FrancophonIA/ELRC3.0 huggingface dataset:
English: • All oral formulations of methotrexate-containing medicinal products with at least one indication requiring once weekly dosing: {The following wording should be reflected:}
Slovenian: • Vse peroralne formulacije zdravil, ki vsebujejo metotreksat, z vsaj eno indikacijo, ki zahteva odmerjanje enkrat na teden: {Izraženo mora biti naslednje besedilo:}
English: Use only once a week on …………………………………………………………….. (include weekday of use in full)
Slovenian: Uporabite samo enkrat na teden v …………………………………………………………….. (napišite v celoti zapisan dan v tednu, ko je treba vzeti zdravilo)
English: • All methotrexate-containing products with at least one indication requiring treatment once a week: {The warning should read as follows:}
Slovenian: • Vsa zdravila, ki vsebujejo metotreksat, z vsaj eno indikacijo, ki zahteva zdravljenje enkrat na teden: {Opozorilo mora biti zapisano, kot sledi:}
English: • All methotrexate-containing products only with indications requiring treatment once a week: {The warning should read as follows:}
Slovenian: • Vsa zdravila, ki vsebujejo metotreksat, samo z indikacijami, ki zahtevajo zdravljenje enkrat na teden: {Opozorilo mora biti zapisano, kot sledi:}
English: • Oral formulations of methotrexate-containing medicinal products with at least one indication requiring treatment once a week:
Slovenian: • Peroralne formulacije zdravil, ki vsebujejo metotreksat, z vsaj eno indikacijo, ki zahteva zdravljenje enkrat na teden:
English: Section 3: How to use <product name> {A boxed warning should be included in this section as follows:} Important warning about the dose of <product name> (methotrexate): Use <product name> only once a week for the treatment of <indication(s) requiring dosing once a week, e.g. rheumatoid arthritis, psoriasis etc.>.
Slovenian: Zdravilo <ime zdravila> uporabljajte samo enkrat na teden za zdravljenje <indikacije/indikacij, ki zahteva/-jo odmerjanje enkrat na teden, npr. revmatoidni artritis, psoriaza itd.>.
English: • All parenteral formulations of methotrexate-containing products with at least one indication requiring treatment once a week (e.g. rheumatologic/dermatological diseases or Crohn's disease) {This section should include the following wording:} Important warning about the dosage of <product name> (methotrexate) In the treatment of <indication(s) requiring dosing once a week, e.g. rheumatoid arthritis, psoriasis, etc.)>, <product name> (methotrexate) must only be used once a week.
Slovenian: Pomembno opozorilo o odmerjanju zdravila <ime zdravila> (metotreksat) Pri zdravljenju <indikacije/indikacij, ki zahteva/-jo odmerjanje enkrat na teden, npr. revmatoidni artritis, psoriaza itd.> se zdravilo <ime zdravila> (metotreksat) sme uporabljati samo enkrat na teden.
English: • All methotrexate-containing medicinal products with at least one indication requiring once weekly dosing:
Slovenian: • Vsa zdravila, ki vsebujejo metotreksat, z vsaj eno indikacijo, ki zahteva odmerjanje enkrat na
English: PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING 7.
Slovenian: PODATKI NA VMESNI OVOJNINI
English: Tablet
Slovenian: 250 µg tablete
English: 17 January 2014 EMA/40615/2014
Slovenian: 17. januar 2014 EMA/40615/2014
English: Czech Republic, France, Greece, Hungary, Italy, Malta, Portugal and Spain.
Slovenian: Češka republika, Francija, Grčija, Madžarska, Italija, Malta, Portugalska in Španija
English: These medicines are therefore not affected by these recommendations.
Slovenian: To pomeni, da ta priporočila za ta zdravila ne veljajo.
English: The review of systemic thiocolchicoside-containing medicines was triggered on 15 February 2013 at the request of Italy, under Article 31 of Directive 2001/83/EC.
Slovenian: Pregled zdravil za sistemsko uporabo, ki vsebujejo tiokolhikozid, je bil sprožen 15. februarja 2013 na zahtevo Italije v skladu s členom 31 Direktive 2001/83/ES.
English: Educational materials for prescribers and patients will also be prepared.
Slovenian: Prav tako bo pripravljeno izobraževalno gradivo za zdravnike, ki predpisujejo ta zdravila, in bolnike.
English: • Patients who have any questions should discuss them with their doctor or pharmacist.
Slovenian: • Bolniki, ki imajo kakršna koli vprašanja, naj se posvetujejo z zdravnikom ali farmacevtom.
English: • It is not recommended for longer-term treatment of chronic conditions.
Slovenian: • Ne priporoča se za dolgotrajno zdravljenje kroničnih bolezni.
English: Women who might become pregnant must use contraception when taking these medicines.
Slovenian: Ženske, ki bi lahko zanosile, morajo med uporabo teh zdravil obvezno uporabljati kontracepcijo.
English: In theory, long-term exposure might increase the risk of cancer although there is currently no evidence of this.
Slovenian: Teoretično lahko dolgotrajna izpostavljenost poveča tudi tveganje za raka, čeprav trenutno ni dokazov za to.
English: Thiocolchicoside is authorised through national procedures in the Czech Republic, France, Greece, Hungary, Italy, Malta, Portugal and Spain.
Slovenian: Tiokolhikozid je bil po nacionalnih postopkih odobren v Češki republiki, Franciji, Grčiji, na Madžarskem, v Italiji, Malti, na Portugalskem in v Španiji.
English: It is available for use by mouth or by injection into the muscles.
Slovenian: Na voljo je za uporabo skozi usta ali za injiciranje v mišice.
English: As a result AIFA asked the CHMP to examine the safety profile of this medicine and consider what regulatory action might be appropriate.
Slovenian: Agencija AIFA je zato zaprosila odbor CHMP, naj prouči varnostni profil tega zdravila in presodi, kakšni regulativni ukrepi bi bili primerni.
English: The Committee's recommendations were based on a review of available data from pre-clinical and clinical studies, published literature and post-marketing experience, and consultations with an expert working party on medicines safety.
Slovenian: Odbor je priporočila podal na podlagi pregleda razpoložljivih podatkov iz predkliničnih in kliničnih študij, objavljene literature in izkušenj v obdobju trženja ter posvetov z delovno skupino izvedencev za varnost zdravil.
English: It is thought to act on receptors in the nervous system that are involved in the regulation of muscle function.
Slovenian: Deloval naj bi na receptorje v živčnem sistemu, ki sodelujejo pri uravnavanju delovanja mišic.
English: The CHMP therefore recommended measures to ensure thiocolchicoside-containing medicines are used as safely as possible.
Slovenian: Odbor CHMP je zato priporočil ukrepe za zagotovitev čim varnejše uporabe zdravil, ki vsebujejo tiokolhikozid.
English: In some countries it is also available as preparations to be applied to the skin, but these latter preparations are not affected by this review.
Slovenian: V nekaterih državah je na voljo tudi v obliki pripravkov, ki se nanesejo na kožo, vendar ti pripravki niso bili vključeni v ta pregled.
English: The Committee concluded that in the light of current evidence the benefit-risk for the medicine remained positive provided appropriate risk-mitigating measures were taken, including restricting the maximum dose and duration of use and contra-indicating use during pregnancy and lactation and in children.
Slovenian: Odbor je zaključil, da je glede na trenutne dokaze razmerje med tveganji in koristmi zdravila še vedno pozitivno pod pogojem, da se izvajajo ustrezni ukrepi za zmanjšanje tveganja, ki vključujejo omejitev največjega odmerka in trajanja zdravljenja ter kontraindikacijo uporabe med nosečnostjo in dojenjem ter pri otrocih.
English: Use is also contra-indicated in pregnancy and lactation or in women of childbearing potential not using contraception, as well as in children or for chronic (long-term) conditions.
Slovenian: Uporaba je kontraindicirana tudi v nosečnosti in med dojenjem, pri ženskah v rodni dobi, ki ne uporabljajo kontracepcije, ter pri otrocih ali pri kroničnih (dolgotrajnih) boleznih.
English: Thiocolchicoside metabolites were not associated with mutagenicity (changes to genes) or clastogenicity (structural damage to chromosomes).
Slovenian: Presnovki tiokolhikozida niso bili povezani z mutagenostjo (spremembe genov) ali klastogenostjo (strukturne poškodbe kromosomov).
English: • The maximum recommended oral dose is 8 mg every 12 hours; treatment duration should be no more than 7 consecutive days.
Slovenian: • Največji priporočeni peroralni odmerek je 8 mg na vsakih 12 ur, zdravljenje pa lahko traja največ 7 zaporednih dni.
English: When given intramuscularly, the maximum dose should be 4 mg every 12 hours, for up to 5 days.
Slovenian: Če se zdravilo daje intramuskularno, je največji odmerek 4 mg na vsakih 12 ur, zdravljenje pa lahko traja največ 5 dni.
English: Preparations for local application to the skin, which do not produce substantial levels of M2 in the body, are not affected by this review.
Slovenian: Pripravki za lokalno nanašanje na kožo, ki ne povzročijo večjih koncentracij presnovka M2 v telesu, v tem pregledu niso bili obravnavani.
English: The Italian medicines regulatory authority therefore requested the CHMP to carry out a full assessment of the benefit-risk balance of systemic medicines containing thiocolchicoside, and issue an opinion on whether their marketing authorisations should be maintained, varied, suspended or withdrawn across the European Union.
Slovenian: Italijanski regulativni organ za zdravila je zato zaprosil odbor CHMP, da celovito oceni razmerje med tveganji in koristmi zdravil za sistemsko uporabo, ki vsebujejo tiokolhikozid, ter izda mnenje o tem, ali naj se dovoljenja za promet s temi zdravili v Evropski uniji ohranijo, spremenijo, začasno umaknejo ali ukinejo.
English: The CHMP opinion was forwarded to the European Commission, which issued a final legally-binding decision, valid across the EU, on 17 January 2014.
Slovenian: Odbor CHMP je mnenje posredoval Evropski komisiji, ki je 17. januarja 2014 izdala končno pravno zavezujočo odločbo, ki velja za celotno EU.
English: • Prescribers will be sent a letter giving them further information on the restriction of indication of systemic thiocolchicoside.
Slovenian: • Zdravniki, ki predpisujejo ta zdravila, bodo prejeli pismo z dodatnimi informacijami o omejitvi indikacije tiokolhikozida za sistemsko uporabo.
English: This results in an abnormal number or arrangement of chromosomes, which can reduce fertility in men and, if it happens during pregnancy, can harm the developing baby in the womb.
Slovenian: Posledica je nenormalno število ali prerazporeditev kromosomov, ki lahko zmanjša plodnost moških, v primeru izpostavljenosti med nosečnostjo pa škoduje otroku, ki se razvija v maternici.
English: The CHMP opinion was forwarded to the European Commission, which endorsed it and issued a final legally-binding decision, valid across the EU, on 17 January 2014.
Slovenian: Odbor CHMP je mnenje posredoval Evropski komisiji, ki ga je potrdila in 17. januarja 2014 izdala končno pravno zavezujočo odločbo, ki velja za celotno EU.
English: • Medicines containing thiocolchicoside must never be taken if you are pregnant or breast-feeding.
Slovenian: • Zdravil, ki vsebujejo tiokolhikozid, ne smete v nobenem primeru uporabljati, če ste noseči ali če dojite.
English: On 21 November 2013 the European Medicines Agency's Committee on Human Medicinal Products (CHMP) recommended that the authorised uses for thiocolchicoside-containing medicines for use by mouth or injection should be restricted across the European Union (EU).
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri Evropski agenciji za zdravila je 21. novembra 2013 priporočil, da se po vsej Evropski uniji (EU) omeji odobrena uporaba zdravil, ki vsebujejo tiokolhikozid in se dajejo peroralno ali z injiciranjem.
English: • Medicines containing thiocolchicoside should not be used during pregnancy and lactation, nor in women of childbearing potential who are not taking appropriate contraceptive measures.
Slovenian: • Zdravila, ki vsebujejo tiokolhikozid, se ne smejo uporabljati med nosečnostjo in dojenjem ter pri ženskah v rodni dobi, ki ne uporabljajo ustreznih kontracepcijskih sredstev.
English: Aneuploidy is an established risk factor for teratogenicity, embryotoxicity or spontaneous abortion, and impaired male fertility.
Slovenian: Anevploidija je dokazan dejavnik tveganja za teratogenost, embriotoksičnost in spontani splav ter zmanjšano plodnost moških.
English: Aneuploidy is a risk factor for harm to the developing fetus, reduced fertility in men and in theory could increase the risk of developing cancer.
Slovenian: Anevploidija je dejavnik tveganja za anomalije razvijajočega se zarodka in zmanjšano plodnost moških, teoretično pa lahko tudi poveča tveganje za nastanek raka.
English: In theory it also increases the risk of cancer, although any significantly increased cancer risk would in general be dependent on long-term exposure to the causative substance.
Slovenian: V teoriji tudi poveča tveganje za nastanek raka, čeprav bi bila za znatno povečanje tega tveganja običajno potrebna dolgoročna izpostavljenost povzročitelju.
English: • New evidence has shown that thiocolchicoside is broken down in the body into a substance called M2, which in sufficient amounts can affect the genetic material of the cells.
Slovenian: • Novi dokazi so pokazali, da se tiokolhikozid v telesu razgradi v snov, imenovano presnovek M2, ki lahko, če je prisotna v zadostnih količinah, negativno vpliva na genski material v celicah.
English: These include restricting the maximum dose and number of days of treatment when given by mouth or injection.
Slovenian: Ti med drugim vključujejo omejitev največjega odmerka in omejitev zdravljenja na določeno število dni, kadar se zdravilo daje peroralnoali z injiciranjem.
English: • The current findings do not apply to topical preparations of thiocolchicoside.
Slovenian: • Trenutne ugotovitve ne veljajo za pripravke tiokolhikozida za lokalno zdravljenje.
English: • In order to minimise the amount of M2 produced in the body, and therefore any associated risks, medicines containing thiocolchicoside are now only recommended for short-term use as an addition to other treatment for pain due to permanent tightening of the muscles where there are problems with the spine, in adults and teenagers from 16 years of age.
Slovenian: • Da bi zmanjšali količino presnovka M2, ki nastane v telesu, in s tem tudi z njim povezana tveganja, so zdravila, ki vsebujejo tiokolhikozid, po novem priporočena samo za kratkotrajno uporabo in samo kot dodatek k drugim zdravilom proti bolečinam zaradi stalne napetosti mišic, ki je posledica težav s hrbtenico, pri odraslih in mladostnikih, starejših od 16 let.
English: The review of thiocolchicoside was triggered by the Italian medicines regulatory agency, AIFA, following new experimental evidence which suggested that thiocolchicoside was broken down in the body into a metabolite called M2 or SL59.0955 that could damage dividing cells, resulting in aneuploidy (an abnormal number or arrangement of chromosomes).
Slovenian: Ponovni pregled tiokolhikozida je sprožila italijanska regulativna agencija za zdravila (AIFA), potem ko so postali na voljo novi dokazi iz eksperimentalnih študij, ki so pokazali, da se tiokolhikozid v telesu razgradi v presnovek, imenovan M2 oziroma SL59.0955, ki lahko poškoduje celice, ki se delijo, in posledično povzroči anevploidijo (tj. nenormalno število ali prerazporeditev kromosomov).
English: Medicine only to be used at low doses for additional short-term relief of painful muscle contractures
Slovenian: Zdravilo se lahko uporablja samo v majhnih odmerkih za dodatno kratkotrajno lajšanje bolečega krčenja mišic
English: These medicines are now recommended only as an add-on treatment for painful muscle contractures (permanent tightening of the muscle tissue) resulting from spinal conditions in adults and adolescents 16 years of age or older.
Slovenian: Ta zdravila se po novem priporočajo samo za dopolnilno zdravljenje bolečega krčenja mišic (stalne napetosti mišičnega tkiva), ki je posledica bolezni hrbtenice pri odraslih in mladostnikih, starih 16 let ali več.
English: The CHMP reviewed the evidence, including the opinions of experts in the field of medicines safety, and concluded that aneuploidy could occur with M2 at levels not much greater than those seen after recommended doses of thiocolchicoside taken by mouth.
Slovenian: Odbor CHMP je pregledal dokaze, vključno z mnenji izvedencev s področja varnosti zdravil, in zaključil, da se lahko anevploidija pojavi pri koncentracijah presnovka M2, ki niso veliko večje od tistih, ki so jih zabeležili po peroralni uporabi priporočenih odmerkov tiokolhikozida.
English: Thiocolchicoside is a muscle relaxant that has been authorised by national procedures in several EU Member States1 for use by mouth or injection into the muscles in the treatment of painful muscular disorders.
Slovenian: Tiokolhikozid je mišični relaksant, ki je bil v več državah članicah EU1 po nacionalnih postopkih odobren za peroralno uporabo ali uporabo z injiciranjem v mišice pri zdravljenju bolečih mišičnih motenj.
English: Patients who are taking thiocolchicoside for a long-term condition should have their treatment reviewed by their doctor at the next scheduled appointment.
Slovenian: Pri bolnikih, ki jemljejo tiokolhikozid za zdravljenje dolgotrajne bolezni, mora zdravnik ob naslednjem načrtovanem obisku ponovno oceniti predpisano zdravljenje.
English: Thiocolchicoside is used as a muscle relaxant in the treatment of painful muscular conditions.
Slovenian: Tiokolhikozid se uporablja kot mišični relaksant za zdravljenje bolečih mišičnih motenj.
English: Preclinical studies indicated that the thiocolchicoside metabolite 3demethylthiocolchicine (M2, SL59.0955) may be associated with aneuploidy (abnormal chromosome number and loss of heterozygosity) in dividing cells, at levels of exposure not much greater than those achieved in the body with maximum recommended oral doses.
Slovenian: Predklinične študije so pokazale, da bi presnovek tiokolhikozida, 3-demetiltiokolhicin (M2, SL59.0955), lahko bil povezan z anevploidijo (tj. nenormalno število kromosomov in izguba heterozigotnosti) v celicah, ki se delijo, pri stopnjah izpostavljenosti, ki niso veliko večje od tistih, ki so jih zabeležili po vnosu največjih priporočenih peroralnih odmerkov v telo.
English: • Treatment should now only be given for 7 days by mouth or 5 days by injection into the muscle.
Slovenian: • Zdravljenje lahko po novem traja samo 7 dni, če se zdravilo jemlje peroralno, in 5 dni, če se daje z injiciranjem v mišico.
English: • Thiocolchicoside-containing medicines are also available for application to the skin but these do not produce the same levels of M2 in the body and are not thought to affect the genetic material of cells.
Slovenian: • Zdravila, ki vsebujejo tiokolhikozid, so na voljo tudi v oblikah za kožni nanos, vendar ta zdravila ne povzročijo enakih koncentracij presnovka M2 v telesu, zato naj ne bi vplivala na genski material v celicah.
English: • Thiocolchicoside is a medicine used in some EU countries for conditions associated with muscle pain.
Slovenian: • Tiokolhikozid je zdravilo, ki se v nekaterih državah EU uporablja za bolezni, ki jih spremljajo bolečine v mišicah.
English: In addition, the dose of thiocolchicoside by mouth or injection should be restricted.
Slovenian: Poleg tega je treba omejiti odmerek tiokolhikozida, ki se daje peroralnoali z injiciranjem.
English: This followed new evidence from experimental studies carried out by a marketing authorisation holder which suggested an effect on chromosomes by a metabolite of thiocolchicoside.
Slovenian: Povod zanj so bili novi dokazi iz eksperimentalnih študij imetnika dovoljenja za promet z zdravilom, ki so pokazali, da presnovek tiokolhikozida negativno vpliva na kromosome.
English: • Patients being treated with systemic thiocolchicoside should have their treatment reviewed at the next scheduled appointment, and appropriate alternative treatments should be considered.
Slovenian: • Zdravljenje bolnikov, ki se zdravijo s tiokolhikozidom za sistemsko uporabo, je treba ob naslednjem načrtovanem obisku ponovno oceniti in razmisliti o uporabi drugih ustreznih oblik zdravljenja.
English: • Pharmacists should refer any patients who present a repeat prescription to their treating physician.
Slovenian: • Farmacevti morajo vse bolnike, ki imajo obnovljiv recept, napotiti k njihovim lečečim zdravnikom.
English: • Systemic thiocolchicoside is recommended only as adjuvant treatment for acute muscle contractures in spinal pathology, for adults and adolescents from 16 years of age.
Slovenian: • Tiokolhikozid za sistemsko uporabo se priporoča samo za adjuvantno zdravljenje akutnega krčenja mišic pri patologiji hrbtenice pri odraslih in mladostnikih, starejših od 16 let.
English: Annex I List of the names, pharmaceutical forms, strength of the medicinal products, routes of administration, Marketing Authorisation Holders in the Member States
Slovenian: Priloga I Seznam imen, farmacevtskih oblik, jakosti zdravila, poti uporabe zdravila,
English: Concentrate for solution for infusion or solution for intrapleural or intraperitoneal use
Slovenian: Koncentrat za raztopino za infundiranje ali raztopina za intraplevralno ali intraperitonealno uporabo
English: Intravenous use Intrapleural use Intraperitoneal use
Slovenian: Intravenska uporaba Intraplevralna uporaba
English: Concentrate for solution for injection / infusion
Slovenian: Koncentrat za raztopino za injiciranje/infundira nje
English: Elsep 2 mg/ml, solution à diluer pour perfusion
Slovenian: 2 mg/ml, solution à diluer pour perfusion
English: MEDA Pharma S.p.A. Viale Brenta 18 IT-20139
Slovenian: Felice Casati, 20 IT-20124
English: In this case talk to your doctor before starting the treatment.
Slovenian: V tem primeru se posvetujte z zdravnikom pred začetkom zdravljenja.
English: The medicine should be taken after meals with a glass of water.
Slovenian: Zdravilo je treba jemati po obroku hrane s kozarcem vode.
English: 4.1 Therapeutic indications [the currently approved indications should be deleted and replaced by the following]
Slovenian: 4.1 Terapevtske indikacije [trenutno odobrene indikacije je treba izbrisati in nadomestiti z naslednjim besedilom]
English: The safety profile of tolperisone containing tablets is supported by data on more than 12,000 patients.
Slovenian: Varnostni profil tablet, ki vsebujejo tolperizon, je podprt s podatki, zbranimi na več kot 12.000 bolnikih.
English: The bioavailability of tolperisone is decreased when taken without food, therefore consistent administration in relation to meals is recommended (see also sections 4.2 and 5.2).
Slovenian: Biološka uporabnost tolperizona je zmanjšana, kadar se jemlje brez hrane, zato je priporočljivo dosledno jemanje v povezavi z obroki hrane (glejte tudi poglavji 4.2 in 5.2).
English: What you need to know before you take {invented name} Do not take {invented name}
Slovenian: Kaj morate vedeti preden boste vzeli zdravilo {Izmišljeno ime zdravila} Ne jemljite zdravila {Izmišljeno ime zdravila}
English: [the wording below should be deleted, as relevant]
Slovenian: [treba je izbrisati naslednje besedilo, kot je primerno]
English: Insufficient food intake may decrease the bioavailability of tolperisone.
Slovenian: Nezadosten vnos hrane lahko zmanjša biološko uporabnost tolperizona.
English: What {invented name} is and what it is used for Tolperisone is a medication that acts on the central nervous system.
Slovenian: Kaj je zdravilo {Izmišljeno ime zdravila} in za kaj ga uporabljamo Tolperizon je zdravilo, ki deluje na osrednji živčni sistem.
English: The majority of the cases express non-serious and self-limiting conditions.
Slovenian: Večina primerov ni izraženih kot resnih in izzvenijo sami.
English: Tolperisone does not influence the CNS effects of alcohol.
Slovenian: Tolperizon ne vpliva na učinke alkohola na CŽS.
English: If you feel these symptoms stop taking this medicine immediately and contact your doctor or the nearest emergency department.
Slovenian: Če se kateri koli od teh simptomov pojavi pri vas, takoj prenehajte jemati to zdravilo in obvestite zdravnika ali najbližji oddelek nujne medicinske pomoči.
English: Hypersensitivity reactions:
Slovenian: Preobčutljivostne reakcije: