FrancophonIA/ELRC3.0 huggingface dataset:
English: Pruban reduces the inflammation of the skin locally.
Maltese: Pruban inaqqas l-infjammazzjoni tal-ġilda lokalment.
English: What is the risk associated with Pruban?
Maltese: Għal xiex jintuża Pruban?
English: The trial showed low level irritation, but no toxicity.
Maltese: Twettqet ukoll prova fuq il-bnedmin, li wriet livell baxx ta' irritazzjoni, iżda l-ebda tossiċità.
English: Other information about Pruban:
Maltese: Aktar tagħrif dwar Pruban:
English: In case of diabetes mellitus, the potential systemic effects of the product may influence blood glucose concentrations.
Maltese: F'każ ta' dijabete mellitu, l-effetti sistemiċi potenzjali tal-prodott jistgħu jkollhom riperkussjonijiet fuq ilkonċentrazzjonijiet tal-glukożju fid-demm.
English: How has Pruban been studied?
Maltese: Kif ġie studjat Pruban?
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Pruban exceeded the risks for the treatment of acute localised moist dermatitis in dogs, and recommended that Pruban be granted a market authorisation.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) ikkonkluda li l-benefiċċji ta' Pruban huma ogħla mir-riskji għat-trattament tad-dermatite umda akuta lokalizzata fil-klieb u rrakkomanda li tinħareġ l-awtorizzazzjoni għat-tqegħid fis-suq għal Pruban.
English: Pruban should not be used in puppies under 6 months of age.
Maltese: Pruban ma għandux jintuża fi ġriewi li għandhom inqas minn 6 xhur.
English: Sprimeo HCT contains lactose.
Maltese: Sprimeo HCT fih lactose.
English: Sprimeo HCT contains wheat starch.
Maltese: Sprimeo HCT fih wheat starch.
English: In controlled clinical trials, the incidence of diarrhoea in Sprimeo HCT-treated patients was 1.3% compared to 1.4% for aliskirenor 1.9% for hydrochlorothiazide-treated patients.
Maltese: Fi provi kliniċi kontrollati, il-frekwenza ta' dijarea f'pazjenti kkurati b'Sprimeo HCT kienet 1.3% meta mqabbla ma' 1.4% f'pazjenti kkurati b'aliskiren jew 1.9% f'pazjenti kkurati b'hydrochlorothiazide.
English: Sprimeo HCT was studied in a placebo-controlled trial including 2,762 hypertensive patients with diastolic blood pressure ≥ 95 mmHg and < 110 mmHg (mean baseline blood pressure of 153.6/99.2 mmHg).
Maltese: Sprimeo HCT kien studjat fi prova ikkontrollata bi plaċebo li kienet tinkludi 2,762 pazjent bilpressjoni għolja bil-pressjoni dijastolika ≥ 95 mmHg u < 110 mmHg (pressjoni medja tal-linja bażi ta' 153.6/99.2 mmHg).
English: The safety of Sprimeo HCT has been evaluated in 9 clinical trials with more than 3,900 patients, including over 700 treated for over 6 months, and 190 for over 1 year.
Maltese: Is-sigurtà ta' Sprimeo HCT kienet evalwata f'9 provi kliniċi b'aktar minn 3,900 pazjent, inklużi aktar minn 700 ikkurati għal aktar minn 6 xhur, u 190 għal aktar minn sena.
English: Sprimeo HCT is available in packs containing 7, 14, 28, 30, 50, 56, 90,or 98 tablets.
Maltese: Sprimeo HCT jiġi f'pakketti li jkun fihom 7, 14, 28, 30, 50, 56, 90 jew 98 pillola.
English: Sprimeo HCT is contraindicated in patients with severe hepatic impairment (see sections 4.3 and 4.4).
Maltese: Sprimeo HCT huwa kontra-indikat f'pazjenti b'indeboliment epatiku sever (ara sezzjonijiet 4.3 u 4.4).
English: Sprimeo HCT 150 mg/12.5 mg film-coated tablets Sprimeo HCT 150 mg/25 mg film-coated tablets Sprimeo HCT 300 mg/12.5 mg film-coated tablets Sprimeo HCT 300 mg/25 mg film-coated tablets Aliskiren/hydrochlorothiazide
Maltese: Sprimeo HCT 150 mg/12.5 mg pilloli miksijin b'rita Sprimeo HCT 150 mg/25 mg pilloli miksijin b'rita Sprimeo HCT 300 mg/12.5 mg pilloli miksijin b'rita Sprimeo HCT 300 mg/25 mg pilloli miksijin b'rita Aliskiren/hydrochlorothiazide
English: Aliskiren/hydrochlorothiazide Over 3,900 hypertensive patients received Sprimeo HCT once daily in clinical trials.
Maltese: Aliskiren/hydrochlorothiazide 'L fuq minn 3,900 pazjent bil-pressjoni għolja irċievew Sprimeo HCT darba kuljum fi provi kliniċi.
English: Due to the hydrochlorothiazide component, Sprimeo HCT is contraindicated in symptomatic hyperuricaemia (see section 4.3).
Maltese: Minħabba l-komponent ta' hydrochlorothiazide, Sprimeo HCT hu kontraindikat f'iperurikemija sintomatika (ara sezzjoni 4.3).
English: The adverse drug reactions previously reported with one of the individual components of Sprimeo HCT (aliskiren and hydrochlorothiazide) and listed in the respective paragraphs on the individual components may occur with Sprimeo HCT.
Maltese: Ir-reazzjonijiet avversi tal-mediċina rrappurtati qabel b'wieħed mill-komponenti individwali ta' Sprimeo HCT (aliskiren u hydrochlorothiazide) u elenkati fil-paragrafi rispettivi dwar il-komponenti individwali jistgħu jseħħu b'Sprimeo HCT.
English: Sprimeo HCT tablets contain two active substances, called aliskiren and hydrochlorothiazide.
Maltese: Il-pilloli ta' Sprimeo HCT fihom żewġ sustanzi attivi, li jisimhom aliskiren u hydrochlorothiazide.
English: Treatment with Sprimeo HCT had an overall incidence of adverse experiences at doses up to 300 mg/25 mg similar to placebo.
Maltese: Kura b'Sprimeo HCT kellha frekwenza globali ta' esperjenzi avversi b'dożi sa' 300 mg/25 mg simili għall-plaċebo.
English: - if you have diabetes mellitus or impaired kidney function and you are treated with either of the following classes of medicines used to treat high blood pressure: an “angiotensin converting enzyme inhibitor” such as enalapril, lisinopril, ramipril etc.
Maltese: jekk tbati minn allerġija jew ażżma. jekk qed tieħu waħda minn dawn il-klassijiet ta' mediċini użati għall-kura tal-pressjoni għolja: “impeditur tal-enzima li tikkonverti angiotensin” bħal enalapril, lisinopril, ramipril eċċ.
English: When administered in hypertensive patients with markedly elevated blood pressure (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg), Sprimeo HCT in doses from 150 mg/12.5 mg to 300 mg/25 mg administered without up-titration from monotherapy demonstrated significantly greater systolic/diastolic blood pressure control rates (< 140/90 mmHg) as compared to the respective monotherapies.
Maltese: Meta tingħata f'pazjenti li jsofru minn pressjoni għolja u li għandhom pressjoni għolja ħafna (pressjoni sistolika ≥ 160 mmHg u/jew pressjoni dijastolika ≥ 100 mmHg), dożi ta' Sprimeo HCT minn 150 mg/12.5 mg sa 300 mg/25 mg mogħtija mingħajr titrazzjoni tad-doża aktar minn monoterapija wrew rati ta' kontroll tal-pressjoni sistolika/dijastolika tad-demm (< 140/90 mmHg) meta imqabbla ma' monoterapiji rispettivi.
English: In another clinical trial, the efficacy and safety of Sprimeo HCT were also assessed in 489 obese hypertensive patients who did not respond to hydrochlorothiazide 25 mg (baseline systolic/diastolic blood pressure 149.4/96.8 mmHg).
Maltese: Fi prova klinika oħra, l-effikaċja u s-sigurtà ta' Sprimeo HCT ħċ kienet evalwata f'489 pazjent obeż bi pressjoni għolja li ma wrewx rispons għal hudrochlorothiazide 25 mg (linja bażi tal-pressjoni sistolika/dijastolika tad-demm 149.4/96.8 mmHg).
English: Sprimeo HCT is contraindicated in patients with anuria or severe renal impairment (GFR < 30 ml/min/1.73 m2) and the concomitant use of Sprimeo HCT with ARBs or ACEIs is contraindicated in patients with renal impairment (GFR < 60 ml/min/1.73 m
Maltese: Sprimeo HCT huwa kontraindikat f'pazjenti li jbatu minn anurja jew indeboliment renali sever (GFR < 30 ml/min/1.73 m2) u l użu konkomitanti ta' Sprimeo HCT ma' ARBs jew ACEIs huwa kontra-indikat f'pazjenti b'indeboliment renali (GFR < 60 ml/min/1.73 m2) (ara sezzjoni 4.3).
English: Medicinal products affected by serum potassium disturbances: Periodic monitoring of serum potassium is recommended when Sprimeo HCT is administered with medicinal products affected by serum potassium disturbances (e.g. digitalis glycosides, antiarrhythmics).
Maltese: Prodotti mediċinali effettwati minn disturbi tal-potassium fis-serum: Monitoraġġ perjodiku talpotassium fis-serum huwa irrikkmandat meta Sprimeo HCT jingħata ma' prodotti mediċinali effettwati minn disturbi tal-potassium fis-serum (eż. digitalis glycosides, anti-arritmijaċi).
English: The rate and extent of absorption of Sprimeo HCT are equivalent to the bioavailability of aliskiren and hydrochlorothiazide when administered as individual monotherapies.
Maltese: Ir-rata u l-livell ta' assorbiment ta' Sprimeo HCT huma ekwivalenti għal biodisponibilità ta' aliskiren u hydrochlorothiazide meta jingħataw bħala monoterapiji individwali.
English: In this population, Sprimeo HCT 150 mg/12.5 mg to 300 mg/25 mg provided dose-dependent systolic/diastolic blood pressure reduction from 20.6/12.4 mmHg to 24.8/14.5 mmHg, which were significantly superior to the respective monotherapies.
Maltese: F'din il-popolazzjoni, Sprimeo HCT 150 mg/12.5 mg sa 300 mg/25 mg ipprovdiet tnaqqis fil-pressjoni sistolika/dijastolika tad-demm minn 20.6/12.4 mmHg sa 24.8/14.5 mmHg, li kienu superjuri b'mod sinifikanti għal monoterapiji rispettivi.
English: Renal artery stenosis and renovascular hypertension No controlled clinical data are available on the use of Sprimeo HCT in patients with unilateral or bilateral renal artery stenosis, or stenosis to a solitary kidney.
Maltese: Stenożi tal-arterja renali u pressjoni renovaskulari għolja M'hemmx tagħrif kliniku kkontrollat dwar l-użu ta' Sprimeo HCT f'pazjenti bi stenożi tal-arterja renali unilaterali jew bilaterali, jew fi stenożi f'kilwa waħda.
English: EU/1/11/683/070 EU/1/11/683/071 EU/1/11/683/072 EU/1/11/683/073 EU/1/11/683/074 EU/1/11/683/075 EU/1/11/683/076
Maltese: EU/1/11/683/070 EU/1/11/683/071 EU/1/11/683/072 EU/1/11/683/073 EU/1/11/683/074
English: In this study, Sprimeo HCT in doses from 150 mg/12.5 mg to 300 mg/25 mg produced dose-dependent blood pressure reductions (systolic/diastolic) from 17.6/11.9 mmHg to 21.2/14.3 mmHg, respectively, compared to 7.5/6.9 mmHg with placebo.
Maltese: F'dan l-istudju, Sprimeo HCT f'dożi minn 150 mg/12.5 mg sa 300 mg/25 mg ikkawżaw tnaqqis fil-pressjoni tad-demm (sistolika/dijastolika) minn 17.6/11.9 mmHg sa 21.
English: If hypokalaemia develops during hydrochlorothiazide therapy Sprimeo HCT should be discontinued until stable correction of the potassium balance.
Maltese: Jekk l-ipokalimja tiżviluppa waqt it-terapija b'hydrochlorothiazide Sprimeo HCT għandu jitwaqqaf sakemm ikun hemm stabilità korretta fil- bilanċ tal-potassju.
English: If blood pressure remains uncontrolled after 2-4 weeks of therapy, the dose may be titrated up to a maximum of Sprimeo HCT 300 mg/25 mg daily.
Maltese: Jekk il-pressjoni tibqa' ma tkunx ikkontrollata wara 2-4 ġimgħat ta' kura, d-doża tista' tiġi titrata sa massimu ta' Sprimeo HCT 300 mg/25 mg kuljum.
English: In this difficult-to-treat population, Sprimeo HCT provided a blood pressure reduction (systolic/diastolic) of 15.8/11.9 mmHg compared to 15.4/11.3 mmHg for irbesartan/hydrochlorothiazide, 13.6/10.3 mmHg for amlodipine/hydrochlorothiazide and 8.6/7.9 mmHg for hydrochlorothiazide monotherapy, with similar safety to hydrochlorothiazide monotherapy.
Maltese: 3 mmHg għal amlodipine/hydrochlorothiazide u 8.6/7.9 mmHg għal monoterapija b'hydrochlorothiazide, b'sigurtà simili għal monoterapija b'hydrochlorothiazide.
English: or an “angiotensin 2 receptor blocker” such as valsartan, telmisartan, irbesartan etc. - if you are on a low-salt diet. - if you have signs and symptoms such as abnormal thirst, dry mouth, general weakness, drowsiness, muscle pain or cramps, nausea, vomiting, or an abnormally fast heart beat which may indicate an excessive effect of hydrochlorothiazide (contained in Sprimeo HCT).
Maltese: “imblukkatur tar-riċetturi ta' angiotensin 2” bħal valsartan, telmisartan, irbesartan, eċċ. jekk qiegħed/qiegħda fuq dieta baxxa mill-melħ. jekk għandek sinjali u sintomi bħal għatx anormali, ħalq xott, dgħjufija ġenerali, ngħas, uġigħ fil-muskoli jew bugħawwieġ, dardir, jew il-qalb tħabbat mgħaġġla b'mod anormali li tista' tindika effett eċċessiv ta; hydrochlorothiazide (li jinsab f'Sprimeo HCT). jekk ikollok reazzjonijiet fil-ġilda bħal raxx wara esponiment għax-xemx. jekk ikollok tnaqqis fil-vista jew uġigħ fl-għajn.
English: Sprimeo HCT 300 mg/12.5 mg film-coated tablets are violet white, oval film-coated tablets imprinted with “CVI” on one side and “NVR” on the other.
Maltese: Sprimeo HCT 300 mg/12.5 mg pilloli miksijin b'rita huma pilloli miksijin b'rita vjola bojod, ovali stampati b' “CVI” fuq naħa u “NVR” fuq l-oħra.
English: HOW TO TAKE SPRIMEO HCT
Maltese: X'fih Sprimeo HCT
English: EU/1/11/683/050 EU/1/11/683/051 EU/1/11/683/052 EU/1/11/683/053 EU/1/11/683/054 EU/1/11/683/055 EU/1/11/683/056
Maltese: EU/1/11/683/050 EU/1/11/683/051 EU/1/11/683/052 EU/1/11/683/053 EU/1/11/683/054
English: EU/1/11/683/030 EU/1/11/683/031 EU/1/11/683/032 EU/1/11/683/033 EU/1/11/683/034 EU/1/11/683/035 EU/1/11/683/036
Maltese: EU/1/11/683/030 EU/1/11/683/031 EU/1/11/683/032 EU/1/11/683/033 EU/1/11/683/034
English: Concomitant use of Sprimeo HCT with ARBs or ACEIs is contraindicated in patients with diabetes mellitus (see section 4.3).
Maltese: L-użu konkomitanti ta' Sprimeo HCT ma' ARBs jew ACEIs huwa kontraindikat f'pazjenti b'dijabete mellitus (ara sezzjoni 4.3).
English: EU/1/11/683/041 EU/1/11/683/042 EU/1/11/683/043 EU/1/11/683/044 EU/1/11/683/045 EU/1/11/683/046
Maltese: EU/1/11/683/041 EU/1/11/683/042 EU/1/11/683/043 EU/1/11/683/044
English: - Each Sprimeo HCT 300 mg/25 mg film-coated tablet contains 300 mg aliskiren (as hemifumarate) and 25 mg hydrocholorothiazide.
Maltese: Kull pillola miksija b'rita ta' Sprimeo HCT 300 mg/25 mg fiha 300 mg aliskiren (bħala ilhemifumarate) u 25 mg hydrochlorothiazide.
English: Sprimeo HCT 300 mg/12.5 mg film-coated tablets Aliskiren/hydrochlorothiazide
Maltese: Sprimeo HCT 300 mg/12.5 mg pilloli miksijin b'rita Aliskiren/hydrochlorothiazide
English: EU/1/11/683/010 EU/1/11/683/011 EU/1/11/683/012 EU/1/11/683/013 EU/1/11/683/014 EU/1/11/683/015 EU/1/11/683/016
Maltese: EU/1/11/683/010 EU/1/11/683/011 EU/1/11/683/012 EU/1/11/683/013 EU/1/11/683/014
English: Sprimeo HCT 150 mg/12.5 mg film-coated tablets Aliskiren/hydrochlorothiazide
Maltese: Sprimeo HCT 150 mg/12.5 mg pilloli miksijin b'rita Aliskiren/hydrochlorothiazide
English: Sprimeo HCT 300 mg/25 mg film-coated tablets Aliskiren/hydrochlorothiazide
Maltese: Sprimeo HCT 300 mg/25 mg pilloli miksijin b'rita Aliskiren/hydrochlorothiazide
English: Sprimeo HCT 150 mg/25 mg film-coated tablets Aliskiren/hydrochlorothiazide
Maltese: Sprimeo HCT 150 mg/25 mg pilloli miksijin b'rita Aliskiren/hydrochlorothiazide
English: There is no clinical experience with Sprimeo HCT in patients with hepatic impairment.
Maltese: M'hemmx esperjenza klinika b'Sprimeo HCT f'pazjenti b'indeboliment epatiku.
English: What Sprimeo HCT contains - Each Sprimeo HCT 150 mg/12.5 mg film-coated tablet contains 150 mg aliskiren (as hemifumarate) and 12.5 mg hydrocholorothiazide.
Maltese: Kull pillola miksija b'rita ta' Sprimeo HCT 150 mg/12.5 mg fiha 150 mg aliskiren (bħala ilhemifumarate) u 12.5 mg hydrochlorothiazide.
English: - Each Sprimeo HCT 150 mg/25 mg film-coated tablet contains 150 mg aliskiren (as hemifumarate) and 25 mg hydrocholorothiazide.
Maltese: Kull pillola miksija b'rita ta' Sprimeo HCT 150 mg/25 mg fiha 150 mg aliskiren (bħala ilhemifumarate) u 25 mg hydrochlorothiazide.
English: Sprimeo HCT has been shown to be effective as a once-a-day antihypertensive treatment in adult patients, regardless of gender, age, body mass index and ethnicity.
Maltese: Sprimeo HCT intwera li huwa effettiv bħala kura li tingħata darba kuljum kontra l-pressjoni għolja f'pazjenti aduti, ikun x'ikun is-sess, l-età, l-indiċi tal-massa tal-ġisem u l-etniċità.
English: - Each Sprimeo HCT 300 mg/12.5 mg film-coated tablet contains 300 mg aliskiren (as hemifumarate) and 12.5 mg hydrocholorothiazide.
Maltese: Kull pillola miksija b'rita ta' Sprimeo HCT 300 mg/12.5 mg fiha 300 mg aliskiren (bħala ilhemifumarate) u 12.5 mg hydrochlorothiazide.
English: EU/1/11/683/021 EU/1/11/683/022 EU/1/11/683/023 EU/1/11/683/024 EU/1/11/683/025 EU/1/11/683/026
Maltese: EU/1/11/683/021 EU/1/11/683/022 EU/1/11/683/023 EU/1/11/683/024
English: Sprimeo HCT 300 mg /25 mg may be administered in patients whose blood pressure is not adequately controlled with aliskiren 300 mg or hydrochlorothiazide 25 mg alone or by Sprimeo HCT 300 mg/12.5 mg or Sprimeo HCT 150 mg/25 mg.
Maltese: Sprimeo HCT 300 mg/25 mg jista' jingħata f'pazjenti li jkollhom il-pressjoni tad-demm li ma tkunx ikkontrollata kif jixraq b'aliskiren 300 mg jew hydrochlorothiazide 25 mg waħidhom jew b'Sprimeo HCT 300 mg/12.5 mg jew b'Sprimeo HCT 150 mg/25 mg.
English: EU/1/11/683/001 EU/1/11/683/002 EU/1/11/683/003 EU/1/11/683/004 EU/1/11/683/005 EU/1/11/683/006
Maltese: EU/1/11/683/001 EU/1/11/683/002 EU/1/11/683/003 EU/1/11/683/004
English: What Sprimeo HCT looks like and contents of the pack Sprimeo HCT 150 mg/12.5 mg film-coated tablets are white, oval film-coated tablets imprinted with “LCI” on one side and “NVR” on the other.
Maltese: Id-Dehra ta' Sprimeo HCT u l-kontenuti tal-pakkett Sprimeo HCT 150 mg/12.5 mg pilloli miksijin b'rita huma pilloli miksijin b'rita bojod, ovali stampati b' “LCI” fuq naħa u “NVR” fuq l-oħra.
English: EU/1/11/683/061 EU/1/11/683/062 EU/1/11/683/063 EU/1/11/683/064 EU/1/11/683/065 EU/1/11/683/066
Maltese: EU/1/11/683/061 EU/1/11/683/062 EU/1/11/683/063 EU/1/11/683/064
English: Sprimeo HCT 150 mg/25 mg film-coated tablets
Maltese: Sprimeo HCT 150 mg/25 mg pilloli miksijin b'rita
English: Sprimeo HCT 300 mg/25 mg film-coated tablets
Maltese: Sprimeo HCT 300 mg/25 mg pilloli miksijin b'rita
English: The concomitant use of Sprimeo HCT with angiotensin II receptor blockers (ARB) or angiotensin converting enzyme inhibitors (ACEI) is contraindicated in patients with renal impairment (GFR < 60 ml/min/1.73 m2) (see sections 4.3, 4.4 and 5.2).
Maltese: L-użu ta' aliskiren ma' ARBs jew ACEIs huwa kontra-indikat f'pazjenti b'dijabete mellitus jew b'indeboliment renali (GFR < 60 ml/min/1.73 m2) u mhuwiex rakkomandat f'pazjenti oħra (ara sezzjonijiet 4.3, 4.4 u 5.1).
English: You may need to stop Sprimeo HCT.
Maltese: Jista' jkun li jkollok twaqqaf Sprimeo HCT.
English: HOW TO STORE SPRIMEO HCT
Maltese: KIF TAĦŻEN SPRIMEO HCT
English: Sprimeo HCT 150 mg/12.5 mg film-coated tablets
Maltese: Sprimeo HCT 150 mg/12.5 mg pilloli miksijin b'rita
English: Sprimeo HCT 150 mg /25 mg may be administered in patients whose blood pressure is not adequately controlled with aliskiren 150 mg or hydrochlorothiazide 25 mg alone or by Sprimeo HCT 150 mg/12.5 mg.
Maltese: Sprimeo HCT 150 mg/25 mg jista' jingħata f'pazjenti li jkollhom il-pressjoni tad-demm li ma tkunx ikkontrollata kif jixraq b'aliskiren 150 mg jew hydrochlorothiazide 25 mg waħidhom jew b'Sprimeo HCT 150 mg/12.5 mg.
English: Sprimeo HCT 300 mg/25 mg film-coated tablets are light yellow, oval film-coated tablets imprinted with “CVV” on one side and “NVR” on the other.
Maltese: Sprimeo HCT 300 mg/25 mg pilloli miksijin b'rita huma pilloli miksijin b'rita sofor ċari, ovali stampati b' “CVV” fuq naħa u “NVR” fuq l-oħra.
English: Sprimeo HCT 150 mg/25 mg film-coated tablets are pale yellow, oval film-coated tablets imprinted with “CLL” on one side and “NVR” on the other.
Maltese: Sprimeo HCT 150 mg/25 mg pilloli miksijin b'rita huma pilloli miksijin b'rita jagħtu fl-isfar, ovali stampati b' “CLL” fuq naħa u “NVR” fuq l-oħra.
English: Sprimeo HCT 300 mg/12.5 mg film-coated tablets
Maltese: Sprimeo HCT 300 mg/12.5 mg pilloli miksijin b'rita
English: Sprimeo HCT 300 mg /12.5 mg may be administered in patients whose blood pressure is not adequately controlled with aliskiren 300 mg or hydrochlorothiazide 12.5 mg alone or by Sprimeo HCT 150 mg/12.5 mg.
Maltese: Sprimeo HCT 300 mg/12.5 mg jista' jingħata f'pazjenti li jkollhom il-pressjoni tad-demm li ma tkunx ikkontrollata kif jixraq b'aliskiren 300 mg jew hydrochlorothiazide 12.5 mg waħidhom jew b'Sprimeo HCT 150 mg/12.5 mg.
English: Do not take Sprimeo HCT - if you are allergic (hypersensitive) to aliskiren or hydrochlorothiazide, to sulphonamide-derived medicines (medicines used to treat chest or urinary infections) or to any of the other ingredients of Sprimeo HCT.
Maltese: Tieħux Sprimeo HCT - jekk inti allerġiku/a (tbati minn sensittività eċċessiva) għal aliskiren jew hydrochlorothiazide, derivati ta' sulphonamide (mediċini li jintużaw għal-kura ta' infezzjonijiet fis-sider jew talawrina) jew sustanzi oħra ta' Sprimeo HCT.
English: Information on Sprimeo HCT interactions
Maltese: Jekk tieħu Sprimeo HCT aktar milli suppost
English: OUTER CARTON OF MULTIPACKS (INCLUDING BLUE BOX) CONTAINING PVC/PCTFE BLISTERS
Maltese: (INKLUŻA L-KAXXA Ċ-ĊELESTI) LI JKUN FIHA L-FOLJI PVC/PCTFE
English: The blood-pressure-lowering effect was sustained during long-term treatment (12 months), and was independent of age, gender, body mass index and ethnicity.
Maltese: L-effett li jbaxxi l-pressjoni inżamm waqt kura li ngħatat fit-tul (12-il xahar), u ma kienetx tiddependi mill-età, sess, indiċi talmassa tal-ġisem u razza.
English: Additional information on individual components Other adverse reactions previously reported with one of the individual components may occur with Sprimeo HCT even if not observed in clinical trials.
Maltese: Reazzjonijiet avversi oħrajn li kienu rrappurtati qabel b'wieħed mill-komponenti individwali jistgħu jseħħu b'Sprimeo HCT anki jekk ma dehrux waqt provi kliniċi.
English: • Prior to launch of the product in the Member State, the national competent authority shall agree the content and format of the educational material with the Marketing Authorisation Holder
Maltese: • Qabel it-tnedija tal-prodott f'kull Stat Membru, l-awtorità kompetenti nazzjonali għandha taqbel dwar il-kontenut u l-format tal-materjal edukattiv mad-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq.
English: The educational pack should contain the following:
Maltese: L-informazzjoni miġbura għandha tinkludi:
English: • Summary of Product Characteristics and Patient Information Leaflet for Cinryze
Maltese: • Materjal edukattiv għal Professjonisti fil-Qasam tal-Kura tas-Saħħa
English: For some patients the prescribing physician may decide that Cinryze may be administered at home by a non Healthcare Professional such as a family member or by self-administration.
Maltese: Għal xi pazjenti, it-tabib li jagħti r-riċetta jista' jiddeċiedi li Cinryze jista' jingħata d-dar minn persuna li mhix Professjonist fil-Qasam tal-Kura tas-Saħħa, bħal membru tal-familja jew mill-pazjent innifsu.
English: • The Marketing Authorisation Holder (MAH) should ensure that, at launch, all Healthcare Professionals who are expected to prescribe Cinryze are provided with an Educational pack.
Maltese: • Materjali edukattivi għal persuni li mhumiex Professjonisti fil-Qasam tal-Kura tas-Saħħa
English: It is the responsibility of the prescribing physician to provide appropriate training to the nonhealthcare professional who will administer the treatment at home, such as the patient for selfadministration or a family member.
Maltese: Hi r-responsabbiltà tat-tabib li jkun qed jagħti r-riċetta li jipprovdi taħriġ adattat li persuna li mhix professjonist fil-qasam tal-kura tas-saħħa li tkun se tagħti l-kura d-dar, bħal pazjent għall-għoti lilu nnifsu jew membru tal-familja.
English: A leaflet providing detailed information on the key elements of the training that should be kept at home for further reference.
Maltese: Fuljett li jipprovdi informazzjoni dettaljata dwar l-elementi ewlenin tat-taħriġ li għandu jinżamm id-dar għal referenza addizzjonali.
English: It is the responsibility of the prescribing physician to verify that all the necessary skills have been acquired by the non-healthcare professional and that Cinryze may be safely and effectively administered at home.
Maltese: Ħiliet meħtieġa għandhom jinkisbu minn persuni li mhumiex professjonisti fil-qasam tal-kura tas-saħħa qabel ma Cinryze jkun jista' jingħata d-dar b'mod sigur u effettiv.
English: It is the responsibility of the prescribing physician to determine which patients may be suitable for home or self-administration of Cinryze
Maltese: ANNESS KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR-RIGWARD TA' L-UŻU MINGĦAJR PERIKLU U EFFETTIV TAL-PRODOTT MEDIĊINALI LI JRIDU JIĠU IMPLIMENTATI