FrancophonIA/ELRC3.0 huggingface dataset:
English: PASI 90 response at Week 48
Maltese: Ġimgħa 48 PASI 75
English: In both studies, 21% had received prior biologic therapy, including 11% who had received at least one anti-tumour necrosis factor alpha (TNFα) agent, and approximately 10% who had received an anti-IL-12/IL-23 agent.
Maltese: Fiż-żewġ studji, 21% kienu rċivew terapija bijoloġika qabel, inkluż 11% li kienu rċivew mill-inqas sustanza waħda kontra l-fattur alfa ta' nekrożi tat-tumur (TNFα, anti-tumour necrosis factor alpha), u madwar 10% li kienu rċivew sustanza kontra
English: Signs of improvement on patient-reported outcomes were maintained through Week 24 (VOYAGE 1 and 2) and Week 48 (VOYAGE 1).
Maltese: Sinjali ta' titjib fuq ir-riżultati rrappuratati mill-pazjent inżammu sa Ġimgħa 24 (VOYAGE 1 u 2) u Ġimgħa 48 (VOYAGE 1).
English: Anti-TB therapy should be considered prior to initiating Tremfya in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.
Maltese: Terapija kontra t-TB għandha titqies qabel jinbeda Tremfya f'pazjenti bi storja ta' TB moħbija jew attiva fil-passat fejn ma jkunx jista' jiġi kkonfernmat li ħadu kors xieraq ta' trattament.
English: Withdrawal patients re-initiated guselkumab (dosed at time of retreatment, 4 weeks later and q8w thereafter) when they experienced at least a 50% loss of their Week 28 PASI improvement.
Maltese: Pazjenti li kienu waqqfu t-trattament reġgħu bdew jirċievu guselkumab (doża mogħtija fiż-żmien tat-trattament mill-ġdid, 4 ġimgħat wara u q8w wara dan) meta kellhom telf ta' mill-inqas 50% mit-titjib ta' PASI tagħhom ta' Ġimgħa 28.
English: Signs of infections may include fever or flu like symptoms; muscle aches; cough; shortness of breath; burning when you urinate or urinating more often than usual; blood in your phlegm (mucus); weight loss; diarrhoea or stomach pain; warm, red, or painful skin or sores on your body which are different from your psoriasis.
Maltese: Sinjali ta' infezzjonijiet jinkludu deni jew sintomi jixbhu lill-influwenza; uġigħ fil-muskoli; sogħla; qtugħ ta' nifs; ħruq meta tagħmel l-awrina jew tagħmel l-awrina aktar spiss mis-soltu; demm fil-bili (mukus); telf ta' piż; dijarea jew uġigħ fl-istonku; ġilda li tinħass sħuna, tkun ħamra jew bl-uġigħ jew feriti fuq il-ġisem tiegħek li jkunu differenti mill-psorjasi.
English: Treatment with guselkumab resulted in significant improvements in the measures of disease activity compared to placebo and adalimumab at Week 16 and compared to adalimumab at Weeks 24 and 48.
Maltese: It-trattament b'guselkumab wassal għal titjib sinifikanti fil-kejl tal-attività tal-marda meta mqabbel mal-plaċebo u ma' adalimumab f'Ġimgħa 16 u mqabbel ma' adalimumab fil-Ġimgħat 24 u 48.
English: Loss of PASI 90 response was noted as early as 4 weeks after withdrawal of guselkumab treatment with a median time to loss of PASI 90 response of approximately 15 weeks.
Maltese: Telf tar-rispons PASI 90 ġie nnutat sa minn 4 ġimgħat wara ttwaqqif tat-trattament b'guselkumab bi żmien medjan għat-telf ta' rispons PASI 90 ta' madwar 15-il ġimgħa.
English: This medicine works by blocking the activity of a protein called IL-23, which is present at increased levels in people with psoriasis.
Maltese: Din il-mediċina taħdem billi timblokka l-attività ta' proteina msejħa IL-23, li hija preżenti f'livelli ogħla f'persuni bil-psorjasi.
English: PRE-FILLED SYRINGE CARTON TEXT (100 mg)
Maltese: KITBA FUQ IL-KARTUNA TAS-SIRINGA MIMLIJA GĦAL-LEST (100 mg)
English: The following side effects are all mild to moderate.
Maltese: L-effetti sekondarji li ġejjin huma kollha minn ħfief sa moderati.
English: Serious hypersensitivity reactions have been reported in the post-marketing setting.
Maltese: Reazzjonijiet serji ta' sensittività eċċessiva ġew irrappurtati fl-ambjent ta' wara t-tqegħid fis-suq.
English: See section 5.3 for information on the excretion of guselkumab in animal (cynomolgus monkey) milk.
Maltese: Ara sezzjoni 5.3 għal informazzjoni dwar l-eliminazzjoni ta' guselkumab fil-ħalib tal-annimali (xadini cynomolgus).
English: Tremfya 100 mg solution for injection in pre-filled syringe.
Maltese: Tremfya 100 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest.
English: Inspect liquid
Maltese: Mard reġjonali
English: Uncommon Hypersensitivity
Maltese: GĦAMLA KWALITATTIVA
English: Summary of Patient Reported Outcomes at Week 16 in VOYAGE 1 and VOYAGE 2 VOYAGE 1
Maltese: Tabella 4: Sommarju tar-Riżultati Rappurtati mill-Pazjent f'Ġimgħa 16 f'VOYAGE 1 u VOYAGE 2
English: Injection site erythema Uncommon Injection site pain
Maltese: Terapija immunosoppressiva jew fototerapija konkomittanti
English: In in vitro models, guselkumab was shown to inhibit the bioactivity of IL-23 by blocking its interaction with cell surface IL-23 receptor, disrupting IL-23-mediated signaling, activation and cytokine cascades.
Maltese: F'mudelli in vitro, guselkumab intwera li jinibixxi l-bijoattività ta' IL-23 billi jimblokka l-interazzjoni tiegħu mar-riċettur ta' IL-23 fuq is-superfiċje taċ-ċellula, u b'hekk ifixkel l-għoti ta' sinjali, l-attivazzjoni u l-kaskati taċċitokin medjati minn IL-23.
English: Needle Guard
Maltese: Pazjenti anzjani
English: Patients were examined at four week intervals for a total of four visits.
Maltese: 4.4 Twissijiet speċjali u prekawzjonijiet għall-użu
English: Guselkumab demonstrated rapid onset of efficacy, with a significantly higher percent improvement in PASI as compared with placebo as early as Week 2 (p < 0.001).
Maltese: Guselkumab wera bidu mgħaġġel ta' effikaċja, b'perċentwal ta' titjib sinifikament ogħla f'PASI meta mqabbel mal-plaċebo sa minn Ġimgħa 2 (p < 0.001).
English: The safety and efficacy of Tremfya in children and adolescents below the age of 18 years have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' Tremfya fit-tfal u fl-adolexxenti taħt l-età ta' 18-il sena għadhom ma ġewx determinati s'issa.
English: Each pre-filled syringe contains 100 mg of guselkumab in 1 mL solution.
Maltese: Kull siringa mimlija għal-lest fiha100 mg ta' guselkumab f'1 mL ta' soluzzjoni.
English: It is supplied as a carton pack containing one single-dose pre-filled pen and as a multipack containing 2 (2 packs of 1) single-dose pre-filled pens.
Maltese: Huwa fornut bħala pakkett ta' kartuna li fiha pinna mimlija għal-lest b'doża waħda u bħala pakkett b'ħafna li fih 2 (2 pakketti ta' 1) pinen mimlija għal-lest b'doża waħda.
English: Tremfya is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of plaque psoriasis.
Maltese: Tremfya huwa maħsub biex jintuża taħt il-gwida u s-superviżjoni ta' tabib b'esperjenza fid-dijanjosi u ttrattament tal-psorjasi bil-plakka.
English: National competent authorities of Member State(s) or reference Member State(s) if applicable, shall ensure that the following conditions are fulfilled by the MAH(s):
Maltese: Awtoritajiet kompetenti nazzjonali ta' Stat(i) Membru/i jew Stat(i) Membru/i ta' referenza jekk applikabbli, għandhom jiżguraw li l-kundizzjonijiet segwenti jiġu ssodisfati mid-Detentur(i):
English: The Marketing Authorisation Holders for the rectal formulations that remain authorised shall conduct a pharmacokinetic study to generate data to allow for a comparison between the rectal and oral formulations.
Maltese: Id-Detenturi tal-Awtorizzazzjonijiet għat-Tqegħid fis-Suq għall-formulazzjonijiet tar-rektum li jibqgħu awtorizzati għandhom iwettqu studju farmakokinetiku biex jiġġeneraw dejta biex ikun jista' jsir paragun bejn il-formulazzjonijiet tar-rektum u dawk orali.
English: The Marketing Authorisation Holders shall perform a drug utilisation study to assess the effectiveness of the risk minimisation measures and to monitor off-label use.
Maltese: Id-Detenturi tal-Awtorizzazzjonijiet għat-Tqegħid fis-Suq għandhom iwettqu studju ta' utilizzazzjoni tal-mediċina biex jivvalutaw l-effikaċja tal-miżuri ta' minimizzazzjoni tar-riskju u biex jiġi sorveljat l-użu mhux skont it-tikketta.
English: A study shall be conducted to generate robust data on the efficacy of domperidone in the relief of symptoms of nausea and vomiting in children at the recommended doses.
Maltese: Għandu jsir studju biex jiġġenera dejta robusta dwar l-effikaċja ta' domperidone, fis-serħan mis-sintomi ta' dardir u rimettar fit-tfal bid-dożi rakkomandati.
English: The final study report shall be submitted to the National Competent Authorities within 36 months of endorsement of the protocol, and updates on progress with recruitment to the study shall be submitted to the National Competent Authorities on a yearly basis.
Maltese: Ir-rapport finali tal-istudju għandu jiġi ppreżentat lill-Awtoritajiet Kompetenti Nazzjonali fi żmien 36 xahar mill-approvazzjoni tal-protokoll, u aġġornamenti dwar il-progress fir-reklutaġġ għall-istudju għandhom jiġu sottomessi lill-Awtoritajiet Kompetenti Nazzjonali fuq bażi annwali.
English: The Marketing Authorisations Holders of products for which a paediatric indication is approved shall submit the protocols of new or ongoing studies to the National Competent Authorities within 4 months of the commission decision for this procedure.
Maltese: Id-Detenturi talAwtorizzazzjonijiet għat-Tqegħid fis-Suq ta' prodotti li għalihom hija approvata indikazzjoni pedjatrika għandhom jissottomettu l-protokolli tal-istudji ġodda jew li għadhom għaddejjin lillAwtoritajiet Nazzjonali Kompetenti fi żmien 4 xhur mid-deċiżjoni tal-Kummissjoni għal din ilproċedura.
English: The study shall be conducted in more than one Member State and the protocol shall be submitted to the PRAC within 3 months of the commission decision for this procedure.
Maltese: L-istudju għandu jsir f'aktar minn Stat Membru wieħed u l-protokoll għandu jiġi ppreżentat lill-PRAC fi żmien 3 xhur mid-Deċiżjoni talKummissjoni għal din il-proċedura.
English: Within 3 months of the commission decision for this procedure, the MAHs shall submit to the National Competent Authorities a Risk Management Plan containing the key elements described in the PRAC assessment report.
Maltese: Fi żmien 3 xhur mid-Deċiżjoni tal-Kummissjoni għal din il-proċedura, id-Detenturi talAwtorizzazzjonijiet għat-Tqegħid fis-Suq għandhom jissottomettu lill-Awtoritajiet Kompetenti Nazzjonali, Pjan tal-Ġestjoni tar-Riskju li jkun fih l-elementi ewlenin deskritti fir-rapport ta' valutazzjoni tal-PRAC.
English: Subcutaneous use pre-filled syringe (glass)
Maltese: Użu taħt il-ġilda siringa mimlija għal-lest (ħġieġ)
English: 1 pre-filled syringe
Maltese: Soluzzjoni għallinjezzjoni
English: Wait 5 minutes
Maltese: Stenna 5 minuti
English: Idifarma Desarrollo Farmaceutico S.L., Polígono Mocholí, C/ Noáin, No.1, 31110 Noáin, Navarra, , Spain.
Maltese: Idifarma Desarrollo Farmaceutico S.L., Polígono Mocholí, C/ Noáin, No.1, 31110
English: CO)NH2 + H2O → 2NH3 +
Maltese: H2N(13CO)NH2 + H2O ® 2NH3 + 13CO2
English: The endogenous production of urea amounts to 25 - 35 g/day.
Maltese: Il-produzzjoni endoġenika ta' l-urea tammonta għal 25 - 35 g/jum.
English: Ireland enquiries@torbetlaboratories.co.uk
Maltese: L-Irlanda customerservices@torbetlaboratories.co.uk
English: • 2 straws.
Maltese: • Żewġ strôs.
English: The test will take about 45 minutes.
Maltese: It-test se jieħu madwar 45 minuta.
English: In comparison with biopsy based techniques for diagnosing H.pylori infection, using data from two therapeutic trials, Pylobactell achieved during different conditions (prestudy and follow-up visits) sensitivity estimates above 95 % with lower one-sided 95 % confidence limit ranging from 93 % to 98 %.
Maltese: Meta mqabbel ma' tekniċi bbażati fuq il-bijopsija bħala dijanjożi għall-infezzjoni ta' l-H. pylori u meta wieħed juża informazzjoni minn żewġ provi terapewtiċi, il-Pylobactell -f'kondizzjoniet differenti (l-eżamijiet mediċi ta' qabel ma' beda l-istudju u dawk ta' wara) - laħaq stimi tas-sensittività ta' 'l fuq minn 95 % bil-lower one-sided 95 % confidence limit bejn 93 % sa 98 %.
English: ATC code: V04C X.
Maltese: V04CX.
English: Number: EU/1/98/064/001
Maltese: In-Numru ta' l-M.A: EU/1/98/064/001
English: All foods contain a substance called carbon 13 (
Maltese: L-ikel kollu fih sustanza li tissejjaħ carbon 13 (
English: Satisfactory specificity and sensitivity have been demonstrated in clinical studies where breath was analysed using isotope ratio mass spectrometry (IRMS).
Maltese: Fi studji kliniċi kienu dimostrati speċifiċità u sensittività sodisfaċenti fejn in-nifs kien analizzat bl-użu ta' isotope ratio mass spectrometry (IRMS).
English: (ii) proton pump inhibitors (PPIs) in the last 14 days?
Maltese: (ii) xi inibituri tal-pompa talproton (PPIs) fl-aħħar 14-il jum?
English: Instruments must be linear over a wide range of CO2 concentrations, typically 1.0 - 6.0%.
Maltese: L-istrumenti għandhom ikunu lineari fuq medda wiesgħa ta' konċentrazzjonijiet ta' CO2, tipikament 1.0 - 6.0%.
English: Date of Test:
Maltese: Id-Data tat-Test:
English: iii.
Maltese: ii.
English: E-mail enquiries@torbetlaboratories.co.uk
Maltese: E-mail. customerservices@torbetlaboratories.co.uk Il-Manifattur
English: Samples logged on by :
Maltese: Il-kampjuni rrekordjati minn:
English: Drink the recommended test meal.
Maltese: Sett ta' test dijanjostiku.
English: (i) antibiotics in the last 28 days?
Maltese: (i) xi antibijotiċi fl-aħħar 28 jum?
English: The specificity estimates were all above 90 % with corresponding lower confidence limits ranging from 85 % to 90 %.
Maltese: L-istimi ta' lispeċifiċità kienu kollha 'l fuq minn 90 %, bil-lower confidence limits korrispondenti minn 85 % sa 90
English: Suppression of H. pylori might give false negative results.
Maltese: It-trażżin ta' l-H. pylori jista' jagħti riżultati negattivi foloz.
English: • you are under 18 years.
Maltese: • inti għandek inqas minn 18-il sena.
English: INFORMATION IN BRAILLE
Maltese: STRUZZJONIJIET DWAR L-UŻU INFORMAZZJONI BIL-BRAILLE
English: Fasting:
Maltese: TAS-SETT:
English: • Security Label and 3 additional bar code labels.
Maltese: • Tikketta tas-sigurtà u 3 tikketti oħra bil-bar kowds.
English: For in vivo diagnosis of gastroduodenal Helicobacter pylori infection.
Maltese: Għal dijanjosi in vivo ta' infezzjoni gastro-duwodenali ta' Helicobacter pylori (H. pylori).
English: Analytical file reference: Laboratory code:
Maltese: Ir-referenza tal-fajl analitiku:
English: • You have taken antibiotics or medication to treat Helicobacter pylori within the last 28 days
Maltese: • Inti ħadt anti-bijotiċi jew mediċini għall-kura ta' Helicobacter pylori fl-aħħar 28 ġurnata.
English: Torbet Laboratories Ireland Ltd, 20 Holles Street, Dublin 2, Ireland.
Maltese: Torbet Laboratories Ireland Ltd, 20 Holles Street, Dublin 2, L-Irlanda.
English: - The active substance is
Maltese: LISTA TA' SUSTANZI MHUX ATTIVI
English: Do not store the kit above 25°C.
Maltese: Taħżinx f'temperatura 'l fuq minn 25°C.
English: Pylobactell, 100 mg, Soluble Tablet
Maltese: Pylobactell 100 mg, pillola li tinħall
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti tar- rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tadDirettiva 2001/83/KE u kwalunke aġġornament sussegwenti ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini
English: The amount of
Maltese: U KWANTITATTIVA
English: Urea is rapidly absorbed from the gastro-intestinal tract and distributed into extracellular and intracellular fluids including lymph, bile, cerebrospinal fluid and blood.
Maltese: L-urea hija assorbita malajr mill-passaġ gastrointestinali u tinxtered fil-fluwidi ekstraċellulari u intraċellulari li jinkludu l-lymph, il-bile, il-fluwidu ċerebrospinali u d-demm.
English: IRMS instruments may be of continuous flow or dual inlet configuration.
Maltese: L-istrumenti tal-IRMS jistgħu jkunu konfigurati b'ċirkolazzjoni kontinwa jew bi dual inlet.
English: • 6 glass tubes, 3 with white caps and 3 with red caps.
Maltese: • 6 tubi tal-ħġieġ, 3 b'tappijiet bojod u 3 b'tappijiet ħomor.
English: Carbon-urea solution
Maltese: Preparazzjoni tas-soluzzjoni ta' 13carbon-urea
English: Pylobactell 100mg soluble tablet C-Urea
Maltese: Pylobactell 100mg pillola li tinħall 13C-Urea
English: Pre-test Breath Samples (3 White Capped Tubes)
Maltese: Il-Kampjuni tan-Nifs ta' Qabel it-test (3 Tubi b'Tappijiet Bojod)
English: t = 40 Collect Post-Urea samples (Red Caps - 3 times).
Maltese: t = 40 Iġbor il-kampjuni Ta' Qabel l-Urea (it-Tappijiet il-Ħomor -3 darbiet).
English: CO2 in the breath samples may be determined by isotope-ratio-mass spectrometry (IRMS) or by another suitably-validated method carried out by any qualified laboratory, and stated as an absolute difference (excess) in the value between the pre-urea and post-urea breath samples (see Section 6.6).
Maltese: Il-proporzjon tal- 13CO2 fil-kampjuni tan-nifs jista' jkun iddeterminat mill-ispettrometrija tal-isotope ratio-mass (IRMS) jew b'xi metodu ieħor li kien ippruvat b'mod xieraq minn kwalunkwe laboratorju kkwalifikat, u ddikjarat bħala d-differenza assoluta (iż-żejjed) fil-valur bejn il-kampjuni tan-nifs ta' qabel u ta' wara l-urea (ara sezzjoni 6.6).
English: Torbet Laboratories Ireland Limited, 20 Holles Street, Dublin 2, Ireland.
Maltese: Torbet Laboratories Ireland Limited, 20 Holles Street, Dublin 2, L-Irlanda.
English: 1 x Pre/Post sample reserved in store.
Maltese: 1 x kampjun Ta' Qabel/Ta' Wara rriservati fil-maħżen.
English: The IRMS must possess a triple collector to allow the simultaneous detection of the ions at mass/charge ratio 44, 45 and 46 fluctuations in the oxygen isotope content.
Maltese: L-IRMS irid ikollu immuntar ta' ġbir triplu biex jippermetti is-sejba fl-istess waqt tal-ijoni f'oxxillazzjonijiet fil-proporzjon ta' piż/ċarġ ta' 44, 45 u 46 fil-kontenut ta' l-isotop ta' l-ossiġnu.
English: If no test meal has been supplied, the most suitable test meal is 200 ml of pure undiluted orange juice.
Maltese: Jekk ma ġietx ipprovduta ikla tat-test, l-aħjar ikla tat-test hija 200 ml ta' meraq tal-larinġ pur mhux dilwit.
English: Adults: The tablet is to be dissolved in water and taken 10 minutes after the start of the breath test procedure.
Maltese: Il-pillola għandha tinħall fl-ilma u tittieħed 10 minuti wara li tkun bdiet l-proċedura tat-test tan-nifs.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq il-website ta' l-Aġenzija Ewropeja dwar ilMediċini http://www.ema.europa.eu.
English: C-urea breath test kit contains a sachet containing the Pylobactell tablet, six glass tubes with caps and bar code labels, three additional bar code labels, a 30 ml mixing and administration glass vial with cap, two straws, a package leaflet and an Analysis Request Form.
Maltese: Is-sett tat-test tan-nifs ta' l-urea ta' Pylobactell 13C fih qartas issiġillat bis-sħana, laminat b'PET/fuljetta rqiqa ta' l-aluminju/LDPE, li fih pillola waħda ta' Pylobactell, sitt tubi tal-ħġieġ bittappijiet u tikketti tal-bar kowd, bi tliet tikketti oħra bil-bar kowd, kunjett tal-ħġieġ ta' 30 ml bit-tapp fejn tħallat u minn fejn tagħti l-prodott, żewġ stros, fuljett ta' tagħrif u Formola tat-Talba għallAnaliżi.
English: BN
Maltese: Noáin
English: Analysis Request Form.
Maltese: Mhux applikabbli.
English: C-urea - The other ingredients are povidone (E1201), microcrystalline cellulose (E460i), colloidal anhydrous silica and sodium benzoate (E211).
Maltese: Kull pillola fiha 100 mg ta' 13C-urea - Is-sustanzi l-oħra huma povidone (E1201), microcrystalline cellulose (E460i), colloidal anhydrous silica u sodium benzoate (E211).
English: Other medicines and Pylobactell
Maltese: Mediċini oħra u Pylobactell
English: Breath samples collected during a test must remain in the original containers before analysis by IRMS.
Maltese: Il-kampjuni tan-nifs miġbura waqt t-test għandhom jibqgħu fil-kontenituri oriġinali qabel analiżi b'IRMS.
English: C-urea.
Maltese: U L-UŻU C.
English: In the case of infection with H.pylori, orally ingested 13C-urea is metabolised by the enzyme urease which is present in H.pylori.
Maltese: F'każ ta' infezzjoni ta' l-H. pylori, il-13C-urea li tinbela' mill-ħalq tiġi metabolizzata mill-enzima, urease li tinsab fl-H. pylori.
English: H. pylori status: -< 3.5 excess 
Maltese: L-istat ta' H. pylori :- < 3.5 ta' d13C żejjed = Negattiv > 3.5 ta' d13C żejjed = Pożittiv
English: MEDICATION RECORD
Maltese: TAL-PRODOTT MEDIĊINALI
English: TEST CHECK LIST
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: If the patient has eaten a heavy meal then it will be necessary to fast for six hours prior to the test.
Maltese: Jekk il-pazjent ikun kiel ikla tqila, huwa neċessarju li jibqa' sajjem għal 6 sigħat qabel it-test.
English: The optimal test meal recommended is 200 ml pure undiluted orange juice.
Maltese: L-aħjar ikla rrakkomandata għat-test hija 200 ml ta' meraq tal-larinġ pur, mhux dilwit.
English: • You have already been diagnosed with H. pylori and have been taking medication aimed to clear up the infection.
Maltese: • Diġà kont dijanjozzat b'H. pylori u kont qed tieħu mediċini bil-għan li tikkura l-infezzjoni.
English: • You have taken H2 antagonists or antacids on the same day of the test. Do not stop taking medication without the advice of your doctor.
Maltese: • Inti ħadt antagonisti ta' H2 jew antaċidi (itaffu l-indiġestjoni) fl-istess ġurnata tat-test.
English: Pylobactell is a breath test for determining the presence of the bacterium, Helicobacter pylori (H. pylori) in the gut (stomach and adjacent bowel) which may be the reason for your stomach (gastric) condition.
Maltese: Huwa wżat biex tiġi determinata l-preżenza tal-batterju Helicobacter pylori (H. pylori) fil-imsaren (stonku u l-musrana ta' ħdejħ).
English: M.A.
Maltese: A.
English: OUTER CARTON/CARDBOARD BOX
Maltese: ANNESS I SOMMARJU TAL-KARATTERISTIĊI
English: Centre:
Maltese: Iċ-Ċentru:
English: EXP {MM/YYYY}
Maltese: GĦALL- ANALIŻI
English: IRMS source parameters and tuning must be optimised daily.
Maltese: Il-parametri u l-aġġustament tas-sorsi ta' l-IRMS għandhom jiġu ottimizzati kuljum.
English: ADDITIONAL KIT ITEM: SECURITY LABEL
Maltese: TIKKETTA TAS-SIGURTÀ {TIKKETTA}
English: • Analysis Request Form.
Maltese: • Formola ta' Talba għall-Analiżi.
English: No side effects to Pylobactell have been reported.
Maltese: L-ebda effetti sekondarji ta' Pylobactell ma kienu rrapportati.
English: • You have taken proton pump inhibitors in the last 14 days
Maltese: • Inti ħadt inibituri tal-proton pump (iwaqqfu l-indiġestjoni) fl-aħħar 14-il ġurnata.
English: If you need to repeat the test, a new kit will be required and it should not be carried out until the following day.
Maltese: Jekk ikun hemm bżonn li t-test jiġi ripetut, dan m'għandux isir qabel il-jum ta' wara.
English: Pharmacotherapeutic group: Other diagnostic agents
Maltese: Il-kodiċi tal-laboratorju:
English: iv.
Maltese: i.
English: One tablet contains: 100 mg
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Pillola waħda fiha: 100 mg ta' 13C-urea
English: A sachet containing one Pylobactell 100 mg soluble tablet.
Maltese: Qartas b'pillola waħda li tinħall ta' Pylobactell 100 mg.
English: 2 x Pre/Post samples + this form for return to a qualified laboratory.
Maltese: 2 x kampjuni Ta' Qabel/Ta' Wara + din il-formola biex jintbagħtu lil-laboratorju kkwalifikat
English: 07 May 2008
Maltese: Data ta' l-aħħar tiġdid: 7 ta' Mejju, 2008
English: Marketing Authorisation Holder: Torbet Laboratories Ireland Limited, 20 Holles Street, Dublin 2, Ireland
Maltese: Torbet Laboratories Ireland Limited, 20 Holles Street, Dublin 2, L-Irlanda
English: Each Pylobactell Breath Test kit contains:
Maltese: KONTENUT TAL-PAKKETT U INFORMAZZJONI OĦRA X'fih Pylobactell: