natgillin/translations-raw huggingface dataset:
IMBRUVICA 140 mg hårde kapsler ibrutinib
IMBRUVICA 140 mg hard capsules ibrutinib
Simplified MCL International Prognostic Index (MIPI), og 72 % havde fremskreden sygdom (ekstranodal involvering og/eller involvering af knoglemarv) ved screening.
At baseline, 39% of patients had bulky disease (≥5 cm), 49% had high-risk score by Simplified MCL International Prognostic Index (MIPI), and 72% had advanced disease (extranodal and/or bone marrow involvement) at screening.
Medianalderen var 68 år (interval: 40 til 84 år), 77 % var mænd, og 92 % var kaukasiere.
The median age was 68 years (range: 40 to 84 years), 77% were male and 92% were Caucasian.
Et højt antal cirkulerende lymfocytter (> 400 x 10
A high number of circulating lymphocytes (>400,000/mcL) may confer increased risk.
IMBRUVICA 140 mg filmovertrukne tabletter: Hver tablet indeholder 140 mg ibrutinib.
IMBRUVICA 140 mg film-coated tablets: Each tablet contains 140 mg of ibrutinib.
IMBRUVICA 140 mg filmovertrukne tabletter IMBRUVICA 280 mg filmovertrukne tabletter IMBRUVICA 420 mg filmovertrukne tabletter IMBRUVICA 560 mg filmovertrukne tabletter ibrutinib
IMBRUVICA 140 mg film-coated tablets IMBRUVICA 280 mg film-coated tablets IMBRUVICA 420 mg film-coated tablets IMBRUVICA 560 mg film-coated tablets ibrutinib
IMBRUVICA 140 mg filmovertrukne tabletter IMBRUVICA 280 mg filmovertrukne tabletter IMBRUVICA 420 mg filmovertrukne tabletter IMBRUVICA 560 mg filmovertrukne tabletter
IMBRUVICA 140 mg film-coated tablets IMBRUVICA 280 mg film-coated tablets IMBRUVICA 420 mg film-coated tablets IMBRUVICA 560 mg film-coated tablets
- Spørg lægen, apotekspersonalet eller sygeplejersken, hvis der er mere, du vil vide.
Check with your doctor, pharmacist or nurse if you are not sure.
Medianalderen var 69 år (interval: 36 til 89 år), 66 % var mænd, og 79 % var kaukasiere.
The median age was 69 years (range, 36 to 89 years), 66% were male, and 79% were Caucasian.
HR = hazard ratio; CI = konfidensinterval; ORR = samlet responsrate; OS = samlet overlevelse; PFS = progressionsfri overlevelse; PR = partielt respons
HR=hazard ratio; CI=confidence interval; ORR=overall response rate; OS=overall survival; PFS=progression-free survival; PR=partial response
Alvorlig hjertesygdom
Cardiac arrhythmia
ICR 64,7 % (95 % CI: 50,1 %; 77,6 %), alle PR'er.
At a median duration follow up of 16.4 months, the ORR by IRC for the 51 relapsed or refractory patients was 64.7% (95% CI: 50.1%; 77.6%), all PRs.
IMBRUVICA 560 mg filmovertrukne tabletter Macrogol
IMBRUVICA 560 mg film-coated tablets Macrogol
28 filmovertrukne tabletter 30 filmovertrukne tabletter
PHARMACEUTICAL FORM AND CONTENTS 28 film-coated tablets
Tabel 11: Effektresultater i PCYC-1127-CA-studiet
Table 11: Efficacy results in Study PCYC-1127-CA Endpoint
Mediantiden efter diagnosticering var 6 år, og det mediane antal tidligere behandlinger var 2 (1 til 11 behandlinger).
The median time since diagnosis was 6 years and the median number of prior treatments was 2 (range, 1 to 11 treatments).
IMBRUVICA 140 mg filmovertrukne tabletter
IMBRUVICA 140 mg film-coated tablets
For patienter med let nedsat leverfunktion (Child-Pugh klasse A) er den anbefalede daglige dosis 280 mg dagligt.
For patients with mild liver impairment (Child-Pugh class A), the recommended dose is 280 mg daily.
IMBRUVICA 280 mg filmovertrukne tabletter Macrogol
IMBRUVICA 280 mg film-coated tablets Macrogol
Medianalderen var 63 år (interval 44 til 86 år), 76 % var mænd, og 95 % var kaukasiere.
The median age was 63 years (range: 44 to 86 years), 76% were male, and 95% were Caucasian.
IMBRUVICA 420 mg filmovertrukne tabletter
IMBRUVICA 420 mg film-coated tablets
Ved baseline havde 53 % af patienterne bulky disease (≥ 5 cm), 21 % havde højrisiko-score iht.
At baseline, 53% of patients had bulky disease (≥5 cm), 21% had high-risk score by Simplified MIPI, 60% had extranodal disease and 54% had bone marrow involvement at screening.
IMBRUVICA 560 mg filmovertrukne tabletter Hver filmovertrukken tablet indeholder 560 mg ibrutinib.
IMBRUVICA 560 mg film-coated tablets Each film-coated tablet contains 560 mg of ibrutinib.
Medianalderen var 68 år (34 til 88 år), 74 % var mænd, og 87 % var kaukasiere.
The median age was 68 years (range, 34; 88 years), 74% were male and 87% were Caucasian.
Gule til orange aflange tabletter (19 mm i længen og 8,1 mm i bredden) med påskriften ”ibr” på den ene side og ”560” på den anden side.
Yellow to orange oblong tablets (19 mm in length and 8.1 mm in width), written with “ibr” on one side and “560” on the other side.
IMBRUVICA 560 mg filmovertrukne tabletter: Hver tablet indeholder 560 mg ibrutinib.
IMBRUVICA 560 mg film-coated tablets: Each tablet contains 560 mg of ibrutinib.
IMBRUVICA 420 mg filmovertrukne tabletter: Hver tablet indeholder 420 mg ibrutinib.
IMBRUVICA 420 mg film-coated tablets: Each tablet contains 420 mg of ibrutinib.
HYLSTER 560 MG TABLET (30 dage)
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 560 MG TABLET (30 days)
Patienterne (n = 269) blev randomiseret 1:1 til enten IMBRUVICA 420 mg dagligt indtil sygdomsprogression eller uacceptabel toksicitet eller chlorambucil med en startdosis på 0,5 mg/kg på dag 1 og 15 i hver 28-dages serie i maksimalt 12 serier.
Patients (n=269) were randomised 1:1 to receive either IMBRUVICA 420 mg daily until disease progression or unacceptable toxicity, or chlorambucil at a starting dose of 0.5 mg/kg on days 1 and 15 of each 28-day cycle for a maximum of 12 cycles, with an allowance for intrapatient dose increases up to 0.8 mg/kg based on tolerability.
Lægemiddelinteraktioner
Drug-drug interactions
HYLSTER 560 MG TABLET (28 dage)
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 560 MG TABLET (28 days)
IMBRUVICA 280 mg filmovertrukne tabletter: Hver tablet indeholder 280 mg ibrutinib.
IMBRUVICA 280 mg film-coated tablets: Each tablet contains 280 mg of ibrutinib.
IMBRUVICA 280 mg filmovertrukne tabletter
IMBRUVICA 280 mg film-coated tablets
HYLSTER 420 MG TABLET (30 dage)
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 420 MG TABLET (30 days)
Analyse af OS demonstrerede en statistisk signifikant reduktion på 57 % af risikoen for død for patienter i IMBRUVICA-armen.
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.
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.
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.
IMBRUVICA 420 mg filmovertrukne tabletter Hver filmovertrukken tablet indeholder 420 mg ibrutinib.
IMBRUVICA 420 mg film-coated tablets Each film-coated tablet contains 420 mg of ibrutinib.
Figur 5: Kaplan-Meier-kurve for PFS (ITT-population) i PCYC-1130-CA-studiet
Figure 5: Kaplan-Meier Curve of PFS (ITT Population) in Study PCYC-1130-CA
Tabel 8: Undergruppeanalyse af PFS (studiet PCYC-1112-CA) Hazard Ratio
Table 8: Subgroup analysis of PFS (Study PCYC-1112-CA)
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.
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.
IMBRUVICA 280 mg filmovertrukne tabletter Hver filmovertrukken tablet indeholder 280 mg ibrutinib.
IMBRUVICA 280 mg film-coated tablets Each film-coated tablet contains 280 mg of ibrutinib.
IMBRUVICA 560 mg filmovertrukne tabletter
IMBRUVICA 560 mg film-coated tablets
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.
Purple oblong tablets (15 mm in length and 7 mm in width), debossed with “ibr” on one side and “280” on the other side.
Figur 8: Kaplan-Meier-kurve for PFS (ITT-population) i PCYC-1127-CA-studiet
Figure 8: Kaplan-Meier Curve of PFS (ITT Population) in Study PCYC-1127-CA
Rød jernoxid (E172)
Yellow iron oxide (E172)
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.
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.
• smerter i ryggen eller leddene
• back pain or joint pain
Potente CYP3A4-hæmmere
Strong CYP3A4 inhibitors
kortåndethed - disse kan være tegn på en infektion (med virus, bakterier eller svampe).
• 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).
HYLSTER 420 MG TABLET (28 dage)
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 420 MG TABLET (28 days)
IMBRUVICA 560 mg tabletter ibrutinib
NAME OF THE MEDICINAL PRODUCT IMBRUVICA 560 mg tablets ibrutinib
Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
Do not take extra doses to make up the missed dose.
IMBRUVICA 140 mg hårde kapsler
NAME OF THE MEDICINAL PRODUCT IMBRUVICA 140 mg hard capsules
HYLSTER 280 MG TABLET (28 dage)
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 280 MG TABLET (28 days)
HYLSTER 280 MG TABLET (30 dage)
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 280 MG TABLET (30 days)
IMBRUVICA 420 mg tabletter ibrutinib
NAME OF THE MEDICINAL PRODUCT IMBRUVICA 420 mg tablets ibrutinib
Hjælpestof(fer), som behandleren skal være opmærksom på Hver 560 mg filmovertrukken tablet indeholder 112 mg lactosemonohydrat.
Each 560 mg film-coated tablet contains 112 mg of lactose monohydrate.
Tal med lægen, apotekspersonalet eller sundhedspersonalet, hvis noget af ovenstående gælder for dig (eller hvis du ikke er sikker), før du tager dette lægemiddel.
If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking this medicine.
IMBRUVICA 280 mg tabletter ibrutinib
NAME OF THE MEDICINAL PRODUCT IMBRUVICA 280 mg tablets ibrutinib
Figur 3: Kaplan-Meier-kurve for OS (ITT-population) i PCYC-1115-CA-studiet
Figure 3: Kaplan-Meier curve of OS (ITT Population) in Study PCYC-1115-CA
modifikation af dosis efter behov (se pkt.
Monitor patient closely for toxicity and follow dose modification guidance as needed (see sections 4.2 and 4.4).
HYLSTER 140 MG TABLET (28 dage)
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 140 MG TABLET (28 days)
IMBRUVICA 140 mg tabletter ibrutinib
NAME OF THE MEDICINAL PRODUCT IMBRUVICA 140 mg tablets ibrutinib
seponer IMBRUVICA
How to store IMBRUVICA
HYLSTER 140 MG TABLET (30 dage)
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 140 MG TABLET (30 days)
• kramper eller smerter i musklerne eller ufrivillige muskelsammentrækninger
• muscle cramps, aches or spasms
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.
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
IMBRUVICA 140 mg og IMBRUVICA 420 mg filmovertrukne tabletter indeholder også sort jernoxid (E172) og gul jernoxid (E172).
• 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).
Tumorlysesyndrom Hyperurikæmi
Tumour lysis syndrome Hyperuricaemia
14 filmovertrukne tabletter
PHARMACEUTICAL FORM AND CONTENTS 14 film-coated tablets
Tal med lægen, apotekspersonalet eller sundhedspersonalet, hvis noget af ovenstående gælder for dig (eller hvis du ikke er sikker), før du tager IMBRUVICA.
If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking IMBRUVICA.
Hvis du har taget for meget IMBRUVICA
If you stop taking IMBRUVICA
Alle forsøgspersoner
All subjects
IMBRUVICA indeholder lactose
IMBRUVICA contains lactose
Vaskulære sygdomme Meget almindelig Blødning* Blå mærker* Hypertension*
Very common Haemorrhage Bruising Hypertension
Hjælpestof(fer), som behandleren skal være opmærksom på Hver 280 mg filmovertrukken tablet indeholder 56 mg lactosemonohydrat.
Each 280 mg film-coated tablet contains 56 mg of lactose monohydrate.
Oral anvendelse Læs indlægssedlen inden brug.
METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use.
Figur 2: Kaplan-Meier-kurve for PFS (ITT-population) i PCYC-1115-CA-studiet
Figure 2: Kaplan-Meier curve of PFS (ITT Population) in Study PCYC-1115-CA
IMBRUVICA 140 mg filmovertrukne tabletter ibrutinib
NAME OF THE MEDICINAL PRODUCT IMBRUVICA 140 mg film-coated tablets ibrutinib
Figur 6: Kaplan-Meier-kurve for PFS (ITT-population) i PCYC-1112- CA-studiet
Figure 6: Kaplan-Meier curve of PFS (ITT Population) in Study PCYC-1112- CA
IMBRUVICA 420 mg filmovertrukne tabletter ibrutinib
NAME OF THE MEDICINAL PRODUCT IMBRUVICA 420 mg film-coated tablets ibrutinib
YDRE KARTON 140 MG KAPSEL
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 140 MG CAPSULE
Hjælpestof(fer), som behandleren skal være opmærksom på Hver 140 mg filmovertrukken tablet indeholder 28 mg lactosemonohydrat.
Each 140 mg film-coated tablet contains 28 mg of lactose monohydrate.
IMBRUVICA 140 mg kapsler ibrutinib
NAME OF THE MEDICINAL PRODUCT IMBRUVICA 140 mg capsules ibrutinib
IMBRUVICA indeholder:
What IMBRUVICA contains
Overfølsomhed over for hjælpestoffer
Intolerance to excipients
IMBRUVICA 140 mg filmovertrukne tabletter Hver filmovertrukken tablet indeholder 140 mg ibrutinib.
QUALITATIVE AND QUANTITATIVE COMPOSITION IMBRUVICA 140 mg film-coated tablets Each film-coated tablet contains 140 mg of ibrutinib.
IMBRUVICA 560 mg filmovertrukne tabletter ibrutinib
NAME OF THE MEDICINAL PRODUCT IMBRUVICA 560 mg film-coated tablets ibrutinib
Urinvejsinfektion
Skin infection
cyster og polypper)
Neoplasms benign and malignant (incl cysts and polyps)
Hjælpestof(fer), som behandleren skal være opmærksom på Hver 420 mg filmovertrukken tablet indeholder 84 mg lactosemonohydrat.
Each 420 mg film-coated tablet contains 84 mg of lactose monohydrate.
IMBRUVICA 280 mg filmovertrukne tabletter ibrutinib
NAME OF THE MEDICINAL PRODUCT IMBRUVICA 280 mg film-coated tablets ibrutinib
CI = konfidensinterval; HR = hazard ratio; CR = komplet respons; ORR = samlet responsrate; OS = samlet overlevelse; PFS = progressionsfri overlevelse
CI=confidence interval; HR=hazard ratio; ORR=overall response rate; OS=overall survival; PFS=progression-free survival IRC evaluated.
Sådan skal du tage IMBRUVICA
How to take IMBRUVICA
Nedsat nyrefunktion
Urticaria Erythema Onychoclasis
Responsrate (CR, VGPR, PR)
Response Rate (CR, VGPR, PR) Median duration of response, months (range)
På tidspunktet for langtidsopfølgningen blev i alt 73 forsøgspersoner (54,9 %), der oprindeligt var randomiseret til chlorambucil-gruppen, efterfølgende skiftet over til ibrutinib.
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.
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)
EU/1/14/945/007 - 28 tablets (2 wallet packs of 14) EU/1/14/945/008 - 30 tablets (3 wallet packs of 10)
Blod og lymfesystem Meget almindelig Neutropeni Trombocytopeni
Tumour lysis syndrome Hyperuricaemia Nervous system disorders Very common Headache Common
EU/1/14/945/011 (28 tabletter) EU/1/14/945/005 (30 tabletter)
EU/1/14/945/011 - 28 tablets (2 wallet packs of 14) EU/1/14/945/005 - 30 tablets (3 wallet packs of 10)
EU/1/14/945/012 (28 tabletter) EU/1/14/945/006 (30 tabletter)
EU/1/14/945/012 - 28 tablets (2 wallet packs of 14) EU/1/14/945/006 - 30 tablets (3 wallet packs of 10)
EU/1/14/945/009 (28 tabletter) EU/1/14/945/010 (30 tabletter)
EU/1/14/945/009 - 28 tablets (2 wallet packs of 14) EU/1/14/945/010 - 30 tablets (3 wallet packs of 10)
Grad ≥ 3 (%)
Grade ≥3
BLISTER 280 MG TABLET
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER 280 MG TABLET
IRC-vurderet
Hazard Ratio
EU/1/14/945/007 (28 tabletter) EU/1/14/945/008 (30 tabletter)
EU/1/14/945/008 (30 tablets)
), hvis fordelene opvejer risikoen, og patienterne skal monitoreres omhyggeligt for tegn på toksicitet.
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.
Fertile kvinder/prævention til kvinder
Women of childbearing potential
Sådan virker IMBRUVICA
How IMBRUVICA works
Obstipation
Epistaxis
BLISTER 420 MG TABLET
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER 420 MG TABLET
Tumorlysesyndrom
Angioedema Panniculitis
BEHOLDERENS ETIKET 140 MG KAPSEL
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL 140 MG CAPSULE
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.
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.
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.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
BLISTER 560 MG TABLET
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER 560 MG TABLET
Effektresultater for PCYC-1127-CA-studiet er vist i tabel 11, og Kaplan-Meier-kurven for PFS er vist i figur 8.
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.
BLISTER 140 MG TABLET
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER 140 MG TABLET
MF (EU)-nummer (Særnavn) Navn Styrke Lægemiddelform Administration Emballage
MA (EU) number (Invented) name Strength Pharmaceutical form Route of administration Immediate Packaging Pack size EU/1/12/763/001 Ecansya
1 flaske + 1 oral doseringssprøjte 10 ml
1 bottle + 1 oral syringe 10 ml
Styrke Lægemiddel form
Strength Pharmaceutical Form
Denne oversigt blev sidst ajourført i 07-2018.
This overview was last updated in 07-2018.
En cyklus varer 3 uger.
A cycle lasts 3 weeks.
Ceplene fik markedsføringstilladelse med gyldighed i hele EU den 7. oktober 2008.
Ceplene received a marketing authorisation valid throughout the EU on 7 October 2008.
Ceplene er godkendt under "særlige omstændigheder".
Ceplene has been authorised under ‘exceptional circumstances'.
Det vil sige, at det ændrer aktiviteten i immunsystemet (kroppens naturlige forsvar).
This means that it changes the activity of the immune system (the body's natural defences).
Mellem hver cyklus skal der være en behandlingsfri periode på 3 uger.
Between each cycle there should be a treatment-free period of 3 weeks.
Hvert år gennemgår agenturet alle nye oplysninger, der bliver tilgængelige, og ajourfører om nødvendigt denne oversigt.
Every year, the Agency will review any new information that may become available and this summary will be updated as necessary.
Histamin er et stof, der forekommer naturligt i kroppen, og som indgår i mange processer.
Histamine is a substance occurring naturally in the body that is involved in many processes.
Andre oplysninger om Ceplene
Other information about Ceplene
Patienterne kan give sig selv indsprøjtningerne, når de er blevet oplært i det.
Patients can inject themselves once they have been trained appropriately.
Det anvendes under patientens første remission (bedringsperiode uden symptomer efter det første behandlingsforløb).
It is used during the patients' first ‘remission' (a period without symptoms of the disease after the first course of treatment).
Som for alle lægemidler bliver data vedrørende brugen af Ceplene løbende overvåget.
As for all medicines, data on the use of Ceplene are continuously monitored.
En oversigt over Ceplene, og hvorfor det er godkendt i EU
An overview of Ceplene and why it is authorised in the EU
AML er sjælden, og Ceplene blev udpeget som "lægemiddel til sjældne sygdomme" den 11. april 2005.
AML is rare, and Ceplene was designated an ‘orphan medicine' (a medicine used in rare diseases) on 11 April 2005.
Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Ceplene opvejer risiciene, og at det kan godkendes til anvendelse i EU.
The European Medicines Agency decided that Ceplene's benefits are greater than its risks and it can be authorised for use in the EU.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Ceplene?
What measures are being taken to ensure the safe and effective use of Ceplene?
Bivirkninger rapporteret for Ceplene vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
Side effects reported with Ceplene are carefully evaluated and any necessary action taken to protect patients.
Ceplene må ikke anvendes hos patienter med alvorlige hjerteproblemer eller hos kvinder, der er gravide eller ammer.
Ceplene must not be used in patients who have severe heart problems or in women who are pregnant or breastfeeding.
For mere information om brug af Ceplene, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
For more information about using Ceplene, see the package leaflet or contact your doctor or pharmacist.
Det fås som en injektionsvæske til indsprøjtning under huden.
It is available as a solution for injection under the skin.
Dette kan forlænge patientens bedringsperiode.
This can increase the length of time the patient stays in remission.
Alt efter patientens respons og forekomsten af bivirkninger kan behandlingen afbrydes eller dosen justeres.
Depending on the patient's response to treatment and side effects, the treatment may have to be suspended or the dose adjusted.
Når Ceplene indgives første gang, skal patientens blodtryk, hjerterytme og lungefunktion tjekkes.
When Ceplene is first given, the patient's blood pressure, heart rate and lung function must be checked.
Yderligere information vedrørende Ceplene findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Further information on Ceplene can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Hvad er Ceplene, og hvad anvendes det til?
What is Ceplene and what is it used for?
Ved behandling af AML menes det at virke ved at beskytte immunsystemets celler mod skade.
In the treatment of AML, it is thought to work by protecting immune system cells from damage.
Det skyldes, at det grundet sygdommens sjældenhed ikke har været muligt at indhente fyldestgørende oplysninger om Ceplene.
This is because it has not been possible to obtain complete information about Ceplene due to the rarity of the disease.
Den anbefalede dosis Ceplene er én injektion to gange dagligt, der indgives 1-3 minutter efter en interleukin-2-injektion.
The recommended dose of Ceplene is one injection twice a day, one to three minutes after an interleukin-2 injection.
Hvorfor blev Ceplene godkendt?
Why has Ceplene been approved?