FrancophonIA/ELRC3.0 huggingface dataset:
English: Cleansing gel for Qutenza contains butylhydroxyanisole
Maltese: Ġell għat-tindif għal Qutenza fih il-butylhydroxyanisole
English: België/Belgique/Belgien S.A. Grünenthal N.V.
Maltese: België/Belgique/Belgien
English: No data are available.
Maltese: L-ebda dejta ma hi disponibbli.
English: • Decreased taste, reduced sensations in limbs, eye irritation, cough, throat irritation, nausea,
Maltese: • Tnaqqis fit-togħma, sensazzjonijiet mnaqqsa fir-riġlejn, , irritazzjoni fl-għajnejn, sogħla,
English: Cutaneous use.
Maltese: Użu kutanju.
English: For painful diabetic peripheral neuropathy consistent and reproducible efficacy has been demonstrated with repeated treatments during a 52-week period.
Maltese: Għal newropatija periferali dijabetika bl-uġigħ l-effikaċja konsistenti u riproduċibbli ntweriet ma 'trattamenti ripetuti matul perjodu ta' 52 ġimgħa.
English: Pharmacokinetic data in humans showed transient, low (< 5 ng/ml) systemic exposure to capsaicin in about one third of PHN patients, in 3% of patients with painful diabetic peripheral neuropathyand in no HIV-AN patients following 60-minute applications of Qutenza.
Maltese: Id-dejta farmakokinetika fil-bnedmin uriet esponiment sistemiku tranżitorju baxx (< 5 ng/ml) għal capsaicin f'madwar terz tal-pazjenti b'nevralġija posterpetika, fi 3% tal-pazjenti b'newropatija periferali dijabetika li tuġgħa u f'ebda pazjent b'newropatija assoċjata mal-HIV wara applikazzjonijiet ta' 60 minuta ta' Qutenza.
English: macrogol 300 carbomer purified water sodium hydroxide (E524) disodium edetate butylhydroxyanisole (E320)
Maltese: macrogol 300 carbomer ilma purifikat sodium hydroxide (E524) disodium edetate butylhydroxyanisole (E320)
English: Unintended exposure
Maltese: Esponiment mhux intenzjonat
English: Clinical efficacy and safety
Maltese: Effikaċja klinika u sigurta
English: Campus 21, Liebermannstraße A01/501 2345 Brunn am Gebirge Tel: +43(0)2236 379 550-0
Maltese: Brunn am Gebirge Tel: +43(0)2236 379 550-0
English: The topical anaesthetic should be applied to cover the entire Qutenza treatment area and surrounding 1 to 2 cm.
Maltese: L-anestetiku topiku għandu jiġi applikat biex ikopri ż-żona kollha tat-trattament b'Qutenza u 1 sa 2 cm madwarha.
English: Efficacy of a single 60-minute application of Qutenza to locations other than the feet has been shown in controlled clinical trials conducted in patients with postherpetic neuralgia (PHN).
Maltese: L-effikaċja ta' applikazzjoni waħda ta' 60 minuta ta' Qutenza għal żoni differenti mis-saqajn intweriet fi provi kliniċi kkontrollati li saru f'pazjenti b'nevralġija posterpetika (PHN).
English: How to store Qutenza
Maltese: Tużax Qutenza
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti għas-sottomissjoni tar-rapporti perjodiċi ta 'aġġornament dwar is-sigurtà għal dan ilprodott mediċinali huma stabbiliti fil-lista ta' dati ta 'referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c (7) tad-Direttiva 2001/83 / KE u kwalunkwe aġġornamenti sussegwenti ppubblikati fuq is-sit elettroniku Ewropew dwar il- mediċini
English: Qutenza contains capsaicin and belongs to a group of medicines called anaesthetics.
Maltese: Qutenza għandu il-capsaicin u jappartjeni għal kategorija ta 'mediċini msejħa anestetiċi.
English: Application site urticaria, application site paraesthesia, application site dermatitis, application site hyperaesthesia, application site inflammation, application site reaction, application site irritation, application site bruising, peripheral oedema
Maltese: Urtikarja fis-sit tal-applikazzjoni, parastesija fis-sit tal-applikazzjoni, dermatite fis-sit tal-applikazzjoni, iperestesija fis-sit tal-applikazzjoni, infjammazzjoni fis-sit tal-applikazzjoni, reazzjoni fis-sit tal-applikazzjoni, irritazzjoni fis-sit tal-applikazzjoni, tbenġil fis-sit tal-applikazzjoni, edema periferika
English: You may experience pain relief between 1 and 3 weeks after treatment.
Maltese: Tista' tesperjenza tnaqqis fl-uġigħ bejn 1 u 3 ġimgħat wara t-trattament.
English: Qutenza must be applied to intact, non-irritated, dry skin, and allowed to remain in place for 30 minutes for the feet (e.g. HIV-associated neuropathy, painful diabetic peripheral neuropathy) and 60 minutes for other locations (e.g. postherpetic neuralgia).
Maltese: Qutenza jrid jiġi applikat fuq ġilda xotta, intatta u mhux irritata, u jitħalla hemm għal 30 minuta fil-każ tas-saqajn (eż. newropatija assoċjata mal-HIV u wġigħ newropatiku periferiku tad- dijabete) u 60 minuta għal postijiet oħra (eż. nevralġija posterpetika).
English: • Itching, bumps, blisters, swelling, dryness on the area where the patch is applied,burning sensation, pain in limbs.
Maltese: • Ħakk, ħotob, infafet, nefħa, nixfa fiż-żona fejn jiġi applikat l-istikk, sensazzjoni ta' ħruq, uġiegħ fid-dirgħajn u ir-riġlejn.
English: Cleansing gel macrogol 300 carbomer purified water sodium hydroxide (E524) disodium edetate butylhydroxyanisole (E320)
Maltese: Ġell għat-tindif macrogol 300 carbomer ilma purifikat sodium hydroxide (E524) disodium edetate butylhydroxyanisole (E320)
English: Muscle spasms
Maltese: TWISSIJA SPEĊJALI
English: Capsaicin-induced alterations in cutaneous nociceptors are reversible and it has been reported and observed that normal function (the detection of noxious sensations) returns within weeks in healthy volunteers.
Maltese: Il-bidliet ikkawżati minn capsaicin fin-noċiċetturi tal-ġilda huma riversibbli u ġie rrappurtat u osservat li l-funzjoni normali (perċezzjoni ta' sensazzjonijiet noċivi) terġa' lura fi ftit ġimgħat f'voluntiera b'saħħithom.
English: Most quantifiable levels were observed at the time of Qutenza removal, with a clear trend towards disappearance by 3 to 6 hours after Qutenza removal.
Maltese: Ħafna mil-livelli kwantifikabbli kienu osservati fil-waqt tat-tneħħija ta' Qutenza, b'tendenza ċara favur l-għajbien fi żmien 3 sa 6 sigħat wara t-tneħħija ta' Qutenza.
English: Other medicines and Qutenza
Maltese: Mediċini oħra u Qutenza
English: Following capsaicin exposure, cutaneous nociceptors become less sensitive to a variety of stimuli.
Maltese: Wara esponiment għal capsaicin, in-noċiċetturi tal-ġilda jsiru inqas sensittivi għal varjetà ta' stimuli.
English: Polyethylene Terephthalate (PET) Film, inner side siliconized printing ink containing Pigment White 6
Maltese: Kisja tal-Polyethylene Terephthalate (PET), bin-naħa ta' ġewwa silikonizzata inka tal-istampar li fiha l-Pigment White 6
English: Qutenza therapy may be repeated at 90-day intervals, if necessary.
Maltese: It-terapija b'Qutenza tista' tiġi ripetuta f'intervalli ta' 90 ġurnata, jekk ikun meħtieġ.
English: Each Qutenza carton contains 1 or 2 sachets and 1 tube of cleansing gel (50 g).
Maltese: Kull kartuna ta' Qutenza fiha qartas 1 jew 2 u tubu ta' ġell għat-tindif (50 g).
English: o Frequency not known: frequency cannot be estimated from the available data
Maltese: Mhux magħruf: ma tistax tittieħed stima tal-frekwenza mid-data disponibbli
English: In controlled trials, the discontinuation rate due to adverse reactions was 2.0% for patients receiving Qutenza and 0.9% for patients receiving control.
Maltese: Fil-provi kkontrollati kollha, ir-rata ta' twaqqif minħabba r-reazzjonijiet avversi kienet ta' 2.0% għall-pazjenti li rċevew Qutenza u 0.9% għall-pazjenti li rċevew is-sustanza ta' kontroll.
English: Contains macrogol 300, carbomer, purified water, sodium hydroxide (E524), disodium edetate and butylhydroxyanisole (E320); See package leaflet for further information.
Maltese: Fih macrogol 300, carbomer, ilma purifikat, sodium hydroxide (sodju idrossidu) (E524), disodium edetate (disodju edetat) u butylhydroxyanisole (butilidrossianisol) (E320); Ara l-fuljett ta' tagħrif għal aktar informazzjoni.
English: Reductions in sensory function have been reported following administration of Qutenza.
Maltese: Nuqqas tal-funzjoni tas-sensi ġew irraportati wara li Quetenza ġie amministrat.
English: Cardiac disorders Uncommon
Maltese: Disturbi kardijaċi Mhux komuni
English: Do not take Qutenza patches away from the clinic.
Maltese: Tiħux l-istikks Qutenza barra mill-klinika.
English: Genotoxicity studies performed with capsaicin show a weak mutagenic response in the mouse lymphoma assay and negative responses in the Ames, mouse micronucleus and chromosomal aberrationin human peripheral blood lymphocytes assays.
Maltese: Studji ta' ġenotossiċità mwettqa b'capsaicin juru rispons mutaġeniku dgħajjef fit-test tal-linfoma filġrieden u rispons negattiv fit-testijiet ta' Ames, tal-mikronukleu tal-ġrieden u tal-aberrazzjoni kromosomika fil-linfoċiti tad-demm periferiku uman.
English: Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Maltese: Huwa important li ji jiġu rrappurtati reazzjonijiet avversi suspettati wara l-awtorizzazjoni tal-prodott mediċinali.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini (EMA) http://www.ema.europa.eu
English: Assuming 1000 cm2 of patch area delivers approximately 1% of capsaicin from the patch to a 60 kg person, the maximum potential exposure to capsaicin is approximately 0.12 mg/kg, once every 3 months.
Maltese: Jekk wieħed jassumi li 1000 cm2 ta' erja tal-istikk tagħti madwar 1% ta' capsaicin mill-istikk lil persuna ta' 60 kg, l-esponiment massimu potenzjali għal capsaicin huwa madwar 0.
English: It is unknown whether capsaicin/metabolites are excreted in human milk.
Maltese: Mhux magħruf jekk capsaicin/metaboliti jiġux eliminati mill-ħalib tas-sider tal-bniedem.
English: In vitro data (active substance dissolution and skin permeation assays) demonstrate that the rate of release of capsaicin from Qutenza is linear during the application time.
Maltese: Dejta in vitro (test ta' taħlil tassustanza attiva u ta' permeazzjoni kutanja) juru li r-rata ta' rilaxx ta' capsaicin minn Qutenza hija waħda lineari matul iż-żmien tal-applikazzjoni.
English: In addition, there have been reported cases of burns, including second degree burns, in patients treated with capsaicin patches (see section 4.8).
Maltese: Barra minn hekk, ġew irrappurtati każijiet ta' ħruq, inkluż ħruq tat-tieni grad, f'pazjenti ttrattati bl-istikks capsaicin (ara sezzjoni 4.8).
English: Efficacy of a single 30-minute application of Qutenza to the feet has been shown in controlled clinical trials conducted in patients with painful Human Imunodeficiency Virus - Associated Neuropathy (HIV-AN) and painful diabetic peripheral neuropathy.
Maltese: L-effikaċja ta' applikazzjoni waħda ta' 30 minuta ta' Qutenza fis-saqajn intweriet fi provi kliniċi kkontrollati li saru f'pazjenti b' newropatija assoċjata mal-virus tal-Imunodefiċjenza tal-bniedem bluġigħ (HIV-AN) u newropatija periferali dijabetika bl-uġigħ.
English: Grünenthal GmbH Zieglerstraße 6
Maltese: Grünenthal GmbH Zieglerstr.
English: Delays in skeletal ossification (reductions in ossified metatarsals) were observed in a rat teratology study at dose levels higher than human therapeutic levels; the significance of this finding for humans is unknown.
Maltese: Ġie osservat dewmien fl-ossifikazzjoni skeletrika (tnaqqis fl-għadam metatarsali ossifikat) fi studju teratoloġiku fuq il-firien f'livell ta' dożaġġ ogħla mil-livelli terapewtiċi umani; mhux magħruf issinifikat ta' din is-sejba għall-bnedmin.
English: The other ingredients of the Qutenza cutaneous patch are:
Maltese: Qutenza stikk kutanju:
English: TUBE OF CLEANSING GEL - LABEL
Maltese: TUBU TAL-ĠELL GĦAT-TINDIF - TIKKETTA
English: The highest concentration of capsaicin detected in patients treated for 60 minutes was 4.6 ng/mL, which occurred immediately after Qutenza removal.
Maltese: L-ogħla konċentrazzjoni ta' capsaicin li nstabet f'pazjenti ttrattati għal 60 minuta kienet 4.6 ng/mL, li seħħet immedjatament wara t-tneħħija ta' Qutenza.
English: Removable protective layer (release liner) polyester film, fluoropolymer-coated
Maltese: Saff protettiv li jitneħħa (kisja ta' rilaxx) film tal-poliester, miksija b'fluoropolymer
English: Each 280 cm 2 cutaneous patch contains a total of 179 mg of capsaicin or 640 micrograms of capsaicin per cm 2 of patch.
Maltese: Kull stikk kutanju ta' 280 cm 2 fih b'kollox 179 mg capsaicin jew 640 mikrogramma capsaicin għal kull cm 2 tal-istikk
English: Outline treatment area.
Maltese: Mhux applikabbli.
English: The cutaneous patch is stored in a paper coated aluminium foil sachet with polyacrylnitril layer.
Maltese: L-istikk kutanju jinħażen f'qartas magħmul minn fojl tal-aluminju miksi bil-karta b'saff ta' polyacrylnitril.
English: Patients experiencing pain during and after patch application should be provided with supportive treatment (see section 4.4).
Maltese: Il-pazjenti li jesperjenzaw uġigħ waqt jew wara l-applikazzjoni tal-istikk għandhom jingħataw trattament ta' sostenn (ara sezzjoni 4.4).
English: Skin and subcutaneous tissue disorders
Maltese: Disturbi fil-ġilda u fit-tessuti sottokutanji
English: Patch
Maltese: Treddigħ
English: Cough, throat irritation
Maltese: Sogħla, irritazzjoni fil-griżmejn
English: The cleansing gel is supplied in a high density polyethylene tube with a polypropylene cap.
Maltese: Il-ġell għat-tindif jiġi fornut f'tubu tal-polyethylene ta' densità għolja b'tapp tal-polypropylene.
English: • in patients with unstable or poorly controlled hypertension or cardiovascular disease: to evaluate, prior to initiating Qutenza treatment, the risk of adverse cardiovascular eventsdue to the potential stress of the procedure.
Maltese: • f'pazjenti li jbatu minn ipertensjoni instabbli jew mhux ikkontrollata sewwa jew b'mard kardjovaskolari: evalwazzjoni, qabel ma jingħata bidu għat-trattament b'Qutenza, tarriskju ta' avvenimenti kardjovaskulari minħabba l-istress potenzjali tal-proċedura.
English: • because of the risk of accidental exposure, the use of nitrile gloves, a mask and protective glasses are recommended
Maltese: • minħabba r-riskju ta' espożizzjoni aċċidentali, l-użu ta' ingwanti tan-nitrile ; maskra u protezzjoni tal-għajnejn huma rakkomandati;
English: Treatment-related discomfort
Maltese: TAL-PRODOTT MEDIĊINALI
English: Qutenza is a cutaneous patch for use on your skin.
Maltese: Rimi ta' stikks Qutenza użati u mhux użati
English: irritation, bruising on the area where the patch is applied.
Maltese: Korriment, avvelenament u komplikazzjonijiet ta' xi proċedura
English: Removable protective (relase liner) polyester film, fluoropolymer-coated
Maltese: Rita tal-polyester, miksija b'fluworopolymer
English: STADA PHARMA Slovakia, s.r.o., Tel: +421 252621933
Maltese: Tel: +421 252621933
English: Your doctor or nurse will remove the patches after 30 minutes if you're being treated for nerve pain on your feet or 60 minutes if you're being treated for nerve pain on other parts of your body.
Maltese: It-tabib jew l-infermier tiegħek se jaqla' l-istikks wara 30 minuta jekk tkun qed tiġi ttrattat(a) għal uġigħ fin-nervituri ta' saqajk jew wara 60 minuta jekk tkun qed tiġi ttrattat(a) għal uġigħ fin-nervituri fuq partijiet oħra ta' ġismek.
English: Each 280 cm 2 patch contains a total of 179 mg of capsaicin or
Maltese: Kull stikk ta' 280 cm 2 fih b'kollox 179 mg capsaicin jew
English: 2 sachets, each containing 1 cutaneous patch and 1 tube of cleansing gel (50 g).
Maltese: 2 qratas, kull wieħed minnhom fih stikk kutanju u tubu ta' ġell għat-tindif (50 g).
English: • to undertake a visual examination of the feet prior to each application of Qutenza and at subsequent clinic visits to detect skin lesions related to underlying neuropathy and vascular insufficiency in patients with painful diabetic peripheral neuropathy
Maltese: • biex twettaq eżami viżwali tas-saqajn qabel kull applikazzjoni ta 'Qutenza u fiż- żjarat kliniċa sussegwenti biex jinstabu l-leżjonijiet tal-ġilda relatati man-newropatija sottostanti u insuffiċjenza vaskulari f'pazjenti b'newropatija periferali dijabetika bl-uġigħ
English: Monitoring and management of application site reactions
Maltese: Monitoraġġ u mmaniġġar ta' reazzjonijiet fis-sit tal-applikazzjoni
English: • in patients using high doses of opioids and with suspected high opioid tolerance: to put in place an alternative pain reduction strategy prior to initiating Qutenza treatment, as these patients may not respond to oral opioid analgesics when used for acute pain during and following the treatment procedure
Maltese: • f'pazjenti li jagħmlu użu minn dożi għoljin ta' opjojdi u b'suspett ta' tolleranza għolja għall-opjojdi: implimentazzjoni ta' strateġija alternattiva għat-tnaqqis tal-uġigħ qabel ittrattament b'Qutenza, billi dawn il-pazjenti jistgħu ma jirrispondux għall-analġeżiċi opjojdi orali meta jintużaw għall-uġigħ akut waqt u wara l-proċedura terapewtika
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single-dose toxicity, and repeated-dose toxicity.
Maltese: It-tagħrif mhux kliniku, magħmul fuq studji konvenzjonali ta' farmakoloġija ta' sigurtà, tossiċità ta' doża waħda u tossiċità ta' dożi ripetuti, ma wera l-ebda periklu partikolari għall-bniedem.
English: Sensations from non TRPV1-expressing cutaneous nerves are expected to remain unaltered, including the ability to detect mechanical and vibratory stimuli.
Maltese: Is-sensazzjonijiet minn nervi kutanji li ma jesprimux TRPV1 huma mistennija li jibqgħu invarjati, fosthom il-ħila li jiġu rilevati stimuli mekkaniċi u vibratorji.
English: Backing layer
Maltese: Il-Ġermanja
English: Based on in vitro studies, approximately 1% of capsaicin is estimated to be absorbed into the epidermal and dermal layers of skin during one-hour applications.
Maltese: Ibbażat fuq studji in vitro, huwa stmat li madwar 1% ta' capsaicin jiġi assorbit fis-saff epidermiku u dermiku tal-ġilda waqt applikazzjonijiet ta' siegħa.
English: itching, muscle spasms, shingles, swelling of limbs.
Maltese: irritazzjoni fil-griżmejn, dardir, ħakk, , spażmi fil-muskoli, ħruq ta' Sant' Antnin, nefħa fir riġlejn.
English: Wait up to 60 minutes, or according to product's instructions for use.
Maltese: Stenna sa 60 minuta, jew segwi listruzzjonijiet għall-użu tal-prodott.
English: A reproductive toxicology study in rats showed a reduction in the number and percent of motile sperm and the number of pregnancies (see section 5.3).
Maltese: Studju tossikoloġiku tar-riproduzzjoni fil-firien wera tnaqqis fin-numru u fil-persentaġġ ta ' sperma motili u n-numru ta' tqaliet (ara sezzjoni
English: Based on human pharmacokinetics, which show transient, low systemic exposure to capsaicin, the likelihood that Qutenza increases the risk of developmental abnormalities when given to pregnant women is very low.
Maltese: Ibbażat fuq il-proprjetajiet farmakokinetiċi tal-bniedem, li juru esponiment sistemiku baxx għal capsaicin, il-probabbiltà li Qutenza jżid ir-riskju ta' anomaliji fl-iżvilupp meta jingħata lil nisa tqal hija baxxa ħafna.
English: A reproductive toxicology study conducted in rats showed a statistically significant reduction in the number and percent of motile sperms in rats treated 3 hours/day beginning 28 days before cohabitation, through cohabitation and continuing through the day before sacrifice.
Maltese: Studju dwar l-effett tossiku fuq is-sistema riproduttiva li sar fil-ġrieden wera tnaqqis statistiku sinifikanti fl-għadd u l-perċentwali ta' sperma motili f'firien ittrattati għal 3 sigħat/ġurnata li bdew 28 ġurnata qabel il-koabitazzjoni, tul il-koabitazzjoni u komplew sal-ġurnata qabel is-sagrifiċċju.
English: Cleansing gel
Maltese: Stikk kutanju wieħed
English: What Qutenza looks like and contents of the pack
Maltese: Id-dehra ta' Qutenza u l-kontenuti tal-pakkett
English: For patients with unstable or poorly controlled hypertension or a history of cardiovascular disease, the risk of adverse cardiovascular events due to the potential stress of the procedure should be considered prior to initiating Qutenza treatment.
Maltese: Fil-każ ta' pazjenti li jbatu b'ipertensjoni instabbli jew mhux ikkontrollata sewwa jew bi storja ta' mard kardjovaskulari, ir-riskju ta' avvenimenti kardjovaskulari avversi minħabba l-istress potenzjali tal-proċedura għandu jiġi kkunsidrat qabel ma jinbeda t-trattament b'Qutenza.
English: The patch should be held in place.
Maltese: Tippruvax taqla' l-istikk int stess.
English: Qutenza is available in packs containing one or two sachets of individually sealed cutaneous patches and a 50 g tube of cleansing gel.
Maltese: Qutenza huwa disponibbli f'pakketti li fihom qartas wieħed jew tnejn ta' stikek kutanji ssiġillati individwalment u tubu ta' 50 g ta' ġell għat-tindif.
English: The safety profile of Qutenza in diabetic patients was consistent with that seen in the non-diabetic population.
Maltese: L-profil tas-sigurtà ta 'Qutenza f'pazjenti dijabetiċi kien konsistenti ma' dak li kien osservat filpopolazzjoni mhux dijabetiċi.
English: Qutenza cutaneous patch: Store flat in original sachet and carton.
Maltese: Qutenza huwa stikk li jintuża darba u jista' jinqata' sabiex jaqbel mad-daqs u l-forma taż-żona tattrattament.
English: Overdose may be associated with severe application site reactions, e.g. application site pain, application site erythema, application site pruritus.
Maltese: Aqla' l-kisja tal-istikk li terħi l-mediċina u applikaha fuq il-ġilda.
English: The full EPAR for Fycompa 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: It is available as tablets (2, 4, 6, 8, 10 and 12 mg) and as an oral suspension (0.5 mg/ml, to be taken by mouth).
Maltese: Jiġi bħala pilloli ( 2, 4, 6, 8, 10 u 12 mg) u bħala sospensjoni orali (0.5 mg/ml, li jittieħed oralment).
English: The active substance in Fycompa, perampanel, is an anti-epileptic medicine.
Maltese: Is-sustanza attiva fi Fycompa, il-perampanel, hija mediċina antiepilettika.
English: This is a summary of the European public assessment report (EPAR) for Fycompa.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Fycompa.
English: In the second study, 33.3% and 33.9% of patients taking 8 mg and 12 mg Fycompa respectively showed a decrease in seizure frequency of at least 50%, compared with 14.7% of patients taking placebo.
Maltese: Fit-tieni studju, 33.3% u 33.9% tal-pazjenti li ngħataw Fycompa f'dożi ta' 8 mg u 12 mg rispettivament urew mill-inqas 50% tnaqqis fil-frekwenza tal-aċċessjonijiet, meta mqabbla ma' 14.7% tal-pazjenti li ngħataw plaċebo.
English: Other information about Fycompa
Maltese: Informazzjoni oħra dwar Fycompa
English: Fycompa is a medicine that contains the active substance perampanel.
Maltese: Fycompa huwa mediċina li fiha s-sustanza attiva perampanel.
English: For primary generalised tonic-clonic seizures Fycompa was shown to be effective in a study involving 164 patients with idiopathic generalised epilepsy.
Maltese: Rigward l-aċċessjonijiet toniċi-kloniċi primarji ġeneralizzati Fycompa wera li huwa effettiv fi studju li involva 164 pazjent li jbatu minn epilessija idjopatika ġeneralizzata.
English: For patients with primary generalised tonic-clonic seizures Fycompa was also more effective than placebo: 47 of 81 patients (58%) given Fycompa had at least a 50% reduction in frequency of seizures, compared with 29 of 81 (36%) of those given the dummy treatment.
Maltese: 47 minn 81 pazjent (58%) li ngħataw Fycompa kellhom mill-inqas tnaqqis ta' 50% fil-frekwenza tal-aċċessjonijiet, meta mqabbla ma' 29 minn 81 (36%) ta' dawk li ngħataw kura finta.