FrancophonIA/ELRC3.0 huggingface dataset:
English: Xerava contains the active substance eravacycline.
Croatian: Xerava sadrži djelatnu tvar eravaciklin.
English: For more information about using Xerava, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Xerava pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: Tetracyclines work by binding to and blocking part of the cell machinery in bacterial cells that is involved in making proteins.
Croatian: Tetraciklini djeluju tako da se vežu na dio staničnog sustava u bakterijskim stanicama koji je uključen u stvaranje bjelančevina i blokiraju ga.
English: In the first study involving 538 patients, Xerava was compared with ertapenem (another antibiotic).
Croatian: U prvom ispitivanju koje je uključivalo 538 bolesnika, lijek Xerava uspoređen je s ertapenemom (drugi antibiotik).
English: In the second study involving 499 patients, Xerava was compared with meropenem (another antibiotic).
Croatian: U drugom ispitivanju koje je uključivalo 499 bolesnika, lijek Xerava uspoređen je s meropenemom (drugi antibiotik).
English: How does Xerava work?
Croatian: Kako djeluje Xerava?
English: How is Xerava used?
Croatian: Kako se Xerava koristi?
English: What benefits of Xerava have been shown in studies?
Croatian: Koje su koristi od lijeka Xerava utvrđene u ispitivanjima?
English: Xerava is an antibiotic used to treat complicated intra-abdominal (belly) infections (cIAI) in adults.
Croatian: Xerava je antibiotik koji se koristi za liječenje kompliciranih intraabdominalnih (trbušnih) infekcija (engl. complicated intra-abdominal infections, cIAI) u odraslih bolesnika. „Kompliciranih“ znači da je infekciju teško liječiti jer se proširila na trbušnu šupljinu.
English: For the full list of side effects of Xerava, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Xerava potražite u uputi o lijeku.
English: Xerava was shown to be as effective as alternative antibiotics in 2 main studies of adults with cIAIs.
Croatian: U dvama glavnim ispitivanjima provedenima na odraslim osobama koje imaju cIAI utvrđeno je da Xerava djeluje jednako učinkovito kao i alternativni antibiotici.
English: Invented name Strength Pharmaceutical Form Route of Administration Packaging
Croatian: Farmaceutski oblik Put primjene
English: Content Package size
Croatian: Veličina pakovanja
English: This takes around 30 minutes.
Croatian: Za to je potrebno otprilike 30 minuta.
English: 96 to 144 weeks
Croatian: 96 do 144 tjedna
English: You will hear the clicking sounds start.
Croatian: Čut ćete da je započeo zvuk klikanja.
English: 52 weeks
Croatian: 52 tjedna
English: This is normal and will not affect your dose.
Croatian: To je normalno i neće utjecati na Vašu dozu.
English: There may be new information.
Croatian: Možda ima novih informacija.
English: Read and follow the advice given in section 7.
Croatian: Pročitajte i slijedite savjete dane u dijelu 7.
English: Following a recovery period of up to 12 weeks, there was evidence of reversibility.
Croatian: Nakon razdoblja oporavka do 12 tjedana, bilo je dokaza reverzibilnosti.
English: This stops nerves from working properly.
Croatian: To sprječava živce da rade normalno.
English: It has not been determined whether these patients respond differently compared with younger patients.
Croatian: Nije utvrđeno odgovaraju li ti bolesnici drugačije u usporedbi s mlađim bolesnicima.
English: • Very rare (<1/10,000) • Not known (cannot be estimated from the available data)
Croatian: • vrlo rijetko (<1/10 000) • nepoznato (ne može se procijeniti iz dostupnih podataka).
English: The median duration was similar between the treatment groups.
Croatian: Medijan trajanja bio je sličan između skupina liječenja.
English: Contact your doctor if you think you may have missed a blood test.
Croatian: Obratite se svom liječniku ako mislite da ste možda propustili test krvi.
English: Do not freeze or expose to high temperatures.
Croatian: Nemojte zamrzavati ili izlagati visokim temperaturama.
English: However, as a precaution, monitoring of complete blood count is recommended every 3 months.
Croatian: Međutim, kao mjera opreza, preporučuje se praćenje kompletne krvne slike svaka 3 mjeseca.
English: Reported experience with overdose is limited.
Croatian: Prijavljeno iskustvo s predoziranjem je ograničeno.
English: Do not make changes unless your doctor tells you to.
Croatian: Nemojte ništa mijenjati osim ako Vam to ne kaže liječnik.
English: This loss of myelin is called demyelination.
Croatian: Ovaj gubitak mijelina naziva se demijelinizacija.
English: It is very important that you do not miss this blood test.
Croatian: Vrlo je važno da ne propustite ove krvne testove.
English: Keep the pack closed until you need to use a new syringe/pen.
Croatian: Držite pakiranje zatvoreno sve dok ne trebate koristiti novu štrcaljku/brizgalicu.
English: Your doctor will tell you whether your illness allows you to drive vehicles and use machines safely.
Croatian: Vaš liječnik će Vam reći da li Vam bolest dopušta da sigurno upravljate vozilima i radite sa strojevima.
English: - if you have ever had tuberculosis (also called TB) or live in a region where TB infections are common, you may be at greater risk of TB.
Croatian: - ako ste ikada imali tuberkulozu (koja se naziva i TB) ili živite na području na kojem su tuberkulozne infekcije uobičajene, možda ste izloženi većem riziku od tuberkuloze.
English: Efficacy in patients with highly active disease Highly active disease was defined as follows:
Croatian: Djelotvornost u bolesnika s visoko aktivnom bolesti Visoko aktivna bolest definirana je kako slijedi:
English: Keep this Card with you during treatment and for 6 months afterwards.
Croatian: Čuvajte ovu karticu uz sebe tijekom liječenja i 6 mjeseci nakon toga.
English: Table 5 and Figures 1-2 show the results for the DECIDE study.
Croatian: Tablica 5 i slike 1-2 prikazuju rezultate ispitivanja DECIDE.
English: It is very important that you have these regular blood tests.
Croatian: Vrlo je važno da redovno obavljate ove krvne testove.
English: Symptoms may disappear completely after the relapse is over but, over time, some problems may remain between relapses and interfere with daily activities.
Croatian: Simptomi mogu u potpunosti nestati nakon relapsa, ali, s vremenom, neki problemi mogu ostati između relapsa i ometati dnevne aktivnosti.
English: A risk to newborns/infants cannot be excluded.
Croatian: Rizik za novorođenčad/ dojenčad ne može se isključiti.
English: If your doctor has told you to stop using your medicine, do not restart unless your doctor tells you to.
Croatian: Ako Vam je liječnik rekao da prestanete primjenjivati lijek, nemojte ponovno započeti s primjenom osim ako Vam to ne kaže liječnik.
English: • The need to exercise caution regarding concomitant use of other hepatotoxic medications;
Croatian: • potrebu opreznog postupanja s obzirom na istodobnu primjenu drugih hepatotoksičnih lijekova
English: • increases in body temperature (fever)
Croatian: • povećanje tjelesne temperature (vrućica)
English: In the absence of compatibility studies, this medicinal product should not be mixed with other products.
Croatian: Zbog nedostatka ispitivanja kompatibilnosti, ovaj lijek se ne smije miješati s drugim lijekovima.
English: Do not touch, clean or manipulate the needle cover.
Croatian: Nemojte dirati, čistiti ili pomicati pokrov igle.
English: These symptoms vary from patient to patient but usually involve problems such as difficulty with walking, vision and balance.
Croatian: Ovi simptomi variraju od bolesnika do bolesnika, ali obično uključuju probleme kao što su poteškoće s hodanjem, vidom i ravnotežom.
English: Try to keep to a set day for it each month.
Croatian: Pokušajte se pridržavati određenog dana svakog mjeseca za to.
English: The Finger Flange will allow you to better grip the syringe and should remain attached.
Croatian: Hvatište za prste Vam omogućava da bolje uhvatite štrcaljku i treba ostati pričvršćeno.
English: The rate of infections and serious infections did not increase over time.
Croatian: Stopa infekcija i ozbiljnih infekcija nije se povećavala s vremenom.
English: This is a type of medicine called a monoclonal antibody.
Croatian: To je vrsta lijeka pod nazivom monoklonsko protutijelo.
English: Do not use this medicine if you notice that:
Croatian: Nemojte koristiti ovaj lijek ako primijetite da je:
English: • blood in your stools
Croatian: • krv u stolici
English: Try to keep to a particular day of the month to help remember your injection.
Croatian: Pokušajte se držati određenog dana u mjesecu što će vam pomoći zapamtiti injekciju.
English: Pharmacotherapeutic group: immunosuppressants, interleukin inhibitors, ATC code: L04AC01
Croatian: Farmakoterapijska skupina: imunosupresivi, inhibitori interleukina, ATK oznaka: L04AC01
English: If you use more Zinbryta than you should
Croatian: Ako primijenite više Zinbryte nego što ste trebali
English: • thoughts of hurting yourself or suicide
Croatian: • misli o samoranjavanju ili samoubojstvu
English: In either case, do not use two injections to make up for a missed dose.
Croatian: U svakom slučaju, nemojte primijeniti dvije injekcije kako biste nadoknadili propuštenu dozu.
English: Daclizumab 150 mg (N=1943)
Croatian: Daklizumab 150 mg (N=1943)
English: Doses up to this level were well tolerated with no evidence of acute toxicity.
Croatian: Doze do te razine se dobro podnose bez ikakvih dokaza akutne toksičnosti.
English: This can help to reduce the number of relapses that you have and slow down the disabling effects of MS.
Croatian: To može pomoći smanjiti broj relapsa koje imate i usporiti onesposobljavajuće učinke multiple skleroze.
English: For additional information on storage at room temperature, see section 6.3.
Croatian: Za dodatne informacije o čuvanju na sobnoj temperaturi, vidjeti dio 6.3.
English: Zinbryta should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Croatian: Zinbryta se smije koristiti tijekom trudnoće samo ako potencijalna korist opravdava potencijalni rizik za fetus.
English: • Recommended storage is controlled refrigeration 2°C to 8°C in the closed original carton to protect from light.
Croatian: • Preporučeno čuvanje je kontrolirano rashlađivanje od 2°C do 8°C u zatvorenoj originalnoj kutiji radi zaštite od svjetlosti.
English: Although human IgG is secreted into human milk, published data suggest that antibodies in breast milk do not enter the neonatal and infant circulations in substantial amounts.
Croatian: Iako se ljudski IgG izlučuje u ljudsko mlijeko, objavljeni podaci pokazuju da protutijela iz majčinog mlijeka ne ulaze u cirkulaciju novorođenčeta i dojenčeta u znatnim količinama.
English: • feeling unusually sad, hopeless or bad about yourself
Croatian: • osjećaj neuobičajene tuge, beznađa ili nezadovoljstva sobom
English: b. Wash your hands with soap and water.
Croatian: b. Operite ruke sapunom i vodom.
English: This is normal and the bubbles do not need to be expelled before your injection.
Croatian: To je normalno i mjehuriće ne treba istisnuti prije injekcije.
English: In addition, the Card explains the need for monitoring of liver function and educates the patient on the importance of adherence to their monthly blood tests.
Croatian: Osim toga, Kartica objašnjava potrebu za praćenjem funkcije jetre i poučava bolesnika o važnosti pridržavanja provođenja mjesečnih krvnih testova.
English: • If you have any further questions, ask your doctor.
Croatian: • Ako imate dodatnih pitanja, obratite se svom liječniku.
English: In case of overdose, patients may require medical attention and appropriate supportive treatment should be given.
Croatian: U slučaju predoziranja, bolesnicima može biti potrebna liječnička pomoć te je potrebno primijeniti odgovarajuće suportivno liječenje.
English: Even if you have had no previous liver problems, your doctor will carry out blood tests to test your liver function.
Croatian: Čak i ako niste imali prethodnih problema s jetrom, liječnik će provesti krvne pretrage kako bi Vam provjerio funkciju jetre.
English: This information does not take the place of talking to your doctor or nurse about your medical condition or your treatment.
Croatian: Ove informacije ne zamjenjuju razgovor s liječnikom ili medicinskom sestrom o Vašem zdravstvenom stanju ili liječenju.
English: For DECIDE, at least 2 relapses (one of which was a clinical relapse) within the prior 3 years was also required
Croatian: Za DECIDE su bila potrebna barem 2 relapsa (od kojih je jedan bio klinički relaps) u prethodne 3 godine.
English: The incidence of the adverse reactions is expressed according to the following categories:
Croatian: Incidencija nuspojava izražena je prema sljedećim kategorijama:
English: Name and address of the manufacturer of the biological active substance:
Croatian: Naziv i adresa proizvođača biološke djelatne tvari:
English: If you are over 55 your doctor may still prescribe Zinbryta.
Croatian: Ako ste stariji od 55 godina, liječnik Vam još uvijek može propisati Zinbrytu.
English: Exposures (AUC) in these studies ranged from 55 to 140 times that observed with the clinical dose.
Croatian: Izloženosti (AUC) u tim ispitivanjima kretale su se u rasponu od 55 do 140 puta veće od one koja je opažena pri kliničkoj dozi.
English: In patients who have had tuberculosis or who live in endemic areas of the disease, screening for active tuberculosis should be performed before starting treatment, and patients should be monitored during treatment.
Croatian: U bolesnika koji su imali tuberkulozu ili koji žive u endemskim područjima bolesti, prije početka liječenja treba provesti probir na aktivnu tuberkulozu, a bolesnike treba nadzirati tijekom liječenja.
English: Clinical trial data from the DECIDE study demonstrated consistent treatment effects in the highly active disease subgroup.
Croatian: Podaci iz kliničkog ispitivanja DECIDE pokazali su dosljedni učinak liječenja u podskupini visoko aktivne bolesti.
English: Vaccination with live vaccines is not advised during treatment and up to 4 months after discontinuation.
Croatian: Cijepljenje živim cjepivom ne savjetuje se tijekom liječenja i do 4 mjeseca nakon prestanka.
English: Time on study (weeks) Number of patients at risk
Croatian: Vrijeme u ispitivanju (tjedni) Broj bolesnika pod rizikom
English: • nervousness, anxiety
Croatian: • nervoza, tjeskoba
English: This has important safety information that you need to know before and during treatment with Zinbryta.
Croatian: Ona sadrži važne sigurnosne informacije koje trebate znati prije i tijekom liječenja Zinbrytom.
English: You could get a needle injury.
Croatian: Mogli biste se ozlijediti iglom.
English: Contact your doctor immediately if you get any serious side effects.
Croatian: Odmah se obratite svom liječniku ako dobijete bilo koju ozbiljnu nuspojavu.
English: Zinbryta has had very little testing in people older than 55 years old.
Croatian: Zinbryta je vrlo slabo ispitana u osoba starijih od 55 godina.
English: This medicinal product should not be used if:
Croatian: Ovaj lijek se ne smije koristiti ako:
English: Do not use more than 1 pen per month.
Croatian: Nemojte upotrijebiti više od 1 brizgalice mjesečno.
English: The 300 mg dose did not provide additional benefit over the 150 mg dose.
Croatian: Doza od 300 mg nije pružila dodatnu korist u odnosu na dozu od 150 mg.
English: Daclizumab had no effect on peri- and post-natal development from birth to up to 6 months in the offspring.
Croatian: Daklizumab nije imao utjecaja na peri- i postnatalni razvoj mladunčadi od rođenja do 6 mjeseci života.
English: Interferon beta-1a (intramuscular) 30 micrograms
Croatian: Interferon beta-1a (intramuskularno) 30 mikrograma
English: Your doctor will decide whether Zinbryta is the right medicine for you.
Croatian: Liječnik će odlučiti je li Zinbryta odgovarajući lijek za Vas.
English: Do not share the pen with anyone else to avoid giving an infection to them or getting an infection from them.
Croatian: Nemojte dijeliti brizgalicu ni s kim drugim kako bi se izbjeglo da svoju infekciju prenesete na druge ili da se infekcija s drugih prenese na Vas.
English: • Patient details, signature and date;
Croatian: • podatke o bolesniku, potpis i datum
English: Throw away any Zinbryta that is accidentally frozen.
Croatian: Bacite Zinbrytu ako je slučajno zamrznuta.
English: Zinbryta is not to be used in children and adolescents younger than 18 years old.
Croatian: Zinbryta se ne smije koristiti u djece i adolescenata mlađih od 18 godina.
English: Note: You might see air bubbles in the medicine window.
Croatian: Napomena: Možda ćete vidjeti mjehuriće zraka u prozorčiću za lijek.
English: This small volume of distribution indicates that daclizumab is primarily confined to the vascular and interstitial spaces.
Croatian: Taj mali volumen distribucije pokazuje da je daklizumab prvenstveno ograničen na krvožilni i intersticijski prostor.
English: • increases in liver enzymes in the blood (these will show up in blood tests)
Croatian: • povećanje jetrenih enzima u krvi (to će se pojaviti u krvnim testovima)
English: There are no data on the effects of Zinbryta on human fertility.
Croatian: Nema podataka o učincima Zinbryte na ljudsku plodnost.
English: If you have injected more than your usual dose, and you notice any side effects, or are concerned, speak with your doctor or nurse.
Croatian: Ako ste injicirali više od uobičajene doze, i primijetite bilo koju nuspojavu, ili ste u nedoumici, razgovarajte sa svojim liječnikom ili medicinskom sestrom.
English: Do not touch the needle.
Croatian: Nemojte dirati iglu.
English: • changes in your blood (anaemia) which may make you feel weak
Croatian: • proljev • promjene u krvi (anemija), koje mogu uzrokovati da se osjećate slabo
English: You should then contact your doctor, nurse or pharmacist.
Croatian: Tada se morate obratiti liječniku, medicinskoj sestri ili ljekarniku.
English: Daclizumab pharmacokinetics are well described by a two-compartment model with first-order absorption and elimination.
Croatian: Farmakokinetika daklizumaba dobro je opisana modelom s dva odjeljka s apsorpcijom i eliminacijom prvog reda.
English: • Store in a refrigerator (2oC to 8oC).
Croatian: • Čuvati u hladnjaku (2oC do 8oC).
English: Read the instructions before you start using Zinbryta and each time you get a refill of your prescription.
Croatian: Pročitajte ove upute prije nego što počnete koristiti Zinbrytu i svaki put kada je ponovno podignete na recept.
English: Patients have received double the recommended dose of Zinbryta with no serious extra side effects.
Croatian: Bolesnici su dobili dvostruko od preporučene doze Zinbryte bez ozbiljnih dodatnih nuspojava.
English: Zinbryta may cause serious liver problems that may be life-threatening or result in death.
Croatian: Zinbryta može uzrokovati ozbiljne probleme s jetrom koji mogu biti životno opasni ili imati za posljedicu smrtni ishod.
English: Prior to launch of Zinbryta in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Croatian: Prije stavljanja lijeka Zinbryta u promet u svakoj državi članici, nositelj odobrenja za stavljanje lijeka u promet mora dogovoriti s nacionalnim nadležnim tijelom sadržaj i oblik edukacijskog programa, uključujući i komunikacijske medije, načine distribucije i bilo koje druge aspekte programa.
English: Do not use the pen if it has been dropped or is visibly damaged.
Croatian: Nemojte koristiti brizgalicu ako je pala ili je vidljivo oštećena.
English: Treatment discontinuation should be considered if an adequate response has not been achieved or the patient fails to follow the requirement for scheduled liver test monitoring.
Croatian: Prekid liječenja treba razmotriti ako nije postignut odgovarajući odgovor ili ako se bolesnik ne pridržava zakazanih pretraga u sklopu traženog praćenja rada jetre.
English: Be sure that this hand is not pushing on the Finger Flange.
Croatian: Pobrinite se da tom rukom ne pritiskate hvatište za prste.
English: Warning!
Croatian: Upozorenje!
English: Dermatitis allergic
Croatian: Alergijski dermatitis
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 01 July 2016
Croatian: Datum prvog odobrenja: 1. lipnja 2016.
English: Side effects may occur even after stopping treatment (see serious side effects in section 4).
Croatian: Nuspojave se mogu pojaviti i nakon prestanka liječenja (vidjeti ozbiljne nuspojave u dijelu 4).
English: Pre-filled syringes/Pre-filled pens contain a single dose only and should be discarded after use.
Croatian: Napunjena štrcaljka/napunjena brizgalica sadrži samo jednu dozu i mora se baciti nakon upotrebe.
English: The most common types of infections were upper respiratory tract infections and viral infections.
Croatian: Najčešće vrste infekcija bile su infekcije gornjih dišnih putova i virusne infekcije.
English: There was no effect on foetal development and no evidence of teratogenicity.
Croatian: Nije bilo utjecaja na razvoj fetusa i nije bilo dokaza teratogenosti.
English: In the DECIDE study (see section 5.1), patients were tested for anti-drug (daclizumab) antibodies at week 4 and approximately every 3 months thereafter.
Croatian: U ispitivanju DECIDE (vidjeti dio 5.1), bolesnici su testirani na protutijela na lijek (daklizumab) u 4. tjednu i otprilike svaka 3 mjeseca nakon toga.
English: Do not use this medicine after the expiry date which is stated on the carton and the label after ‘EXP'.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici iza oznake 'EXP'.
English: (Uncommon - may affect up to 1 in 100 people) • Severe inflammation of the liver which might be life-threatening or result in death
Croatian: (Manje često - mogu se javiti u do 1 na 100 osoba) • teška upala jetre koja može biti opasna za život ili imati za posljedicu smrtni ishod
English: If you experience any of the following, contact your doctor immediately:
Croatian: Ako osjetite bilo što od sljedećeg, odmah se obratite Vašem liječniku:
English: If you have trouble handling the syringe/pen, tell your doctor or nurse who may be able to help.
Croatian: Ako imate problema s rukovanjem štrcaljkom/brizgalicom, obavijestite svog liječnika ili medicinsku sestru koji Vam mogu pomoći.
English: The magnitude of the immune response to the seasonal influenza vaccine, and proportion of patients with seroconversion and seroprotection were consistent with those observed in healthy volunteer populations.
Croatian: Veličina imunološkog odgovora na cjepivo protiv sezonske gripe i udio bolesnika sa serokonverzijom i serozaštitom bili su u skladu s onima zabilježenima kod populacije zdravih dobrovoljaca.
English: Total lymphocyte counts returned to baseline levels approximately 8-12 weeks after the last dose of Zinbryta (150mg).
Croatian: Ukupni broj limfocita vratio se na početne razine približno 8-12-tjedana nakon zadnje doze Zinbryte (150 mg).
English: Keep the leaflet and Card with you during treatment and for 6 months after the last dose of Zinbryta, since side effects may occur even after you have stopped treatment.
Croatian: Čuvajte ovu uputu i karticu uz sebe tijekom liječenja i 6 mjeseci nakon zadnje doze Zinbryte, budući da se nuspojave mogu pojaviti čak i nakon što ste prestali s liječenjem.
English: However, Zinbryta's effect on other vaccines (live vaccines) is not known.
Croatian: Međutim, učinak Zinbryte na druga cjepiva (živa cjepiva) nije poznat.
English: Microglial aggregates in monkeys did not increase in incidence or severity with increased duration of dosing and were not associated with neuronal damage or neurobehavioral effects.
Croatian: Agregati mikroglije u majmuna nisu se povećavali u incidenciji ili težini s povećanjem trajanja doziranja i nisu bili povezani s oštećenjem neurona ili neurobihevioralnim učincima.
English: Other medicines and Zinbryta
Croatian: Drugi lijekovi i Zinbryta