FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Commission granted a marketing authorisation valid throughout the EU to GlaxoSmithKline Biologicals s.a. for Twinrix Paediatric on 10 February 1997.
Maltese: Il-Kummissjoni Ewropea tat l-awtorizzazzjoni għat-tqegħid fis-suq għal Twinrix Paediatric valida flUnjoni Ewropea kollha lil GlaxoSmithKline Biologicals s.a. fl-10 ta' Frar 1997.
English: Twinrix Paediatric contains small amounts of inactivated hepatitis A viruses and the ‘surface antigen' (proteins from the surface) of the hepatitis B virus.
Maltese: Twinrix Paediatric fih ammonti żgħar ta' vajrusis ta' l-epatite A inattivati u l-‘antiġen tal-wiċċ' (proteini mill-wiċċ) tal-vajrus ta' l-epatite B.
English: Twinrix Paediatric is a vaccine.
Maltese: Twinrix Paediatric huwa vaċċin.
English: Twinrix Paediatric is a vaccine, which is available as a suspension for injection.
Maltese: Twinrix Paediatric huwa vaċċin, li jiġi bħala sospensjoni għal injezzjoni.
English: Twinrix Paediatric is used to protect against hepatitis A and hepatitis B infection (diseases that affect the liver).
Maltese: Twinrix Paediatric jintuża biex jilqa' kontra infezzjoni b'epatite A u b'epatite B (mard li jaffettwa lfwied).
English: What is Twinrix Paediatric?
Maltese: X'inhu Twinrix Paediatric?
English: Two studies were carried out in a total of 180 children and adolescents, all of whom received Twinrix Paediatric.
Maltese: Saru żewġ studji fuq total ta' 180 tifel u tifla u adolexxenti, li kollha rċievew Twinrix Paediatric.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Twinrix Paediatric's benefits are greater than its risks for use in non-immune infants, children and adolescents from one year up to and including 15 years who are at risk of both hepatitis A and hepatitis B infection.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għal Użu mill-Bniedem (CHMP) iddeċieda li l-benefiċċji ta' Twinrix Paediatric huma akbar mir-riskji tiegħu għal użu fuq trabi, tfal u adolexxenti mhux immuni li għandhom minn sena sa u inkluż 15-il sena u li huma f'riskju kemm ta' infezzjoni b'epatite A kif ukoll ta' infezzjoni b'epatite B.
English: All children had satisfactory antibody levels to hepatitis A by two months, and almost 100% had protective levels of antibodies to hepatitis B by six months (just before the third vaccine dose).
Maltese: It-tfal kollha kellhom livelli ta' antikorpi sodisfaċenti għallepatite A sa żmien xahrejn, u kważi 100% kellhom livelli ta' protezzjoni ta' antikorpi għall-epatite B sa żmien sitt xhur (eżatt qabel it-tielet doża tal-vaċċin).
English: Other information about Twinrix Paediatric:
Maltese: Tagħrif ieħor dwar Twinrix Paediatric:
English: It contains inactivated (killed) hepatitis A viruses and parts of the hepatitis B virus as active substances.
Maltese: Bħala sustanzi attivi huwa fih vajrusis inattivati (maqtulin) ta' l-epatite A u partijiet mill-vajrus ta' l-epatite B.
English: For the full list of all side effects reported with Twinrix Paediatric, see the Package Leaflet.
Maltese: Għal-lista sħiħa ta' l-effetti sekondarji kollha rrapportati ma' Twinrix Paediatric, ara l-Fuljett ta' Tagħrif.
English: The active substances in Twinrix Paediatric and Twinrix Adult have been available in the EU for a number of years in separate vaccines: Havrix Adult for protection against hepatitis A and Engerix-B for protection against hepatitis B.
Maltese: Is-sustanzi attivi fi Twinrix Paediatric u fi Twinrix Adult ilhom disponibbli fl-UE għal bosta snin f'vaċċini separati:
English: What is the risk associated with Twinrix Paediatric?
Maltese: X'inhu r-riskju assoċjat ma' Twinrix Paediatric?
English: Why has Twinrix Paediatric been approved?
Maltese: Għaliex ġie approvat Twinrix Paediatric?
English: The main measure of effectiveness was the proportion of the children who had developed protective levels of antibodies to hepatitis A and hepatitis B.
Maltese: Ilmiżura ewlenija ta' l-effikaċja kienet il-proporzjon ta' tfal li żviluppaw livelli ta' protezzjoni ta' antikorpi għall-epatite A u l-epatite B.
English: Because Twinrix Paediatric and Twinrix Adult contain identical ingredients, some of the data used to support the use of Twinrix Adult were used to support the use of Twinrix Paediatric.
Maltese: Minħabba li Twinrix Paediatric u Twinrix Adult fihom sustanzi attivi identiċi, xi dejta wżata biex tappoġġja l-użu ta' Twinrix Adult intużat biex tappoġġja l-użu ta' Twinrix Paediatric.
English: How has Twinrix Paediatric been studied?
Maltese: Kif ġie studjat Twinrix Paediatric?
English: Twinrix Paediatric should not be used in people who may be hypersensitive (allergic) to any of the active substances, to any of the other ingredients or to neomycin (an antibiotic).
Maltese: Twinrix Paediatric m'għandux jintuża f'nies li jistgħu jkunu ipersensittivi (allerġiċi) għal kwalunkwe sustanza attiva tiegħu, kwalunkwe sustanza oħra jew għal neomycin (antibijotiku).
English: When a person is given the vaccine, the immune system recognises the viruses and surface antigens as ‘foreign' and makes antibodies against them.
Maltese: Meta persuna tingħata l-vaċċin, is-sistema immunitarja tagħraf l-antiġeni tal-wiċċ bħala ‘barranin' u tagħmel antikorpi kontrihom.
English: Further information on Ocaliva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: Aktar informazzjoni dwar Ocaliva tinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The study showed that Ocaliva was more effective than placebo at reducing the blood levels of bilirubin and ALP: levels decreased by the required amount in 47% (34 out of 73) of patients treated with Ocaliva 10 mg and in 46% (32 out of 70) of patients treated with increasing doses of Ocaliva (from 5 mg up to 10 mg), compared with 10% (7 out of 73) of patients on placebo.
Maltese: L-istudju wera li Ocaliva kien aktar effettiv mill-plaċebo fit-tnaqqis tal-livelli tal-bilirubina u l-ALP fiddemm: il-livelli naqsu bl-ammont meħtieġ f'47% (34 minn 73) tal-pazjenti kkurati b'Ocaliva 10 mg u f'46% (32 minn 70) tal-pazjenti kkurati b'dożi li jiżdiedu ta' Ocaliva (minn 5 mg sa 10 mg), meta mqabbla ma' 10% (7 minn 73) tal-pazjenti fuq paċebo.
English: Ocaliva received a marketing authorisation valid throughout the EU on 12 December 2016.
Maltese: Ocaliva rċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE fit-12 ta' Diċembru 2016.
English: The active substance in Ocaliva, obeticholic acid, is a modified form of a bile acid (the main components of bile).
Maltese: Is-sustanza attiva f'Ocaliva, l-aċidu obetikoliku, hija forma modifikata ta' aċidu biljari (il-komponenti ewlenin tal-bila).
English: Primary biliary cholangitis is rare, and Ocaliva was designated an ‘orphan medicine' (a medicine used in rare diseases) on 27 July 2010.
Maltese: Kolanġite biljari primarja hija rara, u Ocaliva ġie denominat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fis-27 ta' Lulju 2010.
English: Other information about Ocaliva
Maltese: Informazzjoni oħra dwar Ocaliva
English: Ocaliva contains the active substance obeticholic acid.
Maltese: Ocaliva fih is-sustanza attiva aċidu obetikoliku.
English: The safety profile of the medicine was considered to be favourable, with side effects that were tolerable and manageable with supportive treatment (e.g. for itching) and dose adjustments.
Maltese: Il-profil ta sigurtà tal-mediċina kien ikkunsidrat favorevoli, b'effetti sekondarji li kienu tollerabbli u maniġġabbli b'kura ta' sostenn (eż. għall-ħakk) u aġġustamenti fid-doża.
English: Why is Ocaliva authorised in the EU?
Maltese: Għalfejn Ocaliva huwa awtorizzat fl-UE?
English: What information is still awaited for Ocaliva?
Maltese: Liema informazzjoni għadha mistennija għal Ocaliva?
English: Ocaliva is available as tablets (5 and 10 mg) and can only be obtained with a prescription.
Maltese: Ocaliva jiġi bħala pilloli (5 u 10 mg) u jista' jinkiseb biss b'riċetta ta' tabib.
English: How does Ocaliva work?
Maltese: Kif jintuża Ocaliva?
English: Ocaliva has been given ‘conditional authorisation'.
Maltese: Ocaliva ngħata ‘awtorizzazzjoni kondizzjonali'.
English: The first study is designed to demonstrate the clinical benefit of Ocaliva, while the second study will investigate the benefits of Ocaliva in patients with moderate to severe liver disease.
Maltese: L-ewwel studju huwa mfassal biex juri l-benefiċċju kliniku ta' Ocaliva, filwaqt li t-tieni studju se jinvestiga l-benefiċċji ta' Ocaliva f'pazjenti b'marda tal-fwied moderata sa severa.
English: Since Ocaliva has been granted a conditional authorisation, the company that markets Ocaliva will provide additional data from two studies to confirm the effectiveness and safety of the medicine.
Maltese: Peress li Ocaliva ngħata awtorizzazzjoni kondizzjonali, il-kumpanija li tqiegħed Ocaliva fis-suq ser tipprovdi data addizzjonali minn żewġ studji sabiex tikkonferma aktar l-effikaċja u s-sigurtà talmediċina.
English: What are the risks associated with Ocaliva?
Maltese: X'inhuma r-riskji assoċjati ma' Ocaliva?
English: As for all medicines, data on the use of Ocaliva is continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Ocaliva hija ssorveljata kontinwament.
English: Ocaliva has been shown to reduce the blood levels of bilirubin and ALP in patients with primary biliary cholangitis, including those who could not be treated with UDCA.
Maltese: Intwera li Ocaliva jnaqqas illivelli tal-bilirubina u l-ALP fid-demm f'pazjenti b'kolanġite biljari primarja, inklużi dawk li ma setgħux jiġu kkurati b'UDCA.
English: Ocaliva is used to treat adults with a liver disease known as primary biliary cholangitis.
Maltese: Ocaliva jintuża biex jikkura adulti b'marda tal-fwied magħrufa bħala kolanġite biljari primarja.
English: How is Ocaliva used?
Maltese: Kif jaħdem Ocaliva?
English: The most common side effects with Ocaliva are itching (which may affect more than 6 in 10 people) and tiredness (which may affect more than 2 in 10 people).
Maltese: L-effetti sekondarji l-aktar komuni b'Ocaliva huma l-ħakk (li jista' jaffettwa aktar minn 6 persuni minn kull 10) u l-għeja (li tista' taffettwa aktar minn 2 persuni minn kull 10).
English: It works mainly by attaching to receptors in the liver and gut (farnesoid X receptors) which control the production of bile.
Maltese: Din taħdem billi teħel mar-riċetturi fil-fwied u l-imsaren (riċetturi farnesoid X) li jikkontrollaw il-produzzjoni tal-bili.
English: The recommended starting dose is 5 mg once a day or 5 mg once a week, depending on the patient's degree of liver impairment (which should be determined before starting treatment with Ocaliva).
Maltese: Id-doża rakkomandata talbidu hija 5 mg darba kuljum jew 5 mg darba fil-ġimgħa, skont il-livell ta' indeboliment tal-fwied talpazjent (li għandu jiġi ddeterminat qabel il-bidu tal-kura b'Ocaliva).
English: Patients with primary biliary cholangitis have limited treatment options.
Maltese: Pazjenti b'kolanġite biljari primarja għandhom għażliet ta' kura limitati.
English: EMA/841615/2018 EMEA/H/C/000618
Maltese: EMA/841615/2018 EMA/H/C/000618
English: Further information on Tarceva can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Tarceva.
Maltese: ema.europa.eu/medicines/human/EPAR/Tarceva.
English: The medicine contains the active substance erlotinib.
Maltese: Il-mediċina fiha s-sustanza attiva erlotinib.
English: Other information about Tarceva
Maltese: Informazzjoni oħra dwar Tarceva
English: The medicine is available as tablets (25, 100 and 150 mg).
Maltese: Il-mediċina tiġi bħala pilloli (25, 100 u 150 mg).
English: The active substance in Tarceva, erlotinib, belongs to the group ‘EGFR inhibitors'.
Maltese: Is-sustanza attiva f'Tarceva, l-erlotinib, tagħmel parti mill-grupp ta' “inibituri EGFR”.
English: Tarceva received a marketing authorisation valid throughout the EU on 19 September 2005.
Maltese: Tarceva rċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fid-19 ta' Settembru 2005.
English: In the study of Tarceva used in combination with gemcitabine for pancreatic cancer, the most common side effects were tiredness (affecting 73% of patients), rash (69%) and diarrhoea (48%).
Maltese: Fl-istudju ta' Tarceva użat f'kombinazzjoni ma' gemcitabine għal kanċer tal-frixa, l-effetti sekondarji l-aktar komuni kienu għeja (li affettwat 73 % tal-pazjenti), raxx (69 %) u dijarea (48 %).
English: For NSCLC, the usual dose is 150 mg daily.
Maltese: Għal NSCLC, id-doża tas-soltu hija 150 mg kuljum.
English: What are the risks associated with Tarceva?
Maltese: X'inhuma r-riskji assoċjati ma' Tarceva?
English: In studies, the most common side effects with Tarceva when used as monotherapy for lung cancer were rash (affecting 75% of patients), diarrhoea (54%), loss of appetite and tiredness (52% each).
Maltese: Fl-istudji, l-effetti sekondarji l-aktar komuni b'Tarceva meta użat bħala monoterapija għal kanċer talpulmun kienu raxx (li affettwa 75 % tal-pazjenti), dijarea (54 %), telf ta' aptit u għeja (52 % kull wieħed).
English: The greatest benefit was in a subgroup of 49 patients with EGFR activating mutations: those taking Tarceva (22 patients) lived for an average of 44.6 weeks without their disease getting worse, compared with 13 weeks for those taking placebo (27 patients).
Maltese: L-ikbar benefiċċju kien f'sottogrupp ta' 49 pazjent b'mutazzjonijiet attivanti EGFR: dawk li kienu qed jieħdu Tarceva (22 pazjent) għexu għal medja ta' 44.6 ġimgħat mingħajr ma l-marda tagħhom marret għallagħar, meta mqabbla ma' 13-il ġimgħa għal dawk li kienu qed jieħdu l-plaċebo (27 pazjent).
English: Pancreatic cancer
Maltese: Kanċer tal-frixa
English: Among the patients who took Tarceva, the average survival was 8.6 months in those whose tumours were ‘EGFR IHC-positive' (had EGFRs on the cell surface), and 5.0 months in those whose tumours were EGFR IHC-negative.
Maltese: Fost il-pazjenti li ħadu Tarceva, is-sopravivenza medja kienet ta' 8.6 xhur f'dawk li t-tumuri tagħhom kienu “EGFR pożittivi għall-IHC” (kellhom EGFRs fuq il-wiċċ taċ-ċelloli), u 5.0 xhur f'dawk li ttumuri tagħhom kienu EGFR negattivi għall-IHC.
English: The side effects reported with Tarceva are considered manageable.
Maltese: L-effetti sekondarji rrapportati b'Tarceva huma kkunsidrati maniġġabbli.
English: Tarceva is also used in patients with metastatic pancreatic cancer, in combination with gemcitabine (another cancer medicine).
Maltese: Tarceva jintuża wkoll f'pazjenti b'kanċer tal-frixa metastatiku, f'kombinazzjoni ma' gemcitabine (mediċina oħra kontra l-kanċer).
English: For pancreatic cancer, it is 100 mg daily.
Maltese: Għal kanċer tal-frixa, id-doża hija 100 mg kuljum.
English: How is Tarceva used?
Maltese: Kif jaħdem Tarceva?
English: Patients with metastatic cancer taking Tarceva as initial therapy lived without their disease getting worse for an average of 5.9 months, compared with 5.1 months in those taking placebo.
Maltese: Il-pazjenti b'kanċer metastatiku li kienu qegħdin jieħdu Tarceva bħala terapija inizjali għexu mingħajr ma l-marda tagħhom marret għall-agħar għal medja ta' 5.9 xhur, meta mqabbla ma' 5.1 xhur f'dawk li kienu qegħdin jieħdu l-plaċebo.
English: Patients taking Tarceva lived for an average of 10.4 months without their disease getting worse compared with 5.1 months for those receiving chemotherapy medicines.
Maltese: Il-pazjenti li ngħataw Tarceva għexu medja ta' 10.4 xhur mingħajr ma l-marda tagħhom marret għall-agħar, meta mqabbla ma' 5.1 xhur għal dawk li ngħataw mediċini tal-kimoterapija.
English: • previously untreated patients whose cancer cells have certain changes (‘activating mutations') in the gene for a protein called epidermal growth factor receptor (EGFR);
Maltese: (“mutazzjonijiet attivanti”) fil-ġene għal proteina msejħa riċettur tal-fattur tat-tkabbir epidermali
English: • A third study compared Tarceva with placebo in 643 patients with advanced NSCLC whose cancer cells did not have EGFR activating mutations and whose disease was stable after 4 cycles of treatment with platinum-containing chemotherapy.
Maltese: • it-tielet studju qabbel lil Tarceva ma' plaċebo f'643 pazjent b'NSCLC avvanzat li ċ-ċelloli tal-kanċer tagħhom ma kellhomx mutazzjonijiet attivanti EGFR u li l-marda tagħhom kienet stabbli wara erba' ċikli ta' kura b'kimoterapija li fiha l-platinu.
English: As for all medicines, data on the use of Tarceva are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Tarceva hija ssorveljata kontinwament.
English: • The first study compared Tarceva with chemotherapy in 173 patients with advanced NSCLC with activating EGFR mutations who had not received previous chemotherapy.
Maltese: • l-ewwel studju qabbel Tarceva ma' kimoterapija f'173 pazjent b'NSCLC avvanzat b'mutazzjonijiet attivanti EGFR li ma kinux irċevew kimoterapija qabel.
English: Patients taking Tarceva survived for an average of 6.7 months, compared with 4.7 months for the patients taking placebo.
Maltese: Il-pazjenti li kienu qegħdin jieħdu Tarceva għexu medja ta' 6.7 xhur, meta mqabbla ma' 4.7 xhur għall-pazjenti li kienu qegħdin jieħdu plaċebo.
English: • The second study compared Tarceva with placebo (a dummy treatment) in 889 patients with advanced or metastatic NSCLC whose disease had not got worse after 4 cycles of treatment with platinum-containing chemotherapy.
Maltese: • it-tieni studju qabbel lil Tarceva ma' plaċebo (kura finta) fi 889 pazjent b'NSCLC avvanzat jew metastatiku li l-marda tagħhom ma marritx għall-agħar wara erba' ċikli ta' kura b'kimoterapija li fiha l-platinu.
English: Tarceva in combination with gemcitabine was studied in 569 patients with pancreatic cancer that was advanced, unresectable (that cannot be removed by surgery) or metastatic.
Maltese: Tarceva f'kombinazzjoni ma' gemcitabine ġie studjat f'569 pazjent b'kanċer tal-frixa li kien f'fażi avvanzata, li ma setax jitneħħa b'kirurġija (unresectable) jew li kien metastatiku.
English: For the full list of side effects and restrictions with Tarceva, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet b'Tarceva, ara l-fuljett ta' tagħrif.
English: Patients with NSCLC should be tested for EGFR activating mutation before starting Tarceva, unless previous chemotherapy has not worked and other treatments are not suitable.
Maltese: Pazjenti b'NSCLC jenħtieġ li jiġu ttestjati għallmutazzjoni attivanti EGFR qabel ma jibdew Tarceva, sakemm kimoterapija preċedenti ma tkunx ħadmet u kuri oħra ma jkunux xierqa.
English: Tarceva is a cancer medicine used in non-small-cell lung cancer (NSCLC) that is advanced (the cancer has started to spread) or metastatic (it has already spread to other parts of the body).
Maltese: Tarceva huwa mediċina kontra l-kanċer li tintuża f'kanċer tal-pulmun mhux b'ċelloli żgħar (NSCLC) li jkun avvanzat (il-kanċer beda jinfirex) jew metastatiku (il-kanċer diġà nfirex għal partijiet oħra talġisem).
English: • The fourth study compared Tarceva with placebo in 731 patients in whom at least one previous chemotherapy treatment had not worked.
Maltese: • ir-raba' studju qabbel Tarceva ma' plaċebo f'731 pazjent li fuqhom minn tal-inqas kura waħda b'kimoterapija preċedenti ma kinitx ħadmet.
English: • patients with EGFR activating mutations in whom previous chemotherapy has not worked;
Maltese: • pazjenti b'mutazzjonijiet attivanti EGFR li fuqhom kimoterapija preċedenti ma tkunx ħadmet;
English: If needed (for example because of side effects), the dose may be reduced in 50-mg steps.
Maltese: Jekk ikun meħtieġ (pereżempju minħabba l-effetti sekondarji), id-doża tista' titnaqqas f'fażijiet ta' 50-mg.
English: ≥ 1/100 and < 1/10
Maltese: ≥ 1/100 u < 1/10
English: Very common ≥ 1/10 Common
Maltese: Komuni ħafna ≥ 1/10 Komuni
English: Hydrochlorothiazide binds to 65% to plasma proteins; the relative volume of distribution has been determined to be 0.5 to 1.1 l/kg.
Maltese: Hydrochlorothiazide jeħel sa 65 % mal-proteini tal-plażma; il-volum ta' distribuzzjoni relattiv kien determinat li huwa 0.5 sa 1.1 l/kg.
English: The combination is effective irrespective of age, gender and race.
Maltese: It-taħlita hija effettiva irrispettivament mill-età, sess u razza.
English: Adverse reactions to cilazapril
Maltese: Reazzjonijiet avversi għal cilazapril
English: Sexual dysfunction, gynaecomastia
Maltese: Disfunzjoni sesswali, ginekomastja
English: The acute oral toxicity of cilazapril is low.
Maltese: It-tossiċità akuta orali ta' cilazapril hija baxxa.
English: Calcium salts and vitamin D
Maltese: Imluħa tal-kalċju u vitamina D
English: • Some antipsychotics (e.g. thioridazine, chlorpromazine, trifluoperazine, sulpiride, tiapride,
Maltese: • Ċertu antipsikotiċi (eż. thioridazine, chlorpromazine, trifluoperazine, sulpiride, tiapride,
English: - if you have porphyria.
Maltese: - jekk għandek il-porfirja.
English: Cholestyramine/colestipol Cholestyramine and colestipol reduce the absorption of hydrochlorothiazide.
Maltese: Cholestyramine/colestipol Cholestyramine u colestipol jnaqqsu l-assorbiment ta' hydrochlorothiazide.
English: The recommended treatment of Vascace Plus overdosage is intravenous infusion of sodium chloride 9 mg/ml (0.9%) solution.
Maltese: Il-kura rrakkomandata ta' doża eċċessiva ta' Vascace Plus hija infużjoni fil-vini ta' soluzzjoni ta' 9 mg/ml (0.9%) sodium chloride.
English: Other metabolic disorders
Maltese: Disturbi metaboliċi oħra
English: • Class III antiarrhythmics (e.g. amiodarone, sotalol, defetilide, ibutilide)
Maltese: • Sustanzi li jikkuraw arritmija ta' klassi III (eż. amiodarone, sotalol, defetilide, ibutilide)
English: Rash, maculopapular rash, psoriaform dermatitis, psoriasis (exacerbation), lichen planus, exfoliative dermatitis, urticaria, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous pemphigoid, pemphigus, Karposi's sarcoma, vasculitis/purpura, photosensitivity reactions, alopecia, onycholysis
Maltese: Raxx, raxx makulopapulari, dermatite psoriaformi, psorjasi (irkadar), lichen planus, dermatite esfoljattiva, urtikarja, eritema multiforme, sindrome ta' Stevens-Johnson, nekrolisi epidermali tossika, bullous pemphigoid, pemphigus, sarkoma ta' Karposi, vaskulite/purpura, reazzjonijiet ta' fotosensittività, alopeċja, onikolisi
English: Vascace Plus is contraindicated in patients with creatinine clearance <30 ml/min/1.73 m2.
Maltese: Vascace Plus huwa kontra-indikat f'pazjenti bi tneħħija tal-krejatinina < 30 ml/min/1.73 m2.
English: Pharmacotherapeutic group: Antihypertensive; ACE inhibitor and diuretic, ATC code: C09BA08
Maltese: Sustanza kontra l-pressjoni għolja, Kodiċi ATC: C09BA08
English: - Cytotoxic drugs (e.g. methotrexate, cyclophosphamide).
Maltese: - Mediċini ċitotossiċi (eż. methotrexate, cyclophosphamide).
English: • Other medicinal products (e.g. bepridil, cisapride, diphemanil, halofantrine, ketanserin, pentamidine, terfenadine)
Maltese: • Prodotti mediċinali oħra (eż. bepridil, cisapride, diphemanil, halofantrine, ketanserin,
English: EXPIRY DATE [To be completed nationally] EXP
Maltese: DATA TA' META JISKADI [Biex timtela mill-pajjiż partikolari] EXP
English: - Anticholinergics.
Maltese: - Antikolinerġiċi.
English: The category `uncommon' incorporates `rare' (≥1/10'000 and <1/1'000) and `very rare' (<1/10'000), which may be used in some SPCs for other products.
Maltese: Il-kategorija “mhux komuni” tinkludi wkoll “rari” (≥ 1/10,000 u < 1/1,000) u “rari ħafna” (< 1/10,000), li għandu mnejn jintużaw f'xi SPCs għall-prodotti oħra.
English: • Class Ia antiarrhythmics (e.g. quinidine, hydroquinidine, disopyramide)
Maltese: • Sustanzi li jikkuraw arritmija ta' klassi Ia (eż. quinidine, hydroquinidine, disopyramide)
English: Myocardial ischaemia, angina pectoris, tachycardia, palpitations, myocardial infarction, arrhythmia Vascular disorders
Maltese: Iskemija mijokardijaka, anġina pectoris, takikardija, palpitazzjonijiet, infart mijokardijaku, arritmija Disturbi vaskulari