FrancophonIA/ELRC3.0 huggingface dataset:
English: Take your prescribed dose by mouth with water and during your meal.
Croatian: Uzmite propisanu dozu lijeka kroz usta, uz čašu vode, tijekom obroka.
English: Caution should be exercised when both medicines are co-administered.
Croatian: Potreban je oprez kada se oba lijeka primjenjuju istodobno.
English: Do not have sex with a pregnant woman unless you use a condom.
Croatian: Ne smijete imati spolne odnose s trudnicom bez uporabe prezervativa.
English: Study 22
Croatian: Ispitivanje 22
English: Like all medicines, this medicine used in combination with other medicines can cause side effects, although not everybody gets them.
Croatian: Kao i svi lijekovi, ovaj lijek koji se koristi u kombinaciji s drugim lijekovima može uzrokovati nuspojave iako se one neće javiti kod svakoga.
English: suicide, stroke (cerebrovascular events).
Croatian: samoubojstvo, moždani udar (cerebrovaskularni događaji)
English: Not known side effects (frequency cannot be estimated from the available data):
Croatian: Nuspojave nepoznate učestalosti (učestalost se ne može procijeniti iz dostupnih podataka):
English: Less than 30 mL/min
Croatian: Manje od 30 ml/min
English: No histopathological effects on bone were observed.
Croatian: Nisu primijećeni histopatološki učinci na kost.
English: If an entire day has gone by, check with your doctor.
Croatian: Ako je prošao cijeli dan, provjerite s liječnikom što učiniti.
English: Date of first authorisation : 01 July 2009 Date of latest renewal : 16 January 2014
Croatian: Datum zadnje obnove odobrenja: 16. siječnja 2014
English: - Pregnancy (see sections 4.4, 4.6 and 5.3).
Croatian: - Trudnoća (vidjeti dijelove 4.4, 4.6 i 5.3).
English: 30 to 50 mL/min
Croatian: 30 do 50 ml/min
English: You may want to consider asking a family member or close friend to help you stay alert to signs of depression or changes in your behaviour
Croatian: Razmotrite mogućnost da zamolite člana obitelji ili bliskog prijatelja da Vas upozore na znakove depresije ili promjene u ponašanju.
English: • Girl or woman of childbearing age:
Croatian: • Djevojke ili žene u reproduktivnoj dobi:
English: Seek medical help immediately if you develop symptoms of a severe allergic reaction (such as difficulty in breathing, wheezing or hives) while taking this treatment.
Croatian: Odmah potražite liječničku pomoć ako razvijete simptome teške alergijske reakcije (kao što je otežano disanje, piskanje pri disanju ili koprivnjača) dok uzimate ovaj lijek.
English: The effects on growth were less in those children treated for 24 weeks than those treated for 48 weeks.
Croatian: Učinci na rast bili su manji u djece liječene 24 tjedna nego u one liječene 48 tjedana.
English: This medicine stops the multiplication of many types of viruses, including hepatitis C virus.
Croatian: Ovaj lijek zaustavlja umnožavanje mnogih vrsta virusa, uključujući i virus hepatitisa C.
English: - If you have or develop severe kidney or liver problems, this treatment will be stopped.
Croatian: - Ako imate ili razvijete teške tegobe s bubrezima ili jetrom, ovo liječenje će se prekinuti.
English: Be sure to seek emergency care if you notice that you are becoming depressed or have suicidal thoughts or change in your behaviour.
Croatian: Obavezno potražite hitnu medicinsku pomoć ako primijetite da postajete depresivni ili razmišljate o samoubojstvu ili ako primijetite promjene u svom ponašanju.
English: Tell your doctor or pharmacist as soon as possible.
Croatian: Što prije obavijestite svog liječnika ili ljekarnika.
English: It is unknown whether the ribavirin that is contained in sperm will exert its potential teratogenic or genotoxic effects on the human embryo/foetus.
Croatian: Nije poznato hoće li ribavirin sadržan u spermi iskazati potencijalno teratogene ili genotoksične učinke na ljudski embrij/fetus.
English: No data are available in children below 3 years of age.
Croatian: Nema podataka o primjeni u djece u dobi do 3 godine
English: Laboratory values
Croatian: Laboratorijske vrijednosti
English: Paediatric patients (children 3 years of age and older and adolescents)
Croatian: Pedijatrijski bolesnici (djeca u dobi od 3 ili više godina i adolescenti)
English: No ribavirin effects were observed regarding neurobehavioural or reproductive development.
Croatian: Nije bilo učinaka ribavirina na neurološki ili reproduktivni razvoj.
English: Do not chew the film-coated tablets.
Croatian: Nemojte žvakati filmom obložene tablete.
English: Potential to exacerbate immunosuppression
Croatian: Mogućnost pogoršanja imunosupresije
English: Upon discontinuation of dosing the half-life was approximately 298 hours, which probably reflects slow elimination from non-plasma compartments.
Croatian: Nakon prekida primjene poluvijek je iznosio oko 298 sati, vjerojatno zbog spore eliminacije iz neplazmatskih odjeljaka.
English: The study results are summarized in Table 9.
Croatian: Rezultati ispitivanja sažeto su prikazani u Tablici 9.
English: Growth rate decrease (height and/or weight decrease for age)
Croatian: usporen rast (smanjenje tjelesne visine i/ili težine za dob)
English: Although not all of these unwanted effects may occur, they may need medical attention if they do occur.
Croatian: Premda se sve ove nuspojave ne moraju pojaviti, ako se pojave, možda će Vam biti potrebna liječnička pomoć.
English: Long-term efficacy data
Croatian: Podaci o dugoročnoj djelotvornosti
English: Older people (≥ 65 years of age)
Croatian: Stariji (≥ 65 godina)
English: • Increased hormone related to your thyroid (TSH) in children and adolescents
Croatian: • povišene vrijednosti hormona povezanih s Vašom štitnjačom (TSH) u djece i adolescenata
English: These studies suggest that a carcinogenic potential of ribavirin in humans is unlikely.
Croatian: Ova ispitivanja ukazuju na to da kancerogeni potencijal ribavirina u ljudi nije vjerojatan.
English: Mitochondrial toxicity
Croatian: Mitohondrijska toksičnost
English: < 12 g/dL despite 4 weeks at reduced dose
Croatian: <12 g/dl unatoč 4-tjednom liječenju smanjenom dozom
English: These include:
Croatian: One uključuju:
English: Thus, patients who develop fatigue, somnolence, or confusion during treatment must be cautioned to avoid driving or operating machinery.
Croatian: Stoga se bolesnike u kojih se pojavi umor, somnolencija ili konfuzija tijekom liječenja mora upozoriti da izbjegavaju vožnju ili rukovanje strojevima.
English: Of these, sixty-three were sustained responders.
Croatian: Šezdeset i troje njih imalo je trajan virološki odgovor.
English: A dominant lethal assay in rats was negative, indicating that if mutations occurred in rats they were not transmitted through male gametes.
Croatian: Dominantni letalni test u štakora je bio negativan, što znači da se mutacije, ako su se dogodile u štakora, nisu prenijele preko gameta mužjaka.
English: Alternating doses, 200 mg and 400 mg every other day
Croatian: Naizmjenična primjena doze od 200 mg i 400 mg svaki drugi dan
English: This type of transporter is present on virtually all cell types and may account for the high volume of distribution of ribavirin.
Croatian: Ovaj tip prijenosnika prisutan je na gotovo svim tipovima stanica i može objasniti velik volumen distribucije ribavirina.
English: Ribavirin was active in the Balb/3T3 in vitro transformation assay.
Croatian: Ribavirin je bio aktivan u Balb/3T3 in vitro transformacijskom testu.
English: The decision to treat should be made on a case by case basis (see section 4.4).
Croatian: Odluku o liječenju potrebno je donijeti na osnovi pojedinačnih slučajeva (vidjeti dio 4.4).
English: Do not use this medicine after the expiry date which is stated on the outer packaging.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na vanjskom pakiranju.
English: The clinical relevance of results from this single dose study is unknown.
Croatian: Kliničko značenje rezultata ovog ispitivanja s primjenom jedne doze nije poznato.
English: 3 MIU/m2 3 times a week (n = 54)
Croatian: 3 MIU/m2 3 puta na tjedan (n=54)
English: 15 mg/kg/day as 2 divided doses (n = 17)
Croatian: 15 mg/kg/dan u 2 podijeljene doze (n=17)
English: > 4 mg/dL (adults)
Croatian: >4 mg/dl (odrasli)
English: Population pharmacokinetic analysis was performed using sparsely sampled serum concentration values from four controlled clinical trials.
Croatian: Populacijska farmakokinetička analiza učinjena je na temelju malog broja prikupljenih uzoraka vrijednosti serumskih koncentracija iz četiri kontrolirana klinička ispitivanja.
English: As in adult patients, children and adolescents also experienced other psychiatric adverse events (e.g., depression, emotional lability, and somnolence) (see section 4.4).
Croatian: Kao i odrasli bolesnici, djeca i adolescenti su imali i druge psihijatrijske nuspojave (npr. depresiju, emocionalnu labilnost i somnolenciju) (vidjeti dio 4.4).
English: Conventional carcinogenicity rodent studies with low exposures compared to human exposure under therapeutic conditions (factor 0.1 in rats and 1 in mice) did not reveal tumorigenicity of ribavirin.
Croatian: Konvencionalna ispitivanja kancerogenosti u glodavaca pri niskoj izloženosti u usporedbi s izloženošću ljudi u terapijskim uvjetima (faktor 0,1 u štakora i 1 u miševa) nisu pokazala tumorogeničnost ribavirina.
English: For males, clearance was approximately 20 % higher than for females.
Croatian: U muškaraca je klirens bio oko 20% viši nego u žena.
English: Homicidal ideation*, mania*, mental status change
Croatian: homicidalne misli*, manija*, promjena psihičkog stanja
English: Survival of foetuses and offspring was reduced.
Croatian: Preživljenje fetusa i potomaka bilo je smanjeno.
English: Study 11
Croatian: Ispitivanje 11
English: In all cases the treatment was for one year with a follow-up of six months.
Croatian: U svim slučajevima liječenje se provodilo tijekom godine dana, uz 6 mjeseci naknadnog praćenja.
English: 14 film-coated tablets 28 film-coated tablets 42 film-coated tablets 56 film-coated tablets 84 film-coated tablets 112 film-coated tablets 140 film-coated tablets 168 film-coated tablets
Croatian: 14 filmom obloženih tableta 28 filmom obloženih tableta 42 filmom obložene tablete 56 filmom obloženih tableta 84 filmom obložene tablete 112 filmom obloženih tableta 140 filmom obloženih tableta 168 filmom obloženih tableta
English: Bipolar disorder*
Croatian: bipolarni poremećaj*
English: Anaemia occurs shortly after initiation of dosing, but is rapidly reversible upon cessation of treatment.
Croatian: Anemija se razvija ubrzo nakon početka primjene, ali se brzo povlači nakon prekida liječenja.
English: There was no improvement in terms of fibrosis observed in this study.
Croatian: U ovom ispitivanju nije opaženo poboljšanje fibroze.
English: The decrease in CD4+ cell counts was reversible upon dose reduction or cessation of therapy.
Croatian: Smanjenje broja CD4+ stanica bilo je reverzibilno nakon smanjenja doze ili prestanka liječenja.
English: Haemoglobin Adult: ≥ 12 g/dL (females); ≥ 13 g/dL (males) Children and adolescents: ≥ 11 g/dL (females); ≥ 12 g/dL (males)
Croatian: Odrasli: ≥ 12 g/dl (žene); ≥ 13 g/dl (muškarci) Djeca i adolescenti: ≥ 11 g/dl (djevojčice); ≥ 12 g/dl (dječaci)
English: Do not take Ribavirin Teva Pharma B.V. if any of the following apply to you or the child you are caring for.
Croatian: Nemojte uzimati Ribavirin Teva Pharma B.V. ako se bilo što od navedenog odnosi na Vas ili dijete o kojem skrbite.
English: At the end of the recovery period, tibial and femoral changes were minimal although generally statistically significant compared to controls in males at all dose levels and in females dosed with the two highest doses compared to controls.
Croatian: Na kraju razdoblja oporavka tibijalne i femoralne promjene bile su minimalne, premda u pravilu statistički značajne u odnosu na kontrole, pri svim primijenjenim dozama u mužjaka te pri dvije najviše doze u ženki.
English: Laboratory evaluations are to be conducted at weeks 2 and 4 of therapy, and periodically thereafter as clinically appropriate.
Croatian: Laboratorijske pretrage moraju se napraviti u 2. i 4. tjednu liječenja, a nakon toga periodički, prema kliničkoj procjeni.
English: Hepatotoxicity (including fatalities)*
Croatian: hepatotoksičnost (uključujući smrtne ishode)*
English: Haemoglobin in patients with No Cardiac Disease
Croatian: Hemoglobin u bolesnika bez srčane bolesti
English: Seizure (convulsion)*
Croatian: napadaji (konvulzije)*
English: Adding treatment with alfa interferons alone or in combination with ribavirin may increase the risk in this patient subset.
Croatian: Dodavanje liječenja alfa interferonom samim ili u kombinaciji s ribavirinom može povećati rizik u ovoj podskupini bolesnika.
English: Ribavirin accumulates intracellularly and is cleared from the body very slowly.
Croatian: Ribavirin se nakuplja unutar stanica i vrlo sporo se uklanja iz organizma.
English: In the cases in which no specific dose recommendation is made, the following dose should be used: Patient weight: < 75 kg =1,000 mg and > 75 kg = 1,200 mg.
Croatian: U slučajevima kada nema posebnih preporuka za doziranje, treba primijeniti sljedeću dozu: Tjelesna težina bolesnika: <75 kg=1000 mg, a >75 kg=1200 mg.
English: Dose modifications were required in 30 % of patients, most commonly for anaemia and neutropenia.
Croatian: Prilagodba doze bila je potrebna u 30% bolesnika, najčešće zbog anemije i neutropenije.
English: Pulmonary infiltrates*, pneumonitis*, interstitial pneumonitis*
Croatian: plućni infiltrati*, pneumonitis*, intersticijski pneumonitis*
English: Reminder: This medicine is only to be used in combination with other medicines for hepatitis C virus infection.
Croatian: Podsjetnik: Ovaj lijek se koristi u kombinaciji s drugim lijekovima za liječenje infekcije virusom hepatitisa C.
English: Adults:
Croatian: Odrasli:
English: The other ingredients are
Croatian: Drugi sastojci su:
English: Additionally, 98 % (51/52) with normal ALT levels at follow-up week 24 maintained normal ALT levels at their last visit.
Croatian: Nadalje, 98% bolesnika (51/52) s normalnim razinama ALT-a u 24. tjednu praćenja održalo je normalne razine ALT-a na zadnjoj posjeti.
English: There are no data in children or adolescents with a history of cardiac disease.
Croatian: Nema podataka u djece ili adolescenata sa srčanom bolešću u anamnezi.
English: Men whose partners are pregnant must be instructed to use a condom to minimise delivery of ribavirin to the partner.
Croatian: Muškarce čije su partnerice trudne mora se uputiti da koriste kondom kako bi se prijenos ribavirina u tijelo partnerice smanjio na najmanju moguću mjeru.
English: Use of nucleoside analogs, alone or in combination with other nucleosides, has resulted in lactic acidosis.
Croatian: Primjena analoga nukleozida, samih ili u kombinaciji s drugim nukleozidima, izazvala je laktacidozu.
English: The clearance model developed showed that body weight, gender, age, and serum creatinine were the main covariates.
Croatian: Dobiveni model klirensa pokazao je da su tjelesna težina, spol, dob i serumski kreatinin bile glavne kovarijable.
English: Standard blood tests will be taken to check your blood, kidney and liver function.
Croatian: Standardnim pretragama krvi provjerit će se krvna slika, funkcija bubrega i jetre.
English: Treatment should be initiated, and monitored, by a physician experienced in the management of chronic hepatitis C.
Croatian: Liječenje mora započeti i nadzirati liječnik s iskustvom u liječenju kroničnog hepatitisa C.
English: Effects of these covariates on ribavirin clearance appear to be of limited clinical significance due to the substantial residual variability not accounted for by the model.
Croatian: Čini se da učinci ovih kovarijabli na klirens ribavirina imaju ograničen klinički značaj zbog znatne rezidualne varijabilnosti koju model nije objasnio.
English: Final adult height was available for 14 of those children and demonstrated that 12 continued to show height deficits > 15 percentiles, 10 to 12 years after the end of treatment.
Croatian: Konačna visina u odrasloj dobi bila je dostupna za 14 navedene djece te se pokazalo da njih 12 i dalje ima deficite rasta za >15 percentila, 10 do 12 godina nakon završetka liječenja.
English: Neoplasm unspecified
Croatian: nespecificirane novotvorine
English: HCV Genotype
Croatian: HCV genotip
English: Women of childbearing potential/contraception in males and females
Croatian: Žene reproduktivne dobi/kontracepcija u muškaraca i žena
English: Cardiac arrhythmias (primarily supraventricular) usually respond to conventional therapy but may require discontinuation of therapy.
Croatian: Srčane aritmije (prvenstveno supraventrikularne) obično dobro reagiraju na standardnu terapiju, ali mogu zahtijevati prekid terapije.
English: - Breast-feeding - History of severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease, in the previous six months (see section 4.4).
Croatian: - Dojenje - Teška srčana bolest u anamnezi, uključujući nestabilnu ili nekontroliranu srčanu bolest u prethodnih 6 mjeseci (vidjeti dio 4.4).
English: A total of 118 patients were enrolled: 57 % male, 80 % Caucasian, and 78 % genotype 1, 64 % ≤ 12 years of age.
Croatian: U ispitivanje je ukupno uključeno 118 bolesnika: 57% muškaraca, 80% bijelaca i 78% s genotopinom 1 te 64 % ≤12 godina.
English: Discontinue breastfeeding before starting to take this medicine.
Croatian: Prekinite dojenje prije početka uzimanja ovog lijeka.
English: Sarcoidosis*, rheumatoid arthritis (new or aggravated)
Croatian: sarkoidoza*, reumatoidni artritis (novootkriveni ili pogoršanje)
English: These doses in animals produce systemic exposures well below those achieved in humans at therapeutic doses.
Croatian: Ove doze u životinja dovode do sustavne izloženosti znatno manje od one koja se postiže pri terapijskim dozama u ljudi.
English: This medicinal product requires no special storage conditions.
Croatian: Ovaj lijek ne zahtijeva posebne uvjete čuvanja.
English: Ribavirin concentration in seminal fluid is approximately two-fold higher compared to serum.
Croatian: Koncentracija ribavirina u sjemenoj tekućini je približno dva puta veća u usporedbi s koncentracijom u serumu.
English: Nucleoside analogues
Croatian: Analozi nukleozida
English: Genotype 1
Croatian: Genotip 1
English: This would be particularly important in patients with a known history of zidovudine induced anaemia.
Croatian: To je osobito važno u bolesnika koji u anamnezi imaju anemiju uzrokovanu zidovudinom.
English: Steatosis was significantly improved in patients infected with HCV Genotype 3.
Croatian: Steatoza se značajno poboljšala u bolesnika inficiranih genotipom 3 HCV-a.
English: Discontinue ribavirin if:
Croatian: Prekinuti primjenu ribavirina ako je:
English: The selection of ribavirin formulation is based on individual characteristics of the patient.
Croatian: Odabir formulacije ribavirina ovisi o osobinama pojedinog bolesnika.
English: Ribavirin plus interferon
Croatian: Ribavirin uz interferon
English: Ribavirin is a synthetic nucleoside analogue which has shown in vitro activity against some RNA and DNA viruses.
Croatian: Ribavirin je sintetski analog nukleozida koji je pokazao aktivnost in vitro protiv nekih RNK i DNK virusa.
English: Acceptable baseline values that may be considered as a guideline prior to initiation of ribavirin therapy:
Croatian: Prihvatljive početne vrijednosti koje se mogu koristiti kao smjernice prije početka liječenja ribavirinom su:
English: This medicine does not effect your ability to drive or use machines; however, other medicines used in combination with Ribavirin Teva Pharma B.V. may cause sleepiness, tiredness or confusion.
Croatian: Ovaj lijek ne utječe na sposobnost upravljanja vozilima ili strojevima; međutim, drugi lijekovi koji se primjenjuju u kombinaciji s lijekom Ribavirin Teva Pharma B.V. mogu uzrokovati pospanost, umor ili smetenost.
English: This activity could potentiate the risk of lactic acidosis induced by purine nucleoside analogs (e.g. didanosine or abacavir).
Croatian: Takvo djelovanje može povećati rizik od nastanka laktacidoze prouzročene analozima purinskih nukleozida (npr. didanozinom ili abakavirom).
English: Tmax (hr) Cmax (ng/mL) AUC* Apparent clearance L/hr/kg
Croatian: Tmax (h) Cmax (ng/ml) AUC* Prividni klirens l/h/kg
English: The salient safety issue of ribavirin is haemolytic anaemia occurring within the first weeks of therapy.
Croatian: Najistaknutiji sigurnosni problem povezan s primjenom ribavirina je hemolitička anemija, koja se javlja tijekom prvih tjedana liječenja.
English: The major treatment-related change was a reversible mild to moderate anaemia, the severity of which was greater than that produced by either active substance alone.
Croatian: Glavna promjena povezana s liječenjem bila je reverzibilna blaga do umjerena anemija, čija je težina bila veća od one izazvane svakom od tih djelatnih tvari posebno.
English: Dosing for children above 3 years of age and adolescents depends on how much the person weighs and the medicines that are used in combination.
Croatian: Doziranje u djece starije od 3 godine i adolescenata ovisi o tjelesnoj težini bolesnika i lijekovima koji se uzimaju u kombinaciji.
English: Extreme care must be taken to avoid pregnancy in female patients (see section 5.3).
Croatian: Potrebno je strogo paziti da se izbjegne trudnoća u bolesnica (vidjeti dio 5.3).
English: Stevens Johnson syndrome*, toxic epidermal necrolysis*, erythema multiforme*
Croatian: Stevens-Johnsonov sindrom*, toksična epidermalna nekroliza*, multiformni eritem*
English: Although data on approximately 300 prospectively followed pregnancies with paternal exposure to ribavirin have not shown an increased risk of malformation compared to the general population, nor any specific pattern of malformation, either male patients or their female partners of childbearing age must be advised to use an effective contraceptive during treatment with ribavirin and for seven months after treatment.
Croatian: Iako podaci prikupljeni prospektivnim praćenjem oko 300 trudnoća u kojima je otac primao ribavirin nisu pokazali povećan rizik od malformacija u usporedbi s općom populacijom niti ikakvu specifičnu vrstu malformacija, mora se savjetovati bolesnicima muškog spola ili njihovim partnericama u reproduktivnoj dobi da koriste djelotvornu kontracepciju tijekom liječenja ribavirinom i još sedam mjeseci nakon završetka liječenja.
English: In clinical trial C/I98-580, 1,530 naïve patients were treated for one year with one of the following combination regimens:
Croatian: U kliničkom ispitivanju C/I98-580 je 1530 bolesnika koji prethodno nisu bili liječeni liječeno godinu dana jednom od sljedećih kombinacija:
English: Genotoxicity studies have demonstrated that ribavirin does exert some genotoxic activity.
Croatian: Ispitivanja genotoksičnosti pokazala su da ribavirin ima određeno genotoksično djelovanje.
English: Ribavirin dose (mg/kg)
Croatian: Doza ribavirina (mg/kg)
English: Ribavirin transport in non-plasma compartments has been most extensively studied in red cells, and has been identified to be primarily via an es-type equilibrative nucleoside transporter.
Croatian: Prijenos ribavirina u neplazmatske odjeljke najviše se istraživao na crvenim krvnim stanicama te je utvrđeno da se on odvija prvenstveno putem ekvilibracijskog nukleozidnog prijenosnika es-tipa.
English: In terms of activity, about one-third of sustained responders showed improvement and none showed worsening.
Croatian: Što se tiče aktivnosti bolesti, do poboljšanja je došlo u približno jedne trećine, dok pogoršanje nije nastupilo niti u jednog bolesnika s trajnim odgovorom.
English: Decrease in mean height percentile at year 1 of long term follow-up was most prominent in prepubertal age children.
Croatian: Posječno smanjenje na percentilnoj krivulji rasta nakon godinu dana dugoročnog praćenja bilo je najizraženije u djece pretpubertetske dobi.
English: Abnormal behaviour, depressed mood, emotional disorder, fear, nightmare
Croatian: neuobičajeno ponašanje, depresivno raspoloženje, emocionalni poremećaj, strah, noćne more
English: Ribavirin must be used in combination with other medicinal products (see section 5.1).
Croatian: Ribavirin se mora primjenjivati u kombinaciji s drugim lijekovima (vidjeti dio 5.1).