FrancophonIA/ELRC3.0 huggingface dataset:
English: Duration of treatment
Croatian: NAČIN PRIMJENE LIJEKA
English: Zyclara should be left on the skin for approximately 8 hours; after this time it is essential that the cream is removed by washing the area and the hands with mild soap and water.
Croatian: Nakon tog vremena važno je ukloniti kremu pranjem liječenog područja i ruku blagim sapunom i vodom.
English: Zyclara 3.75% cream Imiquimod Cutaneous use
Croatian: Zyclara 3,75% krema imikvimod Za primjenu na koži
English: Lymphadenopathy
Croatian: - proljev
English: Some systemic adverse reactions, including headache 6% (10/160), fatigue 4% (7/160), were reported by Zyclara treated patients in clinical trials.
Croatian: U kliničkim ispitivanjima bolesnici liječeni Zyclarom prijavili su neke sistemske nuspojave uključujući glavobolju 6% (10/160) i umor
English: Inflammation
Croatian: Dojenje
English: After about 8 hours, wash the area where Zyclara was applied with mild soap and water.
Croatian: Nakon otprilike 8 sati, operite područje na koje je
English: Chaussée de la Hulpe 166 Terhulpsesteenweg 1170 Brussels
Croatian: Meda Pharma S.A./N.V. Chaussée de la Hulpe 166 Terhulpsesteenweg 1170 Brussels Tél/Tel: +32 (0)2 5 04 08 11
English: Common (may affect up to 1 in 10 people) - Further reactions at the application site e.g. skin inflammation, itching, pain, burning, irritation,
Croatian: - daljnje reakcije na mjestu primjene npr. upala kože, svrbež, bol, pečenje, iritacija i osip - otečene žlijezde
English: Application site dermatitis Application site bleeding Application site papules Application site paraesthesia Application site hyperaesthesia Application site inflammation Application site scar Application site skin breakdown Application site vesicles Application site warmth Asthenia
Croatian: Nuspojave edem na mjestu primjene vrijed na mjestu primjene iscjedak na mjestu primjene često reakcija na mjestu primjene svrbež na mjestu primjene bol na mjestu primjene oticanje na mjestu primjene pečenje na mjestu primjene iritacija na mjestu primjene osip na mjestu primjene umor vrućica bolest slična gripi bol bol u prsnom košu manje često dermatitis na mjestu primjene krvarenje na mjestu primjene papule na mjestu primjene parestezija na mjestu primjene hiperestezija na mjestu primjene upala na mjestu primjene ožiljak na mjestu primjene pucanje kože na mjestu primjene mjehurići na mjestu primjene toplina na mjestu primjene astenija zimica letargija nelagoda upala
English: Back pain Pain in extremity
Croatian: - bol u leđima
English: Remote site dermatologic reactions
Croatian: Kožne reakcije na udaljenom mjestu
English: Immune system disorders
Croatian: Poremećaji imunološkog sustava rijetko egzacerbacija autoimunih stanja
English: The recommended dose is one tablet, twice a day.
Croatian: Preporučena doza je jedna tableta, dva puta na dan.
English: In this study the majority of patients had a vital capacity less than 60%.
Croatian: U ovom je ispitivanju većina bolesnika imala vitalni kapacitet manji od 60%.
English: No significant increased benefit can be expected from higher daily doses.
Croatian: Ne može se očekivati značajno veća korist od primjene većih dnevnih doza.
English: Tell your doctor if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ako uzimate, nedavno ste uzimali ili biste mogli uzeti bilo koje druge lijekove.
English: The tablets should be taken by mouth, every 12 hours, at the same time of the day each day (e.g. in the morning and evening).
Croatian: Tablete se uzimaju kroz usta svakih 12 sati, u isto doba svakoga dana (npr. ujutro i navečer).
English: However, the power of this study to detect differences between treatment groups was low.
Croatian: Međutim, snaga ovog ispitivanja da otkrije razlike između terapijskih skupina bila je mala.
English: See sections 4.3, 4.4 and 5.2
Croatian: Vidjeti dijelove 4.3, 4.4 i 5.2.
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Croatian: Kao i svi drugi lijekovi, ovaj lijek može uzrokovati nuspojave, iako se one neće javiti kod svakoga.
English: The clinical significance of these results is not known.
Croatian: Klinički značaj ovih nalaza nije poznat.
English: The volume of distribution of riluzole is about 245 ± 69 L (3.4 L/kg).
Croatian: Volumen distribucije riluzola iznosi oko 245 ± 69 l (3,4 l/kg).
English: ALT should be measured every month during the first 3 months of treatment, every 3 months during the remainder of the first year, and periodically thereafter.
Croatian: ALT treba određivati svaki mjesec tijekom prva 3 mjeseca liječenja, svaka 3 mjeseca do kraja prve godine liječenja te periodički nakon toga.
English: The mode of action is unclear.
Croatian: Mehanizam djelovanja nije jasan.
English: The elimination half-life ranges from 9 to 15 hours.
Croatian: Poluvrijeme eliminacije kreće se u rasponu od 9 do 15 sati.
English: If you forget to take your tablet, leave out that dose completely and take the next tablet at the usual time.
Croatian: Ako ste zaboravili uzeti tabletu, preskočite tu dozu i uzmite sljedeću tabletu u uobičajeno vrijeme.
English: Sanofi Winthrop Industrie 56, Route de Choisy au Bac 60205 Compiègne France
Croatian: Sanofi Winthrop Industrie 56, Route de Choisy au Bac 60205 Compiègne Francuska
English: About 90% of the dose is absorbed and the absolute bioavailability is 60 ± 18%.
Croatian: Približno 90% doze se apsorbira, a apsolutna bioraspoloživost iznosi 60 ± 18%.
English: Your doctor may want to take a blood sample to check the number of white blood cells, which are important in fighting infections.
Croatian: Liječnik će možda htjeti uzeti uzorak krvi kako bi provjerio broj bijelih krvnih stanica koje su važne u borbi protiv infekcija.
English: This isolated finding was not noted in any other study or species.
Croatian: Ovaj izolirani nalaz nije zabilježen niti u jednom drugom ispitivanju i niti u jednoj drugoj životinjskoj vrsti.
English: If any of the above applies to you, or if you are not sure, tell your doctor who will decide what to do.
Croatian: Ako se nešto od navedenog odnosi na Vas ili niste sigurni, obavijestite svog liječnika koji će odlučiti što učiniti.
English: If you think you may be pregnant, or if you intend to breast-feed, ask your doctor for advice before taking Riluzole Zentiva.
Croatian: Ako mislite da ste trudni ili namjeravate dojiti, obratite se svom liječniku za savjet prije nego uzmete Riluzole Zentiva.
English: You MUST NOT take Riluzole Zentiva if you are or think you may be pregnant, or if you are breast-feeding.
Croatian: NE SMIJETE uzimati Riluzole Zentiva ako ste trudni, mislite da ste trudni ili dojite.
English: These increases could be associated with jaundice.
Croatian: Ovo povišenje vrijednosti moglo bi biti povezano sa žuticom.
English: Readministration of riluzole to patients in this situation cannot be recommended.
Croatian: Ne može se preporučiti ponovna primjena riluzola bolesnicima u ovoj situaciji.
English: Riluzole did not show any carcinogenicity potential in either rats or mice.
Croatian: Riluzol nije pokazao kancerogeni potencijal niti u štakora niti u miševa.
English: Riluzole Zentiva has not been shown to be effective in the late stages of ALS.
Croatian: Riluzole Zentiva se nije pokazao djelotvornim u kasnim fazama ALS-a.
English: Glucuronides accounted for more than 85% of the metabolites in the urine.
Croatian: Glukuronidi čine više od 85% metabolita u mokraći.
English: U kabelovny 130 102 37 Prague 10 Czech Republic
Croatian: U kabelovny 130 102 37 Prague 10
English: The recommended daily dose in adults or older people is 100 mg (50 mg every 12 hours).
Croatian: Doziranje Preporučena dnevna doza u odraslih ili starijih osoba iznosi 100 mg (50 mg svakih 12 sati).
English: You can drive or use any tools or machines, unless you feel dizzy or light headed after taking this medicine.
Croatian: Možete voziti i rukovati alatima ili strojevima, osim ako osjećate omaglicu ili ošamućenost nakon uzimanja ovog lijeka.
English: Standard tests for genotoxicity performed with riluzole were negative.
Croatian: Standardni testovi genotoksičnosti provedeni s riluzolom bili su negativni.
English: If you take too many tablets, contact your doctor or the nearest hospital emergency department immediately.
Croatian: Ako uzmete previše tableta, odmah se javite svom liječniku ili otiđite u hitnu službu najbliže bolnice.
English: Based on pharmacokinetic data, there are no special instructions for the use of Riluzole Zentiva in this population.
Croatian: Na temelju farmakokinetičkih podataka nema posebnih uputa za primjenu lijeka Riluzole Zentiva u ovoj populaciji.
English: Pharmacotherapeutic group: other nervous system drugs, ATC code: N07XX02.
Croatian: Farmakoterapijska skupina: ostali lijekovi koji djeluju na živčani sustav, ATK oznaka: N07XX02.
English: If you are less than 18 years of age, the use of Riluzole Zentiva is not recommended because there is no information available in this population.
Croatian: Ako ste mlađi od 18 godina, ne preporučuje se primjena lijeka Riluzole Zentiva jer nema podataka za tu populaciju.
English: On the basis of these data, and taking into consideration the negative studies on the carcinogenesis of riluzole in the mouse and rat, the genotoxic effect of this metabolite is not considered to be of relevance in humans.
Croatian: Na temelju tih podataka te uzimajući u obzir negativne rezultate ispitivanja kancerogenosti riluzola u miševa i štakora ne smatra se da je genotoksično djelovanje ovog metabolita važno za ljude.
English: Other medicines and Riluzole Zentiva
Croatian: Drugi lijekovi i Riluzole Zentiva
English: Riluzole is about 97% protein bound and it binds mainly to serum albumin and to lipoproteins.
Croatian: Približno 97% riluzola veže se za proteine, uglavnom za serumski albumin i lipoproteine.
English: The rate and extent of absorption is reduced when riluzole is administered with high-fat meals (decrease in Cmax of 44%, decrease in AUC of 17%).
Croatian: Brzina i stupanj apsorpcije smanjuju se kada se riluzol primjenjuje uz punomasne obroke (Cmax smanjen za 44%, AUC smanjen za 17%).
English: All these findings were noted at doses which were 2-10 times higher than the human dose of 100 mg/day.
Croatian: Svi su ovi nalazi zabilježeni pri dozama koje su 2-10 puta veće od doze za ljude od 100 mg na dan.
English: Although the pathogenesis of ALS is not completely elucidated, it is suggested that glutamate (the primary excitatory neurotransmitter in the central nervous system) plays a role for cell death in the disease.
Croatian: Iako patogeneza ALS-a nije u potpunosti rasvijetljena, smatra se da glutamat (primarni ekscitatorni neurotransmiter u središnjem živčanom sustavu) ima ulogu u odumiranju stanica u ovoj bolesti.
English: Patients should be warned to report any febrile illness to their physicians.
Croatian: Bolesnike treba upozoriti da svaku bolest praćenu vrućicom prijave svojim liječnicima.
English: In case of overdose, treatment is symptomatic and supportive.
Croatian: U slučaju predoziranja primjenjuje se simptomatsko i potporno liječenje.
English: In the majority of the reported cases, symptoms resolved after medicinal product discontinuation and symptomatic treatment.
Croatian: U većini prijavljenih slučajeva simptomi su se povukli nakon prekida uzimanja lijeka i simptomatskog liječenja.
English: D-65926 Frankfurt am Main Germany
Croatian: D-65926 Frankfurt na Majni
English: Intensive testing in seven other standard in vitro or in vivo assays did not show any genotoxic potential of the metabolite.
Croatian: Intenzivna ispitivanja sa sedam drugih standardnih testova in vitro ili in vivo nisu pokazala genotoksični potencijal metabolita.
English: Riluzole is rapidly absorbed after oral administration with maximal plasma concentrations occurring within 60 to 90 minutes (Cmax=173 ± 72 (sd) ng/ml).
Croatian: Riluzol se brzo apsorbira nakon oralne primjene, a maksimalne koncentracije u plazmi postižu se unutar 60 do 90 minuta (Cmax = 173 ± 72 (sd) ng/ml).
English: Tablets are packaged in opaque pvc/aluminium blister cards.
Croatian: Tablete su pakirane u neprozirne PVC/aluminij blister kartice.
English: Date of first authorisation: 07 May 2012 Date of latest renewal: {DD month YYYY}
Croatian: Datum prvog odobrenja: 7. svibnja 2012.
English: Patients should be warned about the potential for dizziness or vertigo, and advised not to drive or operate machinery if these symptoms occur.
Croatian: Bolesnike treba upozoriti na moguću pojavu omaglice ili vrtoglavice te im savjetovati da ne voze i ne rukuju strojevima ako se pojave ti simptomi.
English: This metabolite is rapidly glucuronoconjugated to O- and N-glucuronides.
Croatian: Taj se metabolit brzo konjugira u O-glukuronide i N-glukuronide.
English: Contents of the pack and other information What Riluzole Zentiva contains
Croatian: Sadržaj pakiranja i druge informacije Što Riluzole Zentiva sadrži
English: In rats, riluzole decreased the pregnancy rate and the number of implantations at exposure levels at least twice the systemic exposure of humans given clinical therapy.
Croatian: U štakora je riluzol smanjio stopu trudnoća i broj implantacija pri razinama izloženosti najmanje dva puta višima od sustavne izloženosti u ljudi tijekom kliničke primjene terapije.
English: if you experience cough or difficulties in breathing, as this may be a sign of lung disease (called interstitial lung disease).
Croatian: ako kašljete ili otežano dišete jer to može biti znak bolesti pluća (zvane intersticijska bolest pluća).
English: Severe neutropenia (see section 4.4)
Croatian: Teška neutropenija (vidjeti dio 4.4)
English: Study data indicate that Asian patients may be more susceptible to liver function test abnormalities3.2% (194/5995) of Asian patients and 1.8% (100/5641) of Caucasian patients.
Croatian: Podaci iz ispitivanja ukazuju na to da bolesnici azijskog podrijetla mogu biti skloniji poremećajima vrijednosti testova funkcije jetre - 3,2% (194/5995) bolesnika azijskog podrijetla i 1,8% (100/5641) bijelaca.
English: The metabolites identified in urine are three phenolic derivatives, one ureido-derivative and unchanged riluzole.
Croatian: Metaboliti pronađeni u mokraći obuhvaćaju tri fenolna derivata, jedan ureidni derivat i nepromijenjeni riluzol.
English: IMPORTANT Tell your doctor immediately if you experience any fever (increase in temperature) because Riluzole Zentiva may cause a decrease in the number of white blood cells.
Croatian: Odmah obavijestite svog liječnika ako dobijete vrućicu (povišenu temperaturu) jer Riluzole Zentiva može uzrokovati smanjenje broja bijelih krvnih stanica.
English: Each package contains 28, 56, 98, 112 or 168 tablets.
Croatian: Jedno pakiranje sadrži 28, 56, 98, 112 ili 168 tableta.
English: What Riluzole Zentiva is and what it is used for What you need to know before you take Riluzole Zentiva How to take Riluzole Zentiva Possible side effects
Croatian: Što je Riluzole Zentiva i za što se koristi Što morate znati prije nego počnete uzimati Riluzole Zentiva Kako uzimati Riluzole Zentiva
English: Plasma levels increase linearly with the dose and the pharmacokinetic profile is dose-independent.
Croatian: Razine u plazmi povećavaju se linearno s dozom, a farmakokinetički profil je neovisan o dozi.
English: 56 film-coated tablets 28 film-coated tablets 98 film-coated tablets 112 film-coated tablets 168 film-coated tablets
Croatian: 56 filmom obloženih tableta 28 filmom obloženih tableta 98 filmom obloženih tableta 112 filmom obloženih tableta 168 filmom obloženih tableta
English: Fertility studies in rats revealed slight impairment of reproductive performance and fertility at doses of 15 mg/kg/day (which is higher than the therapeutic dose), probably due to sedation and lethargy.
Croatian: Ispitivanja plodnosti na štakorima otkrila su blagi poremećaj reproduktivne sposobnosti i plodnosti pri dozama od 15 mg/kg na dan (što je više od terapijske doze), vjerojatno zbog sedacije i letargije.
English: There have been no clinical studies to evaluate the interactions of riluzole with other medicinal products.
Croatian: Nisu provedena klinička ispitivanja interakcija riluzola s drugim lijekovima.
English: Riluzole is eliminated mainly in the urine.
Croatian: Riluzol se uglavnom eliminira mokraćom.
English: Riluzole is extensively distributed throughout the body and has been shown to cross the blood brain barrier.
Croatian: Riluzol se široko raspodjeljuje po cijelom tijelu i prolazi kroz krvno-moždanu barijeru.
English: In dogs, haemolytic anaemia was observed.
Croatian: U pasa je opažena hemolitička anemija.
English: ALS is a form of motor neurone disease where attacks of the nerve cells responsible for sending instructions to the muscles lead to weakness, muscle waste and paralysis.
Croatian: ALS je jedan oblik bolesti motoričkih neurona koji napada živčane stanice odgovorne za slanje signala mišićima, što dovodi do slabosti, propadanja mišića i paralize.
English: Meta-analysis including this study and those described above showed a less striking effect on survival for riluzole as compared to placebo although the differences remained statistically significant.
Croatian: Meta-analiza u koju je uključeno ovo kao i ranije opisana ispitivanja nije pokazala toliko izrazit učinak riluzola na preživljenje u usporedbi s placebom, iako su razlike i dalje bile statistički značajne.
English: Survival was defined as patients who were alive, not intubated for mechanical ventilation and tracheotomy-free.
Croatian: Preživljenje je definirano kao razdoblje koje su bolesnici preživjeli bez intubacije za mehaničku ventilaciju i bez traheotomije.
English: Treatment with Riluzole Zentiva should only be initiated by specialist physicians with experience in the management of motor neurone diseases.
Croatian: Liječenje lijekom Riluzole Zentiva smije započeti samo liječnik specijalist s iskustvom u liječenju bolesti motoričkih neurona.
English: Summary of safety profile
Croatian: Sažetak profila sigurnosti primjene
English: No malformations were seen in animal reproductive studies.
Croatian: U ispitivanjima reprodukcije kod životinja nisu opažene malformacije.
English: Riluzole Zentiva stops the release of glutamate and this may help in preventing the nerve cells being damaged.
Croatian: Riluzole Zentiva blokira izlučivanje glutamata, što može pomoći u sprečavanju oštećenja živčanih stanica.
English: What you need to know before you take Riluzole Zentiva Do not take Riluzole Zentiva if you are allergic to riluzole or any of the other ingredients of this medicine (listed in section if you have any liver disease or increased blood levels of some enzymes of the liver (transaminases),
Croatian: Što morate znati prije nego počnete uzimati Riluzole Zentiva Nemojte uzimati Riluzole Zentiva ako ste alergični na riluzol ili neki drugi sastojak ovog lijeka (naveden u dijelu 6), ako imate neku bolest jetre ili povišene razine nekih jetrenih enzima (transaminaza) u krvi,
English: Each tablet contains 50 mg of riluzole and is engraved with “RPR 202” on one side.
Croatian: Jedna tableta sadrži 50 mg riluzola i ima utisnutu oznaku "RPR 202" na jednoj strani.
English: Riluzole Zentiva is not recommended for use paediatric population, due to a lack of data on the safety and efficacy of riluzole in any neurodegenerative diseases occurring in children or adolescents.
Croatian: Ne preporučuje se primjena lijeka Riluzole Zentiva u pedijatrijskoj populaciji jer nema podataka o sigurnosti primjene i djelotvornosti riluzola niti za jednu neurodegenerativnu bolest koja se javlja u djece i adolescenata.
English: For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Croatian: Za sve informacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje gotovog lijeka u promet.
English: If respiratory symptoms develop such as dry cough and/or dyspnoea, chest radiography should be performed, and in case of findings suggestive of interstitial lung disease (e.g. bilateral diffuse lung opacities), riluzole should be discontinued immediately.
Croatian: Razviju li se respiratorni simptomi poput suhog kašlja i/ili dispneje, treba učiniti radiogram prsnog koša te u slučaju nalaza koji upućuju na intersticijsku bolest pluća (npr. bilateralna difuzna zasjenjenja na plućima), odmah obustaviti primjenu riluzola.
English: EU/1/12/768/001 - 56 film-coated tablets EU/1/12/768/002 - 28 film-coated tablets EU/1/12/768/003 - 98 film-coated tablets EU/1/12/768/004 - 112 film-coated tablets EU/1/12/768/005 - 168 film-coated tablets
Croatian: EU/1/12/768/001 - 56 filmom obloženih tableta EU/1/12/768/002 - 28 filmom obloženih tableta EU/1/12/768/003 - 98 filmom obloženih tableta EU/1/12/768/004 - 112 filmom obloženih tableta EU/1/12/768/005 - 168 filmom obloženih tableta
English: Survival, as defined in the second paragraph of section 4.1, was significantly extended for patients who received riluzole as compared to patients who received placebo.
Croatian: Preživljenje, kako je definirano u drugom odlomku u dijelu 4.1, je bilo značajno dulje u bolesnika koji su primali riluzol u odnosu na bolesnike koji su primali placebo.
English: Only 2% of a riluzole dose was recovered unchanged in the urine.
Croatian: Samo 2% doze riluzola pronađeno je u mokraći u nepromijenjenom obliku.
English: Abnormal liver function tests
Croatian: Odstupanja od normalnih vrijednosti testova funkcije jetre
English: The destruction of nerve cells in motor neurone disease may be caused by too much glutamate (a chemical messenger) in the brain and spinal cord.
Croatian: Propadanje živčanih stanica u bolesti motoričkih neurona može biti posljedica prevelike količine glutamata (kemijskog prijenosnika) u mozgu i leđnoj moždini.
English: In a parallel group study designed to assess the efficacy and safety of riluzole in patients at a late stage of the disease, survival time and motor function under riluzole did not differ significantly from that of placebo.
Croatian: U ispitivanju s paralelnim skupinama dizajniranom da procijeni djelotvornost i sigurnost primjene riluzola u bolesnika u kasnom stadiju bolesti, vrijeme preživljenja i motorička funkcija kod primjene riluzola nisu se značajno razlikovale u odnosu na placebo.
English: Increased alanine aminotransferase usually appeared within 3 months after the start of therapy with riluzole; they were usually transient and levels returned to below twice the ULN after 2 to 6 months while treatment was continued.
Croatian: Povišenje vrijednosti alanin aminotransferaze obično se pojavilo unutar 3 mjeseca od početka terapije riluzolom; obično je bilo prolazno i vrijednosti su se uz nastavak liječenja vratile na manje od dva puta iznad GGN nakon 2 do 6 mjeseci.
English: If you take more Riluzole Zentiva than you should
Croatian: Ako uzmete više Riluzole Zentiva tableta nego što ste trebali
English: Therefore, Riluzole Zentiva should not be used in patients with any other form of motor neurone disease.
Croatian: Zentiva ne smije koristiti u bolesnika s nekim drugim oblikom bolesti motoričkih neurona.
English: Undesirable effects ranked under headings of frequency are listed below, using the following convention: 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: Nuspojave navedene u nastavku razvrstane su prema učestalosti pojavljivanja u sljedeće kategorije: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i
English: The effect of riluzole 50 mg/day was not statistically significant compared to placebo and the effect of 200 mg/day was essentially comparable to that of 100 mg/day.
Croatian: Učinak riluzola u dozi od 50 mg na dan nije bio statistički značajan u odnosu na placebo, a učinak doze od 200 mg na dan bio je usporediv s onim kod doze od 100 mg na dan.
English: The median survival time was 17.7 months versus 14.9 months for riluzole and placebo, respectively.
Croatian: Medijan vremena preživljenja iznosio je 17,7 mjeseci za riluzol, a 14,9 mjeseci za placebo.