natgillin/translations-raw huggingface dataset:
2nd treatment week 1 or 2 tablets daily for 4 or 5 days, mid May 
2. teden zdravljenja 1 ali 2 tableti na dan, 4 ali 5 dni, sredi maja
Skin and subcutaneous tissue disorders Common: 
zmanjšanje števila nevtrofilcev Bolezni kože in podkožja Pogosti:
Other disease-modifying medicinal products 
Druga zdravila, ki spreminjajo potek bolezni
100 mg (10 tablets) 
100 mg (10 tablet)
Uncommon (≥1/1,000 to <1/100) 
Občasni (≥ 1/1.000 do < 1/100)
What MAVENCLAD contains 
Kaj vsebuje zdravilo MAVENCLAD
NAME OF THE MEDICINAL PRODUCT Cladribine 10 mg 
IME ZDRAVILA Cladribine 10 mg
Child-resistant packaging. 
Za otroke varno pakiranje.
Therefore, women using systemically acting hormonal contraceptives should add a barrier method during cladribine treatment and for at least 4 weeks after the last dose in each treatment year (see section 4.6). 
Zato morajo ženske, ki uporabljajo sistemske hormonske kontraceptive, med zdravljenjem s kladribinom in še vsaj 4 tedne po zadnjem odmerku v vsakem letu zdravljenja dodatno uporabljati še pregradno metodo (glejte poglavje 4.6).
Note that for some weight ranges the number of tablets may vary from one treatment week to the next. 
Upoštevajte, da se lahko za nekatere razpone telesne mase število tablet med prvim in drugim tednom zdravljenja razlikuje.
Posology 
Pasovec
Rare (≥1/10,000 to <1/1,000) 
Redki (≥ 1/10.000 do < 1/1.000)
Depending on the total number of tablets you have been prescribed, you have to take them over 4 or 5 days, in each treatment week. 
V vsakem tednu zdravljenja morate tablete jemati 4 ali 5 dni, odvisno od skupnega števila tablet, ki vam je bilo predpisano.
50 mg (5 tablets) 
50 mg (5 tablet)
The mechanism by which cladribine exerts its therapeutic effects in MS is not fully elucidated but its predominant effect on B and T lymphocytes is thought to interrupt the cascade of immune events central to MS. 
Patologija MS vključuje kompleksno verigo dogodkov, v katerih igrajo ključno vlogo različni tipi imunskih celic, vključno z avtoreaktivnimi celicami T in B. Mehanizem, s katerim kladribin doseže svoje terapevtske učinke pri MS, ni v celoti pojasnjen, vendar pa domnevajo, da njegov prevladujoč učinek na limfocite B in T prekine kaskado imunskih dogodkov, ključnih za MS.
A Step-by-Step Guide to taking your MAVENCLAD 10 mg tablets 
Navodilo po korakih za jemanje zdravila MAVENCLAD 10 mg tablete
An infection commonly seen with MAVENCLAD is shingles. 
Okužba, ki se pogosto pojavi ob jemanju zdravila MAVENCLAD, je pasovec.
NAME OF THE MEDICINAL PRODUCT MAVENCLAD 10 mg tablets 
IME ZDRAVILA MAVENCLAD 10 mg tablete
MAVENCLAD contains sorbitol 
Zdravilo MAVENCLAD vsebuje sorbitol
th percentile (months) Hazard ratio (95% CI) * p <0.001 compared to placebo 
* p < 0,001 v primerjavi s placebom
60 mg (6 tablets) 
60 mg (6 tablet)
Women using systemically acting hormonal contraceptives should add a barrier method during cladribine treatment and for at least 4 weeks after the last dose in each treatment year (see section 4.5). 
Ženske, ki uporabljajo sistemske hormonske kontraceptive, morajo med zdravljenjem s kladribinom in še vsaj 4 tedne po zadnjem odmerku v vsakem letu zdravljenja dodatno uporabljati še pregradno metodo (glejte poglavje 4.5).
Cases of progressive multifocal leukoencephalopathy (PML) have been reported for parenteral cladribine in patients treated for hairy cell leukaemia with a different treatment regimen. 
Pri parenteralnem dajanju kladribina bolnikom, ki so prejemali različne režime zdravljenja za dlakastocelično levkemijo, so poročali o primerih progresivne multifokalne levkoencefalopatije (PML).
Talk to your doctor or pharmacist before taking MAVENCLAD. 
Pred začetkom jemanja zdravila MAVENCLAD se posvetujte z zdravnikom ali farmacevtom.
You must use effective methods of contraception to avoid becoming pregnant during MAVENCLAD treatment and for 6 months after taking the last dose. 
Uporabljati morate učinkovito metodo kontracepcije, da se izognete zanositvi med zdravljenjem z zdravilom MAVENCLAD in še vsaj 6 mesecev po zadnjem odmerku.
It is recommended that administration of any other oral medicinal product be separated from that of MAVENCLAD by at least 3 hours during the limited number of days of cladribine administration (see section 4.5). 
Priporočljivo je, da v tistih nekaj dneh, ko bolnik dobi kladribin, med jemanjem katerega koli drugega peroralnega zdravila in zdravila MAVENCLAD pretečejo vsaj 3 ure (glejte poglavje 4.5).
Do not take MAVENCLAD, if you are breast-feeding. 
Ne jemljite zdravila MAVENCLAD, če dojite.
Treatment courses 
Ciklusi zdravljenja
Therefore, male patients must take precautions to prevent pregnancy of their partner during cladribine treatment and for at least 6 months after the last dose (see above). 
Zato se morajo moški bolniki med zdravljenjem s kladribinom in še vsaj 6 mesecev po zadnjem odmerku ustrezno zaščititi, da preprečijo zanositev pri svoji partnerici (glejte zgoraj).
List of adverse reactions 
Seznam neželenih učinkov
NAME OF THE MEDICINAL PRODUCT MAVENCLAD 10 mg tablets cladribine 
IME ZDRAVILA MAVENCLAD 10 mg tablete kladribin
You need a second method of contraception during MAVENCLAD treatment and for at least 4 weeks after the last dose. 
Med zdravljenjem z zdravilom MAVENCLAD in še vsaj 4 tedne po zadnjem odmerku morate uporabljati dodatno metodo kontracepcije.
No significant accumulation of cladribine concentration in plasma has been observed after repeated dosing. 
Po večkratnem odmerjanju niso opazili pomembnega kopičenja plazemskih koncentracij kladribina.
See below for a step-by-step guide on how to handle the package and to take the MAVENCLAD tablets. 
Za navodila o ravnanju s pakiranjem in jemanju tablet zdravila MAVENCLAD glejte spodnje navodilo po korakih.
STATEMENT OF ACTIVE SUBSTANCE Each tablet contains 10 mg cladribine. 
NAVEDBA ENE ALI VEČ UČINKOVIN Ena tableta vsebuje 10 mg kladribina.
Elderly 
Odmerek
• Important identified risks Severe (Grade ≥ 3) lymphopenia, to ensure compliance to haematological testing and treatment requirements; Herpes zoster infections, to ensure awareness of signs and symptoms suggestive for these infections; Tuberculosis, to raise awareness about this risk. 
Okužba z virusom herpes zoster, za zagotavljanje zavedanja znakov in simptomov, ki nakazujejo te okužbe;
Therefore, male patients must take precautions to prevent pregnancy of their partner during cladribine treatment and for at least 6 months after the last dose. 
Zato se morajo moški bolniki med zdravljenjem s kladribinom in še vsaj 6 mesecev po zadnjem odmerku ustrezno zaščititi, da preprečijo zanositev pri svoji partnerici.
Malignancies 
Malignosti
See package leaflet for guidance. 
Za navodila glejte navodilo za uporabo.
Male patients must take precautions to prevent pregnancy of their female partner during cladribine treatment and for at least 6 months after the last dose. 
Moški bolniki se morajo med zdravljenjem s kladribinom in še vsaj 6 mesecev po zadnjem odmerku ustrezno zaščititi, da preprečijo zanositev pri svoji partnerici.
• The Prescriber Guide 
B. NAVODILO ZA UPORABO
Take the leaflet from the tray. 
Z nosilca vzemite navodila.
How to store MAVENCLAD 
Shranjevanje zdravila MAVENCLAD
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON 
PODATKI NA ZUNANJI OVOJNINI ŠKATLA
If you are male, you must use effective methods of contraception to prevent your partner from getting pregnant, whilst you are treated with MAVENCLAD and for 6 months after the last dose. 
Če ste moški, morate med zdravljenjem z zdravilom MAVENCLAD in še vsaj 6 mesecev po zadnjem odmerku uporabljati učinkovite metode kontracepcije, da preprečite zanositev pri svoji partnerici.
Leave a gap of at least 3 hours between taking MAVENCLAD and other medicines taken by mouth. 
Preden zaužijete drugo zdravilo, počakajte, da minejo vsaj 3 ure od jemanja zdravila MAVENCLAD.
Talk to your doctor before taking MAVENCLAD if you have liver problems. 
Če imate težave z jetri, se pred začetkom jemanja zdravila MAVENCLAD pogovorite z zdravnikom.
Magnesium stearate 
Razpon telesne mase
These include: ciclosporin, cyclophosphamide and azathioprine (used to suppress the immune system, for example after organ transplantation); methotrexate (used to treat conditions such as psoriasis or rheumatoid arthritis); long-term corticosteroids (used to reduce inflammation, for example in asthma). 
- ciklosporin, ciklofosfamid in azatioprin (uporabljajo se za zaviranje imunskega sistema, na primer po presaditvi organa),
Oral use. 
Način uporabe
This summary was last updated in 04-2013. 
Povzetek je bil nazadnje posodobljen 04-2013.
Nemdatine should be given once a day at the same time every day. 
Zdravilo Nemdatine se daje enkrat dnevno, vsak dan ob istem času.
What measures are being taken to ensure the safe and effective use of Nemdatine? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Nemdatine?
The European Commission granted a marketing authorisation valid throughout the European Union for Nemdatine on 22 April 2013. 
Evropska komisija je dovoljenje za promet z zdravilom Nemdatine, veljavno po vsej Evropski uniji, odobrila dne 22. aprila 2013.
To prevent side effects, the dose of Nemdatine is gradually increased over the first three weeks of treatment: during the first week, the dose is 5 mg; in the second week, it is 10 mg; and during the third week, it is 15 mg. From week four onwards, the recommended maintenance dose is 20 mg once a day. 
Da se preprečijo neželeni učinki, se odmerek zdravila Nemdatine v prvih treh tednih zdravljenja postopoma povečuje: prvi teden je odmerek 5 mg, drugi teden 10 mg, tretji teden pa 15 mg. Od četrtega tedna naprej je priporočeni vzdrževalni odmerek 20 mg enkrat dnevno.
The full EPAR for Nemdatine can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Nemdatine je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Neurotransmitters are chemicals in the nervous system that allow nerve cells to communicate with one another. 
Živčni prenašalci so kemične snovi v živčnem sistemu, ki omogočajo medsebojno komunikacijo živčnih celic.
Treatment should be started and supervised by a doctor who has experience in the diagnosis and treatment of Alzheimer's disease. 
Zdravljenje mora uvesti in nadzorovati zdravnik, ki ima izkušnje z diagnosticiranjem in zdravljenjem Alzheimerjeve bolezni.
What are the benefits and risks of Nemdatine? 
Kakšne so koristi in tveganja, povezani z zdravilom Nemdatine?
Nemdatine is a medicine used to treat patients with moderate to severe Alzheimer's disease, a type of dementia (a brain disorder) that gradually affects memory, intellectual ability and behaviour. 
Nemdatine je zdravilo, ki se uporablja za zdravljenje bolnikov z zmerno do hudo Alzheimerjevo boleznijo, vrsto demence (možganske bolezni), ki postopoma prizadene spomin, intelektualno sposobnost in vedenje.
In addition, overstimulation of the NMDA receptors may result in cell damage or death. 
Poleg tega lahko prekomerna stimulacija receptorjev NMDA povzroči poškodbo ali odmiranje celic.
The cause of Alzheimer's disease is unknown, but memory loss in the disease is believed to be due to a disturbance of message signals in the brain. 
Vzrok za Alzheimerjevo bolezen ni znan, vendar se domneva, da izguba spomina pri bolezni nastane zaradi motenj v prenosu signalov v možganih.
This means that Nemdatine is similar to a ‘reference medicine' already authorised in the European Union (EU) called Ebixa. 
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Ebixa.
What is Nemdatine and what is it used for? 
Kaj je zdravilo Nemdatine in za kaj se uporablja?
Nemdatine is a ‘generic medicine'. 
Zdravilo Nemdatine je „generično zdravilo“.
It is not intended to provide practical advice on how to use Nemdatine. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
This is a summary of the European public assessment report (EPAR) for Nemdatine. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Nemdatine.
The Committee recommended that Nemdatine be approved for use in the EU. 
Priporočil je, da se zdravilo Nemdatine odobri za uporabo v EU.
Memantine works by blocking special types of receptor called NMDA receptors to which the neurotransmitter glutamate normally attaches. 
Memantin deluje tako, da zavira posebno vrsto receptorjev, imenovanih receptorji NMDA, na katere se živčni prenašalec glutamat navadno veže.
Nemdatine is available as 5 mg, 10 mg, 15 mg and 20 mg tablets and can only be obtained with a prescription. 
Zdravilo Nemdatine je na voljo v obliki 5-, 10-, 15- in 20-miligramskih tablet in se izdaja le na recept.
Treatment should only be started if a caregiver is available who will regularly monitor the use of Nemdatine by the patient. 
Zdravljenje se sme uvesti samo, če je na voljo negovalec, ki bo redno spremljal bolnikovo jemanje zdravila Nemdatine.
The tolerance and dose should be assessed within 3 months after starting treatment, and from then on the benefits of continuing treatment with Nemdatine should be reassessed on a regular basis. 
Prenašanje in odmerek zdravila je treba oceniti v 3 mesecih od začetka zdravljenja, od takrat naprej pa je treba koristi zdravljenja z zdravilom Nemdatine ponovno ocenjevati v rednih intervalih.
Because Nemdatine is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's. 
Ker je zdravilo Nemdatine generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
By blocking NMDA receptors, memantine improves the transmission of signals in the brain and reduces the symptoms of Alzheimer's disease. 
Memantin z zaviranjem receptorjev NMDA izboljšuje prenos signalov v možganih in zmanjšuje simptome Alzheimerjeve bolezni.
Other information about Nemdatine 
Druge informacije o zdravilu Nemdatine
Why is Nemdatine approved? 
Zakaj je bilo zdravilo Nemdatine odobreno?
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Nemdatine has been shown to have comparable quality and to be bioequivalent to Ebixa. 
Odbor za zdravila za uporabo v humani medicini (CHMP), ki deluje pri agenciji, je zaključil, da je bilo v s skladu z zahtevami EU dokazano, da ima zdravilo Nemdatine primerljivo raven kakovosti kot zdravilo Ebixa ter da mu je biološko enakovredno.
Changes in the way glutamate transmits signals within the brain have been linked to the memory loss seen in Alzheimer's disease. 
Spremembe načina, kako glutamat prenaša signale v možganih, se povezujejo z izgubo spomina, kakršno je opaziti pri Alzheimerjevi bolezni.
For more information about treatment with Nemdatine, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Nemdatine preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
For more information, see the package leaflet. 
Za več informacij glejte navodilo za uporabo.
It contains the active substance memantine. 
Vsebuje zdravilno učinkovino memantin.
Safety information has been included in the summary of product characteristics and the package leaflet for Nemdatine, including the appropriate precautions to be followed by healthcare professionals and patients. 
V povzetek glavnih značilnosti zdravila in navodilo za uporabo za zdravilo Nemdatine so bile vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Because Nemdatine is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Ebixa. 
Ker je zdravilo Nemdatine generično zdravilo, so bile študije omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Ebixa.
For practical information about using Nemdatine, patients should read the package leaflet or contact their doctor or pharmacist. 
Za praktične informacije o uporabi zdravila Nemdatine naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
The active substance in Nemdatine, memantine, is an antidementia medicine. 
Zdravilna učinkovina zdravila Nemdatine, memantin, je zdravilo za zdravljenje demence.
Therefore, the CHMP's view was that, as for Ebixa, the benefit outweighs the identified risk. 
Zato je menil, da njegove koristi, tako kot pri zdravilu Ebixa, odtehtajo znana tveganja.
The dose may need to be reduced in patients who have moderate or severe problems with their kidneys. 
Pri bolnikih, ki imajo zmerne ali hude težave z ledvicami, bo odmerek zdravila morda treba zmanjšati.
How is Nemdatine used? 
Kako se zdravilo Nemdatine uporablja?
How has Nemdatine been studied? 
Kako je bilo zdravilo Nemdatine raziskano?
How does Nemdatine work? 
Kako zdravilo Nemdatine deluje?
fractures and heart failure). 
zlome in srčno popuščanje).
The Prescriber Guide should highlight the following: 
Priporočilo za zdravnike mora poudariti naslednje:
• Caution in use in the elderly in light of age related risks (in particular bladder cancer, 
• Opozorilo o uporabi pri starejših glede na s starostjo povezana tveganja (zlasti za rak mehurja,
Prior to distribution of the prescriber guide in each Member State, the MAH must agree the content and format of the educational material, together with a communication plan, with the national competent authority. 
Pred distribucijo priporočila za zdravnike v vsaki državi članici, se mora imetnik dovoljenja za promet glede vsebine in oblike izobraževalnega gradiva, vključno z načrtom obveščanja, dogovoriti z nacionalnim pristojnim organom.
ANNEX CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES 
DODATEK POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA, KI JIH IZVAJAJO DRŽAVE ČLANICE
Conditions or restrictions with regard to the safe and effective use of the medicinal product to be implemented by the member states. 
Pogoji ali omejitve v zvezi z varno in učinkovito uporabo zdravila, ki jih izvajajo države članice.
• Patient selection criteria including that Pioglitazone should not be used as first line therapy and emphasising the need for regular review of treatment benefit. 
• Merila za izbiro bolnika, ki vključujejo, da se pioglitazona ne sme uporabljati kot zdravilo prvega izbora in poudarijo potrebo po redni oceni koristi zdravljenja.
The MAH shall provide an educational pack targeting all physicians who are expected to prescribe/use Pioglitazone. 
Imetnik dovoljenja za promet mora zagotoviti izobraževalno gradivo, namenjeno vsem zdravnikom, za katere se pričakuje, da bodo predpisovali/uporabljali pioglitazon.
• This educational pack is aimed at strengthening awareness of important identified risks of bladder cancer and heart failure and the overall recommendations intended to optimise the benefit-risk margin at the patient level. 
• To izobraževalno gradivo je namenjeno ozaveščanju o pomembnih ugotovljenih tveganjih za rak mehurja in srčno popuščanje ter o splošnih priporočilih, da bi dosegli najboljše razmerje med koristjo in tveganjem na ravni bolnika.
• The physician educational pack should contain: The Summary of Product Characteristics, package leaflet, and a Prescriber Guide. 
• Izobraževalno gradivo za zdravnike mora vsebovati: Povzetek glavnih značilnosti zdravila, navodilo za uporabo in priporočilo za zdravnike.
• The risk of heart failure and relevant risk minimisation advice. 
• Tveganje za srčno popuščanje in ustrezen nasvet za zmanjšanje tveganja.
• The risk of bladder cancer and relevant risk minimisation advice. 
• Tveganje za nastanek raka mehurja in ustrezen nasvet za zmanjšanje tveganja.
Package size l t o r 
Velikost pakiranja l t o r
Strength Pharmaceutical Form Route of Administration 
Farmacevtska oblika
Date of first authorisation: 23 March 2015 Date of latest renewal: 
Datum prve odobritve: 23. marec 2015 Datum zadnjega podaljšanja:
The recommended dose is: 
Priporočeni odmerek je:
- If you have uncontrolled very high blood pressure. 
- če imate nenadzorovan zelo visok krvni tlak.
• severe allergic reactions, 
• hude alergijske reakcije;
A risk to the newborns/infants cannot be excluded. 
Tveganja za dojenega novorojenca/otroka ne moremo izključiti.
• You suffer from breathing difficulties such as asthma. 
• imate težave z dihanjem, kot je astma.
Tell your doctor immediately if you notice any of the following: 
Zdravniku takoj povejte, če opazite kaj od naslednjega:
The doctor will decide if you will need to be treated for longer periods. 
Zdravnik se bo odločil, ali vas bo treba zdraviti dlje časa.
Sorbitol is a source of fructose. 
Sorbitol je vir fruktoze.
Use with other anticoagulant agents 
Uporaba z drugimi antikoagulanti
In clinical studies, healthy volunteers received up to two times the proposed daily dose. 
V kliničnih študijah so zdravi prostovoljci prejemali do dvakratni priporočeni dnevni odmerek.
Mean clearance was approximately 43.2 L/kg. 
Povprečni očistek je bil približno 43,2 l/kg.
In this study, semen analysis was conducted after 8 weeks of continuous treatment. 
V tej študiji so analizo semenske tekočine izvedli po 8 tednih stalnega dovajanja zdravila.
Carcinogenicity studies have not been performed. 
Študij kancerogenosti niso izvajali.
Initial excretion was rapid, such that approximately 50% of the administered radioactivity was recovered in the first 24 hours, and 75% was recovered by 48 hours. 
Začetno izločanje je bilo hitro, tako da so približno 50 % uporabljene radioaktivnosti izmerili v prvih 24 urah in 75 % so izmerili po 48 urah.
GP IIb/IIIa inhibitors were permitted for bailout use only and were used in 2.9% of patients. 
Zaviralci GPIIb/IIIa so bili dovoljeni le za reševalno uporabo in so bili uporabljeni pri 2,9 % bolnikov.
This medicine will be given to you by a healthcare professional. 
Zdravilo vam bo dal zdravstveni delavec.
Do not use without dilution. 
Ne uporabite brez redčenja.
The bolus and infusion should be initiated prior to the procedure and continued for at least two hours or for the duration of the procedure, whichever is longer. 
Bolus in infuzijo je treba uvesti pred postopkom in nadaljevati vsaj dve uri ali ves čas trajanja postopka, kar traja dlje.
Your doctor will decide how to treat you, including stopping the medicine and monitoring for signs of side effects. 
Zdravnik se bo odločil o tem, kako vas bo zdravil, vključno s prenehanjem dajanja zdravila in spremljanjem znakov neželenih učinkov.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. 
V primeru pomanjkanja študij kompatibilnosti zdravila ne smemo mešati z drugimi zdravili.
• Bleeding from anywhere in the body. 
• Krvavitev iz katerega koli dela telesa.
Bleeding is the most likely pharmacological effect of overdose. 
Krvavitev je najverjetnejši farmakološki učinek prevelikega odmerjanja.
Table 1 depicts adverse reactions that have been identified based upon a pooling of combined data from all CHAMPION studies. 
V preglednici 1 so navedeni neželeni učinki, ugotovljeni na podlagi združevanja kombiniranih podatkov iz vseh študij CHAMPION.
Swirl gently until all material is dissolved. 
Nežno obračajte tako dolgo, da se raztopi ves material.
Data from the CHAMPION pooled population of over 25,000 PCI patients provide additional clinical support for safety. 
Podatki za združeno populacijo CHAMPION za več kot 25.000 bolnikov s PKI dodatno klinično podpirajo podatke o varnosti.
These effects were not apparent at lower doses and were reversible following cessation of dosing. 
Ti učinki niso bili vidni pri nižjih odmerkih in so bili po prenehanju odmerjanja reverzibilni.
** Transfusion was uncommon 101/12,565 (0.8%). 
** transfuzija je bila občasna 101/12.565 (0,8 %)
No dose adjustment is needed for these populations. 
Pri teh populacijah ni treba prilagajati odmerka.