FrancophonIA/ELRC3.0 huggingface dataset:
English: ANNEX CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Slovenian: PRILOGA POGOJI IN OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA, KI JIH MORA IMPLEMENTIRATI DRŽAVA ČLANICA
English: Overall, the safety profile was considered acceptable.
Slovenian: Na splošno je bil varnostni profil zdravila ocenjen kot sprejemljiv.
English: Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu3151551
Slovenian: Nadaljnje informacije glede določitve zdravila sirote lahko najdete tukaj: ema.europa.eu/medicines/human/orphan-designations/eu3151551
English: The doctor may decide that patients or their caregivers can inject the medicine themselves after they have been properly trained.
Slovenian: Zdravnik bo morda odobril, da lahko bolnik ali njegov negovalec sama injicirata zdravilo, potem sta bila ustrezno usposobljena.
English: The recommended starting dose of Takhzyro is 300 mg every 2 weeks.
Slovenian: Priporočeni začetni odmerek zdravila Takhzyro je 300 mg vsaka dva tedna.
English: The European Medicines Agency therefore decided that Takhzyro's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Takhzyro večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: Further information on Takhzyro can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Takhzyro.
Slovenian: Nadaljnje informacije o zdravilu Takhzyro so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/Takhzyro.
English: What measures are being taken to ensure the safe and effective use of Takhzyro?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Takhzyro?
English: Patients experienced on average 0.3 attacks per month when given Takhzyro injections every 2 weeks and 0.5 attacks when given injections every 4 weeks.
Slovenian: Bolniki so v povprečju doživeli 0,3 napada na mesec, kadar so prejemali injekcije zdravila Takhzyro vsaka dva tedna, in 0,5 napada, kadar so injekcije prejemali vsake štiri tedne.
English: As for all medicines, data on the use of Takhzyro are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Takhzyro stalno spremljajo.
English: Side effects reported with Takhzyro are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Takhzyro, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Takhzyro have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Takhzyro upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: Other information about Takhzyro
Slovenian: Druge informacije o zdravilu Takhzyro
English: Hereditary angioedema is rare, and Takhzyro was designated an ‘orphan medicine' (a medicine used in rare diseases) on 9 October 2015.
Slovenian: Hereditarni angioedem je redka bolezen, zato je bilo zdravilo Takhzyro 9. oktobra 2015 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
English: Attacks of hereditary angioedema can be life threatening when the swelling around the throat presses against the airway.
Slovenian: Napadi hereditarnega angioedema so lahko življenjsko nevarni, kadar oteklina okrog grla pritiska na dihalne poti.
English: Why is Takhzyro authorised in the EU?
Slovenian: Zakaj je zdravilo Takhzyro odobreno v EU?
English: For more information about using Takhzyro, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Takhzyro glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: The most common side effects with Takhzyro (which may affect more than 1 patient in 10) are reactions at the site of injection including erythema (redness), bruising and pain.
Slovenian: Najpogostejši neželeni učinki zdravila Takhzyro (ki se lahko pojavijo pri največ 1 bolniku od 10) so reakcije na mestu injiciranja, vključno z eritemom (rdečina), podplutbo in bolečino.
English: If the patient remains free of attacks with the two-weekly dose, the doctor can reduce the frequency to once every 4 weeks.
Slovenian: Če bolnik med dvotedenskim odmerkom ni imel napada, lahko zdravnik spremeni pogostost jemanja na vsake štiri tedne.
English: Patients with angioedema have rapid swelling under the skin in areas such as the face, throat, arms and legs.
Slovenian: Pri bolnikih z angioedemom pride do hitrega otekanja pod kožo na različnih delih telesa, na primer na obrazu, grlu, rokah in nogah.
English: An overview of Takhzyro and why it is authorised in the EU
Slovenian: Pregled zdravila Takhzyro in zakaj je odobreno v EU
English: What benefits of Takhzyro have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Takhzyro izkazalo v študijah?
English: What are the risks associated with Takhzyro?
Slovenian: Kakšna tveganja so povezana z zdravilom Takhzyro?
English: What is Takhzyro and what is it used for?
Slovenian: Kaj je zdravilo Takhzyro in za kaj se uporablja?
English: Patients with hereditary angioedema have high levels of a substance called ‘bradykinin', which causes blood vessels to widen and leak fluid into the surrounding tissue leading to the swelling attacks seen in angioedema.
Slovenian: Pri bolnikih s hereditarnim angioedemom nastajajo v krvnem obtoku visoke ravni snovi, imenovane „bradikinin“, ki povzročijo, da se krvne žile razširijo in prepuščajo tekočino v okoliško tkivo, kar povzroči napade otekanja, kot jih je mogoče opaziti pri angioedemu.
English: By blocking the actions of kallikrein, lanadelumab helps to prevent the swelling and related symptoms of angioedema.
Slovenian: Lanadelumab z zaviranjem delovanja kalikreina pomaga pri preprečevanju otekanja in drugih simptomov angioedema.
English: Takhzyro can only be obtained with a prescription and should be started under supervision of a doctor experienced in managing hereditary angioedema.
Slovenian: Predpisovanje in izdaja zdravila Takhzyro je le na recept, zdravljenje z njim pa se sme uvesti samo pod nadzorom zdravnika z izkušnjami z zdravljenjem hereditarnega angioedema.
English: For the full list of side effects and restrictions with Takhzyro, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Takhzyro glejte navodilo za uporabo.
English: The active substance in Takhzyro, lanadelumab, works by attaching to and blocking an enzyme in the blood called 'kallikrein', which has several functions, including increasing levels of bradykinin.
Slovenian: Učinkovina v zdravilu Takhzyro, lanadelumab, deluje tako, da se veže na encim v krvi, imenovan „kalikrein“, in ga zavira, kar med drugim povzroči nastajanje visokih ravni bradikinina.
English: EMA/734573/2018
Slovenian: Takhzyro (lanadelumab) EMA/734573/2018
English: Takhzyro is given as an injection under the skin, preferably in the abdomen (belly), thighs or upper arms.
Slovenian: Zdravilo Takhzyro se daje z injiciranjem pod kožo, po možnosti v abdomen (trebuh), stegno ali nadlaket.
English: Takhzyro is a medicine used to prevent attacks of hereditary angioedema in patients aged 12 years and over.
Slovenian: Takhzyro je zdravilo, ki se uporablja pri bolnikih, starih 12 let in več, za preprečevanje napadov hereditarnega angioedema (HAE).
English: Takhzyro is effective in preventing angioedema attacks and the fact that it only needs to be given every 2 or 4 weeks was considered an advantage over existing treatments.
Slovenian: Dejstvo, da ga je treba injicirati vsaka dva tedna ali vsake štiri tedne, naj bi imelo prednosti pred obstoječimi zdravljenji.
English: How does Takhzyro work?
Slovenian: Kako zdravilo Takhzyro deluje?
English: How is Takhzyro used?
Slovenian: Kako se zdravilo Takhzyro uporablja?
English: Takhzyro contains the active substance lanadelumab.
Slovenian: Takhzyro (lanadelumab)
English: Takhzyro was found to be effective in reducing the number of angioedema attacks in a main study in 126 adults and children above 12 years of age with hereditary angioedema.
Slovenian: V glavni študiji, v katero je bilo vključenih 126 odraslih in otrok, starejših od 12 let, s heriditarnim angioedemom, je bilo ugotovljeno, da je zdravilo Takhzyro učinkovito pri zniževanju števila napadov angioedema.
English: This compared with 2 attacks per month for patients on placebo (a dummy treatment).
Slovenian: Bolniki, ki so jemali placebo (zdravilo brez učinkovine), so za primerjavo doživeli dva napada na mesec.
English: • if you think you may need any vaccinations in the near future, including vaccinations for travel to other countries.
Slovenian: • če menite, da boste v kratkem potrebovali katero koli cepljenje, vključno s cepljenji za potovanje v druge države.
English: Key results from all four studies are summarised in table 4.
Slovenian: Ključni rezultati vseh štirih preskušanj so povzeti v preglednici 4.
English: Your doctor will decide if you should receive other treatment at the same time.
Slovenian: Zdravnik se bo odločil, ali boste sočasno prejeli tudi druge oblike zdravljenja.
English: Do not have Rituzena if you have an active infection or a serious problem with your
Slovenian: Zdravila Rituzena ne smete prejeti, če imate aktivno okužbo ali resno težavo s svojim
English: p-value (Wald test, not
Slovenian: p-vrednost (test Wald, ni prilagojen)
English: Rituzena may also cause changes in laboratory tests carried out by your doctor.
Slovenian: Zdravilo Rituzena lahko vpliva tudi na spremembe laboratorijskih preiskav, ki jih naroči vaš zdravnik.
English: Patients should also be advised to inform their partner or caregivers about their treatment, since they may notice symptoms that the patient is not aware of.
Slovenian: Bolnikom je treba naročiti, naj o svojem zdravljenju obvestijo partnerja ali skrbnike, ker bodo morda ti opazili simptome, ki se jih bolniki ne
English: The spread of these abnormal B-lymphocytes is the cause of symptoms you may have.
Slovenian: Nastajanje teh nenormalnih limfocitov B je vzrok simptomom, ki jih morda imate.
English: Read this leaflet carefully before you start taking this medicine because it contains important
Slovenian: Pred začetkom jemanja zdravila natančno preberite navodilo, ker vsebuje za vas pomembne
English: If you can get pregnant, you and your partner must use an effective method of contraception while using Rituzena.
Slovenian: Če bi lahko zanosili, morate vi in vaš partner med uporabo zdravila Rituzena uporabljati učinkovito kontracepcijsko zaščito.
English: Rituzena will be given to you by a doctor or nurse who is experienced in the use of this treatment.
Slovenian: Zdravilo Rituzena vam bo dal zdravnik ali medicinska sestra, ki ima izkušnje z uporabo takšnih zdravil.
English: In the majority of these cases, rituximab was
Slovenian: V večini teh primerov so rituksimab uporabili
English: This leaflet was last revised in MM/YYYY
Slovenian: Navodilo je bilo nazadnje revidirano MM/LLLL
English: • high or low blood pressure (low blood pressure especially when standing upright)
Slovenian: visok ali nizek krvni tlak (nizek krvni tlak zlasti po hitrem vstajanju),
English: • asthma, too little oxygen reaching the body organs
Slovenian: astma, telesne organe doseže premalo kisika,
English: Your doctor will check if you should have any vaccines
Slovenian: Zdravnik bo preveril, ali bi morali biti cepljeni, preden boste dobili
English: Therefore patients with a history of cardiac disease should be monitored closely (see Infusion related reactions, above).
Slovenian: Bolnike z anamnezo bolezni srca je zato treba natančno opazovati (glejte Reakcije, povezane z infuzijo, zgoraj).
English: Efficacy was observed both for patients with newly diagnosed disease and for patients with relapsing
Slovenian: Učinkovitost so ugotovili tako pri bolnikih z novoodkrito boleznijo kot pri bolnikih s ponovitvijo bolezni
English: severe cardiac disoders4 and 6
Slovenian: hude srčne bolezni4 in 6
English: The safety and efficacy of Rituzena in children below 18 years has not been established.
Slovenian: Varnost in učinkovitost zdravila Rituzena pri otrocih do 18 leta starosti nista dokazani.
English: • bacterial or viral infections, bronchitis
Slovenian: bakterijske ali virusne okužbe, bronhitis,
English: Severe infusion-related reactions (such as bronchospasm, hypotension) occurred in up to 12% of the cases.
Slovenian: Hude reakcije, povezane z infuzijo (npr. bronhospazem, hipotenzija), so se pojavile pri največ 12 % bolnikov.
English: Your doctor may need to take special care during your treatment with
Slovenian: Zdravnik bo morda moral biti med zdravljenjem z
English: The risk of disease progression was reduced by 46 % and the risk of relapse by
Slovenian: Tveganje za napredovanje bolezni je bilo manjše za 46 %, tveganje za ponovitev bolezni pa za 51 %.
English: • you have severe heart failure or severe uncontrolled heart disease and have granulomatosis with polyangiitis or microscopic polyangiitis.
Slovenian: • imate hudo srčno popuščanje ali hudo, neurejeno srčno bolezen in imate tudi granulomatozo s poliangiitisom ali mikroskopski poliangiitis.
English: Summary of the safety profile (rheumatoid arthritis)
Slovenian: Povzetek varnostnega profila (revmatoidni artritis)
English: Before giving a subsequent course of rituximab treatment, patients should be re-evaluated for any potential risk for infections.
Slovenian: Pred dajanjem nadaljnjega cikla rituksimaba je treba bolnike ponovno oceniti glede možnega tveganja za okužbe.
English: In contrast, three patients (1.5 %) had cerebrovascular events in the CHOP group, all of which occurred during the follow-up period.
Slovenian: Nasprotno pa so se cerebrovaskularni dogodki pojavili pri treh bolnikih (1,5 %) v skupini CHOP, vsi med obdobjem spremljanja.
English: The cells that are affected by Rituzena help to fight infection and you should wait until the infection has passed before you are given Rituzena.
Slovenian: Celice, ki jih zdravilo Rituzena uniči, pomagajo pri borbi proti okužbam, zato morate počakati, da se okužba pozdravi, preden prejmete zdravilo Rituzena.
English: Patients reporting signs and symptoms of infection following rituximab therapy should be promptly evaluated and treated appropriately.
Slovenian: Bolnike, pri katerih se pojavijo znaki in simptomi okužbe po zdravljenju z rituksimabom, je treba nemudoma pregledati in primerno zdraviti.
English: Rarely Rituzena can cause a serious brain infection, called “Progressive Multifocal Leukoencephalopathy” or PML.
Slovenian: Redko lahko zdravilo Rituzena povzroči resno možgansko okužbo, imenovano progresivna multifokalna levkoencefalopatija ali PML.
English: The prepared infusion solution of rituximab is physically and chemically stable for 24 hours at 2 °C - 8 °C and subsequently 12 hours at room temperature (not more than 30 °C).
Slovenian: Pripravljena infuzijska raztopina rituksimaba je fizikalno in kemijsko stabilna 24 ur pri temperaturi 2 do 8 °C in nato še 12 ur pri sobni temperaturi (pri temperaturi do 30 °C).
English: Only the highest frequency observed in the trials is reported
Slovenian: Navedena je samo največja pogostnost, ugotovljena
English: When you are treated with Rituzena in combination with chemotherapy, you will receive Rituzena every 28 days until you have received 6 doses.
Slovenian: Ko se boste zdravili z zdravilom Rituzena v kombinaciji s kemoterapijo, boste dobili infuzijo zdravila Rituzena vsakih 28 dni, dokler ne prejmete 6 odmerkov.
English: Patient subpopulations - rituximab combination therapy Elderly patients (≥ 65 years)
Slovenian: Podskupine bolnikov - samostojno zdravljenje z rituksimabom Starejši bolniki (≥ 65 let)
English: The European Medicines Agency has waived the obligation to submit the results of studies with rituximab in all subsets of the paediatric population with follicular lymphoma and chronic lymphocytic leukaemia.
Slovenian: Evropska agencija za zdravila je odstopila od obveze za predložitev rezultatov študij z rituksimabom za vse podskupine pediatrične populacije s folikularnim limfomom in kronično limfocitno levkemijo.
English: Rituzena is indicated in adults for the following indications:
Slovenian: Zdravilo Rituzena je pri odraslih indicirano za naslednje indikacije:
English: The alert card contains important safety information for patients regarding potential increased risk of infections, including PML.
Slovenian: Opozorilna kartica vsebuje za bolnika pomembne podatke o varnosti glede možnega povečanega tveganja za okužbe,
English: For these reasons rituximab should not be administered to pregnant women unless the possible benefit outweighs the potential risk.
Slovenian: Zato nosečnice ne smejo prejemati rituksimaba, razen če je pričakovana korist večja od
English: Contents of the pack and other information What Rituzena contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Rituzena
English: Your doctor may decide to stop your Rituzena treatment if these reactions are
Slovenian: Zdravnik se lahko odloči za prenehanje zdravljenja z zdravilom Rituzena, če so te reakcije resne.
English: What Rituzena is and what it is used for
Slovenian: Kaj je zdravilo Rituzena in za kaj ga uporabljamo
English: If you have heart disease or angina, these infusion reactions might get worse.
Slovenian: Če imate obstoječo bolezen srca in angino pektoris, se lahko te reakcije zaradi infundiranja poslabšajo.
English: Mean Cmax was 16 to 19% higher following second infusion compared to the first
Slovenian: Povprečna Cmax je bila za 16 do 19 % večja po drugi infuziji v primerjavi s prvo infuzijo pri obeh odmerkih.
English: Treatment with Rituzena uses four separate infusions given at weekly intervals.
Slovenian: Zdravljenje z zdravilom Rituzena obsega štiri ločene infuzije, ki jih dobite v presledkih enega tedna.
English: No data are
Slovenian: Podatkov ni na
English: Based upon investigator judgment, 15 patients received a second course of rituximab therapy for treatment of relapse of disease activity which occurred between 6 and 18 months after the first course of rituximab.
Slovenian: Na podlagi raziskovalčeve presoje je 15 bolnikov prejelo drugi cikel rituksimaba za zdravljenje ponovne aktivnosti bolezni, ki se je pojavila v obdobju od 6. do 18. meseca po prvem ciklu rituksimaba.
English: Rituzena may be used for the treatment of several different conditions in adults.
Slovenian: Zdravilo Rituzena se uporablja za zdravljenje več različnih bolezni pri odraslih.
English: Currently, there are limited data on possible medicinal product interactions with rituximab.
Slovenian: Trenutno je le malo podatkov o mogočih medsebojnih učinkih zdravil pri uporabi rituksimaba.
English: The analysis of overall survival showed a significant benefit of R-FC treatment over FC chemotherapy alone (p = 0.0319, log-rank test) (Table 5a).
Slovenian: Analiza celokupnega preživetja je pokazala signifikantno korist zdravljenja R-FC glede na samo kemoterapijo FC (p = 0,0319, test log rank) (preglednica 5a).
English: Rituzena in combination with chemotherapy destroys these cells.
Slovenian: Zdravilo Rituzena v kombinaciji s kemoterapijo uniči te celice.
English: The final analysis confirmed that RCHOP treatment was associated with a clinically relevant and statistically significant improvement in the duration of event-free survival (the primary efficacy parameter; where events were death, relapse or progression of lymphoma, or institution of a new anti-lymphoma treatment) (p = 0.0001).
Slovenian: Končna analiza je potrdila, da je bilo zdravljenje z R-CHOP povezano s klinično pomembnim in statistično značilnim podaljšanjem trajanja preživetja brez dogodkov (primarni parameter učinkovitosti; dogodki so bili smrt, ponovitev bolezni ali napredovanje limfoma, ali uvedba novega protilimfomskega zdravljenja) (p = 0,0001).
English: • skin rashes, including acne or spots
Slovenian: kožni izpuščaji, vključno z aknami ali lisami,
English: The transient IgM increase usually returned to at least
Slovenian: Prehodna zvišanja IgM so se običajno vrnila vsaj na raven pred zdravljenjem v 4
English: Patients who have ever had hepatitis B infection will be carefully checked by their doctor for
Slovenian: Bolnike, ki so kdaj imeli okužbo z virusom hepatitisa B, bo zdravnik skrbno spremljal glede znakov te okužbe;
English: During or within the first 2 hours of the first infusion you may develop fever, chills and shivering.
Slovenian: V prvih dveh urah se pri prvi infuziji lahko pojavijo zvišana telesna temperatura, mrazenje in drgetanje.
English: There was a higher incidence of grade 3/4 ADRs in patients with bulky disease than in patients without bulky disease (25.6 % vs. 15.4 %).
Slovenian: Bolniki z obsežno boleznijo so imeli višjo incidenco neželenih učinkov 3. ali 4. stopnje kot bolniki brez obsežne bolezni (25,6 % v primerjavi s 15,4 %).
English: Developmental toxicity studies have been performed in cynomolgus monkeys at doses up to 100 mg/kg (treatment on gestation days 20-50) and have revealed no evidence of toxicity to the foetus due to rituximab.
Slovenian: Študije razvojne toksičnosti so izvajali na opicah Cynomologus z odmerki do 100 mg/kg (dajanje zdravila od 20. do 50. gestacijskega dne) in niso pokazale znakov toksičnosti za plod zaradi rituksimaba.
English: CD20 does not circulate in the plasma as a free antigen and, thus, does not compete for antibody binding.
Slovenian: CD20 ne kroži v plazmi kot prosti antigen in zato
English: Patients with a high tumour burden or with a high number (≥25 x 109/L) of circulating malignant cells such as patients with CLL, who may be at higher risk of especially severe cytokine release syndrome, should only be treated with extreme caution.
Slovenian: Bolnike z veliko tumorsko maso ali velikim številom (≥ 25 x 109/l) krožečih malignih celic, kot so bolniki s KLL, pri katerih obstaja večje tveganje izjemno hudega sindroma sproščanja citokinov, zdravimo le izjemno pazljivo.
English: The incidence of thrombocytopenia was low (<1% , grade 3/4) and was not different between treatment arms.
Slovenian: Incidenca trombocitopenije je bila nizka (< 1 % 3. ali 4. stopnje) in se med zdravljenima skupinama ni razlikovala.
English: • pain in the muscles or in the hands or feet • low number of red blood cells (anaemia)
Slovenian: bolečina v mišicah ali dlaneh ali stopalih, nizko število rdečih krvnih celic (anemija),
English: If a patient develops PML the dosing of rituximab must be permanently discontinued.
Slovenian: Če se pri bolniku razvije PML, je treba uporabo rituksimaba dokončno ukiniti.
English: The majority of patients (81%) showed signs of B cell return, with counts >10 cells/μL by month 12, increasing to 87% of patients by month 18.
Slovenian: Pri večini bolnikov (81 %) se je število celic B ponovno povečalo na > 10 celic/µl do 12. meseca, do 18. meseca pa
English: The antibody is produced by mammalian (Chinese hamster ovary) cell suspension culture and purified by affinity chromatography and ion exchange, including specific viral inactivation and removal procedures.
Slovenian: Protitelo je pridobljeno iz suspenzije kulture celic sesalcev (ovarij kitajskega hrčka) in očiščeno z afinitetno kromatografijo ter ionsko izmenjavo, vključno s specifičnimi postopki inaktivacije
English: Cases of interstitial lung disease, some with fatal outcome, have been reported.
Slovenian: Poročali so o primerih intersticijske bolezni pljuč, nekateri so bili smrtni.
English: Some vaccines should not be given at the same time as Rituzena or in the months after you receive Rituzena.
Slovenian: Nekatera cepiva se ne smejo dajati sočasno z zdravilom Rituzena ali nekaj mesecev po prejetju tega zdravila.
English: What you need to know before you use Rituzena Do not take Rituzena if:
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Rituzena Ne uporabljajte zdravila Rituzena, če: