FrancophonIA/ELRC3.0 huggingface dataset:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR THE 2 MG/ML VIAL
Maltese: KARTUNA GĦALL-KUNJETT TA' 2 mg/ML
English: Hyperleucocytosis
Maltese: Enċefalopatija
English: Children and adolescents TRISENOX is not recommended in children and adolescents below 18 years of age.
Maltese: TRISENOX mhuwiex rakkomandat fi tfal u adolexxenti li għadhom m'għalqux 18-il sena.
English: Medicinal products known to cause hepatotoxic effects Hepatotoxic effects may occur during the treatment with arsenic trioxide, caution is advised when TRISENOX is co-administered with other medicinal products known to cause hepatotoxic effects (see section 4.4 and 4.8).
Maltese: Matul it-trattament b'arsenic trioxide jistgħu jseħħu effetti epatotossiċi, attenzjoni hija rakkomandata meta TRISENOX jingħata flimkien ma' prodotti mediċinali oħra magħrufa li jikkawżaw effetti epatotossiċi (ara sezzjoni 4.4 u 4.8).
English: • some medicines to treat allergies such as hay fever, called antihistamines (e.g. terfenadine and astemizole)
Maltese: • xi mediċini għall-kura ta' allerġiji bħal hayfever, imsejħa antistaminiċi (eż. terfenadine u astemizole)
English: Dilution of TRISENOX
Maltese: Mediċini oħra u TRISENOX
English: Cytogenetics after TRISENOX therapy Table 5
Maltese: Kif jingħata TRISENOX Effetti sekondarji possibbli Kif taħżen TRISENOX
English: Excipients: sodium hydroxide hydrochloric acid water for injections
Maltese: - Is-sustanzi l-oħra huma sodium hydroxide, hydrochloric acid u ilma għal injezzjonijiet.
English: Neutropenia
Maltese: Ipomanjesimja
English: Encephalopathy, Wernicke encephalopathy
Maltese: Prodotti mediċinali antilewkemiċi oħra
English: Common (may affect up to 1 in 10 people): - reduction in blood cell counts (platelets, red and/or white blood cells), increased white blood cells - chills, increased weight - a fever due to an infection and low levels of white blood cells, herpes zoster infection - chest pain, bleeding in the lung, hypoxia (low oxygen level), collection of fluid around the heart or the lung, low blood pressure, abnormal heart rhythm - fit, joint or bone pain, inflammation of the blood vessels - increased sodium or magnesium, ketones in the blood and urine (ketoacidosis), renal function tests abnormal, kidney failure - stomach (abdominal) ache - redness of the skin, swollen face, blurred vision
Maltese: Komuni (jistgħu jaffettwaw sa persuna 1 minn kull 10): - tnaqqis fl-għadd ta' ċelluli tad-demm (plejtlits, ċelluli ħomor u/jew bojod tad-demm), żieda fiċ ċelluli bojod tad-demm - sirdat, żieda fil-piż - deni minħabba infezzjoni u livelli baxx ta' ċelluli bojod tad-demm, infezzjoni b'herpes zoster - uġigħ fis-sider, ħruġ ta' demm fil-pulmun, nuqqas ta' ossiġnu (livell baxx ta' ossiġnu),
English: Special populations Hepatic impairment
Maltese: Infezzjonijiet u infestazzjonijiet
English: - lung infection, infection in the blood - inflammation of the lungs which causes chest pain and breathlessness, cardiac failure - dehydration, confusion - Cerebral disease (Encephalopathy, Wernicke encephalopathy) with various manifestations including difficulties to use arms and legs, speech disorders and confusion
Maltese: - infjammazzjoni tal-pulmun li tikkawża wġigħ fis-sider u qtugħ ta' nifs, insuffiċjenza kardijaka - deidratazzjoni (nixfa), konfużjoni - mard ċerebrali (Enċefalopatija, enċefalopatija ta' Wernicke) b'diversi manifestazzjonijiet inklużi diffikultajiet biex tuża idejk u saqajk, disturbi fid-diskors u konfużjoni
English: NAME OF THE MEDICINAL PRODUCT TRISENOX 2 mg/ml concentrate for solution for infusion arsenic trioxide
Maltese: TAL-PRODOTT MEDIĊINALI TRISENOX 2 mg/mL konċentrat għal soluzzjoni għall-infużjoni arsenic trioxide
English: TRISENOX 1 mg/ml concentrate for solution for infusion Type I borosilicate glass ampoule containing 10 ml of concentrate.
Maltese: Kull mL ta' konċentrat fih 1 mg ta' arsenic trioxide Kull ampulla ta' 10 mL fiha 10 mg ta' arsenic trioxide.
English: - Follow-up of your cognitive and mobility functions if you are at risk for vitamin B1 deficiency.
Maltese: - Segwitu tal-funzjonijiet konjittivi u ta' mobilità tiegħek jekk għandek riskju ta' defiċjenza ta'
English: TRISENOX was administered intravenously over 1 to 2 hours until the bone marrow was free of leukaemic cells, up to a maximum of 60 days.
Maltese: TRISENOX kien mogħti ġol-vina fuq firxa ta' minn 1 sa 2 sagħtejn sakemm il-mudullun ta' l-għadma kien ħieles miċ-ċelluli lewkemiċi, sa massimu ta' 60 ġurnata.
English: In these studies, leucocytosis was not treated with chemotherapeutic medicinal products.
Maltese: F'dawn l-istudji, il-lewkoċitożi ma kinitx ikkurata permezz ta' prodotti mediċinali kemoterapewtiċi.
English: *In the CALGB study C9710, 2 cases of grade ≥3 increased GGT were reported out of the 200 patients who received TRISENOX consolidation cycles (cycle 1 and cycle 2) versus none in the control arm.
Maltese: Żieda f'gamma-glutamyltransferase* Mhux magħruf* Mhux magħruf* *Fl-istudju CALGB C9710, 2 każijiet ta' grad ≥3 żieda f'GGT ġew irrappurtati fil-200 pazjent li rċivew ċikli ta' konsolidazzjoni ta' TRISENOX (ċiklu 1 u ċiklu 2) kontra xejn fil-parti tal-istudju tal kontroll.
English: TRISENOX must be administered intravenously at a dose of 0.15 mg/kg/day, 5 days per week.
Maltese: TRISENOX għandu jingħata ġol-vina b'doża ta' 0.15 mg/kg/jum, 5 ijiem kull ġimgħa.
English: Hypoxia
Maltese: Fertilità
English: No formal carcinogenicity studies of arsenic trioxide have been performed.
Maltese: rikadut bl-arsenic trioxide.
English: Negative Positive Not evaluable
Maltese: Negattivi Pożittivi
English: Differentiation syndrome
Maltese: Sindrome ta' divrenzjar
English: What TRISENOX looks like and contents of the pack - TRISENOX is a concentrate for solution for infusion (sterile concentrate).
Maltese: - TRISENOX hu konċentrat għal soluzzjoni għall-infużjoni (konċentrat sterili).
English: One patient treated under a compassionate use program died from cerebral infarct due to leucocytosis, following treatment with chemotherapeutic medicinal products to lower WBC count.
Maltese: Pazjent wieħed li kien ikkurat skond programm ta' l-użu b'kompassjoni miet minn infart ċerebrali minħabba il-lewkoċitożi wara t-trattament bil-prodotti mediċinali kemoterapewtiċi biex ibaxxu l-kownt WBC.
English: Undesirable effects are listed in table 2 below as MedDRA preferred term by system organ class and frequencies observed during TRISENOX clinical trials in 52 patients with refractory/relapsed APL. Frequencies are defined as: (very common ≥ 1/10), (common ≥ 1/100 to < 1/10), (uncommon ≥ 1/1,000 to < 1/100), not known (cannot be estimated from available data).
Maltese: L-effetti mhux mixtieqa huma elenkati fit-tabella 2 hawn taħt bħala t-terminu ppreferut tal-MedDRA skont il-klassi tas-sistema tal-organi u l-frekwenzi osservati waqt il-provi kliniċi fuq 52 pazjent b'APL/li tirkadi/refrattarja.
English: Pneumonia
Maltese: vitamina
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: Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq ilportal elettroniku Ewropew tal-mediċini.
English: If complete remission has not occurred by day 50, dosing must be discontinued.
Maltese: Jekk ma jkun hemm l-ebda remissjoni kompleta sal jum 50, id-dożaġġ għandu jitwaqqaf.
English: - The other ingredients are sodium hydroxide, hydrochloric acid and water for injections.
Maltese: TA' EĊĊIPJENTI Eċċipjenti: sodium hydroxide, hydrochloric acid, ilma għall-injezzjonijiet,
English: Infections and infestations Herpes zoster
Maltese: Herpes zoster Sepsis
English: This means that the medicine is essentially ‘sodium-free'.
Maltese: Jiġifieri li l-mediċina hi essenzjalment “ħielsa mis-sodium”.
English: How to store TRISENOX
Maltese: Użu ta' TRISENOX
English: At last follow-up, 6 of 12 patients in the single institution study were alive with a median follow-up time of 28 months (range 25 to 29).
Maltese: 6 minn 12-il pazjent fl-istudju ta' istituzzjoni unika kienu ħajjin b'medja ta' żmien medju ta' wara ta' 28-il xahar (firxa minn 25 sa 29).
English: Since no data are available across all hepatic impairment groups and hepatotoxic effects may occur during the treatment with arsenic trioxide caution is advised in the use of TRISENOX in patients with hepatic impairment (see section 4.4 on hepatotoxicity and section 4.8).
Maltese: Peress li ma hemmx tagħrif disponibbli tul il-gruppi kollha ta' indeboliment epatiku u jistgħu jseħħu effetti epatotossiċi matul it-trattament b'arsenic trioxide, attenzjoni hija rakkomandata fl-użu ta' TRISENOX f'pazjenti b'indeboliment epatiku (ara sezzjoni 4.4 dwar l-epatotossiċità u sezzjoni 4.8).
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 12 mg/6 ml
Maltese: 10 kunjetti 12-il mg/6 mL
English: Hyperbilirubinaemia
Maltese: Newtropenija bid-deni
English: Complete remission (CR) was defined as the absence of visible leukaemic cells in the bone marrow and peripheral recovery of platelets and white blood cells.
Maltese: Remissjoni kompleta (RK) kienet definita bħala n-nuqqas ta' ċelluli lewkemiċi viżibbli fil-mudullun ta' l-għadma u rkupru periferali talplejtlits u lewkoċiti.
English: Musculoskeletal and connective tissue disorders Myalgia
Maltese: Disturbi muskolu-skeletriċi u tat-tessuti konnettivi u tal-għadam
English: 500 mg four times a day
Maltese: 500 mg erba' darbiet kuljum
English: Other antileukaemic medicinal products The influence of TRISENOX on the efficacy of other antileukaemic medicinal products is unknown.
Maltese: L-influwenza ta' TRISENOX fuq l-effikaċja ta' prodotti mediċinali oħra antilewkemiċi mhix magħrufa.
English: Caution is advised when TRISENOX is co-administered with other medicinal products known to cause QT/QTc interval prolongation such as macrolide antibiotics, the antipsychotic thioridazine, or medicinal products known to cause hypokalaemia or hypomagnesaemia.
Maltese: Wieħed irid joqgħod attent meta TRISENOX jingħata flimkien ma' prodotti mediċinali oħra li huma magħrufa li jikkawżaw titwil ta' l-intervall Qt/QTc bħal ngħidu aħna antibijotiċi makrolidi, l-antipsychotic thioridazine, jew prodotti mediċinali magħrufa li jikkawżaw ipokalimja jew ipomanjesimja.
English: Total arsenic accumulates mainly in the liver, kidney, and heart and, to a lesser extent, in the lung, hair, and nails.
Maltese: Arsenic totali jakkumula primarjament fil-fwied, kliewi, u qalb u, fi kwantità inqas, fil-pulmun, xagħar, u dwiefer.
English: - reduction in blood cell counts (platelets, red and/or white blood cells), increased white blood cells - chills, increased weight - a fever due to an infection and low levels of white blood cells, herpes zoster infection - chest pain, bleeding in the lung, hypoxia (low oxygen level), collection of fluid around the heart or the lung, low blood pressure, abnormal heart rhythm - fit, joint or bone pain, inflammation of the blood vessels - increased sodium or magnesium, ketones in the blood and urine (ketoacidosis), renal function tests abnormal, kidney failure - stomach (abdominal) ache - redness of the skin, swollen face, blurred vision
Maltese: - tnaqqis fl-għadd ta' ċelluli tad-demm (plejtlits, ċelluli ħomor u/jew bojod tad-demm), żieda fiċ ċelluli bojod tad-demm - sirdat, żieda fil-piż - deni minħabba infezzjoni u livelli baxx ta' ċelluli bojod tad-demm, infezzjoni b'herpes zoster - uġigħ fis-sider, ħruġ ta' demm fil-pulmun, nuqqas ta' ossiġnu (livell baxx ta' ossiġnu),
English: Each carton contains 10 single-use glass ampoules.
Maltese: Kull kartuna fiha 10 ampulli tal-ħġieġ li tużahom darba biss.
English: Substances that are substrates for these P450 enzymes are not expected to interact with TRISENOX.
Maltese: Sustanzi li huma substrati ta' dawn l-enzimi ta' P450 mhux mistennija li jinteraġixxu ma' TRISENOX.
English: The Kaplan-Meier median CR duration for the single institution study is 14 months and has not been reached for the multicentre study.
Maltese: istituzzjoni unika kien 14-il xahar xhur u li qatt ma ntlaħaq fi studju multiċentriku Fil-istadju ta' wara,
English: Gamma-glutamyltransferase increased*
Maltese: L-esperjenza fit-tfal hi limitata.
English: TRISENOX at 0.15 mg/kg daily until CR. During consolidation, ATRA was given at the same dose for periods of 2 weeks on and 2 weeks off for a total of 7 courses, and TRISENOX was given at the same dose 5 days per week, 4 weeks on and 4 weeks off, for a total of 4 courses.
Maltese: Matul il-konsolidazzjoni, ATRA ngħata bl-istess doża għal perjodi ta' ġimagħtejn iva u ġimagħtejn le għal għadd totali ta' 7 korsijiet, u TRISENOX ingħata bl-istess doża 5 ijiem fil-ġimgħa, 4 ġimgħat iva u 4 ġimgħat le, għal għadd totali ta' 4 korsijiet.
English: Renal and urinary disorders Renal failure
Maltese: Disturbi fil-kliewi u fis-sistema urinarja
English: Patients in the single centre study had relapsed following 1-6 prior therapy regimens and 2 patients had relapsed following stem cell transplantation.
Maltese: Pazjenti fl-istudju ċentriku uniku kellhom rikaduta wara 1-6 ir-reġimeni ta' terapija ta' qabel u 2 pazjenti kellhom rikaduta wara t-trapjant taċ-ċelluli staminali.
English: During TRISENOX treatment, 14 of the 52 patients in the APL studies in the relapsed setting had one or more symptoms of APL differentiation syndrome, characterised by fever, dyspnoea, weight gain, pulmonary infiltrates and pleural or pericardial effusions, with or without leucocytosis (see section 4.4).
Maltese: Peress li ma hemmx tagħrif disponibbli tul il-gruppi kollha ta' indeboliment epatiku u jistgħu jseħħu effetti epatotossiċi matul it-trattament b'TRISENOX, attenzjoni hija rakkomandata fl-użu ta' TRISENOX f'pazjenti b'indeboliment epatiku (ara sezzjonijiet 4.4 u 4.8).
English: If symptoms suggestive of serious acute arsenic toxicity (e.g. convulsions, muscle weakness and confusion) appear, TRISENOX must be immediately discontinued and chelating therapy with penicillamine at a daily dose ≤ 1 g per day may be considered.
Maltese: Jekk jidhru s-sintomi li jissuġġerixxu tossiċità serja akuta arsenika (eż. konvulżjonijiet, debbolezza filmuskoli u konfużjoni), TRISENOX għandu jitwaqqaf minnufih u terapija ta' kelazzjoni flimkien ma' penicilamine b'doża ta' kuljum ta' ≤1 g kuljum għandha mnejn tkun ikkonsidrata.
English: Baseline white blood cell (WBC) counts did not correlate with development of leucocytosis on study, and WBC counts during consolidation therapy were not as high as during induction.
Maltese: Ma saru l-ebda studji kliniċi u/jew studji li mhumiex kliniċi dwar il-fertilità bi TRISENOX.
English: If syncope, rapid or irregular heartbeat develops, the patient must be hospitalised and monitored continuously, serum electrolytes must be assessed, TRISENOX therapy must be temporarily discontinued until the QTc interval regresses to below 460 msec, electrolyte abnormalities are corrected, and the syncope and irregular heartbeat cease.
Maltese: Jekk sinkopu, il-qalb tibda tħabbat mgħaġġel jew b'mod irregulari, il-pazjent għandu jintbagħat l-isptar u jkun monitorjat il-ħin kollu, l-elektroliti fis-serum għandhom ikunu assessjati, itterapija b'TRISENOX għandha titwaqqaf temporanjament sakemm l-intervall QTc jerġa' jinżel taħt il460 msec, l-abnormalitjiet elektrolitiċi ikun ikkoreġuti, u s-sinkopu u t-taħbit irregolari tal-qalb jieqfu.
English: Arthralgia
Maltese: Takikardija
English: QT prolongation can lead to a torsade de pointes-type ventricular arrhythmia, which can be fatal.
Maltese: Madankollu, l-effetti tossiċi għaddew permezz ta' twaqqif temporanju ta' arsenic trioxide, ATRA jew it-tnejn li huma.
English: The full EPAR for Qutenza 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: Qutenza capsaicin
Maltese: Qutenza kapsajkin
English: It stimulates the ‘transient receptor potential vanilloid 1' (TRPV1) receptor which is found in the nerves in the skin that detect pain.
Maltese: Din tistimula r-'riċettur temporanju potenzjali vanilloid 1' (TRPV1), riċettur li jinsab fin-nervituri fil-ġilda li jidentifikaw l-uġigħ.
English: The active substance in Qutenza, capsaicin, is a substance normally found in chilli peppers.
Maltese: Is-sustanza attiva f'Qutenza, il-kapsajkin, hija sustanza li normalment tinsab fil-bżar aħmar.
English: This is a summary of the European public assessment report (EPAR) for Qutenza.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Qutenza.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Qutenza on 15 May 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Qutenza fil-15 ta' Mejju 2009.
English: In addition, the company that makes Qutenza will make sure that an educational programme is available for healthcare professionals who will prescribe Qutenza.
Maltese: Barra minn hekk, il-kumpanija li tipproduċi Qutenza se taċċerta li jkun disponibbli programm edukattiv għall-professjonisti tal-kura tas-saħħa li jippreskrivu Qutenza.
English: Other information about Qutenza
Maltese: Aktar informazzjoni dwar Qutenza
English: Alternatively, medicines for pain may be taken.
Maltese: Alternattivament, jistgħu jittieħdu mediċini kontra l-uġigħ.
English: Qutenza has been compared with control patches containing lower amounts of capsaicin (0.04%) in four main studies involving a total of 1,619 adults with moderate to severe neuropathic pain.
Maltese: 04%) f'erba' studji ewlenin li kienu jinvolvu total ta' 1,619-il adult b'uġigħ newropatiku moderat għal sever.
English: A fifth study compared Qutenza with a placebo (dummy) patch in 369 patients with painful peripheral diabetic neuropathy, a form of neuropathic pain associated with diabetes; a supportive study looked at repeated treatment over one year.
Maltese: Il-ħames studju qabbel Qutenza ma' stikka plaċebo (finta) fi 369 pazjenti b'newropatija dijabetika periferika b'uġigħ, forma ta' uġigħ newropatiku assoċjat mad-dijabete; studju ta' appoġġ eżamina kura ripetuta tul sena.
English: In the two studies of patients with post-herpetic neuralgia, the reduction in pain scores after eight weeks was 30 and 32% in patients who were given Qutenza, compared with 20 and 24% in patients who received the control patches.
Maltese: Fiż-żewġ studji fuq pazjenti li jbatu minn nevralġija posterpetika, it-tnaqqis fil-punteġġ tal-uġigħ wara tmien ġimgħat kien 30 u 32% fil-pazjenti kkurati b'Qutenza, meta mqabbel ma' 20 u 24% fil-pazjenti kkurati bl-istikks ta' kontroll.
English: Why has Qutenza been approved?
Maltese: Għaliex ġie approvat Qutenza?
English: All of the patients had neuropathic pain due to either post-herpetic neuralgia (pain that occurs in people who have had shingles, an infection caused by the varicella zoster virus) or HIV-associated neuropathy (damage to the nerves caused by HIV infection).
Maltese: Il-pazjenti kollha kellhom uġigħ newropatiku minħabba nevralġija posterpetika (uġigħ li jbatu minnu l-persuni li jaqbadhom il-ħruq ta' Sant'Antnin, infezzjoni kkawżata mill-virus variċella zoster) jew minħabba newropatija assoċjata mal-HIV (ħsara lin-nervituri kkawżata minn infezzjoni mill-HIV).
English: In patients with painful peripheral diabetic neuropathy, the reduction in pain score from week 2 to after 8 weeks with Qutenza was about 27% compared with 21% for the placebo.
Maltese: Fil-pazjenti b'newropatija dijabetika periferika bl-uġigħ, ittnaqqis fil-punteġġ tal-uġigħ mill-ġimgħa 2 għal wara 8 ġimgħat b'Qutenza kien madwar 27% meta mqabbel ma' 21% għall-plaċebo.
English: In one of the studies of patients with HIV-associated neuropathy, patients who were given Qutenza experienced a 23% reduction in pain scores after 12 weeks compared with an 11% reduction in patients who were given the control.
Maltese: F'wieħed mill-istudji fuq il-pazjenti li jbatu minn newropatija assoċjata mal-HIV, il-pazjenti kkurati b'Qutenza esperjenzaw tnaqqis ta' 23% fil-punteġġ tal-uġigħ wara 12-il ġimgħa meta mqabbla mat-tnaqqis ta' 11% fil-pazjenti kkurati bl-istikks ta' kontroll.
English: Qutenza is a cutaneous patch (a patch that delivers a medicine into the skin).
Maltese: Qutenza huwa stikk kutanju (stikk li jwassal il-mediċina ġol-ġilda).
English: What is the risk associated with Qutenza?
Maltese: X'inhu r-riskju assoċjat ma' Qutenza?
English: Qutenza should remain in place for 30 minutes for the feet and 60 minutes for other parts of the body.
Maltese: Qutenza għandu jibqa' fil-post għal 30 minuta għas-saqajn u għal 60
English: How has Qutenza been studied?
Maltese: Kif ġie studjat Qutenza?
English: In the second study of patients with HIV-associated neuropathy, although Qutenza reduced pain by 30% it was not shown to be more effective than the control.
Maltese: Fit-tieni studji fuq il-pazjenti li jbatu minn newropatija assoċjata mal-HIV, għalkemm Qutenza naqqas l-uġigħ bi 30%, ma ntweriex li dan kien aktar effikaċi meta mqabbel mal-kontroll.
English: It contains the active substance capsaicin (8%).
Maltese: Fih is-sustanza attiva kapsajkin
English: Qutenza can cause a burning sensation on the skin.
Maltese: Qutenza jista' jikkawża sensazzjoni ta' ħruq fuq il-ġilda.
English: The most common side effects with Qutenza (seen in more than 1 patient in 10) are pain and redness at the site of application.
Maltese: L-effetti sekondarji l-aktar komuni b'Qutenza (li dehru f'aktar minn pazjent 1 minn 10) huma wġigħ u ħmura fis-sit tal-applikazzjoni.
English: For the full list of all side effects and restrictions with Qutenza, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha b'Qutenza, ara l-fuljett ta' tagħrif.
English: Before applying Qutenza, the area may be treated with a local anaesthetic to numb it; this helps to reduce discomfort.
Maltese: Qabel l-applikazzjoni ta' Qutenza, il-parti tista' tiġi kkurata b'anestetiku lokali sabiex titraqqad; dan jgħin biex inaqqas l-iskonfort.
English: The rapid release of high doses of capsaicin from Qutenza overstimulates the TRPV1 receptors so they become less sensitive to the stimuli that normally cause neuropathic pain.
Maltese: Ir-rilaxx rapidu ta' dożi għoljin ta' kapsajkin minn Qutenza jistimula żżejjed irriċetturi TRPV1 biex dawn isiru inqas sensittivi għall-istimuli li normalment jikkawżaw uġigħ newropatiku.
English: A risk management plan has been developed to ensure that Qutenza is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Qutenza jintuża bl-aktar mod sigur possibbli.
English: Qutenza should be applied by a doctor or by a healthcare professional under the supervision of a doctor.
Maltese: Qutenza għandu jiġi applikat minn tabib jew minn professjonist tal-kura tas-saħħa taħt is-sorveljanza ta' tabib.
English: It is applied to the most painful areas of the skin.
Maltese: Jiġi applikat fil-partijiet tal-ġilda li juġgħu l-aktar.
English: The full EPAR for Refixia 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: Other information about Refixia
Maltese: Informazzjoni oħra dwar Refixia