FrancophonIA/ELRC3.0 huggingface dataset:
English: You should specifically tell your doctor if you take - medicines that may increase your risk of bleeding such as: - oral anticoagulants, medicines used to reduce blood clotting, - a non-steroidal anti-inflammatory medicine, usually used to treat painful and/or inflammatory conditions of muscle or joints, - heparin or any other injectable medicine used to reduce blood clotting, - ticlopidine, other antiplatelet agent, - a selective serotonin reuptake inhibitor (including but not restricted to fluoxetine or fluvoxamine), medicines usually used to treat depression, - omeprazole or esomeprazole, medicines to treat upset stomach, - fluconazole or voriconazole, medicines to treat fungal infections, - efavirenz, a medicine to treat HIV (human immunodeficiency virus) infections,
Slovenian: Še posebej pomembno je, da obvestite svojega zdravnika, če jemljete - zdravila, ki lahko povečajo tveganje za krvavitve, kot so: o peroralni antikoagulanti, zdravila, ki preprečujejo nastanek krvnih strdkov, o nesteroidna protivnetna zdravila, ki se običajno uporabljajo za lajšanje bolečine in/ali vnetja mišic ali sklepov, o heparin, ali katerokoli drugo zdravilo v obliki injekcij, ki se uporablja za zmanjševanje strjevanja krvi, o tiklopidin, druga antiagregacijska zdravila, o selektivni zaviralci privzema serotonina (vključno a ne omejeno na fluoksetin ali fluvoksamin), zdravila, ki se običajno uporabljajo za zdravljenje depresije, - omeprazol ali esomeprazol, zdravila za zdravljenje težav z želodcem, - flukonazol ali vorikonazol, zdravila za zdravljenje glivičnih okužb,
English: Clopidogrel TAD contains clopidogrel and belongs to a group of medicines called antiplatelet medicinal products.
Slovenian: Zdravilo Klopidogrel TAD vsebuje klopidogrel in spada v skupino zdravil, ki se imenujejo zaviralci agregacije trombocitov.
English: As with other antiplatelet agents, clopidogrel should be used with caution in patients who may be at risk of increased bleeding from trauma, surgery or other pathological conditions and in patients receiving treatment with ASA, heparin, glycoprotein IIb/IIIa inhibitors or non-steroidal anti-inflammatory drugs (NSAIDs) including Cox-2 inhibitors, or selective serotonin reuptake inhibitors (SSRIs) ), or other medicinal products associated with bleeding risk such as pentoxifylline (see section 4.5).
Slovenian: Tako kot druge antitrombotike tudi klopidogrel previdno uporabljamo pri bolnikih, pri katerih zaradi poškodbe, kirurškega posega ali drugih patoloških stanj obstaja tveganje za povečano krvavitev, in pri bolnikih, ki so na zdravljenju z ASA, s heparinom, z zaviralci glikoproteina IIb/IIIa ali z nesteroidnimi protivnetnimi zdravili (NSAIDs), vključno z zaviralci ciklooksigenaze-2 (COX-2, ali s selektivnimi zaviralci privzema serotonina (SSRI), ali z drugimi zdravili, ki so povezana s tveganjem za krvavitve, kot je pentoksifilin (glejte poglavje 4.5).
English: - You should also tell your doctor immediately if you develop a medical condition (also known as Thrombotic Thrombocytopenic Purpura or TTP) that includes fever and bruising under the skin that may appear as red pinpoint dots, with or without unexplained extreme tiredness, confusion, yellowing of the skin or eyes (jaundice) (see section 4 ‘Possible side effects').
Slovenian: - če razvijete bolezensko stanje (znano tudi kot trombotična trombocitopenična purpura ali TTP) z zvišano telesno temperaturo in modricami pod kožo, ki se lahko pojavijo kot drobne rdeče pike, z ali brez nerazložljive hude utrujenosti, zmedenosti, porumenele kože ali oči (zlatenica) (glejte poglavje 4 "Možni neželeni učinki").
English: • Adult patients suffering from acute coronary syndrome: - Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA).
Slovenian: - akutni koronarni sindrom brez elevacije ST spojnice (nestabilna angina ali miokardni infarkt brez Q zobca), vključno z bolniki, katerim je bil vstavljen stent po perkutani koronarni intervenciji, v kombinaciji z acetilsalicilno kislino (ASA - acetylsalicylic acid).
English: What Clopidogrel TAD contains - The active substance is clopidogrel.
Slovenian: Kaj vsebuje zdravilo Klopidogrel TAD - Učinkovina je klopidogrel.
English: Clopidogrel TAD 75 mg film-coated tablets clopidogrel
Slovenian: Klopidogrel TAD 75 mg filmsko obložene tablete klopidogrel
English: Clopidogrel TAD 75 mg film-coated tablets
Slovenian: Klopidogrel TAD 75 mg filmsko obložene tablete
English: Warnings and precautions If any of the situations mentioned below apply to you, you should tell your doctor before taking Clopidogrel TAD: - if you have a risk of bleeding such as - a medical condition that puts you at risk of internal bleeding (such as a stomach ulcer) - a blood disorder that makes you prone to internal bleeding (bleeding inside any tissues, organs or joints of your body).
Slovenian: Opozorila in previdnostni ukrepi Če katerokoli od spodaj navedenih stanj velja za vas, morate o tem obvestiti svojega zdravnika, preden boste vzeli zdravilo Klopidogrel TAD: - če pri vas obstaja tveganje za krvavitev, kot je: - zdravstveno stanje s tveganjem za notranjo krvavitev (rana na želodcu), - krvna motnja, zaradi katere ste bolj nagnjeni k notranji krvavitvi (krvavitev v tkivih, organih ali sklepih vašega telesa), - nedavna huda poškodba, - nedavni kirurški poseg (tudi na zobeh), - načrtovan kirurški poseg (tudi na zobeh) v naslednjih sedmih dneh; - če ste imeli strdek v možganski arteriji (ishemična kap), ki se je pojavil v zadnjih sedmih dneh.
English: • Adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease.
Slovenian: - odraslih bolnikih z miokardnim infarktom (od nekaj dni do manj kot 35 dni), ishemično kapjo
English: TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
Slovenian: TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Nemčija
English: Thrombotic thrombocytopenic purpura (TTP) (see section 4.4), aplastic anaemia, pancytopenia, agranulocytosis, severe thrombocytopenia, aquired haemophilia A, granulocytopenia, anaemia
Slovenian: Bolezni krvi in limfatičnega sistema trombocitopenija, levkopenija, eozinofilija nevtropenija, vključno s hudo nevtropenijo trombotična trombocitopenična purpura (TTP) (glejte poglavje 4.4), aplastična anemija, pancitopenija, agranulocitoza, huda trombocitopenija, pridobljena hemofilija A, granulocitopenija, anemija
English: Clopidogrel should be given as a single daily dose of 75 mg.
Slovenian: Odmerjanje - Odrasli in starejši bolnik Klopidogrel dajemo kot enkratni dnevni odmerek po 75 mg.
English: - If you cut or injure yourself, it may take longer than usual for bleeding to stop.
Slovenian: - se lahko krvavitev ustavi počasneje kot ponavadi, če se urežete ali poškodujete.
English: Marketing Authorisation Holder TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
Slovenian: Imetnik dovoljenja za promet z zdravilom TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Nemčija
English: Tél/Tel: + 32 (0) 487 50 73 62 (BE)
Slovenian: KRKA Belgium, SA. Tél/Tel: + 32 (0) 487 50 73 62 (BE)
English: If you forget to take a dose of Clopidogrel TAD, but remember within 12 hours of your usual time, take your tablet straightaway and then take your next tablet at the usual time.
Slovenian: Če ste pozabili vzeti odmerek in od tega ni minilo več kot 12 ur, ga vzemite takoj, ko se spomnite.
English: Clopidogrel TAD is taken by adults to prevent blood clots (thrombi) forming in hardened blood vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, heart attack, or death).
Slovenian: Proces je znan kot aterotromboza in lahko povzroči aterotrombotične dogodke (kot so kap, srčni napad ali smrt).
English: As a precautionary measure, breast-feeding should not be continued during treatment with Clopidogrel TAD.
Slovenian: Iz varnostnih razlogov naj matere, ki se zdravijo z zdravilom Klopidogrel TAD, ne dojijo.
English: Clopidogrel was not shown to alter fertility in animal studies.
Slovenian: Plodnost Šudije na živalih niso pokazale, da bi klopidogrel vplival na plodnost.
English: How to store Clopidogrel TAD
Slovenian: Shranjevanje zdravila Klopidogrel TAD
English: Luxembourg/Luxemburg KRKA Belgium, SA.
Slovenian: Luxembourg/Luxemburg
English: Side effects with frequency not known (frequency cannot be estimated from the available data): Hypersensitivity reactions with chest or abdominal pain, persistent low blood sugar symptoms.
Slovenian: Preobčutljivostne reakcije z bolečinami v prsih ali trebuhu, vztrajajoči znaki nizke vrednosti sladkorja v krvi.
English: The most common side effect is bleeding.
Slovenian: Najpogostejši neželeni učinek, o katerem so poročali med zdravljenjem z zdravilom Klopidogrel TAD, je krvavitev.
English: This point was not addressed in any of the trials.
Slovenian: Tega dejstva niso upoštevali v nobenem preskušanju.
English: The correct diagnosis includes both clinical and radiological criteria.
Slovenian: Pravilna diagnoza zajema tako klinična kot radiološka merila.
English: Overall summary of the scientific evaluation of diacerein containing medicinal products (see Annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravil, ki vsebujejo diacerein (glejte Prilogo I)
English: In order to minimise these risks several measures were proposed.
Slovenian: Za zmanjšanje teh tveganj so bili predlagani različni ukrepi.
English: In addition, in both cases the study authors reported no difference between groups on analgesic consumption.
Slovenian: Poleg tega avtorji študije v nobenem primeru niso poročali o razlikah med skupinami glede uporabe analgetikov.
English: • The PRAC considered that several new measures should be implemented to minimise these risks.
Slovenian: • odbor PRAC je menil, da je treba za zmanjšanje teh tveganj sprejeti številne nove ukrepe.
English: In addition, the missing data and their handling were considered problematic from a statistical point of view.
Slovenian: Poleg tega so bili s statističnega vidika problematični manjkajoči podatki in ravnanje z njimi.
English: Because of the limited information available on these cases, the PRAC could not conclude on this risk but a cutaneous toxicity of diacerein could not be excluded.
Slovenian: Zaradi omejenih informacij, ki so na voljo o teh primerih, odbor PRAC ni mogel zaključiti o tem tveganju, vendar pa toksičnih učinkov diacereina na kožo ni mogel izključiti.
English: Safety issues
Slovenian: Vidiki varnosti
English: The agreed new data lock point (DLP) of 31 December 2014 for all diacerein-containing medicinal products will be reflected in the list of Union reference dates (EURD list).
Slovenian: Dogovorjeni novi datum zaključka vnosa podatkov za vsa zdravila, ki vsebujejo diacerein, 31. december 2014, bo vključen v seznam referenčnih datumov Unije (seznam EURD).
English: This constituted a concern for the PRAC and it has to be noted that these investigations exposed the patients to invasive examination (i.e. colonoscopy with biopsy).
Slovenian: Odbor PRAC je bil zaradi tega zaskrbljen, poleg tega pa je treba izpostaviti tudi to, da so bili bolniki med hospitalizacijo izpostavljeni invazivni preiskavi (tj. kolonoskopiji z biopsijo).
English: However, the quality of the studies was heterogeneous and publication bias could not be excluded since only published trials and nonpublished trials sponsored by the companies were included in the systematic reviews.
Slovenian: Vendar pa je bila kakovost študij različna, izključiti pa ni mogoče niti pristranskosti objav, saj so bila v sistematske preglede vključena samo objavljena preskušanja in neobjavljena preskušanja, ki so jih sponzorirale družbe.
English: Even though its mechanism of action is not completely known, it differs from non-steroidal anti-inflammatory drugs (NSAIDs) as it does not inhibit prostaglandin synthesis nor affect its levels.
Slovenian: Njegov mehanizem delovanja ni popolnoma znan, vendar se razlikuje od nesteroidnih protivnetnih zdravil (NSAID), saj ne zavira sinteze prostaglandinov, niti ne vpliva na njihovo koncentracijo.
English: In general, treatment includes non-pharmacological therapies such as weight control, physical therapy, exercise, patient education as well as pharmacological intervention.
Slovenian: Zdravljenje običajno vključuje nefarmakološke ukrepe, kot so uravnavanje telesne mase, fizioterapija, telesna vadba in izobraževanje bolnikov, ter farmakološko posredovanje.
English: Double blind placebo controlled clinical trials performed during the last 20 years showed heterogeneous results, which may be explained by the usual high placebo effect in this kind of indications.
Slovenian: Dvojno slepa s placebom kontrolirana klinična preskušanja, ki so jih izvedli v zadnjih 20 letih, so dala različne rezultate, ki jih je mogoče pojasniti z običajno visoko stopnjo placebo učinka pri tovrstnih indikacijah.
English: The PRAC recommended not to use diacerein-containing medicinal product for patients older than 65 years, but did not consider it as a contraindication.
Slovenian: Odbor PRAC je priporočil, naj se zdravila, ki vsebujejo diacerein, ne uporabljajo pri bolnikih, starejših od 65 let, vendar tega ni opredelil kot kontraindikacijo.
English: It is thought that diacerein works by blocking/reducing the actions of interleukin-1β, a protein involved in the process of articular cartilage destruction and synovial inflammation (Yaron M et al., 1999; Alvarez Soria et al., 2008; Legendre F et al., 2009).
Slovenian: Diacerein domnevno deluje tako, da zavira/zmanjšuje delovanje interlevkina-1β, beljakovine, ki sodeluje v procesu propadanja sklepnega hrustanca in sinovialnega vnetja (Yaron M. et al., 1999; Alvarez Soria et al., 2008; Legendre F. et al., 2009).
English: Furthermore, the PRAC considered that periodic updated safety reports (PSURs) should be submitted on a yearly basis.
Slovenian: Poleg tega je odbor PRAC menil, da je treba vsako leto predložiti redno posodobljena poročila o varnosti zdravila (PSUR).
English: The main studies evaluating structural progression or disease modifying properties in OA ((i) Echodiah study (Dougados et al. 2001) with 255 patients in the diacerein arm and 252 under placebo for three years of treatment; and (ii) Pham study (2004) which included 85 patients in the diacerein arm and 85 under placebo during one year) did not show convincing evidence of efficacy of diacerein on pain or physical functioning.
Slovenian: Glavni študiji, v katerih so ocenjevali napredovanje strukturnih sprememb ali vpliv na potek osteoartritisa ((i) študija Echodiah (Dougados et al., 2001) z 255 bolniki v skupini z diacereinom in 252 bolniki v skupini s placebom, ki so jih zdravili tri leta, in (ii) študija Pham (2004) s 85 bolniki v skupini z diacereinom in 85 bolniki v skupini s placebom, ki so jih zdravili eno leto), nista zagotovili prepričljivih dokazov o učinku diacereina na bolečino ali funkcijo sklepov.
English: In general its place in therapy is considered supplementary to the analgesics and anti-inflammatory drugs.
Slovenian: Na splošno velja, da ima svoje mesto pri zdravljenju kot dodatek k analgetikom in protivnetnim zdravilom.
English: Diacerein, as other anthraquinone derivatives, has a hepatotoxic effect for which the mechanism of action is unknown.
Slovenian: Diacerein ima tako kot drugi derivati antrakinonov hepatotoksični učinek, katerega mehanizem delovanja ni znan.
English: The effects of diacerein on pain and physical functioning of the joints have been evaluated in a number of studies as primary endpoints.
Slovenian: Učinke diacereina na bolečino in funkcijo sklepov so kot primarne končne točke ovrednotili v številnih študijah.
English: Having reviewed the final PRAC recommendation dated 6 March 2014 and the revised final PRAC recommendation , the CMDh agreed with the overall scientific conclusions and grounds for recommendation.
Slovenian: Potem ko je pregledala priporočilo odbora PRAC z dne 6. Marca 2014 in pregledano končno priporočilo odbora PRAC, se je skupina CMDh strinjala s splošnimi znanstvenimi zaključki in podlago za priporočilo.
English: • The PRAC considered the procedure under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data, for diacerein containing medicinal products;
Slovenian: • odbor PRAC je obravnaval napotitev v skladu s členom 31 Direktive 2001/83/ES, ki je bila na podlagi farmakovigilančnih podatkov sprožena za zdravila, ki vsebujejo diacerein;
English: It was also noted that in the majority of cases diacerein-induced diarrhoea started soon after treatment initiation, and seemed to be reversible after cessation of treatment.
Slovenian: Prav tako je bilo ugotovljeno, da se je driska zaradi diacereina v večini primerov pojavila kmalu po začetku zdravljenja, po njegovi prekinitvi pa je izginila.
English: Some studies revealed that 25% patients with diarrhoea during diacerein treatment experienced chronic diarrhoeas, defined by diarrhoea persisting more than 4 weeks.
Slovenian: Nekatere študije so pokazale, da je 25 % bolnikov, pri katerih se je med zdravljenjem z diacereinom pojavila driska, imelo kronične driske, opredeljene kot driske, ki so trajale več kot 4 tedne.
English: In the second clinical trial, diacerein was included in one of the control groups in a trial intending to demonstrate the effect of hyaluronic acid intra-articular injections in OA progression which was not demonstrated.
Slovenian: V drugem kliničnem preskušanju so diacerein vključili v eno od kontrolnih skupin v preskušanju, da bi dokazali učinek intraartikularnih injekcij hialuronske kisline na napredovanje OA, kar pa jim ni uspelo.
English: Overall, studies showed a modest but statistically significant effect on pain and physical functioning.
Slovenian: Na splošno so študije pokazale skromen, vendar statistično značilen učinek na bolečino in funkcijo sklepov.
English: In view of the above, the ANSM requested the PRAC to give a recommendation on the balance of benefits and risks of diacerein containing medicinal products in the authorised indications and whether their marketing authorisations should be maintained, varied, suspended or withdrawn.
Slovenian: Na podlagi navedenega je agencija ANSM zaprosila odbor PRAC, naj izda priporočilo v zvezi z razmerjem med tveganji in koristmi zdravil, ki vsebujejo diacerein, pri odobrenih indikacijah in o tem, ali naj se dovoljenja za promet s temi zdravili ohranijo, spremenijo, začasno umaknejo ali prekličejo.
English: The CMDh, having considered the revised final PRAC recommendation dated 10 July 2014 pursuant to Article 107k(1) and (2) of Directive 2001/83/EC, reached a position on the variation of the marketing authorisations of diacerein containing medicinal products for which the amendments to the product information are set out in annex III and subject to the condition set out in Annex IV.
Slovenian: Skupina CMDh je po proučitvi priporočila odbora PRAC z dne 10. julija 2014 v skladu s členom 107k(1) in (2) Direktive 2001/83/ES sprejela stališče glede spremembe dovoljenj za promet z zdravili, ki vsebujejo diacerein, skladno s spremembami informacij o zdravilu, opredeljenimi v Prilogi III, in pod pogojem, določenim v Prilogi IV.
English: The CMDh therefore considered that any existing information on the recommended dose in this patient population should not be deleted from section 4.2 of the SmPC and section 3 of the PL.
Slovenian: Zato je skupina CMDh menila, da se obstoječe informacije o priporočenem odmerku pri tej populaciji bolnikov ne smejo izbrisati iz poglavja 4.2 povzetka glavnih značilnosti zdravila in poglavja 3 navodila za uporabo.
English: Diacerein was mainly indicated as an oral treatment for osteoarthritis (OA), a chronic joint degenerative disease with a high prevalence in the ageing population.
Slovenian: Diacerein je bil v glavnem indiciran za peroralno zdravljenje osteoartritisa (OA), kronične degenerativne bolezni sklepov, ki je zelo razširjena med starajočim se prebivalstvom.
English: Patients should be advised to limit their alcohol intake while on treatment with diacerein.
Slovenian: Bolnikom je treba svetovati, naj med zdravljenjem z diacereinom omejijo uživanje alkohola.
English: Following the adoption of the PRAC recommendation during the November 2013 PRAC meeting, two MAHs expressed their disagreement with the initial recommendation for suspension.
Slovenian: Potem ko je odbor PRAC na seji novembra 2013 sprejel priporočilo, sta dva imetnika dovoljenja za promet z zdravilom izrazila nestrinjanje s prvotnim priporočilom za začasen umik dovoljenj za promet.
English: These included reducing the posology recommendation at the start of the treatment, and new measures such as a contraindication in patients with liver disease, a strong recommendation for patients to stop treatment as soon as diarrhoea occurs and a restriction of use in patients aged 65 years and above.
Slovenian: Ti so vključevali zmanjšanje priporočenega odmerka ob začetku zdravljenja in nove ukrepe, kot so na primer kontraindikacija pri bolnikih z boleznijo jeter, odločno priporočilo, naj bolniki prekinejo zdravljenje, takoj ko se pojavi driska, in omejitev uporabe pri bolnikih, starih 65 let ali več.
English: In addition, meta-analyses confirmed a small but consistent beneficial effect of diacerein on OA symptoms.
Slovenian: Poleg tega so metaanalize potrdile majhen, vendar dosleden ugoden učinek diacereina na simptome osteoartritisa.
English: Diacerein is a symptomatic slow acting drug in osteoarthritis (SYSADOA).
Slovenian: Diacerein je simptomatsko počasi delujoče zdravilo za osteoartritis (SYSADOA - symptomatic slow acting drug in osteoarthritis).
English: Diacerein and its active metabolite, rhein, are anthranquinone derivates.
Slovenian: Diacerein in njegov aktivni presnovek rein sta derivata antrakinona.
English: Also, diacerein is no longer recommended for patients aged 65 years and above.
Slovenian: Prav tako se diacerein ne priporoča več pri bolnikih, starejših od 65 let.
English: Additional risk minimisation measures within a Risk management Plan were not considered necessary.
Slovenian: Menil je, da v načrtu za obvladovanje tveganja ni treba predvideti dodatnih ukrepov za zmanjšanje tveganja.
English: The PRAC considered that it is of importance that patients stop their treatment with diacerein as soon as diarrhoea occurs, in order to prevent diarrhoea complications such as dehydration and hypokalaemia.
Slovenian: Odbor PRAC je menil, da je pomembno, da bolniki prekinejo zdravljenje z diacereinom, takoj ko se pojavi driska, da se preprečijo z njo povezani zapleti, kot sta dehidracija in hipokaliemija.
English: Based on the totality of the data available on the safety and the efficacy of diacerein, and considering all the risk minimisation measures proposed during assessment and the re-examination procedure, the PRAC concluded that the benefit-risk balance of diacerein-containing medicinal products remained favourable in the symptomatic treatment osteoarthritis, subject to changes to the product information and conditions.
Slovenian: Na podlagi vseh razpoložljivih podatkov o varnosti in učinkovitosti diacereina in ob upoštevanju vseh ukrepov za zmanjšanje tveganja, ki so bili predlagani med postopkom ocenjevanja ter ponovnega pregleda, je odbor PRAC zaključil, da je razmerje med tveganji in koristmi zdravil, ki vsebujejo diacerein, pri simptomatskem zdravljenju osteoartritisa še naprej ugodno pod pogojem, da se upoštevajo spremembe informacij o zdravilu in pogoji.
English: In addition treatment with diacerein should be stopped if elevation of hepatic enzymes or suspected signs or symptoms of liver damage are detected.
Slovenian: Poleg tega je treba zdravljenje z diacereinom prekiniti, če se pojavijo zvišane ravni jetrnih encimov ali znaki ali simptomi, ki bi lahko bili povezani s poškodbo jeter.
English: It is acknowledged that OA of the hip and knee is seen more frequently in an elderly population.
Slovenian: Upošteval je, da je osteoartitis kolkov in kolen pogostejši pri starejših ljudeh.