FrancophonIA/ELRC3.0 huggingface dataset:
English: If you need 2 injections, they should be given in different sites to avoid hardening of the skin and should not be given into areas where the skin is tender, bruised, red or hard.
Croatian: Ako trebate 2 injekcije, potrebno ih je davati na različitim mjestima kako bi se izbjeglo otvrdnuće kože, a ne smiju se davati tamo gdje je koža osjetljiva, s modricama, crvena ili tvrda.
English: Common: may affect up to 1 in 10 people - allergic reactions such as rash, swelling or hives - constipation - itching - muscle spasms - injection site reactions, such as pain, redness and swelling where the injection is given.
Croatian: Često: mogu se javiti u do 1 na 10 osoba - alergijske reakcije kao što su osip, oticanje ili koprivnjača - zatvor - svrbež - grčevi mišića - reakcije na mjestu primjene, kao što su bol, crvenilo i oticanje na mjestu na kojem je primijenjena injekcija.
English: In both studies, the patients enrolled had at least a 12-month history of migraine (with or without aura) according to the International Classification of Headache Disorders (ICHD-III) diagnostic criteria.
Croatian: U oba ispitivanja uključeni bolesnici imali su najmanje 12 mjeseci migrene u anamnezi (sa ili bez aure) prema dijagnostičkim kriterijima Međunarodne klasifikacije poremećaja glavobolje (engl.
English: No interaction with oral contraceptives (ethinyl estradiol/norgestimate) or sumatriptan was observed in studies with healthy volunteers.
Croatian: Nije uočena interakcija s oralnim kontraceptivima (etinilestradiol/norgestimat) ili sumatriptanom u ispitivanjima u zdravih dobrovoljaca.
English: In the event of an overdose, the patient should be treated symptomatically and supportive measures instituted as required.
Croatian: U slučaju predoziranja, bolesnika je potrebno liječiti simptomatski i započeti primjenu suportivnih mjera prema potrebi.
English: Animal studies showed no impact on female and male fertility (see section 5.3).
Croatian: Ispitivanja na životinjama nisu pokazala nikakav utjecaj na žensku i mušku plodnost (vidjeti dio 5.3).
English: You may need to use either one or two pens based on your prescribed dose.
Croatian: Možda ćete morati koristiti jednu ili dvije brizgalice na temelju propisane doze.
English: Press the start button.
Croatian: Pritisnite tipku za aktivaciju.
English: Measurable erenumab serum concentrations were observed in the infant monkeys at birth, confirming that erenumab, like other IgG antibodies, crosses the placental barrier.
Croatian: Mjerljive serumske koncentracije erenumaba bile su opažene u novorođenih majmuna kod rođenja, što potvrđuje da erenumab, poput drugih IgG protutijela, prelazi placentalnu barijeru.
English: Before you use the Aimovig pre-filled pen, read this information.
Croatian: Prije nego što upotrijebite Aimovig napunjenu brizgalicu, pročitajte ove informacije.
English: Stretch skin firmly by moving your thumb and fingers in opposite directions, creating an area about five cm wide.
Croatian: Čvrsto rastegnite kožu pomicanjem palca i prstiju u suprotnim smjerovima kako biste dobili područje široko oko pet cm.
English: Monoclonal antibodies like Aimovig are known to pass into breast milk during the first few days after birth, but after this first period Aimovig can be used.
Croatian: Za monoklonska protutijela poput Aimoviga je poznato da prelaze u majčino mlijeko tijekom prvih nekoliko dana nakon poroda, ali nakon tog prvog razdoblja Aimovig se može koristiti.
English: Note: You must push all the way down but do not touch the start button until you are ready to inject.
Croatian: Napomena: morate pritisnuti do kraja ali ne dodirujte tipku za aktivaciju dok niste spremni za ubrizgavanje.
English: It is normal to see a drop of liquid at the end of the needle.
Croatian: Normalno je vidjeti kap tekućine na vrhu igle.
English: 114 cases were received from postmarketing sources and 3 from clinical trials.
Croatian: Sto četrnaest (114) slučajeva je primljeno u razdoblju nakon stavljanja lijeka u promet i 3 iz kliničkih ispitivanja.
English: Patients had a median age of 42 years, 85% were female and 89% were white.
Croatian: Bolesnici su imali medijan dobi od 42 godine, 85% su bile žene, a 89% su bili bijelci.
English: If there is any blood on the skin, press a cotton ball or gauze pad onto the injection site.
Croatian: Ako ima imalo krvi na koži, pritisnite pamučnu vaticu ili gazu preko mjesta primjene.
English: Needle cap contains latex.
Croatian: Kapica igle sadrži lateks.
English: The recommended dose is 70 mg erenumab every 4 weeks.
Croatian: Preporučena doza je 70 mg erenumaba svaka 4 tjedna.
English: As a precautionary measure, it is preferable to avoid the use of Aimovig during pregnancy.
Croatian: Kao mjera opreza, preporučuje se izbjegavati primjenu lijeka Aimovig tijekom trudnoće.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Aimovig in prevention of migraine headaches in one or more subsets of the paediatric population (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Aimovig u sprječavanju migrenskih glavobolja u jednoj ili više podskupina pedijatrijske populacije (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Talk to your doctor about using Aimovig while breast-feeding in order to help you decide whether you should stop breast-feeding or stop using Aimovig.
Croatian: Razgovarajte sa svojim liječnikom o primjeni Aimoviga za vrijeme dojenja kako bi Vam pomogao odlučiti trebate li prestati dojiti ili prestati uzimati Aimovig.
English: Erenumab is not pharmacologically active in rodents.
Croatian: Erenumab nije farmakološki aktivan u glodavaca.
English: Aimovig is expected to have no or negligible influence on the ability to drive and use machines.
Croatian: Očekuje se da Aimovig ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Make sure that you inject the entire contents of both pens.
Croatian: Pazite da ubrizgate cjelokupni sadržaj obiju brizgalica.
English: The injection can be administered into the abdomen, thigh or into the outer area of the upper arm (the arm should be used only if the injection is being given by a person other than the patient; see section 5.2).
Croatian: Injekcija se može primijeniti u abdomen, bedro ili u vanjski dio nadlaktice (nadlakticu se smije koristiti samo ako injekciju daje netko drugi osim bolesnika; vidjeti dio 5.2).
English: Elderly patients (>65 years), patients with opioid overuse in study in chronic migraine, patients with medication overuse in study in episodic migraine, and also patients with pre-existing myocardial infarction, stroke, transient ischaemic attacks, unstable angina, coronary artery bypass surgery or other re-vascularisation procedures within 12 months prior to screening were excluded.
Croatian: Stariji bolesnici (>65 godina), bolesnici s prekomjernom uporabom opioida u ispitivanju kronične migrene, bolesnici s prekomjernom uporabom lijekova u ispitivanju epizodne migrene te bolesnici s prethodnim infarktom miokarda, moždanim udarom, prolaznim ishemijskim napadajima, nestabilnom anginom, premosnicom koronarne arterije ili drugim postupcima revaskularizacije unutar 12 mjeseci prije probira bili su isključeni iz ispitivanja.
English: Reduction in mean monthly migraine days from placebo was observed in a monthly analysis from Month 1 and in a follow-up weekly analysis an onset of erenumab effect was seen from the first week of administration.
Croatian: Smanjenje u srednjem broju dana migrene mjesečno u odnosu na placebo opaženo je u mjesečnoj analizi od 1. mjeseca, a u kontrolnoj tjednoj analizi opažen je nastup učinka erenumaba od prvog tjedna primjene.
English: What you need to know before you use Aimovig
Croatian: Što morate znati prije nego počnete primjenjivati Aimovig
English: Pregnancy Your doctor will decide whether you should stop using Aimovig during pregnancy.
Croatian: Trudnoća Liječnik će Vam pomoći odlučiti trebate li prestati primjenjivati Aimovig tijekom trudnoće.
English: Aimovig has not been studied in patients with certain cardiovascular diseases.
Croatian: Aimovig nije ispitivan u bolesnika s određenim kardiovaskularnim bolestima.
English: Avoid injecting into areas with scars or stretch marks.
Croatian: Izbjegavajte davanje injekcija u područja s ožiljcima ili strijama.
English: Possible side effects are listed below.
Croatian: Moguće nuspojave navedene su u nastavku.
English: For HIT-6: Change and reduction from baseline were evaluated in the last 4 weeks of the 12-week double-blind treatment phase.
Croatian: Za HIT-6: promjena i smanjenje u odnosu na početnu vrijednost procijenjeni su u posljednja 4 tjedna 12-tjedne faze dvostruko slijepog liječenja.
English: Aimovig has not been studied in elderly patients.
Croatian: Aimovig se nije ispitivao u starijih bolesnika.
English: A total of 366 (96%) patients in the erenumab arms and 265 (93%) patients in the placebo arm completed the study (i.e. completed Week 12 assessment).
Croatian: Ukupno je 366 (96%) bolesnika u erenumab skupinama i 265 (93%) bolesnika u placebo skupini dovršilo ispitivanje (tj. dovršilo procjenu u 12. tjednu).
English: Patients were allowed to use acute headache treatments during the study.
Croatian: Bolesnici su smjeli koristiti akutno liječenje za glavobolje tijekom ispitivanja.
English: Demographics and baseline disease characteristics were balanced and comparable between study arms.
Croatian: Demografske i početne karakteristike bolesti bile su uravnotežene i usporedive između ispitivanih skupina.
English: click
Croatian: klik
English: ≥50% MMD responders Percentage [%]
Croatian: Osobe s odgovorom ≥50% u DMM Postotak [%]
English: If you stop using Aimovig
Croatian: Ako prestanete primjenjivati Aimovig
English: Following a single subcutaneous dose of 140 mg or 70 mg erenumab administered to healthy adults, median peak serum concentrations were attained in 4 to 6 days, and estimated absolute bioavailability was 82%.
Croatian: Nakon jednokratne supkutane doze od 140 mg ili 70 mg erenumaba primijenjene u zdravih odraslih osoba, medijan vršnih koncentracija u serumu postignut je za 4 do 6 dana, a procijenjena apsolutna bioraspoloživost bila je 82%.
English: Both a
Croatian: oboje a
English: Erenumab, as a human monoclonal antibody, is not metabolised by cytochrome P450 enzymes and hepatic clearance is not a major clearance pathway for erenumab (see section 4.2).
Croatian: Erenumab, kao humano monoklonsko protutijelo, ne metabolizira se putem enzima citokroma P450 i hepatički klirens nije glavni put klirensa za erenumab (vidjeti dio 4.2).
English: Step 4: Finish
Croatian: 4. korak: završetak
English: There are a limited amount of data from the use of erenumab in pregnant women.
Croatian: Podaci o primjeni erenumaba u trudnica su ograničeni.
English: A study evaluated the effect of a single intravenous dose of 140 mg Aimovig in subjects with stable angina under controlled exercise conditions.
Croatian: Ispitivanje je ocjenjivalo učinak jednokratne intravenske doze od 140 mg Aimoviga u bolesnika sa stabilnom anginom pod kontroliranim uvjetima fizičkog napora.
English: Examine the injection site.
Croatian: Pregledajte mjesto primjene injekcije.
English: Note: The prescribed dose of Aimovig is either 70 mg or 140 mg.
Croatian: Napomena: propisana doza Aimoviga je ili 70 mg ili 140 mg.
English: Other medicines and Aimovig Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: Injection site reactions b
Croatian: Reakcije na mjestu primjene injekcije b
English: Intravenous infusion of CGRP induces migraine-like headache in patients.
Croatian: Intravenska infuzija CGRP-a inducira u bolesnika glavobolju nalik migreni.
English: Pull the grey needle cap straight off and away from your body, only when you are ready to inject.
Croatian: Skinite sivu kapicu s igle tako što ćete je povući okomito i od svog tijela, tek kad ste spremni za injekciju.
English: In the integrated 12-week placebo-controlled phase of the studies, injection site reactions were mild and mostly transient.
Croatian: U integriranoj 12-tjednoj placebom kontroliranoj fazi ispitivanja, reakcije na mjestu primjene injekcije su bile blage i uglavnom prolazne.
English: Do not use the pen(s) if any part appears cracked or broken.
Croatian: Ne upotrebljavajte brizgalicu(e) ako bilo koji dio izgleda napuknut ili slomljen.
English: Efficacy was sustained for up to 1 year in the open-label extension of Study 1 in which patients received 70 mg and/or 140 mg erenumab.
Croatian: Djelotvornost se održala do 1 godine u otvorenom nastavku Ispitivanja 1 u kojem su bolesnici primali 70 mg i/ili 140 mg erenumaba.
English: It is normal to see a drop of liquid at the end of the needle or safety guard.
Croatian: Normalno je vidjeti kap tekućine na vrhu igle ili štitnika.
English: Before administration, the solution should be inspected visually.
Croatian: Prije primjene potrebno je vizualno pregledati otopinu.
English: If your doctor prescribes the 70 mg dose you should have one injection once every 4 weeks.
Croatian: Ako Vaš liječnik propiše dozu od 70 mg, trebate primiti jednu injekciju svaka 4 tjedna.
English: Patient-reported outcome measures HIT-6
Croatian: Mjere ishoda prema procjeni bolesnika HIT-6
English: Firmly pinch the skin at the injection site.
Croatian: Čvrsto uštipnite kožu na mjestu primjene injekcije.
English: Keep holding the stretched/pinched skin.
Croatian: I dalje držite kožu rastegnutom/uštipnutom.
English: Based on this the PRAC considers that hypersensitivity reactions including rash, swelling/oedema and urticaria should be added as new adverse drug reactions in section 4.8 of the SmPC, and in the package leaflet.
Croatian: Na osnovu toga PRAC smatra da je reakcije preosjetljivosti, uključujući osip, oticanje/edem i urtikariju potrebno dodati kao nove nuspojave u dijelu 4.8 sažetka opisa svojstava lijeka (SmPC) i u uputu o lijeku.
English: Population pharmacokinetic analysis of integrated data from the Aimovig clinical studies did not reveal a difference in the pharmacokinetics of erenumab in patients with mild or moderate renal impairment relative to those with normal renal function (see section 4.2).
Croatian: Populacijska farmakokinetička analiza objedinjenih podataka iz kliničkih ispitivanja Aimoviga nije otkrila razliku u farmakokinetici erenumaba u bolesnika s blagim ili umjerenim oštećenjem bubrega u odnosu na one s normalnom bubrežnom funkcijom (vidjeti dio 4.2).
English: Do not use the syringe if any part of it appears cracked or broken.
Croatian: Ne upotrebljavajte štrcaljku ako bilo koji njezin dio izgleda napuknut ili slomljen.
English: In the integrated 12-week placebo-controlled phase of the studies, non-serious cases of rash, pruritus and swelling/oedema were observed, which in the majority of cases were mild and did not lead to treatment discontinuation.
Croatian: U integriranoj 12-tjednoj placebom kontroliranoj fazi ispitivanja, opaženi su ne-ozbiljni slučajevi osipa, pruritusa i oticanja/edema koji su u većini slučajeva bili blagi i nisu doveli do prekida primjene lijeka.
English: Step 1: Prepare
Croatian: 1. korak: priprema
English: If you are having two injections of Aimovig 70 mg, the second injection must be given immediately after the first one at a different injection site.
Croatian: Ako primate dvije injekcije Aimoviga 70 mg, druga injekcija mora se dati odmah nakon prve, ali u neko drugo mjesto.
English: Patients were re-randomised in the active treatment phase (ATP) to 70 mg or 140 mg erenumab.
Croatian: Bolesnici su ponovo randomizirani u fazi aktivnog liječenja (ATP) na 70 mg ili 140 mg erenumaba.
English: While pinching, insert the syringe needle into the skin at an angle of 45 to 90 degrees.
Croatian: Dok držite kožu uštipnutom, ubodite iglu štrcaljke u nju pod kutom od 45 do 90 stupnjeva.
English: With the cap off, place the pen on the skin at an angle of 90 degrees.
Croatian: Skinuvši kapicu, postavite brizgalicu na kožu pod kutom od 90 stupnjeva.
English: Aimovig (erenumab) was evaluated for prophylaxis of migraine in two pivotal studies across the migraine spectrum in chronic and episodic migraine.
Croatian: Aimovig (erenumab) se ocjenjivao za profilaksu migrene u dva pivotalna ispitivanja preko spektra migrene u kroničnoj i epizodnoj migreni.
English: Multipack: 3 (3 packs of 1) pre-filled pens
Croatian: Višestruko pakiranje: 3 (3 pakiranja od po 1) napunjene brizgalice
English: Do not twist or bend the cap.
Croatian: Ne okrećite ni ne savijajte kapicu.
English: Do not leave the grey needle cap off for more than 5 minutes.
Croatian: Pazite da igla ne bude bez sive kapice duže od 5 minuta.
English: ≥75% MMD responders Percentage [%]
Croatian: Osobe s odgovorom ≥75% u DMM Postotak [%]
English: Note: Keep skin stretched or pinched while injecting.
Croatian: Napomena: držite kožu rastegnutu ili uštipnutu dok ubrizgavate.
English: Do not use any pen that has been dropped.
Croatian: Ne upotrebljavajte nijednu brizgalicu koja je prethodno pala.
English: Table 1 lists all adverse drug reactions that occurred in Aimovig-treated patients during the 12-week placebo-controlled periods of the studies, as well as in the post-marketing setting.
Croatian: Tablici 1 navedene su nuspojave do kojih je došlo u bolesnika liječenih Aimovigom tijekom 12tjednih placebom kontroliranih razdoblja ispitivanja, kao i u razdoblju nakon stavljanja lijeka u promet.
English: On the basis of the scientific conclusions for erenumab the CHMP is of the opinion that the benefitrisk balance of the medicinal product(s) containing erenumab is unchanged subject to the proposed changes to the product information.
Croatian: Na temelju znanstvenih zaključaka za erenumab, CHMP smatra da je omjer koristi i rizika lijeka(ova) koji sadrži(e) erenumab nepromijenjen, uz predložene izmjene informacija o lijeku.
English: d p value was calculated based on the odds ratios.
Croatian: d p-vrijednost se računala na temelju omjera izgleda.
English: Do not reuse the pen.
Croatian: Nemojte ponovo koristiti brizgalicu.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Croatian: Od zdravstvenih radnika se traži da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava prije nuspojava: navedenog u Dodatku V.
English: It is unknown whether erenumab is excreted in human milk.
Croatian: Nije poznato izlučuje li se erenumab u majčino mlijeko.
English: Do not use the syringe if it has been dropped.
Croatian: Ne upotrebljavajte štrcaljku ako je prethodno pala.
English: Do not leave the cap off for more than 5 minutes.
Croatian: Pazite da brizgalica ne bude bez kapice duže od 5 minuta.
English: 1 pre-filled pen Component of a multipack.
Croatian: 1 napunjena brizgalica Sastavni dio višestrukog pakiranja.
English: Injection sites should be rotated and injections should not be given into areas where the skin is tender, bruised, red or hard.
Croatian: Mjesta primjene injekcije potrebno je rotirati, a injekcije se ne smiju davati u područja na kojima je koža osjetljiva, s modricama, crvena ili tvrda.
English: Both <0.001a
Croatian: oboje <0,001
English: No dose adjustment is required as the pharmacokinetics of erenumab are not affected by age.
Croatian: Nije potrebno prilagođavanje doze jer dob ne utječe na farmakokinetiku erenumaba.
English: Aimovig is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month.
Croatian: Aimovig je indiciran za profilaksu migrene u odraslih osoba koje imaju migrenu najmanje 4 dana mjesečno.
English: Aimovig works by blocking the activity of the CGRP molecule, which has been linked to migraine (CGRP stands for calcitonin gene-related peptide).
Croatian: Aimovig djeluje tako što blokira aktivnost CGRP molekule, koja je povezana s migrenom (CGRP označava peptid povezan s kalcitoninskim genom, od engl. calcitonin gene-related peptide).
English: A total of 294 patients (92%) for 140 mg, 287 (91%) patients for 70 mg and 284 patients (89%) in the placebo arm completed the double-blind phase.
Croatian: Ukupno je 294 bolesnika (92%) u 140 mg skupini, 287 (91%) bolesnika u 70 mg skupini i 284 bolesnika (89%) u placebo skupini dovršilo dvostruko slijepu fazu.
English: Prepare and clean the injection site(s).
Croatian: Pripremite i očistite mjesto (mjesta) za primjenu injekcije.
English: CGRP is a neuropeptide that modulates nociceptive signalling and a vasodilator that has been associated with migraine pathophysiology.
Croatian: CGRP je neuropeptid koji modulira nociceptivnu signalizaciju i vazodilatator koji je povezan s patofiziologijom migrene.
English: Always keep the sharps disposal container out of the reach of children.
Croatian: Uvijek držite spremnik za odlaganje oštrih predmeta izvan dohvata djece.
English: Also contains: sucrose, polysorbate 80, sodium hydroxide, glacial acetic acid, water for injections.
Croatian: Također sadrži: saharozu, polisorbat 80, natrijev hidroksid, ledenu acetatnu kiselinu, vodu za injekcije.
English: Hypersensitivity reactions including rash, swelling/oedema and urticaria
Croatian: Reakcije preosjetljivosti uključujući osip, oticanje/edem i urtikariju
English: The evidence suggested that there is a causal relationship with hypersensitivity leading to rash and/or oedema and/or urticaria with the administration of erenumab.
Croatian: Dokazi ukazuju da postoji uzročna povezanost između primjene erenumaba i preosjetljivosti koja vodi osipu i/ili edemu i/ili urtikariji.
English: Patients treated with erenumab had a clinically relevant and statistically significant reduction from baseline in the frequency of migraine days from Months 4 to 6 (Figure 2) compared to patients receiving placebo.
Croatian: Bolesnici liječeni erenumabom imali su klinički relevantno i statitistički značajno smanjenje u odnosu na početne vrijednosti u učestalosti dana migrene od 4.do 6.mjeseca (Slika 2) u usporedbi s bolesnicima koji su primali placebo.
English: Injection site pain typically subsided within 1 hour after administration.
Croatian: Bol na mjestu primjene injekcije obično se povlačila u roku od 1 sat nakon primjene.
English: Treatment is intended for patients with at least 4 migraine days per month when initiating treatment with erenumab.
Croatian: Liječenje je namijenjeno bolesnicima koji imaju migrenu najmanje 4 dana mjesečno kad započinju liječenje erenumabom.
English: Note: Keep skin pinched while injecting.
Croatian: Napomena: držite kožu uštipnutu dok ubrizgavate.
English: For detailed instructions on how to inject Aimovig, see “Instructions for use of Aimovig pre-filled pen” at the end of this leaflet.
Croatian: Za detaljne upute o ubrizgavanju Aimoviga, vidjeti “Upute za uporabu Aimovig napunjene brizgalice” na kraju ove upute.
English: For detailed instructions on how to inject Aimovig, see “Instructions for use of Aimovig pre-filled syringe” at the end of this leaflet.
Croatian: Za detaljne upute o ubrizgavanju Aimoviga, vidjeti “Upute za uporabu Aimovig napunjene štrcaljke” na kraju ove upute.
English: - The other ingredients are sucrose, polysorbate 80, sodium hydroxide, glacial acetic acid, water for injections.
Croatian: - Drugi sastojci su saharoza, polisorbat 80, natrijev hidroksid, ledena acetatna kiselina, voda za injekcije.
English: Green safety guard
Croatian: Zeleni štitnik
English: Chronic migraine
Croatian: Kronična migrena
English: What Aimovig contains - The active substance is erenumab.
Croatian: Što Aimovig sadrži - Djelatna tvar je erenumab.
English: In all cases described above, use a new syringe, and if you are unsure contact your doctor or pharmacist.
Croatian: U svim opisanim slučajevima upotrijebite novu štrcaljku, a ako niste sigurni obratite se svom liječniku ili ljekarniku.
English: No dose adjustment is necessary in patients with mild to moderate renal impairment or hepatic impairment (see section 5.2).
Croatian: Nije potrebno prilagođavanje doze u bolesnika s blagim do umjerenim oštećenjem bubrega ili jetre (vidjeti dio 5.2).