natgillin/translations-raw huggingface dataset:
− 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).
– Preobčutljivost za talidomid ali katerokoli pomožno snov. – Nosečnice (glejte poglavje 4. 6). – Ženske v rodni dobi, razen če izpolnjujejo pogoje programa Thalidomide Celgene za preprečevanje nosečnosti (glejte poglavji 4. 4 in 4. 6). – Bolnice, ki niso sposobne slediti kontracepcijskim ukrepom ali se ravnati v skladu z njimi (glejte poglavje 4. 4.).
Teratogenic effects:
Teratogeni učinki:
Thalidomide must never be used by women who are pregnant or could become pregnant.
Nosečnice ali ženske, ki lahko zanosijo, ne smejo nikoli jemati talidomida.
The conditions of the Thalidomide Celgene Pregnancy Prevention Programme must be fulfilled for all male and female patients.
3 Pogoji programa Thalidomide Celgene za preprečevanje nosečnosti morajo biti izpolnjeni pri vseh bolnikih in bolnicah.
Criteria for women of non-childbearing potential:
Merila za ženske, ki ne morejo zanositi:
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.
Predpostavlja se, da bolnica ali partnerica moškega bolnika lahko zanosi, razen če izpolnjuje vsaj eno od naslednjih meril: • Starost ≥ 50 let in naravno amenoroična ≥ 1 leto. * • Prezgodnja odpoved jajčnika, ki jo potrdi specialist ginekolog. • Predhodna bilateralna salpingo- ooforektomija ali histerektomija. • Genotip XY, Turnerjev sindrom, agenezija maternice. * Amenoreja kot posledica zdravljenja raka ne izključuje možnosti zanositve.
Counselling:
Svetovanje:
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.
Za ženske v rodni dobi je talidomid kontraindiciran, razen če so izpolnjeni vsi naslednji pogoji: • Bolnica razume tveganje teratogenih učinkov za nerojenega otroka. • Bolnica razume potrebo po učinkoviti kontracepciji brez prekinitev, 4 tedne pred pričetkom zdravljenja, med celotnim trajanjem zdravljenja ter 4 tedne po koncu zdravljenja. • Tudi če ima ženska, ki lahko zanosi, amenorejo, mora upoštevati vse nasvete za učinkovito kontracepcijo. • Bolnica mora biti zmožna ravnati v skladu z učinkovitimi kontracepcijskimi ukrepi. • Bolnica je obveščena in razume možne posledice nosečnosti in potrebo po takojšnjem posvetovanju, če obstaja tveganje za zanositev. • Bolnica razume potrebo, da se prične zdravljenje kakor hitro je izdan talidomid po negativnem testu nosečnosti. • Bolnica razume potrebo po opravljanju testa nosečnosti vsake 4 tedne in v to privoli. • Bolnica potrdi, da razume nevarnosti in previdnostne ukrepe, potrebne v zvezi z uporabo talidomida.
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.
Ker je talidomid prisoten v spermi, morajo moški bolniki, ki jemljejo talidomid, izpolnjevati naslednje pogoje: • Bolnik razume tveganje teratogenih učinkov pri spolnem občevanju z nosečnico. • Bolnik razume potrebo po uporabi kondoma pri spolnem občevanju z nosečnico ali žensko, ki lahko zanosi, in ne uporablja učinkovite kontracepcije.
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.
Zdravnik, ki predpiše zdravilo, mora zagotoviti naslednje: • Bolnik/ bolnica ravna v skladu s pogoji programa Thalidomide Celgene za preprečevanje nosečnosti. • Bolnik/ bolnica potrdi, da razume zgoraj navedene pogoje.
Contraception:
Kontracepcija:
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.
Ženske v rodni dobi morajo uporabljati učinkovito metodo kontracepcije 4 tedne pred terapijo, med terapijo ter 4 tedne po terapiji s talidomidom in celo v primeru prekinitev odmerjanja, razen če se bolnica zaveže k popolni in neprekinjeni spolni vzdržnosti, ki se potrjuje vsak mesec.
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.
Če bolnica ne uporablja učinkovite kontracepcije, jo je treba napotiti k ustrezno usposobljenemu zdravniku na posvet glede kontracepcije, da jo lahko prične uporabljati.
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)
V nadaljevanju naštete kontracepcijske metode veljajo za učinkovite: • Podkožni hormonski vsadek • Intrauterini sistem (IUS), ki sprošča levonorgestrel • Depo medroksiprogesteronacetata • Sterilizacija jajcevodov • Spolni odnosi samo z moškim partnerjem, ki je imel vazektomijo; vazektomijo je treba potrditi z dvema negativnima analizama sperme • Tablete, ki zavirajo ovulacijo in vsebujejo samo progesteron (t. j. dezogestrel) Zaradi povečanega tveganja za vensko trombembolijo pri bolnicah z multiplim mielomom uporaba kombiniranih peroralnih kontracepcijskih tablet ni priporočljiva (glejte poglavje 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).
Če bolnica 4 trenutno uporablja kombinirano peroralno kontracepcijo, mora preiti na eno od zgoraj naštetih učinkovitih metod.
The risk of venous thromboembolism continues for 4− 6 weeks after discontinuing combined oral contraception.
Tveganje za vensko trombembolijo se nadaljuje še 4- 6 tednov po prekinitvi jemanja kombinirane peroralne kontracepcije.
Pregnancy testing:
Test nosečnosti:
Medically supervised pregnancy tests with a minimum sensitivity of 25 mIU/ ml must be performed for women of childbearing potential as outlined below.
Pri ženskah v rodni dobi je treba izvesti test nosečnosti pod zdravniškim nadzorom z minimalno občutljivostjo 25 m i. e. / ml, kot je opisano spodaj.
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.
Pred začetkom zdravljenja Test nosečnosti pod zdravniškim nadzorom je treba izvesti med posvetovanjem, ko se predpiše talidomid, ali 3 dni pred obiskom zdravnika, ki predpiše zdravilo, ko bolnica že vsaj 4 tedne uporablja učinkovito kontracepcijo.
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.
Nadaljevanje in konec zdravljenja Test nosečnosti pod zdravniškim nadzorom je treba ponoviti vsake 4 tedne, vključno s 4 tedni po koncu zdravljenja.
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.
Ker je talidomid prisoten v spermi, morajo moški bolniki uporabljati kondome med zdravljenjem, 1 teden po prekinitvi odmerjanja in/ ali po koncu zdravljenja, če je partnerica noseča ali v rodni dobi in ne uporablja učinkovite kontracepcije.
Prescribing and dispensing restrictions:
Omejitve v zvezi s predpisovanjem in izdajanjem:
Additional precautions:
Dodatna opozorila:
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.
Bolnike je treba poučiti, da tega zdravila nikoli ne dajo drugi osebi, in da po koncu zdravljenja vrnejo vse neuporabljene kapsule svojim farmacevtom.
Patients should not donate blood or semen during therapy or for 1 week following discontinuation of thalidomide.
Bolniki med zdravljenjem ali 1 teden po prekinitvi zdravljenja s talidomidom ne smejo darovati krvi ali sperme.
Educational materials:
Izobraževalna gradiva:
The Thalidomide Celgene Pregnancy Prevention Programme reinforces the warnings about the teratogenicity of thalidomide, provides advice on contraception before therapy is
Program Thalidomide Celgene za preprečevanje nosečnosti poudarja opozorila o teratogenosti talidomida ter nudi nasvete glede kontracepcije pred začetkom zdravljenja in navodila glede potrebe po testu nosečnosti.
Deep venous thrombosis and pulmonary embolism:
Globoka venska tromboza in pljučna embolija:
An increased risk of deep venous thrombosis (DVT) and pulmonary embolus (PE) has been reported in patients treated with thalidomide (see section 4.8).
Pri bolnikih, ki so jemali talidomid, so poročali o povečanem tveganju za globoko vensko trombozo (GVT) in pljučno embolijo (PE) (glejte poglavje 4. 8).
The risk appears to be greatest during the first 5 months of therapy.
Kaže, da je tveganje je največje prvih 5 mesecev zdravljenja.
Thromboprophylaxis and dosing/ anticoagulation therapy recommendations are provided in section 4.2.
Priporočila glede tromboprofilakse in odmerjanja/ zdravljenja z antikoagulanti so v poglavju 4. 2.
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.
5 Anamneza trombembolitičnih dogodkov ali sočasna uporaba eritropoetskih ali drugih zdravil, kot je nadomestno hormonsko zdravljenje, lahko prav tako poveča tveganje za trombozo pri teh bolnikih.
Therefore, these agents should be used with caution in multiple myeloma patients receiving thalidomide with prednisone and melphalan.
Zato je treba ta zdravila pri bolnikih z multiplim mielomom, ki prejemajo talidomid s prednizonom in melfalanom uporabljati previdno.
Particularly, a haemoglobin concentration above 12g/ dl should lead to discontinuation of erythropoietic agents.
Posebej pomembno je prekiniti zdravljenje z eritropoetskimi zdravili, če se koncentracija hemoglobina dvigne nad 12 g/ dl.
Peripheral neuropathy is a very common, potentially severe, adverse reaction to treatment with thalidomide that may result in irreversible damage (see section 4.8).
Periferna nevropatija je razširjen, potencialno resen neželen učinek pri zdravljenju s talidomidom, ki lahko privede do nepopravljivih okvar (glejte poglavje 4. 8).
In a phase 3 study, the median time to first neuropathy event was 42.3 weeks.
V 3. stopnji študije je bil mediani čas do prvega dogodka nevropatije 42, 3 tedne.
If the patient experiences peripheral neuropathy, follow the dose and schedule modification instruction provided in section 4.2.
Če se pri bolniku pojavi periferna nevropatija, je treba upoštevati navodila za prilagoditev odmerka režima odmerjanja v poglavju 4. 2.
Careful monitoring of patients for symptoms of neuropathy is recommended.
Priporoča se skrbno nadziranje bolnikov v zvezi s simptomi nevropatije.
Medicinal products known to be associated with neuropathy should be used with caution in patients receiving thalidomide (see section 4.5).
Zdravila, za katera je znano, da povzročijo nevropatijo, morajo bolniki, ki prejemajo talidomid, jemati s previdnostjo (glejte poglavje 4. 5).
Syncope and bradycardia:
Sinkopa in bradikardija:
Patients should be monitored for syncope and bradycardia and dose reduction or discontinuation may be required.
Morda bo treba odmerek zmanjšati ali prekiniti zdravljenje.
If at anytime the patient experiences a toxic skin reaction e. g.
Če se pri bolniku kadarkoli pojavi toksična reakcija na koži, npr.
Stevens-Johnson Syndrome, the treatment should be discontinued permanently.
Stevens- Johnsonov sindrom, je treba trajno prekiniti zdravljenje.
Somnolence:
Somnolenca:
Patients should be monitored and dose reduction may be required.
Bolnike je treba nadzirati in jim po potrebi prilagoditi odmerek.
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).
Bolnikom je treba svetovati glede možnega poslabšanja mentalnih in/ ali fizičnih sposobnosti, potrebnih za izvajanje nevarnih nalog (glejte poglavje 4. 7).
6 Patients with renal or hepatic impairment:
Bolniki z okvarjenim delovanjem ledvic ali jeter:
Patients with severe renal or hepatic impairment should be carefully monitored for adverse effects.
Bolnike z okvarjenim delovanjem ledvic ali jeter je treba skrbno nadzirati glede neželenih učinkov.
Lactose intolerance:
Neprenašanje laktoze:
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Bolniki z redkimi dednimi težavami neprenašanja galaktoze, laponsko obliko zmanjšane aktivnosti laktaze ali slabo absorpcijo glukoze- galaktoze ne smejo jemati tega zdravila.
Thalidomide is a poor substrate for cytochrome P450 isoenzymes and therefore clinically important interactions with medicinal products metabolized by this enzyme system are unlikely.
Talidomid je slab substrat za izoencime citokroma P450, zato je verjetnost klinično pomembnih interakcij z zdravili, ki jih metabolizira ta encimski sistem, majhna.
Increase of sedative effects of other medicinal products:
Povečanje sedativnih učinkov drugih zdravil:
Thalidomide has sedative properties thus may enhance the sedation induced by anxiolytics, hypnotics, antipsychotics, H1 anti-histamines, opiate derivatives, barbiturates and alcohol.
Talidomid ima sedativne lastnosti in lahko poveča sedacijo, ki jo povzročijo anksiolitiki, hipnotiki, antipsihotiki, antihistamini H1, derivati opiata, barbiturati in alkohol.
Bradycardic effect:
Učinek bradikardije:
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.
Zaradi potenciala talidomida, da povzroči bradikardijo, je potrebna previdnost pri zdravilih, ki imajo isti farmakodinamični učinek, kot na primer zdravilne učinkovine, za katera je znano, da inducirajo torsade de pointes, zaviralci beta ali zdravila proti holinesterazi.
Medicinal products known to cause peripheral neuropathy:
Zdravila, za katera je znano, da povzročajo periferno nevropatijo:
Medicinal products known to be associated with peripheral neuropathy (e. g. vincristine and bortezomib) should be used with caution in patients receiving thalidomide.
Zdravila, za katera je znano, da povzročajo periferno nevropatijo (npr. vinkristin, bortezomib), morajo bolniki, ki prejemajo talidomid, jemati s previdnostjo.
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.
Pri 10 zdravih ženskah so bili raziskani farmakokinetični profili noretindrona in etinilestradiola po uporabi enega odmerka z 1, 0 mg noretindron acetata in 0, 75 mg etinilestradiola.
The results were similar with and without co-administration of thalidomide 200 mg/ day to steady-state levels.
Rezultati so bili podobni pri sočasni uporabi talidomida v odmerku 200 mg/ dan in brez sočasne uporabe talidomida do ravni stanja dinamičnega ravnovesja.
Multiple dose administration of 200 mg thalidomide q. d. for 4 days had no effect on the international normalized ratio (INR) in healthy volunteers.
Večkratni odmerki po 200 mg talidomida, enkrat na dan po 4 dni, niso imeli učinka na internacionalno normalizirano razmerje (INR) pri zdravih prostovoljcih.
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.
Zaradi povečanega tveganja tromboze pri bolnikih z rakom in potencialnim pospeševanjem metabolizma varfarina s kortikosteroidi se priporoča natančno nadzorovanje ravni INR med zdravljenjem s kombinacijo talidomid- prednizon in v prvih tednih po koncu teh zdravljenj.
In 18 healthy male volunteers, multiple dose administration of 200 mg thalidomide had no apparent effect on the single dose pharmacokinetics of digoxin.
Pri 18 zdravih prostovoljcih uporaba večkratnih 200- mg odmerkov talidomida ni imela vidnega učinka na farmakokinetiko enega odmerka digoksina.
In addition, single dose administration of 0.5 mg digoxin had no apparent effect on thalidomide pharmacokinetics.
Tudi uporaba enega 0, 5- mg odmerka digoksina ni imela nobenega vidnega učinka na farmakokinetiko talidomida.
It is not known whether the effect will be different in multiple myeloma patients.
Ni znano, ali je učinek pri bolnikih z multiplim mielomom drugačen.
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)
Zdravilo Thalidomide Celgene je kontraindicirano med nosečnostjo in pri ženskah v rodni dobi, razen če so izpolnjeni vsi pogoji programa Thalidomide Celgene za preprečevanje nosečnosti (glejte poglavje 4. 3).
Thalidomide is a powerful human teratogen, inducing a high frequency (about 30%) of severe and live-threatening birth defects such as: ectromelia (amelia, phocomelia, hemimelia) of the upper and/ or lower extremities, microtia with abnormality of the external acoustic meatus (blind or absent), middle
Talidomid je močan humani teratogen, ki inducira visoko pogostnost (okrog 30%) resnih in smrtno nevarnih prirojenih okvar, kot so: ektromelija (amelija, fokomelija, hemimelija) zgornjih in/ ali spodnjih okončin, mikrotija z okvarami zunanjega slušnega kanala (slep ali manjkajoč), lezije srednjega in notranjega ušesa (manj pogosto), lezije oči (anoftalmija, mikroftalmija), prirojena srčna bolezen, okvare ledvic.
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 (see section 4.4).
Ženske v rodni dobi morajo uporabljati eno učinkovito metodo kontracepcije 4 tedne pred terapijo, med terapijo ter 4 tedne po terapiji s talidomidom (glejte poglavje 4. 4).
If pregnancy occurs in a woman treated with thalidomide, treatment must be stopped immediately and the patient should be referred to a physician specialised or experienced in teratology for evaluation and advice.
7 Če ženska, ki se zdravi s talidomidom, zanosi, je treba zdravljenje nemudoma prekiniti in bolnico napotiti k zdravniku specialistu za teratologijo ali k zdravniku z izkušnjami v teratologiji, da oceni stanje in bolnici ustrezno svetuje.
Male patients with female partners of childbearing potential:
Moški bolniki s partnericami v rodni dobi:
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 when having sexual intercourse with a pregnant woman or with a woman with childbearing potential who is not using effective contraception.
Ker je talidomid prisoten v spermi, morajo moški bolniki uporabljati kondome med zdravljenjem, 1 teden po koncu prekinitve odmerjanja in/ ali po koncu zdravljenja ob spolnih odnosih z nosečnico ali z žensko, ki lahko zanosi in ne uporablja učinkovite kontracepcije.
If pregnancy occurs in a partner of male patient taking thalidomide, the female partner should be referred to a physician specialised or experienced in teratology for evaluation and advice.
Če partnerica moškega, ki jemlje talidomid, zanosi, jo je treba napotiti k zdravniku specialistu za teratologijo ali zdravniku z izkušnjami v teratologiji, da oceni stanje in bolnici ustrezno svetuje.
It is unknown whether thalidomide is excreted in human breast milk.
Ni znano, ali se talidomid pri ljudeh izloča v materino mleko.
Therefore breast-feeding should be discontinued during therapy with thalidomide.
Zato je treba dojenje med terapijo s talidomidom prekiniti.
However thalidomide may cause somnolence and blurred vision (see section 4.8).
Talidomid lahko povzroči somnolenco in zamegljen vid (glejte poglavje 4. 8).
If affected, patients should be instructed not to drive cars, use machines or perform hazardous tasks while being treated with thalidomide.
Prizadete bolnike je treba poučiti, da v času zdravljena s talidomidom ne smejo voziti avtov, upravljati s stroji ali izvajati nevarnih nalog.
Most patients taking thalidomide can be expected to experience adverse reactions.
Pričakuje se, da se bodo neželeni učinki doživela pojavili pri večini bolnikov, ki jemljejo talidomid.
The clinically important adverse reactions associated with the use of thalidomide in combination with melphalan and prednisone or dexamethasone include: deep vein thrombosis and pulmonary embolism, peripheral neuropathy, severe skin reactions including Stevens Johnson Syndrome and toxic epidermal necrolysis, syncope, bradycardia, and dizziness (see sections 4.2, 4.4 and 4.5).
Klinično pomembni neželeni učinki, povezani z uporabo talidomida v kombinaciji z melfalanom in prednizonom ali deksametazonom, vključujejo: globoko vensko trombozo in pljučno embolijo, periferno nevropatijo, resne kožne reakcije, vključno s sindromom Stevens Johnson in toksično epidermalno nekrolizo, bradikardijo, sinkopo in vrtoglavico (glejte poglavja 4. 2, 4. 4 in 4. 5).
Table 2 contains only the adverse reactions for which a causal relationship with medicinal product treatment could reasonably be established.
Tabela 2 zajema samo neželene učinke, za katere je bilo mogoče razumno vzpostaviti vzročno razmerje z zdravljenjem z zdravilom.
Frequencies given are based on the observations during a pivotal comparative clinical study investigating the effect of thalidomide in combination with melphalan and prednisone in previously untreated multiple myeloma patients.
Navedene pogostnosti temeljijo na opazovanjih med osrednjo primerjalno klinično študijo, ki je raziskovala učinek talidomida v kombinaciji z melfalanom in prednizonom pri bolnikih s predhodno nezdravljenim multiplim mielomom.