FrancophonIA/ELRC3.0 huggingface dataset:
English: The metabolism of valdecoxib may increase when coadministered with enzyme inducers such as rifampicin, phenytoin, carbamazepine or dexamethasone.
Croatian: Metabolizam valdekoksiba može biti pojačan kad se istodobno primjenjuju induktori enzima kao što su rifampicin, fenitoin, karbamazepin ili deksametazon.
English: There is limited clinical experience with Dynastat treatment beyond three days (see section 5.1).
Croatian: Kliničko je iskustvo s liječenjem Dynastatom duljim od tri dana ograničeno (vidjeti dio 5.1).
English: Plasma exposure (AUC and Cmax) to valdecoxib was increased (38% and 24%, respectively) when coadministered with ketoconazole (CYP3A4 inhibitor), however, a dosage adjustment should not generally be necessary for patients receiving ketoconazole.
Croatian: Izloženost valdekoksibu u plazmi (AUC i Cmax) bila je povećana (38% odnosno 24%) kad se istodobno primjenjivao ketokonazol (inhibitor CYP3A4), međutim, prilagodba doziranja općenito ne bi trebala biti neophodna u bolesnika koji primaju ketokonazol.
English: Manufacturer: Pfizer Manufacturing Belgium NV, Rijksweg 12, 2870 Puurs, Belgium
Croatian: Proizvođač: Pfizer Manufacturing Belgium NV, Rijksweg 12, 2870 Puurs, Belgija
English: Parecoxib should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
Croatian: Primjena parekoksiba mora se prekinuti kod prve pojave kožnog osipa, lezija sluznica ili drugih znakova preosjetljivosti.
English: The occurrence of adverse events in patients receiving parecoxib for 4-7 days (median duration 4 days) was low after treatment Day 3 and similar to placebo.
Croatian: Pojava štetnih događaja u bolesnika koji su primali parekoksib od 4 do 7 dana (medijan trajanja iznosio je 4 dana) bila je rijetka nakon 3. dana liječenja i slična onoj zabilježenoj kod primjene placeba.
English: What Dynastat looks like and contents of the pack Dynastat is available as a white to off-white powder.
Croatian: Dynastat je dostupan kao bijeli do gotovo bijeli prašak.
English: For storage conditions of the reconstituted medicinal product see section 6.3.
Croatian: Uvjete čuvanja nakon rekonstitucije lijeka vidjeti u dijelu 6.3.
English: Since prostaglandin synthesis inhibition may result in deterioration of renal function and fluid retention, caution should be observed when administering Dynastat in patients with impaired renal function (see section 4.2) or hypertension, or in patients with compromised cardiac or hepatic function or other conditions predisposing to fluid retention.
Croatian: Budući da inhibicija sinteze prostaglandina može rezultirati pogoršanjem funkcije bubrega i zadržavanjem tekućine, potreban je oprez kad se Dynastat primjenjuje u bolesnika s oštećenjem bubrega (vidjeti dio 4.2) ili hipotenzijom ili u bolesnika s ugroženom srčanom ili jetrenom funkcijom ili drugim stanjima zbog kojih su skloni zadržavanju tekućine.
English: There was a significantly (p<0.05) greater incidence of cardiovascular/thromboembolic events (myocardial infarction, ischemia, cerebrovascular accident, deep vein thrombosis and pulmonary embolism) detected in the parecoxib/valdecoxib treatment group compared to the placebo/placebo treatment group for the IV dosing period (2.2% and 0.0% respectively) and over the entire study period (4.8% and 1.3% respectively).
Croatian: Postojala je značajno veća incidencija (p<0,05) kardiovaskularnih/tromboembolijskih događaja (infarkt miokarda, ishemija, cerebrovaskularni incident, duboka venska tromboza i plućna embolija) u skupini liječenoj parekoksibom/valdekoksibom nego u skupini koja je primala placebo/placebo u razdoblju intravenskog doziranja (2,2% odnosno 0,0%) i tijekom cijelog razdoblja ispitivanja (4,8% i 1,3%).
English: The NSAIDs class is also associated with increased GI complications when coadministered with glucocorticoids, selective serotonin reuptake inhibitors, other antiplatelet drugs, other NSAIDs or patients ingesting alcohol.
Croatian: Skupina nesteroidnih protuupalnih lijekova također je povezana s povećanim GI komplikacijama kada se lijekovi iz ove skupine primjenjuju istodobno s glukokortikoidima, selektivnim inhibitorima ponovne pohrane serotonina, drugim antitrombocitnim lijekovima, drugim nesteroidnim protuupalnim lijekovima ili u bolesnika koji konzumiraju alkohol.
English: Oral anticoagulants include warfarin/coumarin-type and novel oral anticoagulants (e.g. apixaban, dabigatran, and rivaroxaban) (see section 4.5).
Croatian: Oralni antikoagulansi uključuju lijekove tipa varfarina/kumarina i nove oralne antikoagulanse (npr. apiksaban, dabigatran i rivaroksaban) (vidjeti dio 4.5).
English: Average Cmax of parecoxib after IM dosing was lower compared to bolus IV dosing, which is attributed to slower extravascular absorption after IM administration.
Croatian: Prosječni Cmax parekoksiba nakon i.m. doziranja bio je niži u usporedbi s onim nakon i.v. bolus doziranja, što se pripisuje sporijoj ekstravaskularnoj apsorpciji nakon i.m. primjene.
English: Following IV or IM injection, parecoxib is rapidly converted to valdecoxib, the pharmacologically active substance, by enzymatic hydrolysis in the liver.
Croatian: Nakon i.v. ili i.m. injekcije, parekoksib se izrazito brzo konvertira enzimatskom hidrolizom u jetri u valdekoksib, farmakološki djelatnu tvar.
English: The entire contents of the vial should be withdrawn for a single administration.
Croatian: Za jednokratnu primjenu treba izvući cijeli sadržaj bočice.
English: Valdecoxib is eliminated via hepatic metabolism with less than 5% unchanged valdecoxib recovered in the urine.
Croatian: Valdekoksib se eliminira putem jetrenog metabolizma, a manje od 5% neizmijenjenog valdekoksiba otkrije se u mokraći.
English: Administration is by intramuscular (IM) or intravenous (IV) injection.
Croatian: Primjena intramuskularnom (i.m.) ili intravenskom (i.v.) injekcijom.
English: How to use Dynastat
Croatian: Kako primjenjivati Dynastat
English: After reconstitution, the concentration of parecoxib is 20 mg/ml.
Croatian: Nakon rekonstitucije, koncentracija parekoksiba je 20 mg/ml.
English: In two pharmacokinetic interaction studies in rheumatoid arthritis patients receiving a stable weekly methotrexate dose (5-20 mg/week, as a single oral or intramuscular dose), orally administered valdecoxib (10 mg twice daily or 40 mg twice daily) had little or no effect on the steady-state plasma concentrations of methotrexate.
Croatian: U dva farmakokinetička ispitivanja interakcija u bolesnika s reumatoidnim artritisom koji su primali stabilnu, tjednu dozu metotreksata (5-20 mg/tjedno, u obliku jedne peroralne ili intramuskularne doze), peroralno primijenjen valdekoksib (10 mg dvaput dnevno ili 40 mg dvaput dnevno) imao je mali ili nikakav učinak na koncentracije metotreksata u plazmi u stanju dinamičke ravnoteže.
English: 5 + 5 pack: contains 5 powder vials and 5 solvent ampoules.
Croatian: Pakiranje 5+5: sadrži 5 bočica s praškom i 5 ampula s otapalom.
English: In surgery studies in which parecoxib was administered pre-operatively, no evidence of pharmacodynamic interaction was observed in patients receiving parecoxib and the inhalation anaesthetic agents nitrous oxide and isoflurane (see section
Croatian: U kirurškim ispitivanjima u kojima se parekoksib primjenjivao prije operacije nije zamijećen nikakav dokaz farmakodinamičke interakcije u bolesnika koji su primali parekoksib i inhalacijske anestetike dušikov oksid i izofluran (vidjeti dio 5.1).
English: Treatment of post-operative pain following coronary artery bypass graft (CABG) surgery (see sections 4.8 and 5.1).
Croatian: Liječenje poslijeoperacijskog bola nakon operacije ugradnje aortokoronarne premosnice (engl. coronary artery bypass graft, CABG) (vidjeti dijelove 4.8 i 5.1).
English: Chemical and physical in-use stability of the reconstituted solution, which should not be refrigerated or frozen, have been demonstrated for up to 24 hours at 25C.
Croatian: Pokazalo se da je rekonstituirana otopina, koja se ne smije čuvati u hladnjaku niti zamrzavati, kemijski i fizikalno stabilna do 24 sata na temperaturi od 25C.
English: No dose adjustment is generally necessary in elderly patients (≥65 years).
Croatian: U starijih bolesnika (≥ 65 godina) općenito nije potrebna prilagodba doze.
English: Injectable anaesthetics
Croatian: Inhalacijski anestetici
English: Of the patients treated with parecoxib, 317 patients received parecoxib for up to 4 days, 32 patients for up to 5 days, while only 8 patients were treated for up to 6 days and 1 patient for 7 or more days.
Croatian: Od ukupnog broja bolesnika liječenih parekoksibom, 317 bolesnika primalo je parekoksib do 4 dana, 32 bolesnika do 5 dana, dok je samo 8 bolesnika primalo parekoksib do 6 dana, a 1 bolesnik 7 ili više dana.
English: Marketing Authorisation Holder: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
Croatian: Nositelj odobrenja za stavljanje lijeka u promet: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgija
English: Of the patients treated with placebo, 270 patients received placebo for up to 4 days, 43 patients for up to 5 days, while only 3 patients were treated for up to 6 days and 2 patients for 7 or more days.
Croatian: Od ukupnog broja bolesnika liječenih placebom, 270 bolesnika primalo je placebo do 4 dana, 43 bolesnika do 5 dana, dok su samo 3 bolesnika primala placebo do 6 dana, a 2 bolesnika 7 ili više dana.
English: Precipitation may occur when Dynastat is combined in solution with other medicinal products and therefore Dynastat must not be mixed with any other drug, either during reconstitution or injection.
Croatian: Može doći do precipitacije kad se Dynastat kombinira u otopini s drugim lijekovima pa se stoga Dynastat ne smije miješati niti s jednim drugim lijekom, niti tijekom rekonstitucije niti tijekom injiciranja.
English: No dosage adjustment is generally necessary in patients with mild hepatic impairment (Child-Pugh score 5-6).
Croatian: Općenito nije potrebna prilagodba doziranja u bolesnika s blagim oštećenjem jetre (Child-Pugh rezultat 5-6).
English: Intravenous or intramuscular use.
Croatian: Za intravensku ili intramuskularnu primjenu.
English: Administration other than IV or IM
Croatian: Primjena osim i.v. i i.m.
English: Following coronary artery bypass graft surgery, patients administered Dynastat have a higher risk of adverse reactions such as: cardiovascular/thromboembolic events (including myocardial infarction, stroke/TIA, pulmonary embolus, and deep vein thrombosis; see sections 4.3 and 5.1), deep surgical infections, and sternal wound healing complications.
Croatian: Nakon operacije ugradnje aortokoronarne premosnice, bolesnici kojima se primjenjuje Dynastat imaju povećan rizik od nuspojava kao što su: kardiovaskularni/tromboembolijski događaji (uključujući infarkt miokarda, moždani udar/TIA, plućna embolija i duboka venska tromboza; vidjeti dijelove 4.3 i 5.1), duboke kirurške infekcije i komplikacije s cijeljenjem sternalne rane.
English: There were no significant differences between active treatments and placebo for any of the other pre-specified event categories (renal dysfunction/failure, upper GI ulcer complications or surgical wound complications).
Croatian: Nije bilo značajnih razlika između aktivnog liječenja i placeba niti u jednoj drugoj unaprijed definiranoj kategoriji događaja (poremećaj funkcije/zatajenje bubrega, komplikacije ulkusa u gornjem dijelu gastrointestinalnog trakta ili komplikacije kirurške rane).
English: As with other medicinal products known to inhibit prostaglandin synthesis, fluid retention and oedema have been observed in some patients taking parecoxib.
Croatian: Kao i kod drugih lijekova za koje se zna da inhibiraju sintezu prostaglandina, u nekih bolesnika koji uzimaju parekoksib opaženo je zadržavanje tekućine i edemi.
English: No unchanged parecoxib is detected in urine and only trace amounts in the faeces.
Croatian: U mokraći se nije otkrilo neizmijenjenog parekoksiba, a u stolici se otkrio samo u tragovima.
English: In patients with moderate hepatic impairment (Child-Pugh score 7-9), treatment should be initiated with half the usual recommended dose of Dynastat and the maximum daily dose should be reduced to 40 mg since valdecoxib exposures were more than doubled (130%) in these patients.
Croatian: U bolesnika s umjerenim oštećenjem jetre (Child-Pugh rezultat 7-9), liječenje se mora započeti polovicom uobičajene preporučene doze Dynastata i maksimalnu dnevnu dozu treba sniziti na 40 mg, budući da su izloženosti valdekoksibu u tih bolesnika bile više nego udvostručene (130%).
English: Do not use this medicine after the expiry date which is stated on the carton and on the vial label after Exp.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici bočice iza oznake “Rok valjanosti”.
English: In all clinical assessments parecoxib was administered at a fixed time interval whereas the opioids were administered on as needed basis.
Croatian: U svim kliničkim ispitivanjima parekoksib se primjenjivao u uvijek istom vremenskom razmaku, dok su se opioidi primjenjivali po potrebi.
English: Caution is advised in the treatment of patients most at risk of developing a gastrointestinal complication with NSAIDs; the elderly, or patients with a prior history of gastrointestinal disease, such as ulceration and GI bleeding, or patients using acetylsalicylic acid concomitantly.
Croatian: Savjetuje se oprez pri liječenju bolesnika koji su izloženi najvećem riziku od razvoja gastrointestinalnih komplikacija nesteroidnim protuupalnim lijekovima: starijih bolesnika, bolesnika koji su u povijesti bolesti imali gastrointestinalnu bolest kao što je ulkus ili GI krvarenje ili bolesnika koji istodobno uzimaju acetilsalicilnu kiselinu.
English: Plasma exposure of omeprazole (CYP 2C19 substrate) 40 mg once daily was increased by 46% following administration of valdecoxib 40 mg twice daily for 7 days, while the plasma exposure to valdecoxib was unaffected.
Croatian: Izloženost omeprazolu (supstratu CYP 2C19) u plazmi kad se primjenjivao u dozi od 40 mg jedanput dnevno bila je povećana za 46% nakon primjene valdekoksiba u dozi od 40 mg dvaput dnevno tijekom 7 dana, dok je izloženost valdekoksibu u plazmi ostala nepromijenjena.
English: Anticoagulant therapy should be monitored, particularly during the first few days after initiating Dynastat therapy in patients receiving warfarin or other anticoagulants, since these patients have an increased risk of bleeding complications.
Croatian: U bolesnika koji primaju varfarin ili druge antikoagulanse mora se nadzirati antikoagulantna terapija, osobito tijekom prvih nekoliko dana terapije Dynastatom, budući da ti bolesnici imaju povećan rizik od komplikacija s krvarenjem.
English: In the submitted studies, as with other NSAIDs, an increased risk of gastrointestinal ulceration or other gastrointestinal complications compared to use of parecoxib alone was shown for concomitant administration of low-dose acetylsalicylic acid (see section 5.1).
Croatian: U prikazanim se ispitivanjima pokazalo, kao i za druge nesteroidne protuupalne lijekove, da je rizik od gastrointestinalnih ulceracija ili drugih gastrointestinalnih komplikacija povećan kod istodobne primjene niske doze acetilsalicilne kiseline u usporedbi s primjenom samo parekoksiba (vidjeti dio 5.1).
English: Modes of administration other than IV or IM (e.g. intra-articular, intrathecal) have not been studied and should not be used.
Croatian: Drugi načini primjene osim i.v. i i.m. (npr. intrartikularno ili intratekalno) nisu ispitani i stoga se ne smiju primjenjivati.
English: Therefore, patients receiving oral anticoagulants should be closely monitored for their prothrombin time INR, particularly in the first few days when therapy with parecoxib is initiated or the dose of parecoxib is changed (see section 4.4).
Croatian: Stoga u bolesnika koji uzimaju oralne antikoagulanse mora se pažljivo nadzirati protrombinsko vrijeme INR, osobito tijekom prvih nekoliko dana terapije parekoksibom ili nakon promjene doze parekoksiba (vidjeti dio 4.4).
English: Do not take Dynastat: - if you are allergic to parecoxib or any of the other ingredients of this medicine (listed in section
Croatian: • ako ste alergični na parekoksib ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
English: Dynastat has been administered to 335 elderly patients (65-96 years of age) in pharmacokinetic and therapeutic trials.
Croatian: U farmakokinetičkim i terapijskim ispitivanjima, Dynastat je primijenjen u 335 starijih bolesnika (u dobi od 65 do 96 godina).
English: Exposure to valdecoxib was similar in terms of AUC and Cmax following IV and IM administration.
Croatian: Izloženost valdekoksibu bila je slična u pogledu AUC i Cmax nakon i.v. i i.m. primjene.
English: Nine prespecified adverse event categories were evaluated (cardiovascular thromboembolic events, pericarditis, new onset or exacerbation of congestive heart failure, renal failure/dysfunction, upper GI ulcer complications, major non-GI bleeds, infections, non-infectious pulmonary complications, and death).
Croatian: Procjenjivano je devet unaprijed definiranih kategorija štetnih događaja (kardiovaskularni tromboembolijski događaji, perikarditis, novonastalo kongestivno zatajenje srca ili pogoršanje postojećeg, zatajenje/poremećaj funkcije bubrega, komplikacije ulkusa gornjeg gastrointestinalnog trakta, velika krvarenja izvan gastrointestinalnog sustava, infekcije, neinfektivne plućne komplikacije i smrt).
English: Renal function should be monitored when parecoxib and any of these medicinal products are coadministered.
Croatian: Funkcija bubrega mora se nadzirati kad se parekoksib primjenjuje istodobno s nekim od ovih lijekova.
English: The concomitant use of parecoxib with other non- acetylsalicylic acid NSAIDs should be avoided.
Croatian: Mora se izbjegavati istodobna primjena parekoksiba s drugim nesteroidnim protuupalnim lijekovima osim acetilsalicilne kiseline.
English: Coadministration of NSAIDs and ciclosporin or tacrolimus has been suggested to increase the nephrotoxic effect of ciclosporin and tacrolimus because of NSAID effects on renal prostaglandins.
Croatian: Spomenuto je da istodobna primjena nesteroidnih protuupalnih lijekova i ciklosporina ili takrolimusa povećava nefrotoksične učinke ciklosporina i takrolimusa zbog učinka nesteroidnih protuupalnih lijekova na bubrežne prostaglandine.
English: The IM injection is to be given slowly and deeply into the muscle and the IV bolus injection may be given rapidly and directly into a vein or into an existing IV line.
Croatian: I.m. injekcija daje se sporo i duboko u mišić, a i.v. bolus injekcija može se dati brzo i izravno u venu ili u postojeću i.v. liniju.
English: The usual dose to start with is 40 mg. You may be given another dose - either 20 mg or 40 mg - 6 to 12 hours after the first one.
Croatian: Možda ćete dobiti drugu dozu - ili od 20 mg ili od 40 mg - 6 do 12 sati nakon prve.
English: In addition, the following rare, serious adverse reactions have been reported in association with the use of NSAIDs and cannot be ruled out for Dynastat: bronchospasm and hepatitis.
Croatian: Dynastat se ne mogu isključiti ni sljedeće rijetke, ozbiljne nuspojave zabilježene u vezi s primjenom nesteroidnih protuupalnih lijekova: bronhospazam i hepatitis.
English: Metabolism and nutrition disorders Hypokalaemia Hyperglycaemia, anorexia
Croatian: Poremećaji metabolizma i prehrane hipokalemija hiperglikemija, anoreksija
English: Coadministration of IV parecoxib 40 mg with propofol (CYP2C9 substrate) or midazolam (CYP3A4 substrate) did not affect either the pharmacokinetics (metabolism and exposure) or the pharmacodynamics (EEG effects, psychomotor tests and waking from sedation) of IV propofol or IV midazolam.
Croatian: Istodobna primjena i.v. parekoksiba u dozi od 40 mg s propofolom (supstratom CYP2C9) ili midazolamom (supstratom CYP3A4) nije utjecala ni na farmakokinetiku (metabolizam i izloženost), niti na farmakodinamiku (EEG učinke, psihomotorne testove i buđenje iz sedacije) i.v. propofola i i.v. midazolama.
English: Parecoxib administered intravenously to lactating rats as a single dose showed concentrations of parecoxib, valdecoxib and a valdecoxib active metabolite in milk similar to that of maternal plasma.
Croatian: Parekoksib primijenjen intravenski ženkama štakora tijekom laktacije u obliku jednokratne doze pokazao je koncentracije parekoksiba, valdekoksiba i djelatnog metabolita valdekoksiba u mlijeku slične onima u plazmi majke.
English: (Cyprus Branch) Τηλ: +357 22 817690
Croatian: PFIZER ΕΛΛΑΣ Α.Ε. (Cyprus Branch) Τηλ: +357 22 817690
English: Rare (1/10,000 to <1/1000)
Croatian: Rijetko (1/10 000 i
English: Dosing.
Croatian: Doziranje.
English: Dynastat contains the active substance parecoxib.
Croatian: Dynastat sadrži djelatnu tvar parekoksib.
English: Patients who have experienced bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria or other allergic-type reactions after taking acetylsalicylic acid or nonsteroidal antiinflammatory drugs (NSAIDs) including COX-2 inhibitors.
Croatian: Bolesnici koji su imali bronhospazam, akutni rinitis, nosne polipe, angioneurotski edem, urtikariju ili druge reakcije alergijskog tipa nakon uzimanja acetilsalicilne kiseline ili nesteroidnih protuupalnih lijekova (NSAIL), uključujući i inhibitore COX-2.
English: The only other acceptable solvents for reconstitution are:
Croatian: Od drugih otapala za rekonstituciju prihvatljive su samo:
English: Pregnant women on NSAIDs should be closely monitored for amniotic fluid volume.
Croatian: Trudnicama koje uzimaju nesteroidne protuupalne lijekove treba pomno pratiti volumen plodne vode.
English: Uncommon (1/1000 to <1/100)
Croatian: Manje često (1/1000 i <1/100)
English: Reconstitution solvents Reconstitute Dynastat 40 mg with 2 ml sodium chloride 9 mg/ml (0.9%) solution.
Croatian: Otapala za rekonstituciju Rekonstituirajte Dynastat 40 mg s 2 ml otopine natrijevog klorida 9 mg/ml (0,9%).
English: COX-2 inhibitors are not a substitute for acetylsalicylic acid for prophylaxis of cardiovascular thrombo-embolic diseases because of their lack of antiplatelet effects.
Croatian: Acetilsalicilna kiselina i drugi nesteroidni protuupalni lijekovi Inhibitori COX-2 ne mogu zamijeniti acetilsalicilnu kiselinu kod profilakse kardiovaskularnih tromboembolijskih bolesti zato što nemaju antitrombocitne učinke.
English: Therefore, parecoxib should be used with caution in patients with compromised cardiac function, preexisting oedema, or other conditions predisposing to, or worsened by, fluid retention including those taking diuretic treatment or otherwise at risk of hypovolemia.
Croatian: Stoga se parekoksib mora primjenjivati s oprezom u bolesnika s kompromitiranom srčanom funkcijom, postojećim edemima ili drugim stanjima zbog kojih su skloni zadržavanju tekućine ili koja mogu biti pogoršana zbog zadržavanja tekućine, uključujući i bolesnike koji uzimaju diuretike ili imaju rizik od hipovolemije iz drugih razloga.
English: 3 + 3 pack: contains 3 powder vials and 3 solvent ampoules.
Croatian: Pakiranje 3+3: sadrži 3 bočice s praškom i 3 ampule s otapalom.
English: Dynastat has not been studied in cardiovascular revascularization procedures other than coronary artery bypass graft (CABG) procedures.
Croatian: Dynastat nije ispitan u drugim postupcima kardiovaskularne revaskularizacije osim kod ugradnje aortokoronarne premosnice.
English: Rare: may affect up to 1 in 1,000 people ▪ Rash or ulceration in any part of your body (e.g. skin, mouth, eyes, face, lips or tongue), or any other signs of allergic reactions such as skin rash, swelling of the face, lips and tongue,
Croatian: • osip ili ulceracije na nekom dijelu tijela (npr. koži, ustima, očima, licu, usnama ili jeziku) ili bilo koji drugi znakovi alergijske reakcije kao što je kožni osip, oticanje lica, usana i jezika,