natgillin/translations-raw huggingface dataset:
• The most appropriate strategies to monitor the off-label use within national territories
• najustreznejših strategijah za nadzor neodobrene uporabe zdravila znotraj nacionalnega območja,
• Tumour Lysis Syndrome - metabolic complications that can occur during the treatment of cancer and sometimes even without treatment.
• sindrom tumorske lize - presnovni zapleti, ki se lahko pojavijo med zdravljenjem raka, včasih tudi brez zdravljenja.
A female patient or a female partner of a male patient is considered to have childbearing potential unless she meets at least one of the following criteria:
Predpostavlja se, da bolnica ali partnerica moškega bolnika lahko zanosi, razen če izpolnjuje vsaj eno od naslednjih meril:
The risk of venous thromboembolism continues for 4-6 weeks after discontinuing combined oral contraception.
Tveganje za vensko trombembolijo se nadaljuje še 4-6 tednov po ukinitvi jemanja kombinirane peroralne kontracepcije.
• She is informed and understands the potential consequences of pregnancy and the need to rapidly consult her doctor if there is a risk of pregnancy
• Bolnica je obveščena in razume možne posledice nosečnosti in potrebo po takojšnjem posvetovanju z zdravnikom, če obstaja tveganje za zanositev.
• if you are able to become pregnant, unless you are able to follow or comply with the required contraceptive measures to prevent you from becoming pregnant (see section 2 “Warnings and precautions” and “Pregnancy and breast-feeding”).
• če lahko zanosite, razen če lahko sledite potrebnim kontracepcijskim ukrepom za preprečevanje nosečnosti oziroma ravnate v skladu z njimi (glejte poglavje 2 „Opozorila in previdnostni ukrepi“ in „Nosečnost in dojenje“).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Znotraj vsake skupine pogostnosti so neželeni učinki navedeni po padajoči resnosti.
• Sudden pain in your chest or difficulty in breathing.
• Nenadna bolečina v prsih ali težko dihanje.
Hepatitis B virus status should be established before initiating treatment with thalidomide.
Status virusa hepatitisa B je treba ugotoviti pred začetkom zdravljenja s talidomidom.
• if you are able to become pregnant, your doctor will record with each prescription that the necessary measures have been taken and will provide you with this confirmation.
• če lahko zanosite, bo zdravnik z vsakim receptom zabeležil, da so bili izvedeni potrebni ukrepi, in vam izročil to potrdilo.
• Pregnancy and any exposure during pregnancy must be avoided.
• Preprečite nosečnost in vsakršno izpostavitev med nosečnostjo.
The MAH should agree on the implementation of the patient card system in each Member State.
Imetnik dovoljenja za promet z zdravilom se mora dogovoriti o izvajanju sistema kartic za bolnike v vsaki državi članici.
Platelet counts should be monitored on an ongoing basis, in accordance with oncology guidelines.
Redno je treba kontrolirati število trombocitov v skladu z onkološkimi smernicami.
Pharmacotherapeutic group: immunosuppressants, other immunosuppressants, ATC code: L04AX02.
Farmakoterapevtska skupina: zdravila za zaviranje imunske odzivnosti, drugi imunosupresivi, oznaka ATC: L04AX02.
Allergic reactions and severe skin reactions
Alergijske reakcije in hude reakcije na koži
If a patient is currently using combined oral contraception, she should switch to one of the effective methods listed above.
Če bolnica trenutno uporablja kombinirano peroralno kontracepcijo, mora preiti na eno od zgoraj naštetih zanesljivih metod.
The risk of intra-uterine death or severe birth defects, primarily phocomelia, is extremely high.
Tveganje intrauterine smrti ali resnih prirojenih okvar, zlasti fokomelije, je izjemno veliko.
The plasma protein binding of the (+)-(R) and (-)-(S) enantiomers was found to be 55 % and 65 % respectively.
Vezava na plazemske proteine (+)-(R) enantiomerov je znašala 55 % in (-)-(S) enantiomerov 65 %.
If less than 12 hours has elapsed since missing a dose, the patient can take the dose.
Če je od izpuščenega odmerka preteklo manj kot 12 ur, bolnik odmerek lahko vzame.
Do not use this medicine after the expiry date which is stated on the wallet card and the blister after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu poleg oznake ''EXP''.
You will have been given specific instructions by your doctor, particularly on the effects of thalidomide on unborn babies (outlined in the Thalidomide Celgene Pregnancy Prevention Programme).
Zdravnik vam bo dal posebna navodila, zlasti o učinkih talidomida na nerojene otroke (ti so navedeni v Programu Thalidomide Celgene za preprečevanje nosečnosti).
For women taking Thalidomide Celgene Before starting the treatment, you should ask your doctor if you are able to become pregnant, even if you think this is unlikely.
Za ženske, ki jemljejo zdravilo Thalidomide Celgene Pred začetkom zdravljenja morate vprašati zdravnika, ali lahko zanosite, tudi če mislite, da to ni verjetno.
No effects were observed in dogs; however in rats, there was an apparent dose-dependent decrease in total and free T4 that was more consistent in the female.
Učinkov pri psih niso opazili, pri podganah pa je bilo očitno od odmerka odvisno zmanjšanje pri skupnem in prostem T4, ki je bilo bolj enakomerno pri samicah.
The latter appears to be related to thalidomide and occurred at exposures greater than 2.4-fold the human exposure.
Kaže, da je slednje povezano s talidomidom in se pojavi pri izpostavljenostih, ki so 2,4-krat višje od izpostavljenosti pri ljudeh.
Survival time median ± se (month)
Čas preživetja mediana ± sn (mesec)
• National specific requirements agreed with the National Competent Authority regarding: o Distribution of the product o Procedures to ensure that all appropriate measures have been performed prior to thalidomide being dispensed
• posebnih zahtev posameznih držav po dogovoru s pristojnim nacionalnim organom glede: o distribucije zdravila, o postopkov za zagotovitev izvedbe vseh ustreznih ukrepov pred začetkom izdajanja talidomida.
Tell your doctor straight away if you notice any of the following serious side effects:
Takoj obvestite zdravnika, če opazite katerega od naslednjih resnih neželenih učinkov:
Prescribing and dispensing restrictions
Omejitve v zvezi s predpisovanjem in izdajanjem
White blood cell count and differential should be monitored on an ongoing basis, in accordance with oncology guidelines, especially in patients who may be more prone to neutropenia.
Redno je treba kontrolirati število belih krvničk in diferencialno krvno sliko v skladu z onkološkimi smernicami, zlasti pri bolnikih, ki so nagnjeni k nevtropeniji.
Patients should be advised as to the possible impairment of mental and/or physical abilities required for the performance of hazardous tasks (see section 4.7).
Bolnikom je treba svetovati glede možnega poslabšanja mentalnih in/ali fizičnih sposobnosti, potrebnih za izvajanje nevarnih nalog (glejte poglavje 4.7).
> 75 < 1,500 but
> 75 < 1.500, vendar
Treatment with Thalidomide Celgene may cause a virus to become active again in patients who carry it, resulting in a recurrence of the infection.
Zdravljenje z zdravilom Thalidomide Celgene lahko povzroči, da postane virus pri bolnikih, ki ga prenašajo, spet aktiven, zato se okužba ponovi.
Careful monitoring of patients for symptoms of neuropathy is recommended.
Priporoča se skrbno spremljanje bolnikov v zvezi s simptomi nevropatije.
Infections Patients should be monitored for severe infections including sepsis and septic shock.
Okužbe Bolnike je treba spremljati glede pojava hudih okužb, vključno s sepso in septičnim šokom.
In thirteen of these cases, patients took thalidomide alone; amounts ranged from 350 mg to 4000 mg.
Pri trinajstih od teh primerov so bolniki jemali samo talidomid v odmerkih med 350 mg in 4000 mg.
• Medroxyprogesterone acetate depot
• depo medroksiprogesteronacetat
For patients who test positive for HBV infection, consultation with a physician with expertise in the treatment of hepatitis B is recommended.
Pri bolnikih s pozitivnim testom na okužbo s HBV se priporoča posvet z zdravnikom, ki ima izkušnje z zdravljenjem hepatitisa B.
The mean elimination half-life of thalidomide in plasma following single oral doses between 50 mg and 400 mg was 5.5 to 7.3 hours.
Srednja razpolovna doba izločanja talidomida v plazmi po enkratnih peroralnih odmerkih med 50 mg in 400 mg je znašala 5,5 do 7,3 ure.
If the neuropathy resolves to Grade 1 or better, the treatment may be restarted, if the benefit/risk is favourable.
Če se nevropatija izboljša do 1. stopnje ali še bolj, se lahko ponovno prične z zdravljenjem, če je razmerje med koristjo in tveganjem ugodno.
Patients should be instructed to avoid situations where somnolence may be a problem and to seek medical advice before taking other medicinal products known to cause somnolence.
Bolnike je treba poučiti, da naj se izognejo situacijam, kjer somnolenca lahko povzroča težave, in se posvetujejo z zdravnikom, preden vzamejo druga zdravila, za katera je znano, da povzročajo somnolenco.
Patients should be monitored and dose delay, reduction or discontinuation may be required (see section 4.2).
Bolnike je treba spremljati in odmerek odložiti, zmanjšati ali ukiniti (glejte poglavje 4.2).
Do not take Thalidomide Celgene if any of the above applies to you.
Ne jemljite zdravila Thalidomide Celgene, če kar koli od navedenega velja za vas.
• Shaking (tremor).
• tresavica (tremor),
If no improvement or continued worsening of the neuropathy, discontinue treatment.
Če ni izboljšanja ali se nevropatija nenehno slabša, ukinite zdravljenje.
• Having difficulty in seeing or speaking, which is temporary.
• Kratkotrajne težave pri gledanju ali govorjenju.
The controlled distribution system includes the use of a patient card and/or equivalent tool for prescribing and/or dispensing controls, and the collecting of detailed data relating to the indication in order to monitor closely the off-label use within the national territory.
Nadzorovani sistem distribucije vključuje uporabo kartice za bolnika in/ali drugega orodja za nadzor predpisovanja in/ali izdajanja zdravila ter zbiranje podrobnih podatkov v zvezi z indikacijo, da bi skrbno nadzorovali neodobreno uporabo znotraj nacionalnega območja.
If you do not fully understand these instructions, please ask your doctor to explain them again before you take thalidomide.
Če teh navodil niste v celoti razumeli, prosite zdravnika, da vam jih ponovno razloži, preden vzamete talidomid.
Even if you do not have a menstrual bleeding following cancer therapy, you may become pregnant.
Tudi če zaradi zdravljenja raka ali dojenja nimate menstrualne krvavitve, lahko zanosite.
The capsules are supplied in a wallet card containing 28 capsules (2 blisters of 14 capsules each).
Kapsule se nahajajo v škatlah, ki vsebujejo 28 kapsul (2 pretisna omota s po 14 kapsulami).
≤ 75 < 1,500 but
≤ 75 < 1.500, vendar
• Core text as agreed by the CHMP
• osrednjega besedila, kot ga je odobril Odbor za zdravila za uporabo v humani medicini (CHMP),
• Pregnancy prevention requirement, definition and need for adequate contraceptive methods
• opredelitev zahteve preprečevanja nosečnosti in potrebe po ustreznih kontracepcijskih metodah
Bradycardic effect
Učinek bradikardije
This 18 month difference was statistically significant with a hazard ratio of reduction of risk of death in the MPT arm of 0.59, 97.5 % confidence interval of 0.42-0.84 and p-value of < 0.001 (see Figure 1).
Ta 18-mesečna razlika je bila statistično pomembna z znižanjem razmerja nevarnosti tveganja za smrti v skupini MPT z 0,59; 97,5 %, interval zaupanja 0,42-0,84 in vrednostjo p < 0,001 (glejte sliko 1).
ANNEX IV SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION TO THE TERMS OF THE MARKETING AUTHORISATION(S)
PRILOGA IV ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA SPREMEMBO POGOJEV DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM
Symptoms may occur some time after thalidomide treatment has been stopped and may resolve slowly or not at all.
Simptomi se lahko pojavijo nekaj časa po prenehanju zdravljenja s talidomidom in lahko izginejo počasi ali pa sploh ne izginejo.
The MAH shall implement a Pregnancy Prevention Programme (PPP) in each Member State.
Imetnik dovoljenja za promet z zdravilom mora izvajati program za preprečevanje nosečnosti (PPN) v vsaki državi članici.
Educational materials
Izobraževalna gradiva
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)