natgillin/translations-raw huggingface dataset:
2 In individual cases of atrophic gastritis, the breath test result may have a false positive outcome and other tests may be required to confirm the presence of H. pylori.
2 V posameznih primerih atrofičnega gastritisa lahko test pokaže napačen pozitivni rezultat, zaradi česar bodo potrebni drugi testi za potrditev prisotnosti H. pylori.
There are insufficient data on the diagnostic reliability of the Pylobactell test to recommend its use in patients with partial gastrectomy and in patients younger than 18 years (see section 4.2).
Ni zadostnih podatkov o diagnostični zanesljivosti testa Pylobactell, da bi ga lahko priporočali za uporabo pri bolnikih z delno gastrektomijo in bolnikih mlajših od 18 let (glejte poglavje 4. 2).
The results may be affected in general by all treatments interfering with H. pylori status or urease activity.
Na splošno pa lahko na rezultate vplivajo vse vrste zdravljenja, ki ovirajo stanje H. pylori ali aktivnost ureaze.
The endogenous production of urea amounts to 25 - 35 g/ day.
Endogena proizvodnja sečnine znaša 25 - 35 g/ dan.
Other diagnostic agents, ATC code:
Farmakoterapevtska skupina: drugi diagnostiki, oznaka ATC:
In the case of infection with H. pylori, orally ingested 13C-urea is metabolised by the enzyme urease which is present in H. pylori.
V primeru infekcije s H. pylori peroralno zaužito 13C- sečnino presnavlja encim ureaza, ki je prisoten v H. pylori.
The carbon dioxide which is liberated diffuses into the blood vessels and is transported as bicarbonate to the lungs where it is then liberated as 13CO2 in exhaled air.
3 Sproščen ogljikov dioksid difundira v krvne žile in se prenese kot bikarbonat v pljuča, kjer se sprosti kot 13CO2 v izdihanem zraku.
Infection with H. pylori will significantly change the 13C/ 12C - carbon isotope ratio.
Infekcija s H. pylori bo signifikantno spremenila razmerje ogljikovih izotopov 13C/ 12C.
The proportion of 13CO2 in the breath samples may be determined by isotope-ratio-mass spectrometry (IRMS) or by another suitably-validated method carried out by any qualified laboratory, and stated as an absolute difference (excess) in the value between the pre-urea and post-urea breath samples (see section 6.6).
Ta delež je treba navesti kot absolutno razliko (presežek) vrednosti med vzorcema izdihanega zraka pred in po dajanju sečnine (glejte poglavje 6. 6).
The cut off point for discriminating between H. pylori negative and positive patients is set to an excess value of 3.5, i. e. < 3.5 is negative and ≥ 3.5 is positive.
Mejna vrednost ("Cut Off Point") za razlikovanje med bolniki, ki so H. pylori negativni ali pozitivni, je določena z vrednostjo, ki presega 3, 5, t. j. pri vrednosti < 3, 5 gre za negativen rezultat, medtem ko so vrednosti ≥ 3, 5 pozitiven rezultat.
In comparison with biopsy based techniques for diagnosing H. pylori infection, using data from two therapeutic trials, Pylobactell achieved during different conditions (pre-study and follow-up visits) sensitivity estimates above 95% with lower one-sided 95% confidence limit ranging from 93% to 98%.
V primerjavi z metodami za ugotavljanje infekcije s H. pylori, ki temeljijo na biopsiji, ob upoštevanju podatkov dveh terapevtskih preskušanj, je Pylobactell pod različnimi pogoji (pred študijo in ob kontrolnih pregledih bolnikov po zdravljenju) dosegel ocene občutljivosti nad 95% s spodnjo enostransko 95% mejo zaupanja z ustreznimi spodnjimi mejami zaupanja od 93% do 98%.
The specificity estimates were all above 90% with corresponding lower confidence limits ranging from 85% to 90%.
Ocene specifičnosti so vse bile nad 90% z ustreznimi spodnjimi mejami zaupanja od 85% do 90%.
Urea is rapidly absorbed from the gastro-intestinal tract and distributed into extracellular and intracellular fluids including lymph, bile, cerebrospinal fluid and blood.
Sečnina se hitro absorbira iz gastrointestinalnega trakta in porazdeli med zunaj- celične in znotraj - celične tekočine, vklj. z limfo, žolčem, cerebrospinalno tekočino in krvjo.
Povidone (E1201) Microcrystalline cellulose (E460i) Colloidal anhydrous silica Sodium benzoate (E211)
povidon (E1201) mikrokristalna celuloza (E460i) brezvodni koloidni silicijev natrijev benzoat (E211)
4 The Pylobactell 13C-urea breath test kit contains a heat-sealed PET/ aluminium foil/ LDPE laminated sachet containing one Pylobactell tablet, six glass tubes with caps and bar code labels, three additional bar code labels, a 30 ml mixing and administration glass vial with cap, two straws, a package leaflet and an Analysis Request Form.
4 Set dihalnega testa Pylobactell s 13C- sečnino vsebuje zlepljeno laminirano vrečko iz polietilentereftalata/ aluminijaste folije/ polietilena majhne gostote z eno tableto Pylobactell, šest steklenih epruvet z zaporkami in etikete s črtnimi kodami, tri dodatne etikete s črtnimi kodami, 30 ml vialo za mešanje in aplikacijo z zaporko, dve slamici, navodilo za uporabo ter obrazec za naročilo analize.
Collect pre-urea breath samples.
Zberite tri epruvete z vzorci
Three tubes of breath are to be taken by breathing normally through a straw held at the base of a small tube (white top).
izdihanega zraka, pri čemer mora bolnik normalno dihati skozi slamico, ki jo drži na dnu majhne epruvete (bela zaporka).
The patient must expire as the straw is slowly and completely withdrawn from the tube, which is then immediately capped.
Epruveto morate nemudoma zapreti.
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.
Bolnik mora to vsebino ponovno popiti.
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.
Preostali dve etiketi s črtnimi kodami sta namenjeni zdravnikovi uporabi za kartoteko bolnika itd.
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.
Nato škatlo pošljite v analizo laboratoriju.
5 Breath samples collected during the test must remain in the original containers before analysis by IRMS.
5 Vzorci izdihanega zraka, ki se zbirajo med testom, morajo pred analizo z IRMS ostati v originalnih vsebnikih.
A multi-position auto-sampler and bar code reader should be used to allow samples to be tracked throughout the analysis.
Za spremljanje vzorcev tekom celotne analize naj se uporablja samodejni jemalec vzorcev, ki vzorči na več pozicijah ("multi- position autosampler"), in čitalnik črtnih kod.
IRMS source parameters and tuning must be optimised daily.
Izvorne parametre IRMS in nastavitve je treba dnevno optimirati.
Instruments must be linear over a wide range of CO2 concentrations typically 1.0 - 6.0%.
Instrumenti morajo meriti linearno na širokem območju koncentracij CO2 (običajno 1, 0 - 6, 0%).
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.
Interna analizna preciznost mora biti manjša kot ±0, 3 ‰ δ13C za 20 ponovljenih analiz istega referenčnega vzorca plina ter ostati znotraj 3 standardnih deviacij od srednje vrednosti za analizo izdihanega zraka.
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.
IRMS mora biti opremljen s takim trojnim zbiralcem, da omogoča hkratno zaznavanje ionov z razmerji masa/ naboj 44, 45 in 46 fluktuacij vsebnosti izotopov kisika.
Explanation of results: -
Pojasnilo rezultatov: -
Excess δ 13C: - Difference between pre- and post-urea sample measurements.
δ13C: - Razlika v delih na tisoč (‰) glede na dopustni mednarodni standard Presežek δ13C: - Razlika med meritvami pred in po jemanju sečnine.
H. pylori status: -< 3.5 excess δ13C = Negative > 3.5 excess δ13C = Positive
Stanje H. pylori: - < 3, 5 presežek δ13C = negativno ≥ 3, 5 presežek δ13C = pozitivno
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 United Kingdom
EU/ 1/ 98/ 064/ 001
6 EU/ 1/ 98/ 064/ 001
7 May 1998 Date of latest renewal:
Datum pridobitve; 7. maj 1998 Datum zadnjega podaljšanja:
7 May 2003
7. maj 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 United Kingdom
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
- POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, PREDPISANI IMETNIKU
Pylobactell 100 mg soluble tablet 13 C-urea
Pylobactell 100 mg tableta za peroralno raztopino 13 C- sečnina
100 mg 13C-urea
100 mg 13C- sečnine
Povidone (E1201), Microcrystalline cellulose (E460i), Colloidal anhydrous silica, Sodium benzoate (E211).
Povidon (E1201), mikrokristalna celuloza (E460i), brezvodni koloidni silicijev, natrijev benzoat (E211).
One Security Label and three additional bar code labels.
vrečko, ki vsebuje eno 100 mg tableto za peroralno raztopino Pylobactell; šest steklenih epruvet z zaporkami in etiketami s črtnimi kodami; eno 30 ml vialo za mešanje in aplikacijo z zaporko; dve slamici; en obrazec za naročilo analize; eno varnostno etiketo in tri dodatne etikete s črtnimi kodami.
EXP:
UPORABNO DO:
Pylobactell 100 mg soluble tablet 13 C-urea Oral use
Pylobactell 100 mg tableta za peroralno raztopino 13 C- sečnina Peroralna uporaba
EXP
UPORABNO DO
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, United Kingdom.
14 ADDITIONAL KIT ITEM:
14 DODATNI PREDMET SETA:
MIXING AND ADMINISTRATION VIAL
VIALA ZA MEŠANJE IN APLIKACIJO ZDRAVILA
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
Ne vrnite je skupaj s setom.
ADDITIONAL KIT ITEM:
DODATNI PREDMET SETA:
SECURITY LABEL
VARNOSTNA ETIKETA
Pylobactell 100mg soluble tablet 13 C-Urea
Pylobactell 100 mg tableta za peroralno raztopino 13 C- sečnina
leaflet, please tell your doctor.
v tem navodilu, obvestite svojega zdravnika.
What Pylobactell is and what it is used for 2.
Kaj je zdravilo Pylobactell in za kaj ga uporabljamo 2.
Before you use Pylobactell 3.
Kaj morate vedeti, preden boste uporabili zdravilo Pylobactell 3.
How to use Pylobactell 4.
Kako uporabljati zdravilo Pylobactell 4.
How to store Pylobactell 6.
Shranjevanje zdravila Pylobactell 6.
It is used to determine the presence of the bacterium Helicobacter pylori (H. pylori) in the gut (stomach and adjacent bowel).
Uporablja se za ugotavljanje prisotnosti bakterije Helicobacter pylori v prebavilih (želodec in del črevesja).
Your doctor has recommended that you have a 13C-Urea breath test, for one of the following reasons: -
Vaš zdravnik vam je svetoval uporabo dihalnega testa s 13C- sečnino, in sicer iz sledečih razlogov:
• You have already been diagnosed with H. pylori and have been taking medicines aimed to clear up the infection.
• Pri vas je že bila ugotovljena infekcija z bakterijo H. pylori in ste že jemali zdravila za odstranjevanje te okužbe.
Your doctor now wants to find out if the treatment has worked.
Vaš zdravnik želi sedaj ugotoviti, če je bilo zdravljenje učinkovito.
You will be asked to drink a "test meal".
Prosili vas bodo, da popijete t. i. "testni obrok".
This will help keep the test 13C-urea solution in your stomach.
To bo pomagalo zadrževati testno raztopino 13C - sečnine v želodcu.
17 You will then drink the Pylobactell 13C-urea solution.
Nato boste popili Pylobactell raztopino 13C- sečnine.
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.
Če so v vašem želodcu dejansko prisotne in aktivne bakterije H. pylori, bodo te bakterije 13C- sečnino razcepile in to bo možno ugotoviti v ogljikovem dioksidu v vašem izdihanem zraku.
The amount of 13C in these samples will be compared to your normal level.
17 Količina 13C v teh vzorcih se primerja z običajno količino.
BEFORE YOU USE PYLOBACTELL
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO PYLOBACTELL
DO NOT take Pylobactell if you:
NE UPORABLJAJTE zdravila Pylobactell:
- are allergic (hypersensitive) to 13C-urea or to any of the other ingredients in the tablets
- če ste alergični na (preobčutljivi za) 13C- sečnino ali eno od pomožnih snovi v tableti (glejte
(see section 6).
poglavje 6).
- suffer from any medical condition that you think may affect, or be affected by, the test.
- če trpite za boleznijo, ki bi lahko po vašem mnenju imela vpliv na test in/ ali obratno.
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.
če ima lahko post (neuživanje hrane) za vas medicinske posledice. če ste mlajši od 18 let.
• You have taken antibiotics or medication to treat Helicobacter pylori within the last 28 days.
• če ste v zadnjih 28 dneh jemali antibiotike ali zdravila za zdravljenje okužbe z bakterijo Helicobacter pylori.
• You have taken proton pump inhibitors (stops indigestion) in the last 14 days.
• če ste v zadnjih 14 dnevih jemali zaviralce protonske črpalke (zaustavijo dispepsijo).
• You have taken H2 antagonists or antacids (relieves indigestion) on the same day of the test.
• če ste na dan testiranja vzeli H2 antagoniste ali antiacide (olajšajo dispepsijo).
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.
Morate se postiti najmanj 4 ure pred testom, tako da se test opravi na tešče.
If fasting is a problem (e. g. for diabetic patients), please tell your doctor.
Če post za vas predstavlja težavo, npr. če ste sladkorni bolnik, o tem prosimo obvestite svojega zdravnika.
18 Driving and using machines This test should not affect your ability to drive or use machines.
Vpliv na sposobnost upravljanja vozil in strojev Ta test ne bo vplival na vašo sposobnost upravljanja vozil in strojev.
It is recommended that the breath test is performed while you are in a seated position.
18 Priporočamo, da ste med dihalnim testom v sedečem položaju.
You should fast for 4 hours before taking the test (See section 2, Taking Pylobactell with food and drink)
Post: morate se postiti 4 ure pred opravljanjem testa (glejte poglavje 2, Uporaba zdravila Pylobactell skupaj s hrano in pijačo).
Pre-test Breath Samples (3 White Capped Tubes) i.
Vzorci izdihanega zraka pred testom (3 epruvete z belimi zaporkami) i.
Remove the cap from the tube. ii.
Odstranite zaporko z epruvete. ii.
Breathe out through your mouth, using a straw, into the sample tube. iii.
S pomočjo slamice izdihnite skozi usta v epruveto. iii.
Gradually remove the straw from the tube as you breathe out. iv.
Med izdihovanjem postopno potegnite slamico iz epruvete. iv.
Immediately replace the cap. v.
Takoj namestite zaporko. v.
5.
Pripravljanje raztopine 13ogljikove sečnine 5.
Preparing the 13Carbon-urea solution Open the tablet sachet and empty the tablet into the mixer vial.
Odprite vrečko ter dajte tableto v vialo za mešanje.
Wait 30 minutes from the time of drinking the Pylobactell 13C-urea solution.
Med tem ne 6. smete kaditi, jesti ali piti.
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.
Obrazec za naročilo analize Izpolnite obrazec za naročilo analize z bolnikovimi podatki na levi strani obrazca ter z imenom in naslovom zdravnika na desni strani.
19 Put your breath samples and the completed Analysis Request Form back into the carton and send to the address supplied by your doctor.
Test je sedaj končan Dajte vzorce izdihanega zraka nazaj v škatlo ter jih skupaj z izpolnjenim obrazcem za naročilo analize pošljite na naslov, ki vam ga je posredoval zdravnik.
Your doctor will tell you when the results of your test will be available and who to contact for these results.
Zdravnik vas bo obvestil, kdaj bodo rezultati testa in na koga se boste za rezultate obrnili.
If a repeat test is required, it should not be carried out until the following day.
19 Če je potreben ponovni test, se ga ne sme opravljati do naslednjega dne.
13 C and urea are harmless naturally occurring substances which are found in your body.
13 C in sečnina sta nenevarni, naravno prisotni snovi, ki se nahajata tudi v vašem telesu.
Do not store the kit above 25°C.
Set shranjujte pri temperaturi do 25°C.
- The active substance is 13C-urea.
Zdravilna učinkovina je 13C- sečnina.
Each tablet contains 100 mg of 13C-urea
Vsaka tableta vsebuje 100 mg 13C- sečnine.
- The other ingredients are povidone (E1201), microcrystalline cellulose (E460i),
- Pomožne snovi so povidon (E1201), mikrokristalna celuloza (E460i), brezvodni koloidni
colloidal anhydrous silica and sodium benzoate (E211).
silicijev, natrijev benzoat (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.
- 6 steklenih epruvet, 3 z belimi zaporkami in 3 z rdečimi zaporkami,
The contents of this kit are sufficient for a single test.
- 30 ml stekleno epruveto za mešanje z zaporko,
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
(+44) 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, United Kingdom.
20 This leaflet was last approved in
20 Navodilo je bilo odobreno
Detailed information on this medicine is available on the European Medicines Agency (EMEA) website http: / /www. emea. europa. eu/.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu /.
---------------------------------------------------------------------------------------------------
------------------------------------------------------------------------------------------------------------------------------
A multi-position autosampler and bar code reader should be used to allow samples to be tracked throughout the analysis.
Za spremljanje vzorcev tekom celotne analize naj se uporablja samodejni jemalec vzorcev, ki vzorči na več pozicijah ("multi- position autosampler"), in čitalnik črtnih kod.
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.
Interna analizna preciznost mora biti manjša kot ±0, 3 ‰ δ13C za 20 ponovljenih analiz istega referenčnega vzorca plina ter ostati znotraj 3 standardnih deviacij od srednje vrednosti za analizo izdihanega zraka.
δ 13C: - Difference in parts per thousand (‰) with respect to an accepted international standard.
δ13C: - Razlika v delih na tisoč (‰) glede na dopustni mednarodni standard.
21 Excess δ 13C: - Difference between pre- and post-urea sample measurements.
Presežek δ13C: - Razlika med meritvami pred in po jemanju sečnine.
22 ANALYSIS REQUEST FORM:
21 OBRAZEC ZA NAROČILO ANALIZE:
Pylobactell [13Carbon] -UREA BREATH TEST (13C-UBT) for Helicobacter pylori
Pylobactell [13Ogljikov] - DIHALNI TEST S SEČNINO (13C- UBT) za Helicobacter pylori
ANALYSIS REQUEST FORM - Please complete in block capitals
OBRAZEC ZA NAROČILO ANALIZE - Prosimo izpolnite s tiskanimi črkami
Please state clearly address for return of results:
Prosimo navedite točen naslov za povratno pošiljanje rezultatov:
AFFIX BAR-CODE LABEL HERE
TUKAJ NAMESTITE ETIKETO S ČRTNO KODO
PLEASE PLACE BAR-CODE LABEL ON PATIENT RECORDS, IF APPLICABLE
PROSIMO, DA PO POTREBI NAMESTITE ETIKETO S ČRTNO KODO TUDI NA ZDRAVSTVENI KARTON BOLNIKA
Number:
Številka dovoljenja za promet:
EU/ 1/ 98/ 064/ 001 Marketing Authorisation Holder:
EU/ 1/ 98/ 064/ 001 Imetnik dovoljenja za promet z zdravilom:
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, United Kingdom
Medical History - has the patient
Predhodna zdravila - ali je bolnik:
Test Check List
vrsta in datum
& Date
Min
Mins
Seznam za testno preverjanje
If so, please indicate type and when last taken
Če da, prosimo navedite katere in čas zadnjega jemanja
Collect Pre-Urea samples (White Caps - 3 times)
Vzemite vzorce pred zaužitjem sečnine (bele zaporke - 3- krat)
If so, please indicate when treatment ended
Če da, prosimo navedite datum zadnjega dne zdravljenja (iv) jemal druga zdravila?
t = 40
t = 10 t = 40
Collect Post-Urea samples (Red Caps - 3 times).
Vzemite vzorce po zaužitju sečnine (rdeče zaporke - 3 - krat).
Bar-code label and all details entered on Analysis Request
Etiketa s črtno kodo mora biti nameščena na v celoti
Laboratory use only
Prosimo upoštevajte, da imajo točke (i) - (iii) vpliv na rezultat testa.
Form.
izpolnjenem obrazu za naročilo analize.
1 x Pre/ Post sample reserved in store.
Shranite po 1 x vzorec, ki je bil vzet pred zaužitjem sečnine oz. po njem.
2 x Pre/ Post samples + this form for return to a qualified laboratory.
Pošljite po 2 x vzorca, ki sta bila vzeta pred zaužitjem sečnine oz. po njem + ta obrazec
Date received:
Datum prejema:
Analytical file reference:
Laboratorijska koda:
Laboratory code:
Vzorce je vpisal:
QUADRAMET is a solution for injection containing the active substance samarium [153Sm] lexidronam pentasodium.
Zdravilo QUADRAMET je raztopina za injiciranje, ki vsebuje zdravilno učinkovino [153Sm] samarij - leksidronam, pentanatrijeva sol.
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.
Preden bolniki začnejo prejemati zdravilo QUADRAMET, je treba pri njih opraviti posnetek kosti, pri čemer se kot označevalci uporabijo s tehnecijem- 99m [99mTc] radioaktivno označeni bifosfonati, da bi preverili, ali so njihove metastaze take vrste, da se lahko pri njih uporabi zdravilo QUADRAMET.
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).
Odmerek zdravila QUADRAMET se izračuna na temelju bolnikove telesne mase, da bi bil zagotovljen določen odmerek radioaktivnosti (37 mega becquerelov na kilogram telesne mase).
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).
Gre za spojino (vrsta kemične snovi), sestavljeno iz radioaktivnega elementa samarija- 153 (153Sm), ki je vezan na drugo kemično snov, imenovano etilen diamin tetrametilen fosfonska kislina (EDTMP).
As a result, the radiation brought by the samarium-153 can act locally and help to relieve the bone pain.
Ker ima EDTMP veliko afiniteto do kostnega tkiva, se kopiči v kosteh, še posebno v predelih