FrancophonIA/ELRC3.0 huggingface dataset:
English: The company that holds these marketing authorisations was asked to submit any existing data in support of its safety and dosing recommendations, but no relevant data was submitted for assessment as the marketing authorisation holder concluded itself that the data is insufficient to conclude that the benefits outweigh the risks and proposed that the marketing authorisations for the parenteral formulations be revoked.
Slovenian: Na podjetje, ki ima dovoljenja za promet z zdravilom, je bila naslovljena prošnja za predložitev vseh obstoječih podatkov, ki bi podprli varnostna priporočila in priporočila za odmerjanje, vendar imetnik dovoljenj za promet z zdravilom ni predložil nobenih relevantnih podatkov, saj je sam ocenil, da nima dovolj podatkov, na podlagi katerih bi lahko ugotovili, da koristi zdravila odtehtajo tveganja, in je zato predlagal preklic dovoljenj za promet z zdravilom v parenteralnih oblikah.
English: With regard to the safety of tolperisone, the CHMP reviewed the available safety data and retained its previous conclusions that there is a risk of hypersensitivity reactions associated with tolperisone, with data showing that 10% of all reported cases of hypersensitivity were considered to be life-threatening.
Slovenian: CHMP je v zvezi z varnostjo tolperizona pregledal razpoložljive podatke o varnosti in ostal pri svojih prejšnjih zaključkih, da obstaja tveganje za preobčutljivostne reakcije, povezane s tolperizonom, saj so podatki pokazali, da je 10 % vseh primerov, pri katerih so poročali o preobčutljivosti, veljalo za primere z življenjsko nevarnimi zapleti.
English: It is important to note that the evidence of efficacy is mainly based on the results of the Stamenova study, which only included patients with post-stroke spasticity.
Slovenian: Ob tem je treba poudariti, da dokazi o učinkovitosti pretežno temeljijo na rezultatih študije Stamenove, ki pa je zajela zgolj bolnike s spastičnostjo, ki je posledica možganske kapi.
English: • The Committee is of the opinion that the evidence for clinically significant efficacy of tolperisone in the currently approved indications is extremely limited, and therefore the potential benefit for patients in these indications is outweighed by the identified risk.
Slovenian: • da odbor meni, da so dokazi o klinično pomembni učinkovitosti tolperizona v zvezi s trenutno odobrenimi indikacijami izredno skopi, zato ugotovljena tveganja odtehtajo morebitne koristi za bolnike v zvezi s temi indikacijami;
English: While no fatal case of hypersensitivity was reported, around 10% of all cases reported with tolperisone were considered to be life-threatening.
Slovenian: Čeprav ni poročil o smrtnih primerih zaradi preobčutljivosti, pa je bilo med poročili, povezanimi s tolperizonom, 10 % primerov z življenjsko nevarnimi zapleti.
English: Validation of new parameters needs to be done beforehand if proof of efficacy is to be derived from a study.
Slovenian: Če želi študija zagotoviti verodostojne dokaze o učinkovitosti, mora biti postopek validacije novih parametrov opravljen pred začetkom analiz.
English: On the efficacy side, the existing dataset is indicative of a modest effect of tolperisone in the treatment of spasticity caused by neurological disorders, but it is important to note that the evidence is mainly based on the results of the Stamenova study - which only included patients with post-stroke spasticity.
Slovenian: Obstoječi podatki v korist učinkovitosti tolperizona kažejo na zmerne učinke pri zdravljenju spastičnosti, ki je posledica nevroloških motenj, vendar je ob tem treba poudariti, da dokazi pretežno temeljijo na rezultatih študije Stamenove - ki je zajela izključno bolnike s spastičnostjo, ki je posledica možganske kapi.
English: Based on the totality of the data available on the safety and the efficacy of tolperisone and having noted the opinions of the BSWP and the SAG, the CHMP confirmed its initial conclusion that the risk of hypersensitivity is more significant than previously identified at the time of the initial marketing authorisation, and that as a consequence the benefits of tolperisone are outweighed by the risks in the indication “treatment of muscular hypertonicity and muscle spasms associated with locomotor diseases” as well as in the proposed restricted indication “short-term treatment of muscle spasms in adult patients with acute non-specific low back pain”.
Slovenian: CHMP je na podlagi vseh razpoložljivih podatkov o varnosti in učinkovitosti tolperizona ter ob upoštevanju mnenj delovne skupine BSWP in znanstvene svetovalne skupine potrdil svoj prvotni zaključek, da je tveganje za preobčutljivostne reakcije večje, kot je bilo sprva ugotovljeno pri prvotnem dovoljenju za promet z zdravilom, ter da tveganja posledično prevladajo nad koristmi tolperizona v zvezi z indikacijo „zdravljenje mišične hipertonije in mišičnih spazmov, povezanih z obolenji lokomotornega sistema“ in predlagano omejeno indikacijo „kratkoročno zdravljenje mišičnih spazmov pri odraslih bolnikih z akutno nespecifično bolečino v križu“.
English: The only double-blind, placebo-controlled studies identified where parenteral tolperisone was used and that have acceptable methodological standards were conducted in indications where efficacy has not been demonstrated, that have never been approved for the product or included only a very small number of patients in the indication of interest.. No data was submitted in support of the dosing recommendations.
Slovenian: Edine dvojno slepe, s placebom nadzorovane študije, v katerih je bil uporabljen tolperizon v parenteralni obliki in ki so zagotovile sprejemljive metodološke standarde, so bile izvedene v zvezi z indikacijami, pri katerih učinkovitost ni bila dokazana ali ki niso bile odobrene za ta izdelek, oziroma so vključile zelo majhno število bolnikov.
English: The mean improvement in the Ashworth score found in the Stamenova study was 32% in the overall ITT (intention-to-treat) population and 42% in the subgroup of patients receiving 300-450 mg/day).
Slovenian: Študija Stamenove je pri splošni populaciji vključenih bolnikov v povprečju pokazala 32-odstotno izboljšanje na Ashworthovi lestvici, pri podskupini bolnikov, ki so prejemali dnevni odmerek 300-450 mg/dan, pa 42-odstotno.
English: While the results are difficult to interpret due to the lack of a placebo control group to verify assay integrity, this randomised, double-blind actively controlled study provides supporting evidence of efficacy of tolperisone in terms of improvement of mobility in patients with spasticity caused by neurological disorders.
Slovenian: Ker analiza ni vključila kontrolne skupine s placebom, s katero bi lahko potrdili verodostojnost analize, je interpretacija rezultatov sicer otežena, vendar pa je randomizirana, dvojno slepa, aktivno nadzorovana študija zagotovila dodatne dokaze o učinkovitosti tolperizona pri izboljšanju gibalnih sposobnosti bolnikov s spastičnostjo, ki je posledica nevroloških motenj.
English: Treatment of pathologically elevated skeletal muscle tone in organic neurological disorders
Slovenian: Zdravljenje patološko povišanega tonusa skeletnih mišic pri organskih nevroloških motnjah
English: Based on the totality of the data made available on the safety and the efficacy of tolperisone, the CHMP considered that the risk of hypersensitivity is more significant than previously identified, and that as a consequence the demonstrated clinical benefits only outweigh the risks in the restricted indication symptomatic treatment of post-stroke spasticity in adults.
Slovenian: Na podlagi vseh razpoložljivih podatkov glede varnosti in učinkovitosti tolperizona je CHMP ocenil, da je tveganje za preobčutljivostne reakcije večje, kot je bilo sprva ugotovljeno, in da zato dokazane klinične koristi odtehtajo tveganja zgolj v zvezi z indikacijo simptomatsko zdravljenje spastičnosti, ki je posledica možganske kapi pri odraslih.
English: • Little's disease (infantile diplegia spastica) and other encephalopaties accompanied by dystonia
Slovenian: • cerebralna paraliza (infantilna spastična diplegija) in druge encefalopatije, ki jih spremlja distonija.
English: Taken together, the existing dataset is indicative of a modest effect of tolperisone in the treatment of spasticity caused by neurological disorders.
Slovenian: Vsi zbrani obstoječi podatki kažejo na skromne učinke tolperizona pri zdravljenju spastičnosti, ki je posledica nevroloških motenj.
English: The Committee also concluded that the benefit-risk balance of tolperisone-containing parenteral formulations is not positive, and recommends the revocation of the corresponding marketing authorisations.
Slovenian: Odbor je zaključil tudi, da razmerje med tveganji in koristmi pri parenteralnih oblikah zdravil, ki vsebujejo tolperizon, ni pozitivno, ter zato predlaga preklic pripadajočih dovoljenj za promet z zdravilom.
English: Rehabilitation after orthopaedic and trauma surgery
Slovenian: Rehabilitacija po ortopedskih in travmatoloških operacijah
English: Treatment of muscular hypertonicity and muscle spasms associated with locomotor diseases
Slovenian: Zdravljenje mišične hipertonije in mišičnih spazmov, povezanih z obolenji lokomotornega sistema
English: In conclusion the Stamenova study can be regarded as a positive study, the results of which are indicative of a clinically relevant effect of tolperisone in the treatment of patients with post-stroke spasticity.
Slovenian: Zaključimo lahko, da so rezultati študije Stamenove v korist zdravilu in kažejo na klinično pomembne učinke tolperizona pri zdravljenju bolnikov s spastičnostjo, ki je posledica možganske kapi.
English: Treatment of obliterative vascular diseases as well as syndromes due to impaired vascular innervation
Slovenian: Zdravljenje obliterativnih žilnih bolezni ter sindromov, ki so posledica motenj krvnega pretoka
English: o Is not positive for treatment of muscular hypertonicity and muscle spasms associated with locomotor disease.
Slovenian: o negativno pri zdravljenju mišične hipertonije in mišičnih spazmov, povezanih z obolenji lokomotornega sistema;
English: o Is not positive for rehabilitation after orthopaedic and trauma surgery.
Slovenian: o negativno pri rehabilitaciji po ortopedskih in travmatoloških operacijah;
English: Relevant studies also exist in the locomotor indication, the majority of which failed to demonstrate the efficacy of the product.
Slovenian: Pomembne študije so bile opravljene tudi v zvezi z učinkovitostjo tolperizona pri obolenjih lokomotornega sistema, vendar ta v večini študij ni bila dokazana.
English: Hypersensitivity reactions account for more than half of the spontaneous reports in the originators database, followed by adverse events (AEs) from the SOCs Gastrointestinal disorders, General disorders and administration site conditions and Nervous system disorders.
Slovenian: Preobčutljivostne reakcije so bile podlaga za več kot polovico spontanih poročil, zabeleženih v podatkovnih bazah originatorjev, sledijo pa jim neželeni dogodki zaradi motenj prebavil, splošnih težav in sprememb na mestu aplikacije ter bolezni živčevja (glede na organski sistem).
English: • Rehabilitation after orthopaedic and trauma surgery
Slovenian: • rehabilitacija po ortopedskih in travmatoloških operacijah;
English: o Is not positive for treatment of obliterative vascular diseases as well as syndromes due to impaired vascular innervation.
Slovenian: o negativno pri zdravljenju obliterativnih žilnih bolezni ter sindromov, ki so posledica motenj krvnega pretoka;
English: Little's disease and other encephalopaties accompanied by dystonia
Slovenian: Cerebralna paraliza in druge encefalopatije, ki jih spremlja distonija.
English: The Committee, as a consequence, concluded that the benefit-risk balance of tolperisone-containing oral formulations is positive under normal conditions of use only in the symptomatic treatment of post-stroke spasticity in adults, taking into account the changes to the product information agreed.
Slovenian: Odbor je zato sklenil, da je razmerje med tveganji in koristmi pri peroralnih oblikah zdravil, ki vsebujejo tolperizon, v normalnih pogojih uporabe pozitivno zgolj pri simptomatskem zdravljenju spastičnosti, ki je posledica možganske kapi pri odraslih, pri čemer je treba upoštevati dogovorjene spremembe informacij o zdravilu.
English: The Committee concluded that the benefit-risk balance of tolperisone-containing oral formulations is positive under normal conditions of use only in the symptomatic treatment of post-stroke spasticity in adults, subject to the changes to the product information agreed.
Slovenian: Odbor je sklenil, da je razmerje med tveganji in koristmi pri peroralnih oblikah zdravil, ki vsebujejo tolperizon, v normalnih pogojih uporabe pozitivno zgolj pri simptomatskem zdravljenju spastičnosti, ki je posledica možganske kapi pri odraslih, pri čemer je treba upoštevati dogovorjene spremembe informacij o zdravilu.
English: o Is not positive for Little's disease and other encephalopaties accompanied by dystonia.
Slovenian: o negativno pri cerebralni paralizi in drugih encefalopatijah, ki jih spremlja distonija;
English: • The Committee therefore considered that the benefit-risk balance of tolperisone-containing oral formulations under normal conditions of use: o Is positive for symptomatic treatment of post-stroke spasticity in adults.
Slovenian: • da je odbor zato ocenil, da je razmerje med tveganji in koristmi pri peroralnih oblikah zdravil, ki vsebujejo tolperizon, v normalnih pogojih uporabe:
English: EMA/785026/2012
Slovenian: EMA/670858/2012 EMEA/H/C/001173
English: The full EPAR for Clopidogrel ratiopharm can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Clopidogrel ratiopharm je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This means that Clopidogrel ratiopharm is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Plavix.
English: This is a summary of the European public assessment report (EPAR) for Clopidogrel ratiopharm.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Clopidogrel ratiopharm.
English: Clopidogrel ratiopharm is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries).
Slovenian: Zdravilo Clopidogrel ratiopharm se uporablja pri odraslih za preprečevanje aterotrombotičnih dogodkov (težav, ki jih povzročajo krvni strdki in otrdelost krvnih žil).
English: The standard dose of Clopidogrel ratiopharm is one 75 mg tablet once a day.
Slovenian: Standardni odmerek zdravila Clopidogrel ratiopharm je ena 75-miligramska tableta enkrat dnevno.
English: Clopidogrel ratiopharm can be started between a few days and 35 days after the attack;
Slovenian: Zdravilo Clopidogrel ratiopharm se lahko začne jemati od nekaj dni po napadu do 35 dni po njem;
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Clopidogrel ratiopharm.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Clopidogrel ratiopharm, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: Because Clopidogrel ratiopharm is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicine's.
Slovenian: Ker je zdravilo Clopidogrel ratiopharm generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so koristi in tveganja enaki kot pri referenčnem zdravilu.
English: The CHMP concluded that, in accordance with EU requirements, Clopidogrel ratiopharm has been shown to have comparable quality and to be bioequivalent to Plavix.
Slovenian: CHMP je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Clopidogrel ratiopharm primerljivo raven kakovosti kot zdravilo Plavix ter da mu je biološko enakovredno.
English: For more information about treatment with Clopidogrel ratiopharm, read the package leaflet (also part of the EPAR) or contact your
Slovenian: Za več informacij o zdravljenju z zdravilom Clopidogrel ratiopharm preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: The Committee recommended that Clopidogrel ratiopharm be given marketing authorisation.
Slovenian: Odbor je priporočil, da se za zdravilo Clopidogrel ratiopharm odobri dovoljenje za promet.
English: Because Clopidogrel ratiopharm is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
Slovenian: Ker je zdravilo Clopidogrel ratiopharm generično zdravilo, so bile študije z bolniki omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Plavix.
English: Clopidogrel ratiopharm is a ‘generic medicine'.
Slovenian: Clopidogrel ratiopharm je „generično zdravilo“.
English: Clopidogrel ratiopharm can be started between seven days and six months after
Slovenian: Zdravilo Clopidogrel ratiopharm se lahko začne jemati od sedem dni po napadu do šest mesecev po njem;
English: What are the benefits and risks of Clopidogrel ratiopharm?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Clopidogrel ratiopharm?
English: Other information about Clopidogrel ratiopharm
Slovenian: Druge informacije o zdravilu Clopidogrel ratiopharm
English: Clopidogrel ratiopharm is a medicine that contains the active substance clopidogrel.
Slovenian: Clopidogrel ratiopharm je zdravilo, ki vsebuje zdravilno učinkovino klopidogrel.
English: The active substance in Clopidogrel ratiopharm, clopidogrel, is an inhibitor of platelet aggregation.
Slovenian: Zdravilna učinkovina v zdravilu Clopidogrel ratiopharm, klopidogrel, je zaviralec agregacije trombocitov.
English: Clopidogrel ratiopharm can be given to the following groups
Slovenian: Lahko se daje naslednjim skupinam
English: Why has Clopidogrel ratiopharm been approved?
Slovenian: Zakaj je bilo zdravilo Clopidogrel ratiopharm odobreno?
English: The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Clopidogrel ratiopharm, veljavno po vsej Evropski uniji, odobrila dne 23. septembra 2009.
English: How has Clopidogrel ratiopharm been studied?
Slovenian: Kako je bilo zdravilo Clopidogrel ratiopharm raziskano?
English: What is Clopidogrel ratiopharm used for?
Slovenian: Za kaj se zdravilo Clopidogrel ratiopharm uporablja?
English: How is Clopidogrel ratiopharm used?
Slovenian: Kako se zdravilo Clopidogrel ratiopharm uporablja?
English: Trevaclyn with food, drink and alcohol
Slovenian: Zdravilo Trevaclyn skupaj s hrano, pijačo in alkoholom
English: • It is important to follow the advice given in section 3 How to take Trevaclyn.
Slovenian: • Pomembno je, da upoštevate navodila v poglavju 3 Kako jemati zdravilo Trevaclyn.
English: Efficacy and safety of Trevaclyn in combination with simvastatin > 40 mg were not included in this study.
Slovenian: Učinkovitosti in varnosti zdravila Trevaclyn v kombinaciji s simvastatinom > 40 mg v tej študiji niso preučevali.
English: It is not known if Trevaclyn will harm your unborn baby.
Slovenian: Ni znano, ali Trevaclyn škoduje nerojenemu otroku.
English: Your doctor will decide if Trevaclyn is right for you.
Slovenian: Zdravnik bo odločil, ali je zdravilo Trevaclyn primerno za vas.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/458/012
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/08/458/012
English: What Trevaclyn is and what it is used for
Slovenian: Kaj je zdravilo Trevaclyn in za kaj ga uporabljamo
English: Safety and effectiveness of Trevaclyn in paediatric patients under the age of 18 years have not been established.
Slovenian: Varnost in učinkovitost zdravila Trevaclyn pri pediatričnih bolnikih, mlajših od 18 let, nista bili dokazani.
English: • Take Trevaclyn once a day, in the evening or at bedtime.
Slovenian: • Zdravilo Trevaclyn vzemite enkrat na dan, zvečer ali pred spanjem.
English: Therefore, Trevaclyn should not be used in children and adolescents under 18 years of age.
Slovenian: Zato se zdravila Trevaclyn ne sme uporabljati pri otrocih in mladostnikih, mlajših od 18 let.
English: When driving vehicles or operating machines, it should be taken into account that dizziness has been reported (see section 4.8).
Slovenian: Pri vožnji oz. upravljanju s stroji je treba upoštevati, da so poročali o omotici (glejte poglavje 4.8).
English: Side effects of Trevaclyn are:
Slovenian: Neželeni učinki zdravila Trevaclyn so:
English: The frequencies of adverse reactions are ranked according to the following: Very common (≥ 1/10), Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1,000 to < 1/100), Rare (≥ 1/10,000 to < 1/1,000), Very rare (< 1/10,000), Not known (cannot be estimated from the available data).
Slovenian: Neželeni učinki so po pogostnosti razvrščeni takole: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000).
English: What you need to know before you take Trevaclyn
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Trevaclyn
English: A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy should be made taking into account the benefit of breast-feeding to the child and the benefit of Trevaclyn to the woman.
Slovenian: Odločiti se je treba med nadaljevanjem/prenehanjem dojenjain nadaljevanjem/prenehanjem zdravljenja, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja z zdravilom Trevaclyn za mater.
English: Therefore, Trevaclyn should not be used during pregnancy unless clearly necessary.
Slovenian: Zato se zdravila Trevaclyn ne sme uporabljati pri nosečnicah, razen če to ni nujno.
English: Do not take Trevaclyn if any of the above apply to you.
Slovenian: Ne vzemite zdravila Trevaclyn, če kaj od naštetega velja za vas.
English: What Trevaclyn is and what it is used for What you need to know before you take Trevaclyn How to take Trevaclyn
Slovenian: Kaj je zdravilo Trevaclyn in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Trevaclyn Kako jemati zdravilo Trevaclyn Možni neželeni učinki
English: Paediatric population Trevaclyn: No studies have been performed in paediatric patients.
Slovenian: Pediatrična populacija Trevaclyn: Študij pri pediatričnih bolnikih niso izvedli.
English: Trevaclyn has not been studied in children and adolescents who are under 18 years of age.
Slovenian: Zdravilo Trevaclyn ni raziskano pri otrocih in mladostnikih, mlajših od 18 let.
English: HDL cholesterol is often called ‘good' cholesterol because it helps keep the ‘bad' cholesterol from building up in the arteries and because it protects against heart disease.
Slovenian: HDL holesterol pogosto imenujemo "dobri" holesterol, ker pomaga preprečevati kopičenje "slabega" holesterola v arterijah in ker varuje pred boleznijo srca.
English: Trevaclyn is not recommended in pregnancy unless clearly necessary.
Slovenian: Zdravila Trevaclyn v nosečnosti ne priporočamo, razen če je nujno potrebno.
English: If you get dizzy, you should avoid driving or operating machines after taking Trevaclyn.
Slovenian: Če postanete omotični, se med jemanjem zdravila Trevaclyn izogibajte vožnji ali upravljanju strojev.
English: It is not known if Trevaclyn will pass into your breast milk.
Slovenian: Ni znano, ali Trevaclyn prehaja v materino mleko.
English: The effect on lipids was similar whether Trevaclyn was given as monotherapy or was added to ongoing statin therapy with or without ezetimibe.
Slovenian: Učinek na lipide je bil podoben, naj je bilo zdravilo Trevaclyn uporabljeno v monoterapiji ali dodano že vpeljanemu statinskemu zdravljenju, z ezetimibom ali brez njega.