FrancophonIA/ELRC3.0 huggingface dataset:
English: For practical information about using Galliprant, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Croatian: Praktične informacije o primjeni VMP-a Galliprant vlasnici životinja ili uzgajivači trebaju pročitati u uputi o VMP-u, odnosno trebaju se obratiti veterinaru ili ljekarniku.
English: What benefits of Galliprant have been shown in studies?
Croatian: Koje su koristi od VMP-a Galliprant utvrđene u ispitivanjima?
English: Other information about Galliprant?
Croatian: Ostale informacije o VMP-u Galliprant
English: For more information about treatment with Galliprant, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Croatian: Dodatne informacije o terapiji VMP-om Galliprant vlasnici životinja ili uzgajivači trebaju pročitati u uputi o VMP-u, odnosno trebaju se obratiti veterinaru ili ljekarniku.
English: How does Galliprant work?
Croatian: Kako djeluje Galliprant?
English: Packaging Content
Croatian: Unutarnje pakovanje
English: • Inject slowly over 1 to 3 minutes.
Croatian: • Injicirajte polako tijekom 1 do 3 minute.
English: • you have recently had surgery
Croatian: • nedavno ste imali kirurški zahvat
English: Always use an aseptic technique.
Croatian: Uvijek primjenjivati aseptičku tehniku.
English: This is given as one injection every week.
Croatian: Daje se u obliku jedne injekcije svaki tjedan.
English: 40 IU/kg body weight once weekly.
Croatian: 40 IU/kg tjelesne težine jednom tjedno.
English: All evaluated minor surgeries were performed successfully.
Croatian: Svi procijenjeni manji kirurški zahvati uspješno su obavljeni.
English: CV = coefficient of variation.
Croatian: CV (engl. coefficient of variation) = koeficijent varijacije.
English: • Wash your hands and dry them properly using a clean towel or air dry.
Croatian: • Operite ruke i dobro ih osušite čistim ručnikom ili na zraku.
English: Submission of study results: Q2-2028
Croatian: Predaja rezultata ispitivanja: Q2-2028
English: In case of shock, standard medical treatment for shock should be implemented.
Croatian: U slučaju šoka potrebno je primijeniti standardno liječenje za šok.
English: Osmolality: 272 mOsmol/kg.
Croatian: Osmolalnost: 272 mOsm/kg.
English: A single dose is recommended.
Croatian: Preporučuje se samo jedna doza.
English: A double dose should be avoided.
Croatian: Potrebno je izbjegavati dvostruku dozu.
English: Minor surgery including tooth extraction.
Croatian: Manji kirurški zahvat uključujući vađenje zuba.
English: Additional doses can be given if needed.
Croatian: Prema potrebi mogu se dati dodatne doze.
English: • if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na djelatnu tvar ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: Depending on the location and the severity of bleeding you may need a higher dose (80 IU per kg) or extra injections.
Croatian: Ovisno o mjestu i jačini krvarenja možda ćete trebati veću dozu (80 IU po kg) ili dodatne injekcije.
English: • Check the name, strength and colour of the package, to make sure it contains the correct product.
Croatian: • Provjerite naziv, jačinu i boju na pakiranju kako biste bili sigurni da sadrži odgovarajući lijek.
English: Therefore, silica based reagents should be avoided.
Croatian: Zbog toga treba izbjegavati reagense na bazi silicijevog dioksida.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using Refixia.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije nego uzmete lijek Refixia.
English: Do not stop using Refixia without talking to your doctor.
Croatian: Nemojte prestati primjenjivati lijek Refixia bez razgovora sa svojim liječnikom.
English: common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Croatian: (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000); vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: From a microbiological point of view, the reconstituted product should be used immediately.
Croatian: S mikrobiološkog stajališta, rekonstituirani lijek treba se odmah upotrijebiti.
English: • skin reactions at the site of injection
Croatian: • kožne reakcije na mjestu injiciranja
English: Check with your doctor if you are not sure about how to use Refixia.
Croatian: Provjerite s liječnikom ako niste sigurni kako primijeniti lijek Refixia.
English: There were no apparent differences in the pharmacokinetic profiles between normal weight and overweight patients.
Croatian: Nije bilo vidljivih razlika u farmakokinetičkim profilima između bolesnika normalne i prekomjerne težine.
English: In each of these situations, the benefit of treatment with Refixia should be weighed against the risk of these complications.
Croatian: U takvim je situacijama potrebno procijeniti korist od liječenja lijekom Refixia u odnosu na rizik od tih komplikacija.
English: Contents of the pack and other information What Refixia contains
Croatian: Sadržaj pakiranja i druge informacije Što Refixia sadrži
English: What Refixia looks like and contents of the pack
Croatian: Kako Refixia izgleda i sadržaj pakiranja
English: The MAH shall complete, within the stated timeframe, the below measures: Description
Croatian: Nositelj odobrenja dužan je, unutar navedenog vremenskog roka, provesti niže navedene mjere: Opis
English: Consider two repeated doses of 40 IU/kg (in 1-3 day intervals) within the first week after surgery.
Croatian: Razmislite o dvije ponovljene doze od 40 IU/kg (u intervalima od 1-3 dana) tijekom prvog tjedna nakon kirurškog zahvata.
English: Pre-operative dose.
Croatian: Prijeoperacijska doza.
English: For further information, see section 2 “Allergic reactions and development of inhibitors”.
Croatian: Za dodatne informacije pogledajte dio 2 ‘Alergijske reakcije i razvoj inhibitora'.
English: If you stop using Refixia you may no longer be protected against bleeding or a current bleed may not stop.
Croatian: Ako prestanete primjenjivati lijek Refixia, možda više nećete biti zaštićeni od krvarenja ili trenutno krvarenje možda neće stati.
English: Additional doses of 40 IU/kg can be given.
Croatian: Mogu se dati dodatne doze od 40 IU/kg.
English: Do not open the equipment until you are ready to use it.
Croatian: Nemojte otvarati pribor dok niste spremni da ga primijenite.
English: Thrombin then converts fibrinogen into fibrin and a clot is formed.
Croatian: Trombin zatim pretvara fibrinogen u fibrin i stvara se krvni ugrušak.
English: Caution: The pre-filled syringe is made of glass and is designed to be compatible with standard luerlock connections.
Croatian: Oprez: Napunjena štrcaljka izrađena je od stakla i oblikovana da bude kompatibilna sa standardnim luer-lock nastavcima.
English: Discuss with your doctor the dose and number of injections you need.
Croatian: Razgovarajte sa svojim liječnikom o potrebnoj dozi i broju injekcija.
English: Allergic reactions are possible with this medicine.
Croatian: Moguće su alergijske reakcije na ovaj lijek.
English: • pale and cold skin, fast heartbeat, and/or dizziness (low blood pressure).
Croatian: • blijeda i hladna koža, ubrzani otkucaji srca i/ili omaglica (niski krvni tlak).
English: There are insufficient data to provide information on inhibitor incidence in previously untreated patients.
Croatian: Nema dovoljno podataka za davanje informacija o incidenciji inhibitora u prethodno neliječenih bolesnika.
English: • you suffer from other serious illness e.g. liver disease, heart disease, or cancer
Croatian: • bolujete od neke druge ozbiljne bolesti, npr. bolest jetre, bolest srca ili imate rak
English: Half-life (t1/2) (hours)
Croatian: Poluvijek (t1/2) (sati)
English: Tremors have not been reported in the clinical trials.
Croatian: Tremori nisu prijavljeni u kliničkim ispitivanjima.
English: No mechanism behind the tremors was identified.
Croatian: Nije utvrđen nikakav mehanizam u pozadini tremora.
English: What Refixia is and what it is used for
Croatian: Što je Refixia i za što se koristi
English: Your doctor will calculate your dose for you.
Croatian: Liječnik će Vam izračunati dozu lijeka.
English: The specific activity of Refixia is approximately 152 IU/mg protein.
Croatian: Specifična aktivnost lijeka Refixia iznosi približno 152 IU/mg proteina.
English: What you need to know before you use Refixia
Croatian: Što morate znati prije nego počnete primjenjivati lijek Refixia
English: • Take out the number of Refixia packages you need.
Croatian: • Uzmite onoliki broj pakiranja lijeka Refixia koliko trebate.
English: Other medicines and Refixia Tell your doctor if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: No symptoms associated with overdoses have been reported.
Croatian: Nije prijavljen ni jedan simptom povezan s predoziranjima.
English: This finding was not associated with tissue damage or abnormal clinical signs.
Croatian: Taj nalaz nije bio vezan uz oštećenje tkiva ili neuobičajene kliničke znakove.
English: The dose will depend on your weight and what the medicine is being used for.
Croatian: Doza će ovisiti o Vašoj tjelesnoj težini i o tome za što se lijek primjenjuje.
English: In the clinical trial programme, dose adjustment was not performed.
Croatian: U programu kliničkog ispitivanja nije provođena prilagodba doze.
English: You must contact your doctor or an emergency unit immediately if you have early signs of an allergic reaction such as:
Croatian: Odmah se obratite liječniku ili hitnoj medicinskoj službi ako imate rane znakove alergijske reakcije kao što su:
English: If you are not sure if either of the above applies to you, talk to your doctor before using this medicine.
Croatian: Ako niste sigurni odnosi li se nešto od gore navedenog na Vas, obratite se svom liječniku prije nego što primijenite ovaj lijek.
English: When you bleed, Refixia is activated in the blood to form factor IX.
Croatian: Kada krvarite Refixia se aktivira u krvi kako bi se stvorio faktor IX.
English: This incompatibility may prevent administration of the drug and/or result in damage to the needleless connector.
Croatian: Ova inkompatibilnost može onemogućiti primjenu lijeka i/ili dovesti do oštećenja konektora za primjenu bez igle.
English: • If the CVAD line needs to be flushed before or after Refixia injection, use sodium chloride 9 mg/ml solution for injection.
Croatian: • Ako CVAD liniju treba isprati prije ili nakon injekcije lijeka Refixia, upotrijebite 9 mg/ml otopinu natrijeva klorida za injekciju.
English: An overall assessment of haemostatic efficacy was performed by the patient or caretaker (for home treatment) or study site investigator (for treatment under health care professional supervision) using a 4-point scale of excellent, good, moderate, or poor.
Croatian: Ukupnu procjenu hemostatske djelotvornosti obavio je bolesnik ili njegovatelj (za liječenje kod kuće) ili ispitivač na mjestu ispitivanja (za liječenje pod nadzorom zdravstvenog radnika) koristeći 4-stupanjsku ljestvicu za izvrsno, dobro, umjereno ili slabo.
English: If your dose requires more than one vial, repeat steps A to J with additional vials, vial adapters and pre-filled syringes until you have reached your required dose.
Croatian: Ako za dozu trebate više od jedne bočice, ponovite korake od A do J s dodatnim bočicama, nastavcima za bočicu i napunjenim štrcaljkama dok ne dobijete potrebnu dozu.
English: If the medicine has not been used before the new expiry date, it should be disposed of.
Croatian: Ako se lijek ne iskoristi prije novog roka valjanosti, potrebno ga je baciti.
English: The dose in adolescents is also calculated according to body weight and is the same dose as for adults.
Croatian: Doza za adolescente se također računa ovisno o tjelesnoj težini i jednaka je onoj za odrasle.
English: Non-clinical data reveal no concern for humans based on conventional safety pharmacology and repeated dose toxicity studies in rats and monkeys.
Croatian: Neklinički podaci ne ukazuju na rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije i toksičnosti ponovljenih doza na štakorima i majmunima.
English: A pre-operative dose of 80 IU/kg Refixia was effective and no patients required additional doses on the day of surgery.
Croatian: Prijeoperacijska doza od 80 IU/kg lijeka Refixia bila je učinkovita i ni jednom bolesniku nije bila potrebna dodatna doza na dan operacije.
English: Pharmacotherapeutic group: antihaemorrhagics, blood coagulation factor IX, ATC code: B02BD04.
Croatian: Farmakoterapijska skupina: antihemoragici, koagulacijski faktor IX, ATK oznaka: B02BD04.
English: The average molecular weight of Refixia is approximately 98 kDa and the molecular weight of the protein moiety alone is 56 kDa.
Croatian: Prosječna molekularna težina lijeka Refixia je približno 98 kDa, a molekularna težina samog proteinskog dijela je 56 kDa.
English: Dose and duration of the substitution therapy depend on the location and severity of the bleeding, see Table 1 for dosing guidance in bleeding episodes.
Croatian: Doza i trajanje nadomjesne terapije ovise o mjestu i težini krvarenja, vidjeti Tablicu 1 za smjernice za doziranje kod epizoda krvarenja.
English: • Injecting into a CVAD may require using a sterile 10 ml plastic syringe for withdrawal of the reconstituted solution.
Croatian: • Injiciranje u CVAD može zahtijevati uporabu sterilne plastične štrcaljke od 10 ml za uvlačenje pripremljene otopine.
English: Do not use the equipment if it has been dropped, or if it is damaged.
Croatian: Nemojte koristiti pribor ako je pao ili ako je oštećen.
English: The pivotal trial included 74 adolescent (13-17 years) and adult (18-65 years) previously treated patients.
Croatian: Pivotalno ispitivanje obuhvaćalo je 74 adolescentna (13-17 godina) i odrasla (18-65 godina) prethodno liječena bolesnika.
English: Use the injection immediately after reconstitution.
Croatian: Injekciju primijenite odmah nakon pripreme.
English: The dose of Refixia is 40 international units (IU) per kg of body weight.
Croatian: Doza lijeka Refixia je 40 internacionalnih jedinica (IU) po kg tjelesne težine.
English: Cardiovascular event
Croatian: Kardiovaskularni događaji
English: Routine monitoring of factor IX activity levels for the purpose of dose adjustment is not necessary.
Croatian: Rutinsko praćenje razina aktivnosti faktora IX radi prilagodbe doze nije potrebno.
English: In patients with existing cardiovascular risk factors, substitution therapy with FIX may increase the cardiovascular risk.
Croatian: U bolesnika s postojećim kardiovaskularnim čimbenicima rizika, nadomjesna terapija FIX-om može povećati kardiovaskularni rizik.
English: The procedures included 9 orthopaedic, 1 gastrointestinal, and 3 surgeries in the oral cavity.
Croatian: Zahvati su uključivali 9 ortopedskih, 1 gastrointestinalnu i 3 operacije u usnoj šupljini.
English: In patients with haemophilia B, factor IX is missing or does not work properly.
Croatian: U bolesnika s hemofilijom B, faktor IX nedostaje ili nema ispravnu funkciju.
English: No difference in the safety profile of Refixia was observed between previously treated adolescent (12-18 years) and adult patients.
Croatian: Nije primijećena razlika u sigurnosnom profilu lijeka Refixia između prethodno liječenih adolescenata (12-18 godina) i odraslih bolesnika.
English: The listed warnings and precautions apply both to adults and adolescents (12-18 years).
Croatian: Navedena upozorenja i mjere opreza odnose se i na odrasle i na adolescente (12-18 godina).
English: Eighteen out of these 20 joints (90%) were no longer considered target joints at the end of the trial.
Croatian: 20 zglobova (90 %) nije se više smatralo ciljnim zglobovima.
English: It is strongly recommended that every time that Refixia is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the medicinal product.
Croatian: Izričito se preporučuje da se prilikom svake primjene lijeka Refixia u bolesnika zabilježi naziv i serijski broj lijeka kako bi se održala veza između bolesnika i serije lijeka.
English: If symptoms of hypersensitivity occur, patients should be advised to discontinue use of the medicinal product immediately and contact their physician.
Croatian: Ako se pojave simptomi preosjetljivosti, bolesnicima treba savjetovati da odmah prestanu primjenjivati lijek i obrate se svom liječniku.
English: In the absence of compatibility studies, this medicine must not be mixed with other medicinal products or reconstituted with infusion solutions other than the provided histidine solvent.
Croatian: Zbog nedostatka ispitivanja kompatibilnosti, ovaj lijek se ne smije miješati s drugim lijekovima ili rekonstituirati s otopinama za infuziju osim s priloženom otopinom histidina.
English: The risk for developing inhibitors is highest if you have not been treated with factor IX medicines before i.e. for small children.
Croatian: Rizik razvoja inhibitora najveći je ako niste prethodno liječeni lijekovima s faktorom IX, npr. u male djece.
English: Tell your doctor, if any of the following apply to you as there is an increased risk of blood clots during treatment with Refixia:
Croatian: Obratite se svom liječniku ako se nešto od sljedećeg odnosi na Vas jer postoji povećani rizik od nastanka krvnih ugrušaka tijekom liječenja lijekom Refixia:
English: Your doctor may choose another dose or how often the injections should be given, based on your need.
Croatian: Vaš liječnik može odabrati drugu dozu ili učestalost primanja injekcije, ovisno o Vašoj potrebi.
English: Refixia has no influence on the ability to drive and use machines.
Croatian: Refixia ne utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Due to the long half-life of Refixia, the frequency of dosing in the post-surgical period may be extended to once weekly after the first week until bleeding stops and healing is achieved.
Croatian: Zbog dugog poluvijeka lijeka Refixia učestalost doziranja u razdoblju nakon kirurškog zahvata može se produljiti na primjenu jednom tjedno nakon prvog tjedna do zaustavljanja krvarenja i izlječenja.
English: • Lightly squeeze the protective cap with your thumb and index finger as shown.
Croatian: • Lagano stisnite zaštitni pokrov palcem i kažiprstom kako je prikazano.
English: For Refixia some reagents will cause underestimation (30-50%), while most silica containing reagents will cause severe overestimation of the factor IX activity (more than 400%).
Croatian: Kod lijeka Refixia neki reagensi uzrokuju podcjenjivanje (30-50%), a većina reagensa na bazi silicijevog dioksida uzrokovat će veliko precjenjivanje aktivnosti faktora IX (više od 400%).
English: The overall success rate for treatment of breakthrough bleeds was 97.1% (67 out of 69 evaluated bleeds).
Croatian: Ukupna stopa uspjeha u liječenju probojnih krvarenja bila je 97,1% (67 od 69 ocijenjenih krvarenja).
English: No dose adjustment was required for paediatric or adolescent patients in clinical trials.
Croatian: Nije bilo potrebno prilagođavanje doze u pedijatrijskih bolesnika i adolescenata u kliničkim ispitivanjima.
English: Talk to your doctor immediately if your bleeding does not stop as expected or if you have to significantly increase your usage of Refixia in order to stop a bleed.
Croatian: Odmah se obratite liječniku ako se krvarenje ne zaustavi kako bi trebalo ili ako morate značajno povećati primjenu lijeka Refixia kako biste zaustavili krvarenje.
English: • Do not mix Refixia with any other intravenous infusions or medications.
Croatian: • Refixia se ne smije miješati s drugim intravenskim infuzijskim otopinama ili lijekovima.
English: Therefore, factor IX should be used during pregnancy and lactation only if clearly indicated.
Croatian: Stoga se tijekom trudnoće i dojenja faktor IX smije primjenjivati samo ako je to jasno indicirano.
English: The equipment in this package is designed to reconstitute and inject Refixia.
Croatian: Pribor u ovome pakiranju namijenjen je za pripremu i injiciranje lijeka Refixia.
English: Animal reproduction studies have not been conducted with factor IX.
Croatian: Za faktor IX nisu provedena ispitivanja reprodukcije na životinjama.
English: The dose recommendations in adolescents (12-18 years) are the same as for adults: 40 IU/kg body weight.
Croatian: Preporučena doza u adolescenata (12-18 godina) jednaka je onoj u odraslih: 40 IU/kg tjelesne težine.
English: Factor IX is activated by factor XIa and by factor VII/tissue factor complex.
Croatian: Faktor IX aktiviraju faktor XIa i kompleks faktora VII i tkivnog faktora.
English: The European Medicines Agency has deferred the completion of the study with Refixia in previously untreated patients (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je dovršetak ispitivanja lijeka Refixia u prethodno neliječenih bolesnika (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: • Do not use any other way to warm the vial and pre-filled syringe.
Croatian: • Ne koristite nikakav drugi način za zagrijavanje bočice i napunjene štrcaljke.
English: Some needleless connectors with an internal spike are incompatible with the pre-filled syringe.
Croatian: Neki konektori za primjenu bez igle s unutrašnjim šiljkom nisu kompatibilni s napunjenom štrcaljkom.
English: Patients on prophylaxis who forget a dose are advised to take their dose upon discovery and thereafter continue with the usual once weekly dosing schedule.
Croatian: Bolesnicima na profilaksi koji zaborave primijeniti dozu preporučuje se da je primijene čim to primijete te da se nakon toga vrate uobičajenom rasporedu doziranja jednom tjedno.
English: • you have risk factors for heart disease e.g high blood pressure, obesity, or smoking.
Croatian: • imate faktore rizika za bolest srca, npr. visoki krvni tlak, pretilost ili pušenje.
English: This is because if left, the medicine may no longer be sterile and could cause infections.
Croatian: Naime, ako se ne primijeni odmah, lijek možda više neće biti sterilan, pa bi mogao uzrokovati infekcije.
English: Unopened
Croatian: Neotvoreno
English: Long-term studies in animals to evaluate the carcinogenic potential of Refixia, or studies to determine the effects of Refixia on genotoxicity, fertility, development, or reproduction have not been performed.
Croatian: Nisu provedena ni dugotrajna ispitivanja na životinjama kojima bi se procijenio kancerogeni potencijal lijeka Refixia niti ispitivanja kojima bi se utvrdio učinak lijeka Refixia na genotoksičnost, plodnost, razvoj niti reproduktivnost.
English: Previously untreated patients The safety and efficacy of Refixia in previously untreated patients have not yet been established.
Croatian: Sigurnost i djelotvornost lijeka Refixia u prethodno neliječenih bolesnika još nisu ustanovljene.
English: Therefore a pre-heating step or a wash-out is recommended in order to ensure detection of low-titre inhibitors.
Croatian: Zbog toga je preporučeno provesti fazu predgrijavanja ili ispiranja kako bi se osiguralo otkrivanje niskog titra inhibitora.
English: • Do not touch the rubber stopper with your fingers as this can transfer germs.
Croatian: • Ne dirajte gumeni čep prstima jer na taj način možete prenijeti mikroorganizme.
English: Injecting the solution via a central venous access device (CVAD) such as a central venous catheter or a subcutaneous port:
Croatian: Injiciranje otopine putem centralnog venskog pristupa (CVAD, engl. central venous access device) kao što su centralni venski kateter ili potkožni port:
English: 4.4 Special warnings and precautions for use
Croatian: 4.4 Posebna upozorenja i mjere opreza pri uporabi Preosjetljivost