FrancophonIA/ELRC3.0 huggingface dataset:
English: 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 86 68 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
Maltese: (44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
English: The marketing authorisation holder is Glaxo Group Ltd.
Maltese: Id-detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq huwa Glaxo Group Ltd.
English: Quixidar contains the active substance fondaparinux sodium (1.5, 2.5, 5, 7.5 or 10 mg per syringe).
Maltese: Quixidar fih is-sustanza attiva fondaparinux sodium (1.5, 2.5, 5, 7.5 jew 10 mg f'kull siringa).
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) QUIXIDAR EPAR summary for the public
Maltese: RAPPORT TA' VALUTAZZJONI PUBBLIKA EWROPEW (EPAR) QUIXIDAR Sommarju ta' l-EPAR għall-pubbliku
English: The marketing authorisation was renewed on 21 March 2007.
Maltese: L-awtorizzazzjoni għat-tqegħid fis-suq ġiet imġedda fil21 ta' Marzu 2007.
English: This summary was last updated in 09-2007.
Maltese: Dan is-sommarju kien aġġornat l-aħħar f'09-2007.
English: In the treatment of VTE, Quixidar was compared with enoxaparin (DVT: 2,192 patients) or with unfractionated heparin (PE: 2,184 patients).
Maltese: Fit-trattament ta' VTE, Quixidar tqabbel ma' enoxaparin (DVT: 2,192 pazjent) jew ma' eparina mhux frazzjonata (PE: 2,184 pazjent).
English: In the prevention studies, Quixidar was compared with other anticoagulants: enoxaparin (in hip or knee surgery; over 8,000 patients) or dalteparin (in abdominal surgery; 2,927 patients).
Maltese: Fl-istudji talprevenzjoni, Quixidar tqabbel ma' antikoagulanti oħra: enoxaparin (fil-kirurġija fl-irkoppa jew flingroppa; iktar minn 8,000 pazjent) jew dalteparin (fil-kirurġija addominali; 2,927 pazjent).
English: Quixidar (1.5 and 2.5 mg strengths) is used to prevent venous thromboembolic events (VTEs, problems caused by blood clots) in patients who are having major surgery to their legs, such as a hip replacement or surgery to repair a knee or hip fracture.
Maltese: Quixidar (f'dożi ta' 1.5 u 2.5 mg) jintuża fil-prevenzjoni ta' avvenimenti trombolitiċi venużi (VTEs, problemi kkawżati minn demm magħqud) f'pazjenti li jkunu sa jagħmlu operazzjoni serja f'riġlejhom, bħal sostituzzjoni ta' l-ingroppa jew operazzjonijiet għat-tiswija ta' ksur fl-irkoppa jew fl-ingroppa.
English: It was also compared with placebo (a dummy treatment) when looking at patients with an acute illness (839 patients) and patients treated for an additional 24 days following hip fracture surgery (656 patients).
Maltese: Tqabbel ukoll ma' plaċebo (trattament finta) użat ma' pazjenti b'marda akuta (839 pazjent) u ma' pazjenti ttrattati għal 24 jum ieħor wara kirurġija għal ksur fl-ingroppa (656 pazjent).
English: In the study of myocardial infarction with ST segment elevation, Quixidar reduced the risk of death or another heart attack by 14% after 30 days, compared to standard care.
Maltese: Fl-istudju ta' l-infarti mijokardjali b'elevazzjoni tas-segment ST, Quixidar naqqas irriskju ta' mewt jew attakk tal-qalb ieħor b'14% wara 30 jum, meta imqabbel mal-kura standard.
English: The active ingredient in Quixidar, fondaparinux sodium, stops one of the substances (factors) that are involved in the clotting of blood, Factor Xa.
Maltese: Is-sustanza attiva f'Quixidar, fondaparinux sodium, twaqqaf waħda mis-sustanzi (fatturi) li jieħdu sehem fil-koagulazzjoni taddemm, il-Fattur Xa.
English: At higher strengths (5, 7.5 and 10 mg), Quixidar is used to treat VTEs such as deep vein thrombosis (DVT, a blood clot in the leg) or pulmonary embolism (PE, blood clot in the lung).
Maltese: F'qawwiet iktar għolja (5, 7.5 u 10 mg), Quixidar huwa wżat għall-kura tal-VTEs bħal ma huma trombożi fil-vini l-fondi (DVT, embolu fis-sieq) jew emboliżmu pulmonarju (PE, embolu fil-pulmun).
English: Quixidar is an anticoagulant; it prevents the blood from coagulating (clotting).
Maltese: Quixidar hu antikoagulant; jipprevjeni d-demm milli jikkoagula (jagħqad).
English: The effectiveness of Quixidar has been studied for the prevention of and in the treatment of VTE.
Maltese: L-effettività ta' Quixidar ġiet studjata fil-prevenzjoni ta' u fit-trattament ta' VTE.
English: By using Quixidar after surgery, the risk of a blood clot forming is greatly reduced.
Maltese: Bl-użu ta' Quixidar wara operazzjoni, ir-riskju ta' formazzjoni ta' embolu jitnaqqas drastikament.
English: The overall rate of thrombotic events in patients treated with Quixidar was significantly less than in patients treated with placebo or enoxaparin (for patients undergoing leg surgery), and was similar to that seen with enoxaparin (treatment of DVT), dalteparin or unfractionated heparin.
Maltese: Ir-rata globali ta' avvenimenti trombotiċi f'pazjenti ttrattati b'Quixidar kienet ferm inqas minn dik f'pazjenti ttrattati bi plaċebo jew b'enoxaparin (għal pazjenti li kienu se jiġu operati f'saqajhom), u kienet simili għal dik b'enoxaparin (trattament tad-DVT), dalteparin jew eparina mhux frazzjonata.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Quixidar on 21 March 2002.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-Unjoni Ewropea kollha għal-Quixidar fil-21 ta' Marzu 2002.
English: How is Quixidar used?
Maltese: X'inhu Quixidar?
English: The first compared the effects of Quixidar with those of enoxaparin in over 20,000 patients with unstable angina or myocardial infarction without ST segment elevation, and the second compared Quixidar with standard care (unfractionated heparin in eligible patients, or placebo) in over 12,000 patients with myocardial infarction with ST segment elevation.
Maltese: L-ewwel wieħed ikkumpara l-effetti ta' Quixidar ma' dawk ta' enoxaparin f'iktar minn 20,000 -il pazjent li jbatu minn anġina mhux stabbli u infart mijokardjali mingħajr l-elevazzjoni tas-segment ST, u t-tieni wieħed ikkumpara Quixidar mal-kura standard (eparina mhux frazzjonata f'pazjenti eliġibbli, jew plaċebo) f'iktar minn 12,000 -il pazjent li jbatu minn infart mijokardjali b' elevazzjoni tas-segment ST.
English: Why has Quixidar been approved?
Maltese: Għaliex ġie approvat Quixidar?
English: How has Quixidar been studied?
Maltese: Kif ġie studjat Quixidar?
English: In the treatment of DVT or PE, the recommended dose is 7.5 mg once a day by subcutaneous injection, usually for seven days.
Maltese: Fit-trattament ta' DVT jew PE, id-doża rrakkomandata hi ta' 7.5 mg darba kuljum mogħtija permezz ta' injezzjoni taħt il-ġilda, normalment għall-sebat ijiem.
English: What is the risk associated with Quixidar?
Maltese: X'inhu r-riskju assoċjat ma' Quixidar?
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Quixidar's benefits are greater than its risks in both the prevention and the treatment of VTEs, unstable angina and myocardial infarction.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) iddeċieda li Quixidar għandu iktar benefiċċji milli riskji fil-prevenzjoni u fil-kura ta' VTEs, anġina mhux stabbli u infarti mijokardjali.
English: In the prevention of VTEs, the recommended dose of Quixidar is 2.5 mg once a day by subcutaneous injection (under the skin).
Maltese: Fil-prevenzjoni ta' VTEs, id-doża rakkomandata ta' Quixidar hija ta' 2.5 mg darba kuljum amministrata permezz ta' injezzjoni taħt il-ġilda.
English: The 2.5 mg strength is also used to treat patients with unstable angina (a type of chest pain that changes in severity) or who are having a myocardial infarction (heart attack):
Maltese: Il-qawwa ta' 2.5 mg hija wżata wkoll għall-kura ta' pazjenti li jbatu minn anġina li mhijiex stabbli (tip ta' wġigħ fis-sider li jvarja fis-severità) jew li qegħdin jesperjenzaw attakk fil-qalb (infarti mijokardjali - myocardial infarction):
English: Quixidar was at least as effective as enoxaparin in preventing death or an ischaemic event in patients with unstable angina or myocardial infarction without ST segment elevation, with around 5% of the patients in each group had died or had an ischaemic event after nine days.
Maltese: Quixidar kien minn ta' l-inqas effettiv daqs enoxaparin fil-prevenzjoni tal-mewt jew avveniment iskaemiku f'pazjenti li jbatu minn anġina mhux stabbli jew infart mijokarkjali mingħajr elevazzjoni tas-segment ST, b'madwar 5% tal-pazjenti f'kull grupp li mietu jew li kellhom avveniment iskaemiku wara disat ijiem.
English: The main measure of effectiveness was the proportion of patients who died or had an ‘ischaemic event' (restriction of blood supply to an organ, including the heart).
Maltese: Il-miżura prinċipali ta' effikaċja kienet il-proporzjon ta' pazjenti li mietu jew kellhom ‘avveniment iskaemiku' (restrizzjoni tal-provvista tad-demm lejn xi organu, inkluż ilqalb).
English: In all studies, the main measure of effectiveness was the overall rate of thrombotic events (problems caused by blood clots).
Maltese: Fl-istudji kollha, il-mezz prinċipali ta' effikaċja kien ir-rata globali ta' avvenimenti trombotiċi (problemi kkawżati minn emboli).
English: For patients with unstable angina or myocardial infarction, the recommended dose is 2.5 mg once daily by subcutaneous injection, but the first dose is given intravenously (into a vein) through an existing line or as an infusion (drip) in patients with ST segment elevation.
Maltese: Għall-pazjenti li jbatu minn anġina mhux stabbli jew infarti mijokardjali, id-doża rakkomandata hija ta' 2.5mg darba kuljum permezz ta' injezzjoni taħt il-ġilda, imma l-ewwel doża trid tingħata ġo vina (intravenously) permezza ta' linja eżistenti jew bħala infużjoni (drip) fil-pazjenti li għandhom elevazzjoni tas-segment ST.
English: As with other antithrombotic medicines, the most common side effect of Quixidar is bleeding.
Maltese: Bħall-mediċini antitrombotiċi l-oħra, l-iktar effetti sekondarji komuni ta' Quixidar kien il-ħruġ taddemm.
English: For patients who have kidney problems, Quixidar may not be suitable, or the lower 1.5-mg dose may be used.
Maltese: Għall-pazjenti li jbatu minn problemi fil-kliewi, Quixidar jista' ma jkunx adattat, jew inkella tista' tintuża doża iżgħar ta' 1.5-mg.
English: Quixidar should not be used in people who may be hypersensitive (allergic) to fondaparinux sodium or any of the other ingredients, who might be bleeding already, who have acute bacterial endocarditis (an infection of the heart) or have severe kidney problems.
Maltese: Quixidar m'għandux jintuża minn persuni allerġiċi għal fondaparinux sodium jew għal xi sustanza oħra tiegħu, li jista' diġà jkollhom ħruġ ta' demm, li għandhom endokartite batterjali akuta (acute bacterial endocarditis) (infezzjoni fil-qalb) jew li jkollhom problemi serji fil-kliewi.
English: Date of first authorisation: 17 January 2007 Date of latest renewal: 17 January 2012
Maltese: Data tal-ewwel awtorizzazzjoni: 17 ta' Jannar 2007 Data tal-aħħar tiġdid: 17 ta' Jannar 2012
English: Other possible side effects of Imprida:
Maltese: Effetti sekondarji possibli oħra ta' Imprida:
English: Frequency Imprida Amlodipine Valsartan
Maltese: Frekwenza Imprida Amlodipine Valsartan
English: Photosensitivity reaction
Maltese: Sensittività eċċessiva
English: For the full list of excipients, see section 6.1.
Maltese: Għal lista kompluta ta' eċċipjenti, ara sezzjoni 6.1.
English: See also information under the heading “Do not take Imprida”.
Maltese: Ara wkoll l-informazzjoni taħt l-intestatura “Tiħux Imprida”.
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 Imprida.
English: CYP3A4 inducers (anticonvulsant agents [e.g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone], rifampicin, Hypericum perforatum) There is no data available regarding the effect of CYP3A4 inducers on amlodipine.
Maltese: Sustanzi li jinduċu CYP3A4 (sustanzi kontra l-konvulżjonijiet [eż carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone], rifampicin, Hypericum perforatum)
English: • Concomitant use of Imprida 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' Imprida 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 randomised double-blind morbidity-mortality study called the Antihypertensive and LipidLowering treatment to prevent Heart Attack Trial (ALLHAT) was performed to compare newer therapies: amlodipine 2.5-10 mg/day (calcium channel blocker) or lisinopril 10-40 mg/day (ACEinhibitor) as first-line therapies to that of the thiazide-diuretic, chlorthalidone 12.5-25 mg/day in mild to moderate hypertension.
Maltese: Studju randomised u double-blind ta' morbidità u mortalità msejjaħ Prova b'kura Kontra l-Pressjoni Għolja u li Tbaxxi x-Xaħam fid-Demm biex tilqa' kontra Attakk tal-Qalb (ALLHAT) sar biex iqabbel terapiji aktar ġodda: amlodipine 2.5-10 mg/kuljum (imblukkatur tal-kanali tal-kalċju) jew lisinopril 10-40 mg/kuljum (inibitur ACE) bħala terapiji tal-bidu ma' dawk ta' dijuretiċi thiazide, chlorthalidone 12.5-25 mg/kuljum fi pressjoni għolja minn ħafifa sa moderata.
English: Very rare Very rare Very rare
Maltese: Rari ħafna Rari ħafna
English: The safety of Imprida 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' Imprida ġiet meqjusa f'ħames studji kliniċi kontrollati b'5,175 pazjent, li 2,613 minnhom irċevew valsartan kombinat ma' amlodipine.
English: In this study (baseline blood pressure 171/113 mmHg), an Imprida 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' Imprida 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: medicines used to treat bacterial infections (such as rifampicin, erythromycin, clarithromycin, talithromycin); verapamil, diltiazem (heart medicines); simvastatin (a medicine used to control high cholesterol levels); dantrolene (infusion for severe body temperature abnormalities); medicines used to protect against transplant rejection (ciclosporin).
Maltese: clarithromycin, talithromycin); - verapamil, diltiazem (mediċini tal-qalb); - simvastatin (mediċina użata għall-kontroll ta' livelli għoljin ta' kolersterol); - dantrolene (infużjoni għal anormalitajiet severi fit-temperatura tal-ġisem); - mediċini użati għall-protezzjoni kontra rifjut ta' trapjant (ciclosporin).
English: Other medicines and Imprida
Maltese: Mediċini oħra u Imprida
English: Hyperkalaemia
Maltese: Iperlipidimija
English: Coating:
Maltese: Assorbiment:
English: The other ingredients are cellulose microcrystalline; crospovidone type A; silica, colloidal anhydrous; magnesium stearate; hypromellose; macrogol 4000; talc, titanium dioxide (E171); iron oxide, yellow (E172), iron oxide, red (E172).
Maltese: Is-sustanzi l-oħra huma cellulose microcrystalline; crospovidone type A; silica, colloidal anhydrous; magnesium stearate; hypromellose; macrogol 4000; talc, titanium dioxide (E171); iron oxide, yellow (E172), iron oxide, red (E172).
English: The active substances of Imprida are amlodipine (as amlodipine besylate) and valsartan.
Maltese: Is-sustanzi attivi ta' Imprida huma amlodipine(bħala amlodipine besylate) u valsartan.
English: The other ingredients are cellulose microcrystalline; crospovidone type A; silica, colloidal anhydrous; magnesium stearate; hypromellose; macrogol 4000; talc, titanium dioxide (E171); iron oxide, yellow (E172).
Maltese: Is-sustanzi l-oħra huma cellulose microcrystalline; crospovidone type A; silica, colloidal anhydrous; magnesium stearate; hypromellose; macrogol 4000; talc, titanium dioxide (E171); iron oxide, yellow (E172).
English: Linearity Amlodipine and valsartan exhibit linear pharmacokinetics.
Maltese: Amlodipine u valsartan għandhom farmakokinetiċi linjari.
English: Exceptional cases of extrapyramidal syndrome have been reported.
Maltese: Każijiet eċċezzjonali tas-sindromu ekstrapiramidali kienu rrapurtati.
English: Fertility There are no clinical studies on fertility with Imprida.
Maltese: Fertilità Ma saru l-ebda studji kliniċi fuq il-fertilità b'Imprida.
English: Marketing Authorisation Holder Novartis Europharm Limited Frimley Business Park Camberley GU16 7SR United Kingdom
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Novartis Europharm Limited Frimley Business Park
English: Adults with mild to moderate uncomplicated essential hypertension (mean sitting diastolic blood pressure 95 and <110 mmHg) were enrolled.
Maltese: Adulti bi pressjoni għolja naturali mingħajr komplikazzjonijiet, ħafifa għal moderata (medja tal-pressjoni tad-demm dijastolika waqt li jkunu bilqiegħda 95 u <110 mmHg) kienu reklutati.
English: Very rare Leukocytopenia, thrombocytopenia, allergic reactions, hyperglycaemia, hypertonia, peripheral neuropathy, myocardial infarction, arrhythmia (including bradycardia, ventricular tachycardia and atrial fibrillation), vasculitis, pancreatitis, gastritis, gingival hyperplasia, hepatitis, jaundice, hepatic enzymes increased*, angioedema, erythema multiforme, urticaria, exfoliative dermatitis, Stevens-Johnson syndrome,
Maltese: Rari ħafna Lewkoċitopenija, tromboċitopenija, reazzjonijiet allerġiċi, ipergliċemija, ipertonija, newropatija periferali, infart mijokardijaku, arritmija (fosthom bradikardija, takikardija ventrikolari u fibrillazzjoni atrijali), vaskulite, pankreatite, gastrite, iperplasija ġinġivali, epatite, suffejra, żieda fl-enzimi tal-fwied*, anġjoedema, eritema multiformi, urtikarja, dermatite esfoljattiva, sindrome ta' Stevens-Johnson,
English: Uncommon Common
Maltese: Mhux komuni Rari
English: Imprida 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: Imprida 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: No dosage adjustment of Imprida 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: 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, randomised, double-blind, active-controlled, 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 10 mg.
English: Imprida was also studied in an active-controlled study of 130 hypertensive patients with mean sitting diastolic blood pressure ≥110 mmHg and <120 mmHg.
Maltese: Imprida kien studjat ukoll fi studju active-controlled ta' 130 pazjent bi pressjoni għolja bil-pressjoni dijastolika bilqiegħda medja ≥110 mmHg u <120 mmHg.
English: Imprida 10 mg/160 mg film-coated tablets amlodipine/valsartan
Maltese: Imprida 10 mg/160 mg pilloli miksija b'rita amlodipine/valsartan
English: Imprida 5 mg/80 mg film-coated tablets amlodipine/valsartan
Maltese: Imprida 5 mg/80 mg pilloli miksija b'rita amlodipine/valsartan
English: EU/1/06/373/001 EU/1/06/373/002 EU/1/06/373/003 EU/1/06/373/004 EU/1/06/373/005 EU/1/06/373/006 EU/1/06/373/007 EU/1/06/373/008 EU/1/06/373/025 EU/1/06/373/026 EU/1/06/373/027 EU/1/06/373/034 EU/1/06/373/037
Maltese: EU/1/06/373/005 EU/1/06/373/006 EU/1/06/373/007 EU/1/06/373/008 EU/1/06/373/025 EU/1/06/373/026 EU/1/06/373/027 EU/1/06/373/034
English: EU/1/06/373/017 EU/1/06/373/018 EU/1/06/373/019 EU/1/06/373/020 EU/1/06/373/021 EU/1/06/373/022 EU/1/06/373/023 EU/1/06/373/024 EU/1/06/373/031 EU/1/06/373/032 EU/1/06/373/033 EU/1/06/373/036 EU/1/06/373/039
Maltese: EU/1/06/373/017 EU/1/06/373/018 EU/1/06/373/019 EU/1/06/373/020 EU/1/06/373/021 EU/1/06/373/022 EU/1/06/373/023 EU/1/06/373/024
English: Amlodipine should be used with caution together with CYP3A4 inducers.
Maltese: Amlodipine għandu jintuża b'kawtela flimkien ma' indutturi ta' CYP3A4.
English: Following oral administration of Imprida, peak plasma concentrations of valsartan and amlodipine are reached in 3 and 6-8 hours, respectively.
Maltese: Wara li Imprida jittieħed mill-ħalq l-ogħla konċentrazzjonijiet fil-plażma ta' valsartan u amlodipine jintlaħqu fi 3 u 6-8 sigħat, rispettivament.
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-potassium tas-serum, żieda fil-valuri tal-funzjoni tal-fwied inkluż żieda filbilirubin tas-serum, insuffiċjenza u indeboliment tal-kliewi, livell ogħla ta' kreatinina fis-serum, anġjoedima, majalġja, vaskulite, sensittività eċċessiva inkluż
English: Hepatic impairment Imprida is contraindicated in patients with severe hepatic impairment (see section 4.3).
Maltese: Indeboliment tal-fwied Imprida huwa kontra-indikat f'pazjenti b'indeboliment tal-fwied qawwi (ara sezzjoni 4.3).
English: Imprida 5 mg/160 mg film-coated tablets amlodipine/valsartan
Maltese: Imprida 5 mg/160 mg pilloli miksija b'rita amlodipine/valsartan
English: Imprida 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 Imprida 5 mg/160 mg.
Maltese: Imprida 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'Imprida 5 mg/160 mg.
English: Active-controlled trials in patients who were non-responders to monotherapy 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 valsartan 160 mg in 75% of patients treated with amlodipine/valsartan 10 mg/160 mg and 62% of patients treated with amlodipine/valsartan 5 mg/160 mg, compared to 53% of patients remaining on valsartan 160 mg.
Maltese: Provi kkontrollati b'mod attiv f'pazjenti li ma wieġbux għal monoterapija Prova f'ħafna ċentri, randomised, double-blind, active-controlled, 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'valsartan 160 mg f'75% tal-pazjenti kurati b'amlodipine/valsartan 10 mg/160 mg u 62% tal-pazjenti kurati b'amlodipine/valsartan 5 mg/160 mg, imqabbla ma' 53% tal-pazjenti li baqgħu fuq valsartan 160 mg.