natgillin/translations-raw huggingface dataset:
Æskerne med Thalidomide Celgene- kapslerne, vil være påført en advarsel om, at thalidomid er skadeligt for ufødte børn.
The boxes containing Thalidomide Celgene capsules will include a warning stating that thalidomide is harmful to the unborn child.
Andre oplysninger om Thalidomide Celgene:
Other information about Thalidomide Celgene:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Thalidomide Pharmion den 16 april 2008.
The European Commission granted a marketing authorisation valid throughout the European Union for Thalidomide Pharmion on 16 April 2008.
Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Thalidomide Celgene kan ses her.
The summary of opinion of the Committee for Orphan Medicinal Products for Thalidomide Celgene is available here.
Den fuldstændige EPAR for Thalidomide Celgene findes her.
The full EPAR for Thalidomide Celgene can be found here.
EU- nummer EU/ 1/ 08/ 443/ 001
EU number EU/ 1/ 08/ 443/ 001
Navn Thalidomide Celgene
Name Thalidomide Celgene
Styrke 50 mg
Strength 50 mg
Farmaceutisk form Kapsel, hård
Pharmaceutical Form Capsule, hard
Emballagetype Blister (PVC/ PE/ Aclar/ Alu)
Packaging Blister (PVC/ PE/ Aclar/ Alu)
Pakningsstørrelse 28 kapsler
Package size 28 capsules
Hjælpestof( fer):
Excipient:
Hver kapsel indeholder 257, 2 mg vandfri laktose.
Each capsule contains 257.2 mg of anhydrous lactose.
Hård kapsel Hvid, uigennemsigtig med markeringen ” Thalidomide 50 mg Celgene ”.
White opaque capsules marked “ Thalidomide 50 mg Celgene”.
Thalidomide Celgene i kombination med melphalan og prednison som førstevalgsbehandling af patienter med ubehandlet myelomatose i alderen > 65 år eller som er uegnede til højdosis kemoterapi.
Thalidomide Celgene in combination with melphalan and prednisone as first line treatment of patients with untreated multiple myeloma, aged ≥ 65 years or ineligible for high dose chemotherapy.
4. 4).
Thalidomide Celgene is prescribed and dispensed according to the Thalidomide Celgene Pregnancy Prevention Programme (see section 4.4).
Anbefalet dosering for voksne:
Recommended posology in adults:
Den anbefalede perorale dosis er 200 mg pr. dag.
The recommended oral dose is 200 mg per day.
Der bør anvendes højst 12 cyklusser af 6 ugers varighed.
A maximum number of 12 cycles of 6 weeks should be used.
Thalidomide Celgene bør tages som en enkelt dosis før sengetid for at reducere den somnolente virkning.
Thalidomide Celgene should be taken as a single dose at bedtime, to reduce the impact of somnolence.
Thalidomide Celgene kan indtages uafhængigt af måltider.
Thalidomide Celgene can be taken with or without food.
4. 4 og 4. 8).
Patients should be monitored for: thromboembolic events; peripheral neuropathy; rash/ skin reactions; bradycardia, syncope and somnolence (see sections 4.4 and 4.8).
Pausering, dosisreduktion eller seponering kan være nødvendigt afhængigt af toxicitetsgraden (NCI CTC).
Dose delay, reduction or discontinuation, dependent upon the NCI CTC grade, may be necessary.
4. 4, 4. 5 og 4. 8).
The decision to take antithrombotic prophylactic measures should be made after careful assessment of an individual patient’ s underlying risk factors (see sections 4.4, 4.5 and 4.8).
Hvis patienten oplever tromboemboliske hændelser, skal behandlingen standses, og standard
If the patient experiences any thromboembolic events, treatment must be discontinued and standard anticoagulation therapy started.
Så snart patienten er stabiliseret med den antikoagulerende behandling, og passende foranstaltninger er truffet vedrørende eventuelle komplikationer af den tromboemboliske hændelse, kan thalidomidbehandlingen genoptages med den oprindelige dosis, såfremt dette understøttes af en vurdering af fordele og risici.
2 and any complications of the thromboembolic event have been managed, the thalidomide treatment may be restarted at the original dose dependent upon a benefit risk assessment.
Dosisændringer pga. perifer neuropati er beskrevet i tabel 1.
Dose modifications due to peripheral neuropathy are described in Table 1.
Anbefalede dosisændringer for Thalidomide Celgene- relateret neuropati under førstevalgsbehandling af myelomatose
Recommended dose modifications for Thalidomide Celgene related neuropathy in first line treatment of multiple myeloma.
Neuropatigrad Grad 1 (paræstesi, svækkelse og/ eller reflekstab) uden funktionstab
Severity of neuropathy Grade 1 (paraesthesia, weakness and/ or loss of reflexes) with no loss of function
Ændring af dosering og behandling Fortsæt monitorering af patienten med klinisk undersøgelse.
Modification of dose and regimen Continue to monitor the patient with clinical examination.
Reducer dosis eller afbryd behandlingen og fortsæt monitorering af patienten med klinisk og neurologisk undersøgelse.
Reduce dose or interrupt treatment and continue to monitor the patient with clinical and neurological examination.
Hvis neuropatien remitterer til grad 1 eller bedre, kan behandlingen genstartes, hvis dette understøttes af en vurdering af fordele og risici.
If the neuropathy resolves to Grade 1 or better, the treatment may be restarted, if the benefit/ risk is favourable.
Grad 3 (påvirker daglige aktiviteter) Grad 4 (neuropati, der er invaliderende)
Grade 3 (interfering with activities of daily living)
Ingen specifikke doseringsjusteringer til ældre.
No specific dose adjustments are recommended for the elderly.
Patienter med nedsat nyre - eller leverfunktion:
Patients with renal or hepatic impairment:
Thalidomide Celgene er ikke formelt blevet undersøgt hos patienter med nedsat nyre - eller leverfunktion.
Thalidomide Celgene has not formally been studied in patients with impaired renal or hepatic function.
Thalidomide Celgene frarådes til patienter under 18 år, da sikkerhed og virkning ikke er undersøgt.
Thalidomide Celgene is not recommended for use in children below 18 years of age as safety and efficacy have not been established.
4. 4).
− Hypersensitivity to thalidomide or to any of the excipients. − Pregnant women (see section 4.6). − Women of childbearing potential unless all the conditions of the Thalidomide Celgene Pregnancy Prevention Programme are met (see sections 4.4 and 4.6). − Patients unable to follow or comply with the required contraceptive measures (see section 4.4).
Teratogene virkninger:
Teratogenic effects:
Thalidomid må aldrig benyttes af kvinder, der er gravide eller kan blive gravide.
Thalidomide must never be used by women who are pregnant or could become pregnant.
3 Kriterier for kvinder, som ikke er i den fertile alder:
Criteria for women of non-childbearing potential:
En kvindelig patient eller en kvindelig partner til en mandlig patient anses for at være i den fertile alder, medmindre hun opfylder et af følgende kriterier: • Alder ≥ 50 år og naturligt amenorrhoisk i ≥ 1 år * • Tidligt ovariesvigt bekræftet af speciallæge i gynækologi • Tidligere bilateral salpingo- ooforektomi eller hysterektomi • XY- genotype, Turners syndrom, uterin agenesi. * Amenorré som følge af cancerbehandling udelukker ikke muligheden for at blive gravid.
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’ s syndrome, uterine agenesis. *Amenorrhoea following cancer therapy does not rule out childbearing potential.
Rådgivning:
Counselling:
For kvinder i den fertile alder er thalidomid kontraindiceret, medmindre alle efterfølgende betingelser er opfyldt: • Hun forstår den teratogene risiko for det ufødte barn. • Hun forstår nødvendigheden af effektiv svangerskabsforebyggelse uden afbrydelse, 4 uger før behandlingen påbegyndes og under hele behandlingsforløbet samt 4 uger efter endt behandling. • Selv hvis en kvinde i den fertile alder har været uden menstruation, skal hun følge råd og vejledning om effektiv svangerskabsforebyggelse. • Hun skal være i stand til at følge effektive forholdsregler for prævention. • Hun er blevet oplyst om og forstår de potentielle konsekvenser ved graviditet samt nødvendigheden af øjeblikkelig konsultation, hvis der er risiko for graviditet. • Hun forstår nødvendigheden af påbegyndelse af behandling, så snart som thalidomid ordineres efter en negativ graviditetstest. • Hun forstår dette behov og accepterer, at der skal foretages graviditetstest hver 4. uge. • Hun bekræfter, at hun forstår risici og nødvendigheden af de forholdsregler, der er forbundet med anvendelsen af thalidomid.
For women of childbearing potential, thalidomide is contraindicated unless all of the following are met: • She understands the 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 • 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 thalidomide is dispensed following a negative pregnancy test • She understands the need and accepts to undergo pregnancy testing every 4 weeks • She acknowledges that she understands the hazards and necessary precautions associated with the use of thalidomide.
Da thalidomid kan findes i sæd, skal mandlige patienter, der tager thalidomid, opfylde følgende betingelser: • Forstå den teratogene risiko ved seksuelt samvær med en gravid kvinde. • Forstå nødvendigheden af brug af kondom ved seksuelt samvær med en gravid kvinde eller en kvinde i den fertile alder, der ikke benytter effektiv prævention.
As thalidomide is found in semen, male patients taking thalidomide must meet the following conditions: • Understand the teratogenic risk if engaged in sexual activity with a pregnant woman. • Understand the need for the use of a condom if engaged in sexual activity with a pregnant woman or a woman of childbearing potential not using effective contraception.
Den ordinerende læge skal sikre, at: • Patienten overholder betingelserne i Thalidomide Celgenes Svangerskabsforebyggelsesprogram. • Patienten bekræfter, at han/ hun forstår de førnævnte betingelser.
The prescriber must ensure that: • The patient complies with the conditions of the Thalidomide Celgene Pregnancy Prevention Programme • The patient confirms that he (she) understand the aforementioned conditions.
Prævention:
Contraception:
Kvinder i den fertile alder skal benytte en effektiv præventionsmetode i 4 uger før behandlingen, under behandlingen samt 4 uger efter thalidomidbehandlingen, også ved pausering af behandlingen, medmindre patienten forpligter sig til fuldstændig og vedvarende seksuel afholdenhed, som bekræftes månedligt.
Women of childbearing potential must use one effective method of contraception for 4 weeks before therapy, during therapy, and during 4 weeks after thalidomide therapy and even in case of dose interruption unless the patient commits to absolute and continuous abstinence confirmed on a monthly basis.
Hvis der ikke benyttes effektiv prævention, skal patienten henvises til relevant uddannet sundhedspersonale med henblik på rådgivning og påbegyndelse af svangerskabsforebyggelse.
If not established on effective contraception, the patient must be referred preferably to an appropriately trained healthcare professional for contraceptive advice in order that contraception can be initiated.
Vasektomien skal være bekræftet med to negative sædprøver. • Ovulationshæmmende progesteronpiller (dvs. desogesterel)
4 The following can be considered to be examples of effective methods of contraception: • Subcutaneous hormonal 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, combined oral contraceptive pills are not recommended (see section 4.5).
Hvis en patient benytter perorale kombinationspræparater, bør patienten skifte til en af de effektive metoder, der er angivet herover.
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 perorale kombinationspræparater.
The risk of venous thromboembolism continues for 4− 6 weeks after discontinuing combined oral contraception.
Graviditetstestning:
Pregnancy testing:
Der skal foretages lægeligt overvågede graviditetstests med en følsomhed på mindst 25 mIU/ ml på kvinder i den fertile alder som angivet herunder.
Medically supervised pregnancy tests with a minimum sensitivity of 25 mIU/ ml must be performed for women of childbearing potential as outlined below.
Før påbegyndelse af behandling Der bør foretages en lægeligt overvåget graviditetstest i løbet af den konsultation, hvor thalidomid ordineres, eller tidligst 3 dage før besøget hos den ordinerende læge, og når patienten har benyttet et effektivt svangerskabsforebyggende middel i mindst 4 uger.
Prior to starting treatment A medically supervised pregnancy test should be performed during the consultation, when thalidomide 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.
Follow- up og afslutning af behandling En lægeligt overvåget graviditetstest bør gentages hver 4. uge samt 4 uger efter, at behandlingen er afsluttet.
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.
Da thalidomid kan findes i sæd, skal mandlige patienter benytte kondom i behandlingsperioden samt 1 uge efter afbrydelse af behandling og/ eller behandlingsophør, hvis deres partner er gravid eller er i den fertile alder og ikke benytter effektiv prævention.
As thalidomide is found in semen, male patients must use condoms during treatment and for 1 week after dose interruption and/ or cessation of treatment if their partner is pregnant or is of childbearing potential not using effective contraception.
Begrænsninger vedrørende ordination og udlevering:
Prescribing and dispensing restrictions:
Yderligere forholdsregler:
Additional precautions:
Patienterne skal instrueres i aldrig at videregive dette medikament til andre personer og i at returnere ubenyttede kapsler til apoteket efter endt behandling.
Patients should be instructed never to give this medicinal product to another person and to return any unused capsules to their pharmacist at the end of treatment.
Undervisningsmaterialer:
Educational materials:
Med henblik på at hjælpe patienter med at undgå føtal eksponering for thalidomid og for at give yderligere vigtige sikkerhedsoplysninger vil indehaveren af markedføringstilladelsen udlevere undervisningsmateriale
In order to assist patients in avoiding foetal exposure to thalidomide and to provide additional important safety information, the Marketing Authorisation holder will provide educational material to healthcare professionals.
sundhedspersonalet.
5 started and provides guidance on the need for pregnancy testing.
Dyb venøs trombose og lungeemboli:
Deep venous thrombosis and pulmonary embolism:
4. 8).
An increased risk of deep venous thrombosis (DVT) and pulmonary embolus (PE) has been reported in patients treated with thalidomide (see section 4.8).
4. 2.
Thromboprophylaxis and dosing/ anticoagulation therapy recommendations are provided in section 4.2.
Tidligere tilfælde af tromboemboliske hændelser eller samtidig administration af erythropoietiske midler eller andre midler såsom hormonsubstitution kan også øge risikoen for trombose hos disse patienter.
Previous history of thromboembolic events or concomitant administration of erythropoietic agents or other agents such as hormone replacement therapy, may also increase thrombotic risk in these patients.
Specielt bør behandling med erythropoietiske midler afbrydes ved en hæmoglobinkoncentration på over 12 g/ dl.
Particularly, a haemoglobin concentration above 12g/ dl should lead to discontinuation of erythropoietic agents.
4. 8).
Peripheral neuropathy is a very common, potentially severe, adverse reaction to treatment with thalidomide that may result in irreversible damage (see section 4.8).
I en fase 3- undersøgelse var mediantiden til den første neuropatiske hændelse 42, 3 uger.
In a phase 3 study, the median time to first neuropathy event was 42.3 weeks.
4. 2.
If the patient experiences peripheral neuropathy, follow the dose and schedule modification instruction provided in section 4.2.
Det anbefales, at kliniske og neurologiske undersøgelser udføres på patienter før påbegyndelse af behandling med thalidomid samt at rutinemæssig monitorering udføres jævnligt under behandlingen.
It is recommended that clinical and neurological examinations are performed in patients prior to starting thalidomide therapy, and that routine monitoring is carried out regularly during treatment.
4. 5).
Medicinal products known to be associated with neuropathy should be used with caution in patients receiving thalidomide (see section 4.5).
Synkope og bradykardi:
Syncope and bradycardia:
Patienterne skal monitoreres for synkope samt bradykardi, og dosisreduktion eller ophør kan være påkrævet.
Patients should be monitored for syncope and bradycardia and dose reduction or discontinuation may be required.
Hvis patienten på noget tidspunkt oplever toksiske hudreaktioner, f. eks.
If at anytime the patient experiences a toxic skin reaction e. g.
Stevens- Johnson syndrom, bør behandlingen ophøre permanent.
Stevens-Johnson Syndrome, the treatment should be discontinued permanently.
Somnolens:
Somnolence:
Thalidomid forårsager ofte somnolens.
Thalidomide frequently causes somnolence.
Patienterne bør instrueres i at undgå situationer, hvor somnolens kan være et problem, og søge lægens råd før indtagelse af andre medikamenter, der kan forårsage somnolens.
Patients should be instructed to avoid situations where somnolence may be a problem and to seek medical advice before taking other medicinal products known to cause somnolence.
Patienterne bør monitoreres og reduceret dosis kan være påkrævet.
Patients should be monitored and dose reduction may be required.
4. 7).
Patients should be advised as to the possible impairment of mental and/ or physical abilities required for the performance of hazardous tasks (see section 4.7).
Patienter med svækket nyre - eller leverfunktion:
6 Patients with renal or hepatic impairment:
Patienter med svært nedsat nyre - eller leverfunktion bør monitoreres nøje for bivirkninger.
Patients with severe renal or hepatic impairment should be carefully monitored for adverse effects.
Laktoseintolerans:
Lactose intolerance:
Kapslerne indeholder laktose.
The capsules contain lactose.
Patienter med sjældne arvelige problemer som galaktoseintolerans, Lapp laktasemangel eller glukose- galaktose- malabsorption bør ikke tage dette medikament.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
6 Thalidomid er et dårligt substrat for cytochrom P450- isoenzymer, og derfor er klinisk vigtige interaktioner med lægemidler, der metaboliseres af dette enzymsystem, usandsynlige.
Thalidomide is a poor substrate for cytochrome P450 isoenzymes and therefore clinically important interactions with medicinal products metabolized by this enzyme system are unlikely.
Forøgede sedative virkninger af andre lægemidler:
Increase of sedative effects of other medicinal products:
Thalidomid har sedative egenskaber og kan derfor forøge den sedative virkning af anxiolytika, hypnotika, antipsykotika, H1- antihistaminer, opiumderivater, barbiturater og alkohol.
Thalidomide has sedative properties thus may enhance the sedation induced by anxiolytics, hypnotics, antipsychotics, H1 anti-histamines, opiate derivatives, barbiturates and alcohol.
Bradykardiel virkning:
Bradycardic effect:
På grund af thalidomids potentiale for at fremkalde bradykardi bør forsigtighed udvises ved samtidig brug af lægemidler, der har samme farmakodynamiske virkning, såsom betablokkere, kolinesterasehæmmere og aktive stoffer, der vides at kunne inducere torsade de pointes.
Due to thalidomide’ s potential to induce bradycardia, caution should be exercised with medicinal products having the same pharmacodynamic effect such as active substances known to induce torsade de pointes, beta blockers or anticholinesterase agents.
Lægemidler, der kan fremkalde perifer neuropati:
Medicinal products known to cause peripheral neuropathy:
Lægemidler, der er kendt for at være forbundet med perifer neuropati (f. eks. vincristin og bortezomib) bør anvendes med forsigtighed til patienter i behandling med thalidomid.
Medicinal products known to be associated with peripheral neuropathy (e. g. vincristine and bortezomib) should be used with caution in patients receiving thalidomide.
Hormonale svangerskabsforebyggende midler:
Hormonal contraceptives:
Hos 10 raske kvinder blev de farmakokinetiske profiler for norethindron og ethinylestradiol undersøgt efter indtagelse af en enkelt dosis, der indeholdt 1, 0 mg norethinronacetat og 0, 75 mg ethinylestradiol.
In 10 healthy women, the pharmacokinetic profiles of norethindrone and ethinyl estradiol following administration of a single dose containing 1.0 mg of norethindrone acetate and 0.75 mg of ethinyl estradiol were studied.
Resultaterne var næsten ens med og uden samtidig indtagelse af thalidomid 200 mg/ dag indtil steady- state- niveau.
The results were similar with and without co-administration of thalidomide 200 mg/ day to steady-state levels.
Flere doser givet som 200 mg thalidomid 1 gang dagligt i 4 dage havde ingen virkning på international normaliseret ratio (INR) hos raske frivillige.
Multiple dose administration of 200 mg thalidomide q. d. for 4 days had no effect on the international normalized ratio (INR) in healthy volunteers.
På grund af den forøgede risiko for trombose hos cancerpatienter og muligheden for accelereret metabolisme af warfarin med kortikosteroider, anbefales der imidlertid omhyggelig monitorering af INR- værdier ved kombinationsbehandling med thalidomid og prednison indtil en uge efter denne behandlings ophør.
However, due to the increased risk of thrombosis in cancer patients, and a potentially accelerated metabolism of warfarin with corticosteroids, close monitoring of INR values is advised during thalidomide-prednisone combination treatment as well as during the first weeks after ending these treatments.
Hos 18 raske mandlige forsøgspersoner havde flere doser 200 mg thalidomid ingen tydelig virkning på farmakokinetikken for en enkelt dosis digoxin.
In 18 healthy male volunteers, multiple dose administration of 200 mg thalidomide had no apparent effect on the single dose pharmacokinetics of digoxin.
Desuden havde en enkelt dosis 0, 5 mg digoxin ingen tydelig virkning på farmakokinetikken for thalidomid.
In addition, single dose administration of 0.5 mg digoxin had no apparent effect on thalidomide pharmacokinetics.
4. 3).
Thalidomide Celgene is contraindicated during pregnancy and in women of childbearing potential unless all the conditions of the Thalidomide Celgene Pregnancy Prevention Programme are met (see section 4.3)