FrancophonIA/ELRC3.0 huggingface dataset:
English: The Agency considered that the safety profile of Senshio, which was studied for up to 15 months, was in line with medicines working in a similar way (SERMs), but noted, however, that long-term use of SERMs might be associated with risks such as endometrial hyperplasia, stroke and venous thromboembolism and requested further studies to investigate these risks with Senshio.
Maltese: L-Aġenzija kkunsidrat li l-profil tas-sigurtà ta' Senshio, li kien studjat sa 15-il xahar, kien konformi ma' mediċini li jaħdmu b'mod simili (SERMs), iżda nnotat, madankollu, li l-użu fit-tul tas-SERMs jista' jkun assoċjat ma' riskji bħal iperplażja endometrijali, puplesija u tromboemboliżmu venuż u talbet aktar studji biex jiġu investigati dawn ir-riskji b'Senshio.
English: Regarding pain during sexual activity, 58% of women using Senshio reported relief in the first study (compared with 42% receiving placebo) and 63% reported relief during the second study (compared with 48% receiving placebo).
Maltese: Rigward l-uġigħ matul l-attività sesswali, 58 % tan-nisa li jużaw Senshio rrappurtaw serħan fl-ewwel studju (meta mqabbla ma' 42 % li rċevew plaċebo) u 63 % rrappurtaw serħan matul it-tieni studju (meta mqabbla ma' 48 % li rċevew plaċebo).
English: Some women must not use Senshio, including those who have or have had problems with blood clots in veins such as deep-vein thrombosis (DVT), pulmonary embolism (a blood clot in the lungs) and retinal-vein thrombosis (a blood clot at the back of the eye).
Maltese: Xi nisa m'għandhomx jużaw Senshio, inklużi dawk li jkollhom jew kellhom problemi b'emboli tad-demm fil-vini bħal trombożi fil-vini profondi (DVT), emboliżmu pulmonari (embola tad-demm fil-pulmuni) u trombożi tal-vina retinali (embola tad-demm fuq wara tal-għajn).
English: The company that markets Senshio is carrying out a study to further investigate long-term potential risks such as endometrial hyperplasia, stroke and venous thromboembolism.
Maltese: Il-kumpanija li tqiegħed Senshio fis-suq qed twettaq studju biex tinvestiga aktar ir-riskji potenzjali fittul bħal iperplażja endometrijali, puplesija u tromboemboliżmu venuż.
English: Senshio has been compared with placebo (a dummy treatment) in two main studies involving over 1,700 postmenopausal women with vulvovaginal atrophy.
Maltese: Senshio tqabbel ma' plaċebo (kura finta) f'żewġ studji ewlenin li kienu jinvolvu iktar minn 1,700 mara wara l-menopawża b'atrofija vulvovaġinali.
English: In the first study, 66% of women using Senshio reported relief from vaginal dryness (mild or no symptoms) after 12 weeks' treatment compared with 49% in the placebo group.
Maltese: Fl-ewwel studju, 66 % tan-nisa li użaw Senshio rrappurtaw serħan min-nixfa vaġinali (ħafifa jew mingħajr sintomi) wara kura ta' 12-il ġimgħa meta mqabbla ma' 49 % fil-grupp tal-plaċebo.
English: As for all medicines, data on the use of Senshio are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Senshio hija ssorveljata kontinwament.
English: Senshio is a medicine used to treat moderate to severe symptoms of vulvovaginal atrophy (dryness, irritation and soreness around the genital area, and painful sexual intercourse) in women who have been through the menopause.
Maltese: Senshio huwa mediċina li tintuża biex tikkura sintomi moderati sa severi ta' atrofija vulvovaġinali (nixfa, irritazzjoni u wġigħ madwar iż-żona ġenitali, u sess li jikkawża wġigħ) f'nisa li jkunu għaddew mill-menopawża.
English: For the full list of side effects and restrictionsof Senshio, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet ta' Senshio, ara l-fuljett ta' tagħrif.
English: It is used in women who cannot use oestrogen therapy applied in the vagina.
Maltese: Jintuża f'nisa li ma jistgħux jużaw terapija tal-estroġenu applikata fil-vaġina.
English: In the second study, 62% of women using Senshio reported relief from vaginal dryness after 12 weeks (compared with 53% in the placebo group).
Maltese: Fit-tieni studju, 62 % tan-nisa li użaw Senshio rrappurtaw serħan min-nixfa vaġinali wara 12-il ġimgħa (meta mqabbla ma' 53 % fil-grupp talplaċebo).
English: What are the risks associated with Senshio?
Maltese: X'inhuma r-riskji assoċjati ma' Senshio?
English: Side effects reported with Senshio are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Senshio huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: How does Senshio work?
Maltese: Kif jintuża Senshio?
English: The full EPAR for Suvaxyn Circo can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: Suvaxyn Circo also contains adjuvants (ingredients that strengthen the immune response) called squalane, poloxamer 401 and polysorbate 80.
Maltese: Suvaxyn Circo fih ukoll aġġuvanti (ingredjenti li jsaħħu r-rispons immunitarju) imsejħa squalane, poloxamer 401 and polysorbate 80.
English: Suvaxyn Circo+MH RTU is already approved in the EU.
Maltese: Suvaxyn Circo+MH RTU huwa diġà approvat fl-UE.
English: This summary was last updated in December 2017.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'Diċembru 2017.
English: Suvaxyn Circo porcine circovirus vaccine (inactivated)
Maltese: Suvaxyn Circo vaċċin taċ-circovirus tal-qżieqeż (inattivat)
English: This is a summary of the European public assessment report (EPAR) for Suvaxyn Circo.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Suvaxyn Circo.
English: Other information about Suvaxyn Circo
Maltese: Informazzjoni oħra dwar Suvaxyn Circo
English: The studies on the effectiveness of Suvaxyn Circo were carried out with a similar vaccine, Suvaxyn Circo+MH RTU, which contains PCV2 and the bacteria Mycoplasma hyopneumoniae.
Maltese: L-istudji dwar l-effikaċja ta' Suvaxyn Circo saru b'vaċċin simili, Suvaxyn Circo+MH RTU, li fih PCV2 u l-batterja Mycoplasma hyopneumoniae.
English: Infections can produce clinical signs such as weight loss or failure to grow, enlarged lymph nodes, difficulty breathing, pale skin and jaundice (yellowing of the skin).
Maltese: L-infezzjonjiet jistgħu jipproduċu sinjali kliniċi bħal telf fil-piż jew nuqqas ta' żvilupp, limfonodi mkabbra, diffikultà fit-teħid tan-nifs, ġilda pallida u suffejra (sfurija tal-ġilda).
English: Protection lasted 23 weeks after vaccination for PCV2.
Maltese: Il-protezzjoni damet għal 23 ġimgħa wara t-tilqima għal PCV2.
English: The most common side effects with Suvaxyn Circo (which may affect more than 1 in 10 animals) are a short-lived increase in body temperature during the first 24 hours after vaccination and swelling (generally no wider than 2 cm) at the injection site which may last for up to 2 days.
Maltese: L-effetti sekondarji l-aktar komuni b'Suvaxyn Circo (li jistgħu jaffettwaw aktar minn 1 minn kull 10) huma żieda fit-temperatura tal-ġisem li ma ddumx fi żmien 24 siegħa mit-tilqima u nefħa (ġeneralment mhux usa' minn 2 cm) fis-sit tal-injezzjoni li tista' ddum sa jumejn.
English: The European Commission granted a marketing authorisation valid throughout the EU for Suvaxyn Circo on 7 February 2018.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha għal Suvaxyn Circo fil-07/02/2018.
English: Suvaxyn Circo is a vaccine.
Maltese: Suvaxyn Circo huwa vaċċin.
English: Suvaxyn Circo contains an inactivated (killed) active substance derived from porcine circovirus type 2.
Maltese: Suvaxyn Circo fih sustanzi attivi inattivati (maqtula) derivati miċ-ċirkovirus tal-qżieqeż tat-tip 2.
English: Suvaxyn Circo is a veterinary vaccine used to protect pigs over the age of 3 weeks against porcine circovirus type 2 (PCV2).
Maltese: Suvaxyn Circo huwa vaċċin veterinarju li jintuża biex jipproteġi lill-ħnieżer mill-età ta' 3 ġimgħat kontra ċ-ċirkovirus tal-qżieqeż tat-tip 2 (PCV2).
English: What are the risks associated with Suvaxyn Circo?
Maltese: X'inhuma r-riskji assoċjati ma' Suvaxyn Circo?
English: How does Suvaxyn Circo work?
Maltese: Kif jintuża Suvaxyn Circo?
English: Why is Suvaxyn Circo approved?
Maltese: Għaliex ġie approvat Suvaxyn Circo?
English: In the future, if the animals come into contact with the virus the immune system will be able to respond quickly to destroy the virus.
Maltese: Jekk fil-futur l-annimali jiġu f'kuntatt mal-virus, is-sistema immunitarja tkun kapaċi tirreaġixxi aktar malajr biex toqtol il-virus.
English: For the full list of restrictions and side effects with Suvaxyn Circo, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Suvaxyn Circo, ara l-fuljett ta' tagħrif.
English: The effectiveness of Suvaxyn Circo+MH RTU against PCV2 infection was also studied in three field studies.
Maltese: L-effikaċja ta' Suvaxyn Circo+MH RTU kontra l-infezzjoni PCV2 kienet studjata wkoll fi tliet studji fuq il-post.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Suvaxyn Circo's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) tal-Aġenzija ddeċieda li l-benefiċċji ta' Suvaxyn Circo huma akbar mir-riskji tiegħu u rrakkomanda li jkun approvat għall-użu fl-UE.
English: 100 mg/ml
Maltese: Daqs talpakkett mg/ml
English: Name Strength Pharmaceutical Form
Maltese: Isem Qawwa Għamla farmaċewtika
English: Intravenous use vial (glass)
Maltese: Jittieħed minn ġol-vina vjali (talħġieġ)
English: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Latvia, Lithuania, Luxembourg, Malta, The Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, UK
Maltese: L-Awstrija,Il-Belġju , Il-Bulgarija, Ċipru, Ir-Rpubblika Ċeka,IdDanimarka,L-Estonja ,Il-Finlandja,Franza,Il-Ġermanja,Il-Greċja,LUngerija,L-Islanda,L-Irlanda,L-Italja,Il-Latvja,Il-Litwanja,IlLussemburgu,Malta,L-Olanda,In-Norveġja,Il-Polonja,Il-Portugall,IrRumanija,Is-Slovakkja,Is-Slovenja, Spanja, L-Isvezja, Ir-Renju Unit
English: Takeda Global Research and Development Centre (Europe) Ltd 61 Aldwych
Maltese: Takeda Global Research and Development Centre (Europe) Ltd
English: 52066 Aachen
Maltese: 52066 Aachen Germany
English: • Lithium (a medicine for mental health problems).
Maltese: • Lithium (mediċina għal problemi mentali)
English: Palazzo Volta, via F.Sforza - 20080 Basiglio (MI) -Italy
Maltese: Palazzo Volta, via F.Sforza - 20080
English: • Respiratory infection.
Maltese: • Infezzjoni respiratorja
English: This corresponds to a relative risk reduction of 15%.
Maltese: Dan jikkorrispondi għal tnaqqis ta' 15% fir-riskju relattiv.
English: Denmark AstraZeneca A/S Roskildevej 22
Maltese: AstraZeneca A/S Roskildevej 22
English: Germany AstraZeneca GmbH 22876 Wedel, Germany
Maltese: AstraZeneca GmbH 22876 Wedel, Germany
English: This corresponds to a relative risk reduction of 23%.
Maltese: Dan jikkorrispondi għal tnaqqis ta' 23% fir-riskju relattiv.
English: Norway AstraZeneca AS Boks 200 Vinderen NO-0319 Oslo, Norway
Maltese: AstraZeneca AS Boks 200 Vinderen NO-0319 Oslo, Norway
English: It has no agonist activity.
Maltese: Huwa m'għandu l-ebda attività agonista.
English: Buckinghamshire HP10 OHH
Maltese: Buckinghamshire HP10 OH
English: Some studies support the addition of a calcium channel blocker (CCB), as additional strategy, (Farsang et al 2001, Morgan and Anderson 2002 and Lindholm et al 2003).
Maltese: Ċerti studji jappoġġjaw iż-żieda ta' imblokkatur tal-kanal tal-kalċju (CCB), bħala strateġija addizzjonali (Farsang et al 2001, Morgan and Anderson 2002 u Lindholm et al 2003).
English: Germany Takeda Pharma GmbH Viktoriaallee 3-5
Maltese: Takeda Pharma GmbH Viktoriaallee 3-5
English: Pharmacotherapeutic group: Angiotensin II antagonists, plain, ATC code: C09CA06
Maltese: Antagonisti ta' angiotensin II, mingħajr xejn miżjud, Kodiċi ATC: C09CA06
English: The apparent volume of distribution of candesartan is 0.1 l/kg.
Maltese: Il-volum apparenti ta' distribuzzjoni ta' candesartan huwa 0.1 l/kg.
English: AstraZeneca 1, Place Renault 92844 RueilMalmaison Cedex France
Maltese: AstraZeneca 1, Place Renault 92844
English: Atacand is indicated for the:
Maltese: Atacand huwa indikat:
English: Compounds which have been investigated in clinical pharmacokinetic studies include hydrochlorothiazide, warfarin, digoxin, oral contraceptives (i.e. ethinylestradiol/levonorgestrel), glibenclamide, nifedipine and enalapril.
Maltese: Sustanzi li kienu investigati fi studji farmakokinetiċi kliniċi jinkludu hydrochlorothiazide, warfarin, digoxin, kontraċettivi orali (i.e. ethinylestradiol/levonorgestrel), glibenclamide, nifedipine u enalapril.
English: Non-Perforated calendar foil (7, 14, 28, 56 and 98 tablets)
Maltese: TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L-ISTRIXXI Folja bil-kalendarju mhux imtaqqba (7, 14, 28, 56 u 98 pilloli)
English: The blood pressure was reduced from 166/90 to 145/80 mmHg in the candesartan group, and from 167/90 to 149/82 mmHg in the control group.
Maltese: Il-pressjoni tnaqqset minn 166/90 għal 145/80 mmHg fil-grupp ta' candesartan, u minn 167/90 għal149/82 mmHg fil-grupp ta' kontroll.
English: The absolute bioavailability of candesartan is approximately 40% after an oral solution of candesartan cilexetil.
Maltese: Ilbijodisponibbiltà assoluta ta' candesartan hija ta' madwar 40% wara soluzzjoni orali ta' candesartan cilexetil.
English: Whilst there is no controlled epidemiological data on the risk with AIIRAs, similar risks may exist for this class of drugs.
Maltese: Waqt li ma hemmx dejta epidemjoloġika ikkontrollata fuq ir-riskju b' AIIRAs, riskji simili jistgħu jeżistu għal din il-klassi ta' mediċini.
English: Available interaction studies indicate no effect on CYP2C9 and CYP3A4.
Maltese: Studji disponibbli dwar interazzjoni ma indikaw l-ebda effett fuq CYP2C9 u CYP3A4.
English: A number of areas of disharmony were considered, in particular sections 4.1, 4.2, 4.3 and 4.4 of the summary of product characteristics (SPC).
Maltese: Ġew ikkunsidrati numru ta' oqsma ta' nuqqas ta' armonija, b'mod partikolari s-sezzjonijiet 4.1, 4.2, 4.3 u 4.4 tas-sommarju tal-karatteristiċi tal-prodott (SPC).
English: Based on in vitro data, no interaction would be expected to occur in vivo with drugs whose metabolism is dependent upon cytochrome P450 isoenzymes CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1 or CYP3A4.
Maltese: Ibbażata fuq dejta in vitro, l-ebda interazzjoni ma hija mistennija li sseħħ in vivo b' mediċini li l-metaboliżmu tagħhom huwa dipendenti fuq isoenżimi ta' cytochrome P450 CYP1A2, CYP 2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1 jew CYP3A4.
English: Candesartan cilexetil is a prodrug suitable for oral use.
Maltese: Candesartan cilexetil huwa prodrug adattat għal użu orali.
English: Bocskai út 134-146
Maltese: AstraZeneca Kft. 1113 Budapest, Bocskai út 134-146 Hungary
English: AstraZeneca UK Limited, 600 Capability Green, Luton, LU1 3LU, United Kingdom
Maltese: Capability Green, Luton, LU1 3LU, United Kingdom
English: Very rare Leukopenia, neutropenia and agranulocytosis
Maltese: Rari ħafna Lewkopenija, newtropenija u agranuloċitosi
English: • Low blood pressure.
Maltese: • Pressjoni baxxa.
English: Clinical trials in heart failure did not include patients with serum creatinine > 265 mol/l (> 3 mg/dl).
Maltese: Provi kliniċi f'insuffiċjenza tal-qalb ma kinux jinkludu pazjenti bi krejatinina ta' > 265 mol/l (> 3 mg/dl) fis-serum.
English: In the CHARM clinical programme, comparing Atacand in doses up to 32 mg (n=3,803) to placebo (n=3,796), 21.0% of the candesartan cilexetil group and 16.1% of the placebo group discontinued treatment because of adverse events.
Maltese: Fil-programm kliniku CHARM, li qabbel Atacand f''dożi sa 32 mg (n=3,803) ma' plaċebo (n=3,796), 21.0% tal-grupp ta' candesartan cilexetil u 16.1% tal-grupp ta' plaċebo ma komplewx il-kura minħabba każijiet avversi.
English: The frequencies used in the tables throughout section 4.8 are: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000) and very rare
Maltese: Il-frekwenzi li jintużaw fil-tabelli tul sezzjoni 4.8 huma: komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1,000) u rari ħafna (< 1/10,000).
English: Theotokopoulou 4 & Astronafton 151 25 Maroussi Greece
Maltese: Theotokopoulou 4 & Astronafton 151 25
English: • Acetylsalicylic acid (if you are taking more than 3 g each day) (medicine to relieve pain and inflammation).
Maltese: • Acetylsalicylic acid (jekk qed tieħu aktar minn 3 g kuljum) (mediċini li jnaqqsu l-uġigħ u linfjammazzjoni)
English: The corresponding changes in patients with severe renal impairment were approximately 50% and 110%, respectively.
Maltese: It-tibdiliet li jaqblu magħhom f'pazjenti b'indeboliment qawwi tal-kliewi kienu ta' madwar 50% u 110%, rispettivament.
English: Belgium NV AstraZeneca SA Egide Van Ophemstraat 110 B-1180 Brussels
Maltese: NV AstraZeneca SA Egide Van Ophemstraat 110
English: Section 5.1 Pharmacodynamic properties
Maltese: Sezzjoni 5.1 Karatteristiċi farmakodinamiċi
English: In an open label clinical experience trial in 5,156 patients with diastolic hypertension, the blood pressure reduction during candesartan treatment was significantly less in black than non-black patients (14.4/10.3 mmHg vs 19.0/12.7 mmHg, p<0.0001/p<0.0001).
Maltese: Fi prova ta' esperjenza klinika open-label f'5,156 pazjent bi pressjoni dijastolika għolja, it-tnaqqis fil-pressjoni waqt kura b'candesartan kien anqas b'mod sinifikanti f'pazjenti suwed milli f'pazjenti li mhumiex suwed (14.4/10.3 mmHg vs 19.0/12.7 mmHg, p<0.
English: • Water tablets (diuretics).
Maltese: • Pilloli ta' l-ilma (dajuretiċi)
English: The CHMP discussed the rational for this exclusion.
Maltese: Is-CHMP iddiskuta r-razzjonal għal din l-esklużjoni.
English: The active ingredient is candesartan cilexetil.
Maltese: Is-sustanza attiva hija candesartan cilexetil.
English: Candesartan caused a reduction of red blood cell parameters (erythrocytes, haemoglobin, haematocrit).
Maltese: Candesartan ikkawża tnaqqis fil-parametri taċ-ċelluli ħomor (eritroċiti, emoglobina, ematocrit).
English: Common Dizziness/vertigo, headache
Maltese: Sturdament/vertiġini, uġigħ ta' ras
English: Very rare Angioedema, rash, urticaria, pruritus
Maltese: Rari ħafna Anġjoedima, raxx, urtikarja, ħakk
English: Atacand and associated names (see Annex I) 2 mg tablets Atacand and associated names (see Annex I) 4 mg tablets Atacand and associated names (see Annex I) 8 mg tablets Atacand and associated names (see Annex I) 16 mg tablets Atacand and associated names (see Annex I) 32 mg tablets
Maltese: Atacand u ismijiet assoċjati miegħu (ara Anness I) 2 mg pilloli Atacand u ismijiet assoċjati miegħu (ara Anness I) 4 mg pilloli Atacand u ismijiet assoċjati miegħu (ara Anness I) 8 mg pilloli Atacand u ismijiet assoċjati miegħu (ara Anness I) 16 mg pilloli Atacand u ismijiet assoċjati miegħu (ara Anness I) 32 mg pilloli
English: The 32 mg dose is supported by study results in hypertensive patients and by a recently published dose-response analysis by Karlson et al 2009.
Maltese: Id-doża ta' 32 mg hija appoġjata b'riżultati ta' studju ta' pazjenti bi pressjoni għolja u b'analiżi ta' doża-rispons ippubblika riċentament minn Karlson et al 2009.
English: The effects of candesartan cilexetil 8-16 mg (mean dose 12 mg), once daily, on cardiovascular morbidity and mortality were evaluated in a randomised clinical trial with 4,937 elderly patients (aged 70-89 years; 21% aged 80 or above) with mild to moderate hypertension followed for a mean of 3.7 years (Study on COgnition and Prognosis in the Elderly).
Maltese: L-effetti ta' candesartan cilexetil minn 8-16-il mg (doża medja ta' 12-il mg), darba kuljum, fuq ilmorbidità u l-mortalità kardjovaskulari kienu stmati fi prova klinika randomised b'4,937 pazjent anzjan (ta' età minn 70-89 sena; 21% ta' 80 sena jew aktar) bi pressjoni għolja minn ħafifa sa moderata li kienu segwiti għal medja ta' 3.7 snin (Study on COgnition and Prognosis in the Elderly).
English: In a 3-month clinical study in hypertensive patients with type 2 diabetes mellitus and microalbuminuria, antihypertensive treatment with candesartan cilexetil reduced urinary albumin excretion (albumin/creatinine ratio, mean 30%, 95%CI 15-42%).
Maltese: Fi studju kliniku ta' 3 xhur f'pazjenti bi pressjoni għolja b'dijabete mellitus tattip 2 u mikroalbuminurja, kura b'candesartan cilexetil naqqset it-tneħħija tal-albumin mal-awrina (proporzjon ta' albumina/krejatinina, medja 30%, 95%CI 15-42%).
English: The terminal half-life of candesartan is approximately 9 hours.
Maltese: Ilhalf-life terminali ta' candesartan hija ta' madwar 9 sigħat.
English: This placebo controlled, double-blind study programme in chronic heart failure (CHF) patients with NYHA functional class II to IV consisted of three separate studies: CHARM-Alternative (n=2,028) in patients with LVEF  40% not treated with an ACE inhibitor because of intolerance (mainly due to cough, 72%), CHARM-Added (n=2,548) in patients with LVEF  40% and treated with an ACE inhibitor, and CHARM-Preserved (n=3,023) in patients with LVEF > 40%.
Maltese: NYHA minn II sa IV kien jikkonsisti fi tliet studji separati: CHARM-Alternative (n=2,028) f'pazjenti b'LVEF  40% li ma ġewx ikkurat b'impeditur ta' ACE minħabba intolleranza (l-aktar minħabba sogħla, 72%), CHARM-Added (n=2,548) f'pazjenti b'LVEF  40% u kkurati b'impeditur ta' ACE, u CHARM-Preserved (n=3,023) f'pazjenti b'LVEF > 40%.
English: In patients with mild to moderate renal impairment Cmax and AUC of candesartan increased during repeated dosing by approximately 50% and 70%, respectively, but t½ was not altered, compared to patients with normal renal function.
Maltese: F'pazjenti b'indeboliment tal-kliewi minn ħafif sa moderat is- Cmax u l-AUC ta' candesartan żdiedu waqt għoti ta' dożi ripetuti b'madwar 50% u 70%, rispettivament, iżda t-t½ ma nbidlitx, meta mqabbel ma' pazjenti b'funzjoni normali tal-kliewi.
English: The SPC in one MS mentioned the addition of a calcium channel blocker (CCB) as an additional alternative strategy.
Maltese: L-SPC f'wieħed mill-SM semma' ż-żieda ta' imblukkatur tal-kanal tal-kalċju (CCB) bħala strateġija alternattiva addizzjonali.
English: However, the CHMP/PhVWP report on the use of ACE inhibitors and Angiotensin II Receptor Antagonists (ARBs) during the 1st trimester of pregnancy (EMEA/CHMP/PhVWP/474692/2007)
Maltese: Madankollu, ir-rapport tas-CHMP/PhVWP dwar l-użu ta' inibituri ACE u Antagonisti tar-Riċetturi ta' Angiotensin II (ARBs) waqt l-ewwel trimestru tat-tqala (EMEA/CHMP/PhVWP/474692/2007) jindika li kontra-indikazzjoni għal waqt l-ewwel trimestru tat-tqala mhijiex iġġustifikata; l-użu ta' AIIRAs flewwel trimestru tat-tqala mhuwiex irrakkomandat.
English: Musculoskeletal and connective tissue disorders
Maltese: Disturbi muskolu-skelettriċi u tattessuti konnettivi
English: Candesartan is highly bound to plasma protein (more than 99%).
Maltese: Candesartan jintrabat b'mod qawwi mal-proteini tal-plażma (aktar minn 99%).
English: However, all-cause mortality was also assessed in pooled populations, CHARMAlternative and CHARM-Added, HR 0.88 (95%CI: 0.79 to 0.98, p=0.018) and all three studies, HR 0.91 (95%CI: 0.83 to 1.00, p=0.055).
Maltese: Madankollu, il-mortalità minn kull kawża kienet ukoll stmata f'popolazzjonijiet pooled, CHARM-Alternative u CHARM-Added, HR 0.88 (95%CI: 0.79 sa 0.98, p=0.018) u fit-tliet studji, HR 0.91 (95%CI: 0.83 sa 1.00, p=0.055).
English: Non-Perforated foil, Perforated foil
Maltese: Strixxa mhux imtaqqba, strixxa mtaqqba