FrancophonIA/ELRC3.0 huggingface dataset:
English: If this dose does not work well enough to Imraldi 40 mg every other week, your doctor may increase the dosage to 40 mg every week or 80 mg every other week.
Croatian: Ako ne postignete zadovoljavajući odgovor na terapiju lijekom Imraldi u dozi od 40 mg svaki drugi tjedan, Vaš liječnik može povećati doziranje na 40 mg svaki tjedan ili 80 mg svaki drugi tjedan.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (PRE-FILLED SYRINGE PACK)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA (NAPUNJENA BRIZGALICA)
English: If this dose does not work well enough, your child's doctor may increase the dosage to 40 mg every week or 80 mg every other week.
Croatian: Ako ova doza nije dovoljno djelotvorna, djetetov liječnik može povećati doziranje na 40 mg svaki tjedan ili 80 mg svaki drugi tjedan.
English: and uveitis patients.
Croatian: Bolesnici koji su u razdoblju
English: Children and adolescents from 6 to 17 years of age weighing 40 kg or more:
Croatian: Djeca i adolescenti u dobi od 6 do 17 godina,tjelesne težine 40 kg ili više
English: Partial Flared a Assessment of SpondyloArthritis international Society b Baseline is defined as open label baseline when patients have active disease.
Croatian: Početna vrijednost definirala se kao vrijednost na početku razdoblja otvorenog liječenja kada bolesnici imaju aktivnu bolest.
English: arrhythmia, congestive heart failure
Croatian: često tahikardija manje često infarkt miokarda aritmija, kongestivno zatajenje srca rijetko zastoj srca
English: If these medicines do not work well enough, you will be given Imraldi to reduce the signs and symptoms of your Crohn's disease.
Croatian: Ukoliko ti lijekovi ne djeluju dovoljno dobro, u svrhu smanjenja znakova i simptoma Crohnove bolesti bit će Vam propisan lijek Imraldi.
English: • Throw away your used syringe in a special container as instructed by your doctor, nurse or pharmacist.
Croatian: • Iskorištenu brizgalicu bacite u posebni spremnik kako Vas je uputio Vaš liječnik, medicinska sestra ili ljekarnik.
English: Very common Musculoskeletal pain Common
Croatian: Nuspojava rijetko pancitopenija
English: • If you dropped your syringe with the cap ON, it is okay to use the syringe.
Croatian: • Ako Vam štrcaljka ispadne SA štitnikom na igli, možete je upotrijebiti.
English: Table 5 Imraldi Dose for Paediatric Patients with Uveitis Patient Weight
Croatian: Tablica 5 Doza lijeka Imraldi za pedijatrijske bolesnike s uveitisom
English: Breast feeding
Croatian: Zbrinjavanje brizgalice
English: • urinary tract infection;
Croatian: • infekcije mokraćnih putova;
English: Imraldi has not been studied in these patient populations.
Croatian: Nije ispitivano djelovanje lijeka Imraldi u toj populaciji bolesnika te se ne mogu dati preporuke za doziranje.
English: If a faster response is required, your child's doctor may prescribe an initial dose of 160 mg initially (as four 40 mg injections in one day or two 40 mg injections per day for two consecutive days) followed by 80 mg (as two 40 mg injections in one day) two weeks later.
Croatian: Ako je potreban brži odgovor na liječenje, djetetov liječnik može propisati početnu dozu od 160 mg (u obliku četiri injekcije od 40 mg u jednom danu ili kao dvije injekcije od 40 mg na dan tijekom dva uzastopna dana) i zatim 80 mg (u obliku dvije injekcije od 40 mg u jednom danu) nakon dva tjedna.
English: • skin infections (including cellulitis and shingles);
Croatian: • kožne infekcije (uključujući upalu potkožnog tkiva i herpes zoster);
English: • trouble breathing, swallowing;
Croatian: • otežano disanje i gutanje;
English: Adverse Reaction
Croatian: Održana remisija
English: The usual Imraldi dose for adults with ulcerative colitis is 160 mg initially (as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days) followed by 80 mg (as two 40 mg injections in one day) two weeks later and thereafter 40 mg every other week.
Croatian: Uobičajena početna doza lijeka Imraldi za odrasle bolesnike s ulceroznim kolitisom je 160 mg (u obliku četiri injekcije od 40 mg u jednom danu ili dvije injekcije od 40 mg na dan tijekom dva uzastopna dana), nakon čega poslije dva tjedna slijedi doza od 80 mg (u obliku dvije injekcije od 40 mg u jednom danu).
English: RA study IIIa**
Croatian: Ispitivanje RA III
English: If a faster response is required, your doctor may prescribe an initial dose of 160 mg (as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days) followed by 80 mg (as two 40 mg injections in one day) two weeks later.
Croatian: Ako je potreban brži odgovor na liječenje, liječnik može propisati početnu dozu od 160 mg (u obliku četiri injekcije od 40 mg u jednom danu ili kao dvije injekcije od 40 mg na dan tijekom dva uzastopna dana) i zatim 80 mg (u obliku dvije injekcije od 40 mg u jednom danu) nakon dva tjedna.
English: Imraldi 40 mg solution for injection in pre-filled syringe
Croatian: Imraldi 40 mg otopina za injekciju u napunjenoj štrcaljki.
English: 114 paediatric patients from 4 years of age with severe chronic plaque psoriasis (as defined by a PGA ≥4 or >20% BSA involvement or >10 % BSA involvement with very thick lesions or PASI ≥20 or ≥10 with clinically relevant facial, genital, or hand/ foot involvement) who were inadequately controlled with topical therapy and heliotherapy or phototherapy.
Croatian: Psoriasis Area and Severity Index, PASI) od ≥ 20 ili ≥ 10 uz klinički značajnu zahvaćenost lica, genitalija ili šaka/stopala) u kojih bolest nije bila dovoljno dobro kontrolirana topikalnom terapijom i helioterapijom ili fototerapijom.
English: 6 months 12 months a RA study I at 24 weeks, RA study II at 26 weeks, and RA study III at 24 and 52 weeks b 40 mg adalimumab administered every other week c MTX = methotrexate
Croatian: 6 mjeseci 12 mjeseci a Ispitivanje RA I nakon 24 tjedna, ispitivanje RA II nakon 26 tjedana, ispitivanje RA III nakon
English: Your single-dose pre-filled syringe
Croatian: Napunjena brizgalica za jednokratno doziranje
English: Syringe storage
Croatian: Čuvanje štrcaljke
English: The second received 20 mg of adalimumab every week for 52 weeks.
Croatian: Druga je dobivala 20 mg adalimumaba svaki tjedan tijekom 52 tjedna, dok je treća skupina svaki tjedan naizmjenično dobivala 40 mg adalimumaba ili placebo (jedan tjedan 40 mg adalimumaba, drugi tjedan placebo).
English: Cautions
Croatian: Cjepivo
English: Continued therapy should be reconsidered in a patient not responding within this time period.
Croatian: Ako se unutar tog razdoblja ne postigne terapijski odgovor, potrebno je razmotriti nastavak liječenja takvog bolesnika.
English: Nail psoriasis assessments included the Modified Nail Psoriasis Severity Index (mNAPSI), the Physician's Global Assessment of Fingernail Psoriasis (PGA-F) and the Nail Psoriasis Severity Index (NAPSI) (see Table 16).
Croatian: Nail Psoriasis Severity Index, NAPSI) (vidjeti Tablicu 16).
English: Biogen Poland Sp. z o.o.
Croatian: Biogen Belgium NV/S.A
English: • Throw away your used vial in a special container as instructed by your doctor, nurse or pharmacist.
Croatian: • Iskorištenu štrcaljku bacite u posebni spremnik kako Vas je uputio Vaš liječnik, medicinska sestra ili ljekarnik.
English: If a faster effect is required your doctor may prescribe an initial dose of 160 mg (as four 40 mg injections in one day or two 40 mg injections per day for two consecutive days), followed by 80 mg (as two 40 mg injections in one day) two weeks later, and thereafter as 40 mg every other week.
Croatian: Ako je potreban brži učinak, liječnik Vam može propisati početnu dozu od 160 mg (u obliku četiri injekcije od 40 mg u jednom danu ili dvije injekcije od 40 mg na dan tijekom dva uzastopna dana) i zatim 80 mg (u obliku dvije injekcije od 40 mg u jednom danu) nakon dva tjedna.
English: Keep the syringe in the outer carton in order to protect from light.
Croatian: Štrcaljku čuvajte u vanjskoj kutiji zaštićenu od svjetla.
English: 1.9-10.5, respectively).
Croatian: (vidjeti dio 5.1).
English: Uncommon Aortic aneurysm, vascular arterial occlusion, thrombophlebitis
Croatian: Krvožilni poremećaji često hipertenzija, navale crvenila, hematomi manje često aneurizma aorte, okluzije arterijskih žila, tromboflebitis
English:  < 40 kg: 20 mg every week  ≥ 40 kg: 40 mg every week or 80 mg every other week Continued therapy should be carefully considered in a subject not responding by week 12.
Croatian: • ≥ 40 kg: 40 mg svaki tjedan ili 80 mg svaki drugi tjedan
English: Visual impairment, conjunctivitis, blepharitis, eye swelling
Croatian: bakterijske infekcije, infekcije oka, divertikulitis
English: • eye inflammation;
Croatian: • moždani udar;
English: • paediatric plaque psoriasis,
Croatian: • plak psorijaze u djece,
English: If this dose does not work well enough, your doctor may increase the dosage to 40 mg every week or 80 mg every other week.
Croatian: Ako ova doza nije dovoljno djelotvorna, Vaš liječnik Vam može povećati doziranja na 40 mg svaki tjedan ili 80 mg svaki drugi tjedan.
English:  4 pre-filled syringes, each with 1 alcohol pad  6 pre-filled syringes, each with 1 alcohol pad
Croatian: Pakiranja s:  1 napunjena štrcaljka s 2 alkoholna tupfera  2 napunjene štrcaljke, svaka s 1 alkoholnim tupferom  4 napunjene štrcaljke, svaka s 1 alkoholnim tupferom  6 napunjenih štrcaljki, svaka s 1 alkoholnim tupferom
English: Drop outs due to reasons other than treatment failure were censored at the time of dropping out.
Croatian: Bolesnici koji su izašli iz ispitivanja zbog razloga koji nisu bili neuspjeh liječenja bili su cenzurirani u trenutku izlaska iz ispitivanja. a HR za adalimumab naspram placeba iz regresije proporcionalnih hazarda, uz liječenje kao faktor.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (VIAL PACK)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA (PAKIRANJE BOČICE)
English: • Keep the pen out of the sight and reach of children.
Croatian: • Bočicu čuvajte izvan pogleda i dohvata djece.
English: * p <0.001 for adalimumab versus placebo pairwise comparisons of proportions ** p <0.02 for adalimumab versus placebo pairwise comparisons of proportions a Of those receiving corticosteroids at baseline
Croatian: Klinička remisija Klinički odgovor (CR-100) Bolesnici u remisiji bez primjene steroida > = 90 danaa * p < 0,001 za adalimumab naspram placeba, sparena usporedba udjela ** p < 0,02 za lijek adalimumab naspram placeba, sparena usporedba udjela a Onih koji su na početku uzimali kortikosteroide
English: • abnormal blood measurements for sodium;
Croatian: • razina natrija u krvi izvan normalnih vrijednosti;
English: Paraesthesias (including hypoesthesia), migraine, nerve root compression Uncommon Cerebrovascular accident1),
Croatian: vrlo često glavobolja često parestezije (uključujući hipoesteziju), migrena, kompresija korijena živca manje često cerebrovaskularni događaj tremor, neuropatija rijetko multipla skleroza, demijelinizirajući poremećaji (npr. optički neuritis, Guillain-Barréov sindrom)
English: Beyond 16 weeks, patients with inadequate response to Imraldi 40 mg every other week may benefit from an increase in dosage to 40 mg every week or 80 mg every other week.
Croatian: U bolesnika u kojih nije postignut zadovoljavajući odgovor na Imraldi u dozi od 40 mg svaki drugi tjedan nakon 16 tjedana, možda će biti korisno povećati doziranje na 40 mg lijeka svaki tjedan ili 80 mg svaki drugi tjedan.
English: Each 0.8 ml pre-filled syringe contains 40 mg adalimumab.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna napunjena brizgalica s 0,8 ml otopine sadrži 40 mg adalimumaba.
English: Each 0.8 ml single dose vial contains 40 mg of adalimumab.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna bočica s 0,8 ml otopine sadrži 40 mg adalimumaba.
English: - the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.
Croatian: uključujući metotreksat, nije postignut zadovoljavajući odgovor. - liječenje teškog oblika aktivnog i progresivnog reumatoidnog artritisa u odraslih bolesnika koji nisu bili prethodno liječeni metotreksatom.
English: • low blood potasium.
Croatian: • niska razina kalija u krvi.
English: Imraldi 40 mg solution for injection in vial is supplied as a 0.8 ml clear and colourless solution.
Croatian: Imraldi 40 mg otopina za injekciju u bočici dolazi kao 0,8 ml bistre i bezbojne otopine.
English: Biogen Italia s.r.l.
Croatian: Biogen Idec (Ireland) Ltd.
English: 40 mg Adalimumab every week
Croatian: Adalimumab 40 mg svaki tjedan
English: Table 22 Proportion of Patientsa Achieving HiSCRb at Weeks 24 and 36 After Treatment Reassignment from Weekly Adalimumab at Week 12 Placebo (treatment withdrawal) N = 73
Croatian: b u 24. i 36. tjednu nakon preraspodjele liječenja u 12. tjednu, do kada su primali adalimumab svaki tjedan
English: 1 sterile injection syringe 1 sterile needle 1 sterile vial adapter 2 alcohol pads
Croatian: otopina za injekciju 1 napunjena štrcaljka 2 alkoholna tupfera
English: • hair loss;
Croatian: • oticanje lica;
English: • Keep your pen in its carton, and away from light.
Croatian: • Bočicu držite u njenoj kutiji, zaštićenu od svjetla.
English: Adalimumab N=208
Croatian: N = 208
English: 6) Throwing away supplies
Croatian: 6) Zbrinjavanje pribora
English: • heart stops pumping;
Croatian: • zastoj rada srca;
English: No ALT elevations ≥3 × ULN occurred in the Phase 3 trial of adalimumab in paediatric patients with plaque psoriasis.
Croatian: U ispitivanju faze III u kojem se adalimumab primjenjivao u pedijatrijskih bolesnika s plak psorijazom, nisu primijećena povišenja razine ALT-a ≥ 3 × GGN.
English: Week 12 Week 24 *** p < 0.001 for all comparisons between adalimumab and placebo * p < 0.05 for all comparisons between adalimumab and placebo
Croatian: 40 mg adalimumaba primijenjenog svaki drugi tjedan c MTX = metotreksat **p < 0,01, adalimumab u usporedbi s placebom - Nije primjenjivo
English: Children and adolescents from 4 to 17 years of age weighing 30 kg or more The recommended dose of Imraldi is an initial dose of 40 mg, followed by 40 mg one week later.
Croatian: Djeca i adolescenti u dobi od 2 i više godina, tjelesne težine 30 kg ili više Preporučena doza lijeka Imraldi je 40 mg svaki drugi tjedan.
English: Package leaflet: Information for the patient Imraldi 40 mg/0.8 ml solution for injection adalimumab This medicine is subject to additional monitoring.
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Imraldi 40 mg/0,8 ml za injekciju adalimumab s.c.
English: The mean steady-state trough concentration at week 12 through week 36 were approximately 8 to 10 μg/ml during adalimumab 40 mg every week treatment.
Croatian: Kada se adalimumab primjenjivao u dozi od 40 mg svaki tjedan, srednja vrijednost najniže koncentracije u stanju dinamičke ravnoteže od 12. do 36. tjedna iznosila je približno 8 do 10 µg/ml.
English: Tel: + 371 66 16 40 32
Croatian: Ewopharma AG pārstāvniecība Tel: + 371 66 16 40 32
English: If these medicines do not work well enough, patients will be given Imraldi to reduce the signs and symptoms of your disease.
Croatian: Ukoliko ti lijekovi ne djeluju dovoljno dobro, u svrhu smanjenja znakova i simptoma bolesti, bolesnicima će biti propisan lijek Imraldi.
English: Paediatric Crohn's disease
Croatian: • Crohnove bolesti u djece
English: (CLASSIC I) and CD study II (GAIN).
Croatian: (UV I i II).
English: Injection site care
Croatian: Njega mjesta ubrizgavanja
English: Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the Member States
Croatian: Popis naziva, farmaceutskih oblika, jačina lijekova, puteva primjene, nositelja odobrenja za stavljanje lijeka u promet u državama članicama
English: Aftokratoros Nikolaou 2 Athens 17671
Croatian: Alapis ABEE Aftokratoros Nikolaou 2 Athens 17671
English: Abrunheira 2710-089 Sintra Portugal
Croatian: 2710-089 Sintra Portugal
English: Amsterdam GK - 1081 The Netherlands
Croatian: Amsterdam GK - 1081
English: Farmoz - Sociedade Técnico Medicinal, S.A. Rua da Tapada Grande,
Croatian: Farmoz - Sociedade Técnico Medicinal, S.A. Rua da Tapada Grande, 2, Abrunheira
English: Pharmacosmos A/S Roervangsvej 30 Holbaek DK-4300 Denmark
Croatian: Pharmacosmos A/S Roervangsvei 30 Holbaek DK-4300 Denmark
English: Laboratórios Normon, S.A. Rua Armando Villar, Lote 42 1º Dto.
Croatian: Rua Armando Villar, Lote 42 1º Dto.
English: Evropská 846/176a 160 00 Praha 6
Croatian: Sanofi-Aventis, s.r.o. Evropská 846/176a 160 00 Praha 6
English: 57400 ROISSY CdG CEDEX F-95943 France
Croatian: Španjolska GUERBET B.P. 57400 ROISSY CdG CEDEX F-95943
English: Solution for perfusion
Croatian: Otopina za perfuziju
English: G.E.S.
Croatian: Španjolska G.E.S.
English: Sanofi-Aventis SPA Viale Luigi Bodio, 37/B 20158 Milano Italy sodium ferric gluconate complex
Croatian: Sanofi-Aventis SPA Viale Luigi Bodio, 37/B 20158 Milano Italy
English: Concentrate for suspension for infusion
Croatian: Koncentrat za suspenziju za infuziju
English: Germany Sanofi-Aventis Deutschland GmbH Brüningstrasse 50, D-65926 Frankfurt am Main Germany sodium ferric gluconate complex
Croatian: Sanofi-Aventis Deutschland GmbH Brüningstrasse 50, D-65926 Frankfurt am Main Germany
English: Alet Pharmaceuticals M. Alexander 121, Agia Varvara, 12351 Greece
Croatian: Alexander 121, Agia Varvara, 12351 Greece
English: Pharmamatch B.V.
Croatian: Nizozemska Pharmamatch B.V.
English: Pharmachemie B.V. Haarlem - 2031 GA The Netherlands
Croatian: Haarlem - 2031 GA The Netherlands
English: Parenteral use
Croatian: Parenteralna primjena
English: Target Pharma Ltd Menandrou 54 Athens 10431
Croatian: Target Pharma Ltd Menandrou 54
English: Luxembourg Medice Arzneimittel Pütter GmbH & Co KG
Croatian: Luksemburg Medice Arzneimittel Pütter GmbH & Co KG
English: 92931 Paris La Défense Cedex
Croatian: TEVA SANTE 110, Esplanade du Général de Gaulle 92931 Paris La Défense Cedex
English: Laboratorios Normon S.A. Ronda de Valdecarrizo 6 28760 Tres Cantos Madrid
Croatian: Španjolska Laboratorios Normon S.A. Ronda de Valdecarrizo 6
English: Germany Medice Arzneimittel Pütter GmbH & Co KG
Croatian: Španjolska Medice Arzneimittel Pütter GmbH & Co KG
English: FERROLOGIC SOLUTION FOR INJECTION/CONCENTRATE FOR SOLUTION FOR INFUSION 20MG/ML
Croatian: INJECTION/CONCENTRATE FOR SOLUTION FOR INFUSION 20MG/ML
English: Concentrate for solution for infusion/solution for injection
Croatian: PHARMAMATCH, oplossing/concentraat voor oplossing voor injectie
English: Concentrate for solution for injection
Croatian: Koncentrat za otopinu za injekciju
English: Iron(III) isomaltoside complex
Croatian: Željezov (III) izomaltozid
English: Ferric carboxymaltose complex
Croatian: Kompleks željezokarboksimaltoze
English: Jerndextran "Pharmacosmos" 50mg/ml
Croatian: Jerndextran "Pharmacosmos"
English: Genericos Espanoles Laboratorio S.A.Cólquide, 6 - Portal 2, 1 Oficina F.Las Rozas 28230 MADRID Spain
Croatian: Oficina F.Las Rozas 28230 MADRID Spain
English: Rafarm AEBE Korinthou 12, N. Psychiko, 15451 Greece
Croatian: Rafarm AEBE Korinthou 12, N.
English: 4230 Skaelskoer Denmark
Croatian: Alternova A/S Lodshusvej 11 4230 Skaelskoer Denmark
English: Ferric Carboxymaltose
Croatian: Karboksimaltoza
English: Intermed ABEE Kalyftaki 27 Athens 14564 Greece
Croatian: Intermed ABEE Kalyftaki 27
English: Ferric carboxymaltose
Croatian: Željezokarboksimaltoza
English: Luxembourg Pharmacosmos A/S Roervangsvej 30
Croatian: Luksemburg Pharmacosmos A/S Roervangsvej 30
English: Iron (III) hydroxide dextran complex
Croatian: Kompleks željezovog (III) hidroksid dekstrana
English: Luxembourg VIFOR France SA 7-13 Boulevard Paul Emile Victor
Croatian: Luksemburg VIFOR France SA 7-13 Boulevard Paul Emile Victor
English: Romania Pharmacosmos A/S Roervangsvej 30
Croatian: Rumunjska Pharmacosmos A/S Roervangsvej 30
English: Luxembourg Fresenius Medical Care Nephrologica Deutschland GmbH
Croatian: Luksemburg Fresenius Medical Care Nephrologica Deutschland GmbH
English: Romania VIFOR France SA 7-13 Boulevard Paul Emile Victor
Croatian: Rumunjska VIFOR France SA 7-13 Boulevard Paul Emile Victor
English: Finland Pharmacosmos A/S Roervangsvej 30
Croatian: Nizozemska Pharmacosmos A/S Roervangsvej 30
English: FERRO SACCARATO FME
Croatian: Kompleks natrijevog željezovog glukonata
English: Denmark Fresenius Medical Care Nephrologica Deutschland GmbH
Croatian: Nizozemska Fresenius Medical Care Nephrologica Deutschland GmbH
English: Finland Fresenius Medical Care Nephrologica Deutschland GmbH
Croatian: Španjolska Fresenius Medical Care Nephrologica Deutschland GmbH
English: Belgium VIFOR France SA 7-13 Boulevard Paul Emile Victor
Croatian: Nizozemska VIFOR France SA 7-13 Boulevard Paul Emile Victor
English: Do not take another dose during the same night.
Croatian: Ne smijete uzeti još jednu dozu tijekom iste noći.
English: CYP450 inhibitors and inducers
Croatian: Inhibitori i induktori CYP450
English: [Invented Name] should be taken:
Croatian: [Zaštićeno ime] treba uzeti:
English: Other medicines and [Invented name]
Croatian: Drugi lijekovi i [zaštićeno ime]
English: In some patients, a lower dose of 5mg could be effective.
Croatian: U nekih bi bolesnika niža doza od 5 mg mogla biti djelotvorna.
English: In order to reduce the risk, patients should ensure that they will be able to have an uninterrupted sleep of 8 hours (see section 4.8).
Croatian: Kako bi se smanjio rizik, bolesnici bi si trebali osigurati 8 sati neometana sna (vidjeti dio 4.8).
English: A lower dose may be prescribed to some patients.
Croatian: Nekim bolesnicima može se propisati i niža doza.
English: Do not drink alcohol or take other psychoactive substances while you are taking [Invented Name], as it can increase the above listed effects
Croatian: Nemojte piti alkohol niti uzimati druge psihoaktivne tvari dok uzimate [zaštićeno ime] jer to može pojačati gore navedene učinke.
English: The lowest effective daily dose of zolpidem should be used and must not exceed 10 mg.
Croatian: Treba primijeniti najnižu djelotvornu dnevnu dozu zolpidema, koja ne smije biti veća od 10 mg.
English: When zolpidem was administrated with ranitidine or cimetidine, no significant pharmacokinetic interactions were observed.
Croatian: Kada se zolpidem primjenjivao s ranitidinom ili cimetidinom, nisu primijećene značajne farmakokinetičke interakcije.
English: • You may feel drowsy, sleepy, dizzy or confused
Croatian: • možete osjećati omamljenost, pospanost, omaglicu ili zbunjenost
English: Do not exceed 10mg per 24 hours.
Croatian: Ne smijete uzeti više od 10 mg lijeka unutar 24 sata.
English: • Medicines to calm or reduce anxiety
Croatian: • lijekovi za smirenje ili smanjenje tjeskobe
English: The recommended dose per 24 hours is 10 mg of [Invented Name].
Croatian: Preporučena doza tijekom 24 sata je 10 mg lijeka [zaštićeno ime].
English: Patients should be warned not to use alcohol or other psychoactive substances when taking zolpidem.
Croatian: Bolesnike treba upozoriti da ne piju alkohol i da ne uzimaju druge psihoaktivne tvari dok se liječe zolpidemom.
English: • zolpidem is taken within less than 8 hours before performing activities that require mental alertness (see section 4.7);
Croatian: • ako se zolpidem uzme manje od 8 sati prije izvođenja aktivnosti koje zahtijevaju mentalnu budnost (vidjeti dio 4.7)
English: • You take a higher dose than the recommended dose
Croatian: • ako uzmete veću dozu od preporučene
English: The amendments to the Summary of Product Characteristics and package leaflets may need to be subsequently updated by the national competent authorities, in liaison with the Reference Member State if appropriate.
Croatian: Izmjene Sažetka opisa svojstava lijeka i Upute o lijeku će možda naknadno morati revidirati nacionalna nadležna tijela u suradnji s referentnom državom članicom, ako bude potrebno.
English: 4.2 Posology and method of administration [Replaces current sentence ‘The recommended daily dose for adults is 10 mg] The treatment should be taken in a single intake and not be re-administered during the same night.
Croatian: 4.2 Doziranje i način primjene [Zamjenjuje trenutnu rečenicu 'Preporučena dnevna doza za odrasle je 10 mg'] Lijek treba uzeti odjednom i ne smije se ponovno uzeti tijekom iste noći.