natgillin/translations-raw huggingface dataset:
These pregnancy tests should be performed on the day of the prescribing visit or in the 3 days prior to the visit to the prescriber.
Te teste nosečnosti je treba izvesti na dan obiska, ko zdravnik predpiše zdravilo, ali v 3 dneh pred obiskom zdravnika.
Measures of renal function (CrCl) and liver function (blood chemistry) indicate minimal effect of kidney and liver function on the pharmacokinetics of thalidomide.
Meritve delovanja ledvic (CrCl) in jeter (biokemične krvne preiskave) kažejo na minimalni učinek delovanja ledvic in jeter na farmakokinetiko talidomida.
If the patient experiences peripheral neuropathy, follow the dose and schedule modification instruction provided in section 4.2.
Če se pri bolniku pojavi periferna nevropatija, je treba upoštevati navodila za prilagoditev odmerka režima odmerjanja v poglavju 4.2.
Prophylactic antithrombotic medicinal products, such as low molecular weight heparins or warfarin, should be recommended.
Priporočiti morate uporabo profilaktičnih antitrombotikov, kakršni so nizkomolekularni heparini ali varfarin.
For men taking Thalidomide Celgene Thalidomide passes into semen.
Za moške, ki jemljejo zdravilo Thalidomide Celgene Talidomid prehaja v spermo.
The extent of thalidomide metabolism by the liver cytochrome P450 system is minimal and intact thalidomide is not excreted by the kidney.
Obseg presnove talidomida s pomočjo sistema jetrnega citokroma P450 je minimalen; ledvice ne izločajo nespremenjenega talidomida.
Thalidomide causes severe birth defects or death to an unborn baby.
Talidomid povzroča resne prirojene okvare ali smrt nerojenega otroka.
If your partner becomes pregnant whilst you are taking thalidomide, you should inform your doctor immediately.
Če vaša partnerica zanosi, medtem ko jemljete talidomid, morate o tem takoj obvestiti zdravnika.
• XY genotype, Turner's syndrome, uterine agenesis.
• Genotip XY, Turnerjev sindrom, agenezija maternice.
• A fall in the number of red and white blood cells and platelets at the same time (pancytopenia).
• hkraten padec števila rdečih in belih krvničk ter trombocitov (pancitopenija),
The MAH shall agree the details of a controlled distribution system with the National Competent Authorities and must implement such programme nationally to ensure that:
• Dodatni ukrepi za zmanjševanje tveganj Imetnik dovoljenja za promet z zdravilom se mora o podrobnostih sistema nadzorovane distribucije dogovoriti s pristojnimi nacionalnimi organi in izvajati ta program na nacionalni ravni, da tako zagotovi naslednje:
Your doctor should evaluate if you develop additional types of haematological malignancies (called acute myeloid leukaemia and myelodysplastic syndromes) during your treatment with Thalidomide Celgene (see also section 4 “Possible side effects”).
Vaš zdravnik mora oceniti, ali so se pri vas med zdravljenjem z zdravilom Thalidomide Celgene pojavile dodatne vrste hematoloških malignosti (imenovane akutna mieloična levkemija in mielodisplastični sindromi) (glejte tudi poglavje 4 „Možni neželeni učinki“).
Because of the increased risk of venous thromboembolism in patients with multiple myeloma (MM), combined oral contraceptive pills are not recommended (see section 4.5).
Zaradi povečanega tveganja za vensko trombembolijo pri bolnicah z diseminiranim plazmocitomom (DP), uporaba kombiniranih peroralnih kontracepcijskih tablet ni priporočljiva (glejte poglavje 4.5).
It is not known whether the effect will be different in multiple myeloma patients.
Ni znano, ali je učinek pri bolnikih z diseminiranim plazmocitomom drugačen.
• The need to avoid foetal exposure
• potreba po izogibanju izpostavljenosti ploda
For men taking Thalidomide Celgene who have a female partner who is able to become pregnant, please see section 2 “What you need to know before you take Thalidomide Celgene”.
Za moške, ki jemljejo zdravilo Thalidomide Celgene in imajo partnerico, ki lahko zanosi, glejte poglavje 2 „Kaj morate vedeti, preden boste vzeli zdravilo Thalidomide Celgene“.
The MAH shall notify the EMA and the appropriate national patients and victims representatives of the proposed launch date before launch in each Member State.
Imetnik dovoljenja za promet z zdravilom mora Evropsko agencijo za zdravila (EMA) ter ustrezne nacionalne predstavnike bolnikov in žrtev seznaniti s predvidenim datumom prihoda zdravila na trg pred dejanskim prihodom na trg v vsaki državi članici.
The incidence of neutropenia grade 3 or 4 reported as adverse reactions was higher in multiple myeloma patients receiving MPT (Melphalan, Prednisone, Thalidomide) than in those receiving MP (Melphalan, Prednisone): 42.7 % versus 29.5 % respectively (study IFM 99-06).
Incidenca nevtropenije 3. ali 4. stopnje v okviru poročanj neželenih učinkov je bila višja pri bolnikih z diseminiranim plazmocitomom, ki so prejemali MPT (melfalan, prednizon, talidomid), kot pri tistih, ki so prejemali MP (melfalan, prednizon): 42,7 % v primerjavi z 29,5 % (študija IFM 99-06).
Data from patients with end-stage renal disease suggest no impact of kidney function on thalidomide pharmacokinetics.
Podatki bolnikov z ledvično boleznijo končne stopnje ne kažejo na vpliv delovanja ledvic na farmakokinetiko talidomida.
• Safety advice relevant to all patients o Description and management of ischaemic heart disease (including myocardial infarction) o Disposal of unwanted medicinal product o Not to donate blood during treatment (including during dose interruptions) and for at least 7 days following discontinuation of thalidomide
• Varnostne nasvete, pomembne za vse bolnike o opis in obvladovanjeishemične bolezni srca (vključno z miokardnim infarktom) o napotke za odstranjevanje odvečnega zdravila o opozorilo, da bolniki ne smejo darovati krvi med zdravljenjem (tudi v obdobju med prekinitvijo odmerjanja) in še vsaj 7 dni po ukinitvi zdravljenja s talidomidom
• He understands the need for the use of a condom if engaged in sexual activity with a pregnant woman or a woman of childbearing potential not using effective contraception (even if the man has had a vasectomy), during treatment, during dose interruption and for at least 7 days following discontinuation of treatment.
• Bolnik razume potrebo po uporabi kondoma pri spolnem občevanju z nosečnico ali žensko v rodni dobi, ki ne uporablja zanesljive kontracepcije (tudi če je moški prestal vazektomijo) med zdravljenjem, med prekinitvijo odmerjanja in še vsaj 7 dni po ukinitvi zdravljenja.
Patients and physicians are advised to be observant for signs and symptoms of bleeding including petechiae, epistaxis and gastrointestinal haemorrhage, especially in case of concomitant medicinal product prone to inducing bleeding (see sections 4.5 and 4.8).
Bolnikom in zdravnikom se svetuje, naj bodo pozorni na znake in simptome krvavitev, vključno s petehijami, epistakso in gastrointestinalno krvavitvijo, posebno v primeru sočasnega jemanja zdravil, ki lahko povzročijo krvavitve (glejte poglavji 4.5 in
• He understands the teratogenic risk if engaged in sexual activity with a pregnant woman or a woman of childbearing potential.
• Bolnik razume tveganje teratogenih učinkov pri spolnem občevanju z nosečnico ali žensko v rodni dobi.
What you need to know before you take Thalidomide Celgene
Kaj morate vedeti, preden boste vzeli zdravilo Thalidomide Celgene
Melphalan and prednisone were dosed at 0.25 mg/kg/day and 2 mg/kg/day respectively on days 1 to 4 of each 6 weeks cycle.
Odmerek melfalana je znašal 0,25 mg/kg/dan in prednizona 2 mg/kg/dan 1. in 4. dan vsakega 6. tedenskega cikla.
• by stopping the cancer cells developing
• ustavlja razvoj rakavih celic
• The active substance is thalidomide.
• Učinkovina je talidomid.
• Healthcare professional booklet o History of thalidomide, background on Thalidomide Celgene and its licensed indication o Posology
• Brošuro za zdravstvene delavce o zgodovino talidomida, povzetek podatkov o zdravilu Thalidomide Celgene in indikacijah, za katere je odobren o odmerjanje
Medicinal products known to be associated with neuropathy should be used with caution in patients receiving thalidomide (see section 4.5).
Zdravila, za katera je znano, da povzročijo nevropatijo, morajo bolniki, ki prejemajo talidomid, jemati s previdnostjo (glejte poglavje 4.5).
• you have or have had injury to the liver (hepatic disorders) including abnormal liver test results.
• imate ali ste imeli poškodbo jeter (bolezni jeter), vključno z nenormalnimi rezultati jetrnih preiskav;
Frequencies given are based on the observations during a pivotal comparative clinical study investigating the effect of thalidomide in combination with melphalan and prednisone in previously untreated multiple myeloma patients.
Navedene pogostnosti temeljijo na opazovanjih med ključno primerjalno klinično študijo, ki je raziskovala učinek talidomida v kombinaciji z melfalanom in prednizonom pri bolnikih s predhodno nezdravljenim diseminiranim plazmocitomom.
• Pain in the upper abdomen and/or back, which may be severe and which remains for a few days, possibly accompanied by nausea, vomiting, fever and a rapid pulse - these symptoms may be due to the inflammation of the pancreas (pancreatitis).
• bolečina v zgornjem delu trebuha in/ali hrbta, ki je lahko huda in traja nekaj dni, lahko jo spremlja slabost, bruhanje, povišana telesna temperatura in hiter utrip - ti simptomi so lahko posledica vnetja trebušne slinavke (pankreatitis),
• you have experienced fever, chills and severe shaking, and possibly complicated by low blood pressure and confusion (these may be symptoms of severe infections).
• če ste imeli zvišano telesno temperaturo, mrzlico in hudo tresenje, po možnosti z zapletom zaradi nizkega krvnega tlaka in zmedenosti (to so lahko simptomi hudih okužb);
If you are able to become pregnant, your doctor will record with each prescription that the necessary measures, as outlined above, have been taken
Če lahko zanosite, bo vaš zdravnik ob vsakem receptu preveril, ali upoštevate zgoraj navedene nujne ukrepe.
• He understands that if his female partner becomes pregnant whilst he is taking thalidomide or 7 days after he has stopped taking thalidomide, he should inform his treating physician immediately and that it is recommended to refer the female partner to a physician specialised or experienced in teratology for evaluation and advice.
• Bolnik razume, da mora v primeru, da njegova partnerica zanosi, medtem ko on jemlje talidomid, ali v 7 dneh po tem, ko je prenehal jemati talidomid, o tem nemudoma obvestiti lečečega zdravnika in da je priporočljivo napotiti njegovo partnerico k zdravniku specialistu za teratologijo ali zdravniku z izkušnjami v teratologiji, da oceni stanje in bolnici ustrezno svetuje.
Among invasive SPMs, cases of MDS/AML were observed in patients receiving lenalidomide in combination with melphalan or immediately following high dose melphalan and autologous stem cell transplantation.
Med invazivnimi drugimi primarnimi malignostmi so opazili MDS/AML pri bolnikih, ki so prejemali lenalidomid v kombinaciji z melfalanom ali takoj po visokem odmerku melfalana in avtologni presaditvi matičnih celic.
Therefore breast-feeding should be discontinued during treatment with thalidomide.
Zato je treba dojenje med zdravljenjem s talidomidom ukiniti.
It is unknown whether thalidomide is excreted in human breast milk.
Ni znano, ali se talidomid izloča v materino mleko.
o The printing ink is composed of shellac, black iron oxide (E172) and propylene glycol.
o Tiskarsko črnilo vsebuje šelak, črni železov oksid (E172) in propilenglikol.
Absorption of thalidomide is slow after oral administration.
Talidomid se po peroralni uporabi absorbira počasi.
The following can be considered to be examples of effective methods of contraception:
V nadaljevanju naštete kontracepcijske metode veljajo za zanesljive:
• Chest infection (pneumonia), lung disease.
• okužbe prsnega koša (pljučnica), bolezni pljuč,
Thalidomide Celgene contains an active substance called thalidomide.
Zdravilo Thalidomide Celgene vsebuje zdravilno učinkovino, imenovano talidomid.
Women of childbearing potential must use one effective method of contraception for at least 4 weeks before start of treatment, during treatment, and until at least 4 weeks after thalidomide treatment and even in case of dose interruption unless the patient commits to absolute and continuous abstinence confirmed on a monthly basis.
Ženske v rodni dobi morajo uporabljati zanesljivo metodo kontracepcije vsaj 4 tedne pred začetkom zdravljenja, med zdravljenjem ter vsaj 4 tedne po zdravljenju s talidomidom in celo v primeru prekinitve odmerjanja, razen če se bolnica zaveže k popolni in neprekinjeni spolni vzdržnosti, ki se potrjuje vsak mesec.
Maximum daily melphalan dose: 24 mg (subjects ≤ 75 years old) or 20 mg (subjects > 75 years old).
e Največji dnevni odmerek melfalana: 24 mg (osebe, stare ≤ 75 let) ali 20 mg (osebe, stare > 75).
This may be due to blood clots in the veins of your leg (deep vein thrombosis), which is a common side effect.
Vzrok so lahko krvni strdki v venah vaših nog (globoka venska tromboza), ki je pogost neželeni učinek.
• That she should not share the treatment with any other person
• zdravila ne sme dajati nikomur drugemu
• you experience or have experienced in the past severe skin reactions called Stevens-Johnson syndrome, toxic epidermal necrolysis or drug reaction with eosinophilia and systemic symptoms(which is also known as DRESS or drug hypersensitivity syndrome).
• imate ali ste kdaj prej imeli hude reakcije na koži, ki se imenujejo Stevens-Johnsonov sindrom, toksična epidermalna nekroliza ali reakcija na zdravilo z eozionfilijo in sistemskimi simptomi (znana tudi kot DRESS ali sindrom preobčutljivosti na zdravilo).
Taking into account the PRAC Assessment Report on the PSUR(s) for thalidomide, the scientific conclusions of CHMP are as follows:
Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o oceni rednih posodobljenih poročil o varnosti zdravila (PSUR) za talidomid je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel naslednje znanstvene zaključke:
Studies conducted in healthy subjects and patients with multiple myeloma suggest that thalidomide is not influenced to any significant extent by renal or hepatic function (see section 5.2).
Študije, ki so jih opravili pri zdravih preizkušancih in bolnikih z diseminiranim plazmocitomom kažejo, da delovanje ledvic ali jeter nima pomembnega vpliva na talidomid (glejte poglavje 5.2).
Thromboembolic events
Trombembolični dogodki
• She understands the need and accepts to undergo pregnancy testing every 4 weeks except in case of confirmed tubal sterilisation
• Bolnica razume potrebo po opravljanju testa nosečnosti vsake 4 tedne in v to privoli, razen v primeru potrjene sterilizacije jajcevodov.
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
Druga zdravila in zdravilo Thalidomide Celgene Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
Thalidomide Celgene is used with two other medicines called ‘melphalan' and ‘prednisone' to treat adults with a type of cancer called multiple myeloma.
Za kaj zdravilo Thalidomide Celgene uporabljamo Zdravilo Thalidomide Celgene se uporablja z dvema drugima učinkovinama, imenovanima 'melfalan' in 'prednizon' za zdravljenje odraslih bolnikov za vrsto raka, imenovanega diseminirani plazmocitom.
Skin irritation, sores or swelling in the mouth, throat, eyes, nose and around the genitals, oedema and fever and flulike symptoms may occur.
Lahko se pojavijo draženje kože, razjede ali otekline v ustih, žrelu, očeh, nosu in okrog spolovil, edemi, zvišana telesna temperatura in gripi podobni simptomi.
• you have had an allergic reaction whilst taking Thalidomide Celgene such as rash, itching, swelling, dizziness or trouble breathing.
• če ste imeli med uporabo zdravila Thalidomide Celgene alergijsko reakcijo, kot je izpuščaj, srbenje, otekanje, omotica ali težave z dihanjem;
Additional adverse reactions from post-marketing experience with thalidomide and not seen in the pivotal study include febrile neutropenia and pancytopenia.
Dodatna neželena učinka talidomida, ki so ju opazili po prihodu zdravila na trg in ki ju v ključni študiji niso opazili, sta febrilna nevtropenija in pancitopenija.
An increased risk of venous thromboembolism (such as deep vein thrombosis and pulmonary embolism) and arterial thromboembolism (such as myocardial infarction and cerebrovascular event) has been reported in patients treated with thalidomide (see section 4.4).
O povečanem tveganju za vensko trombembolijo (kot sta globoka venska tromboza in pljučna embolija) in arterijsko trombembolijo (kot sta miokardni infarkt in cerebrovaskularni dogodek) so poročali pri bolnikih, ki so bili zdravljeni s talidomidom (glejte poglavje 4.4).
Your doctor may monitor your blood cell counts during treatment with Thalidomide Celgene.
Vaš zdravnik bo morda nadzoroval koncentracijo krvničk med zdravljenjem z zdravilom
A medically supervised pregnancy test should be performed during the consultation, when thalidomide is prescribed or in the 3 days prior to the visit to the prescriber once the patient had been using effective contraception for at least 4 weeks.
Test nosečnosti pod zdravniškim nadzorom je treba izvesti med posvetovanjem, ko se predpiše talidomid, ali 3 dni pred obiskom zdravnika, ki predpiše zdravilo, ko bolnica že vsaj 4 tedne uporablja zanesljivo kontracepcijo.
Always use a condom: o during treatment o for at least 7 days after stopping treatment
Vedno uporabljajte kondom: o med zdravljenjem o še vsaj 7 dni po koncu zdravljenja
Dear Healthcare Professional letter The Dear Healthcare Professional letter will consist of two parts:
Neposredno obvestilo za zdravstvene delavce Neposredo obvestilo za zdravstvene delavce bo sestavljeno iz dveh delov:
The results were similar with and without co-administration of thalidomide 200 mg/day to steady-state levels.
Rezultati so bili podobni pri sočasni uporabi talidomida v odmerku 200 mg/dan in brez sočasne uporabe talidomida do ravni stanja dinamičnega ravnovesja.
Thalidomide Celgene has not formally been studied in patients with impaired renal or hepatic function.
Za zdravilo Thalidomide Celgene niso izvajali formalnih študij pri bolnikih z okvaro ledvične ali jetrne funkcije.
Women of childbearing potential/Contraception in males and females Women of childbearing potential must use one effective method of contraception for at least 4 weeks before start of treatment, during treatment including during dose interruptions, and until at least 4 weeks after thalidomide treatment (see section 4.4).
Ženske v rodni dobi/kontracepcija pri moških in ženskah Ženske v rodni dobi morajo uporabljati zanesljivo metodo kontracepcije vsaj 4 tedne pred začetkom zdravljenja, med zdravljenjem, vključno med prekinitvijo odmerjanja, ter vsaj 4 tedne po zdravljenju s talidomidom (glejte poglavje 4.4).
Thalidomide Celgene in combination with melphalan and prednisone is indicated as first line treatment of patients with untreated multiple myeloma, aged ≥ 65 years or ineligible for high dose chemotherapy.
Zdravilo Thalidomide Celgene v kombinaciji z melfalanom in prednizonom je indicirano za primarno zdravljenje bolnikov z nezdravljenim diseminiranim plazmocitomom, starih ≥ 65 let, ali za bolnike, pri katerih zdravljenje z visokimi odmerki kemoterapije ni primerno.
• The following information should also be provided in the appropriate educational brochure for patients: o Women of childbearing potential
• Ustrezne izobraževalne brošure za bolnike naj vsebujejo tudi naslednje podatke: o Ženske v rodni dobi;
Patients should be monitored for: thromboembolic events, peripheral neuropathy, severe skin reactions, bradycardia, syncope, somnolence, neutropenia and thrombocytopenia (see sections 4.4 and 4.8).
Bolnike je treba nadzorovati za: trombembolične dogodke, periferno nevropatijo, hude kožne reakcije, bradikardijo, sinkopo, somnolenco, nevtropenijo in trombocitopenijo (glejte poglavji 4.4 in 4.8).
Thalidomide may also potentially aggravate existing neuropathy and should therefore not be used in patients with clinical signs or symptoms of peripheral neuropathy unless the clinical benefits outweigh the risks.
zato ga bolniki s kliničnimi znaki ali simptomi za periferno nevropatijo ne smejo uporabljati, razen če so klinične koristi večje kot tveganja.
Black iron oxide (E172) Propylene glycol
Tiskarsko črnilo šelak črni železov oksid (E172) propilenglikol
During the treatment with Thalidomide Celgene you have an increased risk of developing blood clots in the veins and arteries (see also section 4 “Possible side effects”).
Med zdravljenjem z zdravilom Thalidomide Celgene je tveganje za nastanek krvnih strdkov v venah in arterijah povečano (glejte tudi poglavje 4 „Možni neželeni učinki“);
Table 4: Comparison of haematological disorders for the melphalan, prednisone (MP) and melphalan, prednisone, thalidomide (MPT) combinations in study IFM 99-06 (see section 5.1) n (% of patients)
Preglednica 4: Primerjava hematoloških bolezni za kombinacijo melfalana, prednizona (MP) in kombinacijo melfalana, prednizona in talidomida (MPT) v študiji IFM 99-06 (glejte poglavje 5.1).
• Chest pain spreading to the arms, neck, jaw, back or stomach, feeling sweaty and breathless, feeling sick or vomiting.
• Bolečina v prsih, ki izžareva v roke, vrat, čeljust, hrbet ali trebuh, občutek oznojenosti in zasoplosti, siljenje na bruhanje ali bruhanje.
If powder from a broken Thalidomide Celgene capsule makes contact with the skin, wash the skin immediately and thoroughly with soap and water.
Če pride prašek Thalidomide Celgene v stik s kožo, kožo takoj in temeljito sperite z milom in vodo.
For women of childbearing potential, prescriptions of thalidomide should be limited to a maximum of 4 weeks of treatment and continuation of treatment requires a new prescription.
Pri ženskah v rodni dobi je treba predpisovanje talidomida omejiti na največ 4 tedne zdravljenja, za nadaljevanje zdravljenja pa je treba izdati nov recept.
• Severe blood infection (sepsis) accompanied by fever, chills and severe shaking, and possibly complicated by low blood pressure and confusion (septic shock).
• huda okužba krvi (sepsa), ki jo spremljajo povišana telesna temperatura, mrzlica in hudo tresenje, z možnim zapletom zaradi nizkega krvnega tlaka in zmedenostjo (septični šok),
Uncommon (may affect up to 1 in 100 people)
Občasni (pojavijo se lahko pri do 1 od 100 bolnikov)
Increase of sedative effects of other medicinal products Thalidomide has sedative properties, thus may enhance the sedation induced by anxiolytics, hypnotics, antipsychotics, H1 antihistamines, opiate derivatives, barbiturates and alcohol.
Talidomid ima sedativne lastnosti in lahko poveča sedacijo, ki jo povzročijo anksiolitiki, hipnotiki, antipsihotiki, antihistaminiki H1, derivati opiata, barbiturati in alkohol.
Treatment must be initiated and monitored under the supervision of physicians with expertise in managing immunomodulatory or chemotherapeutic agents and a full understanding of the risks of thalidomide therapy and monitoring requirements (see section 4.4).
Zdravljenje lahko začne in nadzira samo zdravnik, ki ima strokovno znanje za ravnanje z imunomodulatorji ali kemoterapevtiki in popolnoma razume tveganja zdravljenja s talidomidom ter zahteve glede nadzorovanja.
The maximum daily melphalan dose is 20 mg in patients > 75 years of age (see Table 1).
Največji dnevni odmerek melfalana pri bolnikih, starih > 75 let, je 20 mg (glejte preglednico 1).
Additional precautions
Dodatna opozorila
• Rash, dryness of the skin.
• izpuščaji, izsušenost kože,
In the male dog, after one year of dosing, reversible bile plugs in canaliculi were observed at exposures greater than 1.9-fold the human exposure.
Po enem letu odmerjanja pri pasjih samcih so opazili reverzibilne zamašitve izvodil žolča pri izpostavljenostih, višjih od 1,9-kratne izpostavljenosti pri ljudeh.