FrancophonIA/ELRC3.0 huggingface dataset:
English: A double-blind randomised dose comparison study of 802 relapsing MS patients (AVONEX 30 micrograms n=402, AVONEX 60 micrograms n=400) has shown no statistically significant differences or trends between the 30 micrograms and the 60 micrograms doses of AVONEX in clinical and general MRI parameters.
Slovenian: Randomizirana, dvojno slepa študija primerjave odmerkov, pri kateri sta sodelovala 802 bolnika s ponavljajočo se MS (zdravilo AVONEX 30 mikrogramov n=402, zdravilo AVONEX 60 mikrogramov n=400) pri kliničnih in splošnih MRI parametrih ni pokazala statistično pomembnih razlik ali trendov med 30 mikrogramskimi in 60 mikrogramskimi odmerki zdravila AVONEX.
English: UAB "JOHNSON & JOHNSON"
Slovenian: Lietuva UAB "JOHNSON & JOHNSON"
English: Each pre-filled syringe of AVONEX contains a single dose only.
Slovenian: Vsaka napolnjena injekcijska brizga zdravila AVONEX vsebuje samo en odmerek.
English: Patients with an EDSS of 1.0 to 3.5 at entry were included in the clinical trial.
Slovenian: V klinično študijo so bili vključeni bolniki, ki so pri vstopu v študijo imeli EDSS od 1 do 3,5.
English: If you have decided to start treatment with Avonex, your doctor may provide you with an Avostartclip titration kit.
Slovenian: V kolikor ste se odločili za pričetek zdravljenja z zdravilom Avonex, vam lahko zdravnik priskrbi komplet za titriranje Avostartclip.
English: 4 Check the injector shield is extended correctly
Slovenian: 4 Preverite, ali je zaščita injektorja pravilno razširjena.
English: There are more details on how to inject Avonex at the end of this leaflet.
Slovenian: Več podrobnosti o injiciranju zdravila Avonex je na koncu tega navodila.
English: • Firmly press until you hear a “click” to seal the needle.
Slovenian: • Čvrsto pritiskajte, dokler ne zaslišite klika, ki pomeni, da je igla zaprta.
English: The highest incidence of adverse reactions associated with AVONEX therapy is related to flu-like symptoms.
Slovenian: Največja incidenca neželenih pojavov v zvezi s terapijo z zdravilom AVONEX je povezana z gripi podobnimi simptomi.
English: Check the liquid in the syringe
Slovenian: Preverite tekočino v injekcijski brizgi
English: Your doctor may provide you with an Avostartclip titration kit which enables you to gradually increase your dose at the start of treatment to help limit flu-like symptoms.
Slovenian: Zdravnik vam lahko priskrbi komplet za titriranje Avostartclip, ki omogoča postopno povečevanje odmerka na začetku zdravljenja, kar pomaga pri blaženju gripi podobnih simptomov.
English: Some people find that after using Avonex Pen, they feel like they have flu.
Slovenian: Nekateri ljudje se po uporabi napolnjenega injekcijskega peresnika Avonex Pen počutijo, kot da imajo gripo.
English: Do not use AVONEX:
Slovenian: Ne uporabljajte zdravila AVONEX:
English: Blood and lymphatic system disorders not known rare pancytopenia, thrombocytopenia thrombotic microangiopathy including thrombotic thrombocytopenic purpura/haemolytic uraemic syndrome*
Slovenian: Bolezni krvi in limfatičnega sistema neznana redki pancitopenija, trombocitopenija trombotična mikroangiopatija, vključno s trombotično trombocitopenično purpuro/hemolitično-uremičnim sindromom*
English: Avonex and allergic reactions
Slovenian: Zdravilo Avonex in alergijske reakcije
English: Do NOT use Avonex if you notice:
Slovenian: NE uporabljajte zdravila Avonex, če opazite:
English: Press the needle onto the syringe.
Slovenian: Iglo potisnite na injekcijsko brizgo.
English: C. Giving the injection
Slovenian: C. Dajanje injekcije
English: Common (≥1/100 to <1/10 patient-years);
Slovenian: Pogosti (≥1/100 do <1/10 bolnikov-let);
English: Avonex works best when you use it at the same time, once a week, on a regular basis.
Slovenian: Učinki zdravila Avonex so najboljši, če ga uporabljate redno, ob istem času, enkrat tedensko.
English: Each syringe is packed in a sealed plastic tray.
Slovenian: Vsaka injekcijska brizga je zapakirana v zapečatenem plastičnem ovoju.
English: In a post-hoc analysis, those patients with a baseline MRI with at least one Gd-enhancing lesion and nine T2 lesions had a two-year risk of suffering a second event of 56% in the placebo group and 21% in the AVONEX treatment group.
Slovenian: V post hoc analizi se je pri bolnikih z osnovno mejo MRI z vsaj enim Gd-stopnjevanjem poškodb in devetimi T2 poškodbami pokazala 56 % možnost drugega napada pri bolnikih, zdravljenih s placebom, in 21 % možnost drugega napada pri bolnikih, zdravljenih z zdravilom AVONEX.
English: Inside the back cover there's a fold-out chart with everything you need to make injections with your Avonex Pen.
Slovenian: Znotraj hrbtne platnice je zložljiva tabela z vsem, kar potrebujete, da s svojim napolnjenim injekcijskim peresnikom Avonex Pen izvedete injiciranje.
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: Renal and urinary disorders rare nephrotic syndrome, glomerulosclerosis (see section 4.4 ‘special warnings and precautions')
Slovenian: Bolezni sečil redki nefrotski sindrom, glomeruloskleroza (glejte poglavje 4.4, Posebna opozorila in previdnostni ukrepi)
English: Avonex Pens are provided in packs of four or twelve for one or three months of injections.
Slovenian: Napolnjeni injekcijski peresniki Avonex Pen so na voljo v pakiranjih po štiri ali dvanajst za eno- ali trimesečno zalogo injekcij.
English: If you are using a syringe that has an Avostartclip attached, you will receive a lower dose of Avonex.
Slovenian: V kolikor uporabljate injekcijsko brizgo s pritrjenim pripomočkom Avostartclip, boste prejeli manjši odmerek zdravila Avonex.
English: What AVONEX PEN looks like and contents of the pack
Slovenian: Izgled zdravila AVONEX PEN in vsebina pakiranja
English: Some people find that after injecting Avonex, they feel like they have flu.
Slovenian: Nekateri ljudje imajo po injiciranju zdravila Avonex občutek, kot da imajo gripo.
English: For further details on use, speak with your doctor.
Slovenian: Za nadaljnje informacije o uporabi se posvetujte z zdravnikom.
English: Respiratory, thoracic and mediastinal disorders common rare not known rhinorrhoea dyspnoea pulmonary arterial hypertension┼
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora pogosti redki neznana rinoreja dispneja pljučna arterijska hipertenzija
English: If you have trouble handling the Avonex Pen, ask your doctor who may be able to help.
Slovenian: Če imate težave z uporabo napolnjenega injekcijskega peresnika Avonex Pen, se posvetujte z zdravnikom, ki vam bo lahko pomagal.
English: The AVOSTARTCLIP titration kit is designed for use with the pre-filled syringe only.
Slovenian: Komplet za titriranje AVOSTARTCLIP je zasnovan samo za uporabo z napolnjeno injekcijsko brizgo.
English: The effects of AVONEX in the treatment of MS were also demonstrated in a randomised double-blind study performed with 383 patients (AVONEX n=193, placebo n=190) with a single demyelinating event associated with at least two compatible brain MRI lesions.
Slovenian: Učinki zdravila AVONEX pri zdravljenju MS so bili prikazani tudi na randomizirani, dvojno slepi študiji, opravljeni na 383 bolnikih (zdravilo AVONEX n=193, placebo n=190), z enim demielinizirajočim napadom, povezanim z vsaj dvema kompatibilnima možganskima MRI poškodbama.
English: - Pulmonary arterial hypertension: A disease of severe narrowing of the blood vessels in the lungs resulting in high blood pressure in the blood vessels that carry blood from the heart to the lungs.
Slovenian: - spremembe v rezultatih testov, vključno s spremembami testov delovanja jeter, - pljučna arterijska hipertenzija: bolezen, ki povzroči hudo zoženje krvnih žil v pljučih, katerega posledica je visok krvni tlak v žilah, po katerih kri teče iz srca v pljuča.
English: Tip: The best area is the upper, outer thigh.
Slovenian: Nasvet: Najboljši predel je zgornji, zunanji del stegna.
English: Limited published data suggest that the safety profile in adolescents from 12 to 16 years of age receiving AVONEX 30 micrograms IM once per week is similar to that seen in adults.
Slovenian: Pediatrična populacija Malo objavljenih podatkov kaže, da je varnostni profil pri mladostnikih, starih od 12 do 16 let, ki dobivajo zdravilo AVONEX 30 mikrogramov i.m.
English: Cardiac disorders not known cardiomyopathy, congestive heart failure (see section 4.4), palpitations, arrhythmia, tachycardia
Slovenian: Srčne bolezni neznana kardiomiopatija, kongestivno srčno popuščanje (glejte poglavje 4.4), palpitacije, aritmija, tahikardija
English: Treatment with Avonex can help to prevent you from getting worse, although it will not cure MS.
Slovenian: Zdravljenje z zdravilom Avonex lahko prepreči poslabšanje multiple skleroze, vendar je ne ozdravi.
English: Natural interferon beta and AVONEX (interferon beta-1a) are glycosylated and have a single N-linked complex carbohydrate moiety.
Slovenian: Naravni interferon beta in zdravilo AVONEX (interferon beta-1a) sta glikozilirana in imata en N-vezani kompleksen ogljikohidratni del.
English: Do not stop your Avonex treatment without speaking to your neurologist.
Slovenian: Ne prenehajte uporabljati zdravila Avonex, ne da se pogovorite z nevrologom.
English: Caution should be used and close monitoring considered when administering AVONEX to patients with severe renal and hepatic failure and to patients with severe myelosuppression.
Slovenian: Previdnost in natančno opazovanje sta potrebna pri dajanju zdravila AVONEX bolnikom z resnimi okvarami ledvic in jeter ter bolnikom z resno supresijo kostnega mozga.
English: • The plastic needle cover will “pop” off.
Slovenian: • Plastični pokrovček igle se bo odlomil.
English: Store the AVONEX PEN in the inner carton in order to protect from light (see section 6.5).
Slovenian: Napolnjen injekcijski peresnik AVONEX PEN shranjujte v notranji škatli za zagotovitev zaščite pred svetlobo (glejte poglavje 6.5).
English: What AVONEX is and what it is used for 2.
Slovenian: Kaj je zdravilo AVONEX in za kaj ga uporabljamo 2.
English: Very common (≥1/10 patient-years);
Slovenian: Zelo pogosti (≥1/10 bolnikov-let);
English: Do not twist it.
Slovenian: Ne sučite ga.
English: Chronic Toxicity: In a 26-week repeated dose toxicity study in rhesus monkeys by intramuscular route once per week, administered in combination with another immunomodulating agent, an anti CD40 ligand monoclonal antibody, no immune response toward interferon beta-1a and no signs of toxicity were demonstrated.
Slovenian: Kronična toksičnost: v 26-tedenski študiji toksičnosti s ponavljajočimi odmerki so opicam Rhesus enkrat tedensko intramuskularno dajali zdravilo, v kombinaciji z drugim imunomodulatorjem, anti
English: • Avonex is injected into a muscle, for example, the upper thigh muscle.
Slovenian: • Zdravilo Avonex se injicira v mišico, na primer v zgornjo stegensko mišico.
English: 1 Clean the injection site
Slovenian: 1 Očistite mesto injiciranja.
English: Thrombotic microangiopathy (TMA): Cases of thrombotic microangiopathy, manifested as thrombotic thrombocytopenic purpura (TTP) or haemolytic uraemic syndrome (HUS), including fatal cases, have been reported with interferon beta products.
Slovenian: Trombotična mikroangiopatija (TMA): Pri zdravilih z interferonom beta so poročali o primerih trombotične mikroangiopatije, ki se je izrazila kot trombotična trombocitopenična purpura (TTP) ali hemolitično-uremični sindrom (HUS), vključno s smrtnimi primeri.
English: Musculoskeletal and connective tissue disorders common not known muscle cramp, neck pain, myalgia2, arthralgia, pain in extremity, back pain, muscle stiffness, musculoskeletal stiffness systemic lupus erythematosus, muscle weakness, arthritis
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva pogosti neznana mišični krči, bolečine v vratu, mialgija2, artralgija, bolečine v udih, bolečine v hrbtu, mišična togost, mišično-skeletna togost sistemski eritematozni lupus, mišična oslabelost, artritis
English: Use a different injection site each week
Slovenian: Vsak teden uporabite drugo mesto injiciranja.
English: Tip: Continue to hold the pen firmly on the skin.
Slovenian: Nasvet: še naprej čvrsto držite napolnjen injekcijski peresnik na kožo.
English: Do not lift the pen away from your skin.
Slovenian: Injekcijskega peresnika ne dvignite s kože.
English: What you need to know before you use AVONEX 3.
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo AVONEX 3.
English: The calculated bioavailability is greater without such adjustments.
Slovenian: Brez takšnega upoštevanja je izračunana biološka uporabnost večja.
English: Air bubble(s) are normal.
Slovenian: Zračni mehurčki so običajni.
English: Do not use it if it is out-of-date.
Slovenian: Ne uporabite ga, če je rok uporabnosti potekel.
English: What AVONEX looks like and contents of the pack Avonex Solution for Injection comes as a ready to use injection.
Slovenian: Izgled zdravila AVONEX in vsebina pakiranja Zdravilo Avonex raztopina za injiciranje je na voljo kot raztopina, pripravljena za injiciranje.
English: Each AVOSTARTCLIP should be used once and then discarded along with any remaining AVONEX in the syringe.
Slovenian: Vsak pripomoček Avostartclip lahko uporabite samo enkrat, nato pa ga je treba zavreči skupaj z morebitnim preostankom zdravila Avonex v brizgi.
English: The injection needle for intramuscular injection is provided.
Slovenian: Priložena je injekcijska igla za intramuskularno injiciranje.
English: Swelling, particularly in the ankles and eyelids, and weight gain.
Slovenian: oteklost, zlasti gležnjev in vek, in povečanje telesne mase.
English: Avostartclips can be attached onto the syringe enabling a reduced dose of Avonex to be injected at the start of treatment.
Slovenian: Pripomoček Avostartclip se lahko namesti na injekcijsko brizgo in omogoči zmanjšanje injiciranega odmerka zdravila Avonex na začetku zdravljenja.
English: If you have used the Avostartclip, the syringe (and the Avostartclip) must be thrown away afterwards.
Slovenian: V kolikor ste uporabili pripomoček Avostartclip, morate po uporabi injekcijsko brizgo (in pripomoček) zavreči.
English: The recommended intramuscular injection site using the AVONEX PEN is the upper, outer thigh muscle.
Slovenian: Priporočeno mesto intramuskularnega injiciranja z uporabo napolnjenega injekcijskega peresnika AVONEX PEN je zgornja, zunanja stegenska mišica.
English: • Peel off the foil from the base of the needle cover.
Slovenian: • Odluščite folijo z baze pokrovčka igle.
English: Patients with myelosuppression may require more intensive monitoring of complete blood cell counts, with differential and platelet counts.
Slovenian: Za bolnike s supresijo kostnega mozga je včasih potrebno intenzivnejše spremljanje celotne krvne slike z diferencialno krvno sliko in številom trombocitov.
English: Contents of the pack and other information What AVONEX contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo AVONEX
English: Check the expiry date on the Avonex Pen label.
Slovenian: Preverite datum izteka roka uporabnosti na oznaki napolnjenega injekcijskega peresnika Avonex Pen.
English: Tip: Do not use external heat sources such as hot water to warm the syringe.
Slovenian: Nasvet: Za ogrevanje injekcijske brizge ne uporabljajte zunanjih virov ogrevanja, kot je topla voda.
English: Skin and subcutaneous tissue disorders common uncommon not known rash, sweating increased, contusion alopecia angioneurotic oedema, pruritus, rash vesicular, urticaria, aggravation of psoriasis
Slovenian: Bolezni kože in podkožja pogosti občasni neznana izpuščaj, povečano znojenje, kontuzija alopecija angionevrotski edem, pruritus, vezikularni izpuščaj, urtikarija, poslabšanje psoriaze
English: Tip: Do not use external heat sources such as hot water to warm Avonex Pen.
Slovenian: Nasvet: Ne uporabljajte zunanjih virov toplote, kot je voda, za ogrevanje napolnjenega injekcijskega peresnika Avonex Pen.
English: • Do not re-use the Avonex Pen.
Slovenian: • Napolnjenega injekcijskega peresnika Avonex Pen ne uporabljajte ponovno.
English: Important information about some of the ingredients of Avonex
Slovenian: Pomembne informacije o nekaterih sestavinah zdravila Avonex
English: Important information about some of the ingredients of AVONEX
Slovenian: Pomembne informacije o nekaterih sestavinah zdravila AVONEX
English: Interferons are a family of naturally occurring proteins that are produced by eukaryotic cells in response to viral infection and other biological inducers.
Slovenian: Izdelujejo jih evkariontske celice kot odgovor na virusne okužbe in druge biološke povzročitelje.
English: The injection needle is provided.
Slovenian: Injekcijska igla je priložena.
English: If you have trouble handling the syringe, ask your doctor who may be able to help.
Slovenian: Če imate težave pri rokovanju z injekcijsko brizgo, se posvetujte z zdravnikom, ki vam bo lahko pomagal.
English: • Avonex Pen has been designed to function only with the supplied needle.
Slovenian: • Napolnjen injekcijski peresnik Avonex Pen je zasnovan tako, da deluje samo s priloženo iglo.
English: Store in the original package (sealed plastic tray) in order to protect from light (see section 6.5).
Slovenian: Shranjujte v originalni ovojnini (zaprt plastičen ovoj) za zagotovitev zaščite pred svetlobo (glejte poglavje 6.5).
English: For further details, speak with your doctor
Slovenian: Za več podrobnosti se posvetujte z zdravnikom.
English: This makes the injection more comfortable than injecting straight from a refrigerator.
Slovenian: Injiciranje bo bolj prijetno, kot če bi injicirali hladno.
English: Pack size: box of four or twelve pre-filled syringes of 0.5 ml.
Slovenian: Velikost pakiranja: škatla s štirimi ali dvanajstimi napolnjenimi injekcijskimi brizgami po 0,5 ml.
English: Investigations common uncommon not known lymphocyte count decreased, white blood cell count decreased, neutrophil count decreased, hematocrit decreased, blood potassium increased, blood urea nitrogen increased platelet count decreased weight decreased, weight increased, liver function tests abnormal
Slovenian: Preiskave pogosti občasni neznana zmanjšano število limfocitov, zmanjšano število levkocitov, zmanjšano število nevrofilcev, znižan hematokrit, povečana vsebnost kalija v krvi, povečana vsebnost dušika iz sečnine v krvi zmanjšano število trombocitov zmanjšanje telesne mase, povečanje telesne mase, nenormalni testi delovanja jeter
English: A. Getting Ready Remove one sealed plastic tray from the refrigerator
Slovenian: Vzemite en zapečaten plastični ovoj iz hladilnika
English: The best area is the upper, outer thigh muscle.
Slovenian: Najboljši predel je zgornja, zunanja stegenska mišica.
English: - The pre-filled syringe is broken.
Slovenian: - da je napolnjena injekcijska brizga zlomljena,
English: You can inject Avonex yourself using the Avonex Pen without the help of your doctor, if they have trained you to do this.
Slovenian: Zdravilo Avonex si lahko injicirate sami z napolnjenim injekcijskim peresnikom Avonex Pen brez pomoči zdravnika, če so vas tega naučili.
English: No information is available on the effects of interferon beta-1a on male fertility.
Slovenian: Podatkov o učinkih interferona beta-1a na plodnost moških ni na voljo.
English: Once a full dose is achieved patients may begin using AVONEX PEN.
Slovenian: Ko dosežete celotni odmerek, lahko začne bolnik uporabljati napolnjen injekcijski peresnik AVONEX
English: The syringe inside the pen is a 1 ml pre-filled syringe made of glass (Type I) with a tamper evident cap and plunger stopper (bromobutyl) containing 0.5 ml of solution.
Slovenian: Brizga znotraj peresnika je 1 ml napolnjena injekcijska brizga iz stekla (tipa I) z varnostno zaporko in zamaškom (bromobutil), ki vsebuje 0,5 ml raztopine.
English: You can inject Avonex yourself without the help of your doctor, if they have trained you to do this.
Slovenian: Navodila za samoinjiciranje Zdravilo Avonex si lahko injicirate sami brez pomoči zdravnika, če so vas tega naučili.
English: The solution for injection can be observed through an oval medication display window on the AVONEX PEN.
Slovenian: Raztopino za injiciranje lahko opazujete skozi ovalno okence za opazovanje zdravila na napolnjenem injekcijskem peresniku AVONEX PEN.
English: They are more common when you first start using Avonex.
Slovenian: Bolj pogosto se pojavijo ob prvi uporabi zdravila Avonex.
English: The AVONEX PEN contains a pre-filled syringe of AVONEX and must be stored in the refrigerator.
Slovenian: Napolnjen injekcijski peresnik AVONEX PEN vsebuje napolnjeno injekcijsko brizgo z zdravilom AVONEX in ga morate shranjevati v hladilniku.
English: For single-use only: The solution for injection in a pre-filled syringe is contained within the AVONEX PEN.
Slovenian: Samo za enkratno uporabo: raztopina za injiciranje v napolnjeni injekciji brizgi je vgrajena v napolnjen injekcijski peresnik AVONEX PEN.
English: Symptoms may include increased bruising, bleeding, fever, extreme weakness, headache, dizziness or light-headedness.
Slovenian: Simptomi lahko vključujejo povečano nastajanje modric, krvavitve, povišano telesno temperaturo, izjemno šibkost,
English: What you need to know before you use AVONEX Do not use AVONEX
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo AVONEX Ne uporabljajte zdravila AVONEX
English: Nervous system disorders very common common not known headache2
Slovenian: Bolezni živčevja zelo pogosti pogosti neznana glavobol2
English: If there is any blood at the site, wipe it off.
Slovenian: Če vidite kri na mestu injiciranja, jo obrišite.
English: (Notes information)
Slovenian: (Opombe)
English: Take one Avonex Pen out of the refrigerator
Slovenian: En napolnjen injekcijski peresnik Avonex Pen vzemite iz hladilnika.
English: Reproductive system and breast disorders uncommon metrorrhagia, menorrhagia
Slovenian: Motnje reprodukcije in dojk občasni metroragija, menoragija
English: Very common side effects (may affect more than 1 in 10 people) - Flu-like symptoms - headache, muscle aches, chills or a fever: see Flu-like symptoms - Headache.
Slovenian: Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov) - Gripi podobni simptomi - glavobol, bolečine v mišicah, mrzlica ali zvišana telesna temperatura:
English: In a box of Avonex there are four or twelve ready to use (pre-filled) syringes, each with 0.5 ml of a clear, colourless liquid inside.
Slovenian: V vsaki škatli zdravila Avonex so štiri ali dvanajst napolnjenih injekcijskih brizg, vsaka vsebuje 0,5 ml prozorne, brezbarvne raztopine.
English: Therefore, in addition to those laboratory tests normally required for monitoring patients with MS, complete and differential white blood cell counts, platelet counts, and blood chemistry, including liver function tests, are recommended during AVONEX therapy.
Slovenian: AVONEX za spremljanje bolnikov z MS, poleg teh laboratorijskih testov, priporočeno opazovati še celotno in diferencialno belo krvno sliko, število trombocitov in teste krvne sestave, vključno s testi delovanja jeter.
English: Limited data of the efficacy/safety of AVONEX 15 micrograms IM once per week (n=8) as compared to no treatment (n=8) with follow up for 4 years showed results in line to those seen in adults, although the EDSS scores increased in the treated group over the 4 year follow-up thus indicating disease progression.
Slovenian: = 8) v primerjavi z bolniki brez zdravljenja (n = 8) s 4-letnim spremljanjem je pokazalo rezultate, ki so podobni kot pri odraslih, čeprav se je stopnja na lestvici EDSS pri zdravljeni skupini v 4 letih spremljanja zvišala, kar kaže na napredovanje bolezni.
English: If the solution for injection contains particulate matter or if it is any colour other than clear colourless, the pre-filled syringe must not be used.
Slovenian: Če raztopina za injiciranje vsebuje delce snovi ali je kakršne koli druge barve, razen brezbarvna, napolnjene injekcijske brizge ne smete uporabiti.
English: The most commonly reported flu-like symptoms are myalgia, fever, chills, sweating, asthenia, headache and nausea.
Slovenian: Gripi podobni simptomi, o katerih so poročali najpogosteje, so mialgija, zvišana telesna temperatura, mrzlica, znojenje, astenija, glavobol in slabost.