natgillin/translations-raw huggingface dataset:
Rixathon is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (PV). 
Zdravilo Rixathon je indicirano za zdravljenje bolnikov z zmernim do hudim navadnim pemfigusom.
OS rates, 
• izpadanje las,
Late 
Občasni
Nervous System Disorders 
Bolezni živčevja glavobol omotica
Malignancies 
ZDRAVILOM
Number of Subjects with Major Relapse 
(ODGOVORNI) ZA SPROŠČANJE SERIJ
• short term increase in the amount of some types of anti-bodies in the blood (called 
Zelo redki neželeni učinki (pojavijo se lahko pri 1 od 10.000 bolnikov): • kratkotrajno povečanje količine nekaterih vrst protiteles v krvi (imenujemo jih imunoglobulini
Severe cardiac disorders 4 and 
Bolezni sečil ledvična odpoved4
All physicians who are expected to prescribe Rixathon for NHL/CLL are provided with the following to reduce the risk of administration route errors: - Product information - HCP Alert card addressing the correct use of Rixathon 
• Dodatni ukrepi za zmanjševanje tveganj Za indikacije ne-Hodgkinovega limfoma (NHL) in kronične levkocitne levkemije (KLL): Vsi zdravniki, ki lahko predpišejo zdravilo Rixathon za NHL in KLL, za zmanjševanje tveganja za napake v dajanju, prejmejo:
Closely monitor patients with pre-existing cardiac conditions and those who experienced prior cardiopulmonary adverse reactions. 
Bolnike, ki imajo težave s srcem, in tiste, pri katerih so v preteklosti opazili kardio- pulmonalne neželene učinke, je treba pozorno spremljati.
A small number of cases of hepatitis-B reactivation, some with fatal outcome, have been reported in granulomatosis with polyangiitis and microscopic polyangiitis patients receiving rituximab in the postmarketing setting. 
Pri bolnikih z granulomatozo s poliangiitisom in mikroskopskim poliangiitisom, ki so rituksimab prejemali v obdobju trženja, so poročali o majhnem številu primerov reaktivacije hepatitisa B; nekateri od teh primerov so se končali s smrtjo.
There are no adequate and well-controlled data from studies in pregnant women, however transient B-cell depletion and lymphocytopenia have been reported in some infants born to mothers exposed to rituximab during pregnancy. 
Pri nekaterih dojenčkih, katerih matere so med nosečnostjo prejemale rituksimab, pa so poročali o prehodnem zmanjšanju števila celic B in limfocitopeniji.
You will always be given Rixathon as a drip (intra-venous infusion). 
Zdravilo Rixathon boste dobili v intravenski infuziji.
Psychiatric Disorders 
KLINIČNI PODATKI
Possible mechanisms of effector-mediated cell lysis include complement-dependent cytotoxicity (CDC) resulting from C1q binding, and antibody-dependent cellular cytotoxicity (ADCC) mediated by one or more of the Fcγ receptors on the surface of granulocytes, macrophages and NK cells. 
ADCC), ki jo posreduje eden ali več receptorjev Fcγ na površini granulocitov, makrofagov ali naravnih celic ubijalk.
1) Estimates were calculated by hazard ratios 
Ocena po prirejeni Sharpovi lestvici Ocena erozij
Severe bullous skin reactions, StevensJohnson Syndrome toxic epidermal necrolysis (Lyell's Syndrome) 
nočno znojenje, +bolezen kože hude bulozne kožne reakcije, StevensJohnsonov sindrom,
• IRRs (including cytokine-release syndrome, tumour-lysis syndrome), see section 4.4. 
Najpogosteje zabeleženi ali opaženi resni neželeni učinki so bili: • z infuzijo povezane reakcije (vključno s sindromom sproščanja citokinov, sindromom razpada tumorja), glejte poglavje 4.4;
This includes rheumatoid arthritis and off-label autoimmune diseases, including Systemic Lupus Erythematosus (SLE) and vasculitis. 
Pri uporabi rituksimaba za zdravljenje revmatoidnega artritisa in avtoimunskih bolezni, ki vključujejo sistemski eritematozni lupus (SLE) in vaskulitis, so poročali o zelo redkih primerih smrtne progresivne multifokalne levkoencefalopatije (PML).
• eating disorders, not eating enough, leading to weight loss 
zaprtost, težave z želodcem, • motnje hranjenja, nezadostno uživanje hrane, kar povzroči hujšanje,
Primary efficacy Progression-free survival (median) log-rank p value hazard ratio (95% CI) risk reduction 
Preživetje brez napredovanja bolezni (mediana) vrednost p v testu log-rank razmerje ogroženosti (95-% IZ) zmanjšanje tveganja
All physicians who are expected to prescribe Rixathon for non-oncology indications are provided with the following: - Product information - HCP educational leaflet - Patient educational leaflet 
Za neonkološke indikacije: Vsi zdravniki, ki lahko predpišejo zdravilo Rixathon za neonkološke indikacije, prejmejo:
vincristine 1.4 mg/m2 up to a maximum of 2 mg on day 1, and prednisolone 40 mg/m2/day on days 15) every 3 weeks for 8 cycles or rituximab 375 mg/m2 in combination with CVP (R-CVP). 
V odprtem randomiziranem preskušanju so skupaj 332 predhodno še nezdravljenih bolnikov s folikularnimi limfomi randomizirali na prejemanje kemoterapije CVP (750 mg/m2 ciklofosfamida, 1,4 mg/m2 vinkristina do največ 2 mg 1. dan in 40 mg/m2/dan prednizolona od 1. do 5. dneva) na 3 tedne 8 ciklov, ali na 375 mg/m2 rituksimaba v kombinaciji s CVP (R-CVP).
• Additional risk minimisation measures For the indications non-Hodgkin´s lymphoma (NHL) and Chronic lymphocytic leukaemia 
Kontraindikacije za uporabo pri ne-Hodgkinovem limfomu in kronični limfocitni levkemiji
ACR20 ACR50 ACR70 EULAR response (good/moderate) Mean change in DAS 
Odziv po EULAR (dober/zmeren)
migraine, dizziness 
zardevanje, splošno slabo počutje,
Severe vision loss5 
bolečine v ušesu izguba sluha5
Disease-free survivala Subgroup analysis PFS 
Analiza podskupin Preživetje brez napredovanja bolezni (PFS)
The following terms have been reported as adverse events during clinical trials, however, were reported at a similar or lower incidence in the rituximab arms compared to control arms: haematotoxicity, neutropenic infection, urinary tract infection, sensory disturbance, pyrexia. 
Naslednji izrazi so bili med kliničnimi preskušanji zabeleženi kot neželeni učinki, a so imeli v skupinah, ki so prejemale rituksimab, podobno ali nižjo incidenco kot v kontrolnih skupinah:
Study Treatment, N 
čas do novega zdravljenja KLL
A total of 6/34 (18%) of rituximab treated patients from the maintenance therapy clinical trial developed ADA. 
V kliničnem preskušanju vzdrževalnega zdravljenja so se ADA pojavila pri skupno 6 od 34 (18 %) bolnikov, zdravljenih z rituksimabom.
• muscle problems - such as tight muscles, joint or muscle pain, back and neck pain 
• koprivnica, močnejše znojenje, nočno znojenje, • težave z mišicami - na primer napete mišice, bolečine v sklepih ali mišicah, bolečine v hrbtu in vratu, • splošno nelagodje, neprijetno počutje ali utrujenost, tresenje, znaki gripe,
Rate 
Delež
< 10 cells/μL after two weekly infusions of rituximab 375 mg/m2, and remained at that level in most patients up to the 6 month time point. 
Pri bolnikih z granulomatozo s poliangiitisom in mikroskopskim poliangiitisom se je število perifernih celic B zmanjšalo na < 10 celic/µl po dveh infundiranjih 375 mg/m2 rituksimaba (po enem na teden) in je na tej ravni ostalo do 6 mesecev.
Immunoglobulins - IgM), chemical disturbances in the blood caused by break-down of dying cancer cells 
IgM), snovi v krvi, ki nastajajo zaradi razgradnje odmirajočih rakavih celic, • okvara živcev v rokah in nogah, paraliza obraza,
(CLL): 
ml volumnu).
• respiratory failure 
• odpoved dihanja,
Pneumocystis jirovecii 
Navadni pemfigus
30 ml (10 mg/ml) 1 vial 
300 mg koncentrat za pripravo raztopine za infundiranje intravenska uporaba viala (steklena) 30 ml (10 mg/ml) 1 viala
MA (EU)-number (Invented) Name Strength Pharmaceutical Form 
(Izmišljeno) ime Jakost
(Invented) name 
Zaščiteno ime Jakost
London, 23 October 2008 Doc. 
London, 23. oktobra 2008 Sklic dok.
Ref. EMEA/544525/2008 
EMEA/180879/2009
It was to be available as prolonged-release tablets (50, 100 and 200 mg). 
Zdravilo naj bi bilo v obliki tablet s podaljšanim sproščanjem (50, 100 in 200 mg).
International non-proprietary name (INN): desvenlafaxine 
Mednarodno nelastniško ime (INN): desvenlafaksin
If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you. 
Če ste vključeni v klinično preskušanje in potrebujete več podatkov o zdravljenju, se obrnite na zdravnika, ki vam je predpisal zdravljenje.
In all of the studies, the effectiveness of the medicine was measured using standard questionnaires for depression. 
V vseh teh študijah so učinkovitost zdravila merili s standardnimi vprašalniki za depresijo.
The CHMP was assessing the responses given by the company to a list of questions. 
CHMP je ocenjeval odgovore, ki jih je družba podala na vprašanja s seznama vprašanj.
Two of the flexible-dose studies also included venlafaxine (however, the studies were not designed to compare the two medicines). 
Dve od študij s prilagodljivimi odmerki zdravila sta vključevali tudi uporabo venlafaksina (vendar ti študiji nista bili zasnovani za primerjavo obeh zdravil).
The effects of Ellefore were first tested in experimental models before being studied in humans. 
Učinki zdravila Ellefore so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
On 13 October 2008, Wyeth Europa Ltd. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Ellefore, for the treatment of major depressive disorder. 
Družba Wyeth Europa Ltd. je dne 13. oktobra 2008 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za dovoljenje za promet z zdravilom Ellefore, namenjenim zdravljenju hudih depresivnih motenj.
In these short-term studies, the main measure of effectiveness was the change in depressive symptoms over the eight weeks of treatment. 
V teh kratkoročnih študijah je bilo glavno merilo učinkovitosti sprememba simptomov depresije v osmih tednih zdravljenja.
Neurotransmitters are chemicals that allow nerve cells to communicate with one another. 
Nevrotransmiterji so kemične spojine, ki živčnim celicam omogočajo medsebojno komunikacijo.
Ellefore was compared with placebo (a dummy treatment) in nine main studies involving a total of over 3,000 adults with major depression. 
Zdravilo Ellefore so primerjali s placebom (zdravilom brez zdravilne učinkovine) v devetih glavnih študijah, ki so vključevale vsega skupaj več kot 3 000 odraslih s hudo depresijo.
Information on the short and long-term effectiveness of Ellefore was also considered to be insufficient, because too few patients in the studies took the doses of Ellefore that were intended for use and because the studies' results were inconsistent. 
Zaradi tega so podatke o kratkoročni in dolgoročni učinkovitosti zdravila Ellefore prav tako označili za nezadostne, saj je premalo bolnikov v študijah vzelo odmerke zdravila Ellefore, ki so bili namenjeni za uporabo, in ker rezultati študij niso bili dosledni.
The substance has been slightly modified with the aim of reducing side effects in patients who have problems breaking venlafaxine down. 
Spojino so malce spremenili, da bi zmanjšali neželene učinke pri bolnikih, ki imajo težave z razgrajanjem venlafaksina.
Questions and answers on the withdrawal of the marketing application for Ellefore 
Vprašanja in odgovori v zvezi z umikom vloge za dovoljenje za promet z zdravilom Ellefore
Desvenlafaxine is derived from venlafaxine, an SNRI that has been used as an antidepressant since the 1990s. 
Desvenlafaksin se pridobiva iz venlafaksina, SNRI, ki so ga uporabljali kot zdravilo proti depresiji od 1990-ih.
What are the consequences of the withdrawal for patients undergoing clinical trials or compassionate use programmes with Ellefore? 
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preizkušanjih ali programih sočutne uporabe zdravila Ellefore?
It works by preventing the neurotransmitters 5-hydroxytryptamine (also called serotonin) and noradrenaline from being taken back up into nerve cells in the brain. 
Deluje tako, da preprečuje ponovno privzemanje nevrotransmiterjev 5hidroksitriptamina (imenovanega tudi serotonin) in noradrenalina v možganske celice.
What documentation did the company present to support its application to the CHMP? 
Katero dokumentacijo je družba predstavila CHMP v podporo svoji vlogi?
The application was at day 166 when the company withdrew. 
Družba je vlogo umaknila na 166. dan postopka.
‘Prolonged release' means that the active substance is released from the tablets over a few hours. 
Izraz podaljšano sproščanje pomeni, da se zdravilna učinkovina iz tablet sprošča več ur.
Four of the studies involving 1,814 patients used a fixed dose of Ellefore, and another four involving 1,229 patients used doses of Ellefore that could be adjusted. 
V štirih študijah, ki so vključevale 1 814 bolnikov, so uporabljali stalni odmerek zdravila Ellefore, v drugih štirih študijah, ki so vključevale 1 229 bolnikov, pa so uporabljali prilagodljive odmerke zdravila Ellefore.
Ellefore was expected to be used to treat major depression in adults. 
Zdravilo Ellefore naj bi se bilo uporabljalo za zdravljenje hudih depresivnih motenj pri odraslih.
Since these neurotransmitters are involved in the control of mood, blocking their re-uptake into nerve cells is expected to improve the symptoms of major depression. 
Ker omenjena nevrotransmiterja sodelujeta pri nadzorovanju razpoloženja, je bilo pričakovati, da se bodo z blokado njihovega ponovnega privzema v živčne celice izboljšali simptomi hude depresije.
By blocking their re-uptake, desvenlafaxine increases the amount of these neurotransmitters in the spaces between certain nerve cells, increasing the level of communication between the cells. 
Desvenlafaksin z blokiranjem ponovnega privzemanja poveča količino teh nevrotransmiterjev v prostorih med posameznimi živčnimi celicami, zaradi česar se poveča raven komunikacije med celicami.
In relation to its parent substance, venlafaxine, desvenlafaxine seemed to be less effective with no advantages in terms of safety and tolerability. 
Videti je, da je desvenlafaksin v primerjavi s starševsko učinkovino, venelafaksinom, manj učinkovit in brez prednosti glede varnosti in prenašanja pri bolnikih.
Ellefore is a medicine that contains the active substance desvenlafaxine. 
Ellefore je zdravilo, ki vsebuje zdravilno učinkovino desvenlafaksin.
What is Ellefore? 
Kaj je zdravilo Ellefore?
Based on the review of the data, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Ellefore could not have been approved for the treatment of major depressive disorder. 
Na podlagi pregleda podatkov je CHMP v času umika vloge izrazil določene zadržke in je začasno menil, da zdravilo Ellefore ne more biti odobreno za zdravljenje hude depresivne motnje.
The CHMP was concerned that, overall, the effectiveness of Ellefore had not been shown convincingly. 
CHMP je menil, da učinkovitost zdravila Ellefore ni bila prepričljivo dokazana.
The active substance in Ellefore, desvenlafaxine, is a ‘serotonin-noradrenaline re-uptake inhibitor' (SNRI). 
Zdravilna učinkovina v zdravilu Ellefore, desvenlafaksin, je inhibitor ponovnega privzema serotonina in noradrenalina (SNRI).
One long-term study looked at how long it took for symptoms to return in a total of 376 patients who had already shown a response to an initial 12 weeks of Ellefore treatment. 
V eni od dolgoročnih študij so pri vsega skupaj 376 bolnikih, ki so se že odzvali na začetno 12tedensko zdravljenje z zdravilom Ellefore, opazovali čas, potreben za ponoven pojav simptomov.
The company informed the CHMP that there are no consequences for patients currently included in clinical trials with Ellefore and that there are no compassionate use programmes ongoing. 
Družba je obvestila CHMP, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Ellefore.
What was Ellefore expected to be used for? 
Za kaj naj bi se zdravilo Ellefore bilo uporabljalo?
Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of Ellefore had not been sufficiently demonstrated and any benefits did not outweigh the identified risks. 
CHMP je v času umika menil, da koristi zdravila Ellefore niso bile zadostno dokazane in da ne odtehtajo znanih tveganj.
How is Ellefore expected to work? 
Kako naj bi zdravilo Ellefore delovalo?
• if you are taking medicines for high blood pressure. 
· če jemljete zdravila za visok krvni tlak.
In-use storage times and conditions prior to use are the responsibility of the user. 
Čas in pogoji shranjevanja pred uporabo so odgovornost uporabnika.
Median TTP: 
mediana TTP:
• if you think you may need any vaccinations in the near future, including vaccinations needed to travel to other countries. 
· če menite, da boste v kratkem potrebovali katero koli cepljenje, vključno s cepljenji, ki bi jih potrebovali za potovanje v druge države.
• Keep this card with you all the time - such as in your wallet or purse. 
· Kartico imejte vedno pri sebi, na primer v denarnici ali torbici.
If not used immediately, preparation should take place in controlled and validated aseptic conditions. 
Če ni uporabljeno takoj, mora priprava potekati v kontroliranih in preverjenih aseptičnih pogojih.
• What to do if you think you might be getting an infection. 
· Kaj storite, če menite, da imate morda okužbo
In total: 8 cycles. 
Skupaj: 8 ciklov.
The corresponding AUCτ ratios were 1.66, 1.17 and 1.32. 
Ustrezna razmerja AUCτ so bila 1,66, 1,17 in 1,32.
† Outcome at 24 weeks 
† Izid po 24 tednih
Three cases had no reported adverse event. 
treh primerih niso poročali o nobenem neželenem dogodku.
How much and how often you will receive your treatment 
Koliko zdravila boste dobili in kako pogosto
In addition, central volume was slightly (9%) lower in females compared to males. 
Poleg tega je bil centralni volumen nekoliko (9 %) nižji pri ženskah kot pri moških.
The most frequent reported or observed serious adverse drug reactions were: 
Najpogosteje zabeleženi ali opaženi resni neželeni učinki so bili:
Date of latest renewal: 2 June 2008 
Datum prve odobritve: 2. junij 1998 Datum zadnjega podaljšanja: 2. junij 2008
• Changes in laboratory tests carried out by your doctor. 
· spremembe rezultatov laboratorijskih preiskav, ki jih naroči vaš zdravnik.
If an injection is interrupted it can be resumed at the same site or another location may be used, if appropriate. 
Če se injiciranje prekine, ga je mogoče nadaljevati na istem mestu, lahko pa se uporabi tudi drugo mesto, če je to primerno.
Proportion with PFS event 
Delež z dogodkom PFS
Overall survival 
celokupno preživetje
1 Antibody Way Oceanside, CA 92056 5802 USA 
1 Antibody Way Oceanside, CA 92056 5802 ZDA
• Additional risk minimisation measures 
· Dodatni ukrepi za zmanjševanje tveganj
Available data suggest that clinical response is usually achieved within 16 - 24 weeks of an initial treatment course. 
Podatki, ki so na voljo, kažejo, da je klinični odziv ponavadi dosežen v roku 16-24 tednov po začetnem ciklu zdravljenja.
All IRRs were CTC Grade 1 or 2. 
Vse IRR so bile 1. ali 2. stopnje po CTC.
This is usually given every 3 weeks up to 8 times. 
Ta se po navadi daje na 3 tedne, do 8-krat.
You must tell your doctor or nurse if you are pregnant, think that you might be pregnant or are planning to become pregnant. 
Zdravniku ali medicinski sestri morate povedati, če ste noseči, menite, da ste noseči, ali načrtujete zanositev.
Proportion of patients with no radiographic change 
Delež bolnikov brez radioloških sprememb
Do not have MabThera if you have an active infection or a serious problem with your immune system. 
Zdravila MabThera ne smete prejeti, če imate aktivno okužbo ali resno težavo s svojim imunskim sistemom.
Take this into account if you are on a low-sodium diet. 
To količino upoštevajte, če ste na dieti z nizkim vnosom natrija.
All patients n=99 
Vsi bolniki n = 99
95.1%b CI (−3.2%, 24.3%) a 
95,1 %b IZ (-3,2 %, 24,3 %) a
Results from trial BP22333 are presented in section 5.2. 
Izsledki preskušanja BP22333 so predstavljeni v poglavju 5.2.
Date of most recent infusion: ____________ Date of first infusion: ___________________ Patient's Name:________________________ Doctor's Name:________________________ Doctor's contact details:_________________ 
Bolnikovo ime:________________________ Zdravnikovo ime:______________________ Zdravnikov telefon:_________________
Your doctor may decide to treat you longer with MabThera (up to 5 years), depending on how you respond to the medicine. 
Zdravnik se lahko odloči, da vas bo z zdravilom MabThera zdravil dlje (do 5 let), odvisno od tega, kako se odzovete na zdravilo.
+myocardial infarction4 and 6, 
+miokardni infarkt4 in 6,
The gender- related pharmacokinetic differences are not considered to be clinically relevant and dose adjustment is not required. 
S spolom povezane razlike v farmakokinetiki ne štejemo za klinično pomembne in prilagajanje odmerkov ni potrebno.
− CI = confidence interval. 
IZ = interval zaupanja.
Your doctor may decide to stop your MabThera treatment if these reactions are serious. 
Zdravnik se lahko odloči za prenehanje zdravljenja z zdravilom MabThera, če so te reakcije resne.
Binet stage A Binet stage B Binet stage C 
stopnja po Binetu A stopnja po Binetu B stopnja po Binetu C
9/L as clinical experience in this population is limited. 
Kliničnih izkušenj v tej populaciji je namreč malo.
Trial BO22334 (SABRINA) 
Preskušanje BO22334 (SABRINA)
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. 
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 validiranih aseptičnih pogojih.
Figure 3: Cumulative incidence over time of first major relapse 
Slika 3: Kumulativna incidenca glede na čas prvega hujšega recidiva
• if you have ever taken medicines which affect your immune system - such as chemotherapy or immune-suppressive medicines. 
· če ste kdaj jemali zdravila, ki vplivajo na imunski sistem - na primer kemoterapijo ali imunosupresivna zdravila.
• Show this card to any doctor, nurse or dentist you see - not just the specialist who prescribes your MabThera. 
· Pokažite jo vsem zdravnikom, medicinskim sestram in zobozdravnikom, ki jih obiščete - ne samo specialistu, ki vam predpiše zdravilo MabThera.
Treatment, N 
Zdravljenje (n)
Twenty nine (0.48%) post-dose observations (all from trial BP22333) were below the quantification limit. 
Devetindvajset (0,48 %) vrednosti po odmerku (vse iz preskušanja BP22333) je bilo pod mejo kvantifikacije.
MabThera will be given to you by a doctor or nurse who is experienced in the use of this treatment. 
Zdravilo MabThera vam bo dal zdravnik ali medicinska sestra, ki ima izkušnje z uporabo takšnih zdravil.
It remains unknown if early detection of PML and suspension of MabThera therapy may lead to similar stabilisation or improved outcome. 
Ni znano, ali lahko zgodnje odkritje PML in ukinitev zdravljenja z zdravilom MabThera doseže podobno stabilizacijo ali izboljšanje izida.
Patients who have ever had hepatitis B infection will be carefully checked by their doctor for signs of this infection 
Bolnike, ki so kdaj imeli okužbo z virusom hepatitisa B, bo zdravnik skrbno spremljal glede znakov te okužbe;
If the dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time. 
Kadar predložitev PSUR in posodobitev RMP sovpadata, se ju lahko predloži istočasno.
Patients should receive MabThera for at least 24 months after achievement of remission (absence of clinical signs and symptoms). 
MabThera prejemati vsaj 24 mesecev po doseženi remisiji (odsotnost kliničnih znakov in simptomov).
No data are available on performing the injection in other sites of the body, therefore injections should be restricted to the abdominal wall. 
Podatkov o injiciranju v druge dele telesa ni, zato mora biti injiciranje omejeno na trebušno steno.