FrancophonIA/ELRC3.0 huggingface dataset:
English: Because the number of patients with these diseases is low, they are considered ‘rare', and mecasermin rinfabate was designated an ‘orphan medicine' (a medicine used in rare diseases) on 20 June 2006.
Maltese: Billi l-għadd ta' pazjenti b'dawn it-tipi ta' mard huwa wieħed baxx, dawn huma meqjusa ‘rari', u mecasermin rinfabate ġie kkategorizzat bħala ‘mediċina orfni' (mediċina użata f'mardiet rari) fl-20 ta' Ġunju 2006.
English: On 26 March 2007, Insmed Europe Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for IPLEX, for the treatment of patients with primary growth hormone insensitivity and of patients with growth hormone gene deletion who have developed neutralising antibodies to growth hormone.
Maltese: Fis-26 ta' Marzu 2007, Insmed Europe Ltd għarrfet uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) li tixtieq tirtira l-applikazzjoni tagħha għall-awtorizzazzjoni għattqegħid fis-suq għal IPLEX, għat-trattament ta' pazjenti b'insensittività primarja għall-ormon tattkabbir u ta' pazjenti bi tħassir tal-ġene ta' l-ormon tat-tkabbir li jkunu żviluppaw antikorpi li jinnewtralizzaw l-ormon tat-tkabbir.
English: In the study, 27 children (aged 3 to 15 years) have been receiving IPLEX for up to one year.
Maltese: Fl-istudju, 27 tifel u tifla (ta' bejn 3 u 15-il sena) qiegħdin jingħataw IPLEX għal perjodu ta' mhux iktar minn sena.
English: Once the company has supplied responses to the questions, the CHMP reviews them and may, before giving an opinion, ask any remaining questions at day 180.
Maltese: Ladarba l-kumpannija tkun tat it-tweġibiet għall-mistoqsijiet, isCHMP janalizzahom u jista', qabel ma jagħti opinjoni, jistaqsi xi mistoqsijiet oħra fil-180 jum.
English: In the body, natural growth hormone promotes growth in children by stimulating the body to produce IGF-I. IGF-I then stimulates the bones to grow.
Maltese: Fil-ġisem, l-ormon tat-tkabbir naturali jippromwovi t-tkabbir fit-tfal billi jistimula l-ġisem sabiex jipproduċi IGF-I.
English: How is IPLEX expected to work?
Maltese: Għal xiex kien mistenni li jintuża IPLEX?
English: The effects of IPLEX were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' IPLEX għall-ewwel ġew ittestjati fuq mudelli esperimentali qabel ma ġew studjati finnies.
English: In IPLEX, IGF-I is bound to IGFBP-3 because this mimics the way in which IGF-1 is carried in the body.
Maltese: Imbagħad IGF-I jeħel ma' IGFBP-3 għax dan jimita l-mod li bih IGF-1 jinġarr filġisem.
English: The CHMP normally takes up to 210 days to evaluate a new application.
Maltese: Is-CHMP normalment jieħu sa mitejn u għaxart ijiem biex jevalwa applikazzjoni ġdida.
English: What are the consequences of the withdrawal for patients undergoing clinical trials / compassionate use programmes with IPLEX?
Maltese: X'inhuma l-konsegwenzi ta' l-irtirar għal pazjenti li qed jieħdu sehem fl-istudji kliniċi / programmi ta' użu li jaqblu ma' IPLEX?
English: IPLEX was to be used in children with short stature whose bodies have problems handling growth hormone because:
Maltese: IPLEX kellu jintuża minn tfal ta' statura qasira li ġisimhom ikollu problemi fil-ġestjoni ta' l-ormon tat-tkabbir minħabba li:
English: • they are not able to make growth hormone and have received growth hormone in the past, but have developed neutralising antibodies, special proteins than can prevent injected growth hormone from having an effect.
Maltese: • ma jkunux kapaċi jipproduċu ormon tat-tkabbir u jkunu ngħataw ormon tat-tkabbir qabel, iżda jkunu żviluppaw antikorpi newtralizzanti, proteini speċjali li jipprevjenu li l-ormon tat-tkabbir jagħmel effett.
English: ‘Primary' means that there is no known reason for the insensitivity.
Maltese: ‘Primarja' tfisser li ma tkun magħrufa l-ebda raġuni għall-insensittività.
English: Its effectiveness has been studied in one clinical trial, which is still ongoing.
Maltese: L-effettività tiegħu ġiet studjata fi studju kliniku, li għadu għaddej.
English: The company informed the CHMP that the withdrawal will have no impact on the ongoing clinical study of the safety and efficacy of IPLEX in the treatment of Growth Hormone Insensitivity Syndrome.
Maltese: Kellu wkoll tħassib dwar il-mod li bih kienet ġiet valutata l-effettività tal-mediċina, speċjalment dwar it-tip ta' pazjenti li kienu inklużi fl-istudju kliniku.
English: QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING AUTHORISATION APPLICATION for IPLEX
Maltese: MISTOQSIJIET U TWEĠIBIET DWAR L-IRTIRAR TA' L-APPLIKAZZJONI GĦALLAWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ għal IPLEX
English: Based on the review of the data at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that IPLEX could not have been approved for the treatment of patients with primary growth hormone insensitivity and of patients with growth hormone gene deletion who have developed neutralising antibodies to growth hormone.
Maltese: Barra minn hekk, il-pazjenti ma kinux ġew trattati għal żmien twil biżżejjed biex ikun jista' jintwera li l-effett tal-mediċina ikompli meta dan jibqa' jintuża għal iktar minn sena.
English: Parenteral formulation
Maltese: Formulazzjoni parenterali
English: Tolperisone exerts its action at 3 levels:
Maltese: Tolperisone iwettaq l-azzjoni tiegħu fi tliet livelli:
English: Tolperisone-containing products are currently approved in the following EU countries: Bulgaria, Cyprus, Czech Republic, Germany, Hungary, Latvia, Lithuania, Poland, Romania and Slovak Republic.
Maltese: Il-prodotti li fihom tolperisone huma attwalment approvati f'dawn il-pajjiżi tal-UE: il-Bulgarija, Ċipru, ir-Repubblika Ċeka, il-Ġermanja, l-Ungerija, il-Latvja, il-Litwanja, il-Polonja, ir-Rumanija u rRepubblika Slovakka.
English: Therefore, in accordance with Article 32(4)(d) of Directive 2001/83/EC, the CHMP recommended:
Maltese: Għaldaqstant, skont l-Artikolu 32(4)(d) tad-Direttiva 2001/83/KE, is-CHMP irrakkomanda:
English: In particular, the CHMP re-assessed 4 pooled analyses (Alken-2005, Farkas-2011, Varga2011a and Varga-2011b) of randomised clinical trials (Pratzel 1995, Struck 2002 and Struck 2004) and requested the Biostatistics Working Party (BSWP) to give its view on the pooled analyses data.
Maltese: B'mod partikolari, is-CHMP reġa' vvaluta 4 analiżi miġbura (Alken-2005, Farkas-2011, Varga-2011a u Varga-2011b) ta' provi kliniċi każwali (Pratzel 1995, Struck 2002 u Struck 2004) u talab lill-Grupp ta' Ħidma tal-Bijostatistika (BSWP ) biex jagħti l-fehma tiegħu dwar id-dejta millanaliżi miġbura.
English: There are a few studies where a parenteral formulation was used.
Maltese: Hemm xi ftit studji li fihom intużat formulazzjoni parenterali.
English: The data available on this indication comes from two observational studies (1986 and 1989) with a total of 166 patients, where 450 mg tolperisone were given daily for a few weeks.
Maltese: Id-dejta disponibbli dwar din l-indikazzjoni ġejja minn żewġ studji ta' osservazzjoni (1986 u 1989) b'total ta' 166 pazjent, li fihom ngħataw 450 mg tolperisone kuljum għal ftit ġimgħat.
English: Mean maximum walking distance per 2 minutes at final visit was approx. 70 meters in the tolperisone and 40 meters in the placebo group.
Maltese: Iddistanza massima medja bil-mixi kull 2 minuti fl-aħħar viżta kienet madwar 70 metru fil-grupp ta' tolperisone u 40 metru fil-grupp tal-plaċebo.
English: On 15 July 2011, Germany triggered a referral under Article 31 of Directive 2001/83/EC.
Maltese: Fil-15 ta' Lulju 2011, il-Ġermanja tat bidu għal riferiment skont l-Artikolu 31 tadDirettiva 2001/83/KE.
English: • Treatment of muscular hypertonicity and muscle spasms associated with locomotor diseases (e.g. spondylosis, spondylarthrosis, cervical and lumbar syndromes, arthrosis of large joints)
Maltese: • Trattament ta' ipertoniċità muskolari u spażmi fil-muskoli assoċjati ma' mard lokomotorju (eż. spondilożi, spondilartrożi, sindromi ċervikali u lombari, artrożi tal-ġogi l-kbar)
English: The actively controlled study was open label, used pentoxyphyllin as control and involved a total of 70 patients.
Maltese: L-istudju kkontrollat b'mod attiv kien open label, li fih intużat pentoxyphyllin bħala kontroll u involva total ta' 70 pazjent.
English: This indication is mainly supported by the Stamenova (2005) study, which is of acceptable quality.
Maltese: Din l-indikazzjoni hija primarjament appoġġjata mill-istudju Stamenova (2005), li huwa ta' kwalità aċċettabbli.
English: Finally, the Hodinka 2001 study also failed to demonstrate a relevant difference in the primary endpoint, and the only transient significant difference observed was in the Roland-Morris Disability Scale at day 7, having disappeared at day 14.
Maltese: Finalment, l-istudju Hodinka tal-2001 ukoll naqas milli juri differenza rilevanti fil-punt aħħari primarju, u l-unika differenza sinifikanti temporanja osservata kienet fl-Iskala ta' Diżabilità Roland-Morris fis-7 jum, li għebet fl-14-il jum.
English: • Treatment of obliterative vascular diseases as well as syndromes due to impaired vascular innervation (e.g. acrocyanosis, dysbasia angioneurotica intermittens)
Maltese: • Trattament ta' mard vaskolari obliterattivi kif ukoll ta' sindromi minħabba innervazzjoni vaskolari indebolita (eż. akroċijanożi, dysbasia angioneurotica intermittens)
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).
Maltese: It-titjib medju fil-punteġġ Ashworth li nstab fl-istudju Stamenova kien ta' 32% fil-popolazzjoni ITT (intenzjoni ta' trattament) globali u 42% fis-sottogrupp ta' pazjenti li ngħataw 300-450 mg/jum).
English: The improvement in Ashworth scale was accompanied by a statistically significant difference in the investigator's overall assessment of efficacy in favour of tolperisone.
Maltese: It-titjib fl-iskala Ashworth kien akkumpanjat minn differenza statistikament sinifikanti fl-evalwazzjoni globali talinvestigatur dwar l-effikaċja favur tolperisone.
English: There is a discrepancy between the patterns of spontaneous reports and the reports from studies.
Maltese: Hemm diskrepanza bejn ix-xejriet ta' rapporti spontanji u r-rapporti mill-istudji.
English: The CHMP also consulted its Neurology Scientific Advisory Group (SAG).
Maltese: Is-CHMP ikkonsulta wkoll mal-Grupp Konsultattiv Xjentifiku dwar in-Newroloġija (SAG) tiegħu.
English: Following the adoption of the CHMP opinion and recommendations during the June 2012 CHMP meeting, re-examination requests were received from Gedeon Richter PLC and PP Nature Balance Lizenz GmbH, as they considered that there is adequate data supporting the efficacy of tolperisone in the “treatment of muscular hypertonicity and muscle spasms associated with locomotor diseases” indication.
Maltese: Wara l-adozzjoni tal-opinjoni tas-CHMP u r-rakkomandazzjonijiet matul il-laqgħa tas-CHMP ta' Ġunju 2012, Gedeon Richter PLC u PP Nature Balance Lizenz GmbH talbu eżami mill-ġdid, peress li kkunsidraw li kien hemm dejta adegwata biex tappoġġa l-effikaċja ta' tolperisone flindikazzjoni għat-"trattament ta' ipertoniċità muskolari u ta' spażmi muskolari assoċjati ma' mard lokomotorju".
English: Further functional secondary parameters (i.e. the modified Barthel Index (assessing activities of daily living), capacity to perform routine activities and walking endurance) consistently favoured tolperisone over placebo.
Maltese: Parametri sekondarji funzjonali oħrajn (jiġifieri l-Indiċi Barthel immodifikat (li jevalwa l-attivitajiet tal-ħajja ta' kuljum), il-kapaċità li jitwettqu attivitajiet ta' rutina u r-reżistenza għall-mixi) iffavorixxew b'mod konsistenti lil tolperisone fuq il-plaċebo.
English: In the Melka study (1997), the reduction in muscle tone (as measured by the Ashworth scale) was accompanied by a consistent improvement in functional parameters indicative of clinical relevance.
Maltese: Fl-istudju Melka (1997), it-tnaqqis fit-ton tal-muskolu (kif imkejjel mill-iskala Ashworth) kien akkumpanjat minn titjib konsistenti f'parametri funzjonali li jindikaw rilevanza klinika.
English: • Little's disease (infantile diplegia spastica) and other encephalopaties accompanied by dystonia
Maltese: • Marda ta' Little (dipleġija spastika infantili) u enċefalopatiji oħrajn akkumpanjati minn distonja
English: Van Denburg et al. (2008) have found a 33% change in the Ashworth Scale to correlate with a 1-point change in the Physician's global assessment score in patients with post-stroke spasticity, indicating clinical relevance.
Maltese: (2008) sabu li bidla ta' 33% fl-Iskala Ashworth hija korrelatata ma' bidla ta' punt (1) fil-punteġġ ta' evalwazzjoni globali tat-Tabib f'pazjenti bi spastiċità ta' wara l-puplesija, u li b'hekk tindika rilevanza klinika.
English: • Acute or chronic treatment of pathologically elevated skeletal muscle tone in organic neurological disorders
Maltese: • Trattament akut jew kroniku tat-ton tal-muskolu skeletali patoloġikament elevat f'disturbi newroloġiċi organiċi
English: Hypotheses include tolperisone metabolites as hapten formations activating the patient's immune system through covalent modification of proteins, or structural similarity to the local anaesthetic lidocaine.
Maltese: L-ipoteżijiet jinkludu metaboliti ta' tolperisone bħala formazzjonijiet hapten li jattivaw is-sistema immuni tal-pazjent permezz ta' modifikazzjoni kovalenti ta' proteini, jew xebh strutturali mal-anestetiku lokali lidocaine.
English: Gedeon Richter PLC proposed to restrict the indication to “Short-term treatment of muscle spasms in adult patients with acute non-specific low back pain”, with a maximum duration of treatment of 7 days.
Maltese: Gedeon Richter PLC ippropona li l-indikazzjoni tiġi ristretta għal "Trattament fuq żmien qasir ta' spażmi muskolari fuq pazjenti adulti b'uġigħ akut mhux speċifiku fil-parti t'isfel tad-dahar", b'tul massimu ta' kura ta' 7 ijiem.
English: • Rehabilitation after orthopaedic and trauma surgery
Maltese: • Rijabilitazzjoni wara kirurġija ortopedika u ta' trawma
English: In the Stamenova study, patients could be titrated up to 900 mg per day, thus only a subgroup (35%) of tolperisone patients was treated within the dose range currently approved in the SPC (150-450 mg).
Maltese: Fl-istudju Stamenova, il-pazjenti setgħu jkunu titrati sa 900 mg kuljum, għalhekk sottogrupp biss (35%) mill-pazjenti b'tolperisone kien ittrattat fi ħdan il-medda tad-doża attwalment approvata fl-SPC (150-450 mg).
English: Treatment of pathologically elevated skeletal muscle tone in organic neurological disorders
Maltese: It-trattament ta' ton muskolari skeletali patoloġikament elevat f'disturbi newroloġiċi organiċi
English: Tolperisone is a centrally acting muscle relaxant first synthesized in 1956, and used in clinical practice since the 1960's.
Maltese: Tolperisone huwa rilassant tal-muskoli li jaġixxi b'mod ċentrali li ġie sintetizzat għall-ewwel darba fl1956, u ilu jintuża fil-prattika klinika sa mis-snin sittin.
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”.
Maltese: Abbażi tat-totalità tad-dejta disponibbli dwar is-sigurtà u l-effikaċja ta' tolperisone u wara li nnota lfehmiet tal-BSWP u tas-SAG, is-CHMP ikkonferma l-konklużjoni inizjali tiegħu li r-riskju ta' ipersensittività huwa aktar sinifikanti milli kien preċedentement identifikat fil-ħin tal-awtorizzazzjoni inizjali għat-tqegħid fis-suq, u li bħala konsegwenza, il-benefiċċji ta' tolperisone huma megħluba mirriskji fl-indikazzjoni għat-"trattament ta' ipertoniċità muskolari u ta' spażmi muskolari assoċjati ma' mard lokomotorju" kif ukoll fl-indikazzjoni ristretta proposta "trattament fuq perjodu ta' żmien qasir ta' spażmi muskolari fuq pazjenti adulti b'uġigħ akut mhux speċifiku fil-parti t'isfel tad-dahar".
English: Tolperisone reduces the reticulo-spinal facilitation in the brainstem and has been shown to be effective in alleviating experimental gamma-rigor of reticular origin.
Maltese: Tolperisone inaqqas il-faċilitazzjoni retikulospinali fiz-zokk enċefaliku u ntwera li huwa effettiv sabiex itaffi lgamma-rigor sperimentali ta' oriġini retikolari.
English: A causal relationship with tolperisone was assessed as at least possible in 90% of all hypersensitivity reactions.
Maltese: Relazzjoni kawżali ma' tolperisone kienet evalwata bħala tal-inqas possibbli f'90% tar-reazzjonijiet kollha ta' ipersensittività.
English: The CHMP endorsed a communication i.e. ‘Dear Healthcare Professional Communication (DHPC)' to communicate the outcome of the present review.
Maltese: Is-CHMP approva komunikazzjoni, jiġifieri ‘Komunikazzjoni Diretta lill-Professjonisti tas-Saħħa (DHPC)' sabiex jiġi kkomunikat l-eżitu ta' din ir-reviżjoni.
English: Annex II Scientific conclusions and grounds for Variation to the terms of the Marketing Authorisations (oral formulations) and Revocation of the Marketing Authorisations (parenteral formulations)
Maltese: Anness II Konklużjonijiet xjentifiċi u raġunijiet għallVarjazzjoni tat-termini tal-Awtorizzazzjonijiet għat-Tqegħid fis-Suq (formulazzjonijiet orali) u Revoka tal-Awtorizzazzjonijiet għat-Tqegħid fis-Suq (formulazzjonijiet parenterali)
English: Tolperisone reduces the sodium influx through the isolated nerve membrane in a dose dependent way, thus amplitude and frequency of action potentials are reduced.
Maltese: Tolperisone inaqqas l-influss tas-sodju minn membrani iżolati tan-nervituri b'mod li jiddependi mid-doża, u b'hekk jitnaqqsu l-potenzjali ta' amplitudni u frekwenza ta' azzjoni.
English: Overall summary of the scientific evaluation of tolperisone-containing products (see Annex I)
Maltese: Sommarju globali tal-evalwazzjoni xjentifika ta' prodotti li fihom tolperisone (ara Anness I)
English: The Feher study (1985) used the Rivermead scale, which has shown high validity and reliability in assessment of motor function in stroke patients.
Maltese: L-istudju Feher (1985) uża l-iskala Rivermead, li wriet validità u affidabbiltà għolja fl-evalwazzjoni tal-funzjoni motorja fil-pazjenti pupletiċi.
English: In contrast, the prematurely terminated Avigen study AV650-018 (2007) failed to demonstrate any effect in the multiple sclerosis population.
Maltese: B'kuntrast ma' dan, l-istudju Avigen AV650-018 (2007) li twaqqaf qabel il-waqt naqas milli juri xi effett fil-popolazzjoni tal-isklerosi multipla.
English: Hypersensitivity reactions account for more than half of the spontaneous reports in the originators database, followed by adverse events (AEs) from the SOCs (System Organ Class) Gastrointestinal disorders, General disorders and administration site conditions and Nervous system disorders.
Maltese: Ir-reazzjonijiet ta' ipersensittività jammontaw għal aktar minn nofs ir-rapporti spontanji fil-bażi ta' dejta tal-oriġinaturi, segwiti minn effetti avversi (AEs) mid-Disturbi gastro-intestinali tal-SOCs (Sistema tal-Klassifika tal-Organi), Disturbi ġenerali u kondizzjonijiet fi mnejn jingħata u Disturbi fis-sistema nervuża.
English: In this randomised, double-blind, placebo controlled, multicentre study efficacy of tolperisone has been shown in the symptomatic treatment of patients with spasticity following cerebral stroke.
Maltese: F'dan l-istudju każwali, ta' għama doppja (double-blind), ikkontrollat minn plaċebo u li sar f'diversi ċentri, l-effikaċja ta' tolperisone intweriet fit-trattament sintomatiku ta' pazjenti bi spastiċità wara puplesija ċerebrali.
English: Rehabilitation after orthopaedic and trauma surgery
Maltese: Rijabilitazzjoni wara kirurġija ortopedika u ta' trawma
English: • Peripheral level - stabilises the membrane of neurons, and consequently supresses the amplitude and frequency of the action potentials.
Maltese: • Livell periferali - jistabbilizza l-membrani tan-newroni, u konsegwentement irażżan ilpotenzjali tal-amplitudni u l-frekwenza tal-azzjoni.
English: Treatment of muscular hypertonicity and muscle spasms associated with locomotor diseases
Maltese: It-trattament ta' ipertoniċità muskolari u ta' spażmi muskolari assoċjati ma' mard lokomotorju
English: • The Committee is also of the opinion that there is evidence of clinically significant efficacy of tolperisone in the symptomatic treatment of post-stroke spasticity in adults.
Maltese: • Il-Kumitat huwa wkoll tal-opinjoni li hemm evidenza ta' effikaċja klinikament sinifikanti ta' tolperisone fit-trattament sintomatiku ta' spastiċità ta' wara l-puplesija fl-adulti.
English: The Struck 2004 study also failed to demonstrate a significant improvement in the primary endpoint.
Maltese: L-istudju Struck tal-2004 naqas ukoll milli juri titjib sinifikanti fil-punt aħħari primarju.
English: For the remaining indications (rehabilitation after orthopaedic and trauma surgery, treatment of obliterative vascular diseases as well as syndromes due to impaired vascular innervation, and Little's disease and other encephalopaties accompanied by dystonia) there is extremely limited evidence of efficacy, mainly based on small studies with inadequate design and including a heterogeneous population.
Maltese: Għall-indikazzjonijiet li jifdal (ir-rijabilitazzjoni wara l-kirurġija ortopedika u ta' trawma, it-trattament ta' mard vaskolari obliterattivi kif ukoll ta' sindromi minħabba innervazzjoni vaskolari indebolita, u lmarda ta' Little u enċefalopatiji oħrajn akkumpanjati minn distonja) hemm evidenza tassew limitata dwar l-effikaċja, ibbażata l-aktar fuq studji żgħar b'għamla inadegwata u li jinkludu popolazzjoni eteroġenea.
English: In the only study in this indication where superiority of tolperisone over placebo in the primary outcome was shown (Pratzel 1995), this was achieved using a new parameter in the formula for calculation which was not pre-determined but rather introduced in post-hoc efficacy analysis.
Maltese: Fl-uniku studju f'din l-indikazzjoni fejn intweriet is-superjorità ta' tolperisone fuq il-plaċebo fl-eżitu primarju (Pratzel 1995), din inkisbet permezz ta' parametru ġdid fil-formola għall-kalkolu li ma kienx iddeterminat minn qabel iżda minflok, ġie introdott fl-analiżi tal-effikaċja post-hoc.
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.
Maltese: Fir-rigward tas-sigurtà ta' tolperisone, is-CHMP irreveda d-dejta disponibbli ta' sigurtà u sostna lkonklużjonijiet preċedenti tiegħu li hemm riskju ta' reazzjonijiet ta' ipersensittività assoċjat ma' tolperisone, b'dejta turi li 10% tal-każijiet kollha ta' ipersensittività rrapportati kienu meqjusin bħala ta' periklu għall-ħajja.