natgillin/translations-raw huggingface dataset:
For all patients Talk to your doctor before taking Thalidomide Celgene if 
Za vse bolnike Posvetujte se z zdravnikom, preden vzamete zdravilo Thalidomide Celgene, če:
• These defects can include shortened arms or legs, malformed hands or feet, eye or ear defects, 
• Te okvare lahko vključujejo krajše roke ali noge, deformirane roke in stopala, okvare oči in ušes ter težave pri notranjih organih.
There are in vitro data indicating that prednisone may give rise to enzyme induction which could reduce the systemic exposure of concomitantly used medicinal products. 
Obstoječi podatki in vitro kažejo, da lahko prednizon povzroči induciranje encima, kar lahko zmanjša sistemsko izpostavljenost zdravilom, ki se uporabljajo hkrati.
Criteria for women of non-childbearing potential 
Merila za ženske, ki niso v rodni dobi
• Bleeding or bruising in the absence of injury. 
• Krvavitev ali modrice, ki niso posledica poškodbe.
Thalidomide Celgene as per the recommended posology has minor or moderate influence on the ability to drive and use machines. 
Če se zdravilo Thalidomide Celgene jemlje v skladu s priporočenim odmerjanjem, ima blag ali zmeren vpliv na sposobnost vožnje in upravljanja strojev.
However, due to the increased risk of thrombosis in cancer patients, and a potentially accelerated metabolism of warfarin with corticosteroids, close monitoring of INR values is advised during thalidomide-prednisone combination treatment as well as during the first weeks after ending these treatments. 
Zaradi povečanega tveganja tromboze pri bolnikih z rakom in potencialnim pospeševanjem metabolizma varfarina s kortikosteroidi se priporoča natančno spremljanje ravni INR med zdravljenjem s kombinacijo talidomid-prednizon in v prvih tednih po koncu teh zdravljenj.
Despite the small number of cases of DRESS, considering that this adverse reaction is a known risk listed in the EU SmPC of the structural analogues lenalidomide and pomalidomide and taking into consideration that other severe cutaneous adverse reactions (SCARs) are already listed in the thalidomide EU SmPC (SJS and TEN), the PRAC concluded that a causal relationship between thalidomide and DRESS cannot be excluded. 
Kljub majhnemu številu primerov DRESS, upoštevajoč, da je ta neželeni učinek znano tveganje, navedeno v povzetku glavnih značilnosti zdravila v EU za strukturna analoga lenalidomid in pomalidomid, ter upoštevajoč, da so drugi hudi kožni neželeni učinki (SCARssevere cutaneous adverse reactions) že navedeni v povzetku glavnih značilnosti zdravila v EU za talidomid (SJS in TEN), je odbor PRAC sklenil, da ni mogoče izključiti vzročne zveze med talidomidom in DRESS.
Thalidomide Celgene is taken daily in treatment cycles, each cycle lasting 6 weeks, in combination with melphalan and prednisone which are taken on days 1 to 4 of each 6 week cycle. 
Zdravilo Thalidomide Celgene se jemlje dnevno v ciklih zdravljenja, vsak cikel traja 6 tednov v kombinaciji z melfalanom in prednizonom, ki se jemljeta od 1. do 4. dne vsakega 6-tedenskega cikla.
For all other patients, prescriptions of thalidomide should be limited to a maximum of 12 weeks of treatment and continuation of treatment requires a new prescription. 
Za vse ostale bolnike je treba predpisovanje talidomida omejiti na največ 12 tednov zdravljenja, za nadaljevanje zdravljenja pa je treba izdati nov recept.
This includes sedatives (such as anxiolytics, hypnotics, antipsychotics, H1 antihistamines, opiate derivatives and barbiturates). 
To vključuje pomirjevala (kot so anksiolitiki, hipnotiki, antipsihotiki, antihistaminiki H1, derivati opiatov in barbiturati);
• you have experienced or have existing neuropathy i.e. nerve damage causing tingling, abnormal co-ordination or pain in your hands or feet (see also section 4 “Possible side effects”). 
• če ste imeli ali imate obstoječo nevropatijo, tj. poškodbe živcev, ki povzročajo mravljinčenje, težave s koordinacijo ali bolečine v rokah ali nogah (glejte tudi poglavje 4 „Možni neželeni učinki“);
Patients with known risk factors for MI, including prior thrombosis, should be closely monitored and action should be taken to try to minimise all modifiable risk factors (e.g. smoking, hypertension, and hyperlipidaemia). 
Bolnike z znanimi dejavniki tveganja za MI, vključno s predhodnimi trombozami, je potrebno skrbno nadzirati in z ustreznimi ukrepi poskusiti zmanjšati tiste dejavnike tveganja, na katere lahko vplivamo (npr. kajenje, hipertenzija in hiperlipidemija).
Symptoms include paraesthesia, dysaesthesia, discomfort, abnormal co-ordination or weakness. 
Simptomi zajemajo parestezijo, disestezijo, nelagodje, nenavadno koordinacijo ali slabost.
Thalidomide does not interact with digoxin. 
Medsebojnega delovanja med talidomidom in digoksinom ni.
Capsule contents Starch, pregelatinised Magnesium stearate 
Vsebina kapsule škrob, predgelirani magnezijev stearat
Thalidomide Celgene works by helping the body's immune system and directly attacking the cancer. 
Način delovanja zdravila Thalidomide Celgene Zdravilo Thalidomide Celgene deluje tako, da pomaga imunskemu sistemu telesa z neposrednim napadom na raka.
Once the patient has been stabilised on the anticoagulation treatment and any complications of the thromboembolic event have been managed, the thalidomide treatment may be restarted at the original dose dependent upon a benefit-risk assessment. 
Ko se bolnika stabilizira z antikoagulacijskim zdravljenjem in so odpravljeni vsi zapleti trombemboličnega dogodka, se lahko ponovno prične zdravljenje s talidomidom v prvotnem odmerku, odvisno od ocene tveganja in koristi.
• Depression, confusion, mood changes, anxiety. 
• depresija, zmedenost, spremembe razpoloženja, tesnoba,
Data from in vitro studies and clinical trials suggest that the immunomodulatory, anti-inflammatory and anti-neoplastic effects of thalidomide may be related to suppression of excessive tumour necrosis factor-alpha (TNF-) production, down-modulation of selected cell surface adhesion molecules involved in leukocyte migration and anti-angiogenic activity. 
Podatki študij in vitro in kliničnih preskušanj kažejo, da so lahko imunomodulatorni, protivnetni in antineoplastični učinki talidomida povezani z zaviranjem prekomerne produkcije tumorskega nekroznega faktorja alfa (TNF-), modulacijo navzdol izbranih adhezijskih molekul celične površine, vpletenih v migracijo levkocitov, in antiangiogensko aktivnostjo.
What Thalidomide Celgene looks like and contents of the pack Thalidomide Celgene are white hard capsules marked “Thalidomide Celgene 50 mg”. 
Izgled zdravila Thalidomide Celgene in vsebina pakiranja Thalidomide Celgene so bele trde kapsule, označene s „Thalidomide Celgene 50 mg“.
• That if she is pregnant or plans to be, she must not take thalidomide 
• če je ženska noseča ali načrtuje nosečnost, ne sme jemati talidomida
Thalidomide is also a non-barbiturate centrally active hypnotic sedative. 
Talidomid je tudi nebarbituratni hipnotik in sedativ z osrednjim delovanjem.
Melphalan c,d,e 
talidomida,b melfalanc,d,e prednizonf
• The patient complies with the conditions of the Pregnancy Prevention Programme including confirmation that she has an adequate level of understanding 
• Bolnik/bolnica ravna v skladu s pogoji programa za preprečevanje nosečnosti, vključno s potrditvijo, da pogoje programa ustrezno razume.
Previously infected patients should be closely monitored for signs and symptoms of viral reactivation, including active HBV infection, throughout therapy. 
Bolnike ki so bili predhodno okuženi je treba ves čas zdravljenja skrbno spremljati glede znakov in simptomov virusne reaktivacije, vključno z aktivno okužbo s HBV.
Stop taking Thalidomide Celgene and see a doctor straight away if you notice the following serious side effects - you may need urgent medical treatment: 
Takoj prenehajte jemati zdravilo Thalidomide Celgene in pojdite takoj k zdravniku, če opazite katerega od naslednjih resnih neželenih učinkov - morda potrebujete nujno zdravljenje: Izredno močne in resne kožne reakcije.
• Pregnancy initial and outcome reporting forms 
• Obrazci za poročanje o začetku in izidu nosečnosti
Oxidative metabolism does not contribute significantly to the overall metabolism of thalidomide. 
Oksidativna presnova ne prispeva pomembno k celotni presnovi talidomida.
These symptoms may be signs of the rare and serious skin reactions Stevens-Johnson syndrome, toxic epidermal necrolysis or DRESS syndrome. 
Ti simptomi so lahko znaki redkih in resnih kožnih reakcij Stevens-Johnsonovega sindroma, toksične epidermalne nekrolize ali sindroma DRESS.
Thalidomide must never be used by women who are pregnant or by women who could become pregnant unless all the conditions of the Pregnancy Prevention Programme are met. 
Nosečnice ali ženske, ki lahko zanosijo, ne smejo nikoli jemati talidomida, razen če so izpolnjeni vsi pogoji programa za preprečevanje nosečnosti.
This could lead to a condition where the tumours break down and cause unusual levels of chemicals in the body which can lead to kidneys failure (this condition is called Tumour Lysis Syndrome) (see also section 4 “Possible side effects”). 
To bi lahko pripeljalo do razkroja tumorjev in sprostitev neobičajnih ravni kemijskih snovi v telo, kar bi lahko povzročilo ledvično odpoved (stanje, ki se imenuje sindrom tumorske lize) (glejte tudi poglavje 4 „Možni neželeni učinki“).
If the patient experiences any thromboembolic events, treatment must be discontinued and standard anticoagulation therapy started. 
Če se pri bolniku pojavijo katerikoli trombembolični dogodki, morate zdravljenje ukiniti in pričeti s standardno antikoagulacijsko terapijo.
Thalidomide Celgene should be taken as a single dose at bedtime, to reduce the impact of somnolence. 
Zdravilo Thalidomide Celgene se jemlje v enkratnem odmerku pred spanjem, za zmanjšanje vpliva somnolence.
A clear mechanism by which thalidomide can induce amenorrhea is not elucidated. 
Mehanizma, s katerim lahko talidomid povzroči amenorejo, še niso ugotovili.
A peri- and postnatal toxicity study performed in rabbits with thalidomide administered at doses up to 500 mg/kg/day resulted in abortions, increased stillbirths and decreased pup viability during lactation. 
Perinatalna in postnatalna študija toksičnosti, izvedena pri kuncih, z odmerki talidomida do 500 mg/kg/dan je povzročila abortuse, povečano število mrtvorojenih mladičev in zmanjšano sposobnost preživetja mladičev med laktacijo.
At the end of your treatment you should return all unused capsules to the pharmacist or doctor. 
Na koncu zdravljenja morate vse neuporabljene kapsule vrniti farmacevtu ali zdravniku.
• Prior to launch, all doctors and pharmacists who intend to prescribe or dispense Thalidomide Celgene receive a Dear Healthcare Professional letter as described below. 
• Pred prihodom zdravila na trg morajo vsi zdravniki in farmacevti, ki nameravajo predpisovati ali izdajati zdravilo Thalidomide Celgene, prejeti Neposredono obvestilo za zdravstvene delavce, kot je opisano spodaj;
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu. 
DATUM ZADNJE REVIZIJE BESEDILA Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/.
No mutagenic or genotoxic effect has been revealed when thalidomide was assayed in a standard battery of genotoxicity tests. 
Mutagenih ali genotoksičnih učinkov talidomida pri izsledkih v nizu standardnih genotoksičnih testiranj niso odkrili.
Educational Healthcare Professional's Kit The Educational Healthcare Professional's Kit shall contain the following elements: 
Paket izobraževalnih gradiv za zdravstvene delavce Paket izobraževalnih gradiv za zdravstvene delavce mora vsebovati naslednje elemente:
Signs and symptoms included visual disturbance, headache, seizures and altered mental status, with or without associated hypertension. 
Znaki in simptomi vključujejo motnje vida, glavobol, epileptične napade in spremenjeni mentalni status s pridruženo hipertenzijo ali brez nje.
Do not drive or use any tools or machines if you experience side effects, such as dizziness, tiredness, sleepiness or blurred vision. 
Vpliv na sposobnost upravljanja vozil in strojev Ne vozite ali uporabljajte katerega koli orodja ali stroja, če imate neželene učinke, kot so omotica, utrujenost, zaspanost ali zamegljen vid.
In addition, single dose administration of 0.5 mg digoxin had no apparent effect on thalidomide pharmacokinetics. 
Tudi uporaba enega 0,5-mg odmerka digoksina ni imela nobenega vidnega učinka na farmakokinetiko talidomida.
Thalidomide is contraindicated during pregnancy and in women of childbearing potential unless all the conditions of the Pregnancy Prevention Programme are met (see section 4.3) 
Talidomid je kontraindiciran med nosečnostjo in pri ženskah v rodni dobi, razen če so izpolnjeni vsi pogoji programa za preprečevanje nosečnosti (glejte poglavje 4.3).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) 
Benigne, maligne in neopredeljene novotvorbe (vključno s cistami in polipi)
Animal studies have shown excretion of thalidomide in breast milk. 
Študije na živalih so pokazale izločanje talidomida v materino mleko.
Amenorrhea during thalidomide therapy should be assumed to result from pregnancy, until it is medically confirmed that the patient is not pregnant. 
Upoštevati morate možnost, da je amenoreja med zdravljenjem s talidomidom lahko posledica nosečnosti, dokler ni medicinsko potrjeno, da bolnica ni noseča.
• You must use one effective method of contraception: o for at least 4 weeks before starting treatment o during treatment o until at least 4 weeks after stopping treatment Your doctor will tell you what method of contraception to use. 
• Uporabljati morate eno zanesljivo kontracepcijsko metodo: o vsaj 4 tedne pred začetkom zdravljenja o med zdravljenjem o vsaj 4 tedne po koncu zdravljenja Vaš zdravnik vam bo povedal, katero metodo kontracepcije uporabiti.
These patients either exhibited no symptoms or exhibited symptoms of drowsiness, irritability, “sickness,” and/or headache. 
Pri teh bolnikih se simptomi niso pojavili ali pa so se pojavili simptomi zaspanosti, razdražljivosti, siljenja na bruhanje in/ali glavobola.
This may be due to blood clots in the arteries leading to your lungs (called ‘pulmonary embolism'), which is a common side effect. 
Vzrok so lahko krvni strdki v arterijah, ki vodijo do vaših pljuč (imenuje se „pljučna embolija“), ki je pogost neželeni učinek.
• Prior to prescribing all healthcare professionals who intend to prescribe (and in agreement with the National Competent Authority, dispense) Thalidomide Celgene are provided with an Educational Healthcare Professional's Kit containing the following: o Educational healthcare professional booklet o Educational brochures for patient o Patient cards o Summary of product characteristics, package leaflet and labelling 
• Pred predpisovanjem prejmejo vsi zdravstveni delavci, ki nameravajo predpisovati (in v skladu z dogovorom s pristojnimi nacionalnimi organi izdajati) zdravilo Thalidomide Celgene, paket izobraževalnih gradiv za zdravstvene delavce, ki vsebuje naslednje: o Izobraževalna brošura za zdravstvene delavce o Izobraževalne brošure za bolnike o Kartice za bolnike o Povzetek glavnih značilnosti zdravila, navodilo za uporabo in označevanje
These complications are caused by the break-down products of dying cancer cells and may include the following: changes to blood chemistry; high potassium, phosphorus, uric acid, and low calcium consequently leading to changes in kidney function, heart beat, seizures, and sometimes death. 
Te zaplete povzročajo razgradni produkti odmirajočih rakavih celic in lahko vključujejo naslednje: spremenjene rezultate krvnih preiskav; visoko raven kalija, fosforja, sečne kisline in nizko raven kalcija, kar posledično povzroči spremembe v delovanju ledvic, utripu srca, konvulzije in včasih smrt,
The effect of thalidomide on thyroid function was assessed in both rats and dogs. 
Učinek talidomida na delovanje ščitnice je bil ocenjen pri podganah in pri psih.
Dispensing of thalidomide to women of childbearing potential should occur within 7 days of the prescription and following a medically supervised negative pregnancy test result. 
Izdajanje talidomida ženskam v rodni dobi je dovoljeno v 7 dneh po izdaji recepta in po zdravniško nadzorovanem negativnem testu nosečnosti.
• Decreased or abnormal sensation (dysaesthesia). 
• oslabljeno ali nenormalno zaznavanje (disestezija),
It is very common that thalidomide causes somnolence. 
Talidomid zelo pogosto povzroči somnolenco.
Thalidomide may cause fatigue (very common), dizziness (very common), somnolence (very common) and blurred vision (common) (see section 4.8). 
Talidomid lahko povzroči utrujenost (zelo pogosto), omotico (zelo pogosto), somnolenco (zelo pogosto) in zamegljen vid (pogosto) (glejte poglavje 4.8).
Some of the cases of HBV reactivation progressed to acute hepatic failure and resulted in discontinuation of thalidomide. 
Nekateri primeri reaktivacije HBV so napredovali v akutno odpoved jeter in imeli za posledico ukinitev talidomida.
The adverse reaction profile reported in patients > 75 years of age treated with thalidomide 100 mg once daily was similar to the adverse reaction profile observed in patients ≤ 75 years of age treated with thalidomide 200 mg once daily (see Table 3). 
Profil neželenih učinkov, o katerih so poročali pri bolnikih, starih > 75 let, zdravljenih s talidomidom 100 mg enkrat na dan, je bil podoben profilu neželenih učinkov, ugotovljenemu pri bolnikih, starih ≤ 75 let, zdravljenih s talidomidom v odmerku 200 mg enkrat na dan (glejte preglednico 3).
Your doctor will tell you how to take Thalidomide Celgene and for how long you will need to take it (see section 2, “What you need to know before you take Thalidomide Celgene”). 
Zdravnik vam bo povedal, kako vzeti zdravilo Thalidomide Celgene in koliko časa ga je treba jemati (glejte poglavje 2 „Kaj morate vedeti, preden boste vzeli zdravilo Thalidomide Celgene“).
Prior to approval by the National Competent Authority and launch of the medicinal product, the MAH should ensure that the educational materials are provided to and reviewed by the national patients' organisations or if such an organisation does not exist or can not be involved, by a relevant patients group. 
Imetnik dovoljenja za promet z zdravilom mora pred odobritvijo s strani pristojnega nacionalnega organa in prihodom zdravila na trg zagotoviti, da se izobraževalno gradivo predložinacionalnim organizacijam za bolnike, da jih pregledajo, oziroma če te ne obstajajo ali če ne morejo sodelovati, zadevnim skupinam bolnikov.
Patients should be instructed not to drive cars, use machines or perform hazardous tasks while being treated with thalidomide if they feel tired, dizzy, sleepy or have blurred vison. 
Bolnike je treba poučiti, da v času zdravljena s talidomidom ne smejo voziti avtomobilov, upravljati strojev ali izvajati nevarnih nalog, če so utrujeni, omotični, zaspani ali imajo zamegljen vid.
Thalidomide does not interact with hormonal contraceptives. 
Med talidomidom in hormonskimi kontraceptivi ni medsebojnega delovanja.
Patients should be evaluated for signs and symptoms of underlying cardiopulmonary disease prior to initiating and during thalidomide therapy. 
Bolnike je treba oceniti glede znakov in simptomov obstoječe kardiopulmonalne bolezni pred uvedbo zdravljenja s talidomidom in med njim.
• Allergic reactions such as a localised or generalised pruritic rash and angioedema (types of allergic reaction that may be manifested as hives, rashes, swelling of eyes, mouth or face, difficulty of breathing, or itching). 
• alergijske reakcije kot je lokalizirani ali generalizirani pruritični izpuščaj in angioedem (vrsta alergijske reakcije, ki se lahko kaže v obliki koprivnice, izpuščajev, oteklosti oči, ust ali obraza, težav z dihanjem ali srbenja),
MP (n=193) 
n (% bolnikov) MP (n=193)
A medically supervised pregnancy test should be repeated every 4 weeks, including 4 weeks after the end of treatment, except in the case of confirmed tubal sterilisation. 
Test nosečnosti pod zdravniškim nadzorom je treba ponoviti vsake 4 tedne, vključno s 4 tedni po koncu zdravljenja, razen v primeru potrjene sterilizacije jajcevodov.
There is a linear relationship between body weight and estimated thalidomide clearance; in multiple myeloma patients with body weight from 47-133 kg, thalidomide clearance ranged from approximately 6-12 L/h, representing an increase in thalidomide clearance of 0.621 L/h per 10 kg body weight increase. 
Med telesno maso in ocenjenim očistkom talidomida je linearno razmerje; pri bolnikih z diseminiranim plazmocitomom s telesno maso med 47 in 133 kg je bil razpon očistka talidomida med približno 6-12 l/h, kar predstavlja povečanje očistka talidomida za 0,621 l/h na 10 kg telesne mase.
• Inflammation of the cells lining your stomach wall. 
• vnetje celic v steni želodca,
• A slow heart rate, heart failure. 
• počasen srčni utrip, popuščanje srca,
Due to thalidomide's potential to induce bradycardia, caution should be exercised with medicinal products having the same pharmacodynamic effect such as active substances known to induce torsade de pointes, beta blockers or anticholinesterase agents. 
Zaradi potenciala talidomida, da povzroči bradikardijo, je potrebna previdnost pri zdravilih, ki imajo isti farmakodinamični učinek, kot na primer zdravilne učinkovine, za katere je znano, da inducirajo torsade de pointes, zaviralci beta ali zdravila proti holinesterazi.
If you forget to take Thalidomide Celgene at your regular time and 
Če ste pozabili vzeti zdravilo Thalidomide Celgene Če ste pozabili vzeti odmerek zdravila Thalidomide Celgene ob običajnem času in
• All treatment initiation forms and/or equivalent tool should contain the following elements: o Teratogenicity warning o Patients receive appropriate counselling prior to treatment initiation o Date of counselling o Affirmation of patient understanding regarding the risk of thalidomide and the PPP measures o Patient details, signature and date o Prescriber name, signature and date o Aim of this document i.e. as stated in the PPP: “The aim of the treatment initiation form is to protect patients and any possible foetuses by ensuring that patients are fully informed of and understand the risk of teratogenicity and other adverse reactions associated with the use of thalidomide. 
• Vsi obrazci za začetek zdravljenja in/ali ustrezno orodje morajo vsebovati naslednje elemente: o opozorilo o teratogenosti o da so bolniki pred začetkom zdravljenja deležni ustreznega svetovanja o datum svetovanja o potrdilo o bolnikovem razumevanju v zvezi s tveganjem talidomida in ukrepi PPN o podatke bolnika, podpis in datum o ime zdravnika, ki je zdravilo predpisal, podpis in datum o namen dokumenta, tj. kot je zabeleženo v PPN: „Cilj obrazca za začetek zdravljenja je zaščititi bolnike in morebitne plode tako, da se zagotovi popolna obveščenost in razumevanje bolnikov glede tveganja teratogenosti in drugih neželenih učinkov, povezanih z uporabo talidomida.
• you have high blood pressure in the arteries of the lungs (see also section 4 “Possible side effects”). 
• imate zvišan krvni tlak v pljučnih arterijah (glejte tudi poglavje 4 „Možni neželeni učinki“);
If Stevens-Johnson syndrome, TEN or DRESS is suspected, use of thalidomide should not be resumed (see section 4.2 and 4.4). 
Ob sumu na Stevens-Johnsonov sindrom, TEN ali DRESS se zdravljenje s talidomidom ne sme nadaljevati (glejte poglavji 4.2 in 4.4).
• Increase in blood pressure within blood vessels that supply the lungs which can lead to shortness of breath, tiredness, dizziness, pain in the chest, a faster heartbeat, or swelling in the legs or ankles (pulmonary hypertension). 
• zvišanje krvnega tlaka v krvnih žilah, ki preskrbujejo pljuča, kar lahko povzroči kratko sapo, utrujenost, omotico, bolečine v prsih, pospešen srčni utrip ali otekanje nog ali gležnjev (pljučna hipertenzija);
Consider reducing dose if symptoms worsen. 
Premislite o zmanjšanju odmerka, če se simptomi poslabšajo, vendar pa ni nujno, da se bodo simptomi po zmanjšanju odmerka izboljšali.