FrancophonIA/ELRC3.0 huggingface dataset:
English: For more information about treatment with Taltz, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Taltz pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: The medicine has been shown to be effective in moderate to severe plaque psoriasis and its side effects are in line with other similar psoriasis medicines.
Croatian: Lijek se pokazao učinkovitim u liječenju umjerene do teške psorijaze, a njegove su nuspojave u skladu s ostalim sličnim lijekovima za liječenje psorijaze.
English: How does Taltz work?
Croatian: Kako djeluje Taltz?
English: How is Taltz used?
Croatian: Kako se Taltz koristi?
English: What benefits of Taltz have been shown in studies?
Croatian: Koje su koristi lijeka Taltz utvrđene u ispitivanjima?
English: For the full list of all side effects and restrictions with Taltz, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Taltz potražite u uputi o lijeku.
English: For practical information about using Taltz, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Taltz pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: Taltz is available as an injection in pre-filled syringes and in pen injectors.
Croatian: Dostupan je u obliku injekcije u napunjenim štrcaljkama i brizgalicama.
English: Taltz contains the active substance ixekizumab.
Croatian: Sadrži djelatnu tvar iksekizumab.
English: 28 x 1tablets (unit dose) (calendar pack)
Croatian: 28 x 1 tableta (jedinična doza) (kalendarsko pakovanje)
English: MA (EU) number (Invented) name Strength Pharmaceutical Form
Croatian: Broj (EU) odobrenja
English: These reactions were generally mild in nature.
Croatian: Te reakcije su uglavnom bile blaže prirode.
English: Stress and irregular exercise should be avoided.
Croatian: Stres i neredovito kretanje treba izbjegavati.
English: 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 dostupne su na web stranici Europske agencije za lijekove http://www.ema.europa.eu/.
English: A U-40 syringe must be used.
Croatian: Mora se koristiti štrcaljka U-40.
English: A white ring may be seen in the neck of some vials, but this does not affect the quality of the product.
Croatian: Bijeli prsten je ponekad vidljiv na grliću nekih bočica, ali to ne utječe na kvalitetu proizvoda.
English: Specific pharmacovigilance requirements:
Croatian: Specifični zahtjevi farmakovigilancije:
English: One IU (International Unit) corresponds to 0.0347 mg of insulin human.
Croatian: Jedna međunarodna jedinica (IU) odgovara količini od 0,0347 mg humanog inzulina.
English: Cats and dogs
Croatian: Mačke i psi
English: EXP {month/year} Once broached use by ...
Croatian: EXP {mjesec/godina} Jednom načet, upotrijebiti do...
English: Store upright in a refrigerator.
Croatian: Čuvati uspravno u hladnjaku.
English: Store upright in a refrigerator (2 °C - 8 °C).
Croatian: Čuvati uspravno u hladnjaku (2 °C - 8 °C).
English: Metabolism:
Croatian: Metabolizam:
English: Particular care should be taken with regard to the accuracy of dosing.
Croatian: Posebno valja pripaziti na preciznost doziranja.
English: ATCvet code: QA10AC01 Insulin (human).
Croatian: ATCvet kod: QA10AC01 Inzulin (humani).
English: Amendment of the periodic safety update report (PSUR) cycle is required, as detailed in the CVMP assessment report.
Croatian: Potrebna je izmjena ciklusa podnošenja periodičkih izvješća o neškodljivosti (PSUR), kako je detaljno opisano u izvješću o procjeni CVMP-a.
English: *produced by recombinant DNA technology
Croatian: *proizveden tehnologijom rekombinantne DNK
English: For unused and broached vials:
Croatian: Za neiskorištene i probušene bočice:
English: Cloudy, white, aqueous suspension.
Croatian: Mutna, bijela, vodena suspenzija.
English: Keep the vial in the outer carton in order to protect from light.
Croatian: Držati bočicu u vanjskom kartonu radi zaštite od svjetla.
English: The product should be administered in the morning and in the evening, approx. 12 hours apart.
Croatian: Proizvod treba primjenjivati ujutro i navečer, u razmaku od približno 12 sati.
English: In the absence of compatibility studies, this product must not be mixed with other veterinary medicinal products.
Croatian: U nedostatku ispitivanja kompatibilnosti ovaj veterinarsko-medicinski proizvod se ne smije miješati s drugim veterinarsko-medicinskim proizvodima.
English: Local injection site reactions were very rarely reported and resolved without cessation of therapy.
Croatian: Lokalne reakcije na mjestu davanja injekcije bile su zabilježene vrlo rijetko te su se povukle bez prekida terapije.
English: Therefore, close glucose monitoring and veterinary supervision is advised.
Croatian: Stoga se preporučuje strogo praćenje razine glukoze i veterinarski nadzor.
English: Do not use for the acute management of diabetic ketoacidosis.
Croatian: Ne primjenjivati za akutnu kontrolu dijabetičke ketoacidoze.
English: Re-evaluation of clinical signs and laboratory parameters should be performed as recommended by the attending veterinarian.
Croatian: Ponovnu procjenu kliničkih znakova i laboratorijskih parametara treba provesti prema preporuci nadležnog veterinara.
English: Any dose adjustment (i.e. increase of dose) should be in general performed after several days (e.g. 1 week) since full action of insulin requires an equilibration phase.
Croatian: Svaku prilagodbu doze (tj. povećanje doze) trebalo bi u pravilu provoditi nakon nekoliko dana (npr. nakon 1 tjedna) jer potpuno djelovanje inzulina zahtijeva fazu uravnoteženja.
English: Avoid introduction of contamination during use.
Croatian: Izbjegavati unošenje kontaminanata za vrijeme primjene.
English: It may then be degraded on passage through the liver or by the kidney.
Croatian: Tada se može razgraditi prolaskom kroz jetru ili putem bubrega.
English: It is recommended to establish a regular twice daily feeding schedule with the owner whether injecting insulin once or twice daily.
Croatian: Preporučuje se uspostaviti raspored redovitog hranjenja dvaput na dan, pri čemu vlasnik treba davati injekciju inzulina jedanput ili dvaput na dan.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the vial after EXP.
Croatian: Ne koristite ovaj veterinarsko-medicinski proizvod poslije isteka roka valjanosti naznačenog na kutiji i bočici poslije EXP.
English: Dosing should be individualised and based on the clinical presentation of each patient.
Croatian: Doziranje treba biti individualizirano te se temeljiti na kliničkoj slici pojedinog pacijenta.
English: In general, insulin requirements during pregnancy and lactation might be different due to a change in the metabolic state.
Croatian: U pravilu, potrebe za inzulinom za vrijeme graviditeta i laktacije mogu biti različite zbog promjena u metaboličkom stanju.
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Croatian: Bilo koji neupotrjebljeni veterinarsko-medicinski proizvod ili otpadni materijali dobiveni primjenom tih veterinarsko-medicinskih proizvoda trebaju se odlagati u skladu s lokalnim propisima.
English: The suspension should be mixed by gently rolling the vial prior to withdrawing each dose from the vial.
Croatian: Suspenziju treba izmiješati laganim okretanjem bočice prije izvlačenja svake doze iz bočice.
English: Overall insulin influences the regulation of the carbohydrate and fat metabolism.
Croatian: Sveukupno, inzulin utječe na regulaciju metabolizma ugljikohidrata i masti.
English: Distribution:
Croatian: Distribucija:
English: The dose should be given concurrently with or immediately after a meal.
Croatian: Dozu treba davati istovremeno s jelom ili neposredno poslije jela.
English: After the daily insulin dose is established, monitoring for diabetic control is recommended.
Croatian: Nakon što se odredi dnevna doza inzulina, preporučuje se praćenje radi kontrole dijabetesa.
English: Pharmacotherapeutic group: Insulins and analogues for injection, intermediate acting.
Croatian: Farmakoterapijska grupa: inzulini i analozi za injekciju, srednjeg djelovanja.
English: Use only according to the benefit-risk assessment by the responsible veterinarian.
Croatian: Primijeniti samo nakon procjene odnosa koristi-rizika od strane odgovornog veterinara.
English: The liver and the kidney are the two main organs which eliminate insulin from the circulation.
Croatian: Jetra i bubreg dva su glavna organa koja eliminiraju inzulin iz krvotoka.
English: THE WORDS "FOR ANIMAL TREATMENT ONLY"
Croatian: RIJEČI “SAMO ZA PRIMJENU NA ŽIVOTINJAMA”
English: The safety and efficacy of ProZinc in breeding, pregnant and lactating animals has not been evaluated.
Croatian: Neškodljivost i djelotvornost ProZinc-a nije utvrđena za vrijeme parenja, graviditeta i laktacije životinja.
English: Target tissue organs are i.e. liver, muscle and adipose tissue.
Croatian: Ciljna tkiva i organi su jetra, mišići i masno tkivo.
English: Initiation
Croatian: Početak
English: Special precautions for use in dogs
Croatian: Posebne mjere opreza za primjenu u pasa
English: If the animal owner is to administer the product, suitable training/advice should be provided by the prescribing veterinarian before using for the first time.
Croatian: Ako će proizvod primjenjivati vlasnik životinje, veterinar koji propisuje terapiju treba mu pružiti odgovarajuću obuku/savjete prije prve uporabe.
English: Monitoring of glucose concentrations should be performed to adjust the dose accordingly.
Croatian: Potrebno je pratiti koncentracije glukoze kako bi se u skladu s tim prilagodila doza.
English: General guidance:
Croatian: Opće smjernice:
English: Each ml contains:
Croatian: Jedan ml sadrži: Djelatna tvar:
English: Medicines should not be disposed via wastewater or household waste.
Croatian: Veterinarsko medicinski proizvodi se ne smiju odlagati u otvorene vode ili kućni otpad.
English: There is a low possibility of an allergic reaction in sensitised individuals.
Croatian: U senzibiliziranih osoba postoji mala mogućnost alergijske reakcije.
English: The owner is advised to have glucose containing products (e.g. honey, dextrose gel) in the household.
Croatian: Vlasniku se preporučuje da u kućanstvu drži proizvode koji sadrže glukozu (npr. med, gel na bazi dekstroze).
English: Very stressful events, inappetance, concomitant treatment with gestagens and corticosteroids or other concomitant diseases (e.g. gastro-intestinal, infectious or inflammatory or endocrine diseases), might influence insulin effectiveness and therefore the insulin dose may need to be adjusted.
Croatian: Vrlo stresni događaji, inapetencija, istovremeno liječenje gestagenima i kortikosteroidima ili druge popratne bolesti (npr. gastrointestinalne, infekcijske ili upalne ili endokrine bolesti), mogu utjecati na djelotvornost inzulina te bi stoga trebalo prilagoditi dozu inzulina.
English: If insufficient improvement in diabetic control is observed after an adequate dose adjustment period of 4 to 6 weeks on once daily treatment, the following options may be considered: - Further adjustments of insulin dose on once daily treatment may be necessary; in particular if dogs undertake increased physical activity, have a change of their usual diet or during concomitant illness.
Croatian: Ako se nakon odgovarajućeg razdoblja prilagodbe doze od 4 do 6 tjedana u liječenju jednom dozom na dan ne zabilježi dovoljno poboljšanje u kontroli dijabetesa, treba razmotriti sljedeće mogućnosti: - U liječenju jednom dozom na dan mogu biti potrebne dodatne prilagodbe doze inzulina; osobito ako se psi bave intenzivnijim fizičkim aktivnostima, ako im se promijeni uobičajena prehrana ili tijekom istovremene bolesti.
English: Fourty per cent of insulin is eliminated by the liver and 60% is eliminated by the kidney.
Croatian: Putem jetre eliminira se 40% inzulina, a putem bubrega 60%.
English: Shelf life after first opening the container: 60 days.
Croatian: Rok valjanosti poslije prvog otvaranja spremnika: 60 dana.
English: The veterinarian should re-evaluate the animal at appropriate intervals and make adjustments to the treatment protocol, for instance dose and dosing regimen, until adequate glycaemic control has been attained.
Croatian: Veterinar bi trebao u odgovarajućim vremenskim razmacima procjenjivati životinju te prilagođavati protokol liječenja, na primjer dozu i režim doziranja, sve dok se ne postigne odgovarajuća kontrola glikemije.
English: 4.4 Special warnings for each target species
Croatian: 4.4 Posebna upozorenja za svaku od ciljnih vrsta
English: Following the binding of insulin with the insulin receptor and the subsequent action, insulin is released back into the extracellular environment.
Croatian: Nakon vezanja inzulina za inzulinske receptore i njegova djelovanja nakon toga, inzulin se otpušta natrag u izvanstanično okruženje.
English: After subcutaneous injection, proteolytic tissue enzymes degrade protamine to permit the absorption of insulin.
Croatian: Nakon potkožnog ubrizgavanja, proteolitički enzimi tkiva razgrađuju protamin kako bi se omogućila apsorpcija inzulina.
English: In the majority of cats the glucose lowering effect lasted for a minimum of 9 hours after first insulin injection.
Croatian: Kod većine mačaka, nakon prve injekcije inzulina, učinak snižavanja glukoze trajao je najmanje 9 sati.
English: Once broached use within 60 days.
Croatian: EXP {mjesec/godina} Jednom načet, upotrijebiti u roku od 60 dana.
English: Protamine zinc recombinant human insulin is an insulin whose absorption and onset of action is delayed by the addition of protamine and zinc leading to crystal formation.
Croatian: Rekombinantni humani protamin-cink inzulin je inzulin čija se apsorpcija i početak djelovanja odgađaju dodatkom protamina i cinka, što dovodi do stvaranja kristala.
English: In cases where hypoglycaemia is suspected, blood glucose measurements should be taken at the time of occurrence (if possible) as well as shortly prior to the next feeding/injection (where applicable).
Croatian: U slučajevima sumnje na hipoglikemiju mjerenja razine glukoze u krvi trebaju se provesti u trenutku njezina nastupa (ako je moguće), kao i nedugo prije sljedećeg hranjenja/injekcije (kada je to primjenjivo).
English: Changes in insulin requirements may result from administration of substances which alter glucose tolerance (e.g. corticosteroids and gestagens).
Croatian: Promjene u potrebama za inzulinom mogu biti posljedica primjene tvari koje mijenjaju podnošljivost glukoze (npr. kortikosteroidi i gestageni).
English: 0.088 mg
Croatian: 0,088 mg fenol
English: Shelf life after first opening the immediate packaging: 60 days.
Croatian: Rok valjanosti poslije prvog otvaranja unutarnjeg pakovanja: 60 dana.
English: The veterinary medicinal product should be administered by subcutaneous injection.
Croatian: Ovaj veterinarsko-medicinski proizvod treba primjenjivati potkožnom injekcijom.
English: The vial is closed with a butyl rubber stopper and sealed with a plastic flip-off cap.
Croatian: Bočica je zatvorena čepom od butilne gume i sigurnosnim plastičnim "flip-off" poklopcem.
English: Adjustments of insulin dose on a once daily regimen, if required, should generally be done in a conservative and gradual manner, (e.g. up to 25% increase/decrease of the dose per injection).
Croatian: Prilagodbe doze inzulina u režimu davanja jedne doze na dan, ako su potrebne, obično treba provoditi umjereno i postupno (npr. do 25 %-tnog povećanja/smanjenja doze po injekciji).
English: Hypoglycaemic reactions were very commonly reported in a clinical study: 26.5% (44 of 166) of treated dogs.
Croatian: Hipoglikemijske reakcije su vrlo često zabilježene u kliničkom ispitivanju: 26,5 % (44 od 166) liječenih pasa.
English: Excipients: Protamine sulfate
Croatian: Pomoćne tvari: protamin-sulfat
English: Hypoglycaemic reactions were very commonly reported in clinical studies: 13% (23 of 176) of treated cats and 26.5% (44 of 166) of treated dogs.
Croatian: Hipoglikemijske reakcije su vrlo često zabilježene u kliničkim ispitivanjima: 13% (23 od 176) liječenih mačaka i 26,5 % (44 od 166) liječenih pasa.
English: Agglomerates (e.g. clumps) can form in insulin suspensions: do not use the product if visible agglomerates persist after gently rolling the vial.
Croatian: U inzulinskim suspenzijama se mogu pojaviti nakupine, odnosno grudice: nemojte upotrijebiti proizvod ukoliko su nakupine vidljive i nakon što ste bočicu provaljali.
English: The main effects of insulin are the reduction in circulating blood glucose concentrations and the storage of fat.
Croatian: Glavni su učinci inzulina smanjenje koncentracija glukoze u krvi te pohrana masti.
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 životinja na 100 tretiranih životinja) - manje česte (više od 1 ali manje od 10 životinja na 1.000 tretiranih životinja) - rijetke (više od 1 ali manje od 10 životinja na 10.000 tretiranih životinja) - vrlo rijetke (manje od 1 životinje na 10.000 tretiranih životinja, uključujući izolirane slučajeve).
English: - Adjustments of insulin dose if required should usually be done between 0.5 to 1 IU insulin per injection.
Croatian: - Prilagodbe doze inzulina, ako su potrebne, obično treba provoditi unutar vrijednosti od 0,5 do 1 IU
English: - Switching to twice daily dosing: In such cases, it is recommended to reduce the dose per injection by one third (e.g. 12 kg dog being treated once daily with 12 IU insulin/injection may be switched to 8 IU insulin/injection administered twice daily).
Croatian: - Prelazak na doziranje dvaput na dan: u ovakvim slučajevima preporučuje se smanjiti dozu po injekciji za jednu trećinu (npr. pas od 12 kg koji jednom na dan prima dozu od 12 IU inzulina/injekcija može se prebaciti na dozu od 8 IU inzulina/injekcija koja se primjenjuje dvaput na dan).
English: Insulin administration should be temporarily stopped and the next dose of insulin adjusted appropriately.
Croatian: Davanje inzulina privremeno treba obustaviti, a sljedeću dozu inzulina prilagoditi na odgovarajući način.
English: Insulin activates insulin receptors and therewith a complex cell signaling cascade which results in increased glucose uptake into the cells.
Croatian: Inzulin aktivira inzulinske receptore i time složenu signalnu kaskadu unutar stanice koja ima za posljedicu povećan unos glukoze u stanice.
English: For newly diagnosed diabetic dogs, a starting dose of 0.5 IU insulin/kg once daily is recommended.
Croatian: Za pse kojima je nedavno dijagnosticiran dijabetes preporučena je početna doza od 0,5 IU inzulina/kg jednom na dan.
English: The initial recommended dose is 0.2 to 0.4 IU insulin/kg bodyweight every 12 hours.
Croatian: Početna preporučena doza iznosi od 0,2 do 0,4 IU inzulina/kg tjelesne mase svakih 12 sati.
English: An overdose of insulin can result in hypoglycaemia in which case immediate administration of a glucose containing solution or gel and/or food is required.
Croatian: Predoziranje inzulinom može imati za posljedicu hipoglikemiju; u tom je slučaju nužno odmah dati otopinu ili gel koji sadržava glukozu i/ili hranu.
English: In an experimental study in healthy dogs, the time to blood glucose nadir after a single subcutaneous injection of 0.8 or 0.5 IU/kg bodyweight of the product was variable between dogs (range 3 to >24 hours), as was the duration of insulin action (range 12 to >24 hours).
Croatian: U eksperimentalnom ispitivanju na zdravim psima, vrijeme do najniže razine glukoze u krvi, nakon jedne potkožne injekcije proizvoda od 0,8 ili 0,5 IU/kg tjelesne mase, razlikovalo se od psa do psa (raspon od 3 sata do >24 sata), kao i trajanje djelovanja inzulina (raspon od 12 sati do > 24 sata).
English: In those cases sufficient endogenous insulin production will be regained and the exogenous insulin dose will need to be adjusted or ceased.
Croatian: U tim će se slučajevima ponovno uspostaviti dovoljna proizvodnja endogenog inzulina te će se doza egzogenog inzulina trebati prilagoditi ili obustaviti.
English: Similarly, feeding cats with a high protein/low carbohydrate diet and changing the diet of any given cat or dog may alter insulin requirements and necessitate a change of insulin dose.
Croatian: Slično tome, prehrana mačaka s visokim sadržajem proteina ili niskim sadržajem ugljikohidrata i promjena prehrane bilo koje mačke ili psa može utjecati na potrebe za inzulinom i zahtijevati promjenu doze inzulina.
English: In addition, interstitial fluid will dilute and break down the formed zinc insulin hexamer complexes and result in a delayed absorption from the subcutaneous depot.
Croatian: Osim toga, intersticijalna tekućina razrjeđuje i razgrađuje formirane heksamerne komplekse inzulina i cinka, što rezultira usporenom apsorpcijom iz potkožnog spremišta.
English: Degradation normally involves endocytosis of the insulin-receptor complex, followed by the action of insulin-degrading enzyme.
Croatian: Razgradnja obično uključuje endocitozu kompleksa inzulina i njegovog receptora, nakon čega slijedi djelovanje enzima za razgradnju inzulina.
English: Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein GERMANY
Croatian: Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein NJEMAČKA
English: - For cats previously controlled on insulin, a higher starting dose up to 0.7 IU insulin/kg bodyweight may be appropriate.
Croatian: - Mačkama koje su prethodno liječene inzulinom može biti prikladnija viša početna doza do 0,7 IU
English: Clinical signs may include hunger, increasing anxiety, unstable locomotion, muscle twitching, stumbling or sinking in the rear legs and disorientation.
Croatian: Klinički znakovi mogu uključivati glad, sve veću tjeskobu, nestabilno kretanje, trzanje mišića, posrtanje ili gubljenje tla pod stražnjim nogama te dezorijentaciju.
English: 55216 Ingelheim/Rhein GERMANY
Croatian: 55216 Ingelheim/Rhein NJEMAČKA
English: To achieve optimal control of diabetes mellitus, dose adjustments should primarily be based on clinical signs.
Croatian: Radi postizanja optimalne kontrole dijabetesa melitusa prilagodbe doze treba prije svega temeljiti na kliničkim znakovima.
English: Clinical signs may include hunger, anxiety, unstable locomotion, muscle twitching, stumbling or sinking in the rear legs and disorientation.
Croatian: Klinički znakovi mogu uključivati glad, tjeskobu, nestabilno kretanje, trzanje mišića, posrtanje ili gubljenje tla pod stražnjim nogama te dezorijentaciju.
English: For initiation of treatment, the recommended dose is 0.5 to 1.0 IU insulin/kg bodyweight once daily every morning (approx. every 24 h).
Croatian: Za početak liječenja preporučena doza iznosi od 0,5 do 1,0 IU inzulina/kg tjelesne mase jednom na dan, svakog jutra (približno svaka 24 sata).
English: Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment) Water for injections
Croatian: 6.1 Popis pomoćnih tvari protamin-sulfat cinkov oksid glicerol dinatrijev fosfat, heptahidrat fenol kloridna kiselina (za podešavanje pH) natrijev hidroksid (za podešavanje pH) voda za injekcije
English: In this case immediate administration of a glucose containing solution or gel and/or food is required.
Croatian: Ako se ovo dogodi, nužno je odmah dati otopinu ili gel koji sadržava glukozu i/ili hranu.
English: Active substance: Insulin human*
Croatian: Humani inzulin*