FrancophonIA/ELRC3.0 huggingface dataset:
English: Inactivated whole avian influenza virus antigen of H5 subtype (strain H5N6, A/duck/Potsdam/2243/84), inducing an HI titre of ≥6.0 log2 as tested according to the potency test.
Maltese: Antiġen sħiħ inattivat tal-virus tal-influwenza avjarja tas-subtip H5 (strejn H5N6, A/duck/Potsdam/2243/84), li jinduċi titru ta' HI ta' ≥6.0log2, kif ittestjat skond it-test ta' potenza.
English: MARKETING AUTHORISATION NUMBER EU/2/07/076/001-004
Maltese: NUMRU TA' L-AWTORIZZAZZJONI TAL-KUMMERĊ EU/2/07/076/001-004
English: 250 ml or 500 ml bottles of glass, hydrolytical class type II or of polyethylene terephthalate (PET).
Maltese: In-natura u l-għamla ta' l-ewwel ippakkjar Fliexken tal-250 jew 500 ml, ta' ħġieġ, ta' klassi idrolitika tip II, jew tal-poli-etilin tereftalejt (PET).
English: Spain
Maltese: Spanja.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Nobilis Influenza H5N6 emulsion for injection for chickens
Maltese: VETERINARJU Nobilis Influenza H5N6 emulsjoni għal injezzjoni għal flieles
English: Store refrigerated (2°C to 8°C).
Maltese: Aħżen u ttrasporta ġo friġġ (2°C - 8°C).
English: SPECIAL STORAGE CONDITIONS Store refrigerated (2°C to +8°C).
Maltese: Aħżen u ttrasporta fil-friġġ (+2°C sa +8°C).
English: Sorbitane mono-oleate Glycine
Maltese: Sorbitejn mono-olejt
English: Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediku veterinarju tinstab fuq il-websajt ta' l-Aġenzija Ewropea għall-Mediċini (EMEA) http://www.emea.europa.eu/
English: For disposal read the package leaflet.
Maltese: Mhux id-daqs tal-pakketti kollha jistgħu qegħdin fis-suq.
English: Up-todate information should be provided on the source countries of origin of the animals supplying the milk for preparation of the Tryptose from BD Biosciences and for the preparation of the casein, and lactose where appropriate, for manufacture of the NZ-Amines purchased from Quest/Kerry.
Maltese: Għandha tiġi pprovduta nformazzjoni aġġornata fuq il-postijiet ta' oriġini minn fejn jiġu l-annimali li jipprovdu l-ħalib għal preparazzjoni tat-tryptose minn BD Biosciences, u għal preparazzjoni ta' kaseina, u lattosju fejn hu proprju, sabiex jiġu manifatturati l-Amini NZ, mixtrija mingħand Quest / Kerry.
English: INDICATION(S) Active immunisation against avian influenza type A, subtype H5.
Maltese: INDIKAZZJONI(JIET) Għal immunizzazzjoni attiva kontra l-Influwenza avjarja tip A, subtip H5.
English: Polysorbate 80 Sorbitan mono oleate (E494)
Maltese: Sorbitan mono-olejt (E 494) Glajsin
English: II.E.9 Batch to batch consistency
Maltese: II.E.9 Konsistenza bejn lott u ieħor.
English: For a full list of excipients see section 6.1
Maltese: Għal-lista sħiħa ta' l-ingredjenti (mhux attivi), ara s-sezzjoni 6.1.
English: Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Maltese: Wim de Körverstraat 35 NL - 5831 AN Boxmeer Olanda
English: PHARMACEUTICAL PARTICULARS
Maltese: TA' FARMAKOVIĠILANZA
English: On dose of 0.5 ml contains:
Maltese: U KWANTITATTIVA Doża ta' 0.5ml fiha:
English: Emulsion for injection
Maltese: Emulsjoni għal injezzjoni
English: After broaching, use within 8 hours, provided the product is not subject to extreme temperatures or contaminated.
Maltese: Wara li tiftaħ, uża fi żmien 8 siegħat, sakemm il-prodott mhux suġġett għal temperaturi estremi, jew ġie kkontaminat.
English: Allow the vaccine to reach a temperature of 15°C - 25°C and shake well before use.
Maltese: Ħalli t-tilqim jilħaq temperatura ta' 15oC - 25oC u ħawwad tajjeb qabel tuża'.
English: 250 or 500 ml multidose glass bottle 250 or 500 ml multidose PET bottle The bottles are closed with a rubber stopper and an aluminium cap.
Maltese: Fliexken tal-ħġieġ ta' aktar minn doża waħda li jesgħu 250 jew 500ml Fliexken tal-PET ta' aktar minn doża waħda li jesgħu 250 jew 500ml Il-fliexken huma magħluqa b'tapp tal-gomma u kappa tal-aluminjum.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intramuscular or subcutaneous injection of 0.25 or 0.5 ml, depending on the age.
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI Titqiba fil-muskolu jew taħt il-ġilda ta' 0.25ml jew 0.5ml skond l-eta'.
English: For active immunisation of chickens against avian influenza type A, subtype H5.
Maltese: Għal immunizzazzjoni attiva fil-flieles, kontra l-Influwenza avjarja tip A, subtip H5.
English: Pharmacotherapeutic group: inactivated vaccine, ATC-vet code: QI01AA23
Maltese: Vaċċin inattivat, Kodici ATĊ veterinarja:
English: If the circulating avian influenza field virus has a different N component to the N6 included in the vaccine, it may be possible to differentiate between vaccinated and infected birds by using a diagnostic test to detect neuraminidase antibodies.
Maltese: Jekk il-virus tal-influwenza avjarja li qed jiċċirkula fil-beraħ għandu l-komponent N tiegħu differenti mill-N6 inkluż fil-vaċċin, ikun possibli li tagħraf tagħżel bejn tjur imlaqqma u dawk infettati billi tuża test dijagnostiku li jagħraf antikorpi nuraminidejs.
English: Results should be provided for final product tests on three batches of Nobilis Influenza H5N6, to demonstrate batch consistency.
Maltese: Għandhom jiġu provduti r-riżultati ta' testijiet fuq il-prodott finali ta' tlett lottijiet ta' Nobilis Influenza H5N6, sabiex tiġi murija konsistenza bejn il-lottijiet.
English: Any person intending to import, sell, supply and/or use Nobilis Influenza H5N6 must consult the relevant Member State's competent authority on the current vaccination policies prior to the import, sale, supply and/or use.
Maltese: Kull persuna li turi l-intenzjoni li timporta, tbiegħ, tipprovdi u/jew tuża Nobilis Influenza H5N6 għandha tikkonsulta ma' l-Awtorità Kompetenti ta' l-Istat Membru dwar il-programmi kurrenti ta' tilqim qabel timporta, tbiegħ, tipprovdi u/jew tuża.
English: MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Maltese: TAS-SUSTANZA BIOLOĠIKA ATTIVA U SID LAWTORIZZAZZJONI TAL-MANIFATTURA RESPONSABBLI
English: Serum antibodies have been shown to persist in chickens for at least 7 months and studies performed with other vaccine strains show that serum antibodies would be expected to persist in chickens for at least 12 months after administration of two doses of vaccine.
Maltese: Anti-korpi fis-sirum ġew murija li jippersistu fil-flieles sa mill-anqas 7 xhur u studji magħmula bi strejns oħra ta' tilqim urew li l-antikorpi fis-sirum jkun mistenni li jippersistu fil-flieles għal tal-anqas 12-il xahar wara amministrazzjoni ta' żewġ dożi tal-vaċċin.
English: a) the administration of the veterinary medicinal product to animals will interfere with the implementation of national programmes for the diagnosis, control and eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
Maltese: a) l-għotja tal-prodott mediċinali veterinarju lill-annimali tinterferixxi ma' l-implimentazzjoni ta' programmi nazzjonali għad-djanjosi, il-kontroll u l-eradikazzjoni tal-mard ta' l-annimali, jew tikkawża diffikultajiet fiċ-ċertifikazzjoni ta' l-assenza tal-kontaminazzjoni f' annimali ħajjin jew fl-ikel jew prodotti oħrajn akkwistati minn annimali ttrattati;
English: Adjuvant: Liquid paraffin
Maltese: PARIR SABIEX
English: The vaccine stimulates active immunity against Avian Influenza virus type A, subtype H5.
Maltese: QI01AA23 Il-vaċċin jistimula immunita attiva kontra l-virus tal-Influwenza Avjarja tip A, subtip H5.
English: Reduction of clinical signs, mortality and excretion of virus after challenge with a virulent H5N1 strain, were shown by two weeks after a single dose vaccination.
Maltese: Tnaqqis ta' sinjali kliniċi, imwiet u tneħħija tal-virus wara tlaqqiegħ ma strejn virulenti ta' H5N1 ġew murija fi żmien ġimgħatejn wara doża waħda ta' tilqim.
English: The following substances contained in the final product are included in Annex II of Council Regulation (EEC) No 2377/90:
Maltese: II tar-Regolament tal-Kunsill (KE) Nru 2377/90:
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) One dose of 0.5 ml contains:
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA U SUSTANZI OĦRA Doża ta' 0.5ml fiha:
English: Marketing authorisation holder: Intervet International B.V. Wim de Körverstraat 35
Maltese: Intervet International B.V.
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary Following the administration of a double dose no adverse reactions other than those described in section 4.6 have been observed.
Maltese: 4.10 Doża eċċessiva (sintomi, proċeduri ta' emerġenza, antidoti)jekk ikun hemm bżonn Wara li ngħatat doża doppja, ma ġewx osservati reazzjonijiet mhux mixtieqa oħra, ħlief dawk imsemmija f'sezzjoni 4.6
English: CONTROL TESTS ON THE FINISHED PRODUCT
Maltese: Test għal identifikazzjoni:
English: Light liquid paraffin
Maltese: JEW RESTRIZZJONIJIET DWAR IL-PROVISTA
English: II.
Maltese: Ċ.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARTON {250ml Bottle / 500ml Bottle}
Maltese: Flixkun ta' 250ml / 500ml
English: Chickens
Maltese: Biss
English: The Applicant is required to submit 3-montly Periodic Update Safety reports for the first 2 years following the initial use in the field and is additionally required to present a protocol that would ensure adequate recording and reporting of field data in relation to suspected adverse reactions including suspected lack of efficacy.
Maltese: Huwa wkoll rikjest protokoll li jassigura rekordjar u rappurtaġġ ta' tagħrif miġbur fil-beraħ, f'relazzjoni ma' effetti mhux mixtieqa suspettati, inkluż nuqqas t'effikaċja.
English: A. LABELLING
Maltese: KWALITATTIVI
English: From 14 days to 6 weeks old: 0.25 or 0.5 ml subcutaneously or intramuscularly 6 weeks and older: 0.5 ml subcutaneously or intramuscularly Future laying hens and breeders should get a second vaccination 4-6 weeks after first vaccination.
Maltese: Minn 14-il ġurnata sa sitt ġimgħat: 0.25 jew 0.5ml taħt il-ġilda jew fil-muskolu.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
Maltese: Isem u indirizz tal-manufatturi tas-sustanza(i) bioloġika(ċi) attiva(i)
English: 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if appropriate
Maltese: .8 Effetti fuq prodotti mediċinali oħra jew effetti oħra
English: 4.9 Amounts to be administered and administration route For subcutaneous or intramuscular use.
Maltese: .9 Doża rakkomandata u l-metodu ta' amministrazzjoni
English: 6.3 Shelf life
Maltese: II.F Stabbilita
English: No information is available on the safety of this vaccine for birds in lay.
Maltese: M'hemmx informazzjoni dwar is-sigurtà ta' din it-tilqima fi tjur tal-bajd.
English: A transient diffuse swelling may occur at the vaccination site in 50% of the animals, which persists for about 14 days.
Maltese: Nefħa mifruxa u li tgħaddi tista' sseħħ fis-sit tal-vaċċinazzjoni f'50% tal-annimali.
English: From 14 days to 6 weeks old: 0.25 or 0.5ml subcutaneously or intramuscularly 6 weeks and older: 0.5ml subcutaneously or intramuscularly Future laying hens and breeders should get a second vaccination 4-6 weeks after first vaccination No information is available on vaccination in the presence of maternally derived antibodies.
Maltese: Jekk il-virus tal-influwenza avjarja li qed jiċċirkula fil-beraħ għandu l-komponent N tiegħu differenti mill-N6, inkluż fil-vaċċin, ikun possibli li tagħraf tagħżel bejn tjur imlaqqma u dawk infettati billi tuża test dijanjostiku li jagħraf antikorpi nuraminidejs.
English: Tryptose: The Applicant should provide a list of suitable source countries for the pigs used as a source of the porcine starting material in tryptose.
Maltese: L-applikant għandu jipprovdi lista ta' postijiet li huma tajba għal produzzjoni ta' qżieqeż li jintużaw bħala sors primarju tal-materjal porċin tal-bidu sabiex isir it-tryptose.
English: ROUTE(S) OF ADMINISTRATION Intramuscular or subcutaneous injection Read the package leaflet before use.
Maltese: Testijiet ta' kontroll fuq il-prodott lest.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One dose of 0.5ml contains:
Maltese: U INGREDJENT(I) OĦRA Doża ta' 0.5ml fiha:
English: This summary was last updated in 02-2012.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi 02-2012.
English: The full EPAR for Temodal 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 is available as capsules (5 mg, 20 mg, 100 mg, 140 mg, 180 mg and 250 mg) and as a powder to be made up into a solution for infusion (drip into a vein).
Maltese: Jiġi f'kapsuli (5 mg, 20 mg, 100 mg, 140 mg, 180 mg u 250 mg) u fi trab li jinħall f'taħlita likwida għall-infużjoni (dripp fil-vina).
English: EPAR summary for the public temozolomide
Maltese: Sommarju tal-EPAR għall-pubbliku temożolomide
English: • adults with newly diagnosed glioblastoma multiforme (an aggressive type of brain tumour).
Maltese: • adulti li ġew dijanjostikati għall-ewwel darba bi glijoblastoma multiforme (tip aggressiv ta' tumur tal-moħħ).
English: The most common side effects with Temodal (seen in more than 1 patient in 10) are nausea (feeling sick), vomiting, constipation, loss of appetite, alopecia (hair loss), headache, fatigue (tiredness), convulsions (fits), rash, neutropenia or lymphopenia (low white blood cell counts), and thrombocytopenia (low blood platelet counts).
Maltese: L-effetti sekondarji l-iżjed komuni b'Temodal (li dehru f'aktar minn pazjent wieħed minn kull għaxra) huma nawżja (dardir), remettar, stitikezza, nuqqas ta' aptit, alopeċja (wqigħ tax-xagħar), uġigħ ta' ras, għeja, konvulżjonijiet (attakki ta' konvulżjoni), raxx, newtropenija jew linfopenija (għadd baxx ta' ċelloli ħomor fid-demm), u tromboċitopenija (għadd baxx ta' pjastrini fid-demm).
English: If the solution for infusion is used, it should be given over a period of 90 minutes.
Maltese: Jekk tintuża t-taħlita għall-infużjoni, din għandha tingħata tul 90 minuta.
English: This is a summary of the European public assessment report (EPAR) for Temodal.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Temodal.
English: Temodal is a medicine that contains the active substance temozolomide.
Maltese: Temodal huwa mediċina li jkun fiha s-sustanza attiva temożolomide.
English: Two of these studies involved patients with glioblastoma multiforme: one looked at the effects of Temodal in 138 patients and the other compared Temodal with procarbazine (another anticancer medicine) in 225 patients.
Maltese: Tnejn minn dawn l-istudji involvew pazjenti bi glijoblastoma multiforme: studju minnhom stħarreġ l-effetti ta' Temodal f'138 pazjent u l-ieħor qabbel Temodal mal-prokarbażina (mediċina oħra kontra l-kanċer) f'225 pazjent.
English: Temodal is an anticancer medicine.
Maltese: Temodal huwa mediċina kontra l-kanċer.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Temodal on 26 January 1999.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Temodal fis-26 ta' Jannar 1999.
English: Why has Temodal been approved?
Maltese: Għaliex ġie approvat Temodal?
English: • adults and children three years of age and over with malignant glioma such as glioblastoma multiforme or anaplastic astrocytoma, when the tumour has returned or got worse after standard treatment.
Maltese: • adulti u tfal minn tliet snin 'il fuq li jbatu minn xi glijoma malinna bħall-glijoblastoma multiforme jew l-astroċitoma anaplastika, meta t-tumur tagħhom jerġa' jitfaċċa jew jiggrava wara l-kura standard.
English: The dose of Temodal depends on body surface area (calculated using the patient's height and weight) and ranges from 75 to 200 mg per square metre, once a day.
Maltese: Id-doża tat-Temodal tiddependi mis-superfiċje tal-ġisem (ikkalkolat bit-tul u l-piż tal-pazjent) u tvarja minn 75 sa 200 mg għal kull metru kwadru, darba kuljum.
English: The active substance in Temodal, temozolomide, belongs to a group of anticancer medicines called alkylating agents.
Maltese: Is-sustanza attiva f'Temodal, it-temożolomide, tappartieni lill-grupp ta' mediċini ta' kontra l-kanċer li jissejħu aġenti alkilanti.
English: Patients receiving the solution for infusion may also have injection site reactions, such as pain, irritation, itching, warmth, swelling and redness, as well as bruising.
Maltese: Il-pazjenti li jingħataw it-taħlita għall-infużjoni jista' jkollhom ukoll reazzjonijiet fil-parti fejn jittaqbu, bħal uġigħ, irritazzjoni, ħakk, sħana, nefħa u ħmura kif ukoll tbenġil.
English: It is used to treat malignant glioma (brain tumours) in the following groups of patients:
Maltese: Jintuża biex ifejjaq il-glijoma malinna (tumuri fil-moħħ) filgruppi ta' dawn il-pazjenti:
English: What is Temodal?
Maltese: Kif jintuża Temodal?
English: In the body, temozolomide is converted to another compound called MTIC.
Maltese: Fil-ġisem it-temozolomide tinbidel f'kompost imsejjaħ MTIC.
English: The first study compared the effectiveness of Temodal and radiotherapy with that of radiotherapy on its own in 573 patients with newly diagnosed glioblastoma multiforme.
Maltese: L-ewwel studju qabbel l-effikaċja tal-għoti ta' Temodal u r-radjuterapija flimkien mal-għoti tarradjuterapija waħedha f'573 pazjent li ġew dijanjostikati għall-ewwel darba bi glioblastoma multiforme.
English: The final study looked at the safety and effectiveness of Temodal in the treatment of 162 patients with anaplastic astrocytoma who were in their first relapse.
Maltese: L-istudju finali ta ħarsa lejn is-sigurtà u l-effikaċja ta' Temodal fit-trattament ta' 162 pazjent b'astroċitoma anaplastika li kienu qed jirkadu għall-ewwel darba.
English: In the comparative study of glioblastoma multiforme that had come back or got worse after previous treatment, it took an average of 2.9 months until the cancer got worse in patients taking Temodal, compared with 1.9 months in the patients taking procarbazine.
Maltese: Fl-istudju komparattiv fuq glijoblastoma multiforme li reġgħet feġġet jew iggravat wara l-kura li kienu diġà ħadu, fil-pazjenti li kienu qed jieħdu Temodal għaddew medja ta' 2.9 xhur sa ma l-kanċer iggrava, apparagun mal-1.9 xhur fil-pazjenti li kienu qed jieħdu l-prokarbażina.
English: In the study of newly diagnosed glioblastoma multiforme, patients survived for an average of 14.6 months when they received Temodal and radiotherapy, compared with 12.1 months with radiotherapy alone.
Maltese: Fl-istudju fuq dawk li ġew dijanjostikati għall-ewwel darba bi glijoblastoma multiforme, il-pazjenti għexu medja ta' 14.6 xhur meta ngħataw Temodal flimkien mar-radjuterapija, apparagun mat-12.1 xhur li għexu dawk li ngħataw ir-radjuterapija biss.
English: For the full list of all side effects reported with Temodal, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji rrappurtati b'Temodal, ara l-fuljett ta' tagħrif.
English: What is the risk associated with Temodal?
Maltese: Għal xiex jintuża Temodal?
English: The CHMP decided that Temodal's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Temodal huma akbar mir-riskji tiegħu u għaldaqstant irrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: Temodal must not be used in people who are hypersensitive (allergic) to temozolomide, any of the other ingredients or dacarbazine (another anticancer medicine).
Maltese: Temodal ma għandux jintuża f'persuni ipersensittivi (allerġiċi) għat-temożolomide, jew għal xi ingredjenti oħra tiegħu jew għad-dakarbażina (mediċina oħra kontra l-kanċer).
English: In anaplastic astrocytoma, it took an average of 5.4 months for the cancer to get worse in patients taking Temodal.
Maltese: F'pazjenti bl-astroċitoma anaplastika li kienu qed jieħdu Temodal, sa ma ggrava l-kanċer ħa medja ta' 5.4 xhur.
English: Other information about Temodal
Maltese: Tagħrif ieħor dwar Temodal
English: A further two studies were carried out in a total of 35 patients with brain tumours to show that the capsules and solution for infusion produce the same levels of temozolomide in the blood.
Maltese: Total ta' 35 pazjent b'tumuri fil-moħħ ħadu sehem f'żewġ studji oħra biex jintwera li l-kapsuli u ttaħlita għall-infużjoni jipproduċu l-istess livelli ta' temożolomide fid-demm.
English: How has Temodal been studied?
Maltese: Kif ġie studjat Temodal?
English: Manufacturer Accord Healthcare Limited Sage House
Maltese: Accord Healthcare Limited Sage House
English: Date of first authorisation: 19 November 2012 Date of latest renewal: 18 September 2017
Maltese: Data tal-ewwel awtorizzazzjoni : 19 ta' Novembru 2012 Data tal-aħħar tiġdid: 18 ta 'Settembru 2017
English: Bundle branch block
Maltese: Blokk tal bundle branch
English: Mean relative changes from baseline % [95% CI]
Maltese: Bidliet relattivi medji millinja bażi % [95% CI]
English: 319, Pinner Road North Harrow Middlesex HA1 4HF United Kingdom
Maltese: 319, Pinner Road North Harrow Middlesex HA1 4HF
English: Lumbar spine L2-L4 BMD
Maltese: Sinsla lumbari L2-L4
English: All patients received 500 mg calcium and 400 IU vitamin D daily.
Maltese: Ilpazjenti kollha rċevew 500 mg kalċju u 400 IU vitamina D kuljum.
English: • smoking cigarettes, or drinking too much alcohol
Maltese: • tipjip ta' sigaretti, jew xorb ta' alkoħol żejjed
English: Phlebitis/ thrombophlebitis
Maltese: Flebite/tromboflebite
English: • a heart rhythm problem called ‘“bundle branch block”'
Maltese: • problema fir-ritmu tal-qalb imsejjħa ‘blokk tal-bundle branch'
English: A relative risk reduction of 61 % was observed after 2 years (p=0.0006).
Maltese: Wara sentejn kien osservat tnaqqis relattiv fir-riskju ta' 61% (p=0.0006).
English: Table 3: Results from 3 years fracture study MF 4411 (%, 95 % CI)
Maltese: Tabella 3: Riżultati mill-istudju fuq 3 snin dwar il-ksur, MF 4411 (%, 95% CI)
English: North Harrow Middlesex HA1 4HF United Kingdom
Maltese: Middlesex HA1 4HF
English: UNIQUE IDENTIFIER - 2D BARCODE <2D barcode carrying the unique identifier included.>
Maltese: barcode 2D li jkollu l-identifikatur uniku inkluż.
English: For storage conditions of the diluted medicinal product, see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħażna wara d-dilwizzjoni tal-prodott mediċinali, ara sezzjoni 6.3.
English: No data are available (see section 5.1 and section 5.2).
Maltese: Dejta mhux disponibbli (ara sezzjoni 5.1 u sezzjoni 5.2).
English: • stomach problems such as ‘“gastroenteritis”' or ‘“gastritis”'
Maltese: • problemi fl-istonku bħal ‘gastroenterite' jew ‘gastrite'
English: Hypersensitivity†, bronchospasm†, angioedema† anaphylactic reaction/shock†
Maltese: Sensittività eċċessiva†, bronkospażm u†, anġjoedima†, reazzjoni/xok k anafilattiku†
English: Frequency categories are defined using the following convention: 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), very rare (<1/10,000), not known (cannot be estimated from the available data).
Maltese: Il-kategoriji ta' frekwenza huma definiti bl-użu tal-konvenzjoni li ġejja: 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), rari ħafna (<1/10,000), mhux magħruf (ma tistax tittieħed stima mid-dejta disponibbli).
English: = serum calcium (mg/dl) + 0.8 x [4 - albumin (g/dl)]
Maltese: = kalċju fis-serum (mg/dl) + 0.8 x [4 - albumina (g/dl)]
English: • eating a balanced diet rich in calcium and vitamin D
Maltese: • li tiekol dieta bilanċjata b'ħafna kalċju u vitamina D
English: • a family history of osteoporosis
Maltese: • passat mediku ta' osteoporożi fil-familja