natgillin/translations-raw huggingface dataset:
Inject the liquid by holding the syringe with your thumb on the plunger, and slowly push the plunger down as far as it will go, until the syringe is completely empty (Figure K and L).
Ob injiciranju tekočine držite brizgo s palcem na batu in bat počasi potisnite do konca navznoter, dokler ni brizga popolnoma prazna (sliki K in L).
Patients and/or caregivers should be trained in the administration of this medicinal product in accordance with the patient information leaflet.
Bolnike in/ali negovalce je treba usposobiti za uporabo tega zdravila skladno z navodilom za uporabo.
If not noticed within 48 hours, then the missed dose should be skipped and the next planned injection given.
Če tega niste opazili v 48 urah, je treba izpuščeni odmerek preskočiti in dati naslednjo načrtovano injekcijo.
Elimination involves both metabolism in tissues and excretion in urine.
Izločanje Izločanje vključuje tako presnovo v tkivih kot tudi izločanje v urin.
Waylivra contains the active substance volanesorsen, which helps to treat a condition called familial chylomicronemia syndrome (FCS).
Zdravilo Waylivra vsebuje učinkovino volanesorsen, ki pomaga pri zdravljenju bolezni, imenovane sindrom družinske hilomikronemije (FCS).
This binding prevents translation of the protein apoC-III, thus removing an inhibitor of triglyceride clearance and enabling metabolism through an LPL-independent pathway.
Ta vezava prepreči prevajanje beljakovine apoC-III, s čimer odstrani zaviralec očistka trigliceridov in omogoči presnovo po poti, neodvisni od LPL.
No starting dose adjustment is necessary for elderly patients.
Pri starejših bolnikih ni treba prilagajati začetnega odmerka.
None of these patients had any major bleeding events and all recovered to normal platelet count following drug discontinuation and administration of glucocorticosteroids where medically indicated.
Pri nobenem od teh bolnikov se ni pojavila večja krvavitev in pri vseh se je število trombocitov normaliziralo po ukinitvi zdravila in dajanju glukokortikosteroidov, kadar je bilo to medicinsko indicirano.
If formation of anti-drug antibodies with a clinically significant effect is suspected, contact the Marketing Authorisation Holder to discuss antibody testing.
Ob sumu na nastanek protiteles proti zdravilu s klinično pomembnim učinkom se obrnite na imetnika dovoljenja za promet z zdravilom za posvetovanje o preiskavah za protitelesa.
What Waylivra is and what it is used for
Kaj je zdravilo Waylivra in za kaj ga uporabljamo
Waylivra should be inspected visually prior to administration.
Zdravilo Waylivra je treba pred dajanjem vizualno pregledati.
For discontinued patients, a haematologist should be consulted prior to resuming treatment.
Pri bolnikih, ki prenehajo jemati to zdravilo, se je treba pred ponovnim začetkom zdravljenja posvetovati s hematologom.
The solution should be clear and colourless to slightly yellow.
Raztopina mora biti bistra in brezbarvna do rahlo rumena.
If you forget to use Waylivra
Če ste pozabili uporabiti zdravilo Waylivra
Name and address of the manufacturer(s) responsible for batch release
Ime in naslov izdelovalca (izdelovalcev) zdravila, odgovornega (odgovornih) za sproščanje serij
Diagnosis of FCS required documentation of at least one of the following: a) Confirmed homozygote, compound heterozygote, or double heterozygote for known loss-offunction mutations in Type 1-causing genes (such as LPL, APOC2, GPIHBP1, or LMF1)
Diagnoza sindroma FCS je zahtevala dokumentacijo vsaj enega od naslednjih meril: a) Potrjeni homozigot, sestavljeni heterozigot ali dvojni heterozigot za znane mutacije z izgubo funkcije v genih, ki povzročajo tip 1 (npr. LPL, APOC2, GPIHBP1 ali LMF1) b) Postheparinska plazemska LPL aktivnost ≤ 20 % normalne.
Monitoring for hepatotoxicity through serum liver enzymes and bilirubin should be assessed on a quarterly basis.
Vsako četrtletje je treba z oceno serumskih jetrnih encimov in bilirubina spremljati hepatotoksičnost.
Injection site reactions did not occur with all injections and resulted in discontinuation for 1 patient in the APPROACH study.
V študiji APPROACH se reakcije na mestu injiciranja niso pojavile pri vseh injekcijah in so zahtevale prekinitev zdravljenja pri enem bolniku.
In the case of overdose, patients should be carefully observed and supportive care administered, as appropriate.
Pri prevelikem odmerjanju je treba bolnike natančno opazovati in jim nuditi ustrezno podporno oskrbo.
o Relevant information on thrombocytopaenia and severe bleeding o Details of the population at higher risk for thrombocytopaenia and bleeding (e.g. those with weight less than 70 kg), and patients for which Waylivra is contraindicated (i.e. patients with chronic or unexplained thrombocytopaenia)
o Podrobnosti o populaciji, pri kateri je tveganje za trombocitopenijo in krvavitve večje (npr. za težje od 70 kg), in bolnike, pri katerih je zdravilo Waylivra kontraindicirano (tj. bolniki s kronično ali nepojasnjeno trombocitopenijo).
Percent Change from Baseline in Fasting Triglycerides: Subset of Patients with Non-Missing Endpoints, Full Analysis Set
Odstotna sprememba od začetne ravni trigliceridov na tešče: podmnožica bolnikov z nemanjkajočimi končnimi točkami, celotna analizirana množica
% change from Baseline in APPROACH n
Odstotek spremembe od izhodišča v študiji APPROACH n
Non-interventional PASS: the applicant should conduct and submit the results of a study based on a Registry in order to evaluate the safety of Waylivra on thrombocytopenia and bleeding(including incidence rate, severity and outcomes) in FCS patients according to the dose recommendation and dose algorithm and investigate adherence with platelet monitoring and dose adjustment requirements.
Neintervencijska študija o varnosti zdravila po pridobitvi dovoljenja za promet z zdravilom (PASS): vlagatelj mora izvesti in predložiti rezultate na register oprte študije za oceno varnosti zdravila Waylivra glede trombocitopenije in krvavitve (vključno s pojavnostjo, resnostjo in izidi) pri bolnikih s sindromom FCS, skladno s priporočili in algoritmom za odmerjanje, in raziskati kompliantnost z zahtevami za spremljanje ravni trombocitov in prilagajanje odmerka.
Based on the population pharmacokinetic analysis, age, body weight, sex, or race has no clinically relevant effect on volanesorsen exposure.
Na podlagi populacijske farmakokinetične analize je bilo ugotovljeno, da starost, telesna masa, spol ali rasa nimajo klinično pomembnega vpliva na izpostavljenost volanesorsenu.
Due to the poor oral bioavailability of volanesorsen, it is considered unlikely that these low milk concentrations would result in systemic exposure from nursing (see section 4.6).
Zaradi slabe peroralne biološke uporabnosti volanesorsena je malo verjetno, da bi te nizke koncentracije v mleku povzročile sistemsko izpostavljenost ob dojenju (glejte poglavje 4.6).
Look at the liquid in the syringe.
Preverite tekočino v brizgi.
Clinical studies included 4 patients with FCS aged 65 treated with volanesorsen in randomised control studies (phase II study CS2, 1 patient; APPROACH 3 patients), and 6 patients aged 65 and over in the open-label extension study (CS7).
Klinične študije so vključevale štiri bolnike s sindromom FCS, stare 65 let, ki so bili z volanesorsenom zdravljeni v randomiziranih kontrolnih študijah (študija 2. faze CS2, en bolnik; trije bolniki v študiji APPROACH), in šest bolnikov, starih 65 let ali več, v nezaslepljeni podaljšani študiji (CS7).
During this time this medicine may be kept at either room temperature or put back into the refrigerator, as needed.
V tem času je to zdravilo mogoče hraniti bodisi pri sobni temperaturi bodisi v hladilniku, kakor je treba.
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say it is essentially ‘sodium-free'.
To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na odmerek, kar v bistvu pomeni „brez natrija“.
Thirteen of these patients had dose adjustment/pause on the study.
Pri trinajstih od teh bolnikov je bilo treba med študijo prilagoditi odmerke ali zdravljenje začasno ustaviti.
In the volanesorsen group, of the 7 patients who had 24 adjudicated pancreatitis attacks in the prior 5 years, none of the patients experienced a pancreatitis attack during the 52 week treatment period.
V skupini bolnikov, zdravljenih z volanesorsenom,od sedmih bolnikov, ki so imeli v predhodnih petih letih 24 napadov pankreatitisa, noben bolnik ni imel v 52-tedenskem obdobju zdravljenja napada pankreatitisa.
Before you are given this medicine other causes of high levels of triglycerides, such as diabetes or problems with your thyroid, will be ruled out by your doctor.
Preden boste prejeli to zdravilo, bo zdravnik izključil druge vzroke visokih ravni trigliceridov, kot so diabetes ali težave s ščitnico.
If injected in the upper arm, the injection should be administered by another person.
Ob injiciranju v nadlaket mora injekcijo dati druga oseba.
Volanesorsen is not a substrate for CYP metabolism, and is metabolised in tissues by endonucleases to form shorter oligonucleotides that are then substrates for additional metabolism by exonucleases.
Volanesorsen ni substrat za presnovo prek CYP in se v tkivih presnavlja z endonukleazami, pri čemer se tvorijo krajši oligonukleotidi, ki so nato substrati za dodatno presnovo z eksonukleazami.
The parent drug and 5- to 7-mer chain-shortened metabolites accounted for approximately 26% and 55% of oligonucleotides recovered in urine, respectively.
Nespremenjeno zdravilo in presnovki z od 5- do 7-merno skrajšano verigo so predstavljali približno 26 % oziroma 55 % oligonukleotidov, ki so se izločili z urinom.
Unchanged volanesorsen is the predominant circulating component.
Prevladujoča komponenta v obtoku je nespremenjeni volanesorsen.
Do not stop using Waylivra unless you have discussed stopping your medicine with your doctor.
Če ste prenehali uporabljati zdravilo Waylivra Zdravila Waylivra ne prenehajte uporabljati, razen če ste se o prenehanju posvetovali z zdravnikom.
If you inject too much Waylivra, contact your doctor or pharmacist, or attend a hospital emergency department immediately, even if there are no symptoms.
Če ste uporabili večji odmerek zdravila Waylivra, kot bi smeli Če injicirate preveč zdravila Waylivra, se posvetujte z zdravnikom ali farmacevtom ali se takoj obrnite na oddelek nujne medicinske pomoči v bolnišnici, tudi če se simptomi niso pojavili.
Waylivra with alcohol
Zdravilo Waylivra skupaj z alkoholom
Patients taking Glybera within 2 years prior to screening were excluded from the study.
Iz študije so bili izključeni bolniki, ki so do 2 leti pred presejanjem jemali zdravilo Glybera.
If the expiry date on the syringe label has passed during the 6 week period at room temperature, the syringe should not be used and should be discarded.
Če je v času šestih tednov pri sobni temperaturi potekel rok trajanja na nalepki brizge, brizge ne smete uporabiti in jo morate zavreči.
Month
Meseci
At a drug concentration 4.1 times the peak drug plasma concentrations (Cmax) of the maximum recommended dose (285 mg subcutaneous injection), volanesorsen did not prolong the heart-rate corrected QT (QTc) interval.
Pri koncentraciji zdravila, enaki 4,1-kratni najvišji plazemski koncentraciji zdravila (Cmaks) največjega priporočenega odmerka (285 mg v subkutani injekciji), volanesorsen ni podaljšal s srčno frekvenco korigiranega intervala QT (QTc).
Throw away the needle cap after injecting.
Pokrovček za iglo po injiciranju zavrzite.
Avoid injecting at the waistline where your clothing may rub or press the injection area.
Izogibajte se injiciranju v predel pasu, kjer se lahko ob območje injiciranja drgnejo ali nanj pritiskajo vaša oblačila.
This being a conditional marketing authorisation and pursuant to Article 14(7) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures:
št. 726/2004, mora imetnik dovoljenja za promet z zdravilom v določenem časovnem okviru izvesti naslednje ukrepe:
Treatment with these medicinal products must be discontinued at platelet levels < 50 x 109/L (see section 4.5).
Zdravljenje s temi zdravili je treba ukiniti pri ravni trombocitov < 50 x 109/l (glejte poglavje 4.5).
If you see blood where you've injected, press the site lightly with the sterile cotton ball or gauze and bandage if needed (Figure O).
Če na mestu injiciranja opazite kri, nanj rahlo pritisnite s sterilnim vatiranim tamponom ali gazo in čezenj po potrebi prilepite obliž (slika O).
In the Phase 3 clinical studies (CS16 and APPROACH), 16% and 30% of volanesorsen-treated patients tested positive for anti-drug antibodies during 6-month and 12-month treatment, respectively.
V kliničnih študijah 3. faze (CS16 in APPROACH) je bilo za protitelesa proti zdravilu pozitivnih 16 % oziroma 30 % bolnikov, zdravljenih 6 oziroma 12 mesecev.
Patients with lower body weight (less than 70 kg) may be more prone to thrombocytopenia during treatment with this medicinal product.
(lažji od 70 kg) so lahko med zdravljenjem s tem zdravilom bolj nagnjeni k trombocitopeniji.
In vitro studies show that volanesorsen is not a substrate or inhibitor of P-glycoprotein (P-gp), breast cancer resistance protein (BCRP), organic anion transporting polypeptides (OATP1B1, OATP1B3), bile salt export pump (BSEP), organic cation transporters (OCT1, OCT2), or organic anion transporters (OAT1, OAT3).
Študije in vitro so pokazale, da volanesorsen ni substrat ali zaviralec glikoproteina P (P-gp), proteina odpornosti pri raku dojke (BCRP), polipeptidnih prenašalcev organskih anionov (OATP1B1, OATP1B3), iztočne črpalke žolčnih soli (BSEP), organskih kationskih prenašalcev (OCT1, OCT2) ali prenašalcev organskih anionov (OAT1, OAT3).
You can help by reporting any side effects you may get.
Tudi sami lahko prispevate k temu tako, da poročate o katerem koli neželenem učinku zdravila, ki bi se utegnil pojaviti pri vas.
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.
• Redno posodobljena poročila o varnosti zdravila Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7)
A history of documented acute pancreatitis was reported for 76% of patients and a history of diabetes was reported for 15% of patients; 21% of patients had a recorded history of lipaemia retinalis and 23% of patients had a recorded history of eruptive xanthomas.
O anamnezi dokumentiranega akutnega pankreatitisa so poročali pri 76 % bolnikov, o anamnezi diabetesa pa pri 15 % bolnikov; 21 % bolnikov je imelo v anamnezi retinalno lipemijo, 23 % pa jih je imelo v anamnezi eruptivne ksantome.
• Made of heavy-duty plastic,
• je narejena iz vzdržljive plastike;
What Waylivra looks like and contents of the pack
Izgled zdravila Waylivra in vsebina pakiranja
Platelet counts recovered after cessation of treatment, but decreased again below 50,000 cells/μl after treatment was resumed in some monkeys.
Po prenehanju zdravljenja se je spet povečalo, po ponovni uvedbi zdravljenja pa se je pri nekaterih opicah spet zmanjšalo pod 50.000 celic/μl.
Pause treatment for ≥4 weeks and resume treatment after platelet levels ≥ 100 x 109/L
Premor za ≥ 4 tedne in nadaljevanje zdravljenja pri številu trombocitov > 100 x 109/l
Mean age was 46 years (range 20-75 years; 5 patients ≥65 years old); 45% were men; 80% were White, 17% were Asian, and 3% were of other races.
Srednja starost je bila 46 let (razpon od 20 do 75 let; 5 bolnikov ≥ 65 let); 45 % je bilo moških; 80 %
May be kept at room temperature for up to 6 weeks.
Zdravilo lahko hranite pri sobni temperaturi do 6 tednov.
Volanesorsen was rapidly and widely distributed to tissues following subcutaneous or intravenous administration in all species evaluated.
Volanesorsen se je po subkutanem ali intravenskem dajanju pri vseh proučevanih vrstah porazdelil hitro in široko.
Decreased platelet counts were also observed in rodent repeated dose studies.
Zmanjšano število trombocitov je bilo opaženo tudi v študijah ponavljajočih odmerkov pri glodavcih.
If the platelet count is below 140 x 109/L another measurement should be taken approximately a week later to reassess.
140 x 109/l, je treba po približno enem tednu opraviti drugo meritev za ponovno oceno.
Volanesorsen is an antisense oligonucleotide designed to inhibit the formation of apoC-III, a protein that is recognised to regulate both triglyceride metabolism and hepatic clearance of chylomicrons and other triglyceride-rich lipoproteins.
Volanesorsen je protismiselni oligonukleotid, zasnovan za zaviranje tvorbe apoC-III, beljakovine, za katero je znano, da uravnava presnovo trigliceridov ter jetrni očistek hilomikronov in drugih s trigliceridi bogatih lipoproteinov.
This medicinal product should be inspected visually prior to administration.
Zdravilo je treba pred dajanjem vizualno pregledati.
How to store Waylivra 6.
Shranjevanje zdravila Waylivra 6.
If any of the above apply to you, or you are not sure, talk to your doctor, nurse or pharmacist before using Waylivra.
Če za vas velja kar koli od navedenega ali o tem niste prepričani, se pred uporabo zdravila Waylivra pogovorite z zdravnikom, medicinsko sestro ali farmacevtom.
Other medicines and Waylivra
Druga zdravila in zdravilo Waylivra
Waylivra is not likely to affect your ability to drive or use machines.
Zdravilo Waylivra nima vpliva na sposobnost vožnje in upravljanja strojev.
If platelet count remains below 140 x 109/L upon a second measurement, Waylivra should not be initiated (see section
Če število trombocitov ostane manjše od 140 x 109/l tudi pri drugi meritvi, se zdravilo Waylivra ne sme uvesti (glejte poglavje 4.3).
Monitoring for evidence of nephrotoxicity by routine urine dipstick is recommended on a quarterly basis.
Priporočeno je četrtletno spremljanje glede znakov nefrotoksičnosti z rutinsko preiskavo urina s testnim lističem.
You should refer to the date you have written on the carton to be sure.
Glede tega preverite datum, ki ste ga napisali na škatlo.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose of 285 mg, that is to say it is essentially ‘sodium-free'.
Zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na odmerek 285 mg, kar v bistvu pomeni "brez natrija".
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity, carcinogenicity or toxicity to reproduction and development.
Neklinični podatki na podlagi običajnih študij farmakološke varnosti, genotoksičnosti, karcinogenosti ali toksičnosti za reprodukcijo in razvoj ne kažejo posebnega tveganja za človeka.
Thrombocytopenia (10, 12%)
Trombocitopenija (10; 12 %)
It is not known if Waylivra passes into breast milk.
Ni znano, ali se zdravilo Waylivra izloča v materino mleko.
Table 2 presents the adverse reactions from the Phase 3 studies in patients with FCS in receiving volanesorsen subcutaneously.
V preglednici 2 so predstavljeni neželeni učinki iz študij 3. faze pri bolnikih s sindromom FCS, ki so subkutano prejemali volanesorsen.
Remove Needle
Odstranite iglo
Remove the needle from the injection site by pulling out at the same angle it was inserted (Figure M).
Iglo odstranite iz mesta injiciranja tako, da jo izvlečete pod enakim kotom, kot je bila vstavljena (slika M).
No data are available in patients with severe renal impairment.
Pri bolnikih s hudo okvaro ledvic podatki niso na voljo.
Starting dose: Weekly After 3 months: Every 2 weeks
Po treh mesecih: vsaka dva tedna
At study entry, 55% of patients were on lipid lowering therapies (48% on fibrates, 29% on fish oils, 20% HMG-CoA reductase inhibitors), 27% were on pain medications, 20% were on platelet aggregation inhibitors, and 14% were on nutritional supplements.
Ob vstopu v študijo je 55 % bolnikov jemalo zdravila za zniževanje lipidov (48 % jih je prejemalo fibrate, 29 % ribja olja, 20 % zaviralce HMG-CoA reduktaze), 27 % jih je jemalo protibolečinska zdravila, 20 % jih je jemalo zaviralce agregacije trombocitov, 14 % pa jih je jemalo prehranska dopolnila.
Get ready to inject 1.
Pripravite se za injiciranje
Use each pre-filled syringe only once and then place in a sharps disposal container for disposal according to community guidelines.
Vsako napolnjeno injekcijsko brizgo uporabite samo enkrat, nato pa jo skladno s smernicami zavrzite v vsebnik za ostre odpadke.
Check the expiry date on the carton.
Preverite rok uporabe na škatli.
In non-clinical studies, levels of volanesorsen in milk were very low in lactating mice.
V nekliničnih študijah so bile ravni volanesorsena v mleku doječih miši zelo nizke.
If administering an injection to someone else as a caregiver, in addition to the above sites:
Če dajete injekcijo komu drugemu kot negovalec,
Do not use this medicine if the solution is cloudy or contains particles; it should be clear and colourless to slightly yellow.
Če je raztopina motna ali vsebuje delce, tega zdravila ne uporabljajte; biti mora bistra in brezbarvna do rahlo rumena.
b The denominator for percentage calculation was the total number of patients in FAS with baseline fasting triglyceride ≥ 750 mg/dL (or 8.5 mmol/L) in each treatment group.
b Imenovalec za odstotni izračun je bilo skupno število bolnikov v FAS, ki so imeli v vsaki skupini zdravljenja začetne trigliceride na tešče ≥ 750 mg/dl (ali 8,5 mmol/l).
Waylivra led to a statistically significant reduction in triglyceride levels as compared to placebo at the primary efficacy endpoint, defined as percent change from baseline to Month 3 in fasting triglycerides, in addition to a lower incidence of pancreatitis over the 52-week treatment period in a post-hoc analysis (Table 4).
Ob uporabi zdravila Waylivra se je v primerjavi s placebom raven trigliceridov statistično pomembno zmanjšala do primarnega izida učinkovitosti, opredeljenega kot odstotna sprememba ravni trigliceridov na tešče od izhodišča do 3. meseca, prav tako pa se je v 52-tedenskem obdobju zdravljenja v analizi post hoc zmanjšala incidenca pankreatitisa (preglednica 4).
Both volanesorsen and shorter oligonucleotide metabolites (predominantly 7-mer metabolites (generated either from 3′-deletions or 5′-deletions))
V človeškem urinu so bili ugotovljeni volanesorsen in krajši oligonukleotidni presnovki (predvsem 7-merni presnovki (nastali z delecijami 3′ ali 5′)).
During this 6 week period, this medicine can be stored at either room temperature or put back in the refrigerator.
V tem času šestih tednov se to zdravilo lahko hrani bodisi pri sobni temperaturi bodisi v hladilniku.
This medicinal product can be removed from refrigeration and stored, in the original carton, at room temperature (below 30 °C) for up to 6 weeks.
To zdravilo se lahko vzame iz hladilnika in hrani v originalni škatli pri sobni temperaturi (pod 30 °C) do šest tednov.
Patients should be instructed to report to their physician immediately if they experience any signs of bleeding, which can include petechiae, spontaneous bruising, subconjunctival bleeding, or other unusual bleeding (including nosebleeds, bleeding from gums, stools, or unusually heavy menstrual bleeding), neck stiffness, atypical severe headache, or any prolonged bleeding.
Bolnikom je treba naročiti, naj nemudoma obvestijo svojega zdravnika, če se pri njih pojavijo kakršni koli znaki krvavitve, vključno s petehijami, spontanimi podplutbami, subkonjunktivalnimi krvavitvami ali drugimi neobičajnimi krvavitvami (vključno s krvavitvami iz nosu, krvavitvami iz dlesni, krvjo v blatu in nenavadno močnimi menstruacijskimi krvavitvami), tog vrat, atipičen hud glavobol ali kakršna koli dolgotrajna krvavitev.
No clinical drug interaction studies have been conducted.
Kliničnih študij medsebojnega delovanja z drugimi zdravili niso izvedli.
Waylivra is very commonly associated with reductions in platelet count in patients with FCS, which may result in thrombocytopenia (see section 4.8).
Trombocitopenija Zdravilo Waylivra je pri bolnikih s sindromom FCS zelo pogosto povezano z zmanjšanjem števila trombocitov, ki lahko povzroči trombocitopenijo (glejte poglavje 4.8).