FrancophonIA/ELRC3.0 huggingface dataset:
English: Caution should be used when administering tasimelteon in combination with fluvoxamine or other strong CYP1A2 inhibitors such as ciprofloxacin and enoxacin because of a potentially large increase in tasimelteon exposure and greater risk of adverse reactions: the AUC0-inf and Cmax of tasimelteon increased by 7-fold and 2-fold, respectively, when co-administered with fluvoxamine 50 mg (after 6 days of fluvoxamine 50 mg per day).
Croatian: inhibitorima kao što su ciprofloksacin i enoksacin zbog mogućeg velikog povećanja izloženosti tazimelteonu i većeg rizika od nuspojava: AUC0-inf povećao se 7 puta, a Cmax tazimelteona 2 puta kada su primijenjeni istodobno s fluvoksaminom od 50 mg (nakon 6 dana uzimanja fluvoksamina od 50 mg dnevno).
English: It may harm them, even if their signs of illness are the same as yours.
Croatian: Može im naškoditi, čak i ako su njihovi znakovi bolesti jednaki vašima.
English: HETLIOZ hard capsules are opaque dark blue printed with “VANDA 20 mg” in white.
Croatian: HETLIOZ tvrde kapsule neprozirne su i tamnoplave boje označene bijelom tintom oznakom „VANDA 20 mg”.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING LABEL FOR 30-COUNT BOTTLE
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU NALJEPNICA ZA BOCU KOJA SADRŽI 30 TABLETA
English: Date of first authorisation: 3 July 2015
Croatian: Datum prvog odobrenja:
English: Package leaflet: Information for the patient HETLIOZ 20 mg hard capsules
Croatian: Uputa o lijeku: Informacija za bolesnika HETLIOZ 20 mg tvrde kapsule tazimelteon
English: Clinical Response in Non-24-Hour Sleep-Wake Disorder The effectiveness of tasimelteon in the treatment of clinical symptoms, including the circadian sleep-wake cycle and clinical global functioning in patients with Non-24 was established in SET and RESET (Table 3).
Croatian: Učinkovitost tazimelteona u liječenju kliničkih simptoma, uključujući cirkadijani ciklus budnosti i spavanja i kliničku procjenu općeg funkcioniranja u bolesnika s poremećajem cirkadijalnog ritma koji ne traje 24 sata, utvrđena je ispitivanjima SET i RESET (Tablica 3).
English: SET Study Clinical response (Entrainment + N24CRS
Croatian: Klinički odgovor (usklađivanje + N24CRS N24CRS ≥ 3(2)
English: How to take HETLIOZ
Croatian: Kako uzimati HETLIOZ
English: The effectiveness of tasimelteon in the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) was established in two randomised, double-masked, placebo-controlled, multicentre, parallel-group studies (SET and RESET) in totally blind patients with Non-24.
Croatian: Klinička djelotvornost i sigurnost Učinkovitost tazimelteona u liječenju poremećaja cirkadijanog ritma budnosti i spavanja koji ne traje 24 sata utvrđena je u dva randomizirana, dvostruko slijepa, placebom kontrolirana ispitivanja s usporednim skupinama (SET i RESET) na potpuno slijepim bolesnicima s poremećajem cirkadijalnog ritma koji ne traje
English: Hard capsule shell Gelatin
Croatian: Ovojnica tvrde kapsule Želatina
English: > 45 min improvement in both nighttime and daytime sleep (%)(5)
Croatian: > 45-minutno poboljšanje u noćnom i dnevnom snu (%)(5) Vrijeme nastupa sna (u minutama)(1),(3) Ispitivanje RESET
English: Caution should be used when administering HETLIOZ in combination with fluvoxamine or other strong CYP1A2 inhibitors, particularly those which also inhibit other enzymes involved in the clearance of HETLIOZ because of a potentially large increase in tasimelteon exposure and greater risk of adverse reactions (see section 4.5).
Croatian: CYP1A2 inhibitorima, naročito onima koji inhibiraju i druge enzime uključene u klirensu lijeka HETLIOZ zbog mogućeg velikog povećanja izloženosti tazimelteonu i većeg rizika od nuspojava (vidjeti dio 4.5.).
English: Hard capsule core Lactose anhydrous Microcrystalline cellulose Croscarmellose sodium Silica, colloidal anhydrous Magnesium sterate
Croatian: Umrežena karmelozanatrij Silicijev dioksid, koloidni bezvodni Magnezijev stearat
English: Common: may affect up to 1 in 10 people - change in sleeping pattern - difficulty in sleeping - dizziness - dry mouth - tiredness - indigestion - feeling sick in the stomach - blood tests which show changes in the way the liver is working (alanine aminotransferase) - unusual dreams - sleepiness
Croatian: - mučnina u želucu - krvne pretrage koje pokazuju promjene u načinu rada jetre (alanin aminotransferaza) - neobični snovi
English: The apparent oral volume of distribution at steady state of tasimelteon in young healthy subjects is approximately 59 - 126 L. At therapeutic concentrations, tasimelteon is about 88.6 - 90.1% bound to proteins.
Croatian: Pri terapijskim koncentracijama, tazimelteon se veže za bjelančevine otprilike 88,6 - 90,1 %.
English: RESET Study
Croatian: Ispitivanje SET
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
Croatian: Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava navedenog u Prilogu V.
English: Tasimelteon has not been studied in patients with severe hepatic impairment (Child-Pugh Class C); therefore caution is recommended when prescribing HETLIOZ to patients with severe hepatic impairment.
Croatian: Tazimelteon nije ispitan u bolesnika s teškim oštećenjem funkcije jetre (Child-Pugh stadij C); stoga je pri propisivanju lijeka
English: Pollakiuria
Croatian: Propilenglikol
English: There was no increase in tumours at the lowest dose tested in rats, which is approximately 10 times the recommended human doseon a mg/m2 basis.
Croatian: koje su otprilike 10 puta više od preporučene doze za ljude na bazi mg/m2.
English: This is deemed even more important for strong CYP1A2 inhibitors also inhibiting other enzymes involved in the clearance of HETLIOZ (e.g. fluvoxamine and ciprofloxacin).
Croatian: Smatra se da je to još važnije za jake CYP1A2 inhibitore koji inhibiraju i druge enzime uključene u klirensu lijeka
English: How HETLIOZ works
Croatian: Kako djeluje HETLIOZ
English: How to store HETLIOZ
Croatian: Kako čuvati HETLIOZ
English: Effects of Tasimelteon 20 mg Treatment on Clinical Response in Non-24 Tasimelteon 20 mg Placebo
Croatian: Tablica 3: Učinak liječenja tazimelteonom u dozi od 20 mg na klinički odgovor bolesnika s poremećajem cirkadijanog ritma koji ne traje 24 sata
English: Taking HETLIOZ
Croatian: Uzimanje lijeka HETLIOZ
English: This includes: - medicines known to reduce the activity of an enzyme called ‘CYP1A2'.
Croatian: - lijekove koji smanjuju aktivnost enzima pod nazivom „CYP1A2”.
English: HETLIOZ contains the active substance tasimelteon.
Croatian: HETLIOZ sadrži djelatnu tvar tazimelteon.
English: Clinical Global Functioning in Non-24 Patients Tasimelteon 20 mg
Croatian: Tablica 4: Klinička procjena općeg funkcioniranja bolesnika s poremećajem cirkadijalnog ritma koji ne traje 24 sata Tazimelteon 20 mg
English: Orange Yellow S (E110)
Croatian: Boja Orange Yellow S (E110) Bijela tinta za označavanje
English: CGI-C (LS mean)
Croatian: CGI-C (srednja vrijednost dobivena metodom najmanjih kvadrata)
English: Entrainment in Non-24-Hour Sleep-Wake Disorder
Croatian: Usklađivanje u bolesnika s poremećajem cirkadijalnog ritma budnosti i spavanja koji ne traje 24 sata
English: You can help by reporting any side effects you may get.
Croatian: Prijavom svih sumnji na nuspojavu i sami možete pomoći.
English: Nighttime sleep on 25% most symptomatic nights >45 minutes increase in average nighttime sleep duration
Croatian: Noćni san u 25 % najsimptomatskijih noći
English: Sensitive to light.
Croatian: Osjetljivo na svjetlost.
English: Do not exceed the stated dose.
Croatian: Ne prekoračite naznačenu dozu.
English: The intervals between the two administrations should not be less than 3 days or more than 17 days.
Croatian: Razmak između dvije primjene ne bi smio biti manji od 3 dana ili veći od 17 dana.
English: In rare cases, the animal may collapse.
Croatian: U rijetkim slučajevima, životinja može kolabirati.
English: There is no known antidote.
Croatian: Ne postoji poznati protuotrov.
English: The product may be stored at 25 °C for 24 hours maximum.
Croatian: Proizvod se može čuvati na 25 °C kroz najviše 24 sata.
English: The syringes are packed into cardboard boxes as follows;
Croatian: Štrcaljke su pakirane u kartonske kutije kako slijedi;
English: Arginine.
Croatian: Arginin.
English: ATCvet code: QL03AA90
Croatian: ATCvet kod: QL03AA90
English: Bovine No MRL required
Croatian: Goveda MRL se ne zahtijeva
English: These clinical signs typically appear between 30 minutes and 2 hours after the first dose and resolve within 2 hours.
Croatian: Ovi se klinički znakovi tipično javljaju između 30 minuta i 2 sata nakon prve doze i nestanu unutar 2 sata.
English: Ask your veterinary surgeon or pharmacist how to dispose of medicines no longer required.
Croatian: Pitajte vašeg veterinara ili farmaceuta kako odlagati proizvode koji vam više nisu potrebni.
English: Store in original packaging.
Croatian: Čuvati u originalnom pakovanju.
English: Shelf -life after first opening the immediate packaging: use immediately.
Croatian: Rok valjanosti poslije prvog otvaranja unutarnjeg pakovanja: upotrijebiti odmah.
English: The product increases the number of circulating neutrophils.
Croatian: Proizvod povećava broj neutrofila u cirkulaciji.
English: Only clear solutions without particles should be used.
Croatian: Treba primjenjiti samo bistre otopine bez čestica.
English: Biological/ Immunomodulat or
Croatian: Biološki/Imuno modulator
English: Available in boxes of 10, 50 or 100 syringes.
Croatian: Dostupan u kutijama od 10, 50 ili 100 štrcaljki.
English: Clinical mastitis is investigated as a change in the appearance of the milk or of the quarter or of both milk and quarter.
Croatian: Klinički mastitis ispitan je kao promjena izgleda mlijeka ili četvrti ili oboje (mlijeka i četvrti).
English: Water for injections.
Croatian: Voda za injekcije.
English: During this EU study, 312 cows were treated with Imrestor for every 10 cases of clinical mastitis that were prevented during the periparturient period.
Croatian: Tijekom ovog ispitivanja u EU, 312 krava je tretirano Imrestorom na svakih 10 slučajeva kliničkog mastitisa koji su bili spriječeni tijekom peripartalnog razdoblja.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 09/12/2015
Croatian: Datum prvog odobrenja: 09/12/2015
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each 2.7 ml pre-filled syringe contains:
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Svaka 2,7 ml napunjena štrcaljka sadrži:
English: Do not mix with any other veterinary medicinal products.
Croatian: Ne miješati s bilo kojim drugim veterinarsko-medicinskim proizvodom.
English: Symptomatic treatment may be required.
Croatian: Katkada je možda potrebno simptomatsko liječenje.
English: Colony stimulating factors regulate the production and functional activities of immune cells.
Croatian: Faktori stimulacije kolonija reguliraju proizvodnju i funkcionalne aktivnosti imunosnih stanica.
English: Milk: zero days.
Croatian: Mlijeko: nula dana.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/15/193/001-003
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/15/193/001-003
English: The efficacy was tested together with normal management practice.
Croatian: Djelotvornost je ispitana zajedno s korištenjem uobičajenog programa upravljanja.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Croatian: Detaljnije informacije o ovom veterinarsko-medicinskom proizvodu dostupne su na web stranici Europske agencije za lijekove (http://www.ema.europa.eu/).
English: Concurrent use of such products should be avoided.
Croatian: Treba izbjegavati istodobnu primjenu takvih proizvoda.
English: A single syringe delivers a dose of 20-40 µg/kg pegbovigrastim for most cows depending on bodyweight: e.g. a dose of 21 µg/kg bodyweight for a 700 kg cow or 33 µg/kg bodyweight for a 450 kg heifer.
Croatian: Jedna štrcaljka sadrži dozu od 20 - 40 µg/kg pegbovigrastima koja je dovoljna za većinu krava ovisno o njihovoj tjelesnoj težini: npr. doza od 21 µg/kg tjelesne težine je za kravu od 700 kg ili 33 µg/kg tjelesne težine je za junicu od 450 kg.
English: The treatment regimen consists of two syringes.
Croatian: Program primjene sastoji se od dvije štrcaljke.
English: The active substance in Imrestor 15 mg solution for injection for cattle is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Croatian: Djelatna tvar u lijeku Imrestor 15 mg otopina za injekcije za goveda je dozvoljena tvar kako je navedeno u tablici 1, Dodatka Uredbe Komisije (EU) br. 37/2010:
English: Personal protective equipment consisting of gloves should be worn when handling broken or damaged syringes.
Croatian: Pribor za osobnu zaštitu koji se sastoji od rukavica treba koristiti pri rukovanju slomljenim ili oštećenim štrcaljkama.
English: The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this product.
Croatian: Pomoćne tvari navedene u dijelu 6.1 SPC-a su ili dozvoljene tvari za koje je u tablici 1, Dodatka Uredbe Komisije (EU) br. 37/2010 navedeno da određivanje MRL nijenužno ili se smatra da se na njih ne primjenjuju odredbe Uredbe (EK) br. 470/2009 kada se primjenjuju u tim veterinarsko medicinskim proizvodima.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the carton and on the pre-filled syringe.
Croatian: Ne koristite ovaj veterinarsko-medicinski proizvod poslije isteka roka valjanosti naznačenog na kutiji i na napunjenoj štrcaljki.
English: If you notice any serious effects or other effects not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Croatian: Ako zamijetite bilo koju ozbiljnu nuspojavu ili druge nuspojave koje nisu opisane u uputi o VMP, molimo obavijestite svog veterinara.
English: Medicines should not be disposed of via wastewater or household waste.
Croatian: Proizvod se ne smije odlagati u otvorene vode ili kućni otpad.
English: Citric acid monohydrate.
Croatian: Citratna kiselina hidrat.
English: As an aid in a herd management programme, to reduce the risk of clinical mastitis in periparturient dairy cows and heifers during the 30 days following calving.
Croatian: Koristi se kao pomoć u programu upravljanja stadom čiji je cilj smanjenje rizika pojave kliničkog mastitisa u peripartalnom razdoblju mliječnih krava i junica tijekom 30 dana nakon teljenja.
English: Subcutaneous administration of the product may induce transient local swelling at the injection site as well as inflammatory reactions which resolve within 14 days post treatment.
Croatian: Potkožna primjena proizvoda može izazvati prolazno lokalno oticanje na mjestu primjene injekcije kao i upalne reakcije koje nestaju unutar 14 dana nakon liječenja.
English: Pregnancy and lactation: Can be used in pregnancy and lactation
Croatian: Graviditet i laktacija: Može se primjeniti tijekom graviditeta i laktacije.
English: PHARMACEUTICAL FORM Solution for injection Clear, colourless to pale yellow solution
Croatian: OBLIK Otopina za injekciju Bistra, bezbojna do blijedo žuta otopina
English: The solution should be visually inspected prior to use.
Croatian: Zato otopinu treba vizualno pregledati prije primjene.
English: The content of a single pre-filled syringe is to be injected subcutaneously to a dairy cow/heifer 7 days before the anticipated date of calving.
Croatian: Sadržaj jedne napunjene štrcaljke treba injicirati potkožno mliječnoj kravi/junici 7 dana prije očekivanog datuma teljenja.
English: In animals, which have pharmaceutically altered immune function e.g. those which have recently received systemically administered corticosteroids or non-steroidal anti-inflammatory drugs the product may not be effective.
Croatian: Kod životinja kojima je farmaceutski izmijenjen imunosni sustav npr. one koje su nedavno primile sustavno primijenjene kortikosteroide ili nesteroidne protuupalne lijekove, proizvod možda neće biti djelotvoran.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s) during the course of one treatment) - 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 životinja pokazuju nuspojavu/e za vrijeme trajanja jednog tretmana) - česte (više od 1 ali manje od 10 životinja na 100 životinja) - manje česte (više od 1 ali manje od 10 životinja na 1.000 životinja) - rijetke (više od 1 ali manje od 10 životinja na 10.000 životinja) - vrlo rijetke (manje od 1 životinje na 10.000 životinja, uključujući izolirane slučajeve).
English: In a European field trial, the incidence of clinical mastitis observed in the treated group was 9.1 % (113/1235) and in the control group 12.4 % (152/1230), showing a relative reduction in mastitis incidence of 26.0 % (p=0.0094).
Croatian: U europskom terenskom ispitivanju pojava kliničkog mastitisa bila je 9,1 % (113/1235) u tretiranoj skupini, a u kontrolnoj skupini je bila 12,4 % (152/1230), što ukazuje na relativno smanjenje pojave mastitisa od 26 % (p=0,0094).
English: People with known hypersensitivity to pegbovigrastim should avoid contact with the veterinary medicinal product.
Croatian: Osobe preosjetljive na pegbovigrastim trebaju izbjegavati kontakt s ovim veterinarsko-medicinskim proizvodom.
English: 2.7 ml of solution for injection in a pre-filled polypropylene colourless syringe with siliconised chlorobutyl stopper and a stainless steel needle with needle guard.
Croatian: 2,7 ml otopine za injekciju u napunjenoj polipropilenskoj bezbojnoj štrcaljki sa silikoniziranim klorobutilnim čepom i iglom od nehrđajučeg čelika s poklopcem.
English: In the case of accidental self-injection, headache and bone and muscle pain may occur.
Croatian: U slučaju da se nehotično samoinjicira, mogu se pojaviti glavobolja i bol u kostima i mišićima.
English: Meat and offal: zero days Milk: zero days
Croatian: Meso i jestive iznutrice: nula dana Mlijeko: nula dana
English: As expected from the mode of action of the active substance, safety data shows that a mild and transient rise in somatic cell counts in individual cows may be seen.
Croatian: Kako se može očekivati po načinu djelovanja djelatne tvari, podaci o neškodljivosti pokazuju da se može uočiti blag i prolazan porast broja somatskih stanica kod pojedinačnih krava.
English: Pharmacotherapeutic group: Colony stimulating factors.
Croatian: FARMAKOLOŠKA SVOJSTVA Farmakoterapijska grupa: faktor stimulacije kolonija.
English: STATEMENT OF ACTIVE SUBSTANCES Each 2.7 ml pre-filled syringe contains 15 mg pegbovigrastim.
Croatian: SASTAV DJELATNIH TVARI Svaka 2,7 ml napunjena štrcaljka sadrži 15 mg pegbovigrastima.
English: Excessive shaking of the syringe may aggregate pegbovigrastim, reducing its biological activity.
Croatian: Pretjerana trešnja štrcaljke može uzrokovati skupljanje (agregaciju) pegbovigrastima, smanjujući njegovu biološku aktivnost.
English: Cattle (dairy cows and heifers).
Croatian: Goveda (mliječne krave i junice).
English: Imrestor 15 mg injection pegbovigrastim
Croatian: Imrestor 15 mg injekcija pegbovigrastim
English: Pegbovigrastim (Pegylated bovine Granulocyte Colony Stimulating Factor [PEG bG-CSF]) 15 mg For the full list of excipients, see section 6.1.
Croatian: Pegbovigrastim (pegilirani goveđi faktor stimulacije granulocitnih kolonija [PEG bG-CSF]) 15 mg Potpuni popis pomoćnih tvari vidi u odjeljku 6.1.
English: Only for subcutaneous injection.
Croatian: Samo za potkožnu injekciju.
English: Bovine granulocyte colony stimulating factor is a naturally occurring protein produced by mononuclear leukocytes, endothelial cells and fibroblasts.
Croatian: Goveđi faktor stimulacije granulocitnih kolonija je prirodna bjelančevina koju proizvode mononuklearni leukociti, endotelijalne stanice i fibroblasti.
English: 4.9 Amounts to be administered and administration route
Croatian: 4.9 Količine koje se primjenuju i put primjene
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Croatian: DOZIRANJE ZA SVAKU CILJNU VRSTU ŽIVOTINJA, METODE I NAČIN ( I) PRIMJENE
English: METHOD AND ROUTE(S) OF ADMINISTRATION Subcutaneous use.
Croatian: NAČIN I PUT(EVI) PRIMJENE Potkožno.
English: MANUFACTURER'S BATCH NUMBER Lot {number}
Croatian: BROJ PROIZVODNE SERIJE Serija {broj}
English: The content of a second pre-filled syringe is to be injected subcutaneously within 24 hours after calving.
Croatian: Sadržaj druge napunjene štrcaljke treba injicirati potkožno unutar 24 sata nakon teljenja.
English: 4.7 Use during pregnancy and lactation
Croatian: 4.7 Primjena tijekom graviditeta, laktacije ili nesenja
English: Remove gloves and wash hands and exposed skin after use.
Croatian: Nakon primjene proizvoda skinite rukavice te operite ruke i izloženu kožu.
English: PACKAGE SIZE 10 pre-filled syringes 50 pre-filled syringes 100 pre-filled syringes
Croatian: VELIČINA PAKOVANJA 10 napunjenih štrcaljki 50 napunjenih štrcaljki 100 napunjenih štrcaljki
English: Based on all field studies, the proportion of mastitis prevented due to herd treatment with Imrestor (Prevented Fraction) is 0.25 (with 95% confidence interval 0.14 - 0.35).
Croatian: Na osnovi svih terenskih ispitivanja omjer mastitisa spriječenog zahvaljujući primjeni Imrestor na stadu (prevenirana frakcija) je 0,25 (uz 95 % intervala pouzdanosti od 0,14 - 0,35).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cartons of 10, 50 or 100 syringes
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU Kutije s 10, 50 ili 100 štrcaljki
English: Or
Croatian: O
English: No information is available with regard to a possible immune reaction towards the product or towards the endogenous molecule (bG-CSF) after repeated use of the product in cows.
Croatian: Nema dostupnih informacija o mogućoj imunosnoj reakciji na proizvod ili na endogenu molekulu (bG-CSF) nakon ponovljene primjene proizvoda na kravama.
English: The cows presented with swelling of mucous membranes (notably vulva and eyelid), skin reactions, increased respiration rate and salivation.
Croatian: Krave su imale oticanje sluznica (osobito stidnice i očnog kapka), kožne reakcije, povećanu frekvenciju disanja i pojačano slinjenje.
English: No information is available on the safety and efficacy of the concurrent use of this product with vaccines.
Croatian: Ne postoje dostupni podaci o neškodljivosti i djelotvornosti istodobne primjene ovog proizvoda s cjepivima.
English: Pegbovigrastim is a modified form of the naturally occurring immunoregulatory cytokine, bovine granulocyte colony stimulating factor (bG-CSF).
Croatian: Pegbovigrastim je prilagođeni oblik prirodnog imunoregulacijskog citokina, goveđeg faktora stimulacije granulocitnih kolonija (bG-CSF).
English: Seek medical advice immediately and show the package leaflet or the label to the physician.
Croatian: Odmah potražiti pomoć liječnika i pokažite mu uputu o VMP ili etiketu.
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Croatian: Detaljne informacije o ovom veterinarsko-medicinskom proizvodu su dostupne na web stranici Europske agencije za ljekove http://www.ema.europa.eu/
English: There is no information about the pharmacokinetics of pegbovigrastim in cattle.
Croatian: Ne postoje podaci o farmakokinetici pegbovigrastima u goveda.