FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients should be monitored for signs of hepatic injury and caution exercised when interferons are used concomitantly with other medicinal products associated with hepatic injury (see sections 4.8 and 5.2).
Slovenian: Bolnike morate spremljati, da ugotovite morebitne znake poškodbe jeter, če se interferoni uporabljajo sočasno z drugimi zdravili, povezanimi s poškodbami jeter (glejte poglavji 4.8 in 5.2).
English: - Blood clots in the small blood vessels may occur during your treatment.
Slovenian: - Med zdravljenjem se lahko pojavijo krvni strdki v majhnih krvnih žilah.
English: Symptoms may include increased bruising, bleeding, fever, extreme weakness, headache, dizziness or light-headedness.
Slovenian: Simptomi lahko vključujejo pogostejše modrice, krvavitve, zvišano telesno temperaturo, izjemno šibkost, glavobol, omotico ali vrtoglavico.
English: The table summarizes ADRs (incidence above placebo and with a reasonable possibility of causality) from 512 patients treated with Plegridy 125 micrograms subcutaneously every 2 weeks and 500 patients who received placebo for up to 48 weeks and post-marketing data.
Slovenian: V preglednici so povzeti neželeni učinki (incidenca večja kot pri placebu in z razumno možnostjo vzročne povezave) za 512 bolnikov, zdravljenih z zdravilom Plegridy 125 mikrogramov subkutano vsaka 2 tedna, in za 500 bolnikov, ki so placebo prejemali do 48 tednov, in podatki med trženjem zdravila.
English: Peginterferon beta-1a is a modified long-acting form of interferon.
Slovenian: Peginterferon beta-1a je modificirana dolgodelujoča oblika interferona.
English: How long to use Plegridy
Slovenian: Kako dolgo uporabljati zdravilo Plegridy
English: Patients may develop antibodies to Plegridy.
Slovenian: Imunogenost Pri bolnikih se lahko razvijejo protitelesa proti zdravilu Plegridy.
English: Patients should be monitored for symptoms or signs of decreased peripheral blood counts (see section
Slovenian: Bolnike je treba opazovati za pojav simptomov ali znakov zmanjšanja perifernih krvnih vrednosti (glejte poglavje 4.8).
English: Do not use your syringe if it has been dropped or is visibly damaged.
Slovenian: Ne uporabite injekcijske brizge, če je padla ali je vidno poškodovana.
English: These blood tests will be in addition to the tests which are normally done to monitor your MS. - The functioning of your thyroid gland will be checked regularly or whenever thought necessary by your doctor for other reasons.
Slovenian: Preiskave bodo opravljene poleg testov, ki so opravljene za spremljanje vaše MS. - Delovanje vaše ščitnice bo redno kontrolirano ali kadar bo zdravnik mislil, da je to potrebno zaradi drugih razlogov.
English: These blood tests will be in addition to the tests which are normally done to monitor your MS. - The functioning of your thyroid gland will be checked regularly or whenever thought necessary by your doctor.
Slovenian: Preiskave bodo opravljene poleg testov, ki so opravljene za spremljanje vaše MS. - Delovanje vaše ščitnice bo redno kontrolirano ali kadar bo zdravnik mislil, da je to potrebno.
English: Subgroups of patients with higher disease activity were defined by relapse and MRI criteria as reported below, with the following efficacy results:
Slovenian: Podskupine bolnikov z večjo aktivnostjo bolezni so bile opredeljene po naslednjih kriterijih recidiva in MRS
English: Upon repeated dosing with peginterferon beta-1a of sexually mature female monkeys, effects on menstrual cycle length and progesterone levels were observed.
Slovenian: Po ponavljajočem se odmerjanju peginterferona beta-1a spolno zrelim opičjim samicam so opazili učinke na dolžino menstrualnega cikla in ravni progesterona.
English: • Gently pinch the skin around the cleaned injection site using thumb and forefinger to create a slight bulge (See Figure G).
Slovenian: • Kožo okoli očiščenega mesta injiciranja nežno stisnite s palcem in kazalcem, da bo nastala rahla guba (glejte sliko G).
English: Lesion mean ratio (95% CI)
Slovenian: povprečno razmerje lezij (95 % IZ)
English: Injection site reactions (e.g. injection site erythema, pain, pruritus, or oedema) were reported by 66% of patients who received Plegridy 125 micrograms every 2 weeks compared to 11% of patients receiving placebo.
Slovenian: O reakcijah na mestu injiciranja (npr. eritem na mestu injiciranja, bolečina, pruritus ali edem) so poročali pri 66 % bolnikov, ki so prejemali zdravilo Plegridy 125 mikrogramov vsaka 2 tedna, v primerjavi z 11 %
English: This can help to reduce the number of relapses that you have and slow down the disabling effects of MS.
Slovenian: To lahko pomaga pri zmanjšanju števila recidivov, ki jih imate, in upočasnitvi onesposabljajočih učinkov MS. Zdravljenje z zdravilom Plegridy lahko pomaga preprečiti poslabšanje MS,
English: 1 Adverse reactions derived only during post marketing experience
Slovenian: 1Neželeni učinki, ki so jih opazili samo med trženjem zdravila.
English: Early clinical features include thrombocytopenia, new onset hypertension, fever, central nervous system symptoms (e.g. confusion, paresis) and impaired renal function.
Slovenian: Zgodnje klinične značilnosti vključujejo trombocitopenijo, nov pojav hipertenzije, zvišano telesno temperaturo, simptome osrednjega živčevja (npr. zmedenost, pareza) in okvarjeno delovanje ledvic.
English: Laboratory findings suggestive of TMA include decreased platelet counts, increased serum lactate dehydrogenase (LDH) due to haemolysis and schistocytes (erythrocyte fragmentation) on a blood film.
Slovenian: Laboratorijski izsledki, ki kažejo na TMA, vključujejo zmanjšano število trombocitov, povečano laktat-dehidrogenazo (LDH) v serumu zaradi hemolize in shistocite (fragmente eritrocitov) na krvnem razmazu.
English: • If you see blood at your injection site, wipe it off with the gauze pad and apply an adhesive bandage or plaster
Slovenian: • Če na mestu injiciranja opazite kri, jo obrišite z blazinico iz gaze in mesto injiciranja prekrijte s samolepilnim povojem ali obližem.
English: Elevations in hepatic enzymes have been observed with the use of Plegridy.
Slovenian: Povišanje jetrnih encimov so opazili pri uporabi zdravila Plegridy.
English: Increased concentrations of neopterin were observed in both healthy subjects and multiple sclerosis patients treated with Plegridy, with a sustained and prolonged elevation over 10 days compared to 5 days observed for non-pegylated interferon beta-1a.
Slovenian: Povišane koncentracije neopterina so opazili pri zdravih osebah in bolnikih z multiplo sklerozo, zdravljenih z zdravilom Plegridy, z ohranjenim in podaljšanim 10-dnevnim zvišanjem v primerjavi s 5 dnevi za nepegilirani interferon beta-1a.
English: Step 8: Check to make sure you received your full dose of Plegridy (see Figure J)
Slovenian: 8. korak: Prepričajte se, da ste prejeli celoten odmerek zdravila Plegridy (glejte sliko J).
English: - If you are allergic to peginterferon beta-1a, interferon beta-1a or any of the ingredients of this medicine (listed in section 6).
Slovenian: - če ste alergični na peginterferon beta-1a, interferon beta-1a ali katero koli sestavino tega zdravila
English: If you remove the cap, do not recap the pen.
Slovenian: Če pokrov odstranite, ga ne smete ponovno natakniti.
English: These will be performed before you start using Plegridy, regularly after treatment with Plegridy has been initiated and then periodically during treatment, even if you have no particular symptoms.
Slovenian: Plegridy, redno po začetku zdravljenja z zdravilom Plegridy in nato občasno med zdravljenjem, tudi ob odsotnosti posebnih simptomov.
English: The incidence of potentially clinically significant decreases in lymphocyte counts (<0.5 x 109/L) (<1%), neutrophil counts (≤1.0 x 109/L) (<1%) and platelet counts (≤100 x 109/L) (≤1%) was similar in Plegridy-treated patients compared to placebotreated patients.
Slovenian: Incidenca potencialno klinično pomembnega zmanjšanja števila limfocitov (< 0,5 x 109/l) (< 1 %), števila nevtrofilcev (≤ 1,0 x 109/l) (< 1 %) in števila trombocitov (≤ 100 x 109/l) (≤ 1 %) je bila pri bolnikih, zdravljenih z zdravilom Plegridy,
English: Subcutaneous peginterferon beta-1a resulted in approximately 4-, 9-, and 13-fold higher exposure (AUC168h) values and approximately 2-, 3.5- and 5-fold higher Cmax, following single doses of 63 (6 MIU), 125 (12 MIU), and 188 (18 MIU) micrograms respectively, compared to intramuscular administration of 30 (6 MIU) micrograms non-pegylated beta-1a.
Slovenian: Subkutano dajanje peginterferona beta-1a je povzročilo za približno 4-, 9- in 13-krat večje vrednosti izpostavljenosti (AUC168h) in za približno 2-, 3,5- in 5-krat večjo vrednost Cmax po uporabi enkratnega odmerka 63 (6 milijonov i.e.), 125 (12 milijonov i.e.) oz. 188 (18 milijonov i.e.) mikrogramov, v primerjavi z intramuskularnim dajanjem 30 (6 milijonov i.e.) mikrogramov nepegiliranega beta-1a.
English: You should see green ticks.
Slovenian: Morali bi videti zelene proge.
English: Patients with myelosuppression may require more intensive monitoring of complete blood cell counts, with differential and platelet counts.
Slovenian: Za bolnike z mielosupresijo je včasih potrebno intenzivnejše spremljanje celotne krvne slike z diferencialno krvno sliko in številom trombocitov.
English: It is important to continue using Plegridy regularly.
Slovenian: Plegridy uporabljate redno.
English: • Each pen can be used once only.
Slovenian: • Vsak injekcijski peresnik smete uporabiti samo enkrat.
English: The most commonly reported adverse reaction leading to discontinuation in patients treated with Plegridy 125 micrograms subcutaneously every 2 weeks was influenza-like illness (<1%).
Slovenian: Neželeni učinek zdravila, za katerega so najpogosteje poročali, da je povzročil prekinitev zdravljenja bolnikov, zdravljenih z zdravilom Plegridy 125 mikrogramov subkutano vsaka 2 tedna, je bila gripi podobna bolezen (< 1 %).
English: Accordingly, the half-life (t1/2) of peginterferon beta-1a is approximately 2-fold longer than non-pegylated interferon beta-1a in healthy volunteers.
Slovenian: Ustrezno je razpolovni čas (t1/2) peginterferona beta-1a približno 2-krat daljši kot za nepegilirani interferon beta-1a pri zdravih prostovoljcih.
English: Note: After the pen has been removed from the injection site, the needle cover will lock to protect against needle injury.
Slovenian: Opomba: Ko injekcijski peresnik odstranite z mesta injiciranja, se bo varovalo igle zaklenilo, da se ne zbodete z iglo.
English: - Epilepsy or other seizure disorders, not controlled by medicine - Heart problems, which can cause symptoms such as chest pain (angina), particularly after any activity; swollen ankles, shortness of breath (congestive heart failure); or an irregular heartbeat (arrhythmia).
Slovenian: - težave s srcem, ki lahko povzročijo simptome, kot so bolečine v prsih (angina pektoris), še zlasti po kakšni aktivnosti; otekle gležnje, zasoplost (kongestivno srčno popuščanje), nepravilen srčni ritem
English: Do not share your Plegridy pre-filled syringe with anyone else to avoid giving an infection to them or getting an infection from them.
Slovenian: Ne delite svoje napolnjene injekcijske brizge zdravila Plegridy z nikomer drugim, da preprečite prenos okužbe s sebe na druge ali z drugih nase.
English: Day 0 (63 micrograms)
Slovenian: Katero pakiranje dan 0 (63 mikrogramov)
English: Following repeated subcutaneous administration of peginterferon beta-1a in rhesus monkeys at doses up to 400-fold (based on exposure, AUC) the recommended therapeutic dose; no effects other than the known mild pharmacological responses by rhesus monkeys to interferon beta-1a were observed after the first and second weekly dose.
Slovenian: Po ponavljajočem se subkutanem dajanju peginterferona beta-1a opicam Rhesus pri odmerkih, ki so bili do 400-krat (na podlagi izpostavljenosti, AUC) višji od priporočenega terapevtskega odmerka, niso po prvem in drugem tedenskem odmerku opazili drugih učinkov, kot znanih blagih farmakoloških odzivov opic Rhesus.
English: Efficacy of Plegridy has been demonstrated over placebo.
Slovenian: Pokazali so, da je zdravilo Plegridy bolj učinkovito od placeba.
English: Try to use Plegridy at the same time on the same day, every time you inject.
Slovenian: Zdravilo Plegridy si poskušajte vsakič injicirati ob istem času dneva.
English: It is generally recommended that patients start treatment with 63 micrograms at dose 1 (on day 0), increasing to 94 micrograms at dose 2 (on day 14), reaching the full dose of 125 micrograms by dose 3 (on day 28) and continuing with the full dose (125 micrograms) every 2 weeks (14 days) thereafter (see Table 1).
Slovenian: Na splošno se priporoča, da se bolniki začnejo zdraviti s 63 mikrogrami v 1. odmerku (na dan 0), 2. odmerek povečajo na 94 mikrogramov (na 14. dan) in s 3. odmerkom dosežejo polni odmerek 125 mikrogramov (na
English: Peginterferon beta-1a was not mutagenic when tested in an in vitro bacterial reverse mutation (Ames) test and was not clastogenic in an in vitro assay in human lymphocytes.
Slovenian: Peginterferon beta-1a v preskusu bakterijske reverzne mutacije in vitro (Amesov test) ni bil mutagen; prav tako ni bil klastogen v preskusu in vitro s človeškimi limfociti.
English: If Plegridy is at room temperature for a total of 30 days, it should be used or discarded.
Slovenian: Zdravilo Plegridy, ki je bilo pri sobni temperaturi skupaj več kot 30 dni, je treba uporabiti ali zavreči.
English: In multiple sclerosis patients, the t1/2 (mean±SE) of peginterferon beta-1a was 78 ± 15 hours at steady state.
Slovenian: Pri bolnikih z multiplo sklerozo je bilo t1/2 (povprečje ± SN) peginterferona beta-1a 78 ± 15 ur v stanju dinamičnega ravnovesja.
English: Plegridy is for subcutaneous use.
Slovenian: Zdravilo Plegridy se uporablja subkutano.
English: Do not share the pen with anyone else to avoid giving an infection to them or getting an infection from them.
Slovenian: Ne delite injekcijskega peresnika z nikomer drugim, da preprečite prenos okužbe s sebe na druge ali z drugih nase.
English: • Plegridy can be removed from and returned to the refrigerator if necessary.
Slovenian: • Po potrebi lahko zdravilo Plegridy vzamete iz hladilnika in ga nato vrnete vanj.
English: - If you are unsure of the number of days you have kept a pen out of the fridge, throw the pen away.
Slovenian: - Če niste prepričani, koliko dni ste peresnik hranili zunaj hladilnika, peresnik zavrzite.
English: A definitive mechanism of action of peginterferon beta-1a in multiple sclerosis (MS) is not known.
Slovenian: Mehanizem delovanja Mehanizem delovanja peginterferona beta-1a pri multipli sklerozi (MS) ni povsem znan.
English: Two serious cases were reported in patients treated with Plegridy: one patient (<1%) experienced severe thrombocytopenia (platelet count <10 x 109/L), another patient (<1%) experienced severe neutropenia (neutrophil count <0.5 x 109/L).
Slovenian: Pri bolnikih, zdravljenih z zdravilom Plegridy, so poročali o dveh resnih primerih: en bolnik (< 1 %) je imel hudo trombocitopenijo (število trombocitov < 10 x 109/l), drugi bolnik (< 1 %) pa je imel hudo nevtropenijo (število nevtrofilcev < 0,5 x 109/l).
English: 1512 patients were randomised to and dosed with 125 micrograms Plegridy injected subcutaneously every 2 (n=512) or 4 (n=500) weeks versus placebo (n=500).
Slovenian: Randomiziranih je bilo 1.512 bolnikov, ki so prejemali odmerek 125 mikrogramov zdravila Plegridy, injiciranega subkutano vsaka 2 (n = 512) ali 4 (n = 500) tedne, v primerjavi s placebom (n = 500).
English: - Read and follow the advice given in the instructions in section 7 “Instructions for injecting
Slovenian: - Pred začetkom preberite in upoštevajte napotke v poglavju 7 »Navodila za injiciranje zdravila
English: c. Continue to hold the pen firmly down on your injection site until the clicking sounds have stopped (see Figure H).
Slovenian: c. Držite injekcijski peresnik trdno pritisnjen na mesto za injiciranje, dokler klikanje ne preneha (glejte sliko H).
English: Cessation of therapy with Plegridy should be considered (see section 4.8).
Slovenian: Treba je razmisliti o prekinitvi zdravljenja z zdravilom Plegridy (glejte poglavje 4.8).
English: What Plegridy looks like and contents of the pack
Slovenian: Izgled zdravila Plegridy in vsebina pakiranja
English: Record date and location
Slovenian: Zabeležite datum in lokacijo.
English: If a dose is missed, it should be administered as soon as possible.
Slovenian: Izpuščeni odmerek je treba dati takoj, ko je mogoče.
English: Frequency not known
Slovenian: (pogostnost neznana).
English: Of the patients who reported flu-like symptoms 90% reported them as mild or moderate in severity.
Slovenian: Pri 90 % bolnikov, ki so poročali o gripi podobnih simptomih, so bili ti blagi ali zmerni.
English: P-value p≤0.0001
Slovenian: vrednost p p ≤ 0,0001
English: In addition to those laboratory tests normally required for monitoring patients with multiple sclerosis, complete blood and differential blood cell counts, platelet counts, and blood chemistries, including liver function tests (e.g. aspartate aminotransferase (AST), alanine aminotransaminase (ALT)), are recommended prior to initiation and at regular intervals following introduction of Plegridy therapy and then periodically thereafter in the absence of clinical symptoms.
Slovenian: Poleg teh laboratorijskih testov, ki so običajno potrebni za spremljanje bolnikov z multiplo sklerozo, je priporočljivo pred uvedbo zdravljenja z zdravilom Plegridy, po uvedbi nato v rednih intervalih in kasneje občasno v odsotnosti kliničnih simptomov opravljati tudi pregled celotne krvne slike z diferencialno krvno sliko, številom trombocitov in biokemične krvne preiskave, vključno z jetrnimi testi (npr. aspartat-aminotransferaza (AST), alanin-aminotransaminaza (ALT)).
English: Do not use Plegridy pre-filled syringe past the expiry date.
Slovenian: Ne uporabite napolnjene injekcijske brizge zdravila Plegridy po datumu izteka roka uporabnosti.
English: • For the Initiation Pack injections, you can use the record table printed on the inside of the lid of the Initiation Pack.
Slovenian: • Za injiciranja zdravila iz začetnega pakiranja lahko uporabite preglednico za beleženje, ki je natisnjena na notranji strani pokrova začetnega pakiranja.
English: Do not remove the cap until you are ready to inject.
Slovenian: Ne snemite pokrova, dokler niste pripravljeni na injiciranje.
English: You could get a needle injury or the pen may lock.
Slovenian: Lahko bi se namreč zbodli z iglo ali zaklenili injekcijski peresnik.
English: Direct comparative data for Plegridy versus non-pegylated interferon beta or data on efficacy of Plegridy after switching from a non-pegylated interferon beta are not available.
Slovenian: Plegridy z nepegiliranim interferonom beta ali podatkov o učinkovitosti zdravila Plegridy po prehodu z nepegiliranega interferona beta ni na voljo.
English: Mean [Median] no. of new T1 hypointense lesions (range) % reduction vs placebo P-value p<0.0001
Slovenian: Povprečno [mediano] št. novih hipointenzivnih lezij T1 (razpon) % zmanjšanja v primerjavi s placebom vrednost p p < 0,0001
English: - If any of these effects trouble you, contact a doctor.
Slovenian: - Če opazite katerega od teh neželenih učinkov, se posvetujte z zdravnikom.
English: They gradually get less as you keep using your injections.
Slovenian: Sčasoma se ublažijo, z nadaljevanjem injiciranja zdravila.
English: No dosage adjustments are necessary in patients with renal impairment based on study data in mild, moderate, and severe renal impairment and end stage renal disease (see sections 4.4 and 5.2).
Slovenian: Ledvična okvara Na podlagi podatkov študije, izvedene pri bolnikih z blago, zmerno in hudo ledvično okvaro ter pri bolnikih s končno ledvično odpovedjo, pri bolnikih z ledvično okvaro prilagajanje odmerka ni potrebno (glejte poglavji 4.4 in 5.2).
English: What Plegridy is and what it is used for
Slovenian: Kaj je zdravilo Plegridy in za kaj ga uporabljamo
English: In the clinical study conducted, the development of antibodies against the PEG moiety of peginterferon beta-1a had no discernible impact on safety, or clinical efficacy (including annualised relapse rate, MRI lesions, and disability progression).
Slovenian: V opravljenih kliničnih študijah ni imel razvoj protiteles proti delu PEG v peginterferonu beta-1a nikakršnega opaznega učinka na varnost ali klinični učinek (vključno z letno stopnjo recidiva, lezijami na
English: The duration of this response was sustained and prolonged for Plegridy, with elevations detected up to 15 days compared to 4 days for non-pegylated interferon beta-1a.
Slovenian: Trajanje odziva se je z zdravilom Plegridy ohranilo in je bilo podaljšano s povišanji, odkritimi do 15 dni, v primerjavi s 4 dnevi za nepegilirani interferon beta-1a.
English: Plegridy has not been studied in patients with hepatic impairment (see section 4.4).
Slovenian: Zdravila Plegridy niso preučili pri bolnikih z jetrno okvaro (glejte poglavje 4.4).
English: Use caution when removing the needle cover to avoid getting a needle stick injury.
Slovenian: Pri odstranjevanju pokrova igle bodite previdni, da se ne zbodete z iglo.
English: Do not inject into an area of the body where the skin is irritated, tender, red, bruised, tattooed, infected, or scarred.
Slovenian: Ne injicirajte v dele telesa, kjer je koža razdražena, občutljiva, pordela, tetovirana, okužena, zabrazgotinjena ali so na njej modrice.
English: • Check the expiry date on the Plegridy pre-filled syringe (See Figure C).
Slovenian: • Preverite datum izteka roka uporabnosti na napolnjeni injekcijski brizgi zdravila Plegridy (glejte sliko C).
English: - Injection site damage
Slovenian: - Poškodba na mestu injiciranja
English: Do not use external heat sources such as hot water to warm the Plegridy pre-filled syringe.
Slovenian: Ne uporabljate zunanjih virov toplote, kot je na primer topla voda, da bi ogreli napolnjeno injekcijsko brizgo zdravila Plegridy.
English: The available information on the effects of interferon beta-1a in the peri- and postnatal periods is limited.
Slovenian: Razpoložljivih informacij o učinkih interferona beta-1a pri obdobju pred rojstvom in po njem je malo.
English: One injection of Plegridy 125 micrograms every 14 days (every two weeks).
Slovenian: Ena injekcija zdravila Plegridy 125 mikrogramov vsakih 14 dni (vsaka dva tedna).
English: Influenza-like illness was experienced by 47% of patients receiving Plegridy 125 micrograms every 2 weeks and 13% of patients receiving placebo.
Slovenian: Gripi podobna bolezen se je pojavila pri 47 % bolnikov, ki so prejemali zdravilo Plegridy 125 mikrogramov vsaka 2 tedna, in pri 13 % bolnikov, ki so dobivali placebo.
English: Do not use the pen if it has been dropped or is visibly damaged.
Slovenian: Ne uporabite injekcijskega peresnika, če je padel ali je vidno poškodovan.
English: Flu-like symptoms are more common when you first start using Plegridy.
Slovenian: Gripi podobni simptomi se pogosteje pojavijo na začetku uporabe zdravila Plegridy.
English: (common - may affect up to 1 in 10 people) If you: - Feel unusually sad, anxious or worthless or - Have thoughts about suicide
Slovenian: - Depresija (pogosti - pojavijo se lahko pri največ 1 od 10 bolnikov) Če: - ste neobičajno žalostni, tesnobni ali imate občutek ničvrednosti ali - če imate samomorilne misli,
English: Plegridy should be administered with caution to patients with a history of seizures, to those receiving treatment with anti-epileptics, particularly if their epilepsy is not adequately controlled with anti-epileptics (see section 4.8).
Slovenian: Bolnikom z epileptičnimi napadi v anamnezi ali tistim, ki se zdravijo z antiepileptiki, še zlasti, če epilepsija ni pod ustreznim nadzorom z antiepileptiki, je treba zdravilo Plegridy dajati previdno (glejte poglavje 4.8).
English: Decreases in white blood cell counts of <3.0 x 109/L were observed in 7% of patients receiving Plegridy and in 1% receiving placebo.
Slovenian: Zmanjšanje števila belih krvnih celic za < 3,0 x 109/l so opazili pri 7 % bolnikov, ki so prejemali zdravilo
English: Peginterferon beta-1a has not been tested for carcinogenicity in animals.
Slovenian: Peginterferon beta-1a ni bil testiran glede kancerogenosti pri živalih.