FrancophonIA/ELRC3.0 huggingface dataset:
English: For more information about treatment with Pemetrexed Sandoz, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Pemetrexed Sandoz pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: Pemetrexed Sandoz is available as a powder that is made up into a solution for infusion (drip) into a vein.
Croatian: Pemetrexed Sandoz dostupan je kao prah koji se priprema kao otopina za intravensku infuziju (drip).
English: What is Pemetrexed Sandoz and what is it used for?
Croatian: Što je Pemetrexed Sandoz i za što se koristi?
English: Other information about Pemetrexed Sandoz
Croatian: Ostale informacije o lijeku Pemetrexed Sandoz
English: To reduce side effects, patients should take a corticosteroid (a type of medicine that reduces inflammation) and folic acid (a type of vitamin), and receive injections of vitamin B12 during treatment with Pemetrexed Sandoz.
Croatian: Kako bi se ublažile nuspojave, bolesnici bi tijekom terapije lijekom Pemetrexed Sandoz trebali uzimati kortikosteroid (vrsta lijeka koji ublažava upale) i folnu kiselinu (vrsta vitamina) te injekcije vitamina B12.
English: What are the benefits and risks of Pemetrexed Sandoz?
Croatian: Koje su koristi i rizici lijeka Pemetrexed Sandoz?
English: For practical information about using Pemetrexed Sandoz, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Pemetrexed Sandoz bolesnici mogu pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
English: • advanced non-small-cell lung cancer of the kind known as ‘non-squamous', where it is used either in combination with cisplatin in previously untreated patients or on its own in patients who have previously received cancer treatment.
Croatian: • uznapredovalog raka pluća nemalih stanica poznatih pod nazivom „neskvamozne”, kada je u kombinaciji s cisplatinom indiciran za liječenje bolesnika koji prethodno nisu primili terapiju ili kao monoterapija za liječenje bolesnika koji su prethodno primili antitumorsku terapiju.
English: For more information, see the summary of product characteristics (also part of the EPAR).
Croatian: Više informacija možete pročitati u sažetku opisa svojstava lijeka (također dio EPAR-a).
English: Pemetrexed Sandoz pemetrexed
Croatian: Pemetrexed Sandoz pemetreksed
English: Treatment should be delayed or stopped, or the dose reduced, in patients whose blood counts are abnormal or who have certain other side effects.
Croatian: U bolesnika s abnormalnom krvnom slikom ili određenim drugim nuspojavama terapiju lijekom treba odgoditi ili prekinuti, odnosno njegovu dozu smanjiti.
English: Why is Pemetrexed Sandoz approved?
Croatian: Zašto je lijek Pemetrexed Sandoz odobren?
English: How is Pemetrexed Sandoz used?
Croatian: Kako se Pemetrexed Sandoz koristi?
English: Pemetrexed Sandoz contains the active substance pemetrexed.
Croatian: Pemetrexed Sandoz sadrži djelatnu tvar pemetreksed.
English: Therefore, the CHMP's view was that, as for Alimta, the benefit outweighs the identified risk.
Croatian: Stoga je stav Odbora kako koristi nadmašuju utvrđene rizike, kao i kod lijeka Alimta.
English: How does Pemetrexed Sandoz work?
Croatian: Kako djeluje Pemetrexed Sandoz?
English: How has Pemetrexed Sandoz been studied?
Croatian: Kako je Pemetrexed Sandoz ispitivan?
English: Duration of immunity: 12 months.
Croatian: Trajanje imuniteta: 12 mjeseci.
English: In laboratory studies and field trials:
Croatian: Kod laboratorijskih i terenskih ispitivanja:
English: Date of last renewal: 16/04/2018
Croatian: Datum posljednjeg produljenja odobrenja: 16/04/2018
English: Iscom-Matrix
Croatian: Iskom-Matrix
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Croatian: Detaljne informacije o ovom veterinarsko-medicinskom proizvodu su dostupne na web stranici Europske medicinske Agencije (http://www.ema.europa.eu/)
English: ATCvet code: QI05AA10.
Croatian: ATCvet kod: QI05AA
English: Protect from light.
Croatian: Zaštiti od svijetla.
English: The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Croatian: Djelatna tvar koja se sastoji od tvari biološkog podrijetla namijenjena za proizvodnju aktivnog imuniteta nije u nadležnosti Uredbe (EC) broj 470/2009.
English: Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Croatian: Rok valjanosti veterinarsko-medicinskog proizvoda pakiranog za prodaju: 2 godine.
English: a) the administration of the product to animals will interfere with the implementation of a national programme for the diagnosis, control or eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
Croatian: a) primjena veterinarsko - medicinskog proizvoda na životinjama će ometati provedbu nacionalnog programa za dijagnostiku, kontrolu i iskorjenjivanje bolesti životinja, ili će izazvati poteškoće u certificiranju odsutnosti kontaminacije kod živih životinja, prehrambenih ili drugih proizvoda dobivenih od tretiranih životinja.
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of its territory if it is established that:
Croatian: Prema članku 71 Direktive 2001/82/EC izmjenama i dopuna, državne članice zabranjuju ili mogu zabraniti uvoz, prodaju, opskrbu i/ili uporabu veterinarsko medicinskih proizvoda na cijelom ili dijelu svog teritorija ako se utvrdi da:
English: b) the disease to which the product is intended to confer immunity is largely absent from the territory in question.
Croatian: b) bolest za koju je veterinarsko medicinski proizvod namijenjen da pruži imunitet, je u velikoj mjeri odsutna iz područja.
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Croatian: Pomoćne tvari (uključujući adjuvanse) navedene u dijelu 6.1 SPC su ili dopuštene tvari za koje je u tablici 1 Dodatka Uredbe Komisije (EU) br. 37/2010 naznačeno da određivanje MRL nije nužno ili se smatra da se na njih ne primjenjuju odredbe Uredbe (EK) br. 470/2009 kada se primjenjuju u tim veterinarsko medicinski proizvodima.
English: Horses.
Croatian: Konji
English: Any person intending to manufacture, import, possess, sell, supply and use Equilis West Nile must first consult the relevant Member State's competent authority on the current vaccination policies, as these activities may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Croatian: Tko namjerava proizvoditi, uvesti, prodavati, opskrbljivati i/ili primjenjivati Equilis West Nile prethodno mora konzultirati nadležno tijelo odnosne države članice u pogledu važećih odredbi o cijepljenju, jer te aktivnosti mogu biti zabranjene u državi članici, u cijelosti ili samo na djelu njezinog teritorija, u skladu s nacionalnim zakonodavstvom.
English: Disodium hydrogen phosphate dihydrate Potassium dihydrogen phosphate Water for injections
Croatian: Dinatrijev hidrogen fosfat dihidrat Kalijev dihidrogen fosfat Voda za injekcije
English: 1 Antigenic units determined by ELISA.
Croatian: 42 mikrograma 1 Jedinice antigena su određene ELISA postupkom.
English: Primary vaccination: first injection from 6 months of age onwards, second injection 3 to 5 weeks later.
Croatian: Primarno cijepljenje: prva injekcija od 6 mjeseci starosti nadalje, druga injekcija od 3 do 5 tjedana kasnije.
English: 250 micrograms
Croatian: 250 mikrograma
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Croatian: Bilo koji neupotrebljeni veterinarsko-medicinski proizvod ili otpadni materijali dobivenih primjenom tih veterinarsko-medicinskih proizvoda mora se odlagati u skladu s lokalnim propisima.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 1 ml contains:
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Svaka doza od 1 ml sadrži:
English: Opalescent suspension.
Croatian: Opalescentna suspenzija.
English: 83 micrograms
Croatian: 83 mikrograma
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 06/06/2013.
Croatian: Datum prvog odobrenja:06/06/2013.
English: Package sizes:
Croatian: Veličina pakovanja:
English: PACKAGE SIZE 10 vials x 1 dose 5 pre-filled syringes x 1 dose 10 pre-filled syringes x 1 dose
Croatian: VELIČINA PAKOVANJA 10 bočica x 1 doza 5 napunjenih šprica x 1 doza 10 napunjenih šprica x 1 doza
English: 42 micrograms
Croatian: 42 mikrograma
English: SPECIAL WARNING(S), IF NECESSARY Read the package leaflet before use.
Croatian: POSEBNA UPOZORENJA, UKOLIKO JE POTREBNO Pročitati uputu o VMP prije primjene.
English: The vaccine stimulates active immunity against West Nile virus in horses.
Croatian: Cjepivo potiče aktivni imunitet protiv virusa zapadnog Nila kod konja.
English: SPECIAL STORAGE PRECAUTIONS Keep out of the sight and reach of children.
Croatian: 11. POSEBNE MJERE PREDOSTROŽNOSTI ZA ČUVANJE Čuvati izvan dosega i pogleda djece.
English: Pharmacotherapeutic group: Immunologicals for Equidae, inactivated viral vaccines.
Croatian: Farmakoterapijska grupa: imunološki pripravci za kopitare; inaktivirano virusno cjepivo.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL
Croatian: OSNOVNI DIJELOVI NAPISANI NA MALIM JEDINICAMA UNUTARNJIH PAKOVANJA NALJEPNICA
English: Onset of immunity: 2 weeks after primary vaccination course of two injections.
Croatian: Početak imuniteta: 2 tjedna nakon osnovnog rasporeda cijepljenja s 2 injekcije.
English: In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Croatian: U slučaju nehotičnog samoinjiciranja odmah potražiti liječničku pomoć i pokazati uputu o VMP ili etiketu.
English: Iscom-Matrix containing: Purified saponin
Croatian: Isokom - Matrix2 koji sadržava: Pročišćeni saponin
English: Antigenic units Opalescent suspension.
Croatian: Antigene jedinice Opalescentna suspenzija.
English: Vaccination schedule: Administer one dose (1 ml) by intramuscular injection, according to the following schedule:
Croatian: Primijeniti 1 dozu (1 ml) intramuskularnom injekcijom, po sljedećem rasporedu:
English: This swelling normally resolves within 1 to 5 days.
Croatian: može vrlo često trajati 1 do 2 dana.
English: EU/2/13/151/002 (5 pre-filled syringes) EU/2/13/151/003 (10 pre-filled syringes)
Croatian: EU/2/13/151/002 (5 napunjenih šprica) EU/2/13/151/003 (10 napunjenih šprica)
English: Revaccination: a yearly booster injection of one dose (1 ml) should be sufficient to achieve a reduction of fever, lesions in the brain and viraemia.
Croatian: Revakcinacija: godišnje revakcinacija od 1 doze (1 ml) bi trebala biti dovoljna da se postigne smanjenje temperature, lezija na mozgu i viremije.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Croatian: Posebne mjere predostrožnost koje mora poduzeti osoba koja primjenjuje veterinarsko-medicinski proizvod na životinjama:
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” For animal treatment only
Croatian: RIJEČI “SAMO ZA PRIMJENU NA ŽIVOTINJAMA” Samo za primjenu na životinjama.
English: Active immunisation of horses against West Nile virus (WNV) to reduce clinical signs of disease and lesions in the brain and to reduce viraemia.
Croatian: Aktivna imunizacija konja protiv virusa zapadnog Nila (VZN) da bi se smanjili klinički znakovi bolesti i lezije na mozgu, te da bi se smanjila viremija.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each dose of 1 ml contains:
Croatian: NAVOĐENJE DJELATNE(IH) TVARI I DRUGIH SASTOJAKA Svaka doza od 1 ml sadrži:
English: Type I glass pre-filled syringes of 1ml (1 dose), containing a plunger with a halogenobutyl end and closed with a halogenobutyl stopper.
Croatian: Napunjene staklene (tipa 1) šprice od 1 ml (1 doza), koje sadrže klip s halogenbutil završetkom i zatvorene s halogenbutil čepom.
English: If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Croatian: Ako zamijetite ozbiljne nuspojave ili druge nuspojave koje nisu opisane u uputi o VMP, molimo javite veterinaru.
English: Disposal: read package leaflet.
Croatian: Odlaganje: pročitati uputu o VMP .
English: DATE OF REVISION OF THE TEXT {MM/YYYY}
Croatian: DATUM REVIZIJE TEKSTA
English: Special warnings for each target species: Vaccinate healthy animals only.
Croatian: 4.4 Posebna upozorenja za svaku od ciljnih vrsta Cijepiti samo zdrave životinje.
English: Inactivated chimeric flavivirus strain YF-WN
Croatian: Inaktivirani himerni flavivirus soj YF-WN
English: PACKAGE LEAFLET: Equilis West Nile suspension for injection for horses
Croatian: Equilis West Nile suspenzija za injekciju za konje
English: Phosphatidylcholine
Croatian: Fosfatildiklolin
English: Marketing authorisation holder and manufacturer responsible for batch release: Intervet International B.V.
Croatian: Naziv i adresa proizvođača odgovornog(ih) za puštanje serije u promet: Intervet International B.V.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 1 ml (1 dose)
Croatian: SADRŽAJ: TEŽINA, VOLUMEN ILI BROJ DOZA
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED {DD/MM/YYYY}
Croatian: 14. DATUM KADA JE UPUTA O VMP ZADNJI PUTA ODOBRENA
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Equilis West Nile suspension for injection for horses
Croatian: UPUTA O VMP Equilis West Nile suspenzija za injekciju za konje
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ BIOLOŠKI DJELATNE TVARI I PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE U PROMET
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Croatian: 4.10 Predoziranje (simptomi, hitni postupci, antidoti), ako je nužno Nakon primjene duple doze cjepiva osim onih nuspojava navedenih u poglavlju 4.6, nisu primijećene druge nuspojave.
English: Cardboard box or plastic box with 10 vials of 1 ml, or 5 or 10 pre-filled syringes of 1 ml
Croatian: Kartonska kutija ili plastična kutija s 10 bočica od 1 ml, 5 ili 10 napunjenih šprica od 1 ml
English: MARKETING AUTHORISATION NUMBER(S) EU/2/13/151/001 (10 vials)
Croatian: EU/2/13/151/001 (10 bočica)
English: After vaccination a mild transient swelling may very commonly develop at the injection site (max. 3 cm in diameter).
Croatian: Nakon cijepljenja vrlo često može doći do blagog, prolaznog oticanja na mjestu uboda (promjera 3 cm maksimalno) koje obično prođe unutar 1 do 5 dana.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/13/151/001-003
Croatian: EU/2/13/151/001-003
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE BOX
Croatian: PODACI NA VANJSKOM PAKOVANJU
English: Type I glass vials of 1 ml (1 dose) closed with a halogenobutyl rubber stopper and sealed with an aluminium cap.
Croatian: 6.5 Osobine i sastav unutarnjeg pakovanja Staklena bočica tipa 1, od 1 ml (1 doza) zatvorena halogenbutil gumenim čepom i zapečaćena aluminijskom kapicom.
English: MARKETING AUTHORISATION HOLDER
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET
English: 1 ml: Inactivated chimeric flavivirus strain YF-WN
Croatian: Djelatna tvar: Inaktivirani himerni flavivirus soj YF-WN ≥ 492 AU1
English: 6.4 Special precautions for storage
Croatian: 11. POSEBNI UVJETI ČUVANJA
English: 1 ml vial, 1 ml pre-filled syringe
Croatian: Bočica od 1 ml, napunjena šprica od 1 ml
English: Active substance:
Croatian: Raspored cijepljenja:
English: Plastic box with 5 or 10 pre-filled syringes of 1 ml (1 dose).
Croatian: Plastična kutija s 5 ili 10 napunjenih šprica od 1 ml (1 doze).
English: Cardboard box with 5 or 10 pre-filled syringes of 1 ml (1 dose).
Croatian: Kartonska kutija s 5 ili 10 napunjenih šprica od 1 ml (1 doza).
English: WITHDRAWAL PERIOD(S) Zero days.
Croatian: KARENCIJA Karencija: 0 dana.
English: Adjuvant:
Croatian: NUSPOJAVE
English: Plastic box with 10 glass vials of 1 ml (1 dose).
Croatian: Plastična kutija s 10 staklenih bočica od 1 ml (1 doze).
English: WITHDRAWAL PERIOD(S) Withdrawal period: Zero days.
Croatian: KARENCIJA Karencija: nula dana.
English: Cardboard box with 10 glass vials of 1 ml (1 dose).
Croatian: Kutija s 10 staklenih bočica od 1 ml (1 doze).
English: BATCH NUMBER Lot {number}
Croatian: PUT(EVI) PRIMJENE
English: Name and address of the manufacturer responsible for batch release
Croatian: PROIZVOĐAČI BIOLOŠKI DJELATNE TVARI I PROIZVOĐAČI ODGOVORAN ZA PUŠTANJE SERIJE U PROMET
English: Capsule, hard blister (alu/PVC) 42 capsules
Croatian: Veličina pakovanja blister (alu/PVC) 42 kapsule
English: Packaging
Croatian: Put primjene Unutarnje pakovanje
English: What you need to know before you take CHAMPIX
Croatian: Što morate znati prije nego počnete uzimati CHAMPIX
English: Varenicline - Loss of consciousness (EPITT no 19146)
Croatian: Vareniklin - gubitak svijesti (EPITT br. 19146)
English: Adopted at the 11-14 June 2018 PRAC
Croatian: Usvojeno na sjednici PRAC-a 11. - 14. lipnja 2018.
English: Stop using <medicine> if you develop these symptoms and contact your doctor or seek medical attention immediately.
Croatian: Prestanite uzimati <lijek> u slučaju nastanka ovih simptoma i odmah se obratite svojem liječniku ili potražite medicinsku pomoć.
English: If signs and symptoms suggestive of these reactions appear, nabumetone should be withdrawn immediately and an alternative treatment considered (as appropriate).
Croatian: U slučaju pojavljivanja znakova i simptoma koji upućuju na te reakcije, potrebno je odmah ukinuti primjenu nabumetona i razmotriti zamjensko liječenje (ako je prikladno).
English: Not known Transient loss of consciousness
Croatian: - Nepoznato o prolazni gubitak svijesti
English: Nabumetone should be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity.
Croatian: Potrebno je prekinuti liječenje nabumetonom pri prvoj pojavi osipa na koži, mukoznih lezija ili bilo kojeg drugog znaka preosjetljivosti.
English: You should not drive, operate complex machinery or engage in any other potentially hazardous activities until you know whether this medicine affects your ability to perform these activities.
Croatian: Ne smijete upravljati vozilom, rukovati složenim strojevima ni poduzimati druge potencijalno opasne aktivnosti dok ne utvrdite utječe li ovaj lijek na Vašu sposobnost da to činite.
English: At the time of prescription patients should be advised of the signs and symptoms and monitored closely for skin reactions.
Croatian: U trenutku propisivanja lijeka bolesnike je potrebno savjetovati o znakovima i simptomima te ih je potrebno pomno pratiti kako bi se uočila moguća pojava kožnih reakcija.
English: Patients appear to be at highest risk of these reactions early in the course of therapy, the onset of the reaction occurring in the majority of cases within the first two months of treatment.
Croatian: Reakcije su se u većini slučajeva pojavile tijekom prva dva mjeseca liječenja.
English: CHAMPIX may be linked with produce dizziness, sleepiness and transient loss of consciousness.
Croatian: CHAMPIX može biti povezan s uzrokovati omaglicom, pospanošću i prolaznim gubitkom svijesti.
English: CHAMPIX may cause dizziness, somnolence and transient loss of consciousness, and therefore may influence the ability to drive and use machines.
Croatian: CHAMPIX može izazvati omaglicu, somnolenciju i prolazni gubitak svijesti te tako utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
English: Nabumetone - Drug reaction with eosinophilia and systemic symptoms (DRESS)(EPITT no 19241)
Croatian: Nabumeton - kožni osip uzrokovan lijekom s eozinofilijom i sistemskim simptomima (DRESS) (EPITT br. 19241)
English: Very rare: Bullous reactions including toxic epidermal necrolysis, Stevens Johnson syndrome, drug reaction with eosinophilia and systemic symptoms, erythema multiforme, angioedema, pseudoporphyria, alopecia
Croatian: Vrlo rijetko: Bulozne reakcije, uključujući toksičnu epidermalnu nekrolizu, Stevens-Johnsonov sindrom, kožni osip uzrokovan lijekom s eozinofilijom i sistemskim simptomima, multiformni eritem, angioedem, pseudoporfiriju, alopeciju
English: CHAMPIX may have minor or moderate influence on the ability to drive and use machines.
Croatian: Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima CHAMPIX može malo ili umjereno utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
English: Package leaflet
Croatian: Tablični prikaz nuspojava
English: Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS), which can be life-threatening or fatal, have been reported very rarely in association with the use of NSAIDs, including nabumetone (see section 4.8).
Croatian: Ozbiljne kožne reakcije, neke od njih smrtonosne, uključujući eksfolijativni dermatitis, StevensJohnsonov sindrom (SJS), toksičnu epidermalnu nekrolizu (TEN) i kožni osip uzrokovan lijekom s eozinofilijom i sistemskim simptomima (DRESS), koje mogu biti opasne po život ili smrtonosne, vrlo rijetko su prijavljene povezano s primjenom NSAIL-ova, uključujući nabumeton (vidjeti dio 4.8).
English: Undesirable effects Nervous system disorders
Croatian: Poremećaji živčanog sustava nepoznato prolazni gubitak svijesti
English: Widespread rash, high body temperature, liver enzyme elevations, blood abnormalities (eosinophilia), enlarged lymph nodes and other body organs involvement (drug reaction with eosinophilia and systemic symptoms which is also known as DRESS or drug hypersensitivity syndrome).
Croatian: Široko rasprostranjeni osip, povišena tjelesna temperatura, povišene razine jetrenih enzima, abnormalnosti u krvi (eozinofilija), povećani limfni čvorovi s uključenosti drugih organa (kožni osip uzrokovan lijekom s eozinofilijom i sistemskim simptomima, poznat i pod nazivom DRESS ili sindrom preosjetljivosti na lijek).
English: Severe cutaneous adverse reactions (SCARs), including exfoliative dermatitis, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with nabumetone treatment (see section 4.4).
Croatian: Teške kožne nuspojave (engl. severe cutaneous adverse reactions, SCARs), uključujući eksfolijativni dermatitis, Stevens-Johnsonov sindrom (SJS), toksičnu epidermalnu nekrolizu (TEN) i kožni osip uzrokovan lijekom s eozinofilijom i sistemskim simptomima (DRESS), prijavljene su povezano s liječenjem nabumetonom (vidjeti dio 4.4).
English: If the patient has developed a serious reaction such as SJS, TEN or DRESS with the use of nabumetone, treatment with nabumetone must not be restarted in this patient at any time.
Croatian: U slučaju da se zbog primjene nabumetona u bolesnika pojave ozbiljne reakcije kao što su StevensJohnsonov sindrom, toksična epidermalna nekroliza ili kožni osip uzrokovan lijekom s eozinofilijom i sistemskim simptomima, ni u jednom trenutku se ne smije ponovno započeti liječiti tog bolesnika nabumetonom.
English: In children, this combination is not recommended
Croatian: U djece se ova kombinacija ne preporučuje.
English: † MedDRA version 13.1
Croatian: † MedDRA verzija 13.1
English: • Seek urgent medical assistance.
Croatian: • potražite hitnu medicinsku pomoć.