FrancophonIA/ELRC3.0 huggingface dataset:
English: Zinforo 600 mg powder for concentrate for solution for infusion Ceftaroline fosamil
Maltese: Zinforo 600 mg trab għal konċentrat għal soluzzjoni għall-infużjoni ceftaroline fosamil
English: The bactericidal action of ceftaroline is mediated through binding to essential penicillinbinding proteins (PBPs).
Maltese: L-azzjoni batteriċidali ta' ceftaroline hija medjata permezz ta' twaħħil ma' proteini essenzjali li jeħlu bil-peniċillina (penicillin-binding proteins, PBPs).
English: Once the intravenous solution is prepared with diluents listed in section 6.6 it should be administered within 6 hours of preparation.
Maltese: Meta s-soluzzjoni għal ġol-vini tiġi ppreparata bid-dilwenti elenkati f'sezzjoni 6.6, din għandha tingħata fi żmien 6 sigħat minn meta tiġi ppreparata.
English: 600 mg b/every 12 hours
Maltese: 600 mg b/kull 12-il siegħa
English: Following the administration of a single 600 mg intravenous dose of radiolabelled ceftaroline fosamil to healthy male adults, approximately 88% of radioactivity was recovered in urine and 6% in faeces.
Maltese: Wara li ngħatat doża waħda fil-vini, ta' 600 mg ta' ceftaroline fosamil radjutikkettat lil adulti rġiel b'saħħithom, madwar 88% tar-radjuattività kienet irkuprata mill-awrina u 6% mill-ippurgar.
English: The mean plasma ceftaroline M-1 to ceftaroline AUC ratio following a single 600 mg intravenous infusion of ceftaroline fosamil in healthy subjects is approximately 20-30%.
Maltese: Il-medja tal-proporzjon tal-AUC ta' ceftaroline M-1 għal ceftaroline fil-plażma wara infużjoni waħda ta' 600 mg ta' ceftaroline fosamil filvini f'individwi b'saħħithom hija madwar 20-30%.
English: However, the frequency of rash in the subgroup of Asian patients receiving Zinforo every 8 hours was very common (18.5%).
Maltese: Madankollu, il-frekwenza tar-raxx fis-sottogrupp ta' pazjenti Asjatiċi li kienu qegħdin jirċievu Zinforo kull 8 sigħat kienet komuni ħafna (18.5%).
English: Zinforo is indicated for the treatment of the following infections in neonates, infants, children, adolescents and adults(see sections 4.4 and 5.1):
Maltese: Zinforo huwa indikat għat-trattament tal-infezzjonijiet li ġejjin fit-trabi tat-twelid, fit-trabi, fit-tfal, fladolexxenti u fl-adulti (ara sezzjonijiet 4.4 u 5.1):
English: Rash was observed at a common frequency in both the pooled Phase III studies in cSSTI with administration of Zinforo every 12 hours (600 mg administered over 60 minutes every 12 hours) and the study in cSSTI with administration every 8 hours (600 mg administered over 120 minutes every 8 hours).
Maltese: III dwar cSSII bl-għoti ta' Zinforo kull 12-il siegħa (600 mg mogħtija fuq perjodu ta' 60 minuta kull 12-il siegħa) kif ukoll flistudju dwar cSSTI b'għoti kull 8 sigħat (600 mg mogħtija fuq perjodu ta' 120 minuta kull 8 sigħat).
English: Efficacy has been demonstrated in clinical studies against the pathogens listed under each indication that were susceptible to ceftaroline in vitro.
Maltese: Fl-istudji kliniċi ġiet murija l-effikaċja kontra l-patoġeni elenkati taħt kull indikazzjoni li kienu suxxettibli għal ceftaroline in vitro.
English: For patients with supranormal renal clearance receiving the standard dose, an infusion time of 60 minutes may be preferable.
Maltese: Għal pazjenti b'eliminazzjoni mill-kliewi supranormali li jirċievu d-doża standard, ħin tal-infużjoni ta' 60 minuta jista' jkun preferibbli.
English: The infusion solution concentration during preparation and administration should not exceed 12 mg/mL ceftaroline fosamil.
Maltese: Ilkonċentrazzjoni tas-soluzzjoni tal-infużjoni waqt it-tħejjija u l-għoti m'għandhiex taqbeż 12 mg/mL ta' ceftaroline fosamil.
English: Complicated skin and soft tissue infections (cSSTI)
Maltese: Infezzjonijiet ikkomplikati tal-ġilda u tat-tessuti rotob (cSSTI)
English: A 250 mL, 100 mL or 50 mL infusion bag can be used to prepare the infusion, based on the patient's volume requirements.
Maltese: Tista' tintuża borża tal-infużjoni ta' 250 mL, 100 mL jew 50 mL biex tiġi ppreparata l-infużjoni, abbażi tal-volum li jkollu bżonn il-pazjent.
English: In addition, the safety assessment in neonates is based on the safety data from 2 trials in which 34 patients (age range from birth to less than 60 days) received Zinforo; 23 of these patients received only a single dose of Zinforo.
Maltese: Barra minn hekk, il-valutazzjoni tas-sigurtà fit-trabi tat-twelid hija bbażata fuq id-data tas-sigurtà minn 2 provi li fihom, 34 pazjent (medda ta' età mit-twelid sa inqas minn 60 jum) irċevew Zinforo; 23 minn dawn il-pazjenti rċevew doża waħda biss ta' Zinforo.
English: • If you are allergic to ceftaroline fosamil or any of the other ingredients of this medicine (listed in section 6).
Maltese: • Jekk inti allerġiku għal ceftaroline fosamil jew għal xi sustanza oħra ta' din il-mediċina (elenkati fis-sezzjoni 6).
English: 400 mg c/every 12 hours
Maltese: 400 mg c/kull 12-il siegħa
English: How to store Zinforo
Maltese: Mediċini oħra u Zinforo
English: The usual recommended dose for adults is 600 mg every 12 hours.
Maltese: Id-doża tas-soltu rakkomandata għall-adulti hija 600 mg kull 12-il siegħa.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as a result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Maltese: • Kull meta s-sistema tal-ġestjoni tar-riskju tiġi modifikata speċjalment minħabba li tasal informazzjoni ġdida li tista' twassal għal bidla sinifikanti fil-profil bejn il-benefiċċju u r-riskju jew minħabba li jintlaħaq għan importanti (farmakoviġilanza jew minimizzazzjoni tar-riskji).
English: The active moiety after Zinforo administration is ceftaroline.
Maltese: Il-parti attiva wara l-għoti ta' Zinforo hija ceftaroline.
English: There is insufficient information to recommend dosage adjustments in adolescents with ESRD aged from 12 to < 18 years and with bodyweight < 33 kg and in children with ESRD aged from 2 to < 12 years.
Maltese: Mhemmx biżżejjed informazzjoni sabiex jiġu rrakkomandati aġġustamenti tad-doża f'adolexxenti li għandhom minn 12 sa < 18-il sena b'piż tal-ġisem < 33 kg u tfal li għandhom minn 2 sa 12-il sena b'ESRD.
English: The available clinical data cannot substantiate efficacy against penicillin non-susceptible strains of S. pneumoniae.
Maltese: Id-data klinika disponibbli ma tistax tissostanzja l-effikaċja kontra razez ta' S. pneumoniae mhux suxxettibbli għall-penicillin.
English: No clinical drug-drug interaction studies have been conducted with ceftaroline fosamil.
Maltese: Ma twettaq l-ebda studju kliniku ta' interazzjoni bejn il-mediċini b'ceftaroline fosamil.
English: The contents of Zinforo vial should be reconstituted with 20 mL of sterile water for injections.
Maltese: Il-kontenut talkunjett ta' Zinforo jrid jiġi rikostitwit b'20 mL ilma għall-injezzjonijiet sterili.
English: When ceftaroline was administered during organogenesis, minor changes in foetal weight and delayed ossification of the interparietal bone were observed in the rat at exposures below that observed clinically.
Maltese: Meta ceftaroline ngħata waqt organoġenesi, ġie osservat tibdil minuri fil-piż tal-fetu u dewmien fl-ossifikazzjoni tal-għadam interparjetali f'esponimenti aktar baxxi minn dawk osservati klinikament.
English: Zinforo should not be used to treat cSSTI due to S. aureus for which the ceftaroline MIC is > 4 mg/L.
Maltese: Zinforo m'għandux jintuża għat-trattament ta' cSSTI minħabba S. aureus li għaliha l-MIC ta' ceftaroline hu > 4 mg/L.
English: You may develop an abnormal lab test (called Coombs test) that looks for certain antibodies which may act against your red blood cells.
Maltese: Jista' joħroġlok test anormali tal-laboratorju (jissejjaħ test ta' Coombs) li jfittex għal xi antikorpi li jistgħu jaħdmu kontra ċ-ċelluli ħomor tad-demm tiegħek.
English: • If you have had previous severe allergic reactions to other antibiotics like penicillin or carbapenem.
Maltese: • Jekk qatt kellek xi reazzjoni allerġika mhux severa għal antibijotiċi oħra bħall-penicillin jew carbapenem
English: Gram-negative micro-organisms • Fusobacterium spp.
Maltese: • Fusobacterium spp.
English: Ceftaroline can be removed by haemodialysis; over a 4 hour dialysis period, approximately 74% of a given dose was recovered in the dialysate.
Maltese: Ceftaroline jista' jitneħħa permezz ta' emodijaliżi; fuq perjodu ta' 4 sigħat, bejn wieħed u ieħor 74% tad-doża mogħtija ġiet irkuprata fid-dijalsat.
English: Ceftaroline should be used with caution in patients with a history of non-severe hypersensitivity reactions to any other beta-lactam antibiotics (e.g. penicillins or carbapenems).
Maltese: Ceftaroline għandu jintuża b'kawtela f'pazjenti li fil-passat sofrew minn reazzjonijiet ta' sensittività eċċessiva mhux severi għal kwalunkwe antibijotiku beta-lactam (eż. penicillins jew carbapenems).
English: Communityacquired pneumonia (CAP)
Maltese: Pnewmonja li tkun ittieħdet millkomunità (CAP)
English: No dosage adjustment is required for the elderly with creatinine clearance values > 50 mL/min (see section 5.2).
Maltese: M'hemmx bżonn ta' aġġustament fid-doża għal pazjenti anzjani b'valuri ta' tneħħija tal-kreatinina ta' > 50 mL/min (ara sezzjoni 5.2).
English: Overall, no adverse effects on fertility or post-natal development were observed in the rat at up to 5 times the observed clinical exposure.
Maltese: B'mod ġenerali, ma kinux osservati effetti avversi fuq il-fertilità jew fuq l-iżvilupp wara t-twelid filfirien b'esponimenti sa 5 darbiet l-esponiment kliniku osservat.
English: The full EPAR for Vemlidy can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It contains the active substance tenofovir alafenamide.
Maltese: Fih is-sustanza attiva tenofovir alafenamide.
English: The terms ‘e-antigen positive' and ‘e-antigen negative' refer to the presence or absence of e-antigen, a hepatitis B viral protein.
Maltese: It-termini ‘pożittiva għall-antiġen-e' u ‘negattiva għall-antiġen-e' jirreferu għall-preżenza jew għannuqqas ta' antiġen-e, proteina virali tal-epatite B.
English: Other information about Vemlidy
Maltese: Informazzjoni oħra dwar Vemlidy
English: This is a summary of the European public assessment report (EPAR) for Vemlidy.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Vemlidy.
English: In a study of 426 patients with ‘e-antigen negative' chronic hepatitis, 94% of patients on Vemlidy had very low levels of viral DNA after 48 weeks of treatment.
Maltese: Fi studju ta' 426 pazjent b'epatite kronika ‘negattiva għall-antiġen-e', 94% tal-pazjenti fuq Vemlidy kellhom livelli baxxi ħafna ta' DNA virali wara 48 ġimgħa ta' kura.
English: In a second study of 875 patients with ‘e-antigen positive' chronic hepatitis, 64% of patients taking Vemlidy and 67% of those taking tenofovir disoproxil fumarate had very low levels of viral DNA after 48 weeks.
Maltese: Fit-tieni studju fuq 875 pazjent b'epatite kronika ‘pożittiva għall-antiġen e', 64% tal-pazjenti li kienu qegħdin jieħdu Vemlidy u 67% ta' dawk li kienu qegħdin jieħdu tenofovir disoproxil fumarate kellhom livelli baxxi ħafna ta' DNA virali wara 48 ġimgħa.
English: The most common side effects with Vemlidy are headache (11% of patients), nausea (6% of patients) and tiredness (6% of patients).
Maltese: L-effetti sekondarji l-aktar komuni b'Vemlidy huma wġigħ ta' ras (11% tal-pazjenti), dardir (6% talpazjenti) u għeja (6% tal-pazjenti).
English: Why is Vemlidy approved?
Maltese: Għaliex ġie approvat Vemlidy?
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom tat-transkriptażi inversa, enzima prodotta mill-virus tal-epatite B li jippermettilha tirriproduċi lilha nnifisha fiċ-ċelloli li tkun infettat.
English: Vemlidy is an antiviral medicine for treating chronic (long-term) hepatitis B, an infectious disease that affects the liver.
Maltese: Vemlidy huwa mediċina antivirali għall-kura tal-epatite B kronika (fit-tul), marda infettiva li taffettwa lfwied.
English: This medicine is used in patients aged 12 years and older weighing at least 35 kg.
Maltese: Din il-mediċina tintuża f'pazjenti ta' aktar minn 12-il sena u li jiżnu talanqas 35 kg.
English: This result was similar to that in patients taking another form of tenofovir (tenofovir disoproxil fumarate) where 93% had very low viral DNA levels.
Maltese: Dan ir-riżultat kien simili għal dak f'pazjenti li kienu qegħdin jieħdu forma oħra ta' tenofovir (tenofovir disoproxil fumarate) fejn 93% kellhom livelli baxxi ħafna ta' DNA virali.
English: The active substance in Vemlidy, tenofovir alafenamide, works by stopping the hepatitis B virus in the liver from multiplying.
Maltese: Is-sustanza attiva f'Vemlidy, tenofovir alafenamide, taħdem billi twaqqaf il-virus tal-epatite B fil-fwied milli jimmultiplika.
English: Vemlidy suppresses levels of hepatitis B virus in the body, and its effectiveness is comparable to that of another tenofovir medicine (tenofovir disoproxil fumarate).
Maltese: Vemlidy irażżan il-livelli tal-virus tal-epatite B fil-ġisem, u l-effikaċja tiegħu hija komparabbli ma' dik ta' mediċina oħra li fiha disoproxil (tenofovir disoproxil fumarate).
English: For the full list of side effects and restrictions see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet, ara lfuljett ta' tagħrif.
English: What are the risks associated with Vemlidy?
Maltese: X'inhuma r-riskji assoċjati ma' Vemlidy?
English: With regard to its risks, the side effects of Vemlidy are manageable.
Maltese: Fir-rigward tar-riskji tiegħu, l-effetti sekondarji ta' Vemlidy huma maniġġevoli.
English: Vemlidy is available as 25 mg tablets which are taken by mouth (one tablet a day) with food.
Maltese: Vemlidy huwa disponibbli bħala pilloli ta' 25 mg li jittieħdu mill-ħalq (pillola waħda kuljum) mal-ikel.
English: In addition, Vemlidy is effective at a lower dose than tenofovir disoproxil fumarate and may lead to reduced side effects in the kidneys and bones.
Maltese: Barra minn dan, Vemlidy huwa effettiv f'doża aktar baxxa minn tenofovir disoproxil fumarate u jista' jwassal għal inqas effetti sekondarji fil-kliewi u fl-għadam.
English: Casein hydrolysate Collagen hydrolysate Salts
Maltese: Casein hydrolysate Collagen hydrolysate
English: Polyoxyethylene fatty acids Ether of fatty alcohols and of polyols Triethanolamine
Maltese: Polyoxyethylene fatty acids Ether tal-fatty alcohols u tal-polyols Triethanolamine
English: EU/2/01/029/001 10 doses: powder (10 bottles) + solvent (10 bottles) EU/2/01/029/002 50 doses: powder (50 bottles) + solvent (50 bottles) EU/2/01/029/003 1 dose: powder (1 bottle) + solvent (1 bottle)
Maltese: EU/2/029/001 10 dożi: trab (10 fliexken) + solvent (10 fliexken) EU/2/01/029/002 50 doża: trab (50 flixkun) + solvent (50 flixkun) EU/2/01/029/003 doża : trab (flixkun) + solvent (flixkun)
English: Solvent : homogeneous white emulsion
Maltese: Solvent: emulsjoni bajda omoġena
English: Date of first authorisation: 26.03.2001 Date of last renewal: 18.04.2006
Maltese: Data tal-aħħar tiġdid : 18.04.2006
English: 10 doses: powder (10 bottles) + solvent (10 bottles) 50 doses: powder (50 bottles) + solvent (50 bottles)
Maltese: 10 dożi: trab (10 fliexken) + solvent (10 fliexken) 50 doża: trab (50 flixkun) + solvent (50 flixkun)
English: Manufacturer responsible for batch release: MERIAL, Laboratoire Porte des Alpes, Rue de l'Aviation, 69800 Saint Priest, France
Maltese: Manifattur li jħalli l-konsenja tmur fis-suq: MERIAL, Laboratoire Porte des Alpes, Rue de l'Aviation, 69800 Saint Priest, Franza
English: Box of 2 x 1 bottle, 2 x 10 bottles and 2 x 50 bottles.
Maltese: Kaxxa ta' 2 x flixkun, 2 x 10 fliexken u 2 x 50 flixkun.
English: Laboratory of Lyon Gerland 254, Avenue Marcel Mérieux 69007 Lyon
Maltese: 254, Avenue Marcel Mérieux
English: Per 1-ml dose: Canine herpesvirus (F205 strain) antigens ............................................... 0.3 to 1.75 µg* *expressed in µg of gB glycoproteins
Maltese: Għal kull doża ta' ml: Antiġeni tal-herpesvirus fil-klieb (F205 strain) ........................... 0.3 sa 1.75 µg* *espressi f'µg ta' glicoproteini gB
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance :
Maltese: Sustanza Attiva :
English: This veterinary medicinal product contains mineral oil.
Maltese: Dan il-prodott veterinarju mediċinali fih żejt minerali.
English: Subcutaneous use.
Maltese: Mhux Applikabbli.
English: Pharmacotherapeutic group : Inactivated viral vaccines ATCvet code: QI07AA06
Maltese: Grupp farmakoterapewtiku: vaċċini virali inattivati
English: 1 dose: powder (1 bottle) + solvent (1 bottle)
Maltese: doża: trab (flixkun) + solvent (flixkun)
English: Sucrose
Maltese: Flixkun
English: Powder and solvent for emulsion for injection.
Maltese: Trab u solvent għal emulsjoni għal injezzjoni.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediku veterinarju tinstab fuq il-websajt tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/.
English: Light paraffin oil
Maltese: Żejt paraffin ħafif
English: No undesirable effects other than those mentioned in the “Adverse reactions” section have been observed after the administration of several doses.
Maltese: L-ebda effetti mhux mixtieqa ħlief dawk imsemmija f'sezzjoni “Effetti mhux mixtieqa” ma ġew osservati wara l-amministrazzjoni ta' diversi dożi.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND
Maltese: MANIFATTUR TAS-SUSTANZA(I) BIJOLOĠIKA(ĊI) ATTIVA(I)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Box of 2 x 1 bottle, 2 x 10 bottles and 2 x 50 bottles
Maltese: Kaxxa ta' 2 x flixkun, 2 x 10 fliexken u 2 x 50 flixkun
English: Eurican Herpes 205 powder and solvent for emulsion for injection.
Maltese: Eurican Herpes 205 trab u solvent għal emulsjoni għall-injezzjoni.
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar dan il-prodott tinstab fuq il-websajt tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/.
English: Eurican Herpes 205 powder and solvent for emulsion for injection
Maltese: Eurican Herpes 205 trab u solvent għal emulsjoni għall-injezzjoni
English: Do not mix with any other veterinary medicinal product except the solvent supplied for use with the veterinary medicinal product.
Maltese: Tħallatx ma prodotti oħra veterinarji mediċinali ħlief mas-solvent provvdut għall-użu mal-prodott veterinarju mediċinali.
English: INDICATIONS
Maltese: MANIFATTURA
English: Purified subunit vaccine for the active immunisation of pregnant bitches to induce passive immunity in puppies against herpesvirus-induced fatal neonatal disease.
Maltese: Subunit ta' vaċċin ippurifikat għall-immunizzazzjoni attiva ta' klieb nisa tqal biex jinduċi immunità passiva fil-ġriewi kontra l-marda fil-frieħ tat-twelid ikkaġunata mill-herpesvirus.
English: The vaccine may commonly cause transient oedema at the site of injection.
Maltese: Dawn huma rari u kura xierqa sintomatika għanda tiġi amministrata.
English: To the physician:
Maltese: Doża eċċessiva:
English: Light paraffin oil ......................................................................................................... 224.8 to 244.1 mg Lyophilisate : white pellet.
Maltese: Żejt paraffin ħafif ....................................................................................................... 224.8 sa' 244.1 mg Lijofiliżat : Pritkuna bajda
English: Eurican Herpes 205 powder for injection
Maltese: VETERINARJU Eurican Herpes 205 trab għall-injezzjoni.
English: ROUTE(S) OF ADMINISTRATION
Maltese: Rue de l'Aviation
English: Active immunisation of bitches to prevent mortality, clinical signs and lesions in puppies resulting from canine herpes virus infections acquired in the first few days of life through passive immunity.
Maltese: Immunizzazzjoni attiva ta' klieb nisa biex tipprevjeni l-mortalità, sinjali kliniċi u leżjonijiet fil-ġriewi kkaġunati mill-infezzjonijiet tal-herpesvirus fil-klieb miksuba fl-ewwel ftit ġranet tal-ħajja permezz ta' immunità passiva.
English: Read the package leaflet before use
Maltese: Mhux id-daqsijiet kollha tal-pakketti jistgħu qegħdin fis-suq
English: Following reconstitution of the powder with the solvent, inject one dose (1ml) of the vaccine via the subcutaneous route, according to the following schedule:
Maltese: Wara r-rikostituzzjon tat-trab mas-solvent, injetta doża waħda (1 ml) tal-vaċcin taħt il-ġilda, skont l iskeda li ġejja:
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Maltese: Isem u indirizz tal-manufattur tas-sustanza(i) bijoloġika(ċi) attiva(i) MERIAL
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Active substance:
Maltese: U INGREDJENT(I) OĦRA Sustanza attiva
English: Hypersensitivity reactions may occur.
Maltese: Jista' jkun hemm reazzjonijiet ta' ipersensittività.
English: Light paraffin oil ......................................................................................................... 224.8 to 244.1 mg For the full list of excipients, see section 6.1.
Maltese: Żejt paraffin ħafif ........................................................................................................ 224.8 sa 244.1 mg
English: EU Number
Maltese: Numru ta' lUE
English: Strength Pharmaceutical form
Maltese: Qawwa Għamla Farmaċewt ika
English: Withdrawal period
Maltese: Klieb
English: EMEA/H/C/850
Maltese: EMEA/H/C/780 RAPPORT PUBBLIKU EWROPEW TA' VALUTAZZJONI (EPAR) ENVIAGE
English: It is available as tablets (pink and round: 150 mg; red and oval: 300 mg).
Maltese: Jiġi bħala pilloli (roża u tondi: 150 mg; ħomor u ovali: 300 mg).
English: The blood pressure was measured in ‘millimetres of mercury' (mmHg).
Maltese: Il-pressjoni tad-demm ġiet imkejla f'‘millimetri ta' merkurju' (mmHG).
English: Combination studies looked at Enviage used with an angiotensin converting enzyme inhibitor (ramipril), an angiotensin receptor blocker (valsartan), a beta-blocker (atenolol), a calcium-channel blocker (amlodipine) and a diuretic (hydrochlorothiazide).
Maltese: L-istudji tat-tqabbil eżaminaw l-effett ta' Enviage użat flimkien ma' inibitur tal-enzima li jikkonverti l-anġjotensina (ramipril), ma' sustanza li timblokka r-riċettur tal-anġjotensina (valsartan), ma' beta-blocker (atenolol), u ma' sustanza li timblokka l-kanali tal-kalċju (amlodipina) u sustanza djuretika (idroklorotijażide).
English: The active substance in Enviage, aliskiren, is a renin inhibitor.
Maltese: Is-sustanza attiva f'Enviage, aliskiren, hi inibitur tar-renina.
English: When the results of the five studies comparing Enviage taken alone with placebo were looked at together, patients aged under 65 years had an average fall in diastolic blood pressure of 9.0 mmHg after eight weeks of taking 150 mg Enviage, from an average of 99.4 mmHg at the start of the study.
Maltese: Meta r-riżultati tal-ħames studji li qabblu Enviage meħud waħdu ma' plaċebo ġew studjati flimkien, il-pazjenti li kellhom inqas minn 65 sena kellhom tnaqqis medju fil-pressjoni dijastolika ta' 9.0 mmHg wara tmien ġimgħat jieħdu 150 mg Enviage, minn medja ta' 99.4 mmHg filbidu tat-trattament.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Enviage to Novartis Europharm Limited on 22 August 2007.
Maltese: Il-Kummissjoni Ewropea tat l-awtorizzazzjoni għat-tqegħid fis-suq għal Enviage lil Novartis Europharm Limited fit-22 ta' Awwissu 2007.
English: Enviage is a medicine that contains the active substance aliskiren.
Maltese: Enviage hu mediċina li fiha s-sustanza attiva aliskiren.
English: This was compared with a fall of 5.8 mmHg from 99.3 mmHg in the patients taking placebo.
Maltese: Min-naħa l-oħra kien hemm tnaqqis ta' 5.8 mmHg minn 99.3 mmHg fil-pazjenti li kienu qed jieħdu l-plaċebo.