FrancophonIA/ELRC3.0 huggingface dataset:
English: No dose adjustment of Polivy is required in patients with creatinine clearance (CrCL) ≥ 30 mL/min.
Danish: Det er ikke nødvendigt at justere dosis af Polivy til patienter med creatininclearance (CrCL) ≥30 ml/min.
English: METHOD OF ADMINISTRATION For IV use after reconstitution and dilution
Danish: Til IV anvendelse efter rekonstitution og fortynding
English: Polivy and any concomitant chemotherapy should be discontinued in patients who develop serious infections.
Danish: Behandling med Polivy og anden samtidig kemoterapi bør seponeres hos patienter, der udvikler alvorlige infektioner.
English: For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.
Danish: For instruktion i rekonstitution og fortynding af lægemidlet før administration, se pkt.
English: Polivy has a minor influence on your ability to drive, cycle or use any tools or machines.
Danish: Polivy påvirker i mindre grad evnen til at føre motorkøretøj, cykle eller håndtere værktøj og maskiner.
English: IRC: Independent Review Committee; INV: Investigator; HR: Hazard Ratio; CI: Confidence Interval, NE: Not evaluable; CMH Cochran-Mantel-Haenszel *Per modified Lugano 2014 criteria: Bone marrow confirmation of PET-CT CR required.
Danish: IRC: Independent Review Committee; INV: Investigator; HR: Hazardratio; KI: Konfidensinterval, NE: Ikke estimér bar; CMH Cochran-Mantel-Haenszel.
English: In vivo studies in rats dosed with polatuzumab vedotin (radiolabel on MMAE) demonstrate that the majority of radioactivity is excreted in faeces and the minority of radioactivity is excreted in urine.
Danish: In vivo-studier med rotter doseret med polatuzumab vedotin (radiomærket på MMAE) har vist, at størstedelen af radioaktiviteten udskilles i fæces og en mindre del i urinen.
English: Tell your doctor or nurse if you are taking, have recently taken or might start taking any other medicines.
Danish: Fortæl det altid til lægen eller sundhedspersonalet, hvis du tager anden medicin, har gjort det for nylig eller planlægger at tage anden medicin.
English: Polivy in combination with bendamustine and rituximab is indicated for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who are not candidates for haematopoietic stem cell transplant.
Danish: Polivy er i kombination med bendamustin og rituximab indiceret til behandling af voksne patienter med relaps/refraktær diffust storcellet B-cellelymfom (DLBCL), som ikke er kandidater til hæmatopoietisk stamcelletransplantation.
English: The monoclonal antibody binds with high affinity and selectivity to CD79b, a cell surface component of the B-cell receptor.
Danish: Det monoklonale antistof binder sig med høj affinitet og selektivitet til CD79b, en af komponenterne i B-cellereceptorens overflade.
English: Tumour lysis syndrome (TLS)
Danish: Tumorlyse syndrom (TLS)
English: This medicine can cause inflammation or damage to cells in the liver that affect the normal function of the liver.
Danish: Dette lægemiddel kan give leverbetændelse eller beskadige levercellerne og nedsætte leverens normale funktion.
English: Elderly No dose adjustment of Polivy is required in patients ≥ 65 years of age (see section 5.2).
Danish: Ældre Det er ikke nødvendigt at justere dosis af Polivy til patienter i aldersgruppen ≥65 år (se pkt.
English: No studies have been conducted to investigate the pharmacokinetics of polatuzumab vedotin in the paediatric population (<18 years old).
Danish: Der er ikke udført studier, der undersøger polatuzumab vedotins farmakokinetik i den pædiatriske population (aldersgruppen <18 år).
English: If you had any of these symptoms before treatment with Polivy, tell your doctor straight away if you notice any changes in them.
Danish: Hvis du har haft ét eller flere af ovenstående symptomer inden du blev behandet med Polivy, skal du straks kontakte lægen, hvis symptomerne ændrer sig.
English: White to greyish-white lyophilized cake.
Danish: Hvidt til gråhvidt lyofilisat.
English: Polatuzumab vedotin is expected to undergo catabolism in patients, resulting in the production of small peptides, amino acids, unconjugated MMAE, and unconjugated MMAE related catabolites.
Danish: Polatuzumab vedotin forventes at kataboliseres hos patienterne, medførende en produktion af små peptider, aminosyrer, ukonjugeret MMAE samt ukonjugerede MMAE-relaterede katabolitter.
English: An antihistamine and antipyretic should be administered prior to the administration of Polivy, and patients should be monitored closely throughout the infusion.
Danish: Antihistamin og antipyretisk behandling bør administreres, før administration af Polivy og patienten bør monitoreres tæt under infusionen.
English: The recommended dose of Polivy is 1.8 mg/kg, given as an intravenous infusion every 21 days in combination with bendamustine and rituximab for 6 cycles.
Danish: Den anbefalede dosis af Polivy er 1,8 mg/kg, givet som intravenøs infusion hver 21. dag i kombination med bendamustin og rituximab i 6 serier.
English: This is called tumour lysis syndrome.
Danish: Dette kaldes tumorlyse-syndrom.
English: Across all arms of study GO29365, 8 out of 134 (6.0%) patients tested positive for anti-polatuzumab vedotin antibodies at one or more post-baseline time points.
Danish: På tværs af alle armene i studiet GO29365, blev 8 ud af 134 (6,0%) patienter testet positive for anti-polatuzumab vedotin-antistoffer på ét eller flere måletidspunkter efter baseline.
English: The administration of Polivy in patients with moderate or severe hepatic impairment (bilirubin greater than 1.5 × upper limit of normal [ULN]) should be avoided.
Danish: Administration af Polivy til patienter med moderat eller svær nedsat leverfunktion (bilirubin værdier >1,5 × øvre normalgrænse) bør undgås.
English: Your doctor, pharmacist or nurse will do blood tests to check for the condition.
Danish: Lægen eller sygeplejerskenvil sørge for, at du får taget blodprøver og bliver testet for tilstanden.
English: ADRs leading to treatment regimen discontinuation in >5% of patients were thrombocytopenia (8.9%) and neutropenia (6.7%).
Danish: Bivirkninger, der medførte seponering af behandlingsregimet hos >5% af patienterne omfattede trombocytopeni (8,9%) og neutropeni (6,7%).
English: For recurrent Grade 2 wheezing or urticaria, or for recurrence of any Grade 3 symptoms, permanently discontinue Polivy.
Danish: Ved tilbagevendende grad 2 hvæsen eller generaliseret urticaria eller ved tilbagevendende grad 3 symptomer af en hver art, skal Polivy behandlingen afbrydes permanent.
English: Table 3: Polivy, bendamustine and rituximab dose modifications for Infusion-related reactions (IRRs)
Danish: Polivy, bendamustin og rituximab dosisændring for infusionsrelaterede reaktioner (IRRs)
English: Upon binding CD79b, polatuzumab vedotin is rapidly internalized and the linker is cleaved by lysosomal proteases to enable intracellular delivery of MMAE.
Danish: Efter bindingen til CD79b, internaliseres polatuzumab vedotin hurtigt, og forbindelsen spaltes af lysosomale proteaser som muliggør intracellulær afgivelse af MMAE.
English: If you miss a dose of Polivy
Danish: Hvis du kommer til at springe en dosis Polivy over
English: Patients receiving concomitant strong CYP3A4 inhibitors (e.g., boceprevir, clarithromycin, cobicistat, indinavir, itraconazole, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole) should be monitored more closely for signs of toxicities.
Danish: Patienter i samtidig behandling med stærke CYP3Ahæmmere (fx boceprevir, clarithromycin, cobicistat, indinavir, itraconazole, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole) bør monitoreres meget tæt for tegn på toksicitet.
English: MMAE is a weak time-dependent inhibitor of CYP3A4/5 but does not competitively inhibit CYP3A4/5 at clinically relevant concentrations.
Danish: MMAE er en svag tidsafhængig hæmmer af CYP3A4/5, men hæmmer ikke kompetitivt CYP3A4/5 i klinisk relevante koncentrationer.
English: Patients aged ≥65 had a numerically higher incidence of serious adverse reactions (64%) than patients aged
Danish: Patienter ≥ 65 år havde en numerisk højere forekomst af alvorlige bivirkninger (64%) end patienter <65 år (53%).
English: Anti-infective prophylaxis should be considered throughout treatment with Polivy.
Danish: Profylaktisk behandling mod infektioner bør overvejes under behandling med Polivy.
English: Healthcare professionals are asked to report any suspected adverse reactions.
Danish: Læger og sundhedspersoner anmodes om at indberette alle formodede bivirkninger.
English: The European Medicines Agency has waived the obligation to submit results of studies with Polivy in all subsets of the paediatric population for the treatment of mature B-cell neoplasms (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Polivy i alle undergrupper af den pædiatriske population til behandling af storcellet Bcellelymfom (se pkt.
English: Tél: +33 (0) 1 47 61 40 00
Danish: Roche Tél: +33 (0) 1 47 61 40 00
English: Based on population pharmacokinetics simulations, a sensitivity analysis predicted exposure to unconjugated MMAE for patients with bodyweight over 100 kg to be increased by 27%.
Danish: Baseret på populationsfarmakokinetiske simulationer vurderer sensitivitetsanalyse, at optagelsen af ukonjugeret MMAE øges med 27% hos patienter med en kropsvægt over 100 kg.
English: Withhold all treatment until platelets recover to >75,000/µL.
Danish: Afbryd al behandling indtil trombocytter stiger til >75.000/µl.
English: If platelets recover to > 75,000/µL after Day 7:
Danish: Hvis trombocytter stiger til >75.000/µl efter dag 7:
English: In vitro studies indicate that MMAE is a substrate for CYP3A4/5 but does not induce major CYP enzymes.
Danish: In vitro-studier indikerer, at MMAE er et substrat for CYP3A4/5, men inducerer ikke større CYPenzymer.
English: Injured liver cells may leak high amounts of certain substances (liver enzymes and bilirubin) into the bloodstream, in which can be detected by blood tests.
Danish: Beskadigede leverceller sender mere af bestemte stoffer ud i blodet (leverenzymer og bilirubin), dette vil kunne ses det på resultater af blodprøver.
English: Patients were randomized 1:1 to receive Polivy plus BR or BR alone for six 21-day cycles.
Danish: Patienterne blev i forholdet 1:1 randomiseret til behandling med Polivy plus BR eller til BR alene i 6 behandlingsserier af 21 dages varighed.
English: If you are not sure, talk to your doctor or nurse before you are given Polivy.
Danish: Hvis du er usikker, skal du kontakte lægen eller sundhedspersonalet inden du får Polivy.
English: Polatuzumab vedotin did not prolong the mean QTc interval to any clinically relevant extent based on ECG data from two open-label studies in patients with previously treated B-cell malignancies at the recommended dosage.
Danish: Polatuzumab vedotin forlængede ikke middel-QTc-intervallet i klinisk relevant grad, baseret på EKGdata fra 2 åbne studier hos patienter med tidligere behandlede B-celle-maligniteter ved anbefalet dosis.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) per dosis, dvs. det er stort set natriumfrit.
English: If the prepared infusion will be transported, remove air from the infusion bag and limit transportation to 30 minutes room temperature (9°C − 25°C) or 24 hours refrigerated (2°C − 8°C).
Danish: Hvis den tilberedte opløsning til infusion skal transporteres, skal luften fjernes fra infusionsposen og transporttid begrænses til 30 minutter ved stuetemperatur (9°C - 25°C) eller 24 timer ved (2°C - 8°C).
English: In the BR arm, serious infections were reported in 30.8% of patients and fatal infections were reported in 10.3% of patients.
Danish: I BR-arm rapporteredes alvorlige infektioner hos 30,8% af patienterne og dødelige infektioner hos 10,3% af patienterne.
English: Polivy is administered as an intravenous infusion.
Danish: Polivy administreres som intravenøs -infusion.
English: OTHER Do not shake Cytotoxic
Danish: Må ikke rystes Cytotoksisk
English: Caution is advised in case of concomitant treatment with CYP3A4 inhibitor.
Danish: Der tilrådes forsigtighed ved samtidig behandling med CYP3A4-hæmmer.
English: When administered with Polivy, the recommended dose of bendamustine is 90 mg/m2/day on Day 1 and Day 2 of each cycle and the recommended dose of rituximab is 375 mg/m2 on Day 1 of each cycle.
Danish: Når bendamustin administreres med Polivy, er den anbefalede dosis af bendamustin 90 mg/m2/dag på dag 1 og dag 2 i hver serie, og den anbefalede dosis af rituximab er 375 mg/m2 på dag 1 i hver serie.
English: 1 To ensure product stability, do not exceed specified storage durations.
Danish: 1Af hensyn til holdbarheden må de specificerede opbevaringstider ikke overskrides.
English: Very common neuropathy peripheral, peripheral sensory neuropathy, dizziness Common gait disturbance, paraesthesia, hypoaesthesia
Danish: Meget almindelig perifer neuropati, perifer sensorisk neuropati, svimmelhed Almindelig gangforstyrrelser, paræstesier, hypoæstesi
English: A risk for breast-feeding children cannot be excluded.
Danish: Risiko for spædbørn der ammes kan ikke udelukkes.
English: Grade 3 or 4 thrombocytopenia or anaemia can also occur with Polivy.
Danish: Der kan også opstå grad 3 eller 4 trombocytopeni eller anæmi i forbindelse med Polivy-behandling.
English: Serious, life threatening or fatal infections, including opportunistic infections, such as pneumonia (including pneumocystis jirovecii and other fungal pneumonia), bacteraemia, sepsis, herpes infection, and cytomegalovirus infection have been reported in patients treated with Polivy (see section 4.8).
Danish: Der er rapporteret alvorlige, livstruende og dødelige infektioner, inklusive opportunistiske infektioner som pneumoni (også pneumocystis jirovecii og andre svampepneumonier), bakteriæmi, sepsis, herpesinfektion og cytomegalovirus infektion hos patienter behandlet med Polivy (se pkt.
English: Based on the mechanism of action and nonclinical studies, Polivy can be harmful to the foetus when administered to a pregnant woman (see section 5.3).
Danish: På baggrund af virkningsmekanismen og ikke-kliniske studier, vurderes det, at Polivy kan skade fostret, hvis det administreres til en gravid kvinde (se pkt.
English: Eligible patients were not candidates for autologous haematopoietic stem cell transplant (HSCT) and had relapsed or refractory disease after receiving at least one prior systemic chemotherapy regimen.
Danish: Patienter egnet til inklusion i studiet var patienter, der ikke var kandidater til autolog hæmatopoietisk stamcelletransplantation (HSCT) og som havde oplevet relaps eller refraktær sygdom i forbindelse med mindst et tidligere systemisk kemoterapi-regimen.
English: Unconjugated MMAE is not predicted to alter the AUC of concomitant medicines that are CYP3A4 substrates (e.g., midazolam).
Danish: Ukonjugeret MMAE forventes ikke at ændre AUC for samtidigt administrerede lægemidler, der er CYP3A4-substrater (fx midazolam).
English: In order to provide further evidence of efficacy and safety of polatuzumab vedotin in DLBCL, the MAH will provide Study GO39942, a randomized, double-blind, placebo controlled trial that evaluates polatuzumab vedotin in combination with R-CHP (rituximab, cyclophosphamide, doxorubicin, prednisone) versus R-CHOP in patients with previously untreated diffuse large B-cell lymphoma.
Danish: For yderligere at bevise effekten og sikkerheden af polatuzumab vedotin i DLBCL, vil indehaveren af markedsføringstilladelsen levere studie GO39942, et randomiseret, dobbeltblindt, placebokontrolleret forsøg, der evaluerer polatuzumab vedotin i kombination med R-CHP (rituximab, cyclophosphamid, doxorubicin, prednison) versus R-CHOP hos patienter med tidligere ubehandlet diffust storcellet B-celle lymfom.
English: Men must use contraception during treatment and for 6 months after the last dose of Polivy.
Danish: Mænd skal bruge prævention under hele behandlingen og i 6 måneder efter sidste dosis af Polivy.
English: • severe infections
Danish: • alvorlige infektioner
English: In women of childbearing potential, the pregnancy status shall be checked prior to treatment.
Danish: Kvinder, der kan blive gravide, skal undersøges for graviditet før behandling.
English: Inspect the intravenous bag for particulates and discard if present.
Danish: Kontrollér den intravenøse pose for partikler.
English: From a microbiological point of view, the prepared solution for infusion should be used immediately.
Danish: Af mikrobiologiske hensyn, bør den tilberedte infusionsopløsning anvendes straks.
English: The adverse drug reactions (ADRs) described in this section were identified during treatment and follow-up of previously treated DLBCL patients from the pivotal clinical trial GO29365.
Danish: De bivirkninger, der beskrives under dette punkt er identificeret under behandling af og opfølgning på tidligere behandlede DLBCL-patienter fra det pivotale kliniske studie, GO29365.
English: Polivy powder for concentrate for solution for infusion is a white to slightly greyish-white cake provided in a glass vial.
Danish: Polivy pulver til koncentrat til infusionsvæske, opløsning er et hvidt til let gråhvidt lyofilisat, leveret i et hætteglas.
English: Infections, including pneumonia and other types of infections, were reported in 53.3% of patients in the Polivy plus BR arm and 51.3% of patients in the BR arm.
Danish: Der er rapporteret infektioner, inklusive pneumoni og andre typer infektioner, hos 53,3% af patienterne i Polivy plus BR-armen og 51,3% af patienterne i BR-armen.
English: • The other ingredients are: succinic acid, sodium hydroxide, sucrose, polysorbate 20.
Danish: • Øvrige indholdsstoffer: succinsyre, natriumhydroxid, saccharose, polysorbat 20.
English: Polivy is for single-use only.
Danish: Polivy er udelukkende beregnet til éngangsbrug.
English: Based on physiological-based pharmacokinetic (PBPK) model simulations of MMAE released from polatuzumab vedotin, strong CYP3A4 and P-gp inhibitors (e.g., ketoconazole) may increase the area under the concentration-time curve (AUC) of unconjugated MMAE by 48%.
Danish: På baggrund af fysiologiske, farmakokinetiske (PBPK) modelsimulationer af MMAE frigjort fra polatuzumab vedotin, kan stærke CYP3A4- og P-gp-hæmmere (fx ketoconazol) øge arealet under koncentrations-tidskurven (AUC) for ukonjugeret MMAE med 48%.
English: No dedicated carcinogenicity studies have been performed with polatuzumab vedotin and/or MMAE.
Danish: Der er ikke udført dedikerede carcinogenicitetsstudier med polatuzumab vedotin og/eller MMAE.
English: If a prior dose reduction to 1.4 mg/kg has occurred, discontinue Polivy.
Danish: Hvis dosis allerede er reduceret til 1,4 mg/kg, skal behandling med Polivy seponeres.
English: Strong CYP3A4 inducers (e.g., rifampicin, carbamazepine, phenobarbital, phenytoin, St John's wort [Hypericum perforatum]) may decrease the exposure of unconjugated MMAE.
Danish: Stærke CYP3A4-induktorer (fx rifampicin, carbamazepine, phenobarbital, phenytoin, perikon (hypericum perforatum)) kan mindske eksponeringen af ukonjugeret MMAE.
English: • The active substance is polatuzumab vedotin.
Danish: • Aktivt stof: Polatuzumab vedotin.
English: Serious adverse reactions were reported in 27% of Polivy plus BR treated patients, which includes febrile neutropenia (6.7%), pyrexia (4.4%), and pneumonia (4.4%).
Danish: Der blev rapporteret alvorlige bivirkninger hos 27% af de patienter, der blev behandlet med Polivy plus BR, omfattende febril neutropeni (6,7%), pyreksi (4,4%), og pneumoni (4,4%)
English: If not recovered to Grade ≤ 1 on or before Day 14, discontinue Polivy.
Danish: Hvis der ikke er bedring til grad ≤1 inden eller på dag 14, skal behandling med Polivy seponeres.
English: The terminal half-life at Cycle 6 was approximately 12 days (95% CI of 8.1-19.5 days) for acMMAE.
Danish: Den terminale halveringstid for acMMAE var i behandlingsserie 6 ca. 12 dage (95% KI for 8,1-19,5 dage).
English: If platelets recover to > 75,000/µL on or before Day 7, resume all treatment without any dose reductions.
Danish: Hvis trombocytter stiger til >75.000/µl inden eller på dag 7, genoptages al behandling uden dosisreduktion.
English: Based on the population PK analysis there is a decrease of plasma unconjugated MMAE exposure (AUC) after repeated every-three-week dosing.
Danish: Baseret på den farmakokinetiske populationsanalyse, er der et fald i optag af ukonjugeret MMAE (AUC) efter gentagen dosering hver 3. uge.
English: The corresponding frequency category for each adverse drug reaction is based on the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1000), very rare (< 1/10,000).
Danish: Tabel over bivirkninger rapporteret i kliniske studier Følgende bivirkninger præsenteres efter systemorganklasse og hyppighed, defineret som: meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1000 til <1/100), sjælden
English: Polivy is given in combination with two other cancer medicines called rituximab and bendamustine.
Danish: Polivy gives i kombination med to andre lægemidler mod kræft, rituximab og bendamustin.
English: In the Polivy plus BR arm, Grade 3 or higher neutropenia, thrombocytopenia, and anaemia were reported in 40%, 37.8%, and 24.4% of patients, respectively.
Danish: I Polivy plus BR-armen blev grad 3 eller højere, neutropeni, trombocytopeni og anæmi rapporteret hos henholdsvis 40%, 37,8% og 24,4% af patienterne.
English: Polivy is a cancer medicine that contains the active substance polatuzumab vedotin.
Danish: Polivy er et lægemiddel mod kræft, der indeholder det aktive stof polatuzumab vedotin,
English: The most frequently-reported (≥ 30%) ADRs in patients treated with Polivy in combination with BR were anaemia (46.7%), thrombocytopenia (46.7%), neutropenia (46.7%), fatigue (40.0%), diarrhoea (37.8%), nausea (33.3%), and pyrexia (33.3%).
Danish: De hyppigst rapporterede bivirkninger (≥30%) hos patienter behandlet med Polivy i kombination med BR var anæmi (46,7%), trombocytopeni (46,7%), neutropeni (46,7%), træthed (40,0%), diarré (37,8%), kvalme (33,3%) og pyreksi (33,3%).
English: Tell your doctor or nurse if you notice any of the following side effects:
Danish: Kontakt lægen eller sundhedspersonalet, hvis du bemærker én eller flere af følgende bivirkninger:
English: Polivy must be reconstituted and diluted using aseptic technique under the supervision of a healthcare professional.
Danish: Polivy skal rekonstitueres og fortyndes under aseptisk håndtering og under supervision af sundhedspersoner.
English: In the Polivy plus BR arm, serious infections were reported in 28.9% of patients and fatal infections were reported in 8.9% of patients.
Danish: I Polivy plus BR-armen rapporteredes alvorlige infektioner hos 28,9% af patienterne og dødelige infektioner hos 8,9% af patienterne.
English: • have headaches
Danish: • får hovedpine
English: Drug interactions with concomitant medicines that are CYP3A4 inhibitors, substrates or inducers and co-medications that are P-gp inhibitors
Danish: Lægemiddelinteraktioner med samtidigt administrerede lægemidler, der er CYP3A4-hæmmere,substrater eller -induktorer samt samtidigt administrerede lægemidler, der er P-gp-hæmmere.
English: Swirl the vial gently until completely dissolved.
Danish: Drej forsigtigt hætteglasset i cirkulære bevægelser indtil lyofilisatet er helt opløst.
English: Defined as all adverse reactions reported as related to study treatment within 24 hours after treatment infusion Uncommon, rare and very rare ADRs: none
Danish: Meget almindelig infusionsrelaterede reaktionerb a Bivirkninger forbundet med dødelig udgang b Defineret som alle bivirkninger rapporteret som relateret til forsøgsbehandling inden for 24 timer efter infusion Ikke almindelige, sjældne og meget sjældne bivirkninger: ingen