FrancophonIA/ELRC3.0 huggingface dataset:
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).
Slovenian: Pri 50 mg/kg/dan (to je nizek večkratnik klinične izpostavljenosti) so opažali vplive na embrio-fetalni razvoj (embrio-fetalna umrljivost in spremembe okostja).
English: Reconstitution time
Slovenian: Čas priprave.
English: Eperzan 30 mg powder and solvent for solution for injection
Slovenian: Eperzan 30 mg prašek in vehikel za raztopino za injiciranje.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each dose contains 30 mg per 0.5 ml following reconstitution.
Slovenian: En odmerek po pripravi vsebuje 30 mg na 0,5 ml.
English: Always use this medicine exactly as your doctor, nurse or pharmacist has told you.
Slovenian: Pri uporabi tega zdravila natančno upoštevajte navodila zdravnika, medicinske sestre ali farmacevta.
English: Difference from insulin glargineb (95% CI)
Slovenian: Sprememba po 52 tednihb Razlika od insulina glarginab (95 % IZ)
English: Stop taking Eperzan.
Slovenian: Zanihajte peresnik
English: Once weekly Eperzan pen 30 mg
Slovenian: Peresnik zdravila Eperzan 30 mg enkrat na teden
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each dose contains 50 mg per 0.5 ml following reconstitution.
Slovenian: En odmerek po pripravi vsebuje 50 mg na 0,5 ml.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/908/002
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM EU/1/13/908/002
English: Step 5 Attach needle 5a Peel tab from outer needle cap (Figure L).
Slovenian: 5a Odlepite prelepko z zunanjega pokrovčka igle (Slika L).
English: or
Slovenian: Redki
English: Eperzan 30 mg powder and solvent for solution for injection Each pen delivers 30 mg albiglutide per 0.5 ml dose following reconstitution.
Slovenian: Vsak peresnik s 30 mg odda 30 mg albiglutida v prostornini 0,5 ml. - Topilo je voda za injekcije.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/908/004
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM EU/1/13/908/004
English: Talk to your doctor if you are taking acarbose and Eperzan at the same time.
Slovenian: Če sočasno jemljete akarbozo in zdravilo Eperzan, se posvetujte z zdravnikom.
English: Discontinuation of treatment
Slovenian: NAČIN IZDAJANJA ZDRAVILA
English: Once weekly Eperzan pen 50 mg
Slovenian: Peresnik zdravila Eperzan 50 mg enkrat na teden
English: Eperzan 50 mg powder and solvent for solution for injection Each pen delivers 50 mg albiglutide per 0.5 ml dose following reconstitution.
Slovenian: Vsak peresnik s 50 mg odda 50 mg albiglutida v prostornini 0,5 ml. - Topilo je voda za injekcije.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/908/001
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM EU/1/13/908/001
English: Sitagliptin 100 mg daily + Metformin 1,500 mg daily
Slovenian: Sitagliptin 100 mg na dan + metformin
English: Acute pancreatitis
Slovenian: Igla Prelepka
English: Twist Pen to Mix Medicine
Slovenian: Zasučite peresnik, da boste premešali zdravilo
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/908/003
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM EU/1/13/908/003
English: Severe gastrointestinal disease
Slovenian: Huda bolezen prebavil
English: DO NOT attach at an angle.
Slovenian: NE NAMEŠČAJTE igle pod kotom.
English: info@glaxosmithkline.dk nlinfo@gsk.com
Slovenian: GlaxoSmithKline GmbH & Co.
English: Follow the steps below in the exact order they are presented.
Slovenian: Sledite spodaj opisanim korakom v natančno takšnem zaporedju, v kakršnem so navedeni.
English: Check with your doctor, nurse or pharmacist if you are not sure.
Slovenian: Če ste negotovi, se posvetujte z zdravnikom, medicinsko sestro ali farmacevtom.
English: Target species
Slovenian: Ciljne živalske vrste
English: • The Committee considered the referral under Article 30 of Directive 2001/83/EC;
Slovenian: • odbor je obravnaval napotitev v skladu s členom 30 Direktive 2001/83/ES;
English: This may lead to hypotension and circulatory collapse.
Slovenian: To lahko vodi do hipotenzije in cirkulacijskega kolapsa.
English: The harmonisation of the quality aspects of this product is considered to be acceptable and adequately justified.
Slovenian: Šteje se, da je usklajenost vidikov kakovosti tega zdravila sprejemljiva in ustrezno utemeljena.
English: Mepivacaine was first approved in 1960 by the US Food and Drug Administration.
Slovenian: Mepivakain je prvič odobril Zvezni urad ZDA za hrano in zdravila leta 1960.
English: In addition minor editorial changes were introduced to improve readability.
Slovenian: Poleg tega so bile vključene manjše uredniške spremembe, ki omogočajo boljšo berljivost.
English: Module 3 - Quality
Slovenian: Modul 3 - Kakovost
English: The quantity to be injected should be determined by the age and weight of the child and the magnitude of the operation.
Slovenian: Količino za injiciranje je treba določiti glede na otrokovo starost in telesno maso ter velikost operacije.
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.
Slovenian: Kot previdnostni ukrep in zaradi pomanjkanja podatkov glede te populacije, ki je lahko ranljivejša, je treba uporabiti najmanjši odmerek, ki zadošča za učinkovito anestezijo.
English: In section 4.9 regarding overdose, two different types are described; absolute and relative overdose.
Slovenian: V poglavju 4.9, ki obravnava preveliko odmerjanje, sta opisani dve različni vrsti: absolutno in relativno preveliko odmerjanje.
English: Pharmacokinetic changes are also observed with aging.
Slovenian: Farmakokinetične spremembe so ugotovljene tudi pri staranju.
English: Other ingredients include sodium chloride, sodium hydroxide and water for injection.
Slovenian: Med drugimi sestavinami so natrijev klorid, natrijev hidroksid in voda za injekcije.
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).
Slovenian: V EU je bilo zdravilo Scandonest v 22 državah članicah odobreno z nacionalnim postopkom, v petih državah članicah (na Švedskem, Finskem, Portugalskem, v Španiji in na Malti) pa s postopkom z medsebojnim priznavanjem.
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.
Slovenian: Posodobljena poglavja Modula 3 vključujejo naslednja poglavja: Učinkovina, Kontrola učinkovine, Specifikacija, Končni izdelek, Opis in sestava končne snovi, Proizvodnja, Opis proizvodnega postopka in kontrole postopka, Validacija in/ali vrednotenje postopka, Kontrola pomožnih snovi, Kontrola končne snovi, Specifikacije, Analitični postopki, Sistem zapiranja vsebnika in Stabilnost.
English: Moreover information on managing dose-related toxicity and other acute emergencies has been included.
Slovenian: Dodatno so bile vključene informacija o obravnavi toksičnosti, povezane z odmerjanjem, in drugih nujnih akutnih stanj.
English: Thus, local anaesthetics should not be used in epileptic patients whose seizures are poorly controlled.
Slovenian: Zato se lokalni anestetiki ne smejo uporabljati pri epileptičnih bolnikih, katerih napadi so slabo nadzirani.
English: The maximum recommended dose is 4.4 mg/kg of body weight with an absolute maximum recommended dose of 300 mg.
Slovenian: Največji priporočeni odmerek je 4,4 mg/kg telesne mase, absolutni največji priporočeni odmerek pa ne sme preseči
English: The CHMP deemed the submitted evidence adequate to support the indication in adults and in children from 4 years of age (ca. 20 kg body weight).
Slovenian: Po mnenju odbora CHMP so predloženi dokazi zadostni za podporo indikaciji pri odraslih in otrocih, starejših od štirih let (s telesno maso približno 20 kg).
English: This recommendation is also supported by the inconsistency of recognition and professional rights of chiropodist profession across EU.
Slovenian: V prid temu priporočilu govori tudi neskladnost priznavanja in poklicnih pravic pedikerjev v državah EU.
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).
Slovenian: Besedilo za način uporabe je bilo usklajeno s standardnimi izrazi „infiltracija in perinevralna uporaba“, pri čemer so bile upoštevane zahteve Evropskega direktorata za kakovost zdravil in zdravstvenega varstva (EDQM).
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;
Slovenian: • odbor je pregledal podatke, ki jih je v podporo predlagani uskladitvi informacij o zdravilu predložil imetnik dovoljenja za promet z zdravilom, med drugim na podlagi predložene dokumentacije in znanstvene razprave v odboru;
English: The CHMP considers that the data submitted in support of the chiropody procedures indication are not adequate to establish the efficacy of using mepivacaine for all chiropody applications and recommended the deletion of this indication.
Slovenian: Odbor CHMP meni, da podatki, predloženi v podporo indikaciji za postopke pedikure, ne zadoščajo za določitev učinkovitosti uporabe mepivakaina pri vseh uporabah za pedikuro in je zato priporočil, da se ta indikacija izbriše.
English: Local anaesthetics as cardiovascular depressants exert a negative inotropic and chronotropic effect on the myocardium and produce peripheral vasodilation.
Slovenian: Lokalni anestetiki, kot so kardiovaskularni depresorji, imajo negativen inotropni in kronotropni učinek na miokardij ter povzročajo periferno vazodilatacijo.
English: The CHMP concluded that the benefit-risk balance of Scandonest and associated names remains favourable, subject to the agreed changes to the product information.
Slovenian: Odbor je zaključil, da je razmerje med tveganji in koristmi zdravila Scandonest in povezanih imen še naprej ugodno, če se upoštevajo dogovorjene spremembe informacij o zdravilu.
English: As a result of the review of mepivacaine during a worksharing procedure in accordance to Article 45 of Regulation No 1901/2006, in 2010, the use of mepivacaine is contraindicated in children below 4 years of age (and less than 20kg of body weight).
Slovenian: Kot rezultat pregleda mepivakaina med postopkom delitve dela iz leta 2010 skladno s členom 45 Uredbe št. 1901/2006 je uporaba mepivakaina kontraindicirana pri otrocih, mlajših od štirih let (s telesno maso manj kot 20 kg).
English: For the recommended doses the patient's body weight has to be taken into account.
Slovenian: Za uporabo priporočenih odmerkov je treba upoštevati telesno maso bolnika.
English: The MAH proposed harmonised dosing recommendations based on the doses studied in clinical trials and supported by pharmacodynamic and pharmacokinetic data and in line with international, European and national guidelines.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predlagal usklajena priporočila za odmerjanje, ki temeljijo na odmerkih, ki so jih proučevali v kliničnih preskušanjih, in ki jih podpirajo farmakodinamični in farmakokinetični podatki ter so skladni z mednarodnimi, evropskimi in nacionalnimi smernicami.
English: The recommended posology in children of an average 0.75 mg (0.025 ml) of mepivacaine solution per kg of body weight is in line with the work-sharing procedure led by EMA in 2010 in accordance with Article 45 of the Paediatric Regulation 1901/2006 (AT/W/0002/pdWS/001).
Slovenian: Povprečni priporočeni odmerek pri otrocih, ki znaša 0,75 mg (0,025 ml) raztopine mepivakaina na kilogram telesne mase, je v skladu s postopkom delitve dela, ki ga je leta 2010 vodila agencija EMA skladno s členom 45 Uredbe št. 1901/2006 o zdravilih za uporabo v pediatrični medicini (AT/W/0002/pdWS/001).
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.
Slovenian: Za priporočila o manjših odmerkih pri bolnikih slabšega zdravja ali s predhodnimi zdravstvenimi težavami, kot so vaskularna obliteracija, arterioskleroza ali diabetično obolenje živcev, ni zadostnih podatkov, zato jih odbor CHMP ne podpira.
English: The relevant posology section for the mepivacaine use in chiropody procedure will be removed as the CHMP supported the deletion of this indication.
Slovenian: Ustrezno poglavje o odmerjanju glede uporabe mepivakaina v postopkih pedikure se odstrani, saj je odbor CHMP podprl izbris te indikacije.
English: The CHMP agreed on a common wording, on fertility, pregnancy and lactation (section 4.6) with data supported from pre-clinical studies.
Slovenian: Odbor CHMP se je strinjal s skupnim besedilom glede plodnosti, nosečnosti in dojenja (poglavje 4.6), ki temelji na podatkih, podprtih s predkliničnimi študijami.
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.
Slovenian: Idealna hitrost injiciranja je 1 ml/min, saj ne povzroča poškodbe tkiva med anestezijo ali po njej in resnih reakcij v primeru nenamernega injiciranja v žilo.
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.
Slovenian: V poglavju 4.4 so bila opozorila prerazporejena v pet kategorij: bolniki s srčno-žilnimi boleznimi, bolniki z obolenji jeter, bolniki z obolenji ledvic, bolniki z epilepsijo in starejši bolniki.
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.
Slovenian: Poglavja 2 (Kakovostna in količinska sestava), 3 (Farmacevtska oblika), 4.7 (Vpliv na sposobnost vožnje in upravljanja strojev), 5.1 (Farmakodinamične lastnosti), 5.2 (Farmakokinetične lastnosti), 6.1 (Seznam pomožnih snovi ), 6.2 (Inkompatibilnosti), 6.3 (Rok uporabnosti), 6.4 (Posebna navodila za shranjevanje ), 6.5 (Vrsta ovojnine in vsebina) in 6.6 (Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom) so bila posodobljena v skladu z njihovo ustrezno usklajeno dokumentacijo o kakovosti (Modul 3) in najnovejšo predlogo za pregled kakovosti dokumentov.
English: Scandonest contains 30 mg/mL of mepivacaine hydrochloride.
Slovenian: Zdravilo Scandonest vsebuje 30 mg/ml mepivakainijevega klorida.
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.
Slovenian: V primeru kontraindikacij za vazokonstriktor so po mnenju odbora CHMP na voljo druge možnosti, na primer drugi lokalni anestetiki (prokain, bupivakain in lidokain), splošna anestezija in dušikov oksid.
English: Other Sections
Slovenian: Druga poglavja
English: Other warnings not related with the above categories were harmonised, such as for patients with coagulation disorder and coadministration of antiplatelet/anticoagulant medicines.
Slovenian: Druga opozorila, ki niso povezana z zgornjimi kategorijami, so bila usklajena, na primer za bolnike z motnjami koagulacije in tiste, ki sočasno prejemajo antiagregacijska/antikoagulacijska zdravila.
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.
Slovenian: Čeprav v zobozdravstvu ni medsebojnega delovanja med lokalnimi anestetiki, ki se dajejo v terapevtskih odmerkih, in standardnimi protiepileptičnimi zdravili, to pri bolnikih z nenadzorovano epilepsijo morda ne velja.
English: The MAH has provided a summary of the literature and studies to support the indication “anaesthesia in dental procedures”.
Slovenian: Imetnik dovoljenja za promet z zdravilom je pripravil povzetek literature in študij v podporo indikaciji „anestezija pri zobozdravstvenih operacijah“.
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.
Slovenian: Medsebojno delovanje z drugimi zdravili (poglavje 4.5) je povzeto v podpoglavjih o aditivnih medsebojnih delovanjih z drugimi lokalnimi anestetiki, antihistaminiki H2, sedativi, antiaritmiki, zaviralci CYP1A2 in propranololom.
English: In the presence of high blood levels, local anaesthetics cross the blood-brain barrier.
Slovenian: Kadar so lokalni anestetiki v krvi prisotni v visokih ravneh, prečkajo krvno-možgansko pregrado.
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).
Slovenian: To informacijo je treba vključiti v poglavje 4.2 povzetka glavnih značilnosti zdravila, pri čemer se je treba sklicevati na poglavje 4.5 (Medsebojno delovanje z drugimi zdravili).
English: The CHMP noted that there is literature evidence that mepivacaine provides vasoconstrictive features compared with anaesthetics from other pharmaceutical groups, however this cannot consist an indication itself.
Slovenian: Odbor je ugotovil, da so v literaturi dokazi o vazokonstriktivnih značilnostih mepivakaina v primerjavi z anestetiki drugih farmacevtskih skupin, vendar to samo po sebi ne predstavlja indikacije.
English: Changes introduced in the SmPC were consistently reflected in the labelling, with some sections left to be completed nationally.
Slovenian: Spremembe, ki so jih uvedli v povzetku glavnih značilnosti zdravila, so bile dosledno vključene v označevanje, nekaj poglavij pa je treba dopolniti na nacionalni ravni.
English: • The Committee considered the identified divergences for Scandonest and associated names, for the indications, posology, contraindications, special warnings and precaution for use, as well as the remaining sections of the SmPC, labelling and package leaflet;
Slovenian: • odbor je upošteval ugotovljene razlike za zdravilo Scandonest in povezana imena za indikacije, odmerjanje, kontraindikacije, posebna opozorila in previdnostne ukrepe ter preostala poglavja povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo;
English: • In addition, the Committee reviewed the documentation submitted by the MAH in support of the proposed harmonised Quality documentation (Module 3);
Slovenian: • odbor je prav tako pregledal dokumentacijo, ki jo je v podporo predlagani usklajeni dokumentaciji o kakovosti (Modul 3) predložil imetnik dovoljenja za promet z zdravilom;
English: Mepivacaine is largely metabolised in the liver by microsomal enzymes and the principal route of excretion is via the kidney.
Slovenian: Mepivakain se v glavnem presnavlja v jetrih z mikrosomskimi encimi, njegova glavna pot izločanja pa je skozi ledvice.
English: On 25 August 2017 Septodont on behalf of all marketing authorisation holders (MAHs) presented to the European Medicines Agency a referral under Article 30 of Directive 2001/83/EC, in order to harmonise the national summary of product characteristics (SmPC), labelling, package leaflet and quality Module 3 of the medicinal products Scandonest and associated names (see Annex I of CHMP opinion).
Slovenian: Družba Septodont je 25. avgusta 2017 v imenu vseh imetnikov dovoljenja za promet z zdravilom Evropski agenciji za zdravila predložila napotitev v skladu s členom 30 Direktive 2001/83/ES, da bi uskladili povzetek glavnih značilnosti zdravila, označevanje, navodilo za uporabo in dokumentacijo o kakovosti (Modul 3) zdravila Scandonest in povezanih imen (glejte Prilogo I k mnenju odbora CHMP).
English: Therefore, the CHMP concluded in the inclusion of the contraindications summarised below: - Hypersensitivity to the active substance (or any local anaesthetics agent of the amide type) or to any of the excipients listed in section 6.1, - Children below 4 years of age (ca. 20 kg body weight), - Severe disorders of atrioventicular conduction not compensated by pace maker, - Poorly controlled epileptic patient.
Slovenian: Odbor CHMP je zato sklenil, da se vključijo kontraindikacije, povzete v nadaljevanju: - preobčutljivost za učinkovino (ali kateri koli lokalni anestetik amidnega tipa) ali katero koli pomožno snov, navedeno v poglavju 6.1; - otroci, mlajši od štirih let (približno 20 kg telesne mase); - hude motnje atrioventrikularnega prevajanja, kadar se ne uporablja srčni spodbujevalnik; - bolniki s slabo nadzirano epilepsijo.
English: If sedatives are used to reduce patient anxiety, lower doses of the anaesthetic should be used, since there is increased risk of adverse effects when central nervous system (CNS) depressants are combined.
Slovenian: Če se sočasno uporabljajo sedativi za zmanjšanje bolnikove anksioznosti, je treba uporabiti manjše odmerke anestetika, saj pri kombinirani uporabi depresorjev centralnega živčnega sistema obstaja večje tveganje neželenih učinkov.
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.
Slovenian: Mepivakain je lokalni anestetik s srednjeročnim učinkom, ki zavira prevajanje živčnih impulzov, tako da zmanjšuje pretok natrija (Na+) med širjenjem akcijskega potenciala v živcu.
English: The statement regarding the risk of possible accumulation of the product leading to toxicity in special populations (elderly and patients with renal and hepatic impairment) has been however endorsed by the CHMP.
Slovenian: Je pa podprl trditev glede tveganja morebitnega kopičenja zdravila, ki lahko vodi do toksičnosti pri določenih populacijah (starejših in bolnikih z okvaro ledvic in jeter).
English: {(Invented) name and associated names, strength pharmaceutical form} is a local anaesthetic indicated for the local and loco-regional anaesthesia in dental surgery in adults, adolescents and children above 4 years of age (c.a.
Slovenian: Zdravilo {(izmišljeno) ime in povezana imena, jakost, farmacevtska oblika} je lokalni anestetik, indiciran za lokalno ali lokoregionalno anestezijo pri zobozdravstvenih operacijah pri odraslih, mladostnikih in otrocih, starejših od štirih let (telesna masa približno 20 kg).
English: Therefore, the CHMP recommended that the statement regarding mepivacaine's use when vasoconstrictor is contraindicated should be moved from section 4.1 to 5.1 (pharmacodynamic properties) of the SmPC.
Slovenian: Zato je priporočil, da se trditev o uporabi mepivakaina v primeru kontraindikacije vazokonstriktorja prestavi iz poglavja 4.1 v poglavje 5.1 (farmakodinamične lastnosti) povzetka glavnih značilnosti zdravila.
English: The revised therapeutic indications in section 4.1 of the SmPC are:
Slovenian: Spremenjene terapevtske indikacije v poglavju 4.1 povzetka glavnih značilnosti zdravila se glasijo:
English: No clinical data on fertility and nursing mothers are available on humans.
Slovenian: Pri ljudeh ni kliničnih podatkov o plodnosti in doječih materah.