natgillin/translations-raw huggingface dataset:
If you have not been treated before for mantle cell lymphoma you will receive VELCADE intravenously or subcutaneously together with the medicines rituximab, cyclophosphamide, doxorubicin and prednisone.
Če vam limfoma plaščnih celic še niso zdravili, boste zdravilo VELCADE prejeli v veno ali v podkožje, skupaj z rituksimabom, ciklofosamidom, doksorubicinom in prednizonom.
• Cysts in the lining of joints (synovial cysts)
• cista sklepne ovojnice (sinovialna cista)
Mantle cell lymphoma
Limfom plaščnih celic (MCL)
• Bleeding from your bowels or stomach
• krvavitev v črevesju ali želodcu
The median age of the patients in the study was 71 years, 50% were male, 88% were Caucasian and the median Karnofsky performance status score for the patients was 80.
Mediana starost bolnikov v študiji je bila 71 let, 50% sodelujočih je bilo moških, 88% belcev.
Do not store above 30 oC. Keep the vial in the outer carton in order to protect from light.
Vialo shranjujte v zunanji škatli, da bo zaščitena pred svetlobo.
• Stomach pain, bloating
• bolečine v trebuhu, napenjanje
Pancreatitis acute, Peritonitis*, Tongue oedema*, Ascites, Oesophagitis, Cheilitis, Faecal incontinence, Anal sphincter atony, Faecaloma*, Gastrointestinal ulceration and perforation*, Gingival hypertrophy, Megacolon, Rectal discharge, Oropharyngeal blistering*, Lip pain, Periodontitis, Anal fissure, Change of bowel habit, Proctalgia, Abnormal faeces
Redki akutni pankreatitis, peritonitis*, edem jezika*, ascites, ezofagitis, heilitis, inkontinenca blata, atonija analnega sfinktra, fekalom*, razjede in perforacije v prebavilih*, hipertrofija dlesni, megakolon, izcedek iz rektuma, orofaringealni mehurji*, bolečina v ustnicah, parodontitis, analna fisura, spremembe pri odvajanju blata, proktalgija, nenormalno blato
(e.g., bleeding from your bowels, stomach, mouth and gum or bleeding in the brain or bleeding from the liver) - red blood cells, which can cause anaemia, with symptoms such as tiredness and paleness - white blood cells may make you more prone to infections or flu-like symptoms.
- rdečih krvnih celic, kar lahko vodi v anemijo, s simptomi kot sta utrujenost in bledica - belih krvnih celic in tako bolj dovzetni za okužbe ali gripi podobne simptome.
If you are given VELCADE for the treatment of multiple myeloma the side effects you may get are listed below:
Če prejemate zdravilo VELCADE za zdravljenje diseminiranega plazmocitoma, se lahko pri vas pojavijo naslednji neželeni učinki:
For additional information concerning dexamethasone, see the corresponding Summary of Product Characteristics.
Za dodatne informacije o deksametazonu glejte Povzetek glavnih značilnosti tega zdravila.
Intravenous reconstitution: After reconstitution, 1 ml of solution for intravenous injection contains 1 mg bortezomib.
Intravenska rekonstitucija: Po rekonstituciji, 1 ml raztopine za intravensko injiciranje vsebuje 1 mg bortezomiba.
> 1.0 x 1.5 x ULN Any
> 1,0 x 1,5 x ULN katera koli ni potrebna zmerna
Up to 6 cycles may be given to patients who achieve at least a partial response after 4 cycles
Bolniki, ki dosežejo vsaj delni odgovor po 4 krogih, lahko prejmejo do 6 krogov zdravljenja.
≤ 30 ml/min (3% in each arm).
Podobno razmerje bolnikov je imelo očistek kreatinina ≤ 30 ml/min (3% v vsakem kraku študije).
• Nose bleeds
#, blefaritis
VELCADE 3.5 mg powder for solution for injection Bortezomib
VELCADE 3,5 mg prašek za raztopino za injiciranje bortezomib
VELCADE in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation.
Zdravilo VELCADE je v kombinaciji z rituksimabom, ciklofosfamidom, doksorubicinom in prednizonom indicirano za zdravljenje odraslih bolnikov z limfomom plaščnih celic, ki še niso prejemali zdravljenja in pri katerih presaditev krvotvornih matičnih celic ni mogoča.
VELCADE 1 mg powder for solution for injection Bortezomib
VELCADE 1 mg prašek za raztopino za injiciranje bortezomib
• Hypersensitivity
• preobčutljivost
This medicine is for intravenous or subcutaneous use.
To zdravilo se daje v veno ali v podkožje.
• that VELCADE is to be given only by IV or SC injections; no other route of administration is allowed
ali s.c., nobena druga uporaba ni dovoljena.
Haemorrhage*, Thrombophlebitis (inc superficial), Circulatory collapse (inc hypovolaemic shock), Phlebitis, Flushing*, Haematoma (inc perirenal)*, Poor peripheral circulation*, Vasculitis, Hyperaemia (inc ocular)*
#, globoka venska tromboza*, krvavitev*, tromboflebitis (vključno s površinskim), cirkulatorni kolaps (vključno s hipovolemičnim šokom), flebitis, pordelost, hematom (vključno s perirenalnim)*, slaba periferna prekrvavitev*, vaskulitis, hiperemija (vključno z očesno)*
Very Common Peripheral sensory neuropathy, Dysaesthesia*, Neuralgia* Common Neuropathies*, Motor neuropathy*, Loss of consciousness (inc syncope), Encephalopathy*, Peripheral sensorimotor neuropathy, Dizziness*, Dysgeusia*, Autonomic neuropathy Uncommon Autonomic nervous system imbalance
Bolezni živčevja Zelo pogosti periferna senzorična nevropatija, disestezija *, nevralgija* Pogosti nevropatije*, motorična nevropatija*, izguba zavesti (vključno s sinkopo), encefalopatija*, periferna senzorična in motorična nevropatija, omotica*, disgevzija*, avtonomna nevropatija
• In cycles 1 to 4, VELCADE is administered twice weekly on days 1, 4, 8, 11, 22, 25, 29 and 32.
- V krogih 1 do 4 se zdravilo VELCADE daje dvakrat na teden,1., 4., 8., 11., 22., 25., 29. in 32. dan. - V krogih 5 do 9 pa enkrat na teden, 1., 8., 22. in 29. dan.
Death (inc sudden), Multi-organ failure, Injection site haemorrhage*, Hernia(inc hiatus)*, Impaired healing*, Inflammation, Injection site phlebitis*, Tenderness, Ulcer, Irritability, Non-cardiac chest pain, Catheter site pain, Sensation of foreign body
Redki smrt (vključno z nenadno), odpoved več organov, krvavitev na mestu injiciranja*, kila (vključno s hiatusno)*, slabše celjenje*, vnetje, flebitis na mestu injiciranja*, občutljivost, razjede, razdražljivost, bolečina v prsih, ki ni srčnega izvora, bolečina na mestu katetra, občutek tujka
breathing that becomes shallow, difficult or stops, wheezing
oteženo ali preneha, sopenje
- Keep this leaflet.
Odluščite tukaj.
Uncommon Pancreatitis (inc chronic)*, Haematemesis, Lip swelling*, Gastrointestinal obstruction (inc small intestinal obstruction, ileus)*, Abdominal discomfort, Oral ulceration*, Enteritis*, Gastritis*, Gingival bleeding, Gastrooesophageal reflux disease*, Colitis (inc clostridium difficile)*, Colitis ischaemic
Občasni pankreatitis (vključno s kroničnim)*, hematemeza, otekanje ustnic*, obstrukcija prebavil (vključno z obstrukcijo tankega črevesa, ileusom)*, neprijeten občutek v trebuhu, razjede v ustih*, enteritis*, gastritis*, krvavitev iz dlesni, gastroezofagealna refluksna bolezen*, kolitis (vključno s kolitisom, povzročenim s clostridium difficile)*, ishemični kolitis
Day 1 Day 2 Day 3 Day rest period rest period
1 dan 2 dan 3 dan premor premor
Peripheral neuropathy in combination regimens Multiple Myeloma
Periferna nevropatija pri kombiniranem zdravljenju Diseminirani plazmocitom
Rest Period Rest Period
premor premor
No new safety concerns were observed when VELCADE was added to the standard pediatric pre-B cell ALL chemotherapy backbone.
Pri dodatku zdravila VELCADE standardni pediatrični pre B-celični ALL osnovni kemoterapevtski shemi niso opazili novih vplivov na varnost.
After reconstitution, 1 ml of solution for subcutaneous injection contains 2.5 mg bortezomib.
Po rekonstituciji praška 1 ml raztopine za subkutano injiciranje vsebuje 2,5 mg bortezomiba.
1.2 Before administration, visually inspect the solution for particulate matter and discolouration.
Pred dajanjem vizualno preverite, da raztopina ne vsebuje delcev in da barva ni spremenjena.
• Shingles (localized including around the eyes or spread across the body)
• opazite pasasti izpuščaj (lokaliziran, vključno s področjem okoli oči ali razširjen po telesu),
Notable differences in the safety profile of VELCADE administered subcutaneously versus intravenously as single agent
Pomembne razlike v varnostnem profilu uporabe zdravila VELCADE v monoterapiji subkutano oz. intravensko
OUTER CARTON, VELCADE 3.5 mg
ŠKATLA VELCADE 3,5 mg
Pegylated liposomal doxorubicin is administered at 30 mg/m² on day 4 of the VELCADE treatment cycle as a 1 hour intravenous infusion administered after the VELCADE 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 VELCADE.
• numbness, tingling, or pain in the hands or feet (neuropathy) in the past
• ste imeli v preteklosti kakršnekoli težave z odrevenelostjo, mravljinci ali bolečino v dlaneh ali stopalih (nevropatija),
Disseminated intravascular coagulation, Thrombocytosis*, Hyperviscosity syndrome, Platelet disorder NOS, Thrombotic microangiopathy (inc thrombocytopenic purpura)
Redki diseminirana intravaskularna koagulacija, trombocitoza*, hiperviskozni sindrom, bolezni trombocitov NOS, trombotična mikroangiopatija (vključno s trombocitopenično purpuro) bolezni krvi NOS, hemoragična diateza, limfocitna infiltracija
Uncommon Hepatotoxicity (inc liver disorder), Hepatitis*, Cholestasis Rare
Občasni hepatotoksičnost (vključno z boleznimi jeter), hepatitis*, holestaza
Uncommon Tumour lysis syndrome, Failure to thrive*, Hypomagnesaemia*, Hypophosphataemia*, Hyperkalaemia*, Hypercalcaemia*, Hypernatraemia*, Uric acid abnormal*, Diabetes mellitus*, Fluid retention
Občasni sindrom tumorske lize, zastoj rasti*, hipomagneziemija*, hipofosfatemija*, hiperkaliemija*, hiperkalciemija*, hipernatriemija*, nenormalne koncentracije sečne kisline*, sladkorna bolezen*, zastajanje tekočine
1.1 Preparation of the 1 mg vial: carefully add 1.0 ml of sterile, 9 mg/ml (0.9%) sodium chloride solution for injection to the vial containing the VELCADE powder by using a 1 ml syringe without removing the vial stopper.
1.1 Priprava 1 mg viale: previdno dodajte 1,0 ml sterilne 9 mg/ml (0,9%) raztopine natrijevega klorida za injiciranje v vialo s praškom zdravila VELCADE.
Change VELCADE treatment schedule to 1.3 mg/m2 once per week
zmanjšajte odmerek zdravila VELCADE na 1,0 mg/m ali spremenite shemo zdravljenja z zdravilom VELCADE na odmerek 1,3 mg/m 2 enkrat na teden
• Redness of skin
• srbenje kože
Each 5 ml vial of VELCADE must be carefully reconstituted with 1 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, by using a 1 ml syringe, without removing the vial stopper.
Vsako 5 ml vialo zdravila VELCADE morate previdno rekonstituirati z 1 ml 9 mg/ml (0,9%) raztopine natrijevega klorida za injiciranje.
• Cancer of the skin
• kožni rak
Prednisone is administered orally at 100 mg/m2 on days 1, 2, 3, 4 and 5 of each VELCADE treatment cycle.
Bolnik jemlje 100 mg/m2 prednizona peroralno na 1., 2., 3., 4. in 5. dan vsakega kroga zdravljenja z zdravilom VELCADE.
Table 1: Recommended* posology modifications for bortezomib-related neuropathy Severity of neuropathy
Preglednica 1: Priporočena* prilagoditev odmerjanja v primeru nevropatije v povezavi z bortezomibom Stopnja nevropatije
Your doctor may change the dose and total number of treatment cycles, depending on your response to the treatment on the occurrence of certain side effects and on your underlying conditions (e.g. liver problems).
Glede na vaš odziv na zdravljenje, pojavnost določenih neželenih učinkov in morebitne druge bolezni (npr. težave z jetri) lahko zdravnik spremeni odmerek in število krogov zdravljenja.
VELCADE in combination with melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for high-dose chemotherapy with haematopoietic stem cell transplantation.
Zdravilo VELCADE je v kombinaciji z melfalanom in prednizonom indicirano za zdravljenje odraslih bolnikov, pri katerih diseminirani plazmocitom še ni bil zdravljen in pri katerih pred presaditvijo krvotvornih matičnih celic kemoterapija v velikih odmerkih ni primerna.
IV on day 1; and prednisone 100 mg/m2 orally on day 1 through day 5 of the 21 day VELCADE treatment cycle.
na 1. dan in 100 mg/m prednizona peroralno na 1. do 5. dan 21-dnevnega cikla zdravljenja z zdravilom VELCADE.
The benefit/risk ratio should be considered prior to continuing VELCADE therapy.
Pred nadaljevanjem zdravljenja z zdravilom VELCADE je potrebno oceniti razmerje med koristjo in tveganjem.
Bortezomib is eliminated more rapidly following the first dose compared to subsequent doses.
V primerjavi s ponovljenimi odmerki, se bortezomib po prvem odmerku hitreje izloči iz telesa.
• shingles (localised including around the eyes or spread across the body)
• pasasti izpuščaj (herpes zoster (lokaliziran, vključno s področjem okoli oči, ali razširjen po telesu))
If you have not been treated before for multiple myeloma, and you are suitable for blood stem cell transplantation you will receive VELCADE intravenously or subcutaneously together with the medicines dexamethasone, or dexamethasone and thalidomide, as induction treatment.
Če pri vas diseminiranega plazmocitoma še niso zdravili in je presaditev krvotvornih matičnih celic za vas primerna, boste kot uvajalno zdravljenje prejeli zdravilo VELCADE v veno ali v podkožje v kombinaciji z deksametazonom ali z deksametazonom in talidomidom.
Intrathecal administration
Intratekalna uporaba
Two randomised, open-label, multicenter Phase III trials (IFM-2005-01, MMY-3010) were conducted to demonstrate the safety and efficacy of VELCADE in dual and triple combinations with other chemotherapeutic agents, as induction therapy prior to stem cell transplantation in patients with previously untreated multiple myeloma.
Bolniki, primerni za presaditev krvotvornih matičnih celic Za potrditev varnosti in učinkovitosti uvajalnega zdravljenja z zdravilom VELCADE v kombinacijah z dvema ali tremi kemoterapevtskimi učinkovinami, pred presaditvijo krvotvornih matičnih celic pri bolnikih s še nezdravljenim diseminiranim plazmocitomom so izvedli dve randomizirani, odprti, multicentrični preskušanji faze III (IFM-2005-01, MMY-3010).
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 VELCADE 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 VELCADE.
Day 1, 2, 3, 4
Dx 40 mg dan, 1, 2, 3, 4
You must read the package leaflets of all medicinal products to be taken in combination with VELCADE for information related to these medicines before starting treatment with VELCADE.
Preden začnete zdravljenje z zdravilom VELCADE preberite tudi navodila za uporabo zdravil, ki jih jemljete skupaj z zdravilom VELCADE.
• Cerebrovascular disorders
• možganskožilne bolezni
• shortness of breath or cough
• slabost (navzea) ali bruhanje
#, Gastrointestinal inflammation*, Dysphagia, Irritable bowel syndrome, Gastrointestinal disorder NOS, Tongue coated, Gastrointestinal motility disorder*, Salivary gland disorder*
#, vnetje prebavil*, disfagija, sindrom razdražljivega črevesja, bolezni prebavil NOS, obložen jezik, motnje črevesne motilitete*, motnje v delovanju žlez slinavk*
VELCADE powder has to be dissolved before administration.
Zdravilo VELCADE je v obliki praška, ki ga je potrebno raztopiti pred injiciranjem.
VELCADE in combination with dexamethasone, or with dexamethasone and thalidomide, is indicated for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with haematopoietic stem cell transplantation.
Zdravilo VELCADE je v kombinaciji z deksametazonom ali deksametazonom in talidomidom indicirano za indukcijsko zdravljenje odraslih bolnikov, pri katerih diseminirani plazmocitom še ni bil zdravljen in pri katerih je pred presaditvijo krvotvornih matičnih celic primerna kemoterapija v velikih odmerkih.
For single use only Do not give by other routes.
Ne sme se dajati po nobeni drugi poti.
In addition, when VELCADE is given in combination with other chemotherapeutic medicinal products, appropriate dose reductions for these products should be considered in the event of toxicities according to the recommendations in the Summary of Product Characteristics.
Kadar dajemo zdravilo VELCADE v kombinaciji z drugimi kemoterapevtiki, je v primeru pojava toksičnosti potrebno razmisliti o zmanjšanju odmerka teh zdravil, skladno z njihovimi povzetki glavnih značilnosti zdravil.
After reconstitution, 1 ml of solution for injection contains 1 mg bortezomib.
Po rekonstituciji, 1 ml raztopine za injiciranje vsebuje 1 mg bortezomiba.
VELCADE is given intravenously on days 1, 4, 8 and 11, followed by a ‘rest period' without treatment.
Zdravilo VELCADE boste prejeli intravensko na 1., 4., 8. in 11. dan, temu pa bo sledil premor brez zdravljenja.
Dehydration, Hypokalaemia*, Hyponatraemia*, Blood glucose abnormal*, Hypocalcaemia*, Enzyme abnormality*
Zelo pogosti zmanjšan apetit Pogosti dehidracija, hipokaliemija*, hiponatriemija*, nenormalne koncentracije glukoze v krvi*, hipokalciemija*, encimske motnje*
Complete blood counts (CBC) with differential and including platelet counts should be frequently monitored throughout treatment with VELCADE.
Med zdravljenjem z zdravilom VELCADE je treba pogosto spremljati število krvnih celic z diferencialno krvno sliko, vključno s številom trombocitov.
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 VELCADE 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 VELCADE.
* Based on NCI Organ Dysfunction Working Group classification for categorising hepatic impairment (mild, moderate,
Na osnovi klasifikacije jetrnih okvar (blaga, zmerna, huda) Delovne skupine za disfunkcije organov nacionalnega onkološkega inštituta ZDA (National Cancer Institute Organ Dysfunction Working Group).
• Muscle spasms
• rak ledvic
• If platelet counts < 25,000 cells/μL.
≥ 75.000 celic/μl.
Posterior Reversible Encephalopathy Syndrome (PRES) There have been reports of PRES in patients receiving VELCADE.
Sindrom reverzibilne posteriorne levkoencefalopatije (PRES - Posterior Reversible Encephalopathy Syndrome)
In addition, when VELCADE 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 VELCADE v kombinaciji z drugimi kemoterapevtiki je v primeru pojava toksičnosti potrebno razmisliti o zmanjšanju odmerka teh zdravil, skladno z njihovimi Povzetki glavnih značilnosti zdravil.
VELCADE is given intravenously or subcutaneously on days 1, 4, 8 and 11, followed by a ‘rest period' without treatment.
Zdravilo VELCADE boste prejeli v veno ali v podkožje na 1., 4., 8. in 11. dan, temu pa bo sledil premor brez zdravljenja.
If you have not been treated before for multiple myeloma, and you are not suitable for blood stem cell transplantation you will receive VELCADE intravenously 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 VELCADE injicirali v veno skupaj z zdraviloma melfalan in prednizon.
If you have not been treated before for multiple myeloma, and you are suitable for blood stem cell transplantation you will receive VELCADE intravenously together with the medicines dexamethasone, or dexamethasone and thalidomide, as induction treatment.
Če pri vas diseminiranega plazmocitoma še niso zdravili in je presaditev krvotvornih matičnih celic za vas primerna, boste kot uvajalno zdravljenje prejeli zdravilo VELCADE v veno v kombinaciji z deksametazonom ali z deksametazonom in talidomidom.
In study LYM-3002 in which VELCADE was administered with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CAP), the incidence of peripheral neuropathy in the combination regimens is presented in the table below:
Pojavnost periferne nevropatije pri kombiniranem zdravljenju v študiji LYM-3002 z zdravilom VELCADE, skupaj z rituksimabom, ciklofosfamidom, doksorubicinom in prednizonom (R-CAP), je navedena v spodnji preglednici:
The vial is contained in a transparent blister pack consisting of a tray with a lid. Each pack contains 1 single-use vial.
Viala je v prozornem omotu, sestavljenem iz pladnja, zaprtega s folijo.
VELCADE as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of adult patients with progressive multiple myeloma who have received at least 1 prior therapy and who have already undergone or are unsuitable for haematopoietic stem cell transplantation.
Zdravilo VELCADE je indicirano za zdravljenje napredujočega diseminiranega plazmocitoma v monoterapiji ali v kombinaciji s pegiliranim liposomskim doksorubicinom ali z deksametazonom pri odraslih bolnikih, ki so prejeli najmanj eno predhodno vrsto zdravljenja in so jim že presadili krvotvorne matične celice ali presaditev pri njih ni primerna.
Each 10 ml vial of VELCADE must be carefully reconstituted with 3.5 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, by using a syringe of the appropriate size, without removing the vial stopper.
Vsako 10 ml vialo zdravila VELCADE morate previdno rekonstituirati s 3,5 ml 9 mg/ml (0,9%) raztopine natrijevega klorida za injiciranje.
After reconstitution, each ml solution contains 1 mg bortezomib.
Po rekonstituciji, 1 ml raztopine vsebuje 1 mg bortezomiba.
Rhabdomyolysis, Temporomandibular joint syndrome, Fistula, Joint effusion, Pain in jaw, Bone disorder, Musculoskeletal and connective tissue infections and inflammations*, Synovial cyst
Redki rabdiomioliza, sindrom temporomandibularnega sklepa, fistula, izliv v sklep, bolečina v čeljusti, bolezni kosti, okužbe in vnetja mišično-skeletnega sistema, vezivnega tkiva*, sinovialna cista
VELCADE 3.5 mg powder for solution for injection is available for intravenous or subcutaneous administration.
Zdravilo VELCADE 3,5 mg prašek za raztopino za injiciranje je namenjeno za intravensko ali subkutano uporabo.
Gastrointestinal and intracerebral haemorrhage, have been reported in association with VELCADE treatment.
V povezavi z zdravljenjem z zdravilom VELCADE so poročali o gastrointestinalni in intracerebralni krvavitvi.
Each 10 ml vial of VELCADE must be carefully reconstituted with 1.4 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, by using a syringe of the appropriate size, without removing the vial stopper.
Vsako 10 ml vialo zdravila VELCADE morate previdno rekonstituirati z 1,4 ml 9 mg/ml (0,9%) raztopine natrijevega klorida za injiciranje.
If you have not been treated before for multiple myeloma, and you are not suitable for blood stem cell transplantation you will receive VELCADE 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 VELCADE injicirali skupaj z zdraviloma melfalan in prednizon.
VELCADE 1 mg powder for solution for injection IS FOR INTRAVENOUS USE ONLY.
Zdravilo VELCADE 1 mg prašek za raztopino za injiciranje je samo za intravensko uporabo.
Refer to the Summary of Product Characteristics of thalidomide for additional information.
Za dodatne podatke glejte Povzetek glavnih značilnosti zdravila s talidomidom.
Antiviral prophylaxis was administered to 26% of the patients in the Vc+M+P arm.
V Vc+M+P kraku študije je protivirusna zdravila prejelo 26% bolnikov.
NA=not applicable, NE=not estimated TTP-Time to Progression
CR+PR+MR; **CR = CR, (IF-); nCR = CR (IF+) NA = ne velja za ta primer, NE = odziva ni bilo mogoče oceniti TTP-čas do napredovanja bolezni CI = interval zaupanja