natgillin/translations-raw huggingface dataset:
No data are available on the association of LEMTRADA with Hepatitis B virus (HBV) or Hepatitis C virus (HCV) reactivation as patients with evidence of active or chronic infections were excluded from clinical trials.
Podatkov o povezavi zdravila LEMTRADA in reaktivacijo okužbe z virusom hepatitisa B (HBV) ali C (HCV) ni na voljo, saj so bili bolniki s potrjenimi aktivnimi ali kroničnimi okužbami izključeni iz kliničnih preskušanj.
It is unknown if LEMTRADA can be transferred to a baby through breast milk, but there is a possibility that it could be.
Ni znano, ali se lahko zdravilo LEMTRADA z materinim mlekom prenese v dojenčka, vendar je to možno.
MS is an autoimmune disease that affects the central nervous system (brain and spinal cord).
MS je avtoimunska bolezen, ki prizadane osrednji živčni sistem (možgane in hrbtenjačo).
Treatment consists of discontinuation of the medicinal product and supportive therapy.
Ukrepanje obsega prekinitev zdravljenja in podporno terapijo.
What you need to know before you are administered LEMTRADA 3.
Kaj morate vedeti, preden boste prejeli zdravilo LEMTRADA 3.
Most cases occurred within the first month after treatment with LEMTRADA.
Večina primerov se je pojavila v prvem mesecu po zdravljenju z zdravilom LEMTRADA.
The majority of these may be due to cytokine release during infusion.
Večina teh primerov je bila lahko posledica sproščanja citokinov med infundiranjem.
Alemtuzumab binds to CD52, a cell surface antigen present at high levels on T (CD3+) and B (CD19+) lymphocytes, and at lower levels on natural killer cells, monocytes, and macrophages.
Alemtuzumab se veže na CD52, površinski antigen, ki je prisoten v velikih količinah na limfocitih T (CD3+) in B (CD19+), v manjših količinah pa na naravnih celicah ubijalkah, monocitih in makrofagih.
1.5/1.3 years
1,5/1,3 let
Alemtuzumab is a protein for which the expected metabolic pathway is degradation to small peptides and individual amino acids by widely distributed proteolytic enzymes.
Alemtuzumab je beljakovina, za katero je pričakovana presnovna pot razgradnja v majhne peptide in posamezne aminokisline zaradi splošno porazdeljenih proteolitičnih encimov.
As with other immunomodulating therapies, potential combined effects on the patient's immune system should be taken into account when considering administration of LEMTRADA.
Kot pri drugih imunomodulacijskih zdravljenjih je treba upoštevati morebitne kombinirane učinke na bolnikov imunski sistem, ko se namerava predpisati zdravilo LEMTRADA.
Cases of cervicocephalic arterial dissections, including multiple dissections, have been reported both within the first days after the LEMTRADA infusion or later on within the first month after the infusion.
O primerih disekcije cervikocefalnih arterij, tudi o več takšnih disekcijah, so poročali tako v prvih dneh po infundiranju zdravila LEMTRADA kot tudi pozneje, v prvem mesecu po infundiranju.
If you are a carrier of hepatitis B or hepatitis C infection (these affect the liver), extra caution is needed before you receive LEMTRADA treatment as it is unknown if treatment could lead to activation of the hepatitis infection which could subsequently damage your liver.
Če ste nosilec virusa hepatitisa B ali C (ki prizadeneta jetra), je potrebna dodatna previdnost pred zdravljenjem z zdravilom LEMTRADA, saj ni znano, ali lahko zdravljenje privede do aktivacije okužbe z virusom hepatitisa, ki bi posledično poškodovala jetra.
Administer within 8 hours after dilution.
Uporabite v 8 urah po redčenju.
There are no adequate clinical safety data on the effect of LEMTRADA on fertility.
Primernih podatkov o klinični varnosti zdravila LEMTRADA za plodnost ni.
The European Medicines Agency has deferred the obligation to submit the results of studies with LEMTRADA in one or more subsets of the paediatric population in RRMS (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila obvezo za predložitev rezultatov študij z zdravilom LEMTRADA za eno ali več podskupin pediatrične populacije z RRMS (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Rate ratio (95% CI) Risk reduction
Razmerje stopenj (95-odstotni IZ) Zmanjšanje tveganja
The safety and efficacy of alemtuzumab in MS were evaluated in 3 randomised, rater-blinded, activecomparator clinical trials and 1 uncontrolled, rater-blinded extension study in patients with RRMS.
Varnost in učinkovitost alemtuzumaba pri MS so ocenjevali v 3 randomiziranih, za ocenjevalce enojno slepih kliničnih preskušanjih z aktivno primerjavo in 1 nekontrolirani podaljšani za ocenjevalce enojno slepi študiji pri bolnikih z RRMS.
Besides LEMTRADA, there are other treatments (including those for MS, or to treat other conditions) which could affect your immune system and so could affect your ability to fight infections.
Poleg zdravila LEMTRADA lahko tudi druga zdravila (za zdravljenje MS ali drugih bolezni) vplivajo na vaš imunski sistem in posledično vašo sposobnost obrambe pred okužbami.
o Platelet count should be obtained immediately after infusion on Days 3 and 5 of the first infusion course, as well as immediately after infusion on Day 3 of any subsequent course.
o Število trombocitov je treba določiti takoj po infundiranju, na 3. in 5. dan prvega ciklusa infuzij ter tudi takoj po infundiranju, na 3. dan vseh nadaljnjih ciklusov.
Patients had an EDSS from 0-3.0, at least 2 clinical episodes of MS in the prior 2 years, and ≥1 gadolinium-enhancing lesion at study entry.
Bolniki so imeli rezultat EDSS od 0 do 3,0, vsaj 2 klinični epizodi MS v preteklih 2 letih in ≥ 1 lezijo po gadolinijevem kontrastiranju ob vključitvi v študijo.
See LEMTRADA Health Care Professional Guide for more information, or read the summary of product characteristics available at the EMA website mentioned above.
Za več informacij preberite vodnik o zdravilu LEMTRADA za zdravstvene delavce ali preberite povzetek glavnih značilnosti zdravila, ki je na voljo na zgoraj omenjeni spletni strani agencije EMA.
In addition, you will be monitored during the infusion and for 2 hours after the infusion has been completed.
Poleg tega vas bodo spremljali med infuzijo in še dve uri po njej.
• During infusion: o Perform continuous/frequent (at least every hour) monitoring of heart rate, blood pressure and overall clinical status of the patients Discontinue the infusion
• Med infundiranjem: o Izvajajte stalen/pogost (vsaj vsako uro) nadzor srčne frekvence, krvnega tlaka in bolnikovega celotnega kliničnega stanja.
• feelings of anxiety, depression
• občutek tesnobe, depresija
If you are using such a medicine, your doctor may ask you to stop this medicine before starting treatment with LEMTRADA.
Če jemljete kakšno takšno zdravilo, vam bo zdravnik morda naročil prekinitev jemanja tega zdravila pred začetkom zdravljenja z zdravilom LEMTRADA.
SC IFNB-1a
alemtuzumab SC IFNB-1a
Clinically significant thrombocytopenia needs to be followed until resolution.
Klinično pomembno trombocitopenijo je treba spremljati, dokler ne mine.
Thyroid disease (see section 4.4 Thyroid Disorders) poses special risks in women who are pregnant.
Bolezni ščitnice (glejte poglavje 4.4 Bolezni ščitnice) so posebej nevarne za nosečnice.
The bag should be inverted gently to mix the solution.
Vrečko je treba previdno obračati, da se raztopina premeša.
The European Medicines Agency has waived the obligation to submit the results of studies with alemtuzumab in children from birth to less than 10 years in treatment of multiple sclerosis (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z alemtuzumabom za otroke od rojstva do manj kot 10 let starosti pri zdravljenju multiple skleroze (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
• Decrease in white blood cell numbers (lymphocytes, leukocytes, neutrophils)
• Znižanje števila belih krvničk (limfocitov, levkocitov, nevtrofilcev)
• Increase in white blood cells counts such as neutrophils, eosinophils (different types of white blood cells) anaemia, decrease in percentage of red blood cells, easy or excessive bruising or bleeding,
• povečanje števila belih krvnih celic, kot so nevtrofilci, eozinofilci (različne vrste belih krvnih celic), anemija, zmanjšanje odstotka rdečih krvničk, hiter nastanek ali pretirane modrice ali krvavitve, otekanje bezgavk
Data from clinical trials in MS has shown that adherence to the blood monitoring requirements and education relative to signs and symptoms of ITP has led to early detection and treatment of ITP with most cases responding to first-line medical therapy.
Podatki iz kliničnih preskušanj pri MS kažejo, da upoštevanje zahtev glede krvnih preiskav in izobraževanje glede znakov in simptomov ITP vodita do zgodnjega odkrivanja in zdravljenja ITP, ki se v večini primerov odzove na zdravljenje prve izbire.
Reported cases of temporally associated events were not related to anti-GBM disease (Goodpasteurs syndrome).
Opisani primeri časovno povezanih dogodkov niso bili povezani z boleznijo s protitelesi proti glomerulni bazalni membrani (Goodpasturov sindrom).
Study name
Ime študije
It is unknown whether alemtuzumab is excreted in human milk.
Ni znano, ali se alemtuzumab izloča v materino mleko pri ljudeh.
2.0/1.6 years
2/1,6 let
Monitoring for side effects and regular testing must continue for 4 years after the last infusion.
Spremljanje neželenih učinkov in redne preiskave je treba nadaljevati še štiri leta po zadnji infuziji.
Your doctor will monitor vital signs, including blood pressure, before and during the infusion.
Zdravnik vam bo pred infundiranjem in med njim kontroliral vitalne znake, vključno s krvnim tlakom.
Your doctor can also prescribe a medicine for cold sores (see section 2: What you need to know before you are administered LEMTRADA - Infections).
Zdravnik vam lahko predpiše tudi zdravilo za herpes na ustnicah (glejte poglavje 2: Kaj morate vedeti, preden boste prejeli zdravilo LEMTRADA - okužbe).
Talk to your doctor if you are thinking about trying to become pregnant.
Posvetujte se z zdravnikom, če načrtujete zanositev.
One patient developed ITP that went unrecognised prior to implementation of monthly blood monitoring requirements and died from intracerebral haemorrhage.
Pri enem bolniku se je pojavila ITP, ki je bila pred uvedbo obveznih mesečnih krvnih preiskav neprepoznana; bolnik je umrl zaradi intracerebralne krvavitve.
You will be given a Patient Alert Card and a Patient Guide with further information.
Prejeli boste bolnikovo kartico in vodnik za bolnike z dodatnimi informacijami.
In mothers with Graves' disease, maternal thyroid stimulating hormone receptor antibodies can be transferred to a developing foetus and can cause transient neonatal Graves' disease.
Pri materah z Gravesovo boleznijo se lahko materina protitelesa proti receptorju za tirotropin prenesejo na razvijajoč se plod in povzročijo prehodno neonatalno Gravesovo bolezen.
• bleeding in lungs
• krvavitev v pljučih
The reduction in the level of circulating B and T cells by LEMTRADA and subsequent repopulation, may reduce the potential for relapse, which ultimately delays disease progression.
Zdravilo LEMTRADA povzroči zmanjšanje ravni krožečih celic B in T in naknadno ponovno naselitev, kar morda zmanjša možnost recidiva in odloži napredovanje bolezni.
Alemtuzumab, is a recombinant DNA-derived humanised monoclonal antibody directed against the 21-28 kD cell surface glycoprotein CD52.
Alemtuzumab je s tehniko rekombinantne DNA pridobljeno humanizirano monoklonsko protitelo, usmerjeno proti 21-28 kD površinskemu glikoproteinu CD52.
Therefore, regardless of pretreatment anti-TPO antibody status patients may develop a thyroid adverse reaction and must have all tests periodically performed as described above.
Torej lahko ne glede na status anti-TPO protiteles pred začetkom zdravljenja bolniki razvijejo na ščitnico vezane neželene dogodke in jim je treba periodično opraviti vse teste, kot je opisano zgoraj.
Most thyroid events were managed with conventional medical therapy however some patients required surgical intervention.
Večina dogodkov, povezanih s ščitnico, je bila obravnavanih z običajnim zdravljenjem, vendar so nekateri bolniki potrebovali kirurški poseg.
It is very important that you are properly treated for a thyroid disorder, especially if you become pregnant after using LEMTRADA.
Zelo pomembno je, da se bolezen ščitnice pravilno zdravi, zlasti če zanosite po uporabi zdravila LEMTRADA.
Store in a refrigerator (2°C - 8°C).
Shranjujte v hladilniku (2 C do 8 C).
Patients with new or enlarging T2 lesions through Year 2
Bolniki z novo ali povečano lezijo T2 v 2. letu
Alemtuzumab was detected in the milk and offspring of lactating female mice.
Alemtuzumab so zaznali v mleku in mladičih doječih miši.
It is not known if LEMTRADA will have an effect on fertility during this period.
Ni znano, ali ima zdravilo LEMTRADA v tem obdobju učinek na plodnost.
In general, once a patient has had a herpes infection, they have an increased risk of developing another one.
Na splošno velja, da je pri bolnikih, ki so imeli herpesno okužbo, tveganje za razvoj ponovne okužbe večje.
Patients with severe active infection until complete resolution.
Bolniki s hudo aktivno okužbo, do njenega popolnega izginotja.
Clinical examination and laboratory tests should be conducted at periodic intervals until at least 48 months following the last treatment course of LEMTRADA in order to monitor for early signs of autoimmune diseases:
Klinični pregled in laboratorijske preiskave je treba opravljati v rednih presledkih še vsaj 48 mesecev po zadnjem zdravljenju z zdravilom LEMTRADA, da bolnike spremljate glede zgodnjih znakov avtoimunskih bolezni:
What LEMTRADA is and what it is used for 2.
Kaj je zdravilo LEMTRADA in za kaj ga uporabljamo 2.
• pain in ear
• bolečine v ušesu
This medicinal product must not be diluted with other solvents.
Zdravila ne smete redčiti z drugimi topili.
In each year of Study 4, patients from both studies continued to show a low risk of forming new T2 (27.4% to 33.2%) or gadolinium-enhancing lesions (9.4% to 13.5%), and the median annual percent change in brain parenchymal fraction ranged from 0.19% to -0.09%.
V vsakem letu študije 4 so imeli bolniki iz obeh študij še naprej majhno tveganje za nastanek novih T2-lezij (27,4 % do 33,2 %) ali z gadolinijem poudarjenih lezij (9,4 % do 13,5 %) in mediani letni odstotek spremembe v deležu možganskega parenhima je segal od 0,19 % do -0,09 %.
It is important that you keep the Patient Alert Card with you during treatment and for 4 years after your last infusion with LEMTRADA, because side effects may occur many years after treatment.
Pomembno je, da med zdravljenjem in še štiri leta po zadnji infuziji zdravila LEMTRADA pri sebi hranite opozorilno kartico bolnika, ker se lahko neželeni učinki pojavijo več let po zdravljenju.
The table below is based on the pooled safety data on all LEMTRADA 12 mg-treated patients during all available follow up in clinical trials.
Spodnja preglednica temelji na združenih podatkih o varnosti pri vseh bolnikih, zdravljenih z 12 mg zdravila LEMTRADA med celotnim spremljanjem v kliničnih preskušanjih, ki je na voljo.
You will also find this information in the Patient Alert Card and Patient Guide that you have been given by your doctor.
Te informacije so tudi v opozorilni kartici za bolnika in vodniku za bolnike, ki ste ju prejeli od zdravnika.
The therapy is recommended as an initial treatment of 2 courses with up to 2 additional treatment courses if needed (see posology) with safety follow-up of patients from initiation of the first treatment course and for at least 48 months after the last infusion of the second treatment course.
Zdravljenje se priporoča v obliki 2 ciklov začetnega zdravljenja z do 2 dodatnima cikloma zdravljenja, če je potrebno, (glejte poglavje o odmerjanju) z varnostnim sledenjem bolnikov od uvedbe prvega cikla zdravljenja do najmanj 48 mesecev po zadnji infuziji drugega cikla zdravljenja.
The type of adverse reactions including seriousness and severity observed in LEMTRADA treatment groups through all available follow-up including patients who received additional treatment courses were similar to those in the active-controlled studies.
Vrsta neželenih učinkov (vključno z njihovo resnostjo in izrazitostjo) v terapevtskih skupinah z zdravilom LEMTRADA je bila med celotnim spremljanjem, ki je na voljo - vključno z bolniki, ki so prejeli dodatne cikle zdravljenja - podobna kot v študijah, kontroliranih z učinkovino.
The safety of immunisation with live viral vaccines following a course of LEMTRADA treatment has not been formally studied in controlled clinical trials in MS and should not be administered to MS patients who have recently received a course of LEMTRADA.
Varnost cepljenja z živimi virusnimi cepivi po zdravljenju z zdravilom LEMTRADA v kontroliranih kliničnih preskušanjih pri MS formalno ni bila preučena, zato se ta cepiva ne smejo dajati bolnikom z MS, ki so jih nedavno zdravili z zdravilom LEMTRADA.
If you develop a thyroid disorder, in most cases you will need to be treated for the rest of your life with medicines to control your thyroid disorder, and in some cases your thyroid gland may have to be removed.
Če se pri vas pojavi bolezen ščitnice, je v večini primerov potrebno zdravljenje z zdravili za obvladovanje bolezni ščitnice do konca življenja, v nekaterih primerih pa je treba ščitnico odstraniti.
The observation of clinically significant changes from baseline in serum creatinine, unexplained haematuria, and/or proteinuria, should prompt further evaluation for nephropathies including immediate referral to a specialist.
Ugotovitvi klinično pomembnih sprememb serumske ravni kreatinina glede na izhodiščno stanje, nepojasnjeni hematuriji in/ali proteinuriji morajo takoj slediti preiskave za nefropatije, vključno s takojšnjo napotitvijo k specialistu.
Patients with active MS, defined as at least 2 relapses within the prior 2 years.
Bolniki z aktivno MS, opredeljeno kot vsaj 2 recidiva v preteklih 2 letih.
The percentage of patients with new or enlarging T2 lesions declined from 50.8% the year prior to Course 3 to 35.9% one year after, and new gadolinium-enhancing lesions from 32.2% to 11.9%.
Odstotek bolnikov z novo T2-lezijo ali povečanjem takšne lezije se je zmanjšal s 50,8 % v letu pred 3. ciklusom na 35,9 % leto pozneje, z novimi z gadolinijem poudarjenimi lezijami pa z 32,2 % na 11,9 %.
• listeriosis/listeria meningitis
• listerioza/listerijski meningitis (vnetje možganskih ovojnic)
This includes any possible side effects not listed in this leaflet.You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
What LEMTRADA is and what it is used for
Kaj je zdravilo LEMTRADA in za kaj ga uporabljamo
If an additional third or fourth course is administered, continue safety follow-up for at least 48 months after the last infusion (see section 4.4).
Če bolnik dobi dodaten tretji ali četrti cikel zdravljenja, je treba varnostno spremljanje nadaljevati še vsaj 48 mesecev po zadnji infuziji (glejte poglavje 4.4).
For these patients, the ARR declined from 0.79 in the year prior to Course 3 to 0.18 one year after, and the mean EDSS score from 2.89 to 2.69.
Pri teh bolnikih je AZT upadlo z 0,79 v letu pred 3. ciklusom na 0,18 leto potem in povprečna ocena EDSS se jim je zmanjšala z 2,89 na 2,69.
LEMTRADA should be administered during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Zdravilo LEMTRADA smete pri nosečnici uporabiti le, če pričakovani koristni učinki odtehtajo potencialno tveganje za plod.
Once you have received LEMTRADA, you will need to undergo regular tests to ensure that any potential side effects can be diagnosed and treated promptly.
Ko prejmete zdravilo LEMTRADA, boste morali opraviti običajne preiskave, da se zagotovita hitra diagnostika in zdravljenje možnih neželenih učinkov.
A clear, colourless to slightly yellow concentrate with pH 7.0 - 7.4.
FARMACEVTSKA OBLIKA koncentrat za raztopino za infundiranje (sterilni koncentrat) Bister, brezbarven do rahlo rumen koncentrat s pH 7,0 - 7,4.
Relapse Rate1
Stopnja recidivov1
LEMTRADA has minor influence on the ability to drive and use machines.
Zdravilo LEMTRADA ima blag vpliv na sposobnost vožnje in upravljanja strojev.
If ITP is suspected a complete blood count should be obtained immediately.
Če sumite na pojav ITP, je treba nemudoma določiti celotno krvno sliko.
It is recommended that the diluted product be administered immediately.
Priporočljivo je, da se razredčeno zdravilo uporabi nemudoma.
It is recommended that patients have completed local immunisation requirements at least 6 weeks prior to treatment with LEMTRADA.
Priporočljivo je, da bolniki opravijo cepljenja po lokalnem programu vsaj 6 tednov pred zdravljenjem z zdravilom LEMTRADA.
The autoimmune conditions can occur many years after treatment with LEMTRADA.
Avtoimunske bolezni se lahko pojavijo več let po zdravljenju z zdravilom LEMTRADA.
In a sub-study in 13 male LEMTRADA-treated patients (treated with either 12 mg or 24 mg), there was no evidence of aspermia, azoospermia, consistently depressed sperm count, motility disorders or an increase in sperm morphological abnormalities.
V podštudiji s 13 moškimi bolniki, zdravljenimi z zdravilom LEMTRADA (zdravljenimi bodisi z 12 mg bodisi s 24 mg), ni bilo dokazov aspermije, azoospermije, stalno zmanjšanega števila spermijev, motenj gibljivosti ali povečanja morfoloških nenormalnosti semenčic.
• red and white blood cells disorders (uncommon - may affect up to 1 in 100 people): diagnosed from your blood tests.
• bolezni rdečih in belih krvničk (občasni - pojavijo se lahko pri največ 1 od 100 bolnikov), ki se določijo na podlagi krvnih preiskav.
Patients with known coagulopathy, on anti-platelet or anti-coagulant therapy.
Bolniki z znano koagulopatijo, na antiagregacijskem ali antikoagulantnem zdravljenju.
Observed autoimmune thyroid disorders included hyperthyroidism or hypothyroidism.
Ugotovljene avtoimunske bolezni ščitnice so vključevale hipertiroidizem in hipotiroidizem.
The rate of thyroid adverse reactions was highest in year three and declined thereafter.
Delež neželenih učinkov povezan s ščitnico je bil največji tretje leto in se je nato zmanjševal.
• tears in carotid or vertebral arteries (blood vessels supplying the brain)
• pretrganje vratnih (karotidnih) ali vretenčnih (vertebralnih) arterij (to so žile, ki oskrbujejo možgane)
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
A. PROIZVAJALEC BIOLOŠKE UČINKOVINE IN PROIZVAJALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
LEMTRADA depletes circulating T and B lymphocytes after each treatment course with the lowest observed values occurring 1 month after a course of treatment (the earliest post-treatment time point in phase 3 studies).
Zdravilo LEMTRADA po vsaki stopnji zdravljenja osiromaši krožeče limfocite T in B, najnižje ravni pa se pa so opazne 1 mesec po zdravljenje (najbolj zgodnja časovna točka po zdravljenju v študijah 3. faze).
Serious events of ITP have been observed in 12 (1%) patients treated in controlled clinical trials in MS (corresponding to an annualised rate 4.7 events/1000 patient years).
Resne pojave ITP so opazili pri 12 (1 %) bolnikih, zdravljenih v kontroliranih kliničnih preskušanjih pri MS (to ustreza na leto preračunanemu deležu 4,7 dogodkov/1000 bolnik-let).
Annualised Relapse rate (ARR) (95% CI)
Letna stopnja recidivov (Annualised Relapse rate - ARR) (95-odstotni IZ)
Read the summary of product characteristics (available at the EMA website mentioned above) for more information.
Za več informacij preberite povzetek glavnih značilnosti zdravila (na voljo na zgoraj omenjeni spletni strani agencije EMA).
Reactions may occur following any of the doses during the treatment course.
Učinki se lahko pojavijo po katerem koli odmerku med ciklusom zdravljenja.
Very Common Common
Zelo pogosti