FrancophonIA/ELRC3.0 huggingface dataset:
English: Total maximum daily dose (to be divided into 2-3 daily doses)
Croatian: GFR ml/min Ukupna maksimalna dnevna doza (podijeljena u 2-3 dnevne doze)
English: Metformin must be discontinued prior to or at the time of the imaging procedure and not restarted until at least 48 hours after, provided that renal function has been re-evaluated and found to be stable, see sections 4.2 and 4.4.
Croatian: Primjena metformina se mora prekinuti prije ili u vrijeme pretrage metodom oslikavanja i s njegovom primjenom smije se ponovno započeti tek 48 sati poslije, pod uvjetom da je funkcija bubrega bila ponovno procijenjena i da je potvrđeno da je stabilna, vidjeti dijelove 4.2 i 4.4.
English: Metformin is contraindicated in patients with GFR<30 mL/min and should be temporarily discontinued in the presence of conditions that alter renal function, see section 4.3.
Croatian: GFR je potrebno procijeniti prije početka liječenja i redovito nakon toga, vidjeti dio 4.2. Metformin je kontraindiciran u bolesnika s GFR<30 ml/min i njegovu je primjenu potrebno privremeno prekinuti ako su prisutna stanja koja mijenjaju funkciju bubrega, vidjeti dio 4.3).
English: 4.3 Contraindications [This section should be revised as follows:]
Croatian: [Ovaj dio treba izmijeniti kako slijedi:]
English: 4.5 Interaction with other medicinal products and other forms of interaction [The wording should be revised as follows:]
Croatian: 4.5 Interakcije s drugim lijekovima i drugi oblici interakcija
English: Factors that may increase the risk of lactic acidosis (see section 4.4) should be reviewed before considering initiation of metformin.
Croatian: Prije nego što se počne razmatrati uvođenje metformina, potrebno je provjeriti čimbenike koji mogu povećati rizik od laktacidoze (vidjeti dio 4.4).
English: MA (EU) number (Invented) name Strength Pharmaceutical Form
Croatian: (Zaštićeno) ime Doza Farmaceutski oblik Put primjene
English: The products were authorised in Estonia, France, Italy, Latvia and Lithuania.
Croatian: Lijekovi su odobreni u Estoniji, Francuskoj, Latviji i Litvi.
English: The majority of cases occurred within 7 days of using the pastes.
Croatian: Većina slučajeva pojavila se unutar 7 dana od uporabe pasti.
English: Tel. +44 (0)20 7418 8427 E-mail: press@ema.europa.eu
Croatian: Telefon +44 (0)20 7418 8427 E-pošta: press@ema.europa.eu
English: • If you have any questions or concerns, speak to your dentist.
Croatian: • Ako imate pitanja obratite se svom stomatologu.
English: The review was initiated at the request of the French medicines agency (ANSM) after new data became available that raised concerns about the safety of these products.
Croatian: Procjena je pokrenuta na zahtjev Francuske agencije za lijekove (ANSM) nakon što su postali dostupni novi podaci koji su podigli zabrinutosti oko sigurnosti ovih proizvoda.
English: Seven days later the tooth is re-opened and the infected pulp is surgically removed.
Croatian: Sedam dana kasnije zub se ponovno otvara, a inficirana pulpa kirurški odstranjuje.
English: The CHMP opinion was forwarded to the European Commission, which endorsed it and issued a final legally binding decision on 11 July 2014.
Croatian: Mišljenje CHMP-a proslijeđeno je Europskoj komisiji koja ga je potvrdila i izdala konačnu, pravno obavezujuću odluku 11. srpnja 2014.
English: • If you require such treatment, your dentist will use other methods available which do not contain arsenic.
Croatian: • Ako Vam je potreban takav tretman, Vaš stomatolog će koristiti druge dostupne metode koje ne uključuju primjenu arsena.
English: The review was carried out by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted an opinion.
Croatian: Procjenu je proveo Odbor za humane lijekove (CHMP) koji je odgovoran za sva pitanja u vezi lijekova za ljudsku uporabu i koji je usvojio mišljenje.
English: The review of Caustinerf arsenical, Yranicid arsenical and associated names was initiated on 24 October 2013 at the request of the French medicines agency, under Article 31 of Directive 2001/83/EC.
Croatian: Procjena za Caustinerf arsenical, Yranicid arsenical i pridružene nazive započela je 24. listopada 2013. na zahtjev Francuske agencije za lijekove u skladu s člankom 31. Direktive 2001/83/EZ.
English: During the review, the CHMP considered measures to minimise the risks identified with these products but concluded that restrictions and additional guidance to dentists would not reduce the risks to an acceptable level.
Croatian: Tijekom procjene, CHMP je razmatrao mjere za smanjenje rizika povezanih s ovim proizvodima, ali je zaključio da ograničenja i dodatne smjernice stomatolozima, neće smanjiti rizike na prihvatljivu razinu.
English: They contain 3 active substances: ephedrine hydrochloride, lidocaine and arsenic trioxide (arsenous anhydride).
Croatian: Sadrže tri djelatne tvari: efedrin hidroklorid, lidokain i arsenov trioksid (arsenov anhidrid).
English: The dental pastes are applied to the tooth after the tooth has been opened surgically.
Croatian: Zubne paste primjenjuju se na zub nakon što se zub kirurški otvori.
English: Dentists should use other alternative methods available for removing dental pulp.
Croatian: Stomatolozi moraju koristiti druge dostupne metode za uklanjanje pulpe zuba.
English: The EMA recommendations are based on a review of data indicating a potential genotoxic effect of the products due to the presence of arsenic trioxide (arsenous anhydride).
Croatian: Preporuke EMA-a temeljile su se na procjeni podataka koji su ukazivali na potencijalni genotoksični učinak proizvoda zbog prisutnosti arsenova trioksida (arsenov anhidrid).
English: Post-marketing surveillance of Caustinerf arsenical and Yranicid arsenical has identified a small number of cases of periodontal necrosis, including 12 cases of osteonecrosis.
Croatian: Istraživanje nakon stavljanja u promet pasti Caustinerf arsenical i Yranicid arsenical identificiralo je nekoliko slučajeva periodontalne nekroze, uključujući 12 slučajeva osteonekroze.
English: In a review conducted by the Agency's Committee for Medicinal Products for Human Use (CHMP), analyses of data from laboratory and population studies indicate that the arsenic contained in them may pose a risk of genotoxic effects that could increase the risk of cancer.
Croatian: U procjeni koju je proveo Odbor Agencije za humane lijekove (CHMP), analize laboratorijskih podataka i ispitivanja na populaciji ukazuju da arsen koji se nalazi u pastama može predstavljati rizik zbog mogućih genotoksičnih učinaka koji bi mogli dodatno povećati rizik od karcinoma.
English: • Caustinerf arsenical and Yranicid arsenical dental pastes will no longer be used for removing damaged nerves in teeth, because they may pose a risk of genotoxic effects (which can cause cancers) and cell death in tissues around the teeth which may be difficult to treat.
Croatian: • Zubne paste Caustinerf arsenical i Yranicid arsenical više se neće koristiti za uklanjanje oštećenih živaca u zubima jer mogu predstavljati rizik od genotoksičnih učinaka (koji mogu uzrokovati karcinom) i smrt stanica u tkivima oko zuba što se može teško liječiti.
English: Therefore, in the light of current standard of care available, the Committee concluded that the benefits of Caustinerf arsenical and Yranicid arsenical do not outweigh their risks and recommended that their marketing authorisations be revoked.
Croatian: Stoga je, s obzirom na trenutačno dostupne standardne skrbi, Odbor zaključilo da koristi Caustinerf arsenical i Yranicid arsenical ne nadmašuju njihove rizike i preporučio ukidanje odobrenja za njihovo stavljanje u promet.
English: In addition, there have been a small number of cases where arsenic is thought to have leaked into the areas around the teeth, causing parts of the tissue to die, including bone (osteonecrosis).
Croatian: Pored toga, mali je broj slučajeva za koje se smatralo da je arsen procurio u područja oko zubi, uzrokujući odumiranje tkiva i kosti (osteonekroza).
English: In vitro studies with Caustinerf arsenical and Yranicid arsenical have confirmed a clastogenic/aneugenic potential and there are published data showing that arsenic compounds have a toxic effect on reproduction in animals.
Croatian: In vitro ispitivanja pasti Caustinerf arsenical i Yranicid arsenical potvrdila su klastogeni/aneugeni potencijal te postoje objavljeni podaci koji ukazuju da arsenove komponente imaju toksični učinak na razmnožavanje u životinja.
English: The risk of arsenic from the dental paste leaking into the general circulation and the tissues surrounding the teeth cannot be excluded.
Croatian: Rizik od curenja arsena iz zubne paste u krvotok i tkivo oko zuba ne može se isključiti.
English: In addition, epidemiology studies have shown an association between arsenic and spontaneous abortions and stillbirths.
Croatian: Osim toga, epidemiološka ispitivanja pokazala su povezanost između arsena i spontanih pobačaja te rađanja mrtve novorođenčadi.
English: The dental pastes, which contain an arsenic-based compound, arsenic trioxide, have been used to remove the damaged nerves in the dental pulp (the inside of the tooth).
Croatian: Zubne paste koje sadrže tvar koja sadrži arsen, arsenov trioksid, koriste se za uklanjanje oštećenih živaca u pulpi zuba (unutar zuba).
English: On 25 April 2014, the European Medicines Agency recommended that the marketing authorisations for the dental pastes Caustinerf arsenical, Yranicid arsenical and associated names be revoked in the EU due to concerns over the risk of genotoxic effects (damage to the genetic material in cells) and cell death in tissues around the teeth.
Croatian: Europska agencija za lijekove preporučila je da se odobrenja za stavljanje u promet zubnih pasti Caustinerf arsenical i Yranicid arsenical te pridruženih naziva povuku u EU zbog sigurnosnih pitanja oko rizika genotoksičnih učinaka (oštećenja genetskog materijala u stanicama) i smrti stanica u tkivima oko zuba.
English: Caustinerf arsenical, Yranicid arsenical and associated names are dental pastes that have been used in procedures to remove the damaged nerves in the dental pulp.
Croatian: Caustinerf arsenical, Yranicid arsenical i pridruženi nazivi zubne su paste koje se koriste u postupcima uklanjanja oštećenih živaca u pulpi zuba.
English: The EMA has concluded that the benefits of Caustinerf arsenical, Yranicid arsenical and associated names do not outweigh their risks and has recommended that their marketing authorisations in the EU be revoked.
Croatian: EMA je zaključila da koristi zubnih pasti Caustinerf arsenical i Yranicid arsenical te pridruženih naziva ne nadmašuju njihove rizike i preporučila je ukidanje odobrenja za njihovo stavljanje u promet u EU-u.
English: The CHMP recommendation was sent to the European Commission and on 11 July 2014 the Commission issued a legally binding decision revoking the authorisations for Caustinerf arsenical, Yranicid arsenical and associated names throughout the EU.
Croatian: Komisija izdala pravno obvezujuću odluku o ukidanju odobrenja za Caustinerf arsenical i Yranicid arsenical i pridružene nazive širom EU-a.
English: 11 July 2014 EMA/431170/2014
Croatian: 11. srpnja 2014.
English: Need help?
Croatian: Treba Vam pomoć?
English: • Improve your physical function.
Croatian: • Poboljšala Vaša fizička funkcionalnost.
English: In these instructions:
Croatian: U ovim uputama:
English: The average follow-up was approximately two years.
Croatian: Prosječno vrijeme praćenja iznosilo je približno dvije godine.
English: These are both normal and do not need to be removed.
Croatian: Oboje je normalno i ne treba se uklanjati.
English: 24 months
Croatian: 24 mjeseca
English: You may also see one or more air bubbles.
Croatian: Možda ćete vidjeti i jedan ili više mjehurića zraka.
English: • You will hear a loud ‘click' sound - don't be alarmed.
Croatian: • Čut ćete glasan "klik" - nemojte se uplašiti.
English: EXP EXP, if stored at room temperature___________________
Croatian: EXP EXP, ako se čuva na sobnoj temperaturi ________________________
English: Do not warm any other way.
Croatian: Nemojte je zagrijavati ni na koji drugi način.
English: Some of these patients died.
Croatian: Neki su od tih bolesnika umrli.
English: • You will also notice an air bubble, which is normal.
Croatian: • Opazit ćete i mjehurić zraka, što je normalno.
English: Patient's Name: _____________________ Doctor's Name: _____________________ Doctor's Phone: _____________________
Croatian: Ime bolesnika: _____________________ Ime liječnika: ______________________ Telefon liječnika: ___________________
English: Your injection is now complete!
Croatian: Injekcija je sada završena!
English: In addition, some previous infections may reappear.
Croatian: Osim toga, mogu se ponovno pojaviti neke prijašnje infekcije.
English: Radiographic response:
Croatian: Radiološki odgovor:
English: VAS: Visual Analogue Scale
Croatian: VAS: vizualna analogna skala
English: This appearance is not unusual for solutions containing protein.
Croatian: Ovakav izgled nije neuobičajen za otopine koje sadrže proteine.
English: Before you begin using this pre-filled pen, you should know how to:
Croatian: Prije nego što počnete koristiti ovu napunjenu brizgalicu, morate znati kako:
English: This type of cancer has usually resulted in death.
Croatian: Ova vrsta raka obično je završila smrću.
English: This usually takes about 3-6 seconds, but it may take up to 15 seconds for you to hear the second ‘click' sound.
Croatian: To obično traje 3-6 sekundi, ali može trajati i do 15 sekundi dok ne čujete. drugi "klik".
English: Show this card to any doctor involved in your treatment.
Croatian: Pokažite ovu karticu svakom liječniku koji sudjeluje u Vašem liječenju.
English: Approximately half the cases were lymphomas.
Croatian: Otprilike polovica tih slučajeva bili su limfomi.
English: Your doctor may decide to stop treatment.
Croatian: Liječnik će možda odlučiti prekinuti liječenje.
English: Ask your doctor or pharmacist how to throw away medicines you no longer use.
Croatian: Pitajte svog liječnika ili ljekarnika kako baciti lijekove koje više ne koristite.
English: Most of these patients were adolescent or young adult males.
Croatian: Ti su bolesnici većinom bili adolescenti ili mlađi odrasli muškarci.
English: The significance of this finding is unknown.
Croatian: Značaj ovog nalaza nije poznat.
English: • Difficulty sleeping
Croatian: • poteškoće sa spavanjem
English: • Some of these reactions may be serious or, rarely, life-threatening.
Croatian: • Neke od ovih reakcija mogu biti ozbiljne ili, rijetko, opasne po život.
English: All patients had a history of heavy smoking.
Croatian: Svi su bolesnici bili teški pušači.
English: Side effects may appear up to several months after the last injection.
Croatian: Nuspojave se mogu pojaviti i nekoliko mjeseci nakon posljednje injekcije.
English: You may or may not feel a needle prick at this time.
Croatian: U tom trenutku možete i ne morate osjetiti ubod igle.
English: After you remove the air bubbles, you may see a line inside the viewing window.
Croatian: Nakon što uklonite mjehuriće zraka, možda ćete u prozorčiću vidjeti jednu liniju.
English: Do not touch the plunger while you do this.
Croatian: Ne dirajte klip dok to radite.
English: Potential for medication errors
Croatian: Mogućnost medikacijskih pogrešaka
English: All treated population (AT)
Croatian: Cjelokupna liječena populacija (AT)
English: It is not known whether this finding was due to effects on the males and/or the females.
Croatian: Nije poznato je li uzrok tog nalaza utjecaj na mužjake i/ili ženke.
English: • You will choose from 2 injection methods.
Croatian: • Odaberite jednu od 2 metode ubrizgavanja.
English: Date of first authorisation: 1 October 2009 Date of latest renewal: 19 June 2014
Croatian: Datum posljednje obnove odobrenja: 19. lipnja 2014.
English: • The yellow indicator will fill about half of the viewing window.
Croatian: • Žuti indikator će ispuniti otprilike pola prozorčića.
English: Always use this medicine exactly as your doctor or pharmacist has told you.
Croatian: Uvijek primijenite ovaj lijek točno onako kako su Vam rekli liječnik ili ljekarnik.
English: This instruction guide does not take the place of talking with your doctor about your medical condition or your treatment.
Croatian: Ove upute ne mogu zamijeniti razgovor s liječnikom o Vašem medicinskom stanju ili liječenju.
English: It is used in adults for the treatment of the following inflammatory diseases:
Croatian: Koristi se u odraslih osoba za sljedeće upalne bolesti:
English: Component of a multipack, cannot be sold separately
Croatian: Sastavni dio višestrukog pakiranja, ne može se izdavati zasebno.
English: Get the rest of your equipment ready
Croatian: Pripremite ostali potreban materijal
English: • Once the button is pressed, it will remain pressed in so you do not need to keep pressure on it.
Croatian: • Kad ste jednom pritisnuli gumb, on će ostati utisnut i ne morate ga više pritiskati.
English: Common: Depression, insomnia
Croatian: Često: depresija, nesanica
English: When to inject your next dose:
Croatian: Kada treba ubrizgati sljedeću dozu:
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, toxicity to reproduction and development.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, reproduktivne i razvojne toksičnosti.
English: • Bacterial infections (such as cellulitis)
Croatian: • bakterijske infekcije (na primjer celulitis)
English: • Talk to your doctor or pharmacist if the yellow indicator is not visible in the window or if you suspect that you may not have received a complete dose.
Croatian: • Obratite se svom liječniku ili ljekarniku ako se u prozorčiću ne vidi žuti indikator ili ako sumnjate da možda niste dobili cijelu dozu.
English: You will need these supplies:
Croatian: Trebat će Vam sljedeći pribor:
English: The prescribed volume of injection should be selected according to patient's height and weight as shown in Table 1.
Croatian: Propisani volumen injekcije treba odrediti na temelju bolesnikove visine i težine, kako je prikazano u Tablici 1.
English: These medicines are used for the treatment of rheumatic diseases.
Croatian: Ti se lijekovi koriste u liječenju reumatskih bolesti.
English: Simponi belongs to a group of medicines called ‘TNF blockers'.
Croatian: Simponi pripada skupini lijekova koji se zovu "TNF blokatori".
English: • Reduce the signs and symptoms of your disease.
Croatian: • Umanjili znakovi i simptomi bolesti.
English: Consequently, these infants may be at increased risk of infection.
Croatian: Posljedično tome, kod te dojenčadi može postojati povećani rizik od infekcije.
English: If the yellow indicator is not shown in the window, the plunger has not advanced adequately, and the injection has not occurred.
Croatian: Ako se žuti indikator nije pojavio u prozorčiću, klip se nije dovoljno pomaknuo, te nije došlo do injiciranja.
English: The effects of this medicine in pregnant women are not known.
Croatian: Nisu poznati učinci ovog lijeka u trudnica.
English: Ask your doctor if you don't know if these fungal infections are common in the area in which you have lived or travelled.
Croatian: Provjerite s liječnikom ako ne znate jesu li te gljivične infekcije uobičajene u područjima u kojima ste živjeli ili putovali.
English: • allergic reactions which may be serious, or rarely, life-threatening (rare).
Croatian: • alergijske reakcije koje mogu biti ozbiljne ili, rijetko, opasne po život (rijetko).
English: What Simponi is and what it is used for
Croatian: Što je Simponi i za što se koristi
English: Injection site reactions generally did not necessitate discontinuation of the medicinal product.
Croatian: Reakcije na mjestu injekcije obično nisu zahtijevale prekid liječenja.
English: • Certain vaccinations may cause infections.
Croatian: • Određena cjepiva mogu prouzročiti infekcije.
English: A patient had to be in remission at both weeks 30 and 54 (without demonstrating a loss of response at any time point through week 54) to achieve durable remission.
Croatian: Bolesnik je morao biti u remisiji i u 30. i u 54. tjednu (bez znakova gubitka odgovora u bilo kojem trenutku do 54. tjedna liječenja) kako bi postigao trajnu remisiju.
English: • If you are allergic (hypersensitive) to golimumab or any of the other ingredients of this medicine (listed in Section 6).
Croatian: • Ako ste alergični (preosjetljivi) na golimumab ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: • reactivation of hepatitis B virus if you are a carrier or have had hepatitis B before (rare).
Croatian: • reaktivacija virusa hepatitisa B ako ste nositelj tog virusa ili ste već prije imali hepatitis B (rijetko).
English: During maintenance treatment, corticosteroids may be tapered in accordance with clinical practice guidelines.
Croatian: Tijekom terapije održavanja može se postupno smanjivati primjena kortikosteroida u skladu sa smjernicama kliničke prakse.
English: Wash your hands well with soap and warm water.
Croatian: Dobro operite ruke sapunom i toplom vodom.
English: Check the window - a yellow indicator confirms proper administration (see figure 9)
Croatian: Provjerite prozorčić - žuti indikator potvrđuje pravilnu primjenu (vidjeti sliku 9)
English: Hepatitis B virus (HBV)
Croatian: Virus hepatitisa B (HBV)
English: The Patient Reminder Card shall contain the following key messages:
Croatian: Kartica s podsjetnikom za bolesnika mora sadržavati sljedeće ključne poruke:
English: This evaluation should include colonoscopy and biopsies per local recommendations.
Croatian: Kontrolni pregledi moraju uključivati kolonoskopiju i biopsiju sukladno lokalnim preporukama.
English: Store in a refrigerator
Croatian: Čuvati u hladnjaku.
English: • You should not take Simponi with medicines containing the active substance anakinra or abatacept.
Croatian: • Ne smijete uzimati Simponi s lijekovima koji sadrže djelatne tvari anakinru ili abatacept.
English: Simponi contains latex and sorbitol
Croatian: Simponi sadrži lateks i sorbitol
English: Do not administer a second dose without speaking to your doctor.
Croatian: Nemojte primijeniti drugu dozu bez prethodnog razgovora s liječnikom.
English: • If you have tuberculosis (TB) or any other severe infection.
Croatian: • Ako imate tuberkulozu (TBC) ili neku drugu tešku infekciju.
English: Other medicines and Simponi
Croatian: Drugi lijekovi i Simponi
English: Golimumab crosses the placenta.
Croatian: Golimumab prolazi kroz placentu.
English: Height (cm)
Croatian: Visina (cm)
English: Some cases have had fatal outcome.
Croatian: Neki su slučajevi imali smrtni ishod.
English: For more information on sorbitol (E420), see Section 2.
Croatian: Za više informacija o sorbitolu (E420) pogledajte dio 2.
English: However, caution should be exercised when treating the elderly and particular attention paid with respect to occurrence of infections.
Croatian: Međutim, potreban je oprez prilikom liječenja starijih osoba, pri čemu osobito treba obratiti pozornost na infekcije.
English: • Provision to record the type, date, and result of TB screenings.
Croatian: • Odredbu da je potrebno zabilježiti vrstu, datum i rezultat probira na tuberkulozu.
English: Your doctor will tell you the correct dose to use.
Croatian: Liječnik će Vam reći koju dozu trebate primijeniti.
English: • Positive blood lupus test
Croatian: • pozitivan krvni nalaz na lupus
English: GO-FORWARD Active RA despite MTX
Croatian: GO-FORWARD Aktivni RA unatoč primjeni MTX
English: • Again, all sites mentioned can be used regardless of your body type or size.
Croatian: • Mogu se koristiti sva navedena mjesta bez obzira na Vašu tjelesnu građu i masu.
English: Similar rates were shown across rheumatologic indications.
Croatian: Slične stope dobivene su u svim reumatološkim indikacijama.
English: The pre-filled pen is to be used only one time.
Croatian: Napunjena brizgalica smije se upotrijebiti samo jednom.
English: If a small dose is set, the plunger will only move a short distance.
Croatian: Ako ste odabrali malu dozu, klip će se samo malo pomaknuti.