natgillin/translations-raw huggingface dataset:
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 zanesljive kontracepcije, jo je treba napotiti k ustrezno usposobljenemu zdravniku na posvet glede kontracepcije, da jo lahko prične uporabljati.
A cumulative search of DRESS cases with thalidomide from spontaneous sources and clinical trials retrieved 8 cases among which 4 cases were assessed as probable or possible drug reaction with eosinophilia and systemic symptoms (DRESS) as per Regiscar criteria. 
Pri kumulativnem iskanju primerov DRESS pri uporabi talidomida iz spontanih virov in kliničnih preskušanj so našli 8 primerov, od katerih so 4 primere ocenili kot verjetno ali možno reakcijo na zdravilo z eozinofilijo in sistemskimi simptomi (DRESS) po merilih Regiscar.
Venous and arterial thromboembolic events 
Venski in arterijski trombembolični dogodki
If you are not sure, talk to your doctor or pharmacist before taking Thalidomide Celgene. 
Če ste negotovi, se posvetujte z zdravnikom ali farmacevtom, preden vzamete zdravilo Thalidomide Celgene.
Some of the cases of herpes zoster reactivation resulted in disseminated herpes zoster, requiring a temporary hold of the treatment with thalidomide and adequate antiviral treatment. 
Nekateri primeri reaktivacije herpesa zostra so napredovali v diseminirani herpes zoster, zaradi katerega je bilo treba začasno prekiniti zdravljenje s talidomidom in uvesti ustrezno protivirusno zdravljenje.
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 and internal ear lesions (less frequent), ocular lesions (anophthalmia, microphthalmia), congenital heart disease, renal abnormalities. 
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.
Hepatic disorders, mainly abnormal liver test results, were reported. 
Poročali so o boleznih jeter, v glavnem o nenormalnih rezultatih jetrnih testov.
Counselling 
Svetovanje
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.
Acute myeloid leukaemia* 
pogosti akutna mieloična levkemija*,^
The initial dose of melphalan is reduced for elderly > 75 years of age considering baseline bone marrow reserve and renal function. 
Začetni odmerek melfalana je treba pri bolnikih, starejših od > 75 let, zmanjšati, pri čemer upoštevamo izhodiščno rezervo kostnega mozga in funkcijo ledvic.
If you are not sure if any of the above apply to you, talk to your doctor before taking Thalidomide Celgene. 
Če ste negotovi, ali se kar koli od zgoraj naštetega nanaša na vas, se posvetujte z zdravnikom, preden vzamete zdravilo Thalidomide Celgene.
• Do not break, open or chew the capsules. 
• Kapsul ne zdrobite, odprite ali žvečite.
If you do become pregnant during the treatment with thalidomide, you must stop the treatment and inform your doctor immediately. 
Če v času zdravljenja s talidomidom zanosite, morate zdravljenje takoj ustaviti in o tem obvestiti zdravnika.
Non-enzymatic hydrolysis of thalidomide, being the primary clearance mechanism, suggests that the potential for drug-drug interactions with thalidomide is low. 
Neencimska hidroliza talidomida, ki je primarni mehanizem izločanja, kaže, da je možnost interakcij med zdravili majhna.
Medicinal products known to cause peripheral neuropathy 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.
Cases of viral reactivation have been reported in patients receiving thalidomide, including serious cases of herpes zoster or hepatitis B virus (HBV) reactivation. 
Pri bolnikih, ki so prejemali talidomid, so poročali o primerih reaktivacije virusov, vključno z resnimi primeri reaktivacije virusa herpes zoster ali virusa hepatitisa B (HBV - hepatitis B virus).
A study in rabbits demonstrated no effect on fertility indices in males or females although testicular degeneration was observed in males. 
Študije na kuncih niso pokazale nobenega učinka na kazalce plodnosti samcev ali samic kljub testikularni degeneraciji, opaženi pri samcih.
The melphalan recommended starting dose is 0.1 to 0.2 mg/kg daily according to bone marrow reserve along with a further 50 % dose reduction for moderate (creatinine clearance: ≥ 30 but < 50 mL/minute) or severe (CrCl: < 30 mL/minute) renal insufficiency. 
Priporočeni začetni odmerek melfalana je 0,1 do 0,2 mg/kg na dan glede na rezervo kostnega mozga, odmerek se zmanjša še za nadaljnjih 50 % pri zmerni (očistek kreatinina: ≥ 30, vendar < 50 ml/minuto) ali hudi (CrCl: < 30 ml/minuto) insuficienci ledvic.
• you have kidney or liver problems (see also section 4 “Possible side effects”). 
• imate težave z ledvicami ali jetri (glejte tudi poglavje 4 „Možni neželeni učinki“).
In addition to thalidomide, hydrolytic products N-(o-carboxybenzoyl) glutarimide and phthaloyl isoglutamine formed via non-enzymatic processes are also present in plasma and in majority in urine. 
Poleg talidomida sta v plazmi in v večji meri v urinu prisotna hidrolitična produkta N-(o-karboksibenzoil) glutarimid in ftaloil izoglutamin, ki nastaneta z neencimskimi procesi.
The prescriber must ensure that: 
Zdravnik, ki predpiše zdravilo, mora zagotoviti naslednje:
• Patient cards and/or equivalent tools: o verification that appropriate counselling has taken place o documentation of childbearing potential status o check box (or similar) which physician ticks to confirm that patient is using effective contraception (if woman of childbearing potential) o verification of initial negative pregnancy test prior to start of treatment (if woman of childbearing potential) o pregnancy test dates and results 
• Kartice za bolnike in/ali ustrezno orodje: o potrdilo o ustreznem svetovanju o dokumentacijo o statusu plodnosti o kontrolno okence (ali podobno) kjer zdravnik potrdi, da bolnik uporablja zanesljivo kontracepcijo (za ženske v rodni dobi) o potrdilo o začetnem negativnem testu nosečnosti pred začetkom zdravljenja (za ženske v rodni dobi) o datume testov nosečnosti in izide
for 4 days had no effect on the international normalized ratio (INR) in healthy volunteers. 
Večkratni odmerki po 200 mg talidomida, enkrat na dan 4 dni, niso imeli učinka na internacionalno normalizirano razmerje (INR - international normalized ratio) pri zdravih prostovoljcih.
o The capsule shell contains gelatin and titanium dioxide (E171). 
o Ovojnica kapsule vsebuje želatino in titanov dioksid (E171).
Results from IFM 99-06, a Phase 3, randomised, open label, parallel group, multicentre study have demonstrated a survival advantage when thalidomide is used in combination with melphalan and prednisone for 12 cycles of 6 weeks in the treatment of newly diagnosed multiple myeloma patients. 
Rezultati randomizirane, odprte, multicentrične študije IFM 99-06 III. faze s paralelnimi skupinami so pokazali prednost preživetja pri uporabi talidomida v kombinaciji z melfalanom in prednizonom 12 ciklov po 6 tednov pri zdravljenju bolnikov z novo diagnosticiranim diseminiranim plazmocitomom.
The reported events occurred in young (premenopausal) women (median age 36 years) receiving thalidomide for non-multiple myeloma indications, had an onset within 6 months of initiating treatment and reversed upon discontinuation of thalidomide. 
Dogodke, o katerih so poročali, so zabeležili pri mladih (predmenopavznih) ženskah (mediana starost 36 let), ki so se zdravile s talidomidom zaradi indikacij, ki niso bile diseminirani plazmocitom, z začetkom v 6 mesecih od uvedbe zdravljenja, izzveneli pa so po ukinitvi talidomida.
Thalidomide interruption or discontinuation should be considered for Grade 2-3 skin rash. 
O prekinitvi ali ukinitvi talidomida je treba razmisliti pri izpuščaju 2.-3. stopnje.
• All educational brochures for patients should contain the following information o That thalidomide is teratogenic o That thalidomide may cause ischaemic heart disease, (including myocardial infarction) o Description of the patient card and its use in the individual Member State o Guidance on handling Thalidomide Celgene for patients, caregivers and family members o National or other applicable specific arrangements for a prescription for thalidomide to be dispensed o That thalidomide must not be given to any other person o That the patient should not donate blood o That the patient should tell their doctor about any adverse events o That any unused capsules should be returned to the pharmacist at the end of the treatment 
• Vse izobraževalne brošure za bolnike morajo zajemati naslednje informacije o da je talidomid teratogen o da talidomid lahko povzroči ishemično bolezen srca (vključno z miokardnim infarktom) o opis kartice za bolnika in njeno uporabo v posameznih državah članicah o smernice za ravnanje z zdravilom Thalidomide Celgene za bolnike, skrbnike in družinske člane o nacionalne ali druge ustrezne posebne dogovore glede predpisovanja in izdajanja talidomida o da se talidomida ne sme dati nikomur drugemu o da bolniki ne smejo darovati krvi o da morajo bolniki zdravnika obvestiti o vseh neželenih učinkih o da je treba ob koncu zdravljenja vse neporabljene kapsule vrniti farmacevtu
• Kidney disease (renal failure). 
• bolezen ledvic (ledvična odpoved).
Table 1: Starting doses for thalidomide in combination with melphalan and prednisone Age (years) 
Preglednica 1: Začetni odmerki talidomida v kombinaciji z melfalanom in prednizonom Starost (leta)
Patients should be monitored for liver function, particularly in case of pre-existing liver disorder or concomitant use of medicinal product susceptible to induce liver dysfunction (see section 4.8). 
Pri bolnikih je treba spremljati delovanje jeter, posebno v primeru obstoječe bolezni jeter ali sočasnega jemanja zdravil, ki lahko povzročijo disfunkcijo jeter (glejte poglavje 4.8).
• Viral infections, including herpes zoster (also known as ‘shingles', a viral disease that causes a painful skin rash with blisters) and recurrence of hepatitis B infection (which can cause yellowing of the skin and eyes, dark brown-coloured urine, right-sided stomach pain, fever and feeling nauseous or being sick). 
• virusne okužbe, vključno s herpesom zostrom (ki je znan tudi kot ‘pasovec', virusna bolezen, ki povzroča boleč kožni izpuščaj z mehurčki) in ponovitvijo okužbe z virusom hepatitisa B (ki lahko povzroči porumenelost kože in oči, temno rjavo obarvan urin, bolečino desno v trebuhu, zvišano telesno temperaturo in slabost s siljenjem na bruhanje);
Melphalan dosing: reduce by 50 % for moderate (creatinine clearance: ≥ 30 but < 50 mL/min) or severe (CrCl: < 30mL/min) renal insufficiency e 
d Odmerjanje melfalana: zmanjšajte odmerek za 50 % pri zmerni (očistek kreatinina: ≥ 30, vendar < 50 ml/min) ali hudi (CrCl: < 30ml/min)
These pregnancy tests should be performed on the day of the prescribing visit or in the 3 days prior to the visit to the prescriber. 
Te teste nosečnosti je treba izvesti na dan obiska, ko zdravnik predpiše zdravilo, ali v 3 dneh pred obiskom zdravnika.
Measures of renal function (CrCl) and liver function (blood chemistry) indicate minimal effect of kidney and liver function on the pharmacokinetics of thalidomide. 
Meritve delovanja ledvic (CrCl) in jeter (biokemične krvne preiskave) kažejo na minimalni učinek delovanja ledvic in jeter na farmakokinetiko talidomida.
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.
Prophylactic antithrombotic medicinal products, such as low molecular weight heparins or warfarin, should be recommended. 
Priporočiti morate uporabo profilaktičnih antitrombotikov, kakršni so nizkomolekularni heparini ali varfarin.
For men taking Thalidomide Celgene Thalidomide passes into semen. 
Za moške, ki jemljejo zdravilo Thalidomide Celgene Talidomid prehaja v spermo.
The extent of thalidomide metabolism by the liver cytochrome P450 system is minimal and intact thalidomide is not excreted by the kidney. 
Obseg presnove talidomida s pomočjo sistema jetrnega citokroma P450 je minimalen; ledvice ne izločajo nespremenjenega talidomida.
Thalidomide causes severe birth defects or death to an unborn baby. 
Talidomid povzroča resne prirojene okvare ali smrt nerojenega otroka.
If your partner becomes pregnant whilst you are taking thalidomide, you should inform your doctor immediately. 
Če vaša partnerica zanosi, medtem ko jemljete talidomid, morate o tem takoj obvestiti zdravnika.
• XY genotype, Turner's syndrome, uterine agenesis. 
• Genotip XY, Turnerjev sindrom, agenezija maternice.
• A fall in the number of red and white blood cells and platelets at the same time (pancytopenia). 
• hkraten padec števila rdečih in belih krvničk ter trombocitov (pancitopenija),
The MAH shall agree the details of a controlled distribution system with the National Competent Authorities and must implement such programme nationally to ensure that: 
• Dodatni ukrepi za zmanjševanje tveganj Imetnik dovoljenja za promet z zdravilom se mora o podrobnostih sistema nadzorovane distribucije dogovoriti s pristojnimi nacionalnimi organi in izvajati ta program na nacionalni ravni, da tako zagotovi naslednje:
Your doctor should evaluate if you develop additional types of haematological malignancies (called acute myeloid leukaemia and myelodysplastic syndromes) during your treatment with Thalidomide Celgene (see also section 4 “Possible side effects”). 
Vaš zdravnik mora oceniti, ali so se pri vas med zdravljenjem z zdravilom Thalidomide Celgene pojavile dodatne vrste hematoloških malignosti (imenovane akutna mieloična levkemija in mielodisplastični sindromi) (glejte tudi poglavje 4 „Možni neželeni učinki“).
Because of the increased risk of venous thromboembolism in patients with multiple myeloma (MM), combined oral contraceptive pills are not recommended (see section 4.5). 
Zaradi povečanega tveganja za vensko trombembolijo pri bolnicah z diseminiranim plazmocitomom (DP), uporaba kombiniranih peroralnih kontracepcijskih tablet ni priporočljiva (glejte poglavje 4.5).
It is not known whether the effect will be different in multiple myeloma patients. 
Ni znano, ali je učinek pri bolnikih z diseminiranim plazmocitomom drugačen.
• The need to avoid foetal exposure 
• potreba po izogibanju izpostavljenosti ploda
For men taking Thalidomide Celgene who have a female partner who is able to become pregnant, please see section 2 “What you need to know before you take Thalidomide Celgene”. 
Za moške, ki jemljejo zdravilo Thalidomide Celgene in imajo partnerico, ki lahko zanosi, glejte poglavje 2 „Kaj morate vedeti, preden boste vzeli zdravilo Thalidomide Celgene“.
The MAH shall notify the EMA and the appropriate national patients and victims representatives of the proposed launch date before launch in each Member State. 
Imetnik dovoljenja za promet z zdravilom mora Evropsko agencijo za zdravila (EMA) ter ustrezne nacionalne predstavnike bolnikov in žrtev seznaniti s predvidenim datumom prihoda zdravila na trg pred dejanskim prihodom na trg v vsaki državi članici.
The incidence of neutropenia grade 3 or 4 reported as adverse reactions was higher in multiple myeloma patients receiving MPT (Melphalan, Prednisone, Thalidomide) than in those receiving MP (Melphalan, Prednisone): 42.7 % versus 29.5 % respectively (study IFM 99-06). 
Incidenca nevtropenije 3. ali 4. stopnje v okviru poročanj neželenih učinkov je bila višja pri bolnikih z diseminiranim plazmocitomom, ki so prejemali MPT (melfalan, prednizon, talidomid), kot pri tistih, ki so prejemali MP (melfalan, prednizon): 42,7 % v primerjavi z 29,5 % (študija IFM 99-06).
Data from patients with end-stage renal disease suggest no impact of kidney function on thalidomide pharmacokinetics. 
Podatki bolnikov z ledvično boleznijo končne stopnje ne kažejo na vpliv delovanja ledvic na farmakokinetiko talidomida.
• Safety advice relevant to all patients o Description and management of ischaemic heart disease (including myocardial infarction) o Disposal of unwanted medicinal product o Not to donate blood during treatment (including during dose interruptions) and for at least 7 days following discontinuation of thalidomide 
• Varnostne nasvete, pomembne za vse bolnike o opis in obvladovanjeishemične bolezni srca (vključno z miokardnim infarktom) o napotke za odstranjevanje odvečnega zdravila o opozorilo, da bolniki ne smejo darovati krvi med zdravljenjem (tudi v obdobju med prekinitvijo odmerjanja) in še vsaj 7 dni po ukinitvi zdravljenja s talidomidom
• He understands 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 (even if the man has had a vasectomy), during treatment, during dose interruption and for at least 7 days following discontinuation of treatment. 
• Bolnik razume potrebo po uporabi kondoma pri spolnem občevanju z nosečnico ali žensko v rodni dobi, ki ne uporablja zanesljive kontracepcije (tudi če je moški prestal vazektomijo) med zdravljenjem, med prekinitvijo odmerjanja in še vsaj 7 dni po ukinitvi zdravljenja.
Patients and physicians are advised to be observant for signs and symptoms of bleeding including petechiae, epistaxis and gastrointestinal haemorrhage, especially in case of concomitant medicinal product prone to inducing bleeding (see sections 4.5 and 4.8). 
Bolnikom in zdravnikom se svetuje, naj bodo pozorni na znake in simptome krvavitev, vključno s petehijami, epistakso in gastrointestinalno krvavitvijo, posebno v primeru sočasnega jemanja zdravil, ki lahko povzročijo krvavitve (glejte poglavji 4.5 in
• He understands the teratogenic risk if engaged in sexual activity with a pregnant woman or a woman of childbearing potential. 
• Bolnik razume tveganje teratogenih učinkov pri spolnem občevanju z nosečnico ali žensko v rodni dobi.
What you need to know before you take Thalidomide Celgene 
Kaj morate vedeti, preden boste vzeli zdravilo Thalidomide Celgene
Melphalan and prednisone were dosed at 0.25 mg/kg/day and 2 mg/kg/day respectively on days 1 to 4 of each 6 weeks cycle. 
Odmerek melfalana je znašal 0,25 mg/kg/dan in prednizona 2 mg/kg/dan 1. in 4. dan vsakega 6. tedenskega cikla.
• by stopping the cancer cells developing 
• ustavlja razvoj rakavih celic
• The active substance is thalidomide. 
• Učinkovina je talidomid.
• Healthcare professional booklet o History of thalidomide, background on Thalidomide Celgene and its licensed indication o Posology 
• Brošuro za zdravstvene delavce o zgodovino talidomida, povzetek podatkov o zdravilu Thalidomide Celgene in indikacijah, za katere je odobren o odmerjanje
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).
• you have or have had injury to the liver (hepatic disorders) including abnormal liver test results. 
• imate ali ste imeli poškodbo jeter (bolezni jeter), vključno z nenormalnimi rezultati jetrnih preiskav;
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 ključno primerjalno klinično študijo, ki je raziskovala učinek talidomida v kombinaciji z melfalanom in prednizonom pri bolnikih s predhodno nezdravljenim diseminiranim plazmocitomom.
• Pain in the upper abdomen and/or back, which may be severe and which remains for a few days, possibly accompanied by nausea, vomiting, fever and a rapid pulse - these symptoms may be due to the inflammation of the pancreas (pancreatitis). 
• bolečina v zgornjem delu trebuha in/ali hrbta, ki je lahko huda in traja nekaj dni, lahko jo spremlja slabost, bruhanje, povišana telesna temperatura in hiter utrip - ti simptomi so lahko posledica vnetja trebušne slinavke (pankreatitis),
• you have experienced fever, chills and severe shaking, and possibly complicated by low blood pressure and confusion (these may be symptoms of severe infections). 
• če ste imeli zvišano telesno temperaturo, mrzlico in hudo tresenje, po možnosti z zapletom zaradi nizkega krvnega tlaka in zmedenosti (to so lahko simptomi hudih okužb);
If you are able to become pregnant, your doctor will record with each prescription that the necessary measures, as outlined above, have been taken 
Če lahko zanosite, bo vaš zdravnik ob vsakem receptu preveril, ali upoštevate zgoraj navedene nujne ukrepe.
• He understands that if his female partner becomes pregnant whilst he is taking thalidomide or 7 days after he has stopped taking thalidomide, he should inform his treating physician immediately and that it is recommended to refer the female partner to a physician specialised or experienced in teratology for evaluation and advice. 
• Bolnik razume, da mora v primeru, da njegova partnerica zanosi, medtem ko on jemlje talidomid, ali v 7 dneh po tem, ko je prenehal jemati talidomid, o tem nemudoma obvestiti lečečega zdravnika in da je priporočljivo napotiti njegovo partnerico k zdravniku specialistu za teratologijo ali zdravniku z izkušnjami v teratologiji, da oceni stanje in bolnici ustrezno svetuje.
WARNING 
OPOZORILO
Among invasive SPMs, cases of MDS/AML were observed in patients receiving lenalidomide in combination with melphalan or immediately following high dose melphalan and autologous stem cell transplantation. 
Med invazivnimi drugimi primarnimi malignostmi so opazili MDS/AML pri bolnikih, ki so prejemali lenalidomid v kombinaciji z melfalanom ali takoj po visokem odmerku melfalana in avtologni presaditvi matičnih celic.
Therefore breast-feeding should be discontinued during treatment with thalidomide. 
Zato je treba dojenje med zdravljenjem s talidomidom ukiniti.
It is unknown whether thalidomide is excreted in human breast milk. 
Ni znano, ali se talidomid izloča v materino mleko.
o The printing ink is composed of shellac, black iron oxide (E172) and propylene glycol. 
o Tiskarsko črnilo vsebuje šelak, črni železov oksid (E172) in propilenglikol.
Absorption of thalidomide is slow after oral administration. 
Talidomid se po peroralni uporabi absorbira počasi.
The following can be considered to be examples of effective methods of contraception: 
V nadaljevanju naštete kontracepcijske metode veljajo za zanesljive:
• Chest infection (pneumonia), lung disease. 
• okužbe prsnega koša (pljučnica), bolezni pljuč,
Thalidomide Celgene contains an active substance called thalidomide. 
Zdravilo Thalidomide Celgene vsebuje zdravilno učinkovino, imenovano talidomid.