FrancophonIA/ELRC3.0 huggingface dataset:
English: More than 80% of the administered sulphur hexafluoride was recovered in exhaled air within 2 minutes after injection and almost 100% after 15 minutes.
Maltese: Iktar minn 80% tal-eżafluworur talkubrit li ngħata kien irkuprat fl-arja li toħroġ man-nifs sa 2 minuti wara l-injezzjoni, u kważi 100% wara 15 il minuta.
English: Intravenous use of SonoVue is contraindicated in patients known to have right-to-left shunts, severe pulmonary hypertension (pulmonary artery pressure >90 mmHg), uncontrolled systemic hypertension, and in patients with adult respiratory distress syndrome.
Maltese: L-użu ta' SonoVue ġol-vini hu kontraindikat f'pazjenti li hu magħruf li għandhom shunts mil-lemin għax-xellug, pressjoni għolja pulmonari severa (pressjoni ta' l-arterja pulmonari > 90 mmHg), pressjoni għolja sistemika mhux ikkontrollata, u f'pazjenti bis-sindrome ta' diffikultà respiratorja ta' l-adulti.
English: Type I colourless glass vial containing 25 mg of dry, lyophilised powder in an atmosphere of sulphur hexafluoride closed with a grey butyl rubber stopper and sealed with an aluminium crimp seal with a flip-off disc. A transfer system ( MiniSpike ).
Maltese: Kunjett tal-ħġieġ mingħajr kulur tat-Tip I li fih 25 mg ta' trab xott u lajofilizzat f'atmosfera ta' eżafluworur tal-kubrit magħluq b'tapp griż tal-lastiku tal-butyl u ssiġillat b'siġill tennej tal-aluminju b'għatu tat-tip flip-off.
English: • Vascular Doppler imaging: 2.4 mL.
Maltese: • Immaġni vaskulari bid-Doppler:
English: For ultrasonography of the excretory urinary tract in paediatric patients, after intravesical administration, SonoVue increases the signal intensity of fluids within the urethra, bladder, ureters, and renal pelvis, and facilitates the detection of reflux of fluid from the bladder into the ureters.
Maltese: Għal ultrasonografija tal-apparat urinarju eskretorju f'pazjenti pedjatriċi, wara għoti intravessikali, SonoVue jżid l-intensità tas-sinjal tal-fluwidi fl-uretra, fil-bużżieqa tal-awrina, fl-ureteri, u fil-pelvi renali, u jiffaċilita d-detezzjoni ta' rifluss ta' fluwidi mill-bużżieqa tal-awrina għal ġol-ureteri.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/177/002
Maltese: NUMRU(I) TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/01/177/002
English: Nausea, Abdominal pain
Maltese: Dardir, uġigħ addominali
English: SonoVue should be administered immediately by injection into a peripheral vein for use in echocardiography and in vascular Doppler imaging in adults or by intravesical administration for use in ultrasonography of the excretory urinary tract in paediatric patients.
Maltese: SonoVue għandu jingħata immedjatament permezz ta' injezzjoni f'vina perferali sabiex jintuża f'ekokardjografija jew f'immaġni Doppler vaskulari fl-adulti jew b'amministrazzjoni intravessikali għal użu f'ultrasonografija tal-passaġġ urinarju eskretorju f'pazjenti pedjatriċi.
English: ** In some of the cases of hypersensitivity, in patients with underlying coronary artery disease, myocardial ischemia and/or myocardial infarctions were also reported.
Maltese: ** F'xi każijiet ta' sensittività eċċessiva, il-pazjenti b'mard ta' l-arterji koronarja eżistenti minn qabel, iskemija mijokardijaku u/jew infart mijokardijaku kienu rapportati wkoll.
English: Talk to your doctor before you are given SonoVue if: - you had a recent myocardial infarction or a recent surgery on your coronary arteries, - you suffer from angina or chest pain or severe cardiac disease, - you suffer from severe heart rhythm disorders, - your cardiac disease has worsened recently, - you have an acute inflammation of the cardiac envelope (endocarditis), - you have artificial heart valves, - you have an acute general inflammation or infection, - you have known blood clotting problem, - you have severe kidney or liver diseases,
Maltese: Kellem lit-tabib tiegħek qabel ma tingħata SonoVue jekk: - kellek infart mijokardijaku riċenti jew kirurġija riċenti fl-arterji koronarji tiegħek, - tbati minn anġina jew uġigħ fis-sider jew mard kardijaku sever, - tbati minn disturbi severi fir-ritmu tal-qalb, - il-mard kardijaku tiegħek għadda għall-agħar, - għandek infjammazzjoni akuta tal-envelop kardijaka (endokarditè), - għandek valvi tal-qalb artifiċjali, - għandek infjammazzjoni ġenerali akuta jew infezzjoni, - għandek problema magħrufa ta' emboliżmu, - għandek mard sever tal-kliewi jew tal-fwied,
English: How to store SonoVue
Maltese: X'fih SonoVue
English: Use extreme caution when considering the administration of Sonvue in patients with recent acute coronary syndrome or clinically unstable ischaemic cardiac disease, including: evolving or ongoing myocardial infarction, typical angina at rest within last 7 days, significant worsening of cardiac symptoms within last 7 days, recent coronary artery intervention or other factors suggesting clinical instability (for example, recent deterioration of ECG, laboratory or clinical findings), acute cardiac failure, Class III/IV cardiac failure, or severe rhythm disorders because in these patients allergy like and/or vasodilatory reactions may lead to life threatening conditions.
Maltese: Uża l-akbar attenzjoni meta tikkonsidra biex tamministra SonoVue f'pazjenti b'sindromu koronarju akut riċenti jew mard kardijaku iskemiku instabbli, li jinkludi infart mijokardijaku li jevolvi jew għaddej, anġina normali waqt is-serħan fi żmien l-aħħar 7 ijiem, tħarrix sinifikanti tas-sintomi kardijaċi fi żmien l-aħħar 7 ijiem, intervent fl-arterja koronarja riċenti jew fatturi oħra li jissuġerixxu instabilità klinika (pereżempju, deterjorazzjoni riċenti tal-ECG, riżultati tal-laboratorju jew kliniċi), falliment kardijaku akut, falliment kardijaku ta' Klassi
English: SonoVue contains sodium
Maltese: Kif jidher SonoVue u l-kontenut tal-pakkett
English: • B-mode imaging of cardiac chambers, at rest or with stress: 2 mL.
Maltese: • Immaġni B-mode tal-kompartimenti tal-qalb, waqt l-pazjent ikun mistrieħ jew waqt li jkun taħt stress:
English: This medicinal product contains less than 1 mmol sodium (23mg) per dose, i.e. essentially ‘sodiumfree'.
Maltese: Dan il-prodott mediċinali fih inqas minn 1 mmol ta' sodju (23 mg) kull doża, jiġifieri essenzjalment ‘ħieles mis-sodju'.
English: PHARMACEUTICAL FORM AND CONTENTS 1 powder vial, 1 pre-filled syringe of solvent, 1 transfer system
Maltese: 1 siringa mimlija għal-lest bis-solvent 1 sistema ta' trasferiment
English: The recommended doses of SonoVue in adults are:
Maltese: Id-dożi rakkomandati ta' SonoVue fl-adulti huma:
English: After introduction of a sterile 6F-8F urinary catheter into the bladder under sterile conditions, the bladder is emptied of urine and then filled with saline (normal sterile 0.9% sodium chloride solution) to approximately one third or half of its predicted total volume [(age in years + 2) x 30] mL.
Maltese: Wara l-introduzzjoni ta' katiter urinarju sterili 6F-8F fil-bużżieqa tal-awrina taħt kundizzjonijiet sterili, il-bużżieqa titbattal mill-awrina u mbagħad timtela bis-salina (soluzzjoni sterili normali ta' 0.9% klorur tas-sodju) għal madwar terz jew nofs il-volum totali mbassra tagħha [(età fi snin + 2) x 30] mL.
English: After emptying the bladder, a saline solution will be introduced into the bladder via a thin tube.
Maltese: Wara li titbattal il-bużżieqa tal-awrina, tiġi introdotta soluzzjoni salina fil-bużżieqa tal-awrina permezz ta' tubu rqiq.
English: In clinical trials, the most commonly reported adverse reactions after intravenous administration are: headache, injection site reaction, and nausea.
Maltese: Fil-provi kliniċi, l-aktar reazzjonijiet avversi rrapportati b'mod komuni wara l-għoti ġol-vini huma: uġigħ ta' ras, reazzjoni fis-sit tal-injezzjoni, u dardir.
English: NAME OF THE MEDICINAL PRODUCT SonoVue 8 microlitres/mL powder and solvent for dispersion for injection
Maltese: IL-PRODOTT MEDIĊINALI SonoVue, 8 mikrolitri / mL trab u solvent għal dispersjoni għall-injezzjoni.
English: SonoVue increases the quality of the Doppler flow image and the duration of clinically-useful signal enhancement in portal vein assessment in adult patients.
Maltese: SonoVue jżid il-kwalità ta' l-immaġni ta' l-influss Doppler u t-tul ta' ħin tat-titjib tas-sinjal b'mod li jkun klinikament utli fl-evalwazzjoni tal-vina portali fil-pazjenti adulti.
English: Method of administration For instructions on reconstitution of the medicinal product before administration see section 6.6 .
Maltese: Metodu ta' kif għandu jingħata Għal struzzjonijiet dwar ir-rikostituzzjoni tal-prodott mediċinali qabel l-għoti ara sezzjoni 6.6.
English: In animal studies, the application of echo-contrast agents revealed biological adverse reactions (e.g. endothelial cell injury, capillary rupture) by interaction with the ultrasound beam.
Maltese: Fi studji fuq l-annimali, l-applikazzjoni ta' sustanzi tal-kuntrast-eku żvelaw reazzjonijiet avversi bijoloġiċi (eż. korriment endoteljali taċ-ċelluli, ftuq kapillari) permezz ta' interazzjoni b'raġġ ultrasoniku.
English: ECG monitoring should be performed in high-risk patients as clinically indicated.
Maltese: Monitoraġġ bl-ECG għandu jsir f'pazjenti li għandhom riskju għoli kif indikat klinikament.
English: SonoVue 8 microlitres/mL powder and solvent for dispersion for injection sulphur hexafluoride
Maltese: SonoVue 8 microlitri/mL trab u solvent għad-dispersjoni għall-injezzjoni eżafluworur tal-kubrit
English: It should be emphasised that stress echocardiography not only can induce an ischaemic episode but also the stressors may induce predictable, dose-dependent effects on the cardiovascular system (e.g., increase in heart rate, blood pressure and ventricular ectopic activity for dobutamine, or decrease in blood pressure for adenosine and dipyridamole) as well as unpredictable, hypersensitivity reactions.
Maltese: Għandu jiġi enfasizzat li ekokardjografija taħt stress, mhux biss tista' tqanqal episodju iskemiku, imma l-istressuri jistgħu jqanqlu effetti prevedibbli, dipendenti fuq id-doża fuq is-sistema kardjovaskulari (eż. żieda fir-rata li biha tħabbat il-qalb, pressjoni tad-demm u attività ventrikulari etopika għal dobutamine, jew tnaqqis fil-pressjoni tad-demm għal adenosine u dipyridamole) kif ukoll reazzjonijiet ta' sensittività eċċessiva mhux prevedibbli.
English: SonoVue is a transpulmonary echocardiographic contrast agent for use in adult patients with suspected or established cardiovascular disease to provide opacification of cardiac chambers and enhance left ventricular endocardial border delineation.
Maltese: SonoVue hu sustanza tal-kuntrast ekokardjografiku transpulmonari għall-użu f'pazjenti adulti fejn hemm suspett ta' mard kardjovaskolari, jew mard kardjovaskolari li kien stabbilit, biex jipprovdi l-opakifikazzjoni tal-kompartimenti tal-qalb u jtejjeb id-delineazzjoni tal-fruntiera endokardjali ventrikulari tax-xellug.
English: Caution is advisable when administering the product to patients with: acute endocarditis, prosthetic valves, acute systemic inflammation and/or sepsis, hyperactive coagulation states and/or recent thromboembolism, and end-stage renal or hepatic disease, as the numbers of patients with those conditions who were exposed to SonoVue in the clinical trials were limited.
Maltese: Għandha tingħata attenzjoni meta dan il-prodott jingħata lil pazjenti b':endokardite akuta, valvoli prostetiċi, infjammazzjoni sistemika akuta u/jew sepsis, stati iperattivi tal-koagulazzjoni u/jew tromboemboliżmu riċenti u mard tal-kliewi jew tal-fwied li jkun fl-aħħar stadju, minħabba li l-għadd ta' pazjenti b'dawk il-kundizzjonijiet li kienu esposti għal SonoVue fil-provi kliniċi kien wieħed limitat.
English: SonoVue must be prepared before use by injecting through the septum 5 mL of sodium chloride 9 mg/mL (0.9%) solution for injection to the contents of the vial.
Maltese: SonoVue għandu jiġi ppreparat qabel ma jintuża billi tinjetta minn ġos-septum 5 mL ta' sodium chloride 9 mg/mL (0.9%) soluzzjoni għall-injezzjoni mal-kontenut tal-kunjett.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 25 mg powder
Maltese: INDIVIDWALI 25 mg ta' trab.
English: As a precautionary measure, it is preferable to avoid the use of SonoVue during pregnancy.
Maltese: Bħala miżura prekawzjonarja, huwa preferibbli li tevita l-użu ta' SonoVue waqt it-tqala.
English: The presence or absence of vesicoureteral reflux with SonoVue ultrasound was compared to the radiographic reference standard.
Maltese: Il-preżenza jew in-nuqqas ta' rifluss vesikureterali permezz ta' ultrasound b'SonoVue tqabbel mal-istandard radjografiku ta' referenza.
English: There are literature reports of the use of the gas in the study of respiratory physiology and in pneumatic retinopexy.The addition of sodium chloride 9 mg/mL (0.9%) solution for injection to the lyophilised powder followed by vigorous shaking results in the production of the microbubbles of sulphur hexafluoride.
Maltese: Iż-żieda ta' sodium chloride 9 mg/mL (0.9%) soluzzjoni għall-injezzjoni mat-trab lyophilisate segwita minn tħawwid bis-saħħa jwassal għall-produzzjoni ta' bżieżaq żgħar ta' eżafluworur tal-kubrit.
English: For storage conditions after reconstitution of the medicinal product, see section 6.3.
Maltese: Għall-kundizzjonijiet tal-ħażna wara r-rikostituzzjoni tal-prodott mediċinali, ara sezzjoni 6.3.
English: Adult population-Intravenous use
Maltese: TAL-PRODOTT MEDIĊINALI
English: Every injection should be followed by a flush with 5 mL of sodium chloride 9 mg/mL (0.9%) solution for injection.
Maltese: Kull injezzjoni għandha tkun segwita minn flaxx b'5 mL ta' klorur tas-sodju 9 mg/mL (0.9%) soluzzjoni għall-injezzjoni.
English: In very rare cases, fatal outcomes have been reported in temporal association with the use of SonoVue.
Maltese: F'każijiet rari ħafna, riżultati fatali kienu rrapportati f'assoċjazzjoni temporali mal-użu ta SonoVue.
English: Chest pain, pain, fatigue
Maltese: Kif għandu jingħata SonoVue
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Sodium chloride 9 mg/mL solution for injection Solvent for SonoVue
Maltese: U MNEJN GĦANDU JINGĦATA Sodium chloride 9 mg/mL (0.9%) soluzzjoni għall-injezzjoni Solvent għal SonoVue
English: A single-dose study and a repeat-dose study, both followed by a treatment-free period, were performed in female rats with local toxicity evaluated through macroscopic and histopathological examination of both kidneys, ureters, the urinary bladder and urethra.
Maltese: Sar studju b'doża unika u studju b'dożi ripetuti, it-tnejn segwiti minn perjodu li fih ma ngħatat l-ebda kura, fuq firien nisa u t-tossiċità lokali ġiet ivvalutata permezz ta' eżami makroskopiku u istopatoloġiku taż-żewġ kliewi, tal-ureteri, tal-bużżieqa tal-awrina u tal-uretra.
English: Pharmacotherapeutic group: Ultrasound contrast media ATC code: VO8DA05.
Maltese: Mezz tal-kuntrast ta' l-ultrasound.
English: Remove the protective disk from the vial.
Maltese: Neħħi d-diska protettiva minn ġol-kunjett.
English: Outer packaging
Maltese: Mard konkomitanti ieħor
English: Chemical and physical stability of the microbubble dispersion has been demonstrated for 6 hours.
Maltese: L-istabbilità kimika u fiżika ntweriet għal 6 sigħat.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2)
Maltese: Prodott mediċinali li jingħata b'riċetta ristretta tat-tabib (Ara Anness I: Sommarju tal-Karatteristiċi talProdott, sezzjoni 4.2).
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity and toxicity to reproduction.
Maltese: Informazzjoni miġbura qabel l-użu kliniku ma tiżvela l-ebda riskju speċjali għall-bniedem, ibbażat fuq studji konvenzjonali dwar is-sigurtà farmakoloġika, il-ġenotossiċità, u dwar it-tossiċità għarriproduzzjoni.
English: How SonoVue is given
Maltese: Twissijiet u prekawzjonijiet
English: Open the MiniSpike transfer system blister and remove syringe tip cap. Open the transfer system cap and connect the syringe to the transfer system by screwing it in clockwise.
Maltese: Iftaħ il-folja tas-sistema ta' trasferiment MiniSpike u neħħi t-tapp f'tarf is-siringa.
English: Unscrew the syringe from the system.
Maltese: Ħoll is-siringa minn mas-sistema.
English: Marketing Authorisation Holder and Manufacturer:
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u l-Manifattur:
English: Type I clear glass pre-filled syringe containing 5 mL sodium chloride 9 mg/mL (0.9%) solution for injection.
Maltese: Siringa mimlija għal-lest tal-ħġieġ ċar tat-Tip I li fiha 5 mL ta' klorur tas-sodju 9 mg/mL (0.9%) soluzzjoni għall-injezzjoni.
English: (Invented) name
Maltese: Numru ta' l-EU Isem ivvintat
English: Lenograstim; lipegfilgrastim; pegfilgrastim - Pulmonary haemorrhage (EPITT no 19181)
Maltese: 3. Lenograstim; lipegfilgrastim; pegfilgrastim - Emorraġija pulmonari (EPITT nru 19181)
English: Pembrolizumab - Aseptic meningitis (EPITT no 19115)
Maltese: Pembrolizumab - Meninġite asettika (EPITT nru 19115)
English: If you are taking any of the following:
Maltese: *Nota:
English: Lenalidomide - Progressive multifocal leukoencephalopathy (PML) (EPITT no 19130)
Maltese: 2. Lenalidomide - Lewkoenċefalopatija multifokali progressiva (PML) (EPITT nru 19130)
English: Adopted at the 14-17 May 2018 PRAC
Maltese: Adottati fil-PRAC ta' bejn l-14 u s-17 ta' Mejju 2018
English: Undesirable effects Nervous system disorders Frequency ‘rare': meningitis (aseptic)
Maltese: Effetti mhux mixtieqa Disturbi fis-sistema nervuża Frekwenza “rari”: meninġite (asettika)
English: Summary of product characteristics 4.8.
Maltese: Sommarju tal-Karatteristiċi tal-Prodott 4.8.
English: • anti-inflammatory and pain-relieving medicines (e.g. naproxen or acetylsalicylic acid (aspirin))
Maltese: • mediċini kontra l-infjammazzjoni u li jtaffu l-uġigħ (eż. naproxen jew acetylsalicylic acid (aspirina))
English: Summary of product characteristics 4.4.
Maltese: Sommarju tal-Karatteristiċi tal-Prodott 4.4.
English: Cases of progressive multifocal leukoencephalopathy (PML), including fatal cases, have been reported with lenalidomide.
Maltese: Każijiet ta' lewkoenċefalopatija multifokali progressiva (PML), inklużi każijiet fatali, ġew irrapportati b'lenalidomide.
English: Undesirable effects Respiratory, thoracic and mediastinal disorders Haemoptysis (uncommon*) Pulmonary haemorrhage (rare*)
Maltese: Effetti mhux mixtieqa Disturbi respiratorji, toraċiċi u medjastinali Emoptisi (mhux komuni *) Emorraġija pulmonari (rari *)
English: A significant increase in bleeding risk was reported with the triple combination of apixaban, ASA and clopidogrel in a clinical study in patients with acute coronary syndrome (see section 4.4).
Maltese: Żieda sinifikanti fir-riskju ta' fsada ġiet irrapportata bil-kombinazzjoni tripla ta' apixaban, ASA u clopidogrel fi studju kliniku f'pazjenti b'sindromu koronarju akut (ara sezzjoni 4.4).
English: Possible side effects (under corresponding frequencies):
Maltese: Effetti sekondarji possibbli (taħt frekwenzi korrispondenti):
English: Interaction with other medicinal products and other forms of interaction Anticoagulants, platelet aggregation inhibitors, SSRIs/SNRIs and NSAIDs
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni Antikoagulanti, inibituri tal-aggregazzjoni tal-plejtlits, SSRIs / SNRIs u NSAIDs
English: Interaction with other medicinal products and other forms of interaction Anticoagulants, antiplatelets, and NSAIDs and SSRIs/SNRIs
Maltese: Antikoagulanti, antipjastrini, u NSAIDs u SSRIs / SNRIs
English: Coughing up blood (haemoptysis) - uncommon* Bleeding from the lung (pulmonary haemorrhage) - rare*
Maltese: Sogħla tad-demm (emoptiżi) - mhux komuni * Fsada mill-pulmun (emorraġija pulmonari) - rari *
English: PML was reported several months to several years after starting the treatment with lenalidomide.
Maltese: PML ġiet irrapportata diversi xhur sa bosta snin wara l-kura b'lenalidomide.
English: These include acetylsalicylic acid (ASA), P2Y12 platelet inhibitors, other antithrombotic agents, fibrinolytic therapy, selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs), and chronic nonsteroidal anti-inflammatory drugs (NSAIDs) (see section 4.5).
Maltese: fibrinolitika, inibituri selettivi ta' assorbiment mill-ġdid ta' serotonina (SSRIs, selective serotonin reuptake inhibitors) jew inibituri ta' assorbiment mill-ġdid ta' serotonina norepinefrina (SNRIs, serotonin norepinephrine reuptake inhibitors) u mediċini anti-infjammatorji mhux sterojdi kroniċi (NSAIDs, nonsteroidal anti-inflammatory drugs) (ara sezzjoni 4.5).
English: • antidepressant medicines called selective serotonin re-uptake inhibitors or serotonin
Maltese: • mediċini antidepressivi msejħa inibituri selettivi tal-assorbiment mill-ġdid ta' serotonina jew inibituri tal-assorbiment mill-ġdid ta' serotonina-norepinefrina
English: What you need to know before you take Lixiana/Roteas Other medicines and Lixiana/Roteas
Maltese: X'għandek tkun taf qabel ma tieħu Lixiana/Roteas Mediċini oħrajn u Lixiana/Roteas
English: At any time during or after your treatment, tell your doctor or nurse immediately if you: experience blurred, loss of or double vision, difficulty speaking, weakness in an arm or a leg, a change in the way you walk or problems with your balance, persistent numbness, decreased sensation or loss of sensation, memory loss or confusion.
Maltese: Fi kwalunkwe ħin waqt jew wara t-trattament tiegħek, għid lit-tabib jew lill-infermier tiegħek minnufih jekk: tesperjenza vista mċajpra, telf tal-vista jew vista doppja, diffikultà biex titkellem, dgħufija fi driegħ jew f'riġel, tibdil fil-mod kif timxi jew problemi bil-bilanċ tiegħek, tnemnim persistenti, sensazzjoni mnaqqsa jew telf ta' sensazzjoni, telf ta' memorja jew konfużjoni.
English: The evaluation for PML should be based on neurological examination, magnetic resonance imaging of the brain, and cerebrospinal fluid analysis for JC virus (JCV) DNA by polymerase chain reaction (PCR) or a brain biopsy with testing for JCV.
Maltese: L-evalwazzjoni għal PML għandha tkun ibbażata fuq eżami newroloġiku, immaġni b'reżonanza manjetika tal-moħħ, u analiżi tal-fluwidu ċerebrospinali għal DNA tal-virus JC (JCV) permezz ta' reazzjoni katina ta' polimerażi (PCR, polymerase chain reaction) jew bijopsija tal-moħħ b'testijiet għal JCV.
English: *Note: Stated frequencies are applicable for pegfilgrastim; for lipegfilgrastim and lenograstim the frequency is to be calculated by the MAHs.
Maltese: Il-frekwenzi ddikjarati huma applikabbli għal pegfilgrastim; għal lipegilgrastim u lenograstim ilfrekwenza għandha tiġi kkalkulata mill-MAHs.
English: Care is to be taken if patients are treated concomitantly with selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs), or non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid.
Maltese: Għandha tingħata attenzjoni jekk pazjenti jiġu ttrattati b'mod konkomitanti b'inibituri selettivi ta' assorbiment mill-ġdid ta' serotonina (SSRIs, selective serotonin reuptake inhibitors) jew inibituri ta' assorbiment mill-ġdid ta' serotonina norepinefrina (SNRIs, serotonin norepinephrine reuptake inhibitors), jew mediċini anti-infjammatorji mhux sterojdi (NSAIDs, non-steroidal anti-inflammatory drugs), inkluż acetylsalicylic acid.
English: What you need to know before you take Eliquis Other medicines and Eliquis
Maltese: X'għandek tkun taf qabel ma tieħu Eliquis Mediċini oħra u Eliquis
English: If PML is confirmed, lenalidomide must be permanently discontinued.
Maltese: Jekk PML tiġi kkonfermata, lenalidomide għandu jitwaqqaf b'mod permanenti.
English: Apixaban; edoxaban - Drug interaction between apixaban or edoxaban and selective serotonin reuptake inhibitors (SSRI) and/or serotonin and noradrenaline reuptake inhibitors (SNRI) leading to increased risk of bleeding (EPITT no 19139)
Maltese: Apixaban; edoxaban - Interazzjoni medika bejn apixaban jew edoxaban u inibituri selettivi ta' assorbiment mill-ġdid ta' serotonina (SSRI, selective serotonin reuptake inhibitors) u/jew inibituri ta' assorbiment mill-ġdid ta' serotonina u noradrenalina (SNRI, serotonin and noradrenaline reuptake inhibitors) li jwasslu għal riskju miżjud ta' fsada (EPITT Nru