qanastek/EMEA-V3 huggingface dataset:
Helicobacter Test INFAI for children of the age 3 -11 45 mg powder for oral solution
Helicobacter Test INFAI għal tfal bejn l- etajiet ta ’ 3 snin sa 11- il sena 45 mg trab ta ’ 13C urea għal soluzzjoni orali
One jar contains 45 mg of 13C-urea powder.
Vażett 1 fih 45 mg trab ta ’ 13C- urea għal.
Powder for oral solution.
Trab għal soluzzjoni li tittieħed mill- ħalq.
Helicobacter Test INFAI for children aged 3 to 11 years may be used for in vivo diagnosis of gastroduodenal Helicobacter pylori infection:
Helicobacter Test INFAI għal tfal bejn l- etajiet ta ’ 3 snin sa 11- il sena jista ’ jintuża għal dijanjosi in vivo ta 'infezzjoni b' Helicobacter pylori li jinsab fl- istonku u l- imsaren.
- for the evalutation of the success of eradication treatment, or,
- Għal valorizzazzjoni tas- suċċess f’ trattament ta ’ eradikazzjoni, jew
- when invasive tests cannot be performed, or
- Meta testijiet invażivi ma jistgħux jiġu mwettqa, jew
- when there are discordant results arising from invasive tests.
- Meta jkun hemm riżultati konfliġġenti li joħorġu mit- testijiet
Helicobacter Test INFAI for children aged 3 to 11 years is a breath test for single administration.
Helicobacter Test INFAI għal tfal bejn l- etajiet ta ’ 3 – 11- il sena huwa test tan- nifs.
Children from the age of 3 to 11 must take the content of 1 jar with 45 mg.
Tfal mill- etajiet ta ’ 3 sa 11- il sena jieħdu l- kontenut ta ’ vażett b ’ 45 mg.
For performance of the test, 100 ml 100% orange juice for patients from the age of 3 to 11 (as a pre- administered test meal), as well as tap water (for dissolving the 13C-urea powder) are necessary.
Sabiex jitwettaq it- test 100 ml 100% meraq tal- larinġ għal pazjenti bejn l- etajiet ta ’ 3 snin sa 11- il sena (bħala ikla ta ’ test amministrata minn qabel), kif ukoll ilma tal- vit (biex jinħall it- trab 13C- urea) huwa meħtieġ.
The suppression of Helicobacter pylori might give false negative results.
It- trażżin ta ’ Helicobacter pylori jista jagħti riżultati li huma negattivamemt foloz.
Therefore the test shall be used after at least four weeks without systemic antibacterial therapy and two weeks after last dose of acid antisecretory agents.
Għalhekk it- test għandu jintuża wara ta ’ l- anqas erba ’ ġimgħat mingħajr terapija antibatterika sistemika u ġimagħtejn wara l- aħħar doża ta ’ aġenti aċidi li jaħdmu kontra t- tnixxija.
It is important to follow the instructions for use adequately (see section 6.6), otherwise the reliability of the outcome will become questionable.
15 Huwa importanti li l- istruzzjonijiet dwar l- użu jiġu segwiti kif deskritt f' sezzjoni 6. 6, inkella l- validità tar- riżultat ma ’ jkunx konklussiv.
15 4.3 Contraindications
4. 3 Kontra- indikazzjonijiet
The test must not be used in patients with documented or suspected gastric infection or atrophic gastritis, which might interfere with the urea breath test (see section 4.2).
It- test m' għandux jintuża fuq pazjenti li għandhom infezzjoni dokumentata jew suspettata fl- istonku jew għandhom gastrite atrofika, li tista ’ tinterferixxi mat- test tan- nifs ta ’ l- urea (jekk jogħġbok irreferi għal sezzjoni 4. 2 – Pożoloġija u metodu ta ’ amministrazzjoni).
Differential diagnosis with invasive endoscopic methods might be indicated in order to examine the presence of any other complicating conditions, e.g. ulcer, autoimmune gastritis and malignancies.
Jista ’ jkun hemm bżonn ta 'dijanjosi differenzjali b' metodi endoskopiċi invażivi sabiex jiġi stabbilit jekk hemmx xi kundizzjonijiet oħrajn preżenti eż. ulċeri, gastrite awtoimmunitarji u malinni.
There is insufficient data on the diagnostic liability of the Helicobacter Test INFAI for children aged 3 to 11 years to recommend its use in patients with gastrectomy and in patients younger than 3 years of age.
Qaghad m' hemmx biżżejjed informazzjoni rigward dispożizzjoni dijanjostika ta ’ Helicobacter Test INFAI għal tfal bejn l- etajiet ta ’ 3 snin sa 11- il sena sabiex din tiġi rakkomandata f’ pazjenti b’ gastrektomija u fi tfal li huma iżgħar minn 3 snin.
Helicobacter Test INFAI for children aged 3 to 11 years will be affected by all treatments interfering with Helicobacter pylori status or urease activity.
Helicobacter Test INFAI għal tfal bejn l- etajiet ta ’ 3 snin sa 11- il sena jiġi affetwat b' kull trattament li jinterferixxi ma ’ l- istat ta ’ Helicobacter pylori jew attività ta ’ urease.
Due to the fact that only 45 mg of 13C-urea is delivered, an overdose is not expected.
Minħabba li 45 mg ta ’ 13C- urea hija fornuta, mhux mistenni li jkun hemm doża eċċessiva.
For the amount of 45 mg 13C-urea, which is administered per unit in the course of the breath test, no pharmacodynamic activity is described.
16 Għall- ammont ta’ 45 mg 13C- urea, mogħti għal kull unità fil- perkors tat- test tan- nifs, l- ebda attività farmakodinamika m’ hija deskritta.
In the presence of Helicobacter pylori the 13C-urea is metabolised by the enzyme urease of Helicobacter pylori.
Fil- preżenza ta ’ Helicobacter pylori l- urea 13C- urea hija metabolizzata bl- enżima urease ta’ Helicobacter pylori.
16 The carbon dioxide diffuses into the blood vessels.
Id- dijossidu karboniku jnixxi fil- vażi tad- demm.
From there it is transported as bicarbonate into the lung and liberated as 13CO2 with the exhaled air.
Minn hemm jiġi trasportat bħala bikarbonat fil - pulmun u liberat bħala 13CO2 fl- arja mitfugħa’ l barra..
The portion of 13CO2 in the breath samples is determined by isotope-ratio-mass-spectrometry (IRMS) and stated as an absolute difference (Δδ-value) between the 00-minute- and the 30-minute-values.
Il- porzjon ta ’ 13CO2 fin- nifs huwa stabbilit bi spettrometrija tal- massa- isotopika proporzjonali (IRMS) u mniżżel bħala differenza assoluta (Δδ- value) bejn il- valuri 00- minuti - u t- 30- minuta.
In comparison to bioptic diagnostics of an infection with Helicobacter pylori, the breath test achieved, in a clinical trial on 168 patients from the age of 3 to 11, a sensitivity of 98.4% [90 %-CI: ≥ 93.9%], and a specificity of 98.1% [90 %-CI: ≥ 95.1%].
B’ paragun ma ’ dijanjotiċi biottiċi ta ’ infezzjoni b’ Helicobacter pylori, it- test tan- nifs, waqt provi kliniċi li saru fuq 168 pazjent bejn l- etajiet ta ’ 3 snin u 11- il sena, kellu sensittività ta ’ 98. 4% [90% - CI: ≥93. 9%], u speċifiċità ta ’ 98. 1% [90% - CI: ≥ 95. 1%].
In the absence of bacterial urease, the whole amount of the administered urea after absorption from the gastrointestinal tract will be metabolised like the endogenous urea.
Fin- nuqqas ta ’ urease batteriku, l- ammont sħiħ ta ’ l- urea amministrat wara assorbiment mill- apparat ta ’ l- istonku u ta ’ l- imsaren għandu jiġi metabolizzat bħal urea endoġenu.
Only in Helicobacter pylori- positive patients does the administration of 45 mg labelled urea lead to a significant increase of 13CO2 in the breath sample within the first 30 minutes.
Huwa biss f’ pazjenti li għandhom Helicobacter pylori li t- teħid ta ’ 45 mg urea ttikkettata jwassal għal żieda sinifikanti ta ’ 13CO2 fil- kampjun tan- nifs fi żmien nofs siegħa.
6.3 Shelf-life
17 6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
17 6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
A test set contains the following parts:
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
Jar (10 ml volume, polystyrene with polyethylene snap cap)
Vażett (volum ta ’ 10 ml, tap li jinqasam tal- polystyrene ma ’ polyethylene) li jkun fih 45 mg 13C trab tal- urea għal soluzzjoni li tittieħed mill- ħalq
containing 45 mg 13C-urea powder for oral solution Labelled sample glass- or plastic- containers for sampling, storing and transporting the breath samples for analysis:
Reċipjenti bit- tikketta tal- ħġieġ – jew plastik - għal kampjunar, ħażna u ġarr tal- kampjuni tan- nifs għal analiżi:
Hold the sample tube upright and stick the bar-code label marked “00-minute-value” round the sample tube, so that the lines of the bar-code are horizontal.
Żomm il- borża tan- nifs 'l fuq u waħħal it- tikketta tal- kodiċi żbarrati mmarkata "00 - minuti- valur" madwar it- tubu tal- kampjun sabiex il- linji tal- kodiċi żbarrati jkunu oriżżontali.
Now 100 ml of 100% orange juice must be drunk by the patient without delay.
Issa 200 ml ta ’ 100% meraq tal- larinġ jew 1 g ta ’ aċidu ċitriku f ’ 200 ml ilma għandu jinxtorob mingħajr dewmien.
Thirty minutes after administration of the test solution (point 7), collect the 30-minute-value samples in the two containers which are left in the test package (Label “Sampling time:
Tletin minuta wara t- teħid tas- soluzzjoni tat- test, iġbor il- kampjuni ta ’ 30 minuta- valur li jinsabu fiż- żewġ reċipjenti li fadal fil- pakkett tat- test (Tikketta: “ Ħin ta 'kampjunar:
The analysis of the 13C/12C-ratio in carbon dioxide of breath is an integrated part of the diagnostic test Helicobacter Test INFAI.
L- analiżi tal- proporzjoni 13C/ 12C- ratio ta ’ dijossidu karboniku fin- nifs jagħmel parti integrali mis- sett dijanjostiku Helicobacter Test INFAI għal tfal bejn l- etajiet ta ’ 3 snin sa 11- il sena.
The accuracy of the test strongly depends on the quality of the breath analysis.
Il- preċiżjoni tat - test tiddependi ħafna fuq il- kwalità ta ’ l- analiżi tan- nifs.
The specification of breath analysis parameters like linearity, stability (reference gas precision), and precision of measurement are fundamental for the accuracy of the system.
L- ispeċifikazzjoni ta ’ parametri ta ’ analiżi tan- nifs bħal linearità, stabbilità (preċiżjoni mal- gass ta ’ referenza) u preċiżjoni fil- kejl huma fundamentali fil- preċiżjoni tas- sistema.
To determine the 13C/12C-ratio of carbon dioxide in breath by mass spectrometric analysis the carbon dioxide must be separated from the breath and introduced into the mass spectrometer.
L- iffissar tal- proporzjoni 13C/ 12C fid- dijossidu karboniku 13C/ 12C fin- nifs b’ analiżi spettrometrika tal - massa, id- dijossidu karboniku għandu jiġi separat minn nifs u mdaħħal fl- ispettrometru tal- massa.
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.
Is - sistema ta ’ preparazzjoni awtomatika għal spettrometri tal- massa isotopika li hi magħmula għal analiżi tan- nifs hija msejsa fuq teknika ta ’ separazzjoni ta ’ influss kontinwu b ’ kromatografija bil- gass.
• Specifications for determining 13C/12C-ratios
19 Speċifikazzjonijiet sabiex jiġu stabbiliti l- proporzjonijiet 13C/ 12C •
The breath test concept relies on the administration of a specifically 13C-labelled urea whose metabolite utilisation is monitored by measuring 13CO2 in the expired breath gas.
Il- kunċett tat- test tan- nifs huwa msawwar fuq it- teħid mill- ħalq speċifiku ta ’ urea ttikkettat 13C li l- użu metaboliku tiegħu jiġi sorveljat bil- kejl ta ’ 13CO2 f’ nifs 'l barra.
• The mass spectrometer must be capable of:
L- ispettrometru tal- massa irid jilħaq dawn l- aspettativi:
The principle tests to verify the specifications are linearity, stability (reference gas precision), and precision of measurement.
It- testijiet prinċipali li jivverifikaw l- ispeċifikazzjonijiet huma linearità, stabbilità (preċiżazzjoni tal - gass ta ’ referenza), u preċiżazzjoni tal- kejl.
≤ 0.3 ‰ for 13C at natural abundance using a 10 ml breath sample tube with 3% CO2 breath concentration
≤ 0. 5 ‰ għal kampjuni tan- nifs li jvarjaw minn bejn 1% u 7% tal - Linearità: konċentrazzjoni ta ’ CO2 ≤ 0. 2 ‰ fuq 10 pulsi konsekkutivi Stabbilità: ≤ 0. 3 ‰ għal 13C f’ abundanza naturali permezz ta ’ tubu ta ’ kampjun Preċiżazzjoni fil- kejl: tan- nifs ta ’ 10ml b 'konċentrazzjoni tan- nifs ta ’ 3% CO2.
Helicobacter pylori infection is present if the difference in 13C/12C of baseline-value and 30-minute- value exceeds 4.0 ‰.
Infezzjoni ta’ Helicobacter pylori huwa preżenti jekk id- differenza ta ’ valur fir- referenza bażi f’ 13C/ 12C u 30 minuta - valur jaqbeż 4. 0 ‰.
Alternatively, any other suitable-validated method may be used, carried out by any objectively qualified laboratory.
Alternattivament, kull laboratorju oġġettivament ikkwalifikat jista ’ iwettaq kull metodu vvalidat kif suppost.
20 ANNEX II
20 ANNESS II
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
DETENTUR TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL- LOTT >
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
• KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDICINALI
22 ANNEX III
22 ANNESS III
24 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
24 TAGĦRIF LI GĦANDU JIDHER FUQ IL- KARTA TA ’ BARRA JEW, FIN- NUQQAS TA 'DAN, FUQ IL - PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON, PACK OF 1 JAR AND 50 JARS
KARTUNA TA ’ BARRA 1VAŻETT / 50 VAŻETT
Helicobacter Test INFAI 75 mg powder for oral solution 13 C-Urea
Helicobacter Test INFAI 75 mg trab għal soluzzjoni orali 13 C urea
1 Jar containing 75 mg 13C-Urea.
Vażett 1 fih 75 mg trab ta ’ 13C- urea għal soluzzjoni orali
1 Diagnostic Test Kit contains:
Is- sett tat- test huwa magħmul mill- biċċiet li ġejjin:
1 Jar containing 75 mg 13C-Urea powder for oral solution 4 containers for breath samples 1 bendable straw Package Leaflet Data sheet for patient documentation Page of labels and sticker
Vażett 1 fih 75 mg trab ta ’ 13C- urea għal soluzzjoni orali 4 reċipjenti għal kampjuni tan- nifs Strô li jitgħawweġ Fuljett ta ’ tagħrif Folja ta ’ l- informazzjoni tal- pazjent għad- dokumentazzjoni.
1 Jar containing 75 mg 13C-Urea powder for oral solution 2 breath bags for breath samples 1 bendable straw Package Leaflet Data sheet for patient documentation Bar code labels and sticker
Vażett 1 fih 75 mg trab ta ’ 13C- urea għal soluzzjoni orali 2 boroż tan- nifs għal kampjuni tan- nifs Strô li jitgħawweġ Fuljett ta ’ tagħrif Folja ta ’ l- informazzjoni tal- pazjent għad- dokumentazzjoni.
50 Jars containing 75 mg 13C-Urea powder for oral solution 100 breath bags for breath samples 50 bendable straws 50 Package Leaflet 50 Data sheets for patient documentation 50 Barcode labels and sticker
50 Vażett 1 fih 75 mg trab ta ’ 13C- urea għal soluzzjoni orali 100 boroż tan- nifs għal kampjuni tan- nifs 50 Strô li jitgħawweġ 50 Fuljett ta ’ tagħrif 50 Folja ta ’ l- informazzjoni tal- pazjent għad- dokumentazzjoni.
For Mass Spectrometry For Infrared Spectroscopy
Għal spettrometrija tal- massa Għal spettroskopija infra- aħmar
Please read enclosed instructions for use.
Jekk jogħġbok aqra l- istruzzjonijiet mehmuża għall- użu
{MM/YYYY}
JIS [XX/ SSSS]
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
PREKAWZJONIJIET SPEĊJALI GĦAR - RIMI TA ’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN.
26 11.
Xejn
142 D-44799 Bochum Germany
INFAI, Institut für biomedizinische Analytik & NMR- Imaging GmbH Universitätsstraße 142 D- 44799 Bochum Il- Ġermanja
Marketing Authorisation Number:
EU/ 1/ 97/ 045/ 001 EU 1/ 97/ 045/ 002
Batch:
< Lott > [numru]
27 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
27 TAGĦRIF LI GĦANDU JIDHER FUQ IL- KARTA TA ’ BARRA JEW, FIN- NUQQAS TA 'DAN, FUQ IL - PAKKETT LI JMISS MAL- PRODOTT
INTERMEDIATE CARTON, PACK SIZE 50
KARTUNA LI TMISS MAL- PRODOTT 50 VAŻETT
1 Jar containing 75 mg 13C-Urea
Vażett 1 fih 75 mg trab ta ’ 13C- urea għal soluzzjoni orali
CLINIPAC 50
ClINIPAC 50
50 Jars containing 75 mg 13C-Urea powder for oral solution
Sett tat- testijiet jikkonsisti minn 50 vażett bil- komponenti addizzjonali li ġejjin
Marketing Authorisation Number:
EU/ 1/ 97/ 045/ 004
JAR LABEL
{NATURA/ TIP} TIKKETTA TAL- VAŻETT
Helicobacter Test INFAI 75 mg powder for oral solution 13 C-Urea Oral use
Helicobacter Test INFAI 75 mg trab għal soluzzjoni orali 13 C urea Jittieħed mill- ħalq
Jar contains 75 mg 13C-Urea
Vażett 1 fih 45 mg trab ta ’ 13C- urea
Keep out of the reach and sight of children.
Test li jintuża darba biss trab għal soluzzjoni orali Jekk jogħġbok aqra l- istruzzjonijiet mehmuża għall- użu Żomm fejn ma ’ jintlaħaqx u ma ’ jidhirx mit- tfal.
EU/1/97/045/001 EU/1/97/045/002
Prodott mediċinali jingħata bir- riċetta tat- tabib Numru Ta ’ L- awtorizzazzjoni Għat- Tqegħid Fis- Suq EU 1/ 97/ 045/ 001 EU 1/ 97/ 045/ 002
30 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
31 TAGĦRIF LI GĦANDU JIDHER FUQ IL- KARTA TA ’ BARRA JEW, FIN- NUQQAS TA 'DAN, FUQ IL - PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON
TABELLA TA’ FUQ IL- VAŻETT
Helicobacter Test INFAI for children of the age 3-11 45 mg powder for oral solution 13 C-Urea
Helicobacter Test INFAI 45 mg trab għal soluzzjoni orali 13 C urea
1 Jar containing 45 mg 13C-Urea.
Vażett 1 fih 45 mg trab ta ’ 13C- urea għal soluzzjoni orali
Powder for oral solution 1 Diagnostic Test Kit contains:
Trab għal soluzzjoni orali
1 Jar containing 75 mg 13C-Urea powder for oral solution 4 containers for breath samples 1 bendable straw Package Leaflet Data sheet for patient documentation Page of labels and sticker
Vażett 1 fih 45 mg trab ta ’ 13C- urea għal soluzzjoni orali 4 reċipjenti għal kampjuni tan- nifs Strô li jitgħawweġ Fuljett ta ’ tagħrif Folja ta ’ l- informazzjoni tal- pazjent għad- dokumentazzjoni.
Oral use Please read the package leaflet before use.
Jekk jogħġbok aqra l- istruzzjonijiet mehmuża għall- użu
Marketing Authorisation Number:
EU/ 1/ 97/ 045/ 003
Helicobacter Test INFAI 45 mg 32 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
33 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Helicobacter Test INFAI for children of the age 3-11 45 mg powder for oral solution 13 C-Urea Oral use
Helicobacter Test INFAI 45 mg trab għal soluzzjoni orali 13 C urea Jittieħed mill- ħalq
Jar contains 45 mg 13C-Urea
Vażett 1 fih 45 mg trab ta ’ 13C- urea
EU/1/97/045/003
Prodott mediċinali jingħata bir- riċetta tat- tabib Numru Ta ’ L- awtorizzazzjoni Għat- Tqegħid Fis- Suq EU 1/ 97/ 045/ 003
33 MINIMUM PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
34 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
BREATH SAMPLE CONTAINERS:
REĊIPJENTI GĦAL KAMPJUNI TAN- NIFS:
GLASS OR PLASTIC
ĦĠIEĠ JEW PLASTIK
NAME OF THE MARKETING AUTHORISATION HOLDER
METODU TA ’ KIF GĦANDU JINGĦATA
Breath sample container
reċipjenti għal kampjuni tan- nifs
00-minute value 30-minute value
valur wara 00 minuti valur wara 30 minuta
Please stick round barcode label
Jekk jogħġbok waħħal madwar it- tikketta tal- barcode
34 MINIMUM PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
35 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
PAGE OF LABELS AND STICKERS
PAĠNA TAT- TIKKETTI U STIKER
142 D -44799 Bochum Germany
INFAI, Institut für biomedizinische Analytik & NMR- Imaging GmbH Universitätsstraße 142 D- 44799 Bochum Il- Ġermanja
Barcodes for 00-minute-value Barcodes for 30-minute-value
Paġna tat- tikketti u stiker Barcode għal fuljett ta ’ l- informazzjoni għad- dokumentazzjoni tal- pazjent Stiker tas- siġill Barcodes għal valur wara 00 minuti Barcodes għal valur wara 30 minuta
36 PACKAGE LEAFLET:
FULJETT TA ’ TAGĦRIF
INFORMATION FOR THE USER Helicobacter Test INFAI 75 mg powder for oral solution 13 C-urea
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU Helicobacter Test INFAI 75 mg trab ta ’ 13C urea għal soluzzjoni orali 13 C- urea
What Helicobacter Test INFAI is and what it is used for 2.
X’ inhu Helicobacter Test INFAI u għalxiex jintuża 2.
Before you take Helicobacter Test INFAI 3.
Qabel ma ’ tieħu Helicobacter Test INFAI 3.
How to take Helicobacter Test INFAI 4.
Kif għandek tieħu Helicobacter Test INFAI 4.
Possible side effects 5 How to store Helicobacter Test INFAI 6.
Kif taħżen Helicobacter Test INFAI 6.
WHAT HELICOBACTER TEST INFAI IS AND WHAT IT IS USED FOR
X’ INHU HELICOBACTER TEST INFAI U GĦALXIEX JINTUŻA
Helicobacter Test INFAI is for diagnostic use only.
Helicobacter Test INFAI huwa għal użu dijanjostiku biss.
Helicobacter Test INFAI is a breath test that can be used for adolescents from the age of 12 and older and adults to determine whether or not you have an infection in the stomach caused by the bacterium Helicobacter pylori.
Helicobacter Test INFAI huwa test tan- nifs li jista ’ jintuża minn adoloxxenti mill- età ta ’ 12- il sena 'l fuq u adulti sabiex jiġi stabbilit jekk hemmx infezzjoni jew le fl- istonku ikkaġunata bil- batterju Helicobacter pylori.
Why do you need to take the Helicobacter Test INFAI?
X' GĦANDEK BŻONN BIEX TIEĦU Helicobacter Test INFAI?
You may have a gastric infection caused by a bacterium called Helicobacter pylori.
Jista ’ ikun li jkollok infezzjoni fl- istonku kkawżata minn batterju msejjaħ Helicobacter pylori.
Your doctor has recommended that you have a Helicobacter Test INFAI for one of the following reasons:
It- tabib tiegħek irrakomanda li inti jkollok Helicobacter Test INFAI minħabba wieħed mir- raġunijiet li ġejjin:
Your doctor wants to confirm whether you are suffering from Helicobacter pylori infection to help diagnose your condition.
It- tabib tiegħek irid jikkonferma jekk intiex qed isofri minn infezzjoni ta ’ Helicobacter pylori sabiex tgħinu fid- dijanjosi tal- kundizzjoni tiegħek.
You have already been diagnosed as being infected with Helicobacter pylori and have been taking medication aimed to clear up the infection.
Inti diġà ġejt dijanjostikat li int infettat b ’ Helicobacter pylori u qed tieħu mediċini mmirati sabiex tfejjaq l- infezzjoni.
Your doctor now wishes to find out if the treatment has been successful.
It- tabib tiegħek jixtieq jarha jekk it- trattment kienx ta ’ suċċess.
How does the test work?
Kif jaħdem it- test?
All foods contain a substance called 13Carbon (1% 13C).
L- ikel kollu fih sustanza msejjaħ 13Carbon (1% 13C).
This 13Carbon can be detected in the carbon dioxide you breathe out of your lungs.
Dan il- 13Carbon ġie intraċċat fid- Dijossidu Karboniku li int tonfoħ barra mill- pulmuni.
The actual amount of 13Carbon in the breath will depend on the kind of food that you have eaten.
L- ammont propju ta ’ 13Carbon fin- nifs tiegħek għandu jiddependi fuq it- tip ta ’ ikel li int tkun ħadt.
You will be asked to drink the “test meal”.
Inti ser tiġi mitlub biex tixrob “ l- ikla tat- test ”.
Following the meal, samples of your breath will be taken (see “Special instructions for use”).
Wara l- ikla, ser jittieħdu kampjuni minn nifs tiegħek (ara “ Struzzjonijiet speċjali għall- użu ”).
These samples will be analysed to measure the “normal” amount of 13Carbon content in the carbon dioxide in your breath.
Dawn il- kampjuni ser jiġu analiżżati sabiex ikejlu l- ammont “ normali ” li jkun hemm ta ’ 13Carbon fid - Dijossidu Karboniku fin- nifs tiegħek.
You will then be asked to drink a solution of 13Carbon-urea.
Inti mbagħad ser tkun mitlub tixrob taħlita likwida ta ’ 13Carbon- urea.
Further samples of your breath will then be taken 30 minutes later and the amount of 13Carbon in the samples measured as before.
Aktar kampjuni tan- nifs tiegħek ser jittieħdu nofs siegħa wara u l- ammont ta ’ 13Carbon fil- kampjuni mkejjel bħal qabel.
The results will be compared and a significant increase in the amount of 13 Carbon in the second set of samples will suggest your doctor that Helicobacter pylori are present.
Ir- riżultati ser jiġu paragunati u żieda sinifikanti fl- ammont ta ’ 13Carbon fit- tieni sett ta ’ kampjuni, ser jindikaw lit- tabib tiegħek li Helicobacter pylori huwa preżenti.
BEFORE YOU TAKE HELICOBACTER TEST INFAI
QABEL MA TUŻA HELICOBACTER TEST INFAI
Please tell your doctor if you suffer from any medical condition that you think may affect, or be affected by the test.
Jekk jogħġbok għarraf lit- tabib jekk tbati minn xi kundizzjoni medika li taħseb li tista ’ taffetwa t- test, jew tiġi affetwata bit- test.
It is also important that you tell your doctor if any of the following circumstances apply to you:
Huwa importanti wkoll li tgħid lit- tabib tiegħek, jekk xi ċirkostanzi minn dawn li ġejjin japplikaw għalik:
form of gastritis), because this might interfere with the urea breath test.
Tieħux X Helicobacter Test INFAI Jekk inti għandek jew jekk hemm suspett li għandek infezzjoni gastrika jew gastrite atropika (forma speċjali ta ’ gastrite) peress li din tista ’ tfixkel it- test tan- nifs ta ’ l- urea.
Various diagnostic tests, including invasive endoscopic tests, could be required to check for the presence of any other complications, such as gastric ulcer, infection of the gastric mucosa caused by an autoimmune reaction, and tumours.
Oqgħod attent ħafna b’ Helicobacter Test INFAI Anke jekk ir- riżultat minn Helicobacter Test INFAI huwa pożittiv, aktar testijiet għandhom mnejn ikunu meħtieġa qabel ma jkun jista ’ jinbeda t- trattament għall- infezzjoni minn Helicobacter pylori (terapija ta ’ eradikazzjoni).
There is insufficient data on the diagnostic reliability of the Helicobacter Test INFAI for recommending its use in patients with gastrectomy.
Qaghad m’ hemmx biżżejjed informazzjoni fuq l- affidabilità dijanjostika ta’ Helicobacter Test INFAI sabiex l- użu tiegħu jiġi wżat f' pazjenti b' gastrektomija.
- In individual cases of A-gastritis (atrophic gastritis), the breath test can lead to false positive
- F' każijiet individwali ta ’ gastritè A (gastrite atrofika), it- test tan- nifs jista 'iwassal għal riżultati
results; other tests may therefore be necessary to confirm the presence of Helicobacter pylori.
Jista ’ jkun hemm bżonn ta ’ aktar testijiet sabiex tiġi konfermata l- preżenza ta ’ Helicobacter pylori.
- If the patient vomits during the test procedure, necessitating the repetition of the test, this should
- Jekk il pazjent jirremetti waqt il- proċedura tat- test, bil- ħtieġa li t- test għandu jiġi ripetut, dan
be done in fasted condition and not before the following day.
għandu jsir f’ kondizzjoni ta ’ sawm u mhux qabel il- ġurnata ta ’ wara.
Taking other medicines Helicobacter Test INFAI is influenced by all medicines related to Helicobacter pylori or urease activity.
Meta tieħu mediċini oħra Helicobacter Test INFAI huwa influwenzat bil- mediċini kollha relatati għal Helicobacter pylori jew attività b ’ urease.
Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine.
Tqala u Treddigħ Itlob il- parir tat- tabib jew ta ’ l- ispiżjar > tiegħek qabel tieħu xi mediċina.
It is not expected that performing the breath test during pregnancy and lactation has a damaging effect.
Mhux mistenni li jekk tieħu t- test tan- nifs waqt it- tqala jew l- irdigħ ikun hemm xi effett ta ’ ħsara.
If you are a patient taking a medicine for eradication therapy it is recommended to check the patient information leaflet of that drug with respect to the details on pregnancy and lactation.
Jekk inti pazjenta li qed tieħu droga għat- terapija ta ’ eradikazzjoni huwa rakkomandat li tiċċekja l - fuljett ta ’ tagħrif tal- pazjent ta 'dik id- droga fir- rigward ta ’ dettalji fuq tqala u irdigħ.
Driving and using machines Helicobacter Test INFAI has no influence on the ability to drive or to use machines.
Sewqan u tħaddim ta ’ magni Helicobacter Test INFAI m’ għandux effett fuq il- ħila biex issuq jew tħaddem magni.
HOW TO TAKE HELICOBACTER TEST INFAI
KIF GĦANDEK TIEĦU HELICOBACTER TEST INFAI
Always take Helicobacter Test INFAI exactly as your doctor has told you.
Dejjem għandek tieħu Helicobacter Test INFAI skond il- parir tat- tabib.
You should perform the test in the presence of your doctor or another qualified person.
Għandek dejjem twettaq it- test fil- preżenza tat- tabib tiegħek jew xi persuna kkwalifikata oħra.
Dosage The following information applies, unless your doctor has otherwise prescribed Helicobacter Test INFAI.
Doża L- informazzjoni li ġejja tapplika, sakemm t- tabib tiegħek ma takx riċetta għal Helicobacter Test INFAI.
Please follow the instructions for use, as otherwise the Helicobacter Test INFAI may not work properly.
Jekk jogħġbok segwi l- istruzzjonijiet dwar l- użu, għax inkella Helicobacter Test INFAI jista ’ ma jaħdimx kif suppost.
38 How much Helicobacter Test INFAI should be used and how often?
39 Kemm għandi nuża Helicobacter Test INFAI u kemm ta ’ spiss?
Patients from the age of 12 must take the content of one jar with 75 mg for one test.
Adoloxxenti mill- età ta ’ 12- il sena 'l fuq u adulti jieħdu l- kontenut ta ’ vażett b ’ 75 mg għal test wieħed.
How and when should Helicobacter Test INFAI be used?
Kif u meta għandu jintuża Helicobacter Test INFAI?
You must have fasted for 6 hours before application, preferably overnight.
Trid tkun sajjem għal 6 sigħat qabel it- teħid, preferibilment wara lejl.
If fasting is a problem, for example for diabetic patients, please tell your doctor.
Jekk is- sawm problema, eż. għal pazjenti dijabettiċi, jekk jogħġbok kellem it- tabib.
The test procedure lasts approximately 40 minutes.
Il- proċedura tat- test tieħu madwar 40 minuta.
The test should be performed following at least four weeks without antibacterial therapy and two weeks after the last administration of an antisecretory medication.
It- test għandu jitwettaq wara ta ’ l- anqas erba ’ ġimgħat mingħajr terapija antibatterika u ġimagħtejn wara l- aħħar amministrazzjoni ta ’ mediċina kontra it- tnixxija.
Both of these substances could influence the results of the Helicobacter Test INFAI.
Dawn iż- żewġ sustanzi jistgħu jaffetwaw ir- riżultati ta ’ Helicobacter Test INFAI.
This is particularly true after Helicobacter eradication therapy.
Dan hu partikolarment minnu wara terapija ta ’ eradikazzjoni ta ’ Helicobacter.
It is important to follow the instructions for use exactly, otherwise the result may be questionable.
Huwa importanti li l- istruzzjonijiet jiġu segwit b’ mod eżatt, inkella r - riżultat ma ’ jkunx affidabbli.
Essential items not supplied with Helicobacter Test INFAI Before the breath test is performed a liquid test meal is taken to delay stomach emptying.
Oġġett ta ’ bżonn mhux fornuti b ’ Helicobacter Test INFAI Qabel ma jitwettaq it- test tan- nifs, tittieħed ikla likwida sabiex tittardja l- iżvujtjar ta ’ l- istonku.
The test meal is not provided with the kit.
L- ikla bħala test mhijiex provduta mas- sett.
Pure orange juice (200 ml) or a solution of citric acid (1 g in 200 ml of water) can be used as a test meal.
Meraq tal- larinġ pur (200 ml) jew taħlita likwida b' aċidu ċitriku (1 g f ’ 200 ml ta ’ ilma) tista ’ tintuża bħala ikla test.
If there is a medical (or other) reason why you cannot take either of these test meals, please tell your doctor, who will suggest an alternative.
Jekk hemm xi raġuni medika (jew oħra) 'l għaliex int ma tistax tieħu xi wieħed minn dawn l- ikliet, jekk jogħġbok għarraf lit- tabib tiegħek, li jissuġerixxi xi alternattiva.
A drinking vessel and tap water is required to dissolve the 13C-urea powder.
Reċipjent tax- xorb u ilma tal- vit huma meħtieġa sabiex jinħall it- trab 13C- urea.
If the test needs to be repeated, this should not be done until the following day.
Jekk hemm bżonn li t- test jiġi ripetut dan m' għandux isir qabel 'l għada.
Special instructions for use (for mass spectrometry) The test is to be performed after instruction by a healthcare professional and under appropriate medical supervision.
Dan il- prodott mediċinali għandu jingħata minn professjonist tal- kura tas- saħħa u taħt superviżjoni medika xierqa.
Each patient should be documented using the provided data sheet.
Kull pazjent għandu jkun dokumentat skond il- folja ta ’ informazzjoni fornuta.
It is recommended that you take the test in a resting position.
Huwa rakkomandat li tieħu t- test f 'pożizzjoni ta ’ serħan.
The test should be carried out after having fasted 6 hours before application, preferably overnight.
It- test għandu jitwettaq wara sawm ta ’ 6 sigħat qabel l- applikazzjoni, preferibbilment wara lejl.
If the test needs to be carried out later in the day, only a light meal like tea and toast is recommended.
Jekk it- test għandu jsir aktar tard matul il- ġurnata, bukkin żgħir bħal te u towst huwa rakkomandat.
The test begins with the collection of samples for determining the baseline values:
It- test jibda bil- ġbir ta ’ kampjuni sabiex jiġi stabbilit il- valur ta ’ referenza bażi.
The straw and sample tubes labelled “sampling time:
Ħu l- istrô u ż- żewġ tubi ta ’ kampjunar bit- tikketta “ Ħin ta ’ kampjunar:
00-minute-value” are taken from the test set.
00- minuti- valur ” barra mis- sett tat- test.
The stopper is removed from one of the sample containers, the straw unwrapped and placed into the container.
Neħħi t- tapp minn wieħed mit- tubi ta ’ kampjunar, neħħi t- tgeżwir ta ’ l- istrô u qiegħed l - istrô fir- reċipjent.
Now the patient breathes gently through the straw into the sample tube until the inside of the sample tube steams up.
Issa ħu n- nifs bil- mod minn ġo l- istrô sakemm il- wiċċ ta ’ ġewwa tat- tubu tal- kampjun ifawwar.
The patient must continue to breathe through the straw while removing it from the sample tube, and then immediately seal the tube with its stopper.
Kompli ħu n- nifs minn ġo l- istrô waqt li qed jitneħħa mit- tubu tal- kampjun imbagħad immedjatament agħlaq it- tubu tal- kampjun bit- tapp tiegħu.
(If the sample tube remains open for more than 30 seconds, the result could be falsified.)
(Kemm- il darba it- tubu tal - kampjun jibqa ’ miftuħ għal aktar minn 30 sekonda, ir- riżultat tat- test jista ’ jkun ħażin).
The sample container should be held upright and the bar-code label marked 00-minute- value will be stuck round the sample container so that the lines of the bar code are horizontal.
Żomm ir- reċipjent tal- kampjun 'l fuq u t- tikketta tal- kodiċi żbarrati mmarkata "00- minuti - valur" madwar it- tubu tal- kampjun sabiex il- linji tal- kodiċi żbarrati jkunu oriżżontali.
Now the second sample container (labelled “sampling time:
Imla t- tieni tubu bil- kampjun (tikketta: “ Ħin ta ’ kampjunar:
00-minute-value”) has to be filled up with breath in the same way as described above.
00- minuta- valur ”) bin- nifs billi tuża l- istess proċedura deskritta hawn fuq.
Then the patient must drink the recommended test meal (200 ml 100% orange juice or 1 g citric acid in 200 ml water).
Ser tiġi mitlub tixrob l- ikla rakkomandata tat- test (200 ml ta ’ 100% meraq tal- larinġ jew 1 g ta ’ aċidu ċitriku f ’ 200 ml ilma).
Now the preparation of the test solution follows.
Issa jmiss il- preparazzjoni tas- soluzzjoni tat- test:
The jar labelled “13C-urea powder” is removed from the test set, opened, and filled up to about three quarters with tap water.
Il- vażett bit- tikketta “ 13C trab tal- urea ” jiġi meħud mis- sett tat- test, jinfetaħ u jimtela sa • tlett kwarti minnu b' ilma tal- vit.
The jar is closed and carefully shaken until all the powder has dissolved completely.
Agħlaq il- vażett u ħallat b’ attenzjoni sakemm it- trab kollu jkun inħall.
The contents is poured into a drinking glass, the jar a second and third time filled with water and the contents transferred into the drinking glass, so that approximately 30 ml of test solution is obtained.
40
The patient should drink this test solution immediately.
Is- soluzzjoni tat- test għandha tinxtorob minnufih mill- pazjent.
The time of intake must be noted.
Il- ħin ta ’ teħid għandu jitniżżel.
30 minutes after the test solution has been taken (point 6), the “30-minute-value” samples are collected in both containers, which remain in the pack (labelled “sampling time:
Tletin minuta wara t- teħid tas- soluzzjoni tat- test (punt 6), iġbor il- kampjuni ta ’ 30 minuta- valur li jinsabu fiż- żewġ reċipjenti li qegħdin fil- pakkett tat- test (bit- tikketta: “ Ħin ta 'kampjunar:
30-minute- value”) as described under points 3 and 4.
30 - minuta- valur ”), kif deskritt taħt punti 3 u 4.
The bar-code labels marked “30-minute-value” must be used for these samples.
Uża t- tikketti tal- kodiċi żbarrata mmarkati “ 30- minuta- valur ” għal dawn il- kampjuni.
All breath samples containers should be placed back into the original packaging.
Qiegħed it- tikketta rilevanti bil- kodiċi żbarrata fuq il- folja tal- informazzjoni għad - dokumentazzjoni tal- pazjent.
This packaging should be sealed with the remaining sticker.
Fl- aħħar issiġġilla l- pakkett bl- istiker li baqa ’.
The package must be sent to a qualified laboratory for analysis.
Il- pakkett għandu jintbagħad f’ laboratorju kkwalifikat għal analiżi.
If you take more Helicobacter Test INFAI than you should Because only 75 mg 13C-urea is provided overdose is not to be expected.
Jekk tieħu Helicobacter Test INFAI aktar milli suppost Minħabba li 75 mg 13C- urea ibiss huwa provdut mhux mistenni li jkun hemm doża eċċessiva..
No side effects are known.
L- ebda effett ieħor m’ huwa magħruf.
HOW TO STORE HELICOBACTER TEST INFAI
KIF TAĦŻEN X Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal.
Keep out of the reach and sight of children.
Taħżinx f ’ 'temperatura ogħla minn 25°C.
Do not use after the expiry date which is stated on the label and carton.
M’ għandekx tuża wara d- data li jiskadi li tidher fuq it- tikketta u l- kartuna ta ’ Helicobacter Test INFAI.
What Helicobacter Test INFAI contains
X’ fih Helicobacter Test INFAI:
- The active substance is 13C-urea.
Is- sustanza attiva hi 13C- urea.
One jar contains 75 mg 13C-urea.
Vażett wieħed fih 75 mg 13C- urea M’ hemmx sustanzi oħra.
- There are no other ingredients.
Id- Dehra ta ’ Helicobacter Test INFAI u l- kontenuti tal- pakkett:
What Helicobacter Test INFAI looks like and contents of the pack Helicobacter Test INFAI is a clear, colourless powder for oral solution.
Helicobacter Test INFAI huwa trab ċar, mingħajr kulur għal soluzzjoni orali.
40 Content of the Test Kit:
Kontenut u KittSett tat- Test għal spettrometrija tal- massa:
Jar (10 ml volume, polystyrene with polyethylene snap cap)
Vażett (volum ta ’ 10 ml, tap li jinqasam tal- polystyrene ma ’ polyethylene) li jkun fih 75 mg 13C trab tal- urea għal soluzzjoni li tittieħed mill- ħalq. orali
containing 75 mg 13C-urea powder for oral solution Labelled sample glass- or plastic- containers for sampling, storing and transporting the breath samples for analysis:
Reċipjenti bit- tikketta tal- ħġieġ – jew plastik - għal kampjunar, ħażna u ġarr tal- kampjuni tan- nifs għal analiżi:
30-minute-value Bendable straw for collection of the breath samples into the corresponding sample containers
Strô li jitgħawweġ għal ġbir ta ’ kampjuni tan- nifs fil- boroż tan- nifs rispettivi fir- reċipjenti relattivi għal kampjunar
Marketing Authorisation Holder and Manufacturer INFAI, Institut für Biomedizinische Analytik und NMR-Imaging GmbH Universitätsstraße 142 D-44799 Bochum Germany
INFAI, Institut für Biomedizinische Analytik und NMR- Imaging GmbH Universitätsstraße 142 D- 44799 Bochum Il- Ġermanja
41 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
42 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok għamel kuntatt mar- rappreżentant lokali tas- Sid ta ’ l- Awtorizzazzjoni tal- Kummerċ.
Norge INFAI, Institut für biomedizinische Analytik und NMR-Imaging GmbH Universitätsstraße 142 D-44799 Bochum Tlf: +49 234 971130 Österreich INFAI, Institut für biomedizinische Analytik und NMR-Imaging GmbH Universitätsstraße 142 D-44799 Bochum Tel: +49 234 971130 Polska INFAI, Institut für biomedizinische Analytik und NMR-Imaging GmbH Universitätsstraße 142 D-44799 Bochum Tel.: +49 234 971130
Österreich INFAI, Institut für biomedizinische Analytik und NMR- Imaging GmbH Universitätsstraße 142 D- 44799 Bochum Tel: +49 234 971130 Polska INFAI, Institut für biomedizinische Analytik und NMR- Imaging GmbH Universitätsstraße 142 D- 44799 Bochum Tel.: +49 234 971130
42 France INFAI France SARL Eurocentre Tertiaire 50, avenue d’Alsace F- 68027 Colmar Tél: +33 389 204382
43 France INFAI France SARL Eurocentre Tertiaire 50, avenue d’ Alsace F - 68027 Colmar Tél: +33 389 204382
Κύπρος INFAI, Institut für biomedizinische Analytik und NMR-Imaging GmbH Universitätsstraße 142 D-44799 Bochum Τηλ: +49 234 971130 Latvija INFAI, Institut für biomedizinische Analytik und NMR-Imaging GmbH Universitätsstraße 142 D-44799 Bochum Deutschland/Germany Tel: +49 234 971130 Lietuva INFAI, Institut für biomedizinische Analytik und NMR-Imaging GmbH Universitätsstraße 142 D-44799 Bochum Deutschland/Germany Tel: +49 234 971130
Κύπρος INFAI, Institut für biomedizinische Analytik und NMR- Imaging GmbH Universitätsstraße 142 D- 44799 Bochum Τηλ: +49 234 971130 Latvija INFAI, Institut für biomedizinische Analytik und NMR- Imaging GmbH Universitätsstraße 142 D- 44799 Bochum Deutschland / Il- Ġermanja Tel: +49 234 971130 Lietuva INFAI, Institut für biomedizinische Analytik und NMR- Imaging GmbH Universitätsstraße 142 D- 44799 Bochum Deutschland / Il- Ġermanja Tel: +49 234 971130
This leaflet was last approved in MM/YYYY. -------------------------------------------------------------------------------------------------------------------------------- The following information is intended for medical or healthcare professionals only:
It- tagħrif li jmiss qed jingħata biss għall- professjonisti fil- qasam mediku:
The breath samples, collected in 10 l glass, plastic sample tubes are analysed by isotope ratio mass spectrometry (IRMS).
Il- kampjuni tan- nifs, miġbura f' tubi tal- ħġieġ – jew plastik jiġu analizzati bi spettrometrija tal- massa isotopika proporzjonali (IRMS).
43 The analysis of the 13C/12C-ratio in carbon dioxide of breath is an integrated part of the diagnostic test Helicobacter Test INFAI.
44 L- analiżi tal- proporzjoni 13C/ 12C- ratio ta ’ dijossidu karboniku fin- nifs jagħmel parti integrali mis- sett dijanjostiku Helicobacter Test INFAI.
To determine the 13C/12C-ratio of carbon dioxide in breath by mass spectrometric analysis the carbon dioxide must be separated from the breath and introduced into the mass spectrometer.
Savbiex jiġi stabbilit il- proporzjoni tad- dijossidu karboniku 13C/ 12C fin- nifs b’ analiżi spettrometrika tal- massa, id- dijossidu karboniku għandu jiġi separat minn nifs u mdaħħal fl- ispettrometru tal- massa.
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.
L- ilma jiġi mneħħi mis- sistema permezz ta ’ trapp ta ’ l- ilma Nafion jew permezz tas- sistema ta ’ preparazzjoni bil- kromatografija tal- gass li tissepara l- gassijiet individwali fil- kolonna ta ’ kromatografija b' gass li fiha jintuża Elju bħala eluwent.
The breath test concept relies on the administration of a specifically 13C-labelled urea whose metabolite utilisation is monitored by measuring 13CO2 in the expired breath gas.
Il- kunċett tat- test tan- nifs huwa msawwar fuq it- teħid speċifiku ta ’ urea ttikkettat 13C li l- użu metaboliku tiegħu jiġi sorveljat bil- kejl ta ’ 13CO2 f’ nifs 'l barra.
The mass spectrometer must be capable of:
L- ispettrometru tal- massa irid jilħaq dawn l- aspettativi:
specifications are linearity, stability (reference gas precision), and
It- testijiet prinċipali li jivverifikaw l- ispeċifikazzjonijiet huma linearità, stabbilità (preċiżazzjoni tal - gass ta ’ referenza), u preċiżazzjoni tal- kejl.
All mass spectrometers for breath analysis must comply with the following specifications:
Kull spettrometru tal- gass għal analiżi tan- nifs irid ikun konformi ma ’ l- ispeċifikazzjonijiet li ġejjin:
≤ 0.5 ‰ for breath samples varying between 1% and 7% CO2 -concentration
≤ 0. 5 ‰ għal kampjuni tan- nifs li jvarjaw minn bejn 1% u 7% tal - Linearità: konċentrazzjoni ta ’ CO2 ≤ 0. 2 ‰ fuq 10 pulsi konsekkutivi Stabbilità:
≤ 0.3 ‰ for 13C at natural abundance using a 10 ml breath sample container with 3% CO2 breath concentration
45 ≤ 0. 3 ‰ għal 13C f’ abundanza naturali permezz ta ’ tubu ta ’ kampjun Preċiżazzjoni fil- kejl: tan- nifs ta ’ 10ml b 'konċentrazzjoni tan- nifs ta ’ 3% CO2.
45 MINIMUM PARTICULARS TO APPEAR ON
46 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
DATA SHEET FOR PATIENT DOCUMENTATION
FOLJA TA ’ L- INFORMAZZJONI TAL- PAZJENT GĦAD- DOKUMENTAZZJONI
Date of test
Data tat- test
Patient´s full name
Isem sħiħ tal- pazjent
Date of birth
Data tat- twelid
Doctor/Hospital Address
Tabib/ Indirizz ta ’ l- Isptar
46 PACKAGE LEAFLET:
47 FULJETT TA ’ TAGĦRIF:
Read all of this leaflet carefully before you start taking this medicine.
Aqra dan- il fuljett kollu qabel tibda tieħu din il- mediċina
- If you have any further questions, ask your doctor or pharmacist.
- Jekk ikollok aktar mistoqsijiet, jekk jogħġbok staqsi lit- tabib jew spiżjar tiegħek.
It may harm them, even if
- Din il- mediċina ġiet mogħtija għall- użu personali tiegħek u m’ għandekx tagħtiha lil persuni
their symptoms are the same as yours.
oħra.
please tell your doctor or pharmacist.
Tista ’ tagħmlilhom il- ħsara, anki jekk ikollom l- istess sintomi tiegħek. >
What Helicobacter Test INFAI is and what it is used for 2.
X’ inhu u Helicobacter Test INFAI għalxiex jintuża 2.
How to take Helicobacter Test INFAI 4.
Kif għandek tuża Helicobacter Test INFAI 4.
You have already been diagnosed has being infected with Helicobacter pylori and have been taking medication aimed to clear up the infection.
Inti diġà ġejt dijanjostikat li int infettat b ’ Helicobacter pylori u qed tieħu mediċini mmirati sabiex tfejjaq l- infezzjoni.
Following the meal, samples of your breath will be taken (see “Special Instructions for use”).
Wara l- ikla, ser jittieħdu kampjuni minn nifs tiegħek (ara “ Struzzjonijiet speċjali għall- użu ”).
- if you have or if it is suspected that you have a gastric infection or an atrophic gastritis (special
Għamla u kontenut farmaċewtiku Helicobacter Test INFAI huwa għal użu dijanjostiku biss.
There is insufficient data on the diagnostic reliability of the Helicobacter Test INFAI for recommending its use in patients with gastrectomy.
Helicobacter Test INFAI huwa test tan- nifs li jista ’ jintuża minn adoloxxenti mill- età ta ’ 12- il sena 'l fuq u adulti sabiex jiġi stabbilit jekk hemmx infezzjoni jew le fl- istonku ikkaġunata bil- batterju Helicobacter pylori.
- In individual cases of A-gastritis (atrophic gastritis), the breath test can lead to false positive
X' GĦANDEK BŻONN BIEX TIEĦU Helicobacter Test INFAI?
results; other tests may therefore be necessary to confirm the presence of Helicobacter pylori.
Jista ’ ikun li jkollok infezzjoni fl- istonku kkawżata minn batterju msejjaħ Helicobacter pylori.
Taking other medicines Helicobacter Test INFAI is influenced by all medicines related to Helicobacter pylori or urease activity.
It- tabib tiegħek irrakomanda li tagħmel Helicobacter Test INFAI, li huwa test sempliċi li ser jistabilixxi l - preżenza tal- batterju Helicobacter pylori fl- istonku jew fl- imsaren, għal xi wieħed minn dawn ir - raġunijiet:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
It- tabib tiegħek irid jikkonferma jekk intiex qed isofri minn infezzjoni ta ’ Helicobacter pylori sabiex tgħinu fid- dijanjosi tal- kundizzjoni tiegħek.
It is not expected that performing the breath test during pregnancy and lactation has a damaging effect.
Inti diġà ġejt dijanjostikat li int infettat b ’ Helicobacter pylori u qed tieħu mediċini mmirati sabiex tfejjaq l- infezzjoni.
You should perform the test in the presence of your doctor or another qualified person.
It- tabib tiegħek jixtieq jarha jekk it- trattment kienx ta ’ suċċess.
How and when should Helicobacter Test INFAI be used?
Kif jaħdem it- test?
1.
L- ikel kollu fih sustanza msejjaħ 13Carbon (1% 13C).
The test should be carried out after having fasted 6 hours before application, preferably overnight.
L- ammont propju ta ’ 13Carbon fin- nifs tiegħek għandu jiddependi fuq it- tip ta ’ ikel li int tkun ħadt.
If the test needs to be carried out later in the day, only a light meal like tea and toast is recommended.
Inti ser tiġi mitlub biex tixrob “ l- ikla tat- test ”.
The test begins with the collection of samples for determining the baseline values:
Wara l- ikla, ser jittieħdu kampjuni minn nifs tiegħek (ara “ Struzzjonijiet speċjali għall- użu ”).
00-minute-value” are taken from the test set.
Dawn il- kampjuni ser jiġu analiżżati sabiex ikejlu l- ammont “ normali ” li jkun hemm ta ’ 13Carbon fid - Dijossidu Karboniku fin- nifs tiegħek.
The stopper is removed from one of the breath bags, the straw unwrapped and placed into the container.
Inti mbagħad ser tkun mitlub tixrob taħlita likwida ta ’ 13Carbon- urea.
The patient must continue to breathe through the straw while removing it from the breath bag, and then immediately seal the breath bag with its stopper.
Aktar kampjuni tan- nifs tiegħek ser jittieħdu nofs siegħa wara u l- ammont ta ’ 13Carbon fil- kampjuni mkejjel bħal qabel.