natgillin/translations-raw huggingface dataset:
In B-ALL patients with relapse 18 36 months from diagnosis (n = 33) the CR rate was 79% (95% CI: 61, 91) and the 4-month event free survival rate was 73% (95% CI: 54, 85).
Pri bolnikih z B-celično ALL in relapsom po 18-36 mesecev po diagnozi (n = 33) je bil delež popolnih odgovorov 79% (95% CI: 61, 91) in delež 4-mesečnega preživetja bolnikov brez dogodkov 73% (95% CI: 54, 85).
Hepatitis B Virus (HBV) reactivation and infection When rituximab is used in combination with bortezomib, HBV screening must always be performed in patients at risk of infection with HBV before initiation of treatment.
Reaktivacija in okužba z virusom hepatitisa B (HBV) Pri bolnikih s tveganjem za okužbo s HBV je treba pred uporabo rituksimaba v kombinaciji z bortezomibom vedno opraviti presejalni test za HBV. Prenašalce virusa hepatitisa B in bolnike, ki so že bili okuženi z virusom hepatitisa B, je treba med zdravljenjem in v nadaljevanju zdravljenja z rituksimabom v kombinaciji z bortezomibom skrbno spremljati glede kliničnih in laboratorijskih znakov aktivne okužbe s HBV.
• instructions for prescribing and administration including the cycles' length and number of cycles, to minimise the risk of medication and dispensing errors potentially induced by the existence of the two different bortezomib combination regimens in the Transplant Induction Setting (Bortezomib SUN plus dexamethasone, and Bortezomib SUN plus dexamethasone and thalidomide).
• Navodila za predpisovanje in odmerjanje, vključno z dolžino in številom krogov zdravljenja z namenom zmanjšati tveganje za napake pri izdajanju in uporabi zdravila, ki bi jih lahko povzročile različne kombinacije režima uvajanja bortezomiba pred transplantacijo (zdravilo
Peripheral embolism, Lymphoedema, Pallor, Erythromelalgia, Vasodilatation, Vein discolouration, Venous insufficiency
Redki periferni embolizem, limfedem, bledica, eritromelalgija, vazodilatacija, sprememba barve ven, venska insuficienca
A statistically significant difference in CR+nCR was observed in favour of the bortezomib combined with dexamethasone and thalidomide group.
Pri CR+nCR so opazili statistično značilno razliko v prid kombinaciji bortezomiba z deksametazonom in talidomidom.
Patients should be closely monitored when given bortezomib in combination with potent CYP3A4 inhibitors.
Sočasno jemanje zdravil Bolnike, ki prejemajo bortezomib v kombinaciji z močnimi inhibitorji encima CYP3A4, je treba skrbno spremljati.
> 1.5 x - 3 x ULN Any
> 1,5-3x ULN katera koli
In Cycles 1-4, Bortezomib SUN is administered twice weekly on days 1, 4, 8, 11, 22, 25, 29 and 32.
V krogih 1 do 4 se zdravilo Bortezomib SUN daje dvakrat na teden, 1., 4., 8., 11., 22., 25., 29. in 32. dan.
In patients with MCL (study LYM-3002), there was a higher incidence (56.7% versus 5.8%) of Grade ≥ 3 thrombocytopenia in the bortezomib treatment group (BzmbR-CAP) as compared to the non-bortezomib treatment group (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone [R-CHOP]).
Pri bolnikih z MCL (študija LYM-3002) je bila pojavnost trombocitopenije stopnje 3 ali več v skupini, ki je prejemala bortezomib (BzmbR-CAP), večja (56,7 % proti 5,8 %), v primerjavi s skupino, ki bortezomiba ni prejemala (rituksimab, ciklofosfamid, doksorubicin, vinkristin in prednizon [R-CHOP]).
CI=confidence interval; CR=complete response; nCR=near complete response; ITT=intent to treat; RR=response rate; Bzmb=bortezomib; BzmbDx=bortezomib, dexamethasone; VDDx=vincristine, doxorubicin, dexamethasone; VGPR=very good partial response; PR=partial response; OR=odds ratio.
CI= interval zaupanja; CR= popoln odziv; nCR= skoraj popoln odziv; ITT=populacija, ki so jo nameravali zdraviti; RR=stopnja odziva; Bzmb=bortezomib; BzmbDx=bortezomib in deksametazon; VDDx=vinkristin, doksorubicin in deksametazon; VGPR=zelo dober delni odziv; PR=delni odziv; OR=razmerje obetov.
Uncommon Cardiac tamponade#, Cardio-pulmonary arrest*, Cardiac fibrillation (inc atrial), Cardiac failure (inc left and right ventricular)*, Arrhythmia*, Tachycardia*, Palpitations, Angina pectoris, Pericarditis (inc pericardial effusion)*, Cardiomyopathy*, Ventricular dysfunction*, Bradycardia
Občasni tamponada srca#, srčno-pljučni zastoj*, srčna fibrilacija (vključno z atrijsko), srčno popuščanje (vključno z levim in desnim prekatom)*, aritmija*, tahikardija*, palpitacije, angina pektoris, perikarditis (vključno s perikardialnim izlivom)*, kardiomiopatija*, disfunkcija prekata*, bradikardija
Clinical efficacy in previously untreated mantle cell lymphoma (MCL) Study LYM-3002 was a Phase III, randomised, open-label study comparing the efficacy and safety of the combination of bortezomib, rituximab, cyclophosphamide, doxorubicin, and prednisone (BzmbR-CAP; n=243) to that of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP; n=244) in adult patients with previously untreated MCL (Stage II, III or IV).
V randomizirani, odprti študiji faze III, LYM-3002, so pri odraslih bolnikih s predhodno nezdravljenim MCL (stopnje II, III ali IV) primerjali učinkovitost in varnost bortezomiba v kombinaciji z rituksimabom, ciklofosfamidom, doksorubicinom, vinkristinom in prednizonom (BzmbR-CAP; n=243) z zdravljenjem z rituksimabom, ciklofosfamidom, doksorubicinom, vinkristinom in prednizonom (R-CHOP; n=244).
You might receive up to 8 cycles (24 weeks).
Lahko boste prejeli do največ 8 krogov zdravljenja (24 tednov).
Bzmb=bortezomib; Dex=dexamethasone CR=Complete Response; nCR=near Complete response PR=Partial Response; MR=Minimal response
CR=popolni odziv; nCR=skoraj popolni odziv PR=delni odziv; MR=minimalni odziv
• 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.
• Navodila za odmerjanje s primeri: kako se izračuna telesna površina bolnika in volumen rekonstituiranega zdravila Bortezomib SUN (za i.v.
Dosage adjustments for transplant eligible patients
Prilagoditev odmerjanja pri bolnikih, primernih za presaditev krvotvornih matičnih celic
Some of these include difficulty breathing, shortness of breath, shortness of breath without exercise,
Nekatere vključujejo oteženo dihanje, zasoplost, zasoplost brez telesnega napora, dihanje, ki postane plitvo, oteženo ali preneha, sopenje
Therefore, caution should be used during handling and preparation.
Splošni previdnostni ukrepi Bortezomib je citotoksično zdravilo, zato je med pripravo in ravnanjem z njim potrebna previdnost.
You might receive up to 6 cycles (24 weeks).
Lahko boste prejeli do 6 krogov zdravljenja (24 tednov).
In the Phase III study patients who received bortezomib subcutaneously compared to intravenous administration had 13% lower overall incidence of treatment emergent adverse reactions that were Grade 3 or higher in toxicity, and a 5% lower incidence of discontinuation of bortezomib.
V študiji faze III so imeli bolniki, ki so prejemali bortezomib subkutano, za 13 % manjšo celokupno incidenco neželenih učinkov zaradi uporabe zdravila s stopnjo toksičnosti 3 ali več in za 5 % manjšo pogostnost prekinitve zdravljenja v primerjavi z bolniki, ki so prejemali bortezomib intravensko.
Hair disorder*
Stopnja jetrne okvare*
Clinical efficacy with subcutaneous administration of bortezomib in patients with relapsed/refractory multiple myeloma
Klinična učinkovitost subkutanega dajanja bortezomiba bolnikom pri relapsu/diseminiranem plazmocitomu, odpornem na zdravljenje
Seizures have been uncommonly reported in patients without previous history of seizures or epilepsy.
Pri bolnikih, ki pred zdravljenjem niso imeli epileptičnih napadov ali epilepsije, so občasno poročali o epileptičnih napadih.
Bortezomib SUN is given intravenously or subcutaneously on days 1, 4, 8 and 11, followed by a ‘rest period' without treatment.
Zdravilo Bortezomib SUN boste prejeli intravensko na 1., 4., 8. in 11. dan, temu pa bo sledil premor brez zdravljenja.
It is specifically designed to inhibit the chymotrypsin-like activity of the 26S proteasome in mammalian cells.
Izdelan je specifično za zaviranje kimotripsinske aktivnosti 26S
Table 6: Recommended starting dose modification for Bortezomib SUN in patients with hepatic impairment Grade of hepatic impairment*
Preglednica 6: Priporočena prilagoditev začetnega odmerka zdravila Bortezomib SUN pri bolnikih z boleznijo jeter
Peripheral sensory neuropathy, Dysaesthesia*, Neuralgia*
Zelo pogosti periferna senzorična nevropatija, disestezija*, nevralgija*
Also included are adverse drug reactions identified in the BzmbR-CAP arm that were considered by investigators to have at least a possible or probable causal relationship to bortezomib based on historical data in the multiple myeloma studies.
Vključeni so tudi neželeni učinki, ugotovljeni v skupini BzmbR-CAP, ki so na podlagi podatkov študij diseminiranega plazmocitoma in po mnenju raziskovalcev najmanj verjetno ali možno povezani z uporabo bortezomiba.
Table 8: Adverse reactions in patients with Mantle Cell Lymphoma treated with BzmbR-CAP in a clinical trial
Preglednica 8: Neželeni učinki pri bolnikih z limfomom plaščnih celic, zdravljenih z BzmbR-CAP v kliničnih preskušanjih Organski sistem Pogostnost Neželeni učinek
Reduce Bortezomib SUN to 0.7 mg/m2 in the first treatment cycle.
Zmanjšati odmerek zdravila Bortezomib SUN v prvem krogu zdravljenja na 0,7 mg/m2.
At least 72 hours should elapse between consecutive doses of Bortezomib SUN.
Med zaporednimi odmerki zdravila Bortezomib SUN mora preteči vsaj 72 ur.
Bzmb (1.3 mg/m2) Day 1, 4
Bzmb (1,3 mg/m2) dan 1, 4
In an exploratory efficacy analysis, a 67.3% response rate (including a 28.6% CR rate) as measured by hematologic response (M-protein) was reported in 49 evaluable patients treated with the maximum allowed doses of 1.6 mg/m2 weekly and 1.3 mg/m2 twice-weekly.
Pri analizi učinkovitosti, merjene s hematološkim odzivom (M-protein), pri 49 bolnikih, pri katerih je bila mogoča ocena in so prejemali največje dovoljene odmerke 1,6 mg/m2 na teden in 1,3 mg/m2 dvakrat na teden, je bila stopnja odziva 67,3 % (vključno z deležem CR 28,6 %).
Bortezomib SUN is for intravenous or subcutaneous use.
Zdravilo Bortezomib SUN je namenjeno za intravensko ali subkutano uporabo.
CI=confidence interval; CR=complete response; nCR=near complete response; ITT=intent to treat; RR=response rate; Bzmb=bortezomib; BzmbTDx=bortezomib, thalidomide, dexamethasone; TDx=thalidomide, dexamethasone; PR=partial response;
CI= interval zaupanja; CR= popoln odziv; nCR= skoraj popoln odziv; ITT=populacija, ki so jo nameravali zdraviti; RR=stopnja odziva; Bzmb=bortezomib; BzmbTDx=bortezomib, talidomid in deksametazon; TDx=talidomid in deksametazon; PR=delni odziv; OR=razmerje obetov
Uncommon Angioedema#, Hypersensitivity* Rare
Občasni angioedem#, preobčutljivost*
• Bortezomib SUN 3.5 mg can be administered both intravenously and subcutaneously
• Zdravilo Bortezomib SUN 3,5 mg se lahko daje intravensko in subkutano.
BzmbR-CAP=bortezomib, rituximab, cyclophosphamide, doxorubicin, and prednisone; R-CHOP= rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone; PN=peripheral neuropathy Peripheral neuropathy included the preferred terms: peripheral sensory neuropathy, neuropathy peripheral, peripheral motor neuropathy, and peripheral sensorimotor neuropathy
BzmbR-CAP=bortezomib, rituksimab, ciklofosfamid, doksorubicin in prednizon; R-CHOP= rituksimab ciklofosfamid, doksorubicin, vinkristin in prednizon; PN=periferna nevropatija
13.1 mo
13,1 meseca
* Primary endpoint a OR for response rates based on Mantel-Haenszel estimate of the common odds ratio for stratified tables; p-values by
* Primarna ocena učinkovitosti a OR za stopnje odziva na osnovi Mantel-Haenszelove ocene razmerja verjetnosti za stratificirane preglednice; p-vrednosti Cochran Mantel-Haenszelovega testa.
Testicular disorder*, Prostatitis, Breast disorder female, Epididymal tenderness, Epididymitis, Pelvic pain, Vulval ulceration
Redki bolezni mod*, prostatitis, bolezni dojk pri ženskah, občutljivost epididimisa, epididimitis, bolečina v medenici, razjede vulve
Common Muscle spasms*, Musculoskeletal pain*, Pain in extremity
Pogosti mišični krči*, mišično-skeletna bolečina*, bolečine v udih
Injection under the skin is in either the thighs or the abdomen.
Pri podkožnem dajanju se zdravilo injicira v stegna ali trebuh.
The CR rate in first-relapsed T-cell ALL patients (n = 22) was 68% (95% CI: 45, 86) and the 4-month event free survival rate was 67% (95% CI: 42, 83).
Delež popolnih odgovorov pri prvih bolnikih s T-celično ALL (n = 22) je bil 68% (95% CI: 45, 86), delež 4-mesečnega preživetja bolnikov brez dogodkov pa 67% (95%
Respiratory failure, Acute respiratory distress syndrome, Apnoea, Pneumothorax, Atelectasis, Pulmonary hypertension, Haemoptysis, Hyperventilation, Orthopnoea, Pneumonitis, Respiratory alkalosis, Tachypnoea, Pulmonary fibrosis, Bronchial disorder*, Hypocapnia*, Interstitial lung disease, Lung infiltration, Throat tightness, Dry throat, Increased upper airway secretion, Throat irritation, Upper-airway cough syndrome
Redki respiratorna odpoved, sindrom akutne dihalne stiske, apneja, pnevmotoraks, atelektaza, pljučna hipertenzija, hemoptiza, hiperventilacija, ortopneja, pnevmonitis, respiratorna alkaloza, tahipneja, pljučna fibroza, bolezni bronhijev*, hipokapnija*, intersticijska bolezen pljuč, infiltracija pljuč, stiskanje v grlu, suho grlo, zvečana sekrecija iz zgornjih dihal, draženje žrela, sindrom kašlja zgornjih dihalnih poti (UACS - Upper-airway cough syndrome)
Early and regular monitoring for symptoms of treatment-emergent neuropathy with neurological evaluation should be considered in patients receiving bortezomib in combination with medicinal products known to be associated with neuropathy (e.g. thalidomide) and appropriate dose reduction or treatment discontinuation should be considered.
(npr. talidomid), je potrebno zgodnje in redno spremljanje pojava simptomov (z zdravljenjem povezane) nevropatije, opraviti nevrološko oceno ter ustrezno zmanjšati odmerek ali razmisliti o ukinitvi zdravljenja.
Rest period Rest period
premor premor
NF-kB is a transcription factor whose activation is required for many aspects of tumourigenesis, including cell growth and survival, angiogenesis, cell-cell interactions, and metastasis.
kB je transkripcijski faktor, katerega aktivacija je potrebna za mnoge stopnje nastanka tumorja, npr.
The analysis demonstrated improved ORR (CR+PR) (odds ratio 3.769; 95% CI 2.045-6.947; p < 0.001), PFS (hazard ratio 0.511; 95% CI 0.309-0.845; p=0.008), TTP (hazard ratio 0.385; 95% CI 0.212-0.698; p=0.001) for bortezomib in combination with dexamethasone over bortezomib monotherapy.
Analiza je dokazala izboljšan ORR (CR+PR) (razmerje obetov 3,769; 95 % CI 2,045-6,947; p < 0,001), PFS (razmerje tveganja 0,511;
If you have not been treated before for multiple myeloma, and you are not suitable for blood stem cell transplantation you will receive Bortezomib SUN together with two other medicines; melphalan and prednisone.
Če vam diseminiranega plazmocitoma še niso zdravili in presaditev krvotvornih matičnih celic za vas ni primerna, vam bodo zdravilo Bortezomib SUN injicirali v veno skupaj z zdraviloma melfalan in prednizon.
The final survival update was performed with a median duration of follow-up of 60.1 months.
Po 60,1 meseca (mediana trajanja spremljanja) so posodobili podatke o končnem preživetju.
Special handling instructions
Posebna navodila za ravnanje z zdravilom.
After reconstitution, each ml solution contains 1 mg bortezomib.
Po rekonstituciji vsak ml raztopine vsebuje 1 mg bortezomiba.
(95% CI) Hazard ratio (95% CI)c p-valued
razmerje tveganja (95 % CI)c p-vrednostd
After reconstitution, 1 ml of solution for intravenous injection contains 1 mg bortezomib.
Po rekonstituciji 1 ml raztopine za intravensko injiciranje vsebuje 1 mg bortezomiba.
Table 7: Adverse reactions in patients with Multiple Myeloma treated with bortezomib in clinical trials, and all post-marketing adverse reactions regardless of indication#
Preglednica 7: Neželeni učinki pri bolnikih z diseminiranim plazmocitomom, zdravljenih z bortezomibom v kliničnih preskušanjih in v obdobju trženja, neodvisno od indikacije Organski sistem Pogostnost Neželeni učinek
It is recommended that patients receive 2 cycles of Bortezomib SUN following a confirmation of a complete response.
Priporočamo, da bolniki po potrjenem popolnem odzivu prejmejo še dva kroga zdravljenja z zdravilom Bortezomib SUN. Priporočamo tudi,
CRf
NF
Common Dyspnoea*, Epistaxis, Upper/lower respiratory tract infection*, Cough*
Pogosti dispneja*, epistaksa, okužba zgornjih/spodnjih dihal*,
Transfusion reaction, Fractures*, Rigors*, Face injury, Joint injury*, Burns, Laceration, Procedural pain, Radiation injuries*
Redki reakcije na transfuzijo, zlomi*, okorelost*, poškodbe obraza, poškodbe sklepov*, opekline, raztrganine, bolečina pri posegu, poškodbe pri obsevanju*
Combination therapy with dexamethasone
Kombinirano zdravljenje z deksametazonom
CR+nCR+PR% (95% CI)
CR+nCR CR+nCR+PR% (95 %
Prophylactic use of granulocyte colony stimulating factors should be considered in case of repeated delays in cycle administration.
Če se zakasnitve krogov zdravljenja ponavljajo, je treba razmisliti o profilaktični uporabi granulocitne kolonije spodbujajočih faktorjev.
Patients in the BzmbTDx group received six 4-week cycles, each consisting of bortezmib (1.3 mg/m2 administered twice weekly days 1, 4, 8, and 11, followed by a 17-day rest period from day 12 to day 28), dexamethasone (40 mg administered orally on days 1 to 4 and days 8 to 11), and thalidomide (administered orally at 50 mg daily on days 1-14, increased to 100 mg on days 15-28 and thereafter to 200 mg daily).
V vsakem krogu so prejeli bortezomib (1.3 mg/m2 dvakrat na teden na 1., 4., 8., in 11. dan, ki mu sledi 17-dnevni premor od 12. do 28. dne), deksametazon (40 mg peroralno na 1. do 4. dan in 8. do 11. dan) in talidomid (50 mg na dan peroralno na 1. do 14. dan, povečan odmerek 100 mg na 15. do 28. dan in potem povečan odmerek 200 mg na dan).
The incidence of herpes zoster among patients in the Bzmb+M+P treatment group was 17% for patients not administered antiviral prophylaxis compared to 3% for patients administered antiviral prophylaxis.
Bzmb+M+P, je prišlo do reaktivacije virusa herpes zoster pri 17 % bolnikov, ki niso prejemali protivirusnih zdravil, pri bolnikih, ki so prejemali protivirusna zdravila, pa je prišlo do reaktivacije virusa pri 3 % bolnikov.
* Based on NCI Organ Dysfunction Working Group classification for categorising hepatic impairment (mild, moderate, severe).
*Na podlagi klasifikacije jetrnih okvar (blaga, zmerna, huda) Delovne skupine za disfunkcije organov nacionalnega onkološkega inštituta ZDA (National Cancer Institute Organ Dysfunction Working Group).
Pegylated liposomal doxorubicin is administered at 30 mg/m2 on day 4 of the Bortezomib SUN treatment cycle as a 1 hour intravenous infusion administered after the Bortezomib SUN injection.
Pegilirani liposomski doksorubicin se daje v obliki 1-urne intravenske infuzije v odmerku 30 mg/m2 na 4. dan kroga zdravljenja, po injiciranju zdravila Bortezomib SUN.
Corneal lesion*, Exophthalmos, Retinitis, Scotoma, Eye disorder (inc. eyelid) NOS, Dacryoadenitis acquired, Photophobia, Photopsia, Optic neuropathy#, Different degrees of visual impairment (up to blindness)*
Redki poškodba roženice*, ekzoftalmus, vnetje mrežnice, skotom, očesne bolezni (vključno z vekami) n.d.n., pridobljen dakrioadenitis, fotofobija, fotopsija, optična nevropatija#, različne stopnje okvare vida (vse do slepote)*
In addition, when Bortezomib SUN is given in combination with other chemotherapeutic medicinal products, appropriate dose reductions for these medicinal products should be considered in the event of toxicities, according to the recommendations in the respective Summary of Product Characteristics.
Kadar dajemo zdravilo Bortezomib SUN v kombinaciji z drugimi kemoterapevtiki, je v primeru pojava toksičnosti treba razmisliti o zmanjšanju odmerka teh zdravil, skladno z njihovimi Povzetki glavnih značilnosti zdravil.
After reconstitution, each ml solution contains 2.5 mg bortezomib.
Po rekonstituciji vsak ml raztopine vsebuje 2,5 mg bortezomiba.
However, the chemical and physical in-use stability has been demonstrated for 8 hours at 25°C stored in the original vial and/or a syringe.
Zdravilo je kemično in fizikalno stabilno 8 ur pri temperaturi do 25 °C, če ga pred uporabo shranjujemo v originalni viali in/ali injekcijski brizgi.
After reconstitution, 1 ml of solution for subcutaneous injection contains 2.5 mg bortezomib.
Po rekonstituciji 1 ml raztopine za subkutano injiciranje vsebuje 2,5 mg bortezomiba.
As a result of a pre-planned interim analysis, the dexamethasone arm was halted at the recommendation of the data monitoring committee and all patients randomised to dexamethasone were then offered bortezomib, regardless of disease status.
Kot rezultat predhodno načrtovane vmesne analize so del preskušanja, v katerem so bolniki dobivali deksametazon, zaključili v skladu s priporočilom komisije, ki je spremljala podatke.
Congenital, familial and genetic disorders
Prirojene in dedne genetske okvare
TDx (N=126)
(n=126)
Respiratory, thoracic and mediastinal disorders
Bolezni dihal, prsnega koša in mediastinalnega
(feeling, hearing, tasting, smelling), attention disturbance, trembling, twitching - arthritis, including inflammation of the joints in the fingers, toes, and the jaw - disorders that affect your lungs, preventing your body from getting enough oxygen.
- vnetje sklepa (artritis), vključno z vnetjem sklepov prstov na roki in nogi ter čeljusti - motnje, ki prizadenejo pljuča in preprečujejo telesu, da bi dobilo dovolj kisika.
Grade ≥ 3 peripheral neuropathy occurred in 6% of patients in the subcutaneous treatment group, compared with 16% in the intravenous treatment group (p=0.0264).
Periferna nevropatija ≥ 3. stopnje se je pojavila pri 6 % bolnikov v skupini s subkutanim dajanjem v primerjavi s 16 %
Marketing Authorisation Holder and Manufacturer Sun Pharmaceutical Industries Europe B.V. Polarisavenue 87
Imetnik dovoljenja za promet z zdravilom in izdelovalec Sun Pharmaceutical Industries Europe B.V.
If you are given Bortezomib SUN for the treatment of multiple myeloma the side effects you may get are listed below:
Če prejemate zdravilo Bortezomib SUN za zdravljenje diseminiranega plazmocitoma, se lahko pri vas pojavijo naslednji neželeni učinki:
Mean total body clearances were 102 and 112 l/h following the first dose for doses of 1.0 mg/m2 and 1.3 mg/m2, respectively, and ranged from 15 to 32 l/h and 18 to 32 l/h following subsequent doses for doses of 1.0 mg/m2 and 1.3 mg/m2, respectively.
Po ponovljenih odmerkih je bil razpon od 15 do 32 l/h za odmerek 1,0 mg/m2 in od 18 do 32 l/h za odmerek 1,3 mg/m2.
An open label, randomised, Phase III non-inferiority study compared the efficacy and safety of the subcutaneous administration of bortezomib versus the intravenous administration.
V odprti, randomizirani študiji faze III na dveh enakovrednih skupinah so primerjali učinkovitost in varnost subkutanega in intravenskega dajanja bortezomiba.
PRf n (%) nCR n (%)
CRf n (%) PRf n (%) nCR n (%) CR+PRf n (%) p-vrednostd
1.1 Preparation of the 3.5 mg vial: carefully add 3.5 ml of sterile, 9 mg/ml (0.9%) sodium chloride solution for injection to the vial containing the Bortezomib SUN powder by using a syringe of the appropriate size without removing the vial stopper.
1.1 Priprava 3,5 mg viale: previdno dodajte 3,5 ml sterilne 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje v vialo s praškom zdravila Bortezomib SUN. Za rekonstitucijo uporabite primerno brizgo, pri tem ne odstranite zamaška z viale.
1.1 Preparation of the 3.5 mg vial: carefully add 1.4 ml of sterile, 9 mg/ml (0.9%) sodium chloride solution for injection to the vial containing the Bortezomib SUN powder by using a syringe of the appropriate size without removing the vial stopper.
1.1 Priprava 3,5 mg viale: previdno dodajte 1,4 ml sterilne 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje v vialo s praškom zdravila Bortezomib SUN. Za rekonstitucijo uporabite primerno brizgo, pri tem ne odstranite zamaška z viale.