FrancophonIA/ELRC3.0 huggingface dataset:
English: Having considered all available data, the MAH's responses and the ad-hoc advisory group recommendations, the CHMP identified and agreed upon a number of risk minimisation measures to be implemented by the MAH to reduce the risk of air/gas embolism associated with the spray use of Tisseel, Tissucol and Artiss.
Maltese: Wara li kkunsidra d-dejta kollha disponibbli, it-tweġibiet tad-Detentur tal-Awtorizzazzjoni għatTqegħid fis-Suq u r-rakkomandazzjonijiet tal-grupp konsultattiv ad-hoc, is-CHMP identifika u qabel dwar għadd ta' miżuri ta' minimizzazzjoni tar-riskju biex jiġu implimentati mid-Detentur talAwtorizzazzjoni għat-Tqegħid fis-Suq biex jitnaqqas ir-riskju ta' emboliżmu tal-gass/arja assoċjat mal-użu ta' Tisseel, Tissucol u Artiss bħala sprej.
English: From 2008 until May 2012, a total of eight cases of life-threatening air embolism were associated with the spray application of the fibrin sealants Quixil or Evicel (of which three had a fatal outcome, in one case no product was administered).
Maltese: Mill-2008 sa Mejju 2012, kien hemm total ta' tmien każijiet ta' emboliżmu tal-arja ta' periklu għallħajja assoċjati mal-applikazzjoni bħala sprej tas-siġillanti tal-fibrina Quixil jew Evicel (li minnhom tlieta kellhom riżultat fatali, f'każ wieħed l-ebda prodott ma kien ingħata).
English: Having considered all the available data, including the MAH written responses and the conclusions of the Ad-hoc Expert meeting, the CHMP agreed that the benefit-risk balance of Beriplast P as supportive treatment where standard surgical techniques are insufficient for improvement of haemostasis (including endoscopic treatment of bleeding gastro-duodenal ulcer) and as a tissue to promote adhesion/sealing or as suture support, is positive under normal conditions of use, subject to the changes to the product information, (see Annex III).
Maltese: Wara li kkunsidra d-dejta kollha disponibbli, inkluż it-tweġibiet bil-miktub tad-Detentur talAwtorizzazzjoni għat-Tqegħid fis-Suq u l-konklużjonijiet tal-laqgħa tal-Grupp Espert Ad-hoc, is-CHMP qabel li l-bilanċ tal-benefiċċju-riskju ta' Beriplast P bħala kura ta' appoġġ fejn tekniċki kirurġiċi standard mhumiex biżżejjed għat-titjib tal-emostasi (inkluż kura endoskopika ta' ulċera gastroduwodenali li qed tnixxi) u bħala tessut biex jippromwovi adeżjoni/issiġillar jew bħala appoġġ tassutura, huwa pożittiv taħt kundizzjonijiet normali ta' użu, soġġett għat-tibdil għall-fuljett ta' tagħrif, (ara Anness III).
English: • The Committee reviewed all the data provided by the MAH in writing and the outcome of the adhoc expert advisory group meeting;
Maltese: • Il-Kumitat irreveda d-dejta kollha pprovduta mid-Detentur tal-Awtorizzazzjoni għat-Tqegħid fisSuq bil-miktub u r-riżultat tal-laqgħa tal-grupp konsultattiv espert ad-hoc;
English: With regard to the efficacy of sprayable fibrin sealants, the CHMP assessed the available information, including data submitted by the MAHs.
Maltese: Fir-rigward tal-effikaċja ta' siġillanti tal-fibrina li jistgħu jiġu sprejjati, is-CHMP evalwa l-informazzjoni disponibbli, inkluż dejta sottomessa mid-Detenturi tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAHs).
English: The anticipated benefit of mandating CO2 use in open surgery may not outweigh the risks linked to inappropriate use of Tisseel/ Tissucol and Artiss.
Maltese: Il-benefiċċju antiċipat bl-obbligu tal-użu ta' CO2 f'kirurġija miftuħa jista' ma jegħlibx ir-riskji marbuta mal-użu inadegwat ta' Tisseel/ Tissucol u Artiss.
English: An ad-hoc expert advisory group meeting was convened in October 2012 at the request of the CHMP, during which the experts discussed the benefits of sprayable fibrin sealants as well as potential risk minimisation measures, in particular with regard to the risk of air embolism.
Maltese: F'Ottubru 2012 fuq talba tas-CHMP tlaqqgħet laqgħa tal-grupp konsultattiv espert ad-hoc, li matulha l-esperti ddiskutew il-benefiċċji ta' siġillanti tal-fibrina li jistgħu jiġu sprejjati kif ukoll miżuri potenzjali ta' minimizzazzjoni tar-riskju, b'mod partikulari fir-rigward tar-riskju ta' emboliżmu talarja.
English: Having considered all the available data, including the MAH responses provided in writing and during oral explanations and the conclusions of the Ad-hoc Expert meeting, the CHMP agreed that the benefitrisk balance of Tisseel, Tissucol and Artiss in their approved indications, is positive under normal conditions of use, subject to the changes to the product information, (see Annex III), together with the agreed risk minimisation measures (see Annex IV) and the agreed Direct Healthcare Professional Communication.
Maltese: Wara li kkunsidra d-dejta kollha disponibbli, inkluż it-tweġibiet tad-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq ipprovduti bil-miktub u waqt spjegazzjonijiet orali u l-konklużjonijiet tal-laqgħa tal-Grupp Espert Ad-hoc, is-CHMP qabel li l-bilanċ tal-benefiċċju-riskju ta' Tisseel, Tissucol u Artiss fl indikazzjonijiet approvati tagħhom, huwa pożittiv taħt kundizzjonijiet normali ta' użu, soġġett għattibdil għall-fuljett ta' tagħrif, (ara Anness III), flimkien mal-miżuri ta' minimizzazzjoni tar-riskju miftiehma (ara Anness IV) u l-Komunikazzjoni Diretta lill-Professjonali tal-Kura tas-Saħħa miftiehma.
English: • The Committee reviewed all the data provided by the MAH in writing and in the oral explanation and the outcome of the ad-hoc expert advisory group meeting;
Maltese: • Il-Kumitat irreveda d-dejta kollha pprovduta mid-Detentur tal-Awtorizzazzjoni għat-Tqegħid fisSuq bil-miktub u fl-ispjegazzjoni orali u r-riżultat tal-laqgħa tal-grupp konsultattiv espert adhoc;
English: The authorised indications for Tisseel/Tissucol and Beriplast P are the “supportive treatment where standard surgical techniques are insufficient for improvement of haemostasis” and “to promote adhesion/sealing or as suture support”.
Maltese: L-indikazzjonijiet awtorizzati għal Tisseel/Tissucol u Beriplast P huma “l-kura ta' appoġġ fejn tekniki kirurġiċi standard mhumiex biżżejjed għat-titjib tal-emostasi” u “biex jippromwovi ladeżjoni/issiġillar jew bħala appoġġ għas-sutura”.
English: A single not well documented non-fatal case of a potential air embolism in association with Tisseel was reported in 2009.
Maltese: Każ uniku mhux fatali u mhux dokumentat sew ta' emboliżmu potenzjali tal-arja assoċjat ma' Tisseel kien irrapportat fl-2009.
English: With regards to safety, the CHMP noted that the main risk with sprayable fibrin sealants is the risk of air embolism, due air entering the vasculature.
Maltese: Fir-rigward tas-sigurtà, is-CHMP innota li r-riskju ewlieni b'siġillanti tal-fibrina li jistgħu jiġu sprejjati huwa r-riskju ta' emboliżmu tal-arja, minħabba arja li tidħol fil-vaskulatura.
English: Furthermore, the device design should have a specific gas pressure governor to be used with the spray applicator and with a limit not above the maximal optimal pressure recommended.
Maltese: Barra minn hekk, id-disinn tal-apparat għandu jkollu regolatur speċifiku tal-pressjoni tal-gass li għandu jintuża mal-applikatur tal-isprej u b'limitu mhux akbar millpressjoni massima ottimali rakkomandata.
English: For Tisseel and Tissucol, which are also recommended for use in laparoscopic procedures, a label for the pressure regulator with a symbol that informs about the correct pressure and distance laparoscopic procedures should also be provided.
Maltese: Għal Tisseel u Tissucol, li huma rakkomandati wkoll għall-użu fi proċeduri laparoskopiċi, għandha wkoll tiġi pprovduta tikketta għar-regolatur tal-pressjoni b'simbolu li jinforma dwar ilpressjoni u d-distanza korretta fi proċeduri laparoskopiċi.
English: Considering the limited evidence of risk of air embolism with those specific products (Tisseel/Tissucol and Artiss), CHMP concluded that beyond the above mentioned risk minimisation measures no further actions were deemed justified.
Maltese: Meta titqies l-evidenza limitata tar-riskju ta' emboliżmu tal-arja ma' dawk il-prodotti speċifiċi (Tisseel/Tissucol u Artiss), is-CHMP ikkonkluda li lil hinn mill-miżuri ta' minimizzazzjoni tar-riskju msemmija hawn fuq, l-ebda azzjoni ulterjuri ma kienet meqjusa ġġustifikata.
English: As a result, gas embolism may occur even with a reduced pressure.
Maltese: Bħala riżultat, emboliżmu tal-gass jista' jseħħ anke bi pressjoni mnaqqsa.
English: In addition, ARTISS is indicated as an adjunct to haemostasis on subcutaneous tissue surfaces.
Maltese: Barra minn hekk, ARTISS huwa indikat bħala żieda mal-emostasi fuq uċuħ subkutanji tat-tessut.
English: Date of first authorisation: 16 January.2007 Date of latest renewal: 21 November 2011
Maltese: Data tal-ewwel awtorizzazzjoni: 16 Jannar 2007 Data tal-aħħar tiġdid: 21 Novembru 2011
English: Other possible side effects of Copalia:
Maltese: Effetti sekondarji possibli oħra ta' Copalia:
English: Slovenská republika Novartis Slovakia r.o.
Maltese: Slovenská republika Novartis s.Slovakia r.o.
English: Frequency Copalia Amlodipine Valsartan
Maltese: Frekwenza Copalia Amlodipine Valsartan
English: See also information under the heading “Do not take Copalia”.
Maltese: Ara wkoll l-informazzjoni taħt l-intestatura “Tiħux Copalia”.
English: Other medicines and Copalia
Maltese: Mediċini oħra u Copalia
English: Age, gender, race or body mass index (≥30 kg/m 2, <30 kg/m 2) did not influence the response to
Maltese: L-età, sess, razza jew l-indiċi tal-massa tal-ġisem (≥30 kg/m2, <30 kg/m2) ma kellhomx effett fuq ir rispons għal Copalia.
English: The safety of Copalia has been evaluated in five controlled clinical studies with 5,175 patients, 2,613 of whom received valsartan in combination with amlodipine.
Maltese: Is-sigurtà ta' Copalia ġiet meqjusa f'ħames studji kliniċi kontrollati b'5,175 pazjent, li 2,613 minnhom irċevew valsartan kombinat ma' amlodipine.
English: • Concomitant use of Copalia with aliskiren-containing products in patients with diabetes mellitus or renal impairment (GFR <60 ml/min/1.73 m2) (see sections 4.5 and 5.1).
Maltese: • L-użu fl-istess ħin ta' Copalia ma' prodotti li jkun fihom aliskiren f'pazjenti b'dijabete mellitus jew indeboliment tal-kliewi (GFR <60 ml/min/1.73 m2) (ara sezzjonijiet 4.5 u 5.1).
English: A hydroxy metabolite has been identified in plasma at low concentrations (less than 10% of the valsartan AUC).
Maltese: Fil-plażma kien identifikat metabolu hydroxy f'konċentrazzjonijiet baxxi (anqas minn 10% tal-AUC ta' valsartan).
English: In this study (baseline blood pressure 171/113 mmHg), a Copalia regimen of 5 mg/160 mg titrated to 10 mg/160 mg reduced sitting blood pressure by 36/29 mmHg as compared to 32/28 mmHg with a regimen of lisinopril/hydrochlorothiazide 10 mg/12.5 mg titrated to 20 mg/12.5 mg.
Maltese: F'dan l-istudju (il-linja bażi tal-pressjoni tad-demm kienet 171/113 mmHg), b'reġimen ta' Copalia ta' 5 mg/160 mg miżjuda għal 10 mg/160 mg naqqset il-pressjoni tad-demm ta' bilqiegħeda b'36/29 mmHg meta imqabbla ma' 32/28 mmHg b'reġimen ta' lisinopril/hydrochlorthiazide 10 mg/12.5 mg miżjuda għal 20 mg/12.5 mg.
English: An increased incidence and severity of renal tubular basophilia/hyalinisation, dilation and casts, as well as interstitial lymphocyte inflammation and arteriolar medial hypertrophy were found at an exposure of 8-13 (valsartan) and 7-8 (amlodipine) times the clinical doses of 160 mg valsartan and 10 mg amlodipine.
Maltese: Żieda fin-numru ta' każijiet u severità ta' bażofilja/ hyalinisation tubulari renali, dilazzjoni u kasts, kif ukoll infjammazzjoni b'limfoċiti fl-interstizzju u ipertrofija tal-arterjola medjali instabu b'esponimenti ta' 8-13 (valsartan) u 7-8 (amlodipine) drabi d-dożi kliniċi ta' 160 mg valsartan u 10 mg amlodipine.
English: The active substances of Copalia are amlodipine (as amlodipine besylate) and valsartan.
Maltese: Is-sustanzi attivi ta' Copalia huma amlodipine (bħala amlodipine besylate) u valsartan.
English: Hepatic impairment Copalia is contraindicated in patients with severe hepatic impairment (see section 4.3).
Maltese: Indeboliment tal-fwied Copalia huwa kontra-indikat f'pazjenti b'indeboliment tal-fwied qawwi (ara sezzjoni 4.3).
English: Copalia 5 mg/80 mg film-coated tablets Copalia 5 mg/160 mg film-coated tablets Copalia 10 mg/160 mg film-coated tablets
Maltese: Copalia 5 mg/80 mg pilloli miksija b'rita Copalia 5 mg/160 mg pilloli miksija b'rita Copalia 10 mg/160 mg pilloli miksija b'rita
English: Copalia is available in packs containing 7, 14, 28, 30, 56, 90, 98 or 280 tablets and in multipacks comprising 4 cartons, each containing 70 tablets, or 20 cartons, each containing 14 tablets.
Maltese: Copalia jiġi f'pakketti li jkun fihom 7, 14, 28, 30, 56, 90, 98 jew 280 pillola u pakketti b'ħafna li jinkludu 4 kartuniet, kull wieħed fih 70 pillola, jew 20 kartuna, kull waħda b'14 -il pillola.
English: Not known Decrease in haemoglobin, decrease in haematocrit, neutropenia, thrombocytopenia, increase of serum potassium, elevation of liver function values including increase of serum bilirubin, renal failure and impairment, elevation of serum creatinine, angioedema, myalgia, vasculitis, hypersensitivity including serum sickness.
Maltese: Tnaqqis fl-emoglobina, tnaqqis fl-ematocrit, newtropenja, tromboċitopenja, żieda fil-potassju tas-serum, żieda fil-valuri tal-funzjoni tal-fwied inkluż żieda fil-bilirubin tas-serum, insuffiċjenza u indeboliment tal-kliewi, livell ogħla ta' kreatinina fisserum, anġjoedima, majalġja, vaskulite, sensittività eċċessiva inkluż mard tas-serum.
English: The no-observed-effect-level for developmental effects was observed at 3- (valsartan) and 4- (amlodipine) fold the clinical exposure (based on AUC).
Maltese: Il-livell fejn ma jidhirx effett għall-effetti tal-iżvilupp kien osservat b'3- (valsartan) u 4-(amlodipine) darbiet l-esponiment kliniku (bażat fuq l-AUC).
English: No dosage adjustment of Copalia is required for patients with mild to moderate renal impairment (GFR >30 ml/min/1.73 m2).
Maltese: M'hemmx bżonn ta' tibdil fid-dożaġġ għall-pazjenti li għandhom indeboliment ħafif għal moderat (GFR >30 ml/min/1.73 m2).
English: Amlodipine has been studied in patients with chronic stable angina, vasospastic angina and angiographically documented coronary artery disease.
Maltese: Amlodipine kien studjat f'pazjenti li jsofru minn anġina kronika stabbli, anġina vażospastika u mard tal-arterja koronarja dokumentat b'anġjografija.
English: The mean incidence of peripheral oedema evenly weighted across all doses was 5.1% with the amlodipine/valsartan combination.
Maltese: Il-medja tal-edima periferali li seħħet, meqjusa b'mod ugwali fil-medda tad-dożi kollha kienet 5.1% bil-kombinazzjoni amlodipine/valsartan.
English: Adverse reactions observed in animal studies with possible clinical relevance were as follows: Histopathological signs of inflammation of the glandular stomach was seen in male rats at an exposure of about 1.9 (valsartan) and 2.6 (amlodipine) times the clinical doses of 160 mg valsartan and 10 mg amlodipine.
Maltese: Reazzjonijiet avversi li dehru fi studji b'annimali li jistgħu jkollhom rilevanza klinika kienu kif ġej: Sinjali istopatoloġici ta' infjammazzjoni tal-istonku glandulari dehru f'firien maskili b'esponimenti ta' madwar 1.9 (valsartan) u 2.6 (amlodipine) -il darba d-dożi kliniċi ta' 160 mg valsartan u 10 mg amlodipine.
English: Copalia 5 mg/80 mg film-coated tablets Copalia 5 mg/160 mg film-coated tablets Copalia 10 mg/160 mg film-coated tablets amlodipine/valsartan
Maltese: Copalia 5 mg/80 mg pilloli miksija b'rita Copalia 5 mg/160 mg pilloli miksija b'rita Copalia 10 mg/160 mg pilloli miksija b'rita amlodipine/valsartan
English: Copalia 10 mg/160 mg tablets are oval and light yellow with “NVR” on one side and “UIC” on the other side.
Maltese: Copalia 10 mg/160 mg pilloli huma ovali u sofor ċari b' “NVR” fuq naħa u “UIC” fuq in-naħa l-oħra.
English: Copalia 5 mg/160 mg tablets are oval and dark yellow “NVR” on one side and “ECE” on the other side.
Maltese: Copalia 5 mg/160 mg pilloli huma ovali u sofor skuri b' “NVR” fuq naħa u “ECE” fuq in-naħa l-oħra.
English: Copalia 10 mg/160 mg film-coated tablets amlodipine/valsartan
Maltese: Copalia 10 mg/160 mg pilloli miksija b'rita amlodipine/valsartan
English: A multicentre, randomised, double-blind, active-controlled, parallel-group trial showed normalisation of blood pressure (trough sitting diastolic blood pressure <90 mmHg at the end of the trial) in patients not adequately controlled on amlodipine 10 mg in 78% of patients treated with amlodipine/valsartan 10 mg/160 mg, compared to 67% of patients remaining on amlodipine 10 mg.
Maltese: Prova f'ħafna ċentri, randomizzata, double-blind, ikkontrollata bl-attiv, bi grupp parallel wasslet għal pressjoni tad-demm normali (il-pressjoni ta' bilqiegħeda l-aktar baxxa kienet <90 mmHg fl-aħħar talprova) f'pazjenti li ma kienux kontrollati sew b'amlodipine 10 mg f'78% tal-pazjenti kurati b'amlodipine/valsartan 10 mg/160 mg, imqabbla ma' 67% tal-pazjenti li baqgħu fuq amlodipine
English: Copalia 5 mg/80 mg film-coated tablets amlodipine/valsartan
Maltese: Copalia 5 mg/80 mg pilloli miksija b'rita amlodipine/valsartan
English: EU/1/06/372/001 EU/1/06/372/002 EU/1/06/372/003 EU/1/06/372/004 EU/1/06/372/005 EU/1/06/372/006 EU/1/06/372/007 EU/1/06/372/008 EU/1/06/372/025 EU/1/06/372/026 EU/1/06/372/027 EU/1/06/372/034 EU/1/06/372/037
Maltese: EU/1/06/372/005 EU/1/06/372/006 EU/1/06/372/007 EU/1/06/372/008 EU/1/06/372/025
English: Exposure to AIIRA therapy during the second and third trimesters is known to induce human foetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia) (see section 5.3).
Maltese: Espożizzjoni għall-kura ta' AIIRA fit-tieni u it-tielet trimestri huwa magħruf li jinduċi tossiċità talfetu uman (funzjoni renali mnaqqsa, oligoidramnios, ittardjar tal-ossifikazzjoni tal-kranju) u tossiċità fit-trabi wara it-twelid (indeboliment renali, pressjoni baxxa, iperkalemia)
English: Intravenous calcium gluconate may be beneficial in reversing the effects of calcium channel blockade.
Maltese: Calcium gluconate mogħti minn ġol vina jista' jgħin biex ireġġa' lura l-effetti tal-imblukkar tal-kanali tal-calcium.
English: Following oral administration of Copalia, peak plasma concentrations of valsartan and amlodipine are reached in 3 and 6-8 hours, respectively.
Maltese: Wara li Copalia jittieħed mill-ħalq l-ogħla konċentrazzjonijiet fil-plażma ta' valsartan u amlodipine jintlaħqu fi 3 u 6-8 sigħat, rispettivament.
English: EU/1/06/372/017 7 film-coated tablets EU/1/06/372/018 14 film-coated tablets EU/1/06/372/019 28 film-coated tablets EU/1/06/372/020 30 film-coated tablets EU/1/06/372/021 56 film-coated tablets EU/1/06/372/022 90 film-coated tablets EU/1/06/372/023 98 film-coated tablets EU/1/06/372/024 280 film-coated tablets EU/1/06/372/031 56x1 film-coated tablet (unit dose) EU/1/06/372/032 98x1 film-coated tablet (unit dose) EU/1/06/372/033 280x1 film-coated tablet (unit dose)
Maltese: EU/1/06/372/017 7 pilloli miksija b'rita EU/1/06/372/018 14-il pillola miksija b'rita EU/1/06/372/019 28 pillola miksija b'rita EU/1/06/372/020 30 pillola miksija b'rita EU/1/06/372/021 56 pillola miksija b'rita EU/1/06/372/022 90 pillola miksija b'rita EU/1/06/372/023 98 pillola miksija b'rita EU/1/06/372/024 280 pillola miksija b'rita EU/1/06/372/031 56xpillola 1 miksija b'rita (doża b'waħda) EU/1/06/372/032 98xpillola 1 miksija b'rita (doża b'waħda) EU/1/06/372/033 280xpillola 1 miksija b'rita (doża b'waħda)
English: EU/1/06/372/009 7 film-coated tablets EU/1/06/372/010 14 film-coated tablets EU/1/06/372/011 28 film-coated tablets EU/1/06/372/012 30 film-coated tablets EU/1/06/372/013 56 film-coated tablets EU/1/06/372/014 90 film-coated tablets EU/1/06/372/015 98 film-coated tablets EU/1/06/372/016 280 film-coated tablets EU/1/06/372/028 56x1 film-coated tablet (unit dose) EU/1/06/372/029 98x1 film-coated tablet (unit dose) EU/1/06/372/030 280x1 film-coated tablet (unit dose)
Maltese: EU/1/06/372/009 7 pilloli miksija b'rita EU/1/06/372/010 14-il pillola miksija b'rita EU/1/06/372/011 28 pillola miksija b'rita EU/1/06/372/012 30 pillola miksija b'rita EU/1/06/372/013 56 pillola miksija b'rita EU/1/06/372/014 90 pillola miksija b'rita EU/1/06/372/015 98 pillola miksija b'rita EU/1/06/372/016 280 pillola miksija b'rita EU/1/06/372/028 56xpillola 1 miksija b'rita (doża waħda)
English: Copalia was also studied in an active-controlled study of 130 hypertensive patients with mean sitting diastolic blood pressure ≥110 mmHg and <120 mmHg.
Maltese: Copalia kien studjat ukoll fi studju kkontrollat bl-attiv ta' 130 pazjent bi pressjoni għolja bil-pressjoni dijastolika bilqiegħda medja ≥110 mmHg u <120 mmHg.
English: Copalia 10 mg/160 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 10 mg or valsartan 160 mg alone or with Copalia 5 mg/160 mg.
Maltese: Copalia 10 mg/160 mg jista' jingħata lill-pazjenti li ma jkollhomx pressjoni kontrollata tajjeb b'amlodipine 10 mg jew valsartan 160 mg waħidhom jew b'Copalia 5 mg/160 mg.
English: Copalia 5 mg/160 mg film-coated tablets amlodipine/valsartan
Maltese: Copalia 5 mg/160 mg pilloli miksija b'rita amlodipine/valsartan
English: Do not take Copalia with grapefruit or grapefruit juice.
Maltese: Tiħux Copalia ma' grejpfrut jew ma' meraq tal-grejpfrut.
English: Copalia 5 mg/80 mg film-coated tablets
Maltese: Copalia 5 mg/80 mg pilloli miksija b'rita
English: EU/1/06/372/034 280 film-coated tablets (4x70) EU/1/06/372/037 280 film-coated tablets (20x14)
Maltese: EU/1/06/372/037 280 pillola miksija b'rita (20x14)
English: As a consequence of the inhibition of the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible individuals.
Maltese: Bħala konsegwenza tal-inibizzjoni tas-sistema renin-angiotensin-aldosterone, tibdil fil-funzjoni renali tista' tkun mistennija f'indvidwi li huma suxxettibli.
English: EU/1/06/372/001 7 film-coated tablets EU/1/06/372/002 14 film-coated tablets EU/1/06/372/003 28 film-coated tablets EU/1/06/372/004 30 film-coated tablets EU/1/06/372/005 56 film-coated tablets EU/1/06/372/006 90 film-coated tablets EU/1/06/372/007 98 film-coated tablets EU/1/06/372/008 280 film-coated tablets EU/1/06/372/025 56x1 film-coated tablet (unit dose) EU/1/06/372/026 98x1 film-coated tablet (unit dose) EU/1/06/372/027 280x1 film-coated tablet (unit dose)
Maltese: EU/1/06/372/001 7 pilloli miksija b'rita EU/1/06/372/002 14-il pillola miksija b'rita EU/1/06/372/003 28 pillola miksija b'rita EU/1/06/372/004 30 pillola miksija b'rita EU/1/06/372/005 56 pillola miksija b'rita EU/1/06/372/006 90 pillola miksija b'rita EU/1/06/372/007 98 pillola miksija b'rita EU/1/06/372/008 280 pillola miksija b'rita EU/1/06/372/025 56xpillola 1 miksija b'rita (doża waħda)
English: EU/1/06/372/017 EU/1/06/372/018 EU/1/06/372/019 EU/1/06/372/020 EU/1/06/372/021 EU/1/06/372/022 EU/1/06/372/023 EU/1/06/372/024 EU/1/06/372/031 EU/1/06/372/032 EU/1/06/372/033 EU/1/06/372/036 EU/1/06/372/039
Maltese: EU/1/06/372/031 EU/1/06/372/032 EU/1/06/372/033 EU/1/06/372/036 EU/1/06/372/039
English: In a long-term, placebo-controlled study (PRAISE-2) of amlodipine in patients with NYHA (New York Heart Association Classification) III and IV heart failure of non-ischaemic aetiology, amlodipine was associated with increased reports of pulmonary oedema despite no significant difference in the incidence of worsening heart failure as compared to placebo.
Maltese: Fi studju fit-tul, kontrollat bi plaċebo (PRAISE-2) b'amlodipine f'pazjenti b'NYHA (Klassifikazzjoni tal-Assoċjazzjoni tal-Qalb Ta' New York) III u IV, insuffiċjenza tal-qalb b'etjoloġija mhux iskemika, amlodipine kien assoċjat ma' numru akbar ta' rapporti ta' edima fil-pulmun minkejja li ma kienx hemm differenza sinifikanti fin-numru ta' pazjenti li l-insuffiċjenza tal-qalb marret għall-agħar meta mqabbla mal-plaċebo.