natgillin/translations-raw huggingface dataset:
Babies from at least 14 days old and children whose body weight is less than 30 kg, should receive 1 mg/ kg twice daily.
Dojenčki, stari vsaj 14 dni, in otroci, ki tehtajo manj kot 30 kg, morajo dobiti 1 mg/ kg dvakrat na dan.
Prepare the ready-to-use solution by mixing the powder with 202 ml of water or by slowly adding water up to the fill mark on the bottle.
Raztopino pripravite za uporabo tako, da prašek zmešate z 202 ml vode, ali s počasnim dolivanjem vode do polnilne oznake na plastenki.
Then screw the cap on tightly and shake the bottle well until the powder dissolves completely, and take or dispense the solution with the measuring cup provided.
Nato vzemite ali odmerite raztopino s priloženo odmerno čašo.
The decision to stop using Zerit should be discussed with your doctor.
115 Če ste prenehali jemati zdravilo Zerit O prenehanju jemanja zdravila Zerit se morate posvetovati s svojim zdravnikom.
Like all medicines, Zerit can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Zerit neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
110 When treating HIV infection it is not always possible to differentiate between unwanted effects caused by Zerit or those caused by any other medicines you may be taking at the same time, or by the complications of the infection.
Pri zdravljenju okužbe s HIV ni vedno mogoče razlikovati med neželenimi učinki, ki jih povzroči zdravilo Zerit, ter med neželenimi učinki drugih zdravil, ki jih morda jemljete hkrati, in zapleti same okužbe.
The most frequently reported side effects in adults taking Zerit in combination with other HIV medicinal products (lamivudine and efavirenz) were skin rash, headache, dizziness and peripheral neuropathy.
Najpogosteje opisani neželeni učinki pri odraslih, ki so zdravilo Zerit jemali v kombinaciji z drugimi zdravili proti HIV (z lamivudinom in efavirenzom), so bili izpuščaj na koži, glavobol, omotica in periferna nevropatija.
The prepared oral solution is stable for 30 days in a refrigerator (2°C -8°C).
Pripravljena peroralna raztopina je stabilna 30 dni, če se jo shranjuje v hladilniku (2°C - 8°C).
Do not use Zerit after the expiry date which is stated on the bottle and on the carton after EXP.
Zdravila Zerit ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na plastenki in škatlici poleg oznake "Uporabno do".
- The active substance is stavudine
- Zdravilna učinkovina je stavudin.
- The other ingredients of the powder are: cherry flavour, methylhydroxybenzoate (E218),
- Pomožne snovi praška so: aroma češnje, metilparahidroksibenzoat (E218),
propylhydroxybenzoate (E216), silicon dioxide, simethicone, sodium carmellose, sorbic acid, stearate emulsifiers and sucrose.
propilparahidroksibenzoat (E216), koloidni silicijev dioksid, simetikon, natrijev karmelozat, sorbinska kislina, stearatni emulgatorji in saharoza.
111 Marketing Authorisation Holder and Manufacturer
Imetnik dovoljenja za promet z zdravilom in izdelovalec
BRISTOL-MYERS SQUIBB PHARMA EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH United Kingdom
BRISTOL- MYERS SQUIBB PHARMA EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH – Velika Britanija
Ελλάδα BRISTOL-MYERS SQUIBB A. E.
117 Ελλάδα BRISTOL- MYERS SQUIBB A. E.
Zevalin is a kit for the preparation of a ‘ radiolabelled’ infusion (drip into a vein) of the active substance ibritumomab tiuxetan.
Zdravilo Zevalin je komplet za pripravo radioaktivno označene infuzije (kapalne infuzije v veno) zdravilne učinkovine ibritumomab tiuksetan.
The radiolabelled medicine is used to treat adult patients with follicular B-cell non-Hodgkin’ s lymphoma.
Radioaktivno označeno zdravilo se uporablja za zdravljenje odraslih bolnikov z ne- Hodgkinovim limfomom folikularnih celic B.
This is a cancer of the lymph tissue (part of the immune system) that affects a type of white blood cell called B-lymphocytes, or B-cells.
To je rak limfnega tkiva (dela imunskega sistema), ki prizadene vrsto belih krvničk, imenovano limfociti B ali celice B.
Zevalin is used in the following groups of patients: • patients who have gone into remission (reduction in the number of cancerous cells) after their first ‘ induction treatment’ (initial chemotherapy treatment) for lymphoma.
• bolnikih, ki so prešli v remisijo (zmanjšanje števila rakavih celic) po prvem „ indukcijskem zdravljenju “ (začetno zdravljenje s kemoterapijo) limfoma.
Zevalin is given as ‘ consolidation therapy’ to improve the remission; • patients in whom rituximab (another treatment for non-Hodgkin ’ s lymphoma) is no longer effective or whose disease has come back after rituximab treatment.
Zdravilo Zevalin se daje kot „ konsolidacijska terapija “ za izboljšanje remisije; • bolnikih, pri katerih rituksimab (druga oblika zdravila za ne- Hodgkinov limfom) ni več učinkovit ali katerih bolezen se je ponovno pojavila po zdravljenju z rituksimabom.
Before treatment with radiolabelled Zevalin, the patients must first receive an infusion of rituximab (at a dose lower than would be used for treatment) to clear B-cells from their circulation, leaving the cancerous B-cells in the lymph tissue.
Pred zdravljenjem z radioaktivno označenim zdravilom Zevalin morajo bolniki najprej dobiti infuzijo rituksimaba (v nižjem odmerku od tistega, ki se sicer uporablja za zdravljenje), da celice B očistijo iz obtoka in pustijo rakave celice B v limfnem tkivu.
This enables Zevalin to deliver radiation more specifically to the cancerous B– cells.
To zdravilu Zevalin omogoča, da se radioaktivno sevanje posebej osredotoči na rakave celice B.
The active substance in Zevalin, ibritumomab, is a monoclonal antibody.
Odmerek zdravila Zevalin se izračuna tako, da bolniku zagotovi ustrezno količino radioaktivnosti glede na njegovo stanje, ugotovljeno na podlagi števila krvnih celic.
Reproduction is authorised provided the source is acknowledged. an antigen) that is found in certain cells in the body.
Kako zdravilo Zevalin deluje?
Ibritumomab has been designed to target an antigen, CD20, which is present on the surface of all B-lymphocytes.
Ibritumomab je bil zasnovan tako, da se veže na antigen CD20, ki je prisoten na površini vseh limfocitov B.
When Zevalin is radiolabelled, the radioactive element yttrium-90 (90Y) is attached to ibritumomab.
Ko se zdravilo Zevalin radioaktivno označi, se radioaktivni element itrij- 90 (90Y) veže na ibritumomab.
When the radiolabelled medicine is injected into the patient, the monoclonal antibody carries the radioactivity to the target CD20 antigen on the B-cells.
Z injiciranjem radioaktivno označenega zdravila v bolnika, monoklonsko protitelo prenese radioaktivnost do ciljnega antigena CD20 v celicah B.
Once the antibody has bound to the antigen, the radiation can act locally and destroy the lymphoma B-cells.
Ko se protitelo veže na antigen, lahko začne sevanje lokalno delovati in uničevati limfom celic B.
For consolidation therapy, Zevalin has been studied in one main study involving 414 patients who had achieved a partial or complete remission during induction treatment for non-Hodgkin’ s lymphoma.
Pri konsolidacijski terapiji so zdravilo Zevalin proučevali v eni glavni študiji, v katero je bilo vključenih 414 bolnikov, ki so dosegli delno ali popolno remisijo med indukcijskim zdravljenjem ne - Hodgkinovega limfoma.
Zevalin has also been studied in a total of 306 patients with non-Hodgkin’ s lymphoma who were not responding to other treatments or whose disease had come back after previous treatment.
Zdravilo Zevalin so proučevali tudi pri skupno 306 bolnikih z ne- Hodgkinovim limfomom, ki se niso odzivali na druga zdravljenja ali pri katerih se je bolezen po predhodnem zdravljenju ponovila.
When Zevalin was used as consolidation therapy, patients survived for longer without their disease getting worse than when they received no further treatment.
Ko se je zdravilo Zevalin uporabilo kot konsolidacijska terapija, so bolniki preživeli dlje časa brez poslabšanja bolezni kot, če niso prejeli nobenega nadaljnjega zdravljenja.
In patients who were not responding to other treatments or whose disease had come back after previous treatment, Zevalin was more effective than rituximab:
Pri bolnikih, ki se niso odzivali na druga zdravljenja ali pri katerih se je bolezen po predhodnem zdravljenju ponovila, je bilo zdravilo Zevalin učinkovitejše od rituksimaba.
80% of the patients receiving radiolabelled Zevalin responded, compared with 56% of the patients receiving rituximab.
Odzvalo se je 80% bolnikov, ki so prejemali radioaktivno označeno zdravilo Zevalin, v primerjavi s 56% bolnikov, ki so prejemali rituksimab.
The most common side effects with Zevalin (seen in more than 1 patient in 10) are anaemia (low red blood cell counts), leucocytopenia and neutropenia (low white blood cell counts), thrombocytopenia (low blood platelet counts), asthenia (weakness), pyrexia (fever), rigors (stiffness) and nausea (feeling sick).
Najpogostejši neželeni učinki zdravila Zevalin (opaženi pri več kot 1 bolniku izmed 10) so slabokrvnost (nizka koncentracija rdečih krvničk), levkocitopenija in nevtropenija (nizka koncentracija belih krvničk), trombocitopenija (nizka koncentracija trompocitov), astenija (splošna oslabelost), pireksija (zvišana telesna temperatura), rigor (okorelost) in navzeja (slabost).
For the full list of all side effects reported with Zevalin, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Zevalin, glejte navodilo za uporabo.
Zevalin must not be used in patients who are pregnant or breast feeding.
Zdravila Zevalin ne smejo uporabljati bolnice, ki so noseče ali dojijo.
The Committee for Medicinal Products for Human Use (CHMP) decided that Zevalin’ s benefits are greater than its risks as consolidation therapy after remission induction in previously untreated patients with follicular lymphoma and for the treatment of adult patients with rituximab relapsed or refractory CD20-positive follicular B-cell non-Hodgkin's lymphoma.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Zevalin kot konsolidacijska terapija po indukciji remisije pri predhodno nezdravljenih bolnikih s folikularnim limfomom in za zdravljenje folikularnih celic B CD20+ pri odraslih bolnikih z ne- Hodgkinovim limfomom, ki se je po zdravljenju z rituksimabom ponovil ali je zanj neodziven, večje od z njim povezanih tveganj.
Zevalin was originally authorised under ‘ Exceptional Circumstances ’ because it had not been possible to obtain complete information about Zevalin.
2/ 3 Zdravilo Zevalin je bilo prvotno odobreno v „ izjemnih okoliščinah “, ker ni bilo mogoče pridobiti vseh informacij o njem.
As the company had supplied the additional information requested, the ‘ Exceptional Circumstances ’ ended on 22 May 2008.
Ker je družba predložila dodatne zahtevane informacije, so „ izjemne okoliščine “ prenehale veljati dne 22. maja 2008.
2/ 3 Other information about Zevalin:
Druge informacije o zdravilu Zevalin:
The European Commission granted a marketing authorisation valid throughout the European Union for Zevalin to Bayer Schering Pharma AG on 16 January 2004.
Evropska komisija je dovoljenje za promet z zdravilom Zevalin, veljavno po vsej Evropski uniji, odobrila družbi Bayer Schering Pharma AG dne 16. januarja 2004.
The marketing authorisation was renewed on 16 January 2009.
Dovoljenje za promet z zdravilom je bilo obnovljeno 16. januarja 2009.
The full EPAR for Zevalin is available here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Zevalin je na voljo tukaj.
Kit for radiopharmaceutica l preparation for infusion
Komplet za pripravo radiofarmaka za infuzijo
1 kit containing:
1 komplet vsebuje:
1 vial of ibritumomab tiuxetan, 1 vial of sodium acetate solution, 1 vial of formulation buffer and 1 empty reaction vial
1 vialo z ibritumomab tiuksetanom, 1 vialo z raztopino natrijevega acetata, 1 vialo s pufrom za pripravo formulacije in eno prazno vialo za pripravo zmesi
Zevalin 1.6 mg/ ml, Kit for radiopharmaceutical preparation for infusion
Zevalin 1, 6 mg/ ml, komplet za pripravo radiofarmaka za infundiranje
Ibritumomab tiuxetan*
ibritumomab tiuksetan *
One vial contains 3.2 mg of ibritumomab tiuxetan
Ena viala vsebuje 3, 2 mg ibritumomab tiuksetana
*produced by a genetically engineered Chinese Hamster Ovary (CHO) cell line conjugated to the chelating agent MX-DTPA
* pridobljen iz kulture genetsko spremenjenih celic jajčnika kitajskega hrčka, konjugiran s kelatorjem MX- DTPA
Zevalin is supplied as a kit for the preparation of yttrium-90 radiolabelled ibritumomab tiuxetan.
Zevalin je na voljo v obliki kompleta za pripravo z itrijem- 90 označenega ibritumomab tiuksetana.
The final formulation after radiolabeling contains 2.08 mg ibritumomab tiuxetan in a total volume of 10 ml.
Končna formulacija po označevanju z radiofarmakom vsebuje 2, 08 mg ibritumomab tiuksetana v skupnem volumnu 10 ml.
Kit for radiopharmaceutical preparation for infusion
komplet za pripravo radiofarmaka za infundiranje
The [90Y]-radiolabelled Zevalin is indicated as consolidation therapy after remission induction in previously untreated patients with follicular lymphoma.
Z [90Y] označeni Zevalin je indiciran kot konsolidacijska terapija t. j. za utrjevanje odgovora, ki je bil dosežen z indukcijskim zdravljenjem pri predhodno nezdravljenih bolnikih s folikularnim limfomom.
The [90Y]-radiolabelled Zevalin is indicated for the treatment of adult patients with rituximab relapsed or refractory CD20+ follicular B-cell non-Hodgkin's lymphoma (NHL).
Z [90Y] označeni Zevalin je indiciran za zdravljenje odraslih bolnikov z ne- Hodgkinovim limfomom (NHL) folikularnih celic B CD20+, ki je po rituksimabu recidiviral ali je zanj neodziven.
[90Y]-radiolabelled Zevalin should only be handled and administered by qualified personnel with appropriate authorisation for the use and manipulation of radionuclides within a designated clinical setting.
Z [90Y] označeni Zevalin sme uporabljati in aplicirati le strokovno usposobljeno osebje z ustreznim pooblastilom za uporabo in rokovanje z radioizotopi v določeni klinični ustanovi.
Its preparation, use, transfer, storage and disposal are subject to the regulations and/ or appropriate authorisation.
Priprava, uporaba, premeščanje, shranjevanje in odlaganje tega zdravila mora potekati v skladu s predpisi in ustreznimi dovoljenji pristojnih organov.
Infusions should be administered under the close supervision of an experienced physician with full resuscitation facilities immediately available (for radiopharmaceutical precautions see also sections 4.4, 6.6 and 12).
Infundiranje se mora izvajati pod strogim nadzorom izkušenega zdravnika, ki mora imeti takoj na razpolago vso opremo za reanimacijo (za previdnostne ukrepe v zvezi z uporabo radiofarmakov glejte poglavja 4. 4, 6. 6 in 12).
Zevalin should be used following pre-treatment with rituximab.
Zevalin se uporablja po predhodnem zdravljenju z rituksimabom.
Refer to the product information of rituximab for detailed guidance on its use.
Za natančna navodila glede uporabe rituksimaba upoštevajte povzetek glavnih značilnosti zdravila.
The prepared infusion solution must be given as a slow intravenous administration over 10 minutes.
Pripravljeno raztopino za infundiranje je treba aplicirati v obliki počasne, 10- minutne intravenske infuzije.
Do not use as an intravenous bolus.
Ne uporabljajte v obliki intravenske aplikacije bolus odmerka.
2 The [90Y]-radiolabelled Zevalin solution must be prepared according to section 12.
2 Z [90Y] označena raztopina Zevalina mora biti pripravljena v skladu z navodili navedenimi v poglavju 12.
For instructions on disposal, see section 6.6.
Za navodila o odstranjevanju glejte poglavje 6. 6.
Before administration to the patient, the percent radioincorporation of the prepared [90Y]-radiolabelled Zevalin must be checked according to the procedure outlined in section 12.
Pred aplikacijo zdravila bolniku je treba v skladu s postopkom opisanim v poglavju 12 preveriti odstotek vsebovane radioaktivnosti pripravljenega z [90Y] označenega Zevalina.
If the average radiochemical purity is less than 95%, the preparation should not be administered.
Če znaša povprečna radiokemijska čistost manj kot 95%, se zdravila ne sme aplicirati.
The recommended radioactivity for patients receiving Zevalin as monotherapy is:
Priporočena doza sevanja za bolnike, ki dobivajo zdravilo Zevalin kot monoterapijo:
patients with 150,000 platelets per mm3 and more:
bolniki s 150. 000 trombociti/ mm3 ali več:
15 MBq [90Y]-radiolabelled Zevalin per kg body weight up to a maximum of 1200 MBq.
15 MBq z [90Y] označenega Zevalina na kg telesne
11 MBq [90Y]- radiolabelled Zevalin per kg body weight up to a maximum of 1200 MBq.
mase do največ 1200 MBq,
The recommend radioactivity for patients receiving Zevalin as consolidation after remission induction is:
11 MBq z [90Y]
patients with 150,000 platelets per mm³ and more:
Priporočena doza sevanja za bolnike, ki dobivajo zdravilo Zevalin kot konsolidacijsko terapijo za utrjevanje odgovora, ki je bil dosežen z indukcijskim zdravljenjem: bolniki s 150. 000 trombociti/ mm3 in več:
patients with fewer than 150,000 platelets per mm³ should not receive Zevalin consolidation treatment.
bolniki z manj kot 150. 000 trombocitov/ mm3 ne smejo dobiti konsolidacijske terapije.
[90Y]-radiolabelled Zevalin may be infused directly by stopping the flow from an infusion bag and administering it directly into the line.
Z [90Y] označeni Zevalin se lahko infundira neposredno v infuzijski kateter, dotok iz vrečke pa se zapre.
A 0.2 or 0.22 micron low protein binding filter must be on line between the patient and the infusion port.
Med bolnikom in infuzijskim portom mora biti nameščen 0, 2 ali 0, 22 mikrometrski filter za vezavo nizkomolekularnih beljakovin.
Flush the line with at least 10 ml of sodium chloride 9 mg/ ml (0.9%) solution after the infusion of [90Y]-radiolabelled Zevalin.
Po aplikaciji z [90Y] označenega Zevalina sperite infuzijski kateter z najmanj 10 ml 0. 9 odstotne raztopine natrijevega klorida (9 mg/ ml).
Treatment consists of two intravenous administrations of rituximab and one administration of [90Y]- radiolabelled Zevalin in the following order:
Zdravljenje se sestoji iz dveh intravenskih aplikacij rituksimaba in ene aplikacije z [90Y] označenega Zevalina v navedenem zaporedju:
Rituximab infusion dose schedule:
1. dan: intravenska infuzija rituximaba Shema odmerjanja rituksimaba v infuziji:
250 mg/ m2 of rituximab.
250 mg rituksimaba/ m2
Rituximab infusion dose schedule:
7., 8. ali 9. dan: intravenska infuzija rituksimaba neposredno pred aplikacijo z [90Y] označenega Zevalina Shema odmerjanja rituksimaba v infuziji:
[90Y]-radiolabelled Zevalin infusion:
Infuzija z [90Y] označenega Zevalina:
10 minute intravenous infusion of [90Y]-radiolabelled Zevalin is given up to a maximum dose of 1200 MBq.
Z [90Y] označeni Zevalin se aplicira v 10- minutni intravenski infuziji do maksimalnega odmerka 1200 MBq.
Repeated use Data on the re-treatment of patients with [90Y]-radiolabelled Zevalin are not available.
Večkratna uporaba Ni podatkov o ponovljenem zdravljenju bolnikov z z [90Y] označenim Zevalinom.
There is no experience in children or adolescents below 18 years of age.
Pri otrocih ali mladostnikih mlajših od 18 let ni izkušenj.
- Hypersensitivity to ibritumomab tiuxetan, to yttrium chloride, to rituximab, to other murine
- Preobčutljivost za ibritumomab tiuksetan, itrijev klorid, rituksimab, druge beljakovine glodalcev
proteins or to any of the excipients.
ali za katerokoli od pomožnih snovi.
- Pregnancy and lactation.
- Nosečnost in dojenje.
Because the Zevalin therapeutic regimen includes the use of rituximab, see also the prescribing information of rituximab.
3 Ker režim zdravljenja z zdravilom Zevalin vključuje uporabo rituksimaba, glejte tudi informacije o predpisovanju rituksimaba.
Radiopharmaceutical agents should only be used by qualified personnel with the appropriate government authorisation for the use and manipulation of radionuclides.
Radiofarmake sme uporabljati le strokovno usposobljeno osebje z ustreznim pooblastilom pristojnega organa za uporabo in rokovanje z radioizotopi.
This radiopharmaceutical may be received, used and administered only by authorised persons in designated settings.
Prejemanje, uporaba in dajanje radiofarmakov lahko poteka le v določenih kliničnih ustanovah, poseg pa smejo izvajati le za to pooblaščene osebe.
Its receipt, storage, use, transfer, and disposal are subject to the regulations and/ or appropriate licences of the local competent official organisations.
Prevzem, shranjevanje, uporaba, premeščanje in odlaganje radiofarmakov mora potekati v skladu s predpisi in/ ali ustreznimi dovoljenji pristojnih organov.
Radiopharmaceuticals should be prepared by the user in a manner which satisfies both radiation safety and pharmaceutical quality requirements.
Uporabnik mora pri pripravi radiofarmakov upoštevati zahteve varstva pred sevanji kot tudi zahteve glede farmacevtske kakovosti.
Appropriate aseptic precautions should be taken, complying with the requirements of Good Manufacturing Practice for pharmaceuticals.
Upoštevati je treba ustrezne varstvene ukrepe za zagotavljanje aseptičnih pogojev, ki so v skladu z Dobro proizvodno prakso za zdravila.
In most patients Zevalin administration results in severe and prolonged cytopenia which is generally reversible.
Pri večini bolnikov uporaba zdravila Zevalin povzroči hudo in dolgotrajno citopenijo, ki je navadno reverzibilna.
In a clinical trial in which Zevalin was administered as consolidation after prior first line chemotherapy a higher frequency of severe and prolonged neutropenia and thrombocytopenia was observed in patients who had received Zevalin within 4 months after a combination chemotherapy of fludarabine with mitoxantrone and/ or cyclophosphamide compared to those patients who had received any other chemotherapy.
V kliničnem preskušanju, v katerem se je zdravilo Zevalin uporabilo kot konsolidacija po začetku prve kemoterapije, so pri bolnikih, ki so zdravilo Zevalin prejeli v štirih mesecih po kombinirani kemoterapiji s fludarabinom in mitoksantronom in/ ali ciklofosfamidom, opazili večjo pogostnost hude in dolgotrajne nevtropenije in trombocitopenije v primerjavi z bolniki, ki so prejemali katero koli drugo kemoterapijo.
Hence the risk of haematological toxicity may be increased when Zevalin is administered shortly (< 4 months) after fludarabine containing regimens.
Zato obstaja tveganje, da se hematološka toksičnost ob uporabi zdravila Zevalin v kratkem času (< 4 mesecih) po režimih, ki vključujejo fludarabin, poveča.
[90Y]-radiolabelled Zevalin should not be administered to patients who are likely to develop life- threatening haematological toxicity signs.
Z [90Y] označeni Zevalin se ne sme dajati bolnikom, pri katerih obstaja nevarnost za življenje ogrožajoče hematološke toksičnosti.
Patients receiving Zevalin as consolidation should have recovered from induction chemotherapy and have achieved a neutrophil count > 1,500/ mm³ and a platelet count > 150,000/ mm³ before Zevalin administration.
Bolniki, ki dobijo zdravilo Zevalin kot konsolidacijsko terapijo, si morajo še pred uporabo zdravila Zevalin opomoči po začetni kemoterapiji in doseči število nevtrofilcev > 1. 500/ mm3 in število trombocitov > 150. 000/ mm3.
Zevalin should not be administered in the patients mentioned below as safety and efficacy has not been established:
Zevalin se ne sme dajati spodaj navedenim skupinam bolnikov, ker varnost in učinkovitost pri njih ni bila ugotovljena:
- patients in whom more than 25% of the bone marrow has been infiltrated by lymphoma cells,
- bolniki, pri katerih je več kot 25% kostnega mozga infiltriranega z limfomskimi celicami;
- patients who have received prior external beam radiation involving more than 25% of active
- bolniki, ki so bili predhodno zdravljeni z obsevanjem, ki je zajelo več kot 25% delujočega
- patients receiving Zevalin as monotherapy with platelet counts < 100,000/ mm3 and patients
kostnega mozga; bolniki, ki dobivajo Zevalin kot monoterapijo s številom trombocitov < 100. 000/ mm3 ter