natgillin/translations-raw huggingface dataset:
Mild to moderate epistaxis represented the most frequent bleeding event.
Najpogostnejša krvavitev je bila blaga do zmerna epistaksa.
What Vargatef looks like and contents of the pack Vargatef 150 mg soft capsules (capsules) are brown-coloured, opaque, oblong capsules imprinted on one side in black with the Boehringer Ingelheim company symbol and the figure “150”.
Zdravilo Vargatef, 150mg mehke kapsule(kapsule), so rjave barve, neprozorne in podolgovate, ki imajo na eni strani v črni barvivtisnjenooznakopodjetjaBoehringer Ingelheim in številko 150.
No increased frequency of impaired wound healing was observed in the LUME-Lung 1 trial.
V preskušanju LUME-Lung 1 niso opazili večje pogostnosti slabšega celjenja ran.
Co-administration with other medicinal products
Sočasno dajanje z drugimi zdravili
However, an increased frequency of arterial thromboembolic events was observed in patients with idiopathic pulmonary fibrosis (IPF) when treated with nintedanib monotherapy.
Toda pri bolnikih z idiopatsko pljučno fibrozo (IPF), zdravljenih z nintedanibom kot monoterapijo, so opazili večjo pogostnost arterijskih trombemboličnih dogodkov.
Breast-feeding should be discontinued during treatment with Vargatef.
Med zdravljenjem z zdravilom Vargatef je treba prenehati z dojenjem.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON (100 mg)
PODATKI NA ZUNANJI OVOJNINI ŠKATLA (100 mg)
Stratified Log-Rank Test p-value** Disease control [%] Odds ratio (95 % CI) p-value+
Vrednost p iz stratificiranega log-rang testa ** Nadzor bolezni [%]
Capsule shell: Gelatin, glycerol (85 %), titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172)
Ovojnica kapsule želatina glicerol (85 %) titanov dioksid (E171) rdeči železov oksid (E172) rumeni železov oksid (E172)
Active brain metastasis
Aktivne metastaze v možganih
MARKETING AUTHORISATION NUMBER(S) EU/1/14/954/001
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/14/954/001
Decrease in the number of white blood cells accompanied by fever (febrileneutropenia) Blood clots in the veins (venous thromboembolism), especially in the legs (symptoms include pain, redness, swelling, and warmth of a limb), which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing (if you notice any of these symptoms, seek medical advice immediately)
Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od10bolnikov) zastrupitev krvi (sepsa)-glejte zgoraj, zmanjšano število belih krvnih celic, ki ga spremlja vročina (febrilna nevtropenija), krvni strdki v venah (venska trombembolija),zlasti v nogah (simptomi vključujejo bolečino, rdečino, oteklino in toploto okončine), ki lahko potujejo po krvnih žilah do pljuč in povzročijo bolečine v prsnem košu in oteženo dihanje (če opazite katerega koli izmed teh simptomov, se takoj posvetujte z zdravnikom); visok krvni tlak (hipertenzija), izguba tekočine (dehidracija), abscesi, majhno število trombocitov (trombocitopenija),
Uncommon side effects (may affect up to 1 in 100 people) Occurrence of holes in the wall of your gut (gastrointestinalperforation) Serious liver problems
Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov) pojav lukenj v črevesnih stenah (predrtje prebavil), hude težave z jetri, vnetje trebušne slinavke (pankreatitis), miokardni infarkt, ledvična odpoved.
Nausea ≥ grade 3 despite anti-emetic treatment Other non-haematological or haematological adverse reaction of ≥ grade 3
Drugi nehematološki ali hematološki neželeni učinki ≥ 3. stopnje
How to store Vargatef
Shranjevanje zdravila Vargatef
QT/QTc measurements were recorded and analysed from a dedicated trial comparing nintedanib monotherapy against sunitinib monotherapy in patients with renal cell carcinoma.
V namenskem preskušanju so primerjali nintedanib in sunitinib kot monoterapiji pri bolnikih s karcinomom ledvičnih celic, ki so jim izmerili in analizirali vrednosti QT/QTc.
In this trial single oral doses of 200 mg nintedanib as well as multiple oral doses of 200 mg nintedanib administered
V tem preskušanju so jim dali bodisi enkratne peroralne odmerke nintedaniba po 200 mg ali večkratne peroralne odmerke po
Iron oxide black (E172) Propylene glycol (E1520)
Črnilo: šelak črni železov oksid (E172) propilenglikol (E1520)
MARKETING AUTHORISATION NUMBER(S) EU/1/14/954/004
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/14/954/004
The major route of elimination of drug related radioactivity after oral administration of [14C] nintedanib was via faecal/biliary excretion (93.4 % of dose, 2.61 % gCV).
C] nintedaniba je bila izločanje z blatom/žolčem (93,4 % odmerka, 2,61 %
AUCτ,ss increased by 25 % for a 50 kg patient (5
Vrednost AUCτ,ss se je povečala za 25 % pri 50-kilogramskem bolniku (5. percentil) in zmanjšala za 19 % pri 100-kilogramskem (95. percentil) glede na tiste z mediano telesno maso 71,5 kg.
Venous thromboembolism Hypertension
venska trombembolija hipertenzija anevrizme in disekcije arterij
Package leaflet: Information for the patient Vargatef 100 mg soft capsules nintedanib
Navodilo za uporabo: Informacije za paciente Vargatef 100 mg mehke kapsule nintedanib
MARKETING AUTHORISATION NUMBER(S) EU/1/14/954/003
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/14/954/003
Plasma levels of electrolytes should be monitored, if relevant gastrointestinal adverse events occur.
Če se pojavijo tovrstni neželeni učinki na prebavila, je treba spremljati raven elektrolitov v plazmi.
After treatment interruption and recovery to grade 1 or baseline, dose reduction from 200 mg twice daily to 150 mg twice daily and - if a 2
Driska ≥ 2. stopnje, ki vztraja več kot 7 zaporednih dni kljub njenemu zdravljenju ALI Driska ≥ 3. stopnje kljub njenemu zdravljenju Po prekinitvi zdravljenja in okrevanju do 1. stopnje ali izhodiščnega stanja je treba odmerek zmanjšati z 200 mg dvakrat na dan na 150 mg dvakrat na dan in, če je potrebno še drugo zmanjšanje, s 150 mg dvakrat na dan na 100 mg dvakrat na dan.
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le na recept s posebnim režimom.
Limited safety data are available in 9 patients with hepatocellular carcinoma and moderate hepatic impairment classified as Child Pugh B. Although no unexpected safety findings were reported in these patients, the data are insufficient to support a recommendation for treatment of patients with moderate hepatic impairment.
B.Čeprav pri teh bolnikih niso poročali o nepričakovanih podatkih o varnosti zdravila, so ti podatki nezadostni, da bi na njihovi podlagi lahko priporočili zdravljenje bolnikov z zmerno jetrno okvaro (Child Pugh B).
Increased liver enzyme values (gamma-glutamyltransferase) in the blood as seen from blood tests
zlatenica (hiperbilirubinemija), povečane vrednosti jetrnih encimov (gama-glutamiltransferaze) v krvi, kar pokažejo krvne preiskave, izguba telesne mase, srbenje, glavobol.
Management of adverse reactions may require interruption, dose reduction, or discontinuation of therapy with Vargatef (see section 4.2).
Zaradi obvladovanja neželenih učinkov bo morda treba zdravljenje z zdravilom Vargatef prekiniti, zmanjšati odmerek ali trajno ukiniti (glejte poglavje 4.2).
Package leaflet: Information for the patient Vargatef 150 mg soft capsules nintedanib
Navodilo za uporabo: Informacije za paciente Vargatef 150 mg mehke kapsule nintedanib
Stratified Log-Rank Test p-value** Progression free survival (PFS)*** - follow-up analysis Patients, n
RO (95-odstotni IZ) Vrednost p iz stratificiranega log-rang testa** Preživetje brez napredovanja***- analiza ob kontrolnem obisku Bolniki, n Število smrti ali napredovanj bolezni, n (%) Mediana PFS [meseci]
Each soft capsule contains100 mg nintedanib (as esilate).
Ena mehka kapsula vsebuje 100 mg nintedaniba (v obliki esilata).
What Vargatef looks like and contents of the pack Vargatef 100 mg soft capsules (capsules) are peach-coloured, opaque, oblong capsules imprinted on one side in black with the Boehringer Ingelheim company symbol and the figure “100”.
Mehke kapsule (kapsule) Vargatef po 100mg so neprozorne podolgovate kapsule v barvi breskve, ki imajo na eni strani v črni barvi natisnjeno oznako podjetja Boehringer Ingelheim in številko 100.
Wound healing complication
Zapleti s celjenjem ran
Increased liver enzyme values (alanine aminotransferase, aspartate aminotransferase, blood alkaline phosphatase) in the blood as seen from blood tests Hair loss (alopecia)
Bolezni jeter, žolčnika in žolčevodov povečana vrednost alaninaminotransferaze (ALT), povečana vrednost aspartataminotransferaze (AST), povečana vrednost alkalne fosfataze v krvi (ALKP)
An enlargement and weakening of a blood vessel wall or a tear in a blood vessel wall (aneurysms and artery dissections)
Neznana (ni mogoče oceniti iz razpoložljivih podatkov) vnetje debelega črevesa, razširitev in oslabitev stene krvne žile ali raztrganina v steni krvne žile (anevrizme in disekcije arterij).
Patients should be closely monitored for thromboembolic events.
Potrebujejo skrbno spremljanje glede pojava znakov in simptomov trombemboličnih dogodkov.
NAME OF THE MEDICINAL PRODUCT Vargatef 150 mg capsules Nintedanib
IME ZDRAVILA Vargatef 150 mg kapsule nintedanib
NAME OF THE MEDICINAL PRODUCT Vargatef 100 mg capsules Nintedanib
IME ZDRAVILA Vargatef 100 mg kapsule nintedanib
Nervous system disorders
Bolezni živčevja periferna nevropatija glavobol
NAME OF THE MEDICINAL PRODUCT Vargatef 100 mg soft capsules nintedanib
IME ZDRAVILA Vargatef 100 mg mehke kapsule nintedanib
Brown-coloured, opaque, oblong soft-gelatin capsule imprinted on one side in black with the Boehringer Ingelheim company symbol and “150”.
Neprozorne, podolgovate mehke želatinske kapsule rjave barve, ki imajo na eni strani črno natisnjeno oznako podjetja Boehringer Ingelheim in številko »150«.
Treatment interruption should be considered in patients who develop signs or symptoms of acute myocardial ischaemia.
Če se pri njih pojavijo znaki ali simptomi akutne miokardne ishemije, je treba razmisliti o prekinitvi zdravljenja.
NAME OF THE MEDICINAL PRODUCT Vargatef 150 mg soft capsules nintedanib
IME ZDRAVILA Vargatef 150 mg mehke kapsule nintedanib
Each soft capsule contains150mg nintedanib (as esilate).
Ena mehka kapsula vsebuje 150 mg nintedaniba (v obliki esilata).
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER (150 mg)
PRETISNI OMOT (150 mg)
Peach-coloured, opaque, oblong soft-gelatin capsules imprinted on one side in black with the Boehringer Ingelheim company symbol and “100”.
Neprozorne, podolgovate mehke želatinske kapsule v barvi breskve, ki imajo na eni strani črno natisnjeno oznako podjetja Boehringer Ingelheim in številko »100«.
STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 100 mg nintedanib (as esilate).
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena kapsula vsebuje 100 mg nintedaniba (v obliki esilata).
Your doctor will decide when to resume your treatment with this medicine
Razmisliti je treba o ukinitvi zdravljenja s tem zdravilom.
Shellac, iron oxide black (E172), propylene glycol (E1520)
šelak, črni železov oksid (E172), propilenglikol (E1520) Izgled zdravilaVargatef in vsebina pakiranja
Interruption, dose reduction or discontinuation of therapy with Vargatef may be required (see section 4.2).
Včasih je treba zdravljenje z zdravilom Vargatef prekiniti, zmanjšati odmerek ali trajno ukiniti (glejte poglavje 4.2).
In clinical trials the frequency was not increased in patients treated with nintedanib plus docetaxel as compared to placebo plus docetaxel.
Bolezni sečil ledvična odpoved (glejte poglavje 4.4) V kliničnih preskušanjih pogostnost ni bila povečana pri bolnikih, zdravljenih z nintedanibom in docetakselom, v primerjavi s placebom in docetakselom.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER (100 mg)
PRETISNI OMOT (100 mg)
As the company had supplied the additional information requested, the ‘exceptional circumstances' ended on 19 March 2012.
Ker je družba predložila zahtevane dodatne informacije, so „izjemne okoliščine“ prenehale veljati 19. marca 2012.
The following is a list of main benefits shown in these studies:
V nadaljevanju je seznam glavnih koristi, ki so jih opazili v omenjenih študijah:
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, izdala 26. aprila 2004.
Other information about Velcade:
Druge informacije o zdravilu Velcade:
The full EPAR for Velcade can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Velcade je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
What measures are being taken to ensure the safe and effective use of Velcade?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Velcade?
Velcade was originally authorised under ‘exceptional circumstances', because, for scientific reasons, limited information was available at the time of approval.
Zdravilo Velcade je prvotno pridobilo dovoljenje za promet v „izjemnih okoliščinah“, saj so bile zaradi znanstvenih razlogov ob odobritvi na voljo le omejene informacije.
It blocks the proteasome, which is a system within the cells that breaks down proteins when they are no longer needed.
Zavira proteasom, tj. sistem v celicah, ki razgrajuje beljakovine, ko te niso več potrebne.
This document is a summary of the European public assessment report (EPAR) for Velcade.
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Velcade.
The main measures of effectiveness in these studies were the number of patients who responded to treatment and how long the patients lived without their disease getting worse.
Glavni merili učinkovitosti v teh študijah sta bili število bolnikov, ki so se odzvali na zdravljenje, in čas preživetja bolnikov brez poslabšanja bolezni.
The main measure of effectiveness was how long the patients lived without their disease getting worse.
Glavno merilo učinkovitosti je bil čas preživetja bolnikov brez poslabšanja bolezni.
It is available in vials (1 and 3.5 mg) as a powder to be made up into a solution for injection.
Na voljo je v vialah (1 in 3,5 mg) kot prašek za pripravo raztopine za injiciranje.
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 je 1,3 mg na kvadratni meter telesne površine (izračunane na podlagi telesne višine in mase bolnika).
It must not be given to patients with acute diffuse infiltrative pulmonary disease or pericardial disease (disease affecting the sac that surrounds the heart).
Prav tako se ne sme dajati bolnikom z akutno difuzno infiltracijsko pljučno boleznijo ali perikardialno boleznijo (boleznijo, ki prizadene osrčnik).
When 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.
Če se beljakovine v rakavih celicah, na primer tiste, ki nadzorujejo rast celic, ne razgradijo, to vpliva na celice tako, da sčasoma odmrejo.
A risk management plan has been developed to ensure that Velcade is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Velcade je bil pripravljen načrt obvladovanja tveganj.
When Velcade is used with other medicines the restrictions for those medicines must also be taken into account, including the requirements for pregnancy testing and prevention with thalidomide.
Kadar se zdravilo Velcade uporablja sočasno z drugimi zdravili, je treba upoštevati tudi omejitve, ki veljajo za ta zdravila, vključno z zahtevami glede testiranja in preprečevanja nosečnosti pri uporabi talidomida.
If a patient develops severe side effects after a treatment cycle, the treatment must be suspended, delayed or the dose adjusted.
Če se po ciklu zdravljenja pri bolniku pojavijo resni neželeni učinki, je treba zdravljenje začasno prekiniti ali prilagoditi odmerek.
What benefit has Velcade shown during the studies?
Kakšne koristi je zdravilo Velcade izkazalo med študijami?
The CHMP decided that Velcade's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Velcade večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
In addition, the company that markets Velcade will ensure that healthcare professionals receive educational material explaining how to calculate the dose and how to prepare and administer the medicine.
Poleg tega bo družba, ki trži zdravilo Velcade, zagotovila, da bodo zdravstveni delavci prejeli izobraževalno gradivo, ki vsebuje pojasnila o izračunavanju ustreznega odmerka ter pripravi in dajanju zdravila.
Velcade must not be used in people who are hypersensitive (allergic) to bortezomib, boron or to any of the other ingredients.
Zdravila Velcade ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) bortezomib, boron ali katero koli drugo sestavino zdravila.
What is the risk associated with Velcade?
Kakšna tveganja so povezana z zdravilom Velcade?
• Around 34% of the patients responded partially or completely to treatment with Velcade (in a study in which Velcade was not compared with any other medicine)
• na zdravljenje z zdravilom Velcade se je delno ali v celoti odzvalo okrog 34 % bolnikov (v študiji, v kateri zdravila Velcade niso primerjali z nobenim drugim zdravilom);
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Velcade.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Velcade, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
When injected under the skin, it is given in the thigh or abdomen (tummy).
Pri injiciranju v podkožje se zdravilo daje v stegno ali abdomen (trebuh).
For more information on the use of Velcade, see the summary of product characteristics (also part of the EPAR).
Za več informacij o uporabi zdravila Velcade glejte povzetek glavnih značilnosti zdravila (ki je prav tako del EPAR).
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 sme uvesti in izvajati samo zdravnik, ki ima izkušnje z zdravljenjem raka s kemoterapijo.
For more information about treatment with Velcade, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Velcade preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Velcade is used to treat multiple myeloma, a blood cancer, in the following groups of patients:
Zdravilo Velcade se uporablja za zdravljenje multiplega mieloma, tj. krvnega raka, pri naslednjih skupinah bolnikov:
In multiple myeloma, Velcade has been evaluated in 10 main studies involving over 4,339 adults, which evaluated the benefits of Velcade alone or in combination with other treatments.
Uporabo zdravila Velcade pri multiplem mielomu so ovrednotili v 10 glavnih študijah, v katerih je sodelovalo več kot 4 339 odraslih in v katerih so ovrednotili koristi zdravila Velcade kot samostojnega zdravila ali v kombinaciji z drugimi zdravili.
The most serious adverse reactions include heart failure, tumour lysis syndrome (complications due to breakdown of cancer cells), pulmonary hypertension (high blood pressure in the arteries of the lungs), posterior reversible encephalopathy syndrome (a reversible brain disorder), acute diffuse infiltrative pulmonary disease (a severe lung problem), and autonomic neuropathy (damage to nerves controlling organs such as the bladder, eyes, gut, heart and blood vessels).
Najresnejši neželeni učinki vključujejo srčno popuščanje, sindrom tumorske lize (zaplete zaradi hitrega razkroja rakavih celic), pulmonarno hipertenzijo (visok krvni tlak v pljučnih arterijah), sindrom posteriorne reverzibilne encefalopatije (reverzibilno možgansko obolenje), akutno difuzno infiltracijsko pljučno bolezen (hudo pljučno obolenje) in avtonomno nevropatijo (poškodbe živcev, ki nadzorujejo delovanje organov, kot so npr. mehur, oči, črevesje, srce in ožilje).
• The study that compared Velcade given under the skin with Velcade given into a vein showed that the percentage of patients who responded partially or completely to treatment was the same (42%) when using either route of administration.
• študija, v kateri so primerjali injiciranje zdravila Velcade v podkožje z injiciranjem zdravila Velcade v veno, je pokazala, da je bil delež bolnikov, ki so se delno ali v celoti odzvali na zdravljenje, enak (42 %) pri obeh poteh dajanja zdravila;
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Velcade, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Velcade in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
• adults whose disease is getting worse after at least one other treatment and who have already had, or cannot undergo, a blood stem-cell transplant.
• odraslih, pri katerih se je bolezen poslabšala po vsaj enem drugem zdravljenju in katerim so že opravili presaditev krvnih matičnih celic ali pa presaditev pri njih ni mogoča.
The active substance in Velcade, bortezomib, is a proteasome inhibitor.
Zdravilna učinkovina zdravila Velcade, bortezomib, je zaviralec proteasoma.
The most commonly reported side effects during treatment with Velcade are nausea (feeling sick), diarrhoea, constipation, vomiting, fatigue (tiredness), pyrexia (fever), thrombocytopenia (low blood platelets count), anaemia (low red blood cell counts), neutropenia (low levels of neutrophils, a type of white blood cell that fights infection), peripheral neuropathy (nerve damage in the hands and feet), headache, paraesthesia (unusual sensations like pins and needles), decreased appetite, dyspnoea (difficulty breathing), rash, herpes zoster (shingles) and myalgia (muscle pain).
Najpogostejši neželeni učinki, o katerih so poročali pri uporabi zdravila Velcade, so navzeja (slabost), driska, zaprtje, bruhanje, utrujenost, pireksija (povišana telesna temperatura), trombocitopenija (nizka raven trombocitov v krvi), anemija (nizka raven rdečih krvničk), nevtropenija (nizka raven nevtrofilcev, tj. vrste belih krvničk, odgovornih za obrambo pred okužbami), periferna nevropatija (poškodbe živcev v rokah in stopalih), glavobol, parestezija (nenavadni občutki, kot je npr. zbadanje), zmanjšanje teka, dispneja (težave z dihanjem), izpuščaji, herpes zoster (pasovec) in mialgija (bolečine v mišicah).
In mantle cell lymphoma, Velcade was evaluated in a main study involving 487 previously untreated adults who were not considered suitable for blood stem-cell transplantation.
Uporabo zdravila Velcade pri limfomu plaščnih celic so ovrednotili v eni glavni študiji, v kateri je sodelovalo 487 predhodno nezdravljenih odraslih, pri katerih presaditev krvnih matičnih celic ni bila primerna.
Doses of Velcade are given intermittently, with rest periods in between doses, in treatment cycles of three to six weeks depending on whether Velcade is given alone or in combination with other medicines.
Odmerki zdravila Velcade se dajejo v intervalih, pri čemer mora biti med dvema zaporednima odmerkoma premor, cikli zdravljenja pa trajajo tri od šest tednov, odvisno od tega, ali se zdravilo Velcade daje kot samostojno zdravilo ali v kombinaciji z drugimi zdravili.