natgillin/translations-raw huggingface dataset:
Informationspakken skal indeholde følgende: o Sæt med oplysningsmateriale til sundhedspersonale o Informationsbrochurer til patienter o Patientkort o Produktresume (SPC), indlægsseddel og mærkning.
The Member States shall agree the details of a controlled distribution system with the MAH according to national regulations and healthcare system and must implement such programme nationally to ensure that: • Prior to launch, all doctors who intend to prescribe Revlimid and all pharmacists who may dispense Revlimid receive a Direct Healthcare Professional Communication as described below. • Prior to prescribing (where appropriate, and in agreement with the National Competent Authority, dispensing) all healthcare professionals who intend to prescribe (and dispense) Revlimid are provided with a physician information pack containing the following: o Educational Health Care Professional’ s kit o Educational brochures for Patients o Patient cards o Summary of Product Characteristics (SPC) and Package Leaflet and Labelling.
Medlemslandene skal ligeledes aftale følgende med indehaveren af markedsføringstilladelsen, før produktet lanceres på markedet: • Hvorledes indsamlingen af detaljerede data omkring indikationen kan gennemføres, så der opnås tæt overvågning af "off- label" - anvendelsen inden for eget område • Implementeringen af nationale foranstaltninger for at vurdere effektiviteten og overholdelsen af PPP
The Member States should also agree with the MAH prior to the launch of the product: • The feasibility of collecting detailed data relating to the indication in order to monitor closely the off-label use within the national territory. • The set-up of national measures to assess the effectiveness of and compliance with the PPP
Den information, der stiles direkte til sundhedspersonale, skal bestå af to elementer:
The Direct Healthcare Professional Communication shall consist of two parts: • A core text as agreed by the CHMP. • National specific requirements agreed with the National Competent Authority regarding: o Distribution of the product o To ensure that all appropriate measures have been performed prior to Revlimid being dispensed
En kernetekst, som skal godkendes af Udvalget for Humanmedicinske Lægemidler (CHMP).
The Educational Healthcare Professional’ s Kit
Specifikke, nationale krav, som er aftalt med den kompetente, nationale myndighed angående: o Distribuering af produktet o Sikkerhed for at alle passende foranstaltninger er blevet iværksat, inden at Revlimid ordineres.
The Educational Health Care Professional’ s Kit shall contain the following elements: • Brief background on lenalidomide and its licensed indication • Posology • The need to avoid foetal exposure due to teratogenicity of lenalidomide in animals and the expected teratogenic effect of lenalidomide in humans including a summary of the interim results of study CC-5013-TOX-004 • Obligations of the health care professional in relation to the prescribing of Revlimid
2 Sættet med oplysningsmateriale til sundhedspersonale
2
Brug hos patienter med nedsat lever - og/ eller nyrefunktion Bortskaffelse af uønsket medicin Lokale, national- specifikke foranstaltninger for at Revlimid, der ordineres på recept, kan udleveres
Need to provide comprehensive advice and counselling to patients That patients should be capable of complying with the requirements for the safe use of Revlimid
Råd om sikkerhed, som er relevante for fødedygtige kvinder o Nødvendigheden af at undgå føtal eksponering o Beskrivelse af PPP o Nødvendigheden af adækvat prævention (også selvom kvinden har amenorrhoea) og definition af adækvat prævention o Graviditetstest- regime Rådgivning om passende test Før behandlingen påbegyndes Under behandlingen baserende på præventionsmetoden Efter behandlingens afslutning o Nødvendigheden af omgående at ophøre med Revlimid, hvis der er mistanke om graviditet o Nødvendigheden af omgående at oplyse det til lægen, hvis der er mistanke om graviditet
o Need to provide patients with appropriate patient educational brochure and patient card • Safety advice relevant to all patients o Description and management of neutropenia and thrombocytopenia including incidence rates from clinical trials o Description and management of thromboembolic risk including incidence rates from clinical trials o Use in patients with hepatic and/ or renal impairment o Disposal of unwanted medicine o Local country specific arrangements for a prescription for Revlimid to be dispensed o Description of risk of hypothyroidism o Explanation of unknown risk of neuropathy with long term use • Description of the PPP and categorisation of patients based on sex and childbearing potential o Algorithm for implementation of PPP o Definition of women of childbearing potential (WCBP) and actions the physician should take if unsure • Safety advice for women of childbearing potential o The need to avoid foetal exposure o Description of the PPP o Need for adequate contraception (even if woman has amenorrhoea) and definition of adequate contraception o Pregnancy test regime Advice on suitable tests Before commencing treatment During treatment based on method of contraception After finishing treatment o Need to stop Revlimid immediately upon suspicion of pregnancy o Need to tell treating doctor immediately upon suspicion of pregnancy • Safety advice for men o The need to avoid foetal exposure o The need to use condoms if sexual partner is a WCBP (even if man has had a vasectomy) During Revlimid treatment For one week following final dose. o That if his partner becomes pregnant whilst he is taking Revlimid or shortly after he has stopped taking Revlimid he should inform his treating doctor immediately • Requirements in the event of pregnancy o Instructions to stop Revlimid immediately upon suspicion of pregnancy o Need to refer to physician specialised or experienced in dealing with teratology and its diagnosis for evaluation and advice o Local contact details for reporting of any suspected pregnancy o Pregnancy reporting form • Check list for physicians ensuring that patients receive the appropriate counselling concerning the treatment, contraceptive methods and pregnancy prevention appropriate for their sex and childbearing status • Adverse event reporting forms
At Revlimid kan forårsage neutropeni og trombocytopeni og at regelmæssige blodtest er nødvendige
The Educational brochures for patients should be of 3 types: • Brochure for women patients of childbearing potential and their partners • Brochure for women patients who are not of childbearing potential • Brochure for male patients
Beskrivelse af patientkortet og dets nødvendighed Bortskaffelse af uønsket medicin Nationale eller andre specifikke foranstaltninger, der finder anvendelse, for at en recept på Revlimid, kan blive udleveret
3 All patient brochures should contain the following elements: • That lenalidomide is teratogenic in animals and is expected to be teratogenic in humans. • That Revlimid may cause neutropenia and thrombocytopenia and the need for regular blood tests • Description of the patient card and its necessity • Disposal of unwanted medicine • National or other applicable specific arrangements for a prescription for Revlimid to be dispensed • That the patient should not give Revlimid to any other person • That the patient should not donate blood • That the patient should tell their doctor about any adverse events
Graviditetstest- regime o Før behandlingen påbegyndes o Hver 4. uge under behandlingen undtagen ved bekræftet ægleder- sterilisation o Efter behandlingens afslutning
Brochure for women patients with childbearing potential • The need to avoid foetal exposure • Description of the PPP • Need for adequate contraception and definition of adequate contraception • Pregnancy test regime o Before commencing treatment o During treatment every 4 weeks except in case of confirmed tubal sterilisation o After finishing treatment • The need to stop Revlimid immediately upon suspicion of pregnancy • The need to contact their doctor immediately upon suspicion of pregnancy
Nødvendigheden af at undgå føtal eksponering Nødvendigheden af at bruge kondomer, hvis partneren, som der er seksuelt samvær med, er fødedygtig (også selvom manden er vasektomeret) o Under behandlingen med Revlimid o I en uge efter sidste dosis.
Brochure for male patients • The need to avoid foetal exposure • The need to use condoms if sexual partner is a WCBP (even if man has had vasectomy) o During Revlimid treatment o For one week following final dose • That the patient should not donate semen • That if his partner becomes pregnant he should inform his treating doctor immediately
Bekræftelse på at der er gennemført en passende rådgivning Dokumentation om mulig fødedygtighed Datoerne for og resultaterne af graviditetstest
The patient card shall contain the following elements: • Verification that appropriate counselling has taken place • Documentation of childbearing status potential • Pregnancy test dates and results
Hvis du ønsker yderligere oplysninger om baggrunden for CHMP' s anbefalinger, kan du læse de faglige drøftel - ser (der ligeledes er en del af EPAR).
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Revlimid er et lægemiddel, der indeholder det aktive stof lenalidomid.
Revlimid is a medicine containing the active substance lenalidomide.
Det leveres som kapsler (hvide:
It is available as capsules (white:
5 mg; blågrønne og gule:
5 mg; blue-green and yellow:
10 mg; blå og hvide:
10 mg; blue and white:
15 mg; hvide:
15 mg; white:
25 mg.
25 mg).
Revlimid er et middel mod kræft.
Revlimid is an anticancer medicine.
Det anvendes i kombination med dexamethason (et antiinflammato - risk lægemiddel) til behandling af voksne med multiple myelomer, når sygdommen tidligere er blevet behandlet mindst 1 gang.
It is used in combination with dexamethasone (an anti-inflammatory medicine) to treat adult patients with multiple myeloma whose disease has been treated at least once in the past.
Da multiple myelomer kun forekommer hos få patienter, blev Revlimid den 12. december 2003 udpe - get som "lægemiddel til sjældne sygdomme".
Because the number of patients with multiple myeloma is low, the disease is considered ‘ rare’, and Revlimid was designated an ‘ orphan medicine ’ (a medicine used in rare diseases) on 12 December 2003.
Revlimid bør kun ordineres af en læge med erfaring i behandling af multiple myelomer.
Treatment with Revlimid must be initiated and monitored by doctors who have experience in the management of multiple myeloma.
Det tages én gang dagligt i 21 dage, efterfulgt af en 7 - dages pause.
Revlimid is taken in repeated 28-day cycles: the patient takes the medicine once a day for 21 days, followed by seven days off the medicine.
I de fire første behandlingsperioder tages dexamethason i en dosis af 40 mg én gang dag - ligt på dag 1 til 4, 9 til 12 og 17 til 20, og i de efterfølgende behandlingsperioder på dag 1til 4.
Dexamethasone should be taken at a dose of 40 mg once a day on days 1 to 4, 9 to 12 and 17 to 20 of the first four cycles, and on days 1 to 4 thereafter.
Den anbefalede dosis af Revlimid er 25 mg dagligt.
The recommended dose of Revlimid is 25 mg a day.
Dosis skal nedsættes eller behandlingen indstilles, hvis dette er nødvendigt på grund af patientens tilstand og blodets indhold af blodplader (de blodlege - mer, der medvirker ved blodets størkning) og af neutrofiler (en type hvide blodlegemer).
This dose should be reduced or treatment interrupted depending on the patient’ s condition and the levels of platelets (components in the blood that aid clotting) and of neutrophils (a type of white blood cell).
Yderligere oplysninger fremgår af pro - duktresuméet, der ligeledes er en del af denne EPAR.
For more information, see the Summary of Product Characteristics (also part of the EPAR).
Revlimid skal tages på nogenlunde samme klokkeslæt hver dag.
Revlimid should be taken at around the same time each day.
Kapslerne skal synkes hele, helst med vand.
The capsules should be swallowed whole, preferably with water.
Det vil sige, at det påvirker aktiviteten af immunsystemet (kroppens naturlige forsvar).
This means that it affects the activity of the immune system (the body ’ s natural defences).
Lenalidomid virker på flere forskellige måder ved multiple myelomer:
Lenalidomide works in a number of different ways in multiple myeloma: it blocks the development of tumour cells, prevents
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. the growth of blood vessels within tumours and also stimulates some of the specialised cells of the immune system to attack the cancerous cells.
Virkningerne af Revlimid blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos menne - sker.
The effects of Revlimid were first tested in experimental models before being studied in humans.
Revlimid var genstand for to hovedundersøgelser, hvori der deltog 704 patienter med multiple mye - lomer.
Revlimid was studied in two main studies involving 704 patients with multiple myeloma.
I begge undersøgelser blev Revlimid sammenlignet med placebo (virkningsløs behandling), og begge blev anvendt i kombination med dexamethason.
In both studies, Revlimid was compared with placebo (a dummy treatment), both taken in combination with dexamethasone.
Behandlingens virkning blev hovedsagelig bedømt på hvor lang tid, der gik, indtil sygdommen forværredes.
The main measure of effectiveness was how long it took until the disease got worse.
Revlimid var mere effektivt end placebo til at forhindre forværring af multiple myelomer.
Revlimid was more effective than placebo at preventing a worsening of multiple myeloma.
Hos dem, der fik placebo, gik der 20, 1 uger.
The results of the two studies taken together showed that, on average, it took 48.3 weeks for the disease to get worse in patients taking Revlimid, compared with 20.1 weeks in those taking placebo.
De almindeligste bivirkninger ved Revlimid (der ses hos flere end 1 ud af 10 patienter) er neutropeni (for lavt antal hvide blodlegemer) træthed, kraftesløshed, forstoppelse, muskelkramper, trombocyto - peni (for lavt antal blodplader), anæmi (for lavt antal røde blodlegemer), diarré og udslæt.
The most common side effects with Revlimid (seen in more than 1 patient in 10) are neutropenia (low neutrophil counts), fatigue (tiredness), asthenia (weakness), constipation, muscle cramp, thrombocytopenia (low platelet counts), anaemia (low red blood cell counts), diarrhoea and rash.
Den fuld - stændige liste over de indberettede bivirkninger ved Revlimid fremgår af indlægssedlen.
For the full list of all side effects reported with Revlimid, see the Package Leaflet.
Lenalidomid forventes at være skadeligt for ufødte børn.
Lenalidomide is expected to be harmful to the unborn child.
Derfor må Revlimid ikke anvendes af gravi - de.
Therefore, Revlimid must not be used in women who are pregnant.
Det må heller ikke anvendes til kvinder i den fødedygtige alder, medmindre de træffer alle de nød - vendige foranstaltninger til at sikre, at de ikke er gravide ved behandlingens begyndelse og ikke bliver det under og i den første tid efter behandlingen.
It must also not be used in women who could become pregnant, unless they take all of the necessary steps to ensure that they are not pregnant before treatment and that they do not become pregnant during or soon after treatment.
Revlimid bør ikke anvendes til patienter, der kan være overfølsomme (allergiske) over for lenalidomid eller nogen af indholdsstofferne.
Revlimid should not be used by people who may be hypersensitive (allergic) to lenalidomide or any of the other ingredients.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Revlimid opve - jer risiciene, når det anvendes i kombination med dexamethason til behandling af multiple myelomer hos patienter, hos hvem sygdommen tidligere er blevet behandlet mindst 1 gang.
The Committee for Medicinal Products for Human Use (CHMP) decided that, in combination with dexamethasone, Revlimid’ s benefits are greater than its risks for the treatment of multiple myeloma patients who have received at least one prior therapy.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Revlimid.
The Committee recommended that Revlimid be given marketing authorisation.
Hvilke foranstaltninger træffes der for at sikre en risikofri anvendelse af Revlimid?
Which measures are being taken to ensure the safe use of Revlimid?
Det firma, der fremstiller Revlimid, vil udarbejde et brev og et sæt informationsmateriale til sund - hedsmedarbejdere og brochurer til patienterne, som forklarer at det forventes at være skadeligt for ufødte børn og med nærmere oplysninger om, hvad de skal gøre for at sikre risikofri anvendelse af lægemidlet.
The company that makes Revlimid will provide a letter and educational kits for healthcare workers, and brochures for patients, explaining the fact that it is expected to be harmful to the unborn child and detailing the steps that need to be taken for the medicine to be used safely.
Firmaet vil desuden sørge for, at der udleveres kort til alle patienter for at sikre, at patien - ten træffer de nødvendige sikkerhedsforanstaltninger.
It will also supply cards for patients to ensure that all appropriate safety measures have been taken by each patient.
Firmaet vil desuden udarbejde et program til forebyggelse af svangerskab i hver medlemsstat og ind - samle oplysninger om, hvorvidt lægemidlet bruges til andre formål end den godkendte indikation.
The company will also set up a pregnancy prevention programme in each Member State and collect information on whether the medicine is used outside its approved indication.
På æskerne med Revlimidkapsler skal der desuden være en advarsel om, at lenalidomid forventes at være skadeligt for ufødte børn.
The boxes containing Revlimid capsules also include a warning stating that lenalidomide is expected to be harmful to the unborn child.
Andre oplysninger om Revlimid:
Other information about Revlimid:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Revlimid til Celgene Europe Limited den 14. juni 2007.
The European Commission granted a marketing authorisation valid throughout the European Union for Revlimid to Celgene Europe Limited on 14 June 2007.
Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme findes her.
The summary of opinion of the Committee for Orphan Medicinal Products for Revlimid is available here.
Den fuldstændige EPAR for Revlimid findes her.
The full EPAR for Revlimid can be found here.
Paknings- størrelse
Pharmaceutical EU Number
EU/ 1/ 07/ 391/ 001
Invented name
Blister (PCTFE/ PVC/ aluminium)
Route of administration
21 kapsler
Packaging
Hård kapsel
Package size
Blister (PCTFE/ PVC/ aluminium)
Hard capsule Hard capsule Hard capsule Hard capsule
Blister (PCTFE/ PVC/ aluminium)
Blister (PCTFE/ PVC/ alu) Blister (PCTFE/ PVC/ alu) Blister (PCTFE/ PVC/ alu) Blister (PCTFE/ PVC/ alu)
21 kapsler
21 capsules 21 capsules 21 capsules 21 capsules
Hver kapsel indeholder 147 mg vandfri lactose.
Each capsule contains 147 mg of anhydrous lactose.
Hvide kapsler, der er mærket “ REV 5 mg ”.
White capsules marked “ REV 5 mg”.
Revlimid i kombination med dexamethason er indiceret til behandling af patienter med myelomatose som allerede har fået mindst én behandling.
Revlimid in combination with dexamethasone is indicated for the treatment of multiple myeloma patients who have received at least one prior therapy.
Behandlingen skal indledes og overvåges under ledelse af læger med erfaring i håndtering af myelomatose (MM).
Treatment must be initiated and monitored under the supervision of physicians experienced in the management of multiple myeloma (MM).
Administration Revlimid bør indtages på cirka samme tidspunkt hver dag.
Administration Revlimid capsules should be taken at about the same time each day.
Kapslerne må ikke knuses eller tygges.
The capsules should not be broken or chewed.
Kapslerne bør sluges hele, helst med vand, enten med eller uden mad.
The capsules should be swallowed whole, preferably with water, either with or without food.
Hvis der er gået mere end 12 timer efter glemt dosis må patienten ikke tage dosis, men skal tage den næste dosis på det normale tidspunkt den efterfølgende dag.
If more than 12 hours has elapsed since missing a dose at the normal time, the patient should not take the dose, but take the next dose at the normal time on the following day.
Anbefalet dosis Den anbefalede startdosis er 25 mg lenalidomid peroralt én gang dagligt på dag 1- 21 i gentagne cyklusser på 28- dages varighed.
Recommended dose The recommended starting dose of lenalidomide is 25 mg orally once daily on days 1-21 of repeated 28-day cycles.
Den anbefalede dosis dexamethason er 40 mg peroralt én gang dagligt på dag 1- 4, 9- 12 og 17- 20 af hver 28- dages cyklus i de første 4 cyklusser af behandlingen og derefter 40 mg én gang dagligt på dag 1- 4 hver 28. dag.
The recommended dose of dexamethasone is 40 mg orally once daily on days 1-4, 9-12, and 17-20 of each 28-day cycle for the first 4 cycles of therapy and then 40 mg once daily on days 1-4 every 28 days.
4. 4).
Dosing is continued or modified based upon clinical and laboratory findings (see section 4.4).
Behandling med lenalidomid må ikke påbegyndes, hvis det absolutte neutrofiltal < 1 x 109/ l og / eller trombocyttal < 75 x 109/ l eller, afhængig af infiltrationen af plasmaceller i rygmarven, thrombocyttal < 30 x 109/ l.
Lenalidomide treatment must not be started if the Absolute Neutrophil Counts (ANC) < 1.0 x 109/ l, and/ or platelet counts < 75 x 109/ l or, dependent on bone marrow infiltration by plasma cells, platelet counts < 30 x 109/ l.
Anbefalede dosisjusteringer under behandlingen og genoptagelse af behandlingen De nedenfor resumerede dosisjusteringer anbefales til håndtering af grad 3 - eller 4- neutropeni eller trombocytopeni eller anden toksicitet af grad 3 eller 4, som vurderes til at være relateret til lenalidomid.
Recommended dose adjustments during treatment and restart of treatment Dose adjustments, as summarised below, are recommended to manage grade 3 or 4 neutropenia or thrombocytopenia, or other grade 3 or 4 toxicity judged to be related to lenalidomide.
2 • Dosisreduktionstrin
2 • Dose reduction steps
Startdosis Dosisniveau 1 Dosisniveau 2 Dosisniveau 3
Starting dose Dose level 1 Dose level 2 Dose level 3
Trombocyttal
Platelet counts
Når trombocyttallet første gang falder til < 30 x 109/ l igen er ≥ 30 x 109/ l
When platelets First fall to < 30 x 109/l Return to ≥ 30 x 109/l For each subsequent drop below 30 x 109/l Return to ≥ 30 x 109/l
Anbefalet forløb afbryd behandlingen med lenalidomid genoptag behandlingen ved dosisniveau 1
Recommended Course Interrupt lenalidomide treatment Resume lenalidomide at Dose Level 1 Interrupt lenalidomide treatment Resume lenalidomide at next lower dose level (Dose Level 2 or 3) once daily.
Dosér ikke under 5 mg/ dag.
Do not dose below 5 mg once daily.
• Absolut neutrofiltal
• Absolute Neutrophil counts (ANC)
Når neutrofiltallet første gang falder til < 0, 5 x 109/ l igen er ≥ 0, 5 x 109/ l, når neutropeni er den eneste observerede toksisitet
When neutrophils First fall to < 0.5 x 109/l Return to ≥ 0.5 x 109/l when neutropenia is the only observed toxicity Return to ≥ 0.5 x 109/l when dose-dependent haematological toxicities other than neutropenia are observed
Anbefalet forløb afbryd behandlingen med lenalidomid genoptag behandlingen med lenalidomid ved startdosis én gang dagligt
Recommended Course Interrupt lenalidomide treatment Resume lenalidomide at Starting Dose once daily Resume lenalidomide at Dose Level 1 once daily
igen er ≥ 0, 5 x 109/ l, når en anden dosisafhængig hæmotokosisk defekt end neutropeni observeres For hvert efterfølgende fald til < 0, 5 x 109/ l
For each subsequent drop below < 0.5 x 109/l Return to ≥ 0.5 x 109/l
genoptag behandlingen med lenalidomid ved dosisniveau 1 én gang dagligt afbryd behandlingen med lenalidomid
Interrupt lenalidomide treatment Resume lenalidomide at next lower dose level (Dose Level 1, 2 or 3) once daily.