natgillin/translations-raw huggingface dataset:
I tilfælde af neutropeni bør lægen overveje at anvende vækstfaktorer i behandlingen af patienterne.
In case of neutropenia, the physician should consider the use of growth factors in patient management.
Pædiatriske patienter Der er ingen erfaring med behandling af børn og unge.
Paediatric patients There is no experience in children and adolescents.
Derfor bør lenalidomid ikke anvendes til den pædiatriske aldersgruppe (0- 17 år).
Therefore, lenalidomide should not be used in the paediatric age group (0-17 years).
Ældre patienter Det er ikke undersøgt, om alder har nogen indflydelse på lenalidomids farmakokinetik.
Elderly patients The effects of age on the pharmacokinetics of lenalidomide have not been studied.
5. 1).
Lenalidomide has been used in clinical trials in multiple myeloma patients up to 86 years of age (see section 5.1).
Der var ingen væsentlig forskel i procentdelen af patienter i alderen 65 år eller derover i lenalidomid/ dexamethason - og placebo/ dexamethason- grupperne.
The percentage of patients aged 65 or over was not significantly different between the lenalidomide/dexamethasone and placebo/dexamethasone groups.
Da det er mere sandsynligt, at ældre
No overall difference in safety or efficacy was observed between these patients and younger patients, but greater pre-disposition of older individuals cannot be ruled out.
3 patienter har nedsat nyrefunktion, skal dosis vælges med omhu, og det tilrådes at overvåge nyrefunktionen.
Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection and it would be prudent to monitor renal function.
Anvendelse til patienter med nedsat nyrefunktion Lenalidomid udskilles især igennem nyrerne, og derfor bør dosis vælges med omhu, og det tilrådes at overvåge nyrefunktionen.
Use in patients with impaired renal function Lenalidomide is substantially excreted by the kidney, therefore care should be taken in dose selection and monitoring of renal function is advised.
Der kræves ingen dosisjusteringer for patienter med let nedsat nyrefunktion.
3 No dose adjustments are required for patients with mild renal impairment.
Følgende dosisjusteringer anbefales ved behandlingsstart hos patienter med moderat til svært nedsat nyrefunktion eller nyresygdom i sidste stadium.
The following dose adjustments are recommended at the start of therapy for patients with moderate or severe impaired renal function or end stage renal disease.
Nyrefunktion (CLcr) Moderat nedsat nyrefunktion (30 ≤ CLcr < 50 ml/ min)
Renal Function (CLcr) Moderate renal impairment (30 ≤ CLcr < 50 ml/min)
Dosisjustering 10 mg/ dag *
Dose Adjustment 10 mg once daily*
Svært nedsat nyrefunktion (CLcr < 30 ml/ min, som ikke kræver dialyse)
Severe renal impairment (CLcr < 30 ml/min, not requiring dialysis)
15 mg hver anden dag **
15 mg every other day**
Nyresygdom i sidste stadium (ESRD, End Stage Renal Disease) (CLcr < 30 ml/ min, som kræver dialyse)
End Stage Renal Disease (ESRD) (CLcr < 30 ml/min, requiring dialysis)
5 mg/ dag.
5 mg once daily.
På dialysedage skal dosis administreres efter dialysen
On dialysis days, the dose should be administered following dialysis.
* Dosis kan sættes op til 15 mg/ dag efter 2 cyklusser, hvis patienten ikke reagerer på behandlingen og tåler behandlingen. ** Dosis kan sættes op til 10 mg/ dag, hvis patienten tåler behandlingen.
* The dose may be escalated to 15 mg once daily after 2 cycles if patient is not responding to treatment and is tolerating the treatment. ** The dose may be escalated to 10 mg once daily if the patient is tolerating the treatment
Anvendelse til patienter med nedsat leverfunktion Lenalidomid er ikke formelt undersøgt hos patienter med nedsat leverfunktion, og der er ingen specifikke dosisanbefalinger.
Use in patients with impaired hepatic function Lenalidomide has not formally been studied in patients with impaired hepatic function and there are no specific dose recommendations.
4. 4 og 4. 6). • Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne.
• Women who are pregnant. • Women of childbearing potential unless all of the conditions of the Pregnancy Prevention Programme are met (see sections 4.4 and 4.6). • Hypersensitivity to the active substance or to any of the excipients.
Advarsel mht. graviditet Lenalidomid er strukturelt i familie med thalidomid.
Pregnancy warning Lenalidomide is structurally related to thalidomide.
Thalidomid er et kendt humant, teratogent aktivt stof, som forårsager svære livstruende fødselsdefekter.
Thalidomide is a known human teratogenic active substance that causes severe life-threatening birth defects.
4. 6 og 5. 3).
Lenalidomide induced in monkeys malformations similar to those described with thalidomide (see sections 4.6 and 5.3).
Hvis lenalidomid indtages under graviditet, kan det forventes, at lenalidomid har en teratogen virkning hos mennesker.
If lenalidomide is taken during pregnancy, a teratogenic effect of lenalidomide in humans is expected.
Betingelserne i “ Programmet til svangerskabsforebyggelse ” skal overholdes af alle patienter, medmindre der er pålidelige beviser for, at patienten ikke er fødedygtig.
The conditions of the Pregnancy Prevention Programme must be fulfilled for all patients unless there is reliable evidence that the patient does not have childbearing potential.
Kriterier for, at kvinder ikke er fødedygtige En kvindelig patient eller en kvindelig partner af en mandlig patient betragtes som værende fødedygtig, medmindre hun opfylder mindst et af følgende kriterier: • Alder ≥ 50 år med naturlig amenorrhoea i ≥ 1 år * • Tidlig menopause bekræftet af en specialiseret gynækolog • Tidligere bilateral salpingo- ooforektomi eller hysterektomi
Criteria for women of non-childbearing potential A female patient or a female partner of a male patient is considered to have childbearing potential unless she meets at least one of the following criteria: • Age ≥ 50 years and naturally amenorrhoeic for ≥ 1 year* • Premature ovarian failure confirmed by a specialist gynaecologist • Previous bilateral salpingo-oophorectomy, or hysterectomy • XY genotype, Turner syndrome, uterine agenesis. *Amenorrhoea following cancer therapy does not rule out childbearing potential.
4 • XY- genotype, Turner- syndrom, uterus- agenesi. * Amenorrhoea som følge af cancerbehandling udelukker ikke fødedygtighed.
Counselling For women of childbearing potential, lenalidomide is contraindicated unless all of the following are met: • She understands the expected teratogenic risk to the unborn child • She understands the need for effective contraception, without interruption, 4 weeks before starting treatment, throughout the entire duration of treatment, and 4 weeks after the end of treatment • Even if a woman of childbearing potential has amenorrhea she must follow all the advice on effective contraception
Rådgivning Lenalidomid er kontraindiceret til fødedygtige kvinder, medmindre alle følgende kriterier opfyldes: • Kvinden er oplyst om og har indsigt i den forventede teratogene risiko for det ufødte barn • Kvinden forstår nødvendigheden af en effektiv, uafbrudt prævention 4 uger før behandlingen indledes, under hele behandlingsforløbet og 4 uger efter behandlingens afslutning • Selv hvis en fødedygtig kvinde har amenorrhea, skal hun følge alle rådene om effektiv prævention • Kvinden skal være i stand til at overholde effektive præventionsmetoder • Kvinden har fået information om og forstår de potentielle følger af graviditet og nødvendigheden af omgående at søge læge, hvis der er risiko for graviditet • Kvinden forstår nødvendigheden af at påbegynde behandlingen med lenalidomid, så snart lægemidlet er blevet ordineret efter en negativ graviditetstest • Kvinden forstår nødvendigheden af og accepterer at få foretaget graviditetstest hver 4. uge, undtagen ved bekræftet ægleder- sterilisation • Kvinden bekræfter, at hun forstår risikoen og de nødvendige sikkerhedsforanstaltninger, som er forbundet med brugen af lenalidomid.
4 • She should be capable of complying with effective contraceptive measures • She is informed and understands the potential consequences of pregnancy and the need to rapidly consult if there is a risk of pregnancy • She understands the need to commence the treatment as soon as lenalidomide is dispensed following a negative pregnancy test • She understands the need and accepts to undergo pregnancy testing every 4 weeks except in case of confirmed tubal sterilisation • She acknowledges that she understands the hazards and necessary precautions associated with the use of lenalidomide.
For mandlige patienter, som tager lenalidomid, foreligger der ingen kliniske data om tilstedeværelsen af lenalidomid i human sædvæske.
For male patients taking lenalidomide, there is no clinical data available on the presence of lenalidomide in human semen.
Mandlige patienter, som tager lenalidomid, skal opfylde følgende betingelser: • Forstå den forventede teratogene risiko ved seksuelt samvær med en fødedygtig kvinde • Forstå nødvendigheden af at bruge kondomer ved seksuelt samvær med en fødedygtig kvinde.
Male patients taking lenalidomide must meet the following conditions: • Understand the expected teratogenic risk if engaged in sexual activity with a woman of childbearing potential • Understand the need for the use of a condom if engaged in sexual activity with a woman of childbearing potential.
Den ordinerende læge skal for fødedygtige kvinder sikre, at: • Patienten overholder betingelserne i “ Programmet til svangerskabsforebyggelse ”, herunder bekræftelse af, at patienten har et passende forståelsesniveau • Patienten har anerkendt ovennævnte betingelser
The prescriber must ensure that for women of childbearing potential: • The patient complies with the conditions of the Pregnancy Prevention Programme, including confirmation that she has an adequate level of understanding • The patient has acknowledged the aforementioned conditions.
Dette gælder selv i tilfælde af dosisafbrydelse, med mindre patienten forpligter sig til absolut og vedvarende seksuel afholdenhed, som bekræftes hver måned.
Contraception Women of childbearing potential must use one effective method of contraception for 4 weeks before therapy, during therapy, and until 4 weeks after lenalidomide therapy and even in case of dose interruption unless the patient commits to absolute and continuous abstinence confirmed on a monthly basis.
Hvis patienten ikke benytter effektiv prævention, skal han/ hun henvises til relevant uddannet sundhedspersonale for at få rådgivning om prævention, således at præventionen kan påbegyndes.
If not established on effective contraception, the patient must be referred to an appropriately trained health care professional for contraceptive advice in order that contraception can be initiated.
Vasektomien skal bekræftes af to negative sædanalyser • P- piller kun med ægløsningshæmmende progestogen (dvs. desogestrel)
The following can be considered to be examples of suitable methods of contraception: • Implant • Levonorgestrel-releasing intrauterine system (IUS) • Medroxyprogesterone acetate depot • Tubal sterilisation • Sexual intercourse with a vasectomised male partner only; vasectomy must be confirmed by two negative semen analyses • Ovulation inhibitory progesterone-only pills (i.e., desogestrel)
4. 5).
Because of the increased risk of venous thromboembolism in patients with multiple myeloma taking lenalidomide and dexamethasone, combined oral contraceptive pills are not recommended (see also section 4.5).
Hvis en patient aktuelt anvender p- piller af kombinationstypen, skal patienten skifte til én af de ovenstående effektive metoder.
If a patient is currently using combined oral contraception the patient should switch to one of the effective method listed above.
Risikoen for venøs tromboemboli vedvarer i 4−6 uger efter ophør med p- piller af kombinationstypen.
The risk of venous thromboembolism continues for 4−6 weeks after discontinuing combined oral contraception.
4. 5)
The efficacy of contraceptive steroids may be reduced during co-treatment with dexamethasone (see section 4.5).
5 Implantater og spiraler, der afgiver levonorgestrel forbindes med en øget infektionsrisiko på opsætningstidspunktet og uregelmæssig vaginal blødning.
Implants and levonorgestrel-releasing intrauterine systems are associated with an increased risk of infection at the time of insertion and irregular vaginal bleeding.
Graviditetstest I overensstemmelse med lokal praksis skal der foretages lægeligt overvågede graviditetstests på fødedygtige kvinder.
This
Dette krav omfatter fødedygtige kvinder, som praktiserer absolut og vedvarende seksuel afholdenhed.
5 requirement includes women of childbearing potential who practice absolute and continuous abstinence.
Ideelt bør graviditetstest, ordinering og udlevering foregå samme dag.
Ideally, pregnancy testing, issuing a prescription and dispensing should occur on the same day.
Udlevering af lenalidomid til fødedygtige kvinder bør ske inden 7 dage efter ordinering.
Dispensing of lenalidomide to women of childbearing potential should occur within 7 days of the prescription.
1) under selve den konsultation, hvor patienten får ordineret lenalidomid, eller 2) i løbet af de sidste 3 dage inden konsultationen hos den ordinerende læge.
Prior to starting treatment A medically supervised pregnancy test should be performed during the consultation, when lenalidomide is prescribed, or in the 3 days prior to the visit to the prescriber once the patient had been using effective contraception for at least 4 weeks.
I begge tilfælde skal patienten have benyttet effektiv prævention i mindst 4 uger.
The test should ensure the patient is not pregnant when she starts treatment with lenalidomide.
Disse graviditetstests skal udføres enten:
Follow-up and end of treatment A medically supervised pregnancy test should be repeated every 4 weeks, including 4 weeks after the end of treatment, except in the case of confirmed tubal sterilisation.
1) under selve den konsultation, hvor patienten får ordineret lenalidomid, eller 2) i løbet af de sidste 3 dage inden konsultationen hos den ordinerende læge.
These pregnancy tests should be performed on the day of the prescribing visit or in the 3 days prior to the visit to the prescriber.
Mænd Det vides ikke, om lenalidomid findes i sædvæske.
Men It is not known whether lenalidomide is present in semen.
Derfor skal alle mandlige patienter benytte kondom under hele behandlingen, under dosisafbrydelse og i 1 uge efter behandlingsophør, hvis deres partner er fødedygtig og ikke bruger prævention.
Therefore all male patients should use condoms throughout treatment duration, during dose interruption and for 1 week after cessation of treatment if their partner is of childbearing potential and has no contraception.
Yderligere sikkerhedsforanstaltninger Patienten skal instrueres i aldrig at overdrage dette lægemiddel til andre og i at aflevere eventuelt ikke anvendte kapsler til apoteket, når behandlingen er afsluttet.
Additional precautions Patients should be instructed never to give this medicinal product to a nother person and to return any unused capsules to their pharmacist at the end of treatment.
Patienten må ikke donere blod eller sæd under behandlingen og i 1 uge efter ophør med behandling med lenalidomid.
Patients should not donate blood or semen during therapy or for 1 week following discontinuation of lenalidomide.
Derfor vil indehaveren af markedsføringstilladelsen udlevere undervisningsmateriale til sundhedspersonale for at skærpe opmærksomheden på advarslerne vedrørende lenalidomids forventede teratogenicitet, for at rådgive om prævention inden behandlingen indledes, og for at rådgive om behovet for graviditetstest.
Educational materials In order to assist patients in avoiding foetal exposure to lenalidomide, the Marketing Authorisation Holder will provide educational material to health care professionals to reinforce the warnings about the expected teratogenicity of lenalidomide, to provide advice on contraception before therapy is started, and to provide guidance on the need for pregnancy testing.
Lægen skal give komplet patientinformation om den forventede teratogene risiko og de strenge svangerskabsforebyggende forholdsregler som specificeret i “ Programmet til svangerskabsforebyggelse ” til fødedygtige kvinder og, hvis det er relevant, til mandlige patienter.
Full patient information about the expected teratogenic risk and the strict pregnancy prevention measures as specified in the Pregnancy Prevention Programme should be given by the physician to women of childbearing potential and, as appropriate, to male patients.
4. 5 og 4. 8).
Venous thromboembolism The combination of lenalidomide with dexamethasone is associated with an increased risk of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients with multiple myeloma (see sections 4.5 and 4.8).
6 Samtidig administration af epoitiner eller DVT i anamnesen kan også øge risikoen for trombose hos disse patienter.
Concomitant administration of erythropoietic agents or previous history of DVT may also increase thrombotic risk in these patients.
Derfor bør epoitiner eller andre stoffer, som kan øge risikoen for trombose, som f. eks. hormonsubstitutionsbehandling, anvendes med forsigtighed hos patienter med myelomatose, som får lenalidomid sammen med dexamethason.
Therefore, erythropoietic agents, or other agents that may increase the risk of thrombosis, such as hormone replacement therapy, should be used with caution in multiple myeloma patients receiving lenalidomide with dexamethasone.
Hvis hæmoglobinkoncentrationen stiger til over 13 g/ dl, bør behandlingen med epoitiner seponeres.
A haemoglobin concentration above 13 g/dl should lead to discontinuation of erythropoietic agents.
Profylaktiske antitrombotiske lægemidler som f. eks. hepariner med lav molekylvægt eller warfarin bør anbefales, især til patienter med yderligere trombotiske risikofaktorer.
Prophylactic antithrombotic medicines, such as low molecular weight heparins or warfarin, should be recommended, especially in patients with additional thrombotic risk factors.
Neutropeni og trombocytopeni Kombinationen af lenalidomid sammen med dexamethason hos patienter med myelomatose er forbundet med en højere forekomst af grad 4- neutropeni (5, 1% af de patienter, som blev behandlet med lenalidomid/ dexamethason, sammenlignet med 0, 6% af de patienter, som blev behandlet med placebo/ dexamethason, se pkt.
Neutropenia and thrombocytopenia The combination of lenalidomide with dexamethasone in multiple myeloma patients is associated with a higher incidence of grade 4 neutropenia (5.1% in lenalidomide/dexamethasone-treated patients
Febrile episoder af grad 4- neutropeni blev observeret mindre hyppigt (0, 6% af de patienter, som blev behandlet med lenalidomid/ dexamethason, sammenlignet med 0, 0% af de patienter, som blev behandlet med placebo/ dexamethason, se pkt.
6 compared with 0.6% in placebo/dexamethasone-treated patients; see section 4.8).
Patienterne bør rådes til straks at rapportere febrile episoder.
Grade 4 febrile neutropenia episodes were observed infrequently (0.6% in lenalidomide/dexamethasone-treated patients compared to 0.0% in placebo/dexamethasone treated patients; see section 4.8).
Det kan være nødvendigt at reducere dosis (se pkt.
A dose reduction may be required (see section 4.2).
Hos patienter med myelomatose er kombinationen af lenalidomid sammen med dexamethason forbundet med en højere forekomst af grad 3 - og grad 4- trombocytopeni (henholdsvis 9, 9% og 1, 4% af de patienter, som blev behandlet med lenalidomid/ dexamethason, sammenlignet med 2, 3% og 0, 0% af de patienter, som blev behandlet med placebo/ dexamethason se pkt.
The combination of lenalidomide with dexamethasone in multiple myeloma patients is associated with a higher incidence of grade 3 and grade 4 thrombocytopenia (9.9% and 1.4%, respectively, in lenalidomide/dexamethasone-treated patients compared to 2.3% and 0.0% in placebo/dexamethasone-treated patients; see section 4.8).
4. 8 Blødningsforstyrrelser).
Patients and physicians are advised to be observant for signs and symptoms of bleeding, including petechiae and epistaxes especially in case of concomitant medication susceptible to induce bleeding (see Section 4.8 Haemorrhagic disorders).
4. 2).
A dose reduction of lenalidomide may be required (see section 4.2).
Der skal foretages en komplet blodanalyse, herunder tælling af hvide blodlegemer med differentialtælling, trombocyttal, hæmoglobin og hæmatokrit ved baseline hver uge i de første 8 uger af behandlingen med lenalidomid og derefter månedligt for at kontrollere for cytopeni.
A complete blood cell count, including white blood cell count with differential count, platelet count, haemoglobin, and haematocrit should be performed at baseline, every week for the first 8 weeks of lenalidomide treatment and monthly thereafter to monitor for cytopenias.
Lenalidomids primære, dosisbegrænsende typer af toksicitet er neutropeni og trombocytopeni.
The major dose limiting toxicities of lenalidomide include neutropenia and thrombocytopenia.
Derfor bør samtidig administration af lenalidomid og andre myelosuppresive stoffer ske med forsigtighed.
Therefore, co-administration of lenalidomide with other myelosuppressive agents should be undertaken with caution.
Nedsat nyrefunktion Lenalidomid udskilles især igennem nyrerne.
Renal impairment Lenalidomide is substantially excreted by the kidney.
4. 2).
Therefore care should be taken in dose selection and monitoring of renal function is advised in patients with renal impairment (see section 4.2).
Thyroideafunktion Der er rapporteret tilfælde af hypothyroidisme, og lægen bør overveje at overvåge thyroideafunktionen.
Thyroid function Cases of hypothyroidism have been reported and monitoring of thyroid function should be considered.
Perifer neuropati Lenalidomid er strukturelt i familie med thalidomid, som er kendt for at forårsage svær perifer neuropati.
Peripheral neuropathy Lenalidomide is structurally related to thalidomide, which is known to induce severe peripheral neuropathy.
På nuværende tidspunkt kan det ikke udelukkes, at lenalidomid har neurotoksisk potentiale ved langtidsbrug.
At this time, the neurotoxic potential of lenalidomide associated with long-term use cannot be ruled out.
Tumorlysesyndrom Da lenalidomid har en anti- neoplastisk aktivitet, kan der optræde komplikationer i form af tumorlysesyndrom.
Tumour Lysis Syndrome Because lenalidomide has anti-neoplastic activity the complications of tumour lysis syndrome may occur.
7 Lactoseintolerans Revlimid- kapsler indeholder lactose.
Lactose intolerance Revlimid capsules contain lactose.
Bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form for hereditær lactasemangel (Lapp Lactase deficiency) eller glucose/ galactosemalabsorption.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Ikke anvendte kapsler Patienter skal rådgives om aldrig at give dette lægemiddel videre til andre og til at aflevere eventuelt ikke anvendte kapsler til apoteket, når behandlingen er afsluttet.
Unused capsules Patients should be advised never to give this medicinal product to another person and to return any unused capsules to their pharmacist at the end of the treatment.
4. 8).
Erythropoietic agents, or other agents that may increase the risk of thrombosis, such as hormone replacement therapy, should be used with caution in multiple myeloma patients receiving lenalidomide with dexamethasone (see sections 4.4 and 4.8).
Perorale præventionsmidler Der er ikke blevet udført interaktionsundersøgelser med perorale præventionsmidler.
Oral contraceptives No interaction study has been performed with oral contraceptives.
I et in vitro- forsøg med humane hepatocytter inducerede lenalidomid i de forskellige undersøgte koncentrationer ikke CYP1A2, CYP2B6, CYP2C9, CYP2C19 og CYP3A4/ 5.
Therefore, induction leading
Derfor forventes der ingen induktion, som fører til reduceret virkning af lægemidler, herunder hormonelle præventionsmidler, hvis lenalidomid administreres alene.
7 to reduced efficacy of drugs, including hormonal contraceptives, is not expected if lenalidomide is administered alone.