FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety and efficacy of Blitzima in children below 18 years has not been established.
Danish: Pædiatrisk population Blitzimas sikkerhed og virkning hos børn under 18 år er ikke klarlagt.
English: • you are allergic to rituximab, other proteins which are like rituximab, or any of the other ingredients of this medicine (listed in section 6)
Danish: • du er allergisk over for rituximab, andre proteiner, der ligner rituximab eller et af de øvrige indholdsstoffer i Blitzima (angivet i punkt 6).
English: For patients who may be at higher risk for relapse, physicians should consider a longer duration of Blitzima maintenance therapy, up to 5 years.
Danish: For patienter, som kan have højere risiko for recidiv, bør lægen overveje en længerevarende vedligeholdelsebehandling med Blitzima, i op til 5 år.
English: Your doctor will check if you should have any vaccines before you receive Blitzima.
Danish: Din læge vil undersøge, om du bør vaccineres inden du får Blitzima.
English: Your doctor may prescribe Blitzima for the treatment of:
Danish: Din læge kan ordinere Blitzima til behandling for:
English: Blitzima will be given to you by a doctor or nurse who is experienced in the use of this treatment.
Danish: Du får Blitzima af en læge eller sygeplejerske med erfaring i denne behandling.
English: You should also tell them about your Blitzima treatment.
Danish: Du skal også fortælle dem om din Blitzima-behandling.
English: • If you are having Blitzima alone Blitzima will be given to you once a week for 4 weeks.
Danish: • Hvis du får Blitzima alene Blitzima gives en gang ugentligt i 4 uger.
English: It is not known whether Blitzima has an effect on you being able to drive or use any tools or machines.
Danish: Det vides ikke, om Blitzima påvirker din evne til at køre motorkøretøj eller arbejde med maskiner.
English: Blitzima should be administered under the close supervision of an experienced healthcare professional, and in an environment where full resuscitation facilities are immediately available (see section 4.4).
Danish: Blitzima skal anvendes under tæt supervision af erfarent sundhedspersonale i omgivelser, hvor komplet genoplivningsudstyr er umiddelbart tilgængeligt (se pkt.
English: Repeated treatment courses with Blitzima are possible.
Danish: Gentagne behandlingsforløb med Blitzima er mulige.
English: • If you respond well to treatment, you may be given Blitzima every 2 or 3 months for two years.
Danish: • Hvis medicinen virker godt hos dig, kan du få Blitzima hver 2. eller 3. måned i op til 2 år.
English: • The need to check, prior to Blitzima treatment, for infections, for immunosuppression, for prior/current medication affecting the immune system and recent history of, or planned, vaccination
Danish: • Nødvendigheden af at kontrollere for infektioner, for immunsuppression, for tidligere/nuværende medicinering, der påvirker immunsystemet, og for nylige og/eller planlagte vaccinationer før behandling med Blitzima påbegyndes
English: Percentage of Patients with First Major Relapse
Danish: Patienter med første større recidiv i procent
English: When Blitzima is given in combination with chemotherapy, standard dose reductions for the chemotherapeutic medicinal products should be applied.
Danish: Når Blitzima gives i kombination med kemoterapi, bør standard dosisreduktioner for de kemoterapeutiske lægemidler anvendes.
English: Blitzima may also cause changes in laboratory tests carried out by your doctor.
Danish: Blitzima kan også ændre resultaterne på de blodprøver, som lægen har bestilt.
English: The cells that are affected by Blitzima help to fight infection and you should wait until the infection has passed before you are given Blitzima.
Danish: Cellerne, der påvirkes af Blitzima hjælper med at bekæmpe infektioner, og du bør vente med behandling med Blitzima, indtil infektionen er forsvundet.
English: If you respond well to treatment, you may be given Blitzima as a maintenance treatment.
Danish: Hvis du reagerer godt på behandlingen, kan du få Blitzima som vedligeholdelsesbehandling.
English: This is because some people have a fall in their blood pressure while they are being given Blitzima.
Danish: Nogle har oplevet, at blodtrykket faldt, mens de fik Blitzima
English: Blitzima contains the active substance “rituximab”.
Danish: Blitzima indeholder det aktive indholdsstof rituximab.
English: Blitzima contains sodium
Danish: Blitzima indeholder natrium
English: Keep this card with you for 2 years after your last dose of Blitzima.
Danish: Opbevar dette kort på dig i 2 år efter, at du har fået den sidste Blitzima-dosis.
English: Following induction of remission with Blitzima, maintenance treatment should be initiated no sooner than 16 weeks after the last Blitzima infusion.
Danish: Efter induktion af remission med Blitzima skal vedligeholdelsesbehandling initieres tidligst 16 uger efter sidste Blitzima infusion.
English: For CLL patients whose lymphocyte counts are > 25 x 109/L it is recommended to administer prednisone/prednisolone 100 mg intravenous shortly before infusion with Blitzima to decrease the rate and severity of acute infusion reactions and/or cytokine release syndrome.
Danish: For CLL-patienter, hvis lymfocyttal er > 25 x 109/l, anbefales det at administrere 100 mg prednison/prednisolon intravenøst kort før infusionen med Blitzima for at reducere hastigheden og sværhedsgraden af akutte infusionsreaktioner og/eller cytokinfrigivelsessyndrom.
English: This should be followed by oral prednisone 1 mg/kg/day (not to exceed 80 mg/day, and tapered as rapidly as possible based on clinical need) during and after the 4 week induction course of Blitzima treatment.
Danish: Dette bør efterfølges af prednison oralt, 1 mg/kg/dag (dog højst 80 mg/dag og nedtitreret så hurtigt som muligt afhængigt af det kliniske behov) under og efter de 4 ugers induktions behandling med Blitzima.
English: If you are having Blitzima with other medicines, some of the side effects you may get may be due to the other medicines.
Danish: Hvis du får Blitzima sammen med anden medicin, kan nogle bivirkninger være forårsaget af den anden medicin.
English: 2Details on infusion related reactions are provided in the description of selected adverse drug reactions section.
Danish: 2 Detaljer omkring infusionsrelaterede reaktioner er angivet i afsnittet ”Beskrivelse af udvalgte bivirkninger”.
English: No dose reductions of Blitzima are recommended.
Danish: Der er ingen anbefalinger vedrørende dosisreduktion af Blitzima.
English: Premedication consisting of an anti-pyretic and an antihistaminic, e.g. paracetamol and diphenhydramine, should always be given before each administration of Blitzima.
Danish: Der bør altid gives præmedicin bestående af et anti-pyretisk lægemiddel samt et antihistamin, f.eks. paracetamol og diphenhydramin, inden hver Blitzima-administration.
English: Log-rank p value
Danish: Log-rank p-værdi
English: If you can get pregnant, you and your partner must use an effective method of contraception while using Blitzima.
Danish: Hvis du er i den fødedygtige alder, skal du og din partner bruge sikker prævention, mens du er i behandling med Blitzima.
English: Rarely Blitzima can cause a serious brain infection, called “Progressive Multifocal Leukoencephalopathy” or PML.
Danish: Blitzima har i sjældne tilfælde forårsaget en alvorlig hjerneinfektion, som kaldes ”Progressiv multifokal leukoencefalopati” (PML).
English: Talk to your doctor, pharmacist or nurse before you are given Blitzima if:
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, inden du får Blitzima, hvis:
English: When you are treated with Blitzima in combination with chemotherapy, you will receive Blitzima infusions on day 0 cycle 1 then day 1 of each cycle for 6 cycles in total.
Danish: Hvis du behandles med Blitzima i kombination med kemoterapi, vil du få Blitzimaen infusion med Blitzima på dag 0 i serie 1 og derefter på dag 1 i hver af i alt 6 serier.
English: • If you are having Blitzima with chemotherapy Blitzima will be given to you on the same day as your chemotherapy.
Danish: • Hvis du får Blitzima sammen med kemoterapi Blitzima gives samme dag som kemoterapien.
English: Pneumocystis jirovecii pneumonia (PCP) prophylaxis is recommended for patients with GPA/MPA or PV during and following rituximab treatment, as appropriate according to local clinical practice guidelines.
Danish: Profylakse mod Pneumocystis jiroveci-pneumoni (PCP) anbefales til patienter med GPA/MPA eller PV under og efter behandling med Blitzima i det omfang, det er relevant i henhold til lokale kliniske retningslinjer.
English: Blitzima should be used in combination with CHOP chemotherapy.
Danish: Blitzima bør anvendes i kombination med CHOP kemoterapi.
English: You will always be given Blitzima as a drip (intravenous infusion).
Danish: Blitzima gives altid i et drop (intravenøs infusion).
English: Blitzima is a clear, colourless solution, supplied as a concentrate for solution for infusion in a glass vial.
Danish: Blitzima er en klar, farveløs opløsning, leveret som koncentrat til infusionsvæske, opløsning i et hætteglas.
English: Blitzima should be administered on day 1 of each chemotherapy cycle, after intravenous administration of the glucocorticoid component of the chemotherapy if applicable.
Danish: Blitzima bør gives på dag 1 i hver kemoterapiserie, efter intravenøs indgift af glukokortikoidkomponenten, hvis det anvendes.
English: Patients treated with Blitzima must be given the patient alert card with each infusion.
Danish: Patienter behandlet med Blitzima skal have udleveret patientkortet ved hver infusion.
English: The MAH must ensure that all physicians who are expected to prescribe Blitzima are provided with the following:
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at alle læger, som kan forventes at udskrive Blitzima, har modtaget følgende:
English: Subsequent doses of Blitzima can be infused at an initial rate of 100 mg/h, and increased by 100 mg/h increments at 30 minute intervals, to a maximum of 400 mg/h.
Danish: Efterfølgende Blitzima-doser kan infunderes med 100 mg/time initialt og øges med 100 mg/time hvert 30. minut til højst 400 mg/time.
English: Medicines given before each Blitzima administration
Danish: Medicin, der gives inden hver behandling med Blitzima
English: • The active ingredient in Blitzima is called rituximab.
Danish: • Aktivt stof i Blitzima: Rituximab.
English: What you need to know before you use Blitzima Do not take Blitzima if:
Danish: Det skal du vide, før du begynder at få Blitzima Du må ikke få Blitzima, hvis:
English: Following induction of remission with other standard of care immunosuppressants, Blitzima maintenance treatment should be initiated during the 4 week period that follows disease remission.
Danish: Efter induktion af remission med andre immunsuppresiva til standardbehandling skal Blitzima vedligeholdelsesbehandling initieres i løbet af en 4 ugers periode efter opnåelse af sygdomsremission.
English: CI: confidence interval; FU: follow-up; TNLT: time to next anti-lymphoma treatment; TNCT: time to next chemotherapy treatment; NR: not reached at time of clinical cut-off.
Danish: KI: konfidensinterval; TNLT: Tid til næste anti-lymfom-behandling; TNCT: Tid til næste kemoterapibehandling; NR: Ikke opnået ved det kliniske skæringstidspunkt.
English: Only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies including Blitzima or patients refractory to previous Blitzima plus chemotherapy.
Danish: Der er kun begrænsede effekt-og sikkerhedsdata tilgængelige for patienter, som tidligere er behandlet med monoklonale antistoffer inklusive Blitzima, og for patienter, som er refraktære over for tidligere behandling med Blitzima og kemoterapi.
English: Blood and lymphatic system neutropenia1
Danish: Blod og lymfesystem neutropeni1
English: Aseptically withdraw the necessary amount of Blitzima, and dilute to a calculated concentration of 1 to 4 mg/mL rituximab into an infusion bag containing sterile, pyrogen-free sodium chloride 9 mg/mL (0.9%) solution for injection or 5% D-Glucose in water.
Danish: Under anvendelse af aseptiske procedurer trækkes den nødvendige mængde Blitzima op og fortyndes til en beregnet koncentration på 1 til 4 mg/ml rituximab i en infusionspose, der indeholder steril, pyrogenfri natriumchloridopløsning til injektion 9 mg/ml (0,9 %) eller 5 % D-glukose i vand.
English: Blitzima is indicated for the treatment of previously untreated patients with stage III-IV follicular lymphoma in combination with chemotherapy.
Danish: Blitzima er indiceret til behandling af tidligere ubehandlede patienter med stadium III-IV follikulært lymfom i kombination med kemoterapi.
English: Very common side effects (may affect more than 1 in 10 people): • allergic reactions that are most likely to occur during an infusion, but can occur up to 24 hours after infusion
Danish: Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 patienter): A. allergiske reaktioner, som normalt forekommer under infusionen, men kan forekomme i op til 24 timer efter infusion B. langvarig depression C. hårtab
English: The Patient Alert Card for Blitzima in non-oncology indications should contain the following key elements:
Danish: Patientkortet for Blitzima for non-onkologiske indikationer skal indeholde følgende nøgle-elementer:
English: In patients with non-Hodgkin's lymphoma and CLL, premedication with glucocorticoids should be considered if Blitzima is not given in combination with glucocorticoid-containing chemotherapy.
Danish: Hos patienter med non-Hodgkin-lymfom og CLL bør det overvejes at give præmedicinering med glukokortikoider, hvis Blitzima ikke gives i kombination med et kemoterapiregime, som indeholder glukokortikoid.
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100) and very rare (< 1/10000).
Danish: Frekvenserne er defineret som meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til ≤ 1/100) og meget sjælden (< 1/10.000).
English: Overall, 4% of patients in the rituximab arm experienced adverse events leading to discontinuation.
Danish: Samlet set oplevede 4 % af patienterne i rituximab-armen bivirkninger der ledte til seponering.
English: Blitzima maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy.
Danish: Blitzima vedligeholdelsesbehandling er indiceret til behandling af follikulært lymfom hos patienter, der responderer på induktionsbehandling.
English: Blitzima should be administered as two 500 mg IV infusions separated by two weeks, followed by a 500 mg IV infusion every 6 months thereafter.
Danish: Blitzima skal administreres som to 500 mg intravenøse infusioner, med to ugers mellemrum, efterfulgt af en 500 mg intravenøs infusion hver 6. måned.
English: In patients where the treatment is working, Blitzima may be continued for 2 years after completing the initial treatment.
Danish: Hvis behandlingen virker, kan Blitzima fortsættes i 2 år efter, den første behandling er givet.
English: Your doctor may need to take special care of you during your treatment with Blitzima.
Danish: Du kan have behov for ekstra overvågning under din behandling med Blitzima.
English: The prepared Blitzima solution should be administered as an intravenous infusion through a dedicated line.
Danish: Den tilberedte Blitzima-opløsning skal gives som en intravenøs infusion gennem en separat anlagt intravenøs adgang.
English: The reported cases had recognised risk factors for PRES/RPLS, including the patients' underlying disease, hypertension, immunosuppressive therapy and/or chemotherapy.
Danish: I de rapporterede tilfælde var der kendte risikofaktorer for PRES / RPLS, herunder patientens underliggende sygdom, hypertension, immunsuppressiv behandling og/eller kemoterapi.
English: Safety and efficacy of Blitzima have not been established in combination with other chemotherapies in diffuse large B cell non-Hodgkin's lymphoma.
Danish: Sikkerhed og effekt af Blitzima er ikke påvist i kombination med andre kemoterapiregimer til behandling af diffust storcellet B-celle non-Hodgkin-lymfom.
English: If you are being treated for pemphigus vulgaris
Danish: d) Hvis du behandles for pemfigus vulgaris
English: • infections of the blood (sepsis), pneumonia, shingles, cold, bronchial tube infections,
Danish: • infektioner i blodet (sepsis), lungebetændelse, helvedesild, forkølelse, infektion i bronkierne,
English: The chemotherapy should be given after the Blitzima infusion.
Danish: Kemoterapien skal gives efter infusionen med Blitzima.
English: In patients with granulomatosis with polyangiitis (Wegener's) or microscopic polyangiitis, methylprednisolone given intravenously for 1 to 3 days at a dose of 1000 mg per day is recommended prior to the first infusion of Blitzima (the last dose of methylprednisolone may be given on the same day as the first infusion of Blitzima).
Danish: Hos patienter med GPA eller MPA anbefales det at give methylprednisolon intravenøst i 1-3 dage i en dosis på 1000 mg pr. dag inden den første Blitzima-infusion (sidste dosis methylprednisolon kan gives samme dag som første Blitzima-infusion).
English: This is equivalent to 2.6% of the recommended maximum daily dietary intake of sodium for an adult
Danish: Dette svarer til 2,6% af den anbefalede maximale daglige indtagelse af natrium for en voksen.
English: The Patient information about Blitzima should contain the following key elements:
Danish: Information til patienten om Blitzima skal indeholde følgende nøgle-elementer:
English: If you are not sure, talk to your doctor, pharmacist or nurse before you are given Blitzima.
Danish: Hvis du er i tvivl, skal du kontakte lægen, apotekspersonalet eller sundhedspersonalet, inden du får Blitzima.
English: In patients with granulomatosis with polyangiitis or microscopic polyangiitis, the number of peripheral blood B cells decreased to <10 cells/μL after two weekly infusions of rituximab 375 mg/m2, and remained at that level in most patients up to the 6 month time point.
Danish: Hos patienter med granulomatose med polyangiitis eller mikroskopisk polyangiitis faldt antallet af B-celler i perifert blod til < 10 celler/mikroliter efter 2 ugentlige infusioner af rituximab 375 mg/m2 og forblev på dette niveau hos de fleste patienter til måned 6.
English: Contents of the pack and other information What Blitzima contains
Danish: Pakningsstørrelse og yderligere oplysninger Blitzima indeholder:
English: Package leaflet: Information for the patient Blitzima 500 mg concentrate for solution for infusion rituximab This medicine is subject to additional monitoring.
Danish: Indlægsseddel: Information til brugeren Blitzima 500 mg koncentrat til infusionsvæske, opløsning rituximab Dette lægemiddel er underlagt supplerende overvågning.
English: Package leaflet: Information for the patient Blitzima 100 mg concentrate for solution for infusion rituximab This medicine is subject to additional monitoring.
Danish: Indlægsseddel: Information til brugeren Blitzima 100 mg koncentrat til infusionsvæske, opløsning rituximab Dette lægemiddel er underlagt supplerende overvågning.
English: Other medicines and Blitzima
Danish: Brug af anden medicin sammen med Blitzima
English: The recommended dosage of Blitzima for the treatment of pemphigus vulgaris is 1000 mg administered as an IV infusion followed two weeks later by a second 1000 mg IV infusion in combination with a tapering course of glucocorticoids.
Danish: Den anbefalede dosis af Blitzima til behandling af PV er 1.000 mg administreret som en intravenøs infusion efterfulgt af endnu en 1.000 mg intravenøs infusion 2 uger senere i kombination med nedtitrerende glukokortikoider.
English: PATIENT ALERT CARD TEXT FOR NON-ONCOLOGY INDICATIONS Blitzima (Rituximab) Alert Card for patients with non-oncology diseases Why have I been given this card?
Danish: TEKST TIL PATIENTKORT FOR IKKE-ONKOLOGISKE INDIKATIONER Blitzima (Rituximab)-patientkort for ikkeonkologiske indikationer
English: Blitzima is provided in sterile, preservative-free, non-pyrogenic, single use vials.
Danish: Blitzima leveres i sterile, pyrogenfri hætteglas uden konserveringsmiddel til engangsbrug.
English: Blitzima is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (PV).
Danish: Blitzima er indiceret til behandling af patienter med moderat til svær pemfigus vulgaris (PV).
English: This is because Blitzima can across the placenta and may affect your baby.
Danish: Blitzima kan overføres til moderkagen og påvirke barnet.
English: Blitzima is used for the treatment of patients with moderate to severe pemphigus vulgaris.
Danish: Blitzima anvendes til behandling af patienter med moderat til svær pemfigus vulgaris.
English: Blitzima monotherapy is indicated for treatment of patients with stage III-IV follicular lymphoma who are chemo-resistant or are in their second or subsequent relapse after chemotherapy.
Danish: Blitzima monoterapi er indiceret til behandling af patienter med grad III-IV follikulært lymfom, som er resistente overfor kemoterapi eller som er i deres andet eller efterfølgende relaps efter kemoterapi.
English: Treatment with rituximab in combination with methotrexate over multiple courses resulted in sustained improvements in the clinical signs and symptoms of RA, as indicated by ACR, DAS28
Danish: Gentagne behandlingsserier med rituximab i kombination med methotrexat resulterede i vedvarende forbedringer af kliniske symptomer på RA angivet ved ACR-DAS28-ESR-og EULAR-respons.
English: Corticosteroids will usually be given by injection before the start of Blitzima treatment.
Danish: Du vil som regel få en indsprøjtning med binyrebarkhormon, inden behandlingen med Blitzima påbegyndes.
English: fungal infections, infections of unknown origin, sinus inflammation, hepatitis B
Danish: svampeinfektioner, infektioner af ukendt oprindelse, bihulebetændelse, leverbetændelse
English: How to store Blitzima
Danish: Sådan får du Blitzima
English: This is because in a few cases, Blitzima could cause hepatitis B to become active again, which can be fatal in very rare cases.
Danish: Det er vigtigt, fordi Blitzima i enkelte tilfælde har forårsaget, at en tidligere leverbetændelse (hepatitis B) er blevet aktiv igen.
English: • unusual feelings of the skin - such as numbness, tingling, pricking, burning, a creeping skin feeling, reduced sense of touch
Danish: • usædvanlig følelse i huden, f.eks. følelsesløshed, prikken, stikken, brænden, myrekryb,
English: Cases of posterior reversible encephalopathy syndrome (PRES)/reversible posterior leukoencephalopathy syndrome (RPLS) have been reported.
Danish: Tilfælde af posterior reversibel encefalopati syndrom (PRES)/reversibel posterior leukoencefalopati syndrom (RPLS) er blevet rapporteret.
English: The Physician information about Blitzima should contain the following key elements:
Danish: Informationen til lægen om Blitzima skal indeholde følgende nøgle-elementer:
English: cell return, with counts >10 cells/μL by month 12, increasing to 87% of patients by month 18.
Danish: Størstedelen af patienterne (81 %) viste tegn på B-celleregenerering med > 10 celler/mikroliter ved måned 12; dette steg til 87 % af patienterne ved måned 18.
English: +myocardial infarction4 and 6, arrhythmia, +atrial fibrillation, tachycardia, +cardiac disorder
Danish: +myokardieinfarkt 4 og 6, arytmier, +atrieflimren, takykardi, +hjertesygdom
English: Granulomatosis with polyangiitis and microscopic polyangiitis Blitzima, in combination with glucocorticoids, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (Wegener's) (GPA) and microscopic polyangiitis (MPA).
Danish: Blitzima er i kombination med glukokortikoider indiceret til behandling af voksne patienter med svær, aktiv granulomatose med polyangiitis (Wegeners granulomatose) (GPA) eller mikroskopisk polyangiitis (MPA).
English: This is because Blitzima can affect the way some other medicines work.
Danish: Det er vigtigt, da Blitzima kan påvirke virkningen af anden medicin, og anden medicin kan påvirke virkningen af Blitzima.