qanastek/EMEA-V3 huggingface dataset:
These breath samples are used to measure the natural level of 13C in the carbon dioxide of the breath.
Dawn il- kampjuni tan- nifs jintużaw biex iqisu l- livell naturali tal - 13C fil- carbon dioxide tan- nifs.
t = 10 minutes.
t = 10 minuti.
The Pylobactell tablet is placed in the 30 ml mixing vial and water added to the marked line.
Il- pillola Pylobactell titpoġġa fil- kunjett ta ’ 30 ml li għandu jintuża biex tkun tista ’ tħallat u l- ilma jitferra ’ sal- linja mmarkata.
The bottle is capped and shaken well to dissolve the tablet.
Il- flixkun jingħalaq bit- tapp u jitħawwad tajjeb biex il - pillola tinħall.
The entire contents must be swallowed immediately by the patient, the bottle is refilled with water to the line and the entire contents are again swallowed by the patient.
Il- kontenut kollu jrid jinbela ’ minnufih mill- pazjent, il- flixkun jerġa ’ jimtela bl- ilma sal- linja u l- kontenut kollu jerġa ’ jinbela ’ mill- pazjent.
t = 40 minutes.
t = 40 minuti.
Collect post-urea (red top) breath samples.
Iġbor il- kampjuni tan- nifs ta ’ wara l- urea (naħa ta ’ fuq ħamra).
Three tubes of breath are to be taken, which are used to measure the presence of excess levels of 13C, which will be present if the patient is H. pylori positive.
Għandhom jittieħdu tlitt tubi tan- nifs, li jintużaw biex iqisu l- preżenza ta ’ livelli żejda ta ’ 13C, li jkunu preżenti jekk il - pazjent huwa pożittiv għall- H. pylori.
On completion of the test retain one pre-urea sample (white top) and one post-urea sample (red top).
Meta t- test jitlesta, żomm kampjun wieħed ta ’ qabel l- urea (naħa ta ’ fuq bajda) u kampjun wieħed ta ’ wara l- urea (naħa ta ’ fuq ħamra).
Return two pre-urea and two post-urea samples to the box.
Poġġi ż- żewġ kampjuni ta ’ qabel l- urea u ż- żewġ kampjuni ta ’ wara l- urea lura fil- kaxxa.
Safely discard the 30 ml mixing vial.
Armi mingħajr periklu l- kunjett ta ’ 30 ml, fejn ikun sar it- taħlit.
Complete the Analysis Request Form; attach one of three spare bar code labels to the area marked "AFFIX BAR CODE LABEL HERE".
Imla l- Formola tat- Talba għall- Analiżi; waħħal waħda mit- tlitt tikketti ż- żejda tal- bar kowd fuq l- ispazju mmarkat "WAĦĦAL IT- TIKKETTA TAL- BAR KOWD HAWNHEKK".
This bar code is the doctor's reference number used at the analysing laboratory as a patient identifier; the two spare bar code labels are for the doctor's use on the patient notes/ files etc.
Din il- bar kowd hija n- numru ta ’ referenza tat- tabib li jintuża fil- laboratorju fejn issir l- analiżi biex ikun identifikat il- pazjent; iż- żewġ tikketti tal- bar kowd żejda huma għall- użu tat- tabib fuq in- noti/ il- fajls tal- pazjent eċċ.
After placing the four sample tubes and paperwork into the box, use the security label provided to seal the lid of the box, and send to a qualified laboratory for analysis.
Wara li tpoġġi l- erba ’ tubi tal- kampjuni u l- karti ġol- kaxxa, uża t- tikketta tas- sigurtà provduta biex tissiġilla l- għatu tal- kaxxa, u ibgħatha għall- analiżi għand il- laboratorju kwalifikat.
Analysis of breath samples and testing specification
L- analiżi tal- kampjuni tan- nifs u l- ispeċifikazzjonijiet ta ’ l- ittestjar
The accuracy and precision of the test depends heavily on the quality of the analysis and therefore only laboratories having appropriate certification are considered qualified to analyse the breath samples.
Ir- reqqa u l- preċiżjoni tat- test jiddependu ħafna fuq il- kwalità ta ’ l- analiżi u għalhekk laboratorji li għandhom iċ- ċertifikazzjoni xierqa biss huma kkunsidrati bħala kwalifikati biex janalizzaw il - kampjuni tan- nifs.
Satisfactory specificity and sensitivity have been demonstrated in clinical studies where breath was analysed using isotope ratio mass spectrometry (IRMS).
Fi studji kliniċi kienu dimostrati speċifiċità u sensittività sodisfaċenti fejn in- nifs kien analizzat bl- użu ta ’ isotope ratio mass spectrometry (IRMS).
5 Breath samples collected during the test must remain in the original containers before analysis by IRMS.
Il- kampjuni tan- nifs miġbura waqt t- test għandhom jibqgħu fil- kontenituri oriġinali qabel analiżi b’ IRMS.
IRMS instruments may be of continuous flow or dual inlet configuration.
L- istrumenti tal- IRMS jistgħu jkunu konfigurati b’ ċirkolazzjoni kontinwa jew bi dual inlet.
A multi-position auto-sampler and bar code reader should be used to allow samples to be tracked throughout the analysis.
5 Għandu jiġi wżat apparat li jieħu l- kampjuni awtomatikament u li jkun jieħu diversi pożizzjonijiet u apparat li jaqra l- bar kowds biex jippermetti li l- kampjuni jkunu intraċċati tul l- analiżi.
IRMS source parameters and tuning must be optimised daily.
Il- parametri u l- aġġustament tas- sorsi ta ’ l- IRMS għandhom jiġu ottimizzati kuljum.
Instruments must be linear over a wide range of CO2 concentrations typically 1.0 - 6.0%.
L- istrumenti għandhom ikunu lineari fuq medda wiesgħa ta ’ konċentrazzjonijiet ta ’ CO2, tipikament 1. 0 - 6. 0%.
This should be checked routinely.
Dan għandu jiġi ċċekkjat ta ’ sikwit.
Internal analytical precision must be less than + 0.3 ‰ δ 13C for 20 replicate analyses of the same reference gas sample and remain within 3SD’ s of the mean for breath analyses.
Il- preċiżjoni analitika interna għandha tkun inqas minn + 0. 3 ‰ δ13C għal 20 analiżi replikat ta ’ l- istess kampjun tal- gass ta ’ referenza u tibqa ’ f’ 3SD’ s tal- medja għall- analiżi tan- nifs.
Transfer of the breath sample through the analytical system must be accomplished without isotope fractionation.
It- trasferiment tal- kampjun tan- nifs fis- sistema analitika għandu jsir mingħajr ma jkun hemm qsim ta ’ l- isotope.
The IRMS must possess a triple collector to allow the simultaneous detection of the ions at mass/ charge ratio 44, 45 and 46 fluctuations in the oxygen isotope content.
L- IRMS irid ikollu immuntar ta ’ ġbir triplu biex jippermetti is- sejba fl- istess waqt tal- ijoni f’ oxxillazzjonijiet fil- proporzjon ta ’ piż/ ċarġ ta ’ 44, 45 u 46 fil- kontenut ta ’ l- isotop ta ’ l- ossiġnu.
There must be provision for correction of instrumental drift during an analysis.
Waqt analiżi għandu jkun hemm meżż ta ’ korrezzjoni għall- varjazzjoni (drift) ta ’ l- istrumenti.
Reference gases must be standardised against an appropriate international standard to allow inter-laboratory comparison of results.
Il- gass ta ’ referenza għandu jkun standardizzat skond stàndard internazzjonali xieraq biex jippermetti l- paragun ta ’ riżultati bejn il- laboratorji.
Alternatively, any other suitably-validated method may be used, carried out by any objectively qualified laboratory.
Alternattivament, kwalunkwe metodu ieħor li huwa pruvat b’ mod xieraq jista ’ jintuża, u applikat minn kull laboratorju ikkwalifikat b’ mod oġġettiv.
Explanation of results: -
Spjegazzjoni tar- riżultati: -
Excess δ 13C: - Difference between pre- and post-urea sample measurements.
δ13C: - Id- differenza f’ partijiet minn kull elf (‰) meta mqabbel ma ’ stàndard internazzjonali aċċettat δ13C żejjed: - Id- differenza bejn il- kejl tal- kampjun ta ’ qabel l- urea u ta ’ wara l- urea
H. pylori status: -< 3.5 excess δ13C = Negative > 3.5 excess δ13C = Positive
< 3. 5 ta ’ δ13C żejjed = Negattiv L- istat ta ’ H. pylori: - > 3. 5 ta ’ δ13C żejjed = Pożittiv
Torbet Laboratories Limited 14D Wendover Road Rackheath Industrial Estate Norwich NR13 6LH United Kingdom
Torbet Laboratories Limited 14D Wendover Road Rackheath Industrial Estate Norwich NR13 6LH Ir- Renju Unit
7 May 1998 Date of latest renewal:
7 ta ’ Mejju, 1998
7 May 2003
7 ta ’ Mejju, 2003
PackPharm Limited 14D Wendover Road Rackheath Industrial Estate Norwich NR13 6LH United Kingdom
Packpharm Limited 14D Wendover Road Rackheath Industrial Estate Norwich NR13 6LH Ir- Renju Unit
Pylobactell 100 mg soluble tablet 13 C-urea
Pylobactell 100 mg pillola li tinħall 13 C- urea
One tablet contains:
Pillola waħda fiha:
100 mg 13C-urea
100 mg ta ’ 13C- urea
Povidone (E1201), Microcrystalline cellulose (E460i), Colloidal anhydrous silica, Sodium benzoate (E211).
Povidone (E1201), Microcrystalline cellulose( E460i), Colloidal anhydrous silica, Sodium benzoate (E211).
The kit contains:
Is- sett fih:
A sachet containing one Pylobactell 100 mg soluble tablet.
Qartas b’ pillola waħda li tinħall ta ’ Pylobactell 100 mg.
Six glass tubes, with caps and bar code labels.
Sitt tubi tal- ħġieġ, bit- tappijiet u tikketti tal- bar kowd.
One 30 ml mixing and administration glass vial with cap.
Kunjett tal- ħġieġ ta ’ 30 ml bit- tapp, biex tħallat u minn fejn tagħti l- prodott.
Two straws.
Żewġ strôs.
One Analysis Request Form.
Formola għat- Talba ta ’ l- Analiżi.
One Security Label and three additional bar code labels.
Tikketta tas- Sigurtà u tliet tikketti oħra bil- bar kowd.
Diagnostic test kit.
Sett ta ’ test dijanjostiku.
FOR ORAL ADMINISTRATION.
GĦALL- GĦOTI ORALI.
SACHET LABEL
IT- TIKKETTA TAL- QARTAS
Pylobactell 100 mg soluble tablet 13 C-urea Oral use
Pylobactell 100 mg pillola li tinħall 13 C- urea Użu orali
To be dissolved in water and taken orally.
Għandu jinħall fl- ilma u jittieħed mill- ħalq.
One tablet
Pillola waħda
Torbet Laboratories Limited, 14D Wendover Road, Rackheath Industrial Estate, Norwich, NR13 6LH, United Kingdom.
Torbet Laboratories Limited, 14D Wendover Road, Rackheath Industrial Estate, Norwich, NR13 6LH, ir- Renju Unit.
14 ADDITIONAL KIT ITEM:
14 OĠĠETT ADDIZZJONALI TAS- SETT:
MIXING AND ADMINISTRATION VIAL
KUNJETT BIEX JIĠI MĦALLAT U MGĦOTI
{LABEL}
{TIKKETTA}
Fill to line with water Dissolve tablet from sachet Shake well to dissolve When dissolved, drink entire contents Refill with water to line, shake bottle and drink Discard this bottle after use Do not return with kit
Imla bl- ilma sas- sinjal Ħoll il- pillola mill- qartas Ħarrek tajjeb biex tħoll Meta tinħall, ixrob il- kontenut kollu Erġa ’ imla bl- ilma sas- sinjal, ħawwad il- flixkun u ixrob Armi dan il- flixkun wara li tużah Tirritornahx mas- sett
ADDITIONAL KIT ITEM:
OĠĠETT ADDIZZJONALI TAS- SETT:
SECURITY LABEL
TIKKETTA TAS- SIGURTÀ
Seal lid of box before returning samples for analysis
Issiġilla l- għatu tal- kaxxa qabel tibgħat il- kampjuni għall- analiżi
Pylobactell 100mg soluble tablet 13 C-Urea
Pylobactell 100 mg pillola li tinħall 13 C- Urea
It may harm
Jista ’ jkollok bżonn terġa ’ taqrah. − Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib tiegħek. − Din il- mediċina ġiet mogħtija lilek.
them, even if their symptoms are the same as yours.
M’ għandekx tgħaddiha lil persuni oħra.
- If any of the side effects gets serious, or if you notice any side effects not listed in this
Tista ’ tagħmlilhom il - ħsara, anki jekk ikollhom l- istess sintomi bħal tiegħek. − Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib tiegħek.
What Pylobactell is and what it is used for 2.
X’ inhu Pylobactell u għalxiex jintuża 2.
Before you use Pylobactell 3.
Qabel ma tuża Pylobactell 3.
How to use Pylobactell 4.
Kif għandek tuża Pylobactell 4.
How to store Pylobactell 6.
Kif taħżen Pylobactell 6.
WHAT PYLOBACTELL IS AND WHAT IT IS USED FOR
X’ INHU PYLOBACTELL U GĦALXIEX JINTUŻA
Pylobactell is a breath test.
Pylobactell huwa test tan- nifs.
It is used to determine the presence of the bacterium Helicobacter pylori (H. pylori) in the gut (stomach and adjacent bowel).
Huwa wżat biex tiġi determinata l- preżenza tal- batterju Helicobacter pylori (H. pylori) fil- imsaren (stonku u l- musrana ta ’ ħdejħ).
This bacterium may be the reason for your stomach (gastric) condition.
Dan il- batterju jista ’ jkun ir- raġuni għall - kundizzjoni tal- istonku (gastrika) tiegħek.
Your doctor has recommended that you have a 13C-Urea breath test, for one of the following reasons: -
It- tabib tiegħek irrakkomanda li inti tieħu test tan- nifs ta ’ l- Urea 13C għal xi waħda minn dawn ir - raġunijiet: -
• Your doctor wants to confirm whether you are suffering from H. pylori infection to help diagnose your condition.
• It- tabib tiegħek irid jikkonferma jekk intix qed tbati minn infezzjoni tal- H. pylori biex jagħmel dijanjosi tal- kondizzjoni tiegħek.
• You have already been diagnosed with H. pylori and have been taking medicines aimed to clear up the infection.
• Diġà kont dijanjozzat b’ H. pylori u kont qed tieħu mediċini bil- għan li tikkura l- infezzjoni.
Your doctor now wants to find out if the treatment has worked.
It - tabib tiegħek issa jrid jara jekk il- kura ħadmitx.
This medicine is for diagnostic use only.
Din il- mediċina hija għall- użu dijanjostiku biss.
All foods contain a substance called carbon 13 (13C), in varying amounts.
L- ikel kollu fih sustanza li tissejjaħ carbon 13 (13C), f’ ammonti li jvarjaw.
This 13C can be detected in the carbon dioxide that you breathe out of your lungs.
13C jista ’ jkun osservat fil - carbon dioxide li inti tarmi ’ l barra mill- pulmuni tiegħek man- nifs.
The actual amount of 13C in the breath will depend on the type of food that you have eaten.
L- ammont attwali ta ’ 13C fin- nifs jiddependi mit- tip ta ’ ikel li inti tkun kilt.
You will be asked to drink a "test meal".
Inti ser tintalab biex tixrob “ ikla tat- test ”.
This will help keep the test 13C-urea solution in your stomach.
Din ser tgħin biex iżżomm is- soluzzjoni ta ’ 13C- urea tat- test fl- istonku tiegħek.
Following the meal, 3 samples of your breath will be taken.
Wara din l- ikla, jittieħdu 3 kampjuni tan- nifs tiegħek.
These samples will be analysed to measure the normal amount of 13C in the carbon dioxide in your breath.
Dawn il- kampjuni tan- nifs ser ikunu analizzati biex jitkejjlu l- livell normali ta ’ 13C fil- carbon dioxide tan- nifs tiegħek.
17 You will then drink the Pylobactell 13C-urea solution.
Int imbagħad ser tixrob is- soluzzjoni ta ’ 13C- urea ta ’ Pylobactell.
If H. pylori is present and active in your stomach, these bacteria will break down the 13C-urea and this is detected in the carbon dioxide in your breath.
Jekk l- He. pylori huwa preżenti u attiv fl- istonku tiegħek, dawn il- batterji jkissru lil 13C- urea, u dan ikun osservat fil- carbon dioxide tan - nifs tiegħek.
A further 3 samples of your breath will then be taken 30 minutes later.
Wara 30 minuta, jittieħdu 3 kampjuni oħra tan- nifs tiegħek.
The amount of 13C in these samples will be compared to your normal level.
17 L- ammont ta ’ 13C f’ dawn il- kampjuni ser ikun imqabbel mal- livell normali tiegħek.
If there is a significant increase in the amount of this will let your doctor know that active H. pylori is present.
Jekk ikun hemm żjieda sinifikanti fl- ammont ta ’ dan, dan jgħarraf lit- tabib tiegħek li H. pylori attivi huwa preżenti.
BEFORE YOU USE PYLOBACTELL
QABEL MA TUŻA PYLOBACTELL
(see section 6).
Tieħux Pylobactell jekk inti: − allerġiku/ a (tbati minnsensittività eċċessiva) għal 13C - urea jew għal xi sustanzi oħra fil- pilloli (ara sezzjoni 6.
- suffer from any medical condition that you think may affect, or be affected by, the test.
− tbati minn xi kondizzjoni medika li inti taħseb li tista ’ taffettwa lit- test, jew li tista ’ tkun affettwata mit- test.
Take special care It is important that you tell your doctor if: • part of your stomach has been removed (partial gastrectomy) as the reliability of the test has not been proven in these patients. • you have or suspect you have a gastric infection. • you have long term stomach problems (atrophic gastritis) as the breath test may give the wrong result and other tests may be required to confirm the presence of H. pylori. • fasting (not taking food) may have medical implications for you. • you are under 18 years.
Oqgħod attent ħafna Huwa importanti wkoll li tgħid lit- tabib tiegħek jekk: • parti mill- istonku tiegħek tneħħiet (gastrektomija parzjali) peress li ma ġiex ippruvat li t- test tista ’ tiddependi fuqu f’ dawn il- pazjenti. • inti għandek jew tissuspetta li għandek infezzjoni gastrika. • inti għandek problemi fl- istonku fit- tul (gastrite atrofika) minħabba li t- test tan- nifs jista ’ jagħti riżultat ħażin u jistgħu jkunu meħtieġa testijiet oħra biex tkun ikkonfermata l- preżenza ta ’ H. pylori. • sawm (ma tieħux ikel) jista ’ jkollu implikazzjonijiet mediċi għalik. • inti għandek inqas minn 18- il sena.
Do not take the test if:
Tagħmilx it- test jekk:
• You have taken antibiotics or medication to treat Helicobacter pylori within the last 28 days.
• Inti ħadt anti- bijotiċi jew mediċini għall- kura ta ’ Helicobacter pylori fl- aħħar 28 ġurnata.
• You have taken proton pump inhibitors (stops indigestion) in the last 14 days.
• Inti ħadt inibituri tal- proton pump (iwaqqfu l- indiġestjoni) fl- aħħar 14- il ġurnata.
• You have taken H2 antagonists or antacids (relieves indigestion) on the same day of the test.
• Inti ħadt antagonisti ta ’ H2 jew antaċidi (itaffu l- indiġestjoni) fl- istess ġurnata tat- test.
Do not stop taking medication without the advice of your doctor.
Tieqafx tieħu l- mediċina mingħajr il- parir tat- tabib tiegħek.
Taking Pylobactell with food and drink You should fast for at least 4 hours before the test, so that the test is carried out on an empty stomach.
Meta tieħu Pylobactell ma ’ l- ikel u max- xorb Għandek issum għal mill- anqas 4 sigħat qabel it- test, sabiex it- test isir fuq stonku vojt.
If you have eaten a heavy meal, it will be necessary to fast for 6 hours before the test.
Jekk tkun kilt ikla tqila, huwa neċessarju li tibqa ’ sajjem/ sajma għal 6 sigħat qabel it- test.
You can drink water during the fasting period.
Jekk is- sawm huwa problema (e. ż. pazjenti dijabetiċi) Tista ’ tixrob l- ilma matul il- perijodu li fih tkun sajjem/ sajma.
If fasting is a problem (e. g. for diabetic patients), please tell your doctor.
Jekk is- sawm huwa problema (e. ż. għall- pazjenti bid- dijabete), jekk jogħġbok, għid lit- tabib tiegħek.
Pregnancy and breast-feeding Pylobactell can be used during pregnancy and breast-feeding.
Tqala u Treddigħ Pylobactell jista ’ jintuża waqt it- tqala u t- treddigħ
18 Driving and using machines This test should not affect your ability to drive or use machines.
Sewqan u tħaddim ta ’ magni Dan it- test m’ għandux jaffettwa l- ħila tiegħek biex issuq jew tħaddem magni.
HOW TO TAKE THE PYLOBACTELL TEST
KIF GĦANDEK TIEĦU PYLOBACTELL
The test will take about 45 minutes.
It- test se jieħu madwar 45 minuta.
It is recommended that the breath test is performed while you are in a seated position.
Se tkun meħtieġa provista ta ’ ilma tax- xorb Huwa rrakkomandat li t- test tan- nifs isir meta inti tkun bilqiegħda.
You must not smoke before or during the test.
M’ għandekx tpejjep eżatt qabel jew waqt it- test.
The test procedure involves the following steps:
18 Il- proċedura tat- test tinvolvi dawn l- passi li ġejjin:
(A brief form of these instructions is included on the back of the Analysis Request Form)
(Ġabra fil- qosor ta ’ dawn l- istruzzjonijiet hija inkluża fuq in- naħa ta ’ wara tal- Formola tat- Talba għall- Analiżi)
Fasting:
Is- Sawm:
You should fast for 4 hours before taking the test (See section 2, Taking Pylobactell with food and drink)
Inti għandek issum għal 4 sigħat qabel ma ’ tieħu t- test (Ara sezzjoni 2, Meta tieħu Pylobactell ma ’ l- ikel u max- xorb)
Test Meal:
L- ikla tat- test:
Drink the recommended test meal.
Ixrob l- ikla rrakkomandata tat- test.
This is not included in this kit but may have been supplied separately.
Din mhix inkluża f’ dan is- sett iżda tista ’ tkun ingħatat separatament.
If no test meal has been supplied, the most suitable test meal is 200 ml of pure undiluted orange juice.
Jekk ma ġietx ipprovduta ikla tat- test, l- aħjar ikla tat- test hija 200 ml ta ’ meraq tal- larinġ pur mhux dilwit.
If you cannot take the recommended test meal, your doctor will advise you of an alternative test meal.
Jekk inti ma tistax tieħu l- ikla rrakkomandata tat- test, it- tabib tiegħek se jinfurmak dwar ikla tat- test alternattiva.
Wait 5 minutes
Stenna 5 minuti
Pre-test Breath Samples (3 White Capped Tubes) i.
Il- Kampjuni tan- Nifs ta ’ Qabel it- test (3 Tubi b’ Tappijiet Bojod)
Remove the cap from the tube. ii.
Neħħi t- tapp mit- tubu. ii.
Breathe out through your mouth, using a straw, into the sample tube. iii.
Ħu n- nifs ’ il barra minn ħalqek, billi tuża stro, ġot- tubu tal- kampjun. iii.
Gradually remove the straw from the tube as you breathe out. iv.
Neħħi l- istro bil- mod minn ġot- tubu waqt li tieħu n- nifs ’ il barra. iv.
Immediately replace the cap. v.
Minnufih erġa ’ poġġi t- tapp f’ postu. v.
Repeat with remaining white capped tubes.
Irrepeti bit- tubi b’ tappijiet bojod li fadal.
It is not necessary to blow hard into the tubes, just breathe normally and cap them quickly.
M’ hemmx għalfejn tonfoħ bil- qawwi ġot- tubi, ħu n- nifs b’ mod normali u poġġi t- tappijiet f’ posthom malajr.
Try to avoid getting saliva in the tubes.
Ipprova evità li tħalli rieq fit- tubi
5.
Preparazzjoni tas- soluzzjoni ta ’ 13carbon- urea 5.
Preparing the 13Carbon-urea solution Open the tablet sachet and empty the tablet into the mixer vial.
Iftaħ il- qartas tal- pillola u itfa ’ l- pillola ġol- kunjett tat- taħlit.
Add water to the mark on the vial and replace the cap.
Żid l- ilma sal- marka li hemm fuq il- kunjett u poġġi t- tapp f’ postu.
Gently shake the vial to dissolve the tablet.
Ħarrek il- kunjett bil- mod biex tħoll il- pillola.
Drink the solution.
Ixrob is- soluzzjoni.
Note the time upon drinking.
Innota l- ħin meta tkun xrobtha.
Fill the vial to the mark again with water and drink.
Imla l- kunjett mill- ġdid bl- ilma sal- marka u ixrob.
Wait 30 minutes from the time of drinking the Pylobactell 13C-urea solution.
Stenna 30 minuta mill- ħin ta ’ meta tkun xrobt is- soluzzjoni.
This is important for the proper functioning of the test.
Dan huwa importanti biex it- test jaħdem kif suppost.
Post-test Breath Samples (3 Red Capped Tubes) Using the red-capped, take samples of your breath as before (see step 4).
Il- Kampjuni tan- Nifs ta ’ Wara t- test (3 tubi b’ Tappijiet Ħomor Billi tuża t- tubi bit- tappijiet ħomor u bit- tikketti ħomor, ħu l- kampjuni tan- nifs tiegħek kif għamilt qabel (ara numru 4).
Analysis Request Form Fill out the analysis request form with the patient details on the left hand side of the form and the doctor’ s name and address on the right hand side.
Formola ta ’ Talba għall- Analiżi Imla l- formola ta ’ talba għall- analiżi bid- dettalji tal- pazjent fuq in- naħa tax- xellug u l- isem u l - indirizz tat- tabib fuq in- naħa tal- lemin.
19 Put your breath samples and the completed Analysis Request Form back into the carton and send to the address supplied by your doctor.
It- Test issa huwa lest Poġġi l- kampjuni tan- nifs tiegħek u l- Formola ta ’ Talba għall- Analiżi mimlija, lura fil- kaxxa tal- kartun u ibgħatha lill- indirizz li tak it- tabib tiegħek.
Your doctor will tell you when the results of your test will be available and who to contact for these results.
It- tabib tiegħek għandu jgħidlek meta r- riżultati ta ’ dan it- test ikunu disponibbli u lil min tikkuntattja għal dawn r- riżultati.
Dispose of the empty sachet, mixing vial and straws as normal waste, but keep this leaflet for reference.
Armi l- qartas miftuħ, kunjett ta ’ taħlit u strôs bħala skart normali, iżda żomm dan il- fuljett għar- referenza
If a repeat test is required, it should not be carried out until the following day.
19 Jekk ikun hemm bżonn ta ’ test ripetut, m’ għandux isir qabel il- ġurnata ta ’ wara.
No side effects to Pylobactell have been reported.
L- ebda effetti sekondarji ta ’ Pylobactell ma kienu rrapportati.
If you notice any side effects, please inform your doctor or pharmacist.
Jekk tinnota xi effetti sekondarji, jekk jogħġbok għarraf lit- tabib jew lill- ispiżjar tiegħek.
13 C and urea are harmless naturally occurring substances which are found in your body.
13 C u urea huma sustanzi naturali, li ma jagħmlux ħsara, u li jinsabu fil- ġisem tiegħek.
HOW TO STORE PYLOBACTELL
KIF TAĦŻEN PYLOBACTELL
Do not store the kit above 25°C.
Taħżinx is- sett ’ l fuq minn 25°C.
The tablet must be taken when dissolved.
Il- pillola għandha tittieħed meta tinħall.
Do not use Pylobactell after the expiry date which is stated on the carton.
Tużax Pylobactell wara d- data ta ’ skadenza li tidher fuq il- kaxxa tal- kartun.
What the Pylobactell tablet contains
X’ fih Pylobactell:
- The active substance is 13C-urea.
Is- sustanza attiva hija 13C- urea.
Each tablet contains 100 mg of 13C-urea
Kull pillola fiha 100 mg ta ’ 13C- urea
- The other ingredients are povidone (E1201), microcrystalline cellulose (E460i),
- Is- sustanzi l- oħra huma povidone (E1201), microcrystalline cellulose (E460i), colloidal
colloidal anhydrous silica and sodium benzoate (E211).
anhydrous silica u sodium benzoate (E211).
Each Pylobactell Breath Test kit contains: • 1 Sachet containing 1 tablet. • 6 glass tubes, 3 with white caps and 3 with red caps. • 30 ml glass mixing tube with cap. • 2 straws. • 1 Analysis Request Form. • 1 Security Label and 3 additional bar code labels.
Tikketta tas- sigurtà u 3 tikketti oħra bil- bar kowds.
The contents of this kit are sufficient for a single test.
Il- kontenut ta ’ dan is- sett huwa biżżejjed għal test wieħed.
If you need to repeat the test, a new kit will be required and it should not be carried out until the following day.
Jekk ikollok bżonn tirrepeti t- test, ikun meħtieġ sett ġdid u dan m’ għandux isir qabel il- jum ta ’ wara.
Torbet Laboratories Limited, 14D Wendover Road, Rackheath Industrial Estate, Norwich, NR13 6LH, United Kingdom Tel. +44 (0)1603 735200 Fax. +44 (0)1603 735217 E-mail. customerservices@typharm. com
Tel. +44 (0) 1603 735200 Fax. +44 (0) 1603 735217 E- mail. customerservices@ typharm. com
PackPharm Limited, 14D Wendover Road, Rackheath Industrial Estate, Norwich, NR13 6LH, United Kingdom.
PackPharm Limited, 14D Wendover Road, Rackheath Industrial Estate, Norwich, NR13 6LH, ir - Renju Unit.
20 This leaflet was last approved in
Dan il- fuljett kien approvat l- aħħar f ’
Detailed information on this medicine is available on the European Medicines Agency (EMEA) website http: / /www. emea. europa. eu/.
20 Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /.
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The following information is intended for laboratory use only:
It- tagħrif li jmiss huwa maħsub biss għall- użu fil- laboratorju:
Analysis of breath samples and testing specification
L- analiżi tal- kampjuni tan- nifs u l- ispeċifikazzjonijiet ta ’ l- ittestjar.
Breath samples collected during a test must remain in the original containers before analysis by IRMS.
Il- kampjuni tan- nifs miġbura waqt t- test għandhom jibqgħu fil- kontenituri oriġinali qabel analiżi b’ IRMS.
A multi-position autosampler and bar code reader should be used to allow samples to be tracked throughout the analysis.
Għandu jiġi wżat apparat li jieħu l- kampjuni awtomatikament u li jkun jieħu diversi pożizzjonijiet u apparat li jaqra l- bar kowds biex jippermetti li l- kampjuni jkunu intraċċati tul l- analiżi.
Internal analytical precision must be less than + 0.3 ‰ δ 13C for 20 replicate analyses of the same reference gas sample and remain within 23SD’ s of the mean for breath analyses.
Il- preċiżjoni analitika interna għandha tkun inqas minn + 0. 3 ‰ δ13C għal 20 analiżi replikat ta ’ l- istess kampjun tal- gass ta ’ referenza u tibqa ’ f’ 3SD’ s tal- medja għall- analiżi tan- nifs.
δ 13C: - Difference in parts per thousand (‰) with respect to an accepted international standard.
< 3. 5 ta ’ δ13C żejjed = Negattiv L- istat ta ’ H. pylori: - > 3. 5 ta ’ δ13C żejjed = Pożittiv
21 Excess δ 13C: - Difference between pre- and post-urea sample measurements.
21 IL- FORMOLA TA ’ TALBA GĦALL - ANALIŻI
Pylobactell [13Carbon] -UREA BREATH TEST (13C-UBT) for Helicobacter pylori
Pylobactell [13Carbon] – IT- TEST TAN- NIFS TA ’ L- UREA (13C- UBT) għall- Helicobacter pylori
ANALYSIS REQUEST FORM - Please complete in block capitals
IL- FORMOLA TA ’ TALBA GĦALL - ANALIŻI - Jekk jogħġbok ikteb b’ ittri kbar.
Please state clearly address for return of results:
Jekk jogħġbok ikteb l- indirizz b’ mod ċar u li jista ’ jinqara, sabiex ir- riżultati jkunu jistgħu jintbagħtu:
Centre:
Iċ- Ċentru:
Patient Name:
L- Isem tal- Pazjent:
Date of Birth:
Id- Data tat- Twelid:
Patient Reference:
Ir- Referenza tal- Pazjent:
Date of Test:
Id- Data tat- Test:
Referring Doctor:
It- Tabib tar- Referenza:
AFFIX BAR-CODE LABEL HERE
WAĦĦAL IT- TIKKETTA TAL- BAR KOWD HAWNHEKK
PLEASE PLACE BAR-CODE LABEL ON PATIENT RECORDS, IF APPLICABLE
JEKK JOGĦĠBOK WAĦĦAL IT- TIKKETTA TAL- BAR KOWD FUQ IR- REGISTRU TAL - PAZJENT, JEKK INHU APPLIKABBLI
Number:
In- Numru ta ’ l- M. A:
EU/ 1/ 98/ 064/ 001 Marketing Authorisation Holder:
EU/ 1/ 98/ 064/ 001 Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
Torbet Laboratories Limited, 14D Wendover Road, Rackheath Industrial Estate, Norwich, NR13 6LH, United Kingdom
Torbet Laboratories Limited, 14D Wendover Road, Rackheath Industrial Estate, Norwich, NR13 6LH, ir- Renju Unit
MEDICATION RECORD
IR- REKORD TAL - MEDIKAZZJONI
TEST CHECK LIST
LISTA TAT- TEST BIEX TIĊĊEKKJA MAGĦHA
Medical History - has the patient
Passat Mediku – il- pazjent ħa:
taken:
Tip & Data
& Date
Minuti
Mins
Lista tat- test biex tiċċekkja magħha
(i) antibiotics in the last 28 days?
(i) xi antibijotiċi fl- aħħar 28 jum?
If so, please indicate type and when last taken
Jekk iva, jekk jogħġbok indika t - tip u meta ttieħdu l- aħħar
Note time patient drinks test meal
Innota l- ħin li l- pazjent jixrob l- ikla tat- test.
(ii) proton pump inhibitors (PPIs) in the last 14 days?
(ii) xi inibituri tal- pompa tal - proton (PPIs) fl- aħħar 14- il jum?
If so, please indicate type and when last taken.
Jekk iva, jekk jogħġbok indika t - tip u meta ttieħdu l- aħħar
Collect Pre-Urea samples (White Caps - 3 times)
Iġbor il- kampjuni tan- nifs ta ’ qabel l- urea (it- Tappijiet il- Bojod - 3 darbiet)
(iii) eradication therapy in the last 28 days?
(iii) xi terapija li tneħħi kollox fl - aħħar 28 jum?
If so, please indicate when treatment ended
Jekk iva, jekk jogħġbok indika meta intemmet l- kura
Patient to drink urea solution, then fill bottle to line again and drink.
Il- pazjent irid jixrob is - soluzzjoni ta ’ l- urea, imbagħad jerġa ’ jimla l - flixkun sas- sinjal mill- ġdid, u jerġa ’ jixrob
(iv) other medication (if applicable)
(iv) xi medikazzjoni oħra (jekk applikabbli)
Collect Post-Urea samples (Red Caps - 3 times).
Iġbor il- kampjuni Ta ’ Qabel l- Urea (it- Tappijiet il- Ħomor - 3 darbiet).
(v) patient fasted for hours
(v) il- pazjent kien sajjem għal sigħat
Check
Iċċekkja
Bar-code label and all details entered on Analysis Request
It- tikketta tal- bar kowd u d - dettalji kollha li nkitbu fuq il - Formola tat- Talba għall -
Laboratory use only
Jekk jogħġbok innota li (i) - (iii) ser jaffettwaw ir- riżultat tat- test.
Form.
Analiżi.
1 x Pre/ Post sample reserved in store.
1 x kampjun Ta ’ Qabel/ Ta ’ Wara rriservati fil- maħżen.
2 x Pre/ Post samples + this form for return to a qualified laboratory.
2 x kampjuni Ta ’ Qabel/ Ta ’ Wara + din il- formola biex jintbagħtu lil- laboratorju kkwalifikat
Date received:
22 Id- data ta ’ meta wasal:
Analytical file reference:
Ir- referenza tal- fajl analitiku:
Laboratory code:
Il- kodiċi tal- laboratorju:
Comments:
Il- Kummenti:
What is QUADRAMET?
X’ inhu QUADRAMET?
QUADRAMET is a solution for injection containing the active substance samarium [153Sm] lexidronam pentasodium.
QUADRAMET hu soluzzjoni li fiha s- sustanta attiva samarium [153Sm] lexidronam pentasodium.
What is QUADRAMET used for?
Għalxiex jintuża QUADRAMET?
QUADRAMET is used to relieve bone pain in patients with multiple painful osteoblastic skeletal metastases (when cancer has spread to the bones).
QUADRAMET jintuża biex itaffi l- uġigħ fl- għadam f’ pazjenti li jkollhom kankru li jkun infirxilhom f’ diversi postijiet fl- għadam (metastasi skeletriċi osteoblastiċi multipli).
Osteoblastic metastases are a type of bone metastasis where new bone tissue grows rapidly.
Il- metastasi osteoblastiċi huma tip ta ’ metastasi tal- għadam li fihom jikber tessut tal- għadam malajr ħafna.
QUADRAMET is only used in bone metastases that can take up a type of chemical called bisphosphonates, as this means that the metastases will also take up QUADRAMET.
QUADRAMET jintuża biss meta jkun hemm metastasi li jistgħu jassorbu tip ta ’ sustanza magħrufa bħala bifosfonati, għax dan ifisser li l- metastasi jkunu jistgħu jassorbu wkoll QUADRAMET.
Before receiving QUADRAMET patients should have a bone scan using bisphosphonates radiolabelled with technetium-99m [99mTc] as markers, to check that their metastases are of the type that QUADRAMET can be used for.
Qabel ma jingħataw QUADRAMET, il- pazjenti jkun irid isirilhom skan tal- għadam bl- użu ta ’ bifosfonati radjutikkettati b’ technetium- 99m [99mTc] bħala markaturi biex ikun magħruf jekk il- metastasi tagħhom humiex tat- tip li jista ’ jintuża QUADRAMET għalihom.
How is QUADRAMET used?
Kif jintuża QUADRAMET?
QUADRAMET should only be handled and given by someone who is authorised to use radioactive medicines and after full oncological (cancer) evaluation.
QUADRAMET għandu jintuża u jingħata biss minn xi ħadd li jkun awtorizzat juża l- mediċini radjuattivi u wara valutazzjoni onkoloġika (tal- kankru) sħiħa.
The dose of QUADRAMET is calculated based on the patient’ s body weight to provide a specific dose of radioactivity (37 mega becquerels per kilogram body weight).
Id- doża ta ’ QUADRAMET hi kkalkulata skond kemm jiżen il- pazjent biex tkun ipprovvduta d- doża speċifika ta ’ radjuattività (37 mega becquerels għal kull kilogramma li jiżen il- pazjent).
The medicine is given by slow intravenous injection (into a vein) over one minute.
Il- mediċina tingħata bil- mod permezz ta ’ injezzjoni intravenuża (fl- vina) li ddum tingħata minuta.
Patients who respond to QUADRAMET generally have relief of their pain within one week of treatment.
Il- pazjenti li jkollhom rispons għal QUADRAMET ġeneralment ikollhom serħan mill- uġigħ fi żmien ġimgħa minn meta jieħdu t - trattament.
The pain relief may last for up to four months.
Jistgħu jibqgħu mingħajr uġigħ sa erba ’ xhur.
How does QUADRAMET work?
Kif jaħdem QUADRAMET?
QUADRAMET is a radiopharmaceutical product.
QUADRAMET hu prodott radjufarmaċewtiku.
Its active substance is samarium [153Sm] lexidronam pentasodium.
Is- sustanza attiva tiegħu hi samarium [153Sm] lexidronam pentasodium.
It is a complex (a type of chemical) made up of a radioactive element, samarium-153 (153Sm), bound to another chemical called ‘ ethylene diamine tetra methylene phosphonic acid’ (EDTMP).
Dan hu kumpless (tip ta ’ sustanza kimika) magħmul minn element radjuattiv, samarium- 153 (153Sm), magħqud ma ’ sustanza kimika oħra magħrufa bħala ethylene diamine tetra methylene phosphonic acid (EDTMP).
When QUADRAMET is injected into a patient, the complex is distributed around the body via the bloodstream.
Meta jkun injettat fil- pazjent, QUADRAMET jinxtered madwar il- ġisem kollu permezz taċ - ċirkulazzjoni tad- demm.
Because EDMTP has a high affinity for bone tissue, it accumulates in the bone, especially in areas of rapid bone growth such as osteoblastic metastases.
Billi EDMTP għandu affinità kbira għat- tessut tal- għadam, dan jakkumula fl - għadam, speċjalment f’ żoni ta ’ żvilupp mgħaġġel tal- għadam bħalma huma l- metastasi osteoblastiċi.
As a result, the radiation brought by the samarium-153 can act locally and help to relieve the bone pain.
Minħabba f’ hekk, ir- radjazzjoni prodotta mis- samarium- 153 tista ’ taġixxi lokalment u dan itaffi l - uġigħ fil- għadam.
(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 2008 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has QUADRAMET been studied?
(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 2008 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kif ġie studjat QUADRAMET?
QUADRAMET has been studied in 373 patients in three main studies.
Għal QUADRAMET saru tliet studji ewlenin bis- sehem ta ’ 373 pazjent.
In two of these, the effectiveness of QUADRAMET was compared with that of placebo (a dummy treatment).
Fi tnejn minn dawn l- istudji, l- effikaċja ta ’ QUADRAMET tqabblet ma ’ dik ta ’ plaċebo (trattament finta).
The main measure of effectiveness was the reduction of pain.
Il- kejl ewlieni ta ’ l - effikaċja kien it- tnaqqis ta ’ l- uġigħ.
This was measured using various means, such as visual or descriptive scales, analgesic (painkiller) use, and assessment by the doctor.
Dan tkejjel permezz ta ’ diversi mezzi, bħal skali viżivi jew deskrittivi, l- użu ta ’ analġeżiċi (mediċini ta ’ kontra l- uġigħ), u eżaminar mit- tabib.
What benefit has QUADRAMET shown during the studies?
X’ benefiċċju wera QUADRAMET matul l- istudji?
QUADRAMET was effective in providing pain relief from osteoblastic bone metastases, and, where it was compared with placebo, more effective than placebo.
QUADRAMET wassal għal serħan effikaċi mill- uġigħ ikkawżat minn metastasi osteoblastiċi fl - għadam, u, meta mqabbla mal- plaċebo, kien iktar effikaċi mill- plaċebo.
In one of the studies, which involved patients with bone metastases from prostate cancer, the patients ’ use of opioid analgesics (such as morphine) was also reduced following treatment with QUADRAMET.
F’ wieħed mill- istudji, li fih ħadu sehem pazjenti b’ metastasi fil- għadam minn kankru fil- prostata, kien hemm tnaqqis fl- użu ta ’ analġeżiċi (bħall- morfina) wara t- trattament b’ QUADRAMET.
What is the risk associated with QUADRAMET?
X’ inhuma r- riskji assoċjati ma ’ QUADRAMET?
The main side effects of QUADRAMET are a reduction in red and white blood cell and platelet counts.
L- effetti sekondarji ewlenin ta ’ QUADRAMET huma tnaqqis fil- għadd ta ’ ċelloli tad- demm bojod u ħomor u fil- għadd ta ’ platelets.
The following side effects have also been reported: asthenia (weakness), nausea (feeling sick), vomiting, diarrhoea, peripheral oedema (fluid retention), headaches, hypotension (low blood pressure), dizziness, myasthenia (muscle weakness), confusion and sweating.
Ġew rappurtati wkoll dawn l- effetti sekondarji: astenija (dgħjufija), nawżea, rimettar, dijarrea, edema periferika (żamma tal- fluwidi), uġigħ ta ’ ras, ipotensjoni (pressjoni baxxa), strudament, mjastenija (dgħjufija fil- muskoli), konfużjoni u ħruġ ta ’ għaraq.
For the full list of all side effects reported with QUADRAMET, see the Package Leaflet.
Ara l- Fuljett ta ’ Tagħrif għal lista sħiħa ta ’ effetti sekondarji rrappurtati ma ’ QUADRAMET.
QUADRAMET should not be used in people who may be hypersensitive (allergic) to EDTMP or to phosphonates (similar chemical compounds).
QUADRAMET m’ għandux jingħata lil nies li għandhom sensittività eċċessiva (allerġiċi) għal EDTMP jew għal fosfonati (komposti kimiċi simili).
It should not be used in pregnant women or in patients who have had chemotherapy or hemi-body external radiotherapy in the previous six weeks.
Lanqas m’ għandu jingħata lil nisa tqal jew lil pazjenti li jkunu ħadu kemoterapija jew radjuterapija esterna fuq parti li tkopri nofs il- ġisem fis- sitt ġimgħat ta ’ qabel.
QUADRAMET should not be used at the same time as any chemotherapy that affects the bone marrow or at the same time as other bisphosphonate medicines if these can interact with the way QUADRAMET fixes to bone metastases.
QUADRAMET m’ għandux jingħata fl- istess żmien li tkun qed tingħata kemoterapija li taffettwa l- mudullun tal- għadam u lanqas fl- istess żmien li jkunu qed jingħataw bifosfonati oħra jekk dawn ikunu jistgħu jinteraġġixxu mal- mod li bih QUADRAMET jeħel mal - metastasi tal- għadam.
Why has QUADRAMET been approved?
Għalxiex ġie approvat QUADRAMET?
The Committee for Medicinal Products for Human Use (CHMP) decided that QUADRAMET’ s benefits are greater than its risks for the relief of bone pain in patients with multiple painful osteoblastic skeletal metastases.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ QUADRAMET fis- serħan mill- uġigħ fil- għadam huma ikbar mir- riskji f’ pazjenti b’ metastasi skeletriċi osteoblastiċi multipli.
The Committee recommended that QUADRAMET be given marketing authorisation.
Il- Kumitat irrakkomanda li QUADRAMET jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Other information about QUADRAMET:
Informazzjoni oħra dwar QUADRAMET:
The European Commission granted a marketing authorisation valid throughout the European Union for QUADRAMET to CIS bio international on 5 February 1998.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal QUADRAMET lil CIS bio international fil- 5 ta ’ Frar 1998.
The marketing authorisation was renewed on 5 February 2003 and on 5 February 2008.
L- awtorizzazzjoni għat - tqegħid fis- suq ġiet imġedda fil- 5 ta ’ Frar 2003 u fil- 5 ta ’ Frar 2008.
The full EPAR for QUADRAMET is available here.
L- EPAR sħiħ dwar QUADRAMET jista ’ jinstab hawnhekk.
This summary was last updated in 12-2007.
Dan is- sommarju kien aġġornat l- aħħar fi: 12- 2007.
Strength
Qawwa 2- 4 GBq/ kunjett
2 to 4 GBq per vial at calibration date
fid- data ta ’ referenza
Solution for injection.
soluzzjoni għall - injezzjoni
Intravenous use
Użu għal ġol - vini
QUADRAMET, solution for injection.
QUADRAMET, soluzzjoni għall- injezzjoni.
Each ml of solution contains 1.3 GBq Samarium [153Sm] lexidronam pentasodium at the reference date (corresponding to 20 to 46 µg/ ml of samarium per vial)
: Kull ml ta ’ soluzzjoni fih 1. 3 GBq Samarium [153Sm] lexidronam pentasodium fid- data ta ’ referenza (li tikkorrespondi għal 20 sa 46 µg/ ml ta ’ samarium għal kull kunjett)
Samarium specific activity is approximately 28 – 65 MBq/ µg of samarium.
Attività speċifika għal samarium hi madwar 28 – 65 MBq/ µg ta ’ sammarium
Each vial contains 2-4 GBq at the reference date.
Kull kunjett fih 2- 4 GBq fid- data ta ’ referenza
Samarium-153 emits both medium-energy beta particles and an imageable gamma photon, and has a period of 46.3 hours (1.93 days).
Samarium- 153 jarmi kemm partikuli beta ta ’ enerġija medja kif ukoll foton gamma li jista ’ jsir xbieha, u għandu perijodu ta ’ 46. 3 sigħat (1. 93 ġranet).
The primary radiation emissions of samarium-153 are shown in Table 1.
L- emissjonijiet tar- radjazzjoni primarja ta ’ samarium - 153 qed jiġu elenkati fit- Tabella 1.
SAMARIUM-153 PRINCIPAL RADIATION EMISSION DATA Radiation Beta Beta Beta Gamma
SAMARIUM- 153 DATA TA ’ EMISSJONI TA ’ RADJAZZJONI PRINĊIPALI Radjazzjoni Beta Beta Beta Gamma
Energy (keV)* 640 710 810 103
Enerġija (keV) * 640 710 810 103
Abundance 30% 50% 20% 29%
Abbundanza 30% 50% 20% 29%
* Maximum energies are listed for the beta emissions, the average beta particle energy is 233 keV.
* L- enerġiji massimi huma elenkati għall- emissjonijiet beta, l- enerġija medja tal- partikula beta hija ta ’ 233 keV.
Clear, colourless to light amber solution with pH ranging between 7.0 and 8.5.
Soluzzjoni ċara, mingħajr kulur għal ambra ċar b’ pH li jvarja nejn 7. 0 u 8. 5.
QUADRAMET is indicated for the relief of bone pain in patients with multiple painful osteoblastic skeletal metastases which take up technetium [99mTc]-labelled biphosphonates on bone scan.
QUADRAMET huwa indikat għas- serħan mill- uġigħ fl- għadam, f’ pazjenti b’ metastasi skeletali ostejoblastika multipla bl- uġigħ, li tieħu biphosphonates immarkati b’ sustanza radjuattiva ta ’ technetium [99mTc] għal skan ta ’ l- għadam.
The presence of osteoblastic metastases which take up technetium [99mTc]-labelled biphosphonates should be confirmed prior to therapy.
Il- preżenza ta ’ metastasi ostejoblastika li tieħu biphosphonates immarkati b’ sustanza radjuattiva ta ’ technetium [99mTc] għandha tiġi kkonfermata qabel it- terapija.
QUADRAMET should only be administered by physicians experienced in the use of radiopharmaceuticals and after full oncological evaluation of the patient by qualified physicians.
2 QUADRAMET għandu jingħata biss minn tobba li għandhom esperjenza fl- użu ta ’ radjufarmaċewtiċi u wara evalwazzjoni sħiħa onkoloġika fuq il- pazjent minn tobba kkwalifikati.
The recommended dose of QUADRAMET is 37 MBq per kg body weight and is to be administered by slow intravenous route through an established intravenous line over a period of one minute.
Id- doża rrakkomandata ta ’ QUADRAMET hija ta ’ 37 MBq għal kull kg tal- piż tal- ġisem u għandha tingħata minn ġol- vina bil- mod permezz ta ’ linja stabbilita għal ġol- vina, fuq perijodu ta ’ minuta.
QUADRAMET should not be diluted before use.
QUADRAMET ma għandux jiġi dilwit qabel l- użu.
2 Patients who respond to QUADRAMET generally experience the onset of pain relief within 1 week after treatment.
Il- pazjenti li jirrispondu għal QUADRAMET ġeneralement jibdew iħossu serħan mill- uġigħ fi żmien ġimgħa mill- kura.
Relief of pain may persist for 4 weeks up to 4 months.
Jista ’ jkun hemm serħan mill- uġigħ għal tul ta ’ żmien li jvara bejn 4 ġimgħat sa 4 xhur.
Patients who experience a reduction in pain may be encouraged to decrease their use of opioid analgesics.
Pazjenti li jkollhom tnaqqis fl- uġigħ jistgħu jiġu mħajjra jnaqqsu l- użu ta ’ analġeżiċi opjojdi.
Repeat administration of QUADRAMET should be based on an individual patient's response to prior treatment and on clinical symptoms.
Ir- ripetizzjoni ta ’ dożi ta ’ QUADRAMET għandha tkun imsejsa skond ir- rispons tal- pazjent individwali għall- kura li ngħatat qabel u fuq is- sintomi kliniċi.
A minimum interval of 8 weeks should be respected, subject to recovery of adequate bone marrow function.
Għandu jkun hemm intervall minimu ta ’ 8 ġimgħat, skond l- irpiljar tal- funzjoni adegwata tal- mudullun.
The data on the safety of repeated dosing are limited and based on compassionate use of the product.
L- informazzjoni dwar is- sigurtà ta ’ dożi ripetuti hija limitata u hija bbażata fuq l- użu tal- prodott f’ individwi.
QUADRAMET is not recommended for use in children below the age of 18 years due to a lack of data on safety and efficacy.
QUADRAMET mhux rakkomandat għal użu fi tfal li għadhom taħt it- 18- il sena minħabba nuqqas ta ’ informazzjoni dwar is- sigurtà u l- effikaċja.
QUADRAMET is contra-indicated: • Hypersensitivity to the active substance (ethylenediaminetetramethylenephosphonate (EDTMP) or similar phosphonates) or to any of the excipients. • in pregnant women (See section 4.6). • in patients having received chemotherapy or hemi-body external radiation therapy in a preceding period of 6 weeks.
QUADRAMET huwa kontra- indikat: • Sensittività eċċessiva għas- sustanza attiva (ethylenediaminemethylenephosphonate (EDTMP)) jew phosphonates simili) jew għal xi sustanzi mhux attivi. • f’ nisa tqal (ara sezzjoni 4. 6). • f’ pazjenti li rċevew kemoterapija jew terapija ta ’ radjazzjoni esterna fuq nofs il- ġisem matul il - perijodu ta ’ 6 ġimgħat preċedenti.
QUADRAMET is used only as a palliative agent and should not be used concurrently with myelotoxic chemotherapy as this may enhance myelotoxicity.
QUADRAMET jintuża biss bħala prodott li jtaffi l- uġigħ u ma għandux jintuża fl- istess ħin ma ’ kemjoterapija mijelotossika minħabba li dan jista ’ jżid il- mijelotossiċità.
It should not be used concurrently with other biphosphonates if an interference is shown on the technetium [99mTc]-labelled biphosphonate bone scans.
M’ għandux jintuża fl- istess ħin ma ’ biphosphonates oħra jekk tidher xi interferenza fl- iskan tal - għadam meħuda b’ biphosphonate mmarkat b’ sustanza radjuattiva ta ’ technetium.
In absence of clinical data, the injected activity should be adapted to the renal function.
Fin- nuqqas ta ’ tagħrif kliniku, l- attività injettata għandha tiġi adattata għal- funzjoni tal- kliewi.
Use of QUADRAMET in patients with evidence of compromised bone marrow reserve from previous therapy or disease involvement is not recommended unless the potential benefit of the treatment outweighs its risks.
L- użu ta ’ QUADRAMET, f’ pazjenti li jidher li għandhom riserva ta ’ mudullun kompromessa minn kura li ngħatat qabel jew minħabba mard, mhuwiex rrakkomandat ħlief f’ każijiet fejn il- benefiċċju potenzjali tal- kura jisboq ir- riskji tiegħu.