FrancophonIA/ELRC3.0 huggingface dataset:
English: • These serious side effects include inflamed or torn tendon, muscle pain or weakness, and joint pain or swelling, walking difficulty, feeling pins and needles, burning pain, tiredness, depression, problems with memory, sleeping, vision and hearing, and altered taste and smell.
Slovenian: • Med resne neželene učinke spadajo vneta ali strgana kita, bolečine v mišicah ali šibkost mišic, bolečine v sklepih ali zatekanje sklepov, težave s hojo, občutek mravljinčenja in zbadanja, pekoča bolečina, utrujenost, depresija, težave s pomnjenjem, spanjem, vidom in sluhom ter spremenjen okus in voh.
English: • Up-to-date summary of product characteristics should be consulted for authorised indications when considering treatment with a fluoroquinolone medicine.
Slovenian: • Pri razmisleku o uporabi zdravljenja s fluorokinolonskim zdravilom je treba upoštevati odobrene indikacije v posodobljenem povzetku glavnih značilnosti zdravila, saj so bile indikacije za ta zdravila omejene.
English: The doctor will consider stopping treatment if the condition does not show any improvement after 16 weeks.
Slovenian: Zdravnik bo razmislil o prenehanju zdravljenja, če se stanje po 16 tednih ne izboljša.
English: Patientsor their carers may inject the medicine themselves if their doctor or nurse considers it appropriate.
Slovenian: Bolniki ali njihovi skrbniki lahko zdravilo sami injicirajo, če zdravnik ali medicinska sestra meni, da je to zanje primerno.
English: Further information on Dupixent can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/dupixent.
Slovenian: Nadaljnje informacije o zdravilu Dupixent so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/dupixentema.europa.eu/medicines/human/EPAR/dupixent.
English: The medicine is for long-term use and the need to continue taking the medicine should be assessed by the doctor at least yearly.
Slovenian: Zdravilo je namenjeno za dolgotrajno uporabo, potrebo po nadaljevanju jemanja zdravila pa mora zdravnik oceniti vsaj enkrat na leto.
English: What measures are being taken to ensure the safe and effective use of Dupixent?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Dupixent?
English: Dupixent received a marketing authorisation valid throughout the EU on 27 September 2017.
Slovenian: Za zdravilo Dupixent je bilo 27. septembra 2017 izdano dovoljenje za promet, veljavno po vsej Evropski uniji.
English: The European Medicines Agency therefore decided that Dupixent's benefits are greater than its risks and it can be authorised in the EU.
Slovenian: Evropska agencija za zdravila je zato sklenila, da so koristi zdravila Dupixent večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: As for all medicines, data on the use of Dupixent are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Dupixent stalno spremljajo.
English: Regarding safety, Dupixent's side effects are generally mild and manageable.
Slovenian: Kar zadeva varnost, so neželeni učinki zdravila Dupixent na splošno blagi in obvladljivi.
English: A further study was carried out in 251 adolescents aged from 12 to less than 18 years with moderate to severe atopic dermatitis.
Slovenian: Izvedena je bila dodatna študija, v kateri je sodelovalo 251 mladostnikov, starih od 12 do 18 let, z zmernim do hudim atopijskim dermatitisom.
English: Side effects reported with Dupixent are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Dupixent, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: What benefits of Dupixent have been shown in studies?
Slovenian: Kakšne koristi zdravila Dupixent so se pokazale v študijah?
English: There have been very rare cases of serum sickness (allergy to foreign proteins) and serum sickness-like reactions.
Slovenian: Zelo redki so primeri serumske bolezni (alergije na tuje beljakovine) in serumski bolezni podobne reakcije.
English: Other information about Dupixent
Slovenian: Druge informacije o zdravilu Dupixent
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Dupixent have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Dupixent upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: An overview of Dupixent and why it is authorised in the EU
Slovenian: Pregled zdravila Dupixent in zakaj je odobreno v EU
English: Why is Dupixent authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Dupixent odobreno v EU?
English: Anaphylaxis (sudden, severe allergic reaction) has been reported very rarely.
Slovenian: Zelo redko je bila opažena anafilaksa (nenadna, huda alergična reakcija).
English: For more information about using Dupixent, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Dupixent glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: What are the risks associated with Dupixent?
Slovenian: Kakšna tveganja so povezana z zdravilom Dupixent?
English: After 12 weeks of treatment, Dupixent improved patients' FEV1 (the maximum volume of air a person can breathe out in one second) by 320 ml (for 200 mg Dupixent) or 340 ml (for 300 mg Dupixent) compared with 180 ml and 210 ml for placebo.
Slovenian: Po 12 tednih zdravljenja je zdravilo Dupixent izboljšalo FEV1 (največjo prostornino zraka, ki jo lahko oseba izdihne v eni sekundi) za 320 ml (ob jemanju 200-miligramskega odmerka) ali 340 ml (ob jemanju 300-miligramskega odmerka) v primerjavi s 180 ml oziroma 210 ml ob prejemanju placeba.
English: Dupixent is a medicine used to treat patients aged 12 years or over with moderate to severe atopic dermatitis (also known as atopic eczema, when the skin is itchy, red and dry).
Slovenian: Dupixent je zdravilo, ki se uporablja za zdravljenje odraslih, starih 12 let ali več, z zmernim do hudim atopijskim dermatitisom (znanim tudi kot atopijski ekcem, kar je stanje, pri katerem je koža srbeča, rdeča in suha).
English: In adolescents weighing less than 60 kg, the 200-mg injection is used.
Slovenian: Pri mladostnikih, ki tehtajo manj kot 60 kg, se uporabi 200-miligramska injekcija.
English: In the first study, involving 1,902 patients, the number of severe flare-ups per year was 0.46 in patients taking 200 mg Dupixent and 0.52 in patients taking 300 mg Dupixent, compared with 0.87 or 0.97 in patients given placebo.
Slovenian: V prvi študiji, ki je vključevala 1 902 bolnika, je bilo število hudih izbruhov letno 0,46 pri bolnikih, ki so jemali 200 mg zdravila Dupixent, in 0,52 pri bolnikih, ki so jemali 300 mg zdravila Dupixent, v primerjavi z 0,87 oziroma 0,97 pri bolnikih, ki so prejemali placebo.
English: What is Dupixent and what is it used for?
Slovenian: Kaj je zdravilo Dupixent in za kaj se uporablja?
English: Patients with atopic dermatitis and patients with asthma produce high levels of proteins called interleukin 4 and interleukin 13 (IL-4 and IL-13), which can cause inflammation of the skin and airways leading to the symptoms of these diseases.
Slovenian: Za bolnike z atopijskim dermatitisom in tiste z astmo so značilne visoke ravni beljakovin, imenovanih interlevkin 4 in interlevkin 13 (IL-4 in IL-13), ki lahko povzročita vnetje kože in dihalnih poti, kar vodi do simptomov teh bolezni.
English: Dupixent is also used to treat severe asthma in patients aged 12 years or over whose asthma is not properly controlled by a combination of high-dose corticosteroids taken by inhalation plus another medicine used for the prevention of asthma.
Slovenian: Zdravilo Dupixent se uporablja tudi za zdravljenje hude astme pri bolnikih, starih 12 let ali več, katerih astma ni ustrezno nadzorovana s kombinacijo visokih odmerkov inhalacijskih kortikosteroidov, in drugega zdravila, ki se uporablja za preprečevanje astme.
English: Dupixent is available as pre-filled syringes containing 200 mg or 300 mg dupilumab in a solution for injection under the skin, usually in the thigh or belly.
Slovenian: Zdravilo Dupixent je na voljo v napolnjenih injekcijskih brizgah, ki vsebujejo 200 mg ali 300 mg dupilumaba v raztopini za injiciranje pod kožo, običajno v stegno ali trebuh.
English: In the first study, which involved 740 patients, participants were given Dupixent or placebo, both in combination with a topical corticosteroid (a medicine for inflammation applied to the skin).
Slovenian: V prvi študiji, ki je vključevala 740 bolnikov, so udeleženci prejemali zdravilo Dupixent ali placebo, oboje v kombinaciji s topikalnim kortikosteroidom (protivnetnim zdravilom, ki se nanese na kožo).
English: Dupixent can only be obtained with a prescription and treatment should be started by a doctor who has experience in the diagnosis and treatment of the conditions Dupixent is used to treat.
Slovenian: Predpisovanje in izdaja zdravila Dupixent je le na recept, zdravljenje z njim pa lahko uvede le zdravnik, ki ima izkušnje z diagnosticiranjem in zdravljenjem bolezni, za katere se to zdravilo uporablja.
English: The active substance in Dupixent, dupilumab, is a monoclonal antibody (a type of protein) designed to block receptors (targets) for IL-4 and IL-13.
Slovenian: Učinkovina v zdravilu Dupixent, dupilumab, je monoklonsko protitelo (vrsta beljakovine), ki zavre receptorje (prijemališča) za IL-4 in IL-13.
English: The second study, involving 210 patients, showed that in 70% of patients given Dupixent their condition improved to the extent that they could reduce their dose of corticosteroids taken by mouth compared with 42% of those given placebo.
Slovenian: V drugi študiji, ki je vključevala 210 bolnikov, je bilo ugotovljeno, da se je pri 70 % bolnikov, ki so prejemali zdravilo Dupixent, stanje izboljšalo do te mere, da so lahko zmanjšali odmerek peroralnih kortikosteroidov v primerjavi z 42 % bolnikov, ki so prejemali placebo.
English: In the treatment of asthma, Dupixent has been shown to reduce the number of asthma flare-ups and the need for oral corticosteroid treatment.
Slovenian: Pri zdravljenju astme je bilo dokazano, da zdravilo Dupixent zmanjša število izbruhov astme in potrebo po peroralnem zdravljenju s kortikosteroidi.
English: Dupixent has been shown to reduce the extent and severity of atopic dermatitis in patients with moderate to severe disease, for whom available therapies are limited.
Slovenian: Dokazali so, da zdravilo Dupixent zmanjšuje obseg in resnost atopijskega dermatitisa pri bolnikih z zmerno do hudo boleznijo, ki imajo omejene možnosti zdravljenja.
English: For all other asthma patients, the first dose is two injections of 200 mg in two different sites.
Slovenian: Za vse druge bolnike z astmo je začetni odmerek dve 200-miligramski injekciji zapored na dve različni mesti.
English: Dupixent is only for use in patients with a type of inflammation of the airways called ‘type 2 inflammation'.
Slovenian: Uporablja se samo pri bolnikih z vrsto vnetja dihalnih poti, imenovanega „vnetje tipa 2“.
English: For atopic dermatitis, the first dose in adults and adolescents weighing 60 kg or more is two injections of 300 mg in two different sites.
Slovenian: Pri atopijskem dermatitisu znaša prvi odmerek pri odraslih in mladostnikih, ki tehtajo 60 kg ali več, dve 300-miligramski injekciji zapored na dve različni mesti.
English: The most common side effect with Dupixent when used in treatment of asthma is redness at the site of injection.
Slovenian: Najpogostejši neželeni učinek zdravila Dupixent pri zdravljenju astme je pordelost na mestu injiciranja.
English: For severe asthma, in patients taking corticosteroids by mouth or patients who also have atopic dermatitis, the first dose is two injections of 300 mg in two different sites.
Slovenian: Za bolnike s hudo astmo, ki prejemajo peroralne kortikosteroide, ali bolnike, ki imajo tudi atopijski dermatitis, je začetni odmerek dve 300-miligramski injekciji zapored na dve različni mesti.
English: By blocking the receptors, dupilumab prevents IL-4 and IL-13 from working and relieves disease symptoms.
Slovenian: Dupilumab z zaviranjem teh receptorjev prepreči delovanje beljakovin IL-4 in IL-13 ter olajša simptome bolezni.
English: This is followed by one 200-mg injection every two weeks.
Slovenian: Temu sledi ena 200-miligramska injekcija vsaka dva tedna.
English: This is followed by one 300 mg injection every two weeks.
Slovenian: Temu sledi ena 300-miligramska injekcija vsak drugi teden.
English: How is Dupixent used?
Slovenian: Kako se zdravilo Dupixent uporablja?
English: For the full list of side effects and restrictions of Dupixent, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Dupixent glejte navodilo za uporabo.
English: Dupixent contains the active substance dupilumab.
Slovenian: Zdravilo Dupixent vsebuje učinkovino dupilumab.
English: In this study, after 16 weeks atopic dermatitis had cleared up or almost cleared up in around 24% of those given Dupixent every 2 weeks compared with around 2% of those given placebo.
Slovenian: V tej študiji je atopijski dermatitis po 16 tednih izginil ali skoraj izginil pri približno 24 % tistih, ki so zdravilo Dupixent prejemali vsak drugi teden, v primerjavi z okoli 2 % tistih, ki so prejemali placebo.
English: How does Dupixent work?
Slovenian: Kako zdravilo Dupixent deluje?
English: The most common side effects with Dupixent when used in treatment of atopic dermatitis are injectionsite reactions (such as redness, swelling and itching),which may affect more than 1 in 10 people, and conjunctivitis (redness and discomfort in the eye), blepharitis (inflammation of the eyelid) and cold sores, which may affect up to 1 in 10 people.
Slovenian: Najpogostejši neželeni učinki zdravila Dupixent pri zdravljenju atopijskega dermatitisa so reakcije na mestu injiciranja (kot so pordelost, otekanje in srbenje), ki se lahko pojavijo pri več kot 1 bolniku od
English: Taking the results of the other two studies together, 37% of patients treated with Dupixent every two weeks had clearing or almost clearing of their atopic dermatitis compared with 9% of patients on placebo.
Slovenian: Skupni rezultati drugih dveh študij kažejo, da je atopijski dermatitis izginil ali skoraj izginil pri 37 % bolnikov, ki so se zdravili z zdravilom Dupixent vsak drugi teden, v primerjavi z 9 % bolnikov, ki so prejemali placebo.
English: After 16 weeks of treatment, 39% of patients treated with Dupixent every two weeks in the first study showed clearing or almost clearing of their atopic dermatitis compared with 12% of patients on placebo.
Slovenian: V prvi študiji je po 16 tednih zdravljenja atopijski dermatitis izginil ali skoraj izginil pri 39 % bolnikov, ki so se z zdravilom Dupixent zdravili vsak drugi teden, v primerjavi z 12 % bolnikov, ki so prejemali placebo.
English: Dupixent was more effective than placebo (a dummy treatment) at reducing the extent and severity of atopic dermatitis in 3 main studies in patients with moderate to severe disease.
Slovenian: Zdravilo Dupixent je bilo v treh glavnih študijah pri bolnikih z zmerno do hudo boleznijo učinkovitejše od placeba (zdravila brez učinkovine).
English: Dupixent was shown to reduce the number of exacerbations (flare-ups) of asthma during treatment in 2 main studies involving patients with asthma that was not adequately controlled by a combination of high-dose inhaled corticosteroids and other medicines.
Slovenian: V dveh glavnih študijah pri bolnikih z astmo, ki ni bila ustrezno urejena s kombinacijo velikih odmerkov inhalacijskih kortikosteroidov in drugih zdravil, so dokazali, da zdravljenje z zdravilom Dupixent zmanjša število poslabšanj (izbruhov) astme.
English: Dupixent or placebo was used on its own in the other two studies involving a total of 1,379 patients.
Slovenian: V drugih dveh študijah, ki sta skupaj vključevali 1 379 bolnikov, sta se zdravilo Dupixent oziroma placebo uporabljala samostojno.
English: It is currently authorised in 12 European Union (EU) Member States (MS).
Slovenian: Trenutno je odobreno v 12 državah članicah Evropske unije (EU).
English: The mechanism of resistance was also harmonised.
Slovenian: Uskladili so tudi mehanizem odpornosti.
English: Section 1, 6.3 and 6.4 have only been partially harmonised as it is considered that these should be adapted nationally.
Slovenian: Poglavja 1, 6.3 in 6.4 so bila usklajena samo delno, saj je treba besedilo v njih sprejeti na nacionalni ravni.
English: Furthermore the committee considered the advice of the Infectious Diseases Working Party.
Slovenian: Poleg tega je odbor upošteval nasvet Delovne skupine za infekcijske bolezni;
English: Overall summary of the scientific evaluation of Amoxil and associated names (see Annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravila Amoxil in povezanih imen(glejte Prilogo I)
English: However, when considering the different sites of infection, insufficient data is available to support these potential indications.
Slovenian: Vendar so glede na različna mesta okužbe razpoložljivi podatki nezadostni, da bi podprli te morebitne indikacije.
English: Infections of the female genital tract are both aetiologically and clinically diverse.
Slovenian: Okužbe ženskih spolovil so etiološko in klinično raznolike.
English: As a result of this harmonisation procedure, the Module 3 was substantially updated and revised to include data which has become available during the years since the first marketing authorisation.
Slovenian: Kot posledica tega usklajevalnega postopka je bil Modul 3 obsežno posodobljen in revidiran, tako da vključuje podatke, ki so postali na voljo v letih po prvi izdaji dovoljenja za promet z zdravilom.
English: The treatment of acute skin infections was effective in about 60-90% of patients depending on the study.
Slovenian: Zdravljenje akutnih kožnih okužb je bilo učinkovito pri približno 60-90 % bolnikov, kar je bilo odvisno od študije.
English: Due to the divergent national decisions taken by Member States concerning the authorisation of the above-mentioned products (and its associated names), the European Commission notified the European Medicines Agency of an official referral under Article 30 of Directive 2001/83/EC in order to resolve divergences amongst the nationally authorised product information and thus to harmonise its divergent product information across the EU.
Slovenian: Zaradi razhajajočih se nacionalnih odločitev, ki so jih sprejele države članice v zvezi z odobritvijo zgoraj navedenega zdravila (in povezanih imen), je Evropska komisija obvestila Evropsko agencijo za zdravila o uradni napotitvi v skladu s členom 30 Direktive 2001/83/ES, z namenom razrešitve razhajanj med nacionalno odobrenimi informacijami o zdravilu in uskladitve razhajajočih se informacij po vsej EU.
English: Therefore, these two possible regimens have been reflected in order for the prescriber to tailor the dosing regimen to the needs of the patient and to improve patient compliance.
Slovenian: Zato sta bila vključena oba mogoča režima, saj predpisovalcu omogočata prilagajanje režima odmerjanja potrebam bolnika in izboljšanje bolnikovega upoštevanja zdravljenja.
English: The few studies presented include different conditions, which further decreases the evidence in support for each condition.
Slovenian: Nekaj predloženih študij vključuje različne pogoje, kar še dodatno zmanjša dokaze, ki bi podprli zdravljenje pri posameznih stanjih.
English: Available data in animal and human do not suggest a reproductive toxicity.
Slovenian: Razpoložljivi podatki pri živalih in človeku ne kažejo vpliva na sposobnost razmnoževanja.
English: The quality of the product is considered satisfactory.
Slovenian: Kakovost zdravila velja za sprejemljivo.
English: Generally, cure rates were lower than in other indications with a high incidence of relapse and recurrence.
Slovenian: Navadno so bili deleži ozdravitve manjši kot pri drugih indikacijah z veliko incidenco relapsov in ponovitev bolezni.
English: The wording on the pharmacotherapeutic group, mechanism of action and ATC code was harmonised.
Slovenian: Besedilo o farmakoterapevtski skupini, mehanizmu delovanja in oznaki ATC je bilo usklajeno.
English: However, in some patient groups (especially in infants and children) drug administration every 8 hours may give rise to some problems of compliance.
Slovenian: Vendar lahko uporaba vsakih 8 ur pri nekaterih bolnikih (predvsem pri dojenčkih in otrocih) povzroči določene težave pri upoštevanju režima.
English: The efficacy rates for amoxicillin were around 80%, which is comparable to the different active controls used in the studies presented.
Slovenian: Delež učinkovitosti amoksicilina je bil približno 80-odstoten, kar je primerljivo z različnimi aktivnimi kontrolami, ki so bile uporabljene v predstavljenih študijah.
English: The breakpoint table was updated based on EUCAST (version 4) dated 01 January 2014.
Slovenian: Preglednica z mejnimi vrednostmi je bila posodobljena skladno z ugotovitvami združenja EUCAST (različico 4) z dne 1. januarja 2014.
English: The content of this section was the same across MSs, however the wording used varied slightly.
Slovenian: Vsebina tega poglavja je bila enaka v vseh državah članicah, vendar se je uporabljeno besedilo rahlo razlikovalo.
English: A harmonised wording of the warning around the potential interference with diagnostic tests already present in 5 member states was also proposed to be implemented across all MS, which was accepted.
Slovenian: Predlagali so tudi, naj se usklajeno besedilo opozorila glede morebitnih motenj pri diagnostičnih preiskavah, ki je že prisotno v petih državah članicah, vključi v vseh državah članicah, kar je bilo sprejeto.
English: However higher cure rates were observed with longer treatment duration (7-10 days) and when the causative organisms were susceptible to amoxicillin.
Slovenian: Vendar so večje deleže ozdravitve opazili pri daljšem zdravljenju (7-10 dni) in kadar so bili povzročitelji občutljivi za amoksicilin.
English: For all indications, to encourage the responsible use of antibacterial agents and to direct prescribers to take note of any existing national or local guidance and opinions on how antibacterial agents should be used the following sentence will be included in this section: “Consideration should be given to official guidance on the appropriate use of antibacterial agents”.
Slovenian: Pri vseh indikacijah se bo za spodbujanje odgovorne uporabe antibiotikov in usmerjanje predpisovalcev, naj upoštevajo vse nacionalne ali lokalne smernice ter mnenja o ustrezni uporabi antibiotikov, v tem poglavju uporabil naslednji stavek: „Upoštevati je treba uradne smernice za ustrezno uporabo antibiotikov“.
English: Peptidoglycan is an integral structural component of the bacterial cell wall and serves to maintain the shape and integrity of the cell.
Slovenian: Peptidoglikan je integralna strukturna sestavina stene bakterijske celice in vzdržuje obliko in neokrnjenost celice.
English: The use of parenteral formulation showed similar results to the oral formulation.
Slovenian: Pri uporabi parenteralne formulacije so ugotovili podobne rezultate kot pri peroralni formulaciji.
English: The CHMP concluded that the risks associated with them were considered sufficiently addressed by wording in other sections of the PI and were removed from this section.
Slovenian: Odbor CHMP je sklenil, da so bila tveganja, povezana z njimi, zadostno obravnavana v besedilih drugih poglavjih navodila za uporabo, zato so bila odstranjena iz tega poglavja.
English: Inhibition of peptidoglycan synthesis leads to weakening of the structure, usually followed by cell lysis and bacterial death.
Slovenian: Zaviranje sinteze peptidoglikanov povzroča oslabitev strukture, čemur navadno sledi celična liza in bakterijska smrt.