natgillin/translations-raw huggingface dataset:
Make sure you tell your doctor if you are taking any medicines which: 
Zdravniku ne smete pozabiti povedati, če jemljete kakršna koli zdravila, ki:
Patients must follow the Thalidomide Celgene Pregnancy Prevention Programme. 
Bolniki morajo upoštevati program Thalidomide Celgene za preprečevanje nosečnosti.
The majority of the reactions occurred within the first 2 months of therapy and resolved spontaneously without treatment after thalidomide discontinuation. 
Večina reakcij se je pojavila v prvih 2 mesecih zdravljenja, nato pa je spontano izzvenela brez zdravljenja, ko je bila uporaba talidomida prekinjena.
• You miss or think you have missed a period, or you have unusual menstrual bleeding, or suspect you are pregnant. 
• vam je izostala menstruacija ali domnevate, da vam je izostala, ali imate neobičajne menstrualne krvavitve ali sumite, da ste noseči;
If you are in doubt, talk to your doctor. 
Če ste negotovi, se posvetujte z zdravnikom.
Patients should be advised of the signs and symptoms of these reactions by their prescribers and should be told to seek medical attention immediately if they develop these symptoms. 
Zdravniki, ki predpisujejo zdravilo, morajo bolnike seznaniti z znaki in simptomi teh reakcij in jim naročiti, naj takoj poiščejo zdravniško pomoč, če se pri njih razvijejo ti simptomi.
Therefore, considering the seriousness of this risk, the PRAC considers that the risk should be reflected in the PI of thalidomide. 
Zato odbor PRAC ob upoštevanju resnosti tega tveganja meni, da se mora tveganje odražati v informacijah o zdravilu za talidomid.
• A hole in part of your large bowel (colon) which can cause infection. 
• luknja v delu debelega črevesa (kolon), ki lahko povzroči okužbo,
The decision to take antithrombotic prophylactic measures should be made after careful assessment of an individual patient's underlying risk factors (see sections 4.4, 4.5 and 4.8). 
O uvajanju zaščitnih ukrepov proti trombozi se morate odločiti po skrbni oceni dejavnikov tveganja pri posameznem bolniku (glejte poglavja 4.4, 4.5 in 4.8).
The major route of excretion was via the urine (> 90 %) while faecal excretion was minor. 
Večina odmerka se je izločila z urinom (> 90 %), izločanje s fecesom pa je bilo manj pomembno.
(For description of symptoms see section 4 “Possible side effects”). 
(Za opis simptomov glejte poglavje 4 »Možni neželeni učinki«.
Patients and physicians are advised to be observant for the signs and symptoms of thromboembolism. 
Bolnike in zdravnike se opozarja, da so pozorni na znake in simptome trombembolizma.
Unchanged thalidomide was a minor component (< 3 % of the dose) in urine. 
V urinu je bil nespremenjeni talidomid manj pomembna sestavina (< 3 % odmerka).
Incidence of neuropathy events leading to discontinuation, dose reduction or interruption increases with cumulative dose and duration of therapy. 
Incidenca nevropatskih dogodkov, ki so povzročili ukinitev, zmanjšanje odmerka ali prekinitev jemanja, se s kumulativnim odmerkom ali trajanjem terapije povečuje.
• Feeling weak, faint or unsteady, lack of energy or strength, low blood pressure. 
• slabotnost, omedlevica ali nestanovitnost, pomanjkanje energije ali moči, nizek krvni tlak,
• Hypersensitivity to thalidomide or to any of the excipients listed in section 6.1. 
• Preobčutljivost na talidomid ali katero koli pomožno snov, navedeno v poglavju 6.1.
These can happen during treatment, or after treatment has stopped. 
Do tega lahko pride med zdravljenjem ali ko je zdravljenje že končano.
Grade 3 (interfering with activities of daily living) 
3. stopnja (ovira dnevne aktivnosti)
If you take more Thalidomide Celgene than you should If you take more Thalidomide Celgene than you should, talk to a doctor or go to a hospital straightaway. 
Če ste vzeli večji odmerek zdravila Thalidomide Celgene, kot bi smeli Če ste vzeli večji odmerek zdravila Thalidomide Celgene, kot bi smeli, se posvetujte z zdravnikom ali pojdite takoj v bolnišnico.
• Treatment initiation forms and/or equivalent tool 
• Obrazce za začetek zdravljenja in/ali ustrezno orodje
Multiple myeloma is a type of cancer which affects a certain type of white blood cell, called the plasma cell. 
Diseminirani plazmocitom je vrsta raka, ki vpliva na določeno vrsto belih krvnih celic, imenovanih plazmatke.
Previous history of thromboembolic events or concomitant administration of erythropoietic agents or other agents such as hormone replacement therapy, may also increase thromboembolic risk in these patients. 
Anamneza trombembolitičnih dogodkov ali sočasna uporaba eritropoetskih ali drugih zdravil, kot je nadomestno hormonsko zdravljenje, lahko prav tako poveča tveganje za trombembolijo pri teh bolnikih.
• She acknowledges that she understands the hazards and necessary precautions associated with the use of thalidomide. 
• Bolnica potrdi, da razume nevarnosti in previdnostne ukrepe, potrebne v zvezi z uporabo talidomida.
• Algorithm for Pregnancy Prevention Plan implementation o This shall assist with patient categorisation, and determination of required pregnancy prevention and testing measures. 
• Algoritem za izvajanje programa za preprečevanje nosečnosti o ta naj pomaga pri razvrstitvi bolnikov in določanju zahtevanega preprečevanja nosečnosti in merilih testiranja
Thalidomide must not be used at any time during pregnancy (see sections 4.4 and 4.6). 
Talidomid se ne sme uporabljati v nobenem obdobju nosečnosti (glejte poglavji 4.4 in 4.6).
• you experienced or have existing slow heart rate (this may be a symptom of bradycardia). 
• ste imeli ali imate počasen srčni utrip (to so lahko simptomi bradikardije);
On the basis of the scientific conclusions for thalidomide the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing thalidomide is unchanged subject to the proposed changes to the product information 
Na podlagi znanstvenih zaključkov za talidomid odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) talidomid, nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
• Male patients unable to follow or comply with the required contraceptive measures (see section 4.4). 
• Moški bolniki, ki niso sposobni slediti kontracepcijskim ukrepom ali se ravnati v skladu z njimi (glejte poglavje 4.4.
To remove the capsule from the blister, press only one end of the capsule out to push it through the foil. 
Kapsulo odstranite iz pretisnega omota tako, da pritisnete samo na en konec kapsule in jo s tem potisnete skozi folijo.
Thalidomide is present in the semen of male patients at levels similar to plasma concentrations (see section 4.4). 
Talidomid je prisoten v spermi moških bolnikov v podobnih koncentracijah kot v plazmi (glejte poglavje 4.4).
• Pregnancy testing requirements ▪ Advice on suitable tests ▪ Frequency (before commencing, monthly during treatment and after finishing treatment) 
• zahteve testa nosečnosti nasvete o ustreznih testih pogostnost (pred pričetkom, mesečno med zdravljenjem in po končanem zdravljenju)
Peripheral neuropathy Dose modifications due to peripheral neuropathy are described in Table 2. 
Periferna nevropatija Spremembe odmerka zaradi periferne nevropatije so opisane v preglednici 2.
• Irregularities of the heartbeat (heart block or atrial fibrillation), feeling faint or fainting. 
• nepravilnosti srčnega utripa (srčni blok ali atrijska fibrilacija), občutek omedlevice ali omedlevanje.
Pack sizes: 28 capsules (two blisters) in a wallet card. 
Velikost pakiranja: 28 kapsul (dva pretisna omota) v škatli.
• Pain or swelling in your legs, especially in your lower leg or calves. 
• Bolečina ali zatekanje nog, zlasti v nižjem delu nog ali mečih.
• you have or have ever had previous viral infection, particularly varicella zoster, hepatitis B infection, or HIV. 
• imate ali ste kadarkoli prej imeli virusno okužbo, posebno norice, pasovca, okužbo z virusom hepatitisa B ali HIV.
• As little as one capsule taken by a pregnant woman can cause a baby to have serious birth defects. 
• Že samo ena kapsula, ki jo vzame nosečnica, lahko povzroči resne prirojene okvare.
Pups from mothers treated with thalidomide had increased abortions, reduced body weight gain, alterations in learning and memory, decreased fertility, and reduced pregnancy index. 
Mladiči mater, zdravljenih s talidomidom, so imeli povišano stopnjo abortusov, zmanjšano pridobivanje telesne mase, spremenjeno učenje in pomnjenje, zmanjšano plodnost in znižan indeks nosečnosti.
Thromboprophylaxis and dosing/anticoagulation therapy recommendations are provided in section 4.2. 
Priporočila glede tromboprofilakse in odmerjanja/zdravljenja z antikoagulanti so v poglavju 4.2.
• She understands the teratogenic risk to the unborn child 
• Bolnica razume tveganje teratogenih učinkov za nerojenega otroka.
No fatalities have been reported and all overdose patients recovered without sequelae. 
Niso poročali o smrtnih primerih in vsi bolniki, ki so vzeli prevelik odmerek, so okrevali brez posledic.
• if you are pregnant or think you may be pregnant or are planning to become pregnant, as Thalidomide Celgene causes birth defects and foetal death. 
• če ste noseči ali menite, da bi lahko bili noseči ali načrtujete zanositev, saj povzroča zdravilo Thalidomide Celgene prirojene okvare in smrt zarodka.
It can also happen sometime after treatment has stopped. 
Lahko nastopi tudi nekaj časa po koncu zdravljenja.
Thalidomide is metabolised almost exclusively by non-enzymatic hydrolysis. 
Talidomid se presnavlja skoraj izključno z neencimsko hidrolizo.
The European Medicines Agency has waived the obligation to submit the results of studies with thalidomide in all subsets of the paediatric population in multiple myeloma (see section 4.2 for information on paediatric use). 
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij s talidomidom za vse podskupine pediatrične populacije (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Patients should be instructed never to give this medicinal product to another person and to return any unused capsules to their pharmacist at the end of treatment. 
Bolnike je treba poučiti, da tega zdravila nikoli ne dajo drugi osebi, in da po koncu zdravljenja vrnejo vse neuporabljene kapsule farmacevtu.
Details of the PPP should be agreed wth the National Competent Authorities in each Member State and put in place prior to the launch of the medicinal product. 
O podrobnostih PPN se je treba dogovoriti s pristojnimi nacionalnimi organi v vsaki državi članici in program uvesti pred prihodom zdravila na trg.
These may be symptoms of a heart attack/myocardial infarction (which may be due to blood clots in the arteries of your heart). 
To so lahko simptomi srčne kapi/miokardnega infarkta (ki je lahko posledica krvnih strdkov v vaših srčnih arterijah).
The median overall survival (OS) was 51.6 ± 4.5 and 33.2 ± 3.2 months in the MPT and MP groups, respectively (97.5 % CI 0.42 to 0.84). 
Mediana celokupnega preživetja (OS) je bila 51,6 ± 4,5 meseca za skupino MPT in 33,2 ± 3,2 meseca za skupino MP (97,5 % IZ 0,42 do 0,84).
Patients should be instructed to seek medical care if they develop symptoms such as shortness of breath, chest pain, arm or leg swelling. 
Bolnikom je treba dati navodila, da poiščejo zdravniško pomoč, če se pojavijo simptomi kot so kratka sapa, bolečine v prsih ali otekanje rok ali nog.
• by stimulating part of the immune system to attack the cancer cells. 
• spodbuja dele imunskega sistema k napadanju rakavih celic
Posterior reversible encephalopathy syndrome (PRES)/ Reversible posterior leukoencephalopathy syndrome (RPLS) 
Sindrom posteriorne reverzibilne encefalopatije (PRES - Posterior reversible encephalophaty syndrome) / sindrom reverzibilne posteriorne levkoencefalopatije (RPLS - Reversible posterior leukoencephalopathy syndrome)
• Even if a woman of childbearing potential has amenorrhea she must follow all the advice on effective contraception 
• Tudi če ima ženska v rodni dobi amenorejo, mora upoštevati vse nasvete za zanesljivo kontracepcijo.
• The other excipients are: o The capsule content contains pregelatinised starch and magnesium stearate. 
• Druge sestavine zdravila so; o Vsebina kapsule vsebuje predgelirani škrob in magnezijev stearat.
In humans, thalidomide is a proven teratogen. 
Pri ljudeh je talidomid dokazano teratogen.
For women of childbearing potential, thalidomide is contraindicated unless all of the following conditions are met: 
Za ženske v rodni dobi je talidomid kontraindiciran, razen če so izpolnjeni vsi naslednji pogoji:
• Teratogenicity and the need to avoid foetal exposure 
• Teratogenost in potreba po izogibanju izpostavljenosti ploda
• Women who are pregnant (see section 4.6). 
• Nosečnice (glejte poglavje 4.6).
The majority of the reported cases had recognized risk factors for PRES/RPLS, including hypertension, renal impairment and concomitant use of high dose corticosteroids and/or chemotherapy. 
Večina primerov, o katerih so poročali, je imela znane dejavnike tveganja za PRES/ RPLS, med drugim hipertenzijo, okvare ledvic in sočasno uporabo kortikosteroidov v velikih odmerkih in/ali kemoterapije.
Ideally, pregnancy testing, issuing a prescription and dispensing should occur on the same day. 
Najbolje je, da test nosečnosti, izdaja recepta in izdaja zdravila potekajo na isti dan.
In documented case reports with hormone evaluation, the event of amenorrhoea was associated with decreased estradiol levels and elevated FSH/LH levels. 
V dokumentiranih poročilih primerov z ovrednotenimi vrednostmi hormonov so dogodek amenoreje povezali z zmanjšanjem ravni estradiola in zvišanjem ravni FSH/LH.
Thalidomide Celgene is prescribed and dispensed according to the Thalidomide Celgene Pregnancy Prevention Programme (see section 4.4). 
Zdravilo Thalidomide Celgene se predpisuje in izdaja v skladu s programom Thalidomide Celgene za preprečevanje nosečnosti (glejte poglavje 4.4).
The recommended dose of thalidomide is 200 mg orally per day. 
Priporočeni odmerek talidomida je 200 mg na dan peroralno.
As thalidomide is found in semen, as a precaution all male patients taking thalidomide must meet the following conditions: 
Ker je talidomid prisoten v spermi, morajo vsi moški bolniki, ki jemljejo talidomid, iz previdnosti izpolnjevati naslednje pogoje:
Capsules should not be opened or crushed (see section 6.6). 
Kapsul ne odpirajte in ne drobite (glejte poglavje 6.6).
In 10 healthy women, the pharmacokinetic profiles of norethindrone and ethinyl estradiol following administration of a single dose containing 1.0 mg of norethindrone acetate and 0.75 mg of ethinyl estradiol were studied. 
Pri 10 zdravih ženskah so bili raziskani farmakokinetični profili noretindrona in etinilestradiola po uporabi enega odmerka z 1,0 mg noretindron acetata in 0,75 mg etinilestradiola.
Thalidomide shows immunomodulatory, anti-inflammatory and potential anti-neoplastic activities. 
Talidomid kaže imunomodulatorne protivnetne in potencialno antineoplastične aktivnosti.
Thalidomide is a poor substrate for cytochrome P450 isoenzymes and therefore clinically important interactions with medicinal products that are inhibitors and/or inducers of this enzyme system are unlikely. 
Talidomid je slab substrat za izoencime citokroma P450, zato je verjetnost klinično pomembnih interakcij z zdravili, ki so zaviralci in/ali induktorji tega encimskega sistema, majhna.
When provided, antiovary antibodies were negative and prolactin level was within the normal range. 
Protiovarijska protitelesa so bila negativna, raven prolaktina pa je bila v mejah normale.
Animal studies have demonstrated differences in species susceptibility to the teratogenic effects of thalidomide. 
Študije na živalih so pokazale razlike pri dovzetnosti vrst za teratogeni učinek talidomida.
In a one-year dog study, enlarged and/or blue discoloration of mammary glands and prolonged estrus were observed in females at exposures equal to 1.8 or greater than 3.6-fold the human exposure, respectively. 
V enoletni študiji na psih so opazili povečano in/ali modro razbarvanje mlečnih žlez in podaljšan estrus pri psicah ob izpostavljenostih, enakih 1,8-krat ali večjih kot 3,6-kratna izpostavljenost pri ljudeh.
This is because alcohol can make you sleepy and Thalidomide Celgene can make you even sleepier. 
Zaradi alkohola ste lahko zaspani, zdravilo Thalidomide Celgene pa vas naredi še bolj zaspane.
Thalidomide is a powerful human teratogen, inducing a high frequency of severe and lifethreatening birth defects. 
Talidomid je močan humani teratogen, ki inducira visoko pogostnost resnih in smrtno nevarnih prirojenih okvar.
The test should ensure the patient is not pregnant when she starts treatment with thalidomide. 
S testom je treba zagotoviti, da bolnica ob začetku zdravljenja s talidomidom ni noseča.
• Fall of blood pressure on standing which may lead to fainting. 
• padec krvnega tlaka ob vstajanju, kar lahko privede do omedlevanja,
• Numbness, tingling, abnormal coordination or pain in your hands and feet. 
• Otrplost, ščemenje, nenavadna koordinacija ali bolečine v rokah ali nogah.
Thalidomide Celgene with food, drink and alcohol Do not drink alcohol while you are taking Thalidomide Celgene. 
Zdravilo Thalidomide Celgene skupaj s hrano, pijačo in alkoholom Ko jemljete zdravilo Thalidomide Celgene, ne pijte alkohola.
• She understands the need to commence the treatment as soon as thalidomide is dispensed following a negative pregnancy test 
• Bolnica razume potrebo, da se prične zdravljenje kakor hitro je izdan talidomid po negativnem testu nosečnosti.
The prescriber must inform male and female patients about the expected teratogenic risk and the strict pregnancy prevention measures as specified in the Pregnancy Prevention Programme and provide patients with appropriate educational brochure for patients, patient card and/or equivalent tool in accordance to the national implemented patient card system. 
Zdravnik, ki predpiše zdravilo, mora bolnike in bolnice seznaniti s pričakovanim tveganjem za teratogenost in strogimi ukrepi za preprečevanje nosečnosti, kot je določeno v programu za preprečevanje nosečnosti, in bolnikom priskrbeti ustrezno izobraževalno brošuro za bolnike, kartico za bolnika in/ali drugo ustrezno orodje v skladu z nacionalno izvajanim sistemom kartic za bolnike.
Adverse reactions for haematological disorders are provided compared to the comparator arm, as the comparator has a significant effect on these disorders (Table 4). 
Neželeni učinki za hematološke bolezni so navedeni v primerjavi s primerjalno vejo, saj ima primerjalno zdravilo pomemben vpliv na te bolezni (preglednica 4).
No specific pattern was identified between hepatocellular and cholestatic abnormalities, with some cases having a mixed presentation. 
Specifičnega vzorca med hepatocelularnimi in holestatskimi nenormalnostmi niso ugotovili, pri čemer so bili nekateri primeri mešani.
It is recommended that clinical and neurological examinations are performed in patients prior to starting thalidomide therapy, and that routine monitoring is carried out regularly during treatment. 
Priporočljivi so klinični in nevrološki pregledi pri bolnikih pred pričetkom zdravljenja s talidomidom in redni rutinski pregledi med zdravljenjem.
Pulmonary hypertension 
Pljučna hipertenzija
Do not breastfeed when taking Thalidomide Celgene as it is not known if thalidomide is passed into human breast milk. 
Med jemanjem zdravila Thalidomide Celgene ne smete dojiti, saj ni znano, ali talidomid prehaja v materino mleko.
Action should be taken to try to minimize all modifiable risk factors (e.g. smoking, hypertension and hyperlipidaemia). 
Z ustreznimi ukrepi je treba zmanjšati vse dejavnike tveganja, na katere lahko vplivamo (npr. kajenje, hipertenzija in hiperlipidemija).
For patients > 75 years of age, the thalidomide recommended starting dose is 100 mg per day. 
Za bolnike, stare > 75 let, je priporočeni začetni odmerek talidomida 100 mg na dan.
Table 3 contains only the adverse reactions for which a causal relationship with medicinal product treatment could reasonably be established observed in the pivotal study and from post-marketing experience. 
Preglednica 3 zajema samo neželene učinke, za katere je bilo mogoče razumno vzpostaviti vzročno povezanost z zdravljenjem z zdravilom in so jih opazili v ključni študiji in po začetku trženja.
• you have experienced sleepiness. 
• če ste bili zaspani;
In 18 healthy male volunteers, multiple dose administration of 200 mg thalidomide had no apparent effect on the single dose pharmacokinetics of digoxin. 
Pri 18 zdravih prostovoljcih uporaba večkratnih 200-mg odmerkov talidomida ni imela vidnega učinka na farmakokinetiko enega odmerka digoksina.
Thromboprophylaxis should be administered for at least the first 5 months of treatment especially in patients with additional thrombotic risk factors. 
Tromboprofilakso je treba dajati vsaj prvih pet mesecev zdravljenja, še zlasti pri bolnikih z dodatnimi dejavniki tveganja za nastanek tromboze.
This may be due to nerve damage (called ‘peripheral neuropathy'), which is a very common side effect. 
Vzrok je lahko okvara živcev (imenuje se „periferna nevropatija“), ki je zelo pogost neželeni učinek.
• She should be capable of complying with effective contraceptive measures 
• Bolnica mora biti zmožna ravnati v skladu z zanesljivimi kontracepcijskimi ukrepi.
No evidence of carcinogenicity was observed at exposures approximately 15, 13 and 39 times the estimated clinical AUC at the recommended starting dose in mice, male rats and female rats respectively. 
Dokazov karcinogenosti pri izpostavitvi približno 15-, 13- in 39-kratni ocenjeni klinični AUC pri priporočljivem začetnem odmerku pri miših ter podganjih samcih in samicah niso opazili.
Severe skin reactions 
Hude reakcije na koži
Caution should be used when thalidomide is given in combination with medicinal products that cause drowsiness. 
Potrebna je previdnost, če se talidomid daje v kombinaciji z zdravili, ki povzročajo zaspanost.
It is used in people who have recently been diagnosed and who have not been prescribed another medicine for their multiple myeloma before who are aged 65 years and over, or aged less than 65 years who cannot be treated with high dose chemotherapy, which can be very difficult for the body to handle. 
Uporablja se pri bolnikih, ki jim je bila ta diagnoza postavljena pred kratkim in ki za zdravljenje diseminiranega plazmocitoma še niso prejemali drugega zdravila ter so stari 65 let in več, ali pri bolnikih, ki so stari manj kot 65 let in ne morejo prejemati visokih odmerkov kemoterapije, ki jih telo lahko zelo težko prenaša.
If you are pregnant, you must not take Thalidomide Celgene. 
Če ste noseči, ne smete jemati zdravila Thalidomide Celgene.
• Maximum duration of treatment prescribed o 4 weeks of treatment for women with childbearing potential o 12 weeks of treatment for men and women without childbearing potential 
• Najdaljše obdobje predpisanega zdravljenja o 4 tedne zdravljenja za ženske v rodni dobi o 12 tednov zdravljenja za moške in ženske, ki niso v rodni dobi
In order to assist patients in avoiding foetal exposure to thalidomide, the Marketing Authorisation Holder will provide educational material to healthcare professionals to reinforce the warnings about the teratogenicity of thalidomide, to provide advice on contraception before treatment is started and provides guidance on the need for pregnancy testing. 
Da bi pomagali bolnikom pri preprečevanju izpostavitve ploda talidomidu, bo imetnik dovoljenja za promet z zdravilom priskrbel izobraževalno gradivo za zdravnike, ki poudarja opozorila o teratogenosti talidomida ter nudi nasvete glede kontracepcije pred začetkom zdravljenja in navodila glede potrebe po testu nosečnosti.
These cells collect in the bone marrow and divide out of control. 
Te celice se zbirajo v kostnem mozgu in nenadzorovano razmnožujejo.
However, this has not formally been studied in patients with impaired renal or hepatic function; therefore patients with severe renal or hepatic impairment should be carefully monitored for any adverse events. 
Vendar pa formalnih študij pri bolnikih z okvarjenim delovanjem ledvic ali jeter niso izvedli; zato je treba bolnike z okvarjenim delovanjem ledvic ali jeter skrbno spremljati glede katerihkoli neželenih dogodkov.