FrancophonIA/ELRC3.0 huggingface dataset:
English: At 10 μM concentrations, bortezomib does not inhibit any of a wide variety of receptors and proteases screened and is more than 1,500-fold more selective for the proteasome than for its next preferable enzyme.
Slovenian: Pri koncentraciji 10 μM bortezomib ne zavira nobenega od številnih različnih pregledanih receptorjev in proteaz ter je za več kot 1500-krat bolj selektiven za proteasom kot za svoj drugi prednostni encim.
English: Treatment duration (median=17 weeks) and duration of follow-up (median=40 months) were comparable in both treatment arms.
Slovenian: (mediana=17 tednov) in trajanje nadaljnjega spremljanja bolnikov (mediana=40 mesecev) sta bila primerljiva v obeh zdravljenih skupinah.
English: May be fatal if given by other routes.
Slovenian: Dajanje po drugi poti je lahko smrtno nevarno.
English: - Haemoglobin ≥ 8 g/dl
Slovenian: - Koncentracija hemoglobina ≥ 8 g/dl.
English: Acute diffuse infiltrative pulmonary and pericardial disease.
Slovenian: Akutna difuzna infiltracijska bolezen pljuč in perikarda.
English: Inhibition of the 26S proteasome prevents this targeted proteolysis and affects multiple signalling cascades within the cell, ultimately resulting in cancer cell death.
Slovenian: Zavora 26Sproteasoma preprečuje to ciljano proteolizo in vpliva na več signalnih kaskad v celici ter končno vodi do smrti rakave celice.
English: Two (1%) of the patients had severe reactions; 1 case of pruritus and 1 case of redness.
Slovenian: Pri dveh bolnikih (1 %) so se pojavile hude reakcije - pri enem pruritus in pri drugem rdečica.
English: Of those, 121 cases reported chalazion, blepharitis, meibomianitis, and/or Meibomian gland dysfunction.
Slovenian: Od teh so v 121 primerih poročali o halaziju, blefaritisu, meibomianitisu in/ali okvari Meibomove žleze.
English: By multivariate analysis, the response rate was independent of myeloma type, performance status, chromosome 13 deletion status, or the number or type of previous therapies.
Slovenian: Pri multivariantni analizi stopnja odziva ni bila odvisna od vrste plazmocitoma, stanja fizične zmogljivosti bolnika, delecije kromosoma 13 in števila ali vrste predhodnih zdravljenj.
English: Herpes zoster virus reactivation
Slovenian: Reaktivacija virusa herpes zoster
English: Management of orthostatic/postural hypotension may include adjustment of antihypertensive medicinal products, rehydration or administration of mineralocorticosteroids and/or sympathomimetics.
Slovenian: Zdravljenje ortostatske oz. posturalne hipotenzije lahko vključuje tudi prilagoditev odmerjanja antihipertenzivov, rehidracijo bolnika ali dajanje mineralokortikosteroidov in/ali simpatikomimetikov.
English: Patients achieving a complete response can continue treatment for at least 2 cycles after the first evidence of complete response, even if this requires treatment for more than 8 cycles.
Slovenian: Bolniki s popolnim odzivom lahko z zdravljenjem nadaljujejo še najmanj dva kroga po prvi ugotovitvi popolnega odziva, tudi če to zahteva zdravljenje, daljše od
English: The overall incidence of diarrhoea, gastrointestinal and abdominal pain, asthenic conditions, upper respiratory tract infections and peripheral neuropathies were 12%-15% lower in the subcutaneous group than in the intravenous group.
Slovenian: Celukupna incidenca driske, gastrointestinalne in abdominalne bolečine, asteničnih stanj, okužb zgornjih dihal in perifernih nevropatij je bila za 12-15 % manjša v subkutani kot v intravenski skupini.
English: If bortezomib is used during pregnancy, or if the patient becomes pregnant while receiving this medicinal product, the patient should be informed of potential for hazard to the foetus.
Slovenian: Če se bortezomib uporablja v času nosečnosti ali če bolnica zanosi med uporabo tega zdravila, jo morate obvestiti o potencialnem tveganju za plod.
English: OTHER SPECIAL WARNING(S), IF NECESSARY CYTOTOXIC.
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA CITOTOKSIČNO.
English: DISPOSAL A vial is for single use only and the remaining solution must be discarded.
Slovenian: ODSTRANJEVANJE ZDRAVILA Viala je namenjena izključno enkratni uporabi, preostalo raztopino morate zavreči.
English: Six percent of patients had an adverse local reaction to subcutaneous administration, mostly redness.
Slovenian: Šest odstotkov bolnikov je imelo lokalne reakcije na mestu subkutanega injiciranja, večinoma rdečico.
English: Response rate populatione n=668
Slovenian: Stopnja odziva populacijae n = 668
English: A total of 218 patients were evaluable for response.
Slovenian: Skupaj so odziv na zdravljenje ocenili pri 218 bolnikih.
English: Secondary endpoints included, time to progression (TTP), time to next anti-lymphoma treatment (TNT), duration of treatment free interval (TFI), overall response rate (ORR) and complete response (CR/CRu) rate, overall survival (OS) and response duration.
Slovenian: Sekundarna ocena je vključevala čas do napredovanja bolezni (TTP), čas do naslednjega zdravljenja limfoma (TNT), trajanje obdobja brez zdravljenja (TFI), celokupno stopnja odziva (ORR) in stopnjo popolnega odziva (CR/CRu), celokupno preživetje (OS) in trajanje odziva.
English: Therefore, patients must be cautious when driving or using machines and should be advised not to drive or operate machinery if they experience these symptoms (see section 4.8).
Slovenian: Bolnike je treba opozoriti naj v primeru pojava teh simptomov ne vozijo ali upravljajo s stroji (glejte poglavje 4.8).
English: The teratogenic potential of bortezomib has not been fully investigated.
Slovenian: Teratogenost bortezomiba še ni bila v celoti raziskana.
English: The ubiquitin-proteasome pathway plays an essential role in regulating the turnover of specific proteins, thereby maintaining homeostasis within cells.
Slovenian: Pot prek kompleksa ubikvitin-proteasom ima pomembno vlogo pri uravnavanju presnove specifičnih beljakovin in tako ohranja homeostazo v celicah.
English: Suicidal ideation*, Adjustment disorder, Delirium, Libido decreased
Slovenian: Redki samomorilne misli*, motnje prilagajanja, delirij, zmanjšan libido
English: In the BzmbTDx group 12% of patients were cytogenetically classified as high risk versus 16% of patients in the TDx group.
Slovenian: V skupini BzmbTDx je imelo 12 % bolnikov citogenetiko visokega tveganja v primerjavi s 16 % v skupini TDx.
English: The majority of the patients in both groups completed treatment, 80% in the BzmbR-CAP group and 82% in the R-CHOP group.
Slovenian: Večina bolnikov v obeh skupinah je zdravljenje zaključila, 80 % v skupini BzmbR-CAP in 82 % v skupini R-CHOP.
English: - Once dissolved, withdraw the appropriate amount of the reconstituted solution according to calculated dose based upon the patient´s Body Surface Area.
Slovenian: DAJANJE ZDRAVILA - Po raztapljanju odvzemite ustrezno količino rekonstituirane raztopine po izračunu odmerka na osnovi bolnikove telesne površine.
English: Grade 1 with pain or Grade 2 (moderate symptoms; limiting instrumental Activities of Daily Living (ADL)**)
Slovenian: Stopnja 1 z bolečino ali stopnja 2 (zmerni simptomi; omejene instrumentalne osnovne vsakodnevne aktivnosti (ADL)**)
English: Tel. +48 22 642 07 75
Slovenian: Tel. +48 22 642 07 75 România
English: Cases resolved in a median of 6 days, dose modification was required in two patients.
Slovenian: Primere so rešili v približno 6 dneh, dvema bolnikoma so morali prilagoditi odmerek zdravila.
English: The primary efficacy endpoint was progression-free survival based on Independent Review Committee (IRC) assessment.
Slovenian: Primarna ocena učinkovitosti je bilo preživetje brez napredovanja bolezni, ki ga je ocenil neodvisni odbor za pregled (Independent Review Committee-IRC).
English: Pregnancy and breast-feeding You should not use Bortezomib SUN if you are pregnant, unless clearly necessary.
Slovenian: Nosečnost in dojenje Če ste noseči, zdravila Bortezomib SUN ne smete uporabljati, razen če je nujno potrebno.
English: At the time of a pre-specified interim analysis, the primary endpoint, time to progression, was met and patients in the M+P arm were offered Bzmb+M+P treatment.
Slovenian: Ob predhodno določenem času vmesne analize je bil dosežen primarni cilj (čas do napredovanja bolezni) in bolnikom v M+P kraku študije so ponudili zdravljenje z Bzmb+M+P.
English: Bortezomib SUN should not be used in children and adolescents because it is not known how the medicine will affect them.
Slovenian: Otroci in mladostniki Zdravilo Bortezomib SUN se pri otrocih in mladostnikih ne sme uporabljati, ker njegovega vpliva nanje ne poznamo.
English: Patients whose levels of paraprotein continue to decrease after 8 cycles can also continue for as long as treatment is tolerated and they continue to respond.
Slovenian: Bolniki, pri katerih se koncentracija paraproteinov po 8 krogih še znižuje, lahko z zdravljenjem nadaljujejo, dokler zdravljenje dobro prenašajo in se odzivajo nanj.
English: Abbreviations: SGOT=serum glutamic oxaloacetic transaminase;
Slovenian: Okrajšave: SGOT = serumska glutamat-oksaloacetat transaminaza
English: BSA-normalized clearance of bortezomib in paediatric patients was similar to that observed in adults.
Slovenian: Očistek bortezomiba normaliziran na BSA je bil pri pediatričnih bolnikih podoben očistku, ki so ga opazili pri odraslih.
English: Of the 669 patients enrolled, 245 (37%) were 65 years of age or older.
Slovenian: 245 (37 %) izmed 669 vključenih bolnikov je bilo starih 65 let ali več.
English: Neuropathy has been managed with supportive care and other therapies.
Slovenian: Nevropatijo so zdravili s podpornim zdravljenjem in z drugimi načini.
English: OR; 95% CI; P valuea
Slovenian: OR; 95 % CI; p-vrednosta
English: Data from in vitro, ex-vivo, and animal models with bortezomib suggest that it increases osteoblast differentiation and activity and inhibits osteoclast function.
Slovenian: Podatki, pridobljeni in vitro, ex-vivo in iz živalskih modelov, kažejo, da bortezomib spodbuja diferenciacijo in aktivnost osteoblastov ter zavira osteoklaste.
English: Patients with pre-existing severe neuropathy may be treated with Bortezomib SUN only after careful risk/benefit assessment.
Slovenian: Bolnike z obstoječo hudo nevropatijo lahko zdravite z zdravilom Bortezomib SUN šele po skrbnem pretehtanju razmerja koristi in tveganj.
English: In patients, overdose more than twice the recommended dose has been associated with the acute onset of symptomatic hypotension and thrombocytopenia with fatal outcomes.
Slovenian: Pri bolnikih je bilo preveliko odmerjanje (odmerki so bili več kot dvakrat večji od priporočenega) povezano z akutnim pojavom simptomatične hipotenzije in trombocitopenije s smrtnimi izidi.
English: ORe (95% CI)=1.428 p-valueg=0.275
Slovenian: ORe (95 % CI)=1,428 p-vrednostg=0,275
English: Treatment with bortezomib is very commonly associated with peripheral neuropathy, which is predominantly sensory.
Slovenian: Zdravljenje z bortezomibom je zelo pogosto povezano s periferno nevropatijo, ki je pretežno senzorična.
English: The incidence of death on treatment was 5% in the subcutaneous treatment group and 7% in the intravenous treatment group.
Slovenian: Incidenca smrti med zdravljenjem je bila v subkutani skupini 5 % in v intravenski skupini 7 %.
English: The similar incidences of these events in both treatment arms, indicated that these adverse drug reactions are not attributable to bortezomib alone.
Slovenian: Podobna pojavnost teh neželenih učinkov v obeh zdravljenih skupinah kaže, da ju ni možno pripisati samo uporabi bortezomiba.
English: Since dialysis may reduce bortezomib concentrations, Bortezomib SUN should be administered after the dialysis procedure (see section 5.2).
Slovenian: Ker lahko dializa zmanjša koncentracijo bortezomiba, je treba zdravilo Bortezomib SUN injicirati po zaključku dializnega postopka (glejte poglavje 5.2).
English: Over a bortezomib concentration range of 0.01 to 1.0 μg/ml, the in vitro protein binding averaged 82.9% in human plasma.
Slovenian: V razponu koncentracij bortezomiba od 0,01 do 1,0 μg/ml je bila in vitro vezava na beljakovine povprečno 82,9 % v človeški plazmi.
English: It is not known whether bortezomib is excreted in human milk.
Slovenian: Ni znano, ali se bortezomib izloča v materino mleko.
English: Efficacy results are presented in Table 16:
Slovenian: Rezultati učinkovitosti so podani v preglednici 16:
English: A pre-treatment chest radiograph is recommended to serve as a baseline for potential post-treatment pulmonary changes.
Slovenian: Pred zdravljenjem je priporočljivo opraviti rentgensko slikanje prsnega koša za oceno potencialnih pljučnih sprememb po zdravljenju.
English: Grade 2 with pain or Grade 3 (severe symptoms; limiting self care ADL***)
Slovenian: Stopnja 2 z bolečino ali stopnja 3 (hudi simptomi; omejene fizične ADL***)
English: Most adverse reactions are mild to moderate in nature and are observed throughout treatment.
Slovenian: Ti neželeni učinki so po jakosti večinoma blagi do zmerni in jih opažamo ves čas zdravljenja.
English: However, cases of severe motor neuropathy with or without sensory peripheral neuropathy have been reported.
Slovenian: Poročali so tudi o primerih resne motorične nevropatije (z ali brez senzorične periferne nevropatije).
English: Rare side effects (may affect up to 1 in 1,000 people) - blood clot in small blood vessels (thrombotic microangiopathy)
Slovenian: Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1.000 bolnikov) - krvni strdek v malih krvnih žilah (trombotična mikroangiopatija)
English: 1 year survival, [95% CI]
Slovenian: 1-letno preživetje, [95 % CI]
English: Response Evaluable Population n=73
Slovenian: Populacija za ovrednotenje odziva n=73
English: Discuss with your doctor when it is safe to restart breast-feeding after finishing your treatment.
Slovenian: Ko zaključite zdravljenje, se z zdravnikom pogovorite o tem, kdaj je varno ponovno začeti z dojenjem.
English: Bortezomib mediated proteasome inhibition affects cancer cells in a number of ways, including, but not limited to, altering regulatory proteins, which control cell cycle progression and nuclear factor kappa B (NF-kB) activation.
Slovenian: Zaviranje proteasoma z bortezomibom vpliva na rakave celice na več načinov, vključno s spremembo regulatornih proteinov, ki nadzorujejo napredovanje celičnega ciklusa in aktivacijo nuklearnega faktorja kappa B (NF-kB).
English: The median duration of treatment was 24.0 weeks and the median number of treatment cycles received was 6.0, and was consistent across treatment groups.
Slovenian: Mediani čas trajanja zdravljenja je bil 24 tednov in mediano število krogov zdravljenja je bilo 6,0 v obeh skupinah.
English: Caution should be exercised when bortezomib is combined with CYP3A4 or CYP2C19 substrates (see section 4.5).
Slovenian: Še posebna previdnost je potrebna, kadar se daje bortezomib v kombinaciji s substrati encima CYP3A4 ali CYP2C19 (glejte poglavje 4.5).
English: Median age of the patients in the study was 57 years, 55% were male and 48% of patients had high-risk cytogenetics.
Slovenian: Mediana starost bolnikov v študiji je bila 57 let, 55 % je bilo moških in 48 % bolnikov je imelo citogenetiko visokega tveganja.
English: The solution will be clear and colourless, with a final pH of 4 to 7.
Slovenian: Nastala bo bistra in brezbarvna raztopina s končnim pH v območju med 4 in 7.
English: Deutschland tel. +49 (0) 214 403 99 192
Slovenian: Deutschland tel. +49 (0) 214 403 99 192 España
English: - Confirm the dose and concentration in the syringe prior to use (check that the syringe is marked as intravenous administration).
Slovenian: - Pred dajanjem zdravila preverite odmerek in koncentracijo v brizgi (prepričajte se, da je na brizgi oznaka za intravensko dajanje).
English: Based on this review, chalazion/blepharitis is considered associated with the use of bortezomib.
Slovenian: Na osnovi tega pregleda halazij/blefaritis povezujejo z uporabo bortezomiba.
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: You will receive 9 cycles (54 weeks).
Slovenian: Prejeli boste 9 krogov zdravljenja (54 tednov).
English: Geometric mean (%CV) clearance was 7.79 (25%) l/hr/m2, volume of distribution at steady-state was 834 (39%) l/m2, and the elimination half-life was 100 (44%) hours.
Slovenian: Geometrični povprečni očistek (%CV) je bil 7,79 l/h/m2 (25%), volumen porazdelitve v dinamičnem ravnovesju 834 l/m2 (39%), razpolovni čas izločanja pa 100 ur (44%).
English: Because of the potential for serious adverse reactions in breast-fed infants, breast-feeding should be discontinued during treatment with bortezomib.
Slovenian: Zaradi morebitnih resnih neželenih učinkov na dojene otroke je treba med zdravljenjem z bortezomibom dojenje prekiniti.
English: Anaphylactic shock, Amyloidosis, Type III immune complex mediated reaction
Slovenian: Redki anafilaktični šok, amiloidoza, z imunskim kompleksom tipa III povzročene reakcije
English: In addition to peripheral neuropathy, there may be a contribution of autonomic neuropathy to some adverse reactions such as postural hypotension and severe constipation with ileus.
Slovenian: Poleg periferne nevropatije lahko avtonomna nevropatija prispeva k nastanku nekaterih neželenih učinkov, npr. posturalne hipotenzije in hude zaprtosti z ileusom.
English: It is not necessary to protect the reconstituted medicinal product from light.
Slovenian: Rekonstituiranega zdravila ni treba zaščititi pred svetlobo.
English: Autonomic neuropathy may be related to bortezomib or bortezomib may aggravate an underlying condition such as diabetic or amyloidotic neuropathy.
Slovenian: Avtonomna nevropatija je lahko povezana z bortezomibom oz. bortezomib lahko poslabša osnovno bolezen, npr. diabetično ali amiloidno nevropatijo.
English: Additional adverse drug reactions identified associated with the use of the combination therapy (BzmbR-CAP) were hepatitis B infection (< 1%) and myocardial ischaemia (1.3%).
Slovenian: Dodatno ugotovljena neželena učinka, povezana z uporabo kombiniranega zdravljenja (BzmbR-CAP), sta bila okužba z virusom hepatitisa B (< 1 %) in ishemija miokarda (1,3 %).
English: Hypersensitivity to the active substance, to boron or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost za učinkovino, bor ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: Regardless of β2-microglobulin levels at baseline, all efficacy parameters (time to progression and overall survival, as well as response rate) were significantly improved on the bortezomib arm.
Slovenian: Ne glede na koncentracijo β2mikroglobulina ob začetku zdravljenja so se tudi vsi parametri učinkovitosti (čas do napredovanja bolezni in celokupno preživetje, kot tudi odziv na zdravljenje) v delu preskušanja z bortezomibom statistično značilno izboljšali.
English: Cardiovascular safety pharmacology studies in monkeys and dogs show that intravenous doses approximately two to three times the recommended clinical dose on a mg/m2 basis are associated with increases in heart rate, decreases in contractility, hypotension and death.
Slovenian: Farmakološka preskušanja kardiovaskularne varnosti zdravila pri opicah in psih kažejo povezavo med intravenskimi odmerki, ki so bili dva- do trikrat višji od priporočenega kliničnega odmerka (v mg/m2), ter povišanjem srčne frekvence, zmanjšanjem kontraktilnosti srca, hipotenzijo in smrtjo.
English: These adverse reactions are based on an integrated data set of 5,476 patients of whom 3,996 were treated with bortezomib at 1.3 mg/m2 and included in Table 7.
Slovenian: Ti neželeni učinki so navedeni na podlagi celotnega nabora podatkov 5.476 bolnikov, od katerih je bilo 3.996 bolnikov zdravljenih z bortezomibom v odmerku 1,3 mg/m2 telesne površine in so vključeni v Preglednico 7.
English: This 21-day period (3 weeks) corresponds to one treatment cycle.
Slovenian: To 21-dnevno obdobje (3 tedni) je en krog zdravljenja.
English: Posterior Reversible Encephalopathy Syndrome (PRES)
Slovenian: Sindrom reverzibilne posteriorne levkoencefalopatije (PRES - Posterior Reversible Encephalopathy
English: Special care is required when treating patients with any risk factors for seizures.
Slovenian: Pri zdravljenju bolnikov z dejavniki tveganja za epileptične napade, je potrebna posebna previdnost.
English: In non-clinical studies, bortezomib had no effects on embryonal/foetal development in rats and rabbits at the highest maternally tolerated doses.
Slovenian: V nekliničnih raziskavah bortezomib ni imel nobenih učinkov na embrionalni/fetalni razvoj pri podganah in kuncih pri največjih odmerkih, ki so jih samice še lahko prenašale.
English: Developmental toxicity studies in the rat and rabbit have shown embryo-fetal lethality at maternally toxic doses, but no direct embryo-foetal toxicity below maternally toxic doses.
Slovenian: Raziskave razvojne toksičnosti pri podganah in kuncih so pokazale embriofetalno smrtnost pri odmerkih, toksičnih za samice, vendar ni bilo neposredne embriofetalne toksičnosti pri odmerkih, manjših od tistih, ki so bili toksični za mater.
English: The reported efficacy data are considered inconclusive (see section 4.2).
Slovenian: Poročani podatki ne dovoljujejo dokončnih zaključkov o učinkovitosti (glejte poglavje
English: Please tell your doctor, or pharmacist if you are taking, have recently taken or might take any other medicines.
Slovenian: Druga zdravila in zdravilo Bortezomib SUN Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste začeli jemati katero koli drugo zdravilo.
English: The incidence of peripheral neuropathy increases early in the treatment and has been observed to peak during cycle 5.
Slovenian: Incidenca periferne nevropatije se poveča v začetku zdravljenja in doseže najvišjo vrednost v 5. krogu zdravljenja.
English: Based on a population pharmacokinetic analysis, clearance of bortezomib increased with increasing body surface area (BSA).
Slovenian: Analiza populacijske farmakokinetike je pokazala, da se očistek bortezomiba zveča z zvečanjem telesne površine (BSA - Body Surface Area).
English: Pharmacotherapeutic group: Antineoplastic agents, other antineoplastic agents, ATC code: L01XX32.
Slovenian: Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe, druga zdravila z delovanjem na novotvorbe; oznaka ATC: L01XX32.
English: A biological plausibility supports the association between bortezomib and chalazion/blepharitis; theoretically, bortezomib-related myelosuppression may facilitate viral infections such as herpes zoster thereby promoting chalazia.
Slovenian: Biološka verjetnost podpira povezavo med bortezomibom in halazijem/blefaritisom; teoretično lahko z bortezomibom povezana mielosupresija spodbudi nastanek virusnih okužb, kot je okužba z virusom herpes zoster, in s tem pospeši nastanek halazija.
English: A group of dialysis patients who were dosed after dialysis was also included in the study (n=8).
Slovenian: V študijo je bila vključena tudi skupina bolnikov na dializi, ki so prejemali zdravilo po dializi (n=8).
English: Cluj-Napoca, Judeţul Cluj România
Slovenian: Str. Fabricii nr 124 Cluj-Napoca, Judeţul Cluj
English: Exposure of bortezomib (dose-normalised AUC and Cmax) was comparable among all the groups (see section 4.2).
Slovenian: (AUC in Cmax normalizirana glede na odmerek) je bila primerljiva med vsemi skupinami (glejte poglavje 4.2).
English: Thalidomide is contraindicated during pregnancy and in women of childbearing potential unless all the conditions of the thalidomide pregnancy prevention programme are met.
Slovenian: Uporaba talidomida je med nosečnostjo in pri ženskah v rodni dobi kontraindicirana, razen če so izpolnjeni vsi pogoji programa preprečevanja nosečnosti za talidomid (Thalidomide Pregnancy Prevention Programme).