natgillin/translations-raw huggingface dataset:
Women of childbearing potential must use one effective method of contraception for at least 4 weeks before start of treatment, during treatment, and until at least 4 weeks after thalidomide treatment 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 zanesljivo metodo kontracepcije vsaj 4 tedne pred začetkom zdravljenja, med zdravljenjem ter vsaj 4 tedne po zdravljenju s talidomidom in celo v primeru prekinitve odmerjanja, razen če se bolnica zaveže k popolni in neprekinjeni spolni vzdržnosti, ki se potrjuje vsak mesec.
Maximum daily melphalan dose: 24 mg (subjects ≤ 75 years old) or 20 mg (subjects > 75 years old). 
e Največji dnevni odmerek melfalana: 24 mg (osebe, stare ≤ 75 let) ali 20 mg (osebe, stare > 75).
This may be due to blood clots in the veins of your leg (deep vein thrombosis), which is a common side effect. 
Vzrok so lahko krvni strdki v venah vaših nog (globoka venska tromboza), ki je pogost neželeni učinek.
• That she should not share the treatment with any other person 
• zdravila ne sme dajati nikomur drugemu
• you experience or have experienced in the past severe skin reactions called Stevens-Johnson syndrome, toxic epidermal necrolysis or drug reaction with eosinophilia and systemic symptoms(which is also known as DRESS or drug hypersensitivity syndrome). 
• imate ali ste kdaj prej imeli hude reakcije na koži, ki se imenujejo Stevens-Johnsonov sindrom, toksična epidermalna nekroliza ali reakcija na zdravilo z eozionfilijo in sistemskimi simptomi (znana tudi kot DRESS ali sindrom preobčutljivosti na zdravilo).
Taking into account the PRAC Assessment Report on the PSUR(s) for thalidomide, the scientific conclusions of CHMP are as follows: 
Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o oceni rednih posodobljenih poročil o varnosti zdravila (PSUR) za talidomid je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel naslednje znanstvene zaključke:
Studies conducted in healthy subjects and patients with multiple myeloma suggest that thalidomide is not influenced to any significant extent by renal or hepatic function (see section 5.2). 
Študije, ki so jih opravili pri zdravih preizkušancih in bolnikih z diseminiranim plazmocitomom kažejo, da delovanje ledvic ali jeter nima pomembnega vpliva na talidomid (glejte poglavje 5.2).
Thromboembolic events 
Trombembolični dogodki
• She understands the need and accepts to undergo pregnancy testing every 4 weeks except in case of confirmed tubal sterilisation 
• Bolnica razume potrebo po opravljanju testa nosečnosti vsake 4 tedne in v to privoli, razen v primeru potrjene sterilizacije jajcevodov.
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. 
Druga zdravila in zdravilo Thalidomide Celgene Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
Thalidomide Celgene is used with two other medicines called ‘melphalan' and ‘prednisone' to treat adults with a type of cancer called multiple myeloma. 
Za kaj zdravilo Thalidomide Celgene uporabljamo Zdravilo Thalidomide Celgene se uporablja z dvema drugima učinkovinama, imenovanima 'melfalan' in 'prednizon' za zdravljenje odraslih bolnikov za vrsto raka, imenovanega diseminirani plazmocitom.
Skin irritation, sores or swelling in the mouth, throat, eyes, nose and around the genitals, oedema and fever and flulike symptoms may occur. 
Lahko se pojavijo draženje kože, razjede ali otekline v ustih, žrelu, očeh, nosu in okrog spolovil, edemi, zvišana telesna temperatura in gripi podobni simptomi.
• you have had an allergic reaction whilst taking Thalidomide Celgene such as rash, itching, swelling, dizziness or trouble breathing. 
• če ste imeli med uporabo zdravila Thalidomide Celgene alergijsko reakcijo, kot je izpuščaj, srbenje, otekanje, omotica ali težave z dihanjem;
Additional adverse reactions from post-marketing experience with thalidomide and not seen in the pivotal study include febrile neutropenia and pancytopenia. 
Dodatna neželena učinka talidomida, ki so ju opazili po prihodu zdravila na trg in ki ju v ključni študiji niso opazili, sta febrilna nevtropenija in pancitopenija.
An increased risk of venous thromboembolism (such as deep vein thrombosis and pulmonary embolism) and arterial thromboembolism (such as myocardial infarction and cerebrovascular event) has been reported in patients treated with thalidomide (see section 4.4). 
O povečanem tveganju za vensko trombembolijo (kot sta globoka venska tromboza in pljučna embolija) in arterijsko trombembolijo (kot sta miokardni infarkt in cerebrovaskularni dogodek) so poročali pri bolnikih, ki so bili zdravljeni s talidomidom (glejte poglavje 4.4).
Your doctor may monitor your blood cell counts during treatment with Thalidomide Celgene. 
Vaš zdravnik bo morda nadzoroval koncentracijo krvničk med zdravljenjem z zdravilom
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. 
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 zanesljivo kontracepcijo.
Always use a condom: o during treatment o for at least 7 days after stopping treatment 
Vedno uporabljajte kondom: o med zdravljenjem o še vsaj 7 dni po koncu zdravljenja
Dear Healthcare Professional letter The Dear Healthcare Professional letter will consist of two parts: 
Neposredno obvestilo za zdravstvene delavce Neposredo obvestilo za zdravstvene delavce bo sestavljeno iz dveh delov:
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.
Thalidomide Celgene has not formally been studied in patients with impaired renal or hepatic function. 
Za zdravilo Thalidomide Celgene niso izvajali formalnih študij pri bolnikih z okvaro ledvične ali jetrne funkcije.
Women of childbearing potential/Contraception in males and females Women of childbearing potential must use one effective method of contraception for at least 4 weeks before start of treatment, during treatment including during dose interruptions, and until at least 4 weeks after thalidomide treatment (see section 4.4). 
Ženske v rodni dobi/kontracepcija pri moških in ženskah Ženske v rodni dobi morajo uporabljati zanesljivo metodo kontracepcije vsaj 4 tedne pred začetkom zdravljenja, med zdravljenjem, vključno med prekinitvijo odmerjanja, ter vsaj 4 tedne po zdravljenju s talidomidom (glejte poglavje 4.4).
Thalidomide Celgene in combination with melphalan and prednisone is indicated as first line treatment of patients with untreated multiple myeloma, aged ≥ 65 years or ineligible for high dose chemotherapy. 
Zdravilo Thalidomide Celgene v kombinaciji z melfalanom in prednizonom je indicirano za primarno zdravljenje bolnikov z nezdravljenim diseminiranim plazmocitomom, starih ≥ 65 let, ali za bolnike, pri katerih zdravljenje z visokimi odmerki kemoterapije ni primerno.
• The following information should also be provided in the appropriate educational brochure for patients: o Women of childbearing potential 
• Ustrezne izobraževalne brošure za bolnike naj vsebujejo tudi naslednje podatke: o Ženske v rodni dobi;
Patients should be monitored for: thromboembolic events, peripheral neuropathy, severe skin reactions, bradycardia, syncope, somnolence, neutropenia and thrombocytopenia (see sections 4.4 and 4.8). 
Bolnike je treba nadzorovati za: trombembolične dogodke, periferno nevropatijo, hude kožne reakcije, bradikardijo, sinkopo, somnolenco, nevtropenijo in trombocitopenijo (glejte poglavji 4.4 in 4.8).
Thalidomide may also potentially aggravate existing neuropathy and should therefore not be used in patients with clinical signs or symptoms of peripheral neuropathy unless the clinical benefits outweigh the risks. 
zato ga bolniki s kliničnimi znaki ali simptomi za periferno nevropatijo ne smejo uporabljati, razen če so klinične koristi večje kot tveganja.
Black iron oxide (E172) Propylene glycol 
Tiskarsko črnilo šelak črni železov oksid (E172) propilenglikol
During the treatment with Thalidomide Celgene you have an increased risk of developing blood clots in the veins and arteries (see also section 4 “Possible side effects”). 
Med zdravljenjem z zdravilom Thalidomide Celgene je tveganje za nastanek krvnih strdkov v venah in arterijah povečano (glejte tudi poglavje 4 „Možni neželeni učinki“);
Table 4: Comparison of haematological disorders for the melphalan, prednisone (MP) and melphalan, prednisone, thalidomide (MPT) combinations in study IFM 99-06 (see section 5.1) n (% of patients) 
Preglednica 4: Primerjava hematoloških bolezni za kombinacijo melfalana, prednizona (MP) in kombinacijo melfalana, prednizona in talidomida (MPT) v študiji IFM 99-06 (glejte poglavje 5.1).
• Chest pain spreading to the arms, neck, jaw, back or stomach, feeling sweaty and breathless, feeling sick or vomiting. 
• Bolečina v prsih, ki izžareva v roke, vrat, čeljust, hrbet ali trebuh, občutek oznojenosti in zasoplosti, siljenje na bruhanje ali bruhanje.
If powder from a broken Thalidomide Celgene capsule makes contact with the skin, wash the skin immediately and thoroughly with soap and water. 
Če pride prašek Thalidomide Celgene v stik s kožo, kožo takoj in temeljito sperite z milom in vodo.
For women of childbearing potential, prescriptions of thalidomide should be limited to a maximum of 4 weeks of treatment and continuation of treatment requires a new prescription. 
Pri ženskah v rodni dobi je treba predpisovanje talidomida omejiti na največ 4 tedne zdravljenja, za nadaljevanje zdravljenja pa je treba izdati nov recept.
• Severe blood infection (sepsis) accompanied by fever, chills and severe shaking, and possibly complicated by low blood pressure and confusion (septic shock). 
• huda okužba krvi (sepsa), ki jo spremljajo povišana telesna temperatura, mrzlica in hudo tresenje, z možnim zapletom zaradi nizkega krvnega tlaka in zmedenostjo (septični šok),
Uncommon (may affect up to 1 in 100 people) 
Občasni (pojavijo se lahko pri do 1 od 100 bolnikov)
Increase of sedative effects of other medicinal products Thalidomide has sedative properties, thus may enhance the sedation induced by anxiolytics, hypnotics, antipsychotics, H1 antihistamines, opiate derivatives, barbiturates and alcohol. 
Talidomid ima sedativne lastnosti in lahko poveča sedacijo, ki jo povzročijo anksiolitiki, hipnotiki, antipsihotiki, antihistaminiki H1, derivati opiata, barbiturati in alkohol.
Treatment must be initiated and monitored under the supervision of physicians with expertise in managing immunomodulatory or chemotherapeutic agents and a full understanding of the risks of thalidomide therapy and monitoring requirements (see section 4.4). 
Zdravljenje lahko začne in nadzira samo zdravnik, ki ima strokovno znanje za ravnanje z imunomodulatorji ali kemoterapevtiki in popolnoma razume tveganja zdravljenja s talidomidom ter zahteve glede nadzorovanja.
The maximum daily melphalan dose is 20 mg in patients > 75 years of age (see Table 1). 
Največji dnevni odmerek melfalana pri bolnikih, starih > 75 let, je 20 mg (glejte preglednico 1).
Additional precautions 
Dodatna opozorila
• Rash, dryness of the skin. 
• izpuščaji, izsušenost kože,
In the male dog, after one year of dosing, reversible bile plugs in canaliculi were observed at exposures greater than 1.9-fold the human exposure. 
Po enem letu odmerjanja pri pasjih samcih so opazili reverzibilne zamašitve izvodil žolča pri izpostavljenostih, višjih od 1,9-kratne izpostavljenosti pri ljudeh.
• Pregnancy Prevention Programme information o Definition of women of childbearing potential and actions the prescriber should take if unsure o Information on what is effective contraception o Safety advice for women of childbearing potential 
• Podatke programa za preprečevanje nosečnosti o opredelitev žensk v rodni dobi in ukrepov za zdravnika, ki zdravilo predpiše, v primeru dvoma o informacije o zanesljivi kontracepciji o varnostne nasvete za ženske v rodni dobi
• A brain condition with symptoms including vision changes, headache, seizures, and confusion, with or without high blood pressure (Posterior Reversible Encephalopathy Syndrome or PRES). 
• bolezen možganov s simptomi, ki vključujejo spremembe vida, glavobol, epileptične napade in zmedenost, ki jih lahko spremlja visok krvni tlak (sindrom posteriorne reverzibilne encefalopatije oz. PRES).
Peripheral neuropathy is a very common, potentially severe, adverse reaction of treatment with thalidomide that may result in irreversible damage (see section 4.4). 
Periferna nevropatija je zelo pogost, potencialno resen neželen učinek pri zdravljenju s talidomidom, ki lahko privede do nepopravljivih okvar (glejte poglavje 4.4).
• Indigestion, feeling sick (nausea), being sick (vomiting), dry mouth. 
• prebavne težave, slabo počutje (navzea), občutek slabosti (bruhanje), suha usta,
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 diseminiranim plazmocitomom, ki prejemajo talidomid s prednizonom in melfalanom uporabljati previdno.
The most 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 najpomembnejši 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 Stevens-Johnsonovim sindromom in toksično epidermalno nekrolizo, bradikardijo, sinkopo in vrtoglavico (glejte poglavja 4.2, 4.4 in 4.5).
What Thalidomide Celgene is and what it is used for 
Kaj je zdravilo Thalidomide Celgene in za kaj ga uporabljamo
• Underactive thyroid (hypothyroidism). 
• premalo aktivna ščitnica (hipotiroidizem),
• That if she needs to change or stop using her method of contraception she should inform: ▪ The physician prescribing her contraception that she is on thalidomide ▪ The physician prescribing thalidomide that she has stopped or changed her method of contraception 
• opozorilo, da mora v primeru spremembe ali prenehanja uporabe kontracepcijske metode obvestiti: zdravnika, ki je predpisal kontracepcijo, da jemlje talidomid zdravnika, ki je predpisal talidomid, da je prenehala uporabljati ali spremenila kontracepcijsko metodo
The MAH should also agree with each Member State prior to the launch of the product: 
Imetnik dovoljenja za promet z zdravilom se mora prav tako v vsaki državi članici pred prihodom zdravila na trg dogovoriti o:
Patients with renal or hepatic impairment 
Bolniki z ledvično ali jetrno okvaro
WARNING: Thalidomide causes birth defects and foetal death. 
OPOZORILO: Talidomid povzroča prirojene okvare in smrt zarodka.
If powder from thalidomide makes contact with the skin, the skin should be washed immediately and thoroughly with soap and water. 
Če pride prašek s talidomidom v stik s kožo, morate kožo takoj in temeljito sprati z milom in vodo.
Physicians should carefully evaluate patients before and during treatment using standard cancer screening and institute treatment as indicated. 
Zdravniki naj pred zdravljenjem in med njim s standardnimi pregledi bolnike skrbno ocenjujejo in uvedejo zdravljenje, kot je indicirano.
The MAH should agree the final text of the Dear Healthcare Professional letter and the contents of the Educational Healthcare Professional's Kit with the National Competent Authority in each Member State prior to launch of the medicinal product and ensure that the materials contain the key elements as described below. 
Imetnik dovoljenja za promet z zdravilom se mora pred prihodom zdravila na trg s pristojnim nacionalnim organom v vsaki državi članici dogovoriti o končnem besedilu Neposrednega obvestila za zdravstvene delavce in vsebini paketa izobraževalnih gradiv za zdravstvene delavce in zagotoviti, da gradiva vsebujejo ključne elemente, kot je opisano spodaj.
• Pregnancy reporting requirements o Instruction to stop thalidomide immediately upon suspicion of pregnancy, if female patient o Need to refer patient to physician specialised or experienced in dealing with teratology for advice and evaluation o Complete pregnancy reporting form as provided in the “Educational Healthcare Professional's Kit” o Local contact details for reporting of any suspected pregnancy 
• Zahteve poročanja nosečnosti o navodilo za bolnice, da je v primeru suma na nosečnost treba takoj ustaviti zdravljenje s talidomidom o potreba po napotitvi k zdravniku specialistu za teratologijo ali zdravniku z izkušnjami v teratologiji zaradi svetovanja in ocenitve o izpolnitev obrazca za poročanje o nosečnosti, ki se nahaja v „Paketu izobraževalnih gradiv za zdravstvene delavce“ o lokalne kontaktne podatke glede poročanja kakršnegakoli suma na nosečnost
Decreased platelet counts were noted in the mouse and rat studies. 
V študijah miši in podgan so opazili zmanjšano število trombocitov.
• by stopping blood vessels growing in the cancer 
• ustavlja rast krvnih žil v rakavem delu
Common (may affect up to 1 in 10 people) 
Pogosti (pojavijo se lahko pri do 1 od 10 bolnikov)
• Levonorgestrel-releasing intrauterine system (IUS) 
• intrauterini sistem (IUS), ki sprošča levonorgestrel
• A condition affecting the skin caused by inflammation of small blood vessels, along with pain in the joints and fever (leukocytoclastic vasculitis). 
• bolezen, ki vpliva na kožo in jo povzroča vnetje krvnih žilic, skupaj z bolečino v sklepih in povišano telesno temperaturo (levkocitoklastični vaskulitis).
In addition to the adverse reactions outlined above, thalidomide in combination with dexamethasone in other clinical studies led to the very common adverse reaction of fatigue; common adverse reactions of transient ischaemic event, syncope, vertigo, hypotension, mood altered, anxiety, blurred vision, nausea and dyspepsia; and uncommon adverse reactions of cerebrovascular accident, diverticular perforation, peritonitis, orthostatic hypotension and bronchitis. 
Poleg zgoraj opisanih neželenih učinkov je talidomid v kombinaciji z deksametazonom v drugih kliničnih študijah povzročil zelo pogost neželeni učinek: utrujenost; pogoste neželene učinke: prehodni ishemični dogodek, sinkopo, vrtoglavico, hipotenzijo, spremembo razpoloženja, anksioznost, nejasen vid, slabost in dispepsijo; in občasne neželene učinke: cerebrovaskularni insult, divertikularno perforacijo, peritonitis, ortostatsko hipotenzijo in bronhitis.
* see section 4.8 description of selected adverse reactions identified from post marketing data ^ Acute myeloid leukaemia and Myelodysplastic syndrome were reported in one clinical study in patients with previously untreated MM receiving the combination of melphalan, prednisone and thalidomide (MPT) 
* glejte poglavje 4.8 Opis izbranih neželenih učinkov † na osnovi podatkov po začetku trženja ^ o akutni mieloični levkemiji in mielodisplastičnem sindromu so poročali v klinični študiji pri bolnikih s predhodno nezdravljenim diseminiranim plazmocitomom, ki so prejemali kombinacijo melfalana, prednizona in talidomida (MPT)
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).
Confusional state, Depression 
Psihiatrične motnje pogosti zmedenost, depresija
As thalidomide is found in semen, as a precaution all male patients must use condoms during treatment, during dose interruption and for at least 7 days following discontinuation of treatment if their partner is pregnant or is of childbearing potential not using effective contraception. 
Ker je talidomid prisoten v spermi, morajo vsi moški bolniki iz previdnosti uporabljati kondome med zdravljenjem, med prekinitvijo odmerjanja in še vsaj 7 dni po ukinitvi zdravljenja, če je partnerica noseča ali v rodni dobi in ne uporablja zanesljive kontracepcije.
Neutropenia 
Nevtropenija
• Fever, chills, sore throat, cough, mouth ulcers or any other symptoms of infection. 
• Zvišana telesna temperatura, mrzlica, boleče grlo, kašelj, razjede v ustih ali katerikoli drugi simptomi okužbe.
Each capsule contains 50 mg of thalidomide. 
Ena kapsula vsebuje 50 mg talidomida.
• Brochure for women of childbearing potential Brochure for women patients who are not of childbearing potential 
• brošure za ženske, ki niso v rodni dobi
Marketing Authorisation Holder Celgene Europe B.V. 
Imetnik dovoljenja za promet z zdravilom Celgene Europe B.V.
Do not take Thalidomide Celgene 
Ne jemljite zdravila Thalidomide Celgene
• Your doctor will make sure that you have pregnancy tests o before treatment o every 4 weeks during treatment o 4 weeks after stopping treatment 
• Bo vaš zdravnik poskrbel, da boste opravili teste nosečnosti o pred zdravljenjem o na vsake 4 tedne med zdravljenjem o 4 tedne po koncu zdravljenja
Capsules should not be opened or crushed. 
• Kapsule ne zdrobite ali žvečite.
• Injury to the liver (hepatic disorder) including abnormal liver test results. 
• poškodbe jeter (bolezni jeter), vključno z nenormalnimi rezultati jetrnih testov,
This may mean that you are more likely to develop infections. 
• nizka koncentracija krvničk, to lahko pomeni, da pri vas obstaja večja verjetnost razvoja okužb.
Proportion thalidomide, the total mean recovery was 93.6 % of the administered dose by day 8. 
Po enkratnem peroralnem odmerku 400 mg radioaktivno označenega talidomida so do 8. dne ponovno pridobili celokupno povprečno vrednost 93,6 % danega odmerka.
The recommended dose is 200 mg (4 x 50 mg capsules) a day for adults aged 75 years and under or 100 mg (2 x 50 mg capsules) a day for adults aged over 75 years. 
Priporočeni odmerek za odrasle, stare 75 let ali manj, je 200 mg (4 x 50 mg kapsule) na dan, za odrasle, starejše od 75 let, pa 100 mg (2 x 50 mg kapsule) na dan, vendar lahko vaš zdravnik določi odmerek za vas, nadzira napredek in prilagodi odmerek.
• slow the heart rate (induce bradycardia, such as anticholinesterases and beta blockers). 
• upočasnijo srčni utrip (povzročijo bradikardijo, kot so zaviralci holinesteraze in antagonisti adrenergičnih receptorjev beta);
Melphalan dosed once daily on Days 1 to 4 of each 42-day cycle. 
c Melfalan se daje enkrat dnevno od 1. do 4. dne vsakega 42-dnevnega cikla.
Due to the sedative effect associated with thalidomide, administration at bedtime is known to generally improve tolerability. 
b Znano je, da zaradi sedativnega učinka, povezanega s talidomidom, dajanje pred spanjem na splošno izboljša prenašanje.
,†, Leukocytoclastic vasculitis 
levkocitoklastični vaskulitis†
You must not donate blood during Thalidomide Celgene treatment and for at least 7 days after stopping treatment. 
Med zdravljenjem z zdravilom Thalidomide Celgene in še vsaj 7 dni po koncu zdravljenja ne smete darovati krvi.