FrancophonIA/ELRC3.0 huggingface dataset:
English: If it is 12 hours or more until your next dose: take the missed tablet as soon as you remember.
Slovenian: • Če je do naslednjega odmerka 12 ur ali več: Vzemite pozabljeno tableto, čim se spomnite.
English: LCS symptom improvement rate
Slovenian: Delež izboljšanja simptomov po LCS
English: The higher average exposures that could be achieved by individuals with no active CYP2D6 may be clinically relevant since adverse effects are related to dose and exposure.
Slovenian: Večja povprečna izpostavljenost, ki jo lahko dosežejo posamezniki brez aktivnega CYP2D6, bi lahko bila klinično pomembna, ker so neželeni učinki povezani z odmerkom in izpostavljenostjo.
English: Do not crush the tablet.
Slovenian: Tablete ne smete zdrobiti.
English: *This adverse reaction can occur in association with other dry conditions (mainly skin reactions) seen with gefitinib.
Slovenian: * Ta neželeni učinek lahko spremlja druga suha stanja (predvsem kožne reakcije), opažene med uporabo gefitiniba.
English: No dose adjustment is required in patients with impaired renal function at creatinine clearance > 20 ml/min.
Slovenian: Odmerka ni treba prilagoditi bolnikom z okvarjenim delovanjem ledvic, ki imajo očistek kreatinina > 20 ml/min.
English: Do not use any other liquids.
Slovenian: Za raztapljanje ne smete uporabiti nobene druge tekočine.
English: N Number of patients randomised.
Slovenian: N število randomiziranih bolnikov.
English: Data from 4 patients with severe hepatic impairment due to liver metastases suggested that steady-state exposures in these patients are also similar to those in patients with normal hepatic function.
Slovenian: Podatki 4 bolnikov s hudo okvaro jeter zaradi metastaz na jetrih kažejo, da je izpostavljenost v stanju dinamičnega ravnovesja tudi pri teh bolnikih podobna kot pri bolnikih z normalnim delovanjem jeter.
English: Phenotypic switch to small cell lung cancer has also been reported in 5-10% of cases.
Slovenian: Poleg tega je bila v 5 do 10 % primerov opisana fenotipska sprememba v drobnocelični rak pljuč.
English: Itraconazole (for fungal infections).
Slovenian: • itrakonazol (za glivične okužbe)
English: Elderly No dose adjustment is required on the basis of patient age (see section 5.2).
Slovenian: Starejši Odmerka ni treba prilagoditi glede na starost (glejte poglavje 5.2).
English: Gefitinib response data is more sparse in patients whose tumours contain the less common mutations; the available data indicates that G719X, L861Q and S7681 are sensitising mutations; and T790M alone or exon 20 insertions alone are resistance mechanisms.
Slovenian: Podatki o odzivu na gefitinib so bolj skromni pri bolnikih, ki imajo tumorje z manj pogostimi mutacijami; podatki, ki so na voljo, kažejo, da mutacije G719X, L861Q in S7681 povečujejo občutljivost, sama mutacija T790M ali same insercije v eksonu 20 pa so mehanizmi odpornosti.
English: Antacids if taken regularly close in time to administration of gefitinib may have a similar effect (see sections 4.5 and 5.2).
Slovenian: Redno jemanje antacidov, uporabljenih blizu časa jemanja gefitiniba, imajo lahko podoben učinek (glejte poglavji 4.5 in 5.2).
English: Approximately 8% of patients had a severe ADR (common toxicity criteria (CTC) grade 3 or 4).
Slovenian: Približno 8 % bolnikov je imelo hude neželene učinke (3. ali 4. stopnjo po Skupnih merilih toksičnosti [common toxicity criteria], CTC).
English: If any of the above applies to you, or if you are not sure, check with your doctor or pharmacist before taking IRESSA.
Slovenian: Če kaj od naštetega velja za vas, ali če niste prepričani, se posvetujte z zdravnikom ali farmacevtom, preden vzamete zdravilo IRESSA.
English: Gefitinib inhibits the transporter protein BCRP in vitro, but the clinical relevance of this finding is unknown.
Slovenian: Gefitinib in vitro zavre transportno beljakovino BCRP, vendar klinični pomen tega ni znan.
English: What IRESSA is and what it is used for What you need to know before you take IRESSA How to take IRESSA
Slovenian: Kaj je zdravilo IRESSA in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo IRESSA Kako jemati zdravilo IRESSA Možni neželeni učinki
English: Gefitinib total plasma clearance is approximately 500 ml/min and the mean terminal half-life is 41 hours in cancer patients.
Slovenian: Celotni plazemski očistek gefitiniba je približno 500 ml/min in povprečni terminalni razpolovni čas je pri onkoloških bolnikih 41 ur.
English: Published studies have shown that genetically modified mice, lacking expression of EGFR, exhibit developmental defects, related to epithelial immaturity in a variety of organs including the skin, gastrointestinal tract and lung.
Slovenian: Objavljene študije kažejo, da se pri genetsko spremenjenih miših, ki nimajo izraženega EGFR, pojavljajo razvojne hibe, povezane z nedozorelostjo epitelija v številnih organih, vključno s kožo, prebavili in pljuči.
English: Adverse reactions by system organ class and frequency Metabolism and nutrition disorders
Slovenian: Neželeni učinki po organskem sistemu in pogostnosti Presnovne in prehranske motnje
English: If a dose is missed, it should be taken as soon as the patient remembers.
Slovenian: Če bolnik pozabi vzeti odmerek, ga mora vzeti, čim se spomni.
English: This may mean that you have an ulcer on the surface of the eye (cornea).
Slovenian: To lahko pomeni, da imate razjedo na površini očesa (roženici).
English: This may give the appearance of bruising or patches of non-blanching rash on the skin.
Slovenian: To lahko daje videz podplutb ali predelov nezbledevajočega izpuščaja na koži.
English: The objective response rate (ORR) in those patients who were tumour and ctDNA mutation positive was 77% (95% CI: 66% to 86%) and in those who were tumour only mutation positive 60% (95% CI: 44% to 74%).
Slovenian: Objektivni delež odziva (Objective response rate - ORR) pri bolnikih s pozitivno tumorsko in ctDNK mutacijo je bil 77 % (95 % IZ: od 66 % do 86 %), pri bolnikih, ki so imeli pozitivno mutacijo le na tumorju pa 60 % (95 % IZ: 44 % do
English: Clinical experience has not shown a causal association between QT prolongation and gefitinib.
Slovenian: Klinične izkušnje ne kažejo vzročne povezave med podaljšanjem intervala QT in gefitinibom.
English: At no-effect levels in both mice and rats there was no margin in clinical exposure.
Slovenian: Na ravni brez učinka pri miših in podganah ni bilo meje klinične izpostavljenosti.
English: In most cases this is associated with other known risk factors, including concomitant medications such as steroids or NSAIDS, underlying history of GI ulceration, age, smoking or bowel metastases at sites of perforation.
Slovenian: V večini primerov je to povezano z obstoječimi dejavniki tveganja, npr. sočasnim jemanjem zdravil, kot so steroidi ali NSAID, anamnezo gastrointestinalnih razjed, starostjo, kajenjem, metastazami na črevesu na mestih perforacije.
English: The role of CYP2D6 in the metabolic clearance of gefitinib has been evaluated in a clinical trial in healthy volunteers genotyped for CYP2D6 status.
Slovenian: Vlogo CYP2D6 v presnovnem očistku gefitiniba so ocenili v kliničnem preskušanju pri zdravih prostovoljcih, genotipiziranih glede statusa CYP2D6.
English: Table 7 Summary of multivariate logistic regression analysis to identify factors that independently predicted for the presence of EGFR mutations in 786 Caucasian patients*
Slovenian: Preglednica 7 Povzetek multivariatne logistične regresijske analize za ugotovitev dejavnikov, ki neodvisno napovejo prisotnost mutacije EGFR, pri 786 bolnikih-belcih*
English: An increased risk of ILD on gefitinib relative to chemotherapy was seen predominantly during the first 4 weeks of treatment (adjusted OR 3.8; 95% CI 1.9 to 7.7); thereafter the relative risk was lower (adjusted OR 2.5; 95% CI 1.1 to 5.8).
Slovenian: Večje tveganje za IBP so med uporabo gefitiniba v primerjavi s kemoterapijo ugotovili predvsem v prvih 4 tednih zdravljenja (korigirano razmerje obetov 3,8; 95 % IZ od 1,9 do 7,7); pozneje se je relativno tveganje zmanjšalo (korigirano razmerje obetov 2,5; 95 % IZ od 1,1 do 5,8).
English: In the ISEL trial, the incidence of ILD-type events in the overall population was approximately 1% in both treatment arms.
Slovenian: V preskušanju ISEL je incidenca učinkov tipa IBP v celotni populaciji, v obeh terapevtskih krakih znašala približno 1 %.
English: From analyses of population pharmacokinetic data in cancer patients, no relationships were identified between predicted steady-state trough concentration and patient age, body weight, gender, ethnicity or creatinine clearance (above 20 ml/min).
Slovenian: Analize populacijskih farmakokinetičnih podatkov onkoloških bolnikov niso pokazale povezanosti med napovedano najnižjo koncentracijo v stanju dinamičnega ravnovesja ter bolnikovo starostjo, telesno maso, spolom, etnično pripadnostjo ali očistkom kreatinina (nad 20 ml/min).
English: Other potential mechanisms of resistance that have been reported following treatment with EGFR signal blocking agents include: bypass signalling such as HER2 and MET gene amplification and PIK3CA mutations.
Slovenian: Med drugimi možnimi mehanizmi odpornosti, opisanimi po zdravljenju z zaviralci signaliziranja EGFR, so obvodi signaliziranja, npr. amplifikacija genov HER2 in MET ter mutacije PIK3CA.
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Slovenian: Študije na živalih so pokazale toksične učinke na sposobnost razmnoževanja (glejte poglavje 5.3).
English: Plasma concentrations were not increased in patients with elevated aspartate transaminase (AST), alkaline phosphatase or bilirubin due to liver metastases (see section 5.2).
Slovenian: Koncentracija v plazmi ni bila povečana pri bolnikih z zvišano aspartat transaminazo (AST), alkalno fosfatazo ali bilirubinom zaradi jetrnih metastaz (glejte poglavje 5.2).
English: In about 60% of cases, resistance is associated with a secondary T790M mutation for which T790M targeted EGFR TKIs may be considered as a next line treatment option.
Slovenian: V približno 60 % primerov je odpornost povezana s sekundarno mutacijo T790M, pri kateri pridejo kot naslednja linija zdravljenja v poštev proti T790M usmerjeni zaviralci tirozin-kinaze EGFR.
English: The signs may include redness, pain, ulcers, blisters, and shedding of the skin.
Slovenian: Med znaki so lahko pordelost, bolečine, razjede, mehurji in lupljenje kože.
English: Time to treatment failure ab
Slovenian: Čas do odpovedi zdravljenja ab
English: For patients unable to tolerate treatment after a therapy interruption, gefitinib should be discontinued and an alternative treatment should be considered.
Slovenian: Bolnikom, ki po prekinitvi zdravljenja zdravila ne prenesejo, je treba gefitinib ukiniti in razmisliti o drugačni terapiji.
English: The dispersion can also be administered through a naso-gastric or gastrostomy tube.
Slovenian: Disperzijo je mogoče uporabiti po nazogastrični ali gastrostomijski sondi.
English: Following oral administration of gefitinib, absorption is moderately slow and peak plasma concentrations of gefitinib typically occur at 3 to 7 hours after administration.
Slovenian: Po peroralni uporabi je absorbcija zmerno počasna in največja koncentracija gefitiniba v plazmi se praviloma pojavi od 3 do 7 ur po uporabi.
English: Five metabolites have been fully identified in excreta and 8 metabolites in plasma.
Slovenian: V iztrebkih so povsem identificirali 5, v plazmi pa 8 presnovkov.
English: Driving and using machines If you feel weak whilst taking this medicine, take care driving or using tools or machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Če se med jemanjem tega zdravila počutite šibki, morate biti glede upravljanja vozil ali strojev previdni.
English: Approximately 3% of patients stopped therapy due to an ADR.
Slovenian: Približno 3 % bolnikov je zaradi neželenih učinkov prenehalo z zdravljenjem.
English: Patients with poorly tolerated diarrhoea or skin adverse reactions may be successfully managed by providing a brief (up to 14 days) therapy interruption followed by reinstatement of the 250 mg dose (see section 4.8).
Slovenian: Pri bolnikih, ki imajo drisko in jo slabo prenašajo, ali imajo neželene učinke na koži, je stanje mogoče uspešno obvladati s kratko (do 14-dnevno) prekinitvijo zdravljenja, ki ji sledi ponovna uvedba odmerka 250 mg (glejte poglavje 4.8).
English: NC Not calculated for overall survival HR as the number of events is too few NR Not reached
Slovenian: NI ni izračunano za razmerje ogroženosti pri skupnem preživetju, ker je število dogodkov premajhno.
English: In the INTEREST trial, the incidence of ILD type events was 1.4% (10) patients in the gefitinib group versus 1.1% (8) patients in the docetaxel group.
Slovenian: V preskušanju INTEREST je bila incidenca učinkov tipa IBP 1,4 % (10 bolnikov) v skupini z gefitinibom in 1,1 % (8 bolnikov) v skupini z docetakselom.
English: Pharmacotherapeutic group: antineoplastic agents, protein kinase inhibitors; ATC code: L01XE02
Slovenian: Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe, zaviralci proteinkinaze Oznaka ATC: L01XE02
English: Skin reactions such as an acne-like rash, which is sometimes itchy with dry and/or cracked skin
Slovenian: • kožne reakcije, npr. aknam podoben izpuščaj, ki je včasih srbeč in ga spremlja suha in/ali razpokana koža
English: Proportion of tumour M+ that are M+ by ctDNA
Slovenian: Delež tumorskih M+, ki so M+ po ctDNK
English: Administration of gefitinib once daily results in 2- to 8-fold accumulation, with steady state exposures achieved after 7 to 10 doses.
Slovenian: Uporaba gefitiniba enkrat na dan povzroči od 2- do 8-kratno kopičenje; izpostavljenost v stanju dinamičnega ravnovesja je dosežena po 7 do 10 odmerkih.
English: If a tumour sample is not evaluable, then circulating tumour DNA (ctDNA) obtained from a blood (plasma) sample may be used.
Slovenian: Če vzorca tumorja ni mogoče oceniti, se lahko uporabi tumorska DNK v obtoku (ctDNK - cirkulirajoča tumorska DNK), dobljena iz krvi (plazme).
English: The results of an in vitro phototoxicity study demonstrated that gefitinib may have phototoxicity potential.
Slovenian: Rezultati študije fototoksičnosti in vitro so pokazali, da gefitinib morda ima fototoksičen potencial.
English: Do not take antacids (to reduce the acid level of your stomach) 2 hours before or 1 hour after taking IRESSA.
Slovenian: • Ne jemljite antacidov (zdravil za zmanjšanje kisline v želodcu) 2 uri pred jemanjem zdravila
English: The levels of exposure to gefitinib achieved in both the extensive and the poor metaboliser groups were wide and overlapping but the mean exposure to gefitinib was 2-fold higher in the poor metaboliser group.
Slovenian: Ravni izpostavljenosti gefitinibu, dosežene v skupini izrazitih in slabih metabolizatorjev so bile široke in so se prekrivale, a povprečna izpostavljenost gefitinibu je bila v skupini slabih metabolizatorjev 2-krat večja.
English: Interstitial lung disease (ILD)
Slovenian: Intersticijska bolezen pljuč (IBP)
English: Gefitinib binds to serum albumin and alpha 1-acid glycoprotein.
Slovenian: Gefitinib se veže na serumski albumin in alfa1-kisli glikoprotein.
English: If a diagnosis of ulcerative keratitis is confirmed, treatment with gefitinib should be interrupted, and if symptoms do not resolve, or if symptoms recur on reintroduction of gefitinib, permanent discontinuation should be considered.
Slovenian: Če je potrjena diagnoza ulcerozni keratitis je potrebno prekiniti zdravljenje z gefitinibom in razmisliti o ukinitvi zdravljenja, v primeru, da simptomi ne prenehajo ali če se simptomi po ponovni uporabi gefitiniba ponovijo.
English: Data from non-clinical (in vitro) studies indicate that gefitinib has the potential to inhibit the cardiac action potential repolarisation process (e.g. QT interval).
Slovenian: Podatki iz predkliničnih (in vitro) študij kažejo, da lahko gefitinib zavre akcijski potencial repolarizacijskega procesa srca (npr. interval QT).
English: If you forget to take IRESSA What to do if you forget to take a tablet depends on how long it is until your next dose.
Slovenian: Če pozabite vzeti tableto, je ukrepanje odvisno od tega, koliko časa je še do naslednjega odmerka.
English: IRESSA is used to treat adults with non-small cell lung cancer.
Slovenian: Zdravilo IRESSA se uporablja za zdravljenje odraslih z nedrobnoceličnim pljučnim rakom.
English: What IRESSA looks like and contents of the pack
Slovenian: Izgled zdravila IRESSA in vsebina pakiranja
English: Children and adolescents IRESSA is not indicated in children and adolescents under 18 years.
Slovenian: Otroci in mladostniki Uporaba zdravila IRESSA pri otrocih in mladostnikih, starih manj kot 18 let, ni priporočena.
English: The IFUM study was a single-arm, multicentre study conducted in Caucasian patients (n=106) with activating, sensitising EGFR mutation positive NSCLC to confirm that the activity of gefitinib is similar in Caucasian and Asian populations.
Slovenian: Študija IFUM je bila multicentrična, z enim krakom in je bila izvedena na kavkazijskih bolnikih (n=106) z nedrobnoceličnim pljučnim rakom z aktivacijskimi, senzitirajočimi EGFR pozitivnimi mutacijami, s katero so potrdili, da je aktivnost gefitiniba podobna pri kavkazijski in azijski populaciji.
English: Gefitinib shows no enzyme induction effects in animal studies and no significant inhibition (in vitro) of any other cytochrome P450 enzyme.
Slovenian: Gefitinib v študijah na živalih ne kaže učinkov na indukcijo encimov in (in vitro) ne zavira pomembno nobenega drugega encima citokroma P450.
English: Numbers in square brackets are 95% confidence intervals for HR c Stratified log-rank test for overall; otherwise cox proportional hazards model d Asian ethnicity excludes patients of Indian origin and refers to the racial origin of a patient group and not necessarily their place of birth
Slovenian: c Stratificirani log-rang test za celotno, sicer Coxov model sorazmernih ogroženosti d Azijska etnična pripadnost izključuje bolnike indijskega porekla in se nanaša na rasno poreklo skupine bolnikov, ne nujno na rojstni kraj.
English: In the overall population, no statistically significant difference between gefitinib and docetaxel (75 mg/m2) was observed for overall survival, progression free survival and objective response rates (see Table 5).
Slovenian: V celotni populaciji ni bilo opaziti statistično značilne razlike med gefitinibom in docetakselom (75 mg/m2), kar zadeva skupno preživetje, preživetje brez napredovanja bolezni in objektivni delež odziva (glejte preglednico 5).
English: Patients presenting with signs and symptoms suggestive of keratitis such as acute or worsening: eye inflammation, lacrimation, light sensitivity, blurred vision, eye pain and/or red eye should be referred promptly to an ophthalmology specialist.
Slovenian: Bolnike z znaki in simptomi, ki kažejo na keratitis, kot so akutni simptomi ali poslabšanja: vnetje oči, solzenje, občutljivost na svetlobo, zamegljen vid, boleče in/ali rdeče oči, je treba takoj napotiti k oftalmologu.
English: Tablets are brown, round, biconvex, impressed with “IRESSA 250” on one side and plain on the other.
Slovenian: Tablete so rjave, okrogle, bikonveksne z vtisnjeno oznako “IRESSA 250” na eni strani in brez oznak na drugi.
English: Most NSCLC tumours with sensitising EGFR kinase mutations eventually develop resistance to IRESSA treatment, with a median time to disease progression of 1 year.
Slovenian: Večina tumorjev nedrobnoceličnega raka pljuč, ki imajo aktivacijske mutacije kinaze EGFR, sčasoma razvije odpornost na zdravilo IRESSA; mediani čas do napredovanja bolezni je 1 leto.
English: Adverse reactions have been assigned to the frequency categories in Table 1 where possible based on the incidence of comparable adverse event reports in a pooled dataset from the ISEL, INTEREST and IPASS phase III clinical trials (2462 IRESSA-treated patients).
Slovenian: Neželeni učinki so v preglednici 1, kjer je mogoče, razvrščeni po kategorijah pogostnosti na podlagi incidence primerljivih poročil o neželenih učinkih v kumulativnem naboru podatkov kliničnih preskušanj III. faze ISEL, INTEREST in IPASS (2462 bolnikov, zdravljenih z zdravilom IRESSA).
English: Increase of a liver enzyme known as alanine aminotransferase in a blood test; if too high, your doctor may tell you to stop taking IRESSA
Slovenian: • zvišanje jetrnega encima, imenovanega alanin-aminotransferaza, na preiskavi krvi; če je raven tega encima previsoka, vam bo zdravnik morda naročil, da nehajte jemati zdravilo IRESSA
English: Do not take a double dose (two tablets at the same time) to make up for a forgotten dose.
Slovenian: Ne vzemite dvojnega odmerka (dveh tablet hkrati), če ste pozabili vzeti prejšnji odmerek.
English: Gastrointestinal perforation has been reported in patients taking gefitinib.
Slovenian: Opisani so bili posamezni primeri gastrointestinalne perforacije pri bolnikih, ki jemljejo gefitinib.
English: Sensitivity
Slovenian: Senzitivnost
English: Three blisters are combined with an aluminium foil laminate over-wrap in a carton.
Slovenian: Trije pretisni omoti so pakirani skupaj z zunanjim ovojem iz laminata aluminijske folije v škatli.
English: A 2-year carcinogenicity study in rats resulted in a small but statistically significant increased incidence of hepatocellular adenomas in both male and female rats and mesenteric lymph node haemangiosarcomas in female rats at the highest dose (10 mg/kg/day) only.
Slovenian: Dveletna študija kancerogenosti pri podganah je pokazala majhno, toda statistično značilno povečanje incidence hepatocelularnih adenomov pri podganjih samcih in samicah ter hemangiosarkomov mezenteričnih bezgavk pri podganjih samicah samo pri največjem odmerku (10 mg/kg/dan).
English: IRESSAcontains the active substance gefitinib which blocks a protein called ‘epidermal growth factor receptor' (EGFR).
Slovenian: Zdravilo IRESSA vsebuje zdravilno učinkovino gefitinib, ki blokira beljakovino, imenovano "receptor epidermalnega rastnega dejavnika" (EGFR).
English: Table 2 Summary of baseline mutation status for tumour and ctDNA samples in all screened patients evaluable for both samples
Slovenian: Preglednica 2: Povzetek izhodiščnega stanja mutacije na tumorju in v vzorcih ctDNK pri vseh presejanih bolnikih, ki so imeli za oceno primerna oba vzorca
English: If you have trouble swallowing the tablet, dissolve it in half a glass of still (non-fizzy) water.
Slovenian: Če tableto težko pogoltnete, jo raztopite v pol kozarca negazirane vode (vode brez mehurčkov).
English: Only robust, reliable and sensitive test(s) with demonstrated utility for the determination of EGFR mutation status of tumours or ctDNA should be used to avoid false negative or false positive determinations (see section 5.1).
Slovenian: Za določanje EGFR mutacije tumorjev ali ctDNK je treba uporabiti robustno, zanesljivo in občutljivo preiskavo/preiskave z dokazano uporabnostjo, da bi se izognili lažno negativnim ali lažno pozitivnim rezultatom (glejte poglavje 5.1).
English: In that study ctDNA derived from serum, not plasma was used for EGFR mutation analysis using the EGFR Mutation Test Kit (DxS) (N= 86).
Slovenian: V tisti študiji so za analizo mutacije EGFR uporabili ctDNK iz seruma, ne iz plazme, določitev pa so opravili s kompletom EGFR Mutation Test (DxS) (N = 86).
English: N Number of patients randomised
Slovenian: N število randomiziranih bolnikov
English: Haemorrhagic cystitis (burning sensations during urination and frequent, urgent need to urinate with blood in the urine).
Slovenian: • hemoragični cistitis (pekoč občutek med uriniranjem in pogosto, nujno siljenje na vodo s krvjo v urinu)
English: Primary endpoint Progression free survival (PFS)
Slovenian: Primarni opazovani dogodek Preživetje brez napredovanja bolezni (PFS)
English: Allergic reaction (common), particularly if symptoms include swollen face, lips, tongue or throat, difficulty to swallow, hives, nettle rash and difficulty breathing.
Slovenian: • Alergijska reakcija (občasno), zlasti če so med simptomi oteklost obraza, ustnic, jezika ali žrela, težko požiranje, koprivnica, izpuščaj in težave z dihanjem.