FrancophonIA/ELRC3.0 huggingface dataset:
English: Median Progression Free survival (months) (95 % CI)
Croatian: Medijan ukupnog preživljenja (mjeseci)
English: • Instructions to stop Erivedge upon suspicion of pregnancy
Croatian: ● prekinuti primjenu lijeka Erivedge ako se sumnja na trudnoću
English: Semen donation Male patients should not donate semen while taking Erivedge and for 2 months after the final dose.
Croatian: Bolesnici ne smiju darivati spermu dok uzimaju Erivedge i 2 mjeseca nakon posljednje doze.
English: You should return unused capsules at the end of your treatment.
Croatian: Na kraju liječenja neiskorištene kapsule morate vratiti.
English: 95 % CI for overall response
Croatian: Bolesnici s odgovorom 11 (33,3%) 95% CI za ukupan odgovor Potpun odgovor
English: Median OS, (months) (95 % CI)
Croatian: (95% CI)
English: • The need to stop Erivedge immediately upon suspicion of pregnancy
Croatian: ● bolesnica mora odmah prestati uzimati Erivedge ako posumnja na trudnoću
English: • vomiting or feeling like you want to vomit (nausea),
Croatian: ● povraćanje ili osjećaj mučnine,
English: ****Individual cases have been reported in patients with medulloblastoma during post-marketing use (see section
Croatian: ****Pojedinačni slučajevi su zabilježeni u bolesnika s meduloblastomom nakon stavljanja lijeka na tržište (vidjeti dio 4.4) ***** Slučajevi oštećenja jetre uzrokovanog lijekovima zabilježeni su u bolesnika nakon stavljanja lijeka na tržište.
English: • you stop using contraception,
Croatian: ● ako prestanete koristiti zaštitu od trudnoće,
English: • Information for patients on the teratogenic risks associated with Erivedge and the need to avoid foetal exposure
Croatian: ● informacije za bolesnike o teratogenim rizicima povezanima s lijekom Erivedge te o potrebi da se izbjegne izlaganje ploda lijeku
English: Do not breast-feed during your treatment and for 24 months after your final dose of this medicine.
Croatian: Nemojte dojiti tijekom liječenja kao ni 24 mjeseca nakon uzimanja posljednje doze ovoga lijeka.
English: Unused capsules should be returned at the end of treatment
Croatian: ● bolesnike je potrebno upozoriti da neiskorištene kapsule moraju vratiti na kraju liječenja
English: In general the safety profile observed was consistent in both mBCC and laBCC patients and across studies as described below.
Croatian: Općenito je opažen sigurnosni profil bio podjednak i u bolesnika s metastatskim karcinomom bazalnih stanica i u bolesnika s lokalno uznapredovalim karcinomom bazalnih stanica te u svim ispitivanjima, kao što je opisano u nastavku.
English: Counselling For a WCBP Erivedge is contraindicated in a WCBP who does not comply with the Erivedge Pregnancy Prevention Programme.
Croatian: Za ženu generativne dobi Erivedge je kontraindiciran u žena generativne dobi koje se ne pridržavaju Programa sprječavanja trudnoće pri primjeni lijeka Erivedge.
English: Increased number of degenerating germ cells and hypospermia in sexually immature dogs observed at ≥ 50 mg/kg/day in the 4-week general toxicity study was of undetermined relationship to vismodegib.
Croatian: U 4-tjednom ispitivanju opće toksičnosti, pri dozi od ≥ 50 mg/kg/dan primijećeni su povećan broj degeneriranih zametnih stanica i hipospermija u spolno nezrelih pasa, ali nije utvrđena povezanost s primjenom vismodegiba.
English: For the mBCC cohort, 97 % of patients had prior therapy including surgery (97 %), radiotherapy (58 %), and systemic therapies (30 %).
Croatian: U kohorti bolesnika oboljelih od metastatskog karcinoma bazalnih stanica prethodno je liječeno 97% bolesnika: kirurškim zahvatom (97%), radioterapijom (58%) i sustavnim liječenjem (30%).
English: • The need for monthly pregnancy tests
Croatian: ● bolesnice moraju svaki mjesec raditi test na trudnoću
English: Persistent lack of menses during treatment with Erivedge should be assumed to indicate pregnancy until medical evaluation and confirmation.
Croatian: Dok se ne provede medicinska procjena i dobije potvrda, treba pretpostaviti da trajan izostanak menstruacije tijekom liječenja lijekom Erivedge ukazuje na trudnoću.
English: • Serious skin reactions have been reported in association with Erivedge treatment.
Croatian: Kod liječenja lijekom Erivedge prijavljene su ozbiljne kožne reakcije.
English: Fertility preservation strategies should be discussed with WCBP prior to starting treatment with Erivedge.
Croatian: Sa ženama generativne dobi potrebno je prije početka liječenja lijekom Erivedge razgovarati o mogućnostima očuvanja plodnosti.
English: • The need to contact the healthcare professional if the female partner suspects that she is pregnant while the patient is treated with Erivedge or in the 2 months following treatment
Croatian: ● bolesnici moraju odmah obavijestiti zdravstvenoga radnika ako im partnerica posumnja da je zanijela tijekom njegova liječenja lijekom Erivedge ili unutar 2 mjeseca po završetku liječenja
English: Erivedge may cause embryo-foetal death or severe birth defects when administered to a pregnant woman (see section 4.6).
Croatian: Kad se primjenjuje u trudnica, Erivedge može uzrokovati smrt embrija/fetusa ili teška prirođena oštećenja (vidjeti dio 4.6).
English: • You should not donate blood at any time during treatment and for 24 months after your final dose of this medicine.
Croatian: Ne smijete darivati krv ni u kojem trenutku tijekom liječenja kao ni 24 mjeseca nakon uzimanja posljednje doze ovoga lijeka.
English: For men taking Erivedge
Croatian: Za muškarce koji uzimaju Erivedge
English: • you need to change contraception.
Croatian: ● ako morate promijeniti metodu zaštite od trudnoće.
English: • diarrhoea,
Croatian: ● proljev,
English: Blood donation Patients should not donate blood while taking Erivedge and for 24 months after the final dose.
Croatian: Bolesnici ne smiju darivati krv tijekom liječenja lijekom Erivedge niti 24 mjeseca nakon uzimanja posljednje doze.
English: • a diaphragm (with spermicide, if available).
Croatian: ● dijafragma (po mogućnosti sa spermicidom).
English: Complete Response 0 Partial Response Stable disease Progressive disease ‡ 1
Croatian: Djelomičan odgovor 11 (33,3%) Stabilna bolest
English: Tel: +371 - 6 7 039831
Croatian: Roche Latvija SIA Tel: +371 - 6 7 039831
English: • Patient Reminder Card
Croatian: ● Karticu podsjetnik za bolesnika
English: STATEMENT OF ACTIVE SUBSTANCE Each capsule contains 150 mg of vismodegib.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna kapsula sadrži 150 mg vismodegiba.
English: Table 2 SHH4476g Erivedge Efficacy Results (IRF 21 months and Investigator assessed
Croatian: Tablica 2 Podaci o djelotvornosti lijeka Erivedge iz ispitivanja SHH4476g (prema ocjeni neovisnog ocjenjivačkog tijela nakon praćenja od 21 mjeseca i prema ocjeni ispitivača nakon praćenja od 39 mjeseci od uključenja posljednjeg bolesnika): bolesnici u kojih je bilo moguće procijeniti djelotvornost *
English: Responders
Croatian: PRIMJENU
English: There was no evidence of genotoxicity in in vitro assays (reverse bacterial mutagenesis [Ames] and human lymphocyte chromosome aberration assays) or in the in vivo rat bone marrow micronucleus assay.
Croatian: [Amesov test] i test kromosomske aberacije na ljudskim limfocitima) ni u mikronukleusnim testovima na koštanoj srži štakora in vivo.
English: After oral administration of a radiolabelled dose, vismodegib is absorbed and slowly eliminated by a combination of metabolism and excretion of parent drug substance, the majority of which is recovered in the faeces (82 % of the administered dose), with 4.4 % of the administered dose recovered in urine.
Croatian: Najveća količina osnovnog spoja pronađena je u fecesu (82% primijenjene doze), a 4,4% primijenjene doze pronađeno je u urinu.
English: Erivedge may cause embryo-foetal death or severe birth defects when administered to a pregnant woman (see section 4.4).
Croatian: Kad se primjenjuje u trudnice, Erivedge može uzrokovati smrt embrija/fetusa ili teška prirođena oštećenja (vidjeti dio 4.4).
English: • constipation,
Croatian: ● umor,
English: • Information for patients of the teratogenic risks associated with Erivedge and the need to avoid foetal exposure
Croatian: ● informacije za bolesnike o teratogenim rizicima povezanima s primjenom lijeka Erivedge te upozorenje da treba izbjegavati izloženost ploda lijeku
English: Madarosis Abnormal hair growth
Croatian: Poremećaji kože i potkožnog tkiva alopecija pruritus osip madaroza abnormalan rast kose
English: • upset stomach or indigestion,
Croatian: ● želučane tegobe ili probavne tegobe,
English: • Intrauterine device (IUD).
Croatian: ● intrauterini uložak.
English: Sodium lauril sulfate Povidone (K29/32) Sodium starch glycolate (Type A) Talc
Croatian: Sadržaj kapsule celuloza, mikrokristalična laktoza hidrat natrijev laurilsulfat povidon (K29/32) natrijev škroboglikolat (vrste A)
English: Use one highly effective method, such as: • a contraceptive depot injection
Croatian: Primjenjujte jednu metodu visoke učinkovitosti, poput:
English: • Do not crush, open or chew the capsule, to avoid unintended exposure to the capsule contents.
Croatian: Kako biste izbjegli nenamjerno izlaganje sadržaju kapsule, kapsulu nemojte drobiti, otvarati ni žvakati.
English: The volume of distribution for vismodegib is low, ranging from 16.4 to 26.6 L. In vitro binding of vismodegib to human plasma proteins is high (97 %) at clinically relevant concentrations.
Croatian: Volumen distribucije vismodegiba je malen, a kreće se u rasponu od 16,4 do 26,6 l.
English: Cases of cuSCC have been reported in advanced BCC patients treated with Erivedge.
Croatian: Slučajevi planocelularnog karcinoma kože prijavljeni su u bolesnika s uznapredovalim karcinomom bazalnih stanica liječenih lijekom Erivedge.
English: • eyelashes falling out (madarosis)
Croatian: ● ispadanje trepavica (madaroza),
English: • a condom (with spermicide, if available)
Croatian: ● prezervativa (po mogućnosti sa spermicidom)
English: ‡ Progression in laBCC cohort is defined as meeting any of the following criteria: (1) ≥ 20 % increase in the sum of the longest dimensions (SLD) from nadir in target lesions (either by radiography or by externally visible dimension),
Croatian: ‡ Progresijom bolesti u kohorti bolesnika oboljelih od lokalno uznapredovalog karcinoma bazalnih stanica smatra se ispunjavanje jednog od sljedećih kriterija: (1) povećanje zbroja najduljih promjera za ≥ 20% u odnosu na najmanju vrijednost ciljnih lezija (utvrđeno radiografski ili na temelju dimenzije vidljivog dijela lezije), (2) novonastala ulceracija ciljnih lezija kod koje tijekom najmanje 2 tjedna nisu primijećeni znakovi zacjeljivanja, (3) novonastale lezije utvrđene radiografski ili fizikalnim pregledom, (4) progresija neciljnih lezija u skladu s RECIST kriterijima.
English: Fertility
Croatian: želatina
English: Nausea Diarrhoea Constipation Vomiting Dyspepsia
Croatian: Poremećaji probavnog sustava mučnina proljev konstipacija povraćanje dispepsija bol u gornjem dijelu abdomena bol u abdomenu
English: Clinically significant PK interactions between vismodegib and pH elevating agents are not expected.
Croatian: Ne očekuju se klinički značajne farmakokinetičke interakcije između vismodegiba i lijekova koji povisuju pH.
English: Musculoskeletal chest pain
Croatian: Planocelularni karcinom kože
English: Among patients who achieved tumour reduction, the median time to maximum tumour reduction occurred in 5.6 and 5.5 months for laBCC and mBCC patients respectively, based on the IRF assessment.
Croatian: Prema procjeni neovisnog ocjenjivačkog tijela, među bolesnicima u kojih je došlo do smanjenja veličine tumora medijan vremena do maksimalnoga smanjenja veličine tumora iznosio je 5,6 mjeseci u bolesnika s lokalno uznapredovalim karcinomom bazalnih stanica i 5,5 mjeseci u bolesnika s metastatskim karcinomom bazalnih stanica.
English: • Patient Brochure
Croatian: ● Knjižicu s podacima za bolesnika
English: • The national part of the DHPC
Croatian: ● nacionalni dio pisma za zdravstvene radnike
English: SPECIAL STORAGE CONDITIONS Do not store above 30 °C
Croatian: POSEBNE MJERE ČUVANJA Ne čuvati na temperaturi iznad 30°C Bocu čuvati čvrsto zatvorenu radi zaštite od vlage
English: • The need to use condoms when having sex with a female partner during treatment and for 2 months after Erivedge treatment
Croatian: ● bolesnici moraju tijekom liječenja lijekom Erivedge i 2 mjeseca po njegovu završetku koristiti prezervative pri spolnom odnosu s partnericom
English: • She must not breast-feed while taking Erivedge and for 24 months after the final dose.
Croatian: ● ne smije dojiti tijekom liječenja lijekom Erivedge niti 24 mjeseca nakon uzimanja posljednje doze.
English: She must use two methods of recommended contraception including one highly effective method and a barrier method during Erivedge therapy and for 24 months after the final dose.
Croatian: Tijekom liječenja lijekom Erivedge i 24 mjeseca nakon uzimanja posljednje doze bolesnica mora koristiti dvije metode preporučene kontracepcije uključujući jednu metodu visoke učinkovitosti i jednu metodu barijere.
English: Rare ( ≥ 1/10,000 to < 1/1,000)
Croatian: Učestalosti su definirane kako slijedi: vrlo često (≥ 1/10) često (≥ 1/100 i < 1/10) manje često (≥ 1/1000 i < 1/100) rijetko (≥ 1/10 000 i <1/1000) vrlo rijetko (< 1/10 000) nepoznato (ne može se procijeniti iz dostupnih podataka).
English: The cap liner is aluminum foil-lined waxed pulp board.
Croatian: Zatvarač je s unutarnje strane obložen navoskanom kartonskom pločicom obloženom aluminijskom folijom.
English: Roche s. r. o. Tel: +420 - 2 20382111
Croatian: Tel: +420 - 2 20382111
English: • Inform patients that they should not donate blood during treatment with Erivedge and for 24 months after their final dose
Croatian: ● zdravstveni radnik mora obavijestiti bolesnike da ne smiju darovati krv tijekom liječenja lijekom Erivedge niti 24 mjeseca nakon posljednje doze
English: Reproductive system and breast disorders
Croatian: Poremećaji reproduktivnog sustava i dojki amenoreja*
English: Hepatic impairment
Croatian: Teške kožne nuspojave
English: • Measures to ensure that all appropriate actions have been performed prior to Erivedge being prescribed and dispensed The MAH shall continuously ensure that all physicians who are expected to prescribe Erivedge are provided with the following: Product information Healthcare professional educational material Healthcare professional reminder card Patient educational material Patient reminder card The healthcare professional educational material for Erivedge should contain the following key elements:
Croatian: Nositelj odobrenja mora kontinuirano paziti da svi liječnici za koje se očekuje da će propisivati Erivedge dobiju sljedeće materijale:
English: • The need to use condoms if his sexual partner is pregnant or a women of childbearing potential (even if the man has had a vasectomy) during treatment and for 2 months after Erivedge treatment
Croatian: ● bolesnik mora tijekom liječenja lijekom Erivedge i 2 mjeseca po njegovu završetku koristiti prezervative (čak i ako se prethodno podvrgnuo vazektomiji) ako je njegova spolna partnerica trudnica ili žena generativne dobi
English: INFORMATION IN BRAILLE erivedge
Croatian: Prijavljivanje nuspojava
English: • an intra-uterine device (“the coil” or IUD)
Croatian: ● materničnog uloška (“spirale”)
English: It has not been determined whether cuSCC is related to Erivedge treatment.
Croatian: Nije utvrđeno je li planocelularni karcinom kože povezan s liječenjem lijekom Erivedge.
English: • The need to use condoms (even if the man has had a vasectomy) if his sexual partner is pregnant or a women of childbearing potential during treatment and for 2 months after Erivedge treatment
Croatian: ● tijekom liječenja lijekom Erivedge i 2 mjeseca po njegovu završetku bolesnik mora koristiti prezervative (čak i ako se prethodno podvrgnuo vazektomiji) ako je njegova spolna partnerica trudnica ili žena generativne dobi
English: • That the patient should not donate blood during treatment and for 24 months after their final dose
Croatian: ● upozorenje da bolesnik ne smije darovati krv tijekom liječenja niti 24 mjeseca nakon posljednje doze
English: • That the patient should not breastfeed during treatment and for 24 months after their final dose
Croatian: ● upozorenje da bolesnica ne smije dojiti tijekom liječenja niti 24 mjeseca nakon posljednje doze
English: Tel: +370 5 2546799
Croatian: UAB “Roche Lietuva” Tel: +370 5 2546799
English: Criteria for a woman of childbearing potential (WCBP) A WCBP is defined in the Erivedge Pregnancy Prevention Programme as:
Croatian: Programu sprječavanja trudnoće pri primjeni lijeka Erivedge žena generativne dobi definira se kao:
English: Capsule shell Iron oxide black (E172) Iron oxide red (E172) Titanium dioxide (E171) Gelatine
Croatian: talk magnezijev stearat Ovojnica kapsule željezov oksid, crni (E172) željezov oksid, crveni (E172)
English: Hepatic enzymes increased**
Croatian: Poremećaji jetre i žuči povišene vrijednosti jetrenih enzima**
English: • Remind patients not to donate blood during treatment and for 24 months after the final dose
Croatian: ● bolesnike je potrebno upozoriti da ne smiju darovati krv tijekom liječenja niti 24 mjeseca nakon posljednje doze
English: Asthenia
Croatian: erivedge
English: • Not to donate semen during treatment and for 2 months after the final dose
Croatian: ● bolesnici ne smiju darovati spermu tijekom liječenja niti 2 mjeseca nakon posljednje doze
English: • stomach pain,
Croatian: ● grčevi mišića,
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients Capsule contents
Croatian: PRILOG I. SAŽETAK OPISA SVOJSTAVA LIJEKA
English: • That if his partner becomes pregnant he should inform the treating healthcare professional immediately
Croatian: ● bolesnik odmah mora obavijestiti nadležnoga zdravstvenog radnika ako njegova partnerica zatrudni
English: • Not to donate blood during treatment and for 24 months after the final dose
Croatian: ● upozorenje da ne smiju darovati krv tijekom liječenja niti 24 mjeseca nakon posljednje doze
English: Printing ink Shellac glaze Iron oxide black (E172)
Croatian: Tinta za označavanje šelak glazura željezov oksid, crni (E172) 6.2 Inkompatibilnosti
English: Cutaneous squamous cell carcinoma (cuSCC)
Croatian: Stevens-Johnsonov sindrom (SJS)/toksična epidermalna nekroliza
English: United Kingdom
Croatian: Njemačka
English: • Adverse event reporting forms
Croatian: ● obrasce za prijavljivanje nuspojava
English: • Not to breastfeed during treatment and for 24 months after Erivedge treatment
Croatian: ● bolesnice ne smiju dojiti tijekom liječenja lijekom Erivedge niti 24 mjeseca po njegovu završetku
English: This may take up to 20 minutes.
Croatian: To može potrajati i do 20 minuta.
English: China, Hong Kong, Indonesia, Japan, Malaysia, Philippines, Singapore, Taiwan and Thailand.
Croatian: Kina, Hong Kong, Indonezija, Japan, Malezija, Filipini, Singapur, Tajvan i Tajland.
English: “m” is medians in months.
Croatian: b “m” su medijani u mjesecima.
English: *from the following studies: INTEREST, ISEL, INTACT 1&2, IDEAL 1&2, INVITE
Croatian: *iz sljedećih studija: INTEREST, ISEL, INTACT 1&2, IDEAL 1&2, INVITE
English: IRESSA did not prolong survival in the overall population.
Croatian: IRESSA nije produljila preživljenje u ukupnoj populaciji.
English: An updated RMP shall be submitted:
Croatian: Ažurirani RMP treba dostaviti:
English: Dose adjustment due to toxicity
Croatian: Prilagodba doze zbog toksičnosti
English: In that study, sensitivity was 43.1%, specificity was
Croatian: U tom je ispitivanju osjetljivost iznosila 43,1%, a specifičnost
English: You can take the tablet with or without food.
Croatian: • Tabletu možete uzeti s ili bez hrane.
English: Unadjusted analysis EFR population
Croatian: Neprilagođena analiza EFR populacija
English: Barbiturates (a type of medicine used for sleeping problems).
Croatian: Barbiturate (vrsta lijekova koji se koriste za liječenje poteškoća sa spavanjem).
English: None of the patients had cancer, all had cirrhosis and some had hepatitis.
Croatian: Niti jedan bolesnik nije imao rak, svi su imali cirozu, a neki hepatitis.
English: Take the tablet at about the same time each day.
Croatian: • Uzmite tabletu u približno isto vrijeme svakoga dana.
English: This leaflet was last revised in {MM/YYYY}
Croatian: Uputa je zadnji puta revidirana u {MM/GGGG}
English: Positive predictive value (9.5% of the overall population are EGFR mutation-positive (M+))
Croatian: Pozitivna prediktivna vrijednost (9,5% ukupne populacije je pozitivno na mutaciju EGFR (M+))
English: The dispersion should be drunk immediately after dispersion is complete (i.e. within 60 minutes).
Croatian: Disperzija se mora popiti odmah nakon što je pripravljena (tj. unutar 60 minuta).
English: Like all medicines this medicine can cause side effects, although not everybody gets them.
Croatian: Kao i svi lijekovi, ovaj lijek može uzrokovati nuspojave iako se one neće javiti kod svakoga.
English: Plasma protein binding is approximately 90%.
Croatian: Vezanje na proteine u plazmi iznosi približno 90%.
English: Rifampicin (for tuberculosis).
Croatian: Rifampicin (za liječenje tuberkuloze).
English: ORR (%) Gefitinib v. Docetaxel
Croatian: ORR (%) Gefitinib v. docetaksel
English: Excipients with known effect:
Croatian: Pomoćna tvar s poznatim učinkom:
English: IRESSA should not be used during pregnancy unless clearly necessary.
Croatian: IRESSA se ne smije primjenjivati tijekom trudnoće, osim ako to nije neophodno.
English: If you are taking a medicine containing this active substance, your doctor may need to do blood tests more often.
Croatian: Ako uzimate lijek koji sadrži tu djelatnu tvar, liječnik će morati češće obavljati pretrage krvi.
English: These patients should be closely monitored for adverse events.
Croatian: Te bolesnike treba pomno nadzirati radi mogućih štetnih događaja.
English: Other potential interactions
Croatian: Ostale moguće interakcije
English: The glass should be swirled occasionally, until the tablet is dispersed (this may take up to 20 minutes).
Croatian: Čašu treba povremeno protresti dok se tableta ne rastopi (to može potrajati do 20 minuta).
English: What IRESSA is and what it is used for
Croatian: Što je IRESSA i za što se koristi
English: Swirl the water until the tablet has dissolved.
Croatian: Miješajte vodu sve dok se tableta ne otopi.
English: This protein is involved in the growth and spread of cancer cells.
Croatian: Ovaj je protein uključen u rast i širenje stanica raka.
English: Loss of appetite
Croatian: • gubitak apetita
English: It is recommended that you avoid becoming pregnant during treatment with IRESSA because IRESSA could harm your baby.
Croatian: Preporučuje se da izbjegavate trudnoću tijekom liječenja lijekom IRESSA jer IRESSA može naškoditi Vašem djetetu.
English: The effects reached statistical significance for the female mice, but not for the males.
Croatian: Učinci su dosegli statističku značajnost za ženke miševa, ali ne i za mužjake.
English: Other medicines and IRESSA
Croatian: Drugi lijekovi i IRESSA
English: Severe skin reactions (rare) affecting large areas of your body.
Croatian: • teške kožne reakcije (rijetko) koje zahvaćaju velike površine tijela.
English: Then take the next tablet at the usual time.
Croatian: Zatim uzmite sljedeću tabletu u uobičajeno vrijeme.
English: This resulted in a 35% increase in exposure to metoprolol.
Croatian: To je rezultiralo 35%-tnim povećanjem izloženosti metoprololu.
English: Allergic reactions (1.1%), including angioedema and urticaria
Croatian: Alergijske reakcije (1,1%), uključujući angioedem i urtikariju
English: Do not use any other liquids.
Croatian: Nemojte koristiti niti jednu drugu tekućinu.
English: 0.0397 1.7 times higher in females than males
Croatian: 0,0397 1,7 puta veći u žena nego u muškaraca
English: In particular, tell your doctor or pharmacist if you are taking any of the following medicines: Phenytoin or carbamazepine (for epilepsy).
Croatian: Posebice, recite svom liječniku ili ljekarniku ako uzimate neki od sljedećih lijekova: Fenitoin ili karbamazepin (za liječenje epilepsije).
English: ADRs usually occur within the first month of therapy and are generally reversible.
Croatian: Nuspojave se obično javljaju tijekom prvog mjeseca liječenja i općenito su reverzibilne.