FrancophonIA/ELRC3.0 huggingface dataset:
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 420 MG TABLET (30 days)
Danish: HYLSTER 420 MG TABLET (30 dage)
English: Analysis of OS demonstrated a 57% statistically significant reduction in the risk of death for patients in the IMBRUVICA arm. Efficacy results for Study PCYC-1112-CA are shown in Table 7.
Danish: Analyse af OS demonstrerede en statistisk signifikant reduktion på 57 % af risikoen for død for patienter i IMBRUVICA-armen.
English: Yellow to orange oblong tablets (19 mm in length and 8.1 mm in width), debossed with “ibr” on one side and “560” on the other side.
Danish: Gule til orange aflange tabletter (19 mm i længden og 8,1 mm i bredden) mærket med ”ibr” på den ene side og ”560” på den anden side.
English: IMBRUVICA 420 mg film-coated tablets Each film-coated tablet contains 420 mg of ibrutinib.
Danish: IMBRUVICA 420 mg filmovertrukne tabletter Hver filmovertrukken tablet indeholder 420 mg ibrutinib.
English: Figure 5: Kaplan-Meier Curve of PFS (ITT Population) in Study PCYC-1130-CA
Danish: Figur 5: Kaplan-Meier-kurve for PFS (ITT-population) i PCYC-1130-CA-studiet
English: Table 8: Subgroup analysis of PFS (Study PCYC-1112-CA)
Danish: Tabel 8: Undergruppeanalyse af PFS (studiet PCYC-1112-CA) Hazard Ratio
English: Yellow-green to green oblong tablets (17.5 mm in length and 7.4 mm in width), written with “ibr” on one side and “420” on the other side.
Danish: Gulliggrønne til grønne aflange tabletter (17,5 mm i længen og 7,4 mm i bredden) med påskriften ”ibr” på den ene side og ”420” på den anden side.
English: IMBRUVICA 280 mg film-coated tablets Each film-coated tablet contains 280 mg of ibrutinib.
Danish: IMBRUVICA 280 mg filmovertrukne tabletter Hver filmovertrukken tablet indeholder 280 mg ibrutinib.
English: IMBRUVICA 560 mg film-coated tablets
Danish: IMBRUVICA 560 mg filmovertrukne tabletter
English: Purple oblong tablets (15 mm in length and 7 mm in width), debossed with “ibr” on one side and “280” on the other side.
Danish: Violette aflange tabletter (15 mm i længen og 7 mm i bredden) med påskriften ”ibr” på den ene side og ”280” på den anden side.
English: Figure 8: Kaplan-Meier Curve of PFS (ITT Population) in Study PCYC-1127-CA
Danish: Figur 8: Kaplan-Meier-kurve for PFS (ITT-population) i PCYC-1127-CA-studiet
English: Yellow iron oxide (E172)
Danish: Rød jernoxid (E172)
English: Yellow-green to green oblong tablets (17.5 mm in length and 7.4 mm in width), debossed with “ibr” on one side and “420” on the other side.
Danish: Gulliggrønne til grønne aflange tabletter (17,5 mm i længden og 7,4 mm i bredden) mærket med ”ibr” på den ene side og ”420” på den anden side.
English: • back pain or joint pain
Danish: • smerter i ryggen eller leddene
English: Strong CYP3A4 inhibitors
Danish: Potente CYP3A4-hæmmere
English: • fever, chills, body aches, feeling tired, cold or flu symptoms, being short of breath - these could be signs of an infection (viral, bacterial or fungal).
Danish: kortåndethed - disse kan være tegn på en infektion (med virus, bakterier eller svampe).
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 420 MG TABLET (28 days)
Danish: HYLSTER 420 MG TABLET (28 dage)
English: NAME OF THE MEDICINAL PRODUCT IMBRUVICA 560 mg tablets ibrutinib
Danish: IMBRUVICA 560 mg tabletter ibrutinib
English: Do not take extra doses to make up the missed dose.
Danish: Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: NAME OF THE MEDICINAL PRODUCT IMBRUVICA 140 mg hard capsules
Danish: IMBRUVICA 140 mg hårde kapsler
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 280 MG TABLET (28 days)
Danish: HYLSTER 280 MG TABLET (28 dage)
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 280 MG TABLET (30 days)
Danish: HYLSTER 280 MG TABLET (30 dage)
English: NAME OF THE MEDICINAL PRODUCT IMBRUVICA 420 mg tablets ibrutinib
Danish: IMBRUVICA 420 mg tabletter ibrutinib
English: Each 560 mg film-coated tablet contains 112 mg of lactose monohydrate.
Danish: Hjælpestof(fer), som behandleren skal være opmærksom på Hver 560 mg filmovertrukken tablet indeholder 112 mg lactosemonohydrat.
English: If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking this medicine.
Danish: Tal med lægen, apotekspersonalet eller sundhedspersonalet, hvis noget af ovenstående gælder for dig (eller hvis du ikke er sikker), før du tager dette lægemiddel.
English: NAME OF THE MEDICINAL PRODUCT IMBRUVICA 280 mg tablets ibrutinib
Danish: IMBRUVICA 280 mg tabletter ibrutinib
English: Figure 3: Kaplan-Meier curve of OS (ITT Population) in Study PCYC-1115-CA
Danish: Figur 3: Kaplan-Meier-kurve for OS (ITT-population) i PCYC-1115-CA-studiet
English: Monitor patient closely for toxicity and follow dose modification guidance as needed (see sections 4.2 and 4.4).
Danish: modifikation af dosis efter behov (se pkt.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 140 MG TABLET (28 days)
Danish: HYLSTER 140 MG TABLET (28 dage)
English: NAME OF THE MEDICINAL PRODUCT IMBRUVICA 140 mg tablets ibrutinib
Danish: IMBRUVICA 140 mg tabletter ibrutinib
English: How to store IMBRUVICA
Danish: seponer IMBRUVICA
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 140 MG TABLET (30 days)
Danish: HYLSTER 140 MG TABLET (30 dage)
English: • muscle cramps, aches or spasms
Danish: • kramper eller smerter i musklerne eller ufrivillige muskelsammentrækninger
English: Progression free survival (PFS) as assessed by an IRC according to IWCLL criteria indicated a 78% statistically significant reduction in the risk of death or progression for patients in the IMBRUVICA
Danish: Progressionsfri overlevelse (PFS), vurderet af IRC i henhold til kriterierne fra IWCLL (International Workshop on CLL), indikerede en statistisk signifikant reduktion på 84 % af risikoen for død eller progression i IMBRUVICA-gruppen.
English: • Tablet film-coat: polyvinyl alcohol, macrogol, talc, titanium dioxide (E171); IMBRUVICA 140 mg and IMBRUVICA 420 mg film-coated tablets also contain black iron oxide (E172) and yellow iron oxide (E172); IMBRUVICA 280 mg film-coated tablets also contain black iron oxide (E172) and red iron oxide (E172); IMBRUVICA 560 mg film-coated tablets also contain red iron oxide (E172) and yellow iron oxide (E172).
Danish: IMBRUVICA 140 mg og IMBRUVICA 420 mg filmovertrukne tabletter indeholder også sort jernoxid (E172) og gul jernoxid (E172).
English: Tumour lysis syndrome Hyperuricaemia
Danish: Tumorlysesyndrom Hyperurikæmi
English: PHARMACEUTICAL FORM AND CONTENTS 14 film-coated tablets
Danish: 14 filmovertrukne tabletter
English: If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking IMBRUVICA.
Danish: Tal med lægen, apotekspersonalet eller sundhedspersonalet, hvis noget af ovenstående gælder for dig (eller hvis du ikke er sikker), før du tager IMBRUVICA.
English: If you stop taking IMBRUVICA
Danish: Hvis du har taget for meget IMBRUVICA
English: All subjects
Danish: Alle forsøgspersoner
English: IMBRUVICA contains lactose
Danish: IMBRUVICA indeholder lactose
English: Very common Haemorrhage Bruising Hypertension
Danish: Vaskulære sygdomme Meget almindelig Blødning* Blå mærker* Hypertension*
English: Each 280 mg film-coated tablet contains 56 mg of lactose monohydrate.
Danish: Hjælpestof(fer), som behandleren skal være opmærksom på Hver 280 mg filmovertrukken tablet indeholder 56 mg lactosemonohydrat.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use.
Danish: Oral anvendelse Læs indlægssedlen inden brug.
English: Figure 2: Kaplan-Meier curve of PFS (ITT Population) in Study PCYC-1115-CA
Danish: Figur 2: Kaplan-Meier-kurve for PFS (ITT-population) i PCYC-1115-CA-studiet
English: NAME OF THE MEDICINAL PRODUCT IMBRUVICA 140 mg film-coated tablets ibrutinib
Danish: IMBRUVICA 140 mg filmovertrukne tabletter ibrutinib
English: Figure 6: Kaplan-Meier curve of PFS (ITT Population) in Study PCYC-1112- CA
Danish: Figur 6: Kaplan-Meier-kurve for PFS (ITT-population) i PCYC-1112- CA-studiet
English: NAME OF THE MEDICINAL PRODUCT IMBRUVICA 420 mg film-coated tablets ibrutinib
Danish: IMBRUVICA 420 mg filmovertrukne tabletter ibrutinib
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 140 MG CAPSULE
Danish: YDRE KARTON 140 MG KAPSEL
English: Each 140 mg film-coated tablet contains 28 mg of lactose monohydrate.
Danish: Hjælpestof(fer), som behandleren skal være opmærksom på Hver 140 mg filmovertrukken tablet indeholder 28 mg lactosemonohydrat.
English: NAME OF THE MEDICINAL PRODUCT IMBRUVICA 140 mg capsules ibrutinib
Danish: IMBRUVICA 140 mg kapsler ibrutinib
English: What IMBRUVICA contains
Danish: IMBRUVICA indeholder:
English: Intolerance to excipients
Danish: Overfølsomhed over for hjælpestoffer
English: QUALITATIVE AND QUANTITATIVE COMPOSITION IMBRUVICA 140 mg film-coated tablets Each film-coated tablet contains 140 mg of ibrutinib.
Danish: IMBRUVICA 140 mg filmovertrukne tabletter Hver filmovertrukken tablet indeholder 140 mg ibrutinib.
English: NAME OF THE MEDICINAL PRODUCT IMBRUVICA 560 mg film-coated tablets ibrutinib
Danish: IMBRUVICA 560 mg filmovertrukne tabletter ibrutinib
English: Skin infection
Danish: Urinvejsinfektion
English: Neoplasms benign and malignant (incl cysts and polyps)
Danish: cyster og polypper)
English: Each 420 mg film-coated tablet contains 84 mg of lactose monohydrate.
Danish: Hjælpestof(fer), som behandleren skal være opmærksom på Hver 420 mg filmovertrukken tablet indeholder 84 mg lactosemonohydrat.
English: NAME OF THE MEDICINAL PRODUCT IMBRUVICA 280 mg film-coated tablets ibrutinib
Danish: IMBRUVICA 280 mg filmovertrukne tabletter ibrutinib
English: CI=confidence interval; HR=hazard ratio; ORR=overall response rate; OS=overall survival; PFS=progression-free survival IRC evaluated.
Danish: CI = konfidensinterval; HR = hazard ratio; CR = komplet respons; ORR = samlet responsrate; OS = samlet overlevelse; PFS = progressionsfri overlevelse
English: How to take IMBRUVICA
Danish: Sådan skal du tage IMBRUVICA
English: Urticaria Erythema Onychoclasis
Danish: Nedsat nyrefunktion
English: Response Rate (CR, VGPR, PR) Median duration of response, months (range)
Danish: Responsrate (CR, VGPR, PR)
English: The CR rate according to IWCLL criteria was 16.2% in the IMBRUVICA arm versus 3.0% in the chlorambucil arm. At the time of long-term follow-up, a total of 73 subjects (54.9%) originally randomized to the chlorambucil arm subsequently received ibrutinib as cross-over treatment.
Danish: På tidspunktet for langtidsopfølgningen blev i alt 73 forsøgspersoner (54,9 %), der oprindeligt var randomiseret til chlorambucil-gruppen, efterfølgende skiftet over til ibrutinib.
English: EU/1/14/945/007 - 28 tablets (2 wallet packs of 14) EU/1/14/945/008 - 30 tablets (3 wallet packs of 10)
Danish: IMBRUVICA 140 mg filmovertrukne tabletter EU/1/14/945/007 - 28 tabletter (2 hylstre med 14) EU/1/14/945/008 - 30 tabletter (3 hylstre med 10)
English: Tumour lysis syndrome Hyperuricaemia Nervous system disorders Very common Headache Common
Danish: Blod og lymfesystem Meget almindelig Neutropeni Trombocytopeni
English: EU/1/14/945/011 - 28 tablets (2 wallet packs of 14) EU/1/14/945/005 - 30 tablets (3 wallet packs of 10)
Danish: EU/1/14/945/011 (28 tabletter) EU/1/14/945/005 (30 tabletter)
English: EU/1/14/945/012 - 28 tablets (2 wallet packs of 14) EU/1/14/945/006 - 30 tablets (3 wallet packs of 10)
Danish: EU/1/14/945/012 (28 tabletter) EU/1/14/945/006 (30 tabletter)
English: EU/1/14/945/009 - 28 tablets (2 wallet packs of 14) EU/1/14/945/010 - 30 tablets (3 wallet packs of 10)
Danish: EU/1/14/945/009 (28 tabletter) EU/1/14/945/010 (30 tabletter)
English: Grade ≥3
Danish: Grad ≥ 3 (%)
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER 280 MG TABLET
Danish: BLISTER 280 MG TABLET
English: Hazard Ratio
Danish: IRC-vurderet
English: EU/1/14/945/008 (30 tablets)
Danish: EU/1/14/945/007 (28 tabletter) EU/1/14/945/008 (30 tabletter)
English: Administer IMBRUVICA to patients with severe renal impairment (<30 mL/min creatinine clearance) only if the benefit outweighs the risk and monitor patients closely for signs of toxicity.
Danish: ), hvis fordelene opvejer risikoen, og patienterne skal monitoreres omhyggeligt for tegn på toksicitet.
English: Women of childbearing potential
Danish: Fertile kvinder/prævention til kvinder
English: How IMBRUVICA works
Danish: Sådan virker IMBRUVICA
English: Epistaxis
Danish: Obstipation
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER 420 MG TABLET
Danish: BLISTER 420 MG TABLET
English: Angioedema Panniculitis
Danish: Tumorlysesyndrom
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL 140 MG CAPSULE
Danish: BEHOLDERENS ETIKET 140 MG KAPSEL
English: Progression-free survival (PFS) was assessed by IRC according to IWCLL criteria indicated a 77% statistically significant reduction in the risk of death or progression in the IMBRUVICA arm. With a median follow-up time on study of 31 months, the median PFS was not reached in the IMBRUVICA+obinutuzumab arm and was 19 months in the chlorambucil+obinutuzumab arm. Efficacy results for Study PCYC-1130-CA are shown in Table 5 and the Kaplan-Meier curve for PFS is shown in Figure 5.
Danish: Med en median opfølgningstid i studiet på 31 måneder blev den mediane PFS ikke nået i IMBRUVICA + obinutuzumab-gruppen og var 19 måneder i chlorambucil + obinutuzumab-gruppen.
English: If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Danish: Hvis du holder op med at tage IMBRUVICA Hold ikke op med at tage dette lægemiddel, medmindre din læge beder dig om det. Spørg lægen, apotekspersonalet eller sundhedspersonalet, hvis der er noget, du er i tvivl om.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER 560 MG TABLET
Danish: BLISTER 560 MG TABLET
English: Progression free survival (PFS) as assessed by IRC indicated an 80% statistically significant reduction in the risk of death or progression in the IMBRUVICA arm. Efficacy results for Study PCYC-1127CA are shown in Table 11 and the Kaplan-Meier curve for PFS is shown in Figure 8.
Danish: Effektresultater for PCYC-1127-CA-studiet er vist i tabel 11, og Kaplan-Meier-kurven for PFS er vist i figur 8.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER 140 MG TABLET
Danish: BLISTER 140 MG TABLET
English: MA (EU) number (Invented) name Strength Pharmaceutical form Route of administration Immediate Packaging Pack size EU/1/12/763/001 Ecansya
Danish: MF (EU)-nummer (Særnavn) Navn Styrke Lægemiddelform Administration Emballage
English: 1 bottle + 1 oral syringe 10 ml
Danish: 1 flaske + 1 oral doseringssprøjte 10 ml
English: Strength Pharmaceutical Form
Danish: Styrke Lægemiddel form
English: This overview was last updated in 07-2018.
Danish: Denne oversigt blev sidst ajourført i 07-2018.
English: A cycle lasts 3 weeks.
Danish: En cyklus varer 3 uger.
English: Ceplene received a marketing authorisation valid throughout the EU on 7 October 2008.
Danish: Ceplene fik markedsføringstilladelse med gyldighed i hele EU den 7. oktober 2008.
English: Ceplene has been authorised under ‘exceptional circumstances'.
Danish: Ceplene er godkendt under "særlige omstændigheder".
English: This means that it changes the activity of the immune system (the body's natural defences).
Danish: Det vil sige, at det ændrer aktiviteten i immunsystemet (kroppens naturlige forsvar).
English: Between each cycle there should be a treatment-free period of 3 weeks.
Danish: Mellem hver cyklus skal der være en behandlingsfri periode på 3 uger.
English: Every year, the Agency will review any new information that may become available and this summary will be updated as necessary.
Danish: Hvert år gennemgår agenturet alle nye oplysninger, der bliver tilgængelige, og ajourfører om nødvendigt denne oversigt.
English: Histamine is a substance occurring naturally in the body that is involved in many processes.
Danish: Histamin er et stof, der forekommer naturligt i kroppen, og som indgår i mange processer.
English: Other information about Ceplene
Danish: Andre oplysninger om Ceplene
English: Patients can inject themselves once they have been trained appropriately.
Danish: Patienterne kan give sig selv indsprøjtningerne, når de er blevet oplært i det.
English: It is used during the patients' first ‘remission' (a period without symptoms of the disease after the first course of treatment).
Danish: Det anvendes under patientens første remission (bedringsperiode uden symptomer efter det første behandlingsforløb).
English: As for all medicines, data on the use of Ceplene are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Ceplene løbende overvåget.
English: An overview of Ceplene and why it is authorised in the EU
Danish: En oversigt over Ceplene, og hvorfor det er godkendt i EU
English: AML is rare, and Ceplene was designated an ‘orphan medicine' (a medicine used in rare diseases) on 11 April 2005.
Danish: AML er sjælden, og Ceplene blev udpeget som "lægemiddel til sjældne sygdomme" den 11. april 2005.
English: The European Medicines Agency decided that Ceplene's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Ceplene opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: What measures are being taken to ensure the safe and effective use of Ceplene?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Ceplene?
English: Side effects reported with Ceplene are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Ceplene vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: Ceplene must not be used in patients who have severe heart problems or in women who are pregnant or breastfeeding.
Danish: Ceplene må ikke anvendes hos patienter med alvorlige hjerteproblemer eller hos kvinder, der er gravide eller ammer.
English: For more information about using Ceplene, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Ceplene, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: It is available as a solution for injection under the skin.
Danish: Det fås som en injektionsvæske til indsprøjtning under huden.
English: This can increase the length of time the patient stays in remission.
Danish: Dette kan forlænge patientens bedringsperiode.
English: Depending on the patient's response to treatment and side effects, the treatment may have to be suspended or the dose adjusted.
Danish: Alt efter patientens respons og forekomsten af bivirkninger kan behandlingen afbrydes eller dosen justeres.
English: When Ceplene is first given, the patient's blood pressure, heart rate and lung function must be checked.
Danish: Når Ceplene indgives første gang, skal patientens blodtryk, hjerterytme og lungefunktion tjekkes.
English: Further information on Ceplene can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information vedrørende Ceplene findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What is Ceplene and what is it used for?
Danish: Hvad er Ceplene, og hvad anvendes det til?
English: In the treatment of AML, it is thought to work by protecting immune system cells from damage.
Danish: Ved behandling af AML menes det at virke ved at beskytte immunsystemets celler mod skade.
English: This is because it has not been possible to obtain complete information about Ceplene due to the rarity of the disease.
Danish: Det skyldes, at det grundet sygdommens sjældenhed ikke har været muligt at indhente fyldestgørende oplysninger om Ceplene.
English: The recommended dose of Ceplene is one injection twice a day, one to three minutes after an interleukin-2 injection.
Danish: Den anbefalede dosis Ceplene er én injektion to gange dagligt, der indgives 1-3 minutter efter en interleukin-2-injektion.
English: Why has Ceplene been approved?
Danish: Hvorfor blev Ceplene godkendt?
English: Further information on the orphan designation can be found here: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Danish: Yderligere oplysninger om lægemidler til sjældne sygdomme findes her: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: What information is still awaited for Ceplene?
Danish: Hvilke oplysninger afventes der stadig for Ceplene?
English: What are the risks associated with Ceplene?
Danish: Hvilke risici er der forbundet med Ceplene?
English: Ceplene and interleukin-2 are given for 10 cycles.
Danish: Ceplene og interleukin-2 indgives i 10 cyklusser.
English: Ceplene can only be obtained with a prescription and should be given under the supervision of a doctor who has experience in the treatment of AML.
Danish: Ceplene udleveres kun efter recept, og behandlingen skal indgives under opsyn af en læge med erfaring i behandling af AML.
English: Ceplene was given in combination with interleukin-2 and compared with no treatment.
Danish: Ceplene blev givet i kombination med interleukin-2 og sammenholdt med ingen behandling.
English: Ceplene (histamine dihydrochloride)
Danish: Ceplene (histamindihydrochlorid)
English: The company that markets Ceplene will provide yearly updates on the safety and effectiveness of Ceplene in combination with interleukin-2 in AML patients in first remission.
Danish: Den virksomhed, der markedsfører Ceplene, skal sørge for årlig opdatering, hvad angår sikkerheden og virkningen ved Ceplene i kombination med interleukin-2 hos AML-patienter i første bedringsperiode.
English: The effectiveness of Ceplene has been studied in one main study involving 320 adults with AML who were in remission following leukaemia treatment.
Danish: Ceplenes virkning er undersøgt i ét hovedstudie af 320 voksne med AML, der var i bedring efter leukæmi-behandling.
English: It must also not be used in patients who have received a bone marrow transplant from a donor, or who are taking steroids (medicines used to reduce or prevent inflammation) given systemically (given by mouth or by injection), clonidine (used to reduce high blood pressure) or histamine H2 blockers (used to treat stomach ulcers, indigestion or heartburn).
Danish: Ceplene må heller ikke anvendes hos patienter, der har fået transplanteret knoglemarv fra en donor, eller som bruger steroider (medicin, der mindsker eller forebygger inflammation) indgivet systemisk (gennem munden eller som injektion), clonidin (mod forhøjet blodtryk) eller histamin H2-blokkere (mod mavesår, fordøjelsesbesvær eller halsbrand).
English: This improves the effectiveness of interleukin-2, a medicine that stimulates the immune system to attack cancerous cells.
Danish: Derved forbedres virkningen af interleukin-2, som er et lægemiddel, der stimulerer immunsystemet til at gå til angreb på kræftceller.
English: Ceplene is a medicine used in combination with interleukin-2 (a cancer medicine) as maintenance treatment in adults with acute myeloid leukaemia (AML), a type of cancer affecting the white blood cells.
Danish: Ceplene er et lægemiddel, der anvendes i kombination med interleukin-2 (et kræftlægemiddel) som vedligeholdelsesbehandling hos voksne med akut myeloid leukæmi (AML), en form for kræft i de hvide blodlegemer.
English: The most common side effects with Ceplene (seen in more than 1 patient in 10) are flushing (reddening), headache, tiredness, fever and inflammation or redness at the injection site.
Danish: De hyppigste bivirkninger ved Ceplene (der kan forekomme hos mere end 1 ud af 10 patienter) er ansigtsblussen, hovedpine, træthed, feber og betændelse eller rødme ved injektionsstedet.
English: When Ceplene is given with interleukin-2, it helps the immune system to kill the leukaemia cells that may remain in the body during remission.
Danish: Når Ceplene gives i kombination med interleukin-2, hjælper det immunsystemet med at dræbe de leukæmiceller, der kan være tilbage i kroppen i bedringsperioden.