natgillin/translations-raw huggingface dataset:
The most common IRRs included cytokine release syndrome, flushing, throat irritation, and tremor.
Najčešće infuzijske reakcije bile su sindrom otpuštanja citokina, crvenilo praćeno osjećajem vrućine, iritacija grla i tremor.
• high blood sugar level, weight loss, swelling in the face and body, high levels of the enzyme “lactate dehydrogenase (LDH)” in the blood, low calcium levels in the blood
povišena razina šećera u krvi, gubitak tjelesne težine, oticanje lica i tijela, povišene razine enzima „laktat dehidrogenaza (LDH)“ u krvi, niske razine kalcija u krvi neuobičajeni osjeti na koži, kao što su utrnulost, trnci, bockanje, žarenje, osjećaj da nešto gmiže po koži, smanjen osjet dodira.
Redness, often associated with blisters, may appear on the skin or on mucous membranes, such as inside the mouth, the genital areas or the eyelids, and fever may be present.
Na koži ili sluznicama, primjerice u ustima, na genitalijama ili kapcima može se pojaviti crvenilo, često udruženo s mjehurićima, a moguća je i vrućica.
Progression-free survival (PFS) Overall survival
Preživljenje bez progresije (PFS)
Rituximab maintenance treatment consisted of a single infusion of rituximab at 375 mg/m2 body surface area given every 2 months until disease progression or for a maximum period of two years.
Terapija održavanja rituksimabom sastojala se od jedne infuzije rituksimaba u dozi od 375 mg/m2 tjelesne površine svaka 2 mjeseca do progresije bolesti ili najdulje dvije godine.
The ORR was 36% (CI95% 21% - 51%; CR 3%, PR 33%) with a median TTP for responding patients of 9.6 months (range 4.5 to 26.8 months).
ORR je iznosio 36 % (95 % CI 21 % - 51 %; CR 3 %, PR 33 %), a medijan TTP-a u bolesnika koji su odgovorili na liječenje 9,6 mjeseci (raspon od 4,5 do
Premedication consisting of an anti-pyretic and an antihistaminic, e.g. paracetamol and diphenhydramine, should always be given before each administration of Ritemvia.
Prije svake primjene lijeka Ritemvia uvijek treba primijeniti premedikaciju koja obuhvaća antipiretik i antihistaminik, npr. paracetamol i difenhidramin.
In a randomised, open-label trial, a total of 399 previously untreated elderly patients (age 60 to 80 years) with diffuse large B cell lymphoma received standard CHOP chemotherapy (cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2, vincristine 1.4 mg/m2 up to a maximum of 2 mg on day 1, and prednisolone 40 mg/m2/day on days 1-5) every 3 weeks for eight cycles, or rituximab 375 mg/m2 plus CHOP (R-CHOP).
U randomiziranom otvorenom ispitivanju ukupno je 399 prethodno neliječenih starijih bolesnika (u dobi od 60 do 80 godina) s difuznim limfomom velikih B-stanica primalo standardnu CHOP kemoterapiju (ciklofosfamid 750 mg/m2, doksorubicin 50 mg/m2, vinkristin 1,4 mg/m2 do najviše 2 mg prvog dana liječenja te prednizolon 40 mg/m2/dan od prvog do petog dana liječenja) svaka 3 tjedna u osam ciklusa liječenja, ili rituksimab u dozi od 375 mg/m2 u kombinaciji s CHOP kemoterapijom (R-CHOP).
EFS - Event Free Survival TTP - Time to progression or death PFS - Progression-Free Survival TTF - Time to Treatment Failure OS rates - survival rates at the time of the analyses
Time to progression or death) PFS - preživljenje bez progresije bolesti (engl.
Further, significantly higher proportion of patients achieved MCIDs for these scores (Table 14).
Nadalje, značajno je veći udio bolesnika postigao
Very rare cases of fatal PML have been reported following the use of rituximab.
Nakon primjene rituksimaba prijavljeni su vrlo rijetki slučajevi PML-a sa smrtnim ishodom.
Table 15 Summary of efficacy by baseline autoantibody status Week 24
Sažetak djelotvornosti prema početnom statusu autoantitijela
The most frequent adverse reactions considered due to receipt of rituximab were IRRs.
Najčešće nuspojave koje se smatraju posljedicom primjene rituksimaba bile su reakcije povezane s infuzijom.
Ritemvia is indicated for the treatment of previously untreated patients with stage III-IV follicular lymphoma in combination with chemotherapy.
Ritemvia je u kombinaciji s kemoterapijom indicirana u liječenju bolesnika oboljelih od folikularnog limfoma stadija III-IV koji prethodno nisu liječeni.
Influenza-like illness Oedema peripheral
Opći poremećaji i reakcije na mjestu primjene vrućica bolest nalik gripi periferni edem
Rituximab maintenance treatment consisted of a single infusion of rituximab at 375 mg/m2 body surface area given every 3 months until disease progression or for a maximum period of two years.
Terapija održavanja rituksimabom sastojala se od primjene jedne infuzije rituksimaba u dozi od 375 mg/m2 tjelesne površine svaka tri mjeseca do progresije bolesti ili najdulje dvije godine.
Figure 2: ACR responses for 4 treatment courses (24 weeks after each course (within patient, within visit) in patients with an inadequate response to TNF-inhibitors (n=146)
(intraindividualno, unutar posjeta) u bolesnika koji nisu dovoljno dobro odgovorili na TNF-inhibitore (n = 146)
Mean pre-therapeutic antibody titres against a panel of antigens (Streptococcus pneumoniae, influenza A, mumps, rubella, varicella) were maintained for at least 6 months after treatment with rituximab.
zaušnjaci, rubela, varičela) prije terapije održala se najmanje 6 mjeseci nakon liječenja rituksimabom.
The safety profile of rituximab in patients with moderate to severe rheumatoid arthritis (RA) is summarised in the sections below.
Sigurnosni profil rituksimaba u bolesnika sa srednje teškim ili teškim reumatoidnim artritisom (RA)
Rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis, and pemphigus vulgaris
Reumatoidni artritis, granulomatoza s poliangiitisom, mikroskopski poliangiitis i obični pemfigus
In the pivotal trial, 166 patients with relapsed or chemoresistant low-grade or follicular B cell NHL received 375 mg/m2 of rituximab as an intravenous infusion once weekly for four weeks.
U pivotalnom je ispitivanju 166 bolesnika s relapsirajućim ili kemorezistentnim, nisko malignim ili folikularnim B-staničnim ne-Hodgkinovim limfomom primilo rituksimab u dozi od 375 mg/m2 putem intravenske infuzije jedanput tjedno tijekom četiri tjedna.
Dizziness Tremor
Probavni poremećaji
Table 3 Adverse drug reactions occurring at 6-months in ≥ 5% of patients receiving rituximab for induction of remission of GPA and MPA, and at a higher frequency than the comparator group, in the pivotal clinical study.
Tablica 3 Nuspojave koje su u 6 mjeseci nastupile u ≥ 5 % bolesnika koji su primali lijek rituksimab za poticanje remisije GPA i MPA i koje su se javile s većom učestalošću nego u usporednoj skupini Organski sustav Nuspojava
Ritemvia 500 mg concentrate for solution for infusion
Ritemvia 500 mg koncentrat za otopinu za infuziju
Cases of posterior reversible encephalopathy syndrome (PRES)/reversible posterior leukoencephalopathy syndrome (RPLS) have been reported in autoimmune conditions.
Neurološki događaji Prijavljeni su slučajevi sindroma reverzibilne posteriorne encefalopatije (engl. posterior reversible encephalopathy syndrome, PRES) odnosno sindroma reverzibilne posteriorne leukoencefalopatije (engl. reversible posterior leukoencephalopathy syndrome, RPLS) u autoimunim stanjima.
Non-Hodgkin's lymphoma
Ne-Hodgkinov limfom
Granulomatosis with polyangiitis and microscopic polyangiitis
Granulomatoza s poliangiitisom i mikroskopski poliangiitis
Infusion-related reactions in the pemphigus vulgaris clinical study were common (58%).
Reakcije povezane s infuzijom bile su česte (58%) u kliničkim ispitivanjima kod običnog pemfigusa.
Decreased haemoglobin
Pretrage snižene razine hemoglobina
Experience from granulomatosis with polyangiitis and microscopic polyangiitis
Iskustva s primjenom kod granulomatoze s poliangitisom i mikroskopskog poliangitisa
Table 4 Adverse drug reactions occurring in ≥ 5% of patients receiving rituximab for maintenance treatment of GPA and MPA, and at a higher frequency than the comparator group
Tablica 4 Nuspojave koje su nastupile u ≥ 5% bolesnika koji su primali lijek rituksimab za terapiju održavanja GPA i MPA i koje su se javile s većom učestalošću nego u usporednoj skupini Organski sustav
3infusion-related reactions (hypertension, nausea, rash, pyrexia, pruritus, urticaria, throat irritation, hot flush, hypotension, rhinitis, rigors, tachycardia, fatigue, oropharyngeal pain, peripheral oedema, erythma)
urtikarija, iritacija grla, navale vrućine, hipotenzija, rinitis, tresavica, tahikardija, umor, bol u ustima i ždrijelu, periferni edem, eritem)
Name:_______________________ Doctor's contact details:________________ Make sure you have a list of all your medicines when you see a health care professional.
Kad posjećujete zdravstvenog djelatnika, obavezno sa sobom ponesite popis svih lijekova koje uzimate.
ORR was 38% (CI95% 26% - 51%; 10% CR, 28% PR) with a projected median TTP for responding patients of 17.8 months (range 5.4 - 26.6).
26 % - 51 %; CR 10 %, PR 28 %), a procijenjeni medijan TTP-a u bolesnika koji su odgovorili na liječenje 17,8 mjeseci (raspon 5,4-26,6 mjeseci).
Repeated treatment courses with Ritemvia are possible.
Ritemvia mogu se ponavljati.
• blocked or runny nose
• začepljen nos curenje iz nosa
In an open-label randomised trial, a total of 322 previously untreated patients with follicular lymphoma were randomised to receive either CVP chemotherapy (cyclophosphamide 750 mg/m2, vincristine 1.4 mg/m2 up to a maximum of 2 mg on day 1, and prednisolone 40 mg/m2/day on days 1-5) every 3 weeks for 8 cycles or rituximab 375 mg/m2 in combination with CVP (R-CVP).
U otvorenom randomiziranom ispitivanju ukupno su 322 prethodno neliječena bolesnika s folikularnim limfomom slučajnim odabirom određena za primanje CVP kemoterapije (ciklofosfamid 750 mg/m2, vinkristin 1,4 mg/m2 do najviše 2 mg prvog dana liječenja, prednizolon 40 mg/m2/dan od prvog do petog dana liječenja) svaka 3 tjedna u 8 ciklusa liječenja, ili rituksimaba u dozi od 375 mg/m2 u kombinaciji s CVP kemoterapijom (R-CVP).
4.06 years
4,06 godina 10.149 godina
Ritemvia 100 mg concentrate for solution for infusion
Ritemvia 100 mg koncentrat za otopinu za infuziju
This syndrome may be associated with some features of tumour lysis syndrome such as hyperuricaemia, hyperkalaemia, hypocalcaemia, hyperphosphataemia, acute renal failure, elevated lactate dehydrogenase (LDH) and may be associated with acute respiratory failure and death.
hipokalcijemijom, hiperfosfatemijom, akutnim zatajenjem bubrega, povišenom razinom laktat dehidrogenaze (LDH), kao i s akutnim zatajenjem dišnog sustava i smrću.
In the clinical trial evaluating rituximab maintenance treatment in relapsed/refractory follicular lymphoma, median IgG levels were below the lower limit of normal (LLN) (< 7 g/L) after induction treatment in both the observation and the rituximab groups.
IgG-a nakon početne terapije bio je ispod donje granice normalnih vrijednosti (< 7 g/l) i u opservacijskoj skupini i u skupini koja je primala rituksimab.
Patients treated with rituximab in combination with methotrexate had a significantly greater reduction in disease activity score (DAS28) than patients treated with methotrexate alone (Table 12).
U bolesnika liječenih rituksimabom u kombinaciji s metotreksatom došlo je do značajno većeg smanjenja aktivnosti bolesti (DAS28, od engl.
Patients with a history of a serious infusion reaction to a biologic therapy for RA were excluded from entry.
U ispitivanje nisu mogli biti uključeni bolesnici koji su u anamnezi imali ozbiljnu infuzijsku reakciju na neki biološki lijek za reumatoidni artritis.
Alopecia Pruritus Urticaria Skin disorder
Poremećaji kože i potkožnog tkiva alopecija svrbež urtikarija poremećaj kože
The mean Cmax (N=15) was 408 µg/mL (range, 97 - 764 µg/mL) after the fifth 500 mg/m2
Prosječni Cmax (N = 15) nakon pete infuzije od 500 mg/m2
Experience from non-Hodgkin's lymphoma and chronic lymphocytic leukaemia
Iskustva s primjenom u ne-Hodgkinovu limfomu i kroničnoj limfocitnoj leukemiji
150 patients originally randomised to placebo + MTX in Trial 1 received at least one course of RTX + MTX by one year * p <0.05, ** p < 0.001.
150 bolesnika prvotno nasumično raspodijeljenih u skupinu koja je primala placebo + metotreksat u Ispitivanju 1 primilo je barem jedan ciklus terapije rituksimab + metotreksat do kraja jedne godine ispitivanja
Mean change in SF‐36 MHS
Srednja vrijednost promjene SF-36 MHS % bolesnika sa SF-36 MHS MCID
Common Uncommon Rare
Obični pemfigus
1 vial contains 500 mg of rituximab.
1 bočica sadrži 500 mg rituksimaba.
• painful joints or back
• umor ili omaglica
9.25 years log-rank p value hazard ratio (95% CI) risk reduction TNLT (median)
(medijan) log-rang p-vrijednost omjer hazarda (95% CI) smanjenje rizika TNLT (medijan)
Contraindications for use in rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis and pemphigus vulgaris
Kontraindikacije za primjenu kod reumatoidnog artritisa, granulomatoze s poliangiitisom, mikroskopskog poliangiitisa i običnog pemfigusa
The frequencies of ADRs reported with rituximab alone or in combination with chemotherapy are summarised in Table 1.
Učestalost nuspojava prijavljenih pri primjeni rituksimaba u monoterapiji ili u kombinaciji s kemoterapijom sažeta je u Tablici
In the clinical trial on induction of remission, cardiac events occurred at a rate of approximately 273 per 100 patient years (95% CI 149-470) at the 6-month primary endpoint.
273 na 100 bolesnik-godina (95 % CI 149-470) u trenutku primarne mjere ishoda nakon 6 mjeseci.
fungal infections, infections of unknown origin, sinus inflammation, hepatitis B
gljivična infekcija, infekcije nepoznate etiologije, +akutni bronhitis, +sinusitis, hepatitis B1
Blood and lymphatic system disorders neutropenia, leucopenia, +febrile neutropenia, +thrombocytope nia anaemia, +pancytopenia, +granulocytope nia coagulation disorders, aplastic anaemia, haemolytic anaemia, lymphadenopa thy transient increase in serum IgM levels3
Poremećaji krvi i limfnog sustava neutropenija, leukopenija, +febrilna neutropenija, +trombocitopenija anemija, +pancitopenija, +granulocitopenija poremećaji zgrušavanja,
Table 10b First-line treatment of chronic lymphocytic leukaemia Hazard ratios of progression-free survival according to Binet stage (ITT) - 48.1 months median observation time Number of Patients
Omjeri hazarda za preživljenje bez progresije bolesti prema Binetovom stadiju (ITT populacija) - medijan vremena promatranja je 48,1 mjesec Preživljenje bez progresije bolesti (PFS)
No patients were withdrawn due to ADRs.
Nijedan bolesnik nije prekinuo liječenje zbog nuspojava.
Also do not breast-feed for 12 months after your last treatment with Ritemvia.
Ne smijete dojiti dijete tijekom liječenja lijekom Ritemvia i još 12 mjeseci nakon posljednje primjene lijeka jer se Ritemvia može izlučiti u majčino mlijeko.
Package leaflet: Information for the patient Ritemvia 500 mg concentrate for solution for infusion rituximab This medicine is subject to additional monitoring.
Uputa o lijeku: Informacije za bolesnika Ritemvia 500 mg koncentrat za otopinu za infuziju rituksimab
In CLL, the overall incidence of grade 3 or 4 cardiac disorders was low both in the first-line study (4% R-FC, 3% FC) and in the relapsed/refractory study (4% R-FC, 4% FC).
3 ili 4 bila niska i u ispitivanju prve linije liječenja (4 % R-FC, 3 % FC) i u ispitivanju relapsirajuće/refraktorne bolesti (4 % R-FC, 4 % FC).
If you have granulomatosis with polyangiitis, microscopic polyangiitis or pemphigus vulgaris also tell your doctor
Imate li granulomatozu s poliangiitisom, mikroskopski poliangiitis ili obični pemfigus,
however transient B-cell depletion and lymphocytopenia have been reported in some infants born to mothers exposed to rituximab during pregnancy.
Ne postoje odgovarajući i dobro kontrolirani podaci iz ispitivanja u trudnica, no u neke dojenčadi čije su majke tijekom trudnoće bile izložene rituksimabu prijavljene su prolazna deplecija B-stanica i limfocitopenija.
The cumulative incidence rate curves showed that time to first major relapse was longer in patients with rituximab starting from month 2 and was maintained up to month 28 (Figure 3).
Krivulje kumulativne stope incidencije pokazuju dulje vrijeme do prvog teškog relapsa u bolesnika liječenih lijekom rituksimab.
In all patients subgroups (gender, age, age adjusted IPI, Ann Arbor stage, ECOG, β2 microglobulin, LDH,
IPI), Ann Arbor stadij, ECOG (engl.
Musculoskeletal disorders arthralgia / musculoskeletal pain, osteoarthritis, bursitis
Poremećaji mišićno-koštanog sustava artralgija/bol u kostima i mišićima,
Package leaflet: Information for the patient Ritemvia 100 mg concentrate for solution for infusion rituximab This medicine is subject to additional monitoring.
Uputa o lijeku: Informacije za bolesnika Ritemvia 100 mg koncentrat za otopinu za infuziju rituksimab
Common side effects (may affect up to 1 in 10 people): infections such as herpes infections and eye infection mood disorders such as irritability and depression skin disorders such as itching, hives, and benign lumps feeling tired or dizzy fever headache pain in the tummy pain in the muscles heart beating faster than normal
Manje česte nuspojave (mogu se javiti u do 1 na 100 osoba): tegobe sa zgrušavanjem krvi, smanjeno stvaranje crvenih krvnih stanica i pojačano uništavanje crvenih krvnih stanica (aplastična hemolitička anemija), otečeni ili povećani limfni čvorovi neraspoloženost i gubitak interesa ili zadovoljstva u obavljanju aktivnosti, nervoza tegobe s osjetom okusa - poput promjena u okusu srčane tegobe - kao što su usporeno kucanje srca ili bol u prsnom košu (angina)
Sodium chloride Tri-sodium citrate dihydrate Polysorbate 80
FARMACEUTSKI PODACI 6.1 Popis pomoćnih tvari natrijev klorid natrijev citrat dihidrat polisorbat 80 voda za injekcije
Table 10a First-line treatment of chronic lymphocytic leukaemia Overview of efficacy results for rituximab plus FC vs. FC alone - 48.1 months median observation time Efficacy Parameter
Pregled rezultata djelotvornosti za rituksimab + FC u odnosu na samo FC (medijan vremena promatranja je 48,1 mjesec) Parametar djelotvornosti
Respiratory, thoracic and mediastinal disorders
Poremećaji dišnog sustava, prsišta i sredoprsja dispneja
The recommended dose of Ritemvia monotherapy used as induction treatment for adult patients with stage III-IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy is: 375 mg/m2 body surface area, administered as an intravenous infusion once weekly for 4 weeks.
• Relapsirajući/refraktorni folikularni limfom Preporučena doza lijeka Ritemvia u monoterapiji kod uvodnog liječenja odraslih bolesnika oboljelih od folikularnog limfoma stadija III-IV koji su rezistentni na kemoterapiju ili su u drugom odnosno sljedećem relapsu nakon kemoterapije iznosi 375 mg/m2 površine tijela, a primjenjuje se u obliku intravenske infuzije jedanput tjedno tijekom četiri tjedna.
This is because some people have a fall in their blood pressure while they are being given Ritemvia.
12 sati prije primjene lijeka Ritemvia zato što nekim bolesnicima može pasti krvni tlak tijekom primjene lijeka Ritemvia.
You might get infections more easily during your treatment with Ritemvia.
Tijekom liječenja lijekom Ritemvia možda ćete biti podložniji infekcijama.
Following two intravenous infusions of rituximab at a dose of 1000 mg, two weeks apart, the mean terminal half-life was 20.8 days (range, 8.58 to 35.9 days), mean systemic clearance was 0.23 L/day (range, 0.091 to 0.67 L/day), and mean steady-state distribution volume was 4.6 L (range, 1.7 to 7.51 L).
Nakon dvije intravenske infuzije rituksimaba u dozi od 1000 mg u razmaku od dva tjedna prosječan terminalni poluvijek bio je 20,8 dana (raspon 8,58 do 35,9 dana), prosječan sistemski klirens
b) If you are being treated for granulomatosis with polyangiitis or microscopic polyangiitis
b) Bolesnici koji se liječe od granulomatoze s poliangiitisom ili mikroskopskog poliangiitisa
Maintenance and relapse
Blagi relapsi
General disorders and administratio n site conditions fever, chills, asthenia, headache tumour pain, flushing, malaise, cold syndrome, +fatigue, +shivering, +multi-organ failure4
astenija, glavobolja bol u predjelu tumora, navale crvenila, opća slabost, sindrom prehlade, +umor, +drhtavica, +zatajenje više organa4
If you are being treated for non-Hodgkin's Lymphoma
a) Bolesnici koji se liječe od ne-Hodgkinova limfoma
Fatigue Pyrexia
Razine IgG-a
The vial contains 500 mg of rituximab.
Bočica sadrži 500 mg rituksimaba.
Follicular lymphoma
Folikularni limfom Monoterapija
Mean change from baseline: Modified total sharp score Erosion score Joint space narrowing score Proportion of patients with no radiographic change
Srednja vrijednost promjene od početnih vrijednosti: Prilagođen ukupan rezultat na Sharpovoj ljestvici
Regular full blood counts, including neutrophil and platelet counts, should be performed during rituximab therapy.
Tijekom terapije lijekom rituksimaba potrebno je redovito kontrolirati kompletnu krvnu sliku, uključujući broj neutrofila i trombocita.
The recommended dose of Ritemvia in combination with chemotherapy for induction treatment of previously untreated or relapsed/ refractory patients with follicular lymphoma is: 375 mg/m2 body surface area per cycle, for up to 8 cycles.
Preporučena doza lijeka Ritemvia u kombinaciji s kemoterapijom za uvodno liječenje bolesnika s prethodno neliječenim ili relapsirajućim/refraktornim folikularnim limfomom iznosi 375 mg/m2
1 vial contains 100 mg of rituximab.
1 bočica sadrži 100 mg rituksimaba.
Hypogammaglobulinaemia (IgA, IgG or IgM below the lower limit of normal) has been observed in granulomatosis with polyangiitis and microscopic polyangiitis patients treated with rituximab.
U bolesnika s granulomatozom s poliangiitisom i mikroskopskim poliangiitisom liječenih rituksimabom opažena je hipogamaglobulinemija (IgA, IgG ili IgM ispod donje granice normalnih vrijednosti).
The vial contains 100 mg of rituximab.
Bočica sadrži 100 mg rituksimaba.
• being sick (vomiting), diarrhoea, pain in the stomach, irritation or ulcers in the throat and mouth, problems swallowing, constipation, indigestion
• koprivnjača, pojačano znojenje, noćno znojenje mišićne tegobe - kao što je napetost u mišićima, bol u zglobovima ili mišićima, bol u vratu i leđima opća nelagoda, uznemirenost ili umor, drhtanje, znakovi gripe zatajenje više organa
Other side effects include: a) If you are being treated for non-Hodgkin's Lymphoma
Koliko ćete lijeka primiti i koliko često a) Bolesnici koji se liječe od ne-Hodgkinova limfoma ako se liječite samo lijekom Ritemvia
Events of neutropenia were observed with rituximab treatment, the majority of which were transient and mild or moderate in severity.
Tijekom liječenja rituksimabom zabilježeni su slučajevi neutropenije koji su većinom bili prolazni te blagog do umjerenog intenziteta.
• allergic reactions (hypersensitivity)
3reakcije povezane s infuzijom (hipertenzija,
Other symptoms included flushing, angioedema, bronchospasm, vomiting, nausea, urticaria/rash, fatigue, headache, throat irritation, rhinitis, pruritus, pain, tachycardia, hypertension, hypotension, dyspnoea, dyspepsia, asthenia and features of tumour lysis syndrome.
glavobolju, iritaciju grla, rinitis, svrbež, bol, tahikardiju, hipertenziju, hipotenziju, dispneju, dispepsiju, asteniju te obilježja sindroma lize tumora.
Combination therapy
Razlika između terapija
Patient subpopulations - rituximab combination therapy Elderly patients (≥ 65 years)
Podskupine bolesnika - liječenje rituksimabom u kombinaciji
Following induction of remission with Ritemvia, maintenance treatment should be initiated no sooner than 16 weeks after the last Ritemvia infusion.
Nakon primjene lijeka Ritemvia za poticanje remisije, terapiju održavanja treba započeti najmanje 16
• unusual feelings of the skin - such as numbness, tingling, pricking, burning, a creeping skin feeling, reduced sense of touch
• poremećaji raspoloženja poput razdražljivosti i depresije • poremećaji kože poput svrbeža, koprivnjače i dobroćudnih kvržica
Ritemvia 500 mg concentrate for solution for infusion Rituximab
Ritemvia 500 mg koncentrat za otopinu za infuziju rituksimab