qanastek/EMEA-V3 huggingface dataset:
To be reconstituted with sodium pertechnetate (99mTc) solution for injection (not included in this kit).
Irid jiġi rikostitwit b’ sodium pertechnetate (99mTc) soluzzjoni għall- injezzjoni (mhix inkluża f' dan is - sett).
White powder for solution for injection.
Sett għall- preparazzjoni radjufarmaċewtika. Trab abjad għal soluzzjoni għall- injezzjoni.
For scintigraphic imaging of suspected malignant tumours in the lung after initial detection, in combination with CT scan or chest X-ray, in patients with solitary pulmonary nodules.
Għat- teħid tar- ritratti xintigrafiċi ta 'tumuri malinni suspettati fil- pulmun wara li jkun hemm l- ewwel indikazzjonijiet, flimkien ma' CT scan jew ritratt bir- reġġi- X tas- sider, f' pazjenti li għandhom għoqod tat- tumur waħedhom fil- pulmun.
The medicinal product is for hospital use or in designated Nuclear Medicine Facilities only, by persons experienced in radioisotope diagnostic imaging.
Il- prodott mediċinali jintuża l- isptar jew f' Faċilitajiet apposta tal- Mediċina Nukleari biss, minn personi b' esperjenza fit- teħid ta 'ritratti radjuisotopiċi għal użu dijanjostiku.
Instructions for reconstitution, handling and disposal are given in section 12.
Istruzzjonijiet għar- rikostituzzjoni, l- immaniġġjar u r- rimi jinsabu f' taqsima 6. 6.
After reconstitution with sodium pertechnetate (99mTc) solution for injection, 99mTc-depreotide is formed.
Wara r- rikostituzzjoni b’ sodium pertechnetate (99mTc) soluzzjoni għall- injezzjoni, jiġi ffurmat 99mTc - depreotide.
99m Tc-depreotide is administered intravenously in a single dose.
99m Tc- depreotide jingħata fil- vina f' doża waħda.
The solution may be diluted with sodium chloride 0.9% w/ v solution for injection for more convenient injection.
Is- soluzzjoni tista 'titħallat b’ 0. 9% w/ v sodium chloride soluzzjoni għall- injezzjoni biex l- injezzjoni ssir b' mod iktar konvenjenti.
SPECT images (Single Photon Emission Computed Tomography) obtained between 2 and 4 hours following 99mTc-depreotide injection are required for optimal image interpretation.
Ir- ritratti SPECT (Tomografija Komputata għall- Emmissjoni ta ’ photon waħda) li jittieħdu bejn sagħtejn u 4 sigħat wara l- injezzjoni ta ’ 99mTc- depreotide huma bżonjużi biex issir l- aħjar interpretazzjoni tar- ritratti.
Dosage for adults The recommended dosage is approximately 47 micrograms depreotide (one vial) labelled with 555-740 MBq of technetium-99m.
Doża għall- adulti Id- doża rakkomandata hi bejn wieħed u ieħor 47 mikrogramma ta 'depreotide (fjala waħda) immarkata bis- sustanza radju- attiva 555 - 740 MBq ta ’ technetium- 99m.
Dosage for elderly (> 65 years) Experience from clinical trials indicates that no dose adjustment is required.
Doża għall- anzjani (> 65 sena) L- esperjenza minn provi kliniċi tindika li m' hemmx bżonn bdil fid- doża.
Children 99m Tc-depreotide is not recommended for use in patients below the age of 18 as data are not available for this age group.
Tfal 99m Tc- depreotide mhux rakkomandat għal pazjenti taħt it- 18- il sena billi m' hemmx tagħrif dwar l- użu tiegħu f’ din l- eta`.
Renal impairment No dose adjustment is required.
Indeboliment tal- kliewi M' hemmx bżonn bdil fid- doża.
See section 4.4
Ara taqsima 4. 4
2 4.3 Contraindications
2 Jekk jittieħed mill- ġdid 99m Tc- depreotide huwa indikat għal użu ta ’ darba.
History of hypersensitivity reaction to depreotide, any of the excipients of NeoSpect or sodium pertechnetate (99mTc) solution for injection.
Sensittività eċċessiva għas depreotide, xi sustanzi mhux attivi ta ’ NeoSpect jew għal sodium pertechnetate (99mTc) soluzzjoni għall- injezzjoni.
Pregnancy and lactation.
Jekk tkun tqila jew qed tredda ’.
The contents of NeoSpect are intended only for use in the preparation of 99mTc-depreotide solution for injection (see section 12).
Il- kontenuti tan- NeoSpect huma maħsuba biss biex jintużaw għall- preparazzjoni ta ’ 99mTc- depreotide soluzzjoni għall- injezzjoni (ara 6. 6).
Unlabelled NeoSpect should not be administered directly to the patient.
NeoSpect li mhux immarkat b' sustanza radju- attiva m' għandux jingħata direttament lill- pazjent.
As with all injectable medicinal products, anaphylactic or anaphylactoid reactions may occur after administration.
Bħal ma jista ’ jiġri b’ kull prodott mediċinali li jingħata bl- injezzjoni, jista 'jkun hemm reazzjonijiet anaflattiċi jew anafilattojdi wara li jingħata l- prodott.
Familiarity with the practice and technique of resuscitation and treatment of anaphylaxis is essential.
Huwa essenzjali li min se jagħti l- prodott ikollu l- prattika fit- teknika li iġġib f’ sensih bniedem li jkun mitluf minn sensih u l- kura ta 'l- anafilassi.
Appropriate treatment and equipment should be readily available.
Il - kura addattata u l- apparat xieraq għandhom ikunu disponibbli.
Care should be exercised in patients with impaired renal function, due to lower renal excretion and probable increase in exposure to radioactivity.
Wieħed għandu joqgħod attent meta l- pazjent ikollu indeboliment fil- funzjoni tal- kliewi, minħabba rata inqas ta 'tneħħija mill- kliewi u l- probabbilta` li l- pazjent ikun iktar espost għar- radjuattivita`.
Care should be exercised in patients with reduced liver function.
Wieħed għandu joqgħod attent meta l- pazjent ikollu indeboliment fil- funzjoni tal- fwied.
This radiopharmaceutical may be handled only by authorised persons in designated clinical settings.
Dan il- prodott farmaċewtiku radjuattiv jista 'jiġi maniġġat biss minn persuni awtorizzati f' ambjenti kliniċi apposta.
Its receipt, storage, use, transfer and disposal are subject to the regulations and/ or appropriate licenses of the local competent official organisations.
Għandu jittieħed, jinħażen, jintuża, jinġarr minn post għall- ieħor u jintrema skond regolamenti u/ jew liċenzji apposta ta 'l- organizzazzjonijiet uffiċjali kompetenti.
Radiopharmaceuticals should be prepared by the user in a manner which satisfies both radiation safety and pharmaceutical quality requirements.
Prodotti farmaċewtiċi radjuattivi għandhom jiġu ppreparati minn min se jużahom b' mod li jissodisfa il - livelli ta 'kwalita` farmaċewtiċi u tas- sigurta` mitluba.
Appropriate aseptic precautions should be taken, complying with the requirements of Good Manufacturing Practice (GMP) for pharmaceuticals.
Għandhom jittieħdu miżuri asettiċi ta ’ prekawzjonijiet, skond il- Prattika ta ’ Manifattura Tajba( GMP) għall- prodotti farmaċewtiċi.
99m Tc-depreotide, must be handled with care, and appropriate safety measures should be used to minimise radiation exposure to clinical personnel.
Wieħed għandu joqgħod attent fl- immaniġġar ta ’ 99mTc- depreotide, u għandhom jittieħdu l- miżuri xierqa ta 'sigurta` biex titnaqqas ir- radjazzjoni li jiġi espost għaliha il- personàl kliniku.
Care should also be taken to minimise radiation exposure to the patient, consistent with proper patient management.
Wieħed għandu joqgħod attent ukoll biex inaqqas kemm jista ’ jkun ir- radjazzjoni li jiġi espost għaliha l- pazjenti, skond kif inhu xieraq fl- immaniġġjar xieraq tal- pazjenti.
To minimise the dose of radiation absorbed by the bladder, adequate hydration should be encouraged to permit frequent voiding during the first few hours after injection.
Biex titnaqqas kemm jista 'jkun id- doża ta' radjazzjoni li tassorbi l- borża ta 'l- urina, għandha tiġi nkoraġġita idrazzjoni adegwata biex ikun hemm tneħħija regolari waqt l- ewwel ftit sigħat wara l - injezzjoni.
Therapy with octreotide acetate can produce severe hypoglycaemia in patients with insulinomas, and other somatostatin analogues are known to impair glucose tolerance.
It- terapija b’ octreotide acetate tista 'tikkawża ipogliċemija qawwija f' pazjenti li għandhom l - insolinomas, u huwa magħruf li analogi tas- somatostatin ixekklu t- tolleranza għall- glukose.
Since depreotide also binds to somatostatin receptors, caution should be exercised when administering this medicinal product to patients with insulinomas or diabetes mellitus.
Billi depreotide jintrabat ukoll mar- reċetturi tas- somatostatin, dan il- prodott mediċinali għandu jingħata b' kawtela lil pazjenti b' insulinomas jew dijabete mellitus
NeoSpect is not recommended for use in children under 18 years of age because data are not available for this age group.
NeoSpect m' għandux jingħata lil tfal taħt it- 18- il sena billi m' hemmx tagħrif dwar pazjenti ta ’ din l - eta ’.
Re-administration:
Meta jittieħed mill- ġdid:
Clinical data reflecting safety and efficacy of multiple injections are only available in 13 patients.
Tagħrif kliniku li jirrifletti s- sigurta` u l- effikaċja ta 'iktar minn injezzjoni waħda teżisti biss dwar 13- il pazjent.
Repeat administration must be avoided.
Il- prodott m' għandux jerġa 'jingħata.
No specific interaction studies with other medicinal products have been performed, and there are little available data on such interactions.
Ma sarux studji formali dwar l- interazzjoni ta 'dan il- prodott ma' prodotti oħra, u ftit hemm tagħrif dwar interazzjonijiet bħal dawn.
Pregnancy Radionuclide procedures carried out on pregnant women also involve radiation doses to the foetus.
It- tqala Il- proċeduri radjunuklidi li jsiru lil nisa tqal jinvolvu wkolli dożi ta 'radjazzjoni lill- fetu.
99m Tc-depreotide is therefore contraindicated in pregnancy.
Għalhekk 99mTc- depreotide huwa kontra- indikat fit- tqala.
3 information should always be sought about pregnancy.
(Ara taqsima 4. 3) Meta jkun hemm il- bżonn li jingħataw prodotti radjuattivi mediċinali lil nisa li jista 'jkollhom it- tfal, dejjem għandha tinkiseb informazzjoni dwar it- tqala.
Any woman who has missed a period should be assumed to be pregnant until proven otherwise.
Wieħed għandu jassumi li kull mara li tilfet pirjid hi tqila sakemm ma jkunx ippruvat il- kontrarju.
Alternative techniques, which do not involve ionising radiation, should be considered.
Għandhom jiġu meqjusa metodi alternattivi li ma jinvolvux radjazzjoni ijonizzanti.
Lactation It is not known whether 99mTc-depreotide is excreted in human milk, 99mTc-depreotide is therefore contraindicated during lactation.
Treddigħ Mhux magħruf jekk 99mTc- depreotide joħroġx fil- ħalib tas- sider fil- bniedem, għalhekk depreotide huwa kontra- indikat waqt li l- mara tkun qed tredda '.
Most of the adverse reactions reported were transient and of mild intensity.
Il- biċċa l- kbira tar- reazzjonijiet mhux mixtieqa li ġew irrappurtati kienu ħfif u li jgħaddu.
All were uncommon (0.1%-1%) in occurrence.
Ma kienux komuni (0. 1% - 1%).
Most frequently reported were headache, nausea, vomiting, diarrhoea, abdominal pain, dizziness, flushing and fatigue.
Dawk li ġew irrappurtati l- aktar kienu uġigħ ta 'ras, nawżja, remettar, diarrea, uġigħ addominali, sturdament, fawra fil- wiċċ u għeja.
For each patient, exposure to ionising radiation must be justifiable on the basis of the likely benefit.
Għal kull pazjent trid tittieħed id- deċiżjoni kemm hu ta 'benefiċċju li jkun espost għar- radjazzjoni ijonizzanti.
The activity administered must be such that the resulting radiation dose is as low as reasonably achievable bearing in mind the need to obtain the intended diagnostic result.
Il- mod kif jingħata jrid ikun tali li jintlaħaq ir- riżultat djanjostiku mixtieq bl- inqas doża ta 'raġġi possibbli.
Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects.
Min ikun espost għar- radjazzjoni ijonizzanti iktar għandu ċans li jkollu l- kanċer u li jiżviluppa difetti li jintirtu.
For diagnostic nuclear medicine investigations, the current evidence suggests that these adverse events will occur with low frequency because of the low radiation doses incurred.
Għal investigazzjonijiet b' mediċina dijanjostika nukleari, l- evidenza s' issa tindika li dawn is- sitwazzjonijiet qajla jseħħu billi d- dożi ta 'radjazzjoni jkunu baxxi.
For most diagnostic investigations using nuclear medicine procedures, the radiation dose delivered (effective dose equivalent) is less than 20 mSv.
Għall- biċċa l- kbira ta ’ l- investigazzjonijiet dijanjostiċi li jużaw proċeduri ta 'mediċina nukleari, id - doża ta' radjazzjoni li tittieħed (l- ekwivalenti tad- doża effettiva) huwa inqas minn 20 mSv.
Higher doses might be justified in some clinical circumstances.
Jista 'jkun hemm bżonn ta' dożi ogħla f' ċerti ċirkustanzi kliniċi.
Observed changes in the laboratory parameters are: increased WBC count, basophils, eosinophils, monocytes and neutrophils, AST, ALT, LDH, total bilirubin and total protein; lowered RBC count and total protein.
Il- bidliet fil- parametri tal- laboratorju li ġew osservati huma: livelli ogħla fl- għadd tal- WBC, tal - bażofili, tal- eżinofili, tal- monoċiti u tan- newtrofili, ta ’ l- AST, l- ALT, l- LDH, tal- bilirubin totali u tal - proteini totali; livelli mnaqqsa fl- għadd tar- RBC u tal- proteinI totali.
No case of overdose has been reported.
L- ebda każ ta ’ doza eċċessiva ma ġie rappurtat.
Treatment of an overdose should be directed towards the support of vital functions.
L- għan tal- kura fil- każ ta 'doża eċċessiva għandu jkun li jsostnu l- funzjonijiet vitali.
Diagnostic radiopharmaceutical for use in tumour detection ATC code:
Prodott radjufarmaċewtiku dijanjostiku biex jiġu identifikati t- tumuri Kodiċi ATC:
V09I A05
V091 A05
Technetium (99mTc) depreotide solution for injection is a diagnostic radiopharmaceutical based upon a synthetic peptide that binds to somatostatin receptors.
Is- soluzzjoni għall- injezzjoni ta 'technetium (99mTc) depreotide hija prodott radjufarmaċewtiku dijanjostiku bbażat fuq peptajd sintetiku li jintrabat mar- riċetturi ta ’ somatostatin.
In vitro data and studies in laboratory animals indicate that 99mTc-depreotide binds with high affinity to somatostatin receptor (SSTR) subtypes 2, 3 and 5.
Tagħrif in vitro u studji fuq l- annimali fil- laboratorju jindikaw li 99mTc- depreotide jintrabat b’ affinita ’ qawwija mas - sottotipi 2, 3 u 5 tar- riċettur ta ’ somatostatin (SSTR).
These receptors are hyper-expressed by malignant tumours.
Dawn ir- riċetturi jiġu espressi aktar bit- tumuri malinni.
The binding affinity of 99mTc-depreotide to SSTR was shown in studies of pancreatic tumours in Lewis rats and in vitro in human tumour membranes.
4 It- tendenza tad- 99mTc- depreotide li jintrabat ma 'l- SSTR intweriet fi studji fuq tumuri tal- firxa f' firien Lewis u in vitro f' membrani tat- tumur fil- bniedem.
The data indicate that the 99mTc-depreotide displays high-affinity binding to somatostatin receptors.
It- tagħrif jindika li 99mTc- depreotide għandu tendenza qawwija li jintrabat mar- reċetturi tas- somatostatin.
The peptide itself has a lower affinity for these receptors.
Il- peptajd innifsu għandu inqas tendenza li jintrabat ma 'dawn ir- reċetturi.
In a clinical study examining the pharmacodynamic effects of the recommended dose of the peptide in human volunteers during an oral GTT (Glucose Tolerance Test), no effects were observed other than the normal physiologic response to oral glucose challenge.
Fi studju kliniku li eżamina l- effetti farmakodinamiċi tad- doża rakkommandata tal- peptajd f' nies li vvolontarjaw għal GTT orali (Test għat- tolleranza tal- glukose), ma ġie osservat l- ebda effett ħlief ir- rispons fiżjoloġiku normali għat- teħid ta 'doża qawwija glukose mill - ħalq.
4 In the pivotal studies, the negative predictive value for NeoSpect in association with CT for solitary pulmonary nodules (SPNs) was 90– 96% at a disease prevalence of 30-50%.
Fl- istudji fundamentali, il- valur negattiv imbassar tan- NeoScan meta ntuża ma 'CT għal għoqod tat - tumur waħidhom fil- pulmun (SPNs) kien ta' bejn id- 90 u s- 96% bi prevalenza tal- marda ta 'bejn it- 30 u l- 50%.
In the same prevalence range the positive predictive value was in the range 52-72%.
Fl- istess medda ta 'prevalenza l- valur pożittiv imbassar kien ta' bejn it- 52 u t- 72%.
The corresponding negative predictive value and positive predictive value for NeoSpect in association with chest X-ray were 96-98% and 61- 78% respectively.
Il- valuri negattivi u pożittivi mbassra għan- NeoSpect li jikkorrispondu ma xulxin, meta ntuża ma 'raġġi X tas - sider kienu ta' bejn is- 96 u t- 98% u bejn il- 61 u t- 78% rispettivament.
In a recent clinical study with a prevalence of malignancy of 49%, the positive predictive value for NeoSpect in association with CT/ chest X-ray was 84% (CI 63.1-94.7%) for all SPNs and 81.8% for lesions equal to or less than 3cm.
Fi studju kliniku li sar reċenti fejn it- tumur malinn kien preżenti f' 49% mill- każi, il- valur pożittiv imbassar għan- NeoSpect meta ntuża ma 'CT/ raġġi X tas- sider kien ta' 84% (CI 63. 1- 94. 7%) għal kull SPN u 81. 8% għal feriti ta '3 ċm jew inqas.
The negative predictive value was 87.5% (CI 66.5-96.7%) for all lesions and 87.5% for lesions equal to or less than 3cm.
Il- valur negattiv imbassar kien ta ’ 87. 5% (Cl 66. 5 – 96. 7%) għall- feriti kollha u 87. 5% għall- feriti ta ’ 3 ċm jew inqas.
However, histology was predominantly obtained by fine needle aspiration (FNA) with 5 out of 49 patients having open thoracotomies.
Madankollu, fil- parti l- kbira tal - każijiet l- istoloġija inkisbet bi ġbid b' labra rqiqa (FNA), u 5 minn 49 pazjent kellhom torakotomija miftuħa.
In view of the false negative rate of FNA (5-8% false negative rate reported), thoracotomy is considered to be the gold standard.
Minħabba ir- rata negattiva falza ta 'l- FNA (ġiet rappurtata rata negattiva falza ta' bejn 5 u 8%), it- torakotomija titqies il- metodu li miegħu iridu jitqabblu l- oħrajn kollha.
Patients with a negative FNA should be followed up clinically as some FNA biopsies may give false negative results.
Pazjenti b' FNA negattiva għandhom jiġu segwiti klinikament billi xi bijopsiji bl- FNA jistgħu jagħtu riżultati negattivi foloz.
The radiation dose from 18FDG-PET (Fluorodeoxyglucose – Positron Emission Tomography) is lower than that from NeoSpect, whilst still achieving high sensitivity and specificity.
Id- doża ta 'radjazzjoni mill - 18FDG- PET (Fluorodeoxyglucose – Tomografija bl- Emissjoni tal- Pożitroni
However PET is not widely available throughout Europe.
Madankollu l- PET ma tantx jinstab fl- Ewropa.
Studies in healthy volunteers have demonstrated that the tracer confers three-compartment pharmacokinetic characteristics with a distribution half-life of less than 5 minutes and a terminal half- life of about 20 hours, and a steady-state volume of distribution of 1.5 to 3 l/ kg.
Studji f' volontarji f' saħħithom urew li t- tracer jagħti karatteristiċi farmakokinetiċi fit- tliet kompartimenti b’ half life ta ’ 5 minuti u b’ half life terminali ta ’ 20 siegħa, u volum ta 'distribuzzjoni stabbli ta' bejn 1. 5 u 3 l/ kg.
Total clearance averaged 2 to 4 ml/ min/ kg.
Ir- rata tat- tneħħija kienet ta 'bejn 2 u 4 ml/ min/ kg.
Renal clearance averaged about 0.3 ml/ min/ kg.
Ir- rata tat- tneħħija mill - kliewi kienet ta 'madwar 0. 3 ml/ min/ kg.
External whole-body gamma scintigraphy showed highest location of radioactivity in the abdomen.
Ix- xintigrafija gamma tal- ġisem kollu minn barra uriet li l - ogħla konċentrazzjonijiet ta 'radjuattivita` kienu fl- addome.
One to 18% of the injected dose of radioactivity appeared in the urine at 4 hours after injection.
Minn 1 sa 18% tad- doża tar- radjuattivita` li kienet injettata dehret fl- urina 4 sigħat wara l- injezzjoni.
Plasma radioactivity is predominantly (> 90%) in parent form, i. e. as 99mTc-depreotide.
Ir- radjuattivita` tal- plażma kienet l- iktar (> 90%) fil- forma oriġinali, i. e. bħala 99mTc- depreotide.
The majority of the radioactivity excreted in urine is in parent form.
Il - maġġoranza tar- radjuattivita` li toħroġ ma 'l- urina hija fil- forma oriġinali.
99m Tc-depreotide binds to the extent of about 12% to plasma proteins in patients and healthy volunteers.
99m Tc- depreotide jintrabat sa 12% mal- proteini tal- plażma kemm f' pazjenti kif ukoll f' voluntiera f' saħħithom.
5.3 Preclinical safety data 99m Tc-depreotide was not mutagenic in vitro in the Ames test or mouse lymphoma test, and it was not clastogenic in vivo in the mouse micronucleus test.
5. 3 Tagħrif ta 'qabel l- użu kliniku dwar is- sigurtà tal- mediċina 99m Tc- depreotide in vitro ma kienx mutaġeniku fit- test ta' Ames jew fit- test tal- limfoma fil- ġrieden, u in vivo u ma kienx klastoġeniku fit- test tal- mikronukleju fil- ġrieden.
Toxic effects observed in the animal studies were not considered to be relevant in clinical use in humans.
L- effetti tossiċi li ġew osservati fl- istudji fuq l- annimali ma tqisux li huma relevanti għal użu kliniku fil- bniedem.
Studies have not been conducted to evaluate carcinogenic potential or effects on fertility.
Ma sarux studji biex jevalwaw il- potenzjal karċinoġeniku jew l- effett fuq il- fertilita`.
Stannous chloride dihydrate 50 micrograms (essential excipient) Sodium α -D-glucoheptonate dihydrate Disodium edetate Hydrochloric acid and/ or sodium hydroxide (pH adjustment)
Stannous chloride dihydrate 50 mikrogrammi (ingredjent mhux attiv essenzjali) sodium α D- glucoheptonate dihydrate
In the absence of incompatibility studies, 99mTc-depreotide must not be mixed with other medicinal products.
Minħabba li ma sarux studji li juru liema huma l- prodotti li ma jaqblux ma '99mTc- depreotide, dan il - prodott mediċinali m’ għandux jitħallat ma ’ prodotti mediċinali oħrajn.
A separate cannula should be used.
Għandha tintuża kannula separata.
5 Following reconstitution and radiolabelling, the material must be used within 5 hours as radiochemical purity and stability have been demonstrated for 5 hours at 25°C.
Wara li jkun rikostitwit u mmarkat b' sustanza radju- attiva, għandu jintuża fi żmien 5 sigħat billi ntwera li s- safa u l- istabilita` radju- attiva jinżammu għal 5 sigħat f' temperatura ta '25°C.
Store in a freezer at or below -10 °C.
Aħżen fil- friża f' temperatura ta ', jew inqas minn, - 10°C.
Store the reconstituted solution for injection for no more than 5 hours at 15 °C - 25 °C using appropriate radiation shielding.
Aħżen is- soluzzjoni rikostitwita għall- injezzjoni għal mhux iktar minn 5 sigħat f' temperatura ta 'bejn il- 15 u l- 25°C għandhom jintużaw barrieri addattati għal kontra r- radjazzjoni.
Storage of radiopharmaceuticals should be in accordance with national regulations on radioactive materials.
Il- ħażna tal- prodotti radjufarmaċewtiċi għandha tkun skond ir- regolamenti nazzjonali dwar sustanzi radju- attivi.
The product is filled in 5 ml type I glass vials.
Il- prodott jitqiegħed fi fjali ta '5 ml tat- tip I.
The containers are closed with butyl rubber stoppers and sealed with aluminium caps.
Il- kontenituri jingħalqu bit- tappijiet tal- gomma butyl u jiġu ssiġillati b' għotjien ta 'l- aluminjum.
NeoSpect is supplied in packs of 1 vial and 5 vials, each vial containing 47 micrograms depreotide.
NeoSpect jiġi f' pakketti ta 'fjala waħda jew 5 fjali, kull fjala jkun fiha 47 mikrogrammi ta ’ depreotide.
Not all pack sizes may be marketed.
Mhux il- qisien kollha tal- pakketti jista 'jitqiegħdu fis- suq.
See section 12
Ara sezzjoni 12.
32 91192 GIF sur YVETTE cedex FRANCE
32 91192 GIF sur YVETTE cedex FRANZA
Technetium-99m disintegrates by isomeric transition with the emission of gamma radiation with an energy of 140 keV and a half life of 6 hours to technetium-99, which can be regarded as quasi stable.
Jsir Technetium- 99, li jista 'jitqies kważi stabbli.
For this product, the effective dose resulting from an administered activity of 555-740 MBq is typically 8.88– 11.84 mSv for a 70 kg individual.
Għal dan il- prodott, id- doża effettiva li tiġi meta tingħata attivita ’ ta ’ 555- 740 MBq tipikament hija ta '8. 88– 11. 84 mSv għal individwu li jiżen 70 kg.
Based on human data, the absorbed radiation doses by individual organs of an average human adult (70 kg) from an intravenous injection of the agent are listed below.
Il- lista li ġejja tagħti d- dożi ta 'radjazzjoni assorbiti mill- organi individwali ta' bniedem adult medju (70 kg) minn injezzjoni fil- vina, skond tagħrif ibbażat fuq riċerka fil- bnedmin.
The values are listed in descending order as mGy/ MBq and assume urinary bladder emptying at 4.8 hours.
Il- valuri qegħdin f' ordni mill- ikbar sa l- iżgħar bħala mGy/ MBq u jassumu li l- borża ta 'l- urina titbattal wara 4. 8 sigħat.
6 Estimated absorbed radiation dose
Stima tad- doża tar- radjazzjoni assorbita
Target Organ Kidneys Spleen Testes Thyroid gland Bone marrow Liver Bone surface Heart wall Lungs Adrenal glands Pancreas Urinary bladder Uterus Small intestine Upper large intestine Ovaries Lower large intestine
Organu Kliewi Milsa Testikoli Glandola tat- tirojde Mudullun Fwied Il- wiċċ l- għadam Il- ħajt tal- qalb Pulmuni Glandoli adrenali Frixa Bużżieqa ta 'l- urina Utru Musrana ż- żgħira Il- parti ta ’ fuq tal- musrana l - kbira
Dose calculations were performed using the standard MIRD method (MIRD Pamphlet No.
Ovarji Il- parti ta ’ isfel tal- musrana l - kbira
1 rev., Soc.
Il- kalkulazzjonijiet tad- dożi saru skond il- metodu standard MIRD (Fuljett ta ’ l- MIRD Nru 1 rev., Soc.
The effective dose (ED) calculated in accordance with ICRP Publication 60 (Pergamon Press, 1991) gave a value of 0.016 mSv/ MBq, corresponding to 11.84 mSv after administration of 740 MBq.
Id- doża effettiva (ED) kkalkulata skond il- pubblikazzjoni ICRP 60 (Pergamon Press, 1991) tat valur ta '0. 016 mSv/ MBq, li jikkorrospondi għal 11. 84 mSv wara li jingħata 740 MBq.
Due to the short, six-hour half-life of technetium-99m, less than 0.1% of the radioactivity remains 60 hours after administration.
Minħabba li l- half life ta ’ t- technetium- 99m hija qasira - 6 sigħat, tibqa 'inqas minn 0. 1% tar - radjuattivita` 60 siegħa wara li tkun ingħatat.
After use, the container and any unused material must be disposed of as radioactive waste in accordance with local requirements.
Wara l- użu, ir- reċipjent u kull fdal tal- prodott li ma jkunx intuża jew skart li jibqa 'wara l- użu tal - prodott għandu jintrema bħala skart radjuattiv kif jitolbu l- ħtiġijiet lokali.
NeoSpect is used for preparation of technetium (99mTc) depreotide solution for injection.
NeoSpect jintuża għall- preparazzjoni ta 'technetium (99mTc) depreotide soluzzjoni għall- injezzjoni.
Sodium pertechnetate (99mTc) solution for injection (Ph. Eur) is used for reconstitution.
Għar- rikostituzzjoni jintuża sodium pertechnetate (99mTc) soluzzjoni għall- injezzjoni (Ph. Eur).
Instructions for the preparation of 99mTc-depreotide:
Istruzzjonijiet kif tipprepara 99mTc- depreotide:
The administration of radiopharmaceutical creates risks for other persons from external radiation or contamination from spills of urine, vomiting etc.
It- teħid ta 'radjufarmaċewtiku joħloq riskji għal persuni oħra minħabba radjazzjoni esterna jew kontaminazzjoni minn tixrid ta' urina, remettar eċċ.
Local regulations for radioactive materials must be applied in the radiation protection precautions and waste disposal.
Iridu jiġu applikati r- regolamenti lokali biex jittieħdu l- prekawzjonijiet meħtieġa għall- protezzjoni mir- radjazzjoni u r- rimi ta 'l- iskart.
Use aseptic technique throughout.
7 Uża teknika asettika f' kull ħin.
The user should wear waterproof gloves and use shielding at all times when handling the reconstituted vial or syringes containing the radioactive agent.
Min juża l- prodott għandu jilbes ingwanti li ma jħallux l- ilma jgħaddi, u jridu dejjem jilbsu l- protezzjoni meta jkunu qed iżommu fjala rikostitwita jew siringi li fihom aġent radjuattiv.
The activity of 99mTc-depreotide administered to the patient should be measured using a suitably calibrated dose calibrator immediately prior to administration to the patient.
L- attivita` ta '99mTc- depreotide li jingħata lill- pazjent għandha titkejjel bi strument li jkejjel id- doża u li jkun kalibrat kif suppost eżatt qabel ma jingħata lill- pazjent.
Prepare a boiling water bath containing a lead vial shield standing in and equilibrated with the boiling water bath.
Ipprepara banju bl- ilma jagħli u li fih kontenitur protettiv taċ- ċomb għall- fjala, li jkun wieqaf fil - banju u ekwilibrat ma 'l- ilma jagħli.
Allow the vial kit to warm to 15 °C - 30 °C and place it in a suitable shielding container and sanitise the rubber septum with sanitising alcohol swab.
Ħalli s- sett tal- fjala jisħon sa bejn 15 °C u 30 °C u poġġih f' kontenitur protettiv xieraq u ssanitizza s- septum tal- gomma b’ biċċa mxarrba bl- alkoħol.
Using a shielded syringe, inject the required radioactivity of up to 1.8 GBq of sodium pertechnetate (99mTc) solution for injection, (diluted as appropriate with sodium chloride 0.9% w/ v solution for injection to a total of 1 ml) into the shielded vial.
Bis- siringa protetta, injetta fi fjala protetta r- radjuattivita` li hemm bżonn sa 1. 8 GBq ta 'sodium pertechnetate (99mTc) soluzzjoni għall- injezzjoni (dilwit skond kif hemm bżonn b’ 0. 9% w/ v sodium chloride soluzzjoni għall- injezzjoni biex ikollok total ta' 1 ml).
See Cautionary notes 1 and 2 7 below.
Ara n- noti ta 'kawtela 1 u 2 iktar' l isfel.
Before removing the syringe from the vial, withdraw a volume of gas from above the solution equal to the volume of pertechnetate added in order to normalise the pressure inside the vial.
Qabel ma tneħħi s- siringa mill- fjala, iġbed volum ta 'gass minn fuq is- soluzzjoni daqs il- volum tal - pertechnetate li ġie miżjud biex il- pressjoni fil- fjala tiġi normalizzata.
Swirl gently for 10 seconds in order to ensure complete dissolution of the powder.
Ħarrek il- fjala bil- mod f' ċirku għal 10 minuti biex tkun ċert li t- trab ikun dab għal kollox.
Immediately transfer the reaction vial to a lead safe in the boiling water bath, maintaining the vial in the upright position.
Eżatt wara, poġġi l- fjala fil- kontenitur taċ- ċomb fil- banju bl- ilma jagħli, filwaqt li żżomm il- fjala wieqfa.
Incubate for 10 minutes in this condition.
Ħalliha fis- sħana għal 10 minuti f' din il- qagħda.
Allow the vial to cool to body temperature (about 15 minutes) at room temperature before proceeding.
Ħalli l- fjala tiksaħ sakemm tasal sat - temperatura tal- ġisem (xi 15- il minuta) fit- temperatura tal- kamra qabel ma tkompli.
The vial should not be cooled under running water, as this may impede labelling.
Il- fjala m' għandhiex titkessaħ fl- ilma ġieri, billi dan jista 'jxekkel il- tikkettar.
Assay the total radioactivity, complete the user radiation label and attach it to the lead shielded vial.
Kejjel kemm hemm radjuattivita`, imla 't- tikketta dwar ir- radjazzjoni u waħħalha mal- fjala bil - protezzjoni taċ- ċomb.
Parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit: visually inspect the reconstituted solution at a safe distance through leaded glass.
Ħares sewwa lejn is- soluzzjoni minn distanza ta 'sigurezza minn ġo ħġieġ biċ- ċomb.
Do not use if the solution is not clear or if it contains visible particulate matter.
Tużax is- soluzzjoni jekk mhix transparenti jew jekk fiha xi frak.
Store the reconstituted solution for injection upright at 15 °C – 25 °C and use within 5 hours of preparation.
Aħżen is- soluzzjoni rikostitwita għall- injezzjoni f’ qagħda wieqfa f' temperatura ta 'bejn il- 15 °C u l- 25 °C u uża fi żmien 5 sigħatminn mindu tkun ippreparajtha.
Cautionary notes
Noti ta 'Kawtela
The volume of diluted sodium pertechnetate (99mTc) solution for injection, added to the vial must be 1 ml.
Il- volum ta 'sodium pertechnetate (99mTc) dilwit bħala soluzzjoni għall- injezzjoni, miżjud fil- fjala għandu jkun ta' 1 ml.
The radioactive amount of the diluted generator eluate must not exceed 1.8 GBq when it is added to the vial.
L- ammont radjuattiv tal- likwidu dilwit m' għandux jaqbeż il- 1. 8 GBq meta jkun miżjud fil- fjala.
The amount of radioactivity is calculated according to the planned time of injection to the patient, to obtain a single patient dose of 555 – 740 MBq from the entire reconstituted vial.
L - ammont ta 'radjuattivita` huwa kkalkulat skond il- ħin ippjanat għall- injezzjoni lill- pazjent, biex ikollok doża waħda għall- pazjent ta' 555 – 740 MBq mill- fjala kollha rikostitwita.
Safety and effectiveness of 99mTc-depreotide were established using investigational material shown to have a radiochemical purity of at least 90% by ITLC prior to administration to patients in clinical studies.
Is- sigurta` u l- effett ta '99mTc- depreotide kienu stabbiliti bl- użu ta' materjal investigattiv li ntwera li kellu safa radjukimika ta 'mill- inqas 90% bl- ITLC qabel ma ngħata lill- pazjenti fi studji kliniċi.
The contents of the NeoSpect vial are not radioactive; however, after the addition of sodium pertechnetate (99mTc) solution for injection, adequate shielding of the final preparation must be maintained.
Il- kontenut tal- fjala tan- NeoSpect mhux radjuattiv; madankollu, wara ż- żieda tas - soluzzjoni għall - injezzjoni ta ’ sodium pertechnetate (99mTc), trid tinżamm il- protezzjoni madwar il- prodott finali.
The labelling reaction involved in the preparation of 99mTc-depreotide depends upon maintaining tin in the divalent (reduced) state.
Ir- reazzjoni fit- tikkettar li hu nvolut fil- preparazzjoni ta ’ 99mTc- depreotide tiddependi fuq li tin jinżam fl- istat divalenti (imnaqqas).
Any oxidant present in the sodium pertechnetate (99mTc) solution for injection might adversely affect the quality of the preparation.
Kull ossidant preżenti fis- sodium pertechnetate (99mTc) soluzzjoni għall- injezzjoni jista 'jaffettwa b' mod negattiv il- kwalita` tal- preparazzjoni.
Sodium pertechnetate (99mTc) solution for injection containing oxidants ought not to be used for the preparation of the labelled product.
Is - soluzzjoni għall- injezzjoni ta ’ sodium pertechnetate (99mTc) li jkun fiha ossidanti m' għandhomx jintużaw għall- preparazzjoni tal- prodotti li ġew tikkettati.
Sodium chloride 0.9% w/ v solution for injection must be used as the diluent.
Is- soluzzjoni għall- injezzjoni ta ’ 0. 9% w/ v sodium chloride trid tintużaw bħala dilwent.
Do not use bacteriostatic sodium chloride solution for injection as a diluent for pertechnetate, because it might adversely affect the radiochemical purity and, hence, the biological distribution of the tracer.
Tużax soluzzjoni għall- injezzjoni ta ’ sodium chloride batterjostatiku bħala dilwent għall - pertechnetate, għax jista 'jaffettwa b’ mod negattiv is- safa radjukimika u, għalhekk, id- distribuzzjoni bijoloġika tas- sustanza li qed tintraċċa.
The contents of the NeoSpect vial are sterile.
Il- kontenuti tal- fjala tan- NeoSpect huma sterili.
The vial contains no bacteriostatic preservative.
Il- fjala ma fihiex preservattivi batterjostatiċi.
It is essential that the user follows the directions carefully and adheres to aseptic procedures during the preparation of the radiopharmaceutical.
Huwa essenzjali li min jużah isegwi l- istruzzjonijiet b’ attenzjoni u jżomm mal- proċeduri asettiċi waqt il- preparazzjoni tal- prodott radjufarmaċewtiku.
Quality control
8 Kontroll tal- kwalita`
An assay of the radiochemical purity of the prepared injection can be performed using the following chromatographic procedures.
L- ittestjar tas- safa radjukimika ta 'l- injezzjoni ppreparata tista' ssir skond dawn il- proċeduri kromatografiċi.
Equipment and Materials 1.
Tagħmir u Materjali 1.
Two Gelman ITLC-SG strips (2 cm x 10 cm) 2.
Żewġ strixxi Gelman ITLC- SG (2 ċm x 10 ċm) 2.
Two developing tanks and covers 3.
Żewġ tankijiet u għotjien għall- iżvilupp 3.
Saturated sodium chloride solution (SSCS)1 (1 See section 1.) below) 4.
Soluzzjoni saturata ta ’ sodium chloride (SSCS) 1 (1 Ara taqsima 1.) hawn isfel) 4.
1:1 (v/ v) methanol / 1M ammonium acetate (MAM)2 (2 See section 2.) below) 5.
1: 1 (v/ v) methanol / 1M ammonium acetate (MAM) 2 (2 Ara taqsima 2.) hawn isfel) 5.
One 1 ml syringe and 21-gauge needle 6.
Siringa tal- 1 ml u labra tat- tip 21 6.
Suitable counting equipment
Apparat xieraq għall- għadd
8 1) Saturated sodium chloride solution (SSCS) May be prepared by adding about five grams of sodium chloride to the bottom of one chromatography chamber; add approximately 10 millilitres of distilled water to the solid sodium chloride and shake periodically during 10 to 15 minutes.
1) Soluzzjoni saturata ta ’ sodium chloride (SSCS) Jista 'jiġi ppreparat billi żżid ħames grammi ta' sodium chloride fil- qiegħ ta 'kaxxa tal - kromatografija; żid bejn wieħed u ieħor 10 millilitri ta' ilma distillat mas- sodium chloride solidu u ħawwad perjodikament għal bejn 10 u 15- il minuta.
Solid sodium chloride should remain at the bottom of the jar; if there is no residue, add more solid sodium chloride and shake again for 10 to 15 minutes.
Sodium chloride solidu għandu jibqa 'f' qiegħ il- vażett; jekk ma jkunx hemm xi fdal, żid iktar sodium chloride u erġa' ħawwad għal bejn 10 u 15- il minuta.
Continue until a solid residue remains.
Kompli sakemm jibqa 'xi fdal solidu.
(The saturated sodium chloride solution can be reused.
(Is - soluzzjoni saturata tas - sodium chloride tista 'terġa' tintuża.
2) 1:1 Methanol / 1M Ammonium Acetate (MAM) 1M Ammonium Acetate - Add 3.9 ± 0.1 grams of solid ammonium acetate to a 50 ml volumetric flask.
Żid iktar ilma distillat jew sodium chloride skond il- bżonn meta se jintuża drabi oħra basta dejjem ikun hemm xi fdal mhux imdewweb tas- sodium chloride f' qiegħ il- kaxxa.) 2) 1: 1 Metanol / 1M Acetat ta 'l- Ammonju (MAM) 1M Ammonium Acetate - Żid 3. 9 ± 0. 1 grammi ta' ammonium acetate solidu fi flixkun volumetriku ta '50 ml.
Add approximately 15 ml of distilled water to the flask, stopper, and swirl to dissolve the solid.
Żid bejn wieħed u ieħor 15 ml ilma distillat fil- flixkun, agħlaq bit- tapp, u ħawwad biex jiddewweb is- solidu.
Add distilled water up to the 50 ml mark, mix thoroughly.
Żid ilma distillat sal- marka tal- 50 ml, u ħallat sew.
The ammonium acetate solution can be used for up to one month.
Is - soluzzjoni ta 'l- ammonium acetate tista' tintuża sa kważi xahar.
Label the solution with a one month expiration date.
Agħmel tikketta mas- soluzzjoni b' data ta 'meta jiskadi ta' xahar.
1:1 Methanol / 1M Ammonium Acetate (MAM) - Carefully mix one part methanol with one part 1M Ammonium Acetate.
1: 1 Methanol / 1M Ammonium Acetate (MAM) - Ħallat b' attenzjonji parti waħda tal- methanol ma 'parti waħda ta' 1M Ammonium Acetate.
The MAM should be prepared fresh daily.
Il- MAM għandu jiġi ppreparat frisk kuljum.
METHOD
METODU
Pour the MAM and SSCS into separate developing tanks to a depth of approximately 0.5 cm.
Ferra l- MAM u s- SSCS f' tankiiet ta 'l- iżvilupp separati għal fond ta' bejn wieħed u ieħor 0. 5 ċm.
Cover the tanks and allow to equilibrate with the solvent vapours.
Agħlaq it- tankijiet u ħallihom ħalli jkun hemm ekwilibrazzjoni mal- fwawar tas- solventi.
Mark two Gelman ITLC-SG strips with a light pencil at 1 cm from the bottoms of each.
Agħmel marka fuq żewġ strixxi Gelman ITLC- SG b' lapes ħafif ċm 1 mill- qiegħ ta 'kull waħda.
Spot one drop (approximately 5-10 microlitres) of 99mTc-depreotide at the origin of each strip using the hypodermic needle.
B' labra ipodermika qattar taqtira waħda (bejn wieħed u ieħor 5- 10 mikrolitri) ta '99mTc- depreotide fil- bidu ta' kull strixxa.
Do not allow the spots to dry.
Tħallix li l- qtar jinxfu.
Do not allow the needle to touch the strip.
Tħallix il- labra tmiss ma 'l- istrixxa.
Place the developing tanks behind a lead shield.
Poġġi t- tankijiet ta 'l- iżvilupp wara protezzjoni taċ- ċomb.
Place one ITLC-SG strip in the MAM developing solvent.
Poġġi strixxa waħda ITLC- SG fis- solvent ta 'l- iżvilupp MAM.
Place the second ITLC-SG strip in the SSCS developing solvent.
Poġġi t- tieni strixxa ITLC- SG fis - solvent ta 'l- iżvilupp SSCS.
Place the strips upright in the respective developing solvent such that the spot is above the solvent line and the top of each strip leans against the side of the tank.
Poġġi l- istrixxi weqfin fis- solvent ta 'l- iżvilupp rispettiv b' tali mod li l - qatra tkun' il fuq mil- linja tas- solvent u t- tarf ta 'fuq taż- żewġ strixxi jserraħ mal- ġenb tat- tank.
Do not allow the sides of the strip to contact the side of the tank.
Tħallix il- ġnub ta 'l- istrixxi jmissu mal- ġnub tat- tank.
Cap the developing tanks.
Għatti t- tankijiet ta 'l - iżvilupp b' għatu.
Allow the solvent front to move to the top of the strip.
Ħalli li l- front tas- solvent jitla 'sal- quċċata ta' l- istrixxa.
Remove the strip from the tank and allow the strip to dry behind a lead shield.
Oħroġ l- istrixxa mit- tank u ħalli l- istrixxa tinxef wara protezzjoni taċ- ċomb.
Cut the strips as described below:
Aqta 'l- istrixxi kif spjegat hawn taħt:
ITLC-SG MAM: cut the strip at Rf 0.40 (40% of the distance from the origin to the solvent front).
ITLC- SG MAM: aqta 'l- istrixxa f' RF 0. 40 (40% tad- distanza mill- oriġini sal- front tas- solvent).
Count each strip section in a dose calibrator and interpret the results as follows:
Għodd kull taqsima ta 'l- istrixxa f' kalibratur tad- doża u interpreta r- riżultati kif ġej:
Percent technetium-99m non-mobile material = A
Persentaġġ ta 'materjal mhux mobbli ta' technetium- 99m = A
Radioactivity in bottom piece of ITLC-SG MAM strip (Rf 0-0.40) A = 100 x ---------------------------------------------------------------------------------- Total radioactivity in both pieces of ITLC-SG MAM strip
Radjuattivita` fil- biċċa t' isfel ta 'l- istrixxa ITLC- SG MAM (Rf 0- 0. 40) A = 100 x
Percent technetium (99mTc) pertechnetate, technetium-99m labelled glucoheptonate and technetium-99m labelled edetate = B
Persentaġġ tat - technetium (99mTc) pertechnetate, glucoheptonate tikkettat b' technetium- 99m u edetate tikkettat b' technetium- 99m = B
Radioactivity in top piece of ITLC-SG SSCS strip (Rf 0.75-1.0) B = 100 x ------------------------------------------------------------------------------ Total radioactivity in both pieces of ITLC-SG SSCS Strip
Radjuattivita` fil- biċċa ta 'fuq ta' l- istrixxa ITLC- SG SSCS (Rf 0. 75- 1. 0) B = 100 x
Percent 99mTc-depreotide:
Persentaġġ ta '99mTc- depreotide:
A value of at least 90% should be obtained in a satisfactory preparation.
Fi preparazzjoni sodisfaċenti jrid ikun hemm valur ta 'mill- inqas 90%.
9 Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - mediċini (EMEA) http: // www. emea. europa. eu /.
Name and address of the manufacturer responsible for batch release CIS bio international B. P.
Isem u indirizz tal- manifattur( i) responsabbli għall- hruġ tal- lott CIS bio international B. P.
32 91192 GIF sur YVETTE cedex FRANCE
32 91192 GIF sur Yvette cedex FRANZA
LABELLING
13 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
NeoSpect 47 micrograms, kit for radiopharmaceutical preparation
NeoSpect 47 mikrogramma, sett għall- preparazzjoni radjufarmaċewtika
Each vial contains:
Kull fjala fiha:
47 micrograms depreotide as depreotide trifluoroacetate
47 mikrogramma depreotide bħala depreotide trifluoroacetate
Sodium α -D-glucoheptonate dihydrate, stannous chloride dihydrate, disodium edetate, hydrochloric acid and/ or sodium hydroxide q. s.
Sodium α -- D- glucoheptonate dihydrate, stannous chloride dihydrate, disodium edetate, hydrochloric acid u/ jew sodium hydroxide q. s.
1 vial 5 vials
Kunjett 1 5 kunjetti
Diagnostic agent for scintigraphic imaging.
Sustanza dijanjostika għal ritratti xintigrafiċi.
Reconstitute with sodium pertechnetate (99mTc) injection.
Irrikostitwixxi b' injezzjoni ta 'sodium pertechnetate (99mTc).
Intravenous use.
Għall- użu fil- vina.
After use, dispose of as radioactive waste.
Wara l- użu, armi bħala skart radjuattiv.
MARKETING AUTHORISATION NUMBERS
NUMRU( I) TA ’ L - AWTORIZZAZZJONI GĦALT- TQEGĦID FIS- SUQ
EU/ 1/ 00/ 154/ 001 1 vial EU/ 1/ 00/ 154/ 002 5 vials
EU/ 1/ 00/ 154/ 001 Kunjett 1 EU/ 1/ 00/ 154/ 002 5 kunjetti
NeoSpect 47 micrograms, kit for radiopharmaceutical preparation Depreotide Intravenous use
NeoSpect 47 mikrogramma, sett għall- preparazzjoni radjufarmaċewtika
Reconstitute with sodium pertechnetate (99mTc) injection
Irrikostitwixxi b' injezzjoni ta ’ sodium pertechnetate (99mTc)
EXP:
< JIS:
99m Tc NeoSpect
Tikketta li trid titwaħħal wara r- rikostituzzjoni 99m Tc NeoSpect
MBq ml hour/ date 99m Tc
MBq ml siegħa/ data 99m Tc
PACKAGE LEAFLET
17 FULJETT TA ’ TAGĦRIF:
NeoSpect 47 micrograms.
NeoSpect 47 mikrogramma.
Kit for radiopharmaceutical preparation Depreotide
Sett għall- preparazzjoni radjufarmaċewtika Depreotide
Please read this leaflet carefully.
Aqra dan il- fuljett kollu qabel tibda tieħu din il- mediċina.
It tells you about your medicine.
Ser jgħidlek dwar il- mediċina tiegħek.
2.
X’ inhu NeoSpect u għalxiex jintuża 2.
3.
Qabel ma tuża NeoSpect 3.
4.
Kif għandek tuża NeoSpect 4.
6.
Kif taħżen NeoSpect 6.
WHAT NeoSpect IS AND WHAT IT IS USED FOR
X’ INHU NeoSpect U GĦALXIEX JINTUŻA
Product type NeoSpect is a radiopharmaceutical product used for diagnostic purposes.
NeoSpect huwa prodott radjufarmaċewtiku li jintuża għal użu dijanjostiku.
A diagnostic radiopharmaceutical is a product which, when injected, temporarily collects in a particular part of the body (for example a tumour).
Prodott dijanjostiku radjufarmaċewtiku huwa prodott li, meta jkun injettat, jinġabar temporanjament f' parti partikolari tal - ġisem (ngħidu aħna f’ tumur).
Because the substance contains a small amount of radioactivity it can be detected from outside the body using special cameras, and a picture, known as a scan, can be taken.
Billi s- sustanza fiha ammont żgħir ta 'radjuattivita` tista' tiġi ntraċċata minn barra l- ġisem bl- użu ta 'kameras speċjali, u jista' jittieħed ritratt, li jissejjaħ skan.
This scan will show exactly the distribution of the radioactivity within the body.
Dan l- iskan juri eżatt kif ir- radjuattivita` tkun mifruxa fil- ġisem.
This can give the doctor valuable information such as the location of a tumour.
Dan jista 'jagħti lit- tabib tagħrif prezzjuż bħal m' hu fejn qiegħed tumur.
What NeoSpect is used for NeoSpect is for diagnostic use only.
NeoSpect huwa għal użu dijanjostiku biss.
NeoSpect is used to provide pictures which show the location of suspected malignant cancer tissue (a tumour) in the lung.
Neospect jintuża biex jipprovdi ritratti li juru fejn qiegħed dak li jista 'jkun it- tessut ta' kancer malinn (tumur) fil- pulmun.
When injected, the radiolabelled compound binds to malignant cancer tissue.
Meta tiġi njettata, is- sustanza radjutikkettata teħel mat- tessut tal- kanċer malinn.
Your doctor will then take a picture (scan) of your lungs using a special camera.
Imbagħad it- tabib tiegħek jieħu ritratt (skan) tal - pulmuni tiegħek b' kamera speċjali.
The area where the radioactive compound is collected, will light up on the picture and give information on the location of the tumour.
Il- parti fejn tinġabar is- sustanza radjutikkettata tjoħroġ ċar fir - ritratt u dan jagħti informazzjoni dwar fejn qiegħed it- tumur.
The evaluation also includes examinations by CT-scan or chest X-ray.
L- evalwazzjoni tinkludi wkoll l- eżamijiet bl- iskan- CTu bir- raġġi- X tas- sider.
BEFORE YOU USE NeoSpect
QABEL MA TUŻA NeoSpect
Do not use NeoSpect
Tieħux NeoSpect
- if you are allergic (hypersensitive) to depreotide or any of the other ingredients of NeoSpect or
- jekk tbati minn reazzjoni allerġika għas- sustanza attiva jew sustanzi oħra f' NeoSpect jew għal
to the radioactive technetium.
technetium radjuattiv.
- if there is any possibility that you are pregnant.
- Jekk hemm possibilta` li int tqila.
- if you are breast-feeding.
- Jekk qed tredda '
Take special care with NeoSpect
Oqgħod attent ħafna b’ NeoSpect
- if you are suffering from diabetes or other related conditions
- jekk tbati bid- dijabete jew kondizzjonijiet relatati
- if you have a renal disease
- jekk tbati minn mard fil- kliewi
- if you have a liver disease
- jekk tbati minn mard fil- fwied
If any of the above mentioned conditions are applicable to you, you should inform your doctor.
18 Jekk tbati minn wieħed minn dawn il- kondizzjonijiet, għandek tinforma lit- tabib.
NeoSpect is not recommended for use in children under 18 years of age, as data are not available for this age group.
NeoSpect mhux rakkomandat għall- użu mit- tfal ta 'taħt it- 18- il sena, billi m’ hemmx tagħrif għal pazjenti ta ’ din l- eta`.
19 The use of NeoSpect does involve exposure to small amounts of radioactivity, however your doctor will always consider the possible risks and benefits when considering the use of this product.
L- użu ta 'NeoSpect jinvolvi espożizzjoni għal ammonti żgħar ta' radjuattivita`, madankollu t- tabib tiegħek dejjem se jikkonsidra r- riskji possibbli u l- benefiċċji meta jkun qed jikkonsidra l- użu ta 'dan il - prodott.