FrancophonIA/ELRC3.0 huggingface dataset:
English: a Intent to Treat (ITT) population b p-value from the stratified log-rank test; analysis by line of therapy excludes stratification for therapeutic history; p <
Slovenian: b P-vrednost iz stratificiranega testa log-rank; v analizi po vrsti terapije ni bila vključena stratifikacija po terapevtski anamnezi, p < 0,0001
English: Hazard ratiob (95% CI) p-valuec a Kaplan-Meier estimate.
Slovenian: p-vrednostc a Ocena po metodi Kaplan-Meier.
English: Frequencies are defined as: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Slovenian: < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000),
English: Common Hyperbilirubinaemia*, Protein analyses abnormal*, Weight decreased, Weight increased
Slovenian: Pogosti hiperbilirubinemija*, nenormalni izvidi analiz proteinov, zmanjšana telesna masa, zvečana telesna masa
English: Aplasia, Gastrointestinal malformation, Ichthyosis
Slovenian: Redki aplazija, gastrointestinalne malformacije, ihtioza
English: A pharmacokinetic study was conducted in patients with various degrees of renal impairment who were classified according to their creatinine clearance values (CrCL) into the following groups: Normal (CrCL ≥ 60 ml/min/1.73 m2, n=12), Mild (CrCL=40-59 ml/min/1.73 m2, n=10), Moderate (CrCL=20-39 ml/min/1.73 m2, n=9), and Severe (CrCL < 20 ml/min/1.73 m2, n=3).
Slovenian: (CrCL=40-59 ml/min/1,73 m2, n=10), zmerna okvara ledvic (CrCL=20-39 ml/min/1,73 m2, n=9) in huda okvara ledvic (CrCL < 20 ml/min/1,73 m2, n=3).
English: Bortezomib SUN might cause tiredness, dizziness, fainting, or blurred vision.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Bortezomib SUN lahko povzroči utrujenost, omotičnost, omedlevico ali zamegljen vid.
English: Four treatment cycles of this combination therapy are administered.
Slovenian: Bolnik prejme štiri kroge zdravljenja s to kombinacijo.
English: An odds ratio (OR) > 1 indicates an advantage for BzmbR-CAP. f Include all CR+CRu, by IRC, bone marrow and LDH.
Slovenian: f Vključuje vse CR+CRu, IRC, kostni mozeg in LDH.
English: Hypotension Bortezomib treatment is commonly associated with orthostatic/postural hypotension.
Slovenian: Zdravljenje z bortezomibom je pogosto povezano z ortostatsko hipotenzijo oz. posturalno hipotenzijo.
English: Therefore, patients should be closely monitored when given bortezomib in combination with potent CYP3A4 inhibitors (e.g. ketoconazole, ritonavir).
Slovenian: Zato je treba bolnike, ki prejemajo bortezomib v kombinaciji z močnimi inhibitorji encima CYP3A4 (npr.
English: • need to handling the medicinal product in sterile setting
Slovenian: • Med ravnanjem z zdravilom je potrebno ves čas strogo upoštevati aseptično pripravo.
English: Peripheral neuropathy in combination regimens Multiple myeloma
Slovenian: Periferna nevropatija pri kombiniranem zdravljenju
English: There are no studies on the use of bortezomib in elderly patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with haematopoietic stem cell transplantation.
Slovenian: Študij o uporabi bortezomiba pri starejših bolnikih, pri katerih diseminirani plazmocitom še ni bil zdravljen in pri katerih je pred presaditvijo krvotvornih matičnih celic primerna kemoterapija v velikih odmerkih, niso izvedli.
English: Bortezomib SUN reconstituted solution is administered as a 3-5 second bolus intravenous injection through a peripheral or central intravenous catheter followed by a flush with sodium chloride 9 mg/ml
Slovenian: Intravensko injiciranje Rekonstituirano raztopino zdravila Bortezomib SUN dajte naenkrat v obliki 3-5 sekund trajajoče bolusne intravenske injekcije prek perifernega ali osrednjega intravenskega katetra, čemur naj sledi izpiranje katetra z 9 mg/ml (0,9 %) raztopino natrijevega klorida za injiciranje.
English: Batch
Slovenian: CHOP.
English: Uncommon Dysacusis (inc tinnitus)*,Hearing impaired (up to and inc deafness), Ear discomfort*
Slovenian: Občasni disakuza (vključno s tinitusom)*, okvara sluha (vse do in vključno z gluhostjo), neprejeten občutek v ušesu*
English: 25.2-36.5 months) for the bortezomib monotherapy patients and 33.0 months (95% CI; 28.9-37.1 months) for the bortezomib plus pegylated liposomal doxorubicin combination therapy patients.
Slovenian: Za bolnike, zdravljene samo z bortezomibom, je bilo mediano OS 30,8 meseca (95 % CI; 25,2-36,5 meseca), za bolnike, zdravljene z bortezomibom v kombinaciji s pegiliranim liposomskim doksorubicinom, pa 33,0 meseca (95 % CI; 28,9-37,1 meseca).
English: • a dose-calculation tool that enables prescribers to input a patient's height and weight in order to calculate the body surface area (BSA) and thereby to determine the appropriate
Slovenian: • Model izračuna s katerim bo lahko predpisovalec izračunal odmerek zdravila in Telesio površino, na podlagi bolnikove višine in telesne mase, in tako določil pravi odmerek zdravila Bortezomib SUN.
English: Nausea and vomiting symptoms*, Diarrhoea*, Stomatitis*, Constipation
Slovenian: Zelo pogosti simptomi navzee in bruhanja*, driska*, stomatitis*,
English: Bortezomib SUN treatment must be initiated under supervision of a physician experienced in the treatment of cancer patients, however Bortezomib SUN may be administered by a healthcare professional experienced in use of chemotherapeutic agents.
Slovenian: Zdravilo Bortezomib SUN pa lahko aplicira tudi zdravstveno osebje, ki ima izkušnje z zdravljenjem s kemoterapevstkimi učinkovinami Zdravilo Bortezomib SUN
English: Six Bortezomib SUN cycles are recommended, although for patients with a response first documented at cycle 6, two additional Bortezomib SUN cycles may be given.
Slovenian: Bolnik prejme šest krogov zdravljenja z zdravilom Bortezomib SUN. Priporočamo, da bolniki, ki dosežejo odziv šele v 6. krogu, prejmejo dva dodatna kroga zdravljenja.
English: Common Sepsis (inc septic shock)*, Herpes zoster (inc disseminated & ophthalmic), Herpes virus infection*, Bacterial infections*, Upper/lower respiratory tract infection*, Fungal infection*, Herpes simplex* Uncommon Hepatitis B, Infection*, Bronchopneumonia
Slovenian: Zelo pogosti pljučnica* Pogosti sepsa (vključno s septičnim šokom)*, herpes zoster (vključno z diseminiranim in očesnim), okužba s herpes virusom*, bakterijske okužbe*, okužba zgornjih/spodnjih dihal*, glivična okužba*, herpes simplex*
English: Bortezomib SUN therapy should be withheld until symptoms of the toxicity have resolved to Grade 1 or baseline.
Slovenian: Zdravljenje z zdravilom Bortezomib SUN je treba prekiniti, dokler se simptomi toksičnosti ne povrnejo na 1. stopnjo ali stanje pred začetkom zdravljenja.
English: * Grouping of more than one MedDRA preferred term.
Slovenian: * združevanje več priporočenih terminov po klasifikaciji MedDRA.
English: The overall incidence of hepatitis B infections was similar in patients treated with BzmbR-CAP or with R-CHOP (0.8% vs 1.2% respectively).
Slovenian: Celokupna pogostnost okužbe z virusom hepatitisa B je bila podobna pri bolnikih, zdravljenih z BzmbR-CAP ali R-CHOP
English: In B-ALL patients with relapse within 18 months of diagnosis (n = 27) the CR rate was 67% (95% CI: 46, 84); the 4-month event free survival rate was 44% (95% CI: 26, 62).
Slovenian: Pri bolnikih z Bcelično ALL in relapsom v manj kot 18 mesecih po diagnozi (n = 27) je bil delež popolnih odgovorov 67% (95% CI: 46, 84) in delež 4-mesečnega preživetja bolnikov brez dogodkov 44% (95%
English: Bzmb=Bortezomib SUN; Dx=dexamethasone; T=thalidomide a Thalidomide dose is increased to 100 mg from week 3 of cycle 1 only if 50 mg is tolerated and to 200 mg from cycle 2 onwards if 100 mg is tolerated.
Slovenian: Bzmb= Bortezomib SUN; Dx=deksametazon; T=talidomid a V 3. tednu 1. kroga se lahko odmerek talidomida poveča na 100 mg samo, če bolnik dobro prenaša odmerek 50 mg in na 200 mg v 2. krogu, če bolnik dobro prenaša odmerek 100 mg. b Bolniki, ki dosežejo vsaj delni odziv po 4 krogih, lahko prejmejo do 6 krogov zdravljenja.
English: Patients in the BzmbDx group received four 21 day cycles, each consisting of bortezomib (1.3 mg/m2 administered intravenously twice weekly on days 1, 4, 8, and 11), and oral dexamethasone (40 mg/day on days 1 to 4 and days 9 to 12, in Cycles 1 and 2, and on days 1 to 4 in Cycles 3 and 4).
Slovenian: V vsakem krogu so prejeli bortezomib (1,3 mg/m2 intravensko dvakrat na teden na 1., 4., 8. in 11. dan) in deksametazon (40 mg/dan, peroralno, 1. do 4. in 9. do 12. dan v 1. in 2. krogu in 1. do 4. dan v 3. in 4. krogu).
English: However, the chemical and physical in-use stability of the reconstituted solution has been demonstrated for 8 hours at 25°C stored in the original vial and/or a syringe.
Slovenian: Rekonstituirana raztopina je kemično in fizikalno stabilna 8 ur pri temperaturi do 25 °C, če jo pred uporabo shranjujemo v originalni viali in/ali injekcijski brizgi.
English: • advice on how to reduce the risk of mix-up of IV and SC reconstituted syringes
Slovenian: • Navodilo kako lahko zmanjšamo možnost zamenjave injekcijskih brizg za i.v.
English: White to off-white lyophilized powder or cake.
Slovenian: Bel do belkast liofiliziran prašek ali pogača.
English: CR=Complete Response; CRu=Complete Response unconfirmed; PR=Partial Response; CI=Confidence Interval, HR=Hazard Ratio;
Slovenian: CR=popolni odziv; CRu=nepotrjen popolni odziv; PR=delni odziv; CI=interval zaupanja, HR=razmerje tveganja; OR=razmerje obetov; ITT=populacija, ki so jo nameravali zdraviti
English: # Post-marketing adverse reaction regardless of indication
Slovenian: * združevanje več priporočenih terminov po klasifikaciji MedDRA. # neželeni učinki v obdobju trženja, neodvisno od indikacije
English: Thalidomide is administered orally at 50 mg daily on days 1-14 and if tolerated the dose is increased to 100 mg on days 15-28, and thereafter may be further increased to 200 mg daily from cycle 2 (see Table 4).
Slovenian: Če odmerek dobro prenaša, se ga lahko poveča na 100 mg od 15. do 28. dneva in nato od 2. kroga zdravljenja naprej na 200 mg na dan (glejte preglednico 4).
English: Table 1: Recommended* posology modifications for bortezomib-related neuropathy Severity of neuropathy
Slovenian: Preglednica 1: Priporočena* prilagoditev odmerjanja v primeru nevropatije v povezavi z bortezomibom
English: • dosing instructions and examples: how to calculate the body surface area of a patient and the volume of reconstituted Bortezomib SUN (both IV and SC use) required for different body surface areas (cross reference to Dosing Slide Rule)
Slovenian: • Navodila za odmerjanje s primeri: kako se izračuna telesna površina bolnika in volume rekonstituiranega zdravila Bortezomib SUN (za i.v.
English: Dose adjustments during treatment and re-initiation of treatment for combination therapy with melphalan and prednisone
Slovenian: Kombinirano zdravljenje z melfalanom in prednizonom
English: During clinical trials, hypoglycemia and hyperglycemia were uncommonly and commonly reported in diabetic patients receiving oral hypoglycemics.
Slovenian: Med kliničnimi preskušanji so pri bolnikih z diabetesom, ki prejemajo peroralne antidiabetike, občasno poročali o hipoglikemiji in pogosto o hiperglikemiji.
English: The reconstituted solution must be inspected visually for particulate matter and discolouration prior to administration.
Slovenian: Rekonstituirano raztopino morate pred uporabo vizualno pregledati, da ugotovite, ali vsebuje delce in ali je spremenila barvo.
English: Patients with moderate or severe hepatic impairment should be started on Bortezomib SUN at a reduced dose of 0.7 mg/m2 per injection during the first treatment cycle, and a subsequent dose escalation to 1.0 mg/m2 or further dose reduction to 0.5 mg/m2 may be considered based on patient tolerability (see Table 6 and sections 4.4 and 5.2).
Slovenian: Na podlagi bolnikovega prenašanja zdravljenja je treba pretehtati možnost povečanja odmerka na 1,0 mg/m2 ali zmanjšanja odmerka na 0,5 mg/m2 (glejte preglednico 6 ter poglavji 4.4 in 5.2).
English: Refer to the Summary of Product Characteristics of thalidomide for additional information.
Slovenian: Za dodatne podatke glejte povzetek glavnih značilnosti zdravila za talidomid.
English: and 32.
Slovenian: 29. in 32. dan.
English: Common Cardiac fibrillation (inc atrial), Arrhythmia*, Cardiac failure (inc left and right ventricular)*, Myocardial ischaemia, Ventricular dysfunction* Uncommon Cardiovascular disorder (inc cardiogenic shock)
Slovenian: Pogosti fibrilacija srca (vključno z atrijsko), aritmija*, srčno popuščanje (vključno s popuščanjem levega in desnega prekata)*, ishemija miokarda, moteno delovanje prekatov*
English: - If platelet counts ≤ 30 x 109/l or ANC ≤ 0.75 x 109/l on a Bortezomib SUN dosing day (other than day 1)
Slovenian: ≤ 30 x 109/l ali ANC ≤ 0,75 x 109/l
English: - Platelet counts should be ≥ 75,000 cells/μl in patients with bone marrow infiltration or splenic sequestration
Slovenian: - Pri bolnikih z infiltracijo kostnega mozga ali sekvestracijo vranice mora biti število trombocitov ≥ 75.000 celic/μl.
English: Change Bortezomib SUN treatment schedule to 1.3 mg/m2 once per week
Slovenian: Bortezomib SUN na odmerek 1,3 mg/m2 enkrat na teden
English: Nine treatment cycles of this combination therapy are administered.
Slovenian: Zdravljenje s to kombinacijo traja devet krogov.
English: The median age of the patients in the study was 71 years, 50% were male, 88% were Caucasian and the median Karnofsky performance status score for the patients was 80.
Slovenian: Mediana starosti bolnikov v študiji je bila 71 let, 50 % sodelujočih je bilo moških, 88 % belcev.
English: Table 9: Incidence of peripheral neuropathy during induction treatment by toxicity and treatment discontinuation due to peripheral neuropathy IFM-2005-01
Slovenian: Preglednica 9: Pojavnost periferne nevropatije med uvajalnim zdravljenjem glede na stopnjo toksičnosti in prekinitev zdravljenja zaradi periferne nevropatije
English: A drug-drug interaction study assessing the effect of rifampicin, a potent CYP3A4 inducer, on the pharmacokinetics of bortezomib (injected intravenously), showed a mean bortezomib AUC reduction of 45% based on data from 6 patients.
Slovenian: Študija medsebojnega delovanja zdravil, ki je ocenjevala učinek rifampicina, močnega inhibitorja encima CYP2C19, na farmakokinetiko bortezomiba (danega intravensko), je na podlagi podatkov 6 bolnikov pokazala povprečno zmanjšanje AUC bortezomiba za 45 %.
English: Method of administration Bortezomib SUN is available for intravenous or subcutaneous administration.
Slovenian: Zdravilo Bortezomib SUN se daje intravensko ali subkutano.
English: Bortezomib SUN in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation.
Slovenian: Zdravilo Bortezomib SUN je v kombinaciji z rituksimabom, ciklofosfamidom, doksorubicinom in prednizonom indicirano za zdravljenje odraslih bolnikov z limfomom plaščnih celic, ki še niso prejemali zdravljenja in pri katerih presaditev krvotvornih matičnih celic ni mogoča.
English: Time to next therapy Events n (%) Mediana (95% CI)
Slovenian: Čas do naslednjega zdravljenja dogodki n (%) Medianaa
English: Thalidomide is a known human teratogenic active substance that causes severe life-threatening birth defects.
Slovenian: Talidomid je učinkovina z znanim teratogenim učinkom pri ljudeh.
English: If you have not been treated before for multiple myeloma, and you are suitable for blood stem cell transplantation you will receive Bortezomib SUN intravenously or subcutaneously together with the medicines dexamethasone, or dexamethasone and thalidomide, as induction treatment: - When Bortezomib SUN is given together with dexamethasone, you will receive Bortezomib SUN intravenously or subcutaneously as a 21-day treatment cycle.
Slovenian: Če pri vas diseminiranega plazmocitoma še niso zdravili in je presaditev krvotvornih matičnih celic za vas primerna, boste kot uvajalno zdravljenje prejeli zdravilo Bortezomib SUN v veno ali v podkožje v kombinaciji z deksametazonom ali z deksametazonom in talidomidom:
English: Seizures
Slovenian: - fistula
English: Do not drive or operate tools or machines if you experience such side effects; even if you do not, you should still be cautious.
Slovenian: Če imate naštete neželene učinke, ne vozite in ne upravljajte orodij ali strojev.
English: Bortezomib SUN must be reconstituted by a healthcare professional (see section 6.6).
Slovenian: mora rekonstituirati zdravstveno osebje (glejte poglavje 6.6).
English: Uncommon Pulmonary embolism, Pleural effusion, Pulmonary oedema (inc acute), Pulmonary alveolar haemorrhage#, Bronchospasm, Chronic obstructive pulmonary disease*, Hypoxaemia*, Respiratory tract congestion*, Hypoxia, Pleurisy*, Hiccups, Rhinorrhoea, Dysphonia, Wheezing
Slovenian: Občasni pljučni embolizem, plevralni izliv, pljučni edem (vključno z akutnim), pljučna alveolarna krvavitev#, bronhospazem, kronična obstruktivna pljučna bolezen*, hipoksemija*, kongestija dihal*, hipoksija, plevritis*, kolcanje, izcedek iz nosu, disfonija, piskanje v pljučih
English: Bortezomib SUN reconstituted solution is administered subcutaneously through the thighs (right or left) or abdomen (right or left).
Slovenian: Subkutano injiciranje Rekonstituirano raztopino zdravila Bortezomib SUN injiciramo subkutano v stegno (desno ali levo)
English: Patients in the BzmbR-CAP treatment arm received bortezomib (1.3 mg/m2; on days 1, 4, 8, 11, rest period days 12-21), rituximab 375 mg/m2 IV on day 1; cyclophosphamide 750 mg/m2 IV on day 1; doxorubicin 50 mg/m2 IV on day 1; and prednisone 100 mg/m2 orally on day 1 through day 5 of the 21 day bortezomib treatment cycle.
Slovenian: Bolniki v skupini BzmbR-CAP so prejeli bortezomib (1,3 mg/m2 na 1., 4., 8., in 11. dan, sledil je premor od 12. do 21. dne), 375 mg/m2 rituksimaba, 750 mg/m2 ciklofosfamida, 50 mg/m2 doksorubicina i.v.
English: Consider dose escalation to 1.0 mg/m2 or further dose reduction to 0.5 mg/m2 in subsequent cycles based on patient tolerability.
Slovenian: 1,0 mg/m2 ali zmanjšanja odmerka na 0,5 mg/m2.
English: - Non-haematological toxicities should have resolved to Grade 1 or baseline.
Slovenian: - Nehematološke toksičnosti se morajo povrniti na 1. stopnjo ali stanje pred začetkom zdravljenja.
English: Thrombocytopenia*, Febrile neutropenia, Neutropenia*, Leukopenia*, Anaemia*, Lymphopenia* Uncommon Pancytopenia*
Slovenian: Zelo pogosti trombocitopenija*, febrilna nevtropenija, nevtropenija*, levkopenija*, anemija*, limfopenija*
English: The benefit/risk ratio should be considered prior to continuing bortezomib therapy.
Slovenian: Pred nadaljevanjem zdravljenja z bortezomibom je treba oceniti razmerje med koristjo in tveganjem.
English: Prednisone is given orally at 100 mg/m2 on days 1, 2, 3, 4 and 5 of the Bortezomib SUN treatment cycle.
Slovenian: Prednizon boste jemali peroralno v odmerku 100 mg/m2 na 1., 2., 3., 4. in 5. dan kroga zdravljenja z zdravilom Bortezomib SUN.
English: For additional information concerning dexamethasone, see the corresponding Summary of Product Characteristics.
Slovenian: Za dodatne informacije o deksametazonu glejte povzetek glavnih značilnosti tega zdravila.
English: Bortezomib exposure is increased in patients with moderate or severe hepatic impairment; these patients should be treated with bortezomib at reduced doses and closely monitored for toxicities (see sections 4.2 and 5.2).
Slovenian: Zato je treba te bolnike zdraviti z manjšimi odmerki bortezomiba in pri njih skrbno spremljati morebitni pojav toksičnosti (glejte poglavji 4.2 in 5.2).
English: Thalidomide is given orally daily at 50 mg up to day 14 of the first cycle, and if tolerated the thalidomide dose is increased to 100 mg on days 15-28 and may be further increased to 200 mg daily from the second cycle onwards.
Slovenian: Če boste odmerek dobro prenašali, se lahko poveča na 100 mg na dan od 15. do 28. dneva in od drugega kroga zdravljenja naprej še na 200 mg na dan.
English: EBMT criteria g All randomised patients with secretory disease
Slovenian: fCR = popolni odgovor; PR = delni odgovor, EBMT kriteriji g Vsi randomizirani bolniki s sekrecijsko boleznijo
English: Common Neuropathies*, Motor neuropathy*, Loss of consciousness (inc syncope), Encephalopathy*, Peripheral sensorimotor neuropathy, Dizziness*, Dysgeusia*, Autonomic neuropathy Uncommon Autonomic nervous system imbalance
Slovenian: Pogosti nevropatije*, motorična nevropatija*, izguba zavesti (vključno s sinkopo), encefalopatija*, periferna senzorična nevropatija, omotica*, disgevzija*,
English: When Bortezomib SUN is given in combination with other medicinal products, refer to their Summaries of Product Characteristics for additional contraindications.
Slovenian: Pri sočasni uporabi Bortezomib SUN z drugimi zdravili glejte povzetke glavnih značilnosti teh zdravil za dodatne kontraindikacije.
English: Each 10 ml vial of Bortezomib SUN must be carefully reconstituted with 1.4 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, by using a syringe of the appropriate size, without removing the vial stopper.
Slovenian: Vsako 10 ml vialo zdravila Bortezomib SUN morate previdno rekonstituirati s 1,4 ml 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje.
English: Each 10 ml vial of Bortezomib SUN must be carefully reconstituted with 3.5 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, by using a syringe of the appropriate size, without removing the vial stopper.
Slovenian: Vsako 10 ml vialo zdravila Bortezomib SUN morate previdno rekonstituirati s 3,5 ml 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje.
English: In patients with advanced myeloma the severity of thrombocytopenia was related to pre-treatment platelet count: for baseline platelet counts < 75,000/μl, 90% of 21 patients had a count ≤ 25,000/μl during the study, including 14% < 10,000/μl; in contrast, with a baseline platelet count > 75,000/μl, only 14% of 309 patients had a count ≤ 25,000/μl during the study.
Slovenian: 309 bolnikov, ki so imeli začetno število trombocitov > 75.000/μl, jih je samo 14 % imelo med preskušanjem število trombocitov ≤ 25.000/μl.
English: Based on the data presented, the PRAC was of the view that the product information should be varied to update Section 4.8 the SmPC and relevant section of the package leaflet to add the following: chalazion, blepharitis and Thrombotic Microangiopathy.
Slovenian: Na osnovi pregledanih podatkov, je PRAC mnenja, da so spremembe v informacijah o zdravilu v poglavju 4.8 povzetka glavnih značilnosti zdravila in ustreznem poglavju navodila za uporabo utemeljene.
English: In study LYM-3002 in which bortezomib was administered with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CAP), the incidence of peripheral neuropathy in the combination regimens is presented in the table below:
Slovenian: skupaj z rituksimabom, ciklofosfamidom, doksorubicinom in prednizonom (R-CAP), je navedena v spodnji preglednici:
English: Fluid overload, Hypochloraemia*, Hypovolaemia, Hyperchloraemia *, Hyperphosphataemia*, Metabolic disorder, Vitamin B complex deficiency, Vitamin B12 deficiency, Gout, Increased appetite, Alcohol intolerance
Slovenian: Redki hipermagneziemija*, acidoza, motnje ravnovesja elektrolitov*, čezmerno nabiranje tekočine, hipokloremija*, hipovolemija, hiperkloremija*, hiperfosfatemija*, presnovne motnje, pomanjkanje vitaminov B-kompleksa, pomanjkanje vitamina B12,
English: NAME OF THE MEDICINAL PRODUCT Bortezomib SUN 3.5 mg powder for solution for injection bortezomib
Slovenian: Navodilo za uporabo Bortezomib SUN 3,5 mg prašek za raztopino za injiciranje bortezomib
English: Incidence Adverse reaction
Slovenian: Občasni anafilaktična reakcija
English: Gastrointestinal and intracerebral haemorrhage, have been reported in association with bortezomib treatment.
Slovenian: V povezavi z zdravljenjem z bortezomibom so poročali o gastrointestinalni in intracerebralni krvavitvi.