FrancophonIA/ELRC3.0 huggingface dataset:
English: Choose the correct syringe from a pack.
Slovenian: Iz pakiranja izberite pravo brizgo.
English: Read the instructions for use before you start using Plegridy and each time you get a refill of your prescription.
Slovenian: Kako injicirati zdravilo Plegridy Preden začnete uporabljati zdravilo Plegridy in vsakič, ko prevzamete nov recept, preberite navodilo za uporabo.
English: Plegridy is not to be used in children and adolescents below 18 years old.
Slovenian: Otroci in mladostniki, stari manj kot 18 let, zdravila Plegridy ne smejo uporabljati.
English: • The liquid is coloured, cloudy or contains floating particles.
Slovenian: • je tekočina obarvana, motna ali so v njej prisotni delci.
English: Day 14 (94 micrograms)
Slovenian: 94 mikrogramov).
English: Hypersensitivity events were reported in 16% of patients treated with Plegridy 125 micrograms every 2 weeks and 14% of patients who received placebo.
Slovenian: O preobčutljivostnih dogodkih so poročali pri 16 % bolnikov, zdravljenih z zdravilom Plegridy 125 mikrogramov vsaka 2 tedna, in pri 14 % bolnikov, ki so prejemali placebo.
English: Step 7: Inject medicine
Slovenian: 7. korak: Injicirajte zdravilo.
English: Throw away any Plegridy that is accidentally frozen.
Slovenian: Zdravilo Plegridy, ki je bilo pomotoma zamrznjeno, zavrzite.
English: Step 11: Check your injection site
Slovenian: 11. korak: Preglejte mesto injiciranja.
English: The incidence of cardiovascular events was similar between Plegridy (125 micrograms every 2 weeks) and placebo treatment groups (7% in each group).
Slovenian: Incidenca srčnožilnih dogodkov je bila v skupini z zdravilom Plegridy (125 mikrogramov vsaka 2 tedna) podobna, kot v skupini s placebom (7 % v vsaki skupini).
English: Solution for injection Multipack: 6 (3 packs of 2) pre-filled pens of 125 micrograms.
Slovenian: raztopina za injiciranje Skupno pakiranje: 6 (3 pakiranja z 2) napolnjenih injekcijskih peresnikov po 125 mikrogramov.
English: How to store Plegridy 6.
Slovenian: Kako uporabljati zdravilo Plegridy 4.
English: The pharmacokinetics of peginterferon beta-1a has not been evaluated in patients with hepatic insufficiency.
Slovenian: Farmakokinetike peginterferona beta-1a niso ocenili pri bolnikih z jetrno insuficienco.
English: The recommended dose of Plegridy is 125 micrograms injected subcutaneously every 2 weeks (14 days).
Slovenian: Priporočeni odmerek zdravila Plegridy je 125 mikrogramov, injiciranih subkutano vsaka 2 tedna (14 dni).
English: • 1 Plegridy Pen (see Figure A)
Slovenian: • 1 injekcijski peresnik zdravila Plegridy (glejte sliko A)
English: Step 8: Remove the pre-filled syringe from your injection site
Slovenian: 8. korak: Napolnjeno injekcijsko iglo odstranite z mesta injiciranja.
English: Both cases resolved following discontinuation of Plegridy.
Slovenian: V obeh primerih so zvišanja izzvenela po prekinitvi uporabe zdravila Plegridy.
English: Not Known
Slovenian: neznana
English: The other ingredients are: Sodium acetate trihydrate, acetic acid glacial, arginine hydrochloride, polysorbate 20 and water for injections (see Section 2 “Plegridy contains Sodium”).
Slovenian: Druge sestavine zdravila so: natrijev acetat trihidrat, koncentrirana ocetna kislina, argininijev klorid, polisorbat 20 in voda za injekcije (glejte poglavje 2 »Zdravilo Plegridy vsebuje natrij«).
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.
Slovenian: *Učinkovina, peginterferon beta-1a, je kovalentni konjugat interferona beta-1a, pridobljenega v ovarijskih celicah kitajskega hrčka, z 20.000 daltoni (20 kDa) metoksipolietilenglikola z veznim O-2-metilpropionaldehidom.
English: Plegridy can be stored at room temperature (up to 25°C) for up to 30 days as long as it is stored away from light.
Slovenian: Zdravilo Plegridy se lahko shranjuje pri sobni temperaturi (do 25 °C) do 30 dni, če je shranjeno zaščiteno pred svetlobo.
English: You need to inject Plegridy once every 2 weeks.
Slovenian: Zdravilo Plegridy si morate injicirati vsaka 2 tedna.
English: Do not take your Plegridy pre-filled syringe out of the injection site until you have pushed the plunger all the way down.
Slovenian: Ne izvlecite napolnjene injekcijske igle zdravila Plegridy iz mesta za injiciranje, preden ste bat potisnili povsem navzdol.
English: Plegridy pre-filled pen must not be used unless the green stripes are visible in the pen injection status window.
Slovenian: Zdravilo Plegridy napolnjen injekcijski peresnik se ne sme uporabiti, razen če so v okencu stanja injiciranja na napolnjenem injekcijskem peresniku Plegridy vidne zelene črte.
English: No data are available from clinical efficacy/safety studies directly comparing pegylated with non-pegylated interferon beta-1a, or from patients switching between non-pegylated and pegylated interferon.
Slovenian: Podatkov iz študij klinične učinkovitosti/varnosti, v katerih bi neposredno primerjali pegilirani interferon beta-1a z nepegiliranim, ali bolnike, ki so prešli z nepegiliranega na pegilirani interferon, ni na voljo.
English: Three simple ways to help reduce the impact of flu-like symptoms:
Slovenian: Vpliv gripi podobnih simptomov zmanjšate na tri preproste načine:
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.
Slovenian: Med opazovanima točkama recidiv in MRS je zdravilo Plegridy 125 mikrogramov z režimom odmerjanja vsaka dva tedna pri 1. letu pokazalo številčno večji učinek zdravljenja kot zdravilo Plegridy z režimom odmerjanja vsake štiri tedne.
English: Box of two or six 125 microgram pre-filled syringes (grey labelled syringes) in sealed plastic trays.
Slovenian: Škatla z dvema ali šestimi 125-mikrogramskimi napolnjenimi injekcijskimi brizgami (brizge s sivimi nalepkami) na zatesnjenih plastičnih pladnjih.
English: Sodium acetate trihydrate, acetic acid glacial, arginine hydrochloride, polysorbate 20, water for injections.
Slovenian: natrijev acetat trihidrat, koncentrirana ocetna kislina, argininijev klorid, polisorbat 20, voda za injekcije
English: Plegridy is to be injected under the skin (subcutaneous injection).
Slovenian: Samoinjiciranje zdravila Zdravilo Plegridy se injicira pod kožo (subkutano injiciranje).
English: Plegridy contains sodium
Slovenian: Zdravilo Plegridy vsebuje natrij
English: Laboratory abnormalities are associated with the use of interferons.
Slovenian: Z uporabo interferona so povezani abnormalni laboratorijski testi.
English: Of the patients who experienced injection site reactions 95% reported them as mild or moderate in severity.
Slovenian: Pri 95 % bolnikov, ki so imeli neželene učinke na mestu injiciranja, so bili ti blagi ali zmerni.
English: Pharmacodynamic responses were evaluated by measuring the induction of interferon-responsive genes including those encoding 2′,5′-oligoadenylate synthetase (2′,5′-OAS), myxovirus resistance protein A (MxA), and several chemokines and cytokines, as well as neopterin (D-erythro-1, 2, 3,trihydroxypropylpterin), a product of the interferon-inducible enzyme, GTP-cyclohydrolase I. Gene induction in healthy human subjects was greater in terms of peak level and exposure (area under the effect curve) for Plegridy compared to non-pegylated interferon beta-1a (IM) when both were given at the same dose by activity (6 MIU).
Slovenian: Farmakodinamične odzive so ocenili z merjenjem indukcije genov, ki se odzivajo na interferon, vključno s tistimi, ki kodirajo 2′,5′-oligoadenilat sintetazo (2′,5′-OAS), protein odpornosti na miksovirus A (MxA) in več kemokinov in citokinov, kot tudi neopterin (D-eritro-1, 2, 3,-trihidroksipropilpterin), produkt encima GTP-ciklohidrolaze I, ki ga inducira interferon.
English: rash or colour change - Changes in your blood which might cause tiredness or reduced ability to fight infection - Increases in liver enzymes in the blood (will show up in blood tests)
Slovenian: - spremembe okoli mesta injiciranja, kot so oteklina, vnetje, modrice, občutek toplote, izpuščaj ali spremenjena barva kože, - spremembe v krvi, ki lahko povzročijo utrujenost ali zmanjšano sposobnost premagati okužbe, - zvišanja jetrnih encimov v krvi, kar se bo pokazalo na rezultatih krvnih preiskav.
English: Full dose injection: 125 micrograms, choose grey syringe
Slovenian: Injekcija s polnim odmerkom: 125 mikrogramov, izberite sivi peresnik
English: • The pen is for use under the skin only (subcutaneous).
Slovenian: • Injekcijski peresnik je namenjen izključno za uporabo pod kožo (subkutano uporabo).
English: Injecting yourself
Slovenian: Po injiciranju
English: Consider the timing of your Plegridy injection.
Slovenian: Razmislite o času injiciranja zdravila Plegridy.
English: • Keep Plegridy pen and all medicines out of reach of children.
Slovenian: • Injekcijski peresnik zdravila Plegridy in vsa druga zdravila shranjujte nedosegljiva otrokom.
English: Do not use external heat sources, such as hot water, to warm your pen.
Slovenian: Ne uporabljate zunanjih virov toplote, kot je na primer topla voda, da bi ogreli injekcijski peresnik.
English: EXP If a refrigerator is not available, pens can be left at room temperature (up to 25°C) for up to 30 days.
Slovenian: EXP Če hladilnika ni na voljo, lahko peresnike do 30 dni shranjujete pri sobni temperaturi (do 25 °C).
English: Step 5: Firmly remove the needle cover
Slovenian: 5. korak: Trdno primite pokrov igle in ga snemite.
English: Plegridy is a clear and colourless solution for injection in a glass pre-filled syringe with an attached needle.
Slovenian: Zdravilo Plegridy je bistra in brezbarvna raztopina za injiciranje v stekleni napolnjeni injekcijski brizgi s pritrjeno iglo.
English: Thrombotic microangiopathy including thrombotic thrombocytopenic purpura/haemolytic uraemic syndrome*
Slovenian: Bolezni krvi in limfatičnega sistema trombocitopenija občasni trombotična mikroangiopatija vključno s trombotično trombocitopenično purpuro/hemolitičnim uremičnim sindromom*
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.
Slovenian: Zdravilo Plegridy je interferon beta-1a, konjugiran na eno, linearno 20 kDa molekulo metoksipolietilenglikola v alfa-amino skupini ostanka N-terminalne aminokisline.
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).
Slovenian: Pri bolnikih, ki so bili 2 leti izpostavljenih zdravilu Plegridy vsaka 2 tedna, je prišlo do statistično značilnih zmanjšanj v primerjavi z bolniki, ki so bili zdravilu Plegridy izpostavljeni vsake 4 tedne, kot je pokazala analiza post-hoc za opazovane dogodke, vključno z ARR (24 %, p = 0,0209), tveganjem za recidiv (24 %, p = 0,0212), tveganjem za napredovanje bolezni s potrditvijo v 24. tednu (36 %, p = 0,0459)
English: Solution for injection 2 pre-filled syringes 6 pre-filled syringes
Slovenian: raztopina za injiciranje 2 napolnjeni injekcijski brizgi 6 napolnjenih injekcijskih brizg
English: Do not use two injections to make up for a missed injection.
Slovenian: Ne uporabite dvojnega odmerka, če ste pozabili na prejšnjo injekcijo.
English: One patient treated with Plegridy in clinical trials experienced an injection site necrosis.
Slovenian: Pri enem bolniku, zdravljenem z zdravilom Plegridy, se je v kliničnih preskušanjih pojavila nekroza na mestu injiciranja.
English: Mean/Median disease duration (years) Mean number of relapses within the past 3 years 2.5 Mean EDSS score at baseline EDSS: Expanded Disability Status Scale Gd+: Gadolinium-enhancing
Slovenian: EDSS: Razširjena lestvica stopnje prizadetosti (Expanded Disability Status Scale) Gd+: vidno z gadolinijem
English: - Plegridy can be kept outside a fridge at room temperature (up to 25°C) for up to 30 days but it must be kept away from light.
Slovenian: - Zdravilo Plegridy lahko shranjujete zunaj hladilnika pri sobni temperaturi (do 25 °C) do 30 dni, vendar ga morate zaščititi pred svetlobo.
English: Injection site erythema was the most commonly reported injection site reaction.
Slovenian: Eritem na mestu injiciranja je bil neželeni učinek, o katerem so najpogosteje poročali kot neželeni učinek na mestu injiciranja.
English: - A low number of white blood cells or platelets, which can cause an increased risk of infection, or bleeding
Slovenian: (aritmija); - težave s ščitnico; - nizko število belih krvnih celic ali krvnih ploščic, kar lahko poveča tveganje za okužbo ali krvavitev.
English: Full dose injection: 125 micrograms, choose grey pen
Slovenian: Injekcija s polnim odmerkom: 125 mikrogramov, izberite sivo brizgo
English: The dose indicates the quantity of the interferon beta-1a moiety of peginterferon beta-1a without consideration of the PEG moiety attached.
Slovenian: Vrednost se nanaša na delež interferona beta-1a v molekuli peginterferona beta-1a, brez upoštevanja deleža polietilenglikola.
English: Mean [Median] no. of Gd-enhancing lesions (range) % reduction vs placebo P-value p<0.0001
Slovenian: Povprečno [mediano] št. lezij, vidnih z gadolinijem (razpon) % zmanjšanja v primerjavi s placebom vrednost p p < 0,0001
English: It is not known whether peginferferon beta-1a is secreted in human milk.
Slovenian: Ni znano, ali se peginferferon beta-1a izloča v materino mleko.
English: You should then contact your doctor, nurse or pharmacist.
Slovenian: tem primeru se obrnite na zdravnika, medicinsko sestro ali farmacevta.
English: (uncommon - may affect up to 1 in 100 people) If you get any of these:
Slovenian: (občasni - pojavijo se lahko pri največ 1 od 100 bolnikov) Če se pojavi kaj od naslednjega:
English: Plegridy should be administered with caution to patients with previous depressive disorders (see section 4.3).
Slovenian: Pri dajanju zdravila Plegridy bolnikom s predhodnimi depresivnimi motnjami je potrebna previdnost (glejte poglavje 4.3).
English: No serious cardiovascular events were reported in patients who received Plegridy in the ADVANCE study.
Slovenian: Pri bolnikih, ki so v študiji ADVANCE prejemali zdravilo Plegridy, niso poročali o resnih srčnožilnih dogodkih.
English: The mean steady state clearance of peginterferon beta-1a was 4.1 ± 0.4 L/hr.
Slovenian: Povprečni očistek peginterferona beta-1a v stanju dinamičnega ravnovesja je bil 4,1 ± 0,4 l/uro.
English: Subjects with end stage renal disease requiring 2-3 times haemodialysis weekly showed similar AUC and Cmax as compared to subjects with normal renal function.
Slovenian: Osebe s končno ledvično odpovedjo, pri katerih so bile potrebne 2 do 3 hemodialize na teden, so imele podobni vrednosti
English: 92% ≥9 T2 lesions baseline 16% EDSS ≥4
Slovenian: 38 % vsaj 1 z Gd+ vidno lezijo ob izhodišču 92 % ≥ 9 T2 lezij ob izhodišču 16 % EDSS ≥ 4
English: Proportion with 12 week confirmed disability progression*
Slovenian: Delež s potrjenim napredovanjem bolezni v
English: the annual relapse rate at 1 year was 0.39 for placebo, 0.29 for Plegridy every 4 weeks and 0.25 for Plegridy every 2 weeks.
Slovenian: 1. letu je bila 0,47 za placebo, 0,35 za zdravilo Plegridy vsake 4 tedne in 0,33 za zdravilo Plegridy vsaka 2 tedna.
English: • Keep Plegridy pre-filled syringe and all medicines out of reach of children.
Slovenian: • Napolnjeno injekcijsko brizgo zdravila Plegridy in vsa druga zdravila shranjujte nedosegljiva otrokom.
English: ┼ Class label for interferon products, see below Pulmonary arterial hypertension $ Class label for interferon products
Slovenian: ┼Označevanje skupine zdravil, ki vsebujejo interferone - glejte Pljučna arterijska hipertenzija spodaj.
English: Serious hypersensitivity reactions including cases of anaphylaxis have been reported as a rare complication of treatment with interferon beta, including Plegridy.
Slovenian: Preobčutljivostne reakcije Pri zdravljenju z interferonom beta, vključno z zdravilom Plegridy, so poročali o resnih preobčutljivostnih reakcijah, vključno s primeri anafilaksije, kot o redkem zapletu, povezanim z zdravljenjem.
English: Step 3: Check your Plegridy pen (see Figure C)
Slovenian: 3. korak: Preglejte svoj injekcijski peresnik zdravila Plegridy (glejte sliko C).
English: Plegridy 125 micrograms every 4 weeks
Slovenian: Zdravilo Plegridy 125 mikrogramov vsake 4 tedne
English: The ADRs are presented as MedDRA preferred terms under the MedDRA System Organ Class.
Slovenian: Neželeni učinki so navedeni z izrazi, ki jih priporoča MedDRA, in glede na MedDRA organske sisteme.
English: • Remove one Plegridy pack out of the fridge and select the appropriate pre-filled syringe from the pack.
Slovenian: • Vzemite eno pakiranje zdravila Plegridy iz hladilnika in izberite pravo napolnjeno injekcijsko brizgo.
English: Events were reported at various time points during treatment and may occur after several years of treatment with interferon beta.
Slovenian: O dogodkih so poročali v različnih časovnih točkah med zdravljenjem in se lahko pojavijo po več letih zdravljenja z interferonom beta.
English: Follow-up
Slovenian: Spremljanje
English: - For patients with ≥2 relapses in the previous year and at least 1 Gd+ lesion (n=273), the annual relapse rate at 1 year was 0.47 for placebo, 0.35 for Plegridy every 4 weeks, and 0.33 for Plegridy every 2 weeks.
Slovenian: - Za bolnike z ≥ 1 recidivom v preteklem letu in ≥ 9 lezij T2 ali ≥ 1 lezija Gd+ (n = 1.401), letna stopnja recidiva v 1. letu je bila 0,39 za placebo, 0,29 za zdravilo Plegridy vsake 4 tedne in 0,25 za zdravilo Plegridy vsaka 2 tedna.
English: Before use - Parts of Plegridy Pen (Figure A)
Slovenian: Pred uporabo - sestavni deli injekcijskega peresnika zdravila Plegridy (slika A)
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.
Slovenian: Zdravilo Plegridy je interferon beta-1a, konjugiran z eno linearno molekulo z 20.000 Da metoksipolietilenglikol-O-2-metilpropionaldehida (20 kDa mPEG-O-2-metilpropionaldehid) s stopnjo substitucije 1 mol polimera na mol proteina.
English: Worsening of cardiac disease has been reported in patients receiving interferon beta.
Slovenian: Pri bolnikih, ki so dobivali interferon beta, so poročali o poslabšanju bolezni srca.
English: Day 0
Slovenian: 1. odmerek dan 0
English: A treatment effect was observed as early as 6 months, with Plegridy 125 micrograms every 2 weeks demonstrating a 61% reduction (p<0.0001) in new or newly enlarging T2 lesions as compared with placebo.
Slovenian: 125 mikrogramov vsaka 2 tedna pokazalo 61 % zmanjšanje (p < 0,0001) novih ali na novo povečanih lezij
English: HR 95% CI P-value p=0.0383
Slovenian: 95 % IZ vrednost p p = 0,0383
English: (rare - may affect up to 1 in 1,000 people) If you get some or all of these symptoms: - Foamy urine - Fatigue - Swelling, particularly in the ankles and eyelids, and weight gain.
Slovenian: (redki - pojavijo se lahko pri največ 1 od 1.000 bolnikov) Če se pojavijo kateri ali vsi od naslednjih simptomov: - penast urin, - utrujenost,
English: A pre-filled syringe of Plegridy is contained within a single-use, disposable, spring-powered pen injector called Plegridy Pen.
Slovenian: Napolnjena injekcijska brizga zdravila Plegridy je vgrajena v injekcijskem peresniku za enkratno uporabo z vzmetjo, ki ga po uporabi zavržete, in se imenuje Plegridy napolnjen injekcijski peresnik.
English: Note: Do not touch or blow on this area again before giving your injection.
Slovenian: Opomba: Tega mesta se do injiciranja ne dotikajte več in nanj ne pihajte.
English: 47% ≥2 relapses in prior year
Slovenian: 83 % še nezdravljeni bolniki 47 % ≥ 2 recidiva v preteklem letu
English: Events were reported at various time points during treatment and may occur several weeks to several years after starting treatment with interferon beta.
Slovenian: dogodkih so poročali v različnih časovnih točkah med zdravljenjem in se lahko pojavijo po več tednih do več let po začetku zdravljenja z interferonom beta.
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.
Slovenian: boleznijo minimalnih sprememb (MCD, minimal change disease), membranoproliferativnim glomerulonefritisom (MPGN) in membransko glomerulopatijo (MGN).
English: Giving your injection Step 5: Remove the Plegridy pen cap a. Pull the pen cap straight off and set it aside (see Figure E).
Slovenian: a. Potegnite pokrov napolnjenega injekcijskega peresnika naravnost s peresnika in ga odložite (glejte sliko E).
English: • For the first injections, you can use the record table printed on the inside of the lid of the
Slovenian: • Za prva injiciranja lahko uporabite preglednico za beleženje, ki je natisnjena na notranji strani pokrova začetnega pakiranja.
English: Step 3: Check the Plegridy pre-filled syringe
Slovenian: 3. korak: Preglejte napolnjeno injekcijsko brizgo zdravila Plegridy.
English: The serum half-life of peginterferon beta-1a is prolonged compared with non-pegylated interferon beta-1a.
Slovenian: Razpolovni čas peginterferona beta-1a v serumu je daljši kot pri nepegiliranem interferonu beta-1a.
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.
Slovenian: - akutna ali kronična bolečina, težave z mehurjem ali črevesjem, spolne težave in težave z vidom,
English: - Store in a refrigerator (fridge), 2º-8ºC.
Slovenian: - Shranjujte v hladilniku pri temperaturi med 2 ºC in 8 ºC.
English: • Let the Plegridy pre-filled syringe warm to room temperature for at least 30 minutes.
Slovenian: • Počakajte vsaj 30 minut, da se napolnjena injekcijska brizga zdravila Plegridy segreje na sobno temperaturo.
English: Let the pen warm to room temperature for at least 30 minutes.
Slovenian: Počakajte vsaj 30 minut, da se injekcijski peresnik segreje na sobno temperaturo.
English: - For patients with ≥1 relapse in the previous year and ≥9 T2 lesions or ≥1 Gd+ lesion (n=1401),
Slovenian: - Za bolnike z ≥ 2 recidivoma v preteklem letu in vsaj 1 lezijo Gd+ (n = 273), letna stopnja recidiva v
English: Grey
Slovenian: siva
English: HR 95% CI P-value p=0.0069
Slovenian: 95 % IZ vrednost p p = 0,0069
English: - Feeling off-balance or light headed, walking problems, stiffness and muscle spasms, tiredness,
Slovenian: Mednje lahko spadajo: - občutek neuravnoteženosti ali omotičnosti, težave pri hoji, togost in mišični krči, utrujenost,
English: Multipacks containing 6 (3 packs of 2) 125 microgram pre-filled pens (grey labelled pens).
Slovenian: Skupna pakiranja, ki vsebujejo po 6 (3 pakiranja po 2) 125-mikrogramskih napolnjenih injekcijskih peresnikov (peresniki s sivimi nalepkami).
English: There are no data on the effects of peginferferon beta-1a on human fertility.
Slovenian: Ni podatkov o vplivu peginferferona beta-1a na plodnost pri ljudeh.
English: Syringe label
Slovenian: Oznaka na brizgi
English: • Hold the Plegridy pre-filled syringe at a 90° angle to the injection site.
Slovenian: Plegridy držite pod kotom 90° na mesto injiciranja.
English: • Let the injection site dry before injecting the dose.
Slovenian: • Pred injiciranjem odmerka počakajte, da se koža posuši.
English: See section 4 for the symptoms of an allergic reaction.
Slovenian: Glejte poglavje 4 za simptome alergijske reakcije; - če imate hudo depresijo ali razmišljate o samomoru.