natgillin/translations-raw huggingface dataset:
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). 
CHOP (750 mg/m2 ciklofosfamida, 50 mg/m2 doksorubicina, 1,4 mg/m2 do največ 2 mg/m2 vinkristina na prvi dan ter 40 mg/m2 prednizolona na 1. do 5. dan) vsake 3 tedne 8 ciklov ali pa 375 mg/m2 rituksimaba in sheme CHOP (R-CHOP).
Similarly, a good to moderate European League Against Rheumatism (EULAR) response was achieved by significantly more rituximab treated patients treated with rituximab and methotrexate compared to patients treated with methotrexate alone (Table 12). 
doseglo pomembno več bolnikov, ki so se zdravili z rituksimabom in metotreksatom, kakor bolnikov, ki so se zdravili samo z metotreksatom (preglednica 12).
Ritemvia is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (PV). 
Zdravilo Ritemvia je indicirano za zdravljenje bolnikov z zmernim do hudim navadnim pemfigusom.
• pain in the muscles • heart beating faster than normal 
hitrejše bitje srca kot običajno.
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. 
Pri bolnikih z granulomatozo s poliangiitisom ali mikroskopskim poliangiitisom, ki so prejemali rituksimab, so opažali hipogamaglobulinemijo (IgA, IgG ali IgM pod spodnjo mejo normale).
No patients were withdrawn due to ADRs. 
Zaradi neželenih učinkov zdravila ni iz študije izstopil noben bolnik.
P<0.0001 
mediana TTP: 14,7 p < 0,0001
Common Uncommon Rare 
navadnega pemfigusa
• respiratory failure 
Srčne bolezni
Respiratory, thoracic and mediastinal disorders bronchospasm4, respiratory disease, chest pain, dyspnoea, increased cough, rhinitis asthma, bronchiolitis obliterans, lung disorder, hypoxia interstitial lung disease7 
bolečina v prsnem košu, dispneja, izrazitejši kašelj, rinitis astma, bronhiolitis obliterans,
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. 
Neželeni učinki, ki so se v 6 mesecih pojavili pri ≥ 5% bolnikov, ki so prejeli rituksimab za indukcijo remisije GPA in MPA, in pogosteje kot v primerjalni skupini.
Cases of hepatitis B reactivation, including those with a fatal outcome, have been reported in rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis patients receiving rituximab. 
Pri bolnikih z revmatoidnim artritisom, granulomatozo s poliangiitisom in mikroskopskim poliangiitisom, ki so prejemali rituksimab, so poročali o primerih reaktivacije hepatitisa B, vključno s smrtnim izidom.
Mean Cmax for serum rituximab following first infusion was 170 to 175 μg/mL for 2 × 500 mg dose and 317 to 370 μg/mL for 2 × 1000 mg dose. 
do 175 μg/ml za 2 x 500 mg odmerek ter 317 do 370 μg/ml za 2 x 1.000 mg odmerek.
Ritemvia 100 mg concentrate for solution for infusion Rituximab 
Ritemvia 100 mg koncentrat za raztopino za infundiranje rituksimab
Acne 
ORR
Common side effects (may affect up to 1 in 10 people): 
Pogosti neželeni učinki (pojavijo se lahko pri do 1 od 10 bolnikov):
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. 
ki so prejemale rituksimab, podobno ali nižjo incidenco kot v kontrolnih skupinah: hematotoksičnost,
EULAR Response (%) 
OS (%)
Rate 
CR
Cases of progressive multifocal leukoencephalopathy with fatal outcome have been reported following use of rituximab for the treatment of autoimmune diseases. 
Pri uporabi rituksimaba za zdravljenje avtoimunskih bolezni so poročali o smrtnih primerih progresivne multifokalne levkoencefalopatije, in sicer pri revmatoidnem artritisu in avtoimunskih boleznih, za katere zdravilo ni odobreno, sistemskem eritematoznem lupusu (SLE) in vaskulitisu.
Cases of posterior reversible encephalopathy syndrome (PRES)/reversible posterior leukoencephalopathy syndrome (RPLS) have been reported in autoimmune conditions. 
Poročali so o primerih sindroma posteriorne reverzibilne encefalopatije (PRES, posterior reversible encephalopathy syndrome)/oziroma sindroma reverzibilne posteriorne levkoencefalopatije (RPLS, reversible posterior leukoencephalopathy syndrome).
Herpes zoster Nasopharyngitis 
Infekcijske in parazitske bolezni okužba sečil bronhitis herpes zoster nazofaringitis
Gastrointestinal dyspepsia, diarrhoea, 
Bolezni prebavil dispepsija, diareja, gastroezofagealni refluks, razjede v ustih,
• What you need to know before having 
• Kaj morate vedeti, preden prejmete zdravilo Ritemvia
CHOP 11.6 R-CHOP 22.1 CR 14.3 PR 14.3 
CR 13,0 % 24,3 % 0,0007
Treatment of relapse 
Zdravljenje recidivov
• bald spots on the scalp, chills, headache 
plešasti predeli na lasišču, mrzlica, glavobol,
• tight or painful muscles 
trzanje ali tresenje mišic,
Disease‐free survivala Subgroup analysis PFS 
Preživetje brez boleznia (DFS) Analiza podskupin Preživetje brez napredovanja bolezni (PFS)
This is because side effects can develop several months after you have had treatment. 
Kartico pri sebi hranite še 2 leti po zadnjem odmerku zdravila Ritemvia, ker se lahko neželeni učinki pojavijo več mesecev po zdravljenju.
• producing more tears, tear duct problems, inflamed eye (conjunctivitis) 
omotica ali občutek tesnobe, močnejše solzenje, težave s solznimi izvodili, vnetje očesa (konjunktivitis), zvonjenje v ušesih, bolečine v ušesu,
Radiographic response Structural joint damage was assessed radiographically and expressed as change in modified 
Radiološka ocena Strukturno okvaro sklepov so ocenili radiološko in jo izrazili kot spremembo ocene po prirejeni Sharpovi lestvici (mTSS, modified Total Sharp Score) in njenih komponent, ocene erozij in ocene zožitve sklepne špranje.
3infusion-related reactions (generalised oedema, bronchospasm, wheezing, laryngeal oedema, angioneurotic oedema, generalised pruritis, anaphylaxis, anaphylactoid reaction) 
3reakcije, povezane z infuzijo (hipertenzija, navzea, kožni izpuščaj, pireksija,
Please talk to your doctor or nurse if you have any questions about the information in this card. 
Če imate kakršna koli vprašanja o tej kartici, se posvetujte z zdravnikom ali medicinsko sestro.
This is a type of protein called a “monoclonal antibody”. 
Zdravilo Ritemvia vsebuje učinkovino rituksimab, ki je vrsta beljkovine, imenovana monoklonsko protitelo.
Adverse drug reaction1 
Neželeni učinek1
(n=268) or R-FCM (n=44), according to the investigators' choice. 
R-FC (n = 408) Vrednost p v testu log-rang
This is equivalent to 2.6% of the recommended maximum daily dietary intake of sodium for an adult. 
priporočenega največjega dnevnega vnosa natrija s hrano za odrasle osebe.
LogRank p 
Vrednost p v testu lograng
Muscle spasms Arthralgia 
hipoksija intersticijska bolezen pljuč7
Bronchitis Rhinitis 
Bolezni prebavil driska
Please see cytokine release syndrome above for severe reactions. 
V zvezi s hudimi neželenimi učinki glejte zgornji opis sindroma sproščanja citokinov.
Similarly, in all studies a good to moderate European League Against Rheumatism (EULAR) response was achieved by significantly more rituximab treated patients treated with rituximab and methotrexate compared to patients treated with methotrexate alone (Table 12). 
Podobno je v vseh študijah dober do zmeren odziv po klasifikaciji Evropske lige za boj proti revmatizmu (EULAR, European League Against Rheumatism)
The European Commission issued a decision on 17 February 2012. 
Evropska komisija je odločbo izdala dne 17. februarja 2012.
Outcome of a procedure under Article 31 of Directive 2001/83/EC as amended 
Rezultat postopka v skladu s členom 31 Direktive 2001/83/ES, kakor je bila spremenjena
At the time of the review, pholcodine-containing medicines had been withdrawn from the markets in Sweden (in the 1980s) and Norway (in 2007). 
V času pregleda so zdravila, ki vsebujejo folkodin, umaknili s trga na Švedskem (v osemdesetih letih prejšnjega stoletja) in Norveškem (leta 2007).
Pholcodine-containing medicines are currently approved in the EU in Belgium, France, Ireland, Lithuania, Luxembourg, Malta, Slovenia, Spain and the United Kingdom, either subject to medical prescription or as over-the-counter medicines. 
Zdravila, ki vsebujejo folkodin, so trenutno odobrena v EU v Belgiji, Franciji, na Irskem, v Litvi, Luksemburgu, na Malti, v Sloveniji, Španiji in Združenem kraljestvu, kjer so bodisi na recept ali v prosti prodaji.
A group of experts in immunology and anaesthesia was also convened to provide advice. 
Za nasvet je zaprosil tudi skupino strokovnjakov za imunologijo in anestezijo.
Therefore, it recommended that all marketing authorisations for medicines containing pholcodine should be maintained throughout the European Union (EU). 
Zato je priporočil, da se v vsej Evropski uniji (EU) ohranijo vsa dovoljenja za promet z zdravili, ki vsebujejo folkodin.
Pholcodine is an opioid medicine that is used for the treatment of non-productive (dry) cough in children and adults. 
Folkodin je opioidno zdravilo, ki se uporablja za zdravljenje neproduktivnega (suhega) kašlja pri otrocih in odraslih.
To assess its safety, the Committee reviewed the results from preclinical and clinical studies, postmarketing data, epidemiological studies and data from the published literature. 
Za oceno varnosti je Odbor pregledal rezultate predkliničnih in kliničnih študij, podatke iz obdobja trženja, epidemiološke študije in podatke iz objavljene literature.
Why was pholcodine reviewed? 
Zakaj je bil folkodin pregledan?
They may be available as syrups, oral solutions, suppositories, tablets and capsules under various trade names and as generics. 
Kot sirupi, peroralne raztopine, svečke, tablete in kapsule so na voljo pod različnimi tržnimi imeni in kot generična zdravila.
• Patients and healthcare professionals are reminded that the benefits of pholcodine continue to outweigh its risks for the treatment of non-productive cough. 
• Bolnike in zdravstvene delavce je treba opomniti, da koristi uporabe folkodina še naprej odtehtajo tveganja pri zdravljenju neproduktivnega kašlja.
What is pholcodine? 
Kaj je folkodin?
It works directly in the brain, depressing the cough reflex by reducing the nerve signals that are sent to the muscles involved in coughing. 
Deluje neposredno v možganih, kjer zavre refleks kašlja z zmanjšanjem živčnih signalov, ki se pošiljajo mišicam, ki sodelujejo pri kašlju.
Cross-sensitisation has also been observed in countries where pholcodine is not on the market, suggesting that other substances may also trigger cross-sensitisation and that the observed changes in reporting rates may be explained by other factors. 
Križno senzibilizacijo so opazili tudi v državah, v katerih folkodina ni na trgu, kar kaže na to, da lahko križno senzibilizacijo sprožijo tudi druge snovi in da je mogoče opažene spremembe v stopnjah poročanja razložiti z drugimi dejavniki.
No new risks have been identified with pholcodine. 
Novih tveganj zaradi uporabe folkodina niso opredelili.
Pholcodine has been used as a cough suppressant since the 1950s. 
Folkodin se uporablja kot zdravilo za pomirjanje kašlja od petdesetih let prejšnjega stoletja.
Consequently, the French medicines regulatory agency changed the prescription status for these medicines in France from over-the-counter to prescription-only, and asked the CHMP to carry out a full assessment of the benefit-risk balance of pholcodine and to issue an opinion on whether the marketing authorisations for pholcodine-containing products should be maintained, varied, suspended or withdrawn across the EU. 
Posledično je francoska regulativna agencija za zdravila spremenila status predpisovanja za ta zdravila v Franciji iz zdravil, na voljo brez recepta, na zdravila na zdravniški recept, in zaprosila CHMP, da opravi popolno oceno razmerja med tveganji in koristmi za folkodin ter izda mnenje, ali naj se dovoljenje za promet z zdravili, ki vsebujejo folkodin, v EU ohrani, spremeni, začasno odvzame ali umakne.
Regarding pholcodine's benefits, the CHMP noted that there is a large body of data demonstrating the effectiveness of opioids in the management of non-productive cough and that pholcodine has been in use for several decades. 
V zvezi s koristmi folkodina je CHMP navedel, da obstajajo številni podatki, ki dokazujejo učinkovitost opioidov pri obvladovanju neproduktivnega kašlja, in da se folkodin uporablja že več desetletij.
NMBAs are used in emergency hospital procedures to prevent spontaneous muscle movements during surgery. 
Blokatorji živčnomišičnega prenosa se uporabljajo v urgentnih bolnišničnih postopkih za preprečevanje spontanih mišičnih gibov med operacijo.
Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of pholcodine-containing medicines continue to outweigh their risks, and therefore recommended that all marketing authorisations for these medicines should be maintained. 
Na podlagi ocene trenutno razpoložljivih podatkov in znanstvene razprave v Odboru je CHMP zaključil, da koristi zdravil, ki vsebujejo folkodin, še naprej odtehtajo tveganja, in zato priporočil, da se vsa dovoljenja za promet s temi zdravili ohranijo.
The CHMP considered that, although this is biologically plausible, the available data are weak and not fully consistent. 
Čeprav je to biološko verjetno, CHMP meni, da so razpoložljivi podatki neprepričljivi in ne povsem dosledni.
In 2009, a study was published indicating that the reduction in pholcodine consumption in these countries was associated with a decrease in reports of anaphylactic reactions to neuromuscular blocking agents (NMBAs). 
Leta 2009 je bila objavljena študija, ki nakazuje, da je bilo zmanjšanje porabe folkodina v teh državah povezano z manjšim številom poročil o anafilaktičnih reakcijah na blokatorje živčnomišičnega prenosa.
Further publications in 2010 and 2011 from the same authors supported the hypothesis that pholcodine use may increase the likelihood of patients having an anaphylactic reaction if they are exposed to an NMBA. 
Nadaljnje objave istih avtorjev iz let 2010 in 2011 so podprle hipotezo, da lahko uporaba folkodina poveča verjetnost anafilaktične reakcije pri bolnikih, izpostavljenih blokatorjem živčnomišičnega prenosa.
The CHMP reviewed all the available data on the effects of pholcodine as a cough suppressant. 
CHMP je pregledal vse razpoložljive podatke o učinkih folkodina kot sredstva za pomirjanje kašlja.
The Committee noted that the study in Sweden and Norway looked at changes in reporting rates of adverse reactions to NMBAs following the withdrawal of these medicines, without convincingly establishing a causal link with pholcodine use. 
Odbor je opozoril, da obravnavajo študije na Švedskem in Norveškem spremembe v stopnji poročanja neželenih učinkov na blokatorje živčnomišičnega prenosa po ukinitvi uporabe teh zdravil, vendar prepričljive vzročne zveze z uporabo folkodina ne vzpostavijo.
The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the existing evidence of the risk is weak, and that the benefits of pholcodine continue to outweigh its risks. 
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so obstoječi dokazi o tveganju neprepričljivi in da koristi uporabe folkodina še naprej odtehtajo njegova tveganja.
Regarding pholcodine's safety, the majority of adverse effects reported with pholcodine are those commonly seen with opioid medicines. 
V zvezi z varnostjo folkodina je večina neželenih učinkov, o katerih poročajo pri uporabi folkodina, enaka kot pri drugih opioidnih zdravilih.
The European Medicines Agency has completed a review of the safety and effectiveness of pholcodine, following concerns that its use may put people at risk of developing anaphylactic (severe allergic) reactions to neuromuscular blocking agents used during surgery. 
Evropska agencija za zdravila je zaključila pregled varnosti in učinkovitosti folkodina, saj je bila izražena skrb, da se lahko zaradi njegove uporabe pri bolnikih pojavi tveganje za razvoj anafilaktičnih (hudih alergijskih) reakcij na blokatorje živčnomišičnega prenosa, ki se uporabljajo med operacijami.
from spontaneous reports also suggested a 25% increase in anaphylactic reactions to NMBAs coinciding with a 9% increase in pholcodine use. 
Franciji podatki iz spontanih poročil kažejo na 25-odstotno povečanje anafilaktičnih reakcij na blokatorje živčnomišičnega prenosa, kar sovpada z 9-odstotnim povečanjem uporabe folkodina.
Therefore, the CHMP concluded that the existing evidence does not support the conclusion that the use of pholcodine-containing medicines presents a risk of developing anaphylactic reactions to NMBAs. 
Zato je CHMP zaključil, da obstoječi dokazi ne podpirajo sklepa, da predstavlja uporaba zdravil, ki vsebujejo folkodin, tveganje za razvoj anafilaktičnih reakcij na blokatorje živčnomišičnega prenosa.
The hypothesis that pholcodine use could trigger anaphylactic reactions to NMBAs is based on the body producing antibodies against pholcodine, which eventually trigger reactions to NMBAs (‘crosssensitisation'). 
Hipoteza, da lahko uporaba folkodina sproži anafilaktične reakcije na blokatorje živčnomišičnega prenosa, temelji na tem, da v telesu nastajajo protitelesa proti folkodinu, ki sčasoma sprožijo reakcijo na blokatorje živčnomišičnega prenosa („križna senzibilizacija“).
The Committee nevertheless recommended that a new post-marketing study investigating the possibility of an association between pholcodine and anaphylactic reactions to NMBAs should be carried out. 
Odbor je kljub temu priporočil izvedbo nove študije v obdobju trženja, ki naj prouči možno povezavo med folkodinom in anafilaktičnimi reakcijami na blokatorje živčnomišičnega prenosa.
• Patients taking pholcodine-containing medicines can continue to do so, and should contact their doctor or pharmacist if they have any questions about their treatment. 
Če imajo kakršna koli vprašanja o svojem zdravljenju, naj se posvetujejo z zdravnikom ali farmacevtom.
In France, data 
V
Overall Survival was the key secondary study endpoint. 
Celokupno preživetje je bil ključni sekundarni cilj študije.
Take the medicine pack with you. 
Škatlo zdravila vzemite s seboj.
• you have ever had blood clots in the past. 
• ste kadar koli v preteklosti imeli krvne strdke.
Carcinogenicity studies have not been conducted. 
Študij kancerogenosti niso izvajali.
31 August 2023 
31. avgust 2023
A national controlled distribution system has been implemented in collaboration with each National Competent Authority. 
Nacionalno nadzorovani sistem razdeljevanja je bil uveden v sodelovanju z vsakim pristojnim nacionalnim organom.
When this happens, it is called ‘response'. 
Pojav takega stanja se imenuje "odziv".
However, treatment can reduce the signs and symptoms of the disease, or make them disappear for a period of time. 
Vendar lahko zdravljenje zmanjša znake in simptome bolezni ali povzroči, da za nekaj časa izginejo.
CONCLUSIONS ON THE REQUEST FOR ONE-YEAR MARKETING PROTECTION PRESENTED BY THE EUROPEAN MEDICINES AGENCY 
SKLEPNE UGOTOVITVE O ODSTOPANJU ZAHTEVKU ZA ENOLETNO TRŽNO ZAŠČITO KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
Children and adolescents Imnovid is not recommended for use in children and young people under 18 years. 
Otroci in mladostniki Zdravilo Imnovid ni priporočeno za uporabo pri otrocih in mladostnikih, starih manj kot 18 let.
Overall Survival: ITT Population 
Celokupno preživetje: populacija ITT
Final clinical study report: 
Končno poročilo o klinični študiji:
Day (of 21-day cycle) 
Dan (21-dnevnega cikla)
See also section 4 “Possible side effects”). 
Glejte tudi poglavje 4 "Možni neželeni učinki").
Your partner should also tell her doctor straight away. 
Tudi vaša partnerica mora o tem takoj obvestiti svojega zdravnika.
Patients should be advised to report febrile episodes promptly. 
Bolnikom je treba svetovati, da o febrilnih epizodah poročajo takoj.
Allergic reactions and severe skin reactions 
Alergijske reakcije in hude kožne reakcije
If this happens to you, do not drive or operate tools or machinery. 
Če se vam to zgodi, ne vozite avtomobila in ne upravljajte orodja ali strojev.
Blood donation and blood tests 
Darovanje krvi in krvne preiskave
WARNING: Risk of severe birth defects. 
OPOZORILO: Tveganje hudih prirojenih okvar.
*In case of neutropenia, the physician should consider the use of growth factors. 
*V primeru nevtropenije naj zdravnik razmisli o uporabi rastnih faktorjev.
Pomalidomide should only be resumed after a thorough evaluation of the benefits and the risks. 
Pomalidomid smemo spet začeti dajati šele po temeljiti oceni koristi in tveganj.
• Increased blood pressure. 
• zvišan krvni tlak,
Based on these results, the observed effects were attributed to the treatment of females. 
Na podlagi teh rezultatov so opazovane učinke pripisali zdravljenju samic.
Patients may require use of blood product support and /or growth factors. 
Bolniki bodo morda potrebovali podporo v obliki krvnih izdelkov in/ali rastnih faktorjev.
The systemic exposure (AUC) of pomalidomide increases in an approximately linear and dose proportional manner. 
Sistemska izpostavljenost (AUC) pomalidomidu se zvišuje približno linearno in sorazmerno z odmerkom.
These patients should be monitored closely and appropriate precautions taken. 
Te bolnike je treba skrbno spremljati in ustrezno ukrepati.
Note: CI=Confidence interval; IRAC=Independent Review Adjudication Committee; NE = Not Estimable. 
Opomba: IZ = interval zaupanja; IRAC = Neodvisni presojevalni odbor (Independent Review Adjudication Committee); NE = ni mogoče oceniti.
Your doctor should check whether you have ever had hepatitis B infection. 
Vaš zdravnik mora preveri, ali ste kadar koli prej imeli okužbo s hepatitisom B.
You may feel tired and weak, and short of breath and you are also more likely to get infections. 
Mogoče boste utrujeni in šibki in boste imeli kratko sapo in boste bolj dovzetni tudi za okužbe,
• You must follow the contraception advice described in this leaflet. 
Upoštevati morate nasvete o kontracepciji, opisane v tem navodilu.
Pomalidomide must not be taken during pregnancy, since a teratogenic effect is expected. 
Pomalidomida se ne sme jemati med nosečnostjo, ker se pričakuje teratogeni učinek.
System Organ Class/ Preferred Term 
Organski sistem/preferenčni izraz
Treatment continued until patients had disease progression. 
Zdravljenje se je nadaljevalo do napredovanja bolezni.
Each cycle lasts 28 days (4 weeks). 
Vsak cikel traja 28 dni (4 tedne).
In case of permanent discontinuation of any component of the treatment regimen, continuation of the remaining medicinal products is at the physician's discretion. 
V primeru trajne ukinitve katere koli sestavine režima zdravljenja je nadaljnje dajanje preostalih zdravil prepuščeno zdravnikovi presoji.
• A spinning feeling in your head, making it difficult to stand up and move normally. 
• občutek vrtenja v glavi, zaradi katerega težko stojite in se normalno premikate,
Based on Cox proportional hazards model. 
Na podlagi Coxovega modela proporcionalnih tveganj.
The capsules should not be opened, broken or chewed (see section 6.6). 
Kapsul ni dovoljeno odpirati, zdrobiti ali žvečiti (glejte poglavje 6.6).
Imnovid hard capsules should be taken orally at the same time each day. 
Zdravilo Imnovid trde kapsule je treba jemati peroralno vsak dan ob istem času.
• if you are allergic to pomalidomide or any of the other ingredients of this medicine (listed in section 6). 
• če ste alergični na pomalidomid ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
In the event of overdose, supportive care is advised. 
V primeru prevelikega odmerka se svetuje podporna nega.