FrancophonIA/ELRC3.0 huggingface dataset:
English: HbA1c (%) at week 12 Baseline (mean) Change from baseline Difference from placebo (95% CI) 24 hour SBP at week 12 Baseline (mean) Change from baseline Difference from placebo (95% CI) 24 hour DBP at week 12 Baseline (mean) Change from baseline Difference from placebo (95% CI) Full analysis set (FAS) LOCF, values after taking antidiabetic rescue therapy censored Mean adjusted for baseline HbA1c, baseline eGFR, geographical region and number of antihypertensive medicinal products LOCF, values after taking antidiabetic rescue therapy or changing antihypertensive rescue therapy censored Mean adjusted for baseline SBP, baseline HbA1c, baseline eGFR, geographical region and number of antihypertensive medicinal products Mean adjusted for baseline DBP, baseline HbA1c, baseline eGFR, geographical region and number of antihypertensive medicinal products * p-value <0.0001 ** p-value <0.001
Croatian: Srednja vrijednost prilagođena za početnu vrijednost sistoličkog krvnog tlaka (SKT), početnu vrijednost HbA1c, početnu vrijednost eGFR, zemljopisno područje i broj antihipertenzivnih lijekova Srednja vrijednost prilagođena za početnu vrijednost dijastoličkog krvnog tlaka (DKT), početnu vrijednost HbA1c, početnu vrijednost eGFR, zemljopisno područje i broj antihipertenzivnih lijekova * p-vrijednost<0,0001 ** p-vrijednost <0,001
English: Full analysis set (FAS) using last observation carried forward (LOCF) prior to glycaemic rescue therapy Mean adjusted for baseline value Not evaluated for statistical significance as a result of the sequential confirmatory testing procedure LOCF, values after antihypertensive rescue censored * p-value <0.0001
Croatian: Srednja vrijednost prilagođena za početnu vrijednost Statistička značajnost nije ocjenjivana zbog provođenja naknadnog testa kao potvrde LOCF, cenzurirane vrijednosti nakon dodavanja terapije za postizanje zadovoljavajućeg krvnog tlaka (engl. antihypertensive rescue) * p-vrijednost<0,0001
English: NAME OF THE MEDICINAL PRODUCT Jardiance 10 mg film-coated tablets empagliflozin
Croatian: Jardiance 10 mg filmom obložene tablete empagliflozin
English: GENERAL CLASSIFICATION FOR SUPPLY
Croatian: Klasifikacija organskih sustava
English: The full EPAR for Ritemvia can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/ritemvia
Croatian: Cjeloviti EPAR za lijek Ritemvia nalazi se na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/ritemvia
English: Ritemvia received a marketing authorisation valid throughout the EU on 13 July 2017.
Croatian: Lijek Ritemvia dobio je odobrenje za stavljanje u promet koje je na snazi u EU-u od 13. srpnja 2017.
English: What measures are being taken to ensure the safe and effective use of Ritemvia?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Ritemvia?
English: This means that Ritemvia is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Croatian: To znači da je lijek Ritemvia vrlo sličan drugom biološkom lijeku („referentnom lijeku”) koji je već odobren u EU-u.
English: What is Ritemvia and what is it used for?
Croatian: Što je Ritemvia i za što se koristi?
English: Ritemvia (rituximab)
Croatian: Ritemvia (rituksimab)
English: In this study improvement was seen in 96% of cases (67 of 70 patients) with Ritemvia and 90% (63 of 70 patients) with Rituxan.
Croatian: U tom ispitivanju zabilježeno je poboljšanje u 96 % slučajeva (67 od 70 bolesnika) koji su uzimali lijek Ritemvia i 90 % (63 od 70 bolesnika) koji su uzimali lijek Rituxan.
English: An overview of Ritemvia and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Ritemvia i zašto je odobren u EU-u
English: Side effects reported with Ritemvia are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Ritemvia pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Patients with GPA, MPA or pemphigus vulgaris must also not receive Ritemvia if they have severe heart problems.
Croatian: Isto tako, bolesnici s bolestima GPA, MPA ili običnim pemfigusom ne smiju primati lijek Ritemvia ako imaju ozbiljne probleme sa srcem.
English: Other information about Ritemvia
Croatian: Ostale informacije o lijeku Ritemvia
English: Depending on the condition it is used to treat, Ritemvia may be given with chemotherapy (other cancer medicines) or medicines used for inflammatory disorders (corticosteroids).
Croatian: Ovisno o bolesti koja se liječi, Ritemvia se može primjenjivati uz kemoterapiju (drugi lijekovi za rak) ili lijekove koji se koriste za upalne poremećaje (kortikosteroidi).
English: The study showed that Ritemvia and MabThera had comparable effects on arthritis symptoms: after 24 weeks, the proportion of patients with a 20% improvement in symptom score (called ACR20) was 74% (114 of 155 patients) with Ritemvia and 73% (43 of 59 patients) with MabThera.
Croatian: Ispitivanje je pokazalo da lijekovi Ritemvia i MabThera imaju usporedive učinke na simptome artritisa: udio bolesnika s 20 % poboljšanja u ocjeni simptoma (ACR20) nakon 24 tjedna primjene lijeka Ritemvia iznosio je 74 % (114 od 155 bolesnika), u odnosu na 73 % (43 od 59 bolesnika) koji su uzimali lijek MabThera.
English: Ritemvia is a ‘biosimilar medicine'.
Croatian: Ritemvia je „biosličan lijek”.
English: Why is Ritemvia authorised in the EU?
Croatian: Zašto je lijek Ritemvia odobren u EU-u?
English: The most common side effects with rituximab are reactions related to the infusion (such as fever, chills and shivering) which occur in most cancer patients and in more than 1 in 10 GPA or MPA patients at the time of the first infusion.
Croatian: Najčešće su nuspojave rituksimaba reakcije povezane s infuzijom (kao što su vrućica, drhtavica i zimica), koje se pojavljuju kod većine bolesnika oboljelih od raka i kod više od 1 na 10 osoba koje boluju od GPA i MPA bolesti nakon prve infuzije.
English: Because Ritemvia is a biosimilar medicine, the studies on effectiveness and safety of rituximab carried out with MabThera do not all need to be repeated for Ritemvia.
Croatian: Budući da je lijek Ritemvia biosličan lijek, ispitivanja djelotvornosti i sigurnosti provedena za lijek MabThera nije potrebno ponavljati za lijek Ritemvia.
English: Ritemvia should be given under the close supervision of an experienced healthcare professional and in a place where facilities for resuscitating patients are immediately available.
Croatian: Osim toga, lijek Ritemvia potrebno je davati pod pomnim nadzorom iskusnog zdravstvenog radnika i na mjestu u kojem su izravno dostupni odjeli za oživljavanje bolesnika.
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Ritemvia has a highly similar structure, purity and biological activity to MabThera and is distributed in the body in the same way.
Croatian: Europska agencija za lijekove zaključila je da, u skladu sa zahtjevima EU-a za bioslične lijekove, lijek Ritemvia ima vrlo sličnu strukturu, čistoću i biološku aktivnost kao i lijek MabThera te se u tijelu raspoređuje na isti način.
English: The active substance in Ritemvia, rituximab, is a monoclonal antibody (a type of protein) designed to recognise and attach to a protein called CD20 present on the surface of B cells (types of white blood cells).
Croatian: Djelatna tvar u lijeku Ritemvia je rituksimab, monoklonsko protutijelo (vrsta bjelančevine) koje prepoznaje i veže se za bjelančevine pod nazivom CD20 koje se nalaze na površini B-stanica (vrsta bijelih krvnih stanica).
English: What are the risks associated with Ritemvia?
Croatian: Koji su rizici povezani s lijekom Ritemvia?
English: Doctors prescribing Ritemvia for cancer will be provided with educational material reminding them of the need to use the medicine only by infusion into a vein.
Croatian: Liječnici koji propisuju lijek Ritemvia za liječenje raka dobit će edukativne materijale koji ih podsjećaju na potrebu da primjenjuju lijek samo intravenskom infuzijom.
English: As for all medicines, data on the use of Ritemvia are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Ritemvia kontinuirano se prate.
English: In GPA and MPA, destroying the B cells lowers the production of antibodies thought to play an important role in attacking the blood vessels and causing inflammation.
Croatian: U bolesnika s bolestima GPA i MPA uništavanje B-stanica smanjuje proizvodnju protutijela za koja se smatra da imaju važnu ulogu u napadu na krvne žile i uzrokovanju upale.
English: Ritemvia must not be used in people who are hypersensitive (allergic) to rituximab, mouse proteins or any of the other ingredients.
Croatian: Lijek Ritemvia ne smiju upotrebljavati osobe koje su preosjetljive (alergične) na rituksimab, mišje bjelančevine ili bilo koji drugi sastojak lijeka.
English: The reference medicine for Ritemvia is MabThera.
Croatian: Referentni lijek za lijek Ritemvia je MabThera.
English: The company that markets Ritemvia will provide doctors and patients using the medicine for noncancer conditions with educational material including information on the need to give the medicine where facilities for resuscitation are available and on the risk of infection, including PML.
Croatian: Tvrtka koja lijek Ritemvia stavlja u promet, liječnicima i bolesnicima koji primjenjuju lijek za bolesti koje nisu zloćudne dostavit će edukativni materijal, uključujući informacije o potrebi davanja lijeka na odjelima opremljenima aparatima za oživljavanje te o riziku od upale, uključujući PML.
English: Ritemvia can only be obtained with a prescription.
Croatian: Ritemvia se izdaje samo na recept.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ritemvia have also been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Ritemvia nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: For more information about using Ritemvia, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Ritemvia pročitajte uputu o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: Therefore, the Agency's view was that, as for MabThera, the benefits of Ritemvia outweigh the identified risks and it can be authorised for use in the EU.
Croatian: Stoga je stav Agencije da, kao i kod lijeka MabThera, koristi od lijeka Ritemvia nadmašuju identificirane rizike te da lijek može biti odobren za primjenu u EU-u.
English: When rituximab attaches to CD20, it causes the death of B cells, which helps in lymphoma and CLL, where B cells have become cancerous.
Croatian: Kad se rituksimab veže na bjelančevinu CD20, uzrokuje odumiranje B-stanica, što pomaže bolesnicima s limfomom i KLL-om kod kojih su B-stanice postale kancerogene.
English: The safety of Ritemvia has been evaluated, and on the basis of all the studies carried out the side effects of the medicine are considered to be comparable to those of the reference medicine MabThera.
Croatian: Ocijenjena je sigurnost primjene lijeka Ritemvia i na temelju svih provedenih ispitivanja nuspojave lijeka smatraju se usporedivima s onima za referentni lijek MabThera.
English: Ritemvia is a medicine used in adults to treat the following blood cancers and inflammatory conditions:
Croatian: Ritemvia je lijek za liječenje sljedećih vrsta raka krvi i upala u odraslih bolesnika:
English: In addition, Ritemvia has been compared with MabThera given into a vein in a main study involving 372 patients with active rheumatoid arthritis (an inflammatory disease).
Croatian: Nadalje, lijek Ritemvia uspoređen je s lijekom MabThera primjenom u venu u glavnom ispitivanju u kojem su sudjelovale 372 osobe koje boluju od reumatoidnog artritisa (upalna bolest).
English: It is available as a concentrate for making a solution that must be given by infusion (drip) into a vein.
Croatian: Lijek je dostupan kao koncentrat za otopinu koja se daje kao infuzija (ukapavanje) u venu.
English: What benefits of Ritemvia have been shown in studies?
Croatian: Koje su koristi od lijeka Ritemvia utvrđene u ispitivanjima?
English: Laboratory studies comparing Ritemvia with MabThera have shown that the active substance in Ritemvia is highly similar to that in MabThera in terms of structure, purity and biological activity.
Croatian: Laboratorijska ispitivanja u kojem su uspoređivani lijekovi Ritemvia i MabThera pokazala su da je djelatna tvar u lijeku Ritemvia vrlo slična djelatnoj tvari u lijeku MabThera u pogledu strukture, čistoće i biološke aktivnosti.
English: All these data were considered sufficient to conclude that Ritemvia will behave in the same way as MabThera in terms of its effectiveness and safety in its authorised uses.
Croatian: Svi ti podatci smatraju se dovoljnima za donošenje zaključka da će lijek Ritemvia za odobrene indikacije djelovati jednako kao lijek MabThera u pogledu učinkovitosti i sigurnosti primjene.
English: How does Ritemvia work?
Croatian: Kako djeluje Ritemvia?
English: Studies have also shown that giving Ritemvia produces similar levels of the active substance in the body to giving MabThera.
Croatian: Ispitivanja su pokazala i da primjena lijeka Ritemvia dovodi do slične razine djelatne tvari u tijelu kao i primjena lijeka MabThera.
English: In addition, a study comparing Ritemvia to MabThera in patients with rheumatoid arthritis (which can support its use in other inflammatory disorders such as GPA and MPA) showed that both medicines are similarly effective, and a supportive study in follicular lymphoma showed effectiveness in cancer.
Croatian: Nadalje, ispitivanje u kojem su se usporedili lijekovi Ritemvia i MabThera u bolesnika s reumatoidnim artritisom (što podržava njihovu uporabu za druge upalne poremećaje, kao što su GPA i MPA) pokazalo je da je učinkovitost oba lijeka slična.
English: Ritemvia contains the active substance rituximab.
Croatian: Ritemvia sadrži djelatnu tvar rituksimab.
English: Further evidence came from supportive studies including one involving 121 patients with advanced follicular lymphoma, where adding Ritemvia to chemotherapy medicines was at least as effective as adding Rituxan, the US version of MabThera.
Croatian: Pokazalo se da je dodavanje lijeka Ritemvia lijekovima za kemoterapiju barem jednako učinkovito kao dodavanje lijeka Rituxan, američke verzije lijeka MabThera.
English: How is Ritemvia used?
Croatian: Kako se Ritemvia primjenjuje?
English: For the full list of side effects of Ritemvia, see the package leaflet.
Croatian: Potpuni popis zabilježenih nuspojava povezanih s lijekom Ritemvia potražite u uputi o lijeku.
English: Strength Pharmaceutical form Route of administration Packaging Package size EU/1/09/536/001 Topotecan Actavis 1 mg l t o r
Croatian: Unutarnje pakovanje Veličina pakovanja EMEA/H/C/001031/0000/001 Topotecan Actavis 1 mg Prašak za koncentrat za otopinu za infuziju Za infuziju u venu bočica
English: You may take Levetiracetam Accord with or without food.
Croatian: Levetiracetam Accord možete uzeti sa ili bez hrane.
English: Levetiracetam Accord must be taken twice a day, once in the morning and once in the evening, at about the same time each day.
Croatian: Levetiracetam Accord se mora uzimati dva puta na dan, jednom ujutro i jednom navečer, u približno isto vrijeme svaki dan.
English: Elderly (65 years and older)
Croatian: Starije osobe (65 godina i starije)
English: The film-coating contains:
Croatian: Film ovojnica sadrži:
English: Date of first authorisation: 03rd October 2011 Date of latest renewal: 22nd July 2016
Croatian: Datum posljednje obnove odobrenja: 22. srpanj 2016
English: This includes, any possible side effects not listed in this leaflet.
Croatian: To uključuje i svaku moguću nuspojavu koja nije navedena u ovoj uputi.
English: This decrease is more pronounced during the third trimester (up to 60% of baseline concentration before pregnancy).
Croatian: To smanjenje koncentracije bilo je više izraženo tijekom trećeg trimestra (do 60% u odnosu na bazičnu koncentraciju prije trudnoće).
English: What Levetiracetam Accord is and what it is used for
Croatian: Što je Levetiracetam Accord i za što se koristi
English: The lowest effective dose should be used.
Croatian: Treba koristiti najmanju učinkovitu dozu.
English: current epidemiological studies (on about 100 children) do not suggest an increased risk of neurodevelopmental disorders or delays.
Croatian: Međutim, trenutna epidemiološka ispitivanja (na približno 100 djece) ne ukazuju na povećani rizik od neurorazvojnih poremećaja ili kašnjenja u razvoju.
English: - Do not stop your treatment without your doctor's advice as this could increase your seizures.
Croatian: • Nemojte prekinuti liječenje bez savjeta liječnika jer to može pojačati napadaje.
English: If you forget to take Levetiracetam Accord Contact your doctor if you have missed one or more doses.
Croatian: Ako ste zaboravili uzeti Levetiracetam Accord Obavijestite liječnika ako ste zaboravili uzeti jednu ili više doza.
English: (monotherapy).
Croatian: (monoterapija).
English: Levetiracetam is used for the epilepsy form in which the fits initially affect only one side of the brain, but could thereafter extend to larger areas on both sides of the brain (partial onset seizure with or without secondary generalisation).
Croatian: Levetiracetam se koristi za oblik epilepsije u kojem napadaji započinju u jednoj strani mozga, ali se nakon toga mogu proširiti na veće područje u obje strane mozga (parcijalni napadaj sa ili bez sekundarne generalizacije).
English: PVC/Alu blister pack:
Croatian: PVC/Al blister pakiranje:
English: When you will first start taking Levetiracetam Accord, your doctor will prescribe you a lower dose (500 mg each day) during 2 weeks before giving you the lowest general dose of 1000 mg.
Croatian: Kad prvi put počnete uzimati Levetiracetam Accord, liječnik će Vam propisati manju dozu (500 mg svaki dan) tijekom 2 tjedna prije davanja najmanje uobičajene doze od 1000 mg.
English: The leaflet was last revised in (month/YYYY).
Croatian: Ova uputa je zadnji puta revidirana u {mjesec/GGGG}
English: Pharmacotherapeutic group: antiepileptics, other antiepileptics ATC code: N03AX14.
Croatian: Farmakoterapijska skupina: antiepileptici, ostali antiepileptici, ATK oznaka: N03AX14.
English: Therefore, the interaction of Levetiracetam with other substances, or vice versa, is unlikely.
Croatian: Iz toga proizlazi da interakcija Levetiracetama s drugim tvarima, i obrnuto, nije vjerojatna.
English: Adverse reactions are presented in the order of decreasing seriousness and their frequency is defined as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) and very rare (<1/10,000).
Croatian: Nuspojave su prikazane u padajućem nizu s obzirom na ozbiljnost i njihova učestalost je definirana na sljedeći način: vrlo često (≥1/10); često (≥1/100 i <1/10); manje često (≥1/1000 i <1/100); rijetko (≥1/10 000 i <1/1000) i vrlo rijetko (<1/10 000).
English: How to store Levetiracetam Accord Contents of the pack and other information
Croatian: Kako čuvati Levetiracetam Accord Sadržaj pakiranja i druge informacije
English: What Levetiracetam Accord is and what it is used for What you need to know before you take Levetiracetam Accord How to take Levetiracetam Accord Possible side effects
Croatian: Što je Levetiracetam Accord i za što se koristi Što morate znati prije nego počnete uzimati Levetiracetam Accord Kako uzimati Levetiracetam Accord Moguće nuspojave
English: Levetiracetam Accord is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).
Croatian: Levetiracetam Accord jest antiepileptik (lijek koji se koristi u liječenju epileptičkih napadaja).
English: Creatinine clearance (ml/min/1.73m2)
Croatian: Klirens kreatinina (ml/min/1,73m2)
English: Prevalence is significantly higher in Japanese patients when compared to nonJapanese patients.
Croatian: Prevalencija je značajno veća u japanskih bolesnika u usporedbi s bolesnicima koji nisu japanskog podrijetla.
English: What you need to know before you take Levetiracetam Accord
Croatian: Što morate znati prije nego počnete uzimati Levetiracetam Accord
English: Therefore a 50 % reduction of the daily maintenance dose is recommended when the creatinine clearance is < 60 ml/min/1.73m2.
Croatian: Stoga se preporučuje 50%-tno smanjenje dnevne doze održavanja ako je klirens kreatinina < 60 ml/min/1,73 m2.
English: Suicide, suicide attempt, suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents including levetiracetam.
Croatian: Samoubojstvo, pokušaj samoubojstva te samoubilačke ideje i ponašanje bili su prijavljivani kod bolesnika liječenih antiepileptičkim lijekovima uključujući levetiracetam.
English: Should your doctor decide to stop your Levetiracetam Accord treatment, he/she will instruct you about the gradual withdrawal of Levetiracetam Accord.
Croatian: Ako Vaš liječnik odluči prekinuti liječenje Levetiracetam Accordom, uputit će Vas kako postupno prekinuti liječenje Levetiracetam Accordom.
English: Hypersensitivity to the active substance or other pyrrolidone derivatives or to any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na djelatnu tvar ili neke druge pirolidonske derivae ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: This medicinal product does not require any special storage conditions.
Croatian: - Ovaj lijek ne zahtijeva posebne uvjete čuvanja.
English: Levetiracetam is indicated as adjunctive therapy
Croatian: Levetiracetam je indiciran kao dodatna terapija
English: In a study reflecting clinical practice, the concomitant antiepileptic medication could be withdrawn in a limited number of patients who responded to levetiracetam adjunctive therapy (36 adult patients out of 69).
Croatian: U studiji, koja je bila odraz kliničke prakse bilo je moguće prekinuti istodobno antiepileptičko liječenje u ograničenog broja bolesnika koji su odgovorili na dodatno liječenje levetiracetamom (36 od 69 odraslih bolesnika).
English: It is therefore recommended to adjust the maintenance daily dose of levetiracetam, based on creatinine clearance in patients with moderate and severe renal impairment (see section 4.2).
Croatian: Stoga se preporučuje prilagođavanje dnevne doze održavanja Levetiracetama s obzirom na klirens kreatinina u bolesnika s umjerenim i teškim oštećenjem bubrega (vidjeti dio 4.2).
English: The pharmacokinetic results indicated that half-life was shorter (5.3 h) than for adults (7.2 h) and apparent clearance was faster (1.5 ml/min/kg) than for adults (0.96 ml/min/kg).
Croatian: Farmakokinetički podaci ukazuju da je poluvijek života (5,3 h) kraći nego u odraslih (7,2 h), a prividni klirens (1,5 ml/min/kg) brži je nego u odraslih (0,96 ml/min/kg).
English: Results related to behavioural and emotional functioning indicated a worsening in levetiracetam treated patients on aggressive behaviuor as measured in a standardised and systematic way using a validated instrument (CBCL - Achenbach Child Behavior Checklist).
Croatian: Rezultati ocjene funkcioniranja ponašanja i emocionalnog funkcioniranja uputili su na pogoršanje u smislu agresivnijeg ponašanja u skupini koja je uzimala levetiracetam, ocijenjenog na standardiziran i sistematičan način koristeći validirani instrument (CBCL - Achenbach Child Behavior Checklist).
English: Alopecia,eczema, pruritus,
Croatian: Alopecija, ekcem, pruritis,
English: 500 to 1, 500 mg twice daily 500 to 1,000 mg twice daily 250 to 750 mg twice daily 250 to 500 mg twice daily 500 to 1,000 mg once daily (2)
Croatian: 500 do 1500 mg dva puta na dan 500 do 1000 mg dva puta na dan 250 do 750 mg dva puta na dan 250 do 500 mg dva puta na dan 500 do 1000 mg jedanput na dan (2)
English: • severe allergic reactions (DRESS, anaphylactic reaction [severe and important allergic reaction], Quincke's oedema [swelling of the face, lips, tongue and throat]);
Croatian: • tjelesne težine alergijske reakcije (DRESS, anafilaktička reakcija [teška i ozbiljna alergijska reakcija], angioedem [oticanje lica, usana, jezika i grla];