natgillin/translations-raw huggingface dataset:
In the Phase II study, patients who did not obtain an optimal response to therapy with bortezomib alone were able to receive high-dose dexamethasone in conjunction with bortezomib.
Bolniki v preskušanju faze II, ki niso dosegli optimalnega odziva na zdravljenje z bortezomibom v monoterapiji, so poleg bortezomiba lahko prejemali tudi deksametazon v velikih odmerkih.
HRb (95% CI)=0.63 p-valued < 0.001
HRb (95 % CI)=0,63
In the BzmbR-CAP group, 22.5% of patients received platelet transfusions compared to 2.9% of patients in the R-CHOP group.
V skupini BzmbR-CAP je prejelo infuzijo trombocitov 22,5 % bolnikov, v skupini R-CHOP pa 2,9 % bolnikov.
* Survival update based on a median duration of follow-up at 60.1 months mo: months
* preživetje na osnovi podatkov po 60,1 mesecih spremljanja CI=interval zaupanja
In study IFM-2005-01 bortezomib combined with dexamethasone [BzmbDx, n=240] was compared to vincristine- doxorubicin-dexamethasone [VDDx, n=242].
V študiji IFM-2005-01 so primerjali kombinacijo bortezomiba in deksametazona [BzmbDx, n=240] s kombinacijo vinkristin-doksorubicin-deksametazon VDDx, n=242].
b Hazard ratio estimate is based on a Cox proportional-hazard model adjusted for stratification factors: β2-microglobulin,
b Ocena razmerja tveganja na podlagi Coxovega proporcionalnega modela, prilagojena na podlagi stratifikacijskih dejavnikov: β2-mikroglobulin, albumin in regija.
When compared to patients with normal hepatic function, mild hepatic impairment did not alter dosenormalised bortezomib AUC.
Ob primerjavi z bolniki z normalnim delovanjem jeter pri bolnikih z blago jetrno okvaro ni bilo sprememb v povprečnem, na odmerek normaliziranem AUC bortezomiba.
Bzmb=Bortezomib SUN; M=melphalan, P=prednisone
Bzmb=bortezomib; Dex=deksametazon
12.8 mo
12,8 meseca
In a clinical trial, two patients (out of 2) given high-dose cytarabine (2 g/m2 per day) by continuous infusion over 24 hours with daunorubicin and bortezomib for relapsed acute myelogenous leukaemia died of ARDS early in the course of therapy, and the study was terminated.
V kliničnem preskušanju sta dva bolnika (od dveh), pri katerih so akutno mielogeno levkemijo zdravili z visokim odmerkom citarabina v 24-urni kontinuirani infuziji (2 g/m2 na dan) skupaj z daunorubicinom in bortezomibom, umrla zaradi SARS na začetku zdravljenja in študijo so zaključili.
Injury, poisoning and procedural complications
Poškodbe, zastrupitve in Občasni padci, kontuzije
Potentially immunocomplex-mediated reactions Potentially immunocomplex-mediated reactions, such as serum-sickness-type reaction, polyarthritis with rash and proliferative glomerulonephritis have been reported uncommonly.
Morebitne reakcije, povzročene z imunskimi kompleksi Občasno so poročali o reakcijah, morda povzročenih z imunskimi kompleksi, kot so serumska bolezen, poliartritis z izpuščajem in proliferativni glomerulonefritis.
Following an intravenous bolus or subcutaneous injection of a 1.3 mg/m2 dose to patients with multiple myeloma (n=14 in the intravenous group, n=17 in the subcutaneous group), the total systemic exposure after repeat dose administration (AUClast) was equivalent for subcutaneous and intravenous administrations.
Pri bolnikih z diseminiranim plazmocitomom se po intravenski bolusni ali subkutani injekciji pri odmerku 1,3 mg/m2 (n=14 pri intravenski in n=17 pri subkutani skupini) je bila skupna sistemska izpostavljenost po ponovljenem odmerku (AUClast) ekvivalentna pri subkutanem in intravenskem dajanju.
You do not need to check the pH of the solution.
Vrednosti pH raztopine ni treba preverjati.
In subsequent doses, mean maximum observed plasma concentrations ranged from 67 to 106 ng/ml for the 1.0 mg/m2 dose and 89 to 120 ng/ml for the 1.3 mg/m2 dose.
Pri ponovljenih odmerkih so bile povprečne vrednosti najvišjih plazemskih koncentracij v razponu od 67 do 106 ng/ml pri odmerku 1,0 mg/m2 in od 89 do 120 ng/ml pri odmerku 1,3 mg/m2.
When toxicity resolves re-initiate Bortezomib SUN treatment and reduce dose to 0.7 mg/m2 once per week.
Nato ponovno uvedite zdravljenje z zdravilom Bortezomib SUN in zmanjšajte odmerek na 0,7 mg/m2 enkrat na teden.
Adverse drug reactions identified as those with a ≥ 1% incidence, similar or higher incidence in the BzmbR-CAP arm and with at least a possible or probable causal relationship to the components of the BzmbR-CAP arm, are listed in Table 8 below.
V preglednici 8 so navedeni ugotovljeni neželeni učinki s pogostnostjo ≥ 1 %, ki je bila podobna ali večja v skupini BzmbR-CAP in z najmanj verjetno ali možno vzročno povezanostjo s komponentami v skupini BzmbR-CAP.
Bortezomib SUN 3.5 mg powder for solution for injection IS FOR SUBCUTANEOUS OR INTRAVENOUS USE.
Zdravilo Bortezomib SUN 3,5 mg prašek za raztopino za injiciranje je ZA SUBKUTANO ALI INTRAVENSKO UPORABO.
Day 1, 2, 3, 4 Day 8, 9, 10, 11
Dx 40 mg dan 1, 2, 3, 4 dan 8, 9, 10, 11
Therefore, the concomitant use of bortezomib with strong CYP3A4 inducers (e.g., rifampicin, carbamazepine, phenytoin, phenobarbital and St. John's Wort) is not recommended, as efficacy may be reduced.
Ker se lahko zmanjša učinkovitost, se sočasna uporaba bortezomiba z močnimi induktorji encima CYP3A4 (npr. rifampicinom, karbamazepinom, fenitoinom, fenobarbitalom in šentjanževko) ne priporoča.
You will receive 4 cycles (12 weeks).
Prejeli boste 4 kroge zdravljenja (12 tednov).
There is no evidence to suggest that dose adjustments are necessary in patients over 65 years of age with multiple myeloma or with mantle cell lymphoma.
Ni dokazov, da je pri bolnikih, starejših od 65 let, z diseminiranim plazmocitomom ali limfomom plaščnih celic, potrebna prilagoditev odmerka.
- If several Bortezomib SUN doses in a cycle are withheld (≥ 3 doses during twice weekly administration or ≥ 2 doses during weekly administration)
Bortezomib SUN v enem krogu zdravljenja (≥ 3 odmerke pri odmerjanju dvakrat na teden ali ≥ 2 odmerka pri odmerjanju enkrat na teden)
Bortezomib SUN therapy should be withheld until symptoms of the toxicity have resolved to Grade 2 or better.
Zdravljenje z zdravilom Bortezomib SUN je treba prekiniti, dokler se simptomi toksičnosti ne povrnejo na 2. stopnjo ali še izboljšajo.
Platelet transfusion for the treatment of thrombocytopenia should be considered when clinically appropriate.
Če je klinično ustrezno, je treba za zdravljenje trombocitopenije razmisliti o transfuziji trombocitov.
Common Hypertension*, Hypotension*, Orthostatic hypotension
Pogosti hipertenzija*, hipotenzija*, ortostatska hipotenzija
Bortezomib SUN treatment must be withheld at the onset of any ≥ Grade 3 bortezomib-related non-haematological toxicities (excluding neuropathy) or ≥ Grade 3 haematological toxicities (see also section .4).
Zdravljenje z zdravilom Bortezomib SUN je treba prekiniti ob pojavu katere koli z uporabo bortezomiba povezane nehematološke toksičnosti stopnje ≥ 3 (razen nevropatije) ali hematološke toksičnosti stopnje ≥ 3 (glejte tudi poglavje 4.4).
Age The pharmacokinetics of bortezomib were characterized following twice weekly intravenous bolus administration of 1.3 mg/m2 doses to 104 paediatric patients (2-16 years old) with acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML).
Farmakokinetiko bortozomiba so ovrednotili po intravenski aplikaciji bolusnega odmerka 1,3 mg/m2 dvakrat na teden 104 pediatričnim bolnikom (starim 2-16 let) z akutno limfoblastno levkemijo (ALL
RECONSTITUTION FOR SUBCUTANEOUS INJECTION
REKONSTITUCIJA ZA SUBKUTANO INJICIRANJE
Progressive multifocal leukoencephalopathy (PML) Very rare cases with unknown causality of John Cunningham (JC) virus infection, resulting in PML and death, have been reported in patients treated with bortezomib.
Pri bolnikih, zdravljenih z bortezomibom, so poročali o zelo redkih primerih okužbe z virusom JC (John Cunningham virus), z neznano vzročno povezavo, ki je vodila v PML in smrt.
The Reconstitution poster shall contain the following key elements:
Plakat z navodili za rekonstitucijo mora vsebovati naslednje ključne elemente:
For storage conditions after reconstitution of the medicinal product, see section 6.3.
Za pogoje shranjevanja po rekonstituciji zdravila glejte poglavje 6.3. 6.5 Vrsta ovojnine in vsebina
Time to progression Events n (%) Mediana (95% CI)
Čas do napredovanja bolezni dogodki n (%) medianaa (95 % CI)
Autologous stem cell transplants were received by 198 (82%) patients and 208 (87%) patients in the VDDx and BzmbDx groups respectively; the majority of patients underwent one single transplant procedure.
Avtologno presaditev krvotvornih matičnih celic so opravili pri 198 (82 %) bolnikih v skupini VDDx in 208 (87 %) bolnikih v skupini BzmbDx.
Melphalan and prednisone should both be given orally on days 1, 2, 3 and 4 of the first week of each Bortezomib SUN treatment cycle.
Melfalan in prednizon je treba dati peroralno na 1., 2., 3. in 4. dan v prvem tednu vsakega kroga zdravljenja z zdravilom Bortezomib SUN.
Patients with baseline Grade ≥ 2 peripheral neuropathy or platelet counts < 50,000/μl were excluded.
Bolniki, ki so imeli na začetku študije stopnjo periferne nevropatije ≥ 2 ali število trombocitov < 50,000/µl, so bili izključeni.
Tell your doctor straight away if you notice any of the following symptoms: - muscle cramping, muscle weakness - confusion, visual loss or disturbances, blindness, seizures, headaches - shortness of breath, swelling of your feet or changes in your heart beat, high blood pressure, tiredness, fainting - coughing and breathing difficulties or tightness in the chest.
Takoj obvestite svojega zdravnika, če opazite katerega koli od naslednjih simptomov: - mišični krči, mišična šibkost - zmedenost, izguba ali motnje vida, slepota, epileptični napadi, glavoboli - težko dihanje, otekanje nog ali spremembe srčnega utripa, visok krvni tlak, utrujenost,
If you are given Bortezomib SUN together with other medicines for the treatment of mantle cell lymphoma the side effects you may get are listed below:
Če prejemate zdravilo Bortezomib SUN skupaj z drugimi zdravili za zdravljenje limfoma plaščnih celic, se lahko pri vas pojavijo naslednji neželeni učinki:
Platelet transfusion should be considered when clinically appropriate (see section 4.2).
Če je klinično ustrezno, je treba razmisliti o transfuziji trombocitov (glejte poglavje 4.2).
All grade peripheral neuropathy and grade ≥ 3 peripheral neuropathy were observed in 40% and 8.5% of patients, respectively.
Periferno nevropatijo (vseh stopenj) so opazili pri 40 %, periferno nevropatijo stopnje ≥ 3 pa pri 8,5 % bolnikov.
If any discolouration or particulate matter is observed, the solution should be discarded.
Če opazite kakršno koli spremembo barve ali delce v raztopini, jo morate zavreči.
Efficacy results are presented in Table 11:
Podatki o učinkovitosti so navedeni v preglednici 11:
The patients at risk of tumour lysis syndrome are those with high tumour burden prior to treatment.
Tveganje za pojav sindroma razpada tumorja je večje pri bolnikih z večjo maso tumorja pred začetkom zdravljenja.
It is also recommended that responding patients who do not achieve a complete remission receive a total of 8 cycles of Bortezomib SUN therapy.
da odzivni bolniki, ki ne dosežejo popolne remisije, prejmejo skupno 8 krogov zdravljenja z zdravilom.
Common Vision abnormal*
Pogosti nenormalen vid *
Grade ≥ 3 non-haematological toxicities
Nehematološka toksičnost stopnje ≥ 3
The median number of cycles received for both groups was 4 cycles.
Mediano število krogov zdravljenja je bilo 4 v obeh skupinah.
Neoplasm malignant, Leukaemia plasmacytic, Renal cell carcinoma, Mass, Mycosis fungoides, Neoplasm benign*
Redki maligne neoplazme, plazmocitna levkemija, karcinom ledvičnih celic, masa, fungoidna mikoza, benigne neoplazme*
Antiviral prophylaxis was administered to 137 of 240 patients (57%) in the BzmbR-CAP arm.
V BzmbR-CAP kraku študije je protivirusna zdravila prejelo 137 od 240 bolnikov (57 %).
Table 15: Summary of efficacy analyses comparing subcutaneous and intravenous administrations of bortezomib
Preglednica 15: Povzetek analize učinkovitosti subkutanega in intravenskega dajanja bortezomiba Skupina z intravenskim injiciranjem
Based on animal studies, the penetration of bortezomib through the blood-brain barrier appears to be limited, if any and the relevance to humans is unknown.
Na podlagi rezultatov raziskav na živalih je prehajanje bortezomiba preko hematoencefalne bariere omejeno oz. zanemarljivo.
- Injection sites should be rotated for successive injections.
- Mesta injiciranja je treba med zaporednimi injiciranji menjavati.
Subcutaneous use: Add 1.4 ml 0.9% sodium chloride to make 2.5 mg/ml final concentration.
Subkutana uporaba: dodajte 1,4 ml sterilne 0,9 % raztopine natrijevega klorida za končno koncentracijo 2,5 mg/ml.
For additional information concerning melphalan and prednisone, see the corresponding Summary of Product Characteristics.
Za dodatne informacije o melfalanu in prednizonu glejte ustrezna Povzetka glavnih značilnosti zdravila.
Time related events
Časovno pogojeni
When Bortezomib SUN is given in combination with other medicinal products, the Summary of Product Characteristics of these other medicinal products must be consulted prior to initiation of treatment with Bortezomib SUN.
Kadar se zdravilo Bortezomib SUN uporablja v kombinaciji z drugimi zdravili, je treba prebrati povzetke glavnih značilnosti teh zdravil pred začetkom zdravljenja z zdravilom Bortezomib SUN.
Patients experiencing new or worsening peripheral neuropathy should undergo neurological evaluation and may require a change in the dose, schedule or route of administration to subcutaneous (see section 4.2).
Pri bolnikih, pri katerih se periferna nevropatija pojavi prvič ali se obstoječa periferna nevropatija poslabša, je treba napraviti nevrološko oceno in po potrebi prilagoditi odmerek ali shemo odmerjanja ali preiti na subkutano dajanje (glejte poglavje 4.2).
Adverse reactions are listed below by system organ class and frequency grouping.
Neželeni učinki v spodnji preglednici so navedeni po organskih sistemih in po pogostnosti.
Sun Pharmaceutical Industries Europe B.V.
IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM Sun Pharmaceutical Industries Europe B.V.
Bortezomib SUN is for single use only.
Zdravilo Bortezomib SUN je samo za enkratno uporabo.
e Mantel-Haenszel estimate of the common odds ratio for stratified tables is used, with IPI risk and stage of disease as stratification factors.
e Uporabljena je Mantel-Haenszelova ocena razmerja obetov za stratificirane preglednice, skupaj s stratifikacijskima dejavnikoma IPI-tveganjem in stadijem bolezni.
In the Phase III study comparing bortezomib administered intravenously versus subcutaneously, the incidence of Grade ≥ 2 peripheral neuropathy events was 24% for the subcutaneous injection group and 41% for the intravenous injection group (p=0.0124).
V študiji faze III z bortezomibom, ki je primerjala intravensko in subkutano dajanje zdravila, je bila pogostnost dogodkov periferne nevropatije 2. stopnje v skupini, ki je prejemala zdravilo subkutano, 24 %, v skupini, ki je prejemala zdravilo intravensko, pa 41 % (p=0,0124).
** Instrumental ADL: refers to preparing meals, shopping for groceries or clothes, using telephone, managing money, etc; ***Self care ADL: refers to bathing, dressing and undressing, feeding self, using the toilet, taking medicinal products, and not bedridden.
** Instrumentalna ADL: zajema pripravo obrokov, nakup živil ali oblačil, uporabo telefona, upravljanje z denarjem, itd;
PHARMACEUTICAL FORM AND CONTENTS Powder for solution for injection 1 vial
prašek za raztopino za injiciranje 1 viala
HBV infection with fatal outcomes occurred in 0.8% (n=2) of patients in the non-bortezomib treatment group (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone; R-CHOP ) and 0.4% (n=1) of patients receiving bortezomib in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (BzmbR-CAP).
Do okužbe s HBV s smrtnim izidom je prišlo pri 0,8 % (n=2) bolnikov v skupini, ki ni prejemala bortezomiba (rituksimab, ciklofosfamid, doksorubicin, vinkristin in prednizon; skupina R-CHOP), in pri 0,4 % (n=1) bolnikov v skupini, ki je prejemala bortezomib v kombinaciji z rituksimabom, ciklofosfamidom, doksorubicinom in prednizonom (skupina BzmbR-CAP).
Bortezomib is a proteasome inhibitor.
Mehanizem delovanja Bortezomib je zaviralec proteasoma.
Main efficacy results are presented in Table 13.
Glavni rezultati so zbrani v preglednici 13.
What Bortezomib SUN contains - The active substance is bortezomib.
Kaj vsebuje zdravilo Bortezomib SUN - Učinkovina je bortezomib.
Neuropathic pain and/or peripheral neuropathy Patients who experience bortezomib-related neuropathic pain and/or peripheral neuropathy are to be managed as presented in Table 1 (see section 4.4).
Nevropatična bolečina in/ali periferna nevropatija Bolnike, ki imajo nevropatično bolečino in/ali periferno nevropatijo v povezavi z jemanjem bortezomiba, zdravite v skladu s preglednico 1 (glejte poglavje 4.4).
For Bortezomib SUN dosage adjustments, dose modification guidelines described for monotherapy should be followed.
Za prilagoditev odmerjanja zdravila Bortezomib SUN je treba upoštevati navodila za odmerjanje, opisana pri samostojnem zdravljenju.
g P-value from the Cochran Mantel-Haenszel chi-square test, with IPI and stage of disease as stratification factors.
g Vrednost p iz Cochran Mantel-Haenszelovega hi-kvadrat testa, skupaj s stratifikacijskima dejavnikoma IPI-tveganjem in stadijem bolezni.
For additional information concerning pegylated liposomal doxorubicin, see the corresponding Summary of Product Characteristics.
Za dodatne informacije o pegiliranem liposomskem doksorubicinu glejte povzetek glavnih značilnosti tega zdravila.
Bortezomib is metabolised by liver enzymes.
Bortezomib se presnavlja z jetrnimi encimi.
Bortezomib was positive for clastogenic activity (structural chromosomal aberrations) in the in vitro chromosomal aberration assay using Chinese hamster ovary (CHO) cells at concentrations as low as 3.125 μg/ml, which was the lowest concentration evaluated.
V in vitro preskusu kromosomskih aberacij z uporabo ovarijskih celic kitajskega hrčka (CHO-celic) je bil bortezomib v koncentraciji samo 3,125 μg/ml, ki je bila najnižja ovrednotena koncentracija,
20.7 mo
20,7 meseca
LIST OF EXCIPIENTS Excipient: mannitol (E421)
SEZNAM POMOŽNIH SNOVI Pomožna snov: manitol (E421).
ORe (95% CI)=1.688 p-valueg=0.007
ORe (95 % CI)=1,688
It is unknown if the pharmacokinetics of bortezomib are influenced in patients with severe renal impairment not undergoing dialysis (CrCL < 20 ml/min/1.73 m2).
Vpliv hude okvare ledvic na farmakokinetiko bortezomiba pri bolnikih, ki se še ne zdravijo z dializo (CrCL< 20 ml/min/1,73 m2), ni znan.
This study met its primary objective of non-inferiority for response rate (CR+PR) after 4 cycles of single agent bortezomib for both the subcutaneous and intravenous routes, 42% in both groups.
V študiji je bil dosežen primarni cilj neinferiornosti, 42 % stopnja odziva (CR+PR) po 4 krogih zdravljenja z bortezomibom v monoterapiji pri subkutani in intravenski uporabi.
4.63 (2.61, 8.22); < 0.001a 3.46 (1.90, 6.27); < 0.001a
4,63 (2,61; 8,22); < 0,001a
The demographic and baseline disease characteristics were generally well balanced between the two treatment arms: median patient age was 66 years, 74% were male, 66% were Caucasian and 32% Asian, 69% of patients had a positive bone marrow aspirate and/or a positive bone marrow biopsy for
Bolniki v obeh skupinah so na splošno imeli podobne demografske in bolezenske značilnosti: mediana starost bolnikov je bila 66 let, 74 % je bilo moških, 66 % je bilo belcev in 32 % azijcev,
• different reconstitution requirements for Bortezomib SUN 3.5 mg IV or SC use
• Različne zahteve za rekonstitucijo zdravila Bortezomib SUN 3,5 mg pri i.v.
The effect of hepatic impairment on the pharmacokinetics of bortezomib was assessed in a Phase I study during the first treatment cycle, including 61 patients primarily with solid tumors and varying degrees of hepatic impairment at bortezomib doses ranging from 0.5 to 1.3 mg/m2.
Vpliv jetrne okvare na farmakokinetiko bortezomiba v odmerkih od 0,5 do 1,3 mg/m2 so ocenjevali v študiji faze I med prvim ciklom zdravljenja, ki je vključevala 61 bolnikov s primarno solidnimi tumorji in različnimi stopnjami jetrne okvare.
Meningitis (inc bacterial), Epstein-Barr virus infection, Genital herpes, Tonsillitis, Mastoiditis, Post viral fatigue syndrome
Redki meningitis (vključno z bakterijskim), okužba z virusom Epstein-Barr, genitalni herpes, tonzilitis, mastoiditis,
In a study in previously untreated mantle cell lymphoma patients, 42.9% and 10.4% of patients exposed to bortezomib were in the range 65-74 years and ≥ 75 years of age, respectively.
V študiji z bortezomibom pri bolnikih, pri katerih limfom plaščnih celic še ni bil zdravljen, je bilo 42,9 % bolnikov, starih 65-74 let, in 10,4 % bolnikov, starih ≥ 75 let.
• potential risks of administration errors including overdosing, underdosing and that inadvertent intrathecal administration has resulted in death
• Možna tveganja napak pri uporabi zdravila, vključno z informacijami o prevelikem odmerjanju,
1-year Overall Survival (%)e
1-letno celokupno preživetje (%)e (95 % CI)
There is no known specific antidote for bortezomib overdose.
Specifični antidot za bortezomib ni znan.
Main efficacy results are presented in Table 12.
Glavni rezultati so zbrani v preglednici 12.
Frequencies are defined as: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100);
Pogostnost neželenih učinkov je opredeljena, kot sledi: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do
Granulocyte colony stimulating factors may be administered for haematologic toxicity according to local standard practice.
Glede na lokalne smernice se za hematološke toksičnosti lahko daje granulocitne kolonije spodbujajoče faktorje.
Treatment with Bortezomib SUN can very commonly cause a decrease in the numbers of red and white blood cells and platelets in your blood.
- težave s kašljem in dihanjem ali tiščanje v prsih Zdravljenje z zdravilom Bortezomib SUN lahko zelo pogosto povzroči zmanjšanje števila rdečih in belih krvnih celic ter krvnih ploščic.
RECONSTITUTION FOR INTRAVENOUS INJECTION
REKONSTITUCIJA ZA INTRAVENSKO INJICIRANJE
Bortezomib SUN should not be administered intrathecally.
Zdravila Bortezomib SUN se ne sme dajati intratekalno.
When Bortezomib SUN is given in combination with thalidomide you must follow the pregnancy prevention programme for thalidomide (see package leaflet for thalidomide).
Če jemljete zdravilo Bortezomib SUN v kombinaciji s talidomidom, morate upoštevati program za preprečevanje nosečnosti, ki velja za talidomid (glejte navodilo za uporabo talidomida).
This 4-week period is considered a treatment cycle.
To 4-tedensko obdobje predstavlja en krog zdravljenja.
Taking into account the PRAC Assessment Report on the PSUR(s) for bortezomib, 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 bortezmib, je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel naslednje znanstvene zaključke:
Combination therapy with melphalan and prednisone Bortezomib SUN is administered via intravenous or subcutaneous injection in combination with oral melphalan and oral prednisone as shown in Table 2.
Zdravilo Bortezomib SUN se daje intravensko ali subkutano v kombinaciji s peroralnim melfalanom in prednizonom, kot je prikazano v preglednici 2.
A statistically significant difference in CR+nCR was observed in favour of the bortezomib combined with dexamethasone group.
Opazili so statistično značilno razliko v CR+nCR v prid skupine, ki je prejemala bortezomib in deksametazon.
Injection sites should be rotated for successive injections.
Mesta injiciranja je treba med zaporednimi injiciranji menjavati.
What Bortezomib SUN looks like and contents of the pack Bortezomib SUN 3.5 mg powder for solution for injection is a white to off-white powder or cake.
Izgled zdravila Bortezomib SUN in vsebina pakiranja Bortezomib SUN 3,5 mg prašek za raztopino za injiciranje je bela do belkasta pogača ali prašek.