qanastek/EMEA-V3 huggingface dataset:
The breath bag should be held upright and the bar-code label marked 00-minute-value will be stuck on the breath bag.
Ir- riżultati ser jiġu paragunati u żjieda sinifikanti fl- ammont ta ’ 13Carbon fit- tieni sett ta ’ kampjuni, ser jindikaw lit- tabib tiegħek li Helicobacter pylori huwa preżenti.
Then the patient must drink the recommended test meal (200 ml 100% orange juice or 1 g citric acid in 200 ml water).
Jekk jogħġbok għarraf lit- tabib jekk tbati minn xi kundizzjoni medika li taħseb li tista ’ taffetwa t- test, jew tiġi affetwata bit- test.
Now the preparation of the test solution follows.
Huwa importanti wkoll li tgħid lit- tabib tiegħek, jekk xi ċirkostanzi minn dawn li ġejjin japplikaw għalik:
•
M' għandekx tieħu 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.
The jar labelled “13C-urea powder” is removed from the test set, opened, and filled up to about three quarters with tap water.
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).
• •
49 Qaghad m’ hemmx biżżejjed informazzjoni fuq l- affidabilità dijanjostika ta’ Helicobacter Test INFAI sabiex l- użu tiegħu jiġi wżat f' pazjenti b' gastrektomija.
The jar is closed and carefully shaken until all the powder has dissolved completely.
- F' każijiet individwali ta ’ gastritè A (gastrite atrofika), it- test tan- nifs jista 'iwassal għal riżultati
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.
Jista ’ jkun hemm bżonn ta ’ aktar testijiet sabiex tiġi konfermata l- preżenza ta ’ Helicobacter pylori.
The patient should drink this test solution immediately.
- Jekk il pazjent jirremetti waqt il- proċedura tat- test, bil- ħtieġa li t- test għandu jiġi ripetut, dan
The time of intake must be noted.
għandu jsir f’ kondizzjoni ta ’ sawm u mhux qabel il- ġurnata ta ’ wara.
30 minutes after the test solution has been taken (point 5), the “30-minute-value” samples are collected in one breath bag, which remains in the pack (labelled “sampling time:
Konsum ta ’ mediċini oħrajn Helicobacter Test INFAI huwa influwenzat bil- mediċini kollha relatati għal Helicobacter pylori jew attività b ’ urease.
30-minute- value”) as described above.
Jekk jogħġbok kellem lit- tabib tiegħek.
The bar-code labels marked “30-minute-value” must be used for these samples.
Jekk jogħġbok iftakar li din l- informazzjoni tista ’ tapplika għal mediċini kollha użati riċentement.
The corresponding bar-code label must be put on the data sheet for patient documentation.
Tqala u irdigħ Mhux mistenni li jekk tieħu t- test tan- nifs waqt it- tqala jew l- irdigħ ikun hemm xi effett ta ’ ħsara.
The package must be sent to a qualified laboratory for analysis.
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.
If you take more Helicobacter Test INFAI than you should Because only 75 mg 13C-urea is provided overdose is not to be expected.
Sewqan u tħaddim ta ’ magni Helicobacter Test INFAI m’ għandux effett fuq il- ħila biex issuq jew tħaddem magni.
HOW TO STORE HELICOBACTER TEST INFAI
KIF TAĦŻEN X
Do not store above 25°C.
Taħżinx f ’ 'temperatura ogħla minn 25°C.
These measures will help to protect the environment.
M’ għandekx tuża wara d- data li jiskadi li tidher fuq it- tikketta u l- kartuna ta ’ Helicobacter Test INFAI.
One jar contains 75 mg 1 3C-urea.
Vażett wieħed fih 75 mg 13C- urea M’ hemmx sustanzi oħra.
Content of the Test Kit with 1 jar:
Test jikkonsisti minn vażett 1 bil- komponenti addizzjonali li ġejjin:
containing 75 mg 13C-urea powder for oral solution Labelled sample breath bags for sampling, storing and transporting the breath samples for analysis:
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.
breath bags:
Boroż tan- nifs:
corresponding sample tubes
Strô li jitgħawweġ għal ġbir ta ’ kampjuni tan- nifs fir- reċipjenti relattivi boroż tan- nifs
50 Content of the Test Kit with 50 jars:
Sett tat- testijiet jikkonsisti minn 50 vażett bil- komponenti addizzjonali li ġejjin:
51 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
51 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok għamel kuntatt mar- rappreżentant lokali tas- Sid ta ’ l- Awtorizzazzjoni tal- Kummerċ.
België/Belgique/Belgien INFAI, Institut für biomedizinische Analytik und NMR-Imaging GmbH Universitätsstraße 142 D-44799 Bochum Tél/Tel: +49 234 971130 България INFAI, Institut für biomedizinische Analytik und NMR-Imaging GmbH Universitätsstraße 142 D-44799 Bochum Teл.: +49 234 971130 Česká republika INFAI, Institut für biomedizinische Analytik und NMR-Imaging GmbH Universitätsstraße 142 D-44799 Bochum Tel: +49 234 971130 Danmark BioCare Nordic ApS Langebjergvaenget 8A DK-4000 Roskilde Tlf: +45 4646 1191
България INFAI, Institut für biomedizinische Analytik und NMR- Imaging GmbH Universitätsstraße 142 D- 44799 Bochum Teл.: +49 234 971130 Česká republika INFAI, Institut für biomedizinische Analytik und NMR- Imaging GmbH Universitätsstraße 142 D- 44799 Bochum Tel.: +49 234 971130
Luxembourg/Luxemburg INFAI, Institut für biomedizinische Analytik und NMR-Imaging GmbH Universitätsstraße 142 D-44799 Bochum Tél/Tel: +49 234 971130 Magyarország INFAI, Institut für biomedizinische Analytik und NMR-Imaging GmbH Universitätsstraße 142 D-44799 Bochum Tel.: +49 234 971130 Malta INFAI, Institut für biomedizinische Analytik und NMR-Imaging GmbH Universitätsstraße 142 D-44799 Bochum Tel: +49 234 971130 Nederland INFAI, Institut für biomedizinische Analytik und NMR-Imaging GmbH Universitätsstraße 142 D-44799 Bochum Tel: +49 234 971130
Magyarország INFAI, Institut für biomedizinische Analytik und NMR- Imaging GmbH Universitätsstraße 142 D- 44799 Bochum Tel.: +49 234 971130 Malta INFAI, Institut für biomedizinische Analytik und NMR- Imaging GmbH Universitätsstraße 142 D- 44799 Bochum Tel: +49 234 971130
52 France INF AI France SARL Eurocentre Tertiaire 50, avenue d’Alsace F- 68027 Colmar Tél: +33 389 204382
52 France INFAI France SARL Eurocentre Tertiaire 50, avenue d’ Alsace F - 68027 Colmar Tél: +33 389 204382
The breath samples, collected in breath bags are analysed by non-dispersive infrared spectroscopy (NDIR).
Il- kampjuni tan- nifs, miġbura f’ boroż tan- nifs ta ’ 100 ml, jiġu analizzati b’ spettrometrija infra- ħamra li ma tinxteridx (NDIR).
53 The analysis of the 13C/12C-ratio in carbon dioxide of breath is an integrated part of the diagnostic test Helicobacter Test INFAI.
53 L- analiżi tal- proporzjoni 13C/ 12C- ratio ta ’ dijossidu karboniku fin- nifs jagħmel parti integrali mill- kitt dijanjostiku Helicobacter Test INFAI.
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 tan0nifs bħal linejarità, stabbilità (preċiżjoni mal - gass ta ’ referenza) u preċiżjoni fil- kejl huma fundamentali fil- preċiżjoni tas- sistema.
• Sample preparation for Infrared Spectroscopy (NDIR)
• Preparazzjoni Spettrometrija Infra- ħamra (NDIR)
• Infrared spectroscopic analysis
• Analiżi spettroskopika infra- ħamra
To analyse the carbon dioxide in breath a broad band infrared radiation bunch emitted by an infrared radiation source is alternately sent through the measuring chamber and a reference chamber by means of a beam chopper.
Sabiex jiġi analizzat id- dijossidu karboniku fin- nifs, balla ta ’ radjazzjoni infra- ħamra fuq faxxa wiesgħa mitfugħa minn sors ta ’ radjazzjoni infra- aħmar jiġi mibgħut b’ alternanzza minn ġol - kompartament ta ’ kejl u kompartament ta ’ referenza permezz ta ’ tagħmir li jaqta ’ r- raġġ.
The modulated infrared beams then enter the infrared detectors, which are double layer transmission detectors with a front, and a rear chamber each filled with one of the isotopicly pure gases (13CO2 or 12CO2, respectively) to be measured.
Ir- raġġi infra - ħomor immodulati mbagħad jidħlu fl- intraċċaturi infra- ħomor, li huma intraċċaturi ta ’ trasmissjoni dopji b’ kompartament fuq quddiem u ieħor fuq wara, li kull wieħed minnhom huwa mimli b’ gassijiet isotopikament puri (13CO2 jew 12CO2, rispettivament) li jridu jiġi mkeja.
The infrared radiation in the measuring chamber is weakened by the gas component to be measured.
Ir- radjazzjoni infra- ħamra fil - kompartament tal- kejl tiġi mdgħajfa bil- komponent tal- gass li jrid jiġi mkejjel.
Thus the radiation equilibrium between measuring and comparative beam is disturbed.
B' hekk, l- ekwilibriju ta ’ radjazzjoni bejn ir- raġġ ta ’ kejl u r- raġġ komparattiv huwa disturbat.
In consequence there is a temperature fluctuation, which in its turn causes a fluctuating pressure in the front chamber of the infrared detector.
Bħala konsegwenza ta ’ hekk, hemm bidla fit- temperatura, li tikkaġuna bidla fil- pressjoni fil- kompartament ta ’ quddiem ta ’ l - intraċċatur infra- aħmar.
A membrane capacitor connected with this chamber, which is exposed to a high resistance direct voltage, transforms these pressure fluctuations into an alternating voltage, which is a measure of the isotopic composition of breath carbon dioxide.
vultaġġ dirett b ’ reżistenza għolja jitrasforma dawn il- bidliet fil- pressjoni f' vultaġġ li jalterna, li hu kejl tal- kompożizzjoni isotopika tad- dijossidu karboniku fin- nifs.
• Sample Inlet
• Introduzzjoni tal- kampjun
A semi-automatic sample inlet system injects the measuring gas in definite amounts into the zero gas circulating in the gas circuit of the infrared spectrometer.
Sistema li tippermetti d- dħul ta ’ kampjun b ’ mod semi- awtomatiku tinjetta l- gass li jrid jitkejjel f’ ammonti stabbiliti fiż- żero gass li jkun qed jiċirkula fiċ- ċirkwit ta ’ l- ispettrometru infra- aħmar.
This enables measurement of the 13C/12C ratio at any CO2 concentration above 1%.
Dan jippermetti l- kejl tal- proporzjon 13C/ 12C f 'kull konċentrazzjoni' l fuq minn ta ’ 1%.
The breath test concept is based upon the oral administration of 13C-labelled urea whose enzymatic hydrolysis is monitored by measuring 13CO2 in breath using non-dispersive infrared spectrometry.
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 spettrometrija infra- ħamra li ma ’ tinxteredx.
Infrared spectrometers for breath analysis must comply with the following specifications:
Spettrometri infra- ħomor għal analiżi tan- nifs għandhom jikkonformaw ta 'l- ispeċifikazzjonijiet li ġejjin:
Minimum of 3 replicate analyses of one and the same sample during operation
Minimu ta ’ 3 analiżi ripettivi fuq l- istess kampjun waqt l- impjieg Ħażna tal- parametri ta ’ ħidma u tar- riżultati taħt aċċess tas- sigurtà sabiex jiġi evitat kull manipulazzjoni 'l quddiem proporzjon 13C/ 12C fir- rigward ta ’ PDB (Pee Dee Beliminate)
Storing of operating parameters and results under security access to avoid later manipulation
< 200 µl
For verifying the specifications linearity, stability, and precision of measurement have to be tested.
Għal verifikazzjoni ta 'l- ispeċifikazzjonijiet, iridu jiġu ttestjati linejarità, istabbilità u preċiżjoni ta' kejl.
54 Linearity:
54 Aġġustament fil- punt żero ta ’ l- intraċċaturi permezz taż- żero gass li jiġi prodott fl- ispettrometru.
≤ 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 - Linejarità: konċentrazzjoni ta ’ CO2 ≤ 0. 2 ‰ fuq 10 pulsi konsekkutivi Stabbilità: ≤ 0. 5 ‰ għal 13C f’ abbundanza naturali permezz ta ’ borża tan- nifs ta ’ Preċiżazzjoni fil- kejl:
Alternatively, any other suitably validated method may be used, carried out by any objectively qualified laboratory.
Alternativament, kull laboratorju oġġetivament ikkwalifikat jista ’ iwettaq kull metodu vvalidat kif suppost.
55 MINIMUM PARTICULARS TO APPEAR ON
55 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
INFORMATION FOR THE USER Helicobacter Test INFAI for children of the age 3-11 45 mg powder for oral solution 13 C-urea
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU Helicobacter Test INFAI għal tfal bejn l- etajiet ta ’ 3 snin sa 11- il sena 45 mg trab ta ’ 13C urea għal soluzzjoni orali 13C urea
if 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 for children of the age 3-11 years is and what it is used for 2.
X’ inhu Helicobacter Test INFAI u għalxiex jintuża 2.
Before you take Helicobacter Test INFAI for children of the age 3 -11 3.
Qabel ma ’ tieħu Helicobacter Test INFAI għal tfal bejn l- etajiet ta ’ 3 snin sa 11- il sena 3.
How to take Helicobacter Test INFAI for children of the age 3-11 4.
Kif għandek tuża Helicobacter Test INFAI għal tfal bejn l- etajiet ta ’ 3 snin sa 11- il sena 4.
Possible side effects 5 How to store Helicobacter Test INFAI for children of the age 3-11 6.
Kif taħżen Helicobacter Test INFAI għal tfal bejn l- etajiet ta ’ 3 snin sa 11- il sena 6.
WHAT HELICOBACTER TEST INFAI FOR CHILDREN AGED 3 TO 11 YEARS IS AND WHAT IT IS USED FOR
X’ INHU HELICOBACTER TEST INFAI GĦAL TFAL BEJN L- ETAJIET TA ’ 3 SNIN SA 11- IL SENA U GĦALXIEX JINTUŻA
Helicobacter Test INFAI for children of the age 3-11 is for diagnostic use only.
Għamla farmaċewtika u kontenut Helicobacter Test INFAI huwa għal użu dijanjostiku biss.
Helicobacter Test INFAI for children aged 3-11 years is a breath test, which can be used to determine if there is an infection in the stomach or duodenum caused by the bacteria Helicobacter pylori.
Helicobacter Test INFAI għal tfal bejn l- etajiet ta ’ 3 snin sa 11- il sena huwa trab li jittieħed mill- ħalq.
Why do you need to take the Helicobacter Test INFAI for children of the age 3-11?
X' GĦANDEK BŻONN BIEX TIEĦU L- Helicobacter Test INFAI għal tfal bejn l- etajiet ta ’ 3 snin sa 11- il sena?
Your doctor has recommended that you have a Helicobacter Test INFAI for children of the age 3-11 for one of the following reasons:
It- tabib tiegħek irrakomanda li tagħmel Helicobacter Test INFAI għal tfal bejn l- etajiet ta ’ 3 snin sa 11- il sena, 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:
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 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.
BEFORE YOU T AKE HELICOBACTER TEST INFAI FOR CHILDREN OF THE AGE 3-11
QABEL MA ’ TUŻA HELICOBACTER TEST INFAI GĦAL TFAL BEJN L- ETAJIET TA ’ 3 SNIN SA 11- IL SENA
Do not take Helicobacter Test INFAI for children of the age 3-11
M' għandekx tieħu Helicobacter Test INFAI għal tfal bejn l- etajiet ta ’ 3 snin sa 11- il sena 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.
Take special care with Helicobacter Test INFAI for children of the age 3-11 Even if the result of Helicobacter Test INFAI is positive, further tests might be necessary before a treatment of a Helicobacter pylori infection (eradication therapy) may be started.
Oqgħod attent ħafna b’ Helicobacter Test INFAI għal tfal bejn l- etajiet ta ’ 3 snin sa 11- il sena 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).
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.
Hemm diversi testijiet dijanjostiċi varji, li jinkludu testijiet endoskopiċi invażivi li jistgħu jkunu meħtieġa sabiex jiċċekjaw għal preżenza ta ’ kumplikazzjonijiet oħrajn bħalma huma ulċeri fl- istonku, infezzjoni tal- mukożsa ta ’ l- istonku kkaġunata b’ reazzjoni awtoimmitarja, u tumuri.
There is insufficient data on the diagnostic reliability of the Helicobacter Test INFAI for children of the age 3-11 for recommending its use in patients with gastrectomy.
Qaghad m’ hemmx biżżejjed informazzjoni fuq l- affidabilità dijanjostika ta ’ Helicobacter Test INFAI għal tfal bejn l- etajiet ta ’ 3 snin sa 11- il sena 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’ gastrite A (gastrite atrofika), it- test tan- nifs jista 'iwassal għal riżultati
Taking other medicines Helicobacter Test INFAI for children of the age 3-11 is influenced by all medicines related to Helicobacter pylori or urease activity.
Jekk jogħġbok kellem lit- tabib tiegħek.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Jekk jogħġbok iftakar li din l- informazzjoni tista ’ tapplika ukoll għal mediċini kollha użati riċentement.
HOW TO TAKE HELICOBACTER TEST INFAI FOR CHILDREN OF THE AGE 3-11
KIF JINTUŻA HELICOBACTER TEST INFAI GĦAL TFAL BEJN L- ETAJIET TA ’ 3 SNIN SA 11- IL SENA
Dosage The following information applies, unless your doctor has otherwise prescribed Helicobacter Test INFAI for children of the age 3-11.
Doża L- informazzjoni li ġejja tapplika, sakemm it- tabib tiegħek ma takx riċetta għal Helicobacter Test INFAI għal tfal bejn l- etajiet ta ’ 3 snin sa 11- il sena.
Please follow the instructions for use, as otherwise the Helicobacter Test INFAI for children of the age 3-11 years may not work properly.
Jekk jogħġbok segwi l- istruzzjonijiet dwar l- użu, għax inkella Helicobacter Test INFAI għal tfal bejn l- etajiet ta ’ 3 snin sa 11- il sena jista ’ ma jaħdimx kif suppost.
How much Helicobacter Test INFAI for children of the age 3-11 should be used and how often?
58 Kemm għandi nuża Helicobacter Test INFAI għal tfal bejn l- etajiet ta ’ 3 snin sa 11- il sena u kemm ta ’ spiss?
Patients from the age of 3-11 must take the content of one jar with 45 mg for one test.
Pazjenti bejn l- etajiet ta ’ 3 snin sa 11- il sena jieħdu l- kontenut ta ’ vażett b ’ 45 mg għal test wieħed..
How and when should Helicobacter Test INFAI for children of the age 3-11 be used?
Kif u meta għandu jintuża Helicobacter Test INFAI għal tfal bejn l- etajiet ta ’ 3 snin sa 11- il sena?
58 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 for children of the age 3-11.
Dawn iż- żewġ sustanzi jistgħu jaffetwaw ir- riżultati ta ’ Helicobacter Test INFAI għal tfal bejn l- etajiet ta ’ 3 snin sa 11- il sena.
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 for children of the age 3-11 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 għal tfal bejn l- etajiet ta ’ 3 snin sa 11- il sena 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 m' hijiex provduta mas- sett.
Pure orange juice (100 ml) 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.
Special Instructions for use (for mass spectrometry) The test is to be performed after instruction by a healthcare professional and under appropriate medical supervision.
Struzzjonijiet speċjali dwar l- użu (għal spettrometrija tal- massa)
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, imbagad immedjatament aglaq it- tubu bit- tapp tiegħu.
(If the sample tube remains open for more than 30 seconds, the test result might be falsified.)
(Kemm- il darba t- 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 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.
Then the patient must drink the recommended test meal (100 ml 100% orange juice).
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).
The jar labelled “ 13C-urea powder” is removed from the test set, opened, and filled up to about three quarters with tap water.
Ferragħ il - kontenut f’ tazza.
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.
59 Ferragħ il- kontenut f’ tazza, imla l- vażett 13C- urea sax- xifer b’ ilma għat- tieni u tielet darba • u ferragħ dawn il- kontenut ta ’ dawn fit- tazza sabiex int ikollok volum totali ta ’ madwar 30 ml ta ’ taħlita likwida tat- test).
30 minutes after the test solution has been taken (point 6), the “30-minute-value” samples are collected in both containers, which remains 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 above.
30 - minuta- valur ”), kif deskritt taħt punti 3 u 4.
If you take more Helicobacter Test INFAI for children of the age 3-11 than you should Because only 45 mg 13C-urea is provided overdose is not to be expected.
Jekk tieħu aktar Helicobacter Test INFAI għal tfal bejn l- etajiet ta ’ 3 snin sa 11- il sena milli suppost Minħabba li 45 mg 13C- urea ibiss huwa provdut mhux mistenni li jkun hemm doża eċċessiva..
HOW TO STORE HELICOBACTER TEST INFAI FOR CHILDREN OF THE AGE 3-11
KIF TAĦŻEN HELICOBACTER TEST INFAI GĦAL TFAL BEJN L- ETAJIET TA ’ 3 SNIN SA 11- IL SENA
Do not store above 25°C.
Taħżinx f’ temperatura ogħla minn 25°C.
These measures will help to protect the environment.
M’ għandekx tuża wara d- data li jiskadi li tidher fuq it- tikketta u l- kartuna ta ’ Helicobacter Test INFAI għal tfal bejn l- etajiet ta ’ 3 snin sa 11- il sena.
What Helicobacter Test INFAI for children of the age 3-11contains
X’ fih Helicobacter Test INFAI:
One jar contains 45 mg 13C-urea.
Vażett wieħed fih 45 mg 13C- urea M’ hemmx sustanzi oħra.
What Helicobacter Test INFAI for children of the age 3-11 looks like and contents of the pack Helicobacter Test INFAI for children of the age 3-11 years is a clear, colourless powder for oral solution.
Helicobacter Test INFAI huwa trab ċar, mingħajr kulur għal soluzzjoni orali.
Content of the Test Kit:
Kontenut u Sett 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 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,
corresponding sample tubes
Strô li jitgħawweġ għal ġbir ta ’ kampjuni tan- nifs fil- boroż tan- nifs rispettivi.
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
60 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
61 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok għamel kuntatt mar- rappreżentant lokali tas- Sid ta ’ l- Awtorizzazzjoni tal- Kummerċ.
61 France INFAI France SARL Eurocentre Tertiaire 50, avenue d’Alsace F- 68027 Colmar Tél: +33 389 204382
62 France INFAI France SARL Eurocentre Tertiaire 50, avenue d’ Alsace F - 68027 Colmar Tél: +33 389 204382
62 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 - 63 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 linejarità, stabbilità (preċiżjoni mal- gass ta ’ referenza) u preċiżjoni fil- kejl huma fundamentali fil- preċiżjoni tas- sistema.
≤ 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 10ml breath sample tube with 3% CO2 breath concentration
64 ≤ 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 ’ 13 12 C / C 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 oġġetivament ikkwalifikat jista ’ iwettaq kull metodu vvalidat kif suppost.
64 MINIMUM PARTICULARS TO APPEAR ON
65 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
What is Helixate NexGen?
X’ inhu Helixate NexGen?
Helixate NexGen is a powder and solvent that are mixed together to make a solution for injection.
Helixate NexGen huwa trab u solvent li jitħalltu flimkien biex jiffurmaw soluzzjoni għal injezzjoni.
Helixate NexGen contains the active substance octocog alfa (recombinant coagulation factor VIII).
Helixate NexGen fih is- sustanza attiva octocog alfa (fattur tal- koagulazzjoni VIII rikombinanti).
What is Helixate NexGen used for?
Għalxiex jintuża Helixate NexGen?
Helixate NexGen is used for the treatment and prevention of bleeding in patients with haemophilia A (an inherited bleeding disorder caused by lack of factor VIII).
Helixate NexGen jintuża għall- kura u l- prevenzjoni ta ’ fsada f’ pazjenti b’ emofilja A (disturb ta ’ fsada ereditarju kkawżat min- nuqqas ta ’ fattur VIII).
Helixate NexGen is intended for either short-term or long-term use.
Helixate NexGen huwa maħsub għal użu fuq perjodu fit- tul jew qasir.
How is Helixate NexGen used?
Kif jintuża Helixate NexGen?
Helixate NexGen should be started by a doctor who has experience in the treatment of haemophilia.
Helixate NexGen għandu jinbeda minn tabib li jkollu esperjenza fil- kura ta ’ l- emofilja.
Helixate NexGen is given by intravenous injection (into a vein) over several minutes, up to a rate of 2 ml per minute.
Helixate NexGen jingħata b’ injezzjoni fil- vini fuq diversi minuti, sa rata massima ta ’ 2 ml fil- minuta.
The dose and frequency depend on whether Helixate NexGen is used to treat haemorrhage (bleeding) or prevent it during surgery.
Id- doża u l- frekwenza jiddependu fuq jekk Helixate NexGen jintużax biex tiġi kkurata l- emorraġija (fsada) jew biex jimpediha waqt il- kirurġija.
The dose is also adjusted depending on the severity of the haemorrhage or the type of surgery.
Id- doża tiġi aġġustata wkoll skond il- gravità ta ’ l- emorraġija jew it - tip ta ’ kirurġija.
Helixate NexGen can also be given as a continuous infusion (drip into a vein) for at least seven days in patients undergoing major surgery.
Helixate NexGen jista ’ jingħata wkoll bħala infużjoni kontinwa (dripp ġo vina) għal mill- anqas 7 ijiem f’ pazjenti sottoposti għal operazzjoni maġġuri.
Full details on how to calculate the doses are included in the Package Leaflet.
Dettalji sħaħ dwar kif għandhom jiġu kkalkulati d- dożi huma inklużi fil- Fuljett ta ’ Tagħrif.
How does Helixate NexGen work?
Kif jaħdem Helixate NexGen?
The active substance in Helixate NexGen, octocog alfa, is a blood coagulation factor protein.
Is- sustanza attiva f’ Helixate NexGen, octocog alfa, hija proteina tal- fattur tal- koagulazzjoni tad - demm.
In the body, factor VIII is one of the substances (factors) involved in blood coagulation (clotting).
Fil- ġisem, il- fattur VIII hu wieħed mis- sustanzi (fatturi) involuti fil- koagulazzjoni (tagħqid) tad- demm.
Patients with haemophilia A lack factor VIII, and this causes blood coagulation problems, such as bleeding in the joints, muscles or internal organs.
Pazjenti bl- emofilja A huma neqsin mill- fattur VIII, u dan jikkawża problemi ta ’ koagulazzjoni tad- demm, bħal fsada fil- ġogi, fil- muskoli jew fl- organi interni.
Helixate NexGen is used to replace the missing factor VIII.
Helixate NexGen jintuża biex jissostitwixxi l- fattur VIII nieqes.
It corrects the factor VIII deficiency and gives temporary control of the bleeding disorder.
Huwa jsewwi d- defiċjenza tal- fattur VIII u jagħti kontroll temporanju tad- disturb tal- fsada.
Octocog alfa is not extracted from human plasma but produced by a method known as ‘ recombinant DNA technology’: it is made by a cell that has received a gene (DNA), which makes it able to produce human coagulation factor VIII.
Octocog alfa mhuwiex estratt minn plasma umana iżda huwa prodott b’ metodu magħruf bħala ‘ teknoloġija rikombinanti tad- DNA ’: huwa magħmul minn ċellola li tkun irċeviet ġene (DNA), li jagħmilha kapaċi li tipproduċi l- fattur tal- koagulazzjoni VIII uman.
How has Helixate NexGen been studied?
Kif ġie studjat Helixate NexGen?
Helixate NexGen is similar to the medicine KOGENATE, but it is prepared differently so that there are no human-derived proteins in the medicine.
Helixate NexGen huwa simili għall- mediċina KOGENATE, iżda huwa ppreparat b’ mod differenti sabiex ma hemm l- ebda proteini derivati mill- bniedem fil- mediċina.
Helixate 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Minħabba dan, l- istudji li saru 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu. http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged NexGen given as an intravenous injection has been studied in 66 patients who had been previously treated with recombinant coagulation factor VIII and 61 children who had not.
Helixate NexGen mogħti bħala injezzjoni fil- vini ġie studjat f’ 66 pazjent li kienu rċevew kura qabel bil- fattur tal - koagulazzjoni VIII rikombinanti u f’ 61 tifel/ tifla li ma kinux.
The main measure of effectiveness in the studies was the number of treatments required to stop each new bleed.
Il- kejl prinċipali f’ dawn l- istudji kien in - numru ta ’ trattamenti meħtieġa biex titwaqqaf kull fsada ġdida.
Helixate NexGen has also been studied as a continuous infusion in 15 patients with haemophilia A undergoing major surgery.
Helixate NexGen ġie studjat ukoll bħala infużjoni kontinwa fi 15- il pazjent b’ emofilja A sottoposti għal operazzjoni maġġuri.
The main measure of effectiveness was the doctor’ s assessment of how well bleeding was stopped.
Il- kejl prinċipali ta ’ l- effikaċja kien l- evalwazzjoni tat- tabib dwar kemm twaqqfet tajjeb il- fsada.
What benefit has Helixate NexGen shown during the studies?
X’ benefiċċju wera Helixate NexGen matul l- istudji?
In the previously treated patients, overall, 95% of bleeds responded to one or two intravenous injections of Helixate NexGen.
Fil- pazjenti li rċevew kura qabel, globalment, 95% tal- fsid irrisponda għal 1 jew 2 injezzjonijiet fil - vina ta ’ Helixate NexGen.
In the previously untreated patients, about 90% of bleeding episodes responded to treatment with one or two intravenous injections.
Fil- pazjenti li ma rċevewx kura qabel, madwar 90% ta ’ l- episodji ta ’ fsada rrispondew għal kura b’ 1 jew 2 injezzjonijiet fil- vini.
When given as a continuous infusion, stopping bleeding was assessed as ‘ excellent ’ in all 15 patients.
Meta ngħata bħala infużjoni kontinwa, it- twaqqif tal- fsada kien valutat bħala ‘ eċċellenti ’ fil- 15- il pazjent kollha kemm huma.
What is the risk associated with Helixate NexGen?
X’ inhu r- riskju assoċjat ma ’ Helixate NexGen?
Haemophilia A patients may develop antibodies (inhibitors) to factor VIII.
Il- pazjenti b’ emofilja A jistgħu jiżviluppaw antikorpi (inibituri) għall- fattur VIII.
An antibody is a protein produced by the body in reaction to unknown agents as part of the natural defence system of the body.
Antikorp huwa proteina li jipproduċi l- ġisem b’ reazzjoni għal aġenti mhux magħrufa bħala parti mis- sistema ta ’ difiża naturali tal- ġisem.
In clinical trials with Helixate NexGen, this happened in 14% of previously untreated patients and in 17% of children who had been treated for less than five days in the past.
Fil- provi kliniċi b’ Helixate NexGen, dan ġara f’ 14% mill- pazjenti li ma kinux ingħataw kura qabel u fi 17% ta ’ tfal li kienu qed jingħataw kura għal inqas minn ħamest ijiem fil - passat.
However, it is seen in less than 0.2% of patients treated for more than 100 days.
Madanakollu, l- iżvilupp ta ’ antikorpi deher f’ inqas minn 0. 2% tal- pazjenti ittrattati għal iktar minn 100 jum.
If antibodies develop, Helixate NexGen will not work effectively.
Jekk l- iżvilupp ta ’ l- antikorpi jseħħ, Helixate NexGen ma jaħdimx b’ mod effettiv.
Hypersensitivity (allergic reactions) has sometimes been seen in patients treated with factor VIII-containing products.
Xi reazzjonijiet allerġiċi dehru xi kultant f’ pazjenti kkurati bi prodotti li fihom il- fattur VIII.
Other side effects seen in rare cases were dysgeusia (taste disturbances), nausea, reactions at the injection site, pyrexia (fever), allergic or anaphylactic (severe allergic) reactions, abnormal blood pressure, dizziness, pruritus (itching) and rash.
Effetti sekondarji oħrajn li dehru f’ każijiet rari kienu dysgeusia (disturbi fit- togħma), nawżeja, reazzjonijiet fil- post ta ’ l- injezzjoni, pyrexia (deni), reazzjonijiet ta ’ allerġija jew anaphylactic (allerġija severa), pressjoni tad- demm mhux normali, sturdament, prurite (ħakk) u raxx.
Helixate NexGen should not be used in people who may be hypersensitive (allergic) to recombinant coagulation factor VIII, to mouse or hamster protein or to any of the other ingredients.
Helixate NexGen m’ għandux jintuża f’ nies li jista ’ jkunu allerġiċi għall- fattur ta ’ koagulazzjoni VIII rikombinanti, għal proteini tal- ġurdien jew tal- ħamsters jew għal xi sustanzi oħra.
Why has Helixate NexGen been approved?
Għaliex ġie approvat Helixate NexGen?
The Committee for Medicinal Products for Human Use (CHMP) decided that Helixate NexGen’ s benefits are greater than its risks for the treatment and prevention of bleeding in patients with haemophilia A (congenital factor VIII deficiency).
Il- Kumitat dwar il- Prodotti Mediċinali għal Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Helixate NexGen huma akbar mir- riskji tiegħu għall- kura u l- prevenzjoni ta ’ fsada f’ pazjenti b’ emofilja A (defiċjenza konġenitali tal- fattur VIII).
The Committee recommended that Helixate NexGen be given marketing authorisation.
Il- Kumitat irrikkmanda li Helixate NexGen jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Helixate NexGen:
Tagħrif ieħor dwar Helixate NexGen:
The European Commission granted a marketing authorisation valid throughout the European Union for Helixate NexGen on 4 August 2000.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha, għal Helixate NexGen, fl- 4 ta ’ Awwissu 2000.
The marketing authorisation was renewed on 4 August 2005.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fl- 4 ta ’ Awwissu 2005.
The marketing authorisation holder is Bayer HealthCare AG.
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq hu Bayer HealthCare AG.
The full EPAR for Helixate NexGen is available here.
L- EPAR sħiħ għal Helixate NexGen jista ’ jinstab hawn.
This summary was last updated in 10-2007.
Dan is- sommarju kien aġġornat l- aħħar fl- 10- 2007.
Invented name Strength
Qawwa
Intravenous use
Għal użu ġol- vina.
powder: vial (glass); solvent: vial (glass)
1 fjala (ħġieġ); Solvent:
powder:
1 fjala (ħġieġ)
250 IU; solvent:
Trab:
2.5 ml (100 IU/ ml)
250 IU; Ilma għall- injezzjoni 2. 5 ml (100 IU/ ml)
1 vial + 1 vial + 1 set of administration devices*
1 fjala + 1 fjala + Sett ta ’ tagħmir ta ’ amministrazzjoni *
500 IU; solvent:
Trab:
2.5 ml (200 IU/ ml)
500 IU; Ilma għall- injezzjoni 2. 5 ml (200 IU/ ml)
1000 IU; solvent:
Trab:
2.5 ml (400 IU/ ml)
1000 IU; Ilma għall- injezzjoni 2. 5 ml (400 IU/ ml)
2000 IU; solvent:
Trab:
5.0 ml (400 IU/ ml)
2000 IU; Ilma għall- injezzjoni 5, 0 ml (400 IU/ ml)
vial + vial + set of administration devices*
1 fjala + 1 fjala + Sett ta ’ tagħmir ta ’ amministrazzjoni *
* - 1 filter transfer device 20/ 20
* - tagħmir tal- filter 1 li jitrasferixxi 20/ 20
- 1 venipuncture set
- sett 1 għat- titqib tal- vina
- 1 disposable 5 ml syringe
- siringa ta ’ 5 ml li tintrema wara li tintuża
- 2 sterile alcohol swabs for single use
- 2 msiħ sterili bl- alkoħol biex jintużaw darba.
Helixate NexGen 250 IU Powder and solvent for solution for injection.
Helixate NexGen 250 IU Trab u solvent għal soluzzjoni għall- injezzjoni
Recombinant Coagulation factor VIII, 250 IU/ vial.
Fattur VIII tal- koagulazzjoni rikombinanti 250 IU/ kunjett.
Recombinant Coagulation factor VIII is produced from genetically engineered baby hamster kidney cells containing the human factor VIII gene.
Fattur VIII tal- koagulazzjoni rikombinanti hu magħmul bl- inġinerija ġenetika minn razza ta 'ċelluli tal - kliewi tal- ferħ tal- ħamster, li għandhom il- ġene tal- fattur VIII tal- bniedem.
Solvent: water for injections.
Solvent: ilma għall- injezzjoni.
The product reconstituted with the accompanying 2.5 ml of water for injections contains approximately 100 IU octocog alfa/ ml.
Meta l- prodott jiġi rikostitwit b’ 2, 5 ml ilma għall- injezzjoni, li hu inkluż, il- prodott ikun fih madwar 100 IU octocog alfa/ ml.
The potency (IU) is determined using the one-stage clotting assay against the FDA Mega standard which was calibrated against WHO standard in IU.
Il- qawwa (IU) hija stabbilita permezz ta 'assaġġ ta ’ l- emboliżmu fuq stadju wieħed li jitqabbel ma' Mega standard ta 'l- FDA li ġie kkalibrat fuq standard tal- WHO u mkejjel b' IU.
The specific activity is approximately 4000 IU/ mg protein.
L- attività speċifika hija madwar 4000 IU/ mg ta ’ proteina.
The powder is provided in a vial as a dry white to slightly yellow powder or cake.
It- trab jinsab f’ kunjett bħala trab xott jew kejk ta ’ 'lewn bajdani li jkanġi ftit fl- isfar.
The solvent is water for injections provided in a vial.
Is- solvent jikkonsisti minn ilma għall- injezzjonijiet li jiġi f’ kunjett.
Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).
Għal kura u l- profilassi tal- fsada f 'pazjenti li għandhom l- emofilja A (nuqqas konġenitali tal- fattur VIII).
This preparation does not contain von Willebrand factor and is therefore not indicated in von Willebrand's disease.
Din il- preparazzjoni ma fihiex il- fattur von Willebrand u għalhekk m' hiex intiża biex tintuża għal- kura tal- marda von Willebrand.
Treatment should be initiated under the supervision of a physician experienced in the treatment of haemophilia.
Il- kura għandha tiġi mibdija taħt is- sorveljanza ta ’ tabib b’ esperjenza fit- terapija ta 'l- emofilja.
Posology The number of units of factor VIII administered is expressed in International Units (IU), which are related to the current WHO standard for factor VIII products.
Pożologġija L- għadd ta 'unitajiet tal- fattur VIII li jingħata huwa mkejjel b’ Unitajiet Internazzjonali (IU), li huma relatati ma ’ l- istandard attwali tal- WHO dwar prodotti tal- fattur VIII.
Factor VIII activity in plasma is expressed either as a percentage (relative to normal human plasma) or in International Units (relative to the International Standard for factor VIII in plasma).
L- attività tal- fattur VIII fil - plażma hija mfissra bħala perċentwali (mqabbla ma ’ plażma normali tal- bniedem), jew bħala Unitajiet Internazzjonali (IU) (mqabbla ma ’ l- standard internazzjonali ta ’ fattur VIII fil- plażma).
One International Unit (IU) of factor VIII activity is equivalent to that quantity of factor VIII in one ml of normal human plasma.
Unità Internazzjonali waħda (IU) ta ’ attività ta ’ fattur VIII, hija ekwivalenti għall- ammont ta ’ fattur VIII li hemm ġo 1 ml ta ’ plażma normali tal- bniedem.
The calculation of the required dosage of factor VIII is based on the empirical finding that 1 International Unit (IU) factor VIII per kg body weight raises the plasma factor VIII activity by 1.5% to 2.5% of normal activity.
Id- doża meħtieġa tiġi maħduma fuq tagħrif miksub li juri li 1 Unità Internazzjonali (IU) ta ’ fattur VIII għal kul kg ta ’ piż tal- ġisem, jgħolli l- attività tal - fattur VIII fil- plażma b’ 1. 5% sa 2. 5% ta ’ l- attività normali.
The required dosage is determined using the following formulae:
Id- doża meħtieġa hija stabbilita skond dawn il- formuli:
Required IU = body weight (kg) x desired factor VIII rise (% of normal) x 0.5
IU meħtieġa = piż tal- ġisem (kg) x żjieda mixtieqa tal- fattur VIII (% tan- normal) x 0. 5
Expected factor VIII rise (% of normal) =
Żjieda mixtieqa tal- fattur VIII (% tan- normal) =
2 x administered IU body weight (kg)
2 x IU li jingħata piż tal- ġisem (kg)
The dosage and duration of the substitution therapy must be individualised according to the patient's needs (weight, severity of disorder of the haemostatic function, the site and extent of the bleeding, the titre of inhibitors, and the factor VIII level desired).
Id- doża u ż- żmien tat- terapija ta 'sostituzzjoni jridu jiġu adattati skond il- ħtiġijiet individwali tal - pazjent (piż, is- severità tad- disturbi fil- funzjoni emostatika, minn fejn u b’ kemm qawwa qed inixxi d - demm, l- ammont misjub ta ’ sustanzi inibituri, u l- livell ta ’ fattur VIII mixtieq).
The following table provides a guide for factor VIII minimum blood levels.
It- tabella li ġejja hija gwida ta ’ kemm għandhom ikunu l- livelli minimi tal- fattur VIII fid- demm.
In the case of the haemorrhagic events listed, the factor VIII activity should not fall below the given level (in% of normal) in the corresponding period:
F’ każijiet ta ’ l- emorraġgiji elenkati, il- livell ta ’ l- attività tal- fattur VIII, ma tridx ikun anqas mill- livell indikat (bħala% tan- normal) waqt dan il- perjodu:
Degree of haemorrhage/ Type of surgical procedure Haemorrhage
Qawwa ta ’ l- emorraġija / Tip ta ’ proċedura kirurġika Emorraġġija
Factor VIII level required (%) (IU/ dl)
Livell ta’ Fattur VIII meħtieġ (%) (IU/ dl)
Frequency of doses (hours)/ Duration of therapy (days)
Frekwenza tad- dożi (sigħat) / Dewmien tat- terapija (ġranet) Irrepeti d- doża kull 12 sa 24 siegħa.
Early haemarthrosis, muscle bleed or oral bleed
Emartrosi bikrija, fsada fil - muskoli jew mill- ħalq.
At least 1 day, until the bleeding episode as indicated by pain is resolved or healing is achieved.
Mill- anqas darba kuljum, sakemm jitaffa l- uġigħ ta ’ l- emorraġija jew ikun hemm fejqan.
More extensive haemarthrosis, muscle bleed or haematoma
Emartrosi aktar mifruxa, fsada fil- muskoli jew ematoma.
Repeat infusion every 12 - 24 hours for 3 - 4 days or more until pain and disability are resolved.
Irrepeti l- infużjoni kull 12 sa 24 siegħa għal 3- 4 ijiem jew aktar, sakemm jitfejjaq l- uġigħ u d - diżabilità.
Life threatening bleeds such as intracranial bleed, throat bleed, severe abdominal bleed Surgery
Kirurġija
Repeat infusion every 8 to 24 hours until threat is resolved
Irrepeti l- infużjoni kull 8 sa 24 siegħa sakemm tieqaf it- theddida.
Minor including tooth extraction
Minuri Inkluż qlugħ ta ’ snien.
Every 24 hours, at least 1 day, until healing is achieved.
sa meta jkun hemm fejqan.
Major
Maġġuri
80 - 100 (pre- and
80 - 100 (qabel u wara l - operazzjoni)
a) By bolus infusions Repeat infusion every 8 - 24 hours
a) Permezz ta ’ bolus infużjonali.
until adequate wound healing occurs, then continue with therapy for at least another 7 days to maintain a factor VIII activity of 30% to 60% b) By continuous infusion Raise factor VIII activity pre- surgery with an initial bolus infusion and immediately follow with continuous infusion (in IU/ Kg/ h) adjusting according to patient ’ s daily clearance and desired factor VIII levels for at least 7 days.
Għolli l- attività ta ’ fattur VIII qabel l- intervent kirurġiku permezz ta ’ bolus infużjonali fil- bidu u minnufih segwi b’ infużjoni kontinwa (f’ IU/ Kg/ h) u aġġusta skond ir- rata ta ’ eliminazzjoni ta ’ kuljum tal - pazjent u l- livelli ta ’ fattur VIII mixtieqa almenu għal 7 ijiem
The amount to be administered and the frequency of administration should always be adapted according to the clinical effectiveness in the individual case.
L- ammont li jiġi mogħti, kif ukoll il- frekwenza għandhom dejjem ikunu msejsa skond l- effettività klinika ta 'kif l- individwu jirrispondi.
Under certain circumstances larger amounts than those calculated may be required, especially in the case of the initial dose.
F’ ċerti każi, jista ’ jkun hemm bżonn ta’ ammonti akbar minn dawk ikkalkulati, speċjalment fil- każ ta 'l- ewwel doża.
During the course of treatment, appropriate determination of factor VIII levels is advised in order to guide the dose to be administered and the frequency at which to repeat the infusions.
3 Huwa rakkomandat li l- livell tal- fattur VIII jiġi stabbilit sew matul it- trattament biex ikun hemm gwida dwar id- doża u l- frekwenza ta ’ l- infużjoni li trid tiġi mogħtija.
Individual patients may vary in
Fil- każ ta 'intervent kirurġiku maġġur, monitoraġġ preċiż tat- terapija ta ’ sostituzzjoni permezz ta' l- analiżi ta 'koagulazzjoni (l - attività tal- fattur VIII fil- plażma) huwa indispensabbli.