FrancophonIA/ELRC3.0 huggingface dataset:
English: There was also a higher incidence of infusion reactions in patients with high anti-pegloticase antibody titres: 46% (18 of 39) in the KRYSTEXXA every 2 weeks group compared to 9% (4 of 46) in patients with low or no antibody titres.
Maltese: 46% (18 minn 39) fil-grupp li kien qiegħed jieħu KRYSTEXXA kull ġimgħatejn meta mqabbla ma' 9% (4 minn 46) fil-pazjenti b'titri baxxi jew bl-ebda titri ta' antikorpi.
English: The applicant should conduct a long-term EU observational study to end December 2018 on safety of pegloticase use in adult hyperuricemic patients with severe debilitating chronic tophaceous gout and efficacy and safety data in reexposed patients.
Maltese: L-applikant għandu jwettaq studju osservazzjonali tal-UE fuq perjodu twil li għandu jintemm f'Diċembru 2018 tas- sigurtà dwar l-użu ta' pegloticase fuq pazjenti adulti b'iperuriċemija b'gotta tophaceous kronika severa debilitanti u dejta ta' sigurtà u ta' effikaċja fuq pazjenti li reġgħu ġew esposti.
English: KRYSTEXXA should be discontinued if 2 consecutive levels above 6 mg/dl have been measured.
Maltese: KRYSTEXXA għandu jitwaqqaf jekk ikunu tkejlu żewġ livelli konsekuttivi ogħla minn 6 mg/dl.
English: - if you are currently taking other medicines to lower your uric acid level - if you have been told you have heart failure - if you have ever been told you have an enzyme deficiency that causes anaemia - if you weigh over 100 kg - if you have been treated with KRYSTEXXA before
Maltese: - jekk attwalment qed tieħu mediċini oħra biex tbaxxi l-livell tal-aċidu uriku tiegħek - jekk qalulek li għandek insuffiċjenza tal-qalb - jekk qatt qalulek li għandek defiċjenza tal-enzimi li tikkawża anemija - jekk tiżen aktar minn 100 kg - jekk irċevejt kura preċedenti bi KRYSTEXXA
English: Posology
Maltese: Iżrael
English: KRYSTEXXA contains an enzyme called uricase that transforms the uric acid into a substance called allantoin, which can be removed easily in the urine.
Maltese: KRYSTEXXA fih enzim magħruf bħala uricase li jbiddel l-aċidu uriku f'sustanza magħrufa bħala allantoin, li tista' faċilment titneħħa fl-awrina.
English: This compared with flare rates of 41%and 67% in the same groups in the subsequent 3 months, and gout flares were infrequent in patients that received pegloticase 8 mg every 2 weeks for over one year.
Maltese: Dan meta mqabbel ma' rati ta' rikaduti ta' 41% u ta' 67% fl-istess grupp fit-3 xhur sussegwenti, u rikaduti tal-gotta ma kinux frekwenti f'pazjenti li rċevew pegloticase 8 mg kull ġimgħatejn għal aktar minn sena.
English: How to use KRYSTEXXA
Maltese: Id-doża ta' KRYSTEXXA
English: Before you start treatment with KRYSTEXXA, your doctor may recommend that you take other medicines (such as an antihistamine, paracetamol and a corticosteroid) to help reduce the risk that you will get infusion-related reactions due to this treatment.
Maltese: Qabel ma tibda l-kura bi KRYSTEXXA, it-tabib tiegħek jista' jirrakkomanda li tieħu mediċini oħra (bħal antistamina, paracetamol u kortikosterojdi) biex jgħinu jnaqqsu r-riskju li jkollok reazzjonijiet relatati mal-infużjoni minħabba din il-kura.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with KRYSTEXXA in one or more subset of the paediatric population in the treatment and/or prevention of hyperuricaemia related to Tumour Lysis Syndrome (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini iddifferiet l-obbligu li jiġu ppreżentati r-riżultati tal-istudji b'KRYSTEXXA f'subsett wieħed jew aktar tal-popolazzjoni pedjatrika fil-kura u/jew prevenzjoni ta' iperuriċemija relatata mas-Sindrome tal-Lisi tat-Tumur (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: As anti-pegloticase antibodies can bind to the PEG moiety of KRYSTEXXA, there may be potential for binding to other PEGylated products.
Maltese: Peress li antikorpi kontra pegloticase jistgħu jeħlu mal-PEG moiety ta' KRYSTEXXA, jista' jkun hemm il-potenzjal għal irbit ma' prodotti PEGylated oħra.
English: Because of the immunogenicity of KRYSTEXXA, patients receiving retreatment may be at increased risk of infusion-related reactions, including anaphylaxis.
Maltese: Minħabba l-immunoġeniċità ta' KRYSTEXXA, pazjenti li jirċievu kura mill-ġdid jistgħu jkunu f'riskju akbar ta' reazzjonijiet relatati mal-infużjoni, inkluż anafilassi.
English: Very common: Nausea
Maltese: Ipergliċemija Mhux komuni: Iperkalemija
English: The applicant should submit yearly interim reports.
Maltese: L-applikant għandu jissottometti rapporti interim annwali.
English: Clear to slightly opalescent, colourless solution at pH 7.3±0.3.
Maltese: Konċentrat għal soluzzjoni għal infużjoni. Soluzzjoni ċara għal ftit opalexxenti, mingħajr kulur b'pH ta' 7.3±0.3.
English: Gout flares
Maltese: Tħawwadx.
English: As shown in Table 2, a greater proportion of patients treated with KRYSTEXXA 8 mg every 2 weeks were responders as compared to patients receiving placebo.
Maltese: Kif jidher fit-Tabella 2, proporzjon akbar ta' pazjenti li rċevew kura bi KRYSTEXXA 8 mg kull ġimgħatejn kienu pazjenti li rrispondew meta mqabbla ma' pazjenti li rċevew plaċebo.
English: Uncommon side effects: (may affect up to 1 in 100 people): worsening of a type of heart disease called congestive heart failure, skin infection, elevated potassium levels in the blood Frequency not known (cannot be estimated from available data): destruction of red blood cells If you get any side effects, talk to your doctor, pharmacist or nurse.
Maltese: Effetti sekondarji mhux komuni: (jistgħu jaffetwaw sa persuna 1 minn kull 100): aggravar ta' tip ta' marda tal-qalb msejħa insuffiċjenza konġestiva tal-qalb, infezzjoni tal-ġilda, livelli elevati ta' potassju fid-demm
English: Package Leaflet: Information for the user KRYSTEXXA 8 mg concentrate for solution for infusion
Maltese: Informazzjoni għall-utent KRYSTEXXA 8 mg konċentrat għal soluzzjoni għal infużjoni Pegloticase
English: It is especially important to tell your doctor if you are currently taking other urate-lowering medicines (such as allopurinol or Febuxostat) or medicines containing polyethylene glycol (PEG) (such as pegylated interferon or Doxorubicin).
Maltese: Huwa speċjalment importanti li tgħid lit-tabib tiegħek jekk attwalment qiegħed tieħu mediċini oħra li jbaxxu l-urate (bħal allopurinol jew Febuxostat) jew mediċini li fihom polyethylene glycol (PEG) (bħal pegylated interferon jew Doxorubicin).
English: As the development of these adverse events may have been prevented in at least some of these cases if the patients would not have been treated with concomitant urate lowering substances, an amendment of the summary of product characteristics focusing on the importance of stopping treatment with uric acid lowering agents with regard to masking the results of serum uric acid values (and therefore increasing the risk for infusion reactions and anaphylactic reactions) should be implemented.
Maltese: Billi l-iżvilupp ta' dawn l-avvenimenti avversi seta' ġie evitat f'mill-inqas xi wħud minn dawn il-każijiet jekk il-pazjenti ma jkunux ġew ikkurati b'sustanzi li jnaqqsu l-urate mogħtija fl-istess ħin, għandha tiġi implimentata emenda tas-sommarju tal-karatteristiċi tal-prodott li tiffoka fuq limportanza tat-twaqqif tal-kura b'sustanzi li jnaqqsu l-urate acid minħabba li jaħbu r-riżultati tal-valuri ta' uric acid fis-serum (u għalhekk iżidu r-riskju għal reazzjonijiet għall-infużjoni u reazzjonijiet anafilattiċi).
English: MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Maltese: TAS-SUSTANZA(I) BIJOLOĠIKA(ĊI) ATTIVA(I) U> MANIFATTUR(I) RESPONSABBLI MILL
English: Common: Joint swelling
Maltese: Għall-użu ġol-vina
English: Since concomitant use of oral urate-lowering therapy may potentially mask the rise of serum uric acid associated with the loss of response, patients taking concomitant oral urate-lowering therapy may be at increased risk of infusion reactions and/or anaphylaxis.
Maltese: Peress li l-użu konkomitanti ta' terapija orali li tnaqqas l-urate tista' potenzjalment taħbi ż-żieda talaċidu uriku fis-serum assoċjata mat-telf ta' rispons, pazjenti li qegħdin jieħdu terapija orali konkomitanti li tnaqqas l-urate jistgħu jkunu f'riskju ogħla ta' reazzjonijiet għall-infużjoni u/jew anafilassi.
English: Medicinal product subject to medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Maltese: Prodott mediċinali li jingħata bir-riċetta tat-tabib (ara Anness I: Sommarju tal-Karatteristiċi talProdott, sezzjoni 4.2).
English: The frequency of gout flares may increase after initiation of treatment with KRYSTEXXA, despite gout prophylaxis with colchicine or NSAIDs, but the frequency and severity of gout flares diminishes after 3 months of KRYSTEXXA therapy.
Maltese: Il-frekwenza ta' rikaduti tal-gotta tista' tiżdied wara l-bidu tal-kura bi KRYSTEXXA, minkejja profilassi għall-gotta bi colchicine jew b'NSAIDs, iżda l-frekwenza u s-severità ta' rikaduti tal-gotta jonqsu wara 3 xhur ta' terapija bi KRYSTEXXA.
English: The MAH shall perform the pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in the Risk Management Plan presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the Committee for Medicinal Products for Human Use (CHMP).
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH) għandu jwettaq l-attivitajiet ta' farmakoviġilanza kif deskritt fil-Pjan ta' Farmakoviġilanza kif maqbul fil-Pjan tal-Ġestjoni tar-Riskju ppreżentat f'Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti tal-RMP kif maqbul mill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP).
English: Uncommon: Cellulitis
Maltese: Insuffiċjenza konġestiva tal-qalb
English: Not known: Haemolysis
Maltese: Reazzjoni Avversa
English: Very common side effects (may affect more than 1 in 10 people): hives, skin rash, itchy, dry or irritated skin, nausea
Maltese: Effetti sekondarji komuni ħafna (jistgħu jaffetwaw lil aktar minn persuna 1 minn kull 10): urtikarja, raxx fuq il-ġilda, ħakk fuq il-ġilda, ġilda xotta jew irritata, nawżja
English: The duration of treatment should be based upon maintenance of response (serum uric acid levels < 6 mg/dl) and clinical judgment.
Maltese: It-tul taż-żmien tal-kura għandu jiġi bbażat fuq iż-żamma ta' rispons (livelli ta' aċidu uriku fis-serum < 6 mg/dl) u fuq ġudizzju kliniku.
English: Very common: Infusion related reaction Common: Anaphylaxis, influenza like illness
Maltese: Komuni ħafna: Reazzjoni relatata mal-infużjoni Komuni: Anafilassi, mard bħal tal-influwenza
English: • Appropriate aseptic technique should be used when preparing the infusion.
Maltese: • Għandha tintuża teknika asettika xierqa waqt il-preparazzjoni tal-infużjoni.
English: KRYSTEXXA should be given to you by a doctor or nurse experienced in the treatment of severe chronic gout in a healthcare centre.
Maltese: L-ebda każ ta' doża eċċessiva bi KRYSTEXXA ma ġie rrapportat matul l-iżvilupp kliniku.
English: It is recommended to start this treatment 1 week before initiation of KRYSTEXXA and continue for at least 6 months, unless medically contraindicated or not tolerated.
Maltese: Huwa rakkomandat li din il-kura tinbeda ġimgħa waħda qabel ma jinbeda KRYSTEXXA u titkompla għal mill-inqas 6 xhur, sakemm ma jkunx medikament kontraindikat jew ma tiġix ittollerata.
English: The data for long-term treatment from controlled clinical studies are limited.
Maltese: Id-dejta minn studji kliniċi kkontrollati dwar kura fuq perjodu twil hija limitata.
English: KRYSTEXXA 8 mg concentrate for solution for infusion is supplied in 2 ml glass vials containing 1 ml concentrate.
Maltese: KRYSTEXXA 8 mg konċentrat għal soluzzjoni għal infużjoni jiġi fornut f'kunjetti tal-ħġieġ ta' 2 ml li fihom 1 ml ta' konċentrat.
English: • a rash, itching or hives tell your doctor or nurse IMMEDIATELY, since any of these may be signs of a serious allergic reaction.
Maltese: • raxx, ħakk jew urtikarja għid lit-tabib jew lill-infermier tiegħek MINNUFIĦ, peress li kwalunkwe wieħed minn dawn jista' jkun sinjal ta' reazzjoni allerġika severa.
English: The effect of treatment on tophi was assessed using standardized digital photography and image analysis by a Central Reader blinded to treatment assignment.
Maltese: L-effett tal-kura fuq it-tofi kien evalwat bl-użu ta' fotografija diġitali standardizzata u analiżi talimmaġni permezz ta' Reader Ċentrali blindati għall-kura assenjata.
English: Your doctor may test you for G6PD before you start KRYSTEXXA.
Maltese: It-tabib tiegħek jista' jittestjak għal G6PD qabel ma tibda KRYSTEXXA.
English: KRYSTEXXA will be administered by a doctor or nurse who will monitor you for side effects while you receive KRYSTEXXA and for some time afterwards.
Maltese: KRYSTEXXA għandu jingħata min tabib jew infermier li sejjer jimmonitorjak għal effetti sekondarji waqt li tirċievi KRYSTEXXA u għal xi ħin wara.
English: Contents of the pack and other information What KRYSTEXXA contains
Maltese: Żieda fir-rikaduti tal-gotta hija spiss osservata meta jinbeda KRYSTEXXA.
English: Reports of infusion related reactions or anaphylaxis coincident with concomitant use of oral urate lowering agents were submitted in this Periodic Safety Update Report, where infusion reactions in 28 cases and 9 cases with anaphylactic reactions were reported.
Maltese: Konklużjonijiet xjentifiċi u raġunijiet għal varjazzjoni għat-termini tal-awtorizzazzjonijiet għattqegħid fis-suq Rapporti ta' reazzjonijiet relatati mal-infuzjoni jew anafilassi li kienu jikkoinċidu mal-użu konkomitanti ta' aġenti orali li jnaqqsu l-urate, ġew sottomessi f'dan ir-Rapport Perjodiku Aġġornat dwar is-Sigurtà, fejn ġew irrappurtati reazzjonijiet għall-infużjoni fi 28 każ u 9 każijiet b'reazzjonijiet anafilattiċi.
English: This induces a concentration gradient between serum uric acid and tissue/joints deposits of monosodium urate resulting in the migration of urate from tissues/joints, which makes it accessible to conversion to allantoin.
Maltese: Dan iwassal għal gradjent tal-konċentrazzjoni bejn l-aċidu uriku fis-serum u d-depożiti ta' monosodium urate fit-tessut/ġogi li jwassal għall-migrazzjoni ta' urate mit-tessut/ġogi, li jagħmluh aċċessibbli għallkonverżjoni f'allantoin.
English: It is unknown whether pegloticase or its metabolites are excreted in human milk.
Maltese: Mhuwiex magħruf jekk pegloticase jew il-metaboliti tiegħu jiġux eliminati fil-ħalib uman.
English: KRYSTEXXA is a clear to slightly opalescent colourless solution.
Maltese: KRYSTEXXA ma jeħtieġx li jitwaqqaf minħabba rikaduta tal-gotta.
English: Antibodies to pegloticase associated with clearance of pegloticase resulted in a small stimulation in the elimination of urate.
Maltese: Dawk is-suġġetti li ma kellhomx antikorpi kontra pegloticase li eliminaw lil pegloticase kellhom effett sinifikanti fuq l-istimulazzjoni fl-eliminazzjoni ta' urate.
English: The benefit/risk balance should be assessed for each individual patient on an on-going basis considering the effect on tophus resolution as well as the risk of infusion reactions, gout flares, and potentially increased cardiac risk.
Maltese: Il-bilanċ tal-benefiċċju/riskju għandu jiġi evalwat għal kull pazjent individwali fuq bażi kontinwa u għandu jitqies l-effett fuq ir-riżoluzzjoni tat-tofus kif ukoll ir-riskju ta' reazzjonijiet għall-infużjoni, rikaduti tal-gotta, u żieda potenzjali fir-riskju kardijaku.
English: Metabolism and nutrition disorders Common: Hyperglycaemia Cardiac disorders
Maltese: Disodium hydrogen phosphate dihydrate
English: Among the other secondary endpoints, reduction from baseline in the number of tender and swollen joints were observed in patients treated with KRYSTEXXA every 2 weeks while there was little change in patients on placebo.
Maltese: Fost l-endpoints sekondarji l-oħra, kien osservat tnaqqis mil-linja bażi fl-għadd ta' ġogi sensittivi u minfuħin fil-pazjenti li rċevew kura bi KRYSTEXXA kull ġimgħatejn filwaqt li ma tantx kien hemm tibdil fil-pazjenti fuq plaċebo.
English: Common: Vomiting
Maltese: Komuni ħafna: Nawżja Komuni: Remettar
English: KRYSTEXXA has not been formally studied in patients with congestive heart failure, but a small number of patients with pre-existing cardiovascular conditions who were treated with pegloticase in the clinical trials had exacerbations of their congestive heart failure.
Maltese: KRYSTEXXA ma ġiex formalment studjat fuq pazjenti b'insuffiċjenza konġestiva tal-qalb, iżda għadd żgħir ta' pazjenti b'kondizzjonijiet kardjovaskulari pre-eżistenti li rċevew kura bi pegloticase fil-provi kliniċi kellhom aggravar tal-insuffiċjenza konġestiva tal-qalb tagħhom.
English: No dose adjustment is needed for patients 65 years of age and older (see section 5.2).
Maltese: Pazjenti anzjani Ma huwa meħtieġ l-ebda aġġustament tad-doża għal pazjenti 'l fuq minn 65 sena (ara sezzjoni 5.2).
English: Intraperitoneal use
Maltese: Insuman Infusat
English: EU/1/97/030/054 Insuman Infusat 100 IU/ml vials (glass)
Maltese: Suspensjoni għall- Użu għal taħt il-ġilda skartoċċ (ħġieġ) f'pinna
English: vials (glass)
Maltese: Użu għal ġol-peritonew kunjett (ħġieġ)
English: Recombinant Hepatitis B surface antigen (S protein), adsorbed Inactivated type 1 Poliovirus Inactivated type 2 Poliovirus Inactivated type 3 Poliovirus
Maltese: Antiġen tas-superfiċje ta' l-epatite B (proteina S) manifatturat b'teknoloġija rekombinanti, adsorbit
English: Diphtheria toxoid, adsorbed Tetanus toxoid, adsorbed
Maltese: Toxoid tat-tetnu, adsorbit
English: Filamentous haemagglutinin, adsorbed 25 micrograms Pertactin, adsorbed
Maltese: Filamentous haemagglutinin, adsorbit
English: Invented name Strength Pharmaceutical
Maltese: Isem inventat
English: Package size
Maltese: t x
English: Copalia amlodipine / valsartan
Maltese: Copalia amlodipina / valsartan
English: The full EPAR for Copalia 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 European Commission granted a marketing authorisation valid throughout the EU for Copalia on 16 January 2007.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha għal Copalia fis16 ta' Jannar 2007.
English: This is a summary of the European public assessment report (EPAR) for Copalia.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Copalia.
English: The most common side effects with Copalia (seen in between 1 and 10 patients in 100) are headache, nasopharyngitis (inflammation of the nose and throat), influenza (flu), hypokalaemia (low blood potassium levels), various types of oedema (swelling), fatigue (tiredness), flushing (reddening), asthenia (weakness) and hot flushes.
Maltese: L-effetti sekondarji l-aktar komuni b'Copalia (li dehru f'bejn pazjent 1 u 10 minn 100) huma wġigħ ta' ras, nasofarinġite (infjammazzjoni tal-imnieħer u tal-gerżuma), influwenza, ipokalemija (livelli baxxi ta' potassju fid-demm), tipi varji ta' edema (nefħa), għeja, ħmura, astenija (debbulizza) u fwawar.
English: What is the risk associated with Copalia?
Maltese: X'inhu r-riskju assoċjat ma' Copalia?
English: In the studies comparing the combination in patients who were already taking either amlodipine or valsartan, the blood pressure in patients taking valsartan alone had fallen by 6.6 mmHg after eight weeks, compared with 9.6 and 11.4 mmHg in the patients adding 5 or 10 mg amlodipine, respectively.
Maltese: Fl-istudji li qabblu l-kombinazzjoni fil-pazjenti li diġà kienu qegħdin jieħdu l-amlodipina jew il-valsartan, il-pressjoni tad-demm tal-pazjenti li kienu qegħdin jieħdu l-valsartan waħdu niżlitilhom b'6.6 mmHg wara tmien ġimgħat, meta mqabbla ma' 9.6 u 11.4 mmHg fil-pazjenti li żiedu 5 jew 10 mg amlodipina rispettivament.
English: What is Copalia?
Maltese: X'inhu Copalia?
English: Why has Copalia been approved?
Maltese: Għaliex ġie approvat Copalia?
English: The fifth, smaller study compared the combination with lisinopril and hydrochlorothiazide (another combination used to treat hypertension) in 130 patients with severe hypertension.
Maltese: Ilħames studju, fuq skala iżgħar, qabbel il-kombinazzjoni ma' lisinopril u idroklorotijażide (kombinazzjoni oħra użata għall-kura tal-ipertensjoni) f'130 pazjent b'ipertensjoni gravi.
English: Copalia contains two active substances, amlodipine and valsartan.
Maltese: Copalia fih żewġ sustanzi attivi, l-amlodipina u l-valsartan.
English: Copalia is a medicine that contains two active substances, amlodipine and valsartan.
Maltese: Copalia huwa mediċina li fiha żewġ sustanzi attivi, l-amlodipina u l-valsartan.
English: The CHMP decided that Copalia's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Copalia huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: Copalia must not be used in patients who have severe liver or bile problems, patients with certain heart problems and patients with severe hypotension (low blood pressure).
Maltese: Copalia ma għandux jintuża minn pazjenti bi problemi gravi fil-fwied, jew problemi biljari, jew minn pazjenti b'ċerti problemi tal-qalb u minn pazjenti b'ipotensjoni gravi (pressjoni tad-demm baxxa).
English: It blocks special channels on the surface of cells called calcium channels, through which calcium ions normally enter the cells.
Maltese: Din timblokka l-kanali speċjali fuq il-wiċċ taċċelluli magħrufa bħala kanali tal-kalċju, li minnhom normalment il-joni tal-kalċju jidħlu fiċ-ċelluli.
English: Copalia must also not be used in combination with aliskiren-containing medicines (also used to treat essential hypertension) in patients with type 2 diabetes or in patients with moderate or severe kidney impairment.
Maltese: Copalia ma għandux jintuża wkoll flimkien ma' mediċini li fihom l-aliskiren (użati wkoll fil-kura tal-ipertensjoni essenzjali) f'pazjenti bid-dijabete tat-tip 2, jew f'pazjenti li jbatu minn insuffiċjenza moderata jew gravi fil-kliewi.
English: Copalia must not be used in patients who are hypersensitive (allergic) to amlodipine or other medicines in the ‘dihydropyridine derivatives' class, to valsartan, or to any of the other ingredients.
Maltese: Copalia ma għandux jintuża f'pazjenti li jkunu ipersensittivi (allerġiċi) għall-amlodipina jew mediċini oħra tal-klassi tad-'derivati diidropiridiniċi', għall-valsartan, jew għal kwalunkwe wieħed mill-ingredjenti l-oħra.
English: Two studies (involving 1,891 patients) compared the combination in patients whose hypertension was not adequately controlled with either 10 mg amlodipine or 160 mg valsartan.
Maltese: Żewġ studji (li kienu jinvolvu 1,891 pazjent) qabblu l-kombinazzjoni f'pazjenti li għalihom ma kienx possibbli li lipertensjoni tagħhom tiġi kkontrollata adegwatament b'10 mg amlodipina jew f'160 mg valsartan.
English: For the full list of all side effects reported with Copalia, see the package leaflet.
Maltese: Għallista sħiħa tal-effetti sekondarji kollha rrappurtati b'Copalia, ara l-fuljett ta' tagħrif.
English: Copalia is taken by mouth as one tablet once a day with some water.
Maltese: Copalia jittieħed oralment bħala pillola waħda darba kuljum bi ftit ilma.
English: How has Copalia been studied?
Maltese: Kif ġie studjat Copalia?
English: Mundipharma Oy Rajatorpantie 41 B 01640 Vantaa Finland
Maltese: Il-Finlandja Mundipharma Oy Rajatorpantie 41 B 01640
English: Sweden Mundipharma AB Mölndalsvägen 30B Göteborg
Maltese: L-Isvezja Mundipharma AB Mölndalsvägen 30B Göteborg
English: Napp Pharmaceuticals Ltd. Cambridge Science Park Milton Road
Maltese: Ir-Renju Unit Napp Pharmaceuticals Ltd. Cambridge Science Park Milton Road
English: Mundipharma AS Dicks vei 10B, 1366 Lysaker
Maltese: In-Norveġja Mundipharma AS Dicks vei 10B, 1366
English: Germany Mundipharma GmbH Mundipharma Str. 2, Limburg
Maltese: Il-Ġermanja Mundipharma GmbH Mundipharma Str. 2, Limburg