natgillin/translations-raw huggingface dataset:
Manufacturing authorisation issued by the French Ministère des Affaires Sociales, Ministère délégué à la Santé, and the Ministère de l'Agriculture et de la Forêt on 31 March 1992.
Dovoljenje za proizvodnjo je izdalo francosko Ministère des Affaires Sociales (Ministrstvo za socialne zadeve), Ministère délégué à la Santé (Ministrstvo pristojno za zdravstvo) in Ministère de l'Agriculture et de la Forêt (Ministrstvo za kmetijstvo in gozdarstvo) 31. marca 1992.
No special precautions.
Ni posebnih previdnostnih ukrepov.
Annex II of Council Regulation (EEC) No 2377/90 Pharmacologically active substance(s)
Dodatek II k Uredbi Sveta (EGS) Št. 2377/90 Farmakološko aktivna(e)
5 to 7 weeks before farrowing
5-7 tednov pred prasitvijo
50 dose
50 odmerkov
Laboratoire de Toulouse 4 Chemin du Calquet 31300 TOULOUSE FRANCE
Laboratoire de Toulouse 4 Chemin de Calquet 31300 TOULOUSE FRANCIJA
Vaccination may cause a slight hyperthermia (less than 1.5°C during a maximum period of 24 hours).
Cepljenje lahko povzroči rahel dvig telesne temperature ( manj kot 1,5oC v obdobju do največ 24 ur).
Wash and disinfect hands after use.
Po uporabi si umijte in razkužite roke.
Do not mix with any other vaccine.
Ne mešajte z nobenim drugim cepivom.
Therefore the safety and efficacy of this product when used with any other (either when used on the same day or at different times) has not been demonstrated.
Tako varnost in učinkovitost tega cepiva ob sočasni uporabi s katerikoli drugim cepivom (uporabljenim isti dan ali ob drugem času) nista potrjeni.
No information is available on the compatibility of this vaccine with any other.
Ni podatkov o sočasni uporabi tega cepiva s katerim koli drugim cepivom.
- Since the protection of piglets is ensured by colostrum intake, each piglet should ingest a sufficient quantity of colostrum within 6 hours of birth.
- Ker zaščito pujskov zagotavlja zaužitje kolostruma, bi moral vsak pujsek zaužiti zadostno količino kolostruma v prvih šestih urah po rojstvu.
In sows and gilts, the vaccine induces the specific seroconversion of vaccinated animals; piglets are passively immunised by intake of colostrum and milk containing adhesin-specific antibodies.
Pri svinjah in mladicah cepivo sproži specifično serokonverzijo cepljenih živali; pujski se pasivno imunizirajo z zaužitjem kolostruma in mleka, ki vsebuje specifična protitelesa proti adhezinom.
1 OJ No L 290 of 05.12.95 2 OJ No L 110 of 26.04.97 3 OJ No L 272 of 25.10.96 4 OJ No L 290 of 05.12.95 5 OJ No L 143 of 27.06.95
1UL št L 290 z dne 05.12.95 2UL št L 110 z dne 26.04.97 3UL št L 272 z dne 25.10.96 4UL št L 290 z dne 05.12.95 5UL št L 143 z dne 27.06.95
- Vaccinate only healthy animals.
- Cepite le zdrave živali.
No undesirable effects have been observed after the administration of twice the recommended dosage.
Po vnosu dvakratnega priporočenega odmerka se niso pojavili nobeni neželeni učinki.
In the case of accidental self-injection, seek medical advice immediately and show the package insert or label to a physician.
V primeru nenamernega samo-injiciranja se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali nalepko na zunanji ovojnini.
All food producing species
Vse živali za proizvodnjo živil
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with the local requirements
Vsako neporabljeno zdravilo ali odpadne snovi, ki nastanejo iz teh zdravil, je treba odstraniti v skladu z nacionalnimi zahtevami.
Name and address of the manufacturer of the biological active substance
Ime in naslov proizvajalca biološko aktivne učinkovine
One 2 ml dose according to the following schedule: Primary vaccination:
En 2 ml odmerek po naslednjem razporedu: Primarno cepljenje:
Revaccination: 1 injection 2 weeks before each subsequent farrowing.
Revakcinacija: 1 odmerek dva tedna pred vsako naslednjo prasitvijo.
Use sterile syringe and needles.
Uporabljajte sterilne brizge in igle.
Shelf-life: 18 months at 2 - 8 °C.
Rok uporabnosti: 18 mesecev pri temperaturi 2- 8 oC
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency https://www.ema.europa.eu/
Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila http://ema.europa.eu
Laboratoire Porte des Alpes Rue de l'Aviation F-69800 SAINT PRIEST
Laboratoire Porte des Alpes Rue de l'Aviation F-69800 SAINT PRIEST FRANCIJA
One 2 ml dose intramuscularly in the neck in the area behind the ear, according to the following schedule:
En 2 ml odmerek intramuskularno v področje vratu za ušesom po naslednjem razporedu:
- Do not administer in conjunction with other medicinal products.
Ne uporabljajte skupaj z drugimi zdravili.
2 weeks before farrowing.
2 tedna pred prasitvijo
Broached vial: 3 hours.
Načeta viala: 3 ure
Store and transport at 2°C - 8°C, protected from light.
Shranjujte in prevažajte pri temperaturi 2°C - 8°C, zaščiteno pred svetlobo.
*: 1 SA.U: quantity sufficient to obtain an agglutinating antibody titre of 1 log10 in the guinea pig.
*: 1 SA.U: količina, ki zadošča za doseganje aglutinacijskega titra protiteles 1 log10 pri morskem prašičku
MARKETING AUTHORISATION HOLDER Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein GERMANY
IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein
Intramuscular injection
Intramuskularno injiciranje
Intramuscular injection in the neck in the area behind the ear.
Intramuskularno injiciranje v področje vratu za ušesom Pred uporabo dobro pretresite vialo.
Administer using aseptic procedures.
Injicirajte v skladu z aseptičnimi pravili.
Adhesins:
Dodatek:
All food producing species For use only as a preservative in multidose vaccines at a concentration not exceeding 0.02%
Uporablja se le kot zaščitno sredstvo za večodmerna cepiva, koncentracija ne sme preseči
4.2 Indications for use specifying the target species
4.2 Indikacije za uporabo pri ciljnih živalskih vrstah
Adhesins: F4 (F4ab, F4ac, F4ad), F5, F6, F41 Aluminium adjuvant
adhezini F4 (F4ab, F4ac, F4ad), F5, F6, F41 Aluminijski adjuvant
Primary vaccination:
Primarno cepljenje: Prvi odmerek:
Aluminium hydroxide1
Aluminijev hidroksid1
First injection:
Prvi odmerek:
MANUFACTURER FOR THE BATCH RELEASE MERIAL
PROIZVAJALEC ZA SPROSTITEV SERIJ MERIAL
Second injection:
Drugi odmerek:
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
POGOJI TER OMEJITVE GLEDE OSKRBE IN UPORABE
Shelf life of broached vial: 3 hours.
Rok uporabnosti za načeto vialo: 3 ure.
Thiomersal2
Tiomersal2
Sodium hydroxide3
Natrijev hidroksid3
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
A. PROIZVAJALEC BIOLOŠKE UČINKOVINE IN IMETNIK(I) DOVOLJENJA ZA
Thiomersal Aluminium hydroxide Sodium chloride
Aluminijev hidroksid Natrijev hidroksid
250 doses =100 ml vial.
250 odmerkov = 100 ml steklena viala.
Sodium chloride4
Natrijev klorid3
Neocolipor suspension for injection
Neocolipor suspenzija za injiciranje
5 doses = 10 ml vial.
5 odmerkov = 10 ml steklena viala.
Adjuvanted inactivated vaccine for the reduction of neonatal enterotoxicosis of piglets, caused by E. coli strains, expressing the adhesins F4ab, F4ac, F4ad, F5, F6 and F41.
Inaktivirano cepivo z dodatkom (adjuvansom) za zmanjšanje pojava poporodne enterotoksemije pri pujskih, ki jo povzročajo sevi bakterije E. coli, ki izločajo adhezine F4ab, F4ac, F4ad, F5, F6 in F41.
Manufacturer responsible for batch release
Proizvajalec odgovoren za sprostitev serije
2 ml = 1 dose 10 d
2 ml= 1 odmerek, 10 odmerkov
E. coli adhesin F4 (F4ab, F4ac, F4ad), at least....................................................... 2.1 SA U* E. coli adhesin F5, at least ...................................................................................... 1.7 SA.U* E. coli adhesin F6, at least ...................................................................................... 1.4 SA.U* E. coli adhesin F41, at least .................................................................................... 1.7 SA.U*
E.coli adhezin F4 (F4ab, F4ac, F4ad), najmanj ..................................................... 2,1 SA.U** E.coli adhezin F5, najmanj ..................................................................................... 1,7 SA.U* E.coli dhezin F6, najmanj ....................................................................................... 1,4 SA.U* E.coli adhezin F41, najmanj ................................................................................... 1,7 SA.U*
Other provisions
Druga določila
DATE OF FIRST RENEWAL OF THE AUTHORISATION
DATUM ZADNJE REVIZIJE NAVODIL ZA UPORABO
Hydrochloric acid5
Klorovodikova kislina5
2 ml = 1 dose 5d
2 ml =1 odmerek, 5 odmerkov
Neocolipor
Tiomersal
20 ml vial
20 ml steklena viala.
100 ml vial
100 ml steklena viala.
Shake the vial vigorously prior to use.
Vialo pred uporabo dobro pretresite.
10 ml vial
10 ml steklena viala.
Reduction of neonatal enterotoxicosis of piglets, caused by E. coli strains, expressing the adhesins F4ab, F4ac, F4ad, F5, F6 and F41, during the first days of life.
Zmanjšanje pojava poporodne enterotoksemije pujskov v obdobju prvih nekaj dni po porodu, ki jo povzročajo sevi bakterije E.coli, ki izločajo adhezine F4ab, F4ac, F4ad, F5, F6 in F41.
EU/2/98/008/004 100 ml vial.
EU/2/98/008/004 100 ml steklena viala.
The vaccine contains the inactivated strains of E. coli expressing the adhesins F4ab, F4ac, F4ad, F5, F6 and F41, which cause neonatal enterotoxicosis in piglets, in aluminium hydroxide adjuvant.
Ti sevi bakterije E.coli izločajo adhezine F4ab, F4ac, F4ad, F5, F6 in F41, ki povzročajo poporodno enterotoksemijo pujskov.
EU/2/98/008/001 10 ml vial.
EU/2/98/008/001 10 ml steklena viala.
10 doses = 20 ml vial.
2 ml= 1 odmerek, 10 odmerkov = 20 ml steklena viala.
Aluminium (as hydroxide) .................................................................................... 1.4 mg
Aluminij (v hidroksidni obliki) .............................................................................. 1,4 mg
E. coli adhesin F4 (F4ab, F4ac, F4ad), at least….2.1 SA.U* E. coli adhesin F5, at least………………………1.7 SA.U* E. coli adhesin F6, at least………………………1.4 SA.U* E. coli adhesin F41, at least…………………….1.7 SA.U* *: 1 SA.U: quantity sufficient to obtain an agglutinating antibody titre of 1 log10 in the guinea pig.
E.coli adhezin F4 (F4ab, F4ac, F4ad), najmanj ........................................................... 2,1 SA U* E.coli adhezin F5, najmanj .......................................................................................... 1,7 SA.U* E.coli adhezin F6, najmanj .......................................................................................... 1,4 SA.U* E.coli adhezin F41, najmanj ........................................................................................ 1,7 SA.U*
Veterinary medicinal product subject to prescription.
Oskrba le na podlagi veterinarskega recepta.
EU/2/98/008/002 20 ml vial.
EU/2/98/008/002 20 ml steklena viala.
EU/2/98/008/003 50 ml vial.
EU/2/98/008/003 50 ml steklena viala.
Aluminium (as hydroxide) ..................................................................................... 1.4 mg
Dodatek: Aluminij (v hidroksidni obliki) ........................................................................ 1,4 mg
Shake the vial vigorously before use.
Pred uporabo dobro pretresite vialo.
PACKAGE LEAFLET Neocolipor
NAVODILO ZA UPORABO Neocolipor
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROSTITEV SERIJE
Box of 25-dose 50 ml vial (glass type I vial with butyl rubber stopper).
Škatla z vialo z 10 ml - pet odmerkov (steklo tipa I z butil gumenim zamaškom) Škatla z vialo z 20 ml - deset odmerkov (steklo tipa I z butil gumenim zamaškom) Škatla z vialo s 50 ml - petindvajset odmerkov (steklo tipa I z butil gumenim zamaškom) Škatla z vialo s 100 ml - petdeset odmerkov (steklo tipa I z butil gumenim zamaškom)
25 doses = 50 ml vial.
2 ml = 1 odmerek, 25 odmerkov 50 ml steklena viala.
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN ZAOSTANKOV
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE
VARNE IN UČINKOVITE UPORABE
CI=Confidence Interval
CI = interval zaupanja
1-year Overall Survival (%)
1-letno celokupno preživetje (%)
Response rate n: response-evaluable patients
Stopnja odziva n: odgovor preiskovanih bolnikov
This medicine must not be used in children and adolescents because it is not known how it will affect them.
Otroci in mladostniki Bortezomib se pri otrocih in mladostnikih ne sme uporabljati, ker njegovega vpliva nanje ne poznamo.
n: ITT patients Progression free survival (IRC)
n: bolniki (ITT) Preživetje brez napredovanja bolezni (IRC)
MARKETING AUTHORISATION NUMBER(S) EU/1/19/1397/001
ŠTEVILKA DOVOLJENJA ZA PROMET EU/1/19/1397/001
Table 14: Summary of disease outcomes from the Phase III (APEX) and Phase II studies Phase III
Preglednica 14: Povzetek izidov bolezni v študijah faze III (APEX) in II faza III
For dose adjustments, see table 5 below.
Za prilagajanje odmerkov glejte spodnjo preglednico 5.
This medicinal product does not require any special temperature storage condition.
Za shranjevanje zdravila ni posebnih temperaturnih omejitev.
AST=aspartate aminotransferase; ULN=upper limit of the normal range.
AST = aspartat-aminotransferaza; ULN - upper limit of the normal range = zgornja meja razpona normalnih vrednosti.
The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.>
Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve PSUR za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
The median survival of all patients enrolled was 17 months (range < 1 to 36+ months).
Mediana preživetja vseh bolnikov, vključenih v raziskavo je bila 17 mesecev (območje < 1 do 36+ mesecev).
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Zdravila ne smete mešati z drugimi zdravili, razen s tistimi, ki so omenjena v poglavju 6.6. 6.3 Rok uporabnosti
You must tell your doctor if you have any of the following:
Zdravniku povejte, če:
a Based on Independent Review Committee (IRC) assessment (radiological data only).
Na osnovi ocene neodvisnega odbora (Independent Review Committee-IRC) (samo podatki slikovnih diagnostičnih metod).
Do not use this medicine after the expiry date stated on the vial and the carton after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na viali in škatli poleg oznake EXP.
Bortezomib must be reconstituted by a healthcare professional (see section 6.6).
Bortezomib mora rekonstituirati zdravstveno osebje (glejte poglavje 6.6).
The AUClast geometric mean ratio was 0.99 and 90% confidence intervals were 80.18%-122.80%.
Stopnja geometrične sredine AUCzadnji je bila 0,99 in 90 % intervali zaupanja 80,18 %-122,80 %.
Very common Decreased appetite Common
Zelo pogosti zmanjšan apetit
From a microbiological point of view, the reconstituted solution should be used immediately after preparation.
Z mikrobiološkega stališča je rekostituirano raztopino treba porabiti takoj po pripravi.
Cycle 1
cikel 1
Grade 1 (asymptomatic; loss of deep tendon reflexes or paresthesia) with no pain or loss of function
Stopnja 1 (asimptomatična; izguba refleksa globoke tetive ali parestezija) brez bolečine ali izgube funkcije ni potrebna
Median duration Days (months)
Mediana trajanja odziva dnevi (meseci)
Patients achieving a complete response can continue treatment for at least 2 cycles after the first evidence of complete response, even if this requires treatment for more than 8 cycles.
Bolniki s popolnim odgovorom lahko z zdravljenjem nadaljujejo še najmanj dva cikla po prvi ugotovitvi popolnega odgovora, tudi če to zahteva zdravljenje, daljše od 8 ciklov.
- The other ingredients are mannitol (E421).
- Druga sestavina zdravila je manitol (E421).
In a few cases, patients who have had hepatitis B might have a repeated attack of hepatitis, which can be fatal.
Pri bolnikih, ki so imeli hepatitis B, lahko bolezen ponovno izbruhne, kar je lahko v redkih primerih smrtno.
The educational material shall consist of the following:
Izobraževalno gradivo mora vsebovati:
Refers to response rate after second transplant for subjects who received a second transplant (42/240 [18%] in BDx group and 52/242 [21%] in VDDx group).
Nanaša se na stopnjo odgovora po drugi presaditvi pri posameznikih, pri katerih je bila le-ta izvedena (42/240 [18 %] v skupini BDx in 52/242 [21 %] v skupini VDDx).
e Median duration of follow up is 11.8 months
Mediano trajanje nadaljevanja zdravljenja je 11,8 mesecev.
Abbreviations: SGOT=serum glutamic oxaloacetic transaminase;
Okrajšave: SGOT = serumska glutamat-oksaloacetat transaminaza;
Treatment with bortezomib can very commonly cause a decrease in the numbers of red and white blood cells and platelets in your blood.
Zdravljenje z bortezomibom lahko zelo pogosto povzroči zmanjšanje števila rdečih in belih krvnih celic ter krvnih ploščic.
Do not drive or operate tools or machines if you experience such side effects; even if you do not, you must still be cautious.
Če imate navedene neželene učinke ne vozite in ne upravljajte orodij ali strojev, pa tudi če jih nimate morate vseeno biti previdni.
Bortezomib may have a moderate influence on the ability to drive and use machines.
Bortezomib ima lahko zmeren vpliv na sposobnost vožnje in upravljanja strojev.
B=bortezomib; M=melphalan, P=prednisone
B = bortezomib; M = melfalan, P = prednizon
Detailed information on this medicinal product is available on the website of European Medicinal Agency http://www.ema.europa.eu
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/.
If the toxicity is not resolved or if it recurs at the lowest dose, discontinuation of bortezomib must be considered unless the benefit of treatment clearly outweighs the risk.
Če toksičnost ne mine ali če se ponovi tudi pri najmanjšem odmerku, morate razmisliti o ukinitvi bortezomiba, razen če koristi zdravljenja odtehtajo s tem povezano tveganje.
Fresenius Kabi Oncology Plc, Lion Court, Farnham Road, Bordon, Hampshire, GU35 0NF, United Kingdom
Fresenius Kabi Oncology Plc, Lion Court, Farnham Road, Bordon, Hampshire, GU35 0NF, Velika Britanija
In each Member State, the Marketing Authorisation Holder (MAH) shall agree the content and format of the educational material with the national competent authority.
Imetnik dovoljenja za promet z zdravilom se mora v vsaki državi članici s pristojnim nacionalnim organom dogovoriti glede oblike in vsebine izobraževalnih gradiv.
Patients with pre-existing severe neuropathy may be treated with bortezomib only after careful risk/benefit assessment.
Bolnike z obstoječo hudo nevropatijo lahko zdravite z bortezomibom šele po skrbnem pretehtanju razmerja med koristjo in tveganjem.
Once weekly bortezomib (cycles 5-9)
Odmerjanje bortezomiba enkrat na teden (cikli 5-9)
It is also recommended that responding patients who do not achieve a complete remission receive a total of 8 cycles of bortezomib therapy.
Priporočamo tudi, da odzivni bolniki, ki ne dosežejo popolne remisije, prejmejo skupno 8 ciklov zdravljenja z bortezomibom.
In the BTDx group 12% of patients were cytogenetically classified as high risk versus 16% of patients in the TDx group.
V skupini BTDx je imelo 12 % bolnikov citogenetiko velikega tveganja v primerjavi s 16 % v skupini TDx.
c p-value d
c p-vrednost d
• Inflammation or haemorrhage of the blood vessels that can appear as small red or purple dots
• vnetje ali krvavitev iz krvnih žil, ki se lahko kaže z majhnimi rdečimi ali vijoličnimi pikami
When bortezomib is given together with thalidomide and dexamethasone, the duration of a treatment cycle is 28 days (4 weeks).
Če jemljete bortezomib skupaj z talidomidom in deksametazonom, traja en cikel zdravljenja 28 dni (4 tedne).
The overall incidence of diarrhoea, gastrointestinal and abdominal pain, asthenic conditions, upper respiratory tract infections and peripheral neuropathies were 12%-15% lower in the subcutaneous group than in the intravenous group.
Celukupna incidenca driske, gastrointestinalne in abdominalne bolečine, asteničnih stanj, okužb zgornjih dihal in perifernih nevropatij je bila za 12 %-15 % manjša v subkutani kot v intravenski skupini.
At the time of a pre-specified interim analysis, the primary endpoint, time to progression, was met and patients in the M+P arm were offered B+M+P treatment.
Ob predhodno določenem času vmesne analize je bil dosežen primarni cilj (čas do napredovanja bolezni) in bolnikom v M+P kraku študije so ponudili zdravljenje z B+M+P.
At 10 μM concentrations, bortezomib does not inhibit any of a wide variety of receptors and proteases screened and is more than 1,500-fold more selective for the proteasome than for its next preferable enzyme.
Pri koncentraciji 10 μM bortezomib ne zavira nobenega od številnih različnih pregledanih receptorjev in proteaz in je več kot 1.500-krat bolj selektiven za proteasom kot za njegov drugouvrščeni prednostni encim.
The total storage time for the reconstituted medicinal product should not exceed 96 hours (if stored at 25°C) and 8 days (if stored at 2-8 °C) prior to administration.
Skupen čas shranjevanja rekonstituiranega zdravila pred injiciranjem ne sme biti daljši od 96 ur (če se shranjuje pri 25°C) ter 8 dni (če se shranjuje pri 2-8°C).
Secondary endpoints included, time to progression (TTP), time to next anti-lymphoma treatment (TNT), duration of treatment free interval (TFI), overall response rate (ORR) and complete response (CR/CRu) rate, overall survival (OS) and response duration.
Sekundarna ocena je vključevala čas do napredovanja bolezni (TTP), čas do naslednjega zdravljenja limfoma (TNT), trajanje obdobja brez zdravljenja (TFI), celokupno stopnjo odziva (ORR) in stopnjo popolnega odziva (CR/CRu), celokupno preživetje (OS) in trajanje odziva.
Grade 4 (life-threatening consequences; urgent intervention indicated) and/or severe autonomic neuropathy
Stopnja 4 (posledice, ki ogrožajo življenje; potrebno je nujno ukrepanje ) in/ali huda avtonomna nevropatija ukinite bortezomib
In the refractory population of the Phase II study, responses were determined by an independent review committee and the response criteria were those of the European Bone Marrow Transplant
Odziv na zdravljenje v populaciji bolnikov faze II preskušanja, ki so bili odporni na zdravljenje, je ugotavljala neodvisna komisija, ki je uporabila kriterije za odziv Evropske skupine za transplantacijo kostnega mozga (European Bone Marrow Transplant Group).
Time to response CR+PR (days)
Čas do odziva CR + PR (dnevi)
• If several bortezomib doses in a cycle are withheld (≥ 3 doses during twice weekly administration or ≥ 2 doses during weekly administration)
• Če preskočite več odmerkov bortezomiba v enem ciklu zdravljenja (≥ 3 odmerke pri odmerjanju dvakrat na teden ali ≥ 2 odmerka pri odmerjanju enkrat na teden)
Grade 1 with pain or grade 2 (moderate symptoms; limiting instrumental Activities of Daily Living (ADL)**)
Stopnja 1 z bolečino ali stopnja 2 (zmerni simptomi; omejene instrumentalne osnovne vsakodnevne aktivnosti (ADL)**)
As this medicine is being given by your doctor or nurse, it is unlikely that you will be given too much.
Če ste prejeli večji odmerek bortezomiba, kot bi smeli To zdravilo vam bo injiciral vaš zdravnik ali medicinska sestra zato ni verjetno, da bi ga lahko prejeli preveč.
CR=Complete Response; nCR=near Complete response PR=Partial Response; MR=Minimal response
CR = popolni odgovor; nCR = skoraj popolni odgovor; PR = delni odgovor; MR = minimalni odgovor