FrancophonIA/ELRC3.0 huggingface dataset:
English: Plegridy is interferon beta-1a conjugated to a single, linear 20 kDa methoxy poly(ethyleneglycol) molecule at the alpha-amino group of the N-terminal amino acid residue.
Croatian: Plegridy je interferon beta-1a konjugiran s jednom, linearnom molekulom metoksipoli(etilenglikola) od 20 kDa na alfa-amino skupini N-terminalnog kraja aminokiseline.
English: Hepatic function
Croatian: Jetrena funkcija
English: • For the Initiation Pack injections, you can use the record table printed on the inside of the lid of the Initiation Pack.
Croatian: • Za injekcije iz pakiranja za početak liječenja možete koristiti tablicu za bilježenje koja je otisnuta na unutarnjem dijelu poklopca pakiranja za početak liječenja.
English: Supplies needed for your Plegridy Pen injection:
Croatian: Pribor potreban za injekciju pomoću brizgalice Plegridy:
English: - Blood clots in the small blood vessels may occur during your treatment.
Croatian: - Tijekom liječenja mogu se pojaviti krvni ugrušci u malim krvnim žilama.
English: Plegridy 125 micrograms every 2 weeks
Croatian: Plegridy 125 mikrograma svaka 2 tjedna
English: The recommended dose of Plegridy is 125 micrograms injected subcutaneously every 2 weeks (14 days).
Croatian: Preporučena doza Plegridyja je 125 mikrograma primijenjeno supkutanom injekcijom svaka 2 tjedna (14 dana).
English: c. Let your injection site dry on its own before injecting your dose.
Croatian: c. Pustite da se mjesto za injekciju samo osuši prije ubrizgavanja doze.
English: • Let the Plegridy pre-filled syringe warm to room temperature for at least 30 minutes.
Croatian: • Ostavite napunjenu štrcaljku Plegridyja najmanje 30 minuta na sobnoj temperaturi da se zagrije.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACK OUTER CARTON Pre-filled pen 125 mcg Multipack (with bluebox)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA VIŠESTRUKOG PAKIRANJA Višestruko pakiranje napunjene brizgalice od 125 μg (s plavim okvirom)
English: Do not use external heat sources such as hot water to warm the Plegridy pre-filled syringe.
Croatian: Nemojte koristiti vanjske izvore topline poput vruće vode kako biste zagrijali napunjenu štrcaljku Plegridyja.
English: How to Inject Plegridy
Croatian: Kako ubrizgati Plegridy
English: • If needed, Plegridy may be stored in the closed original carton without refrigeration up to 25°C for up to 30 days.
Croatian: • Po potrebi se Plegridy može čuvati u zatvorenoj originalnoj kutiji izvan hladnjaka na temperaturi do 25°C najdulje 30 dana.
English: Full dose injection: 125 micrograms, choose grey syringe
Croatian: Injekcija pune doze: 125 mikrograma, izaberite sivu štrcaljku
English: Neopterin concentrations return to baseline after the two week dosing interval.
Croatian: Koncentracije neopterina se vraćaju na početno stanje nakon 2-tjednog intervala doziranja.
English: *The active substance, peginterferon beta-1a, is a covalent conjugate of interferon beta-1a, produced in Chinese Hamster Ovary cells, with 20,000 Dalton (20 kDa) methoxy poly(ethyleneglycol) using an O-2-methylpropionaldehyde linker.
Croatian: *Djelatna tvar, peginterferon beta-1a, kovalentni je konjugat interferona beta-1a proizvedenog u stanicama jajnika kineskog hrčka, s metoksipolietilenglikolom od 20 000 Daltona (20 kDa) preko poveznika O-2-metilpropionaldehida.
English: Do not share your Plegridy pen.
Croatian: Nemojte dijeliti s drugima svoju brizgalicu Plegridy.
English: Do not remove the cap until you are ready to inject.
Croatian: Nemojte skidati kapicu prije nego što budete spremni dati injekciju.
English: Read the instructions in section 7 “Instructions for injecting Plegridy pre-filled syringe” at the end of this leaflet before you start using Plegridy.
Croatian: Pročitajte upute u dijelu 7 „Upute za ubrizgavanje Plegridyja u napunjenoj štrcaljki“ na kraju ove upute prije nego što počnete koristiti Plegridy.
English: Syringe label
Croatian: Oznaka štrcaljke
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.
Croatian: (na temelju izloženosti, AUC) većima od preporučene terapijske doze; nije bilo drugih učinka osim poznatih blagih farmakoloških odgovora rezus majmuna na interferon beta-1a opaženih poslije prve i druge tjedne doze.
English: Box of two or six 125 microgram pre-filled syringes (grey labelled syringes) in sealed plastic trays.
Croatian: Kutija s dvije ili šest napunjenih štrcaljki od 125 mikrograma (sivo označene štrcaljke) u zatvorenim plastičnim spremnicima.
English: • Keep Plegridy pre-filled syringe and all medicines out of reach of children.
Croatian: • Čuvajte štrcaljku Plegridyja i sve lijekove izvan dohvata djece.
English: Nephrotic syndrome, glomerulosclerosis
Croatian: Poremećaji bubrega i mokraćnog sustava nefrotski sindrom, glomerulonefritis rijetko
English: Consider the timing of your Plegridy injection.
Croatian: Vodite računa o tome kada ćete primijeniti injekciju Plegridyja.
English: Pulmonary arterial hypertension has been seen at various time points during treatment, including several years after starting treatment with interferon beta-products.
Croatian: Plućna arterijska hipertenzija uočena je u različitim vremenskim točkama tijekom liječenja, i do nekoliko godina nakon početka liječenja lijekovima koji sadrže interferon beta.
English: The active substance in Plegridy is peginterferon beta-1a.
Croatian: Djelatna tvar u Plegridyju je peginterferon beta-1a.
English: Plegridy binds to the type I interferon receptor on the surface of cells and elicits a cascade of intracellular events leading to the regulation of interferon-responsive gene expression.
Croatian: I na površini stanica, te izaziva slijed intracelularnih zbivanja vodeći do ekspresije gena koje regulira interferon.
English: Pre-Filled Syringe 125 mcg
Croatian: Napunjena brizgalica 125 μg
English: Box of two 125 microgram pre-filled pens (grey labelled pens) in a protective plastic tray.
Croatian: Kutija s dvije napunjene brizgalice od 125 mikrograma (sivo označene brizgalice) u zaštitnom plastičnom spremniku.
English: You need to inject Plegridy once every 2 weeks.
Croatian: Plegridy morate primijeniti jednom svaka 2 tjedna.
English: Regular thyroid function tests are recommended in patients with a history of thyroid dysfunction or as clinically indicated.
Croatian: Bolesnicima koji su prethodno imali disfunkciju štitnjače preporučuje se redovni test funkcije štitnjače ili kako je klinički indicirano.
English: - The 125 micrograms grey pens are provided in a pack containing either two or six pre-filled pens.
Croatian: - Sive brizgalice od 125 mikrograma nalaze se u pakiranju koje sadrži bilo dvije ili šest napunjenih brizgalica.
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.
Croatian: Incidencija potencijalno klinički značajnog pada broja limfocita (<0,5 x 109/l) (<1%), broja neutrofila (≤1,0 x 109/l) (<1%), i broja trombocita
English: Multipacks containing 6 (3 packs of 2) 125 microgram pre-filled pens (grey labelled pens).
Croatian: Višestruko pakiranje sadrži 6 (3 pakiranja od 2) napunjenih brizgalica od 125 mikrograma (sivo označene brizgalice).
English: 1 mL pre-filled syringe made of glass (Type I) with a bromobutyl rubber stopper and thermoplastic and polypropylene rigid needle shield, containing 0.5 mL of solution.
Croatian: Napunjena štrcaljka volumena 1 ml od stakla (tip I) s brombutilnim gumenim čepom i termoplastičnim i polipropilenskim krutim štitnikom igle, koja sadrži 0,5 ml otopine.
English: Sodium acetate trihydrate, acetic acid glacial, arginine hydrochloride, polysorbate 20, water for injections.
Croatian: POPIS POMOĆNIH TVARI Natrijev acetat trihidrat, acetatna kiselina ledena, argininklorid, polisorbat 20 i voda za injekcije.
English: How long to use Plegridy
Croatian: Kako dugo primjenjivati Plegridy
English: Do not rest the pen on the injection site until you are ready to inject.
Croatian: Nemojte naslanjati brizgalicu na mjesto za injekciju prije nego što budete spremni ubrizgati lijek.
English: The pharmacokinetics of peginterferon beta-1a has not been evaluated in patients with hepatic insufficiency.
Croatian: Farmakokinetika peginterferona beta-1a nije procijenjena u bolesnika koji imaju insuficijenciju jetre.
English: Do not use the pen if it has been dropped or is visibly damaged.
Croatian: Nemojte upotrijebiti brizgalicu ako je ispala ili ima vidljiva oštećenja.
English: Swelling around the face (lips, tongue or throat) Skin rashes or redness
Croatian: - otežano disanje - oticanje u području lica (usana, jezika ili grla) - osip ili crvenilo kože
English: If a refrigerator is not available, syringes can be left at room temperature (up to 25°C) for up to 30 days.
Croatian: Ako hladnjak nije dostupan, štrcaljke se može ostaviti na sobnoj temperaturi (do 25°C) do 30 dana.
English: - The 125 micrograms grey syringes are provided in a pack containing either two or six pre-filled syringes.
Croatian: - Sive štrcaljke od 125 mikrograma nalaze se u pakiranju koje sadrži bilo dvije ili šest napunjenih štrcaljki.
English: Patients exposed to Plegridy every 2 weeks showed statistically significant reductions compared to patients exposed to Plegridy every 4 weeks over 2 years in a post-hoc analysis for endpoints including ARR (24%, p=0.0209), the risk of relapse (24%, p=0.0212), the risk of disability progression with 24 week confirmation (36%, p=0.0459), and MRI endpoints (new/enlarging T2 60%, Gd+ 71%, and new T1 hypointense lesions 53%; p<0.0001 for all).
Croatian: Bolesnici izloženi Plegridyju svaka 2 tjedna pokazali su statistički značajna smanjenja u odnosu na bolesnike koji su bili izloženi Plegridyju svaka 4 tjedna tijekom 2 godine u post hoc analizi ishoda uključujući ARR (24%, p=0,0209), rizik od relapsa (24%, p=0,0212), rizik od progresije onesposobljenosti potvrđen u 24. tjednu (36%, p=0,0459), i MR ishode (nove/povećane
English: Caution - Do not recap the Plegridy pre-filled syringe.
Croatian: Oprez - Nemojte vraćati pokrov na napunjenu štrcaljku Plegridyja.
English: The syringe inside the pen is a 1 mL pre-filled syringe made of glass (Type I) with a bromobutyl rubber stopper and thermoplastic and polypropylene rigid needle shield, containing 0.5 mL of solution.
Croatian: Štrcaljka unutar brizgalice je napunjena štrcaljka volumena 1 ml od stakla (tip I) s brombutilnim gumenim čepom i termoplastičnim i polipropilenskim čvrstim štitnikom igle, koja sadrži 0,5 ml otopine.
English: Plegridy is an interferon beta-1a conjugated with a single, linear molecule of 20,000 Da methoxy poly(ethyleneglycol)-O-2-methylpropionaldehyde (20 kDa mPEG-O-2-methylpropionaldehyde) at a degree of substitution of 1 mole of polymer/mole of protein.
Croatian: Plegridy je interferon beta-1a konjugiran s jednom, linearnom molekulom metoksipoli(etilenglikol)-O-2-metilpropionaldehida od 20 000 Da (20 kDa mPEG-O-2-metilpropionaldehid) stupnja supstitucije od 1 mola polimera po molu proteina.
English: The serum half-life of peginterferon beta-1a is prolonged compared with non-pegylated interferon beta-1a.
Croatian: Poluvijek peginterferona beta-1a u serumu je produljen u usporedbi s nepegiliranim interferonom beta-1a.
English: 63 micrograms, choose orange syringe
Croatian: 63 mikrograma, odaberite narančastu štrcaljku
English: Full dose injection: 125 micrograms, choose grey pen
Croatian: Injekcija pune doze: 125 mikrograma, odaberite sivu brizgalicu
English: Influenza-like illness was experienced by 47% of patients receiving Plegridy 125 micrograms every 2 weeks and 13% of patients receiving placebo.
Croatian: Bolest nalik gripi razvilo je 47% bolesnika koji su primali 125 mikrograma Plegridyja svaka 2 tjedna i 13% bolesnika koji su dobivali placebo.
English: Across relapse and MRI endpoints Plegridy 125 micrograms every two weeks showed a numerically greater treatment effect over the Plegridy every four weeks dosing regimen at year 1.
Croatian: 125 mikrograma Plegridyja svaka dva tjedna pokazala je brojčano veći učinak liječenja nego Plegridy u režimu doziranja od svaka četiri tjedna nakon 1 godine.
English: Blue
Croatian: Plava
English: 1 Adverse reactions derived only during post marketing experience
Croatian: 1 Nuspojave zabilježene samo nakon stavljanja lijeka u promet.
English: Caution should be used and close monitoring considered when administering Plegridy to patients with severe hepatic impairment.
Croatian: Potreban je oprez i pomno praćenje kod primjene Plegridyja u bolesnika s teškim oštećenjem jetre.
English: Do not reuse your Plegridy pen.
Croatian: Nemojte ponovno upotrijebiti štrcaljku Plegridyja.
English: • Plegridy pre-filled syringe is for injecting the medicine under the skin only (subcutaneous)
Croatian: • Napunjena štrcaljka Plegridyja namijenjena je ubrizgavanju lijeka samo pod kožu (supkutano).
English: Alternate the sites you use for injections.
Croatian: Mijenjajte mjesta davanja injekcija.
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).
Croatian: Na temelju podataka iz ispitivanja za bolesnike s blagim, umjerenim i teškim oštećenjem bubrega te terminalnim bubrežnim zatajenjem nije potrebna prilagodba doze u bolesnika s oštećenjem bubrega (vidjeti dijelove 4.4 i 5.2).
English: Warnings and precautions Talk to your doctor if you have ever had:
Croatian: Upozorenja i mjere opreza Obratite se liječniku ako ste ikada imali: - depresiju ili probleme koji utječu na Vaše raspoloženje - misli o samoubojstvu
English: EXP If a refrigerator is not available, pens can be left at room temperature (up to 25°C) for up to 30 days.
Croatian: EXP Ako hladnjak nije dostupan, brizgalice se može ostaviti na sobnoj temperaturi (do 25°C) do 30 dana.
English: Plegridy has not been studied in patients with hepatic impairment (see section 4.4).
Croatian: Plegridy nije ispitivan u bolesnika s oštećenjem funkcije jetre (vidjeti dio 4.4).
English: Which dose
Croatian: Koju dozu
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Pre-Filled Syringe Double Lid Initiation Pack
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP Pakiranje za početak liječenja s napunjenim štrcaljkama i dvostrukim poklopcem
English: Close the pack and put back in the fridge after removing one pen.
Croatian: Nakon što ste izvadili jednu brizgalicu, zatvorite pakiranje i vratite ga u hladnjak.
English: numbness in the face, arms or legs - Acute or chronic pain, bladder and bowel problems, sexual problems and problems with vision - Difficulty thinking and concentrating, depression.
Croatian: - akutnu ili kroničnu bol, probleme s mjehurom i crijevima, seksualne probleme i poteškoće s vidom
English: Of a total of 1468 patients, 658 patients continued at least 4 years of treatment with Plegridy.
Croatian: njih 658 nastavilo je liječenje Plegridyjem najmanje 4 godine.
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji kože i potkožnog tkiva alopecija$
English: Hypersensitivity events were reported in 16% of patients treated with Plegridy 125 micrograms every 2 weeks and 14% of patients who received placebo.
Croatian: Slučajevi preosjetljivosti prijavljeni su u 16% bolesnika koji su primali 125 mikrograma Plegridyja svaka 2 tjedna i 14% bolesnika koji su dobivali placebo.
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).
Croatian: Općenito se preporučuje da bolesnik započinje liječenje s 1. dozom od 63 mikrograma (0. dan), zatim je poveća u 2. dozi na 94 mikrograma (14. dan), dosegnuvši 3. dozu kao punu dozu od
English: 5.3 Preclinical safety data
Croatian: 5.3 Neklinički podaci o sigurnosti primjene Toksičnost
English: In the ATTAIN extension study, long-term efficacy with Plegridy was maintained with continuous treatment up to 4 years as shown by clinical and MRI measures of MS disease activity.
Croatian: U nastavku ispitivanja ATTAIN, klinička i MR mjerenja aktivnosti multiple skleroze pokazala su da se dugoročna djelotvornost Plegridyja održala uz kontinuirano liječenje do 4 godine.
English: Sodium acetate trihydrate Acetic acid, glacial Arginine hydrochloride Polysorbate 20
Croatian: FARMACEUTSKI PODACI 6.1 Popis pomoćnih tvari natrijev acetat trihidrat acetatna kiselina, ledena argininklorid polisorbat 20
English: What Plegridy is used for
Croatian: Za što se koristi Plegridy
English: The ADRs are presented as MedDRA preferred terms under the MedDRA System Organ Class.
Croatian: Nuspojave su navedene prema MedDRA-inim preporučenim pojmovima i razvrstane po MedDRA klasifikaciji organskih sustava.
English: Pulmonary arterial hypertension┼
Croatian: plućna arterijska hipertenzija┼ nepoznato
English: Fertility and developmental studies in rhesus monkeys have been carried out with non-pegylated interferon beta-1a.
Croatian: Ispitivanja plodnosti i razvoja u rezus majmuna provedena su s nepegilirarnim interferonom beta-1a.
English: Flu-like symptoms are more common when you first start using Plegridy.
Croatian: Simptomi nalik gripi češći su na početku liječenja Plegridyjem.
English: - If you have trouble handling the syringe, ask your doctor or nurse who may be able to help.
Croatian: Ako imate problema pri rukovanju štrcaljkom, zatražite od svog liječnika ili medicinske sestre da Vam pomogne.
English: Solution for injection 2 pre-filled pens
Croatian: Otopina za injekciju 2 napunjene brizgalice
English: Plegridy 63 micrograms solution for injection in pre-filled syringe Plegridy 94 micrograms solution for injection in pre-filled syringe Plegridy 125 micrograms solution for injection in pre-filled syringe Plegridy 63 micrograms solution for injection in pre-filled pen Plegridy 94 micrograms solution for injection in pre-filled pen Plegridy 125 micrograms solution for injection in pre-filled pen
Croatian: Plegridy 63 mikrograma otopina za injekciju u napunjenoj štrcaljki Plegridy 94 mikrograma otopina za injekciju u napunjenoj štrcaljki Plegridy 125 mikrograma otopina za injekciju u napunjenoj štrcaljki Plegridy 63 mikrograma otopina za injekciju u napunjenoj brizgalici Plegridy 94 mikrograma otopina za injekciju u napunjenoj brizgalici Plegridy 125 mikrograma otopina za injekciju u napunjenoj brizgalici
English: 1 pre-filled syringe of 63 micrograms 1 pre-filled syringe of 94 micrograms
Croatian: 1 napunjena brizgalica od 63 mikrograma 1 napunjena brizgalica od 94 mikrograma
English: Quickly insert the needle straight into the skin fold until the needle is fully under the skin.
Croatian: Brzim potezom ubodite iglu ravno u nabor kože tako da igla cijela uđe pod kožu (pogledajte sliku H).
English: (uncommon - may affect up to 1 in 100 people) If you get any of these:
Croatian: - Ozbiljne alergijske reakcije (manje često - mogu se pojaviti u manje od 1 na 100 osoba) Ako vam se pojavi bilo što od sljedećeg:
English: Cases of nephrotic syndrome with different underlying nephropathies including collapsing focal segmental glomerulosclerosis (FSGS), minimal change disease (MCD), membranoproliferative glomerulonephritis (MPGN) and membranous glomerulopathy (MGN) have been reported during treatment with interferon-beta products.
Croatian: Slučajevi nefrotskog sindroma s različitim nefropatijama u podlozi, uključujući kolapsnu fokalnu segmentalnu glomerulosklerozu (FSGS), bolest minimalnih promjena (engl. minimal change disease,
English: Grey
Croatian: Siva
English: Plegridy pre-filled syringe must not be used if the liquid is coloured, cloudy, or contains floating particles.
Croatian: Plegridy u napunjenoj štrcaljki ne smije se koristiti ako je tekućina obojena, zamućena ili ako sadrži plutajuće čestice.
English: If you get any of these symptoms: - Any break in the skin together with swelling, inflammation or fluid leaking around the injection site
Croatian: - bilo kakvo oštećenje kože popraćeno oteklinom, upalom ili curenjem tekućine oko mjesta injekcije
English: - Feeling off-balance or light headed, walking problems, stiffness and muscle spasms, tiredness,
Croatian: Simptomi mogu uključiti: - osjećaj neravnoteže ili ošamućenosti, probleme s hodanjem, ukočenost i grčeve mišića, umor,
English: Do not pull back on the plunger.
Croatian: Nemojte vraćati kapicu na brizgalicu.
English: Pack sizes: - The Plegridy Initiation Pack contains one orange pre-filled syringe of 63 micrograms and one blue pre-filled syringe of 94 micrograms.
Croatian: Veličine pakiranja: - Plegridy pakiranje za početak liječenja sadrži jednu narančastu napunjenu brizgalicu od 63 mikrograma i jednu plavu napunjenu brizgalicu od 94 mikrograma.
English: Dose 1
Croatian: 1. doza
English: The majority of enzyme elevations were <3 times the upper limit of normal (ULN).
Croatian: Većina povišenih razina enzima su bile <3 puta gornje granice normale (GGN) Povišenje alanin aminotransferaze i aspartat aminotransferaze (>5 puta GGN), zabilježeno je u 1% i u
English: Plegridy pre-filled pen must not be used if the liquid is coloured, cloudy, or contains floating particles.
Croatian: Plegridy u napunjenoj brizgalici ne smije se koristiti ako je tekućina obojena, zamućena ili ako sadrži plutajuće čestice.
English: • Plegridy pre-filled syringe is for subcutaneous injection (injection into skin).
Croatian: • Napunjena štrcaljka Plegridyja namijenjena je za davanje potkožne injekcije (supkutane injekcije).
English: Treatment with Plegridy should not be restarted (see section
Croatian: Terapiju Plegridyjem ne smije se ponovno započeti (vidjeti dio 4.8).
English: Thrombotic microangiopathy including thrombotic thrombocytopenic purpura/haemolytic uraemic syndrome*
Croatian: Poremećaji krvi i limfnog sustava tromobocitopenija manje često trombotička mikroangiopatija uključujući trombotičku trombocitopeničnu purpuru/hemolitičko-uremijski sindrom*
English: When you are ready to inject, carefully follow the instructions in section 7 “Instructions for injecting Plegridy pre-filled syringe”, at the end of this leaflet.
Croatian: Kada ste spremni za ubrizgavanje, pažljivo slijedite upute u dijelu 7 “Upute za ubrizgavanje Plegridyja u napunjenoj štrcaljki”, na kraju ove upute o lijeku.
English: Events were reported at various time points during treatment and may occur several weeks to several years after starting treatment with interferon beta.
Croatian: Događaji su zabilježeni u različitim vremenima tijekom liječenja, a mogu se pojaviti nekoliko tjedana do nekoliko godina nakon početka liječenja interferonom beta.
English: In post marketing experience, serious hypersensitivity events including cases of anaphylaxis (frequency not known) have been reported following Plegridy administration.
Croatian: U razdoblju nakon stavljanja lijeka u promet zabilježeni su ozbiljni slučajevi preosjetljivosti nakon primjene Plegridyja, uključujući anafilaksiju (nepoznate učestalosti).
English: Initiation Pack.
Croatian: iz pakiranja.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Pre-Filled Syringe Double Lid 125 mcg
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP Pakiranje s napunjenom štrcaljkom od 125 μg i dvostrukim poklopcem
English: Whether to discontinue therapy following a single site of necrosis is dependent on the extent of necrosis (see section 4.8).
Croatian: ovisi o opsegu nekroze (vidjeti dio 4.8).
English: Table on the inner lid Injection Record Day 0 (63 micrograms) Day 14 (94 micrograms) Date
Croatian: 0. dan (63 mikrograma) 14. dan (94 mikrograma) Datum
English: P-value p≤0.0001
Croatian: P-vrijednost p≤0,0001
English: It is not known whether peginferferon beta-1a is secreted in human milk.
Croatian: Nije poznato izlučuje li se peginterferon beta-1a u majčino mlijeko.