FrancophonIA/ELRC3.0 huggingface dataset:
English: The Agency considered Ebymect to be effective for treating type 2 diabetes; it also leads to weight loss, which is considered beneficial in patients with diabetes.
Slovenian: Menila je, da je zdravilo Ebymect učinkovito pri zdravljenju sladkorne bolezni tipa 2; poleg tega pa povzroči zmanjšanje telesne mase, kar je koristno za bolnike s sladkorno boleznijo.
English: Further studies confirmed that different doses of dapagliflozin with metformin decreased HbA1c more than placebo plus comparable doses of metformin, and that dapagliflozin plus metformin was at least as effective in reducing HbA1c levels as the diabetes medicine glipizide (a type of medicine known as a sulphonylurea).
Slovenian: Dodatne študije so potrdile, da različni odmerki dapagliflozina v kombinaciji z metforminom znižajo ravni HbA1c bolj kot placebo in primerljivi odmerki metformina ter da je dapagliflozin v kombinaciji z metforminom vsaj tako učinkovit pri znižanju ravni HbA1c kot zdravilo za zdravljenje sladkorne bolezni glipizid (vrsta zdravila, imenovana sulfonilsečnina).
English: How does Ebymect work?
Slovenian: Kako zdravilo Ebymect deluje?
English: One study showed that after 24 weeks of treatment, patients taking dapagliflozin plus metformin had an average reduction in body weight of around 2 kg more than those taking placebo plus metformin.
Slovenian: Ena od študij je pokazala, da se je po 24 tednih zdravljenja pri bolnikih, ki so jemali dapagliflozin skupaj z metforminom, telesna masa v povprečju zmanjšala za približno 2 kg več kot pri bolnikih, ki so jemali placebo v kombinaciji z metforminom.
English: Two other studies showed that dapagliflozin taken with metformin and another diabetes medicine, sitagliptin or insulin, for 24 weeks, further decreased HbA1c: the dapagliflozin combination decreased HbA1c levels by 0.40% more than placebo and metformin when added to sitagliptin, and by 0.61% more than placebo and metformin when added to insulin.
Slovenian: Dve drugi študiji sta pokazali, da je dapagliflozin v kombinaciji z metforminom in drugim zdravilom za zdravljenje sladkorne bolezni, sitagliptinom ali insulinom, po 24 tednih jemanja dodatno znižal ravni HbA1c: ko so ga dodajali sitagliptinu, je dapagliflozin v kombinaciji z metforminom znižal ravni HbA1c za 0,40 % več kot placebo in metformin; ko so ga dodajali insulinu, pa za 0,61 % več kot placebo in metformin.
English: How is Ebymect used?
Slovenian: Kako se zdravilo Ebymect uporablja?
English: For the full list of side effects with Ebymect, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Ebymect, glejte navodilo za uporabo.
English: In one main study, when dapagliflozin was used at a dose of 5 mg twice a day in addition to metformin (the same combination as in Ebymect), it decreased HbA1c (glycosylated haemoglobin) levels by 0.65% after 16 weeks, compared with a reduction of 0.30% with placebo (a dummy treatment) and metformin.
Slovenian: V eni glavni študiji je dapagliflozin, ki so ga uporabili v odmerku 5 mg dvakrat na dan skupaj z metforminom (enaka kombinacija kot v zdravilu Ebymect), po 16 tednih znižal ravni HbA1c (glikoziliranega hemoglobina) za 0,65 %, medtem ko sta placebo (zdravilo brez učinkovine) in metformin povzročila 0,30-odstotno znižanje.
English: • patients with diseases that could cause tissue hypoxia (reduced levels of oxygen in body tissues), such as heart or lung failure (where the heart and lungs do not work as well as they should), recent heart attack or shock;
Slovenian: bolnikih s katero koli obliko akutne metabolične acidoze (kopičenja kisline v krvi), kot je diabetična ketoacidoza (visoke ravni kislin, imenovanih ketoni) ali laktacidoza (kopičenje mlečne kisline v telesu); bolnikih z diabetično predkomo (nevarnim stanjem, ki se lahko pojavi pri sladkorni bolezni); bolnikih z okvaro delovanja jeter; bolnikih s hudo okvaro delovanja ledvic ali z obolenji, ki bi lahko vplivala na delovanje ledvic, kot so na primer dehidracija, huda okužba ali šok; bolnikih z boleznimi, ki bi lahko povzročile hipoksijo tkiv (zmanjšano vsebnost kisika v telesnih tkivih), kot sta srčno popuščanje ali respiratorna insuficienca (pri katerih srce in pljuča ne delujejo tako dobro, kot bi morali), nedavni srčni napad ali šok; bolnikih z intoksikacijo z alkoholom (pijanih bolnikih) ali tistih, ki redno pijejo prekomerne količine alkohola.
English: • Pain without injuring yourself
Slovenian: • bolečina, ne da bi se poškodovali,
English: Ελλάδα ΒΙΑΝΕΞ Α.Ε.
Slovenian: ΒΙΑΝΕΞ Α.Ε.
English: Egis Gyógyszergyár Zrt.
Slovenian: Magyarország Egis Gyógyszergyár Zrt.
English: • The importance of sharing this information with their partner or caregiver
Slovenian: • pomembno dejstvo, da te informacije delijo s svojim partnerjem ali skrbnikom,
English: Do not have Blitzima if you have an active infection or a serious problem with your immune system.
Slovenian: Zdravila Blitzima ne smete prejeti, če imate aktivno okužbo ali resno težavo s svojim imunskim sistemom.
English: Patients should receive Blitzima for at least 24 months after achievement of remission (absence of clinical signs and symptoms).
Slovenian: Bolniki morajo zdravilo Blitzima prejemati vsaj 24 mesecev po doseženi remisiji (odsotnost kliničnih znakov in simptomov).
English: EGIS SLOVAKIA spol.
Slovenian: Slovenská republika EGIS SLOVAKIA spol.
English: Blitzima may also cause changes in laboratory tests carried out by your doctor.
Slovenian: Zdravilo Blitzima lahko vpliva tudi na spremembe laboratorijskih preiskav, ki jih naroči vaš zdravnik.
English: Blitzima will be given to you by a doctor or nurse who is experienced in the use of this treatment.
Slovenian: Zdravilo Blitzima vam bo dal zdravnik ali medicinska sestra, ki ima izkušnje z uporabo takšnih zdravil.
English: Your doctor may decide to stop your Blitzima treatment if these reactions are serious.
Slovenian: Zdravnik se lahko odloči za prenehanje zdravljenja z zdravilom Blitzima, če so te reakcije resne.
English: • Show this card to any doctor, nurse or dentist you see - not just the specialist who prescribes your Blitzima.
Slovenian: • Pokažite jo vsem zdravnikom, medicinskim sestram in zobozdravnikom, ki jih obiščete - ne samo specialistu, ki vam predpiše zdravilo Blitzima.
English: If you can get pregnant, you and your partner must use an effective method of contraception while using Blitzima.
Slovenian: Če bi lahko zanosili, morate vi in vaš partner med uporabo zdravila Blitzima uporabljati učinkovito kontracepcijsko zaščito.
English: The safety and efficacy of Blitzima in children below 18 years has not been established.
Slovenian: Varnost in učinkovitost zdravila Blitzima pri otrocih do 18 leta starosti nista dokazani.
English: Percentage of Patients with First Major Relapse
Slovenian: Odstotek bolnikov s prvim hujšim recidivom
English: Your doctor may decide to treat you longer with Blitzima (up to 5 years), depending on how you respond to the medicine.
Slovenian: Zdravnik se lahko odloči, da vas bo z zdravilom Blitzima zdravil dlje (do 5 let), odvisno od tega, kako se odzovete na zdravilo.
English: Table 14 Physical function and quality of life outcomes at week 24 in Trial 1
Slovenian: Funkcijska zmogljivost in vpliv na kakovost življenja po 24 tednih v preskušanju 1.
English: Infections Tell your doctor immediately if you get signs of an infection including:
Slovenian: Okužbe Zdravniku nemudoma povejte, če se vam pojavijo znaki okužbe, na primer:
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 °C - 8 °C, unless dilution has taken place in controlled and validated aseptic conditions.
Slovenian: Če je ne uporabimo takoj, je za čas in pogoje shranjevanja pred uporabo odgovoren uporabnik; čas običajno ne sme presegati 24 ur pri temperaturi od 2 °C do 8 °C, razen če je bila raztopina pripravljena v nadzorovanih in vlidiranih aseptičnih pogojih.
English: Your doctor will check if you should have any vaccines before you receive Blitzima.
Slovenian: Vaš zdravnik bo preveril, ali bi morali biti cepljeni, preden boste dobili zdravilo Blitzima.
English: The risk of disease progression was reduced by 46% and the risk of relapse by 51%.
Slovenian: Tveganje za napredovanje bolezni je bilo manjše za 46%, tveganje za ponovitev bolezni pa za 51%.
English: Blitzima should be administered under the close supervision of an experienced healthcare professional, and in an environment where full resuscitation facilities are immediately available (see section 4.4).
Slovenian: Zdravilo Blitzima je treba dajati pod nadzorom izkušenega zdravnika in v okolju, kjer so vsi pripomočki za oživljanje nemudoma na voljo (glejte poglavje 4.4).
English: You may be asked not to take these other medicines 12 hours before you are given Blitzima.
Slovenian: Morda vam bo naročil, da ne jemljite teh drugih zdravil 12 ur, preden boste dobili zdravilo Blitzima.
English: Significant difference from placebo at the primary time point: * p < 0.05, **p < 0.001 ***p ≤ 0.0001 MCID HAQ-DI ≥0.22, MCID SF-36 PHS >5.42, MCID SF-36 MHS >6.33
Slovenian: Značilna razlika v primerjavi s placebom ob času primarnega cilja študije: * p < 0,05; **p < 0,001; ***p ≤ 0,0001 MCID HAQDI ≥ 0,22; MCID SF-36 PHS > 5,42; MCID SF-36 MHS > 6,33
English: Date of first authorisation: 13 July 2017 Date of latest renewal:
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 13. julij 2017
English: • Warning on the risk of infections and PML, including the symptoms
Slovenian: • opozorilo za tveganje okužb in PML, vključno s simptomi,
English: The final efficacy analysis included all randomised patients (197 CHOP, 202 R-CHOP), and had a median follow-up duration of approximately 31 months.
Slovenian: Končna analiza učinkovitosti je vključevala vse randomizirane bolnike (197 CHOP, 202 R-CHOP), mediana trajanja sledenja bolnikov je bila približno 31 mesecev.
English: Significant improvement in health related quality of life was also demonstrated with significant improvement in both the physical health score (PHS) and mental health score (MHS) of the SF-36.
Slovenian: Ugotovljeno je bilo tudi značilno izboljšanje zdravstvenih kazalcev kakovosti življenja z značilnim izboljšanjem ocene telesnega zdravja (PHS, Physical Health Score) in duševnega zdravja (MHS, Mental Health Score) po SF-36.
English: EGIS Praha, spol.
Slovenian: Česká republika EGIS Praha, spol.
English: Rarely Blitzima can cause a serious brain infection, called “Progressive Multifocal Leukoencephalopathy” or PML.
Slovenian: Redko lahko zdravilo Blitzima povzroči resno možgansko okužbo, imenovano progresivna multifokalna levkoencefalopatija ali PML.
English: If you respond well to treatment, you may be given Blitzima as a maintenance treatment.
Slovenian: Če se boste na zdravilo dobro odzvali, boste lahko zdravilo Blitzima prejemali kot vzdrževalno zdravljenje.
English: Τηλ: +30 210 8009111 - 120
Slovenian: Τηλ: +30 210 8009111 - 120 España
English: Blitzima is indicated in adults for the following indications:
Slovenian: Zdravilo Blitzima je pri odraslih indicirano za naslednje indikacije:
English: The cells that are affected by Blitzima help to fight infection and you should wait until the infection has passed before you are given Blitzima.
Slovenian: Celice, ki jih zdravilo Blitzima uniči, pomagajo pri borbi proti okužbam, zato morate počakati, da se okužba pozdravi, preden prejmete zdravilo Blitzima.
English: • Detailed information on the risk of infections and PML
Slovenian: • podrobne podatke o tveganju za okužbe in PML,
English: • If you respond well to treatment, you may be given Blitzima every 2 or 3 months for two years.
Slovenian: Če se boste dobro odzvali na zdravljenje, boste lahko zdravilo Blitzima dobivali na dva ali tri mesece, in sicer dve leti.
English: When should I not have Blitzima?
Slovenian: Kdaj ne smete prejeti zdravila Blitzima?
English: 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)
Slovenian: Odzivi ACR za 4 cikle zdravljenja (24 tednov po vsakem ciklu (intraindividualno, znotraj pregledov) pri bolnikih, ki niso zadostno odgovorili zdravljenje z zaviralci TNF (n = 146).
English: This is because there is not much information about the use of Blitzima in children and young people.
Slovenian: O uporabi zdravila Blitzima pri otrocih in mladostnikih namreč ni veliko informacij.
English: In patients treated for haematological malignancies, B cell recovery began within 6 months of treatment and generally returned to normal levels within 12 months after completion of therapy, although in some patients this may take longer (up to a median recovery time of 23 months post-induction therapy).
Slovenian: Pri bolnikih, ki so se zdravili zaradi hematoloških malignih bolezni, so se celice B začele obnavljati v 6 mesecih zdravljenja, njihovo število pa se je v splošnem vrnilo v normalno stanje v 12 mesecih po končanem zdravljenju, pri nekaterih bolnikih pa je lahko trajalo dlje (mediani čas okrevanja je bil do 23 mesecev po indukcijskem zdravljenju).
English: The analysis of all secondary parameters (response rates, progression-free survival, disease-free survival, duration of response) verified the treatment effect of R-CHOP compared to CHOP.
Slovenian: Z analizo vseh sekundarnih parametrov (deleža odgovorov, preživetja brez napredovanja bolezni, preživetja brez bolezni, trajanja odgovora) so preverjali učinke zdravljenja z R-CHOP v primerjavi z zdravljenjem s shemo CHOP.
English: This is because Blitzima may pass into breast milk.
Slovenian: Zdravilo Blitzima namreč lahko prehaja v materino mleko.
English: During the treatment period (induction treatment phase comprising of R-CHOP for at most eight cycles), four patients (2%) treated with R-CHOP, all with cardiovascular risk factors, experienced thromboembolic cerebrovascular accidents during the first treatment cycle.
Slovenian: Med obdobjem zdravljenja (faza indukcijskega zdravljenja, ki je obsegalo R-CHOP vsaj osem ciklov) so se pri štirih bolnikih (2%), zdravljenih z R-CHOP, ki so vsi imeli kardiovaskularne dejavnike tveganja, med prvim ciklom zdravljenja pojavili trombembolični cerebrovaskularni dogodki.
English: No dose reductions of Blitzima are recommended.
Slovenian: Odmerka zdravila Blitzima ni priporočljivo zmanjšati.
English: • Information on the Patient Alert Card
Slovenian: • informacije o opozorilni kartici za bolnika.
English: weeks (Table 13).
Slovenian: meseca (slika 3).
English: This should be followed by oral prednisone 1 mg/kg/day (not to exceed 80 mg/day, and tapered as rapidly as possible based on clinical need) during and after the 4 week induction course of Blitzima treatment.
Slovenian: Temu mora slediti 1 mg/kg/dan prednizona peroralno (odmerek ne sme preseči 80 mg/dan in ga je treba zmanjšati, kolikor hitro je mogoče glede na klinične potrebe) med in po 4-tedenskem indukcijskem zdravljenjem z zdravilom Blitzima in po njem.
English: Blitzima may be used for the treatment of several different conditions in adults.
Slovenian: Zdravilo Blitzima se uporablja za zdravljenje več različnih bolezni pri odraslih.
English: Treatment with rituximab in combination with methotrexate over multiple courses resulted in sustained improvements in the clinical signs and symptoms of RA, as indicated by ACR, DAS28ESR and EULAR responses which was evident in all patient populations studied (Figure 2).
Slovenian: Zdravljenje z rituksimabom v kombinaciji z metotreksatom v več ciklih je prineslo stalno izboljšanje kliničnih znakov in simptomov RA, kot so pokazali odzivi po ACR, DAS28-ESR in EULAR; to je bilo opazno v vseh raziskovanih populacijah bolnikov (slika 2).
English: Very common side effects (may affect more than 1 in 10 people): • allergic reactions that are most likely to occur during an infusion, but can occur up to 24 hours after infusion
Slovenian: Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov): alergijske reakcije, ki se najverjetneje pojavijo med infuzijo, a se lahko pojavijo tudi do 24 ur po infuziji, dolgotrajna depresija, izpadanje las.
English: For patients who may be at higher risk for relapse, physicians should consider a longer duration of Blitzima maintenance therapy, up to 5 years.
Slovenian: Pri bolnikih z večjim tveganjem za recidiv je treba razmisliti o dolgotrajnejšem vzdrževalnem zdravljenju z zdravilom Blitzima, do 5 let.
English: There are no data on the safety of rituximab in patients with moderate heart failure (NYHA class III) or severe, uncontrolled cardiovascular disease.
Slovenian: Podatkov o varnosti zdravila rituksimab pri bolnikih z zmernim srčnim popuščanjem (III. razred NYHA) ali hudo, neobvladljivo boleznijo srca ni.
English: Some vaccines should not be given at the same time as Blitzima or in the months after you receive Blitzima.
Slovenian: Nekatera cepiva se ne smejo dajati sočasno z zdravilom Blitzima ali nekaj mesecev po prejetju tega zdravila.
English: This is because some people have a fall in their blood pressure while they are being given Blitzima.
Slovenian: Nekaterim ljudem se namreč med prejemanjem zdravila Blitzima krvni tlak zniža;
English: Your doctor may prescribe Blitzima for the treatment of:
Slovenian: Zdravnik vam lahko zdravilo Blitzima predpiše za zdravljenje:
English: Only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies including Blitzima or patients refractory to previous Blitzima plus chemotherapy.
Slovenian: Na voljo so le omejeni podatki glede učinkovitosti in varnosti pri bolnikih, ki so se predhodno zdravili z monoklonskimi protitelesi, vključno z zdravilom Blitzima, ali pri bolnikih, ki se na prejšnje zdravljenje z zdravilom Blitzima in kemoterapijo niso odzvali.
English: Blitzima can be given alone or with other medicines called “chemotherapy”.
Slovenian: Zdravilo Blitzima lahko uporabljamo samostojno ali skupaj z drugimi zdravili, ki jih imenujemo kemoterapija.
English: The safety of immunisation with live viral vaccines, following rituximab therapy has not been studied for NHL and CLL patients and vaccination with live virus vaccines is not recommended.
Slovenian: Varnosti imunizacije z živimi virusnimi cepivi po zdravljenju z zdravilom rituksimab pri bolnikih z NHL in KLL niso proučevali in cepljenje z živimi virusnimi cepivi ni priporočljivo.
English: Median TTP:
Slovenian: mediana PFS:
English: Astro-Pharma GmbH Tel: +43 1 97 99 860
Slovenian: Ö sterreich Astro-Pharma GmbH Tel: +43 1 97 99 860
English: This is because in a few cases, Blitzima could cause hepatitis B to become active again, which can be fatal in very rare cases.
Slovenian: V maloštevilnih primerih namreč lahko bolezen zaradi zdravila Blitzima ponovno izbruhne; to je lahko v zelo redkih primerih smrtno.
English: Respiratory system Cases of interstitial lung disease, some with fatal outcome, have been reported.
Slovenian: Dihala Poročali so o primerih intersticijske bolezni pljuč, nekateri so bili smrtni.
English: This is because Blitzima can across the placenta and may affect your baby.
Slovenian: Zdravilo Blitzima namreč prehaja skozi posteljico (placento) in lahko škoduje otroku.
English: When you are treated with Blitzima in combination with chemotherapy, you will receive Blitzima infusions on day 0 cycle 1 then day 1 of each cycle for 6 cycles in total.
Slovenian: Ko se boste zdravili z zdravilom Blitzima v kombinaciji s kemoterapijo, boste dobili infuzijo zdravila Blitzima 0. dan 1. cikla in nato 1. dan vsakega naslednjega cikla, skupaj 6 ciklov.
English: Your doctor may need to take special care of you during your treatment with Blitzima.
Slovenian: Zdravnik bo morda moral biti med zdravljenjem z zdravilom Blitzima posebej poskrbeti za vas.
English: Other medicines and Blitzima
Slovenian: Druga zdravila in zdravilo Blitzima
English: Blitzima should be used in combination with CHOP chemotherapy.
Slovenian: Zdravilo Blitzima je treba uporabljati v kombinaciji s kemoterapijo CHOP.
English: Reactivation of hepatitis B infection has also been very rarely reported in rheumatoid arthritis patients receiving rituximab (see section 4.4).
Slovenian: O reaktivaciji okužbe z virusom hepatitisa B so zelo redko poročali tudi pri bolnikih z revmatoidnim artritisom, ki so prejemali rituksimab (glejte poglavje 4.4).
English: Radiographic analysis at 2 years in Trial 1 demonstrated significantly reduced progression of structural joint damage in patients receiving rituximab in combination with methotrexate compared to methotrexate alone as well as a significantly higher proportion of patients with no progression of joint damage over the 2 year period.
Slovenian: Radiološka analiza v preskušanju 1 je po 2 letih pokazala značilno manjše napredovanje strukturnih okvar sklepov pri bolnikih, ki so prejemali rituksimab v kombinaciji z metotreksatom, kot pri tistih, ki so prejemali samo metotreksat; prav tako je pokazala značilno večji delež bolnikov brez napredovanja okvar sklepov v 2-letnem obdobju.
English: If you are not sure, talk to your doctor, pharmacist or nurse before you are given Blitzima.
Slovenian: Če ste negotovi, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, preden dobite zdravilo Blitzima.
English: At month 28, major relapse (defined by the reappearance of clinical and/or laboratory signs of vasculitis activity ([BVAS] > 0) that could lead to organ failure or damage or could be life threatening) occurred in 3 patients (5%) in the rituximab group and 17 patients (29%) in the azathioprine group (p=0.0007).
Slovenian: Po 28 mesecih so hujši recidiv (opredeljen kot ponoven pojav kliničnih in/ali laboratorijskih znakov aktivnosti vaskulitisa ([BVAS] > 0), ki bi lahko povzročil odpoved organa ali okvaro ali bi lahko bil življenjsko nevaren) zabeležili pri 3 bolnikih (5 %) v skupini z zdravilom rituksimab in pri 17 bolnikih (29 %) v skupini z azatioprinom (p = 0,0007).
English: Efficacy in autoantibody (RF and or anti-CCP) seropositive patients Patients seropositive to Rheumatoid Factor (RF) and/or anti-Cyclic Citrullinated Peptide (antiCCP) who were treated with rituximab in combination with methotrexate showed an enhanced response compared to patients negative to both.
Slovenian: Učinkovitost pri serološko pozitivnih (RF in/ali anti-CCP) bolnikih Bolniki, serološko pozitivni za revmatoidni faktor (RF) in/ali anti-ciklični citrulinirani peptid (anti-CCP), ki so prejemali rituksimab v kombinaciji z metotreksatom, so imeli izrazitejši odziv kot bolniki, negativni za oba.
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Slovenian: Pogostnosti so opredeljene kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000) in ni znano (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov).
English: Before you are given Blitzima, you will be given other medicines (pre-medication) to prevent or reduce possible side effects.
Slovenian: Zdravila, ki jih boste dobili pred vsakim dajanjem zdravila Blitzima Preden boste dobili zdravilo Blitzima, boste dobili druga zdravila (to imenujemo premedikacija) za preprečitev ali zmanjšanje možnih neželenih učinkov.
English: Aseptically withdraw the necessary amount of Blitzima, and dilute to a calculated concentration of 1 to 4 mg/mL rituximab into an infusion bag containing sterile, pyrogen-free sodium chloride 9 mg/mL (0.9%) solution for injection or 5% D-Glucose in water.
Slovenian: Aseptično odvzamemo potrebno količino rituksimaba in jo razredčimo, da dobimo izračunano koncentracijo od 1 do 4 mg/ml rituksimaba v infuzijski vrečki, ki vsebuje sterilno apirogeno 0,9-% raztopino natrijevega klorida za injiciranje (9 mg/ml) ali 5-% raztopino D-glukoze v vodi.
English: The safety of immunisation with live viral vaccines following rituximab therapy has not been studied.
Slovenian: Varnosti imunizacije z živimi virusnimi cepivi po zdravljenju z zdravilom rituksimab niso proučevali.