FrancophonIA/ELRC3.0 huggingface dataset:
English: In type 2 diabetes, the pancreas does not make enough insulin to control the level of glucose in the blood or the body is unable to use insulin effectively.
Croatian: Dijabetes tipa 2 bolest je pri kojoj gušterača ne proizvodi dovoljno inzulina za kontrolu razine glukoze u krvi ili pri kojoj tijelo ne može učinkovito iskoristiti inzulin.
English: Saxagliptin, the active substance in Onglyza, has been shown to be more effective than placebo (a dummy treatment) at controlling blood glucose in 8 main studies in over 3,900 patients.
Croatian: Saksagliptin, djelatna tvar u lijeku Onglyza, pokazao se učinkovitijim od placeba (prividnog liječenja) u kontroli razine glukoze u krvi u osam glavnih ispitivanja kojima je bilo obuhvaćeno više od 3 900 bolesnika.
English: Onglyza is a diabetes medicine used with diet and exercise to treat adults with type 2 diabetes to control their blood glucose (sugar) level.
Croatian: Onglyza je lijek protiv dijabetesa koji se primjenjuje uz dijetu i tjelovježbu za liječenje odraslih osoba oboljelih od dijabetesa tipa 2 radi kontroliranja razine glukoze (šećera) u krvi.
English: Why is Onglyza approved?
Croatian: Zašto je lijek Onglyza odobren?
English: In these studies saxagliptin was used as an ‘add-on' to other diabetes medicines in patients in whom previous treatment had failed.
Croatian: U tim je ispitivanjima saksagliptin primijenjen kao dodatak drugim lijekovima protiv dijabetesa u bolesnika u kojih prethodno liječenje nije bilo uspješno.
English: Onglyza has been shown to be effective at controlling blood glucose levels both on its own and as addon to other diabetes medicines.
Croatian: Lijek Onglyza pokazao se djelotvornim u kontroli razina glukoze u krvi i kao monoterapija i kao dodatak drugim lijekovima protiv dijabetesa.
English: For practical information about using Onglyza, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Onglyza bolesnici trebaju pročitati u uputi o lijeku, odnosno trebaju se obratiti svojem liječniku ili ljekarniku.
English: By increasing levels of incretin hormones in the blood, saxagliptin stimulates the pancreas to produce more insulin when blood glucose levels are high.
Croatian: Povisujući razinu inkretinskih hormona u krvi saksagliptin potiče gušteraču na proizvodnju više inzulina pri visokoj razini glukoze u krvi.
English: A further study compared saxagliptin with metformin in patients who had not previously received substantial treatment with diabetes medicines.
Croatian: U dodatnom ispitivanju analiziran je saksagliptin u kombinaciji s metforminom u bolesnika koji prethodno nisu primali jaču terapiju lijekova protiv dijabetesa.
English: What benefits of Onglyza have been shown in studies?
Croatian: Koje su koristi lijeka Onglyza utvrđene u ispitivanjima?
English: How does Onglyza work?
Croatian: Kako djeluje Onglyza?
English: Saxagliptin given on its own has also been shown to be more effective than placebo at controlling blood glucose in four studies: in patients given saxagliptin HbA1c levels fell by around 0.5 percentage points more than in patients given placebo.
Croatian: Monoterapija saksagliptinom također se pokazala učinkovitijom od placeba pri kontroli razine glukoze u krvi tijekom četiriju ispitivanja: u bolesnika koji su primali saksagliptin razina HbA1c pala je za oko 0,5 postotnih bodova više nego u bolesnika koji su primali placebo.
English: For the full list of all side effects reported with Onglyza, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih pri primjeni lijeka Onglyza potražite u uputi o lijeku.
English: How is Onglyza used?
Croatian: Kako se Onglyza koristi?
English: • In 565 patients not satisfactorily controlled on a thiazolidinedione (diabetes medicines such as pioglitazone and rosiglitazone), HbA1c levels fell by around 0.9 percentage points in patients adding saxagliptin compared with a fall of around 0.3 percentage points in patients who added placebo.
Croatian: • U 565 bolesnika čija se bolest nije zadovoljavajuće kontrolirala tiazolidinedionima (lijekovima protiv dijabetesa kao što su pioglitazon i roziglitazon), razina HbA1c pala je za oko 0,9 postotnih bodova u bolesnika čijoj je terapiji dodan saksagliptin, dok je u bolesnika koji su primali placebo zabilježen pad od oko 0,3 postotna boda.
English: • In 257 patients who took saxagliptin with metformin and a sulphonylurea, HbA1c levels fell by around 0.7 percentage points, compared with a fall of 0.1 percentage points in patients who were given placebo in place of saxagliptin.
Croatian: • U 257 bolesnika koji su uzimali saksagliptin s metforminom i sulfonilurejom, razina HbA1c pala je za oko 0,7 postotnih bodova, dok je u bolesnika koji su primali placebo umjesto saksagliptina zabilježen pad od oko 0,1 postotnog boda.
English: • In 457 patients not satisfactorily controlled on insulin (with or without metformin), HbA1c levels fell by around 0.7 percentage points in patients adding saxagliptin compared with a fall of around 0.3 percentage points in patients adding placebo.
Croatian: • U 457 bolesnika čija se bolest nije zadovoljavajuće kontrolirala inzulinom (s metforminom ili bez njega), razina HbA1c pala je za oko 0,7 postotnih bodova u bolesnika čijoj je terapiji dodan saksagliptin, dok je u bolesnika koji su primali placebo zabilježen pad od oko 0,3 postotna boda.
English: • In 743 patients not satisfactorily controlled on metformin alone, HbA1c levels fell by around 0.7 percentage points (from around 8.1% to around 7.4%) in patients adding saxagliptin compared with a rise of around 0.1 percentage points in patients adding placebo.
Croatian: • U 743 bolesnika čija se bolest nije zadovoljavajuće kontrolirala uz monoterapiju metforminom, razina HbA1c pala je za oko 0,7 postotnih bodova (s oko 8,1 % na oko 7,4 %) u bolesnika čijoj je terapiji dodan saksagliptin, dok je u bolesnika koji su primali placebo zabilježen porast od oko 0,1 postotnog boda.
English: • In 534 patients not satisfactorily controlled with metformin alone, adding saxagliptin reduced HbA1c levels by around 0.9 percentage points and adding saxagliptin and dapagliflozin reduced HbA1c levels by 1.5 percentage points.
Croatian: • U 534 bolesnika čija se bolest nije zadovoljavajuće kontrolirala uz monoterapiju metforminom, dodavanjem saksagliptina razina HbA1c smanjena je za oko 0,9 postotnih bodova, dok je dodavanjem saksagliptina i dapagliflozina razina HbA1c smanjena za oko 1,5 postotnih bodova.
English: • In 768 patients not satisfactorily controlled on a sulphonylurea, HbA1c levels fell by around 0.6 percentage points in patients adding saxagliptin compared with a rise of around 0.1 percentage points in patients who added placebo.
Croatian: • U 768 bolesnika čija se bolest nije zadovoljavajuće kontrolirala sulfonilurejom, razina HbA1c pala je za oko 0,6 postotnih bodova u bolesnika čijoj je terapiji dodan saksagliptin, dok je u bolesnika koji su primali placebo zabilježen porast od oko 0,1 postotnog boda.
English: • In 315 patients not satisfactorily controlled with metformin and dapagliflozin, adding saxagliptin to treatment with dapagliflozin and metformin reduced HbA1c levels by 0.5 percentage points, compared with a reduction of 0.2 percentage points when placebo was added to dapagliflozin and metformin.
Croatian: • U 315 bolesnika čija se bolest nije zadovoljavajuće kontrolirala metforminom i dapagliflozinom, dodavanjem saksagliptina terapiji dapagliflozinom i metforminom smanjene su razine HbA1c za oko 0,5 postotnih bodova, u usporedbi sa smanjenjem od 0,2 postotnog boda pri dodavanju placeba kombinaciji dapagliflozina i metformina.
English: • In 320 patients not controlled with metformin and saxagliptin, adding dapagliflozin to saxagliptin and metformin reduced HbA1c levels by 0.8 percentage points, compared with a reduction of 0.1 percentage points when placebo was added to saxagliptin and metformin.
Croatian: • U 320 bolesnika čija se bolest nije zadovoljavajuće kontrolirala metforminom i saksagliptinom, dodavanjem dapagliflozina saksagliptinu i metforminu smanjene su razine HbA1c za oko 0,8 postotnih bodova, u usporedbi sa smanjenjem od 0,1 postotnog boda pri dodavanju placeba kombinaciji saksagliptina i metformina.
English: Onglyza contains the active substance saxagliptin.
Croatian: Onglyza sadržava djelatnu tvar saksagliptin.
English: Where necessary, cats can be re-treated at 12-week intervals.
Croatian: Ukoliko je potrebno, mačke mogu biti ponovo tretirane u intervalima od 12 tjedana.
English: Date of first authorisation: 08/05/2018
Croatian: Datum prvog odobrenja: 08/05/2018
English: ATCvet code: QP54AB52.
Croatian: ATCvet kod: QP54AB52.
English: Each cardboard box contains 1 or 2 pipettes.
Croatian: Svaka kartonska kutija sadrži 1 ili 2 pipete.
English: This includes cuddling the animal and sharing a bed with the animal.
Croatian: Uključujući maženje životinje i dijeljenje kreveta sa životinjom.
English: This product can cause eye irritation.
Croatian: Ovaj proizvod može uzrokovati iritaciju oka.
English: Do not allow the product to enter water courses as this may be dangerous for fish and other aquatic organisms.
Croatian: Ne dopustite da proizvod uđe u otvorene vodene tokove jer to može biti opasno za ribe i druge vodene organizme.
English: A used pipette should immediately be disposed of.
Croatian: Iskorištenu pipetu treba odmah baciti.
English: Weight of cat (kg)
Croatian: Težina mačke (kg)
English: Step 2: The cat should be standing or lying with its back horizontal for easy application.
Croatian: Korak 2: mačka treba stajati ili ležati s leđima u horizontalnom položaju za lakšu primjenu.
English: Do not use directly on skin lesions.
Croatian: Ne primjenjivati izravno na ozljede na koži.
English: Parasite control is recommended throughout the period of potential infestation risk.
Croatian: Kontrola parazita preporučuje se tijekom razdoblja potencijalnog rizika od infestacije.
English: It takes up to 48 hours for the application site to become dry but it will be noticeable for longer.
Croatian: Potrebno je do 48 sati da se mjesto aplikacije osuši, ali biti će vidljivo i duže.
English: The product is highly flammable.
Croatian: Proizvod je vrlo zapaljiv.
English: Within each weight band, the content of one whole pipette should be used.
Croatian: Unutar svakog težinskog raspona potrebno je primijeniti sadržaj jedne cijele pipete.
English: In case of contact with the eyes, immediately rinse thoroughly with water.
Croatian: U slučaju kontakta s očima, odmah ih temeljito isperite vodom.
English: In the absence of available data, treatment of kittens less than 9 weeks of age and cats less than 1.2 kg bodyweight is not recommended.
Croatian: U nedostatku dostupnih podataka, ne preporučuje se tretiranje mačića mlađih od 9 tjedana i mačaka lakših od 1,2 kg tjelesne mase.
English: The cap will stay on the pipette; it is not possible to remove it.
Croatian: Poklopac će ostati na pipeti; nije ga moguće ukloniti.
English: Pregnancy, lactation and fertility:
Croatian: Graviditet, laktacija i plodnost:
English: Fluralaner is an acaricide and insecticide.
Croatian: Fluralaner je akaricid i insekticid.
English: Avoid frequent swimming or shampooing the animal because the maintenance of effectiveness of the product in these cases has not been tested.
Croatian: Izbjegavajte često kupanje ili šamponiranje životinje jer očuvanje djelotvornosti proizvoda u takvim slučajevima nije ispitano.
English: Do not allow recently treated animals to groom each other.
Croatian: Ne dopustite da nedavno tretirane životinje timare jedna drugu.
English: Step 3: Squeeze the pipette gently and apply the entire contents directly to the cat's skin.
Croatian: Korak 3: lagano pritisnite pipetu i primijenite cijeli sadržaj izravno na kožu mačke.
English: The sachets should only be opened immediateley prior to use.
Croatian: Vrećice se trebaju otvarati samo neposredno prije primjene.
English: Each pipette delivers:
Croatian: Svaka pipeta sadrži:
English: The period between treatment and return from the endemic areas should not exceed 60 days.
Croatian: Vrijeme između tretiranja do povratka u needemično područje ne bi trebalo biti duže od 60 dana
English: 5831 AN Boxmeer The Netherlands
Croatian: 5831 AN Boxmeer Nizozemska
English: Contact may occur either directly, when handling the product, or when handling the treated animal.
Croatian: Kontakt može biti direktan prilikom primjene proizvoda ili dodirivanjem tretirane životinje.
English: The use of this veterinary medicinal product should be based on the assessment of each individual case and on local epidemiological information about the current susceptibility of the target species in order to limit the possibility of a future selection for resistance.
Croatian: Primjenu ovog veterinarsko- medicinskog proizvoda treba temeljiti na procjeni svakog pojedinog slučaja te na temelju lokalnih epidemioloških informacija o trenutnoj osjetljivosti ciljne vrste, kako bi ograničili mogućnosti buduće selekcije za rezistenciju.
English: Lot:{number}
Croatian: Lot:{broj}
English: Do not allow treated animals to come into contact with untreated animals until the application site is dry.
Croatian: Ne dopustite da tretirane životinje dođu u kontakt s netretiranim sve dok im se mjesto primjene ne osuši.
English: Diethyltoluamide (DEET) Acetone
Croatian: Dietiltoluamide (DEET) Aceton
English: If you notice any side effects, even those not already listed in this package leaflet or you think the medicine has not worked, please inform your veterinary surgeon.
Croatian: Ako zamijetite bilo koju nuspojavu, čak i one koje nisu navedene u ovoj uputi o VMP ili mislite da veterinarsko-medicinski proizvod ne djeluje, molimo obavijestite svog veterinara.
English: The pipette is open and ready for application when the breaking of the seal is felt.
Croatian: Pipeta je otvorena i spremna za primjenu kada se osjeti pucanje brtve.
English: In case of spillage onto, for example table or floor surfaces, remove excess product using paper tissue and clean the area with detergent.
Croatian: U slučaju prolijevanja, na primjer na stol ili podne površine, uklonite višak proizvoda pomoću papirnatog ručnika i očistite područje deterdžentom.
English: Each ml of solution contains 280 mg fluralaner and 14 mg moxidectin.
Croatian: Svaki ml otopine sadrži 280 mg fluralanera i 14 mg moksidektina.
English: Bravecto Plus spot-on solution is available in three pipette sizes.
Croatian: Bravecto Plus otopina za nakapavanje dostupna je u tri veličine pipeta.
English: Read package leaflet for full user safety information.
Croatian: Pročitati uputu o VMP za potpune sigurnosne informacije.
English: Special warnings for each target species:
Croatian: Posebna upozorenja za svaku od ciljnih vrsta:
English: Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class under specific circumstances.
Croatian: Rezistencija parazita na bilo koju određenu klasu antihelmintika može se razviti nakon učestale, ponavljajuće primjene antihelmintika te klase pod određenim okolnostima.
English: For cats more than 12.5 kg, use a combination of two pipettes that most closely matches the body weight.
Croatian: Za mačke teže od 12,5 kg, koristite kombinaciju dviju pipeta koje najbliže odgovaraju tjelesnoj masi.
English: The effect on Dirofilaria immitis larvae has been shown to last over a period of 60 days after treatment with the product.
Croatian: Pokazalo se da učinak na larve Dirofilaria immitis traje u periodu od najmanje 60 dana nakon tretiranja ovim proizvodom.
English: Care should be taken to avoid contact with the eyes of the animal.
Croatian: Potrebno je poduzeti mjere kako bi izbjegli kontakt proizvoda s očima životinje.
English: This veterinary medicinal product does not require any special temperature storage conditions.
Croatian: Ovaj veterinarsko-medicinski proizvod ne zahtijeva nikakve posebne temperaturne uvjete čuvanja.
English: Clear colourless to yellow solution.
Croatian: Prozirna bezbojna do žuta otopina.
English: 27460 Igoville
Croatian: 27460 Igoville Francuska
English: Place the pipette tip on the base of the skull of the cat.
Croatian: Postavite vrh pipete na bazu lubanje mačke.
English: This product is for topical use and should not be administered orally.
Croatian: Proizvod je za topikalnu primjenu i ne smije se primjenjivati oralno.
English: Treatment of male breeding animals is not recommended.
Croatian: Ne preporučuje se tretiranje mužjaka za rasplod.
English: It is important to apply the dose as indicated to prevent the animal from licking and ingesting the product.
Croatian: Važno je primijeniti dozu kako je naznačeno, kako bi životinju spriječili da liže i proguta proizvod.
English: No therapeutic effect against adult Dirofilaria immitis has been established.
Croatian: Utvrđeno je da ne postoji terapijski učinak protiv adultnih oblika Dirofilaria immitis.
English: Keep away from heat, sparks, open flame or other sources of ignition.
Croatian: Držite ga dalje od izvora topline, iskri, otvorenog plamena ili drugih izvora zapaljenja.
English: EXP: {month/year}
Croatian: EXP: {mjesec/godina}
English: Do not use this veterinary medicinal product after the expiry date stated on the packaging after EXP.
Croatian: Ne koristite veterinarsko-medicinski proizvod poslije isteka roka valjanosti naznačenog na pakiranju iza oznake EXP.
English: The flea life cycle is broken due to the rapid onset of action and long lasting efficacy against adult fleas on the animal and the absence of viable egg production.
Croatian: Životni ciklus buhe je prekinut zbog brzog početka djelovanja i dugotrajnog učinka protiv adultnih oblika buha na životinji te izostanka proizvodnje vitalnih jajašaca.
English: Intervet UK Limited Walton Manor, Walton, Milton Keynes, Buckinghamshire, MK7 7AJ United Kingdom
Croatian: Walton Manor, Walton, Milton Keynes, Buckinghamshire, MK7 7AJ Velika Britanija
English: The safety of the veterinary medicinal product has not been established in pregnant or lactating animals and therefore use in such animals is not recommended.
Croatian: Neškodljivost veterinarsko-medicinskog proizvoda nije utvrđena u gravidnih životinja ili u životinja u laktaciji i stoga se primjena kod takvih životinja ne preporučuje.
English: This product is harmful after ingestion.
Croatian: Ovaj proizvod je štetan nakon gutanja.
English: Manufacturer responsible for batch release: Intervet Productions
Croatian: Proizvođač odgovoran za puštanje serije u promet: Intervet Production
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU Kartonska kutija
English: The pipette should be held by the base or by the upper rigid portion below the cap in an upright position (tip up) for opening it.
Croatian: Pipetu treba držati za bazu ili za gornji kruti dio ispod poklopca, u uspravnom položaju za otvaranje (vrh gore).
English: The onset of effect (killing effect) for ticks (I. ricinus) and fleas (C. felis) is within 48 hours after treatment.
Croatian: Početak djelovanja (učinak ubijanja) na krpelje (I. ricinus) i buhe (C. felis) je unutar 48 sati od tretiranja.
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: Milton Keynes Buckinghamshire MK7 7AJ
Croatian: Buckinghamshire MK7 7AJ
English: Macrocyclic lactones including moxidectin have been shown to be substrates for p-glycoprotein.
Croatian: Pokazalo se da su makrociklički laktoni, uključujući i moksidektin, supstrat za p-glikoprotein.
English: An in vitro study also demonstrated that very low concentrations of fluralaner stop the production of viable eggs by fleas.
Croatian: In vitro ispitivanje također pokazuje da vrlo male koncentracije fluralanera kod buha zaustavljaju proizvodnju vitalnih jajašaca.
English: Milbemycins and avermectins have a common mode of action that is based on the binding of ligandgated chloride channels (glutamate-R and GABA-R).
Croatian: Milbemicini i avermektini imaju zajednički način djelovanja koji se temelji na vezanju ligandom kontroliranih kloridnih kanala (glutamat-R i GABA-R).
English: Binding of glutamate-gated chloride channels, which are specific to invertebrates and do not exist in mammals, is considered the main mechanism for the anthelmintic and insecticidal activity.
Croatian: Vezanje glutamatom kontroliranih kloridnih kanala, koji su specifični za beskralježnjake i ne postoje u sisavaca, smatra se glavnim mehanizmom antihelmintskog i insekticidnog djelovanja.
English: Therefore, during treatment with Bravecto Plus, other products that can inhibit p-glycoprotein (e.g. cyclosporine, ketoconazole, spinosad, verapamil) should only be used concomitantly according to the benefit-risk assessment of the responsible veterinarian.
Croatian: Stoga, tijekom tretmana s Bravecto Plus, ostali proizvodi koji mogu inhibirati p-glikoprotein (npr. ciklosporini, ketokonazol, spinosad, verapamil) mogu se istodobno primjenjivati samo u skladu s procjenom koristi-rizika od strane odgovornog veterinara.
English: If skin contact does occur, wash the affected area immediately with soap and water.
Croatian: Ukoliko dođe do kontakta, odmah isprati zahvaćeno područje sapunom i vodom.
English: Fluralaner has a high potency against ticks and fleas by exposure via feeding, i.e. it is systemically active on target parasites.
Croatian: Fluralaner ima visoku potentnost protiv krpelja i buha koji su mu izloženi putem hranjenja, tj. sustavno djeluje na ciljne parazite.
English: Seek further veterinary examination (i.e. otoscopy) 28 days after treatment to determine whether there is re-infestation requiring additional treatment.
Croatian: Potražiti dodatnu veterinarsku pretragu (npr otoskopiju) 28 dana nakon tretiranja da bi se utvrdilo da li je došlo do reinfestacije, što traži dodatno liječenje.
English: For the prevention of heartworm disease caused by Dirofilaria immitis for 8 weeks.
Croatian: Za sprječavanje bolesti uzrokovane srčanim crvom Dirofilaria immitis kroz 8 tjedana.
English: Unit dose pipette made of laminated aluminium/polypropylene foil closed with a high-density polyethylene (HDPE) cap and packed in a laminated aluminium foil sachet.
Croatian: Pipeta s pojedinačnom dozom napravljena od laminirane aluminijske/polipropilenske folije, zatvorena poklopcem od polietilena visoke gustoće (HDPE) i pakirana u vrećicu od laminirane aluminijske folije.
English: This leads to an increased membrane permeability of nematode and arthropod nerve and/or muscle cells for chloride ions and results in hyperpolarization, paralysis and death of the parasites.
Croatian: To dovodi do povećane propusnosti membrane živčanih i/ili mišićnih stanica nematoda i člankonožaca za kloridne ione te rezultira hiperpolarizacijom, paralizom i smrću parazita.
English: The product should be applied on cats up to 6.25 kg body weight in one spot at the base of the skull and in two spots at the base of the skull on cats greater than 6.25 kg bodyweight.
Croatian: Proizvod treba primjenjivati na mačkama tjelesne mase do 6,25 kg na jedno mjesto na bazi lubanje, a u mačaka tjelesne mase veće 6,25 kg na dva mjesta na bazi lubanje.
English: Apply to skin.
Croatian: 3. Primijenite na kožu.
English: Step 1: Immediately before use, open the sachet and remove the pipette.
Croatian: Način primjene: Korak 1: neposredno prije primjene otvorite vrećicu i izvadite pipetu.
English: Ticks and fleas need to start feeding on the host to become exposed to fluralaner; therefore the risk of the transmission of parasite borne diseases cannot be excluded.
Croatian: Krpelji i buhe moraju započeti s hranjenjem na domaćinu kako bi se izložili fluralaneru; stoga se rizik od prijenosa parazitima prenosivih bolesti ne može isključiti.
English: Pipette content (ml) Fluralaner (mg)
Croatian: Sadržaj pipete (ml) Fluralaner (mg)