FrancophonIA/ELRC3.0 huggingface dataset:
English: nausea, vomiting Uncommon: dyspepsia, diarrhoea
Maltese: Komuni ħafna: tqallih, rimettar Mhux komuni: dispepsja, dijarea
English: Children under the age of 18 must not take Parareg.
Maltese: Tfal taħt l-età ta' 18-il sena m'għandhomx jieħdu Parareg.
English: Treatment of secondary hyperparathyroidism (HPT) in patients with end-stage renal disease (ESRD) on maintenance dialysis therapy.
Maltese: Kura ta' iperparatirojdiżmu sekondarju (HPT) f'pazjenti b'mard renali ta' l-aħħar stadju (ESRD) fuq terapija ta' manutenzjoni b'dijalisi.
English: Secondary Hyperparathyroidism
Maltese: GĦALL-HRUĠ TAL
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/293/009 - carton of 14 tablets
Maltese: FIS-SUQ EU/1/04/292/009 - Kaxxa b'14 -il pillola EU/1/04/292/010
English: There were no effects on fertility in males or females at exposures up to 4 times a human dose of 180 mg/day (safety margins in the small population of patients administered a maximum clinical dose of 360 mg daily would be approximately half those given above).
Maltese: Ma kienx hemm effetti fuq il-fertilità fl-irġiel jew n-nisa f'espożizzjonijiet sa 4 darbiet id-doża umana ta' 180 mg/kuljum (marġini ta' siġurtà fil-popolazzjoni żgħira ta' pazjenti mogħtija id-doża klinikali massima ta' 360 mg kuljum tkun madwar nofs dawk mogħtija hawn fuq).
English: An open-label extension of this study showed no further reductions in free and total testosterone concentrations over a period of 3 years in Mimpara-treated patients.
Maltese: Estensjoni open-label ta' dan l-istudju ma wrietx aktar tnaqqis fil-konċentrazzjoni ta' testosterone ħieles u fil-konċentrazzjoni tat-testosterone totali fuq perijodu ta' 3 snin f' pazjenti kkurati b' Parareg.
English: • antibiotics used to treat bacterial infections (telithromycin, rifampicin);
Maltese: • anti-bijotiċi wżati għall-kura ta' infezzjonijiet ikkawżati mill-batterji (telithromycin,
English: The calcium sensing receptor on the surface of the chief cell of the parathyroid gland is the principal regulator of PTH secretion.
Maltese: Jintuża biex jikkura problemi ta' organi magħrufa bħala glandoli paratirojdi.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/293/004
Maltese: FIS-SUQ EU/1/04/293/004
English: Caution should be exercised when Parareg is administered with individually titrated, narrow therapeutic index medications that are predominantly metabolised by CYP2D6.
Maltese: Għandha tintuża kawtela meta Parareg tingħata ma' mediċini, ttitrati individwalment li għandhom indiċi terapewtiku dejjaq u li huma metabolizzati pimarjament minn CYP2D6.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/293/008
Maltese: FIS-SUQ EU/1/04/293/008
English: Compared to subjects with normal liver function, average AUC of cinacalcet was approximately 2-fold higher in subjects with moderate impairment and approximately 4-fold higher in subjects with severe impairment.
Maltese: Meta mqabbla ma' individwi b'funzjoni normali tal-fwied, l-AUC medja ta' cinacalcet kienet madwar darbtejn ogħla f'individwi b'indeboliment moderat u madwar 4-darbiet ogħla f' individwi b'indeboliment sever.
English: Herbal medicine: summary for the public
Maltese: Mediċina erbali: sommarju għall-pubbliku
English: Committee on Herbal Medicinal Products (HMPC)
Maltese: Il-Kumitat għall-Prodotti Mediċinali Erbali (HMPC)
English: When handling the powder preparation, inhalation of the powder should be avoided as this may lead to allergic sensitization and the potential development of allergies.
Maltese: Fl-immaniġġar tal-preparazzjoni tat-trab, għandu jiġi evitat it-teħid tat-trab man-nifs billi dan jista' jwassal għal sensibilizzazzjoni allerġika u liżvilupp potenzjali ta' allerġiji.
English: Side effects have been reported with ispaghula husk medicines, including flatulence and abdominal distension (swelling of the belly).
Maltese: Kienu rrappurtati effetti sekondarji bil-mediċini tal-qoxra ta' żerrigħet il-briegħed, inklużi gass flistonku u distensjoni addominali (nefħa taż-żaqq).
English: Ispaghula husk is the common name for the seed coats of the plant Plantago ovata Forssk.
Maltese: Il-qoxra ta' żerrigħet il-briegħed hija l-isem komuni għall-qoxra taż-żerriegħa tal-pjanta Plantago ovata Forssk.
English: Allergic reactions including rhinitis (runny nose), conjunctivitis (reddening and inflammation of the white of the eye), bronchospasm (excessive and prolonged contraction of the airway muscles) and anaphylaxis (severe allergic reaction) may also occur.
Maltese: Jistgħu jseħħu wkoll reazzjonijiet allerġiċi fosthom rinite (imnieħer inixxi), konġuntivite (ħmura u infjammazzjoni fl-abjad tal-għajn), bronkospażmu (kontrazzjoni eċċessiva u fit-tul tal-muskoli talpassaġġi tal-arja) u anafilassi (reazzjoni allerġika severa).
English: Further information on the HMPC assessment of ispaghula husk medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Maltese: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: It can be used in adults and children above the age of 6 years for the treatment of constipation and to soften the stools but should only be used in adults and children over the age of 12 years when used to increase the fibre intake.
Maltese: Tista' tintuża fl-adulti u t-tfal ta' 'l fuq minn 6 snin għall-kura talistitikezza u biex trattab l-ippurgar iżda għandha tintuża biss f'adulti u tfal ta' 'l fuq minn 12-il sena meta tintuża biex iżżid l-ammont ta' fibra li jittieħed.
English: The HMPC concluded that ispaghula husk can be used for the treatment of habitual constipation (constipation not caused by a physical change to an organ) and in conditions where softening of the stools is desirable to reduce pain when they are passed, such as anal fissures, haemorrhoids and after surgery to the anus or rectum.
Maltese: L-HMPC ikkonkluda li l-qoxra ta' żerrigħet il-briegħed tista' tintuża għall-kura tal-istitikezza abitwali (stitikezza mhux ikkawżata minn tibdil fiżiku f'organu) u f'kundizzjonijiet fejn it-trattib tal-ippurgar ikun mixtieq sabiex jitnaqqas l-uġigħ meta jiġi mgħoddi, bħal qsim fl-anus, murliti u wara kirurġija fl-anus jew fir-rektum.
English: Ispaghula husk contains dietary fibre, which when mixed with water forms a gel-like mass that works as a mild laxative (medicine used to treat constipation).
Maltese: Il-qoxra ta' żerrigħet il-briegħed fiha l-fibra dijetetika, li meta titħallat mal-ilma tifforma massa qisha ġell li taħdem bħala lassattiv ħafif (mediċina użata għall-kura tal-istitikezza).
English: What are the risks associated with Ispaghula husk medicines?
Maltese: X'inhuma r-riskji assoċjati mal-mediċini tal-qoxra ta' żerrigħet il-briegħed?
English: Further information on the risks associated with ispaghula husk medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Maltese: Aktar informazzjoni dwar ir-riskji assoċjati mal-mediċini tal-qoxra ta' żerrigħet il-briegħed, inklużi lprekawzjonijiet xierqa għall-użu sigur tagħhom, tinsab fil-monografu taħt it-tab ‘Id-dokumenti kollha' fis-sit elettroniku tal-Aġenzija:
English: What are the HMPC conclusions on its medicinal uses?
Maltese: X'inhuma l-konklużjonijiet tal-HMPC dwar l-użu mediċinali tiegħu?
English: The use of ispaghula husk in hypercholesterolaemia always requires medical supervision.
Maltese: L-użu tal-qoxra ta' żerrigħet il-briegħed fl-iperkolesterolemija dejjem jeħtieġ superviżjoni medika.
English: 15 March 2012
Maltese: 15 ta' Marzu 2012
English: The full European Public Assessment Report for Tyverb 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: The application was withdrawn after ‘day 90'.
Maltese: L-applikazzjoni ġiet irtirata wara 'jum 90'.
English: Tyverb has been authorised in the EU since June 2008.
Maltese: Tyverb ilu awtorizzat fl-UE sa minn Ġunju 2008.
English: What is Tyverb?
Maltese: X'inhu Tyverb?
English: Tyverb is a medicine that contains the active substance lapatinib.
Maltese: Tyverb huwa mediċina li fiha s-sustanza attiva lapatinib.
English: The active substance in Tyverb, lapatinib, belongs to a group of medicines called protein kinase inhibitors.
Maltese: Is-sustanza attiva f'Tyverb, lapatinib, tifforma parti mill-grupp ta' mediċini msejħa inibituri talprotein kinases.
English: This means that the CHMP had evaluated the documentation provided by the company and formulated lists of questions.
Maltese: Dan ifisser li s-CHMP kien evalwa d-dokumentazzjoni pprovduta mill-kumpanija u fformula listi ta' mistoqsijiet.
English: It is available as tablets.
Maltese: Huwa disponibbli f'pilloli.
English: Tyverb is available in all EU Member States.
Maltese: Tyverb huwa disponibbli flIstati Membri kollha tal-UE.
English: On 15 February 2012, Glaxo Group Ltd. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a change to the marketing authorisation for Tyverb, to add the use in combination with paclitaxel for the treatment of metastatic breast cancer.
Maltese: Fil-15 ta' Frar 2012, Glaxo Group Ltd. għarraf uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għallUżu mill-Bniedem (CHMP) bl-intenzjoni li jirtira l-applikazzjoni tiegħu għal bidla fl-awtorizzazzjoni għattqegħid fis-suq għal Tyverb, sabiex iżid l-użu flimkien ma' paclitaxel għall-kura tal-kanċer tas-sider metastatiku.
English: What was Tyverb expected to be used for?
Maltese: Għalxiex kien mistenni li jintuża Tyverb?
English: These compounds work by blocking enzymes known as protein kinases, which can be found in some receptors on the surface of cancer cells including HER2.
Maltese: Dawn il-komposti jaħdmu billi jimblukkaw enzimi magħrufa bħala protein kinases, li jistgħu jinstabu f'ċerti riċetturi fil-wiċċ taċ-ċelloli tal-kanċer inkluż HER2.
English: How is Tyverb expected to work?
Maltese: Kif huwa mistenni li jaħdem Tyverb?
English: About a quarter of breast cancers express HER2.
Maltese: Madwar kwart tal-kanċers tas-sider jiġġeneraw HER2.
English: The company presented data from one main study involving a total of 444 patients with metastatic breast cancer that was expressing large quantities of HER2.
Maltese: Il-kumpanija ppreżentat dejta minn studju ewlieni wieħed li kien jinvolvi total ta' 444 pazjent b'kanċer tas-sider metastatiku li kien qed jiġġenera kwantitajiet kbar ta' HER2.
English: Tyverb is used when the cancer is advanced or metastatic.
Maltese: Tyverb jintuża meta l-kanċer ikun avvanzat jew metastatiku.
English: Tyverb was also expected to be used in combination with paclitaxel (another anticancer medicine) for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2.
Maltese: Tyverb kien ukoll mistenni li jintuża flimkien ma' paclitaxel (mediċina oħra kontra l-kanċer) għall-kura ta' pazjenti b'kanċer tas-sider metastatiku li t-tumuri tagħhom jiġġeneraw HER2 żejda.
English: HER2 is a receptor for epidermal growth factor and is involved in stimulating the cells to divide uncontrollably.
Maltese: HER2 huwa riċettur għallfattur tat-tkabbir epidermali u jistimola ċ-ċelloli sabiex jinqasmu b'mod inkontrollabbli.
English: In particular, the Committee could not exclude the possibility that Tyverb in combination with paclitaxel is inferior to the standard treatment, trastuzumab plus paclitaxel.
Maltese: B'mod partikolari, ilKumitat ma setax jeskludi l-possibbiltà li Tyverb flimkien ma' paclitaxel huwa inferjuri għall-kura standard, trastuzumab flimkien ma' paclitaxel.
English: The CHMP was concerned that the main study, which compared Tyverb with placebo, did not allow the Committee to conclude on how Tyverb compares with other authorised treatments.
Maltese: Is-CHMP kien imħasseb li l-istudju ewlieni, li qabbel lil Tyverb mal-plaċebo, ma kienx jippermetti lillKumitat jikkonkludi dwar kif Tyverb jista' jitqabbel ma' kuri oħrajn awtorizzati.
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had concerns and was of the provisional opinion that Tyverb could not have been approved for use in combination with paclitaxel in the treatment of metastatic breast cancer.
Maltese: Fuq il-bażi tar-reviżjoni tad-dejta u t-tweġiba tal-kumpanija għal-listi ta' mistoqsijiet tas-CHMP, fiżżmien tal-irtirar, is-CHMP kellu xi tħassib u kien tal-opinjoni provviżorja li Tyverb ma setax jiġi approvat għall-użu flimkien ma' paclitaxel għall-kura tal-kanċer tas-sider metastatiku.
English: In its letter notifying the Agency of the withdrawal of application, the company stated that its decision to withdraw the application was based on the CHMP's assessment that the lack of a study comparing Tyverb with another treatment hampered the proper assessment of the benefit-risk balance in European patients in the applied indication.
Maltese: Fl-ittra tagħha li tgħarraf lill-Aġenzija bl-irtirar tal-applikazzjoni, il-kumpanija ddikjarat li d-deċiżjoni tagħha li tirtira l-applikazzjoni kienet ibbażata fuq l-evalwazzjoni tas-CHMP li n-nuqqas ta' studju li jqabbel lil Tyverb ma' kura oħra kien ifixkel l-evalwazzjoni xierqa tal-bilanċ bejn il-benefiċċju u r-riskju fil-pazjenti Ewropej fl-indikazzjoni applikata.
English: 30-minute value
Maltese: 30-minuta-valur
English: Linearity:
Maltese: Linearità:
English: Component
Maltese: Komponent
English: • tumours
Maltese: • tumuri
English: INFAI GmbH An der Kohlenbahn 39 D-58135 Hagen Germany
Maltese: INFAI GmbH An der Kohlenbahn 39 D-58135 Hagen
English: Date of test
Maltese: Data tat-test
English: Quantity
Maltese: Kwantità
English: ≤ 0.2 ‰ on 10 consecutive pulses
Maltese: ≤ 0.2 ‰ fuq 10 pulsi konsekkutivi
English: Infrared spectroscopy (NDIR)
Maltese: Spettroskopija infrared (NDIR)
English: The test procedure lasts approximately 40 minutes.
Maltese: Il-proċedura tat-test tieħu madwar 40 minuta.
English: INFAI GmbH Gottfried-Hagen-Str. 60-62 D-51105 Köln Germany
Maltese: INFAI GmbH Gottfried-Hagen-Str. 60-62 D-51105
English: • The active substance is 13C-urea.
Maltese: • Is-sustanza attiva hi 13C-urea.
English: Mass spectrometry (IRMS)
Maltese: Spettrometrija tal-piż (IRMS)
English: Date of first authorisation: 14 August 1997 Date of latest renewal: 14 August 2007
Maltese: Data tal-ewwel awtorizzazzjoni: 14 Awi 1997 Data tal-aħħar tiġdid: 14 Awi 2007
English: IE, UK INFAI UK Ltd., Tel: +44 1904 435 228, United Kingdom PL Dr Piktel Medic@l Systems, Tel: +48 85 744 7770
Maltese: IE, UK INFAI UK Ltd., Tel: +44 1904 435 228, United Kingdom PL Dr Piktel Medic@
English: NAME OF THE MEDICINAL PRODUCT
Maltese: TA' PRODOTTI MEDIĊINALI
English: 3 % CO2 breath concentration
Maltese: konċentrazzjoni ta' CO2
English: • Helicobacter pylori (see section 3, second paragraph under “Method of use”)
Maltese: • Helicobacter pylori (Ara sezzjoni 3, it-tieni paragrafu taħt “Metodu kif jintuża”)
English: 13C/12C-ratio with respect to Pee Dee Beliminate (PDB)
Maltese: Proporzjon 13C/12C fir-rigward ta' Pee Dee Beliminate (PDB)
English: • 4 weeks after a therapy against a bacterial infection
Maltese: • erba' ġimgħat ta' terapija kontra infezzjoni batterjali
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jippreżenta rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott f'konformità mar-rekwiżiti mniżżla fil-lista tad dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: What is in this leaflet:
Maltese: Ħin ta' kampjonar:
English: Barcodes for 00-minute-value Barcodes for 30-minute-value
Maltese: Barcodes għal valur wara 00 minuti Barcodes għal valur wara 30 minuta
English: Helicobacter pylori infection is present if the difference in 13C/12C of baseline-value and 30-minutevalue exceeds 4.0 ‰.
Maltese: Infezzjoni ta'Helicobacter pylori huwa preżenti jekk id-differenza ta' valur fir-referenza bażi f'13C/12C u 30 minuta - valur jaqbeż 4.0 ‰.
English: EXPIRY DATE BATCH NUMBER OTHER
Maltese: DATA META JISKADI NUMRU TAL-LOTT
English: Sampling time: 30-minute-value
Maltese: Ħin ta' kampjunar: 30-minuta-valur
English: C of baseline-value and 30-minute value exceeds 4.0 ‰.
Maltese: 13C/12C u 30 minuta - valur jaqbeż 4.0 ‰.
English: In comparison to bioptic diagnostics of an infection with Helicobacter pylori, the breath test achieved in clinical trials on 457 patients, a sensitivity in the range of 96.5 % to 97.9 % [95 %-CI: 94.05 %-99.72 %], and a specificity range from 96.7 % to 100 %.
Maltese: B'paragun ma' dijanjostiċi biotiċi ta' infezzjoni b' Helicobacter pylori, it-test tan-nifs, waqt provi kliniċi li saru fuq 457 pazjent, kellu sensittività fil medda ta' 96.5% sa 97.9% [95 %-CI: 94.05 % - 99.
English: EXP: {MM/YYYY}
Maltese: <Lott> [numru]
English: Sample loop:
Maltese: Loop tal-kampjun:
English: and stated as an absolute difference (Δδ-value) between the 00-minute- and the 30-minute-values.
Maltese: u mniżżel bħala differenza assoluta (Δδ-value) bejn il-valuri 00-minuti- u t-30-minuta.
English: The portion of 13CO2 in the breath samples is determined by isotope-ratio-mass-spectrometry (IRMS)
Maltese: Il-porzjon ta' 13CO2 fin-nifs huwa stabbilit bi spettrometrija tal-massa-isotopika proporzjonali (IRMS)
English: • Mass spectrometric analysis
Maltese: • Analiżi spettrometrika tal-massa
English: • Fill the
Maltese: Fil-preżenza ta'
English: Batch:
Maltese: PC:
English: [95 %-CI: 94.17 %-103.63 %], whereas in clinical trials on 93 adolescents from the age 12-17, a sensitivity of 97.7 % [90 %-CI: 91.3 %], and a specificity of 96.0 % [90 %-CI: 89.7 %] were achieved.
Maltese: 94.17 % - 103.63 %], filwaqt li fi provi kliniċi fuq 93 adoloxxent bejn l-etajiet ta' 12 - 17, ġiet miksuba sensittività ta' 97.7% [95 %-CI: 94.17 % - 103.63 %] u speċifiċità ta' 96.0%.[90 %-CI:
English: You will then be asked to drink a solution of carbon-13-urea.
Maltese: Inti mbagħad ser tkun mitlub tixrob taħlita likwida ta' carbon-13 urea.
English: • Infrared spectroscopic analysis
Maltese: • Analiżi spettrometrika tal-piż
English: • 100 ml 100 % orange juice
Maltese: • 100 ml 100 % meraq tal-larinġ jew
English: • 200 ml 100 % orange juice or
Maltese: • 200 ml 100 % meraq tal-larinġ jew
English: 2H2N(13CO)NH2 + 2H2O Enzyme urease 4NH3 + 213CO2
Maltese: 4NH3 + 213CO2
English: White, crystalline powder for oral solution.
Maltese: Trab abjad u kristallin għal soluzzjoni orali.
English: DATE OF REVISION OF THE TEXT
Maltese: TABELLA
English: • Sample preparation for (IRMS)
Maltese: • Preparazzjoni tal-kampjun għal (IRMS)
English: Sampling time: 00-minute-value
Maltese: Ħin ta' kampjunar: 00-minuti-valur
English: “Sampling time: 00-minute-value” out of the test set.
Maltese: “Ħin ta' kampjunar: 00-minuti-valur” barra mis-sett tat-test.
English: Precision of measurement: ≤ 0.3 ‰ for 13C at natural abundance using a 10 ml breath sample tube with 3 % CO2 breath concentration
Maltese: ≤ 0.3‰ għal 13C f'abbundanza naturali bl-użu ta' tubu bil-kampjun tan nifs ta' 10 ml bi 3% ta' konċentrazzjoni tan-nifs CO2
English: Germany
Maltese: Köln
English: Ammonia which is produced as described above by the bacterial hydrolysis is included into the metabolism as NH4+.
Maltese: Ammonia li tiġi prodotta kif deskritt hawn fuq bl-idroliżi batterika hija inkluża fil-metaboliżmu bħala NH4+.
English: Helicobacter Test INFAI is a white, crystalline powder for oral solution.
Maltese: Helicobacter Test INFAI hu trab abjad u kristallin għal soluzzjoni orali.
English: The breath samples, collected in 100 ml breath bags, are analysed by non-dispersive infrared spectrometry (NDIR).
Maltese: Il-kampjuni tan-nifs, miġbura f'boroż tan-nifs ta' 100 ml, jiġu analizzati b'spettrometrija infra-red li ma tinxteridx (NDIR).
English: C-ratios
Maltese: VO4CX
English: All foods contain a substance called carbon-13 (13C).
Maltese: L-ikel kollu fih sustanza msejjaħ carbon-13 (13C).
English: For calibration and measurement necessary CO2-free air (zero-gas) will be produced via an integrated CO2-absorber in the analysator.
Maltese: Għal kalibrazzjoni u kejl meħtieġ, arja mingħajr CO2 (gass żero) għandha toħroġ permezz ta' assorbitur ta' CO2 integrat fl-analizzatur.
English: The portion of 13CO2 in the breath samples is determined by non-dispersive infrared spectrometry and stated as an absolute difference (Δδ-value) between the 00-minute- and the 30-minute-values.
Maltese: Il-porzjon ta' 13CO2 fin-nifs huwa stabbilit bi spettrometrija infra-ħamra li ma tinxteredx u mniżżel bħala differenza assoluta (Δδ-value) bejn il-valuri 00-minuti- u t-30-minuta.
English: EU/1/97/045/002 EU/1/97/045/004
Maltese: EU/1/97/045/001 EU/1/97/045/002 EU/1/97/045/004
English: Precision of measurement: ≤ 0.5 ‰ for 13C at natural abundance using a 100 ml breath bag with
Maltese: ≤ 0.5‰ għal 13C f'abbundanza naturali permezz ta' borża tan-nifs ta'
English: • stomach ulcer
Maltese: enżima urease
English: Multiple replicate analyses: Minimum of 3 replicate analyses of the same sample during operation Security access:
Maltese: Analiżi ripettitivi multipli: Minimu ta' 3 analiżi ripettivi fuq l-istess kampjun waqt l-impjieg Aċċess ta' sigurtà:
English: The automatic preparation system for isotope mass spectrometers which is dedicated for breath test analysis is based on a gas-chromatographic continuous flow separation technique.
Maltese: Is sistema ta' preparazzjoni awtomatika għal spettrometri tal-piż għal isotopes, li hi ddedikata għal analiżi ta' test tan-nifs, hi bbażata fuq teknika ta' separazzjoni tal-fluss kontinwu gass kromatografiku.
English: Adjustment:
Maltese: Stabbiltà:
English: For introduction of the carbon dioxide into the analyser many sample inlet systems are available.
Maltese: Għal introduzzjoni ta' dijossidu karboniku fl-analizzatur hemm diversi sistemi ta' dħul disponibbli.
English: Jar (10 ml volume, polystyrene with polyethylene snap cap)
Maltese: Vażett (volum ta' 10 ml, tap li jinqasam tal-polystyrene ma' polyethylene)
English: Jar contains 45 mg 13C-urea
Maltese: Vażett wieħed fih 45 mg 13C-urea
English: • Specifications for determining 13C/12C-ratios
Maltese: • Speċifikazzjonijiet sabiex jiġu stabbiliti l-proporzjonijiet 13C/12C
English: Posology
Maltese: TIKKETTA
English: Content of the test kit with 50 jars:
Maltese: Kontenut tal-kitt tat-test b'50 vażett:
English: ≤ 0.5 ‰ for breath samples varying between 1 % and 7 % CO2-concentration
Maltese: ≤ 0.5 ‰ għal kampjuni tan-nifs li jvarjaw minn bejn 1 % u 7 % tal konċentrazzjoni ta' CO2
English: The orally applied 13C-urea is metabolised to carbon dioxide and ammonia or is integrated into the body's own urea cycle.
Maltese: L-urea 13C meħuda mill-ħalq hija metabolizzata għal dijossidu karboniku u ammonia jew inkella tiġi integrata fiċ-ċiklu uriku tal-ġisem.
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini http://www.ema.europa.eu/.
English: • Hold the sample tube upright and stick the bar-code label marked “00-minute-value”
Maltese: • Żomm il-borża tan-nifs 'il fuq u t-tikketta tal-kodiċi żbarrati mmarkata “00-minuti-valur”
English: Water is removed from the sample by means of a Nafion water trap or the gas-chromatographic preparation system that separates the individual gases in a gas chromatographic column with Helium as eluent.
Maltese: L-ilma jitneħħa mill-kampjun permezz ta' Nafion water trap jew tas-sistema preparazzjoni gasskromatografiku li tifred il-gassijiet individwali f'kolonna kromatografika ta' gass bil-Helium bħala eluwent.