FrancophonIA/ELRC3.0 huggingface dataset:
English: SonoVue is indicated for use in ultrasonography of the excretory tract in paediatric patients from newborn to 18 years to detect vesicoureteral reflux.
Slovenian: Zdravilo SonoVue je indicirano za uporabo pri ultrazvoku sečnih izvodil pri pediatričnih bolnikih od novorojenčka do 18. leta, za odkrivanje vezikoureternega refluksa.
English: What SonoVue is and what it is used for What you need to know before you are given SonoVue How SonoVue is given
Slovenian: Kaj je zdravilo SonoVue in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli zdravilo SonoVue Kako uporabljati zdravilo SonoVue Možni neželeni učinki
English: SonoVue is an ultrasound contrast agent that contains tiny bubbles filled with a gas called sulphur hexafluoride.
Slovenian: Zdravilo SonoVue je kontrastno sredstvo za ultrazvočni pregled, ki vsebuje drobne mehurčke, napolnjene s plinom, imenovanim žveplov heksafluorid.
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.
Slovenian: Bodite izredno previdni, ko razmišljate o uporabi zdravila SonoVue pri bolnikih z nedavnim akutnim koronarnim sindromom ali klinično nestabilno ishemično boleznijo srca, vštevši razvijajoči se ali že obstoječi miokardni infarkt, tipično angino pektoris v mirovanju v zadnjih sedmih dneh, s pomembnim slabšanjem srčnih simptomov v zadnjih sedmih dneh, z nedavnim posegom na koronarnih arterijah ali z drugimi faktorji, ki bi kazali klinično nestabilnost (npr. nedavno poslabšanje EKG, laboratorijskih ali kliničnih izvidov), z akutno srčno odpovedjo, s srčno odpovedjo razreda III/IV ali hudo aritmijo, ker lahko pri teh bolnikih alergijam podobne in/ali vazodilatatorne reakcije vodijo v okoliščine, ki bi utegnile ogroziti življenje.
English: Paediatric population-Intravesical use
Slovenian: Pediatrična populacija - intravezikalna uporaba
English: The vial is for a single use only.
Slovenian: Viala je samo za enkratno uporabo.
English: If your are an adult SonoVue helps to obtain clearer ultrasound pictures of your heart, your blood vessels and/or tissues of the liver and breast.
Slovenian: Pri odraslih osebah zdravilo SonoVue pomaga pridobiti jasnejšo ultrazvočno sliko srca, ožilja in/ali tkiva jeter in prsi.
English: Uncommon side effects (may affect up to 1 in 100 people): - Headache - Numbness - Dizziness - Strange taste in the mouth - Redness - Chest discomfort - Feeling sick (nausea) - Abdominal pain - Skin rash - Feeling hot - Local reactions where the injection was given such as: pain or an unusual sensation at the injection site
Slovenian: občasni neželeni učinki(pojavijo se lahko pri največ 1 od 100 ljudi): - glavobol, - odrevenelost, - omotica, - čuden okus v ustih, - rdečina, - neprijeten občutek v prsnem košu, - siljenje na bruhanje (navzea), - bolečina v trebuhu, - kožni izpuščaj, - občutek vročine, - lokalne reakcije na mestu injiciranja, kot so: bolečina ali nenavaden občutek na mestu injiciranja.
English: SonoVue helps to obtain clearer pictures of the urinary tract in children .
Slovenian: Zdravilo SonoVue pomaga pridobiti jasnejšo sliko sečil pri otrocih.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of the dispersion contains 8 µL sulphur hexafluoride microbubbles, equivalent to 45 micrograms.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA En ml disperzije vsebuje 8 µl mikromehurčkov žveplovega heksafluorida, kar ustreza 45 mikrogramom.
English: Do not use SonoVue:
Slovenian: Ne uporabljajte zdravila SonoVue,
English: For patients under 18 years of age SonoVue can be used only for ultrasound of the urinary tract.
Slovenian: Pri bolnikih, mlajših od 18 let se zdravilo SonoVue lahko uporablja samo za ultrazvok sečil.
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.
Slovenian: Intravenska uporaba zdravila SonoVue je kontraindicirana pri bolnikih z desno-levim šantom, akutnim endokarditisom, umetnimi srčnimi zaklopkami, s hudo pulmonalno hipertenzijo (pulmonalni arterijski tlak > 90 mm Hg), nenadzorovano hipertenzijo in pri odraslih bolnikih z respiratornim distresnim sindromom.
English: Invert the system and carefully withdraw SonoVue into the syringe.
Slovenian: Obrnite sistem in previdno potegnite SonoVue nazaj v injekcijsko brizgo.
English: In clinical trials, the most commonly reported adverse reactions after intravenous administration are: headache, injection site reaction, and nausea.
Slovenian: Najpogosteje poročani neželeni učinki po intravenski uporabi v kliničnih študijah so: glavobol, reakcija na mestu injiciranja, in navzea.
English: During a single examination, a second injection of the recommended dose can be made when deemed necessary by the physician.
Slovenian: Med preiskavo lahko zdravnik, kadar meni, da je potrebno, da še dodatni priporočeni odmerek.
English: Adverse Drug Reactions Frequency Category
Slovenian: Neželeni učinki zdravila Pogostost
English: However, based on its rapid elimination from the body via the expired air, it is considered that the breastfeeding can be resumed two to three hours after administration of SonoVue.
Slovenian: Ni znano, ali se žveplov heksafluorid izloča v materino mleko, vendar pa se, na podlagi hitrega izločanja iz telesa preko izdihanega zraka, smatra, da se lahko z dojenjem nadaljuje dve do tri ure po dajanju zdravila SonoVue.
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.
Slovenian: Zdravilo SonoVue poveča kakovost dopplerskega posnetka pretoka in trajanje klinično uporabnega pojačanega signala za preiskavo portalne vene pri odraslih bolnikih.
English: SonoVue is a kit which includes a glass vial containing white powder, a glass syringe containing the solvent and a transfer system.
Slovenian: Zdravilo SonoVue je pakiran v kompletu, ki vsebuje bel prašek, stekleno injekcijsko brizgo z vehiklom in sistem za prenos.
English: No adverse reactions were reported.
Slovenian: Neželeni učinki niso bili poročani.
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.
Slovenian: Pri ultrazvoku sečnih izvodil pri otrocih, po intravezikalni uporabi, zdravilo SonoVue poveča jakost signala tekočin znotraj sečnice, mehurja, sečevodov in ledvičnega meha in tako omogoča odkrivanje refluksa tekočin iz mehurja v sečevode.
English: Nausea, Abdominal pain
Slovenian: Bolezni prebavil abdominalna bolečina, navzea bruhanje
English: What SonoVue looks like and contents of the pack
Slovenian: Izgled zdravila SonoVue in vsebina pakiranja
English: Immediately following the first voiding, the bladder may be refilled with saline for a second cycle of voiding and imaging, without the need of a second SonoVue administration.
Slovenian: Takoj po prvem praznjenju se lahko mehur napolni s fiziološko raztopino za drugi cikel praznjenja mehurja in slikanja, pri kateremu dodajanje zdravila SonoVue ni potrebno.
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 ).
Slovenian: Brezbarvna viala stekla tipa I vsebuje 25 mg suhega, liofiliziranega praška v atmosferi žveplovega heksafluorida, zaprta s sivim zamaškom iz butilne gume in zatesnjena z zoženim aluminijastim tesnilom z dvižno zaporko.
English: SonoVue increases the accuracy in detection or exclusion of abnormalities in cerebral arteries and extracranial carotid or peripheral arteries in adult patients by improving the Doppler signal to noise ratio.
Slovenian: Zdravilo SonoVue poveča natančnost pri zaznavanju ali izključitvi anomalij v cerebralnih arterijah in v ekstrakranialnih karotidnih arterijah ali perifernih arterijah pri odraslih bolnikih z izboljšanjem dopplerjevega razmerja med signalom in šumom.
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.
Slovenian: Svetujemo previdnost pri dajanju zdravila SonoVue bolnikom z: akutnim endokarditisom, umetnimi zaklopkami, akutnim sistemskim vnetjem in/ali sepso, s hiperaktivnimi motnjami koagulacije in/ali nedavno tromboembolijo in odpovedjo jeter ali ledvic, ker je število bolnikov s temi stanji, ki so v kliničnih preskušanjih prejeli zdravilo SonoVue omejeno.
English: Slide the vial into the transparent sleeve of the transfer system and press firmly to lock the vial in place.
Slovenian: Potisnite vialo v prozorno cev sistema za prenos in čvrsto pritisnite, da se viala usede na svoje mesto.
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.
Slovenian: Zdravilo SonoVue je transpulmonalno ehokardiografsko kontrastno sredstvo, ki se uporablja pri odraslih bolnikih s sumom na ali z dokazanim kardiovaskularnim obolenjem, da zagotovi opacifikacijo srčnih votlin in izboljša razmejitev konture endokardija levega ventrikla.
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja osip pruritus
English: Adult population-Intravenous use
Slovenian: Odrasla populacija - intravenska uporaba
English: If SonoVue is not used immediately after reconstitution the dispersion will be shaken again before being drawn up into a syringe.
Slovenian: Če zdravila SonoVue ne uporabite takoj po rekonstituciji, je treba disperzijo ponovno pretresti, preden jo povlečete v brizgo.
English: Doppler of macrovasculature
Slovenian: Doppler velikih žil
English: The following side effects have been reported with SonoVue:
Slovenian: Pri zdravilu SonoVue so poročali o naslednjih neželenih učinkih:
English: PHARMACEUTICAL FORM Powder and solvent for dispersion for injection.
Slovenian: FARMACEVTSKA OBLIKA Prašek in vehikel za disperzijo za injiciranje Beli prašek
English: Marketing authorisation holder Bracco International B.V.
Slovenian: Bracco International B.V.
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.
Slovenian: Zdravilo SonoVue morate aplicirati takoj z injiciranjem v periferno veno za uporabo pri ehokardiografskem in vaskularnem dopplerskem slikanju pri odraslih ali z intravezikalnim injiciranjem za uporabo pri ultrazvoku sečnih zvodil pri pediatričnih bolnikih.
English: False negative cases can occur with voiding ultrasonography with SonoVue and have not been clarified (see section 5.1).
Slovenian: Interpretacija ultrazvočne cistografije z zdravilom SonoVue in omejitve uporabe Pri uporabi zdravila SonoVue za ultrazvočno cistografijo za odkrivanje vezikoureternega refluksa lahko pride do lažno negativnih primerov za katere vzroki niso razjasnjeni (glejte poglavje 5.1).
English: It was therefore concluded that SonoVue is well tolerated in the urinary tract in the rat.
Slovenian: Zato je bilo zaključeno, da se zdravilo SonoVue dobro prenaša v sečilih pri podganah.
English: BATCH NUMBER Lot:
Slovenian: ŠTEVILKA SERIJE Številka serije:
English: Administration of SonoVue is followed by completion of bladder filling with saline until patient has the urge to micturate or there is the first slight sign of back pressure to the infusion.
Slovenian: Apliciranju zdravila SonoVue sledi aplikacija fiziološke raztopine do napolnitve mehurja, dokler bolnik ne začuti potrebo po uriniranju ali dokler se ne pojavi prvi rahel znak protitlaka na infuzijo.
English: Headache, paraesthesia, dizziness, dysgeusia
Slovenian: Bolezni živčevja glavobol, parestezija, omotica, disgevzija vazovagalna reakcija
English: If SonoVue is not used immediately after reconstitution the microbubble dispersion should be shaken again before being drawn up into a syringe.
Slovenian: Če se zdravila SonoVue ne porabi takoj po rekonstituiranju, se mora disperzijo ponovno pretresti, predno se jo potegne v injekcijsko brizgo.
English: SonoVue improves display of the vascularity of liver and breast lesions during Doppler sonography in adult patients leading to more specific lesion characterisation.
Slovenian: Zdravilo SonoVue izboljša prikaz vaskularnosti lezij v jetrih in dojkah pri dopplerski sonografiji, kar pri odraslih bolnikih daje bolj specifične podatke o lezijah.
English: How to store SonoVue
Slovenian: Kako uporabljati zdravilo SonoVue
English: Intravesical use
Slovenian: Intravezikalna uporaba
English: SonoVue contains sodium
Slovenian: Zdravilo SonoVue vsebuje natrij
English: Unscrew the syringe from the transfer system.
Slovenian: Odvijte injekcijsko brizgo s sistema za prenos.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each mL of the dispersion contains 8 µLsulphur hexafluoride microbubbles, equivalent to 45 micrograms.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Vsak ml disperzije vsebuje 8 µl mikromehurčkov žveplovega heksafluorida, kar ustreza 45 mikrogramom.
English: The intensity of the reflected signal is dependent on concentration of the microbubbles and frequency of the ultrasound beam .The interface between the sulphur hexafluoride bubble and the aqueous medium acts as a reflector of the ultrasound beam thus enhancing blood echogenicity and increasing contrast between the blood and the surrounding tissues .
Slovenian: Mejna ploskev med mehurčkom žveplovega heksafluorida in vodnim medijem deluje kot odbojnik ultrazvočnih valov in tako poveča ehogenost krvi in poveča kontrast med krvjo in okoliškimi tkivi.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity and toxicity to reproduction.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, genotoksičnosti in vpliva na sposobnost razmnoževanja ne kažejo posebnega tveganja za človeka.
English: Moreover, ECG and blood pressure monitoring should be performed during SonoVue-enhanced echocardiography with a pharmacological stress (e.g. with dobutamine).
Slovenian: Poleg tega, kadar se zdravilo SonoVue uporablja za ehokardiografijo s farmakološko obremenitvijo (npr. z dobutaminom), se mora spremljati EKG in krvni tlak.
English: This product should only be used by physicians experienced in diagnostic ultrasound imaging.
Slovenian: Zdravilo SonoVue lahko daje samo zdravnik z izkušnjami v diagnostiki z ultrazvokom.
English: Distearoylphosphatidylcholine Dipalmitoylphosphatidylglycerol Sodium Palmitic acid
Slovenian: Makrogol 4000 distearilfosfatidilholin natrijev fosfatidilglicerildipalmitat palmitinska kislina
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Sodium chloride 9 mg/mL solution for injection Solvent for SonoVue
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Raztopina natrijevega klorida 9 mg/ml za injiciranje Vehikel za zdravilo SonoVue
English: ECG monitoring should be performed in high-risk patients as clinically indicated.
Slovenian: Bolniki z nestabilnim kardiopulmonalnim statusom Opazovanje z EKG mora biti izvajano pri bolnikih z visoko stopnjo tveganja.
English: What SonoVue contains
Slovenian: Kaj vsebuje zdravilo SonoVue
English: A low mechanical index (≤ 0.4) is recommended for imaging the bladder, ureters, and kidney during ultrasonography of the urinary tract with contrast.
Slovenian: Za slikanje mehurja, sečevodov in ledvic pri ultrazvoku sečil s kontrastnim sredstvom se priporoča nizek mehanski indeks (≤ 0,4).
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.
Slovenian: Odprite pretisni omot MiniSpike sistema za prenos in odstranite pokrovček injekcijske brizge.
English: SonoVue should be administered immediately after drawing into the syringe by injection into a peripheral vein.
Slovenian: Zdravilo SonoVue se mora injicirati bolniku v periferno veno takoj, ko se potegne disperzijo v brizgo.
English: SonoVue 8 microlitres/mL powder and solvent for dispersion for injection sulphur hexafluoride
Slovenian: SonoVue 8 mikrolitrov/ml prašek in vehikel za disperzijo za injiciranje žveplov heksafluorid
English: Musculoskeletal, connective tissue and bone disorders
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva bolečine v hrbtu
English: Overdose is not likely to happen since SonoVue is given by a doctor.
Slovenian: Če prejmete večji odmerek zdravila SonoVue, kot bi smeli Preveliko odmerjanje ni verjetno, saj vam zdravilo SonoVue da zdravnik.
English: - The other ingredients are: macrogol 4000, distearoylphosphatidylcholine,
Slovenian: - Pomožne snovi: makrogol 4000, distearilfosfatidilholin, natrijev fosfatidilglicerildipalmitat,
English: Solvent: Sodium chloride 9 mg/mL (0.9%) solution for injection.
Slovenian: Vehikel: 9 mg/ml (0,9%) raztopina natrijevega klorida za injiciranje.
English: SonoVue is for use with ultrasound imaging to enhance the echogenicity of the blood, or of fluids in the urinary tract which results in an improved signal to noise ratio.
Slovenian: Zdravilo SonoVue uporabljamo pri ultrazvočnih preiskavah, kjer poveča ehogenost krvi ali tekočine v sečilih, kar se pokaže z izboljšanim razmerjem med signalom in šumom.
English: SonoVue will then be administered through the thin tube and will be followed by administration of saline to continue filling the bladder.
Slovenian: Nato se skozi cevko vnese zdravilo SonoVue, čemur sledi vnašanje fiziološke raztopine za nadaljnje polnjenje mehurja.
English: Every injection should be followed by a flush with 5 mL of sodium chloride 9 mg/mL (0.9%) solution for injection.
Slovenian: Vsakemu injiciranju sledi izpiranje s 5 ml 9 mg/ml (0,9%) raztopine natrijevega klorida za injiciranje.
English: NAME OF THE MEDICINAL PRODUCT SonoVue 8 microlitres/mL powder and solvent for dispersion for injection
Slovenian: IME ZDRAVILA SonoVue 8 mikrolitrov/ml prašek in vehikel za disperzijo za injiciranje
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.
Slovenian: Dodatek 9 mg/ml (0,9%) raztopine natrijevega klorida za injiciranje k liofiliziranemu prašku ob močnem stresanju ustvari mikromehurčke žveplovega heksafluorida.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION SonoVue 8 microlitres/mL powder for dispersion for injection sulphur hexafluoride
Slovenian: IME ZDRAVILA IN POT(I) UPORABE SonoVue 8 mikrolitrov/ml prašek za disperzijo za injiciranje žveplov heksafluorid
English: The glass syringe contains sodium chloride 9 mg/mL (0.9%) solution for injection.
Slovenian: Steklena injekcijska brizga vsebuje 9 mg/ml (0,9 %) raztopino natrijevega klorida za injiciranje.
English: For ultrasound scan of urinary tract in children the recommended dose is 1 mL per patient to be administered into the bladder as follows:
Slovenian: Ultrazvok sečil pri otrocih: priporočeni odmerek, ki se ga daje v mehur je 1 ml na bolnika, po naslednjem postopku: po izpraznjenju mehurja, se vanj skozi tanko cevko vnese fiziološko raztopino.
English: Type I clear glass pre-filled syringe containing 5 mL sodium chloride 9 mg/mL (0.9%) solution for injection.
Slovenian: Napolnjena, prozorna injekcijska brizga iz stekla tipa I s 5 ml 9 mg/ml (0,9%) raztopine natrijevega klorida za injiciranje.
English: It did not reveal any test item-related lesions in any of the examined organs, in particular in the urinary bladder, in both the single-dose and the repeat-dose studies.
Slovenian: Tako pri študiji z enkratnim odmerkom kot pri študiji s ponavljajočimi se odmerki, poškodbe povezane s testnimi vzorci pri pregledanih organih, še zlasti v sečnem mehurju, niso bile odkrite.
English: Nervous system disorders
Slovenian: Žilne bolezni zardevanje hipotenzija
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.
Slovenian: Skozi zamašek k vsebini viale vbrizgajte 5 ml 9 mg/ml (0,9%) raztopine natrijevega klorida za injiciranje.
English: Chest discomfort, injection site reaction, feeling hot
Slovenian: Splošne težave in spremembe na mestu aplikacije nelagodje v prsnem košu, reakcija na mestu injiciranja, občutek vročine bolečine v prsnem košu, bolečina, utrujenost
English: Outer packaging
Slovenian: Ultrazvok sečnih izvodil
English: Vomiting
Slovenian: Odmerjanje
English: dipalmitoylphosphatidylglycerol sodium, palmitic acid.
Slovenian: palmitinska kislina.
English: Rash
Slovenian: Rok
English: Empty the contents of the syringe into the vial by pushing on the plunger rod.
Slovenian: S pritiskom na bat izpraznite vsebino injekcijske brizge v vialo.
English: Interpretation of voiding urosonography with SonoVue and limitations of use
Slovenian: Shranjevanje zdravila SonoVue Vsebina pakiranja in dodatne informacije
English: METHOD OF ADMINISTRATION
Slovenian: NAČIN UPORABE ZDRAVILA
English: For single use only
Slovenian: Zdravilo je za enkratno uporabo
English: Vision blurred,
Slovenian: Očesne bolezni zamegljen vid
English: If you are taking any of the following:
Slovenian: Če jemljete katero koli od naslednjih zdravil:
English: Adopted at the 14-17 May 2018 PRAC
Slovenian: Sprejeto na seji odbora PRAC od 14. do 17. maja 2018
English: Patients should also be advised to inform their partner or caregivers about their treatment, since they may notice symptoms that the patient is not aware of.
Slovenian: Bolnikom je treba tudi priporočiti, naj svojega partnerja ali skrbnike obvestijo o svojem zdravljenju, ker lahko opazijo simptome, ki se jih bolnik ne zaveda.
English: Summary of product characteristics 4.4.
Slovenian: Povzetek glavnih značilnosti zdravila 4.4.
English: If you had these symptoms prior to treatment with lenalidomide, tell your doctor about any change in these symptoms.
Slovenian: Če ste imeli te simptome že pred začetkom zdravljenja z lenalidomidom, o kakršni koli njihovi spremembi obvestite zdravnika.
English: The following medicines may increase the effects of Eliquis and increase the chance for unwanted bleeding:
Slovenian: Naslednja zdravila lahko okrepijo učinek zdravila Eliquis in s tem povečajo tveganje za pojav neželene krvavitve:
English: Pembrolizumab - Aseptic meningitis (EPITT no 19115)
Slovenian: Pembrolizumab - Aseptični meningitis (EPITT št. 19115)
English: PML was reported several months to several years after starting the treatment with lenalidomide.
Slovenian: O nastopu PML so poročali od več mesecev do več let po začetku zdravljenja z lenalidomidom.
English: Concomitant use of medicines affecting haemostasis may increase the risk of bleeding.
Slovenian: Sočasna uporaba zdravil, ki vplivajo na hemostazo, lahko zveča nevarnost krvavitve.