FrancophonIA/ELRC3.0 huggingface dataset:
English: In 1,715 hypertensive patients with type 2 diabetes, proteinuria ≥ 900 mg/day and serum creatinine ranging from 1.0-3.0 mg/dl, the long-term effects (mean 2.6 years) of Irbesartan BMS on the progression of renal disease and all-cause mortality were examined.
Maltese: F'1,715-il pazjent bi pressjoni għolja u b'dijabete tip 2, proteinuria ≥ 900 mg/jum u krejatinina fisserum li tvarja minn 1.0 - 3.0 mg/dl, ġew eżaminati l-effetti fit-tul (medja ta' 2.6 sena) ta' Irbesartan BMS fuq l-avvanz ta' mard renali u l-kawżi kollha ta' mortalità.
English: NAME OF THE MEDICINAL PRODUCT Irbesartan BMS 150 mg tablets.
Maltese: Irbesartan BMS 150 mg pilloli.
English: MARKETING AUTHORISATION NUMBERS EU/1/06/375/028-033
Maltese: NUMRI TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/06/375/028-033
English: MARKETING AUTHORISATION NUMBERS EU/1/06/375/006-010
Maltese: NUMRI TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/06/375/006-010
English: NAME OF THE MEDICINAL PRODUCT Irbesartan BMS 75 mg tablets irbesartan
Maltese: Irbesartan BMS 75 mg pilloli irbesartan
English: MARKETING AUTHORISATION NUMBERS EU/1/06/375/011-015
Maltese: NUMRI TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/06/375/011-015
English: Irbesartan exhibits linear and dose proportional pharmacokinetics over the dose range of 10 to 600 mg. A less than proportional increase in oral absorption at doses beyond 600 mg (twice the maximal recommended dose) was observed; the mechanism for this is unknown.
Maltese: Inqas minn żieda proporzjonali t'assorbiment orali b'dożi 'il fuq minn 600 mg (id-doppju taddoża massima rrikmandata) ġie osservat; għalfejn jiġri dan għadu mhux magħruf.
English: NAME OF THE MEDICINAL PRODUCT Irbesartan BMS 300 mg tablets irbesartan
Maltese: Irbesartan BMS 300 mg pilloli irbesartan
English: MARKETING AUTHORISATION NUMBERS EU/1/06/375/016-021
Maltese: NUMRI TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/06/375/016-021
English: MARKETING AUTHORISATION NUMBERS EU/1/06/375/022-027
Maltese: NUMRI TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/06/375/022-027
English: Cartons of 56 tablets: 4 blister cards of 14 tablets in PVC/PVDC/Aluminium blisters.
Maltese: Pakketti ta' 56 pillola: 4 kards ta' folji ta' 14-il pillola f'folji tal-PVC/PVDC/Aluminju.
English: MARKETING AUTHORISATION NUMBERS EU/1/06/375/001-005
Maltese: NUMRI TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/06/375/001-005
English: EXP
Maltese: BMS
English: In 1.7% of hypertensive patients with advanced diabetic renal disease treated with irbesartan, a decrease in haemoglobin*, which was not clinically significant, has been
Maltese: F'1.7% tal-pazjenti bi pressjoni għolja b'mard dijabetiku avanzat renali kkurati b'irbesartan, kien osservat tnaqqis fl-emoglobina*, li ma kienx klinikament sinifikanti.
English: Skin and subcutaneous tissue disorders: Leukocytoclastic vasculitis
Maltese: Lactose: dan il-prodott mediċinali fih il-lactose.
English: Irbesartan BMS 150 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Maltese: Irbesartan BMS 150 mg jinstabu f'pakketti f'folji ta' 14, 28, 56 jew 98 pillola.
English: Hepato-biliary disorders: Hepatitis, abnormal liver function
Maltese: Epatite, funzjoni anormali tal-fwied
English: Renovascular hypertension: there is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with medicinal products that affect the renin-angiotensin-aldosterone system.
Maltese: Pressjoni għolja renovaskulari: hemm riskju ikbar ta' pressjoni baxxa severa u ta' insuffiċjenza renali meta pazjenti li għandhom stenosi bilaterali ta' l-arterja renali jew stenosi ta' l-arterja b'kilwa waħda taħdem, jiġu kkurati bi prodotti mediċinali li jaffettwaw is-sistema renin-angiotensin-aldosterone.
English: Cartons of 98 tablets: 7 blister cards of 14 tablets in PVC/PVDC/Aluminium blisters.
Maltese: Pakketti ta' 98 pillola: 7 kards ta' folji ta' 14-il pillola f'folji tal-PVC/PVDC/Aluminju.
English: Irbesartan BMS 300 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Maltese: Irbesartan BMS 300 mg jinstabu f'pakketti f'folji ta' 14, 28, 56 jew 98 pillola.
English: Uncommon: heart rate increased, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems with sexual performance), chest pain.
Maltese: Mhux komuni: taħbit tal-qalb aktar mgħaġġel, fwawar, sogħla, dijarea, indiġestjoni/qrusa flistonku, disfunzjoni sesswali (problemi fl-attività sesswali), uġigħ fis-sider.
English: Irbesartan BMS 75 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Maltese: Irbesartan BMS 75 mg jinstabu f'pakketti f'folji ta' 14, 28, 56 jew 98 pillola.
English: Musculoskeletal and connective tissue disorders: Common:
Maltese: Disturbi muskolu-skeltrali, tal-connective tissue u fl-għadam:
English: Excipient: 51.00 mg of lactose monohydrate per film-coated tablet.
Maltese: Sustanza mhux attiva: 51.00 mg ta' lactose monohydrate kull pillola.
English: Cartons of 56 x 1 tablet; 7 blister cards of 8 x 1 tablet each in PVC/PVDC/Aluminium perforated unit dose blisters.
Maltese: Pakketti ta' 56 x 1 pillola miksija b'rita: 7 kards ta' folji ta' 8 x 1 pilloli miksijin b'rita f'folji perforati tal-PVC/PVDC/Aluminju ta' doża waħda.
English: There is no clinically important effect on serum uric acid or urinary uric acid secretion.
Maltese: M'hemmx effett ta' importanza klinika fil-livelli tal-uric acid fis-serum jew fil-ħruġ tal-uric acid ma' l-awrina.
English: Each tablet of Irbesartan BMS 75 mg contains 75 mg irbesartan.
Maltese: Kull pillola ta' Irbesartan BMS 75 mg fiha 75 mg ta' irbesartan.
English: Over a subsequent two week period where patients were re-randomized to either active medicinal product or placebo, patients on placebo had increases of 2.4 and 2.0 mmHg in SeSBP and SeDBP compared to +0.1 and -0.3 mmHg changes respectively in those on all doses of irbesartan (see section 4.2).
Maltese: Fuq il-perjodu tal-ġimagħtejn ta' wara fejn il pazjenti ġew re-randomised jew għal prodott mediċinali attiv jew għal plaċebo, il-pazjenti fuq plaċebo kellhom żidiet ta' 2.4 u 2.0 mmHg fis-SeSBP u SeDBP meta mqabbla ma' bidliet rispettivi ta' +0.1 u0.3 mmHg f'dawk fuq id-dożi kollha ta' irbesartan (ara sezzjoni 4.2).
English: What Irbesartan BMS looks like and contents of the pack Irbesartan BMS 150 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2872 engraved on the other side.
Maltese: Id-dehra ta' Irbesartan BMS u l-kontenuti tal-pakkett Il-pilloli Irbesartan BMS 150 mg huma bojod għal offwajt, ibbuzzati fuq iż-żewġ naħat, ovali, b'qalb stampata fuq naħa waħda u n-numru 2872 imnaqqax fuq in-naħa l-oħra.
English: What Irbesartan BMS looks like and contents of the pack Irbesartan BMS 300 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2873 engraved on the other side.
Maltese: Id-dehra ta' Irbesartan BMS u l-kontenuti tal-pakkett Il-pilloli Irbesartan BMS 300 mg huma bojod għal offwajt, ibbuzzati fuq iż-żewġ naħat, ovali, b'qalb stampata fuq naħa waħda u n-numru 2873 imnaqqax fuq in-naħa l-oħra.
English: Each tablet of Irbesartan BMS 150 mg contains 150 mg irbesartan.
Maltese: Kull pillola ta' Irbesartan BMS 150 mg fiha 150 mg ta' irbesartan.
English: EU/1/06/375/011 - 14 tablets EU/1/06/375/012 - 28 tablets EU/1/06/375/013 - 56 tablets EU/1/06/375/014 - 56 x 1 tablets EU/1/06/375/015 - 98 tablets
Maltese: EU/1/06/375/011 - 14-il pillola EU/1/06/375/012 - 28 pillola EU/1/06/375/013 - 56 pillola EU/1/06/375/014 - 56 x 1 pillola EU/1/06/375/015 - 98 pillola
English: Prior treatment with high dose diuretics may result in volume depletion and a risk of hypotension when initiating therapy with Irbesartan BMS (see section 4.4).
Maltese: Kura li ssir qabel b'dożi għoljin ta' dijuretiċi tista' tirriżulta f'nuqqas fil-volum u riskju ta' pressjoni baxxa meta tinbeda l-kura b'Irbesartan BMS (ara sezzjoni 4.4).
English: What Irbesartan BMS looks like and contents of the pack Irbesartan BMS 75 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2871 engraved on the other side.
Maltese: Id-dehra ta' Irbesartan BMS u l-kontenuti tal-pakkett Il-pilloli Irbesartan BMS 75 mg huma bojod għal offwajt, ibbuzzati fuq iż-żewġ naħat, ovali, b'qalb stampata fuq naħa waħda u n-numru 2871 imnaqqax fuq in-naħa l-oħra.
English: The frequency of the side effects listed below is defined using the following convention: Very common: at least 1 in 10 patients or more Common: at least 1 in 100 and less than 1 in 10 patients Uncommon: at least 1 in 1000 and less than 1 in 100 patients
Maltese: Komuni ħafna: talanqas 1 minn kull 10 pazjenti jew aktar Komuni: talanqas 1 minn kull 100 pazjent u anqas minn 1 minn kull 10 pazjenti Mhux komuni: talanqas 1 minn kull 1000 pazjent u anqas minn 1 minn kull 100 pazjent
English: What Irbesartan BMS looks like and contents of the pack Irbesartan BMS 75 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2771 engraved on the other side.
Maltese: Id-dehra ta' Irbesartan BMS u l-kontenuti tal-pakkett Il-pilloli Irbesartan BMS 75 mg huma bojod għal offwajt, ibbuzzati fuq iż-żewġ naħat, ovali, b'qalb stampata fuq naħa waħda u n-numru 2771 imnaqqax fuq in-naħa l-oħra.
English: Irbesartan BMS 150 mg film-coated tablets are supplied in blister packs of 14, 28, 56, 84 or 98 filmcoated tablets.
Maltese: Irbesartan BMS 150 mg miksijin b'rita jinstabu f'pakketti f'folji ta' 14, 28, 56, 84 jew 98 pillola miksija b'rita.
English: Pregnancy
Maltese: Disgeweżja
English: EU/1/06/375/016 - 14 tablets EU/1/06/375/017 - 28 tablets EU/1/06/375/018 - 56 tablets EU/1/06/375/019 - 56 x 1 tablets EU/1/06/375/020 - 84 tablets EU/1/06/375/021 - 98 tablets
Maltese: EU/1/06/375/016 - 14-il pillola EU/1/06/375/017 - 28 pillola EU/1/06/375/018 - 56 pillola EU/1/06/375/019 - 56 x 1 pillola EU/1/06/375/020 - 84 pillola EU/1/06/375/021 - 98 pillola
English: Important information about some of the ingredients of Irbesartan BMS Irbesartan BMS contains lactose.
Maltese: M'hemmx biżżejjed informazzjoni speċifika disponibbli fuq il-kura tad-doża eċċessiva b'Irbesartan BMS.
English: What Irbesartan BMS looks like and contents of the pack Irbesartan BMS 300 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2773 engraved on the other side.
Maltese: Id-dehra ta' Irbesartan BMS u l-kontenuti tal-pakkett Il-pilloli Irbesartan BMS 300 mg huma bojod għal offwajt, ibbuzzati fuq iż-żewġ naħat, ovali, b'qalb stampata fuq naħa waħda u n-numru 2773 imnaqqax fuq in-naħa l-oħra.
English: EU/1/06/375/022 - 14 tablets EU/1/06/375/023 - 28 tablets EU/1/06/375/024 - 56 tablets EU/1/06/375/025 - 56 x 1 tablets EU/1/06/375/026 - 84 tablets EU/1/06/375/027 - 98 tablets
Maltese: EU/1/06/375/022 - 14-il pillola EU/1/06/375/023 - 28 pillola EU/1/06/375/024 - 56 pillola EU/1/06/375/025 - 56 x 1 pillola EU/1/06/375/026 - 84 pillola EU/1/06/375/027 - 98 pillola
English: Cartons of 84 film-coated tablets: 6 blister cards of 14 film-coated tablets in PVC/PVDC/Aluminium blisters.
Maltese: Pakketti ta' 84 pillola miksija b'rita: 6 kards ta' folji ta' 14-il pillola miksija b'rita f'folji talPVC/PVDC/Aluminju.
English: It is important that you continue to take Irbesartan BMS until your doctor tells you otherwise.
Maltese: Ġeneralment, Irbesartan BMS ma għandux effetti ma' mediċini oħra.
English: Irbesartan BMS 300 mg film-coated tablets are supplied in blister packs of 14, 28, 56, 84 or 98 filmcoated tablets.
Maltese: Irbesartan BMS 300 mg miksijin b'rita jinstabu f'pakketti f'folji ta' 14, 28, 56, 84 jew 98 pillola miksija b'rita.
English: Irbesartan BMS 75 mg film-coated tablets are supplied in blister packs of 14, 28, 56, 84 or 98 filmcoated tablets.
Maltese: Irbesartan BMS 75 mg miksijin b'rita jinstabu f'pakketti f'folji ta' 14, 28, 56, 84 jew 98 pillola miksija b'rita.
English: EU/1/06/375/006 - 14 tablets EU/1/06/375/007 - 28 tablets EU/1/06/375/008 - 56 tablets EU/1/06/375/009 - 56 x 1 tablets EU/1/06/375/010 - 98 tablets
Maltese: EU/1/06/375/006 - 14-il pillola EU/1/06/375/007 - 28 pillola EU/1/06/375/008 - 56 pillola EU/1/06/375/009 - 56 x 1 pillola EU/1/06/375/010 - 98 pillola
English: The frequency of adverse reactions listed below is defined using the following convention:
Maltese: Il-frekwenza ta' l-effetti sekondarji elenkati hawn isfel hija definita bl-użu tal-konvenzjoni li ġejja:
English: EU/1/06/375/028 - 14 tablets EU/1/06/375/029 - 28 tablets EU/1/06/375/030 - 56 tablets EU/1/06/375/031 - 56 x 1 tablets EU/1/06/375/032 - 84 tablets EU/1/06/375/033 - 98 tablets
Maltese: EU/1/06/375/028 - 14-il pillola EU/1/06/375/029 - 28 pillola EU/1/06/375/030 - 56 pillola EU/1/06/375/031 - 56 x 1 pillola EU/1/06/375/032 - 84 pillola EU/1/06/375/033 - 98 pillola
English: What Irbesartan BMS looks like and contents of the pack Irbesartan BMS 150 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2772 engraved on the other side.
Maltese: Id-dehra ta' Irbesartan BMS u l-kontenuti tal-pakkett Il-pilloli Irbesartan BMS 150 mg huma bojod għal offwajt, ibbuzzati fuq iż-żewġ naħat, ovali, b'qalb stampata fuq naħa waħda u n-numru 2772 imnaqqax fuq in-naħa l-oħra.
English: NAME OF THE MEDICINAL PRODUCT Irbesartan BMS 75 mg film-coated tablets irbesartan
Maltese: Irbesartan BMS 75 mg pilloli miksijin b'rita irbesartan
English: EU/1/06/375/001 - 14 tablets EU/1/06/375/002 - 28 tablets EU/1/06/375/003 - 56 tablets EU/1/06/375/004 - 56 x 1 tablets EU/1/06/375/005 - 98 tablets
Maltese: EU/1/06/375/001 - 14-il pillola EU/1/06/375/002 - 28 pillola EU/1/06/375/003 - 56 pillola EU/1/06/375/004 - 56 x 1 pillola EU/1/06/375/005 - 98 pillola
English: HOW TO STORE IRBESARTAN BMS
Maltese: Jekk tinsa tieħu Irbesartan BMS
English: Hepatic impairment: in patients with mild to moderate cirrhosis, the pharmacokinetic parameters of irbesartan are not significantly altered.
Maltese: Indeboliment epatiku: f'pazjenti b'ċirrożi ħafifa għal moderata, il-parametri farmakokinetiċi ta' irbesartan ma jitbidlux b'mod sinifikanti.
English: Gastrointestinal disorders: Dysgeusia
Maltese: Mhux komuni: sogħla
English: Excipient: 15.37 mg of lactose monohydrate per tablet.
Maltese: 37 mg ta' lactose monohydrate kull pillola.
English: Cartons of 14 tablets: 1 blister card of 14 tablets in PVC/PVDC/Aluminium blisters.
Maltese: Pakketti ta' 14-il pillola: kard ta' folji ta' 14-il pillola f'folji tal-PVC/PVDC/Aluminju.
English: Peak plasma concentrations are attained at 1.5 - 2 hours after oral administration.
Maltese: L-ogħla konċentrazzjonijiet fil-plażma jintleħqu wara 1.5-2 sigħat wara li jittieħed mill-ħalq.
English: Renal impairment and kidney transplantation: when Irbesartan BMS is used in patients with impaired renal function, a periodic monitoring of potassium and creatinine serum levels is recommended.
Maltese: Indeboliment renali u trapjant tal-kliewi: meta Irbesartan BMS jintuża f'pazjenti b'indeboliment renali, hija irrikmandata osservanza perjodika tal-livelli tal-potassju u tal-krejatinina fis-serum.
English: No significant pharmacokinetic or pharmacodynamic interactions were observed when irbesartan was coadministered with warfarin, a medicinal product metabolised by CYP2C9.
Maltese: prodott mediċinali metabolizzat minn CYP2C9.
English: Treatment of renal disease in patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive medicinal product regimen (see section 5.1).
Maltese: Kura għall-mard renali f'pazjenti li għandhom pressjoni għolja u dijabete mellitus ta' tip 2 bħala parti mill-kura kontra il-pressjoni għolja (ara sezzjoni 5.1).
English: Irbesartan BMS is used to treat high blood pressure (essential hypertension) to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory evidence of impaired kidney function.
Maltese: Irbesartan BMS inaqqas ir-rata tat-tnaqqis tal-funzjoni tal-kliewi f'pazjenti bi pressjoni għolja u b'dijabete ta' tip 2.
English: Primary aldosteronism: patients with primary aldosteronism generally will not respond to antihypertensive medicinal products acting through inhibition of the renin-angiotensin system.
Maltese: Aldosteroniżmu primarju: pazjenti b'aldosteroniżmu primarju ġeneralment ma jirrispondux għal prodotti mediċinali ta' kontra l-pressjoni għolja li jaħdmu billi jimpedixxu s-sistema renin-angiotensin.
English: BRISTOL-MYERS SQUIBB FARMACÊUTICA PORTUGUESA, S.A.
Maltese: BRISTOL-MYERS SQUIBB FARMACÊUTICA
English: Take special care with Irbesartan BMS Tell your doctor if any of the following apply to you: if you get excessive vomiting or diarrhoea if you suffer from kidney problems if you suffer from heart problems if you receive Irbesartan BMS for diabetic kidney disease.
Maltese: Irbesartan BMS jipprevjeni li angiotensin-II tingħaqad ma' dawn ir-riċetturi, u jwassal il-vini tad-demm biex jirrilassaw u b'hekk ilpressjoni tinżel.
English: Strength Pharmaceutical Form Route of Administration Immediate Packaging
Maltese: Għamla farmaċewtika
English: EMA/643080/2009 EMEA/V/C/000145
Maltese: EMEA/V/C/000145
English: ZULVAC 8 Bovis EMA/643080/2009
Maltese: EMA/12498/2010
English: The European Commission granted a marketing authorisation valid throughout the EU for ZULVAC 8 Bovis on 15 January 2010.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE għal ZULVAC 8 Bovis fil15 ta' Jannar 2010.
English: In 2013 the CVMP considered that the submitted data were adequate for the authorisation of ZULVAC 8 Bovis to convert to a normal status.
Maltese: Fl-2013 is-CVMP qies li d-dejta mressqa kienet adegwata sabiex l-awtorizzazzjoni ta' ZULVAC 8 Bovis tinbidel għal status normali.
English: ZULVAC 8 Bovis contains bluetongue virus of one type (serotype 8).
Maltese: ZULVAC 8 Bovis fih vajrus tal-lingwablu ta' tip wieħed (serotip 8).
English: Results from a series of laboratory safety trials performed with a vaccine of similar composition containing serotypes 1 and 8 and of studies performed with a vaccine of the same composition but of different serotype, used in sheep were presented in order to extrapolate safety conclusions.
Maltese: Ir-riżultati minn serje ta' provi ta' sigurta' laboratorja b'vaċċin b'kompożizzjoni simili li fiha s-serotipi 1 u 8 u studji li saru b'vaċċin bl-istess kompożizzjoni iżda b'serotip differenti, użati fin-ngħaġ kienu ppreżentati sabiex jiġu estrapolati konklużjonijiet dwar issigurta'.
English: After the second injection, animals may show a slight, temporary increase in body temperature of 0.4 ºC, in the 24 hours after vaccination.
Maltese: Wara t-tieni injezzjoni, l-annimali jistgħu juru żieda żgħira fit-temperatura tal-ġisem ta' 0.4ºC, fi żmien 24 siegħa mill-vaċċinazzjoni.
English: Inactivated vaccine against Bluetongue virus, serotype 8
Maltese: Vaċċin inattivat kontra l-marda tal-vajrus tal-Lingwablu, serotip 8
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of ZULVAC 8 Bovis exceed the risks in the prevention of viraemia caused by the bluetongue virus serotype 8 in cattle from three months of age.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) kkonkluda li l-benefiċċji tal-użu ta' ZULVAC 8 Bovis jisbqu lir-riskji fil-prevenzjoni tal-viremija kkawżata mis-serotip 8 tal-vajrus tallingwablu fil-bhejjem tal-ifrat minn tliet xhur 'il fuq.
English: Protection starts from 25 days after the last injection and lasts for at least a year.
Maltese: Il-protezzjoni tibda taħdem minn 25 jum wara l-għoti tal-aħħar injezzjoni u ddum mill-inqas sena.
English: Another laboratory study looked at the duration of the immunity following vaccination with ZULVAC 8 Bovis.
Maltese: Studju tal-laboratorju ieħor ħares lejn iż-żmien tal-immunita' wara lvaċċinazzjoni b'ZULVAC 8 Bovis.
English: What is ZULVAC 8 Bovis?
Maltese: X'inhu ZULVAC 8 Bovis?
English: What is the risk associated with ZULVAC 8 Bovis?
Maltese: X'riskji huma assoċjati ma' ZULVAC 8 Bovis?
English: ZULVAC 8 Bovis is a vaccine.
Maltese: ZULVAC 8 Bovis huwa vaċċin.
English: The safety of the vaccine was studied in laboratory safety studies carried out with ZULVAC 8 Bovis in cattle.
Maltese: Is-sigurtà tal-vaċċin ġiet studjata permezz ta' studji ta' sigurtà fil-laboratorju mwettqa b'ZULVAC 8 Bovis fil-bhejjem tal-ifrat.
English: ZULVAC 8 Bovis is used in cattle to protect them against bluetongue disease, an infection caused by the bluetongue virus which is transmitted by midges.
Maltese: ZULVAC 8 Ovis jintuża fil-bhejjem tal-ifrat biex jipproteġihom kontra l-marda tal-lingwablu, li hija infezzjoni kkawżata mill-vajrus tal-lingwablu li jiġi trażmess mill-insetti dipteri.
English: Why has ZULVAC 8 Bovis been approved?
Maltese: Għaliex ġie approvat ZULVAC 8 Bovis?
English: ZULVAC 8 Bovis is a vaccine that is available as a suspension for injection.
Maltese: ZULVAC 8 Bovis huwa vaċċin li jiġi f'sospensjoni għal inezzjoni.
English: How has ZULVAC 8 Bovis been studied?
Maltese: Kif ġie studjat ZULVAC 8 Bovis?
English: In the future, if the animals are exposed to the bluetongue virus the immune system will be able to produce antibodies more quickly.
Maltese: jekk l-annimali jkunu esposti għall-virus tal-lingwablue, is-sistema immunitarja tkun kapaċi tipproduċi antikorpi aktar malajr.
English: Nederland Teva Nederland B.V.
Maltese: Nederland B.V.
English: Italia Teva Italia S.r.l.
Maltese: Italia S.r.l.
English: België/Belgique/Belgien
Maltese: A./AG, Belgique/Belgien
English: Lietuva UAB "Sicor Biotech"
Maltese: UAB "Sicor Biotech"
English: Date of first authorisation: 16 August 2012 Date of latest renewal:
Maltese: Data tal-ewwel awtorizzazzjoni: 16 ta' Awwissu 2012 Data tal-aħħar tiġdid:
English: Tabulated list of adverse reactions
Maltese: Lista tabulata bir-reazzjonijiet avversi
English: It is supplied in packs sizes of 1, 5 and 10.
Maltese: Jiġi f'daqsijiet ta' 1, 5 u 10 pakketti.
English: The incidence of delayed hip fracture healing was comparable between zoledronic acid (34 [3.2%]) and placebo (29 [2.7%]).
Maltese: L-inċidenza ta' fejqan imdewwem ta' ksur tal-ġenbejn kienet paragunabbli bejn zoledronic acid (34 [3.2 %]) u plaċebo (29 [2.7 %]).
English: After 6 months, zoledronic acid showed 96% (169/176) and 89% (156/176) response and serum alkaline phosphatase (SAP) normalisation rates compared to 74% (127/171) and 58% (99/171) for risedronate (all p<0.001).
Maltese: Zoledronic acid wriet rati ta' rispons u ta' treġġigħ lura għan-normal tas-serum alkaline phosphatase (SAP) ta' 96% (169/176) u 89% (156/176) mqabbla ma' 74% (127/171) u 58% (99/171) għal risedronate (kollha kellhom p<0.
English: Solution for infusion 100 ml
Maltese: Soluzzjoni għall-infużjoni 100 ml
English: This corresponds to a 28% reduction in the risk of all cause mortality (p=0.01).
Maltese: Dan jikkorrispondi għal tnaqqis ta' 28 % fir-riskju tal-mortalità minn kwalunkwe kawża (p=0.01).
English: Placebo (N=1,062) event rate
Maltese: Rata ta' avveniment i bi plaċebo (N=1,062)
English: EU/1/12/772/004
Maltese: EU/1/12/772/003 EU/1/12/772/004
English: 1 bottle of 100 ml.
Maltese: 100 ml
English: Zoledronic acid Teva Pharma is supplied in multipacks of 5 (5 x 1) or 10 (10 x 1) bags .
Maltese: Zoledronic acid Teva Pharma jinsab f'pakketti ta' flixkun wieħed u f'pakketti multipli ta' 5 (5 x 1) jew 10 (10 x 1) fliexken.
English: Excipients: Mannitol, sodium citrate and water for injections.
Maltese: Eċċipjenti: Mannitol, sodium citrate u ilma għall-injezzjonijiet.
English: The total body clearance is 5.04 ± 2.5 l/h, independent of dose, and unaffected by gender, age, race or body weight.
Maltese: It-tneħħija totali mill-ġisem hija 5.04 ± 2.5 l/h, indipendenti mid-doża, u mhux affettwat missess, età, razza jew piż tal-ġisem.
English: The zoledronic acid group revealed approximately 2.5 mm less height loss compared to placebo (95% CI: 1.6 mm, 3.5 mm) [p<0.0001].
Maltese: Il-grupp fuq Zoledronic acid wera madwar 2.5 mm anqas telf fit-tul meta mqabbel malplaċebo (95% CI: 1.6 mm, 3.5 mm) [p<0.0001].