qanastek/EMEA-V3 huggingface dataset:
Because of potential bone marrow suppression after administration, blood counts should be monitored weekly for at least 8 weeks, beginning 2 weeks after administration of QUADRAMET, or until recovery of adequate bone marrow function.
Dan għandu jibda minn ġimagħtejn wara li jingħata QUADRAMET, jew sakemm il- mudullun jirpilja il- funzjoni adegwata tiegħu.
The patient should be encouraged to ingest (or receive by intravenous administration) a minimum of 500 ml of fluids prior to injection and should be encouraged to void as often as possible after injection to minimise radiation exposure to the bladder.
Il- pazjent għandu jiġi mħajjar jixrob (jew jirċievi permezz ta ’ injezzjoni ġol- vina), minimu ta ’ 500 ml ta ’ fluwidi qabel l- injezzjoni u għandu jiġi infurmat li jkun aħjar jekk jagħmel l- awrina ta ’ spiss kemm jista ’ jkun wara l- injezzjoni sabiex inaqqas l- espożizzjoni għar- radjazzjoni fil- bużżieqa ta ’ l- awrina.
The clearance of QUADRAMET being rapid, the precautions relating to the excreted urinary radioactivity need not be taken after 6-12 hours following administration.
Minħabba li r- rata ta ’ tneħħija ta ’ QUADRAMET iseħħ malajr, ma hemmx għalfejn li jittieħdu l - prekawzjonijiet li għandhom x’ jaqsmu mar- radjuattività ta ’ l- awrina eliminata wara 6- 12- il siegħa li tingħata d- doża.
Special precautions, such as bladder catheterisation, should be taken during six hours following administration to incontinent patients to minimise the risk of radioactive contamination of clothing, bed linen, and the patient's environment.
3 Għandhom jittieħdu prekawzjonijiet speċjali, bħall- bżonn ta ’ kateter fil- bużżieqa ta ’ l- awrina, matul sitt sigħat wara li tingħata d- doża lil pazjenti inkontineti, sabiex jitnaqqas kemm jista ’ jkun ir- riskju ta ’ kontaminazzjoni radjuattiva ta ’ l- ilbies, lożor, u l- ambjent tal- pazjent.
For the other patients the urine should be collected for at least six (6) hours.
Għal pazjenti oħra, l- awrina għandha tinġabar għall- inqas għal sitt (6) sigħat.
Bladder catheterisation should be undertaken in patients with urinary obstruction.
F’ dawk il- pazjenti li għandhom xi sadd fil- passaġġ ta ’ l- awrina, għandu jintuża kateter.
3 Radiopharmaceuticals may be received, used and administered only by authorised persons in designated clinical settings.
Ir- radjufarmaċewtiċi jistgħu jaslu, jiġu użati u jiġu mogħtija biss minn persuni awtorizzati f’ ambjenti kliniċi xierqa.
Its receipt, storage, use, transfer and disposal are subject to the regulations and the appropriate licences of the local competent official organisations.
Il- wasla, il- ħażna, l- użu, it- trasferiment u r- rimi għandhom isiru skond ir- regolamenti u l- liċenzji xierqa ta ’ l- organizzazzjonijiet uffiċjali kompetenti lokali.
Radiopharmaceuticals should be prepared by the user in a manner which satisfies both radiation safety and pharmaceutical quality requirements.
Ir- radjufarmaċewtiċi għandhom jiġu ppreparati minn min ser jużhom b’ mod li jissodisfa kemm il - ħtiġijiet tas- sigurtà tar- radjazzjoni kif ukoll il- ħtiġijiet tal- kwalità farmaċewtika.
Appropriate aseptic precautions should be taken, complying with the requirements of Good Manufacturing Practice for pharmaceuticals.
Għandhom jittieħdu prekawzjonjiet asettiċi xierqa, li jikkonformaw mal- ħtiġijiet tal- Prattika ta ’ Manifattura Tajba għall - farmaċewtiċi.
Because of the potential for additive effects on bone marrow, the treatment should not be given concurrently with chemotherapy or external beam radiation therapy.
Minħabba l- potenzjal għal effetti addittivi fuq il- mudullun, il- kura m` għandiex tingħata fl- istess ħin mal- kimoterapija jew mat- terapija tar- radjazzjoni b’ raġġi esterni.
QUADRAMET may be given subsequent to either of these treatments after allowing for adequate marrow recovery.
QUADRAMET jista ’ jingħata wara kull wieħed minn dawn iż- żewġ trattamenti jekk kemm- il darba ikun tħalla żmien biżżejjed biex il - mudullun jirpilja.
QUADRAMET is contra-indicated(see 4.3) in pregnancy.
QUADRAMET m’ għandux jintuża fit- tqala (ara 4. 3).
The possibility of pregnancy must strictly be ruled out.
Il- possibilità ta ’ tqala għandha tiġi eliminata għal kollox.
Women of childbearing potential have to use effective contraception during the treatment and the whole period of follow-up.
Nisa li jista ’ jkollhom it- tfal għandhom jużaw kontraċezzjoni effettiva waqt it- trattament u l- perijodu kollu għal follow- up.
There are no available clinical data relating to the excretion of QUADRAMET in human milk.
Ma hemm l- ebda tagħrif kliniku dwar l- eliminazzjoni ta ’ QUADRAMET fil- ħalib uman.
If therefore QUADRAMET administration is deemed necessary, formula feeding should be substituted for breast-feeding and the expressed feeds discarded.
Għalhekk, jekk jitqies li jkun hemm bżonn li jingħata QUADRAMET, l- irdigħ mis- sider għandu jiġi sostitwit bil - ħalib tal- formula u l- ħalib li jinħareġ mis- sider għandu jintrema.
4.7 Effects on ability to drive and use machines
4. 7 Effetti fuq l- ħila biex issuq u tħaddem magni
Decreases in white blood cell and platelet counts and anaemia were observed in patients receiving QUADRAMET.
Ġie osservat tnaqqis fl- għadd ta ’ ċelluli bojod tad- demm u fl- għadd tal- plejtlits kif ukoll anemija f’ pazjenti li ngħataw QUADRAMET.
In clinical trials white blood cell and platelet counts decreased to a nadir of approximately 40% to 50% of baseline 3 to 5 weeks after a dose, and generally returned to pre-treatment levels by 8 weeks post treatment.
Fi provi kliniċi, l- għadd ta ’ ċelluli bojod tad- demm u l- għadd ta ’ plejtlits naqas għal l- aktar punt baxx ta ’ madwar 40% sa 50% tal- linja ta ’ riferiment bażi, 3 sa 5 ġimgħat wara d- doża, u ġeneralment reġa ’ lura għal- livelli ta ’ qabel il- kura sa 8 ġimgħat wara.
The few patients who experienced Grade 3 or 4 hematopoietic toxicity usually either had a history of recent external beam radiation therapy or chemotherapy or had rapidly progressive disease with probable bone marrow involvement.
Il- ftit pazjenti li kellhom tossiċità ematopojetika ta ’ Grad 3 jew 4 normalment kienu ħadu jew terapija ta ’ radjazzjoni bir- raġġi esterni reċentement, jew kemjoterapija, jew kellhom marda progressiva ħafna bil- probabbilità tal- involviment tal- mudullun.
A small number of patients have reported a transient increase in bone pain shortly after injection (flare reaction).
Numru żgħir ta ’ pazjenti rrapportaw żieda temporanja fl- uġigħ tal- għadam ftit wara l- injezzjoni (reazzjoni lokalizzata).
This is usually mild and self-limiting and occurs within 72 hours of injection.
Normalment, din tkun ħafifa u tgħaddi weħidha fi żmien 72 siegħa mill - injezzjoni.
Such reactions are usually responsive to analgesics.
Reazzjonijiet bħal dawn normalment jirrispondu tajjeb għall- analġesiċi.
Adverse drug reactions such as nausea, vomiting, diarrhoea and sweating were reported.
Ġew irrapportati reazzjonijiet avversi bħal tqalligħ, remettar, dijarea u għeriq.
Hypersensitivity reactions including rare cases of anaphylactic reaction have been reported after QUADRAMET administration.
4 Reazzjonijiet ta ’ sensittività eċċessiva li jinkludu każijiet rari ta ’ reazzjoni anafilattika ġew irrapportati wara li ngħata QUADRAMET.
A few patients experienced cord/ root compressions, disseminated intravascular coagulation and cerebrovascular accidents.
Xi ftit pazjenti ħassew tagħfis tal- kord/ għerq, koagulazzjoni intravaskulari mxerrda u aċċidenti ċerebrovaskulari.
The occurrence of these events may be linked to the patients’ disease evolution.
L- okkorrenza ta ’ dawn il- każijiet tista ’ tiġi attribwita ma ’ l- evoluzzjoni tal- mard fil - pazjent.
When there are spinal metastases at the cervico-dorsal level, an increased risk of spinal cord compression cannot be excluded.
Meta jkun hemm metastasi fl- ispina fil- livell ċerviko- dorsali, ma jistax jiġi eskluż riskju akbar ta ’ tagħfis fuq is- sinsla tad- dahar.
4 The radiation dose resulting from therapeutic exposure may result in higher incidence of cancer and mutations.
Id- doża ta ’ radjazzjoni li tirriżulta minn espożizzjoni terapewtika tista ’ tgħolli l- inċidenza ta ’ kanċer u mutazzjonijiet.
In all cases, it is necessary to ensure that the risks of the radiation are less than from the disease itself.
Fil- każijiet kollha, hemm bżonn li r- riskji tar- radjazzjoni jkunu inqas mill- marda nnifisa.
The product should only be administered by qualified personnel in authorised settings.
Il- prodott għandu jiġi mogħti biss minn personàl kkwalifikat f’ ambjenti awtoriżżati.
The possibility of pharmacological overdose is therefore remote.
Il- possibilità ta ’ doża farmakoloġika eċċessiva hija għalhekk remota.
The risks to be expected are associated with the inadvertent administration of excess radioactivity.
Ir- riskji li wieħed jistenna huma assoċjati ma ’ għoti ta ’ radjuattività eċċessiva bi żball.
Radiation dose to the body can be limited by promoting a diuresis and frequent voiding of urine.
Id- doża ta ’ radjazzjoni għall- ġisem tista ’ tiġi limitata permezz ta ’ dijureżi u billi l- pazjent jagħmel l- awrina ta ’ spiss.
PHARMACOLOGIC PROPERTIES
TAGĦRIF FARMAKOLOĠIKU
ATC Code:
Il- grupp farmakoterapewtiku: diversi radjufarmaċewtiċi li jtaffu l- uġigħ, Kodiċi ATC:
QUADRAMET has an affinity for skeletal tissue and concentrates in areas of bone turnover in intimate association with hydroxyapatite; studies in rats have demonstrated that QUADRAMET is cleared rapidly from the blood and localises to growing areas of bone matrix, specifically the layer of osteoid undergoing mineralisation.
QUADRAMET għandu affinità għat- tessut skeletali u jikkonċentra f’ partijiet fejn jinbidel l- għadam, f’ assoċjazzjoni ma ’ hydroxyapatite; studji li saru fuq il- firien, urew li QUADRAMET jitneħħa malajr mid- demm u jillokalizza f’ żoni ta ’ tkabbir tal- matriċi ta ’ l- għadam, b’ mod speċifiku fis- saff ta ’ l - ostejojdi li jkun għaddej minn mineralizzazzjoni.
In clinical studies employing planar imaging techniques, QUADRAMET accumulates with a lesion- to-normal bone ratio of approximately 5 and a lesion-to-soft tissue ratio of approximately 6.
Fi studji kliniċi fejn intużaw metodi ta ’ planar imaging, intwera li QUADRAMET jakkumula b’ proporzjon ta ’ bejn wieħed u ieħor 5 darbiet aktar f ’ għadam b’ leżjoni milli f’ għadam normali.
Thus, areas of metastatic involvement can accumulate significantly greater amounts of QUADRAMET than surrounding normal bone.
Għalhekk, fejn hemm metastasi, jistgħu jakkumulaw ammonti akbar, li huma sinfikanti ta ’ QUADRAMET milli fl- għadam normali tad- dawra.
In patients, QUADRAMET is rapidly cleared from the blood.
QUADRAMET jiġi mneħħi malajr mid- demm meta jingħata lill- pazjenti.
Thirty minutes after injection of the agent to 22 patients, only 9.6 ± 2.8% of the administered activity remained in plasma.
Tletin minuta wara l - injezzjoni ta ’ QUADRAMET lil 22 pazjent, 9. 6 ± 2. 8% biss ta ’ l- attività li ngħatat baqgħet fil - plażma.
At 4 and 24 hours, plasma radioactivity had decreased from 1.3 ± 0.7% to 0.05 ± 0.03%.
F’ 4 u 24 siegħa, ir- radjuattività naqset minn 1. 3 ± 0. 7% għal 0. 05 ± 0. 03%.
Urinary excretion occurred predominantly during the first 4 hours (30.3 ± 13.5%).
L- eliminazzjoni fl- awrina seħħet primarjament matul l- ewwel 4 sigħat (30. 3 ± 13. 5%).
At 12 hours, 35.3 ± 13.6% of the administered activity had been excreted into the urine.
Wara 12- il siegħa, 35. 3 ± 13. 6% ta ’ l- attività li ngħatat ġiet eliminata fl- awrina.
Analysis of urine samples found the radioactivity to be present as the intact complex.
Minn analiżi tal- kampjuni ta ’ l- awrina nstab li r- radjuattività preżenti kienet mill- prodott intatt.
Less urinary excretion occurred in patients who had extensive bony metastases, regardless of the amount of radiopharmaceutical administered.
Kien hemm inqas eliminazzjoni fl- awrina, f’ pazjenti li kellhom metastasi ta ’ l- għadam estensiv, irrispettivament mid- doża ta ’ radjufarmaċewtiku mogħtija.
Total skeletal uptake of QUADRAMET in studies of 453 patients with a variety of primary malignancies was 65.5 ± 15.5% of the administered activity.
Sar studju fuq 453 pazjent b’ varjetà ta ’ tumuri primarji malinni fejn deher li t- teħid totali ta ’ QUADRAMET fit- tessuti skeletali, kien ta ’ 65. 5 ± 15. 5% ta ’ l- attività mogħtija.
A positive correlation was found between skeletal uptake and the number of metastatic sites.
Instabet korelazzjoni pożittiva bejn it- teħid fit- tessuti skeletali u n- numru ta ’ siti metastatiċi.
In contrast, skeletal uptake was inversely proportional to plasma radioactivity at 30 minutes.
F’ kuntrast għal dan, wara 30 minuta, it- teħid fit- tessuti skeletali kien inversament propozjonali għar- radjuattività tal- plażma.
The radiolysis products of Sm-EDTMP showed a renal toxicity in rats and dogs with a no effect level of 2.5 mg/ kg.
5 Il- prodotti ta ’ radjoliżi ta ’ Sm- EDTMP urew tossiċità fil- kliewi tal- firien u tal- klieb, u b’ livell ta ’ mingħajr effett ta ’ 2. 5 mg/ kg.
Repeated dose administration of samarium [153Sm]-EDTMP to dogs indicated a slightly longer time for depressed bone marrow and peripheral haematological parameters to recover when compared to recovery following only single dose administration.
Dożi ripetuti ta ’ samarium [153Sm] - EDTMP fuq il- klieb indikaw ħin kemmxejn itwal sabiex il - mudullun jirpilja min- nuqqas ta funżjoni, u biex jiġu għan- normal il- parametri ematoloġiċi periferali, meta mqabbla ma ’ l- għoti ta ’ doża waħda biss.
Radioactive Sm-EDTMP has not been tested for mutagenicity/ carcinogenicity but due to the radiation dose resulting from therapeutic exposure it should be regarded as presenting a genotoxic/ carcinogenic risk.
Sm- EDTMP radjuattiv ma ġiex studjat għal mutaġeniċità/ karċinoġeniċità iżda minħabba d- doża ta ’ radjazzjoni li tirriżulta mill- espożizzjoni terapewtika, dan għandu jitqies bħala riskju ta ’ ġenotossiċita ’ u karċinoġeniċita ’.
5 Non-radioactive Sm-EDTMP showed no mutagenic potential in a battery of in vivo and in vitro tests.
Sm- EDTMP mhux radjuattiv ma wera ebda potenzjali mutaġeniku fi provi in vivo u in vitro.
The same results were observed for Sm-EDTMP enriched with radiolysis degradants.
Ġew osservati l- istess riżultati għal Sm- EDTMP imsaħħaħ b’ degradati tar- radjoliżi.
In a carcinogenic potential study of EDTMP, osteosarcomas occurred in rats at high doses.
Fi studju dwar il- potenzjal karċinoġeniku ta ’ EDTMP, irriżultaw ostjosarkomi fil- firien f’ dożi għoljin.
In the absence of genotoxic properties, these effects can be assigned to the EDTMP chelatant properties leading to osseous metabolism disturbances.
Fin- nuqqas ta ’ karatteristiċi ġenotossiċi, dawn l- effetti jistgħu jkunu attribwiti mal- karatteristika ta ’ EDTMP li jifforma chelates, li wara jwassal għal disturbi fil- metaboliżmu tal- għadam.
No studies have been performed to assess the effect of QUADRAMET on reproduction.
Ma saru ebda studji sabiex jiġi stmat l- effett ta ’ QUADRAMET fuq ir- riproduzzjoni.
Total EDTMP (as EDTMP. H2O) Calcium-EDTMP sodium salt (as Ca) Total sodium (as Na) Water for Injections
EDTMP totali (bħala EDTMP. H2O) Calcium- EDTMP sodium salt (bħala Ca) Sodju totali (bħala Na) Ilma għall- injezzjonijiet
In the absence of compatibility studies, this medicinal product must not be mixed with the other medicinal products.
Minħabba li ma sarux studji li juru liema huma l- prodotti li ma jablux miegħu, dan il- prodott mediċinali m’ għandux jitħallat ma ’ prodotti mediċinali oħrajn.
1 day from the activity reference time stated on the label.
Ġurnata mill- ħin ta ’ referenza ta ’ l- attività mogħti fuq it- tikketta.
Use within 6 hours of thawing.
Uża fi żmien 6 sigħat wara li jinħall.
After thawing, do not freeze again.
Wara li jinħall, terġax tiffriżah.
QUADRAMET is delivered frozen in dry ice.
QUADRAMET jiġi iffriżat f’ silġ niexef.
Store in a freezer at -10°C to -20°C in the original package.
Aħżen fil- friża f’ temperatura ta ’ - 10°C sa - 20°C fil- pakkett oriġinali.
Storage procedures should be in accordance with local regulations for radioactive substances.
Il- proċeduri tal- ħażna għandhom ikunu konformi mar- regolamenti lokali għal sustanzi radjuattivi.
15 ml colourless European Pharmacopoeia Type I drawn glass vial closed with Teflon-coated chlorobutyl/ natural rubber stopper and aluminium flip-off overseal.
Kunjett tal- ħġieġ ta ’ 15 ml ta ’ Tip I tal- Farmakopea Ewropea mingħajr kulur magħluq b’ tapp tal - chlorobutyl miksi bit- Teflon/ gomma naturali u b’ siġill ta ’ l- aluminju li jinfetaħ b’ daqqa ta ’ saba ’.
Each vial contains 1.5 ml (2 GBq at calibration) to 3.1 ml (4 GBq at calibration) of solution for injection.
Kull kunjett fih 1. 5 ml (2 GBq waqt il- kalibrazzjoni) sa 3. 1 ml (4 GBq waqt il- kalibrazzjoni) ta ’ soluzzjoni għall- injezzjoni.
The administration of radiopharmaceuticals creates risks to other persons from external radiation or contamination from spills of urine, vomiting etc.
6 L- għoti ta ’ radjufarmaċewtiċi joħloq riskji għal persuni oħra minn radjazzjoni esterna jew minn kontaminazzjoni minnħabba tixrid ta ’ l- awrina, remettar, eċċ.
Radiation protection precautions in accordance with national regulations must therefore be taken.
Għalhekk għandhom jittieħdu l - prekawzjonijiet ta ’ protezzjoni mir- radjazzjoni b’ mod konformi mar- regolamenti nazzjonali.
(See section 12, for detailed instructions of product preparation)
(Ara sezzjoni 12, għal informazzjoni dettaljata dwar il- preparazzjoni tal- prodott)
CIS bio international Boîte Postale 32 F-91192 GIF-SUR-YVETTE Cedex FRANCE
CIS bio international Boîte Postale 32 F- 91192 GIF- SUR- YVETTE Cedex FRANZA
05.02.1998 Date of the last renewal:
05. 02. 1998 Data ta ’ l- aħħar reviżjoni:
The estimated absorbed radiation doses to an average adult patient from an intravenous injection of QUADRAMET are shown in Table 2.
Stima tad- dożi ta ’ radjazzjoni assorbita, f’ pazjent adult medju minn injezzjoni ġol- vina ta ’ QUADRAMET, hija mniżżla fit- Tabella 2.
The dosimetry estimates were based on clinical biodistribution studies using methods developed for radiation dose calculations by the Medical Internal Radiation Dose (MIRD) Committee of the Society of Nuclear Medicine.
Dawn il - metodi ħarġu mill- Kumitat tad- Doża ta ’ Radjazzjoni Interna Medika (MIRD) tas- Soċjetà tal- Mediċina Nukleari.
Because QUADRAMET is excreted in the urine, radiation exposure was based on a urinary voiding interval of 4.8 hours.
Billi QUADRAMET jitneħħa fl- awrina, espożizzjoni għar- radjazzjoni kienet ibbażata fuq intervall ta ’ l- eliminazzjoni ta ’ l- awrina ta ’ 4. 8 sigħat.
Radiation dose estimates for bone and marrow assume that radioactivity is deposited on bone surfaces, in accordance with autoradiograms of bone samples taken from patients who received QUADRAMET.
L- istimi tad- doża ta ’ radjazzjoni għall- għadam u għall - mudullun, jassumu li r- radjuattività tiġi ddepożitata fuq s- superfiċje ta ’ l- għadam, skond l - awtoradjugrammi tal- kampjuni ta ’ għadam meħudin minn pazjenti li rċevew QUADRAMET.
7 Radiation dose to specific organs, which may not be the target organ of therapy, may be influenced significantly by pathophysiological changes induced by the disease process.
Id- doża tar- radjazzjoni fuq organi speċifiċi, li jistgħu ma jkunux l- organi immirati għat- terapija, tista ’ tiġi influwenzata b’ mod sinifikanti bit- tibdil patofiżjoloġiku kkaġunat mill- proċess tal- marda.
This should be taken into consideration when using the following information:
Dan għandu jiġi kkunsidrat meta tintuża l- informazzjoni li ġejja:
TABLE 2:
7 TABELLA 2:
RADIATION ABSORBED DOSES Organ Adrenals Brain Chest Gallbladder Ascending colon wall Descending colon wall Small intestine Myocardial wall Kidneys Liver Lungs Muscle Ovaries Pancreas Red marrow Bone surfaces Skin Spleen Stomach Testes Thymus Thyroid Urinary bladder wall Uterus Effective dose (mSv/ MBq)
DOŻI ASSORBITI MIR- RADJAZZJONI Doża assorbita minn kull attività injettata Organu (mGy/ MBq) Adrenali Moħħ Sider Il- marrara Ir- riti tal- kolon li telgħin ’ l fuq Ir- riti tal- kolon li nieżlin ’ l isfel Il- musrana ż- żgħira Ir- rita mijokardijaka Kliewi Fwied Pulmun Muskoli Ovarji Frixa Mudullun aħmar Is- superfiċje ta ’ l- għadam Ġilda Milsa Stonku Testikoli Timu Tirojde Ħitan tal- bużżieqa ta ’ l- awrina Utru Doża effettiva (mSv/ MBq)
Absorbed dose per injected activity (mGy/ MBq) 0.009 0.011 0.003 0.004 0.005 0.010 0.006 0.005 0.018 0.005 0.008 0.007 0.008 0.005 1.54 6.76 0.004 0.004 0.004 0.005 0.004 0.007 0.973 0.011 0.307
0. 009 0. 011 0. 003 0. 004 0. 005 0. 010 0. 006 0. 005 0. 018 0. 005 0. 008 0. 007 0. 008 0. 005 1. 54 6. 76 0. 004 0. 004 0. 004 0. 005 0. 004 0. 007 0. 973 0. 011 0. 307
For this product the effective dose resulting from an injected activity of 2 590 MBq is 796 mSv.
Għal dan il- prodott, id- doża effettiva li tirriżulta minn attività injettata ta ’ 2 590 MBq hija ta ’ 796 mSv.
For an administered activity of 2 590 MBq, the typical radiation dose to the target organ, skeletal metastases, is 86.5 Gy and the typical radiation doses to the critical organs are: normal bone surfaces 17.5 Gy, red marrow 4.0 Gy, urinary bladder wall 2.5 Gy, kidneys 0.047 Gy and ovaries 0.021 Gy.
Għal attività mogħtija ta ’ 2 590 MBq, id- doża tipika ta ’ radjazzjoni għall- organu mmirat, fejn hemm metastasi skeletali, hija ta ’ 86. 5 Gy u d- dożi tipiċi ta ’ radjazzjoni għall- organi kritiċi huma: s - superfiċje tal- għadam normali 17. 5 Gy, mudullun aħmar 4. 0 Gy, ħitan tal- bużżieqa ta’ l- awrina 2. 5 Gy, kliewi 0. 047 Gy u ovarji 0. 021 Gy.
Allow the product to thaw at room temperature before administration.
Ħalli l- prodott jinħall f’ temperatura tal- kamra qabel ma jingħata.
The solution for injection should be visually inspected before use.
Is- soluzzjoni għall- injezzjoni għandha tiġi osservata viżwalment qabel l- użu.
It should be clear without particles.
Għandha tkun ċara u mingħajr frak.
The operator should be careful to protect the eyes while inspecting the solution for clarity.
Wieħed għandu joqgħod attent li jipproteġi għajnejh waqt li jkun qiegħed jeżamina s - soluzzjoni għaċ- ċarezza.
The activity should be measured by a dose calibrator immediately before administration.
8 L- attività għandha tiġi mkejla b’ kalibratur tad- dożi immedjatament qabel ma tingħata.
Verification of the dose to be administered and patient identification are necessary prior to administration of QUADRAMET.
Hemm bżonn li tiġi vverifikata d- doża li tkun ser tingħata u li tiġi vverifikata l- identifikazzjoni tal- pazjent qabel ma jingħata QUADRAMET.
For radiation safety reasons, the patient should be treated in a facility with the appropriate agreement for the therapeutic use of radioactive non-sealed sources.
Għal raġunijiet ta ’ sigurtà dwar ir- radjazzjoni, il- pazjent għandu jiġi ttrattat fil- ftehim xieraq dwar l - użu terapewtiku minn sorsi radjuattivi mhux issiġillati.
He/ she will be released when exposure rates comply with the limits prescribed by the regulations in force.
Hu/ hu jistgħu jiġu rilaxxati meta r- rati ta ’ espożizzjoni jikkonformaw mal- limiti preskritti mir- regolamenti fis- seħħ.
Detailed information on this medicinal 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
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
DETENTUR TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦAR- ĦRUĠ TAL- LOTT
CIS bio international Boîte Postale 32 F-91192 Gif-sur-Yvette cedex France
CIS bio international Boîte Postale 32 F- 91192 Gif- sur- Yvette cedex Franza
13 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
13 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
{METALLIC BOX / LEADPOT}
{KAXXA METALLIKA / KONTENITUR TAĊ- ĊOMB}
QUADRAMET, solution for injection
QUADRAMET, soluzzjoni għall- injezzjoni
STATEMENT OF THE ACTIVE SUBSTANCE(S)
DIKJARAZZJONI TAS- SUSTANZAATTIVA
Samarium [153Sm] lexidronam pentasodium (Corresponding to 20 to 46 µg/ ml of samarium)
(Li tikkorrespondi għal 20 sa 46 µg/ ml ta ’ samarium)
1.3 GBq/ ml at reference date.
1. 3 GBq/ ml fid- data ta ’ referenza
Total EDTMP (as EDTMP. H2O) Calcium-EDTMP sodium salt (as Ca) Total sodium (as Na) Water for injections
EDTMP totali (bħala EDTMP. H2O) Calcium- EDTMP sodium salt (bħala Ca) Sodju totali (bħala Na) Ilma għall- injezzjonijiet.
Solution for injection in a single-dose vial.
Taħlita likwida għall- injezzjoni fi fjala ta ’ doża waħda.
GBq/ vial,
GBq/ fjala,
Read package leaflet before use
Aqra l- fuljett ta ’ tagħrif qabel l- użu
For intravenous use
Użu għall ġol- vini.
Keep out of reach and sight of children
Żommu fejn ma jintlaħaqx u ma jidhirx mit- tfal.
OTHER SPECIAL WARNING
TWISSIJIJ( IET) SPEĊJALI OĦRA, JEKK MEĦTIEĠA
Store in a freezer at -10°C to -20°C in the original package
Aħżen fil- friża ftemperatura ta ’ - 10°C sa - 20°C fil- pakkett oriġinali
Use within 6 hours of thawing
Uża fi żmien 6 sigħat minn meta jinħall
Dispose of as radioactive waste in accordance with local law
Armi bħala fdal radjuattiv b’ mod konformi mal- liġi lokali
CIS bio international, Boîte Postale 32, 91192 GIF-SUR-YVETTE Cedex, FRANCE
CIS bio international, Boîte Postale 32, 91192 GIF- SUR- YVETTE Cedex, FRANZA
MARKETING AUTHORISATION NUMBER
NUMRU( I) TA 'L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
< Justification for not including Braille accepted >
< Il- Ġustifikazzjoni biex ma jkunx inkluż il- Braille hija aċċettata. >
15 MINIMUM PARTICULARS TO APPEAR ON SMALL INTERMEDIATE PACKAGING UNITS
15 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
GLASS VIAL
- KUNJETT TAL- ĦĠIEĠ
QUADRAMET, solution for injection Samarium [153Sm] lexidronam pentasodium For intravenous use
Użu għal ġol- vini
DD/ MM/ YYYY (12 h CET)
JJ/ XX/ SSSS( 12 h CET)
Manufacturer:
Manufattur:
QUADRAMET, solution for injection Samarium [153Sm] lexidronam pentasodium.
QUADRAMET, soluzzjoni għall- injezzjoni Samarium [153Sm] lexidronam pentasodium.
You may need to read it again.
Jista ’ jkollok bżonn terġa` taqrah.
- If you have any further questions, ask your doctor or your pharmacist.
Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
What QUADRAMET is and what it is used for 2.
X’ inhu QUADRAMET u għalxiex jintuża 2.
Before you take QUADRAMET 3.
Qabel ma tieħu QUADRAMET 3.
How to take QUADRAMET 4.
Kif għandek tieħu QUADRAMET 4.
How to store QUADRAMET 6.
Kif taħżen QUADRAMET 6.
WHAT QUADRAMET IS AND WHAT IT IS USED FOR
X’ INHU QUADRAMET U GĦALXIEX JINTUŻA
QUADRAMET is a medicinal product for therapeutic use only.
QUADRAMET huwa prodott mediċinali għal użu terapewtiku biss.
This radiopharmaceutical is used for the treatment of bone pain due to your disease.
Dan ir- radjufarmaċewtiku jintuża għall- kura tal- uġigħ fl- għadam minħabba l- marda tiegħek.
QUADRAMET has a high affinity for skeletal tissue.
QUADRAMET għandu affinità għolja għat- tessut skeletali.
Once injected it concentrates in bone lesions.
Meta jiġi injettat, ikun hemm konċentrazzjoni tiegħu fil- leżjonijiet ta ’ l- għadam.
Because QUADRAMET contains small amounts of a radioactive element, samarium-153, radiations are delivered locally to the bone lesions, allowing to develop the palliative action on bone pain.
Minħabba li QUADRAMET fih ammonti żgħar ta ’ l- element radjuattiv, samarium- 153, ir- radjazzjonijiet jingħataw lokalment fuq il- leżjonijiet ta ’ l - għadam, biex jittaffa l- uġigħ ta ’ l- għadam.
BEFORE YOU TAKE QUADRAMET
QABEL MA TIEĦU QUADRAMET
Do not take QUADRAMET:
Tieħux QUADRAMET
• If you are hypersensitive (allergic) to ethylene diamine tetramethylene phosphonic acid (EDTMP) or similar phosphonate compounds, • If you are pregnant, • If you have received chemotherapy or hemibody field external radiation therapy in a preceding period of 6 weeks.
• Jekk inti tbati minn sensittività eċċessiva (allerġija) għal ethylene diamine tetramethylene phosphonic acid (EDTMP) jew prodotti simili ta ’ komposti ta ’ phosphonate, • Jekk inti tqila, • Jekk irċevejt kimoterapija jew terapija ta ’ radjazzjoni esterna fuq nofs il- gisem matul perijodu preċedenti ta ’ 6 ġimgħat.
Take special care with QUADRAMET:
Oqgħod attent ħafna b’ QUADRAMET
QUADRAMET is not recommended for use in children below 18 years of age.
QUADRAMET mhux rakkomandat għal użu fi tfal li għandhom inqas minn 18- il sena.
Your doctor will take blood samples weekly for at least 8 weeks to check your platelets, white and red blood cell counts which may slightly decrease due to the therapy.
It- tabib tiegħek ser jeħodlok kampjuni tad- demm kull ġimgħa għal mill- inqas 8 ġimgħat, sabiex jiċċekkja l- għadd tal- plejtlits, u taċ- ċelluli bojod u ħomor tad- demm li jistgħu jonqsu kemmxejn minħabba l- kura.
During 6 hours following the injection of QUADRAMET, your physician will encourage you to drink and void as often as possible.
Matul l- ewwel 6 sigħat wara l- injezzjoni ta ’ QUADRAMET, it- tabib tiegħek ser iħajrek tixrob u tgħaddi l- awrina ta ’ spiss kemm jista ’ jkun.
He will decide at which time you will be authorised to leave the nuclear medicine department.
Huwa għandu jiddeċiedi f’ liema ħin inti tkun awtoriżżat toħroġ mid- dipartiment tal- mediċina nukleari.
18 In the case of urine incontinence or urinary obstruction you will get a urine catheter for about 6 hours.
18 Fil- każ ta ’ inkontinenza ta ’ l- awrina jew xi sadd fil- passaġġ ta ’ l- awrina, ikollok bżonn kateter ta ’ l - awrina għal madwar 6 sigħat.
For the other patients the urine should be collected for at least 6 hours.
Għall- pazjenti l- oħra, l- awrina għandha tinġabar għal mill- anqas 6 sigħat.
If your renal function is decreased, the amount of product will be adapted.
Jekk il- funzjoni tal- kliewi tiegħek hija mnaqqsa, l- ammont tal- prodott li tieħu għandu jiġi adattat għalik.
Taking other medicines:
Meta tieħu mediċini oħra
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines including medicines obtained without a prescription.
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
QUADRAMET must not be administered to pregnant women.
QUADRAMET ma għandux jingħata lil nisa tqal.
If QUADRAMET administration to a breastfeeding woman is deemed necessary, breastfeeding should be stopped.
Jekk jitqies neċessarju li jingħata QUADRAMET lil mara li qed tredda ’, din m’ għandiex tibqa tredda ’.
HOW TO TAKE QUADRAMET
KIF GĦANDEK TIEĦU QUADRAMET
Your doctor will want to carry out a special scan before administering QUADRAMET to ascertain whether you are likely to benefit from QUADRAMET.
It- tabib tiegħek se jkun irid jagħmillek skan speċjali qabel jagħtik QUADRAMET, sabiex jara jekk QUADRAMET jkunx ser jagħmillek ġid.
One single dose of 37 megabecquerel (Becquerel is the unit in which radioactivity is measured) of QUADRAMET per kilogram of body weight is to be injected.
Doża waħda ta ’ 37 megabecquerel (Becquerel huwa l- unità li biha titkejjel ir- radjuattività) ta ’ QUADRAMET għal kull kilogramm tal- piż tal- ġisem li għandu jiġi injettat.
If you have the impression that the effect of QUADRAMET is too strong or too weak, talk to your doctor or pharmacist.
Jekk inti għandek l- impressjoni li l- effett ta ’ QUADRAMET huwa qawwi wisq jew dgħajjef wisq, kellem lit- tabib jew lill- ispiżjar tiegħek.
Method and route of administration
Metodu u mnejn għandu jingħata
QUADRAMET is to be administered by slow injection into a vein.
QUADRAMET għandu jingħata permezz ta ’ injezzjoni ġol- vina li tingħata bil- mod.
Frequency of administration
Frekwenza ta ’ l- għotja tad- dożi
This medicinal product is not intended to be injected on a regular or continuous basis.
Dan il- prodott mediċinali mhuwiex intenzjonat li jiġi njettat fuq bażi regolari u kontinwa.
The administration can however be repeated after 8 weeks following injection, subject to the evolution of your disease.
Iżda d- doża tista ’ tiġi ripetuta wara 8 ġimgħat, skond l- evoluzzjoni tal- marda tiegħek.
You will be authorised to leave the nuclear medicine department after a dosimetric follow-up (generally within 6 hours following QUADRAMET injection).
Inti tiġi awtoriżżat toħroġ mid- dipartiment ta ’ mediċina nukleari wara li tiġi analizzat għad- dożimetrija (ġeneralment fi żmien 6 sigħat wara l- injezzjoni ta ’ QUADRAMET).
If you take more QUADRAMET than you should
19 Jekk tieħu QUADRAMET aktar milli suppost
QUADRAMET being supplied as a single-dose vial, an accidental overdose is unlikely to occur.
Billi QUADRAMET jiġi f’ kunjett ta ’ doża waħda, mhux probabbli li tieħu doża żejda b’ mod aċċidentali.
Radiation dose to the body can be limited by increasing fluid intake and frequent voiding of urine.
Id- doża ta ’ radjazzjoni fuq il- ġisem tista ’ tiġi mnaqqsa billi tinkoraġixxi t- teħid ta ’ fluwidi u l- iżvojtar ta ’ l- awrina ta ’ spiss.
Like all medicines, QUADRAMET can have side effects, although not everybody gets them.
Bħal kull mediċina oħra, QUADRAMET jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd
The undesirable effects due to QUADRAMET administration are linked with a decrease of red and white blood cells, and platelets.
L- effetti mhux mixtieqa minħabba l- għoti ta ’ QUADRAMET huma assoċjati ma ’ tnaqqis żgħir fiċ - ċelluli ħomor u bojod tad- demm, u fil- plejtlits.
Cases of bleeding have been reported, some of which have been serious.
Każijiet ta ’ emorraġija ġew irrapportati, u xi wħud minn dawn kienu serji.
This is the reason why your blood counts will be monitored strictly for a few weeks following QUADRAMET injection.
Din hija r- raġuni għala l- għadd tad- demm tiegħek ser jiġi eżaminat b’ mod strett għal ftit ġimgħat wara l- injezzjoni bi QUADRAMET.
You may exceptionally feel a slight increase in bone pain a few days after QUADRAMET injection.
B’ mod eċċeżżjonali, inti tista ’ tħoss żieda ħafifa fl- uġigħ ta ’ l- għadam ftit ġranet wara l- injezzjoni ta ’ QUADRAMET.
You should not be alarmed at this; in such case, your pain medicine will be slightly increased.
F’ każ bħal dan, il- kura li qed tieħu għall - uġigħ tiġi miżjuda xi ftit.
This effect is moderate and brief and will disappear after some hours.
Dan l- effett huwa moderat u qasir u għandu jmur wara ftit sigħat.
Adverse drug reactions such as nausea, vomiting, diarrhoea and sweating were reported.
Ġew irrapportati reazzjonijiet avversi tal- mediċina bħal tqalligħ, remettar, dijarea u għeriq.
Hypersensitivity reactions including rare cases of anaphylactic reaction have been reported after QUADRAMET administration.
Reazzjonijiet ta ’ sensittività eċċessiva li jinkludu każijiet rari ta ’ reazzjoni anafilattika ġew irrapportati wara li ngħata QUADRAMET.
In rare cases, the following undesirable effects have been observed: neuralgia, coagulation disorders, cerebrovascular accidents.
F’ każijiet rari, ġew osservati l- effetti mhux mixtieqa li ġejjin: nevralġija, problemi fil- koagulazzjoni u aċċidenti ċerebrovaskulari.
These effects were deemed to be related to the progression of the disease.
Dawn l- effetti ġew meqjusin li għandhom x’ jaqsmu mal- progress tal - marda.
If you experience back pain or sensory abnormalities, please inform your physician as soon as possible.
Jekk jkollok uġigħ fid- dahar jew problemi fis- sensi, jekk jogħġbok avża lit- tabib tiegħek kemm jista ’ jkun malajr.
HOW TO STORE QUADRAMET
KIF TAĦŻEN QUADRAMET
Do not use QUADRAMET after the expiry date which is stated on the label.
Tużax QUADRAMET wara d- data ta ’ skadenza li tidher fuq it- tikketta.
QUADRAMET expires 1 day from the activity reference time stated on the label.
QUADRAMET jiskadi wara ġurnata miż- żmien ta ’ referenza ta ’ l- attività indikat fuq it- tikketta.
Store at – 10°C to – 20°C in a freezer in its original packaging.
Aħżen fi friża f’ temperatura ta ’ – 10°C sa – 20°C fil- pakkett oriġinali tiegħu.
QUADRAMET should be used within 6 hours of thawing.
QUADRAMET għandu jintuża fi żmien 6 sigħat minn meta jinħall.
The product label includes the appropriate storage conditions and the expiry date for the batch of product.
20 It- tikketta tal- prodott tinkludi l- kundizzjonijiet ta ’ ħażna xierqa u d- data ta ’ skadenza għal- lott tal - prodott.
Hospital personnel will ensure that the product is stored correctly and not administered to you after the stated expiry date.
Il- personàl ta ’ l- isptar għandhom jiżguraw li l- prodott jiġi maħżun b’ mod korrett u ma jiġix mogħti lilek wara d- data ta ’ skadenza msemmija.
Storage procedures should be in accordance with national regulations for radioactive materials.
Il- proċeduri ta ’ ħażna għandhom ikunu konformi mar- regolamenti nazzjonali għal materjali radjuattivi.
FURTHER INFORMATION
X’ fih QUADRAMET
What QUADRAMET contains The active substance is samarium [153Sm] lexidronam pentasodium.
Is- sustanza attiva hi samarium [153Sm] lexidronam pentasodium.
Each ml of solution contains 1.3 GBq Samarium [153Sm] lexidronam pentasodium at the reference date (corresponding to 20-46 µg/ ml of samarium per vial).
Kull ml ta ’ soluzzjoni fih 1, 3 GBq Samarium [153Sm] lexidronam pentasodium fid- data ta ’ riferiment (li jikkorispondi għal 20- 46 µg/ ml of samarium kull kunjett)
The other ingredients are Total EDTMP (as EDTMP. H2O), calcium-EDTMP sodium salt (as Ca),
Is- sustanzi l- oħra huma EDTMP totali (bħala EDTMP. H2O), calcium- EDTMP sodium salt (bħala Ca) sodju totali (bħala Na), ilma għall- injezzjonijiet.
20 total sodium (as Na), water for injections.
Id- Dehra ta ’ QUADRAMET u l- kontenuti tal- pakkett:
What QUADRAMET looks like and contents of the pack QUADRAMET is a solution for injection.
QUADRAMET hu soluzzjoni għall- injezzjoni
This medicinal product is a clear, colourless to light amber solution which is packed in a 15 ml colourless European Pharmacopoeia Type I drawn glass vial closed with Teflon-coated chlorobutyl/ natural rubber stopper and aluminium flip-off overseal.
Il- prodott mediċinali huwa soluzzjoni ċara, mingħajr kulur għal ambra ċara li tiġi ppakkjata f’ kunjett mingħajr kulur tal- ħġieġ miġbud ta ’ Tip I tal- Farmakopea Ewropea b’ għatu ta ’ chlorobutyl/ lasktu naturali li għandu kisja tat- Teflon u tapp ta ’ l- aluminju li jista ’ jinqala ’ bis- suba ’
Each vial contains 1.5 ml (2 GBq at reference) to 3.1 ml (4 GBq at reference) of solution for injection.
Kull kunjett fih 1. 5 ml (riferiment ta ’ 2 GBq) sa 3. 1 ml (riferiment ta ’ 4 GBq) ta ’ soluzzjoni għall - injezzjoni.
The leaflet was last approved on ().
Dan il- fuljett kien approvat l- aħħar f ’.
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.
The following information is intended for medical or healthcare professionals only:
It- tagħrif li jmiss qed jingħata biss għal professjonisti fil- mediċina jew fil- qasam tas- saħħa:
For detailed information refer to the Summary of Product Characteristics of QUADRAMET.
Għal informazzjoni dettaljata rreferi għal Sommarju tal- Karatteristiċi tal- Prodott ta ’ QUADRAMET.
INSTRUCTIONS FOR USE, HANDLING AND DISPOSAL
STRUZZJONIJIET GĦALL- UŻU, MANIĠĠAR U GĦAR- RIMI
Read directions for use thoroughly before starting the preparation procedure.
Aqra l- istruzzjonijiet għall- użu sewwa qabel tibda l- proċedura ta ’ preparazzjoni.
All procedures should be conducted using aseptic techniques and standard precautions for handling radionuclides.
Il- proċeduri kollha għandhom jitwettqu billi jintużaw metodi asettiċi u billi jittieħdu l- prekawzjonijiet stàndard għall- immaniġġar tar- radjunuklidi.
Use of radiopharmaceutical agents
Użu ta ’ prodotti radjufarmaċewtiċi
Radiopharmaceuticals should only be used by qualified personnel with the appropriate government authorisation for the use and handling of radionuclides.
Ir- radjufarmaċewtiċi għandhom jintużaw biss minn personàl ikkwalifikat bl- awtorizzazzjoni xierqa tal- gvern għall- użu u maniġġar tar- radjunuklidi.
This radiopharmaceutical may be received, used and administered only by authorised persons in designated clinical settings.
Il- mod kif tirċievih, taħżnu,
Its receipt, storage, use, transfer and disposal are subject to the regulations and/ or appropriate licences of the local competent official organisations.
21 tużah, titrasferih u tarmih għandu jkunu skond ir- regolamenti u/ jew liċenzji xierqa ta ’ l - organizzazzjonijiet uffiċjali kompetenti lokali.
Radiopharmaceuticals should be prepared by the user in a manner which satisfies both radiation safety and pharmaceutical requirements.
Ir- radjufarmaċewtiċi għandhom jiġu ppreparati minn min ser jużhom b’ mod li jissodisfa kemm il - ħtiġijiet tas- sigurtà tar- radjazzjoni kif ukoll il- ħtiġijiet farmaċewtiċi.
Appropriate aseptic precautions should be taken, complying with the requirements of Good Manufacturing Practice for pharmaceuticals.
Għandhom jittieħdu prekawzjonijiet asettiċi xierqa, li jikkonformaw mal- ħtiġijiet tal - Prattika ta ’ Manifattura Tajba għall - prodotti farmaċewtiċi.
Method of preparation
Metodu ta ’ preparazzjoni
Allow the product to thaw at room temperature before administration.
Ħalli l- prodott jinħall fit- temperatura tal- kamra qabel ma jingħata.
It should be clear without particles.
Għandha tkun ċara mingħajr frak.
The operator should be careful to protect the eyes while inspecting the solution for clarity.
Wieħed għandu joqgħod attent li jipproteġi għajnejh waqt li jkun qiegħed jeżamina t - taħlita għaċ- ċarezza.
21 The activity should be measured by a dose calibrator immediately before administration.
L- attività għandha tiġi mkejla b’ kalibratur tad- dożi immedjatament qabel ma tingħata.
Verification of the dose to be administered and patient identification are necessary prior to administration of QUADRAMET.
Hemm bżonn li tiġi vverifikata d- doża li tkun ser tingħata u li tiġi vverifikata l- identifikazzjoni tal- pazjent qabel ma jingħata l- QUADRAMET.
Usual precautions regarding sterility and radioprotection should be respected.
Il- prekawzjonijiet normali dwar l- isterilità u r- radjuprotezzjoni għandhom jiġu rispettati.
The administration of radiopharmaceuticals creates risks to other persons from external radiation or contamination from spills of urine, vomiting etc.
L- għoti ta ’ radjufarmaċewtiċi joħloq riskji għal persuni oħra minn radjazzjoni esterna jew kontaminazzjoni minnħabba tixrid ta ’ l- awrina, remettar, eċċ.
For radiation safety reasons, the patient should be treated in a facility with the appropriate agreement for the therapeutic use of radioactive non-sealed sources.
Għal raġunijiet ta ’ sigurtà mir- radjazzjoni, il- pazjent għandu jiġi kkurat f’ postijiet xierqa għall- użu terapewtiku ta ’ prodotti radjuattivi mhux issiġillati.
He will be released when exposure rates comply with the limits prescribed by the regulations in force.
Huwa jitħalla jitlaq meta r- rati ta ’ l- espożizzjoni jikkonformaw mal- limiti preskritti bir- regolamenti fis- seħħ.
Radioactive waste must be disposed of in conformity with the relevant national and international regulations.
L- iskart radjuattiv għandu jintrema skond ir- regolamenti nazzjonali u internazzjonali relevanti.
ed EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR)
at RAPPORT TA ’ VALUTAZZJONI PUBBLIKA EWROPEW (EPAR)
QUINTANRIX
zz QUINTANRIX
ris EPAR summary for the public
ori Sommarju ta ’ l- EPAR għall- pubbliku
tho This document is a summary of the European Public Assessment Report (EPAR).
t aw Dan id- dokument huwa sommarju tar- Rapport ta ’ Valutazzjoni Pubblika Ewropew (EPAR).
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to
Huwa jispjega kif il- Kumitat għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ivvaluta l- istudji mwettqa, sabiex jaslu għar- rakkomandazzjonijiet tagħhom dwar kif tintuża l- mediċina.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Jekk inti teħtieġ aktar informazzjoni dwar il- kundizzjoni medika tiegħek jew it- trattament tiegħek, aqra l- Fuljett ta ’ Tagħrif (huwa parti wkoll mill- EPAR) jew ikkuntattja lit- tabib jew lill- ispiżjar
r of the EPAR).
ux tiegħek.
What is Quintanrix? ge lon Quintanrix is a vaccine, which is available as a powder and suspension to be made up into a suspension for injection.
Quintanrix huwa vaċċin, li jiġi bħala trab u sospensjoni li jitħallat f’ sospensjoni għal injezzjoni.
It contains the following active substances: toxoids (chemically weakened toxins) from diphtheria and tetanus, inactivated (killed) Bordetella pertussis (a bacterium that causes whooping cough), parts of the hepatitis B virus and polysaccharides (sugars) from the bacterium no
Fih is - ’ g ħ sustanzi attivi li ġejjin: tossojdi (tossini kimikament imdgħajjfin) minn difterite u tetnu, Bordetella pertussis inattivat (maqtul) (batterju li jikkaġuna sogħla konvulżiva), partijiet mill- virus ta ’ l- epatite B u polisakkaridi (zokkrijiet) mill- batterju Haemophilus influenzae tip b (‘ Hib ’, batterju li jikkaġuna im
Haemophilus influenzae type b (‘ Hib’, a bacterium that causes meningitis).
meninġite).
What is Quintanrix used for?
Għalxiex jintuża Quintanrix?
Quintanrix is used to vaccinate infants under one year of age against diphtheria, tetanus, pertussis t
Quintanrix jintuża għat- tilqim ta ’ trabi li għandhom inqas minn sena kontra difterite, tetnu, pertussi li l
It uc
(sogħla konvulżiva), epatite B u mard ‘ invażiv ’ ikkaġunat minn Hib (bħalma hija meninġite batterika).
is also used as a booster immunisation of young children during the second year of life.
Jintuża wkoll bħala tilqima buster għal fuq tfal żgħar matul it- tieni sena ta ’ ħajjithom.
It should be used according to official recommendations.
Għandu jintuża ina
The medicine can only be obtained with a prescription. rod
Il- mediċina tista ’ tinkiseb biss b’ riċetta tat- tabib.
How is Quintanrix used?
Kif jintuża Quintanrix? diċ
The recommended vaccination schedule for Quintanrix is three doses, given at intervals of at least four weeks within the first six months of life.
L- iskeda ta ’ tilqim irrakkomandata għal Quintanrix hija tliet dożi, mogħtija f’ intervalli ta ’ mill- inqas erba ’ ġimgħat matul l- ewwel sitt xhur ta ’ ħajja.
The lP
L- ewwel doża tista ’ tingħata fl- età ta ’ sitt ġimgħat.
After the first vaccination course, a booster should be given, preferably before the end of the second year of life.
Il - vaċċin jingħata b’ injezzjoni fil- fond ġo muskolu, preferibbilment fil- koxxa.
Quintanrix can also be used to boost previous vaccinations against diphtheria, tetanus and na
Wara l- ewwel kors ta ’ tilqim, għandu jingħata buster, preferibbilment qabel it- tieni sena tal- ħajja. me
pertussis, against hepatitis B or against Hib, when it should be given at least six months after the last dose of the first vaccination course.
Quintanrix jista ’ jintuża wkoll biex isaħħaħ tilqim preċedenti kontra difterite, tetnu u pertussi, kontra epatite B jew kontra Hib, meta għandu jingħata għallinqas sitt xhur wara l- aħħar doża ta ’ l- ewwel kors ta ’ tilqim.
Quintanrix can be given to children who received a hepatitis B vaccine at birth. i dic
Quintanrix jista ’ jingħata lil tfal li rċievew vaċċin kontra l- epatite B mat- twelid. ott
How does Quintanrix work?
Kif jaħdem Quintanrix?
Quintanrix is a vaccine.
Quintanrix huwa vaċċin.
Vaccines work by ‘ teaching’ the immune system (the body’ s natural defences) how to defend itself against diseases.
Il- vaċċini jaħdmu billi ‘ jgħallmu ’ lis- sistema immunitarja (id- difiżi naturali tal- ġisem) kif tiddefendi ruħha kontra l- mard.
Quintanrix contains small amounts of:
Quintanrix fih ammonti żgħar ta ’: od
Me
• tossojdi minn batterji li jikkaġunaw difterite u tetnu; • B. pertussis sħiħ maqtul; • polisakkaridi estratti mill - ‘ kapsuli ’ li jiċċirkndaw il- batterju Hib – il- polisakkaridi huma Pr
When an infant is given the vaccine, the immune system recognises the parts of the bacteria and viruses as ‘ foreign’ and makes antibodies against them.
Meta tarbija tingħata t- tilqima, is- sistema immunitarja tagħraf il- partijiet mill- batterji u virusijiet bħala ‘ barranin ’ u tagħmel antikorpi kontra tagħhom.