FrancophonIA/ELRC3.0 huggingface dataset:
English: SUMMARY OF PRODUCT CHARACTERISTICS
Slovenian: PRILOGA I POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
English: • Inflammation and swelling of the tubes in your lungs (bronchitis).
Slovenian: • vnetje in zatekanje pljučnih žil (bronhitis),
English: • The need for pregnancy tests i.e. before treatment, at least every 4 weeks during treatment and at least 4 weeks after treatment
Slovenian: • potreba po testih nosečnosti, in sicer pred zdravljenjem, vsaj vsake 4 tedne med samim zdravljenjem in vsaj 4 tedne po zdravljenju
English: Acute myeloid leukaemia (AML) and myelodysplastic syndromes (MDS) AML and MDS were reported in one clinical study in patients with previously untreated multiple myeloma receiving the combination of melphalan, prednisone, and thalidomide (see section 4.4).
Slovenian: Akutna mieloična levkemija (AML) in mielodisplastični sindromi (MDS) V klinični študiji so poročali o AML in MDS pri bolnikih s predhodno nezdravljenim disemininiranim plazmocitomom, ki so prejemali kombinacijo melfalana, prednizona in talidomida (glejte poglavje 4.4).
English: Teratogenicity
Slovenian: Teratogenost
English: If pregnancy occurs in a woman treated with thalidomide, treatment must be stopped immediately and the patient should be referred to a physician specialised or experienced in teratology for evaluation and advice.
Slovenian: Če ženska, ki se zdravi s talidomidom, zanosi, je treba zdravljenje nemudoma ustaviti in bolnico napotiti k zdravniku specialistu za teratologijo ali k zdravniku z izkušnjami v teratologiji, da oceni stanje in bolnici ustrezno svetuje.
English: Myocardial infarction (MI) has been reported in patients receiving thalidomide, particularly in those with known risk factors.
Slovenian: Pri bolnikih, zlasti pri tistih z znanimi dejavniki tveganja, ki so prejemali talidomid, so poročali o miokardnem infarktu (MI).
English: • She understands the need for effective contraception, without interruption, at least 4 weeks before starting treatment, throughout the entire duration of treatment, and at least 4 weeks after the end of treatment
Slovenian: • Bolnica razume potrebo po zanesljivi kontracepciji brez prekinitev, vsaj 4 tedne pred pričetkom zdravljenja, med celotnim trajanjem zdravljenja ter vsaj 4 tedne po koncu zdravljenja.
English: • The need for effective contraception, without interruption, at least 4 weeks before starting treatment, throughout the entire duration of treatment, and at least 4 weeks after the end of treatment
Slovenian: • potrebna je zanesljiva kontracepcija brez prekinitev, vsaj 4 tedne pred pričetkom zdravljenja, med celotnim trajanjem zdravljenja ter vsaj 4 tedne po koncu zdravljenja
English: There is minimal cytochrome P450 catalysed hepatic metabolism of thalidomide.
Slovenian: Obstaja minimalna jetrna presnova talidomida, katalizirana s citokromom P450.
English: The benefit achieved with thalidomide and the risk of AML and MDS must be taken into account before initiating treatment with thalidomide in combination with melphalan and prednisone.
Slovenian: Pred uvedbo zdravljenja s talidomidom v kombinaciji z melfalanom in prednizonom je treba upoštevati oboje, koristi talidomida in tveganje AML in MDS.
English: • Bleeding from the stomach or bowels (gastrointestinal haemorrhage).
Slovenian: • krvavitev iz želodca ali črevesa (krvavitev prebavil),
English: 2 D bar code carrying the unique identifier
Slovenian: EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.
English: Prednisone dosed once daily on Days 1 to 4 of each 42-day cycle.
Slovenian: f Prednizon se daje enkrat na dan od 1. do 4. dne vsakega 42-dnevnega cikla.
English: • Treatment initiation forms and/or equivalent tool for women with no childbearing potential should also include: o Confirmation that the physician has discussed the following:
Slovenian: • Obrazci za začetek zdravljenja in/ali ustrezno orodje za ženske, ki niso v rodni dobi, morajo vsebovati tudi: o Potrdilo, da se je zdravnik pogovoril o naslednjem:
English: Table 2: Recommended dose modifications for thalidomide -related neuropathy in first line treatment of multiple myeloma
Slovenian: Preglednica 2: Priporočene spremembe odmerkov za nevropatijo, povezano s talidomidom, za primarno zdravljenje diseminiranega plazmocitoma Resnost nevropatije
English: Acute myeloid leukaemia (AML) and myelodysplastic syndromes (MDS) A statistically significant increase of AML and MDS was observed in one clinical study in patients with previously untreated MM receiving the combination of melphalan, prednisone, and thalidomide (MPT).
Slovenian: Akutna mieloična levkemija (AML) in mielodisplastični sindromi (MDS) V klinični študiji so pri bolnikih s predhodno nezdravljenim diseminiranim plazmocitomom, ki so prejemali kombinacijo melfalana, prednizona in talidomida (MPT), opazili statistično pomembno povečanje AML in MDS.
English: It is important to note that a small number of patients with multiple myeloma may develop additional types of cancer, especially haematological malignancies, and it is possible that this risk may be increased with Thalidomide Celgene treatment; therefore your doctor should carefully evaluate the benefit and risk when you are prescribed Thalidomide Celgene.
Slovenian: Pomembno je omeniti, da se lahko pri majhnem številu bolnikov z diseminiranim plazmocitomom razvijejo dodatne vrste raka, zlasti hematološke malignosti.
English: Particularly, a haemoglobin concentration above 12g/dl should lead to discontinuation of erythropoietic agents.
Slovenian: Posebej pomembno je ukiniti zdravljenje z eritropoetskimi zdravili, če se koncentracija hemoglobina dvigne nad 12 g/dl.
English: Thalidomide causes birth defects and foetal death.
Slovenian: Talidomid povzroča prirojene okvare in smrt zarodka.
English: Myelodysplastic syndrome*
Slovenian: občasni mielodisplastični sindrom*,^
English: If pregnancy occurs in a partner of a male patient taking thalidomide, the female partner should be referred to a physician specialised or experienced in teratology for evaluation and advice.
Slovenian: Če partnerica moškega, ki jemlje talidomid, zanosi, jo je treba napotiti k zdravniku specialistu za teratologijo ali zdravniku z izkušnjami v teratologiji, da oceni stanje in bolnici ustrezno svetuje.
English: Dose delay, reduction or discontinuation, dependent upon the NCI CTC (National Cancer Institute Common Toxicity Criteria) grade, may be necessary.
Slovenian: Glede na stopnjo toksičnosti po splošnih merilih Nacionalnega inštituta za raka (NCI CTC - National Cancer Institute Common Toxicity Criteria) bo morda potrebna odložitev, zmanjšanje odmerka ali ukinitev zdravljenja.
English: Patients with severe organ impairment should be carefully monitored for adverse reactions.
Slovenian: Posebnih priporočil o odmerkih za to skupino bolnikov ni. Bolnike s hudo okvaro organov je treba skrbno spremljati v zvezi z neželenimi učinki.
English: 200 mg daily 0.125 mg/kg daily 2 mg/kg daily
Slovenian: 0,125 mg/kg na dan
English: • Obligations of healthcare professionals who intend to prescribe or dispense Thalidomide Celgene including o The need to provide comprehensive advice and counselling to patients o That patients should be capable of complying with the requirements for the safe use of thalidomide o Need to provide patients with the appropriate patient educational material o Report any pregnancy, or adverse events to Celgene and the local health authority (if applicable to a Member State) using the forms provided in the “Educational Healthcare Professional's Kit”
Slovenian: • Obveznosti zdravstvenih delavcev, ki nameravajo predpisovati ali izdajati zdravilo Thalidomide Celgene, kar vključuje: o obveznost izčrpnega svetovanja bolnikom, o bolniki morajo biti sposobni izpolnjevati zahteve za varno uporabo talidomida, o bolnikom je treba izročiti ustrezna izobraževalna gradiva,
English: Cases of allergic reactions/angioedema and serious cutaneous reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported with the use of Thalidomide.
Slovenian: Pri uporabi talidomida so poročali o primerih alergijskih reakcij/angioedema in resnih reakcijah na koži, vključno s Stevens-Johnsonovim sindromom (SJS), toksično epidermalno nekrolizo (TEN) in reakcijo na zdravilo z eozinofilijo in sistemskimi simptomi (DRESS).
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu, kjer so na voljo tudi povezave do drugih spletnih strani o redkih boleznih in zdravljenju.
English: • Fever, feeling generally unwell.
Slovenian: • povišana telesna temperatura, splošno slabo počutje,
English: • That if his partner becomes pregnant he should inform his treating doctor immediately and always use a condom during intercourse
Slovenian: • opozorilo, da je treba v primeru zanositve partnerice nemudoma obvestiti zdravnika, ki vodi zdravljenje, in med odnosom vedno uporabljati kondom
English: • Treatment initiation forms and/or equivalent tool for women of childbearing potential should also include: o Confirmation that the physician has discussed the following:
Slovenian: • Obrazci za začetek zdravljenja in/ali ustrezno orodje za ženske v rodni dobi morajo vsebovati tudi naslednje elemente: o Potrdilo, da se je zdravnik pogovoril o naslednjem:
English: Always take Thalidomide Celgene exactly as your doctor or pharmacist has told you to.
Slovenian: Pri jemanju zdravila Thalidomide Celgene natančno upoštevajte navodila zdravnika ali farmacevta.
English: Haematological disorders
Slovenian: Hematološke bolezni
English: • Swelling of hands and feet.
Slovenian: • zatekanje rok in nog,
English: An increased incidence of second primary malignancies (SPM) has also been observed in patients with newly diagnosed MM receiving lenalidomide.
Slovenian: Pri bolnikih z novo diagnosticiranim disemniniranim plazmocitomom, ki so prejemali lenalidomid, so opazili tudi zvišano incidenco drugih primarnih malignosti.
English: • The need for pregnancy tests i.e. before treatment, at least every 4 weeks during treatment and after treatment
Slovenian: • potrebno je izvesti teste nosečnosti pred zdravljenjem, vsaj vsake 4 tedne med zdravljenjem in po zdravljenju
English: As such the metabolism of thalidomide is not expected to be affected by hepatic or renal dysfunction.
Slovenian: Ne pričakuje se, da bi jetrna ali ledvična disfunkcija vplivala na presnovo talidomida.
English: All unused capsules should be returned to the pharmacist at the end of treatment.
Slovenian: Po koncu zdravljenja je treba vse neuporabljene kapsule vrniti farmacevtu.
English: Somnolence
Slovenian: Somnolenca
English: Pulmonary embolism*, Interstitial lung disease, Bronchopneumopathy, Dyspnea
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora pogosti pljučna embolija*, intersticijska pljučna bolezen, bronhopnevmopatija, dispneja neznana pogostnost pljučna hipertenzija†
English: • That thalidomide is found in semen and the need to use condoms if sexual partner is pregnant or is a woman with childbearing potential not using effective contraception
Slovenian: • talidomid je prisoten v spermi, zato mora pri spolni partnerici, ki je noseča ali v rodni dobi in ne uporablja zanesljive kontracepcije, uporabiti kondom
English: Thalidomide must be discontinued for angioedema, Grade 4 rash, exfoliative or bullous rash, or if SJS, TEN or DRESS is suspected, and should not be resumed following discontinuation for these reactions.
Slovenian: Talidomid je treba ukiniti pri angioedemu, izpuščaju 4. stopnje, eksfoliativnem ali buloznem izpuščaju in pri sumu na SJS, TEN ali DRESS in ga po ukinitvi zaradi teh reakcij ne smemo spet začeti dajati (glejte poglavji 4.2 in 4.8).
English: Patients treated with thalidomide have an increased risk of venous thromboembolism (such as deep vein thrombosis and pulmonary embolism) and arterial thromboembolism (such as myocardial infarction and cerebrovascular event) (see section 4.8).
Slovenian: Pri bolnikih, ki so se zdravili s talidomidom, je tveganje za vensko trombembolijo (kot sta globoka venska tromboza in pljučna embolija) večje (glejte poglavje 4.8).
English: Platelet Count (/µL)
Slovenian: Število trombocitov (/µl)
English: NAME OF THE MARKETING AUTHORISATION HOLDER
Slovenian: IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le na recept s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: How to take Thalidomide Celgene
Slovenian: Kako jemati zdravilo Thalidomide Celgene
English: • Blurred vision.
Slovenian: • zamegljen vid,
English: Adverse reactions from post-marketing experience such as febrile neutropenia and pancytopenia were reported with thalidomide.
Slovenian: Pri talidomidu so poročali o neželenih učinkih v okviru izkušenj v obdobju trženja, kot sta febrilna nevtropenija in pancitopenija.
English: Patients should be monitored for syncope, bradycardia and atrioventricular block; dose reduction or discontinuation may be required.
Slovenian: Sinkopa, bradikardija in atrioventrikularni blok Bolnike je treba spremljati za sinkopo, bradikardijo in atrioventrikularni blok.
English: Thalidomide Celgene 50 mg thalidomide
Slovenian: IME ZDRAVILA Thalidomide Celgene 50 mg talidomid
English: • Hearing decreased or deafness.
Slovenian: • poslabšanje sluha ali gluhost,
English: Thalidomide Celgene 50 mg hard capsules thalidomide
Slovenian: Thalidomide Celgene 50 mg trde kapsule talidomid
English: Patients should not donate blood during treatment (including during dose interruptions) and for at least 7 days following discontinuation of thalidomide.
Slovenian: Bolniki med zdravljenjem (vključno med prekinitvijo odmerjanja) in še vsaj 7 dni po ukinitvi zdravljenja s talidomidom ne smejo darovati krvi.
English: Most patients taking thalidomide can be expected to experience adverse reactions.
Slovenian: Pričakuje se, da se bodo neželeni učinki pojavili pri večini bolnikov, ki jemljejo talidomid.
English: Toxic skin eruption, Rash, Dry skin
Slovenian: Bolezni kože in podkožja občasni toksični kožni izpuščaj, izpuščaj, suha koža neznana pogostnost
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Slovenian: ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI Neuporabljeno zdravilo morate vrniti farmacevtu.
English: Deep vein thrombosis*
Slovenian: Žilne bolezni pogosti globoka venska tromboza*
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJ Ime in naslov izdelovalcev, odgovornih za sproščanje serij Celgene Distribution B.V.
English: Dose delay, reduction or discontinuation, dependent upon the NCI CTC grade, may be necessary.
Slovenian: Glede na stopnjo NCI CTC bo morda potrebna odložitev, zmanjšanje odmerka ali ukinitev zdravljenja.
English: Male patients should not donate semen or sperm during treatment (including during dose interruptions) and for at least 7 days following discontinuation of thalidomide.
Slovenian: Moški bolniki med zdravljenjem (vključno med prekinitvijo odmerjanja) in še vsaj 7 dni po ukinitvi zdravljenja s talidomidom ne smejo darovati semenčic ali sperme.
English: The distribution of thalidomide is not influenced by age, gender, renal function and blood chemistry variables, to any significant level.
Slovenian: Starost, spol, delovanje ledvic in parametri biokemičnih krvnih preiskav nimajo pomembnega vpliva na porazdelitev talidomida.
English: 100 mg daily 0.20 mg/kg daily 2 mg/kg daily
Slovenian: 0,20 mg/kg na dan
English: Hearing impaired or deafness
Slovenian: Okvara jeter in ledvic
English: Thalidomide Celgene 50 mg hard capsules
Slovenian: IME ZDRAVILA Thalidomide Celgene 50 mg trde kapsule
English: What Thalidomide Celgene is
Slovenian: Thalidomide Celgene.
English: Thalidomide Celgene 50 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Thalidomide Celgene 50 mg
English: Do not use if you notice any damage or signs of tampering.
Slovenian: Ne uporabljajte tega zdravila, če opazite poškodbe ali znake odpiranja.
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before taking this medicine in the following situations:
Slovenian: Pred začetkom jemanja zdravila Thalidomide Celgene se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro v naslednjih primerih:
English: • That he should not donate semen during treatment (including during dose interruptions) and for at least 7 days following discontinuation of thalidomide
Slovenian: • opozorilo, da med zdravljenjem (tudi v obdobju med prekinitvijo odmerjanja) in še vsaj 7 dni po koncu zdravljenja ne sme darovati sperme
English: Reporting of side effects
Slovenian: Okrepitev sedativnih učinkov drugih zdravil
English: Hepatic and renal impairment
Slovenian: Srčne in žilne bolezni
English: 100 mg daily 0.10 mg/kg daily 2 mg/kg daily
Slovenian: 0,10 mg/kg na dan
English: • Implant
Slovenian: • vsadek
English: • The need to stop thalidomide immediately upon suspicion of pregnancy
Slovenian: • opozorilo, da je v primeru suma na nosečnost treba takoj ustaviti zdravljenje s talidomidom
English: 6.6 Special precautions for disposal and other handling
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Kapsul ne odpirajte in ne drobite.
English: Cases of pulmonary hypertension, some fatal, have been reported in patients treated with thalidomide.
Slovenian: Pri bolnikih, zdravljenih s talidomidom, so poročali o primerih pljučne hipertenzije, ki se je včasih končala s smrtjo.
English: • Need to stop thalidomide immediately upon suspicion of pregnancy
Slovenian: • takoj po sumu na nosečnost mora prenehati uporabljati talidomid
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA Za peroralno uporabo.
English: 200 mg daily 0.25 mg/kg daily 2 mg/kg daily
Slovenian: 0,25 mg/kg na dan
English: Neutropenia, Leukopenia, Anaemia, Lymphopenia, Thrombocytopenia
Slovenian: Bolezni krvi in limfatičnega sistema zelo pogosti nevtropenija, levkopenija, anemija, limfopenija, trombocitopenija pogosti febrilna nevtropenija†, pancitopenija†
English: WALLET CARD
Slovenian: ŠTEVILKA SERIJE Lot
English: Vascular disorders
Slovenian: Trombocitopenija
English: Serious cutaneous reactions including Stevens-Johnson syndrome TEN and DRESS have been reported with the use of thalidomide therapy.
Slovenian: Pri zdravljenju s talidomidom so poročali o hudih kožnih reakcijah, vključno s Stevens-Johnsonovim sindromom, TEN in DRESS.
English: If thalidomide makes contact with the mucous membranes, they should be thoroughly flushed with water.
Slovenian: V primeru stika talidomida s sluznico jo morate temeljito sprati z obilico vode.
English: • Take this medicine by mouth.
Slovenian: • Zdravilo se uporablja peroralno.
English: Thrombocytopenia, including grade 3 or 4 adverse reactions, has been reported in multiple myeloma patients receiving MPT.
Slovenian: Pri bolnikih z diseminiranim plazmocitomom, ki so prejemali MPT, so poročali o trombocitopeniji, vključno z neželenimi učinki 3. ali 4. stopnje.
English: Other medicines and Thalidomide Celgene
Slovenian: Shranjevanje zdravila Thalidomide Celgene
English: • The need to contact their doctor immediately upon suspicion of pregnancy o Male patients
Slovenian: • opozorilo, da mora v primeru suma na nosečnost, o tem nemudoma obvestiti zdravnika o Moški bolniki; • potreba po izogibanju izpostavljenosti ploda
English: LABELLING AND PACKAGE LEAFLET
Slovenian: PRILOGA III OZNAČEVANJE IN NAVODILO ZA UPORABO
English: Discontinue treatment
Slovenian: Ukinite zdravljenje.
English: You will be more prone to bleeding and bruising.
Slovenian: • imate zmanjšano število trombocitov, zato boste bolj nagnjeni h krvavitvam in modricam;
English: Printing ink
Slovenian: PRETISNI OMOTI
English: Neutropenia Leukopenia Anaemia
Slovenian: nevtropenija levkopenija anemija limfopenija trombocitopenija
English: Renal failure
Slovenian: insuficienci ledvic.
English: Viral infections, including herpes zoster and hepatitis B virus reactivation
Slovenian: Infekcijske in parazitske bolezni pogosti pljučnica neznana pogostnost hude okužbe (npr. smrtno nevarna sepsa, vključno s septičnim šokom)†, virusne okužbe, vključno z reaktivacijo virusa herpes zoster in virusa hepatitisa B†
English: Immune System Disorders Not Known
Slovenian: Bolezni endokrinega sistema neznana pogostnost hipotiroidizem†
English: What Thalidomide Celgene contains
Slovenian: Kaj vsebuje zdravilo Thalidomide Celgene:
English: 28 hard capsules
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 28 trdih kapsul
English: • Constipation.
Slovenian: • zaprtje,
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni jeter, žolčnika in žolčevodov neznana pogostnost bolezni jeter†
English: , Drug reaction with eosinophilia and systemic symptoms*
Slovenian: Stevens-Johnsonov sindrom*,†, toksična epidermalna nekroliza*,†, reakcija na zdravilo z eozinofilijo in sistemskimi simptomi*,†,
English: • That she should not donate blood during treatment (including during dose interruptions) and for at least 7 days following discontinuation of thalidomide
Slovenian: • med zdravljenjem (tudi v obdobju med prekinitvijo odmerjanja) in še vsaj 7 dni po ukinitvi jemanja talidomida ne sme darovati krvi
English: †, Pancreatitis Gastrointestinal haemorrhage
Slovenian: neznana pogostnost perforacije v prebavilih†, pankreatitis†, gastrointestinalna krvavitev †
English: if you are over 65 years of age.
Slovenian: - če ste starejši od 65 let.
English: OS was similar.
Slovenian: OS je bil podoben.
English: 100% of planned dose
Slovenian: 100 % načrtovanega odmerka
English: if you drink alcohol or are an alcoholic.
Slovenian: - če pijete alkohol ali ste alkoholik.
English: The following information is intended for healthcare professionals only:
Slovenian: Naslednje informacije so namenjene samo zdravstvenim delavcem:
English: The amount of alcohol in this medicinal product may alter the effects of other medicines.
Slovenian: Količina alkohola v tem zdravilu lahko spremeni učinke drugih zdravil.
English: Harmful for those suffering from alcoholism.
Slovenian: Škodljivo je za tiste, ki trpijo za alkoholizmom.
English: This medicinal product must not be mixed with other medicinal products, except those mentioned in section 6.6.
Slovenian: Zdravila ne smemo mešati z drugimi zdravili, razen s tistimi, ki so omenjena v poglavju 6.6.
English: Unopened vial 3 years.
Slovenian: Neodprta viala 3 leta
English: These reactions can occur very early in the first infusion, but may also occur with subsequent infusions.
Slovenian: Te reakcije se lahko pojavijo že zelo zgodaj med prvo infuzijo, lahko pa tudi šele pri poznejših infuzijah.
English: Via Franco Gorgone Zona Industriale 95100 Catania Italy
Slovenian: Via Franco Gorgone Zona Industriale 95100 Catania Italija
English: Side effects for which frequency is not known (cannot be estimated from available data):
Slovenian: Neželeni učinki, pri katerih pogostnost ni znana (ni mogoče oceniti iz razpoložljivih podatkov):
English: Discuss alternatives with your doctor.
Slovenian: O alternativnih možnostih se posvetujte z zdravnikom.
English: Torisel is used to treat the following types of cancer in adults:
Slovenian: Zdravilo Torisel se uporablja za zdravljenje naslednjih vrst raka pri odraslih:
English: If you are concerned about this, tell your doctor immediately.
Slovenian: Če vas to skrbi, takoj obvestite zdravnika.
English: Use a new vial.
Slovenian: Uporabite novo vialo.
English: The primary study endpoint was overall survival (OS).
Slovenian: Primarni opazovani dogodek je bilo celokupno preživetje (OS).
English: Immunosuppressants may affect responses to vaccination.
Slovenian: Imunosupresivi lahko vplivajo na odziv na cepljenje.
English: Do not use Torisel:
Slovenian: Ne uporabljajte zdravila Torisel: