FrancophonIA/ELRC3.0 huggingface dataset:
English: On background therapy of insulin glargine (started at 10 units and titrated to  20 units per day), Eperzan 30 mg SC once weekly (with uptitration to 50 mg if inadequately controlled after Week 8) was compared to prandial insulin lispro (administered daily at mealtimes, started according to standard of care and titrated to effect).
Croatian: uspoređivao se Eperzan u supkutanoj dozi od 30 mg jedanput tjedno (uz mogućnost povećanja doze na 50 mg ako glikemija nije dovoljno dobro regulirana nakon 8 tjedana) s prandijalnom primjenom inzulina lispro (primjenjivao se svakodnevno u vrijeme obroka, uz početnu dozu sukladnu standardnom liječenju i postupno povećanje do postizanja učinka).
English: anhydrous (see section 2 under ‘Sodium content'), trehalose dihydrate, mannitol, polysorbate 80.
Croatian: - Drugi sastojci su: natrijev dihidrogenfosfat hidrat i natrijev hidrogenfosfat, bezvodni (pogledajte dio 2. pod 'Sadržaj natrija'), trehaloza dihidrat, manitol (E421), polisorbat 80.
English: Eperzan 30 mg SC weekly (with uptitration to 50 mg weekly at Week 6) was compared to liraglutide 1.8 mg daily (titrated up from 0.6 mg at Week 1 and 1.2 mg at Week 1 to Week 2) in patients inadequately controlled on monotherapy or combination oral antidiabetic therapy (metformin, thiazolidinedione, or sulphonylureas).
Croatian: (doza se povećavala s 0,6 mg u 1. tjednu i 1,2 mg u 2. tjednu) u bolesnika u kojih glikemija nije bila dovoljno dobro regulirana monoterapijom ili kombiniranom terapijom oralnim antidijabeticima (metforminom, tiazolidindionom ili sulfonilurejom).
English: Proportion Achieving HbA1c <7% Body Weight (kg)
Croatian: Udio bolesnika koji su postigli HbA1c < 7% Tjelesna težina (kg)
English: Albiglutide slowed gastric emptying compared with placebo for both solids and liquids when 100 mg was administered as a single dose in healthy subjects (see section 5.1).
Croatian: U zdravih ispitanika koji su primili jednokratnu dozu od 100 mg, albiglutid je usporio pražnjenje želuca u usporedbi s placebom i kod krute hrane i kod tekućina (vidjeti dio 5.1).
English: Tlf: + 45 36 35 91 00 info@glaxosmithkline.dk
Croatian: GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00 info@glaxosmithkline.dk
English: Pens may be stored at room temperature, not exceeding 30C, for no more than a total of 4 weeks prior to use.
Croatian: Brizgalice se prije uporabe mogu čuvati na sobnoj temperaturi, ne višoj od 30°C, tijekom najviše 4 tjedna.
English: Effects on embryo-foetal development (embryo-foetal lethality and skeletal variations) were observed at 50 mg/kg/day (at low multiple of clinical exposure).
Croatian: Pri dozi od 50 mg/kg na dan (pri niskom višekratniku kliničke izloženosti) primijećeni su učinci na embriofetalni razvoj (embriofetalna smrtnost i koštane varijacije).
English: Pen storage
Croatian: Čuvanje brizgalice
English: Difference from sitagliptin + metforminb, (95% CI)
Croatian: Razlika u odnosu na sitagliptin + metforminb (95% CI)
English: Results at 52 weeks in an active-controlled study comparing Eperzan 30 mg SC weekly (with optional uptitration to 50 mg weekly) to insulin glargine (titrated weekly per prescribing information) as addon therapy in patients inadequately controlled on metformin  sulfonylurea
Croatian: Rezultati nakon 52 tjedna u ispitivanju kontroliranom aktivnim lijekom u kojem se Eperzan u supkutanoj dozi od 30 mg tjedno (uz mogućnost povećanja doze na 50 mg tjedno) uspoređivao s inzulinom glarginom (čija se doza povećavala svakoga tjedna sukladno preporukama za doziranje) kao dodatak liječenju u bolesnika u kojih glikemija nije bila dovoljno dobro regulirana metforminom ±
English: The mean daily dose of insulin lispro at Week 26 was 31 IU, and at Week 52, 69% of patients treated with Eperzan were on 50 mg weekly.
Croatian: Srednja dnevna doza inzulina lispro nakon 26 tjedana liječenja iznosila je 31 IU, a u 52. tjednu,
English: The efficacy of Eperzan was evaluated in a 3-year randomised, double-blind, placebo-controlled, multicentre study (n = 296) in patients inadequately controlled on diet and exercise.
Croatian: placebom kontroliranom, multicentričnom ispitivanju (n = 296) u bolesnika u kojih glikemija nije bila dovoljno dobro regulirana dijetom i tjelovježbom.
English: Inspect the pen for ‘1' in the number window and expiration date.
Croatian: Provjerite da li je na brizgalici u prozorčiću prikazan broj ‘1' i provjerite rok valjanosti.
English: Waiting may result in a blocked or clogged needle.
Croatian: protivnom se otopina u igli može osušiti i začepiti iglu.
English: Patients may store the pens at room temperature, not exceeding 30C, for no more than a total of 4 weeks prior to use.
Croatian: Prije uporabe bolesnici mogu čuvati brizgalice na sobnoj temperaturi, ne višoj od 30°C, tijekom najviše 4 tjedna.
English: Remove Outer Needle Cap
Croatian: 1. korak Skinite vanjski zatvarač igle
English: The between-treatment difference in HbA1c of 0.1% (-0.04, 0.27) from baseline at 52 weeks for Eperzan and insulin glargine met the prespecified noninferiority margin (0.3%).
Croatian: Eperzan i liječenja inzulinom glarginom od 0,1% (-0,04; 0,27) u odnosu na početnu vrijednost postigla je unaprijed određenu graničnu vrijednost neinferiornosti (0,3%).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL - Multipack containing 12 single-dose pens and 12 pen needles (3 packs of 4 pens and 4 needles ) -with blue box
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKO OZNAČIVANJE - Višestruko pakiranje sadrži 12 jednodoznih brizgalica i 12 igli za brizgalicu (3 pakiranja od 4 brizgalice i 4 igle) -s plavim okvirom
English: 2b Slowly and gently rock the pen side-to-side 5 times (like a windscreen wiper) (Figure H).
Croatian: 5 puta (poput brisača na vjetrobranskom staklu) (slika H).
English: Change at Week 32b Difference from liraglutideb (95% CI)
Croatian: Početna vrijednost (srednja) Promjena nakon 32 tjednab Razlika u odnosu na liraglutidb (95% CI)
English: -1.5 (-2.1, -1.0) c a Intent to treat population - last observation carried forward b Adjusted mean c P<0.05 for treatment difference
Croatian: -1,5 (-2,1; -1,0) c a Populacija koju se namjeravalo liječiti - prijenos posljednje zabilježenih vrijednosti b Prilagođena srednja vrijednost c P<0,05 za razliku između liječenja
English: Immune system disorders
Croatian: Poremećaji probavnog sustava proljev,
English: Complete dissolution for the 50 mg pen usually occurs within 7 minutes but may take up to 10 minutes.
Croatian: 7 minuta, ali može biti potrebno i do 10 minuta.
English: The primary endpoint was change in HbA1c from baseline at 26 weeks.
Croatian: Primarna mjera ishoda bila je promjena HbA1c nakon 26 tjedana u odnosu na početne vrijednosti.
English: It is okay to have large air bubbles on top of the liquid.
Croatian: Veliki mjehurići zraka na površini tekućine normalna su pojava.
English: Severe gastrointestinal disease
Croatian: Teška bolest probavnog sustava
English: • DO NOT attach needle until instructed in Step 5.
Croatian: • NEMOJTE pričvrstiti iglu prije 5. koraka.
English: Among patients randomised to other comparators, the incidence of symptomatic hypoglycaemia was 7% to 33% when used with a sulphonylurea or insulin and 2% to 4% in combinations without these medicinal products.
Croatian: kod istodobne primjene sulfonilureje ili inzulina te 2% do 4% u kombinacijama koje nisu uključivale ta dva lijeka.
English: The adjusted mean change in body weight from baseline at 52 weeks was -1.0 kg for Eperzan (N = 122) and +1.7 kg for insulin lispro (N = 141).
Croatian: Eperzan (N = 122) i +1,7 kg za inzulin lispro (N = 141).
English: Teл.
Croatian: AUC-a).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each dose contains 50 mg per 0.5 ml following reconstitution.
Croatian: Nakon pripreme za primjenu, jedna doza sadrži 50 mg u 0,5 ml.
English: Read package leaflet
Croatian: Tablični prikaz nuspojava
English: • constipation
Croatian: • povraćanje
English: You inject Eperzan under your skin in your stomach area, upper leg (thigh) or in the back of your upper arm. You can inject the same area of your body each week, but don't inject in exactly the same place every time.
Croatian: Eperzan se injicira pod kožu na području trbuha, natkoljenici (bedru) ili stražnjem dijelu nadlaktice.
English: On background therapy of metformin 1,500 mg daily plus glimepiride 4 mg daily, Eperzan 30 mg SC weekly (with optional uptitration to 50 mg weekly after a minimum of 4 weeks) was compared to placebo or pioglitazone 30 mg daily (with optional titration to 45 mg/day).
Croatian: (uz mogućnost povećanja doze na 50 mg tjedno nakon najmanje 4 tjedna) uspoređivao se s placebom ili pioglitazonom u dozi od 30 mg na dan (uz mogućnost povećanja doze na 45 mg/dan).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each dose contains 30 mg per 0.5 ml following reconstitution.
Croatian: Nakon pripreme za primjenu, jedna doza sadrži 30 mg u 0,5 ml.
English: PARTICULARS TO APPEAR ON INTERMEDIATE PACKAGING CARTON - Multipack containing 12 single-dose pens and 12 pen needles (3 packs of 4 pens and 4 needles ) - without blue box
Croatian: PODACI KOJI SE MORAJU NALAZITI NA MEĐUPAKIRANJU KUTIJA - Višestruko pakiranje sadrži 12 jednodoznih brizgalica i 12 igli za brizgalicu (3 pakiranja od 4 brizgalice i 4 igle) -bez plavog okvira
English: There were no albiglutide related findings in thyroids of monkeys given up to 50 mg/kg/week for up to 52 weeks (75 times clinical exposure based on AUC).
Croatian: 50 mg/kg tjedno tijekom maksimalno 52 tjedna (izloženost 75 puta veća od kliničke, na temelju
English: Active-controlled study versus liraglutide in combination with metformin, thiazolidinedione, or sulphonylurea (as monotherapy or dual therapy)
Croatian: Ispitivanje kontrolirano aktivnim lijekom naspram inzulina glargina kao dodatka liječenju metforminom ± sulfonilurejom
English: Acarbose
Croatian: Akarboza
English: Outer Needle Cap Inner Needle Cap Needle
Croatian: Vjer ojat nost dog ađaj a
English: -0.6 (-1.1, -0.1)c a Intent to treat population - Last Observation Carried Forward (ITT-LOCF) b Adjusted mean c P<0.05 for treatment difference
Croatian: -0,6 (-1,1; -0,1)c a Populacija koju se namjerava liječiti - prijenos posljednje zabilježenih vrijednosti (ITT-LOCF)
English: DO NOT attach at an angle.
Croatian: NEMOJTE pričvrstiti iglu pod kutom.
English: Pull off Needle Caps and Discard
Croatian: PRIČVRŠĆIVANJE IGLE, UKLANJANJE ZRAKA IZ ULOŠKA I PRIPREMA BRIZGALICE
English: Step 5 Attach needle 5a Peel tab from outer needle cap (Figure L).
Croatian: 5a Odlijepite zaštitnu naljepnicu s vanjskog zatvarača igle (slika L).
English: The primary endpoint was change in HbA1c from baseline at 32 weeks.
Croatian: Primarna mjera ishoda bila je promjena vrijednosti HbA1c nakon 32 tjedna u odnosu na početne vrijednosti.
English: Difference from insulin glargineb (95% CI)
Croatian: Promjena nakon 52 tjednab Razlika u odnosu na inzulin glarginb (95% CI)
English: • raised and itchy rashes,
Croatian: • uzdignuti osip praćen svrbežom
English: Once weekly Eperzan pen 30 mg
Croatian: Eperzan 30 mg tjedno
English: Rock Pen
Croatian: sulfonilurejom
English: Placebo Sitagliptin Glimepiride Albiglutide x axis; Weeks (Rescue free), y axis; Probability of event
Croatian: Placebo Sitagliptin Glimepirid Albiglutid
English: • indigestion
Croatian: • mučnina
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/908/002
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/908/002
English: The primary endpoint was change in HbA1c from baseline at 52 weeks.
Croatian: Primarna mjera ishoda bila je promjena HbA1c nakon 52 tjedna u odnosu na početne vrijednosti.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/908/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/908/001
English: • Use the pen immediately after you have attached and primed the needle otherwise the solution can dry up inside the needle and block it.
Croatian: • Brizgalicu upotrijebite odmah nakon što na nju pričvrstite iglu i provjerite protok lijeka.
English: Reconstitution time
Croatian: ROK VALJANOSTI
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/908/004
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/908/004
English: a Intent to treat population - last observation carried forward b Adjusted mean c P<0.05 for treatment difference
Croatian: b Prilagođena srednja vrijednost c P<0,05 za razliku između liječenja
English: Magyarország GlaxoSmithKline Kft. Tel.: + 36 1 225 5300
Croatian: GlaxoSmithKline d.o.o. Tel:++385 1 6051 999
English: IMPORTANT: There are two needle caps, an outer and inner needle cap. 7b While holding the pen in the air, remove outer needle cap (Figure Q) and inner needle cap (Figure R).
Croatian: VAŽNO: Postoje dva zatvarača igle, vanjski i unutarnji.
English: Table 4.
Croatian: Pogledajte dio 4.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/908/003
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/908/003
English: info@glaxosmithkline.dk nlinfo@gsk.com
Croatian: GlaxoSmithKline GmbH & Co.
English: In addition minor editorial changes were introduced to improve readability.
Croatian: Dodatno su uvedene manje uredničke promjene kako bi se poboljšala čitljivost.
English: This may lead to hypotension and circulatory collapse.
Croatian: To može dovesti do hipotenzije i cirkulatornog kolapsa.
English: Other Sections
Croatian: Drugi odjeljci
English: In the EU, Scandonest is authorised in 22 Member States (MS) through national procedures, and in 5 MSs (Sweden, Finland, Portugal, Spain, Malta) through mutual recognition procedure (MRP).
Croatian: Lijek Scandonest odobren je u EU-u putem nacionalnih postupaka u 22 države članice, a u pet država članica (Švedska, Finska, Portugal, Španjolska, Malta) putem postupka međusobnog priznavanja (MRP).
English: For the recommended doses the patient's body weight has to be taken into account.
Croatian: Pri utvrđivanju preporučene doze potrebno je uzeti u obzir tjelesnu težinu bolesnika.
English: The harmonisation of the quality aspects of this product is considered to be acceptable and adequately justified.
Croatian: Smatra se da je usklađivanje aspekata kakvoće za ovaj lijek prihvatljivo i obrazloženo na odgovarajući način.
English: Only the most major changes have been discussed in details below.
Croatian: U nastavku su detaljno opisane samo najznačajnije izmjene.
English: Other ingredients include sodium chloride, sodium hydroxide and water for injection.
Croatian: Ostali sastojci uključuju natrijev klorid, natrijev hidroksid i vodu za injekciju.
English: In section 4.9 regarding overdose, two different types are described; absolute and relative overdose.
Croatian: U odjeljku 4.9 o predoziranju opisana su dva oblika predoziranja, apsolutno i relativno predoziranje.
English: Section 4.3 - Contraindications
Croatian: Odjeljak 4.3 - Kontraindikacije
English: • The Committee considered the referral under Article 30 of Directive 2001/83/EC;
Croatian: Direktive 2001/83/EZ;
English: The rate of 1 ml/min is considered ideal as it does not produce tissue damage during or after anaesthesia and any serious reaction in the event of accidental intravascular injection.
Croatian: Brzina ubrizgavanja od 1 ml/min smatra se optimalnom jer ne uzrokuje oštećenja tkiva tijekom ili nakon anestezije, ni bilo kakve ozbiljne reakcije u slučaju nehotične intravaskularne primjene.
English: Section 4.1 - Therapeutic indications
Croatian: Odjeljak 4.1 - Terapijske indikacije
English: In the presence of high blood levels, local anaesthetics cross the blood-brain barrier.
Croatian: Kada su prisutni u visokim koncentracijama u krvi, lokalni anestetici prolaze kroz krvno-moždanu barijeru.
English: The maximum recommended dose is 4.4 mg/kg of body weight with an absolute maximum recommended dose of 300 mg.
Croatian: Najveća preporučena doza iznosi 4,4 mg/kg tjelesne težine, a najveća preporučena ukupna doza iznosi
English: As a precautionary measure and due to lack of data in this potentially more vulnerable population, the lowest dose leading to efficient anaesthesia should be applied.
Croatian: Kao mjera opreza te zbog nedostatka podataka o ovoj populaciji bolesnika koja je potencijalno osjetljivija, trebalo bi primijeniti najnižu dozu dovoljnu za učinkovitu anesteziju.
English: Moreover information on managing dose-related toxicity and other acute emergencies has been included.
Croatian: Nadalje, uvrštene su informacije o liječenju toksičnosti ovisne o dozi i drugih hitnih akutnih stanja.
English: The quantity to be injected should be determined by the age and weight of the child and the magnitude of the operation.
Croatian: Količinu lijeka koja se ubrizgava treba odrediti prema dobi i tjelesnoj težini djeteta, te težini zahvata.
English: Sections 2 (qualitative and quantitative composition), 3 (pharmaceutical form), 4.7 (Effects on ability to drive and use machines), 5.1 (pharmacodynamic properties), 5.2 (pharmacokinetic properties), 6.1 (list of excipients), 6.2 (incompatibilities), 6.3 (shelf life), 6.4 (special precautions for storage) 6.5 (nature and contents of container) and 6.6 (Special precautions for disposal and other handling) have been updated in line with their respective harmonised Quality documentation provided in module 3 and in line with the latest QRD template.
Croatian: Odjeljci 2. (kvalitativni i kvantitativni sastav), 3. (farmaceutski oblik), 4.7 (utjecaj na sposobnost upravljanja vozilima i rada sa strojevima), 5.1 (farmakodinamička svojstva), 5.2 (farmakokinetička svojstva), 6.1 (popis pomoćnih tvari), 6.2 (inkompatibilnosti), 6.3 (rok valjanosti), 6.4 (posebne mjere pri čuvanju lijeka), 6.5 (vrsta i sadržaj spremnika) i 6.6 (posebne mjere za zbrinjavanje i druga rukovanja lijekom) ažurirane su u skladu s pripadajućom usklađenom dokumentacijom o kakvoći iz Modula 3 i u skladu s najnovijim obrascem dokumenata za ispitivanje kakvoće.
English: Scandonest contains 30 mg/mL of mepivacaine hydrochloride.
Croatian: Lijek Scandonest sadrži 30 mg/ml mepivakain hidroklorida.
English: Local anaesthetics as cardiovascular depressants exert a negative inotropic and chronotropic effect on the myocardium and produce peripheral vasodilation.
Croatian: Lokalni anestetici kao što su kardiovaskularni depresori imaju negativan inotropni i kronotropni učinak na miokard i uzrokuju perifernu vazodilataciju.
English: The recommendations on lower doses for patients with reduced health and pre-existing conditions such as vascular obliterations, arteriosclerosis or diabetes-related nerve damage are not supported by sufficient data and are not endorsed by the CHMP.
Croatian: Preporuke u pogledu nižih doza za bolesnike slabijeg zdravlja i s postojećim bolestima, kao što su vaskularne obliteracije, arterioskleroza ili oštećenja živaca povezana sa šećernom bolesti, nisu potkrijepljene dostatnim podatcima te ih CHMP ne prihvaća.
English: The CHMP is of the opinion that in case of vasoconstrictor contraindication there are alternative options, such as other local anaesthetics (procaine, bupivacaine and lidocaine), general anaesthesia and nitrous oxide.
Croatian: Mišljenje je CHMP-a da u slučaju kontraindikacije za primjenu vazokonstriktora postoje alternativne mogućnosti, kao što je primjena drugih lokalnih anestetika (prokain, bupivakain i lidokain), opće anestezije i dušikova oksida.
English: Whereas
Croatian: Doziranje
English: • The Committee reviewed the data submitted by the MAH in support of the proposed harmonisation of the Product Information, including based on the documentation submitted and the scientific discussion within the Committee;
Croatian: • Odbor je pregledao podatke koje je u prilog predloženog usklađenja informacija o lijeku dostavio nositelj odobrenja za stavljanje lijeka u promet, uključujući na temelju dostavljene dokumentacije i znanstvenih rasprava unutar Odbora;
English: No clinical data on fertility and nursing mothers are available on humans.
Croatian: Nisu dostupni klinički podatci o plodnosti u ljudi i o majkama dojiljama.
English: The relevant posology section for the mepivacaine use in chiropody procedure will be removed as the CHMP supported the deletion of this indication.
Croatian: Izbrisat će se odgovarajući odjeljak o doziranju prilikom primjene mepivakaina u tretmanima pedikure jer je CHMP podržao brisanje te indikacije.
English: Although in dental practices, local anaesthetics administrated in therapeutic dosages do not interact with standard antiepileptic drugs, the situation for patients with uncontrolled epilepsy may be different.
Croatian: Iako prilikom primjene terapijskih doza lokalnog anestetika u stomatološkoj praksi ne dolazi do interakcije sa standardnim antiepilepticima, u bolesnika s nekontroliranom epilepsijom situacija bi mogla biti drukčija.
English: The updated sections of Module 3 sections include: Active substance, Control of active substance, Specification, Finished product, Description and composition of the finished substance, Manufacture, Description of manufacturing process and process controls, Process validation and/or evaluation, Control of Excipients, Control of Finished substance, Specifications, Analytical procedures, Container Closure System and Stability.
Croatian: Ažurirani odjeljci Modula 3 uključuju: Djelatna tvar, Provjera kakvoće djelatne(-ih) tvari, Zahtjev kakvoće, Gotov lijek, Opis i sastav konačne tvari, Proizvodnja, Opis proizvodnog postupka i procesne kontrole, Validacija i/ili evaluacija proizvodnog postupka, Provjera kakvoće pomoćnih tvari, Provjera kakvoće konačne tvari, Zahtjevi kakvoće, Analitički postupci, Unutarnje pakovanje i Stabilnost.
English: Mepivacaine is an intermediate-acting local anaesthetic, which inhibits the conduction of nerve impulses by decreasing sodium (Na+) flow during propagation of the nerve action potential.
Croatian: Mepivakain je lokalni anestetik srednjeg trajanja djelovanja koji inhibira provođenje živčanih impulsa smanjivanjem protoka natrija (Na+) tijekom propagacije akcijskog potencijala živaca.
English: The wording for the method of use was harmonised to the standard terms “infiltration and perineural use” taking in consideration the requirements from the EDQM (European Directorate for the Quality of Medicines & HealthCare).
Croatian: Tekst o načinu primjene usklađen je sa standardnim izrazima „infiltracija i perineuralna primjena” uzimajući u obzir zahtjeve Europske uprave za kakvoću lijekova i zdravstvenu skrb (EDQM).
English: Mepivacaine is largely metabolised in the liver by microsomal enzymes and the principal route of excretion is via the kidney.
Croatian: Mepivakain se uglavnom metabolizira mikrosomalnim enzimima jetre, a glavni način izlučivanja je putem bubrega.
English: In section 4.4, the warnings have been re-organised in five categories: patients with cardiovascular disorders, hepatic disease, kidney disease, epileptic and elderly patients.
Croatian: Upozorenja u odjeljku 4.4 preraspoređena su u pet kategorija: bolesnici s kardiovaskularnim poremećajima, bolesnici s bolešću jetre, bolesnici s bolešću bubrega, bolesnici s epilepsijom i stariji bolesnici.
English: However, all sections of the PI have been harmonised.
Croatian: Međutim, usklađeni su svi odjeljci informacija o lijeku.
English: This information should be reflected in the SmPC section 4.2 with a cross reference to section 4.5 (Interactions with other medicinal products).
Croatian: Te informacije trebalo bi navesti u odjeljku 4.2 sažetka opisa svojstava lijeka s unakrsnom referencom na odjeljak 4.5 (Interakcije s drugim lijekovima).
English: Interactions with other medicinal products (section 4.5) have been summarised in additive interactions with other local anaesthetics, H2 antihistaminics, sedatives, antiarrhythmic drugs, CYP1A2 inhibitors and propranolol.
Croatian: U sažetom prikazu interakcija s drugim lijekovima (odjeljak 4.5) navodi se aditivan učinak interakcija s drugim lokalnim anesteticima, H2 antihistaminicima, sedativima, antiaritmicima, inhibitorima CYP1A2 i propranololom.
English: Pharmacokinetic changes are also observed with aging.
Croatian: U starijih bolesnika također su zabilježene farmakokinetičke promjene.