natgillin/translations-raw huggingface dataset:
This medicinal product contains 0.150 mmol sodium (which is 3.45 mg sodium) per ml of concentrate.
To zdravilo vsebuje 0, 150 mmol natrija (kar je 3, 45 mg natrija) na mililiter koncentrata.
HOW TO STORE VECTIBIX
SHRANJEVANJE ZDRAVILA VECTIBIX
Vectibix will be stored in the healthcare facility where it is used.
Vectibix bo shranjen v zdravstveni ustanovi, kjer bo uporabljen.
Do not use Vectibix after the expiry date which is stated on the label and carton after EXP.
Shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
Medicines should not be disposed of via wastewater or household waste.
Zdravila Vectibix ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli za oznako "Upor. do:".
25 6.
25 Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
The active substance is panitumumab 20 mg/ ml.
Zdravilna učinkovina je panitumumab 20 mg/ ml.
The other ingredients of Vectibix are sodium chloride, sodium acetate trihydrate, acetic acid (glacial) and water for injections.
Pomožne snovi v zdravilu Vectibix so natrijev klorid, natrijev acetat trihidrat, ledocetna kislina in voda za injekcije.
Vectibix is a colourless liquid that may contain visible particles and is supplied in a vial.
Na voljo je v vialah.
Each pack contains one vial of either 5 ml, 10 ml or 20 ml of concentrate.
Eno pakiranje vsebuje eno vialo s 5 ml, 10 ml ali 20 ml koncentrata.
This medicine has been given “ conditional approval”.
To pomeni, da se pričakujejo dodatni dokazi o zdravilu.
This means that there is more evidence to come about this medicine.
Evropska agencija za zdravila (EMEA) bo vsako leto ponovno pregledala nove podatke o zdravilu in posodobila navodilo za uporabo, če bo potrebno.
The European Medicines Agency (EMEA) will review new information on the medicine every year and this leaflet will be updated as necessary. ---------------------------------------------------------------------------------------------------------------------------
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Dilute in a total volume of 100 ml.
Razredčite v skupni količini
Doses higher than 1000 mg should be diluted in 150 ml 0.9% sodium chloride injection.
Odmerke, večje od 1000 mg, morate razredčiti v 150 ml 0, 9% raztopine natrijevega klorida za injiciranje.
27 Vectibix must be administered as an intravenous infusion via an infusion pump, using a low protein binding 0.2 or 0.22 micrometer in-line filter, through a peripheral line or indwelling catheter.
Vectibix morate aplicirati v intravenski infuziji z infuzijsko črpalko in uporabo 0, 2 - ali 0, 22- mikrometrskega linijskega filtra z majhno vezavo beljakovin, in sicer skozi periferen venski kanal ali stalni kateter.
Doses higher than 1000 mg should be infused over approximately 90 minutes.
Odmerke, večje od 1000 mg, je treba infundirati približno 90 minut.
Velcade is a powder that is made up into a solution for injection.
Zdravilo Velcade je prašek za pripravo raztopine za injiciranje.
It contains the active substance bortezomib.
Vsebuje zdravilno učinkovino bortezomib.
Velcade is an anticancer medicine.
Velcade je zdravilo proti raku.
It is used to treat adults with multiple myeloma, a cancer of the plasma cells in the bone marrow.
Uporablja se za zdravljenje odraslih z multiplim mielomom, rakom plazemskih celic v kostnem mozgu.
Velcade is used in the following groups:  patients who have not been treated before and who are not suitable for high-dose chemotherapy with bone marrow transplant.
Zdravilo Velcade se uporablja pri naslednjih skupinah bolnikov:  bolnikih, ki predhodno še niso bili zdravljeni in za katere kemoterapija z visokimi odmerki zdravil in sočasno presaditvijo kostnega mozga ni primerna.
In these patients, Velcade is used in combination with melphalan and prednisone (other medicines for multiple myeloma);  patients whose disease is progressive (getting worse) and who have failed to respond to at least one other treatment and have already had, or cannot undergo, a bone marrow transplant.
Pri teh bolnikih se zdravilo Velcade uporablja v kombinaciji z melfalanom in prednizonom (drugima zdraviloma za multipli mielom);  bolnikih z napredovalo boleznijo (slabšanjem stanja), ki se niso odzvali na vsaj eno drugo vrsto zdravljenja in katerim so že presadili kostni mozeg ali presaditev kostnega mozga pri njih ni mogoča.
Velcade is used on its own in these patients.
Zdravilo Velcade se pri teh bolnikih uporablja kot samostojno zdravilo.
Treatment with Velcade should only be started and given under the supervision of a doctor who has experience in the use of cancer chemotherapy.
Zdravljenje z zdravilom Velcade lahko uvede in izvaja samo zdravnik, ki ima izkušnje z zdravljenjem raka s kemoterapijo.
The recommended starting dose is 1.3 mg per square metre body surface area (calculated using the patient ’ s height and weight).
Priporočeni začetni odmerek znaša 1, 3 mg na kvadratni meter telesne površine (izračunane na podlagi bolnikove višine in mase).
The solution is given as a three- to five-second injection through a catheter (a thin sterile tube) into a vein.
Raztopina se injicira v veno skozi kateter (ozko sterilno cevko), kar traja tri do pet sekund.
When used in combination with melphalan and prednisone, Velcade is given twice a week on weeks 1, 2, 4 and 5 of a six-week treatment cycle.
Zdravilo Velcade v kombinaciji z melfalanom in prednizonom se daje dvakrat tedensko v 1., 2., 4. in 5. tednu šesttedenskega ciklusa zdravljenja.
This cycle is repeated three more times, followed by five cycles of once-weekly injections.
Tak ciklus zdravljenja ponovimo še trikrat, čemur sledi pet ciklusov zdravljenja, v katerih bolnik prejme le eno injekcijo na teden.
When used on its own, Velcade is given twice a week on weeks 1 and 2 of a three-week treatment cycle.
Kadar se zdravilo Velcade uporablja kot samostojno zdravilo, ga bolniku dajemo dvakrat tedensko, in sicer v 1. in 2. tednu tritedenskega ciklusa zdravljenja.
Patients who respond fully to treatment should receive two more cycles, but patients who only partially respond to treatment should receive up to eight cycles.
Bolniki s popolnim odzivom na zdravljenje naj prejmejo še dva dodatna ciklusa zdravljenja, bolniki s samo delnim odzivom na zdravljenje pa največ osem ciklusov zdravljenja.
If a patient develops severe side effects after a treatment cycle, the treatment must be suspended and the dose adjusted.
Če se po ciklusu zdravljenja pri bolniku pojavijo resni neželeni učinki, je treba zdravljenje začasno prekiniti in odmerek prilagoditi.
When
Če se beljakovine v rakavih
Reproduction is authorised provided the source is acknowledged. the proteins in the cancer cells, such as the proteins that control the growth of the cells, are not broken down, the cells are affected and they eventually die.
Reproduction is authorised provided the source is acknowledged. celicah, na primer beljakovine, ki nadzorujejo rast celic, ne razgradijo, to prizadene celice tako, da te odmrejo.
The effectiveness of Velcade has been studied in four main studies.
Učinkovitost zdravila Velcade so proučevali v štirih večjih študijah.
The first study involved 682 patients who had not been treated before and were not suitable for high- dose chemotherapy with bone marrow transplant.
Prva študija je vključevala 682 predhodno nezdravljenih bolnikov, ki niso bili primerni za kemoterapijo z visokimi odmerki zdravil in sočasno presaditev kostnega mozga.
The study compared the effects of adding Velcade to melphalan and prednisone with those of melphalan and prednisone alone.
V študiji so učinke dodajanja zdravila Velcade melfalanu in prednizonu primerjali z učinki zdravljenja samo z melfalanom in prednizonom.
The other three studies looked at patients who had received at least one previous treatment and whose disease was getting worse during their most recent treatment.
Ostale tri študije so bile izvedene pri bolnikih, ki so prejeli vsaj eno predhodno zdravljenje in katerih bolezensko stanje se je med zadnjim zdravljenjem poslabšalo.
In one study, the effectiveness of Velcade was compared with that of high-dose dexamethasone (another medicine for multiple myeloma) in 669 patients.
V eni študiji so pri 669 bolnikih učinkovitost zdravila Velcade primerjali z učinkovitostjo deksametazona v visokem odmerku (drugega zdravila za zdravljenje multiplega mieloma).
In the other two studies, including a total of 256 patients, Velcade was not compared with any other treatments.
V ostalih dveh študijah, ki sta vključevali skupno 256 bolnikov, zdravila Velcade niso primerjali z nobenim drugim zdravljenjem.
The main measures of effectiveness were the number of patients who responded to treatment and the time taken for the disease to get worse.
Glavni merili učinkovitosti sta bili število bolnikov, ki so se odzvali na zdravljenje, in čas do poslabšanja bolezenskega stanja.
In patients who had not been treated before, adding Velcade to melphalan and prednisone increased the time until the disease got worse: it took an average of 20.7 months in patients receiving Velcade and 15.0 months in those receiving only melphalan and prednisone.
Pri predhodno nezdravljenih bolnikih je dodajanje zdravila Velcade melfalanu in prednizonu podaljšalo čas do poslabšanja bolezenskega stanja: pri bolnikih, ki so prejemali zdravilo Velcade, je do poslabšanja prišlo po 20, 7 meseca, medtem ko je pri bolnikih, ki so dobivali samo melfalan in prednizon, do poslabšanja prišlo po 15, 0 meseca.
In patients who had been treated before, the time taken for the disease to get worse was, on average, 6.2 months with Velcade and 3.5 months with dexamethasone in the comparative study.
Pri predhodno zdravljenih bolnikih je bil povprečen čas do poslabšanja stanja 6, 2 meseca za zdravilo Velcade in 3, 5 meseca za deksametazon v primerjalni študiji.
In the other two studies, around 34% of the patients responded partially or completely to treatment with Velcade.
V drugih dveh študijah se je na zdravljenje z zdravilom Velcade delno ali popolnoma odzvalo okrog 34% bolnikov.
The most common side effects with Velcade (seen in more than 1 patient in 10) are herpes zoster (shingles), thrombocytopenia (low blood platelet counts), anaemia (low red blood cell counts), neutropenia (too few of the white blood cells that fight infection), reduced appetite, peripheral neuropathy with paraesthesia (tingling or numbness and pins and needles), headache, dyspnoea (breathlessness), nausea (feeling sick), diarrhoea, vomiting, constipation, rash, myalgia (muscle pain), fatigue (tiredness) and pyrexia (fever).
Najpogostejši neželeni učinki zdravila Velcade (opaženi pri več kot 1 bolniku od 10) so herpes zoster (pasovec), trombocitopenija (nizka koncentracija trombocitov v krvi), anemija (nizka koncentracija rdečih krvničk), nevtropenija (premalo belih krvničk za boj proti okužbam), zmanjšan apetit, periferna nevropatija s parestezijo (mravljinčenje ali odrevenelost ter zbadanje), glavobol, dispneja (oteženo dihanje), navzeja (občutek slabosti), driska, bruhanje, zaprtje, izpuščaji, mialgija (bolečine v mišicah), utrujenost in pireksija (povišana telesna temperatura).
For the full list of all side effects reported with Velcade, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Velcade, glejte navodilo za uporabo.
Velcade should not be used in people who may be hypersensitive (allergic) to bortezomib, boron or to any of the other ingredients.
Zdravilo Velcade se ne sme uporabljati pri osebah, ki utegnejo biti preobčutljive za (alergične na) bortezomib, boron ali katero koli drugo sestavino zdravila.
It must not be given to patients with severe liver disease, ‘ acute diffuse infiltrative pulmonary disease’ (a severe lung problem) or pericardial disease (disease affecting the sac that surrounds the heart).
Prav tako se ne sme dajati bolnikom s hudim obolenjem jeter, z „ akutno difuzno infiltracijsko pljučno boleznijo “ (hudim obolenjem pljuč) ali s perikardialno boleznijo (boleznijo, ki prizadene osrčnik).
The Committee for Medicinal Products for Human Use (CHMP) decided that Velcade’ s benefits are greater than its risks for the treatment of multiple myeloma.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Velcade pri zdravljenju multiplega mieloma večje od z njim povezanih tveganj.
The Committee recommended that Velcade be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Velcade odobri dovoljenje za promet.
Velcade has been authorised under ‘ Exceptional Circumstances’, because, for scientific reasons, it has not been possible to obtain complete information on the medicine.
Zdravilo Velcade je bilo odobreno v „ izjemnih okoliščinah “, saj zaradi znanstvenih razlogov ni bilo mogoče pridobiti vseh informacij o njem.
What information is still awaited for Velcade?
Katere informacije o zdravilu Velcade še pričakujemo?
The company that makes Velcade will carry out further studies looking in particular at the distribution of Velcade in the body (especially after repeated doses), and at the risk of patients developing amyloidosis (a build-up of a type of protein called amyloid in the body) or of amyloidosis getting worse.
Družba, ki izdeluje zdravilo Velcade, bo izvedla nadaljnje študije, ki bodo proučile zlasti porazdelitev zdravila Velcade v telesu (še posebej po ponovljenih odmerkih) in tveganje, da se pri bolnikih razvije amiloidoza (kopičenje vrste beljakovine, imenovane amiloid, v telesu) oziroma da se ta poslabša.
The European Commission granted a marketing authorisation valid throughout the European Union for Velcade on 26 April 2004.
Evropska komisija je dovoljenje za promet z zdravilom Velcade, veljavno po vsej Evropski uniji, odobrila dne 26. aprila 2004.
The marketing authorisation holder is Janssen-Cilag International NV.
Imetnik dovoljenja za promet z zdravilom je družba Janssen- Cilag International NV.
The marketing authorisation was renewed on 26 April 2009.
Dovoljenje za promet je bilo podaljšano 26. aprila 2009.
2/ 3 The full EPAR for Velcade is available here.
2/ 3 Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Velcade je na voljo tukaj.
ANNEX A EU Number
< Številka postopka
Invented name
< zaščiteno ime >
Strength
< vsebina
EU/ 1/ 04/ 274/ 001 EU/ 1/ 04/ 274/ 002
EU/ 1/ 04/ 274/ 001
3.5 mg 1 mg
1 viala
Powder for solution for injection Powder for solution for injection
EU/ 1/ 04/ 274/ 002
Intravenous use Intravenous use
prašek za raztopino za intravensko za injiciranje uporabo
vial (glass) vial (glass)
Viala (steklena)
1 1.
VELCADE 1 mg prašek za raztopino za injiciranje
NAME OF THE MEDICINAL PRODUCT
KAKOVOSTNA IN KOLIČINSKA SESTAVA
VELCADE 1 mg powder for solution for injection
Vsaka viala vsebuje 1 mg bortezomiba (v obliki estra manitola in borove kisline).
After reconstitution, 1 ml of solution for injection contains 1 mg bortezomib.
Po rekonstituciji praška 1 ml raztopine za injiciranje vsebuje 1 mg bortezomiba.
VELCADE in combination with melphalan and prednisone is indicated for the treatment of patients with previously untreated multiple myeloma who are not eligible for high-dose chemotherapy with bone marrow transplant.
4. 1 Terapevtske indikacije
VELCADE is indicated as monotherapy for the treatment of progressive multiple myeloma in patients who have received at least 1 prior therapy and who have already undergone or are unsuitable for bone marrow transplantation.
Zdravilo VELCADE je v kombinaciji z melfalanom in prednizolonom indicirano za zdravljenje bolnikov, pri katerih diseminirani plazmocitom še ni bil zdravljen in pri katerih kemoterapija v visokih odmerkih, pred presaditvijo kostnega mozga, ni primerna.
Posology for monotherapy The recommended starting dose of bortezomib is 1.3 mg/ m2 body surface area twice weekly for two weeks (days 1, 4, 8, and 11) followed by a 10-day rest period (days 12-21).
Priporočeni začetni odmerek bortezomiba je 1, 3 mg/ m2 telesne površine dvakrat na teden dva tedna (dnevi 1, 4, 8 in 11), čemur naj sledi 10- dnevni premor (od 12. do 21. dne).
This 3-week period is considered a treatment cycle.
To skupaj 3- tedensko obdobje predstavlja en krog zdravljenja.
It is recommended that patients with a confirmed complete response receive 2 additional cycles of VELCADE beyond a confirmation.
Priporočamo, da bolniki s potrjenim popolnim odzivom prejmejo še dva dodatna kroga zdravljenja z zdravilom VELCADE.
It is also recommended that responding patients who do not achieve a complete remission receive a total of 8 cycles of VELCADE therapy.
Priporočamo tudi, da odzivni bolniki, ki ne dosežejo popolne remisije, prejmejo 8 krogov zdravljenja z zdravilom.
Currently there are limited data concerning re-treatment with VELCADE.
Trenutno je podatkov o zdravljenju z zdravilom VELCADE malo.
Dose adjustments during treatment and re-initiation of treatment for monotherapy VELCADE treatment must be withheld at the onset of any Grade 3 non-haematological or any Grade 4 haematological toxicities, excluding neuropathy as discussed below (see also section 4.4).
Zdravljenje z zdravilom VELCADE morate prekiniti ob pojavu katerekoli nehematološke toksičnosti 3. stopnje ali katerekoli hematološke toksičnosti 4. stopnje, z izjemo nevropatije, kot je opisano v nadaljevanju (glejte tudi poglavje 4. 4).
Once the symptoms of the toxicity have resolved, VELCADE treatment may be re-initiated at a 25% reduced dose (1.3 mg/ m2 reduced to 1.0 mg/ m2; 1.0 mg/ m2 reduced to 0.7 mg/ m2).
Ko znaki toksičnosti minejo, lahko zdravljenje z zdravilom VELCADE ponovno uvedete, vendar s 25% manjšim odmerkom (1, 3 mg/ m2 zmanjšano na
If the toxicity is not resolved or if it recurs at the lowest dose, discontinuation of VELCADE 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 premisliti o ukinitvi zdravila VELCADE, razen če koristi zdravljenja odtehtajo s tem povezano tveganje.
2 Patients who experience bortezomib-related neuropathic pain and/ or peripheral neuropathy are to be managed as presented in Table 1 (see section 4.4).
Bolnike, ki imajo nevropatično bolečino in/ ali periferno nevropatijo v povezavi z jemanjem bortezomiba, zdravite v skladu s Preglednico 1 (glejte poglavje 4. 4).
Patients with pre-existing severe neuropathy may be treated with VELCADE only after careful risk/ benefit assessment.
Bolnike z obstoječo hudo nevropatijo lahko zdravite z zdravilom VELCADE šele po skrbnem pretehtanju razmerja koristi in tveganj.
Grade 1 with pain or Grade 2 (interfering with function but not with activities of daily living)
Priporočena * prilagoditev odmerjanja v primeru nevropatije v povezavi z bortezomibom Prilagoditev odmerjanja Stopnja nevropatije Stopnja 1 (parestezije, oslabljeni in/ ali odsotni refleksi) brez bolečine ali izguba funkcije Stopnja 1 z bolečino ali stopnja 2 (motnje funkcije, vendar ne vsakdanjih dejavnosti)
Reduce to 1.0 mg/ m2
ukrepanje ni potrebno zmanjšajte odmerek na 1, 0 mg/ m2
Grade 2 with pain or Grade 3 (interfering with activities of daily living)
Stopnja 2 z bolečino ali stopnja 3
Withhold VELCADE treatment until symptoms of toxicity have resolved.
ukinite zdravljenje z zdravilom VELCADE, dokler ne minejo znaki toksičnosti.
When toxicity resolves re-initiate VELCADE treatment and reduce dose to 0.7 mg/ m2 and change treatment schedule to once per week.
Nato ponovno uvedite zdravljenje z zdravilom VELCADE in zmanjšajte odmerek na 0, 7 mg/ m2 ter spremenite pogostnost odmerjanja na enkrat na teden.
Grade 4 (sensory neuropathy which is disabling or motor neuropathy that is life threatening or leads to paralysis) and/ or severe autonomic neuropathy
Stopnja 4 (senzorična nevropatija, ki onemogoča vsakdanje dejavnosti ali motorična nevropatija, ki ogroža življenje ali vodi v paralizo) in/ ali močna avtonomna nevropatija
*Based on posology modifications in Phase II and III multiple myeloma studies and post-marketing experience.
* na osnovi prilagoditev odmerjanja v študijah II. in III. faze pri bolnikih z diseminiranim plazmocitomom in postmerketinških izkušenj.
Paediatric patients VELCADE is not intended for use in children below 18 due to lack of data on safety and efficacy (see sections 5.1 and 5.2).
Pediatrični bolniki Zaradi pomanjkljivih podatkov o varnosti in učinkovitosti zdravilo VELCADE ni namenjeno uporabi pri otrocih, mlajših od 18 let (glejte poglavji 5. 1 in 5. 2).
Elderly patients There is no evidence to suggest that dose adjustments are necessary in the patients over 65 years of age (see section 4.8).
Starejši bolniki Ni znakov ali dokazov, ki bi potrdili, da je pri bolnikih starejših od 65 let potrebna prilagoditev odmerka (glejte poglavje 4. 8).
Renal impairment The pharmacokinetics of bortezomib are not influenced in patients with mild to moderate renal impairment (CrCL (Creatinine Clearance) > 20 ml/ min/ 1.73 m2); therefore, dose adjustments are not necessary for these patients.
Okvarjeno delovanje ledvic Pri bolnikih z blago do zmerno okvaro ledvic (očistek kreatinina (CrCL) > 20 ml/ min/ 1, 73 m2) ni vpliva na farmakokinetiko bortezomiba, zato pri njih prilagoditev odmerka ni potrebna.
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).
Ni znano ali je farmakokinetika bortezomiba spremenjena pri bolnikih s hudo okvaro delovanja ledvic, ki se ne zdravijo z dializo (CrCL < 20 ml/ min/ 1, 73 m2).
Since dialysis may reduce bortezomib concentrations, VELCADE should be administered after the dialysis procedure (see section 5.2).
Ker lahko dializa zmanjša koncentracije bortezomiba, ga je treba dajati po zaključitvi dializnega postopka (glejte poglavje 5. 2).
Hepatic impairment VELCADE has not been studied in patients with impaired hepatic function.
Okvarjeno delovanje jeter Zdravila VELCADE niso preskusili pri bolnikih z okvarjenim delovanjem jeter.
Significant hepatic impairment may have an impact on the elimination of bortezomib and may increase the likelihood of interactions with other active substances.
Huda jetrna okvara lahko vpliva na izločanje bortezomiba in lahko poveča verjetnost medsebojnega delovanja z drugimi učinkovinami.
Patients with impaired liver function should be treated with extreme caution and a dose reduction should be considered (see sections 4.3 and 4.4).
Bolnike z motenim delovanjem jeter je treba zdraviti zelo previdno in jim po potrebi zmanjšati odmerek (glejte poglavji 4. 3. in 4. 4.).
Posology for combination therapy VELCADE (bortezomib) is administered in combination with oral melphalan and oral prednisone for nine 6-week treatment cycles as shown in Table 2.
Zdravilo VELCADE (bortezomib) se daje v kombinaciji s peroralnim melfalanom in prednizolonom.
In Cycles 1-4, VELCADE is administered twice weekly (days 1, 4, 8, 11, 22, 25, 29 and 32).
Zdravljenje traja devet 6- tedenskih krogov, kot je prikazano v Preglednici 2.
In Cycles 5-9, VELCADE is administered once weekly (days 1, 8, 22 and 29).
V krogih 1- 4 se zdravilo VELCADE daje dvakrat na teden (dnevi 1, 4, 8, 11, 22, 25, 29 in 32), v krogih 5- 9 pa enkrat na teden (dnevi 1, 8, 22 in 29).
Melphalan and prednisone should both be given orally on days 1, 2, 3 and 4 of the first week of each cycle.
Melfalan in prednizolon je treba dati peroralno na dan 1, 2, 3 in 4 v prvem tednu vsakega kroga zdravljenja.
Table 2: Recommended posology for VELCADE in combination with melphalan and prednisone for patients with previously untreated multiple myeloma Twice weekly VELCADE (cycles 1-4)
Priporočeno odmerjanje zdravila VELCADE v kombinaciji z melfalanom in prednizolonom pri bolnikih s predhodno nezdravljenim diseminiranim plazmocitomom Odmerjanje zdravilaVELCADE dvakrat na teden (krogi 1- 4)
--
)
4
4 8
P (60 mg/ m2)
M (9 mg/ m2) P (60 mg/ m2)
1 2 3 4 period
dan dan dan dan 1 2 3
period
premor
Once weekly VELCADE (cycles 5-9)
Odmerjanje zdravila VELCADE enkrat na teden (krogi 5- 9)
Vc
2
-- -- --
-- -- -- dan
Day 8
8
rest
mor
Day 22
22
1.3 mg/ m2)
M (9 mg/ m2) P (60 mg/ m2)
1
dan dan dan dan 1 2 3
Day Day Day 2 3 4
4
rest -- period
pre - -- -- mor
Vc = VELCADE; M = melphalan, P=prednisone
Vc=VELCADE; M=melfalan, P=prednizolon