FrancophonIA/ELRC3.0 huggingface dataset:
English: Relapse rate derived variables / MRI-derived variables
Maltese: Progressjoni fl-EDSS Miri sekondarji Varjabbli derivati mir-rata ta' rkadar / varjabbli derivati millMRI
English: • The diluted medicinal product is to be used as soon as possible and within 8 hours of dilution.
Maltese: • Il-prodott mediċinali dilwit għandu jintuża mill-aktar fis possibbli u sa 8 sigħat mid-dilwizzjoni.
English: In addition to this leaflet you will be given a Patient Alert Card, which contains important safety information that you need to know before you are given TYSABRI (pronounced tie-SA-bree) and during treatment with TYSABRI.
Maltese: Minbarra dan il-fuljett inti se tingħata Kartuna ta' Allarm tal-Pazjent, li fiha informazzjoni importanti dwar is-sigurtà li inti teħtieġ li tkun taf qabel tingħata TYSABRI (ippronunċjat tie-SA-bree) u waqt kura b'TYSABRI.
English: Mean number of new or newlyenlarging T2-hyperintense lesions
Maltese: Kategorija ta' frekwenza Infezzjonijiet u infestazzjonijiet Infezzjoni fl-apparat tal-awrina Komuni
English: • Itchy rash (hives)
Maltese: • Tħossok mdardar (rimettar)
English: Symptoms of serious infections including:
Maltese: Sintomi ta' infezzjonijiet serji li jinkludu:
English: If the diluted medicinal product is stored at 2˚C - 8˚C (do not freeze), allow the solution to warm to room temperature prior to infusion.
Maltese: Jekk il-prodott mediċinali dilwit huwa maħżun f'2˚C - 8˚C (tiffriżax), ħalli is-soluzzjoni tilħaq it-temperatura tal-kamra qabel l-infużjoni.
English: VCAM-1, CS-1 and osteopontin that mediates the firm adhesion and transmigration of leukocytes into the brain parenchyma and may perpetuate the inflammatory cascade in CNS tissue.
Maltese: sess, funżjoni tal-fwied u tal-kliewi, u l-preżenza ta' antikorpi għal natalizumab fuq il-farmakokinetika.
English: • Each vial is for single-use only.
Maltese: • Kulur skur mhux tas-soltu ta' l-awrina.
English: After 2 years of treatment, patients should be reinformed about the risks of TYSABRI, especially the increased risk of Progressive Multifocal Leukoencephalopathy (PML), and should be instructed together with their caregivers on early signs and symptoms of PML.
Maltese: kura, il-pazjenti għandhom jiġu infurmati mill-ġdid dwar ir-riskji ta' TYSABRI, speċjalment dwar iżżjieda fir-riskju ta' Lewkoenċefalopatija Multifokali Progressiva (PML), u flimkien mal-persuni li jieħdu ħsiebhom għandhom jiġu mgħarrfa dwar is-sinjali u s-sintomi bikrija ta' PML.
English: EXP
Maltese: PML
English: • Information that atypical/opportunistic infections, in particular PML, may occur with TYSABRI and include: o That the risk of PML increases with increasing duration of treatment and that treatment beyond 24 months carries additional risk and other factors associated with an increased risk for the development of PML
Maltese: • Informazzjoni li infezzjonijiet mhux tipiċi/opportunistiċi, b'mod partikolari PML, jistgħu jseħħu b'TYSABRI inkluż:
English: Disruption of these molecular interactions prevents transmigration of mononuclear leukocytes across the endothelium into inflamed parenchymal tissue.
Maltese: L-alterazzjoni ta' dawn l-interazzjonijiet molekolari tipprevjeni it-transmigrazzjoni ta' lewkoċiti mononuklejari minn ġo l-endotilju għal ġot-tessut parenkemali nfjammat.
English: A group of symptoms caused by a serious infection of the brain including: - Changes in personality and behaviour such as confusion, delirium or loss of consciousness, seizures (fits), headache, nausea / vomiting, stiff neck, extreme sensitivity to bright light, fever, rash (anywhere on the body).
Maltese: Fl-esperjenza ta' wara t-tqegħid fis-suq, kien hemm rapporti ta' reazzjonijiet ta' sensittività eċċessiva li seħħew flimkien ma' wieħed jew aktar mis-sintomi li ġejjin: pressjoni baxxa, pressjoni għolja, uġigħ fis-sider, skomdu fis-sider, qtugħ ta' nifs, anġjoedima, flimkien ma' sintomi aktar komuni bħal raxx u utikarja.
English: Physicians should refer to the Physician Information and Management Guidelines for further information on managing the risk of PML in TYSABRI-treated patients.
Maltese: Gwida ta' Informazzjoni lit-Tabib u Mmaniġġjar għal aktar informazzjoni dwar l-immaniġġjar tar-riskju ta' PML f'pazjenti kkurati b'TYSABRI.
English: JC virus is a common virus which infects many people but does not normally cause noticeable illness.
Maltese: JC huwa virus komuni li jinfetta ħafna nies iżda normalment ma jikkawżax mard li jidher.
English: • If you are allergic to natalizumab or any of the other ingredients of this medicine (listed in section 6).
Maltese: • Jekk inti allerġiku għal natalizumab jew għal xi sustanza oħra ta' din il-mediċina (elenkati fis sezzjoni 6).
English: • Physician information about TYSABRI
Maltese: • Informazzjoni għat-tobba dwar TYSABRI
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Maltese: Tqala Studji fuq l-annimali wrew tossiċità fuq is-sistema riproduttiva (ara sezzjoni 5.3
English: After dilution for use, this medicinal product contains 17.7 mmol (or 406 mg) sodium per dose.
Maltese: Wara d-dilwazzjoni għall-użu, dan il-prodott mediċinali ikun fih 17.7 mmol (jew 406 mg) ta' sodium f'kull doża.
English: Natalizumab is a selective adhesion-molecule inhibitor and binds to the α4-subunit of human integrins, which is highly expressed on the surface of all leukocytes, with the exception of neutrophils.
Maltese: Natalizumab huwa inibitur selettiv tal-molekola ta' adeżjoni u jeħel mas-sotto-unità α4 tal-integrins umani, li jinstabu fi kwantità għolja fil-wiċċ tal-lewkoċiti kollha, bl-eċċezzjoni tan-newtrofili.
English: After dilution with sodium chloride 9 mg/ml (0.9%) solution for injection, immediate use is recommended.
Maltese: Wara d-dilwazzjoni b'sodium chloride 9 mg/ml (0.9%) soluzzjoni għall-injezzjoni, huwa rrakkomandat użu mmedjat.
English: o A stratification of the risk of developing PML based on the identified risk factors and presentation of the PML risk in a given time interval of treatment as well as the cumulative PML risk o Diagnosis and prognosis of symptomatic and asymptomatic PML differentiation between PML and MS
Maltese: Kura b'immunosoppressanti qabel l-użu ta' TYSABRI o Stratifikazzjoni tar-riskju ta' żvilupp ta' PML ibbażat fuq il-fatturi ta' riskju identifikati u l-preżentazzjoni tar-riskju ta' PML f'intervall ta' ħin partikulari ta' kura kif ukoll ir riskju kumulattiv ta' PML o Dijanjosi u l-pronjosi ta' sintomatika u asintomatika ta' PML divrenzjar bejn PML u MS
English: Randomised
Maltese: Tilqim
English: Natalizumab showed no effects on in vitro assays of α4-integrin-positive tumour line proliferation or cytotoxicity.
Maltese: Dawn l-istudji ma wrew l-ebda evidenza ta' effetti teratoġeniċi jew effetti fuq it-tkabbir tal-frieħ.
English: Before initiation of treatment with TYSABRI, a recent (usually within 3 months) MRI should be available as a reference, and be repeated at least on a yearly basis.
Maltese: Qabel ma tinbeda l-kura b'TYSABRI, għandu jkun disponibbli MRI riċenti (ġeneralment sa 3 xhur) bħala referenza, u dan għandu jiġi ripetut mill-inqas fuq bażi ta' kull sena.
English: Cases from published literature reported transient mild to moderate thrombocytopenia and anaemia observed in infants born to women exposed to TYSABRI in their third trimester of pregnancy.
Maltese: Każijiet mil-letteratura ppubblikata rrappurtataw li ġew osservati tromboċitopenija u anemija temporanji minn ħfief sa moderati fi trabi mwielda lil nisa esposti għal TYSABRI fit-tielet trimestru tat-tqala tagħhom.
English: If any doubt exists, further evaluation, including MRI scan preferably with contrast (compared with pre-treatment baseline MRI), CSF testing for JC Viral DNA and repeat neurological assessments, should be considered as described in the Physician Information and Management Guidelines (see educational guidance).
Maltese: Jekk ikun hemm xi dubji, għandu jiġi kkunsidrat li jsiru aktar eżamijiet, inluż scan ta' l-MRI preferibbilment b'kuntrast (imqabbel ma' MRI fil-linja bażi ta' qabel il-kura), l-eżaminazzjoni tas-CSF għal DNA Virali JC u ripetizzjoni ta' valutazzjonijiet newroloġiċi kif deskritt fl-Informazzjoni għat-Tabib u Linji Gwida għall-Immaniġġjar (ara gwida ta' edukazzjoni).
English: • Information about any registry or other monitoring system set up in the Member State and how to enter patients
Maltese: • Informazzjoni dwar kull reġistru jew sistema ta' sorveljanza oħra mwaqqfa fl-Istat Membru u kif jiddaħħlu l-pazjenti
English: Mean number of Gd-enhancing lesions
Maltese: Ilma għall-injezzjonijiet
English: • Severe anaemia (decrease in your red blood cells which can make your skin pale and can make you feel breathless or lacking energy)
Maltese: • Anemija severa (tnaqqis fl-għadd taċ-ċelluli ħomor fid-demm li jista' jagħmel il-ġilda tiegħek pallida u jista' jġiegħel li jħossok bi qtugħ ta' nifs jew b'nuqqas ta' enerġija).
English: Current evidence suggests that the risk of PML is low at an index equal to or below 0.9 and increases substantially above 1.5 for patients who have been on treatment with TYSABRI for longer than 2 years (see the Physician Information and Management Guidelines for further information).
Maltese: Evidenza kurrenti tissuġġerixxi li r-riskju ta' PML hu baxx f'indiċi daqs jew inqas minn 0.9, u jiżdied b'mod sostanzjali f'indiċi ta' aktar minn 1.5 għal pazjenti li kienu fuq kura b'TYSABRI għal aktar minn sentejn (ara l-Linji Gwida ta' Informazzjoni lit-Tabib u Mmaniġġjar għal aktar informazzjoni).
English: This should be considered if you are on a controlled sodium diet.
Maltese: Dan għandu jiġi kkunsidrat minn pazjenti fuq dieta ta' sodium ikkontrollat.
English: Vomiting
Maltese: Pharma
English: The diluted medicinal product is to be used as soon as possible and within 8 hours of dilution.
Maltese: Il-prodott mediċinali dilwit għandu jintuża mill-aktar fis possibbli u sa 8 sigħat mid-dilwizzjoni.
English: Data from clinical trials, a prospective pregnancy registry, post-marketing cases and available literature do not suggest an effect of TYSABRI exposure on pregnancy outcomes.
Maltese: Dejta minn provi kliniċi, reġistru prospettiv tat-tqala, każijiet ta' wara t-tqegħid fis-suq u l-letteratura disponibbli, ma jissuġġerixxux effett ta' esponiment ta' TYSABRI fuq ir-riżultati tat-tqala.
English: A further mechanism of action of natalizumab may be to suppress ongoing inflammatory reactions in diseased tissues by inhibiting the interaction of α4-expressing leukocytes with their ligands in the extracellular matrix and on parenchymal cells.
Maltese: Natalizumab ma wera l-ebda effett ta' proliferazzjoni jew ċitotossiċità fuq testijiet in vitro b'razzez ta' ċelluli tat-tumur pożittivi għal α4-integrin.
English: Events reported more commonly with natalizumab than with placebo included dizziness, nausea, urticaria and rigors.
Maltese: Episodji rrappurtati aktar komuni b'natalizumab milli bil-plaċebo inkludew sturdament, tqalligħ, urtikarja u rogħda ta' bard.
English: Tel: +386 1 511 02 90
Maltese: Biogen Pharma d.o.o. Tel: +386 1 511 02 90
English: NAME OF THE MEDICINAL PRODUCT TYSABRI 300 mg concentrate for solution for infusion natalizumab
Maltese: Informazzjoni għall-pazjent TYSABRI 300 mg konċentrat għal soluzzjoni għall-infużjoni natalizumab
English: Progression on EDSS
Maltese: Gwida ta' edukazzjoni
English: The treatment continuation form should contain the elements of the treatment initiation form and, in addition, a statement that the risks of PML increase with duration of treatment and that treatment beyond 24 months carries additional risk.
Maltese: Il-formola ta' kontinwazzjoni tal-kura għandu jkun fiha l-elementi tal-formola tal-bidu tal-kura u barra dan, dikjarazzjoni li r-riskji ta' PML jiżdiedu mat-tul tal-kura u li kura ta' aktar minn 24 xahar għandha riskju addizzjonali.
English: PHARMACEUTICAL FORM AND CONTENTS concentrate for solution for infusion 1 x 15 ml vial
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT konċentrat għal soluzzjoni għall-infużjoni
English: − Prolonged dizziness
Maltese: Reazzjonijiet allerġiċi
English: A study in pregnant cynomolgus monkeys demonstrated natalizumab-related changes in the foetus that included mild anaemia, reduced platelet counts, increased spleen weights and reduced liver and thymus weights.
Maltese: Xi infezzjonijiet oħrajn minbarra PML jistgħu jkunu serji wkoll u jiżviluppaw minħabba viruses, batterji, jew kawżi oħrajn.
English: Testing for serum anti-JCV antibody prior to initiating TYSABRI therapy or in patients receiving the medicinal product with an unknown antibody status is recommended.
Maltese: Huwa rrakkomandat ittestjar għal antikorpi kontra JCV fis-serum qabel tinbeda t-terapija b'TYSABRI jew f'pazjenti li qed jirċievu l-prodott mediċinali li għandhom stat ta'
English: In anti-JCV antibody positive TYSABRI treated patients who have not used prior immunosuppressants the level of anti-JCV antibody response (index) is associated with the level of risk for PML.
Maltese: F'pazjenti li jkunu pożittivi għal antikorpi kontra JCV, ikkurati b'TYSABRI, li ma jkunux użaw terapija b'immunosoppressanti fil-passat, il-livell ta' rispons ta' antikorpi kontra JCV (indiċi) hu assoċjat mal-livell ta' riskju għal PML.
English: NAME OF THE MEDICINAL PRODUCT TYSABRI 300 mg concentrate for solution for infusion
Maltese: TYSABRI 300 mg konċentrat għal soluzzjoni għall-infużjoni
English: • That TYSABRI therapy is to be initiated and continuously supervised by specialised physicians experienced in the diagnosis and treatment of neurological conditions, in centres with timely access to MRI.
Maltese: • Li t-terapija b'TYSABRI għandha tinbeda u tiġi sorveljata kontinwament minn tobba speċjalizzati b'esperjenza fid-dijanjosi u l-kura ta' kundizzjonijiet newroloġiċi, f'ċentri b'aċċess f'waqtu għal MRI.
English: Patients should have had at least 1 relapse in the previous year while on therapy, and have at least 9 T2-hyperintense lesions in cranial Magnetic Resonance Image (MRI) or at least 1 Gadolinium-enhancing lesion.
Maltese: Ilpazjenti ried ikollhom minn ta' l-inqas episodju wieħed ta' rkadar fis-sena ta' qabel waqt li kienu qed jirċievu t-terapija, u minn ta' l-inqas 9 leżjonijiet T2 iperintensi f'Magnetic
English: Intravenous use.
Maltese: natalizumab.
English: PML should be considered as a differential diagnosis in any MS patient taking TYSABRI presenting with neurological symptoms and/or new brain lesions in MRI.
Maltese: Għandhom ikunu disponibbli riżorsi għall-immaniġġjar ta' reazzjonijiet ta' sensitività eċċessiva u aċċess għall-MRI.
English: The highest incidence of adverse reactions identified from placebo-controlled trials in multiple sclerosis patients with natalizumab given at the recommended dose, are reported as dizziness, nausea, urticaria and rigors associated with infusions.
Maltese: L-ogħla inċidenza ta' reazzjonijiet avversi identifikati minn provi kkontrollati bil-plaċebo b'natalizumab mogħti bid-doża rrakkomandata f'pazjenti bi sklerożi multipla, huma rrappurtati bħala sturdament, tqalligħ, urtikarja u rogħda ta' bard assoċjati mal-infużjonijiet.
English: TYSABRI is indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following patient groups:
Maltese: TYSABRI huwa indikat bħala monoterapija li timmodifika l-marda fi sklerożi multipla attiva ħafna li tirkada u tbatti għall-ġruppi ta' pazjenti li ġejjin:
English: Tel.: +48 22 351 51 00
Maltese: Biogen Poland Sp. z o.o. Tel.: +48 22 351 51 00
English: In post-marketing experience, there have also been reports of eosinophilia (eosinophil count >1,500/mm3) without clinical symptoms.
Maltese: (għadd ta' eżinofili >1,500/mm3) mingħajr sintomi kliniċi.
English: There have been cases of a rare brain infection called PML (progressive multifocal leukoencephalopathy) that have occurred in patients who have been given TYSABRI.
Maltese: Kien hemm każijiet ta' infezzjoni rari tal-moħħ imsejjħa PML (lewkoenċefalopatija multifokali progressiva) li seħħew f'pazjenti li ngħataw TYSABRI.
English: • You must not use TYSABRI if you are being treated with other medicines to treat your MS, such as beta-interferons or glatiramer acetate.
Maltese: • M'għandekx tuża TYSABRI jekk qed tiġi kkurat b'mediċini oħra għall-kura ta' MS, bħal beta-interferons jew glatiramer acetate.
English: Frequency category
Maltese: KLASSIFIKAZZJONI ĠENERALI
English: • Dizziness
Maltese: • Tertir
English: The interaction between α4β1 and its targets is an important component of pathological inflammation in the brain and disruption of these interactions leads to reduced inflammation.
Maltese: L-interazzjoni bejn α4β1 u l-miri tagħha hija parti importanti tal-infjammazzjoni patoloġika fil-moħħ u disintegrazzjoni ta' dawn l-interazzjonijiet twassal għal tnaqqis fl-infjmmazzjoni.
English: The MAH shall implement agreed measures for monitoring within a time frame agreed with the National Competent Authorities.
Maltese: Wara diskussjonijiet u ftehim mal-Awtoritajiet Kompetenti Nazzjonali f'kull Stat Membru fejn
English: Instructions for use:
Maltese: Kunjett mhux miftuħ:
English: A benefit-risk evaluation of the use of TYSABRI during pregnancy should take into account the patient's clinical condition and the possible return of disease activity after stopping the medicinal product.
Maltese: Evalwazzjoni dwar il-benefiċċju-riskju tal-użu ta' TYSABRI matul it-tqala għandha tikkunsidra l-kundizzjoni klinika tal-pazjenta u r-ritorn possibbli tal-attività tal-marda wara li tieqaf tieħu il-prodott mediċinali.
English: In these cases the presence of antibodies should be evaluated and if these remain positive in a confirmatory test after at least 6 weeks, treatment should be discontinued, as persistent antibodies are associated with a substantial decrease in efficacy of TYSABRI and an increased incidence of hypersensitivity reactions (see section 4.8).
Maltese: F' dawn il-każijiet l-preżenza ta' dawn l-antikorpi għandha tiġi evalwata u jekk din tibqa pożittiva f'test ta' konferma wara tal-inqas 6 ġimgħat, il-kura għandha titwaqqaf, la darba anti korpi persistenti huma assoċjati ma tnaqqis sostanzjali f' l-effikaċja ta' TYSABRI u iżid iċ-ċans ta' reazzjonijiet ta' sensittività eċċessiva (Ara sezzjoni 4.8).
English: Urinary tract infection
Maltese: EFFIKAĊI TAL-PRODOTT MEDIĊINALI
English: The full EPAR for Optimark can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The active substance in Optimark, gadoversetamide, contains gadolinium, a ‘rare-earth' metal element.
Maltese: Is-sustanza attiva f'Optimark, il-gadoversetamide, fiha l-gadolinju, element metalliku rari 'rare-earth'.
English: The recommended dose is 0.2 ml per kilogram body weight.
Maltese: Id-doża rakkomandata hija 0.2 ml għal kull kilo tal-piż tal-ġisem.
English: Other information about Optimark:
Maltese: Informazzjoni oħra dwar Optimark:
English: This is a summary of the European public assessment report (EPAR) for Optimark.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Optimark.
English: NSF causes thickening of the skin and connective tissues.
Maltese: L-NSF tikkaġuna tħaxxin fil-ġilda u fit-tessuti konnettivi.
English: This compared with an increase of 0.66 points with the comparator contrast agent, from a baseline of 1.60 points.
Maltese: Dan tqabbel ma' żieda simili ħafna ta' 0.66 punti mal-aġent ta' kuntrast komparatur, minn linja ta' bażi ta' 1.60 punti.
English: In the studies of liver abnormalities, both medicines increased the score by an average of 0.38 points from a baseline of 1.82 points.
Maltese: Fl-istudji fuq l-anormalitajiet fil-fwied, iż-żewġ mediċini żiedu l-punteġġ b'medja ta' 0.38 punti minn linja ta' bażi ta' 1.82 punti.
English: Once injected, gadolinium interacts with the water molecules.
Maltese: Ġaladarba jiġi injettat, il-gadolinju jinteraġixxi mal-molekuli tal-ilma.
English: Each scan's clarity was scored on a four-point scale.
Maltese: Iċċarezza ta' kull skann ngħatat punteġġ fuq skala b'erba' punti.
English: Optimark has been studied in four main studies involving a total of 804 patients who had or were thought to have abnormalities in the brain or spine (two studies in 401 patients) or in the liver (two studies in 403 patients).
Maltese: Optimark ġie studjat f'erba' studji ewlenin fuq total ta' 804 pazjenti li kellhom jew li kien hemm suspett li seta' kellhom xi anormalitajiet fil-moħħ jew fis-sinsla (żewġ studji fuq 401 pazjent) jew fil-fwied (żewġ studji fuq 403 pazjenti).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Optimark on 23 July 2007.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Optimark valida fl-Unjoni Ewropea kollha fit-23 ta' Lulju 2007.
English: It is used in adults and in children from two years of age who are undergoing magnetic resonance imaging (MRI), a type of scan where images of the internal organs are taken.
Maltese: Jintuża fuq adulti u fuq tfal minn sentejn 'il fuq li tkun ser issirilhom immaġni b'reżonanza manjetika (MRI), li hija tip ta' skann li tiġbed immaġni tal-organi interni.
English: What is the risk associated with Optimark?
Maltese: X'inhuma r-riskji assoċjati ma' Optimark?
English: Optimark is a solution for injection that contains the active substance gadoversetamide.
Maltese: Optimark huwa soluzzjoni għall-injezzjoni li fiha s-sustanza attiva gadoversetamide.
English: It must not be used in patients who have severely reduced kidney function, in patients who have had or are about to have a liver transplant, or in babies aged less than four weeks, due to a risk of a condition called nephrogenic systemic fibrosis (NSF).
Maltese: M'għandux jintuża minn pazjenti li kellhom tnaqqis serju fil-funzjoni tal-kliewi, minn pazjenti li kien sarilhom jew li jkun ser isirilhom trapjanat tal-fwied, jew minn trabi taħt l-erba' ġimgħat, minħabba riskju ta' kundizzjoni msejħa ‘fibrożi sistemika nefroġenika' (NSF).
English: In the two studies of brain and spine abnormalities taken together, scans taken with Optimark had a score increase of 0.63 points on average from a ‘baseline' of 1.58 points without Optimark.
Maltese: Fiż-żewġ studji fuq l-anormalitajiet tal-moħħ u tas-sinsla meħudin flimkien, l-iskannijiet meħuda b'Optimark kellhom żieda medja ta' 0.63 punti fil-punteġġ minn 'linja ta' bażi' ta' 1.58 punti mingħajr Optimark.
English: The most common side effects with Optimark (seen in between 1 and 10 patients in 100) are headache, dysgeusia (taste disturbances) and feeling hot. For the full list of all side effects reported with Optimark, see the package leaflet.
Maltese: L-effetti sekondarji l-iktar komuni ta' Optimark (li dehru f'bejn pazjent wieħed u 10 minn kull 100) huma wġigħ ta' ras, diżgewsija (disturbi fit-togħma) u sħanat.
English: What is Optimark?
Maltese: Kif jaħdem Optimark?
English: Optimark allows images to be taken for up to an hour after it has been injected, although the best time to take a scan depends on the location and type of abnormality that is being examined.
Maltese: Optimark jippermetti li jittieħdu immaġnijiet sa massimu ta' siegħa wara li jkun ġie injettat, għalkemm l-aħjar ħin biex isir skann jiddependi mill-post u mit-tip ta' anormalità li tkun qed tiġi eżaminata.
English: The scans were analysed by three radiologists (doctors specialised in carrying out and interpreting scans of the body).
Maltese: L-iskannijiet ġew analizzati minn tliet radjologi (tobba li jispeċjalizzaw fit-twettiq u fl-interpretazzjoni tal-iskannijiet tal-ġisem).
English: Patients who have moderate problems with their kidneys should only receive Optimark if their doctor has carefully balanced the benefits and risks of using it.
Maltese: Jenħtieġ li l-pazjenti li jkollhom problemi moderati fil-kliewi jingħataw Optimark biss jekk it-tabib tagħhom ikun qies bir-reqqa l-benefiċċji u r-riskji tal-użu tiegħu.
English: In Optimark, the gadolinium is attached to another chemical so that the metal is not released in the body but stays ‘trapped' until it is eliminated from the body in the urine.
Maltese: F'Optimark, il-gadolinju jeħel ma' sustanza kimika oħra sabiex il-metall ma jiġix rilaxxat fil-ġisem u jibqa' ‘maqbud' sakemm jitneħħa mill-ġisem mal-urina.