FrancophonIA/ELRC3.0 huggingface dataset:
English: In general data from influenza vaccinations in pregnant women do not indicate adverse foetal and maternal outcomes attributable to the vaccine.
Croatian: Općeniti podaci dobiveni nakon cijepljenja trudnica protiv influence ne upućuju na to da su se neželjeni ishodi za fetus i majku mogli pripisati cjepivu.
English: • injection site pain, reddening.
Croatian: • bol na mjestu injiciranja, crvenjenje.
English: Animal data have not shown effects on female fertility.
Croatian: Nisu dostupni podaci o utjecaju na plodnost u ljudi.
English: Store in a refrigerator (2 °C - 8 °C).
Croatian: 6.4 Posebne mjere pri čuvanju lijeka Čuvati u hladnjaku (2°C - 8°C).
English: Common ≥ 1/100 to
Croatian: Često ≥1/100 i
English: - Thrombocytopenia**
Croatian: - Trombocitopenija**
English: Rare (affects 1 to 10 users in 10,000):
Croatian: Rijetko (javljaju se kod 1 do 10 korisnika na 10 000):
English: Table 2: Vaccine Efficacy against Culture-Confirmed Influenza Attack Rate (%)
Croatian: Tablica 2: Djelotvornost cjepiva protiv gripe potvrđene na kulturi stanica Broj ispitanika po protokolu
English: Keep the pre-filled syringe in the outer carton in order to protect
Croatian: Čuvati napunjenu štrcaljku u vanjskom pakiranju radi zaštite
English: This includes any possible side effects not listed in this leaflet.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
Croatian: Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava navedenog u Dodatku V.
English: Very common (affects more than 1 user in 10):
Croatian: Vrlo često (javljaju se kod više od 1 korisnika na 10):
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACK - Outer carton box for containing 2 carton boxes with 10 syringes each (with or without needles)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VIŠESTRUKO PAKIRANJE - Vanjska kartonska kutija koja sadrži 2 kartonske kutije s 10 štrcaljki u svakoj
English: The following additional adverse reactions were reported from post-marketing surveillance with
Croatian: Sljedeće dodatne nuspojave prijavljene su na temelju postmarketinškog praćenja trovalentnih sezonskih cjepiva dobivenih na jajima:
English: Uncommon ≥ 1/1000 to
Croatian: Manje često ≥1/1000 i
English: Pregnancy, breast-feeding and fertility
Croatian: 4.6 Plodnost, trudnoća i dojenje
English: For intramuscular use.
Croatian: Za primjenu u mišić.
English: What Optaflu looks like and contents of the pack Optaflu is a suspension for injection in a pre-filled syringe (ready-to-use syringe).
Croatian: Optaflu je suspenzija za injekciju u napunjenoj štrcaljki (štrcaljka spremna za uporabu).
English: Children and adolescents:
Croatian: I DOHVATA DJECE
English: • Fainting can occur following, or even before, any needle injection.
Croatian: • nakon, ili čak i prije bilo kojeg uboda iglom može se javiti nesvjestica.
English: 1 pre-filled syringe (0.5 ml) with needle 10 pre-filled syringes (0.5 ml) with needle 1 pre-filled syringe (0.5 ml) without needle 10 pre-filled syringes (0.5 ml) without needle
Croatian: 1 napunjena štrcaljka (0,5 ml) s iglom 10 napunjenih štrcaljki (0,5 ml) s iglom 1 napunjena štrcaljka (0,5 ml) bez igle 10 napunjenih štrcaljki (0,5 ml) bez igle
English: The vaccine complies with the WHO recommendation (northern hemisphere) and EU decision for
Croatian: Ovo je cjepivo usklađeno s preporukom Svjetske zdravstvene organizacije (sjeverna hemisfera) i odlukom EU-a za sezonu 2015./2016.
English: Table 3: Comparative Efficacy of Optaflu versus Placebo against Culture-Confirmed
Croatian: Tablica 3: Usporedna djelotvornost protiv influence, potvrđene na kulturi stanica, Optaflua u odnosu na placebo, prema podtipovima virusa influence
English: These transitory false-positive results may be due to IgM production in response to the vaccine.
Croatian: Ovi rezultati mogu biti prolazni lažno pozitivni zbog stvaranja
English: Optaflu contains sodium chloride and potassium chloride This vaccine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
Croatian: Ovo cjepivo sadrži manje od 1 mmol natrija (23 mg) po dozi, tj. sadrži zanemarive količine natrija.
English: Carton box for syringe(s) without needle - 1 pre-filled syringe (0.5 ml) without needle - 10 pre-filled syringes (0.5 ml) without needle
Croatian: Kartonska kutija za štrcaljku(e) bez igle - 1 napunjena štrcaljka (0,5 ml) bez igle - 10 napunjenih štrcaljki (0,5 ml) bez igle
English: The following side effects have been observed during clinical trials and post-marketing surveillance:
Croatian: Tijekom kliničkih ispitivanja i praćenja nakon stavljanja gotovog lijeka u promet primijećene su sljedeće nuspojave:
English: Organ class
Croatian: Organski sustav
English: • fever, headache, vomiting and drowsiness progressing to coma or fits (convulsions) which are symptoms of an inflammation of the brain and spinal cord
Croatian: • vrućica, glavobolja, povraćanje i omamljenost koji se razvijaju do kome ili napadaja (konvulzija),
English: Carton Box for syringe(s) with needle - 1 pre-filled syringe (0.5 ml) with needle - 10 pre-filled syringes (0.5 ml) with needle
Croatian: Kartonska kutija za štrcaljku(e) s iglom - 1 napunjena štrcaljka (0,5 ml) s iglom - 10 napunjenih štrcaljki (0,5 ml) s iglom
English: What OPTAFLU is and what it is used for
Croatian: Što Optaflu sadrži
English: Not known (cannot be estimated from the available data) Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Croatian: manje često (≥1/1000 i <1/100) rijetko (≥1/10 000 i <1/1000) nepoznato (ne može se procijeniti iz dostupnih podataka) Unutar svake grupe učestalosti nuspojave su prikazane u padajućem nizu prema ozbiljnosti.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Influenza virus surface antigens (haemagglutinin and neuraminidase)*, inactivated, of the following
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Površinski antigeni virusa influence (hemaglutinin i neuraminidaza)*, inaktivirani, sljedećih sojeva: soj sličan A/California/7/2009 (H1N1)pdm09 (divlji tip A/Brisbane/10/2010)
English: • gastrointestinal disorders such as abdominal pain, diarrhoea or disturbance of the digestive tract These reactions are usually mild and only last a few days.
Croatian: • poremećaji probavnog sustava poput boli u trbuhu, proljeva ili poremećaja u probavnom traktu
English: ** Seroconversion = negative pre-vaccination HI titer and post-vaccination HI titer ≥40; significant increase = positive pre-vaccination HI titer and at least a 4-fold increase in post-vaccination HI titer.
Croatian: pozitivan HI titar prije cijepljenja i najmanje 4 puta povećanje HI titra nakon cijepljenja.
English: Influenza virus surface antigens (haemagglutinin and neuraminidase)*, inactivated, of the following
Croatian: Površinski antigeni virusa influence (hemaglutinin i neuraminidaza)*, inaktivirani, sljedećih sojeva: soj sličan A/California/7/2009 (H1N1)pdm09
English: It is available as tablets (1 and 2 mg).
Croatian: Dostupan je u tabletama (1 i 2 mg).
English: Resolor prucalopride
Croatian: Resolor prukaloprid
English: The full EPAR for Resolor can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR nalazi se internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: A risk management plan has been developed to ensure that Resolor is used as safely as possible.
Croatian: Razvijen je plan upravljanja rizikom kako bi se osiguralo da se Resolor koristi što je sigurnije moguće.
English: This summary was last updated in 06-2015.
Croatian: Sažetak je posljednji put ažuriran u 06.2015.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Resolor on 15 October 2009.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje za lijek Resolor na snazi u Europskoj uniji od 15. listopada 2009.
English: The result from patients who received Resolor at the higher dose of 4 mg was similar to those who took the 2 mg dose.
Croatian: Rezultat za bolesnike koji su primili Resolor pri većoj dozi od 4 mg bio je sličan onima koji su uzeli dozu od 2 mg.
English: Resolor was more effective than placebo at treating chronic constipation.
Croatian: Resolor je bio djelotvorniji od placeba u liječenju kronične konstipacije.
English: This means that it works like a substance in the body called 5-hydroxytryptamine (5-HT, also known as serotonin) and attaches to receptors for 5-HT in the gut called ‘5-HT4 receptors'.
Croatian: To znači da djeluje kao tvar u tijelu naziva 5-hidroksitriptamin (5-HT, koji je također poznat pod nazivom serotonin) i vezuje se na receptore za 5-HT u crijevima naziva „receptori 5-HT4”.
English: In the same way, when prucalopride attaches to and stimulates these receptors, it increases this movement and allows the bowels to empty faster.
Croatian: Na isti način, kada se prukaloprid vezuje na i potiče ove receptore, on pojačava rad crijeva i omogućuje brže pražnjenje crijeva.
English: What measures are being taken to ensure the safe and effective use of Resolor?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Resolor?
English: Patients aged over 65 years should start with a 1 mg dose once a day, and this can be increased to 2 mg once a day if needed.
Croatian: Žene starije od 65 godina trebaju započeti s 1 mg jedanput na dan; po potrebi se doza može povisiti na 2 mg jedanput na dan.
English: Other information about Resolor
Croatian: Ostale informacije o lijeku Resolor
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Resolor.
Croatian: Objašnjava kako je Odbor za lijekove za primjenu kod ljudi (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet i svoje preporuke o uvjetima za primjenu lijeka Resolor.
English: It must also not be used in patients with intestinal perforation or obstruction, severe inflammatory conditions of the intestines such as Crohn's disease, ulcerative colitis (inflammation of the large intestine causing ulceration and bleeding) and toxic megacolon and megarectum (very serious complications of colitis).
Croatian: Ne smije se primjenjivati u bolesnika s intestinalnom perforacijom ili opstrukcijom, teškim upalnim stanjima crijeva, poput Crohnove bolesti, ulceroznog kolitisa (upalom debeloga crijeva koja uzrokuje ulceraciju i krvarenje) te toksičnim megakolonom i megarektumom (vrlo teškim komplikacijama kolitisa).
English: This is a summary of the European public assessment report (EPAR) for Resolor.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Resolor.
English: For more information about treatment with Resolor, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Resolor pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: The active substance in Resolor, prucalopride, is a ‘5-HT4 receptor agonist'.
Croatian: Djelatna tvar u lijeku Resolor, prukaloprid, je „agonist receptora 5-HT4”.
English: The recommended dose of Resolor is 2 mg taken once a day.
Croatian: Preporučena doza lijeka Resolor je 2 mg jedanput na dan.
English: Resolor is a medicine that contains the active substance prucalopride.
Croatian: Resolor je lijek koji sadrži djelatnu tvar prukaloprid.
English: The main measure of effectiveness in the studies was the number of patients who completely emptied their bowels at least three times a week over a 12 week period without the help of laxatives.
Croatian: Glavna mjera djelotvornosti bio je broj bolesnika koji su u potpunosti ispraznili svoja crijeva u posljednja tri puta tijekom razdoblja od 12 tjedana bez pomoći laksativa.
English: The most common side effects with Resolor (seen in more than 1 patient in 10) are headache, nausea (feeling sick), diarrhoea and abdominal (tummy) pain.
Croatian: Najčešće nuspojave lijeka Resolor (koje se mogu javiti u više od 1 na 10 osoba) su glavobolja, mučnina (osjećaj slabosti), proljev i abdominalna bol (bol u trbuhu).
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Resolor, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana u sažetak opisa svojstava lijeka kao i u uputu za lijek Resolor uključene su sigurnosne informacije uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: The patients had not responded well enough to previous treatment with laxatives.
Croatian: Bolesnici nisu uspjeli postići odgovarajuće odgovore ranijim liječenjima laksativima.
English: When 5-HT binds to these receptors, it normally stimulates movement in the gut.
Croatian: Kada se 5-HT veže na ove receptore, uobičajeno je da potiče pražnjenje crijeva.
English: What is Resolor?
Croatian: Što je Resolor?
English: What is the risk associated with Resolor?
Croatian: Koji su rizici povezani s lijekom Resolor?
English: Resolor is used to treat symptoms of chronic (long-term) constipation in adults for whom laxatives (medicines that trigger bowel movements) do not work well enough.
Croatian: Resolor se koristi za liječenje simptoma kronične (dugotrajne) konstipacije u žena u kojih se laksativima (lijekovima koji potiču pražnjenje crijeva) nije uspjelo postići odgovarajuće olakšanje.
English: Over the 12-week period, 24% (151 out of 640) of patients who received Resolor 2 mg completely emptied their bowels at least three times a week, compared with 11% (73 out of 645) of patients who received placebo.
Croatian: Tijekom razdoblja od 12 tjedana, 24% (151 od 640) bolesnika koji su primali Resolor od 2 mg u potpunosti je ispraznilo svoja crijeva najmanje tri puta na tjedan, u usporedbi s 11% (73 od 645) koji su primili placebo.
English: Resolor (2 or 4 mg once a day) was compared with placebo (a dummy treatment) in three main studies involving 1,999 patients with chronic constipation, 88% of whom were women.
Croatian: Resolor (2 ili 4 mg jedanput na dan) uspoređen je s placebom (liječenjem bez djelatne tvari) u tri glavna ispitivanja koja su obuhvatila 1.999 bolesnika s kroničnom konstipacijom, od kojih su 88% bile žene.
English: In the study of men with chronic constipation, 38% of patients treated with Resolor 2 mg (67 out of 177) completely emptied their bowels at least three times a week, compared with 18% of those given placebo (32 out of 181).
Croatian: U ispitivanju muškaraca s kroničnom konstipacijom, 38% bolesnika koji su primali 2 mg lijeka Resolor (67 od 177) potpuno je ispraznila svoja crijeva najmanje tri puta na tjedan, u usporedbi s 18% (32 od 181) koji su primili placebo.
English: Resolor must not be used in patients with kidney problems requiring dialysis (a blood clearance technique).
Croatian: Resolor se ne smije primjenjivati u bolesnika s oštećenjima bubrega kojima je potrebna dijaliza (tehnika pročišćavanja krvi).
English: Why has Resolor been approved?
Croatian: Zašto je Resolor odobren?
English: The CHMP decided that Resolor's benefits are greater than its risks and recommended that it be given marketing authorisation..
Croatian: CHMP je odlučio da koristi od lijeka Resolor nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za korištenje u Europskoj uniji.
English: Resolor 2 mg once a day was also compared with placebo in another main study involving 374 men with chronic constipation.
Croatian: Uzimanje 2 mg lijeka Resolor jedanput dnevno također je u drugom ispitivanju s 374 muškarca s kroničnom konstipacijom uspoređeno s placebom.
English: What benefit has Resolor shown during the studies?
Croatian: Koje su koristi lijeka Resolor utvrđene u ispitivanjima?
English: What is Resolor used for?
Croatian: Za što se Resolor koristi?
English: How has Resolor been studied?
Croatian: Kako je Resolor ispitan?
English: How is Resolor used?
Croatian: Kako se Resolor koristi?
English: For the full list of all side effects reported with Resolor, see the package leaflet.
Croatian: Potpuni popis nuspojava koje su zabilježene s lijekom Resolor potražite u uputi o lijeku.
English: How does Resolor work?
Croatian: Kako djeluje Resolor?
English: Strength Pharmaceutical Form Route of Administration Packaging
Croatian: Farmaceutski oblik Put primjene Unutarnje pakiranje
English: EU Number
Croatian: Broj EU odobrenja Zaštićeno ime Doza
English: ATCvet code: QC03CA04.
Croatian: ATCvet kod: QC03CA04.
English: Treatment should be symptomatic.
Croatian: Liječenje treba biti simptomatsko.
English: The plasma protein binding was > 98%.
Croatian: Vezanje za proteine plazme bilo je > 98%.
English: 10 DATE OF REVISION OF THE TEXT {DD/MM/YYYY}
Croatian: 10 DATUM REVIZIJE TEKSTA {DD/MM/GGGG}
English: Refer to section 4.5.
Croatian: Pogledati odjeljak 4.5.
English: Any remaining tablet part should be discarded after 7 days.
Croatian: Preostali dio tablete treba baciti nakon 7 dana.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 31/07/2015
Croatian: Datum prvog odobrenja: 31/07/2015
English: MARKETING AUTHORISATION NUMBER(S) EU/2/15/184/001-008
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/15/184/001-008
English: A large proportion of the dose (between 61% and 70%) is excreted in the urine as unchanged parent drug.
Croatian: Veliki dio doze (između 61% i 70%) izlučio se urinom kao nepromijenjen izvorni lijek.
English: Tablets.
Croatian: Tablete.
English: Two metabolites (a dealkylated and a hydroxylated metabolite) were also identified in urine.
Croatian: Dva metabolita (dealkilirani i hidroksilirani metabolit) bila su također prisutna u urinu.
English: Once signs of congestive heart failure have been controlled and the patient is stable, if long term diuretic therapy with this product is required it should be continued at the lowest effective dose.
Croatian: Kada je postignuta kontrola znakova kongestivnog zatajenja srca i pacijent je stabilan, ako je potrebno dugotrajno diuretsko liječenje ovim proizvodom, treba ga nastaviti najnižom djelotvornom dozom.
English: This in turn decreases free water reabsorption resulting in increased water excretion/urine production.
Croatian: To uzrokuje smanjenje reapsorpcije slobodne vode te posljedično pojačano izlučivanje vode/stvaranje urina.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Croatian: OSNOVNI PODACI KOJI SE MORAJU NALAZITI NA BLISTERIMA ILI TRAKAMA
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains:
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Svaka tableta sadržava:
English: Polychlorotrifluoroethylene-PVC/aluminium blister pack (each blister pack contains 10 tablets) and is packaged in an outer cardboard box.
Croatian: Poliklorotrifluoroetilen-PVC/aluminij blister pakovanje (svako blister pakovanje sadrži 10 tableta) pakirano u vanjsku kartonsku kutiju.
English: All strengths are available in the following pack sizes: Pack sizes of 30 or 100 tablets.
Croatian: Sve jačine su dostupne u sljedećim veličinama pakovanja: Pakovanje sadržava 30 ili 100 tableta.
English: This product may cause increased urination and/or gastrointestinal disturbances if ingested.
Croatian: Ovaj proizvod može uzrokovati pojačano mokrenje i/ili gastrointestinalne smetnje ako se proguta.
English: Feeding significantly increased torasemide AUClast by 36% on average and slightly delayed Tmax but no significant impact on Cmax was detected.
Croatian: Hranjenje je značajno povećalo AUClast torasemida, u prosjeku za 36%, te malo odgodilo Tmax no nije zabilježen značajan utjecaj na Cmax.
English: EU/2/15/184/001 30 tablets of 0.75 mg EU/2/15/184/002 100 tablets of 0.75 mg EU/2/15/184/003 30 tablets of 3 mg EU/2/15/184/004 100 tablets of 3 mg EU/2/15/184/005 30 tablets of 7.5 mg EU/2/15/184/006 100 tablets of 7.5 mg EU/2/15/184/007 30 tablets of 18 mg EU/2/15/184/008 100 tablets of 18 mg
Croatian: EU/2/15/184/001 30 tableta od 0,75 mg EU/2/15/184/002 100 tableta od 0,75 mg EU/2/15/184/003 30 tableta od 3 mg EU/2/15/184/004 100 tableta od 3 mg EU/2/15/184/005 30 tableta od 7,5 mg EU/2/15/184/006 100 tableta od 7,5 mg EU/2/15/184/007 30 tableta od 18 mg EU/2/15/184/008 100 tableta od 18 mg 17. BROJ PROIZVODNE SERIJE PROIZVOĐAČA
English: UpCard tablets can be administered with or without food.
Croatian: UpCard tablete se mogu davati s hranom ili bez nje.
English: The daily schedule of administration can be timed to control the period of micturition according to need.
Croatian: Raspored primjene tijekom dana može se prilagoditi kako bi se, prema potrebi, kontrolirao period mokrenja.
English: If the level of diuresis requires alteration, the dose may be increased or decreased within the recommended dose range by increments of 0.1 mg/kg bodyweight.
Croatian: Ako je potrebna promjena razine diureze, doza se može povećavati ili smanjivati unutar preporučenog raspona doza u koracima po 0,1 mg/kg tjelesne težine.
English: The use of UpCard is not recommended during pregnancy, lactation and in breeding animals.
Croatian: Primjena UpCard tableta se ne preporučuje tijekom graviditeta, laktacije ili u rasplodnih životinja.
English: While the animal is on treatment, these parameters should be monitored at very regular intervals according to the benefit-risk assessment performed by the responsible veterinarian.
Croatian: Za vrijeme liječenja životinje potrebno je nadzirati ove parametre u pravilnim razmacima prema procjeni koristi i rizika provedenoj od strane odgovornog veterinara.
English: Frequent re-examinations of the dog will enhance the establishment of an appropriate diuretic dose.
Croatian: Česti kontrolni pregledi psa poboljšat će utvrđivanje odgovarajuće doze diuretika.
English: 4.4 Special warnings for each target species None.
Croatian: 4.4 Posebna upozorenja za svaku od ciljnih vrsta životinja
English: In healthy dogs and after once daily administration for 5 days, the mean percentage of increase in excreted urine over 24 hours ranged between 33% and 50% at 0.15 mg/kg, between 181% and 328% at 0.4 mg/kg and between 264% and 418% at 0.75 mg/kg.
Croatian: U zdravih pasa, nakon primjene jedne doze dnevno, tijekom 5 dana, srednja vrijednost postotka povećanja izlučivanja urina tijekom 24 sata bila je u rasponu između 33% i 50% pri 0,15 mg/kg, između 181% i 328% pri 0,4 mg/kg te između 264% i 418% pri 0,75 mg/kg.
English: Blister pack
Croatian: Blister pakovanje
English: Loop diuretics mainly inhibit the Na+/2Cl-/K+ carrier from the luminal side of the cell.
Croatian: Diuretici Henleove petlje uglavnom inhibiraju Na+/2Cl-/K+ nosač na luminalnoj strani stanice.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the carton.
Croatian: Ne koristite veterinarsko-medicinski proizvod poslije isteka roka valjanosti naznačenog na kutiji.
English: Occurrence of soft faeces is transient, mild, and does not necessitate the withdrawal of the treatment.
Croatian: Pojava meke feces je prolazna, blaga i ne zahtijeva prekid liječenja.
English: Concomitant use with veterinary medicinal products affecting electrolyte balance (corticosteroids, amphotericin B, cardiac glycosides, other diuretics) requires careful monitoring.
Croatian: Istovremena primjena s veterinarsko-medicinskim proizvodima koji utječu na ravnotežu elektrolita (kortikosteroidi, amfotericin B, srčani glikozidi, drugi diuretici) zahtijeva pažljivo praćenje.
English: Any part tablet should be stored in the blister pack or in a closed container for a maximum of 7 days.
Croatian: Bilo koji dio tablete treba čuvati u blister pakiranju ili u zatvorenom spremniku najduže 7 dana.
English: The safety of the veterinary medicinal product has not been established during pregnancy or lactation.
Croatian: Neškodljivost veterinarsko-medicinskog proizvoda tijekom graviditeta ili laktacije nije utvrđena.