FrancophonIA/ELRC3.0 huggingface dataset:
English: In Studies I and II, patients receiving reslizumab 3 mg/kg had significant reductions in asthma exacerbations (50% and 59%, respectively) compared to placebo (see Table 4).
Danish: I studie I og II havde patienter, der fik reslizumab 3 mg/kg, signifikante reduktioner i astmaeksacerbationer (hhv. 50 % og 59 %) sammenlignet med placebogruppen (se tabel 4).
English: Excipients: sodium acetate trihydrate, acetic acid glacial, sucrose, water for injections.
Danish: Hjælpestoffer: natriumacetattrihydrat, koncentreret eddikesyre, saccharose, vand til injektionsvæsker.
English: Patients with severe eosinophilic asthma
Danish: Patienter med svær eosinofil astma
English: Myalgia was reported in 0.97% of patients (10 out of 1,028) in the 3 mg/kg reslizumab group of the placebo-controlled asthma studies compared with 0.55% of patients (4 out of 730) in the placebo group.
Danish: I de placebokontrollerede astmastudier blev myalgi rapporteret hos 0,97 % af patienterne (10 ud af 1.028) i gruppen med 3 mg/kg reslizumab, sammenlignet med 0,55 % af patienterne (4 ud af 730) i placebogruppen.
English: Sodium acetate trihydrate Acetic acid glacial Sucrose
Danish: Natriumacetattrihydrat Koncentreret eddikesyre Saccharose
English: Effect on blood eosinophils
Danish: Virkning på eosinofile celler i blodet
English: Each vial of 2.5 mL contains 25 mg of reslizumab and each vial of 10 mL contains 100 mg of reslizumab.
Danish: Hvert 2,5 ml hætteglas indeholder 25 mg reslizumab, og hvert 10 ml hætteglas indeholder 100 mg reslizumab.
English: 1 vial of 2.5 mL 2 vials of 2.5 mL 1 vial of 10 mL 2 vials of 10 mL
Danish: 1 hætteglas på 2,5 ml 2 hætteglas på 2,5 ml 1 hætteglas på 10 ml 2 hætteglas på 10 ml
English: CINQAERO should be administered by a healthcare professional prepared to manage hypersensitivity reactions including anaphylaxis (see section 4.4).
Danish: CINQAERO skal administreres af sundhedspersoner, som er uddannet til at behandle overfølsomhedsreaktioner, herunder anafylaksi (se pkt.
English: Each mL of concentrate contains 10 mg of reslizumab (10 mg/mL).
Danish: En ml koncentrat indeholder 10 mg reslizumab (10 mg/ml).
English: No noteworthy differences in the pharmacokinetics of reslizumab were observed across these renal function groups.
Danish: Der blev ikke observeret nogen bemærkelsesværdige forskelle i reslizumabs farmakokinetik mellem disse grupper.
English: Overall population Reslizumab 3 mg/kg (n=477)
Danish: Samlet population Reslizumab 3 mg/kg (n = 477)
English: Effect on sputum eosinophils
Danish: Virkning på eosinofile celler i sputum
English: Each vial of 2.5 mL contains 0.05 mmol (1.15 mg) of sodium.
Danish: Hjælpestof, som behandleren skal være opmærksom på Hvert 2,5 ml hætteglas indeholder 0,05 mmol (1,15 mg) natrium.
English: A suitable injection syringe should be used to withdraw the needed amount of the concentrate from the vial(s) (see section 4.2).
Danish: Der skal anvendes en egnet injektionssprøjte til at trække den nødvendige mængde af koncentratet op af hætteglasset/hætteglassene (se pkt.
English: - The other excipients are sodium acetate, acetic acid glacial, sucrose and water for injections.
Danish: - Øvrige indholdsstoffer: natriumacetat, koncentreret eddikesyre, saccharose og vand til injektionsvæsker.
English: How CINQAERO works
Danish: Sådan virker CINQAERO
English: CINQAERO 10 mg/mL sterile concentrate reslizumab
Danish: CINQAERO 10 mg/ml koncentrat, sterilt reslizumab
English: CINQAERO is provided as a concentrate for solution for infusion in a single-use vial.
Danish: CINQAERO leveres som koncentrat til infusionsvæske, opløsning, i et engangshætteglas.
English: Hepatic impairment No dose adjustment is required in patients with hepatic impairment (see section 5.2).
Danish: Nedsat leverfunktion Dosisjustering er ikke nødvendig hos patienter med nedsat leverfunktion (se pkt.
English: Slowly dispense the contents of the syringe(s) into an infusion bag containing 50 mL of sodium chloride 9 mg/mL (0.9%) solution for infusion.
Danish: Indholdet af sprøjten/sprøjterne overføres langsomt til en infusionspose med 50 ml natriumchlorid-infusionsvæske 9 mg/ml (0,9 %).
English: Renal impairment No dose adjustment is required in patients with renal impairment (see section 5.2).
Danish: Nedsat nyrefunktion Dosisjustering er ikke nødvendig hos patienter med nedsat nyrefunktion (se pkt.
English: CINQAERO 10 mg/mL concentrate for solution for infusion reslizumab
Danish: CINQAERO 10 mg/ml koncentrat til infusionsvæske, opløsning reslizumab
English: Vials with 2.5 mL concentrate (25 mg reslizumab)
Danish: Hætteglas med 2,5 ml koncentrat (25 mg reslizumab)
English: Reslizumab has not been studied in patients concurrently taking immunosuppressant medicinal products other than oral corticosteroids (OCS); therefore, the safety and efficacy profile of reslizumab in these patients is unknown.
Danish: Reslizumab er ikke blevet undersøgt hos patienter, der samtidigt tager andre immunsuppressive lægemidler end orale kortikosteroider (OCS).
English: Preparation of solution for infusion
Danish: Fremstilling af infusionsvæske
English: CINQAERO 10 mg/mL concentrate for solution for infusion
Danish: CINQAERO 10 mg/ml koncentrat til infusionsvæske, opløsning
English: Each vial of 2.5 mL contains 25 mg of reslizumab.
Danish: Hvert 2,5 ml hætteglas indeholder 25 mg reslizumab.
English: Reslizumab has not been studied in patients with hepatic impairment.
Danish: Reslizumab er ikke blevet undersøgt hos patienter med nedsat leverfunktion.
English: One vial of 2.5 mL contains 25 mg reslizumab.
Danish: Et hætteglas på 2,5 ml indeholder 25 mg reslizumab.
English: One vial of 10 mL contains 100 mg reslizumab.
Danish: Et hætteglas på 10 ml indeholder 100 mg reslizumab.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 16 hours at 2 °C-8 °C, unless dilution has taken place in controlled and validated aseptic conditions.
Danish: Hvis det ikke anvendes straks, er opbevaringstid og -betingelser før anvendelse brugerens ansvar, og det vil normalt ikke være over
English: Each vial of 10 mL contains 100 mg of reslizumab.
Danish: Hvert 10 ml hætteglas indeholder 100 mg reslizumab.
English: What CINQAERO is and what it is used for What you need to know before you are given CINQAERO How CINQAERO is given
Danish: Det skal du vide, før du begynder at få CINQAERO Sådan får du CINQAERO Bivirkninger
English: How to store CINQAERO
Danish: Sådan får du CINQAERO
English: Asthma exacerbations were evaluated only in the exacerbation studies (Studies I and II: reslizumab
Danish: Astmaeksacerbationer blev kun evalueret i eksacerbationsstudierne (studie I og II: reslizumab 3 mg/kg [n = 14] og placebo [n = 11]).
English: Each mL of concentrate contains 10 mg of reslizumab.
Danish: En ml koncentrat indeholder 10 mg reslizumab.
English: Exacerbation history
Danish: Tidligere eksacerbationer
English: Of these subjects, 1,006 asthma patients were exposed for at least 6 months, 759 exposed for at least 1 year and 237 exposed for longer than 2 years (up to 3 years).The following adverse reactions have been reported with reslizumab during placebo-controlled asthma studies for up to 52 weeks of treatment with a 3 mg/kg dose given intravenously (1,028 patients).
Danish: Nedenstående bivirkninger er blevet rapporteret med reslizumab i placebokontrollerede astmastudier med op til 52 ugers behandling med en dosis på 3 mg/kg givet intravenøst (1.028 patienter).
English: Baseline mean blood eosinophil count, µL-1
Danish: Gennemsnitligt blodeosinofiltal ved baseline, x 109/l
English: Batch
Danish: ACQ
English: 3 mg/kg [n=14] and placebo [n=11]).
Danish: 3 mg/kg sammenlignet med placebo.
English: Asthma exacerbation ratea
Danish: Astmaeksacerbationsr atea
English: Date of first authorisation: 06 February 2009 Date of latest renewal: 13 November 2013
Danish: Dato for første markedsføringstilladelse: 6. februar 2009 Dato for seneste fornyelse: 13. november 2013
English: Although this interaction has not been formally investigated, there is no evidence that such an interaction is harmful.
Danish: Selvom denne interaktion ikke er formelt undersøgt, er der ingen tegn på, at en sådan interaktion er skadelig.
English: The significance of these changes is unknown.
Danish: Det vides ikke, hvilken betydning disse ændringer har.
English: The subcutaneous route is preferred in most cases.
Danish: Subkutan administration er at foretrække i de fleste tilfælde.
English: If you are a stem cell donor, you must be aged between 16 and 60 years.
Danish: Hvis du er en stamcelledonor, skal du være mellem 16 og 60 år.
English: 83607 Holzkirchen Germany
Danish: 83607 Holzkirchen Tyskland
English: Please tell your doctor immediately during treatment:
Danish: Fortæl det omgående til lægen under behandlingen:
English: The usual dose varies depending on your illness and weight.
Danish: Den normale dosis varierer afhængigt af din sygdom og din vægt.
English: At the end of this period, the product should not be put back in the refrigerator and should be disposed of.
Danish: Ved afslutningen af denne periode må lægemidlet ikke sættes tilbage i køleskabet, men skal bortskaffes.
English: As with all therapeutic proteins, there is a potential for immunogenicity.
Danish: I lighed med alle andre terapeutiske proteiner er der potentiale for immunogenicitet.
English: Regular monitoring of blood counts is recommended (see above).
Danish: Regelmæssig monitorering af blodværdierne anbefales (se ovenfor).
English: It is important to tell your doctor if you:
Danish: Det er vigtigt, at du fortæller det til lægen, hvis du:
English: 10 6336 Langkampfen Austria
Danish: 10 6336 Langkampfen Østrig
English: You should talk to your doctor about your risks of developing cancers of the blood and what testing should be done.
Danish: Du bør tale med lægen om dine risici for at udvikle former for blodkræft og om hvilke prøver der skal tages.
English: Growth factors are proteins that are produced naturally in the body but they can also be made using biotechnology for use as a medicine.
Danish: Vækstfaktorer er proteiner, der dannes naturligt i kroppen, men de kan også fremstilles ved hjælp af bioteknologi, så de kan bruges som et lægemiddel.
English: Dilution prior to administration (optional)
Danish: Fortynding før administration (valgfri)
English: Sixty-five percent of the patients studied in the SCN trial program were under 18 years of age.
Danish: Femogtres procent af patienterne, der blev undersøgt i SCN-forsøgsprogrammet, var under 18 år.
English: Meta-Analysis
Danish: Meta-analyse
English: Binding antibodies do occur as expected with all biologics; however, they have not been associated with neutralising activity at present.
Danish: Bindende antistoffer forekommer, som det kan forventes med alle biologiske stoffer, men de er ikke blevet associeret med neutraliserende aktivitet på nuværende tidspunkt.
English: Subcutaneous or intravenous use.
Danish: Subkutan eller intravenøs brug.
English: Regular blood tests will be taken to monitor the number of white blood cells in your body.
Danish: Der vil tages regelmæssige blodprøver for at overvåge antallet af hvide blodlegemer i din krop.
English: Timing of leukapheresis: 1 or 2 leukaphereses on days 5 and 6 are often sufficient.
Danish: Tidsskema for leukaferese: 1 eller 2 leukafereser på dag 5 og 6 er ofte tilstrækkeligt.
English: It is unknown whether filgrastim/metabolites are excreted in human milk.
Danish: Det er ukendt, om filgrastim/metabolitter udskilles i human mælk.
English: The choice of route should depend on the individual clinical circumstance.
Danish: Valg af administrationsvej afhænger af de individuelle kliniske forhold.
English: You, or people caring for you, can be taught how to give subcutaneous injections so that you can continue your treatment at home.
Danish: Du eller dine omsorgspersoner kan få instruktion i, hvordan man giver en subkutan indsprøjtning, så du kan fortsætte behandlingen hjemme.
English: When the response has been obtained, the minimal effective dose to maintain this level should be established.
Danish: Når der er opnået respons, bør den lavest effektive dosis til opretholdelse af dette niveau, fastlægges.
English: Thereafter, it is recommended that the ANC is measured at least twice per week for the first 2 weeks and subsequently once per week or once every other week during maintenance therapy.
Danish: Derefter anbefales det, at ANC måles mindst to gange om ugen de første 2 uger og derefter en gang ugentligt eller en gang hver anden uge under vedligeholdelsesbehandlingen.
English: N Acute Grade II - IV GvHD
Danish: Studieperiode N Akut grad II - IV GvHD
English: This medicine may cause dizziness.
Danish: Dette lægemiddel kan gøre dig svimmel.
English: In other circumstances, additional leukaphereses may be necessary.
Danish: I andre tilfælde kan det være nødvendigt med yderligere leukafereser.
English: Overall, reports were more common after IV administration.
Danish: Samlet var rapporterne mere almindelige efter intravenøs administration.
English: For patients who have not had extensive chemotherapy, one leukapheresis is often sufficient.
Danish: Til patienter, som ikke har fået omfattende kemoterapi, er én leukaferese ofte tilstrækkeligt.
English: <{MM/YYYY}>
Danish: {MM/ÅÅÅÅ}
English: Infections and malignancies causing myelosuppression
Danish: Infektioner og maligniteter som forårsager myelosuppression
English: The volume of distribution in blood is approximately 150 ml/kg.
Danish: Fordelingsvolumen i blodet er cirka 150 ml/kg.
English: Clinical trials with filgrastim have included a small number of elderly patients but special studies have not been performed in this group and therefore specific dosage recommendations cannot be made.
Danish: Kliniske forsøg med filgrastim har inkluderet et lille antal ældre patienter, men der er ikke udført specielle studier hos denne gruppe, og der kan derfor ikke gives specifikke doseringsanbefalinger.
English: There are no prospectively randomised comparisons of the two recommended mobilisation methods (Filgrastim alone, or in combination with myelosuppressive chemotherapy) within the same patient population.
Danish: Der er ingen prospektivt randomiserede sammenligninger mellem de to anbefalede metoder til mobilisering (filgrastim alene eller i kombination med myelosuppressiv kemoterapi) inden for samme patientpopulation.
English: Causes of transient neutropenia, such as viral infections should be excluded.
Danish: Årsager til forbigående neutropeni, såsom virusinfektioner, bør udelukkes.
English: • in patients with advanced HIV infection which will help reduce the risk of infections.
Danish: • hos patienter med fremskreden hiv-infektion, hvor det vil hjælpe med at reducere risikoen for infektioner.
English: These changes all reversed after discontinuation of treatment.
Danish: Alle disse ændringer var reversible efter behandlingsophør.
English: Your doctor may regularly test your urine if you experience this side effect or if protein is found in your urine (proteinuria).
Danish: Din læge vil muligvis kontrollere din urin regelmæssigt, hvis du oplever denne bivirkning, eller hvis der findes protein i din urin (proteinuri).
English: It is advisable to wait and see how you feel after taking Filgrastim HEXAL and before driving or operating machinery.
Danish: Det er tilrådeligt at vente og se, hvordan du har det, efter du tager Filgrastim HEXAL, og før du fører motorkøretøj eller betjener maskiner.
English: Insert the needle into the skin fold with a quick, firm action.
Danish: Indfør kanylen i huden med en hurtig, fast bevægelse.
English: Nevertheless, a risk of promotion of a malignant myeloid clone cannot be excluded.
Danish: Risikoen for dannelse af et malignt myeloidt klon kan dog ikke udelukkes.
English: • increase of certain enzymes in the blood
Danish: • forhøjet niveau af visse enzymer i blodet
English: The safety and efficacy of filgrastim have not been assessed in normal donors < 16 years or > 60 years.
Danish: Sikkerheden og virkningen af filgrastim er ikke undersøgt hos raske donorer < 16 år eller > 60 år.
English: G-CSF can promote growth of myeloid cells in vitro and similar effects may be seen on some nonmyeloid cells in vitro.
Danish: G-CSF kan fremme væksten af myeloide celler in vitro, og sammenlignelige virkninger kan observeres hos nogle ikke-myeloide celler in vitro.
English: A reduction in the number of white blood cells (neutropenia) can occur for several reasons and makes your body less able to fight infection.
Danish: Et fald i antallet af hvide blodlegemer (neutropeni) kan opstå af flere årsager, og det gør din krop mindre i stand til at bekæmpe infektioner.
English: * recombinant methionylated human granulocyte-colony stimulating factor (G-CSF) produced in E. coli by recombinant DNA technology.
Danish: * rekombinant-methionyl humant granulocyt-kolonistimulerende faktor (G-CSF) fremstillet i E. coli ved rekombinant DNA-teknologi.
English: • before high-dose chemotherapy to make the bone marrow produce more stem cells which can be collected and given back to you after your treatment.
Danish: • før højdosis-kemoterapi for at få knoglemarven til at danne flere stamceller, som kan indsamles og gives tilbage til dig efter din behandling.
English: How is Filgrastim HEXAL given and how much should I take?
Danish: Hvordan gives Filgrastim HEXAL, og hvor meget skal jeg tage?
English: Pharmacotherapeutic group: Immunostimulants, colony stimulating factors, ATC Code: L03AA02
Danish: Farmakoterapeutisk klassifikation: Immunstimulerende midler, kolonistimulerende faktorer, ATC-kode: L03AA02
English: In some cases, symptoms have recurred with rechallenge, suggesting a causal relationship.
Danish: I nogle tilfælde kom symptomerne tilbage ved gentagen provokation, hvilket tyder på en årsagssammenhæng.
English: Instructions on how to inject yourself
Danish: Instruktion i, hvordan du giver dig selv en indsprøjtning
English: It is recommended that the ANC is measured daily for the first 2 - 3 days of filgrastim administration.
Danish: Det anbefales, at ANC måles dagligt de første 2 - 3 dage af administrationen af filgrastim.
English: Human G-CSF is a glycoprotein which regulates the production and release of functional neutrophils from the bone marrow.
Danish: Humant G-CSF er et glykoprotein, som regulerer dannelsen og frigivelsen af funktionelle neutrofiler fra knoglemarven.
English: No undesirable effects directly attributable to this degree of leukocytosis have been reported.
Danish: Der er ikke rapporteret om nogen bivirkninger, som direkte kan tilskrives denne grad af leukocytose.
English: There is a positive linear correlation between the dose and the serum concentration of filgrastim, whether administered intravenously or subcutaneously.
Danish: Der er en positiv lineær korrelation mellem dosis og serumkoncentrationen af filgrastim, uanset om det er administreret intravenøst eller subkutant.
English: Do not increase the dose your doctor has given you.
Danish: Du må ikke øge den dosis, lægen har ordineret.
English: • think you may be pregnant; or
Danish: • har mistanke om, at du er gravid eller
English: It is recommended that the apheresis centre perform a systematic record and tracking of the stem cell donors for at least 10 years to ensure monitoring of long-term safety.
Danish: Det anbefales, at aferesecentret systematisk registrerer og sporer data for stamcelledonorer i mindst 10 år af hensyn til monitorering af langtidssikkerheden.
English: The choice of mobilisation method should be considered in relation to the overall objectives of treatment for an individual patient.
Danish: Mobiliseringsmetoden bør vælges efter, at de overordnede behandlingsmål for den enkelte patient er overvejet.
English: The clinical relevance of this finding to multiple dose administration is not clear.
Danish: Den kliniske relevans af dette fund ved administration af flere doser er ikke klarlagt.
English: The efficacy of treatment was clear for this age-group, which included most patients with congenital neutropenia.
Danish: Virkningen af behandlingen var tydelig i denne aldersgruppe, der omfattede de fleste patienter med medfødt neutropeni.
English: Only clear solutions without particles should be used.
Danish: Der må kun anvendes klare, partikelfrie opløsninger.
English: Effects of filgrastim on prenatal development have been studied in rats and rabbits.
Danish: Filgrastims indvirkning på prænatal udvikling er blevet undersøgt hos rotter og kaniner.
English: Possible interactions with other haematopoietic growth factors and cytokines have not yet been investigated in clinical trials.
Danish: Mulige interaktioner med andre hæmatopoietiske vækstfaktorer og cytokiner er ikke undersøgt i kliniske forsøg.
English: If you have missed an injection, or injected too little, contact your doctor as soon as possible.
Danish: Hvis du har glemt en indsprøjtning, eller hvis du har indsprøjtet for lidt, skal du kontakte din læge så snart som muligt.
English: Form a skin fold by pinching the skin between thumb and forefinger.
Danish: Dan en hudfold ved at klemme huden mellem tommel- og pegefinger.
English: If you experience a loss of response or failure to maintain a response with filgrastim treatment, your doctor will investigate the reasons why including whether you have developed antibodies which neutralise filgrastim's activity.
Danish: Hvis du oplever tab af respons eller ikke kan opretholde respons på behandlingen med filgrastim, vil din læge undersøge årsagerne til dette, herunder om du har udviklet antistoffer, som neutraliserer filgrastims aktivitet.
English: Filgrastim HEXAL can be used:
Danish: Filgrastim HEXAL kan anvendes:
English: • unusual change in the urine
Danish: • usædvanlig ændring af urin
English: The data in the tables below describe adverse reactions reported from clinical trials and spontaneous reporting.
Danish: Data i tabellerne nedenfor beskriver bivirkninger rapporteret fra kliniske forsøg og spontan rapportering.
English: Following established chemotherapy for solid tumours, lymphomas, and lymphoid leukaemia, it is expected that the duration of treatment required to fulfil these criteria will be up to 14 days.
Danish: Efter etableret kemoterapi mod solide tumorer, lymfomer og lymfoid leukæmi kan det forventes, at varigheden af den behandling, der kræves for at opfylde disse kriterier, er op til 14 dage.
English: Filgrastim HEXAL is a biosimilar medicinal product.
Danish: Filgrastim HEXAL er et biosimilært lægemiddel.
English: Therefore, spleen size should be carefully monitored (e.g. clinical examination, ultrasound).
Danish: Derfor bør miltstørrelsen monitoreres omhyggeligt (f.eks. ved klinisk undersøgelse og ultralyd).
English: Since lithium promotes the release of neutrophils, lithium is likely to potentiate the effect of filgrastim.
Danish: Da lithium øger frigivelsen af neutrofiler, er det muligt, at lithium forstærker virkningen af filgrastim.
English: - Mobilisation of peripheral blood progenitor cells (PBPCs).
Danish: - Mobilisering af perifere blodstamceller (PBPC'er).
English: The solution should be visually inspected prior to use.
Danish: Opløsningen bør kontrolleres visuelt før brug.
English: MedDRA system organ class
Danish: Systemorganklasse i henhold til MedDRA
English: • lungs do not function as they should, causing breathlessness (respiratory failure)
Danish: • lungerne fungerer ikke som de skal og forårsager åndenød (respirationssvigt)
English: If partial use of a syringe is required, remove unwanted solution before injection.
Danish: Hvis en delvis anvendelse af injektionssprøjten er nødvendig, skal den uønskede opløsning fjernes før indsprøjtningen.
English: The only consistently reported adverse event was musculoskeletal pain‚ which is no different from the experience in the adult population.
Danish: De eneste uønskede hændelser, der vedvarende blev rapporteret, var muskel- og ledsmerter, hvilket ikke er forskelligt fra erfaringen hos den voksne population.