Rare
Croatian: akutno zatajenje bubrega, hematurija, proteinurija rijetko:
English: One ml solution contains 0.04 mg zoledronic acid (as monohydrate).
Croatian: Jedan ml otopine sadrži 0,04 mg zoledronatne kiseline (u obliku hidrata).
English: Each bag of 100 ml contains 5 mg zoledronic acid (as monohydrate).
Croatian: Jedna vrećica od 100 ml sadrži 5 mg zoledronatne kiseline (u obliku hidrata).
English: Clinical trial results in the treatment of TIH
Croatian: Rezultati kliničkih ispitivanja liječenja hiperkalcijemije izazvane tumorom
English: Anaemia
Croatian: pancitopenija
English: One bag contains 4 mg of zoledronic acid (as monohydrate).
Croatian: Jedna vrećica sadrži 4 mg zoledronatne kiseline (u obliku hidrata).
English: Zoledronic acid does not inhibit human P450 enzymes in vitro, shows no biotransformation and in animal studies < 3% of the administered dose was recovered in the faeces, suggesting no relevant role of liver function in the pharmacokinetics of zoledronic acid.
Croatian: < 3% primijenjene doze otkriveno je u stolici, što pokazuje da funkcija jetre nema značajnu ulogu u farmakokinetici zoledronatne kiseline.
English: Each bag with 100 ml of solution contains 4 mg zoledronic acid (as monohydrate).
Croatian: Jedna vrećica sa 100 ml otopine sadrži 4 mg zoledronatne kiseline (u obliku hidrata).
English: Interstitial lung disease (inflammation of the tissue around the air sacks of the lungs) Flu-like symptoms including arthritis and joint swelling.
Croatian: - bolest intersticija pluća (upalna bolest tkiva oko zračnih mjehurića u plućima).
English: - Any other medicines that contain zoledronic acid which are used to treat osteoporosis and other noncancer diseases of the bone, or any other bisphosphonate, since the combined effects of these medicines together with Zoledronic Acid Hospira are unknown.
Croatian: Bolesnici koji se liječe zoledronatnom kiselinom Hospira ne smiju se istodobno liječiti takvim lijekovima ili bilo kojim drugim bisfosfonatom, budući da nisu poznati kombinirani učinci tih lijekova.
English: Pam 90 mg zoledronic acid
Croatian: 4,0 mg zoledronatne kiseline
English: If you missed a dose of Zoledronic Acid Hospira Contact your doctor or hospital as soon as possible to re-schedule your appointment.
Croatian: Obratite se liječniku ili bolnici što je prije moguće kako biste ugovorili novi termin.
English: One vial contains 4 mg zoledronic acid (as monohydrate).
Croatian: Jedna bočica sadrži 4 mg zoledronatne kiseline (u obliku hidrata).
English: Mannitol
Croatian: Osteonekroza
English: How Zoledronic Acid Hospira is given
Croatian: Koliko se često daje Zoledronatna kiselina Hospira
English: Each bag with 100 ml of solution contains 5 mg zoledronic acid (as monohydrate).
Croatian: Jedna vrećica sa 100 ml otopine sadrži 5 mg zoledronatne kiseline (u obliku hidrata).
English: Atypical fractures of the femur During post-marketing experience the following reactions have been reported (frequency rare):
Croatian: Opći poremećaji i reakcije na mjestu primjene vrlo često:
English: Pre-existing hypocalcaemia must be treated by adequate intake of calcium and vitamin D before initiating therapy with zoledronic acid (see section 4.3).
Croatian: D prije početka terapije zoledronatnom kiselinom (vidjeti dio 4.3).
English: TIH:
Croatian: Rok valjanosti:
English: − Hypersensitivity reactions.
Croatian: reakcija preosjetljivosti rijetko:
English: As a consequence of low calcium values: irregular heart beat (cardiac arrhythmia; secondary to hypocalcaemia).
Croatian: Rijetko (može se javiti u do 1 na 1000 osoba): - kao posljedica niskih razina kalcija: nepravilni otkucaji srca (srčana aritmija zbog hipokalcemije). - poremećaj rada bubrega koji se zove Fanconijev sindrom (kojeg inače može odrediti Vaš liječnik pomoću određenih testova urina).
English: − High blood pressure, shortness of breath, dizziness,anxiety,sleep disturbances,taste disturbances, trembling, tingling or numbness of the hands or feet, diarrhea, constipation, abdominal pain, dry mouth.
Croatian: Poremećaji živčanog sustava često glavobolja, omaglica manje često letargija, parestezija, somnolencija, tremor, sinkopa, poremećaj okusa
English: Common (may affect up to 1 in 10 people):− Headache and a flu-like syndrome consisting of fever, fatigue, weakness, drowsiness, chills and bone, joint and/or muscle ache.
Croatian: Vrlo rijetko (može se javiti u do 1 na 10 000 osoba): - nesvjestica zbog niskog krvnog tlaka - jaki, ponekad onesposobljavajući bolovi u kostima, zglobovima i/ili mišićima.
English: You should not be given Zoledronic Acid Hospira if you are pregnant.
Croatian: Ako ste trudni, ne smije Vam se dati Zoledronatna kiselina Hospira.
English: - This product does not require any special storage conditions.
Croatian: - Ovaj lijek ne zahtijeva posebne uvjete čuvanja.
English: Serum calcium should be measured and hypocalcaemia must be corrected before initiating zoledronic acid therapy.
Croatian: Prije uvođenja terapije zoledronatnom kiselinom potrebno je odrediti razinu kalcija u serumu i korigirati hipokalcemiju.
English: Psychiatric disorders Uncommon: Anxiety, sleep disturbance
Croatian: Psihijatrijski poremećaji manje često nesanica
English: 30 tablets
Croatian: 100 mg Filmom obložena tableta
English: ATCvet code: QI02AB17.
Croatian: ATCvet kod: QI02 AB17.
English: Cattle (cows and heifers).
Croatian: Goveda (krave i junice).
English: Under these circumstances, appropriate and rapid symptomatic treatment should be administered.
Croatian: U tom slučaju potrebno je primijeniti odgovarajuću i hitnu simptomatološku terapiju.
English: A third dose should be administered 2 months thereafter.
Croatian: Treću dozu treba dati nakon 2 mjeseca.
English: For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.
Croatian: Za bilo koju informaciju o ovom veterinarsko-medicinskom proizvodu, molimo da kontaktirate lokalnog zastupnika nositelja odobrenja za stavljanje u promet.
English: Shelf life of the veterinary medicinal product as packaged for sale: 18 months.
Croatian: Rok valjanosti veterinarsko-medicinskog proizvoda kada je zapakiran za prodaju: 18 mjeseci.
English: The full immunisation scheme induces immunity from approximately day 13 after the first injection until approximately day 78 after the third injection.
Croatian: Provedbom cjelovitog programa imunizacije potiče se imunost od oko 13-og dana nakon prve injekcije do otprilike 78-og dana nakon treće injekcije.
English: The whole herd should be immunised.
Croatian: Treba imunizirati cijelo stado.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.
Croatian: Ne koristiti ovaj veterinarsko medicinski proizvod poslije isteka roka valjanosti naznačenog na etiketi poslije EXP.
English: Immunisation has to be considered as one component in a complex mastitis control program that addresses all important udder health factors (e.g. milking technique, dry-off and breeding management, hygiene, nutrition, housing, bedding, cow comfort, air and water quality, health monitoring) and other management practices.
Croatian: Imunizaciju treba smatrati jednim od sastavnih dijelova kompleksnog programa kontrole mastitisa, koji uključuje sve čimbenike važne za zdravo vime (npr. tehnika mužnje, upravljanje zasušivanjem i uzgojem, higijena, hranidba, nastambe, ležišta, udobnost krava, kvaliteta zraka i vode, nadzor zdravstvenog stanja) i druge načine upravljanja.
English: The full immunisation program should be repeated with each gestation.
Croatian: Cjelovit program imunizacije treba ponoviti kod svakog graviditeta.
English: They would mainly be: swelling (up to 5 cm2 on average), which disappears within 1 or 2 weeks at most.
Croatian: U većini slučajeva je to: oteklina (u prosjeku do 5 cm2), koja nestaje u roku od 1 do najviše 2 tjedna.
English: Very rare adverse reactions:
Croatian: NUSPOJAVE Vrlo rijetke nuspojave:
English: The active substances being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Croatian: Djelatne tvari koje se sastoj od tvari biološkog podrijetla, namijenjene za stvaranje aktivne imunosti i na koje se ne primjenjuju odredbe Uredbe (EK) br. 470/2009.
English: Date of first authorisation: 11/02/2009 Date of last renewal: 10/02/2014
Croatian: Datum posljednjeg produljenja odobrenja: 10/02/2014
English: In some cases, there may also be pain at the inoculation site that spontaneously subsides in a maximum of 4 days.
Croatian: U nekim slučajevima, na mjestu cijepljenja može se pojaviti i bol, koja spontano popusti nakon najviše 4 dana.
English: Administer one dose (2 ml) by deep intramuscular injection in the neck muscles at 45 days before the expected parturition date and 1 month thereafter administer a second dose (at least 10 days before calving).
Croatian: Primijeniti jednu dozu (2 ml) dubokom intramuskularnom injekcijom u vratne mišiće 45 dana prije očekivanog termina poroda i još jednu dozu po proteku 1 mjeseca (a najmanje 10 dana prije teljenja).
English: Sodium alginate Calcium chloride, dihydrate Simeticone
Croatian: Natrijev alginat Klacijev klorid dihidrat Simetikon
English: NAME OF THE VETERINARY MEDICINAL PRODUCT
Croatian: NAZIV VETERINARSKO MEDICINSKOG PROIZVODA
English: Store and transport refrigerated (2 °C - 8 °C).
Croatian: Čuvati i prevoziti rashlađeno (2 °C - 8 °C).
English: If you are accidentally injected with this veterinary medicinal product, seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you.
Croatian: Ukoliko ste nehotično injicirani ovim veterinarsko-medicinskim proizvodom, potražite hitnu medicinsku pomoć čak ako je injicirana vrlo mala količina i sa sobom ponesite uputu o VMP.
English: Accidental injection is dangerous - read the package leaflet before use.
Croatian: Nehotično injiciranje je opasno - vidi uputu o VMP prije primjene.
English: Pregnancy and lactation: Can be used during pregnancy and lactation.
Croatian: Primjena tijekom graviditeta i laktacije: Može se primijeniti tijekom graviditeta i laktacije.
English: For herd immunisation of healthy cows and heifers, in dairy cattle herds with recurring mastitis problems, to reduce the incidence of sub-clinical mastitis and the incidence and the severity of the clinical signs of clinical mastitis caused by Staphylococcus aureus, coliforms and coagulase-negative staphylococci.
Croatian: Imunizacija stada zdravih krava i junica, u stadima mliječnih krava gdje se opetovano javlja problem mastitisa, da bi se umanjila učestalost subkliničkog mastitisa te učestalost i težina kliničkih znakova kliničkog mastitisa, koje uzrokuju Staphylococcus aureus, koliformne bakterije i koagulaza-negativni stafilokoki.
English: Name and address of the manufacturer of the biological active substances
Croatian: Naziv i adresa proizvođača biološki djelatne(ih) tvari
English: 1 dose (2 ml) 5 doses (10 ml) 25 doses (50 ml)
Croatian: 1 doza (2 ml) 5 doza (10 ml) 25 doza (50 ml)
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Croatian: Učestalost nuspojava je određena sukladno sljedećim pravilima: - vrlo česte (više od 1 na 10 tretiranih životinja pokazuju nuspojavu(e)) - česte (više od 1 ali manje od 10 tretiranih životinja na 100 životinja) - manje česte (više od 1 ali manje od 10 tretiranih životinja na 1.000 životinja) - rijetke (više od 1 ali manje od 10 tretiranih životinja na 10.000 životinja) - vrlo rijetke (manje od 1 životinje na 10.000 tretiranih životinja, uključujući izolirane slučajeve).
English: Pharmacotherapeutic group: Immunologicals for bovidae, inactivated bacterial vaccines for cattle.
Croatian: Farmakoterapijska grupa: imunološki pripravci za goveda, inaktivirana bakterijska cjepiva za goveda.
English: Ivory-coloured homogeneous emulsion.
Croatian: Homogena emulzija boje slonovače.
English: - A mean transient increase in body temperature of about 1 °C, in some cows up to 2 °C, may occur in the first 24 hours after injection based on post-authorisation pharmacovigilance reporting.
Croatian: U prvih 24 sata nakon injiciranja može doći do prolaznog porasta tjelesne temperature, prosječno za otprilike 1 C, a u nekih krava do 2 C, temeljem izvješća farmakovigilanciji nakon dobivanja odobrenja za stavljanje u promet.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE
Croatian: 13. RIJEČI “SAMO ZA PRIMJENU NA ŽIVOTINJAMA I UVJETI ILI OGRANIČENJA U POGLEDU OPSKRBE I PRIMJENE
English: The injections should be preferably administered on the alternate sides of the neck.
Croatian: Po mogućnosti, injiciranje treba obaviti naizmjenično na obje strane vrata.
English: EU/2/08/092/001 1 glass vial 1 dose EU/2/08/092/002 10 glass vials 1 dose EU/2/08/092/003 20 glass vials 1 dose EU/2/08/092/004 1 glass vial 5 doses EU/2/08/092/005 10 glass vials 5 doses EU/2/08/092/006 1 glass vial 25 doses EU/2/08/092/007 10 glass vials 25 doses EU/2/08/092/008 1 PET vial of 5 doses
Croatian: EU/2/08/092/004 1 staklena bočica s 5 doza EU/2/08/092/005 10 staklenih bočica s 5 doza EU/2/08/092/006 1 staklena bočica s 25 doza EU/2/08/092/007 10 staklenih bočica s 25 doza EU/2/08/092/008 1 PET bočica s 5 doza EU/2/08/092/009 1 PET bočica s 25 doza EU/2/08/092/010 1 PET bočica s 125 doza
English: The vials are closed with a rubber stopper and aluminium cap.
Croatian: Ampule su zatvorene gumenim čepom i aluminijskim prstenom.
English: To stimulate active immunity against Staphylococcus aureus, coliforms and coagulase-negative staphylococci.
Croatian: Poticanje aktivne imunosti protiv Staphylococcus aureus, koliformnih bakterija i koagulazenegativnih stafilokoka.
English: E. coli J5 inactivated > 50 RED60 (Rabbit effective dose in 60% of the animals (serology)).
Croatian: E. coli J5 inaktivirana > 50 RED60 (djelotvorna doza u kunića, u 60% životinja (serološki nalaz)).
English: Polyethylene (PET) vials of 10, 50 and 250 ml.
Croatian: Polietilenske (PET) ampule od 10, 50 i 250 ml.
English: One dose contains: E. coli J5 inactivated; S. aureus (CP8) strain SP 140 inactivated.
Croatian: E.coli J5 inaktivirana; S.aureus (CP8) soj SP 140 inaktiviran.
English: Incompatibilities: Do not mix with any other veterinary medicinal product.
Croatian: Inkompatibilnosti: Ne miješati s bilo kojim drugim cjepivom ili veterinarsko-medicinskim proizvodom.
English: Allow the vaccine to reach a temperature of 15 °C to 25 °C before administration.
Croatian: Prije primjene pričekajte da cjepivo dostigne temperaturu od 15 °C do 25 °C.
English: 1 vial of 1 dose (2 ml) 10 vials of 1 dose (2 ml) 20 vials of 1 dose (2 ml) 1 vial of 5 doses (10 ml) 10 vials of 5 doses (10 ml) 1 vial of 25 doses (50 ml) 10 vials of 25 doses (50 ml) 1 vial of 125 doses (250 ml) 125 doses (250 ml)
Croatian: 1 bočica s 1 dozom (2 ml) 10 bočica s 1 dozom (2 ml) 20 bočica s 1 dozom (2 ml) 1 bočica s 5 doza (10 ml) 10 bočica s 5 doza (10 ml) 1 bočica s 25 doza (50 ml) 10 bočica s 25 doza (50 ml) 1 bočica s 125 doza (250 ml)
English: Withdrawal period: Zero days.
Croatian: KARENCIJE Karencija: nula dana.
English: - Anaphylactic-type reactions may occur in some sensitive animals which might be life-threatening based on post-authorisation pharmacovigilance reporting.
Croatian: - Kod nekih osjetljivih životinja može doći do po život opasnih reakcija anafilaktičkog tipa, temeljem izvješća farmakovigilanciji nakon dobivanja odobrenja za stavljanje u promet.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard boxes, PET vial (250 ml)
Croatian: PODACI NA VANJSKOM PAKOVANJU Kartonske kutije, PET ampule (250 ml)
English: EU/2/08/092/001-010
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/08/092/001-010