qanastek/EMEA-V3 huggingface dataset:
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il- Mediċini (EMEA) http: // www. emea. europa. eu /
144 HYPERGLYCAEMIA AND HYPOGLYCAEMIA
IPERGLIĊEMIJA U IPOGLIĊEMIJA
- you have not injected your insulin or not injected enough, or if it has become less effective,for
- int ma injettajtx l- insulina tiegħek jew ma injettajtx biżżejjed, jew jekk saret anqas effettiva, per
- you r insulin pen does not work properly,
eżempju minħabba ħażna ħażina,
- you lose carbohydrates due to vomiting or diarrhoea,
- int qed titlef il- karboidrati dovut minħabba remettar jew dijarea,
145 Hypoglycaemia is also more likely to occur if
L- ipogliċemija hija wkoll aktar probabbli li sseħħ jekk:
- you have just begun insulin treatment or changed to ano ther insulin preparation (when changing
- int għadek tibda t- trattament bl- insulina jew qlibt għal preparat ieħor ta ’ insulina, (meta tbiddel mill -
arm),
- 142 -
Examples of symptoms that tell you that your blood sugar level is falling too much or too fast: sweating, clammy skin, anxiety, fast heart beat, high blood pressure, palpitations and irregular heartbeat,.
Eżempji ta ’ sintomi li juruk li l- livell taz- zokkor fid- demm tiegħek qed jaqa ’ wisq, jew qiegħed jinżel wisq malajr: għaraq żejjed, ġilda twaħħal, l- ansjetà, il- qalb tħabbat mgħaġġla, pressjoni għolja tad- demm, palpitazzjonijiet u l- qalb tħabbat b’ mod irregolari.
The se symptoms often develop before the symptoms of a low sugar level in the brain.
Dawn is- sintomi ta ’ spiss jiżviluppaw qabel is- sintomi dovuti għal livell baxx taz- zokkor fil- moħħ.
If necessary, more frequent blood sugar testing can help to identify mild hypoglycaemic episodes that might otherwise be overlooked.
Jekk hemm bżonn, it- testijiet aktar spissi għaz- zokkor fid- demm jistgħu jgħinuk biex tintebaħ bi ġrajjiet ta ’ l- ipogliċemija ħafifa li altrimenti jista ’ jkun ma kontx tinduna bihom.
146 What should you do if you experience hypoglycaemia?
X’ għandek tagħmel f’ każ ta ’ ipogliċemija?
SoloStar.
LANTUS soluzzjoni għall- injezzjoni f’ pinna mimlija għal- lest, SoloStar.
INSTRUCTIONS FOR USE
STRUZZJONIJIET DWAR L- UŻU
If you are not able to follow all the instructions completely on your own, use SoloStar only if you have help from a person who is able to follow the instructions.
Jekk m’ intix kapaċi issegwi l - istruzzjonijiet kollha waħdek, uża SoloStar biss jekk issib għajnuna minn persuna oħra li tista ’ ssegwi l - istruzzjonijiet.
SoloStar is a disposable pen for the injection of insulin.
SoloStar hija pinna għall- injezzjoni ta ’ l- insulina, li tintrema wara li tinħela.
Only use needles that are compatible for use with SoloStar. • Always perform the safety test before each injection. • This pen is only for your use.
Uża biss labar li huma kompatibbli ma ’ l- użu ta ’ SoloStar. • Dejjem agħmel test ta ’ sigurtà qabel kull injezzjoni. • Din il- pinna hija għall- użu tiegħek biss.
Do not share it with anyone else. • If your injection is given by another person, special caution must be taken by this person to avoid accidental needle injury and transmission of infection. • Never use SoloStar if it is damaged or if you are not sure that it is working properly. • Always have a spare SoloStar in case your SoloStar is lost or damaged.
Taqsamhiex ma ’ ħaddieħor. • Jekk l- injezzjoni tiegħek tingħata minn persuna oħra, għandha tittieħed attenzjoni speċjali minn din il - persuna biex tevita li tweġġa ’ aċċidentalment bil- labra u titrasmetti xi infezzjoni. • Qatt m’ għandek tuża SoloStar jekk tkun bil- ħsara jew jekk m’ intix ċert li qed taħdem sew. • Dejjem żomm SoloStar żejda f’ każ li s- SoloStar tiegħek tintilef jew jiġrilha l- ħsara.
Check the label on your SoloStar to make sure you have the correct insulin.
Iċċekkja t- tikketta tas- SoloStar tiegħek biex tiżgura ruħek li għandek l- insulina korretta.
The Lantus Solostar is grey with a purple injection button.
Lantus SoloStar hija ta ’ kulur griż bil- buttun ta ’ l- injezzjoni ta ’ kulur vjola.
Lantus is a clear insulin.
Lantus hija insulina ċara.
Do not use this SoloStar if the insulin is cloudy, coloured or has particles.
Tużax din is- SoloStar jekk l- insulina hija mdardra, ikkulurita jew għandha xi partikuli.
Always use a new sterile needle for each injection.
ġdida għal- kull injezzjoni.
This helps prevent contamination, and potential needle blocks.
Dan jgħin biex telimina l- kontaminazzjoni, tnaqqas ir -
• If the needle is not kept straight while you attach it, it can damage the rubber seal and cause leakage, or break the needle.
• Jekk il- labra ma tinżammx dritta waqt li qed tqabbadha, din tista ’ tagħmel ħsara l- woxer tal- lastku, u bħala riżultat ta ’ dan, il- pinna tibda tqattar, jew il- labra tinkiser.
Perform a Safety test
Tagħmel test ta ’ sigurtà
Select a dose of 2 units by turning the dosage selector.
Agħżel doża ta ’ żewġ unitajiet billi ddawwar is- selettur tad- dożaġġ.
Take off the outer needle cap and keep it to remove the used needle after injection.
Neħħi l- kappa ta ’ barra tal- labra u żommha biex tkun tista ’ tneħħi l- labra użata biha, wara l- injezzjoni.
149 You may have to perform the safety test several times before insulin is seen.
- 145 -
If you turn past your dose, you can turn back down.
Jekk tiskorri d- doża B. tiegħek waqt li qed iddawwar, tista ’ terġa tiġi lura.
• Do not push the injection button while turning, as insulin will come out.
• Timbuttax il- buttun ta ’ l- injezzjoni waqt li qed iddawwar, għax inkella l- insulina toħroġ.
In this case, either you can inject what is remaining in the pen and complete your dose with a new SoloStar or use a new SoloStar for your full dose.
F’ dan il- każ, jew tista ’ tinjetta dak li fadal fil- pinna u tkompli bid- doża tiegħek b’ pinna ġdida SoloStar, jew tuża SoloStar ġdida għad- doża sħiha.
Use the injection method as instructed by your healthcare professional.
Uża l- metodu ta ’
150 C.
Ċ.
Slowly count to 10 before you withdraw the needle from the skin.
10 sek
This helps prevent: • Contamination and/or infection, • Entry of air into the insulin reservoir and leakage of insulin, which can cause inaccurate dosing.
• Il- kontaminazzjoni u/ jew l- infezzjoni • Id- dħul ta ’ l- arja fir- riżervwar ta ’ l- insulina u li l- insulina tqattar mill- pinna, li jistgħu jikkawżaw dożaġġ ineżatt.
To reduce the risk of accidental needle injury, never replace the inner needle cap. • If your injection is given by another person, special caution must be taken by this person when removing and disposing the needle.
• Jekk l- injezzjoni tiegħek ser tingħata minn persuna oħra, għandha tittieħed attenzjoni speċjali minn din il- persuna waqt li tneħħi u tarmi l- labra.
Follow recommended safety measures for removal and disposal of needles (e.g. a one handed capping technique) in order to reduce the risk of accidental needle injury and transmission of infectious diseases.
Segwi l- miżuri irrakkomandati ta’ sigurtà għat- tneħħija u r - rimi tal- labar (e. g. tintuża id waħda biex tpoġġi l- kappa lura fuq il- labra) biex b’ hekk jonqos ir- riskju li wieħed iweġġa ’ aċċidentalment bil- labra u jkun trasmess xi mard infettiv.
If you are concerned that your SoloStar may be damaged, use a new one.
Jekk int qed tinkwieta li s- SoloStar tiegħek seta ’ ġralha xi ħsara, armiha u uża waħda ġdida.
151
- 147 -
It explains how the Committee for Medicinal products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
Huwa jispjega kif il- Kumitat għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ivvaluta l- istudji mwettqin, biex jilħaq ir- rakkomandazzjonijiet tagħhom dwar kif tintuża l- mediċina.
What is LeukoScan?
X’ inhu LeukoScan?
LeukoScan is a vial containing a powder to be made into a solution for injection.
LeukoScan huwa kunjett li fih trab sabiex isir soluzzjoni għall- injezzjoni.
The powder contains the active substance sulesomab.
It- trab fih is- sustanza attiva sulesomab.
What is LeukoScan used for?
Għal x’ hiex jintuża LeukoScan?
LeukoScan is not used on its own, but must be radiolabelled before use.
LeukoScan ma jintużax waħdu, iżda għandu jiġi radjutikkettat qabel l- użu.
Radiolabelling is a technique where a substance is tagged (labelled) with a radioactive compound.
Ir- radjutikkettar huwa teknika fejn sustanza tiġi tagged (ittikkettata) b’ kompost radjuattiv.
LeukoScan is radiolabelled by mixing it with a solution of radioactive technetium (99mTc).
LeukoScan huwa radjutikkettat billi jiġi mħallat ma ’ soluzzjoni ta ’ techmetium radjuattiv (99mTc).
This radiolabelled medicine is for diagnostic use.
Din il- mediċina radjutikkettata hija għal użu djanjostiku.
LeukoScan is used to find the site and extent of infection or inflammation in patients with suspected osteomyelitis (bone infection), including patients with diabetic foot ulcers.
LeukoScan jintuża biex jinstab is- sit u l - ammont ta ’ infezzjoni jew infjammazzjoni f’ pazjenti b’ suspett ta ’ osteomyelitis (infezzjoni fl - għadam), inkluż pazjenti b’ ulċeri tas- saqajn ikkawżati minn dijabete.
How is LeukoScan used?
Kif jintuża LeukoScan?
Radiolabelled LeukoScan treatment should only be handled and given by someone who is authorised to use radioactive medicines.
It- trattament b’ LeukoScan radjutikkettat jista ’ jiġi ġestit u mogħti minn xi ħadd li huwa awtorizzat li juża mediċini radjuattivi.
The radiolabelled solution is given as an intravenous injection, and a scintigraphy is carried out 1 to 8 hours later.
Is- soluzzjoni radjutikkettata hija mogħtija bħala injezzjoni mill- vina, u mbagħad issir sintigrafija minn 1 sa 8 sigħat wara.
Scintigraphy is a scanning method that uses a special camera (gamma camera) that can detect radioactivity.
Sintigrafija hija metodu ta ’ scanning li juża kamera speċjali (kamera gamma) li tista ’ tikxef ir- radjuattività.
Because LeukoScan has not been studied in patients aged 21 years or younger, doctors should carefully weigh the benefits and the risks of its use before administering it to a patient in this age group.
Peress li LeukoScan ma ġiex studjat f’ pazjenti ta ’ 21 sena jew inqas, it- tobba għandhom jgħarblu b’ attenzjoni l- benefiċċji u r- riskji ta ’ l- użu tiegħu qabel jagħtuh lil pazjent f’ dan il- grupp ta ’ età.
How does LeukoScan work?
Kif jaħdem LeukoScan?
The active substance in LeukoScan, sulesomab, is a monoclonal antibody.
Is- sustanza attiva f’ LeukoScan, suleomab, hija anti- korp monoklonali.
A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and bind to a specific structure (called an antigen) that is found in certain cells in the body.
Anti- korp monoklonali huwa anti- korp (tip ta ’ proteina) li kien iddisinjat biex jagħraf u jeħel ma ’ struttura speċifika (magħrufa bħala antiġen) li tinsab f’ ċerti ċelluli tal- ġisem.
Sulesomab has been designed to target an antigen called NCA90, which is present on the surface of granulocytes (a type of white blood cell).
Sulesomab ġie iddisinjat biex jimmira antiġen magħruf bħala NCA90, li huwa preżenti fil- wiċċ ta ’ granuloċiti (tip ta ’ ċellula tad- demm bajda).
When LeukoScan is radiolabelled, the radioactive compound technetium-99 (99mTc) becomes attached to sulesomab.
Meta LeukoScan ikun radjutikkettat, il- kompost radjuattiv technetium- 99 (99mTc) jeħel ma ’ sulesomab.
When the radiolabelled medicine is injected into the patient, the monoclonal antibody carries the radioactivity to the target antigen on the granulocytes.
Meta l- mediċina radjutikkettata tiġi injettata fil- pazjent, l- antikorp monoklonali jġorr ir- radjuattività għall - antiġen fil- mira fuq il- granuloċiti.
As large numbers of granulocytes gather at the site of an infection, the radioactivity will accumulate where there is an infection, and it can be detected using special scanning techniques, such as scintigraphy or SPECT (single photon emission computed tomography).
Hekk kif numru kbir ta ’ granuloċiti jinġabru fis- sit ta ’ injezzjoni, ir - radjuattività takkumula fejn ikun hemm infezzjoni u din tista ’ tinkixef bl- użu ta ’ tekniki speċjali ta ’ scanning, bħal sintigrafija jew SPECT (single photon emission computed tomography).
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has LeukoScan 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 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kif ġie studjat LeukoScan?
LeukoScan has been studied in two main studies.
LeukoScan ġie studjat f’ żewġ studji prinċipali.
The first investigated LeukoScan in the detection of osteomyelitis in 102 patients with diabetic foot ulcers.
L- ewwel investiga LeukoScan fil- kxif ta ’ osteomyelitis f’ 102 pazjenti b’ ulċeri tas- saqjn dijabetiċi.
The second study investigated LeukoScan in 130 patients with suspected long bone osteomyelitis.
It- tieni studju investiga LeukoScan f’ 130 pazjent b’ long bone osteomyelitis suspettata.
Among these 232 patients, 158 had also undergone a scan using a standard scintigraphy technique (when the patient receives a specially prepared injection of their own white blood cells radiolabelled with a suitable radioactive marker).
Fost dawn il- 232 pazjent, 158 għamlu wkoll scan bl- użu ta ’ teknika sintigrafika standard (meta l- pazjent jirċievi injezzjoni preparata b’ mod speċjali għaċ- ċelluli tad- demm bojod tagħhom stess radjutikkettati b’ marker radjuattiv xieraq).
The main measure of effectiveness was the comparison of the diagnosis made using LeukoScan imaging with the diagnosis from bone biopsy histopathology and microbial culture (when a bone sample is taken and grown in a laboratory to see if it is carrying an infection).
Il- kejl prinċipali ta ’ effikaċja kien it - tqabbil tad- djanjosi magħmula bl- użu ta ’ l- imaging ta ’ LeukoScan bid- djanjosi mill- istopatoloġija ta ’ bijopsija ta ’ l- għadam u l- kultura mikrobika (meta jittieħed kampjun ta ’ l- għadam u jitkabbar f’ laboratorju biex jiġi verfikat jekk hux qed iġorr infezzjoni).
What benefit has LeukoScan shown during the studies?
X’ benfiċċju wera LeukoScan matul dawn l- istudji?
When the results of both studies were looked at together, LeukoScan was shown to be as effective in diagnosing bone infections as the biopsy and culture technique.
Meta r- riżultati taż- żewġ studji ġew studjati flimkien, intwera li LeukoScan huwa effettiv fid- djanjosi ta ’ l- għadam daqs kemm hu effettiv fil- bijopsija u t- teknika tal- kultura.
LeukoScan was more effective than the standard technique of radiolabelled white blood cells, with a higher sensitivity (detection of 88% of the infections with LeukoScan, compared to 73% with the radiolabelled white blood cells).
Intwera li LeukoScan huwa aktar effettiv mit- teknika standard ta ’ radjuttikkettar ta ’ ċelluli bojod radjutikkettati, b’ sensittività ogħla (kxif ta ’ 88% ta ’ l- infezzjonijiet b’ LeukoScan, imqabbel ma ’ 73% ta ’ ċelluli bojod tad- demm radjutikkettati).
What is the risk associated with LeukoScan?
X’ inhu r- riskju assoċjat ma ’ LeukoScan?
Rare side effects are eosinophilia (increase in eosinophils, a type of white blood cells) and facial rash.
Effetti sekondarji rari huma eosinofilja (żieda fil- eosinofili, tip ta ’ ċelluli bojod tad- demm) u raxx tal - wiċċ.
For the full list of all side effects reported with LeukoScan, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha rrapportati ma ’ LeukoScan, ara l- Fuljett ta ’ Tagħrif.
LeukoScan should not be used in people who may be hypersensitive (allergic) to sulesomab, mouse proteins, or any of the other ingredients.
LeukoScan m’ għandux jintuża f’ persuni li jistgħu jkunu sensittivi żżejjed (allerġiċi) għal sulesomab, proteini tal- ġrieden, jew għal xi sustanza oħra.
It should not be used in pregnant women.
Huwa m’ għandux jintuża f’ nisa li jkunu qed jistennew tarbija.
Why has LeukoScan been approved?
Għalfejn ġie approvat LeukoScan?
The Committee for Medicinal products for Human Use (CHMP) decided that LeukoScan’ s benefits are greater than its risks for determining the location and extent of infection/ inflammation in bone in patients with suspected osteomyelitis, including patients with diabetic foot ulcers.
Il- Kumitat għal prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benfiċċji ta ’ LeukoScan huma akbar mir- riskji tiegħu għad- determinazzjoni tas- sit u l- firxa ta ’ l - infezzjoni/ infjammazzjoni fl- għadam f’ pazjenti b’ suspett ta ’ osteomjelite, inkluż pazjenti b’ ulċeri tas - saqajn ikkawżati minn dijabete.
They recommended that LeukoScan be given marketing authorisation.
Huma rrakkomandaw li LekoScan jingħata awtorizzazzjoni għat - tqegħid fis- suq.
Other information about LeukoScan:
Informazzjoni oħra dwar LeukoScan:
The European Commission granted a marketing authorisation valid throughout the European Union, for LeukoScan to Immunomedics GmbH on 14 February 1997.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea, għal LeukoScan għal Immunomedics GmbH fl- 14 ta ’ Frar 1997.
The marketing authorisation was renewed on 14 February 2002 and 14 February 2007.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fl- 14 ta ’ Frar 2002 u fl- 14 ta ’ Frar 2007.
The full EPAR for LeukoScan is available here.
EPAR sħiħ għal LeukoScan huwa disponibbli minn hawnhekk.
This summary was last updated in 02-2007.
Dan is- sommarju ġie aġġornat l- aħħar fi 02- 2007.
LeukoScan 0.31 mg, powder for solution for injection
Leukoscan 0. 31 mg, trab ghal soluzzjoni ghall- injezzjoni
Each 3 ml vial contains 0.31 mg sulesomab (IMMU-MN3 murine Fab′ -SH antigranulocyte monoclonal antibody fragments) for the preparation of 99mTc labelled LeukoScan.
Kull fjala fiha 0. 31 mg sulesomab (IMMU- MN3 framment ta antikorpu monoklonali antigranulocita) ghall- preparazzjoni ta ’ Leukoscan immarkat bil Tc99m.
For a full list of excipients, see section 6.1.
Din il- fjala ma fihiex il- parti radjuattiva Għal- lista kompleta ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1.
Powder for solution for injection.
Trab ghal soluzzjoni ghall- injezzjoni
LeukoScan is indicated for diagnostic imaging for determining the location and extent of infection/ inflammation in bone in patients with suspected osteomyelitis, including patients with diabetic foot ulcers.
Leukoscan jintuza biex jittiehdu ritratti biex tigi ddterminata il- post u l- estent ta ’ infezzjoni/ infjammazzjoni fl- ghadam it- twal f’ pazjenti b’ infezzjoni fl- ghadam, inkluz dawk il- pazjenti li ghandhom problemi f’ riglejhom minhabba l- mard tad- dijabete.
LeukoScan has not been employed to diagnose osteomyelitis in patients with sickle cell anaemia.
Leukoscan qatt ma ntuza ghad- dijanjosi ta ’ infezzjoni f’ pazjenti bl- anemija mediterranja.
The radiolabelled solution should be administered as an intravenous injection.
Is- soluzzjoni radjuattiva ghandha tinghata bhala injezzjoni fil- vina.
After injection, any remaining portion of the reconstituted solution should be discarded.
Wara l- injezzjoni, il- parti li ma ntuzatx ghandha tintrema ’.
LeukoScan is not recommended for use in children.
Leukoscan mhux irrakkomandat għall- użu fit- tfal
Formal studies have not been performed in patients with renal or hepatic impairment.
Ma sarux studji f’ pazjenti bi problemi fil- fwied jew fil- kliewi.
However, due to the low dose of protein administered and the short half-life of 99mTc, dosage adjustment is probably not necessary in such patients.
Ma dan kollu, minhabba il- kwantita ’ baxxa ta ’ protejina li tinghata u l- hajja qasira ta Tc99m, x’ aktarx m’ hemmx bzonn ta ’ l- ebda tibdil fid - doza..
Radiopharmaceutical agents should be used only by qualified personnel with appropriate government authorisation for the use and manipulation of radionuclides.
Il- prodotti radjuattivi ghandhom jintuzaw biss minn professjonisti li ghandhom il- licenzja tal- gvern.
2 This radiopharmaceutical may be received, used and administered only by authorised persons in designated clinical settings.
Dan il- prodott jista jigi uzat u somministrat biss minn persuni awtorizzati f’ strutturi dedikati.
Its receipt, storage, use, transfer and disposal are subject to the regulations and/ or appropriate licenses of local competent official organisations.
L- uzu, il - hazna u kull trasferiment iehor tal- prodott ghandu jsir skond ir- regoli lokali.
Immediately prior to use, contents of the vial are reconstituted in the unlabeled form to prepare LeukoScan [99mTc].
Ezatt qabel l- uzu, il- kontenut tal- fjala jigu rikonstitwiti fil- forma ta ’ Leukoscan (Tc99m).
The unreconstituted contents of the vial before radiolabelling are not to be directly administered to patients.
Il- prodott m’ ghandux jigi somministrat qabel ir- rikostitwizzjoni.
For instructions for preparation see section 6.6.
Biex tipprepara, ara sezzjopni 6. 6
For readministration see section 4.4.
Biex jinghata t- tieni darba, ara sezzjoni 4. 4
Patients with known allergies or hypersensitivity to mouse proteins.
Sensittivita ’ eccesiva ghall- protejini mehudin mill- grieden.
4.4 Special warnings and special precautions for use
2 4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu
Administration of LeukoScan to young subjects should only be performed after consideration of the possible risks and benefits to the individual subject.
Ma sarux studji fuq l- akkuratezza tal- prodott f’ pazjenti taht il- 21 sena Il- prodott ghandu jinghata lil pazjenti zghar biss wara li jigu kkunsidrati ir- riskji u l- benifficji lil pazjent
Recommended imaging protocol
Kif jittiehdu ir- ritratti
Immunoscintigraphy should be performed one to eight hours after injection.
Dawn ghandhom jittiehdu minn siegha sa tmin sieghat wara l- injezzjoni
There was essentially no difference in the detection of the presence or absence of osteomyelitis between the 1-2 hour timepoint and the 5-8 hour timepoint after injection.
Ma kien hemm l- ebda differenza bejn 1- 2 siegha u 5- 8 sieghat ghad- dijanjosi ta ’ infezzjoni.
This suggests that imaging can be accomplished anytime between one and eight hours after injection (at the convenience of the nuclear medicine department and the patient).
Wiehed ghalhekk jifhem li ir- ritratti jistghu jittiehdu bejn siegha u tmien sieghat wara l- injezzjoni (skond il - bzonnijiet tad- dipartiment tal- medicina nuklejari u tal- pazjent).
Planar imaging in all views necessary to adequately visualise the affected area at 1-8 h post-injection with at least 500 k counts or ten minutes per view should be made.
Ritratti planari huma necessjari biew jigu viswalizzati il- partijiet li qed jigu studjati u ghandhom jittiehdu mill inqas 500 elf kolp jew ghaxar minuti kul ritratt.
Image acquisition in analogue and/ or digital word-mode and at least a 128 x 128 matrix is recommended.
Matrix ta ’ 128 x 128 huwa rrakomandat
Single photon emission computed tomography (SPECT) imaging can also be conducted and may aid in differentiating osteomyelitis from soft tissue infections.
Single Photon Emission Computed Tomography (SPECT) jista ’ jsir ukoll u dan jista ’ jghin biew tiddistingwi bejn infezzjoni fl- ghadam minn dik fil- gilda.
SPECT acquisition parameters recommended are:
Ghal SPECT, dawn huma il- parametri li ghandhom jintuzaw:
60 projections in a 360o step-and-shoot technique, 30 seconds per view in at least a 64 x 64 matrix.
60 ritratt fuq 360 grad, 30 sekonda kull ritratt, matrix ta ’ 64 x 64.
Data processing by filtered backprojection and reconstruction in three planes (transaxial, coronal, and sagittal) is recommended.
Wara, jintuza filtered back projection.
Interpretation of the images
Interpretazzjoni tar- ritratti
When a bone scan is negative, imaging with LeukoScan may rarely show a positive response and this may indicate early osteomyelitis.
Meta scan tal- ghadam huwa posittiv u Leukoscan huwa negattiva, x’ aktarx illi m’ hemmx infezzjoni Meta scan tal- ghadam huwa negattive, Leukoscan kultant jista ’ jkun posittiv u dan jista ’ jkun indikazzjoni ta ’ infezzjoni bikrija.
3 Hypersensitivity
Sensittivita ’ eccessiva
Anaphylactic and other hypersensitivity reactions are possible whenever mouse protein materials are administered to patients.
Reazzjoni anafilattika hija possibli meta jintuzaw protejini tal- grieden fil- bnedmin.
Appropriate cardiopulmonary resuscitation facilities and trained personnel should be available for immediate use in the event of an adverse reaction.
Facilitajiet ghandhom ikunu mghammra ghal dawn l- eventwalitajiet.
Human Anti-mouse Antibody (HAMA)
Human Anti- mouse Antibody (HAMA)
In clinical trials involving over 350 patients, no induction of human anti-mouse antibody (HAMA) to antibody fragments has been observed nor has there been any elevation of HAMA levels in patients with pre-existing HAMA.
Fi studji li saru fuq 350 pazjent, l- ebda wiehed ma sviluppa HAMA.
Patients who have previously received murine monoclonal antibody products are more likely to have HAMA.
Pazjenti li inghatalhom qabel dawn il- protejini ghandhom possibilita ’ akbar li jizviluppaw HAMA.
The overall radiation dose received by the patient over time should also be taken into account.
M’ hemmx bizzejjed informazzjoni fuq jekk il- prodott jistax jintuza t- tieni darba fl- istess pazjent.
HAMA titers should be determined before repeated administration of LeukoScan.
F’ dan il- kaz, ghandu jigi mkejjel il- HAMA
LeukoScan is not expected to bind to leukocytes in patients with paroxysmal nocturnal hemoglobinuria.
4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarjiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
Formal drug interaction studies have not been performed, but no drug interactions have been described to date, including patients receiving antibiotics.
Ma sarux studji dwar l- effett ta ’ mediċini jew ta ’ affarijiet oħra fuq l- effett farmaċewtiku tal- prodott.
Women of childbearing potential
Nisa li jistghu johorgu tqal
Any woman who has missed a period should be assumed to be pregnant until proven otherwise.
Meta ghandhom jintuzaw prodotti radjuattivi f’ nisa li jafu jkunu tqal, wiehed ghandu dejjem jistaqsi.
Where uncertainty exists, it is important that radiation exposure should be the minimum consistent with achieving the desired clinical information.
Jekk hemm xi dubju fuq jekk mara hiex tqila jew le, wiehed ghandu, jekk possibli, ifittex mezzi ohrajn biex jikseb l- informazzjoni li ma juzawx radjazzjoni.
LeukoScan is contraindicated in pregnancy.
Leukoscan m’ ghandux jintuza fit- tqala
4 Lactation
3 Treddigh
If the administration is considered necessary, breast feeding should be interrupted and the expressed feeds discarded.
Wiehed ghandu jara jekk tistax tigi iddiferita il- procedura sakemm l’ omm tieqaf tredda ’.
It is usual to advise that breast feeding can be restarted when the level in the milk will not result in a radiation dose to the child greater than 1 mSv.
Jekk ghandu jigi somministrat xorta wahda Leukoscan, it- treddigh ghandu jieqaf u l- halib mormi.
Due to the short six-hour, half-life of 99mTc, a dose of less than 1 mSv in mother’ s milk can be expected 24 hours after the administration of LeukoScan [99mTc].
Jista jerga jibda t - treddigh wara 24 siegha.
The following minor, self-limiting, rare adverse events were reported in the clinical trials and considered at least possibly related to LeukoScan: eosinophilia (3); and facial rash (1).
Fl- istudji li saru, gew irrapurtati dawn l- effetti mhux mixtieqa li jafu kellhom x’ jaqsmu ma Leukoscan; eosinophilia u hmura fil- wicc.
None of these were considered serious, and all resolved without sequelae.
Dawn ma hallew l- ebda effett permanenti.
Post-marketing experience currently comprises greater than 70,000 vials sold, with two reports of self- limiting allergic reactions.
Wara li l- prodott kien fuq is- suq, inbieghu iktar minn 70, 000 fjala u kien hemm zewg rapporti ta ’ rejazzjonijiet allergici.
Statistically significant reductions in white blood cell (WBC) count were observed in the controlled studies at 24 hours post-injection, from a mean value of 8.9 to a mean value of 8.0 (× 103/ mm3), but remained within the normal range, and returned to their pre-injection values by the time of the next measurement at 10 days.
Kien hemm nuqqas fic- celluli bojod tad- demm (white blood cells WBC) 24 siegha wara l- injezzjoni minn medja ta ’ 8. 9 ghal 8. 0 (x 103/ mm3) imma baqghu fin- normal u gew lura ghal li kienu 10 ijiem wara l- injezzjoni.
By contrast, in non-infected subjects, transient increases in WBC count were seen 24 hours after LeukoScan administration.
F’ pazjenti minghajr infezzjoni kien hemm zieda fil- WBC wara l- injezzjoni.
The magnitude of these increases were assessed by the investigators to be of no clinical consequence on an individual patient basis.
Iz- zieda ma kinitx kkunsidrata bhala importanti.
It is unknown whether the changes in WBC or eosinophil counts observed, although of no clinical significance, are due to a transient effect on WBC function.
Mhux maghruf jekk il- bidliet fin- numru ta ’ WBC huwa dovut ghal xi effett fuq il- funzjoni taghhom.
In vitro, a positive binding to lymphocytes up to 2-6% has been shown.
In vitro, kien hemm rabta ta ’ 2- 6% ma ’ lymphocytes.
The effect on lymphocyte function has not been determined.
L- effett fuq il- funzjoni taghhom ma giex stabilit.
No induction of human anti-mouse antibody (HAMA) reactive with fragment was observed in any patient administered LeukoScan.
Ma kien hemm l- ebda pazjent li wera HAMA
Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects.
3 Ghal kull pazjent, id- dosa ta ’ radjazzjoni li tinghata ghandha tigi bbilancjata mal- benificcju li dak il - pazjent jiehu. Id- dosa ghandha tkun baxxa kemm jista ’ jkun biex jittiehed l- informazzjoni dijanjositku.
For diagnostic nuclear medicine investigations, the current evidence suggests that the adverse effects will occur with low frequency because of the low radiation doses incurred.
Ghal investigazzjonijiet tal- medicina nuklejari, jidher illi effetti mhux mixtieqa jigru b’ frekwenza baxxa minhabba id- dosa baxxa ta ’ radjazzjoni.
For most diagnostic investigations using a nuclear medicine procedure, the radiation dose delivered (effective dose/ EDE) is less than 20 mSv.
Ghal hafna mill- investigazzjonijiet tal- medicina nuklejari, id- dosa hija inqas minn 20 mSv.
Higher doses may be justified in some clinical circumstances.
Kultant, jistghu jigu ggustifikati dozi aktar qawwija.
The maximum amount of LeukoScan [99mTc] that can be administered safely has not been determined.
L- ammont massimu ta ’ Leukoscan li jista ’ jinghata ma giex iddeterminat.
In clinical trials, single doses of 1.0 mg of LeukoScan radiolabelled with 900 ± 200 MBq of 99mTc were administered to 11 patients with various types of infection and there were no adverse reactions at this dose.
Fi studji klinici, dozi ta ’ 1. 0 mg ta ’ Leukoscan bi 900 + 200 MBq Tc99m inghataw lil 11 il- pazjent b’ diversi tipi ta ’ infezzjoni u ma kien hemm l- ebda rejazzjoni.
In the unlikely event of a radiation overdose being administered with LeukoScan [99mTc], the absorbed dose to the patient may be reduced by increased oral or intravenous intake of fluids to promote excretion of the radiolabel.
F’ kaz mhux tas- soltu ta ’ doza qawwija li tinghata, wiehed ghandu jixrob hafna jew jinghataw likwidi fil- vina biex jzid l- eliminazzjoni tas- sostanza mill – gisem.
ATC code:
Dijanjositku Kodiċi ATC:
At the concentrations and activities used for diagnostic procedures, LeukoScan does not appear to exert any pharmacodynamic effects.
Fil- kwantitajiet li tintuza, Leukoscan ma tidhirx li ghandha effett farmakodinamiku.
The antibody (IMMU-MN3) recognizes an antigenic structure shared by a surface glycoprotein (NCA-90) of granulocytes and the tumour marker, carcinoembryonic antigen (CEA).
L- antibody (IMMU- MN3) jaghraf struttura NCA- 90 fuq wicc il- WBC u il- marker tumorali CEA.
In a single-group, open-label, uncontrolled study of 53 patients with acute or chronic infections of unknown origin or extent, doses of LeukoScan from 0.1 mg to 1.0 mg were studied.
4 Fi studju fuq 53 pazjent b’ infezzjonijet akuti jew kronici, dozi ta ’ 0. 1 sa 1. 0 mg ta ’ Leukoscan gew studjati.
There was no dose- response effect for imaging efficacy (sensitivity or specificity) over antibody doses ranging from 0.1 mg to 1.0 mg.
Ma kien hemm l- ebda differenza fl- akkuratezza fuq din il- medda bejn 0. 1 mg u 1. 0 mg.
In vitro studies have demonstrated that LeukoScan has no effect on either up-regulation or down- regulation of granulocytes, but LeukoScan does appear to bind more avidly to activated rather than resting granulocytes.
Studji in vitro wrew li Leukoscan m’ ghandu l- ebda effett fuq il- funzjoni tal- WBC imma jorbot b’ mod iktar efficjenti ma ’ dawk il WBC attivati.
On the basis of two controlled clinical trials of LeukoScan to demonstrate the safety and effectiveness of this product for defining the presence and location of osteomyelitis, in a total of 175 evaluable patients, LeukoScan had a sensitivity of 88.2%, a specificity of 65.6%, an accuracy of 76.6%, a positive predictive value of 70.8%, and a negative predictive value of 85.5%.
Fuq bazi ta ’ zewg studji li saru, f’ total ta ’ 175 pazjent, Leukoscan wera sensittivita ’ ta ’ 88. 2%, specificita ta 65. 6%, akkuratezza ta ’ 76. 6%, valur predittiv pozittiv ta ’ 70. 8% u valur predittiv negattiv ta 85. 5%.
69.4%).
F’ grupp izghar ta ’ pazjenti, Leukoscan gie mqabbel ma ritratti li ttiehdu wara li il WBC gew marbuta ma In111 jew Tc99m u kien hemm zieda ta ’ sensitivita ’ ta ’ Leukoscan meta mqabbel ma ritratti li ttiehdu bil WBC (87. 7% vs 72. 6%, p = 0. 003 bit- test ta ’ McNemar) minghajr lebda tnaqqis fl - ispecificita mqabbel mal WBC (67. 1% vs 69. 4%).
The clinical results indicate that among different presentations of osteomyelitis, LeukoScan can show different results.
Ir- rizultati klinici juru li fid- diversi tipi ta ’ infezzjoni fl- ghadam, Leukoscan jista ’ juri rizultati differenti.
72.9%), in diagnosing osteomyelitis in patients with diabetic foot ulcers than in patients with other sites of long bone osteomyelitis.
Il- prodott huwa iktar sensittiv (93. 9% vs 80. 6%) imma inqas specifiku (51. 6% vs 72. 9%) f’ pazjenti diabetici b’ ulceri f’ riglejhom milli f’ pazjenti b’ infezzjonijiet fl- ghadam it- twal.
75.8%, respectively).
Minkejja dan, l- akkuratezza hija simili fiz- zewg gruppi (77. 5% vs 75. 8%).
This difference is perhaps explained by the anatomically and pathophysiology more complicated clinical setting of osteomyelitis in the diabetic foot, making differentiation of soft tissue and bone infection more difficult than in other presentations of long bone osteomyelitis.
Dan x’ aktarx huwa dovut ghall - anatomija tar- rigel fejn huwa iktar difficli li tiddistingwi bejn l- ghadam u l- gilda.
An evaluation of potential clinical impact of LeukoScan demonstrated that LeukoScan could change clinical management in 50.2% or improve clinical outcome in 43.4% of the 175 evaluable patients with suspected osteomyelitis.
Jidher illi Leukoscan jista ’ jbiddel it- terapija fi 50. 2% jew itejjeb ir- rizultat kliniku fi 43. 4% minn dawn il 175 pazjent.
In 49.7% of the patients, LeukoScan was presumed to provide clinical benefit not achievable by other available diagnostic imaging methods, with the potential that the diagnosis could have been made by LeukoScan alone in 70.3% of the patients.
Jidher ukoll illi Leukoscan ta ’ informazzjoni li ma setghux jaghtu metodi ohrajn u d- dijanjosi setghat saret bil- Leukoscan wahdu fi 70. 3% tal- pazjenti.
These benefits were also accompanied by a substantial reduction (85.4%) in the number of patients who would require other diagnostic imaging procedures.
Kien hemm ukoll tnaqqis sostanzjali fin- numru ta ’ pazjenti li kellhom bzonn testijiet ohrajn (85. 4%).
Since LeukoScan cross-reacts with CEA, it should be borne in mind that it may interact with CEA producing tumours.
Minhabba illi Leukoscan jorbot ukoll ma CEA, dan jista ’ jorbot ma ’ tumuri li ghandhom CEA.
Pharmacokinetic studies were performed after the intravenous administration of the product.
Studji farmakinetci saru wara li l- prodott inghata fil- vina.
At one hour after infusion, the blood level was 34% of baseline, 17% at four hours and 7% of baseline at 24 hours.
Wara siegha, il- livell fid- demm kien 34% tal- bazi, 17% wara 4 sieghat u 7% wara 24 siegha.
The distribution half-life was approximately 1.5 hours; the route of excretion is essentially renal with 41% of the radiolabel excreted in urine over the first 24 hours after administration.
Kien hemm tnaqqis bin- nofs kull 1. 5 siegha u il - prodott jigi eliminat mill- kliewi b’ 41% jigi eliminat fl- urina wara 24 siegha.
These revealed no remarkable findings.
Studji limitati hafna biss saru bil- prodott u ma kien hemm l- ebda effetti.
It should be noted, however, that these studies did not assess genotoxicity, carcinogenic potential, or toxicity to reproduction.
Ma gewx evalwati il - potenzjal li jipproduci tumori u lanqas l- effett fuq is- sistema ta ’ riproduzzjoni.
Stannous Chloride, Dihydrate Acetic Acid, Glacial (Trace) Sodium Potassium Tartrate, Tetrahydrate Sucrose
Stannous Chloride, Dihydrate Acetic Acid, Glacial (Trace) Sodium Potassium Tartrate, Tetrahydrate Sucrose
Sodium Chloride Hydrochloric Acid (Trace) Sodium Acetate, Trihydrate Nitrogen
Sodium Chloride Hydrochloric Acid (Trace) Sodium Acetate, Trihydrate Nitrogen
This medicinal product must not be mixed with other medicinal products except those mentioned in 6.6 or 12.
M’ ghandux jigi mhallat ma ’ prodotti medicinali ohrajn hlief dawk imsemmija fi 6. 6 jew 12
Reconstituted and radiolabelled material - 4 hours.
6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
6.4 Special precautions for storage
48 xahar 5 6. 4 Prekawzjonijiet speċjali għall- ħażna
Kit - Store in a refrigerator (2ºC - 8ºC).
Mizmum f’ temperatura ta ’ 2- 8°C.
Do not freeze.
Tiffrizahx.
Reconstituted and radiolabelled material - Do not store above 25ºC.
Wara r- rikostituzzjoni, izzomx f’ temperatura iktar minn 25°C.
Do not refrigerate or freeze.
Tiffrizahx
One vial prepared so as to contain 0.31 mg lyophilised LeukoScan monoclonal antibody fragment.
Fjala fiha 0. 31 mg Leukoscan monoclonal antibody.
The Type I glass vial is closed with a grey butyl rubber stopper with a green flip-off seal.
Vjala tal- hgieg tat- tip 1 maghluq b’ siggill tal- gomma girza u tapp ahdar fuqu.
Pack size: one vial per carton container.
Fjala wahda f’ kull kaxxa
6.6 Special precautions for disposal and other handling
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema < u għal immaniġġar ieħor >
Read complete directions thoroughly before starting the preparation procedure.
Aqra bil- galbu qabel ma tibda tipprepara
LeukoScan is a sterile, lyophilised formulation, containing 0.31 mg of sulesomab per vial and includes 0.22 mg stannous chloride dihydrate, 3.2 mg potassium sodium tartrate tetrahydrate, 7.4 mg sodium acetate trihydrate, 5.5 mg sodium chloride, glacial acetic acid (trace), hydrochloric acid (trace), 37.8 mg sucrose, nitrogen (vacuum).
Leukoscan huwa trap sterilizzat li fih f’ kull fjala 0. 31 mg sulesomab, 0. 22 mg stannous chloride dihydrate, 3. 2 mg potassium sodium tartrate tetrahydrate, 7. 4 mg sodium acetate trihydrate, 5. 5 mg sodium chloride, glacial acetic acid (trace), hydrochloric acid (trace), 37. 8 mg sucrose, nitrogen (vacuum).
The imaging agent, technetium-99m LeukoScan [technetium-99m sulesomab] is formed by reconstitution of the contents of the LeukoScan vial with 0.5 mL sodium chloride for injection followed by the addition of 1100 MBq of sodium pertechnetate [99mTc] in 1 mL of Sodium Chloride for Injection.
Il- prodott biex jittiehdu r- ritratti, technetium- 99m Leukoscan (technetium- 99m sulesomab) jigi wara li zzid 0. 5 sodium chloride fil- fjala ta Leukoscan u wara zzid 1100 MBq ta ’ sodium pertechnetate (Tc99m) f’ 1ml ta ’ sodium chloride ghall- injezzjoni.
The resulting solution has a pH of 4.5-5.5 and is intended for intravenous use only.
Is- soluzzjoni ghandha pH ta ’ 4. 5 - 5. 5 u ghandu uzu biss i. v.
Appropriate aseptic precautions should be taken, complying with the requirements of Good Manufacturing Practices (GMP) for pharmaceuticals.
Prodotti radjuattivi ghandhom jigu ppreparati skond ir- regolamenti lokali u ghandhom jintuzaw Good Manufacturing Practices (GMP).
Reconstituted radiopharmaceuticals should be handled using waterproof gloves, adequate shielding of radioactivity, and aseptic technique.
Dawn il- prodotti ghandhom jigu intuzati bil- kura necessarja, bl- ingwanti li ma jghaddix l- ilma minnhom u teknici asettici.
Method of preparation
Metodu ta ’ preparazzjoni:
Obtain 900 ± 200 MBq of freshly eluted 99mTc sodium pertechnetate eluate from any commercial source which has been eluted within the past 24 hours.
Ipprepara 900 + 200 MBq ta ’ Tc99m sodium pertechnetate sa volum ta ’ 1ml 2.
Clean the rubber closure of each vial such as with an alcohol wipe.
Naddaf it- tapp tal- gomma bl- alkohol.
3.
Zid 0. 5 ml ta ’ sodium chloride fil- fjlala skermata ta ’ Leukoscan 3.
Swirl and shake the vial contents gently for 30 seconds to insure dissolution.
Hawwad ghal 30 sekonda biex tholl it- trab.
Add the prepared eluate into the shielded vial, shake and allow the labelling reaction to proceed for ten minutes.
Zid il- parti radjuattiva 4.
Total volume in vial equals 1.5 ml.
Hawwad u halli ghal 10 minuti 5.
LeukoScan [99mTc] can be used after ten minutes and should be used within four hours after preparation.
Igbed ammont ta ’ radjuattivita ’ sufficjenti.
Do not refrigerate after formulation.
Leukoscan jista ’ jintuza 10 minuti wara li jigi ippreparat u qabel ma jghaddu 4 sieghat.
6.
Izzomx il- prodott fil- fridge wara li jkun lest 6.
Prior to administration, the solution should be inspected visually for particulate matter and discoloration, and quality control should be performed (see section 12).
Hares lejn il- likwidu u ghamel il- kontrolli ta ’ kwalita ’.
If either are present, the product should be discarded.
Jekk hemm xi frak jew mhux ta ’ kulur car, ghandek tarmi il- prodott.
Immunomedics GmbH Otto-Röhm-Straße 69 D-64293 Darmstadt Germany
Immunomedics GmbH Otto- Röhm- Straße 69 D- 64293 Darmstadt Germany
Date of first authorisation:
Data ta ’ l- ewwel awtorizzazjoni:
14 February 1997
Data ta ’ l- ewwel tigdid:
20.05.2007
14 ta ’ Frar 1997 20. 05. 2007
DOSIMETRY
DOŻIMETRIJA
For this medicinal product, the effective dose equivalent resulting from an administered activity of 750 MBq is typically 7.7 mSv for a 70 kg individual.
Ghal dan il- prodott mediku, id- doza ekwivalenti effettiva ghal attivita ’ somministrata ta ’ 750MBq hija tipikament 7. 7 mSv f’ persuna li tizen 70 kg
9 Technetium [99mTc] disintegrates with the emission of gamma radiation with an energy of 140 keV and a half life of 6 hours to technetium [99Tc] which can be regarded as quasi stable.
Technetium (tc99m) jiddisintegra b’ emissjoni ta ’ raggi gamma b’ energija ta ’ 140 keV u half life ta ’ 6 sieghat ghal technetium (tc99) li huwa stabbli.
These dose estimates assume a urinary bladder voiding interval of two hours.
Id- doza stmata li tinghata f’ persuna ta ’ 70 kg hija imnizzla f’ table 1.
These values were calculated according to Medical Internal Radiation Dosimetry.
Dawn gew stmati skond il Medical Internal Radiation Dosimetry
LeukoScan [99mTc]
INSERT TABLE 1
INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS
STRUZZJONIJIET GĦALL- PREPARAZZJONI TA ’ PRODOTTI RADJUFARMAĊEWTIĊI
10 LeukoScan is reconstituted with 0.5 ml isotonic sodium chloride injection.
Leukoscan huwa rikostitwit bi 0. 5 ml ta ’ sodium chloride.
Following reconstitution, 1 ml sodium pertechnetate [99mTc] is added.
Wara, jizdiedu 1ml ta ’ sodium pertechnetate (Tc99m).
The recommended adult dose is 0.25 mg of Fab′ fragment labelled with 900 ± 200 MBq of technetium 99m Tc pertechnetate (approximately 1.2 ml).
Id- doza fil- kbar hija ta ’ 0. 25 mg Fab markata bi 900 + 200 technetium Tc99m pertechnetate (cirka 1. 2 ml).
After radiolabelling the antibody and diluting a 10 µl sample with 1.5 ml saline, immediately determine the radiochemical purity by Instant Thin Layer Chromatography on silica gel impregnated glass fiber strips, 1 × 9 cm using acetone as the solvent.
Wara li jigi ppreparat, il- purezza radjukimika ghandha tigi ddeterminata b ’ Instant Thin Layer Chromatography fuq gel tas- silica fuq fiibri tal- hgieg.
When the solvent front is within 1 cm of the top of the strip, remove it, cut it in half and place each into a glass tube.
Meta l- likwidu huwa 1cm mill- parti ta ’ fuq tal- karta, ghandha titnehha, maqsuma minn nofs u kull parti mqieghda f’ tubu tal- hgieg.
Count each tube in a gamma scintillation counter, dose calibrator or radiochromatogram analyzer.
Kull tubu ghada tinghadd f’ gamma scintillation counter, kalibratur jew radiochromatogram analyser.
Calculate the percent free technetium as follows:
Il- persentagg ta ’ technetium mhux marbut jigi kklalkolat hekk:
% Free Technetium = Activity in top half of strip × 100 Total Activity.
x 100
The radiolabelled product should not contain more than 10% free technetium.
M’ ghandux ikun hemm izjed minn 10% mhux marbut.
Any unused product or waste material should be disposed of in accordance with local requirements.
Il- prodott li ma jintuzax ghandu jintrema skond ir- regolamenti lokali.
11 ANNEX II
7 ANNESS II
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA BIJOLOĠIKA ATTIVA U DETENTUR TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL - LOTT B.
SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING AUTHORISATION HOLDER
OBBLIGAZZJONIJIET SPEĊIFIĊI — TAD- DETENTUR TA ’ AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
12 A.
8 A.
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA BIJOLOĠIKA ATTIVA U DETENTUR TA ’ L - AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL - LOTT
Name and address of the manufacturer(s) of the biological active substance(s)
Isem u indirizz tal- manifattur tas- sustanza bijoloġika attiva
13 ANNEX III
9 ANNESS III
14 A.
10 A.
15 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
11 TAGĦRIF LI GĦANDU JIDHER FUQ < IL- PAKKETT TA ’ BARRA > < U > < IL- PAKKETT LI JMISS MAL- PRODOTT >
(CONTAINER PACKAGE LABEL)
{NATURA/ TIP}
LeukoScan 0.31 mg, powder for solution for injection sulesomab
Leukoscan 0. 31 mg, trab ghal soluzzjoni ghall- injezzjoni
One vial contains 0.31 mg sulesomab
Fjala fiha 0. 31 mg sulesomab
Each vial contains stannous chloride, sodium chloride, sodium potassium tartrate, sodium acetate, sucrose, nitrogen.
Kull fjala fiha stannous chloride, sodium chloride, sodium potassium tartrate, sodium acetate, sucrose, nitrogen.
0.31 mg sulesomab Powder for solution for injection
0. 31 mg sulesomab Trab ghal soluzzjoni ghall- injezzjoni
METHOD AND ROUTe(S) OF ADMINISTRATION
MOD TA ’ KIF U MNEJN JINGĦATA
For Intravenous Use.
Ghall- uzu i. v.
Read the package leaflet before use.
Aqra il- fuljett qabel l- uzu
For diagnostic use only.
Ghall- uzu dijanjostiku biss.
After mixing with Tc, the final product must be disposed of as radioactive waste in accordance with local law.
Wara li jigi mhallat bil Tc99m, il- prodott finali ghandu jintrema skond ir - regolamenti lokali
16 EXP MM/ YYYY
XX/ SSSS
Store in a refrigerator (2ºC-8ºC).
Zomm f’ temperatura bejn 2°C u 8°C.
Do not freeze.
Tiffrizax.
After use, the container should be disposed of as radioactive waste.
Wara l- uzu, ghandu jintrema bhala skart radjuattiv
Immunomedics GmbH Otto-Röhm-Straße 69 D-64293 Darmstadt Germany Telephone: +49-6151- 66 715 66 Fax: +49-6151-66 715 77
Immunomedics GmbH Otto- Röhm- Straße 69 D- 64293 Darmstadt Germany Telephone: +49- 6151 - 66 715 66 Fax: +49- 6151- 66 715 77
BATCH NUMBER
14.
Batch #
15.
GENERAL CLASSIFICATION FOR SUPPLY
ISEM TAL- PRODOTT MEDIĊINALI
Medicinal product subject to medical prescription
{Isem (ivvintat) qawwa għamla farmaċewtika} {Sustanza( i) attiva( i)}
INSTRUCTION FOR USE
DATA TA ’ META JISKADI
INFORMATION IN BRAILLE
OĦRAJN
17 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
14 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
(VIAL LABEL)
{NATURA/ TIP}