FrancophonIA/ELRC3.0 huggingface dataset:
English: Gamithromycin levels in lung reached a maximum in less than 24 hr, with lung-to-plasma ratio of > 264 indicating that gamithromycin was absorbed rapidly into the target tissue for BRD.
Maltese: Gamithromycin fil-pulmun laħqu l-massimu f'inqas minn 24 siegħa, b'ratio fil-pulmun għall-plasma ta' > 264 li jindikaw li l-gamithromycin ġie assorbit malajr mit-tessut immirat għal BRD.
English: Gamithromycin is an azalide, 15-membered semisynthetic macrolide class antibiotic with uniquely positioned alkylated nitrogen at 7a-position of the lactone ring.
Maltese: Gamithromycin huwa azalide, antibijotiku semisintetiku tal-klassi 15-membered tal-makrolidi b'
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box (500 ml)
Maltese: Kaxxa tal-kartun (500 ml)
English: • Rare (more than 1 but less than 10 animals in 10,000 animals treated)
Maltese: • Rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal ikkurat)
English: Based on laboratory animal data, gamithromycin has not produced any evidence of specific developmental or reproductive effects.
Maltese: Minn informazzjoni bbażata fuq studji fuq annimali fil-laboratorju, il-gamithromycin ma pprovdiex evidenza speċifika ta' effetti selettivi tal-iżvilupp jew riproduttività.
English: Gamithromycin administered subcutaneously into the neck of sheep at a single dose of 6 mg/kg body weight is rapidly absorbed, and maximum plasma concentrations were observed between 15 minutes and 6 hours after dosing (2.30 hours on average) with high absolute bioavailability of 89%.
Maltese: Il-gamithromycin amministrat taħt il-ġilda ġol-għonq fin-nagħaġ f'doża waħda ta' 6mg/kg ta' piż talġisem jiġi assorbit malajr, u konċentrazzjonijiet massimi fil-plasma ġew osservati bejn 15-il minuta u 6 sigħat wara li ġiet mogħtija d-doża (medja ta' sagħtejn u nofs) bi bijodisponibilità assoluta għolja ta' 89%.
English: Veterinary medicinal product subject to prescription.
Maltese: Prodott veterinarju mediċinali li jingħata bi preskrizzjoni.
English: The active substance in ZACTRAN 150 mg/ml solution for injection for cattle, sheep and pigs is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Maltese: Is-sustanza attiva fiż-ZACTRAN soluzzjoni ta' 150 mg/ml għal injezzjoni għal bovini hija sustanza permessa kif deskritta fit-Tabella 1 tal-anness għar-Regolament tal-Kummissjoni (UE) N.
English: Not for use in animals producing milk for human consumption
Maltese: Mhux għallużu f'annimali li jipproduċu ħalib għall konsum uman
English: A single dose of 6 mg gamithromycin/kg body weight (equivalent to 1 ml/25 kg body weight) into the neck (cattle and pigs) or anterior to the shoulder (sheep).
Maltese: Doża waħda ta' 6 mg gamithromycin/kg ta' piż tal-ġisem (ekwivalenti għal 1 ml/25 kg piż tal-ġisem) għal ġol-għonq (bovini u ħnieżer) jew anterjuri għall-ispalla (nagħaġ).
English: The excipients listed in section 6.1 of the SPC are allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required.
Maltese: Is-sustanzi mhux attivi elenkati f'sezzjoni 6.1 tal-SPC huma sustanzi permessi li għalihom Tabella 1 tal-anness tar-Regolament tal-Kummissjoni (UE) Numru 37/2010 tindika li l-ebda MRL mhu meħtieġ.
English: Ask your veterinary surgeon how to dispose of medicines no longer required.
Maltese: Saqsi lil kirurgu veterinarju tiegħek dwar kif l-aħjar li tarmi l-mediċini li ma jkunux aktar meħtieġa.
English: Pigs: intramuscular injection.
Maltese: Ħnieżer: injezzjoni għal ġol-muskoli.
English: Muscle Skin and fat in natural proporti ons
Maltese: Muskolu, Ġilda u xaħam fi proporzjo nijiet naturali Fwied Kliewi
English: Gamithromycin skin concentrations were much higher than the plasma concentrations resulting in skin/plasma concentration ratios of approximately 21, 58, and 138 at two, five and ten days post-dosing, respectively, demonstrating extensive distribution and accumulation in skin tissue.
Maltese: 138 wara jumejn, ħames u għaxart ijiem wara d-dożaġġ rispettivament, li juri distribuzzjoni estensiva u akkumulazzjoni fit-tessut tal-ġilda.
English: Do not use this veterinary medicinal product simultaneously with other macrolides or antibiotics known as lincosamides.
Maltese: Tużax dan il-prodott veterinarju mediċinali simultanjament ma' makrolidi oħra jew antibijotiċi magħrufa bħala linkosamidi.
English: One ml contains:
Maltese: Kull ml fih:
English: The 500 ml vial is for cattle and pigs only.
Maltese: Il-kunjett ta' 500 ml huwa għall-bovini u ħnieżer biss.
English: Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Maltese: Żmien li l-prodott mediċinali veterinarju jista' jinżamm fuq l-ixkaffa ppakkjat għall-bejgħ: 3 snin.
English: Bovine 20 μg/kg 200 μg/kg
Maltese: 20 μg/kg 200 μg/kg 100 μg/kg
English: Gamithromycin administered intramuscularly in pigs at single dose of 6 mg/kg body weight, resulted in rapid absorption with peak plasma concentrations observed after 5 to 15 min, with a long plasma half-life (about 4 days).
Maltese: Il-gamithromycin amministrat ġol-muskolu fil-ħnieżer f'doża waħda ta' 6mg/kg ta' piż tal-ġisem irriżulta f'assorbiment ta' malajr, b'konċentrazzjonijiet massimi fil-plasma osservati wara 5 sa 15-il minuta b'half-life tal-plasma twila (madwar 4 ijiem).
English: For treatment of cattle over 250 kg and sheep over 125 kg body weight, divide the dose so that no more than 10 ml (cattle) or 5 ml (sheep) are injected at a single site.
Maltese: Għal kura ta' bovini 'l fuq minn 250 kg ta' piż tal-ġisem u nagħaġ 'il fuq minn 125 kg ta' piż tal-ġisem , aqsam id-doża sabiex mhux iżjed minn 10 ml (bovini) u 5 ml (nagħaġ) jiġu injettati f'post wieħed.
English: For treatment of cattle over 250 kg and sheep over 125 kg body weight, divide the dose so that no more than 10 ml (cattle) and 5 ml (sheep) are injected at a single site.
Maltese: Għall-kura ta' bovini 'l fuq minn 250kg u nagħaġ 'il fuq minn 125 kg ta' piż tal-ġisem, aqsam id-doża sabiex ma jiġux injettati iżjed minn 10 ml (bovini) jew 5 ml (nagħaġ) f'post wieħed.
English: Colourless to pale yellow solution.
Maltese: Soluzzjoni bla kulur sa isfar ċar.
English: Not authorised for use in lactating animals producing milk for human consumption.
Maltese: Mhux awtorizzat li jintuża f'annimali li qed jipproduċu ħalib għall-konsum uman .
English: Use according to the benefit/risk assessment by the responsible veterinarian.
Maltese: Uża biss skont kif il-veterinarju responsabbli jqis il-benefiċċju / riskju tal-prodott.
English: For the full list of excipients, see section 6.1.
Maltese: 1 mg Għal-lista sħiħa tal-ingredjenti mhux attivi, ara sezzjoni 6.1.
English: Fat
Maltese: IEĦOR
English: ZACTRAN 150 mg/ml solution for injection for cattle and pigs gamithromycin
Maltese: VETERINARJU ZACTRAN soluzzjoni ta' 150 mg/ml għal injezzjoni għal bovini, nagħaġ u ħnieżer
English: STATEMENT OF THE MRLs
Maltese: Il-livelli tal
English: Macrolides inhibit bacterial protein biosynthesis by binding to the 50S ribosomal subunit and by preventing peptide chain elongation.
Maltese: Il-makrolidi in generali jwaqqfu l-bijosintesi talproteina tal-batterji billi jintrabtu mal-50S ribosomal subunit u jimpedixxu żieda fit-tul tal-katina peptide.
English: Pigs Intramuscular injection.
Maltese: GĦAMLA FARMAĊEWTIKA Soluzzjoni għal injezzjoni.
English: EU/2/08/082/001 EU/2/08/082/002 EU/2/08/082/004 EU/2/08/082/005 EU/2/08/082/007
Maltese: EU/2/08/082/005 EU/2/08/082/006 EU/2/08/082/007
English: Benefit/Risk Assessment
Maltese: Valutazzjoni Benefiċċju/Riskju
English: The originator medicinal product is Mydeton and it was developed by Gedeon Richter, Ltd.
Maltese: Ilprodott mediċinali oriġinatur huwa Mydeton u ġie żviluppat minn Gedeon Richter, Ltd.
English: Tolperisone is metabolised by the cytochrome P450 system in particular CYP2D6.
Maltese: Tolperisone huwa metabolizzat mis-sistema ta' cytochrome P450 b'mod partikolari CYP2D6.
English: The MAH presented a new study report, MDTP-T20091B, which was a PK study sponsored by Meditop performed in 48 healthy volunteers.
Maltese: Il-MAH ippreżenta rapport ta' studju ġdid, MDTP-T20091B, li kien studju PK sponsorjat minn Meditop imwettaq fuq 48 voluntier b'saħħtu.
English: b./ muscular hypertension and muscular spasm accompanying locomotors diseases c./ rehabilitation after orthopaedic and traumatological surgery.
Maltese: b./ pressjoni għolja fil-muskoli u spażmi muskolari li jakkompanjaw mard lokomotiv c./ riabilitazzjoni wara kirurġija ortopedika u trawmatoloġika.
English: The CHMP considered that the “Well-Established” use in accordance to Article 10(a) of Directive 2001/83/EC for Myderison has not been demonstrated.
Maltese: Is-CHMP qies li l-użu “Stabbilit Sew” skont l-Artikolu 10(a) tad-Direttiva 2001/83/KE għal Myderison ma ntweriex.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF MYDERISON
Maltese: TAL-EVALWAZZJONI XJENTIFIKA TA' MYDERISON
English: The CHMP, based on the data submitted by the MAH, concluded that the benefit/risk ratio of clinical use of tolperisone is negative.
Maltese: Is-CHMP, abbażi tad-dejta ppreżentata mill-MAH, ikkonkluda li l-proporzjon tal-benefiċċju/riskju ta' użu kliniku ta' tolperisone huwa wieħed negattiv.
English: From these 15 publications only one (Pratzel et al 1996) was published in an international peer reviewed journal that had acceptable standard and scientific value (double blind, randomised, placebo controlled).
Maltese: Minn dawn il-15-il pubblikazzjoni, waħda biss (Pratzel et al 1996) ġiet ippubblikata f'ġurnal internazzjonali rivedut fost ilpari li kellu standard u valur xjentifiku aċċettabbli (double blind, randomizzat, ikkontrollat bi plaċebo).
English: In conclusion, the CHMP is of the opinion that the MAH's response is not sufficient to have reliable information about the PK characteristics of Myderison.
Maltese: Finalment, is-CHMP huwa tal-opinjoni li r-risposta tal-MAH mhijiex suffiċjenti biex ikun hemm informazzjoni affidabbli dwar il-karatteristiċi PK ta' Myderison.
English: Question 4 - The MAH was asked to provide data taken from scientific literature on possible drug-drug interactions especially with drugs metabolised by CYP2D6 enzyme system.
Maltese: Mistoqsija 4 - Il-MAH intalab jipprovdi dejta meħuda minn litteratura xjentifika dwar l-interazzjonijiet mediċina-mediċina possibbli b'mod speċjali ma' mediċini metabolizzati minn sistema ta' enzimi CYP2D6.
English: Tolperisone is a centrally acting muscle relaxant indicated in the spasticity of the skeletal muscles.
Maltese: Tolperisone huwa rilassant tal-muskoli li jaġixxi ċentralment indikat fl-ispastiċità tal-muskoli skeletali.
English: The Marketing Authorisation Holder, Meditop Pharmaceutical Co. Ltd., was applying for marketing authorisations for Myderison in Czech Republic, Germany, Lithuania, Poland, Romania and Slovakia.
Maltese: Ltd., kien qed japplika għal awtorizzazzjonijiet għat-tqegħid fis-suq għal Myderison fir-Repubblika Ċeka, fil-Ġermanja, fil-Litwanja, fil-Polonja, fir-Rumanija u fis-Slovakja.
English: The third indication of Mydeton, rehabilitation after orthopaedic and traumatological surgery, is supported only by two observational studies.
Maltese: It-tielet indikazzjoni ta' Mydeton, riabilitazzjoni wara kirurġija ortopedika u trawmatoloġika, hija appoġġjata biss minn żewġ studji ta' osservazzjoni.
English: a./ increased tone and spasticity of the skeletal muscles due to organic neurological disorders.
Maltese: a./ żieda fis-saħħa u fl-ispastiċità tal-muskoli skeletali dovuti għal disturbi newroloġiċi organiċi.
English: Question 2 - The MAH had to provide sufficient information on pharmacokinetics of tolperisone hydrochloride and comment on the relevance of bibliographic data submitted which concern a product different from Myderison.
Maltese: Mistoqsija 2 - Il-MAH kellu jipprovdi informazzjoni biżżejjed dwar il-farmakokinetiċi ta' tolperisone hydrochloride u kellu jikkummenta dwar ir-relevanza tad-dejta biblijografika sottomessa dwar prodott differenti minn Myderison.
English: The clinical relevance of interindividual variability of tolperisone PK and the potential impact of CYP2D6 polymorphism of the drug are unknown.
Maltese: Ir-relevanza klinika tal-varjabbiltà bejn individwu u ieħor ta' tolperisone PK u l-impatt potenzjali tal-polimorfiżmu ta' CYP2D6 tal-mediċina mhumiex magħrufin.
English: From these 6 papers only one (Stamenova et al. 2005) was published in an international peer reviewed journal.
Maltese: Minn dawn is-6 studji, wieħed biss (Stamenova et al. 2005) ġie ppubblikat f'ġurnal internazzjonali rivedut fost il-pari.
English: The majority of clinical studies with tolperisone have been performed in a dose range of 150-450 mg/day.
Maltese: Il-maġġoranza tal-istudji kliniċi b'tolperisone twettqu f'medda tad-doża ta' 150-450 mg/kuljum.
English: The MAH stated, after assessment of own PK data, that no significant difference was observed in the relevant bibliographic data reviewed concerning similar products containing tolperisone.
Maltese: Il-MAH qal, wara valutazzjoni tad-dejta PK stess, li ma ġiet osservata ebda differenza sinifikanti fid-dejta biblijografika relevanti riveduta dwar prodotti simili li fihom tolperisone.
English: The trial was a placebo controlled, randomised, double blind dose-titration study of high standard.
Maltese: Il-prova kienet studju ta' titrazzjoni tad-doża kkontrollat bi plaċebo, randomizzat, double blind ta' standard għoli.
English: Furthermore, the oral dose might need to be individualised within the recommended dose range 150-450 mg / day according to the clinical needs.
Maltese: Barra minn hekk, id-doża orali tista' tkun individwalizzata fi ħdan ilmedda tad-doża rakkomandata 150-450 mg / kuljum skont il-ħtiġijiet kliniċi.
English: No dose-response relationship has been established; the MAH used as main reference, in justifying the posology of Myderison, the SPC of Mydeton, DRUGDEX and other un-specified products.
Maltese: Ma ġiet stabbilita ebda relazzjoni doża-rispons; il-MAH uża bħala referenza ewlenija, fl-iġġustifikar talpożoloġija ta' Myderison, l-SPC ta' Mydeton, DRUGDEX u prodotti oħrajn mhux speċifikati.
English: These data show that tolperisone was well tolerated in clinical use, and the side effects (generalized body weakness, fatigue, and dizziness) observed in these clinical trials were usually mild or moderate and did not necessitate the discontinuation of the treatment.
Maltese: Din id-dejta turi li tolperisone kien tollerat sewwa fl-użu kliniku, u l-effetti sekondarji (dgħjufija tal-ġisem ġeneralizzata, għeja u sturdament) osservati f'dawn ilprovi kliniċi normalment kienu ħfief għal moderati u ma kinux jeħtieġu t-twaqqif tat-trattament.
English: In view of the above the CHMP considered that information to justify the proposal for section 4.5 of the SPC was missing and therefore no conclusions could be reached on this regards.
Maltese: Minħabba dak li ntqal hawn fuq, is-CHMP qies li l-informazzjoni sabiex il-proposta għal sezzjoni 4.5 talSPC tkun iġġustifikata kienet nieqsa u għalhekk ma setgħet issir ebda konklużjoni f'dan ir-rigward.
English: The publications were grouped in three chapters according to the indications:
Maltese: Il-pubblikazzjonijiet ġew raggruppati fi tliet kapitoli differenti skont l-indikazzjonijiet:
English: Still, one of the studies performed by Stamonova et al (2005) was a dose range, dose titration study.
Maltese: Xorta waħda, wieħed mill-istudji mwettqa minn Stamonova et al (2005) kien studju tal-firxa tad-doża, titrazzjoni tad-doża.
English: Thirteen cases of more serious side effects (allergic/hypersensitivity reactions) have also been published in the literature; the detailed analysis of the safety profile of tolperisone, including these serious adverse reactions, is missing from the documentation submitted.
Maltese: Tlettax-il każ ta' effetti sekondarji aktar serji (reazzjonijiet allerġiċi/ta' ipersensittività) ġew ippubblikati wkoll fil-litteratura; l-analiżi aktar dettaljata tal-profil tas-sigurtà ta' tolperisone, inkluż dawn irreazzjonijiet avversi serji, hija nieqsa mid-dokumentazzjoni sottomessa.
English: To further justify the data submitted, the MAH referred to the SPC of the authorised originator product (Mydeton).
Maltese: Biex jiġġustifika aktar id-dejta ppreżentata, il-MAH irrefera għall-SPC tal-prodott oriġinatur awtorizzat (Mydeton).
English: The safety profile of tolperisone was not analysed in detail by the MAH.
Maltese: Il-profil tas-sigurtà ta' tolperisone ma ġiex analizzat fid-dettall mill-MAH.
English: Question 5 - The MAH was asked to present the quantitative aspects of the use of the substance within the community.
Maltese: Mistoqsija 5 - Il-MAH intalab jippreżenta l-aspetti kwantitattivi tal-użu tas-sustanza fi ħdan il-komunità.
English: Question 3 - The MAH was asked to provide data from scientific literature justifying the dosing recommended in the proposed SPC.
Maltese: Mistoqsija 3 - Il-MAH intalab jipprovdi dejta mil-litteratura xjentifika li tiġġustifika d-dożaġġ rakkomandat fl-SPC propost.
English: GROUNDS FOR REFUSAL
Maltese: U RAĠUNIJIET GĦAL RIFJUT
English: The MAH presented 15 abstracts on the indication “muscular hypertension and muscular spasm accompanying locomotors diseases”.
Maltese: Il-MAH ippreżenta 15-il astratt dwar l-indikazzjoni “żieda fis-saħħa u fl-ispastiċità tal-muskoli skeletali dovuti għal disturbi newroloġiċi organiċi”.
English: The CHMP noted that in his response the MAH refers to in vitro studies focusing on the enzymes which are involved in the metabolism of tolperisone.
Maltese: Is-CHMP innota li fir-risposta tiegħu, il-MAH jirreferi għal studji in-vitro li jiffokaw fuq l-enzimi li huma involuti fil-metaboliżmu ta' tolperisone.
English: The CHMP addressed a list of questions and a further list of outstanding issues to the Marketing Authorisation Holder to clarify its concerns regarding: efficacy (including therapeutic indication and the optimal daily dose), safety (drug interactions), kinetic properties, and extent of use of tolperisone.
Maltese: Is-CHMP indirizza lista ta' mistoqsijiet u lista oħra ta' kwistjonijiet pendenti lid-Detentur talAwtorizzazzjoni għat-Tqegħid fis-Suq sabiex jiċċara t-tħassib tiegħu fir-rigward ta': l-effikaċja (inkluż indikazzjoni terapewtika u d-doża ottimali ta' kuljum), is-sigurtà (interazzjonijiet tal-mediċini), ilkaratteristiċi kinetiċi, u l-firxa tal-użu ta' tolperisone.
English: The MAH admitted that no formal or specific drug interaction studies with tolperisone have been performed and only limited clinical reports are available from several publications.
Maltese: Il-MAH ammetta li ma sar ebda studju formali jew speċifiku dwar l-interazzjoni tal-mediċina b'tolperisone u rapporti kliniċi limitati biss huma disponibbli minn bosta pubblikazzjonijiet.
English: Based on the submitted data it can not be ignored that tolperisone might represent an effective and relatively safe treatment option of spasticity and painful reflex spasm due to organic neurological disorders or accompanying locomotor diseases but the poor quality of the clinical trials and data presentations make it difficult to give a general recommendation on the proper use of tolperisone in the indication claimed by the MAH.
Maltese: Abbażi tad-dejta sottomessa, ma jistax jiġi injorat il-fatt li tolperisone jista' jirrappreżenta għażla ta' trattament effettiv u relattivament sikur tal-ispastiċità u tal-ispażmu ta' rifless b'uġigħ minħabba disturbi newroloġiċi organiċi jew mard lokomutur li jiġi miegħu iżda l-kwalità dgħajfa tal-provi kliniċi u lpreżentazzjonijiet tad-dejta, jagħmluha diffiċli sabiex tingħata rakkomandazzjoni ġenerali dwar l-użu proprju ta' tolperisone fl-indikazzjoni kklejmjata mill-MAH.
English: According to the published data, tolperisone can be co-administered with: sedatives, hypnotics, and NSAID-s with no relevant or unwanted drug interactions.
Maltese: Skont id-dejta ppubblikata, tolperisone jista' jingħata fl-istess ħin ma': sedattivi, ipnotiċi u NSAID-s mingħajr ebda interazzjoni tal-mediċini relevanti jew mhux mixtieqa.
English: This procedure concerns a bibliographic application of tolperisone film-coated tablets with Hungary as the Reference Member State in the Mutual Recognition Procedure (MRP).
Maltese: Din il-proċedura għandha x'taqsam ma' applikazzjoni biblijografika ta' pilloli miksijin b'rita ta' tolperisone bl-Ungerija tkun l-Istat Membru ta' Referenza fil-Proċedura ta' Rikonoxximent Reċiproku (MRP).
English: A Potential Serious Risk for Public Health was raised by the Czech Republic, Lithuania and Slovakia.
Maltese: Riskju Serju Potenzjali għas-Saħħa Pubblika tqajjem mir-Repubblika Ċeka, mil-Litwanja u misSlovakkja.
English: Regarding the metabolic profile of tolperisone the in vitro data which are discussed in the response document do not substitute for the in vivo interaction studies and do not allow conclusive on possible PK or PD drug-drug interactions.
Maltese: Rigward il-profil metaboliku ta' tolperisone, id-dejta in vitro li hija diskussa fid-dokument ta' rispons ma tissostitwixxix l-istudji ta' interazzjoni in vivo u ma twassalx għal interazzjonijiet possibbli mediċina-mediċina PK jew PD.
English: The MAH emphasized the inter-individual differences in the AUC and Cmax of the drug which were variable after oral tolperisone treatment.
Maltese: Il-MAH emfażizza d-differenzi bejn individwu u ieħor fl-AUC u Cmax tal-mediċina li kienu varjabbli wara trattament orali ta' tolperisone.
English: The PK parameters have been compared to the innovator product however the results of the PK study had not been included.
Maltese: Il-parametri PK tqabblu mal-prodott innovatur, madankollu, ir-riżultati talistudju PK ma ġewx inklużi.
English: This study, according to the MAH, confirmed the PK parameters of the relevant publications.
Maltese: Dan l-istudju, skont il-MAH, ikkonferma l-parametri PK talpubblikazzjonijiet relevanti.
English: In this trial tolperisone in dose of 300 mg daily proved to be significantly superior to placebo in treatment of painful reflex muscle spasm, in patients with diseases of the spine column or proximal joints.
Maltese: F'din il-prova, tolperisone f'doża ta' 300 mg kuljum intwera li kien ferm superjuri għal plaċebo fil-kura ta' spażmi muskolari ta' rifless b'uġigħ, f'pazjenti b'mard tal-kolonna spinali jew tal-ġogi prossimali.
English: The MAH submitted six abstracts of selected publications to support the claimed indication increased tone and spasticity of the skeletal muscles due to organic neurological disorders.
Maltese: Il-MAH issottometta sitt astratti ta' pubblikazzjonijiet magħżula biex jappoġġja l-indikazzjoni kklejmjata żieda fis-saħħa u fl-ispastiċità tal-muskoli skeletali dovuti għal disturbi newroloġiċi organiċi.
English: The MAH argued that no specifically designed dose-response/dose-titration study was performed for tolperisone.
Maltese: Il-MAH argumenta li ma sar ebda studju ddisinjat speċifikament doża-rispons/doża-titrazzjoni għal tolperisone.
English: The MAH did not intend to claim different dosage range and posology.
Maltese: Il-MAH ma kellux l-intenzjoni li jisħaq fuq medda u pożoloġija tad-doża differenti.
English: The CHMP is of the opinion that the documentation submitted by the MAH is not sufficient to demonstrate the efficacy and safety of tolperisone.
Maltese: Is-CHMP huwa tal-opinjoni li d-dokumentazzjoni sottomessa mill-MAH mhijiex suffiċjenti biex turi leffikaċja u s-sigurtà ta' tolperisone.
English: The MAH only presented a list of drugs used in combination or in parallel with tolperisone and stated that no report on unwanted interaction with tolperisone had been reported in the clinical trials.
Maltese: Il-MAH ippreżenta biss lista ta' mediċini użati f'kombinazzjoni jew b'mod parallel ma' tolperisone u ddikjara li ebda rapport jew interazzjoni mhux mixtieqa ma' tolperisone ma ġiet irrapportata mal-provi kliniċi.
English: No data of epidemiological studies on the safety of tolperisone in clinical use have been provided.
Maltese: Ebda dejta ta' studji epidemjoloġiċi dwar is-sigurtà ta' tolperisone fl-użu kliniku ma ġiet ipprovduta.