natgillin/translations-raw huggingface dataset:
• 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.
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: