FrancophonIA/ELRC3.0 huggingface dataset:
English: If you are a woman of childbearing potential, you are advised not to become pregnant and to use adequate contraception while using Raptiva.
Slovenian: Če ste ženska v rodnem obdobju, vam svetujemo, da v času uporabe zdravila Raptiva ne zanosite in
English: See section 4.8 regarding the effects on the hepatic function.
Slovenian: Za učinke na delovanje jeter glejte poglavje 4.8.
English: • Check you have the right dose, then remove the syringe from the EasyMIX adapter using a ‘twist and pull' action.
Slovenian: • Preverite, da imate pravilen odmerek in odstranite injekcijsko brizgo z adapterja EasyMIX tako
English: Your doctor will advise you what to do when insufficient response to treatment or worsening of your disease is observed.
Slovenian: Vaš zdravnik vam bo svetoval kaj storiti v primeru nezadostnega odziva ali poslabšanja bolezni (glejte tudi »Bodite posebno pozorni pri uporabi zdravila Raptiva«).
English: This will also push the bubbles out of the syringe and into the vial.
Slovenian: To bo tudi potisnilo zračne mehurčke iz injekcijske brizge v vialo.
English: The clinician should evaluate the patient to determine if the symptoms are indicative of neurological dysfunction, and if so, whether these symptoms are possibly suggestive of PML.
Slovenian: Zdravnik mora bolnika pregledati in ugotoviti, če simptomi kažejo na nevrološke motnje.
English: Each vial contains a retrievable amount of 125 mg of efalizumab.
Slovenian: Vsaka viala vsebuje razpoložljivo količino 125 mg efalizumaba.
English: The pharmacokinetics of efalizumab in paediatric patients have not been studied.
Slovenian: Farmakokinetike efalizumaba pri otrocih niso proučevali.
English: Efalizumab is cleared by nonlinear saturable elimination (dose dependent).
Slovenian: Efalizumab se izloča z nelinearno saturabilno dinamiko izločanja (od odmerka odvisno).
English: In clinical trials, mean lymphocyte counts approximately doubled relative to baseline in subjects receiving 1.0 mg/kg/wk of Raptiva.
Slovenian: V kliničnih preskušanjih se je povprečno število limfocitov približno podvojilo glede na izhodiščno vrednost pri bolnikih, ki so prejemali 1,0 mg/kg/teden Raptive.
English: • The other ingredients are polysorbate 20, histidine, histidine hydrochloride monohydrate and
Slovenian: • Pomožne snovi so polisorbat 20, histidin, histidinijev klorid monohidrat in saharoza.
English: One vial of Raptiva should be reconstituted with the solvent before use.
Slovenian: Pred uporabo morate eno vialo Raptive rekonstituirati z vehiklom.
English: • Notice symptoms of low blood platelet counts, such as easy bleeding from the gums, bruising or pinpoint red spots on the skin.
Slovenian: - Opazite simptome nizkega števila trombocitov, kot so nagnjenost h krvavitvam iz dlesni, modrice ali pojav točkastih rdečih pik na koži.
English: Not all pack sizes may be available in each
Slovenian: Na trgu ni vseh navedenih
English: You should continue to inject Raptiva as long as instructed to do so by your doctor.
Slovenian: Z injiciranjem zdravila Raptiva morate nadaljevati tako dolgo, kot vam je predpisal zdravnik.
English: Remove the shield from the injection needle.
Slovenian: Iz injekcijske igle ostranite varovalni pokrovček.
English: PACKAGE LEAFLET: INFORMATION FOR THE USER Raptiva 100 mg/ml powder and solvent for solution for injection Efalizumab
Slovenian: NAVODILO ZA UPORABO Raptiva 100 mg/ml prašek in vehikel za raztopino za injiciranje efalizumab
English: In study IMP24011, approximately half of the patients (46.8%) who were partial responders (50% to 74% improvement on PASI, similar to PGA good) after 12 weeks of Raptiva treatment achieved a PASI 75 response at week 24.
Slovenian: Srednji čas do relapsa med PASI odzivnimi bolniki je bil v razponu od 58 do 74 dni po zadnjem odmerku Raptive v začetnem obdobju zdravljenja.V študiji IMP24011, je približno polovica bolnikov (46,8 %), ki so bili delno odzivni (50 % do 75 % izboljšan PASI, podobno kot PGA - dobro) doseglo po 12 tednih zdravljenja z Raptivo PASI 75 odziv v 24 tednu.
English: Before vaccination, treatment with Raptiva should be withheld for 8 weeks and can resume 2 weeks after vaccination.
Slovenian: Zdravljenje z Raptivo je treba prekiniti 8 tednov pred cepljenjem in se ga lahko nadaljuje 2 tedna po cepljenju (glejte poglavje 4.5).
English: Patients with history of malignancies.
Slovenian: Bolniki z malignimi obolenji v preteklosti.
English: In placebo controlled clinical trials, infection rates in Raptiva-treated patients was approximately 27.3% versus 24.0% in placebo-treated patients.
Slovenian: V s placebom kontroliranih kliničnih preskušanjih je bil delež okužb bolnikov, ki so prejemali Raptivo približno 27,3 %, v primerjavi z 24,0 % pri bolnikih, ki so prejemali placebo.
English: There have been no formal drug interaction studies performed with Raptiva.
Slovenian: Za Raptivo niso izvedli nobenih študij o interakcijah z drugimi zdravili.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOX OF 1 VIAL AND 1 PRE-FILLED SYRINGE BOX OF 4 VIALS AND 4 PRE-FILLED SYRINGES BOX OF 12 VIALS AND 12 PRE-FILLED SYRINGES
Slovenian: ŠKATLA Z 1 VIALO IN 1 NAPOLNJENO INJEKCIJSKO BRIZGO ŠKATLA S 4 VIALAMI IN 4 NAPOLNJENIMI INJEKCIJSKIMI BRIZGAMI ŠKATLA Z 12 VIALAMI IN 12 NAPOLNJENIMI INJEKCIJSKIMI BRIZGAMI
English: • Gently tap the syringe to make any bubbles rise to the top of the syringe.
Slovenian: • Rahlo potrkajte po injekcijski brizgi, da se zračni mehurčki dvignejo proti vrhu brizge.
English: In addition, the incidences of specific tumours in Raptiva patients were in line with those observed in
Slovenian: Poleg tega je bila incidenca specifičnih tumorjev v skupini, ki je prejemala Raptivo v skladu z incidenco opaženo v kontrolnih populacijah bolnikov s psoriazo.
English: No lymphomas were observed following 6 months treatment with an antibody analogue of efalizumab in a 6 months study with p53 +/+ wild type mice.
Slovenian: V 6 mesecev trajajoči študiji s p53+/+ tipom divjih miši, niso po 6 mesecih terapije z analogom protitelesa efalizumabu, opazili nobenih limfomov.
English: Solvent: Type I glass pre-filled syringe.
Slovenian: Vehikel: Napolnjene injekcijske brizge iz stekla tipa I.
English: Name and address of the manufacturer(s) of the biological active substance Genentech, Inc.
Slovenian: Ime in naslov izdelovalca (izdelovalcev) biološke zdravilne učinkovine
English: Patients should not receive live and live-attenuated vaccines during Raptiva treatment.
Slovenian: Med zdravljenjem z Raptivo bolniki ne smejo prejemati živih ali živih oslabljenih cepiv.
English: Cases of inflammatory polyradiculoneuropathy have been observed in post-marketing surveillance in patients receiving Raptiva (see section 4.8).
Slovenian: Pri bolnikih, ki so prejemali Raptivo, so opazili primere vnetne poliradikulonevropatije (glejte poglavje 4.8).
English: MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH
Slovenian: A. IZDELOVALEC (IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE IN IMETNIK(I) DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE
English: 4 vials of powder for solution for injection.
Slovenian: 4 viale s praškom za raztopino za injiciranje.
English: Primary Endpoint: Proportion of Subjects with ≥75% improvement in PASI after 12 weeks of Treatment (PASI 75)
Slovenian: Primarni cilj: Delež bolnikov s ≥ 75 % izboljšanjem PASI po 12 tednih zdravljenja (PASI 75) Efalizumab a
English: 12 pre-filled syringes of 1.3 ml solvent.
Slovenian: 12 napolnjenih injekcijskih brizg z 1,3 ml vehikla.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for use with Raptiva
Slovenian: IME ZDRAVILA IN POT(I) UPORABE
English: • Rare: Side effects that may occur in 1 to 10 out of 10,000 patients;
Slovenian: V ta namen smo uporabili naslednjo klasifikacijo: - Zelo pogosti: neželeni učinki, ki se lahko pojavijo pri več kot 1 od 10 bolnikov; - Pogosti: neželeni učinki, ki se lahko pojavijo pri 1 do 10 bolnikov od 100 bolnikov; - Občasni: neželeni učinki, ki se lahko pojavijo pri 1 do 10 bolnikov od 1.000 bolnikov; - Redki: neželeni učinki, ki se lahko pojavijo pri 1 do 10 bolnikov od 10.000 bolnikov; - Zelo redki: neželeni učinki, ki se lahko pojavijo pri manj kot 1 bolniku od 10.000 bolnikov;
English: All values returned to baseline levels upon therapy
Slovenian: Vse vrednosti so se povrnile na izhodiščno vrednosti ob prekinitvi zdravljenja.
English: • Holding the EasyMIX outer cover, carefully peel back and remove the protective film using the tab.
Slovenian: • Medtem ko držite zunanji pokrovček adapterja EasyMIX, previdno odlepite in odstranite zaščitno plast, tako da primete za jeziček.
English: JC virus infection resulting in PML has been reported in post-marketing surveillance in a patient with psoriasis receiving Raptiva (see section 4.4).
Slovenian: Pri bolniku s psoriazo, ki je prejemal zdravilo Raptiva, so v okviru postmarketinških izkušenj poročali o pojavu JC virusne okužbe, ki se je kazala v obliki PML (glejte poglavje 4.4).
English: In all five studies, patients randomized to the Raptiva dose group achieved statistically significantly better responses than placebo on the primary endpoint (PASI 75 response) (see Table 2 below) and on
Slovenian: * po presoji bolnikovega zdravljenja psoriaze v preteklosti V vseh petih študijah so bolniki naključno zbrani v skupine, ki so prejemale Raptivo dosegli statistično pomembno boljše rezultate za primarni cilj študij (PASI 75 odziv) (glejte spodaj tabelo 2 ) in sekundarne cilje učinkovitosti, kot bolniki, ki so prejemali placebo.
English: Animal studies indicate an impairment of the immune function of the offspring (see section 5.3).
Slovenian: Študije na živalih kažejo na okvaro delovanja imunskega sistema pri
English: Lymphocyte count returned to baseline after therapy discontinuation.
Slovenian: Število limfocitov se je vrnilo na izhodiščno vrednost po prekinitvi zdravljenja.
English: Covariates as baseline PASI, baseline lymphocyte count and age had modest effects on clearance;
Slovenian: Kovariable kot so izhodiščni PASI, izhodiščno število limfocitov in starost so le malo vplivale na očistek; spol in etično poreklo nista imela vpliva.
English: Pull back the plunger very slightly.
Slovenian: Zelo narahlo izvlecite bat.
English: 4 pre-filled syringes of 1.3 ml solvent.
Slovenian: 4 napolnjene injekcijske brizge z 1,3 ml vehikla.
English: RELEASE
Slovenian: Dojenje
English: After subcutaneous administration of efalizumab peak plasma concentrations are reached after 12 days.
Slovenian: Po subkutani uporabi doseže efalizumab največjo plazemsko koncentracijo po 1-2 dneh.
English: Infections
Slovenian: Bolezni živčevja
English: Comparison with intravenous data indicated an average bioavailability of about 50% at the recommended dose level of 1.0 mg/kg/wk subcutaneous.
Slovenian: Primerjava z intravenskimi podatki kaže, da je povprečna biološka uporabnost priporočenega subkutanega odmerka
English: 12 vials of powder for solution for injection.
Slovenian: 12 vial s praškom za raztopino za injiciranje.
English: One vial of powder contains a retrievable amount of 125 mg of efalizumab.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena viala s praškom vsebuje razpoložljivo količino 125 mg efalizumaba.
English: Immediately withdraw the needle and clean the skin with an alcohol swab using a circular motion.
Slovenian: Vzemite si dovolj časa, da injicirate vso raztopino.Takoj izvlecite injekcijsko iglo in s krožnimi gibi očistite kožo z alkoholno blazinico.
English: 1 pre-filled syringe of 1.3 ml solvent.
Slovenian: 1 napolnjena injekcijska brizga z 1,3 ml vehikla.
English: What Raptiva looks like and contents of the pack Raptiva is presented as a powder and solvent for solution for injection.
Slovenian: Zdravilo Raptiva je v obliki praška in vehikla za raztopino za injiciranje.
English: Subsequent doses: 1 mg/kg
Slovenian: Enkratni začetni odmerek: 0,7 mg/kg 0,07 ml
English: If you discontinue treatment with Raptiva without substitution treatment, your psoriasis may significantly worsen.
Slovenian: Če prekinete zdravljenje z zdravilom Raptiva brez nadomestnega zdravljenja, se lahko vaši simptomi psoriaze pomembno poslabšajo (glejte »Bodite posebno pozorni pri uporabi zdravila Raptiva«).
English: • Attach the pre-filled syringe containing the solvent to the EasyMIX adapter with a ‘push and twist' action.
Slovenian: • Na adapter EasyMIX pritrdite napolnjeno injekcijsko brizgo z vehiklom, tako da pritisnete in obrnete.
English: 1 vial of powder for solution for injection.
Slovenian: 1 viala s praškom za raztopino za injiciranje.
English: When taking Raptiva you might be more vulnerable to infections (see Take special care with Raptiva) this effect might be enhanced by other medicines that are used to treat psoriasis and that also make you more vulnerable to infections.
Slovenian: V času zdravljenja z zdravilom Raptiva, ste lahko bolj dovzetni za okužbe (glejte »Bodite posebno pozorni pri uporabi zdravila Raptiva«).
English: Treatment of adult patients with moderate to severe chronic plaque psoriasis who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including
Slovenian: Zdravljenje odraslih bolnikov z zmerno do hudo kronično psoriazo s plaki, ki se ne odzivajo na ali imajo kontraindikacije za oziroma ne prenašajo drugega sistemskega zdravljenja, vključno s ciklosporinom, metotreksatom in PUVA (psoraleni in ultravijolični žarki A).
English: • Gently push the plunger up until the dose to be given remains in the syringe.
Slovenian: • Nežno pritiskajte bat kolikor je potrebno za nastavitev pravilnega odmerka.
English: In large placebo-controlled clinical studies, these reactions were observed in approximately 41% of Raptiva-treated patients and 24% in placebo-treated patients over 12 weeks of treatment.
Slovenian: ki so se zdravili z Raptivo in pri 24 % bolnikov, ki so prejemali placebo tekom 12 tednov zdravljenja.
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product
Slovenian: • POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, PREDPISANI IMETNIKU Izdaja zdravila je le pod omejenimi pogoji in na recept (glejte Dodatek I: Povzetek glavnih značilnosti
English: Patients should not receive live and live-attenuated vaccines while on Raptiva therapy.
Slovenian: Med zdravljenjem z Raptivo bolniki ne smejo prejemati živih ali živih oslabljenih cepiv (Glejte
English: For this purpose the following classification has been used:
Slovenian: Volumen raztopine za injiciranje je treba računati na sledeč način:
English: (n=369) b (n=162) b (n=232) b (n=450) b (n=529) b a
Slovenian: (n=369) b
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SOLVENT PRE-FILLED SYRINGE LABEL
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English: Tell your doctor or go to the local casualty and stop using Raptiva immediately if you:
Slovenian: Obvestite svojega zdravnika ali poiščite najbližjo nujno zdravniško pomoč in takoj prenehajte z uporabo zdravila Raptiva, če: - Opazite hudo preobčutljivostno ali alergijsko reakcijo, kot je npr. anafilaksija.
English: Primary Endpoint: Proportion of Subjects with ≥75% improvement in PASI after 12 weeks of
Slovenian: Primarni cilj študije: Delež bolnikov s ≥ 75 % izboljšanjem PASI po 12 tednih zdravljenja (PASI 75) Efalizumab a
English: Breast-feeding
Slovenian: Urtikarija
English: España
Slovenian: Italia
English: Packs of 1 vial of powder, 1 pre-filled syringe of solvent, 1 EasyMIX adapter for reconstitution and Packs of 4 vials of powder, 4 pre-filled syringes of solvent, 4 EasyMIX adapters for reconstitution and Packs of 12 vials of powder, 12 pre-filled syringes of solvent, 12 EasyMIX adapters for reconstitution
Slovenian: Pakiranju, ki vsebuje 12 vial s praškom, 12 napolnjenih injekcijskih brizg z vehiklom, 12 adapterjev EasyMIX za rekonstitucijo in 12 injekcijskih igel za injiciranje.
English: One case of JC virus infection resulting in PML has been reported in post-marketing surveillance in a patient with psoriasis receiving Raptiva (see section 4.8).
Slovenian: V okviru postmarketinških izkušenj so poročali o enem primeru JC virusne okužbe, ki se je kazala kot PML pri bolniku, ki je imel psoriazo in je prejemal zdravilo
English: Dosing for adults (18-64 years) and the elderly (≥ 65 years) The usual dose is an initial single injection of 0.7 mg/kg followed by weekly injections of 1.0 mg/kg.
Slovenian: Običajen odmerek je enkratna začetna injekcija z 0,7 mg/kg, ki ji sledijo tedenske injekcije z 1,0 mg/kg.
English: Nervous system disorders
Slovenian: Bolniki z oslabljenim imunskim sistemom.
English: Medicinal product subject to medical prescription.
Slovenian: Imetnik dovoljenja za promet z zdravilom
English: (n=529) b contraindicated to, or intolerant to two or
Slovenian: (n=529) b
English: • Take the Raptiva out of the refrigerator and lay out on a clean surface everything you need: o one vial containing the Raptiva powder o one pre-filled syringe containing the solvent o one EasyMIX adapter for reconstitution o one needle for subcutaneous injection, and
Slovenian: Pakiranju, ki vsebuje 1 vialo s praškom, 1 napolnjeno injekcijsko brizgo z vehiklom, 1 adapter EasyMIX za rekonstitucijo in 1 injekcijsko iglo za injiciranje.
English: Efalizumab a
Slovenian: Levkocitoza in limfocitoza:
English: France Merck Lipha Santé s.a.s.
Slovenian: Merck Serono S.p.A.
English: Prof János Borvendég (Hungary)
Slovenian: prof. János Borvendég (Madžarska)
English: The European Commission issued a decision on 09 August 2010.
Slovenian: Evropska komisija je odločbo izdala dne 9. avgusta 2010.
English: The company wanted the authorisation to be recognised in the Czech Republic, Germany, Lithuania, Poland and Slovakia (the concerned Member States).
Slovenian: Družba je želela, da bi bilo dovoljenje za promet z zdravilom priznano na Češkem, v Nemčiji, Litvi, na Poljskem in Slovaškem (zadevne države članice).
English: • efficacy and safety had not been sufficiently demonstrated;
Slovenian: • učinkovitost in varnost nista bili ustrezno dokazani;
English: 1 Article 29 of Directive 2001/83/EC as amended, referral on the grounds of potential serious risk to public health
Slovenian: 1 Člen 29 Direktive 2001/83/ES, kakor je bila spremenjena, o napotitvi na podlagi možnega resnega tveganja za javno zdravje.
English: Ref.: EMEA/CHMP/675340/2009 rev. EMEA/H/A-29/1118
Slovenian: : EMEA/CHMP/675340/2009 rev. EMEA/H/A-29/1118
English: London, 09 August 2010 Doc.
Slovenian: London, 9. avgusta 2010 Sklic dok.
English: The review was carried out under an ‘Article 29' referral1.
Slovenian: Pregled je bil izveden v skladu z napotitvenim postopkom iz člena 29.1
English: Why was Myderison reviewed?
Slovenian: Zakaj je bilo zdravilo Myderison pregledano?
English: Questions and answers on the referral for Myderison tablets containing tolperisone hydrochloride 50 and 150 mg
Slovenian: Vprašanja in odgovori v zvezi z napotitvenim postopkom za zdravilo Myderison, tablete, ki vsebujejo tolperizon hidroklorid 50 in 150 mg
English: The grounds for the referral were that the medicine did not meet the ‘well established use' criteria.
Slovenian: Razlog za napotitev je bilo neizpolnjevanje kriterijev za „dobro uveljavljeno uporabo“ zdravila.
English: • the company had not presented sufficient information on the way the medicine is dealt with by the body (pharmacokinetics);
Slovenian: • družba ni predstavila zadostnih informacij o odzivanju telesa na zdravilo (farmakokinetika);
English: • interactions with other medicines had not been adequately evaluated in pre-clinical and clinical studies.
Slovenian: • interakcije z drugimi zdravili v predkliničnih in kliničnih študijah niso bile ustrezno ovrednotene.
English: The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Myderison.
Slovenian: Evropska agencija za zdravila je končala postopek arbitraže, do katerega je prišlo po nesoglasju med državami članicami Evropske unije (EU) glede odobritve zdravila Myderison.
English: However, the Member States were not able to reach an agreement and the Hungarian medicines regulatory agency referred the matter to the CHMP for arbitration on 20 December 2008.
Slovenian: Vendar se navedene države članice niso uspele dogovoriti, zato je madžarska regulatorna agencija za zdravila dne 20. decembra 2008 zadevo napotila na CHMP v arbitražo.
English: What is Myderison?
Slovenian: Kaj je zdravilo Myderison?
English: These are criteria a company can use to obtain access to the market for medicines where the active substance has been in used for a number of years, and the company can rely on published literature to support their application for marketing authorisation.
Slovenian: To so kriteriji, na podlagi katerih lahko družba pridobi dostop do tržišča za zdravila v primerih, kadar se zdravilna učinkovina uporablja že vrsto let, družba pa lahko vlogo za pridobitev dovoljenja za promet z zdravilom utemelji z objavljeno literaturo.
English: The marketing authorisation in Hungary should also be revocated.
Slovenian: Tudi na Madžarskem je treba dovoljenje za promet z zdravilom preklicati.
English: • the dosing recommended in the prescribing information had not been adequately documented nor justified;
Slovenian: • priporočila glede odmerjanja v informacijah o predpisovanju zdravila niso ustrezno dokumentirana niti utemeljena;
English: Myderison is a medicine that is used to treat skeletal muscle spasticity (stiffness of voluntary muscles).
Slovenian: Myderison je zdravilo, ki se uporablja za zdravljenje spastičnosti skeletnih mišic (otrdelost skeletnih mišic).
English: In this instance, the concerns were that:
Slovenian: V tem primeru so bili ugotovljeni naslednji zadržki.
English: Meditop Pharmaceutical Co. Ltd submitted Myderison for mutual recognition on the basis of the initial authorisation granted by Hungary on 28 March 2006.
Slovenian: Družba Meditop Pharmaceutical Co. Ltd je za zdravilo Myderison vložila vlogo za postopek z medsebojnim priznavanjem na podlagi prvotnega dovoljenja za promet, ki je bilo odobreno na Madžarskem, dne 28. marca 2006.
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Myderison do not outweigh its risks, and therefore the marketing authorisation should not be granted in the concerned Member States.
Slovenian: Na podlagi ocene trenutno razpoložljivih podatkov in znanstvenih razprav znotraj odbora CHMP je ta zaključil, da koristi zdravila Myderison ne odtehtajo z njim povezanih tveganj, zato v zadevnih državah članicah ni mogoče odobriti dovoljenja za promet z zdravilom.
English: By reducing these impulses, tolperisone is expected to reduce muscle contraction, helping to relieve the stiffness.
Slovenian: Z zmanjševanjem teh impulzov naj bi tolperizon zmanjševal krčenje mišic ter tako pomagal blažiti otrdelost.
English: Committee also required that the marketing authorisation for Myderison in Hungary should be revocated.
Slovenian: Odbor je prav tako zahteval, da se dovoljenje za promet z zdravilom Myderison na Madžarskem prekliče.
English: The exact way tolperisone works is not known, but it is thought to act in the brain and spinal cord to reduce the nerve impulses that make the muscles contract and become rigid.
Slovenian: Natančen način delovanja tolperizona ni znan, vendar pa naj bi vplival na možgane in hrbtenjačo ter tako zmanjševal živčne impulze, ki povzročajo krčenje mišic in njihovo togost.
English: 22 January 2009
Slovenian: 4. maj 2009
English: The active substance in Myderison, tolperisone, is a centrally acting muscle relaxant.
Slovenian: Zdravilna učinkovina v zdravilu Myderison, tolperizon, je centralno delujoč mišični relaksant.