FrancophonIA/ELRC3.0 huggingface dataset:
English: Yargesa is available as 100 mg capsules to be taken by mouth.
Maltese: Yargesa jiġi bħala kapsuli ta' 100 mg li għandhom jittieħdu mill-ħalq.
English: Therefore, the CHMP's view was that, as for Zavesca, the benefit outweighs the identified risk.
Maltese: Għaldaqstant, il-fehma tas-CHMP kienet li, bħal fil-każ ta' Zavesca, ilbenefiċċju huwa akbar mir-riskju identifikat.
English: The recommended starting dose is one capsule three times a day.
Maltese: Id-doża inizjali rakkomandata hija kapsula waħda tliet darbiet kuljum.
English: Yargesa is used in patients who cannot receive enzyme-replacement therapy.
Maltese: Yargesa jintuża f'pazjenti li ma jistgħux jieħdu terapija ta' sostituzzjoni talenzima.
English: EMA/332109/2012 Rev. 1 EMEA/H/A-30/1262
Maltese: 1 EMEA/H/A-30/1262
English: Tavanic is marketed in the following EU Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden and United Kingdom.
Maltese: Tavanic huwa mqiegħed fis-suq fl-Istati Membri tal-UE li ġejjin: l-Awstrija, il-Belġju, il-Bulgarija, Ċipru, ir-Repubblika Ċeka, l-Estonja, il-Finlandja, Franza, il-Ġermanja, il-Greċja, l-Ungerija, l-Irlanda, l-Italja, il-Litwanja, il-Lussemburgu, Malta, il-Pajjiżi l-Baxxi, il-Polonja, il-Portugall, is-Slovakkja, is-Slovenja, Spanja, l-Iżvezja u r-Renju Unit.
English: What is Tavanic?
Maltese: X'inhu Tavanic?
English: Tavanic is an antibiotic that belongs to the group ‘fluoroquinolones'.
Maltese: Tavanic huwa antibijotiku li jagħmel parti mill-grupp ta' ‘fluoroquinolones'.
English: On 24 May 2012 the European Medicines Agency completed a review of Tavanic.
Maltese: Fl-24 ta' Mejju 2012 l-Aġenzija Ewropea għall-Mediċini temmet reviżjoni ta' Tavanic.
English: Tavanic was identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)).
Maltese: Tavanic ġie identifikat li jeħtieġ armonizzazzjoni mill-Grupp ta' Koordinazzjoni dwar il-Proċeduri Reċiproki u Deċentralizzati - Umani (CMD(h)).
English: • Tavanic 250 mg and 500 mg film-coated tablets are indicated in acute bacterial sinusitis, acute exacerbation of chronic bronchitis, community-acquired pneumonia and complicated skin and soft tissue infections only when other commonly used antibacterial agents are not recommended.
Maltese: • Tavanic 250 mg u 500 mg pilloli miksijin b'rita huma indikati f'sinusite batterjali akuta, f'aggravar akut ta' bronkite kronika, fi pnewmonja li tittieħed mill-komunità u f'infezzjonijiet ikkumplikati tal ġilda u tat-tessut artab biss meta aġenti batterjali użati normalment mhumiex rakkomandati.
English: In addition, the Committee added new side effects in section 4.8 including ligament rupture, hypoglycaemic coma, benign intracranial hypertension, as well as palpitations and ventricular tachycardia, which may result in cardiac arrest.
Maltese: Barra minn hekk, il-Kumitat żied effetti sekondarji ġodda fissezzjoni 4.8 inkluż il-qtugħ ta' ligamenti, koma ipogliċemika, pressjoni għolja intrakranjali beninna, kif ukoll palpitazzjonijiet u takikardja ventrikulari, li jistgħu jwasslu għal arrest kardijaku.
English: Having harmonised the indications, the CHMP also harmonised the recommendations on the posology and frequency of administration of Tavanic, including the posology for acute exacerbations of chronic bronchitis and pyelonephritis.
Maltese: Wara li armonizza l-indikazzjonijiet, is-CHMP armonizza wkoll ir-rakkomandazzjonijiet dwar ilpożoloġija u l-frekwenza tal-għoti ta' Tavanic, inkluża l-pożoloġija għal aggravar akut ta' bronkite kronika u ta' pajelonefrite.
English: Why was Tavanic reviewed?
Maltese: Għaliex ġie rivedut Tavanic?
English: • Tavanic 5mg/ml solution for infusion is indicated in community-acquired pneumonia and complicated skin and soft tissue infections only when other commonly used antibacterials are not recommended.
Maltese: • Tavanic 5 mg/ml soluzzjoni għal infużjoni hija indikata għal pnewmonja li tittieħed mill-komunità u f'infezzjonijiet ikkumplikati tal-ġilda u tat-tessut artab biss meta antibatteriċi użati normalment ma jkunux rakkomandati.
English: They are also indicated in pyelonephritis and complicated urinary tract infections (UTI), chronic bacterial prostatitis, uncomplicated cystitis and for the post-exposure prophylaxis and curative treatment of
Maltese: Hija indikata wkoll fil-pajelonefrite u f'infezzjonijiet ikkumplikati tal-apparat urinarju (UTI), fi prostatite batterjali kronika, u għall-profilassi wara l-espożizzjoni u l-kura kurattiva ta' antraċe li tittieħed permezz ta' inalazzjoni.
English: Based on the data reviewed, the CHMP decided a harmonisation of the contraindications of Tavanic in patients hypersensitive (allergic) to levofloxacin, any other quinolone or any of the excipients, in patients with epilepsy, in patients with history of tendon disorders related to fluoroquinolone administration, in children or growing adolescents, during pregnancy and in breast-feeding women.
Maltese: Abbażi tad-dejta riveduta, is-CHMP iddeċieda favur l-armonizzazzjoni tal-kontra-indikazzjonijiet ta' Tavanic f'pazjenti b'sensittività eċċessiva (allerġiċi) għal levofloxacin, għal xi quinolone ieħor jew għal kwalunkwe eċċipjent ieħor, f'pazjenti b'epilessija, f'pazjenti bi storja ta' disturbi fit-tendini relatati malgħoti ta' fluoroquinolone, fit-tfal u fl-adoloxxenti li qegħdin jikbru, matul it-tqala u f'nisa li qegħdin ireddgħu.
English: Tavanic is authorised in the EU via national procedures.
Maltese: Tavanic huwa awtorizzat fl-UE permezz ta' proċeduri nazzjonali.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the product information for Tavanic in the European Union (EU).
Maltese: Il-Kumitat għallProdotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija kkonkluda li jeħtieġ li l-informazzjoni tal-preskrizzjoni għal Tavanic tiġi armonizzata fl-Unjoni Ewropea (UE).
English: The amended information to doctors and patients is available here for solution for infusion and tablets.
Maltese: L-informazzjoni emendata għat-tobba u għall-pazjenti hija disponibbli hawn għas-soluzzjoni għal infużjoni u għall-pilloli.
English: The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.
Maltese: Is-CHMP, fid-dawl tad-dejta sottomessa u d-diskussjoni xjentifika fil-Kumitat, kien tal-opinjoni li lSmPCs, it-tikkettar u l-fuljetti ta' tagħrif għandhom jiġu armonizzati fl-UE kollha.
English: After reviewing the available data supporting the use of the medicine, the CHMP agreed that:
Maltese: Wara li rreveda d-dejta disponibbli b'appoġġ għall-użu tal-mediċina, is-CHMP qabel li:
English: The full EPAR for Zaltrap can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The medicine contains the active substance aflibercept.
Maltese: Il-mediċina fiha s-sustanza attiva aflibercept.
English: This is a summary of the European public assessment report (EPAR) for Zaltrap.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Zaltrap.
English: Zaltrap was investigated in one main study involving 1,226 adults with metastatic colorectal cancer that had not responded to oxaliplatin-based treatment.
Maltese: Zaltrap ġie investigat fi studju ewlieni wieħed li involva 1,226 adult b'kanċer kolorettali metastatiku li ma kinux irrispondew għal kura bbażata fuq oxaliplatin.
English: The most common effects that led to treatment being permanently stopped were problems with the circulation including hypertension, infections, tiredness, diarrhoea, dehydration, stomatitis, neutropenia, proteinuria, and pulmonary embolism (a clot in a blood vessel supplying the lungs).
Maltese: L-effetti sekondarji l-aktar komuni li wasslu biex il-kura titwaqqaf b'mod permanenti kienu problemi biċċirkolazzjoni inkluż ipertensjoni, infezzjonijiet, għeja, dijarea, deidratazzjoni, stomatite, newtropenja, proteinurja, u emboliżmu pulmonari (koagulazzjoni f'vażu li jforni l-pulmuni).
English: The most common side effects with Zaltrap in combination with FOLFIRI (which may affect more than 20 patients in 100) are leucopenia and neutropenia (low levels of white cells in the blood, including the type that fight infections), diarrhoea, proteinuria (protein in the urine), increased blood levels of liver enzymes (aspartate and alanine transaminases), stomatitis (inflammation of the mouth), tiredness, thrombocytopenia (low blood platelet counts), hypertension (high blood pressure), weight loss, decreased appetite, epistaxis (nose bleeds), abdominal pain, dysphonia (speech disturbance), increases in creatinine in the blood (a marker of kidney problems), and headache.
Maltese: L-effetti sekondarji l-aktar komuni b'Zaltrap f'kombinazzjoni ma' FOLFIRI (li jistgħu jaffettwaw aktar minn 20 pazjent minn kull 100) huma lewkopenja u newtropenja (livelli baxxi ta' ċelloli bojod fiddemm, inkluż it-tip li jiġġieldu l-infezzjonijiet), dijarea, proteinurja (proteina fl-awrina), livelli miżjudin fid-demm ta' enzimi tal-fwied (aspartate u alanine transaminases), stomatite (infjammazzjoni talħalq), għeja, tromboċitopenja (għadd baxx tal-pjastrini fid-demm), ipertensjoni (pressjoni tad-demm għolja), telf fil-piż, tnaqqis fl-aptit, epistassi (fsada mill-imnieħer), uġigħ addominali, disfonja (disturbi fid-diskors), żidiet fil-kreatinina fid-demm (markatur ta' problemi tal-kliewi), u uġigħ ta' ras.
English: Zaltrap is used with FOLFIRI, which is a treatment combining the medicines irinotecan, 5-fluorouracil, and folinic acid.
Maltese: Zaltrap jintuża ma' FOLFIRI, li huwa kura li tikkombina l-mediċini irinotecan, 5-fluorouracil, u aċidu foliniku.
English: Why is Zaltrap approved?
Maltese: Għaliex ġie approvat Zaltrap?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zaltrap on 1 February 2013.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Zaltrap fl-1 ta' Frar 2013.
English: Other information about Zaltrap
Maltese: Informazzjoni oħra dwar Zaltrap
English: The active substance in Zaltrap, aflibercept, is a protein that attaches to vascular endothelial growth factor (VEGF) and placenta growth factor (PlGF), substances that circulate in the blood and make blood vessels grow.
Maltese: Is-sustanza attiva f'Zaltrap, l-aflibercept, hija proteina li teħel ma' fattur tat-tkabbir endoteljali vaskulari (VEGF, vascular endothelial growth factor) u fattur ta' tkabbir tal-plaċenta (PIGF, placenta growth factor), sustanzi li jiċċirkolaw fid-demm u jġiegħlu lill-vażi jikbru.
English: Zaltrap is given as an infusion (drip) into the vein over one hour, at a dose of 4 mg per kilogram body weight.
Maltese: Zaltrap jingħata bħala infużjoni (dripp) fil-vina fuq perjodu ta' siegħa, b'doża ta' 4 mg għal kull kilogramma piż tal-ġisem.
English: What are the risks associated with Zaltrap?
Maltese: X'inhuma r-riskji assoċjati ma' Zaltrap?
English: In this study, Zaltrap was more effective than placebo at increasing survival of patients: patients treated with Zaltrap plus FOLFIRI lived an average of 13.5 months, whereas patients treated with placebo and FOLFIRI lived an average of 12.1 months.
Maltese: F'dan l-istudju, Zaltrap kien aktar effettiv mill-plaċebo biex iżid is-sopravivenza tal-pazjenti: il-pazjenti kkurati b'Zaltrap flimkien ma' FOLFIRI għexu medja ta' 13.5 xhur, waqt li l-pazjenti kkurati bil-plaċebo u FOLFIRI għexu medja ta' 12.1 xhur.
English: For the full list of all side effects reported with Zaltrap, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Zaltrap, ara l-fuljett ta' tagħrif.
English: Zaltrap is a cancer medicine used to treat adults with metastatic colorectal cancer (cancer of the large bowel that has spread to other parts of the body) for whom treatment based on another medicine, oxaliplatin, has not worked or the cancer got worse.
Maltese: Zaltrap huwa mediċina kontra l-kanċer li jintuża biex jikkura adulti b'kanċer kolorettali metastatiku (kanċer tal-musrana l-kbira li jkun inxtered għal partijiet oħrajn tal-ġisem) li għalihom, kura bbażata fuq mediċina oħra, oxaliplatin, ma tkunx ħadmet jew il-kanċer ikun iggrava.
English: This is then followed by the FOLFIRI treatment.
Maltese: Din imbagħad tiġi segwita mill-kura b'FOLFIRI.
English: How does Zaltrap work?
Maltese: Kif jaħdem Zaltrap?
English: For further details, see the package leaflet.
Maltese: Zaltrap tqabbel mal-plaċebo (kura finta) meta miżjud ma' FOLFIRI.
English: Overall, the European Medicines Agency decided that Zaltrap's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: Għalhekk, l-Aġenzija Ewropea għall-Mediċini iddeċidiet li l-benefiċċji ta' Zaltrap huma akbar mir-riskji tiegħu u rrakkomandat li jkun approvat għall-użu fl-UE.
English: (Invented) nameStrength Pharmaceutical Form Route of AdministrationImmediate PackagingPack size
Maltese: Isem (ivvintat) Qawwa Forma Farmaċewtika
English: 21 January 2013
Maltese: 21 ta' Jannar 2013
English: Tolperisone is a muscle relaxant.
Maltese: Tolperisone huwa rilassant tal-muskoli.
English: What is tolperisone?
Maltese: X'inhu tolperisone?
English: Medicines containing tolperisone are available as tablets and/or solution for injection in Bulgaria, Cyprus, Czech Republic, Germany, Hungary, Latvia, Lithuania, Poland, Romania and Slovakia, under various trade names.
Maltese: Mediċini li fihom tolperisone huma disponibbli bħala pilloli u/jew soluzzjoni għal injezzjoni fil-Bulgarija, Ċipru, ir-Repubblika Ċeka, il-Ġermanja, l-Ungerija, il-Latvja, il-Litwanja, il-Polonja, ir-Rumanija u sSlovakkja taħt ismijiet kummerċjali varji.
English: The CHMP reviewed data on the effectiveness of oral and injectable tolperisone in the different indications, including data from published clinical studies and analyses of various studies provided by the companies that market these medicines.
Maltese: Is-CHMP irreveda dejta tal-effikaċja ta' tolperisone orali u injettabbli fl-indikazzjonijiet differenti, inkluż dejta minn studji kliniċi ppubblikati u analiżi ta' diversi studji pprovduti mill-kumpaniji li jpoġġu dawn il-mediċini fis-suq.
English: The Committee also reviewed the available postmarketing data on spontaneous reports of side effects.
Maltese: Il-Kumitat irreveda wkoll id-dejta ta' wara t-tqegħid fis-suq disponibbli dwar rapporti spontanji tal-effetti sekondarji.
English: Only in the treatment of spasticity caused by neurological diseases was a study considered to be of acceptable quality, showing a moderate improvement of 32% in spasticity with oral tolperisone, compared with a 14% improvement in the placebo (a dummy treatment) group.
Maltese: Kien biss fil-kura tal-ispastiċità kkawżata minn mard newroloġiku li studju tqies li huwa ta' kwalità aċċettabbli, li wera titjib moderat ta' 32% fl-ispastiċità b'tolperisone orali meta mqabbel ma' titjib ta' 14% fil-grupp tal-plaċebo (trattament finta).
English: These include neurological diseases (related to the brain or nerves, such as multiple sclerosis), locomotor diseases (related to the spine and large joints such as the hip), vascular diseases (related to the blood vessels), rehabilitation following surgery, and Little's disease (also known as cerebral palsy, a rare disease where there is damage to parts of the brain that control movement).
Maltese: Dawn jinkludu mard newroloġiku (relatat mal-moħħ jew man-nervituri, bħal sklerożi multipla), mard relatat mal-lokomozzjoni (relatat mal-ispina u ma' ġogi kbar bħall-ġenbejn), mard vaskulari (relatat mal-vini tad-demm), riabilitazzjoni wara kirurġija, u lmarda ta' Little (magħrufa wkoll bħala palsija ċerebrali, marda rari fejn ikun hemm ħsara għal partijiet tal-moħħ li jikkontrollaw il-moviment).
English: The available data to support the use of tolperisone-containing medicines in locomotor diseases, vascular diseases, rehabilitation following surgery and Little's disease are limited and not convincing.
Maltese: Id-dejta disponibbli sabiex tappoġġa l-użu ta' mediċini li fihom tolperisone f'mard lokomotorju, mard vaskulari, riabilitazzjoni wara kirurġija u lmarda a' Little hija limitata u mhux konvinċenti.
English: On 21 June 2012, the European Medicines Agency completed a review of the safety and effectiveness of tolperisone.
Maltese: Fil-21 ta' Ġunju 2012, l-Aġenzija Ewropea tal-Mediċini temmet reviżjoni tas-sigurtà u l-effikaċja ta' tolperisone.
English: However, the study only included adults with post-stroke spasticity.
Maltese: Madankollu, l-istudju inkluda biss adulti bi spastiċità wara puplesija.
English: Why were tolperisone-containing medicines reviewed?
Maltese: Għaliex mediċini li fihom tolperisone ġew riveduti?
English: • Patients should note that symptoms of hypersensitivity can include flushing, rash, severe itching of the skin (with raised lumps), wheezing, difficulty breathing, difficulty in swallowing, fast heartbeat, low blood pressure and fast decrease in blood pressure.
Maltese: • Il-pazjenti għandhom jinnotaw li s-sintomi ta' sensittività eċċessiva jistgħu jinkludu ħmura fil-wiċċ, raxx, ħakk sever tal-ġilda (b'infafet imqabbżin), tħarħir, diffikultà fit-teħid tan-nifs, diffikultà biex jibilgħu, taħbit tal-qalb mgħaġġel, pressjoni tad-demm baxxa u tnaqqis veloċi fil-pressjoni taddemm.
English: Therefore, based on the evaluation of the currently available data and considering that the risk of hypersensitivity reactions is more significant than previously identified, the CHMP concluded that the benefits of oral tolperisone-containing medicines continue to outweigh its risks only when used in the treatment of post-stroke spasticity in adults.
Maltese: Għaldaqstant, fuq il-bażi tal-evalwazzjoni tad-dejta disponibbli attwalment u filwaqt li jiġi kkunsidrat li r-riskju ta' reazzjonijiet ta' sensittività eċċessiva huwa aktar sinifikanti milli identifikat preċedentament, is-CHMP ikkonkluda li l-benefiċċji ta' mediċini li fihom tolperisone orali jibqgħu jisbqu r-riskji tiegħu meta użat fil-kura ta' spastiċità ta' wara puplesija fl-adulti.
English: Regarding the safety of tolperisone, the CHMP noted that more than half of the spontaneous reports of side effects with tolperisone were hypersensitivity reactions, while only a small number of hypersensitivity reports had been observed during the clinical trials that supported tolperisone's marketing authorisation.
Maltese: Fir-rigward tas-sigurtà ta' tolperisone, is-CHMP innota li aktar minn nofs ir-rapporti spontanji ta' effetti sekondarji b'tolperisone kienu reazzjonijiet ta' sensittività eċċessiva, filwaqt li numru żgħir biss ta' rapporti ta' sensittività eċċessiva ġew osservati matul il-provi kliniċi li appoġġaw l-awtorizzazzjoni għattqegħid fis-suq ta' tolperisone.
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.
Maltese: Il-mod eżatt ta' kif jaħdem tolperisone mhuwiex magħruf, iżda huwa maħsub li jaġixxi fil-moħħ u finnerv qawwi tas-sinsla sabiex inaqqas l-impulsi tan-nervituri li jġiegħlu lill-muskoli jinġibdu u jsiru riġidi.
English: As tolperisone-containing medicines have been developed by different companies and have been authorised through national procedures in the EU Member States, they are used to treat different conditions in different countries.
Maltese: Minħabba li mediċini li fihom tolperisone ġew żviluppati minn kumpaniji differenti u ġew awtorizzati permezz ta' proċeduri nazzjonali fl-Istati Membri differenti tal-UE, jintużaw biex jikkuraw kundizzjonijiet differenti f'pajjiżi differenti.
English: • Patients should be informed of the possibility of hypersensitivity reactions during treatment with tolperisone.
Maltese: • Il-pazjenti għandhom jiġu infurmati bil-possibilità ta' reazzjonijet ta' sensittività eċċessiva b'tolperisone.
English: • Patients currently using tolperisone for any other indication or using injectable tolperisone should speak to their doctor at their next routine appointment so they can switch to an appropriate alternative treatment.
Maltese: • Il-pazjenti li fil-preżent jużaw tolperisone għal kwalunkwe indikazzjoni oħra jew li jużaw tolperisone injettabbli għandhom jitkellmu mat-tabib tagħhom fl-appuntament ta' rutina li jmiss tagħhom sabiex ikunu jistgħu jaqilbu għal kura alternattiva xierqa.
English: • Prescribers are advised that the indication for oral tolperisone has been restricted to the treatment of post-stroke spasticity in adults.
Maltese: • Dawk li jagħtu riċetta għal din il-mediċina għandhom ikunu avżati li l-indikazzjoni għal tolperisone orali ġiet ristretta għall-kura ta' spastiċità wara kirurġija fl-adulti.
English: On 15 July 2011, it asked the CHMP to issue an opinion on whether the marketing authorisations for tolperisone-containing products should be maintained, varied, suspended or withdrawn across the EU.
Maltese: Fil-15 ta' Lulju 2011, talbet lis-CHMP sabiex joħroġ opinjoni dwar jekk l-awtorizzazzjonijiet għat-tqegħid fis-suq għal prodotti li fihom tolperisone għandhomx jinżammu, jiġu varjati, sospiżi jew irtirati madwar l-UE.
English: Questions and answers on the review of tolperisonecontaining medicines
Maltese: Mistoqsijiet u tweġibiet dwar ir-reviżjoni ta' mediċini li fihom tolperisone
English: The European Commission issued a decision on this opinion on 21 January 2013.
Maltese: Il-Kummissjoni Ewropea ħarġet deċiżjoni fuq din l-opinjoni fil-21 ta' Jannar 2013.
English: In addition, numerous reports of hypersensitivity (allergic) reactions to tolperisone had been reported post marketing in Germany.
Maltese: Barra minn hekk, bosta rapporti dwar reazzjonijiet ta' sensittività eċċessiva (allerġiċi) għal tolperisone ġew irrapportati wara t-tqegħid fis-suq fil-Ġermanja.
English: In addition, since extremely limited data are available to support the safety and dosing recommendations of injectable tolperisone, the CHMP concluded that the benefits of this formulation do not outweigh the identified risks, and that the marketing authorisations for tolperisone-containing medicines given by injection should be revoked.
Maltese: Barra minn hekk, minħabba li hemm ammont estremament limitat ta' dejta disponibbli sabiex jappoġġa r-rakkomandazzjonijiet tas-sigurtà u ta' dożaġġ ta' tolperisone injettabbli, is-CHMP ikkonkluda li l-benefiċċji ta' din il-formolazzjoni ma jisbqux ir-riskji identifikati u li l-awtorizzazzjonijiet għat-tqegħid fis-suq għal mediċini li fihom tolperisone mogħtija permezz ta' injezzjoni għandhom jiġu revokati.
English: • Patients should be aware that the benefits of oral tolperisone continue to outweigh its risks only for the treatment of post-stroke spasticity in adults.
Maltese: • Il-pazjenti għandhom ikunu konxji li l-benefiċċji ta' tolperisone orali jibqgħu jisbqu r-riskji tiegħu biss għall-kura ta' spastiċità wara puplesija fl-adulti.
English: Tolperisone-containing medicines have been authorised in several countries in the EU since the 1960s for the treatment of muscle spasms (involuntary contractions) and spasticity caused by different conditions.
Maltese: Mediċini li fihom tolperisone ilhom awtorizzati f'bosta pajjiżi flUE sa mis-snin sittin għall-kura ta' spażmi tal-muskoli (kontrazzjonijiet involontarji) u spastiċità ikkawżata minn kundizzjonijiet differenti.
English: The Committee also recommended that the marketing authorisations for tolperisonecontaining medicines given by injection should be revoked throughout the European Union (EU).
Maltese: Il-Kumitat irrakkomanda wkoll li l-awtorizzazzjonijiet għat-tqegħid fis-suq għal mediċini li fihom tolperisone mogħtija b'injezzjoni għandhom jiġu revokati madwar l-Unjoni Ewropea (UE) kollha.
English: Rubraca (rucaparib)
Maltese: Rubraca (rukaparib)
English: Rubraca is available as tablets of 200, 250 and 300 mg.
Maltese: Rubraca jiġi bħala pilloli ta' 200, 250 u 300 mg.