FrancophonIA/ELRC3.0 huggingface dataset:
English: • A small number of people being treated with anti-epileptics such as pregabalin have had thoughts of harming or killing themselves.
Croatian: • Mali broj ljudi koji se liječe antiepileptičkim lijekovima kao što je pregabalin razmišljali su o samoozljeđivanju ili samoubojstvu.
English: The safety and efficacy in children and adolescents (under 18 years of age) has not been established and therefore, pregabalin should not be used in this age group.
Croatian: Djeca i adolescenti Sigurnost i djelotvornost u djece i adolescenata (mlađih od 18 godina) nisu ustanovljene te stoga pregabalin ne treba koristiti u ovoj dobnoj skupini.
English: * Total daily dose (mg/day) should be divided as indicated by dose regimen to provide mg/dose.
Croatian: * Ukupnu dnevnu dozu (mg/dan) treba podijeliti prema navedenom režimu doziranja kako bi se odredili miligrami po jednoj dozi.
English: In table 2 below all adverse reactions, which occurred at an incidence greater than placebo and in more than one patient, are listed by class and frequency: 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); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Croatian: U Tablici 2 u nastavku, sve nuspojave koje su se javile s većom incidencijom u odnosu na placebo i u više od jednog bolesnika popisane su prema organskim sustavima i učestalosti pojavljivanja: 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: Therefore, patients should be advised to exercise caution until they are familiar with the potential effects of the medicinal product.
Croatian: Stoga bolesnicima treba savjetovati da budu oprezni dok se ne upoznaju s mogućim učincima lijeka.
English: hard capsules regularly at the same time each day.
Croatian: Važno je da Pregabalin Zentiva k.s. tvrde kapsule uzimate redovito, svakoga dana u isto vrijeme.
English: In clinical trials up to 12 weeks for both peripheral and central neuropathic pain, a reduction in pain was seen by week 1 and was maintained throughout the treatment period.
Croatian: U kliničkim ispitivanjima u trajanju do 12 tjedana je i kod periferne i centralne neuropatske boli, smanjenje boli opaženo u prvom tjednu liječenja i održalo se tijekom cijelog trajanja liječenja.
English: • Pregabalin may cause blurring or loss of vision, or other changes in eyesight, many of which are temporary.
Croatian: • Pregabalin može uzrokovati zamagljen vid, gubitak vida ili druge promjene vida, od kojih su mnoge privremene.
English: The degree of dizziness, sleepiness and decreased concentration may be increased if pregabalin is taken together with medicinal products containing:
Croatian: Omaglica, pospanost i smanjenje koncentracije mogu se pojačati ako se pregabalin uzima zajedno s lijekovima koji sadrže:
English: • Hepatitis (inflammation of the liver).
Croatian: • hepatitis (upala jetre)
English: It is advised not to drink alcohol while taking Pregabalin Zentiva k.s..
Croatian: Preporučuje se da ne pijete alkohol dok uzimate Pregabalin Zentiva k.s.
English: should not be taken during pregnancy or when breast-feeding, unless you are told otherwise by your doctor.
Croatian: Pregabalin Zentiva k.s. se ne smije uzimati tijekom trudnoće ili dojenja, osim ako Vam liječnik nije rekao drugačije.
English: Population pharmacokinetic analysis showed that creatinine clearance was a significant covariate of pregabalin oral clearance, body weight was a significant covariate of pregabalin apparent oral volume of distribution, and these relationships were similar in paediatric and adult patients.
Croatian: Populacijska farmakokinetička analiza pokazala je da je klirens kreatinina bio značajna kovarijabla klirensa peroralno primijenjenog pregabalina, tjelesna težina bila je značajna kovarijabla prividnog volumena distribucije peroralno primijenjenog pregabalina, a ti su odnosi bili slični kod pedijatrijskih i odraslih bolesnika.
English: The safety and efficacy of pregabalin in children below the age of 12 years and in adolescents (12 - 17 years of age) have not been established.
Croatian: Pedijatrijska populacija Sigurnost i djelotvornost pregabalina u djece mlađe od 12 godina i adolescenata (12-17 godina) nisu ustanovljene.
English: Pregabalin may produce dizziness, sleepiness and decreased concentration.
Croatian: Pregabalin može izazvati omaglicu, pospanost i smanjenu koncentraciju.
English: There are no clinical data on the effects of pregabalin on female fertility.
Croatian: Nema kliničkih podataka o učincima pregabalina na plodnost žena.
English: SPECIAL STORAGE CONDITIONS Do not store above 30 °C.
Croatian: POSEBNE MJERE ČUVANJA Ne čuvati na temperaturi iznad 30°C.
English: The N- methylated derivative of pregabalin, the major metabolite of pregabalin found in urine, accounted for 0.9% of the dose.
Croatian: N-metilirani derivat pregabalina, glavni metabolit pregabalina ustanovljen u mokraći, činio je 0,9% doze.
English: • Heart rhythm disturbances, increased heart rate, low blood pressure, high blood pressure, changes in heartbeat, heart failure.
Croatian: • poremećaji srčanog ritma, ubrzani puls, nizak krvni tlak, visok krvni tlak, promjene otkucaja srca, zatajenje srca
English: There are no adequate data from the use of pregabalin in pregnant women.
Croatian: Nema odgovarajućih podataka o primjeni pregabalina u trudnica.
English: The adverse events observed in a pharmacokinetic and tolerability study that enrolled patients from 3 months to 16 years of age (n = 65) with partial onset seizures were similar to those observed in adults.
Croatian: Štetni događaji zapaženi u ispitivanju farmakokinetike i podnošljivosti koje je uključivalo bolesnike u dobi od 3 mjeseca do 16 godina (n=65) s parcijalnim napadajima bili su slični onima zapaženima u odraslih.
English: The pregabalin clinical programme involved over 8,900 patients exposed to pregabalin, of whom over 5,600 were in double-blind placebo controlled trials.
Croatian: Kliničkim programom ispitivanja pregabalina obuhvaćeno je više od 8900 bolesnika izloženih pregabalinu, od kojih je više od 5600 bilo uključeno u dvostruko slijepa, placebom kontrolirana ispitivanja.
English: The efficacy and safety of pregabalin as adjunctive treatment for epilepsy in paediatric patients below the age of 12 and adolescents has not been established.
Croatian: Pedijatrijska populacija Djelotvornost i sigurnost pregabalina kao dodatne terapije za epilepsiju u pedijatrijskih bolesnika mlađih od 12 godina i adolescenata nisu ustanovljene.
English: Pregabalin has been shown to cross the placenta in rats and is present in the milk of lactating rats.
Croatian: Pregabalin prolazi kroz placentu u štakora te je prisutan u mlijeku ženki štakora u laktaciji.
English: Do not use this medicine after the expiry date which is stated on the blister and carton after “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na blisteru i kutiji iza „Rok valjanosti“ ili „EXP“.
English: • When pregabalin is taken with other medicines that may cause constipation (such as some types of pain medicines) it is possible that gastrointestinal problems may occur (e.g. constipation, blocked or paralysed bowel).
Croatian: • Kada se pregabalin uzima s drugim lijekovima koji mogu uzrokovati zatvor (kao što su neke vrste lijekova protiv bolova), moguće je da se pojave probavne tegobe (primjerice zatvor, blokada ili paraliza crijeva).
English: This decrease in pregabalin oral clearance is consistent with decreases in creatinine clearance associated with increasing age.
Croatian: To smanjenje klirensa peroralno primijenjenog pregabalina u skladu je sa smanjenjem klirensa kreatinina povezanim s rastućom dobi.
English: • Pregabalin has been associated with dizziness and somnolence, which could increase the occurrence of accidental injury (fall) in elderly patients.
Croatian: • Liječenje pregabalinom povezuje se s pojavom omaglice i pospanosti, što može povećati broj slučajnih ozljeda (padova) u starijih bolesnika.
English: In repeated dose toxicity studies in rats and monkeys CNS effects were observed, including hypoactivity, hyperactivity and ataxia.
Croatian: U ispitivanjima toksičnosti ponovljenih doza na štakorima i majmunima opaženi su učinci na SŽS, uključujući hipoaktivnost, hiperaktivnost i ataksiju.
English: and certain other medicines may influence each other (interaction).
Croatian: Pregabalin Zentiva k.s. i neki drugi lijekovi mogu djelovati jedni na druge (interakcija).
English: Treatment of pregabalin overdose should include general supportive measures and may include haemodialysis if necessary (see section 4.2 table 1).
Croatian: Liječenje predoziranja pregabalinom mora obuhvatiti opće potporne mjere, a po potrebi može uključivati i hemodijalizu (vidjeti dio 4.2, Tablica 1).
English: If you are an elderly patient (over 65 years of age), you should take Pregabalin Zentiva k.s.
Croatian: Ako ste bolesnik u starijoj dobi (iznad 65 godina), Pregabalin Zentiva k.s. trebate uzimati normalno, osim ako imate problema s bubrezima.
English: contains lactose monohydrate If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Croatian: Pregabalin Zentiva k.s. sadrži laktozu hidrat Ako Vam je liječnik rekao da ne podnosite neke šećere, obratite se liječniku prije uzimanja ovog lijeka.
English: 25 mg hard capsules are packed into alu/alu (OPA/alu/PVC/alu) blisters as primary packaging.
Croatian: Pregabalin Zentiva k.s. 25 mg tvrde kapsule zapakirane su u alu/alu (OPA/alu/PVC/alu) blistere kao primarno pakiranje.
English: Concerning discontinuation of long-term treatment of pregabalin, data suggest that the incidence and severity of withdrawal symptoms may be dose-related.
Croatian: Što se tiče prekida dugotrajnog liječenja pregabalinom, podaci upućuju na to da incidencija i težina simptoma ustezanja mogu biti povezani s dozom.
English: The other ingredients are lactose monohydrate, pregelatinized maize starch, talc, titanium dioxide (E171), gelatin, shellac, black iron oxide (E172).
Croatian: Drugi sastojci su: laktoza hidrat, prethodno geliran kukuruzni škrob, talk, titanijev dioksid (E171), želatina, šelak, crni željezov oksid (E172).
English: than you should Call your doctor or go to the nearest hospital emergency unit immediately.
Croatian: Ako uzmete više lijeka Pregabalin Zentiva k.s. nego što ste trebali Odmah nazovite svog liječnika ili otiđite u hitnu službu najbliže bolnice.
English: The most common adverse events observed in the 14-day study with pregabalin treatment were somnolence, upper respiratory tract infection, and pyrexia (see sections 4.2, 5.1 and 5.2).
Croatian: Najčešći štetni događaji opaženi u 14-dnevnom ispitivanju liječenja pregabalinom bili su somnolencija, infekcija gornjih dišnih puteva i pireksija (vidjeti dijelove 4.2, 5.1 i 5.2).
English: is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.
Croatian: Pregabalin Zentiva k.s. indiciran je kao dodatna terapija u odraslih osoba s parcijalnim napadajima, sa ili bez sekundarne generalizacije.
English: Pregabalin may cause dizziness and somnolence and therefore may influence the ability to drive or use machines.
Croatian: Pregabalin može izazvati omaglicu i somnolenciju te tako utjecati na sposobnost upravljanja vozilima ili rada sa strojevima.
English: is not intended to be used alone, but should always be used in combination with other anti-epileptic treatment.
Croatian: Pregabalin Zentiva k.s. nije namijenjen za samostalnu primjenu, nego se uvijek mora uzimati u kombinaciji s drugim antiepileptičkim lijekovima.
English: There have also been postmarketing reports of loss of consciousness, confusion and mental impairment.
Croatian: Nakon stavljanja lijeka u promet prijavljeni su i gubitak svijesti, konfuzija i slabljenje mentalnih sposobnosti.
English: • There have been reports of reduction in brain function (encephalopathy) in some patients taking pregabalin when they have other conditions.
Croatian: • Prijavljeno je smanjenje moždane funkcije (encefalopatija) u nekih bolesnika koji su uzimali pregabalin, a bolovali su i od drugih bolesti.
English: Pregabalin 14 mg/kg/day significantly reduced the log-transformed partial onset seizure frequency versus placebo (p=0.0223); pregabalin 7 mg/kg/day did not show improvement relative to placebo.
Croatian: Primjena pregabalina u dozi od 14 mg/kg na dan značajno je smanjila logaritamski transformiranu učestalost parcijalnih napadaja u odnosu na placebo (p=0,0223); primjena pregabalina u dozi od 7 mg/kg na dan nije dovela do poboljšanja u usporedbi s placebom.
English: After oral administration of pregabalin in paediatric patients in the fasted state, in general, time to reach peak plasma concentration was similar across the entire age group and occurred 0.5 hours to 2 hours postdose.
Croatian: Nakon peroralne primjene pregabalina u pedijatrijskih bolesnika natašte, vrijeme do postizanja vršne koncentracije u plazmi bilo je općenito slično u svim dobnim skupinama, a nastupilo je 0,5 do 2 sata nakon doze.
English: • Some patients with diabetes who gain weight while taking pregabalin may need an alteration in their diabetic medicines.
Croatian: • Nekim bolesnicima sa šećernom bolešću koji dobiju na težini dok uzimaju pregabalin možda će trebati promijeniti terapiju lijekovima protiv šećerne bolesti.
English: What you need to know before you take Pregabalin Zentiva k.s.
Croatian: Što morate znati prije nego počnete uzimati Pregabalin Zentiva k.s.
English: is used to treat a certain form of epilepsy (partial seizures with or without secondary generalisation) in adults.
Croatian: Pregabalin Zentiva k.s. se koristi za liječenje nekih oblika epilepsije (parcijalnih napadaja sa ili bez sekundarne generalizacije) u odraslih osoba.
English: Pregabalin has been studied in 6 controlled trials of 4 - 6 week duration, an elderly study of 8 week duration and a long-term relapse prevention study with a double blind relapse prevention phase of 6 months duration.
Croatian: Pregabalin je ispitivan u 6 kontroliranih ispitivanja u trajanju od 4-6 tjedana, u 8-tjednom ispitivanju u starijih osoba te u dugoročnom ispitivanju prevencije relapsa s dvostruko slijepom fazom prevencije relapsa u trajanju od 6 mjeseci.
English: As pregabalin clearance is directly proportional to creatinine clearance (see section 5.2), dose reduction in patients with compromised renal function must be individualised according to creatinine clearance (CLcr), as indicated in table 1 determined using the following formula.
Croatian: Budući da je klirens pregabalina upravo razmjeran klirensu kreatinina (vidjeti dio 5.2), u svakog pojedinog bolesnika s oslabljenom funkcijom bubrega doza se mora prilagoditi sukladno njegovu klirensu kreatinina (CLcr), kako je navedeno u Tablici 1, pomoću sljedeće formule:
English: may be taken with or without food.
Croatian: Pregabalin Zentiva k.s. može se uzimati s hranom ili bez nje.
English: The pregabalin safety profile observed in four paediatric studies in patients with partial seizures with or without secondary generalisation (12-week efficacy and safety study in patients 4 to 16 years of age, n = 295; 14-day efficacy and safety study in patients 1 month to younger than 4 years of age, n = 175; pharmacokinetic and tolerability study, n = 65; and 1 year open label follow on safety study, n = 54) was similar to that observed in the adult studies of patients with epilepsy.
Croatian: Sigurnosni profil pregabalina zabilježen u četiri pedijatrijska ispitivanja u bolesnika s parcijalnim napadajima sa sekundarnom generalizacijom ili bez nje (12-tjedno ispitivanje djelotvornosti i sigurnosti u bolesnika u dobi od 4 do 16 godina, n=295, 14-dnevno ispitivanje djelotvornosti i sigurnosti u bolesnika u dobi od 1 mjeseca do manje od 4 godine, n=175, ispitivanje farmakokinetike i podnošljivosti, n=65 i jednogodišnje otvoreno ispitivanje praćenja sigurnosti, n=54) bio je sličan onome zapaženom u ispitivanjima u odraslih bolesnika s epilepsijom.
English: is and what it is used for What you need to know before you take Pregabalin Zentiva k.s.
Croatian: Što je Pregabalin Zentiva k.s. i za što se koristi Što morate znati prije nego počnete uzimati Pregabalin Zentiva k.s.
English: Median 24-hour seizure frequencies at baseline and at the final visit were 4.7 and 3.8 for pregabalin 7 mg/kg/day, 5.4 and 1.4 for pregabalin 14 mg/kg/day, and 2.9 and 2.3 for placebo, respectively.
Croatian: Medijan učestalosti napadaja tijekom 24 sata na početku ispitivanja i pri zadnjem posjetu iznosio je 4,7 i 3,8 za pregabalin u dozi od 7 mg/kg na dan, 5,4 i 1,4 za pregabalin u dozi od 14 mg/kg na dan te 2,9 i 2,3 za placebo.
English: • oxycodone (used as a pain-killer).
Croatian: • oksikodon (koristi se protiv bolova)
English: In preclinical studies, there was no indication of racemisation of pregabalin S-enantiomer to the R-enantiomer.
Croatian: U nekliničkim istraživanjima nije bilo znakova racemizacije S-enantiomera pregabalina u
English: Stevens-Johnson syndrome, cold sweat Musculoskeletal and connective tissue disorders Common
Croatian: Stevens-Johnsonov sindrom, hladan znoj
English: Pregabalin may have minor or moderate influence on the ability to drive and use machines.
Croatian: Pregabalin može malo ili umjereno utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
English: When taken with certain other medicines, pregabalin may potentiate the side effects seen with these medicines, including respiratory failure and coma.
Croatian: Kada se uzima s nekim drugim lijekovima, pregabalin može pojačati nuspojave tih lijekova, uključujući zatajenje disanja i komu.
English: Results of a 12-week placebo controlled study of 295 paediatric patients aged 4 to 16 years and a 14-day placebo-controlled study of 175 paediatric patients aged 1 month to younger than 4 years of age performed to evaluate the efficacy and safety of pregabalin as adjunctive therapy for the treatment of partial onset seizures and a 1 year open label safety study in 54 paediatric patients from 3 months to 16 years of age with epilepsy indicate that the adverse events of pyrexia and upper respiratory infections were observed more frequently than in adult studies of patients with epilepsy (see sections 4.2, 4.8 and 5.2).
Croatian: godina i 14-dnevnog placebom kontroliranog ispitivanja koje je provedeno u 175 pedijatrijskih bolesnika u dobi od 1 mjeseca do manje od 4 godine radi procjene djelotvornosti i sigurnosti pregabalina kao dodatne terapije za liječenje parcijalnih napadaja i jednogodišnjeg otvorenog ispitivanja sigurnosti u 54 pedijatrijska bolesnika u dobi od 3 mjeseca do 16 godina s epilepsijom ukazuju na to da su štetni događaji pireksija i infekcija gornjih dišnih putova zabilježeni češće nego u ispitivanjima u odraslih bolesnika s epilepsijom (vidjeti dijelove 4.2, 4.8 i 5.2).
English: Talk to your doctor or pharmacist before taking Pregabalin Zentiva k.s.
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku ili ljekarniku prije nego uzmete Pregabalin Zentiva k.s.
English: The 50 mg capsules also contain propylene glycol, strong ammonia solution, potassium hydroxide.
Croatian: Kapsule od 50 mg sadrže i propilenglikol, jaku otopinu amonijaka, kalijev hidroksid.
English: you notice decreased urination, you should tell your doctor as stopping the medicine may improve this.
Croatian: Ako tijekom uzimanja lijeka Pregabalin Zentiva k.s. primijetite da manje mokrite, morate o tome obavijestiti svog liječnika jer se prekidom primjene lijeka to može poboljšati.
English: Because renal elimination is the major elimination pathway, dose reduction in patients with renal impairment and dose supplementation following haemodialysis is necessary (see section 4.2 table 1).
Croatian: Budući da je eliminacija putem bubrega glavni put eliminacije, bolesnicima s oštećenjem bubrega potrebno je smanjiti dozu te dati dopunsku dozu nakon hemodijalize (vidjeti dio 4.2, Tablica 1).
English: The most common adverse events observed in the 12-week study with pregabalin treatment were somnolence, pyrexia, upper respiratory tract infection, increased appetite, weight increased, and nasopharyngitis.
Croatian: Najčešći štetni događaji zabilježeni u 12-tjednom ispitivanju liječenja pregabalinom bili su somnolencija, pireksija, infekcija gornjih dišnih putova, povećani apetit, povećanje tjelesne težine i nazofaringitis.
English: In the 14-day placebo-controlled study, paediatric patients (1 month to younger than 4 years of age) were assigned to pregabalin 7 mg/kg/day, pregabalin 14 mg/kg/day, or placebo.
Croatian: U 14-dnevnom placebom kontroliranom ispitivanju pedijatrijski su bolesnici (u dobi od 1 mjeseca do manje od 4 godine) dobivali pregabalin u dozi od 7 mg/kg na dan, pregabalin u dozi od 14 mg/kg na dan ili placebo.
English: * Alanine aminotransferase increased (ALT) and aspartate aminotransferase increased (AST).
Croatian: Rijetko smanjenje broja bijelih krvnih stanica *povećanje alanin aminotransferaze (ALT) i aspartat aminotransferaze (AST).
English: In the clinical studies where ophthalmologic testing was conducted, the incidence of visual acuity reduction and visual field changes was greater in pregabalin-treated patients than in placebo-treated patients; the incidence of fundoscopic changes was greater in placebo-treated patients (see section
Croatian: U kliničkim ispitivanjima u kojima su provedene oftalmološke pretrage, smanjenje oštrine vida i promjene vidnog polja javljali su se s većom incidencijom u bolesnika liječenih pregabalinom nego u bolesnika koji su primali placebo; incidencija promjena očne pozadine bila je veća u bolesnika koji su primali placebo (vidjeti dio 5.1).
English: is indicated for the treatment of peripheral and central neuropathic pain in adults.
Croatian: Pregabalin Zentiva k.s. indiciran je za liječenje periferne i centralne neuropatske boli u odraslih osoba.
English: Shellac
Croatian: • šelak
English: is used to treat long lasting pain caused by damage to the nerves.
Croatian: Pregabalin Zentiva k.s. koristi se za liječenje dugotrajne boli uzrokovane oštećenjem živaca.
English: • There have been reports of heart failure in some patients when taking pregabalin; these patients were mostly elderly with cardiovascular conditions.
Croatian: • U nekih je bolesnika pri uzimanju pregabalina prijavljeno zatajenje srca; radilo se uglavnom o starijim bolesnicima s postojećim bolestima srca i krvožilja.
English: In controlled clinical trials (4 - 8 week duration) 52% of the pregabalin treated patients and 38% of the patients on placebo had at least a 50% improvement in HAM-A total score from baseline to endpoint.
Croatian: U kontroliranim kliničkim ispitivanjima (u trajanju od 4-8 tjedana), u 52% bolesnika liječenih pregabalinom te 38% bolesnika koji su primali placebo je na kraju ispitivanja zabilježeno najmanje 50%-tno poboljšanje ukupnog rezultata na HAM-A ljestvici u odnosu na početne vrijednosti.
English: Pregabalin has been studied in 10 controlled clinical trials of up to 13 weeks with twice a day dosing (BID) and up to 8 weeks with three times a day (TID) dosing.
Croatian: Pregabalin je ispitan u 10 kontroliranih kliničkih ispitivanja u trajanju do 13 tjedana s režimom doziranja dva puta na dan, odnosno u trajanju do 8 tjedana s režimom doziranja tri puta na dan.
English: Other medicines and Pregabalin Zentiva k.s.
Croatian: Drugi lijekovi i Pregabalin Zentiva k.s.
English: After discontinuation of short-term and long-term treatment with pregabalin withdrawal symptoms have been observed in some patients.
Croatian: Nakon prekida kratkotrajnog i dugotrajnog liječenja pregabalinom, u nekih su bolesnika opaženi simptomi ustezanja.
English: • if you are allergic to pregabalin or any of the other ingredients of this medicine (listed in section
Croatian: Nemojte uzimati Pregabalin Zentiva k.s. • ako ste alergični na pregabalin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)