FrancophonIA/ELRC3.0 huggingface dataset:
English: • non-Hodgkin's lymphoma that is resistant to treatment or has come back;
Slovenian: • ne-Hodgkinovega limfoma, ki je odporen proti zdravljenju ali se je ponovil;
English: • testicular cancer that is resistant to treatment or has come back;
Slovenian: • raka mod, ki je odporen proti zdravljenju ali se je ponovil;
English: On 14 October 2015, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Vepesid in the EU.
Slovenian: Da bi uskladili dovoljenja za promet z zdravilom Vepesid v EU, je Evropska komisija 14. oktobra 2015 napotila zadevo na odbor CHMP.
English: • acute myeloid leukaemia that is resistant to treatment or has come back;
Slovenian: • akutne mieloične levkemije, ki je odporna proti zdravljenju ali se je ponovila;
English: Vepesid was identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh).
Slovenian: Skupina za usklajevanje za postopek z medsebojnim priznavanjem in decentralizirani postopekzdravila za uporabo v humani medicini (CMDh) je ugotovila, da je za zdravilo Vepesid potrebno usklajevanje.
English: It works in a number of different ways:
Slovenian: Deluje na več različnih načinov:
English: 5 years
Slovenian: 5 let
English: These measures will prevent misuse.
Slovenian: Ta ukrep prepreči zlorabo.
English: This is called a ‘remission'.
Slovenian: To se imenuje 'remisija'.
English: The risk increased over time and was about 2 % after two years and about 4 % after three years.
Slovenian: Tveganje se je s časom povečalo in je bilo približno 2 % po dveh letih in približno 4 % po treh letih.
English: Grades 3 and 4*
Slovenian: 3. in 4. stopnja*
English: Take your next capsules at the usual time the next day.
Slovenian: Naslednje kapsule vzemite ob običajni uri naslednji dan.
English: It has no antibacterial effects.
Slovenian: Nima nobenih antibakterijskih učinkov.
English: Figure 1: Overall survival according to treatment
Slovenian: Slika 1: Celokupno preživetje glede na zdravljenje
English: • Sexual dysfunction, for example impotence.
Slovenian: • spolna disfunkcija, na primer impotenca,
English: This decrease did not result in clinical signs.
Slovenian: To zmanjšanje ni povzročilo kliničnih znakov.
English: Key elements to be included
Slovenian: Ključni elementi, ki morajo biti zajeti
English: • Swallow the capsules whole with a full glass of water.
Slovenian: • Pogoltnite cele kapsule s polnim kozarcem vode.
English: Date of first authorisation: 16 April 2008 Date of latest renewal: 08 February 2018
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 16. april 2008 Datum zadnjega podaljšanja: 08. februar 2018
English: The relevance to humans is unknown.
Slovenian: Pomen za ljudi ni znana.
English: Not known (frequency cannot be estimated from the available data) :
Slovenian: Neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti)
English: However, the signs and symptoms can be greatly reduced or disappear for a period of time.
Slovenian: Vendar pa se lahko znaki in simptomi za nekaj časa v veliki meri zmanjšajo ali izginejo.
English: It is not a contract and does not absolve anybody from his/her responsibilities with regard to the safe use of the product and prevention of foetal exposure.”
Slovenian: To ni pogodba in nikogar ne odvezuje njegovih odgovornosti v zvezi z varno uporabo zdravila in preprečevanjem izpostavljenosti ploda temu zdravilu“.
English: This can damage the bone and kidneys.
Slovenian: To lahko poškoduje kosti in ledvice.
English: Read it carefully and follow the related instructions.
Slovenian: Natančno jo preberite in upoštevajte navodila.
English: • are used for contraception.
Slovenian: • se uporabljajo za kontracepcijo.
English: AND ≥ 100,000
Slovenian: IN ≥ 100.000
English: It may become very severe, painful and disabling.
Slovenian: Bolečina lahko postane zelo huda, boleča in onesposabljajoča.
English: Taking this medicine
Slovenian: Jemanje tega zdravila
English: The risk appears to be greatest during the first 5 months of therapy.
Slovenian: Kaže, da je tveganje največje prvih 5 mesecev zdravljenja.
English: • you do not understand the contraception advice given to you by your doctor or if you do not feel able to follow this advice.
Slovenian: • ne razumete nasvetov za kontracepcijo, ki vam jih da vaš zdravnik, ali se ne čutite sposobne slediti tem nasvetom;
English: See also further information in this section under “Warnings and precautions” and “Pregnancy and breast-feeding”.
Slovenian: Glejte tudi dodatne informacije v tem poglavju pod „Opozorila in previdnostni ukrepi“ in „Nosečnost in dojenje“.
English: Your doctor should check whether you have ever had hepatitis B infection.
Slovenian: Vaš zdravnik mora preveriti, ali ste kadarkoli prej imeli okužbo s hepatitisom B;
English: However, patients with age > 75 years are potentially at risk for a higher frequency of serious adverse reactions.
Slovenian: Vendar pa je pri bolnikih, starejših od 75 let, možno tveganje večje pogostnosti resnih neželenih učinkov.
English: Time from randomization ( month )
Slovenian: Čas od randomizacije (mesec)
English: This belongs to a group of medicines which affect how your immune system works.
Slovenian: To zdravilo spada v skupino zdravil, ki vplivajo na način delovanja vašega imunskega sistema.
English: You must follow the contraception advice given to you by your doctor.
Slovenian: Upoštevati morate nasvet v zvezi s kontracepcijo, ki vam ga je dal vaš zdravnik.
English: This applies even if the man has had a vasectomy.
Slovenian: To velja tudi, če je moški prestal vazektomijo.
English: A national controlled distribution system has been implemented in collaboration with each National Competent Authority.
Slovenian: V sodelovanju z vsakim nacionalnim pristojnim organom se izvaja nacionalno nadzorovan sistem distribucije.
English: Grade 1 (paraesthesia, weakness and/or loss of reflexes) with no loss of function
Slovenian: 1. stopnja (parestezija, slabotnost in/ali izguba refleksov) brez izgube funkcij
English: This side effect usually happens after you have been taking this medicine for several months but can happen sooner than this.
Slovenian: Ta neželeni učinek običajno nastopi, ko to zdravilo jemljete več mesecev, vendar lahko nastopi tudi prej.
English: Peripheral neuropathy generally occurs following chronic use over a period of months.
Slovenian: Periferna nevropatija se na splošno pojavlja po kronični uporabi v obdobju več mesecev.
English: If possible, take the medicine pack and this leaflet with you.
Slovenian: Če je možno, vzemite s seboj pakiranje zdravila in to navodilo.
English: • Post-marketing and compliance assessment (as applicable to a Member State)
Slovenian: • Ocenitev izkušenj v obdobju trženja in skladnosti (kot velja v posamezni državi članici)
English: Modification of dose and regimen
Slovenian: Sprememba odmerka in režima
English: Further to the per protocol analysis, an update was conducted for the IFM 99-06 study providing an additional 15 months follow-up data.
Slovenian: Poleg analize po protokolu so izvedli posodobitev za študijo IFM 99-06 z dodatnimi 15-mesečnimi podatki sledenja.
English: A maximum number of 12 cycles of 6 weeks (42 days) should be used.
Slovenian: Dovoljenih je največ 12 ciklov po 6 tednov (42 dni).
English: Cases of PRES/RPLS have been reported.
Slovenian: Poročali so o primerih PRES/ RPLS.
English: The maximum plasma concentrations are reached 1-5 hours after administration.
Slovenian: Največje koncentracije v plazmi se dosežejo 1-5 ur po uporabi.
English: • more than 12 hours have passed: do not take your capsules.
Slovenian: • je minilo več kot 12 ur: ne vzemite kapsul.
English: You will have been given an educational brochure for patient by your doctor.
Slovenian: Od zdravnika boste prejeli izobraževalno brošuro za bolnika.
English: In this study the age range of patients was 65-75 years, with 41 % (183/447) of patients 70 years old or older.
Slovenian: V tej študiji je znašal starostni razpon bolnikov 65-75 let, z 41 % (183/447) bolnikov, starih 70 let ali več.
English: • less than 12 hours have passed: take your capsules immediately.
Slovenian: • je minilo manj kot 12 ur: nemudoma vzemite kapsule.
English: However, reports following relatively shortterm use also exist.
Slovenian: Poročajo pa tudi o pojavljanju po relativno kratkem času uporabe.
English: The majority of the radioactive dose was excreted within 48 hour following dose administration.
Slovenian: Večina radioaktivnega odmerka se je izločila v 48 urah po dajanju odmerka.
English: • You have heterosexual intercourse without using an effective method of contraception.
Slovenian: • imate heteroseksualne spolne odnose brez uporabe zanesljive kontracepcijske metode.
English: • are associated with neuropathy such as other treatments for cancer.
Slovenian: • so povezana z nevropatijo, kot so druga zdravila za zdravljenje raka;
English: • Sexual intercourse with a vasectomised male partner only; vasectomy must be confirmed by two negative semen analyses
Slovenian: • spolni odnosi samo z moškim partnerjem, ki je imel vazektomijo; vazektomijo je treba potrditi z dvema negativnima analizama sperme
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so dolčene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
English: • Worsening of Parkinson's disease symptoms (such as tremor, depression or confusion).
Slovenian: • poslabšanje simptomov Parkinsonove bolezni (kot so tremor, depresija ali zmedenost),
English: Other side effects include:
Slovenian: Drugi neželeni učinki vključujejo:
English: • Take the capsules as a single dose before going to bed.
Slovenian: • Kapsule vzemite kot enkraten odmerek pred spanjem.
English: This includes medicines obtained without a prescription, including herbal medicines.
Slovenian: To vključuje tudi zdravila, ki ste jih dobili brez recepta, vključno z zdravili rastlinskega izvora.
English: Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10,000 to < 1/1000); very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Slovenian: Pogostnost je opredeljena kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000) in neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
English: If you experience such symptoms, speak to your doctor straight away, who may reduce the dose or discontinue the treatment.
Slovenian: Če izkusite take simptome, takoj povejte zdravniku, ki bo lahko zmanjšal odmerek ali prekinil zdravljenje.
English: Your doctor may check if you have a high total amount of tumour throughout the body, including your bone marrow.
Slovenian: Vaš zdravnik lahko preveri, ali imate številne tumorje po vsem telesu, vključno v kostnem mozgu.
English: The conditions of the Pregnancy Prevention Programme must be fulfilled for all male and female patients.
Slovenian: Pogoji programa za preprečevanje nosečnosti morajo biti izpolnjeni pri vseh bolnikih in bolnicah.
English: In a phase 3 study, the median time to first neuropathy event was 42.3 weeks.
Slovenian: V 3. stopnji študije je bil mediani čas do prvega dogodka nevropatije 42,3 tedne.
English: • Periodic Safety Update Reports (PSUR)
Slovenian: • Redno posodobljena poročila o varnosti zdravila (PSUR)
English: In addition, the addition of interruption or discontinuation recommendations regarding the risk of severe skin reactions in general, in line with the one already approved for the structural analogues lenalidomide and pomalidomide, is supported.
Slovenian: Poleg tega podpira vključitev priporočil za prekinitev ali ukinitev v zvezi s tveganjem za hude reakcije na koži na splošno, v skladu z že odobrenim priporočilom za strukturna analoga lenalidomid in pomalidomid.
English: Total systemic exposure (AUC) is proportional to dose at single-dose conditions.
Slovenian: Skupna sistemska izpostavljenost (AUC) je sorazmerna z odmerkom pri pogojih enega odmerka.
English: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Slovenian: Pred začetkom jemanja zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke.
English: The median dose of thalidomide was 217 mg and > 40 % of patients received 9 cycles.
Slovenian: Mediana odmerka talidomida je znašala 217 mg in > 40 % bolnikov je prejelo 9 ciklov.
English: No time dependency of the pharmacokinetics has been observed.
Slovenian: Časovne odvisnosti farmakokinetike niso opazili.
English: This will make you less likely to feel sleepy at other times.
Slovenian: Zaradi tega bo verjetnost, da se boste ob drugih trenutkih počutili zaspane, manjša.
English: It may not go away, or may go away slowly.
Slovenian: Lahko se zgodi, da sploh ne izgine ali izgine počasi.
English: Follow-up and end of treatment
Slovenian: Nadaljevanje in konec zdravljenja
English: • Premature ovarian failure confirmed by a specialist gynaecologist.
Slovenian: • Prezgodnja odpoved jajčnikov, ki jo potrdi specialist ginekolog.
English: • if you are allergic to thalidomide or any of the other ingredients of this medicine listed in section 6 “Contents of the pack and other information”.
Slovenian: • če ste alergični na talidomid ali katero koli drugo sestavino tega zdravila, navedeno v poglavju 6 „Vsebina pakiranja in dodatne informacije“.
English: Eighteen cases of overdose have been reported in the literature concerning doses up to 14.4 grams.
Slovenian: V literaturi so poročali o osemnajstih primerih prevelikega odmerjanja za odmerke do 14,4 grama.
English: • Educational brochures for patients: o The educational brochures for patients should be of 3 types:
Slovenian: • Izobraževalne brošure za bolnike: o Izobraževalne brošure za bolnike morajo biti treh vrst:
English: Other less frequent abnormalities have also been described.
Slovenian: Poročali so tudi o drugih manj pogostih okvarah.
English: Thalidomide has a chiral centre and is used clinically as a racemate of (+)-(R)- and (-)-(S)-thalidomide.
Slovenian: Talidomid ima kiralni center in se uporablja klinično kot racemat (+)-(R)- in (-)-(S)-talidomida.
English: Do not take thalidomide if you are pregnant or could become pregnant.
Slovenian: Ne jemljite talidomida, če ste noseči ali bi lahko zanosili.
English: In one 2-year-old child who took 700 mg, there was an abnormal plantar response in addition to drowsiness and irritability.
Slovenian: Pri dvoletnem otroku, ki je vzel odmerek 700 mg, je poleg zaspanosti in razdražljivosti prišlo tudi do nenormalnega plantarnega odziva.
English: Pregnancy testing
Slovenian: Test nosečnosti
English: In the event of an overdose, the patient's vital signs should be monitored and appropriate supportive care given to maintain blood pressure and respiratory status.
Slovenian: V primeru prevelikega odmerka je treba nadzirati življenjske znake bolnika in nuditi ustrezno podporno zdravljenje za vzdrževanje krvnega tlaka in stanje dihanja.
English: The use of thalidomide could be associated with menstrual disorders including amenorrhea.
Slovenian: Uporaba talidomida je lahko povezana z menstrualnimi motnjami, vključno z amenorejo.
English: A diagnosis of PRES/RPLS requires confirmation by brain imaging.
Slovenian: Za diagnozo PRES/ RPLS je potrebna potrditev s slikanjem možganov.
English: • Previous bilateral salpingo-oophorectomy, or hysterectomy.
Slovenian: • Predhodna bilateralna salpingo-ooforektomija ali histerektomija.
English: However, combined hormonal contraceptives are not recommended due to the increased risk of venous thromboembolic disease.
Slovenian: Vendar pa kombinirani hormonski kontraceptivi niso priporočljivi zaradi povečanega tveganja za vensko trombembolično bolezen.
English: • you have had a heart attack, have ever had a blood clot in the past, or if you smoke, have high blood pressure or high cholesterol levels.
Slovenian: • ste imeli srčni infarkt, ste kdaj v preteklosti imeli krvni strdek, če kadite, imate visok krvni tlak ali visoke vrednosti holesterola.
English: Reduce dose or interrupt treatment and continue to monitor the patient with clinical and neurological examination.
Slovenian: Zmanjšajte odmerek ali prekinite zdravljenje in nadaljujte z nadzorovanjem bolnika s kliničnimi in nevrološkimi pregledi.
English: Co-administration of food delayed absorption but did not alter the overall extent of absorption.
Slovenian: Sočasno zaužitje hrane je absorpcijo upočasnilo, a ni vplivalo na njen skupni obseg.
English: Therefore, do not have unprotected intercourse, even if you had a vasectomy.
Slovenian: Zaradi tega ne imejte nezaščitenih spolnih odnosov, tudi če ste prestali vazektomijo.
English: MP - T
Slovenian: MP MP-T
English: If more than 12 hours has elapsed since missing a dose at the normal time, the patient should not take the dose, but take the next dose at the normal time on the following day.
Slovenian: Če je od izpuščenega odmerka ob običajnem času preteklo več kot 12 ur, bolnik odmerka ne sme vzeti, pač pa naj vzame naslednji odmerek ob običajnem času naslednji dan.
English: Teratogenic effects
Slovenian: Teratogeni učinki
English: • cause sleepiness as thalidomide may increase their effects.
Slovenian: • povzročajo zaspanost, saj lahko talidomid poveča njihov učinek.
English: Continue to monitor the patient with clinical examination.
Slovenian: Nadaljujte z nadzorovanjem bolnika s kliničnimi pregledi.
English: Prior to starting treatment
Slovenian: Pred začetkom zdravljenja
English: It is recommended to press only on one end of the capsule to remove it from the blister, thereby reducing the risk of capsule deformation or breakage.
Slovenian: Priporočljivo je pritisniti samo na en konec kapsule, da jo odstranite iz pretisnega omota, s čimer boste zmanjšali nevarnost, da bi se kapsula deformirala ali prelomila.
English: Do not apply pressure on the centre of the capsule as this can cause it to break.
Slovenian: Ne pritiskajte na osrednji del kapsule, ker bi jo s tem lahko prelomili.
English: The in vivo relevance of these findings is unknown.
Slovenian: Pomembnost teh izsledkov in vivo ni znana.
English: You must stop treatment and inform your doctor straight away if:
Slovenian: Takoj morate zdravljenje ustaviti in obvestiti zdravnika, če:
English: PVC/PCTFE/aluminium blister containing 14 capsules.
Slovenian: Pretisni omot iz PVC/PCTFE/aluminija, ki vsebuje 14 kapsul.
English: • Sleepiness, feeling tired.
Slovenian: • zaspanost, utrujenost,
English: Children and adolescents Thalidomide Celgene is not recommended for use in children and young people under 18 years.
Slovenian: Uporaba zdravila Thalidomide Celgene ni priporočljiva pri otrocih in mladostnikih, starih manj kot 18 let.
English: The spectrum of activity of thalidomide is not fully characterised.
Slovenian: Spekter aktivnosti talidomida ni v celoti podrobno opisan.
English: All 4 cases involved other possible contributing factors preventing the establishment of a definite direct causal relationship between thalidomide and DRESS, but a link with thalidomide could also not be excluded.
Slovenian: Pri vseh 4 primerih so bili prisotni tudi drugi možni prispevajoči dejavniki, zaradi česar ni bilo mogoče dokazati dokončne neposredne vzročne zveze med talidomidom in DRESS, vendar pa povezave s talidomidom ni bilo mogoče izključiti.
English: • Brochure for male patients
Slovenian: • brošure za moške bolnike
English: Results of the user testing will have to be provided to the national competent authority and final materials validated at a national level.
Slovenian: Izsledke testiranja uporabnikov se predloži pristojnim nacionalnim organom, končno dokumentacijo pa se ovrednoti na nacionalni ravni.
English: • The collection of detailed data to understand demographics of target population, indication and number of women of child bearing potential in order to monitor closely the off-label use within national territory.
Slovenian: • zbiranju podrobnih podatkov, da bi razumeli demografijo ciljne populacije, indikacijo in število žensk v rodni dobi, z namenom natančnega spremljanja neodobrene uporabe znotraj nacionalnega območja.
English: No specific dose adjustments are recommended for the elderly ≤ 75 years of age.
Slovenian: Ni priporočil o posebnem prilagajanju odmerkov za starejše bolnike, stare ≤ 75 let.
English: Grade 2 (interfering with function but not with activities of daily living)
Slovenian: 2. stopnja (ovira funkcije, vendar ne dnevnih aktivnosti)
English: The adverse reaction of the skin may appear as rashes with or without blisters.
Slovenian: Neželena reakcija na koži se lahko pokaže kot izpuščaji z mehurji ali brez njih.
English: In plasma, unchanged thalidomide represents 80 % of the circulatory components.
Slovenian: V plazmi nespremenjeni talidomid predstavlja 80 % sestavin v krvnem obtoku.
English: • The patient has acknowledged the aforementioned conditions.
Slovenian: • Bolnik/bolnica sprejema zgoraj navedene pogoje.
English: This requirement includes women of childbearing potential who practice absolute and continuous abstinence.
Slovenian: Ta zahteva vključuje ženske v rodni dobi, ki se zavežejo k popolni in neprekinjeni spolni vzdržnosti.
English: • are used for heart problems and complications (such as digoxin), or for thinning the blood (such as warfarin).
Slovenian: • se uporabljajo za zdravljenje težav in zapletov s srcem (kot je digoksin) ali za redčenje krvi (kot je varfarin);
English: • The most appropriate strategies to monitor the off-label use within national territories
Slovenian: • najustreznejših strategijah za nadzor neodobrene uporabe zdravila znotraj nacionalnega območja,
English: • Tumour Lysis Syndrome - metabolic complications that can occur during the treatment of cancer and sometimes even without treatment.
Slovenian: • sindrom tumorske lize - presnovni zapleti, ki se lahko pojavijo med zdravljenjem raka, včasih tudi brez zdravljenja.
English: 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:
Slovenian: Predpostavlja se, da bolnica ali partnerica moškega bolnika lahko zanosi, razen če izpolnjuje vsaj eno od naslednjih meril:
English: The risk of venous thromboembolism continues for 4-6 weeks after discontinuing combined oral contraception.
Slovenian: Tveganje za vensko trombembolijo se nadaljuje še 4-6 tednov po ukinitvi jemanja kombinirane peroralne kontracepcije.
English: • She is informed and understands the potential consequences of pregnancy and the need to rapidly consult her doctor if there is a risk of pregnancy
Slovenian: • Bolnica je obveščena in razume možne posledice nosečnosti in potrebo po takojšnjem posvetovanju z zdravnikom, če obstaja tveganje za zanositev.
English: • if you are able to become pregnant, unless you are able to follow or comply with the required contraceptive measures to prevent you from becoming pregnant (see section 2 “Warnings and precautions” and “Pregnancy and breast-feeding”).
Slovenian: • če lahko zanosite, razen če lahko sledite potrebnim kontracepcijskim ukrepom za preprečevanje nosečnosti oziroma ravnate v skladu z njimi (glejte poglavje 2 „Opozorila in previdnostni ukrepi“ in „Nosečnost in dojenje“).
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Slovenian: Znotraj vsake skupine pogostnosti so neželeni učinki navedeni po padajoči resnosti.
English: • Sudden pain in your chest or difficulty in breathing.
Slovenian: • Nenadna bolečina v prsih ali težko dihanje.