natgillin/translations-raw huggingface dataset:
The most common side effects with Rebif (seen in more than 1 patient in 10) are flu-like symptoms, neutropenia, lymphopenia and leucopenia (low white blood cell counts), thrombocytopenia (low blood platelet counts), anaemia (low red blood cell counts), headache, inflammation and other reactions at the injection site, and increases in transaminases (liver enzymes).
Najpogostejši neželeni učinki zdravila Rebif (opaženi pri več kot 1 bolniku izmed 10) so gripi podobni simptomi, nevtropenija, limfopenija in levkopenija (nizke koncentracije belih krvničk), trombocitopenija (nizke koncentracije trombocitov), anemija (nizke koncentracije rdečih krvničk), glavobol, vnetje in druge reakcije na mestu injiciranja ter zvišanje transaminaze (jetrnih encimov).
For the full list of all side effects reported with Rebif, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Rebif, glejte navodilo za uporabo.
Rebif should not be used in people who have a history of hypersensitivity (allergy) to natural or recombinant interferon beta, or any of the other ingredients.
Zdravila Rebif ne smejo uporabljati osebe z anamnezo preobčutljivosti za (alergije na) naravni ali rekombinantni interferon beta ali katero koli drugo sestavino zdravila.
Rebif must also not be used in patients who are suffering from severe depression or having thoughts about suicide.
Zdravila Rebif ne smejo uporabljati bolniki s hudimi depresivnimi motnjami ali samomorilskimi mislimi.
Why has Rebif been approved?
2/ 3 Zakaj je bilo zdravilo Rebif odobreno?
The Committee for Medicinal Products for Human Use (CHMP) decided that Rebif’ s benefits are greater than its risks for the treatment of relapsing MS.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Rebif za zdravljenje multiple skleroze z zagoni večje od z njim povezanih tveganj.
The Committee recommended that Rebif be given marketing authorisation.
Odbor je zato priporočil, da se za zdravilo Rebif odobri dovoljenje za promet.
The European Commission granted a marketing authorisation valid throughout the European Union for Rebif to Serono Europe Limited on 4 May 1998.
Evropska komisija je dovoljenje za promet z zdravilom Rebif, veljavno po vsej Evropski uniji, odobrila družbi Serono Europe Limited dne 4. maja 1998.
The marketing authorisation was renewed on 4 May 2003 and on 4 May 2008.
Dovoljenje za promet z zdravilom je bilo obnovljeno dne 4. maja 2003 in 4. maja 2008.
The full EPAR for Rebif is available here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Rebif je na voljo tukaj.
Route of Administratio n
Pot uporabe
22 µg (6 million IU)
22 mikrogramov (6 milijonov i. e.)
0.5 ml (12 million IU/ ml)
0, 5 ml (12 milijonov i. e. / ml)
44 µg (12 million IU)
44 mikrogramov (12 milijonov i. e.)
0.5 ml (24 million IU/ ml)
0, 5 ml (24 milijonov i. e. / ml)
8.8 µg (2.4 m IU) + 22 µg (6 m IU)
8, 8 mikrogramov (2, 4 milijona i. e.) 22 mikrogramov
pre-filled syringe (glass)
Napolnjena injekcijska brizga (steklo) Napolnjena injekcijska
0.2 ml (12 m IU/ ml) + 0.5 ml (12 m IU/ ml)
0, 2 ml (12 milijonov i. e. / ml)
Initiation pack:
Začetno pakiranje:
6 pre-filled syringes of 8.8 µg + 6 pre- filled syringes of 22 µg
8, 8 mikrogramov in 6 napolnjenih injekcijskih brizg po 22 mikrogramov
EU/ 1/ 98/ 063/ 008
1/ 2 EU/ 1/ 98/ 063/ 008
1.5 ml (12million IU/ ml)
1, 5 ml (12 milijonov i. e. / ml)
1.5 ml (24million IU/ ml)
1, 5 ml (24 milijonov i. e. / ml)
8.8 µg/ 0.1 ml Solution for 22 µg/ 0.25 ml injection
Raztopina za injiciranje
1.5 ml (24 million IU/ ml)
1, 5 ml (24 milijonov i. e. / ml)
2 cartridges
2 vložki
Each pre-filled syringe (0.5 ml) contains 22 micrograms (6 MIU*) of interferon beta-1a**.
Ena napolnjena injekcijska brizga (0, 5 ml) vsebuje 22 mikrogramov (6 milijonov i. e. *) interferona beta- 1a **.
* Million International Units, measured by cytopathic effect (CPE) bioassay against the in-house IFN beta-1a standard which is calibrated against the current international NIH standard (GB-23-902-531). ** produced in Chinese hamster ovary Cells (CHO-K1) by recombinant DNA technology.
* milijon mednarodnih enot, merjeno z biološkim testom s citopatskim učinkom (CPE) po IFN beta- 1a standardu proizvajalca, ki je kalibriran po trenutnem mednarodnem NIH standardu (GB- 23- 902- 531). ** pridobljen s tehnologijo rekombinantne DNK na ovarijskih celicah kitajskega hrčka (CHO- K1).
2.5 mg benzyl alcohol For a full list of excipients, see section 6.1.
2, 5 mg benzilalkohola Za celoten seznam pomožnih snovi glejte poglavje 6. 1.
Clear to opalescent solution, with pH 3.5 to 4.5 and osmolarity 250 to 450 mOsm/ l.
Bistra do opalescentna raztopina s pH 3, 5 do 4, 5 in osmolarnostjo 250 do 450 mOsm/ l.
In clinical trials, this was characterised by two or more acute exacerbations in the previous two years (see section 5.1).
V kliničnih preskušanjih je bilo to opredeljeno z dvema ali več zagoni bolezni v obdobju zadnjih dveh let (glejte poglavje 5. 1).
Efficacy has not been demonstrated in patients with secondary progressive multiple sclerosis without ongoing relapse activity (see section 5.1).
Učinkovitost ni bila ugotovljena pri bolnikih s sekundarno progresivno multiplo sklerozo, ki nimajo aktivnih zagonov (glejte poglavje 5. 1).
Rebif is available in three strengths:
Zdravilo Rebif je na voljo v treh jakostih:
8.8 micrograms, 22 micrograms and 44 micrograms.
8, 8 mikrogramov, 22 mikrogramov in 44 mikrogramov.
For patients initiating treatment with Rebif, Rebif 8.8 micrograms and Rebif 22 micrograms are available in a package that corresponds to the patient needs for the first month of therapy.
Za bolnike, ki začenjajo zdravljenje z zdravilom Rebif sta na voljo Rebif 8, 8 mikrogramov in Rebif 22 mikrogramov v pakiranju, ki ustreza potrebam bolnika za prvi mesec zdravljenja.
When first starting treatment with Rebif, dose should be gradually escalated in order to allow tachyphylaxis to develop thus reducing adverse reactions.
Na začetku prvega zdravljenja z zdravilom Rebif se odmerek postopno viša z namenom razvoja tahifilaksije in s tem zmanjšanja neželenih učinkov.
Method of administration Prior to injection and for an additional 24 hours after each injection, an antipyretic analgesic is advised to decrease flu-like symptoms associated with Rebif administration.
Način uporabe Pred injiciranjem in še naslednjih 24 ur po vsaki injekciji je priporočena uporaba antipiretičnega analgetika za zmanjševanje gripi podobnih simptomov, povezanih z uporabo zdravila Rebif.
2 At the present time, it is not known for how long patients should be treated.
Zaenkrat ni znano, kako dolgo bi se bolniki morali zdraviti.
It is recommended that patients should be evaluated at least every second year in the 4-year period after initiation of treatment with Rebif and a decision for longer term treatment should then be made on an individual basis by the treating physician.
2 bolnika pregleda najmanj vsako drugo leto v 4- letnem obdobju od začetka zdravljenja z zdravilom Rebif in na individualni osnovi sprejme odločitev o dolgoročnem zdravljenju.
Paediatric use No formal clinical trials or pharmacokinetic studies have been conducted in children or adolescents.
Pediatrična uporaba Pri otrocih in mladostnikih niso izvedli formalnih kliničnih ali farmakokinetičnih preskušanj.
However, limited published data suggest that the safety profile in adolescents from 12 to 16 years of age receiving Rebif 22 micrograms subcutaneously three times per week is similar to that seen in adults.
Vendar pa omejeni objavljeni podatki kažejo, da je varnostni profil za mladostnike, stare od 12 do 16 let, ki prejemajo subkutano zdravilo Rebif 22 mikrogramov trikrat na teden, podoben tistemu pri odraslih.
There is very limited information on the use of Rebif in children under 12 years of age and therefore Rebif should not be used in this population.
Zelo malo je podatkov o uporabi zdravila Rebif pri otrocih mlajših od 12 let, zato se zdravilo Rebif pri tej starostni skupini ne sme uporabljati.
• Initiation of treatment in pregnancy (see section 4.6). • Hypersensitivity to natural or recombinant interferon-β, or to any excipients. • Current severe depression and/ or suicidal ideation (see sections 4.4 and 4.8).
• Začetek zdravljenja v nosečnosti (glejte poglavje 4. 6) • Preobčutljivost za naravni ali rekombinantni interferon beta ali katerokoli sestavino zdravila. • Trenutna huda depresija in/ ali samomorilne misli (glejte poglavji 4. 4 in 4. 8).
Patients should be informed of the most frequent adverse reactions associated with interferon beta administration, including symptoms of the flu-like syndrome (see section 4.8).
Bolnik mora biti seznanjen z najbolj pogostimi neželenimi učinki, povezanimi z uporabo interferona beta, vključno s simptomi gripi podobnega sindroma (glejte poglavje 4. 8).
Rebif should be administered with caution to patients with previous or current depressive disorders in particular to those with antecedents of suicidal ideation (see section 4.3).
Zdravilo Rebif moramo uporabljati previdno pri bolnikih, ki so imeli ali trenutno imajo depresivne bolezni, zlasti pri tistih s predhodnimi samomorilskimi mislimi (glejte poglavje 4. 3).
Patients treated with Rebif should be advised to immediately report any symptoms of depression and/ or suicidal ideation to their prescribing physician.
Bolnike, ki se zdravijo z zdravilom Rebif moramo opozoriti, da o morebitnih znakih depresije in/ ali samomorilskih mislih takoj poročajo svojemu zdravniku.
Cessation of therapy with Rebif should be considered (see sections 4.3 and 4.8).
Proučiti moramo možnost prenehanja zdravljenja z zdravilom Rebif (glejte poglavji 4. 3 in 4. 8).
Rebif 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 sections 4.5 and 4.8).
Zdravilo Rebif moramo uporabljati previdno pri bolnikih, ki so imeli v preteklosti epileptične napade ter pri bolnikih, ki se zdravijo z antiepileptiki, zlasti pri tistih, kjer napadov ni bilo mogoče zadovoljivo kontrolirati z antiepileptiki (glejte poglavji 4. 3 in 4. 8).
Patients with cardiac disease, such as angina, congestive heart failure or arrhythmia, should be closely monitored for worsening of their clinical condition during initiation of therapy with interferon beta-1a.
Bolnike s srčnimi boleznimi kot so angina pektoris, kongestivno srčno popuščanje ali aritmija, moramo skrbno spremljati na poslabšanje njihove klinične slike med uvajanjem zdravljenja z interferonom beta- 1a.
Symptoms of the flu-like syndrome associated with interferon beta-1a therapy may prove stressful to patients with cardiac conditions.
Znaki gripi podobnega sindroma, ki so povezani z zdravljenjem z interferonom beta- 1a, lahko stresno vplivajo na srčne bolnike.
Injection site necrosis (ISN) has been reported in patients using Rebif (see section 4.8).
Pri bolnikih, ki uporabljajo zdravilo Rebif, so poročali o nekrozi na mestu injiciranja (ISN) (glejte poglavje 4. 8).
To minimise the risk of injection site necrosis patients should be advised to: • use an aseptic injection technique, • rotate the injection sites with each dose.
Za zmanjševanje tveganja nastanka nekroz na mestu injiciranja, moramo bolnikom svetovati, da: • uporabljajo aseptično tehniko injiciranja • po vsakem odmerku zamenjajo mesto vboda.
If the patient experiences any break in the skin, which may be associated with swelling or drainage of fluid from the injection site, the patient should be advised to consult with their physician before continuing injections with Rebif.
Bolniku moramo svetovati, da se v primeru pojava kakršnekoli razpoke v koži, ki jo lahko spremlja oteklina ali odtekanje tekočine iz mesta injiciranja, posvetuje s svojim zdravnikom, preden nadaljuje z uporabo injekcij zdravila Rebif.
3 In clinical trials with Rebif, asymptomatic elevations of hepatic transaminases (particularly alanine aminotransferase (ALT)) were common and 1-3% of patients developed elevations of hepatic transaminases above 5 times the upper limit of normal (ULN).
V kliničnih študijah z zdravilom Rebif je bilo pogosto asimptomatsko zvišanje jetrnih transaminaz 3 (zlasti alanin- aminotransferaze (ALT)) in 1- 3% bolnikov je razvilo povečanje jetrnih transaminaz, ki je preseglo 5- kratne vrednosti zgornje meje normalne ravni (ULN).
Dose reduction of Rebif should be considered if ALT rises above 5 times the ULN, and gradually re-escalated when enzyme levels have normalized.
Pretehtati moramo potrebo po zmanjšanju odmerka zdravila Rebif, če ALT naraste čez 5 - kratno ULN in nato odmerek postopoma povečevati, ko se raven encimov normalizira.
Rebif should be initiated with caution in patients with a history of significant liver disease, clinical evidence of active liver disease, alcohol abuse or increased serum ALT (> 2.5 times ULN).
Zdravljenje z zdravilom Rebif moramo uvajati previdno pri bolnikih s pomembnimi jetrnimi boleznimi v anamnezi, s klinično potrjeno aktivno jetrno boleznijo, zlorabo alkohola ali zvišano serumsko ravnjo ALT (> 2, 5 - kratna ULN).
Treatment with Rebif should be stopped if icterus or other clinical symptoms of liver dysfunction appear (see section 4.8).
Zdravljenje z zdravilom Rebif moramo ukiniti, če se pojavi zlatenica ali drugi klinični znaki motenj v delovanju jeter (glejte poglavje 4. 8).
Rebif, like other interferons beta, has a potential for causing severe liver injury (see section 4.8) including acute hepatic failure.
Zdravilo Rebif ima, tako kot drugi interferoni, potencial za povzročanje hudih jetrnih poškodb (glejte poglavje 4. 8), vključno z jetrno odpovedjo.
Laboratory abnormalities are associated with the use of interferons.
Z uporabo interferonov so povezani abnormalni laboratorijski testi.
Patients being treated with Rebif may occasionally develop new or worsening thyroid abnormalities.
Pri bolnikih, ki se zdravijo z zdravilom Rebif se lahko občasno razvijejo ali pa poslabšajo motnje delovanja ščitnice.
Thyroid function testing is recommended at baseline and if abnormal, every 6-12 months following initiation of therapy.
Preiskave delovanja ščitnice se priporoča na začetku zdravljenja in če so rezultati abnormalni, vsakih 6 do 12 mesecev od začetka zdravljenja.
If tests are normal at baseline, routine testing is not needed but should be performed if clinical findings of thyroid dysfunction appear (see section 4.8).
Če so vrednosti testov ob pričetku normalne, rutinske preiskave niso potrebne, vendar se morajo izvajati, če se pojavijo klinični znaki motenj delovanja ščitnice (glejte poglavje 4. 8).
Caution should be used, and close monitoring considered when administering interferon beta-1a to patients with severe renal and hepatic failure and to patients with severe myelosuppression.
Pri bolnikih s hudim ledvičnim in jetrnim odpovedovanjem ter bolnikih s hudo mielosupresijo, moramo interferon beta- 1a uporabljati previdno in pod skrbnim nadzorom.
Serum neutralising antibodies against interferon beta-1a may develop.
Lahko se razvijejo serumska nevtralizirajoča protitelesa na interferon beta- 1a.
Clinical data suggest that after 24 to 48 months of treatment with Rebif 22 micrograms, approximately 24% of patients develop persistent serum antibodies to interferon beta-1a.
Klinični podatki kažejo, da se po 24 do 48 mesecih zdravljenja z zdravilom Rebif 22 mikrogramov, približno pri 24% bolnikov razvije vztrajen pojav serumskih protiteles na interferon beta- 1a.
The presence of antibodies has been shown to attenuate the pharmacodynamic response to interferon beta-1a (Beta-2 microglobulin and neopterin).
Pokazalo se je, da prisotnost protiteles slabi farmakodinamični odziv na interferon beta- 1a (beta- 2 mikroglobulin in neopterin).
If a patient responds poorly to therapy with Rebif, and has neutralising antibodies, the treating physician should reassess the benefit/ risk ratio of continued Rebif therapy.
Pri bolnikih, kjer je odziv na zdravljenje slab in so razvili protitelesa, mora lečeči zdravnik ponovno pretehtati razmerje koristi in tveganja pri nadaljevanju zdravljenja z zdravilom Rebif.
The use of various assays to detect serum antibodies and differing definitions of antibody positivity limits the ability to compare antigenicity among different products.
Uporaba različnih testov za dokazovanje serumskih protiteles in različne definicije mej za pozitivnost protiteles omejujejo možnost primerjave antigenskih lastnosti med različnimi izdelki.
Rebif has not yet been investigated in patients with primary progressive multiple sclerosis and should not be used in such patients.
Zdravilo Rebif še ni bilo raziskano pri bolnikih s primarno progresivno multiplo sklerozo, zato se ga pri teh bolnikih ne sme uporabljati.
This medicinal product contains 2.5 mg benzyl alcohol per dose.
To zdravilo vsebuje 2, 5 mg benzilalkohola na odmerek.
Must not be given to premature babies or neonates.
Uporaba pri nedonošenčkih ali novorojenčkih ni dovoljena.
May cause toxic reactions and anaphylactoid reactions in infants and children up to 3 years old.
Lahko povzroči toksične reakcije in anafilaktoidne reakcije pri dojenčkih in otrocih do 3 leta starosti.
No interaction studies have been performed with interferonbeta-1a in humans.
Študij medsebojnega delovanja z drugimi zdravili za interferon beta- 1a pri človeku niso izvedli.
Caution should be exercised when administering Rebif in combination with medicinal products that have a narrow therapeutic index and are largely dependent on the hepatic cytochrome P450 system for clearance, e. g. antiepileptics and some classes of antidepressants.
Previdnost se zahteva pri uporabi zdravila Rebif v kombinaciji z zdravili, ki imajo ozek terapevtski indeks in se v glavnem razgrajujejo preko jetrnega citokrom P450 sistema, npr.
4 The interaction of Rebif with corticosteroids or adrenocorticotropic hormone (ACTH) has not been studied systematically.
Medsebojno delovanje zdravila Rebif s kortikosteroidi ali adrenokortikotropnim hormonom (ACTH) še ni sistematično raziskano.
There is limited information on the use of Rebif in pregnancy.
Podatki o uporabi zdravila Rebif v nosečnosti so omejeni.
Therefore initiation of treatment is contraindicated during pregnancy (see section 4.3).
Zato je začetek zdravljenja v nosečnosti kontraindiciran (glejte poglavje4. 3).
If the patient becomes pregnant or plans to become pregnant while taking Rebif she should be informed of the potential hazards and discontinuation of therapy should be considered (see section 5.3).
Če v času zdravljenja z zdravilom Rebif bolnica zanosi ali načrtuje nosečnost, jo moramo poučiti o potencialnih nevarnostih in razmisliti o ukinitvi zdravljenja z zdravilom Rebif (glejte poglavje 5. 3).
It is not known whether Rebif is excreted in human milk.
Ni znano, če se pri človeku zdravilo Rebif izloča z mlekom.
Because of the potential for serious adverse reactions in breast-fed infants, a decision should be made whether to discontinue breast-feeding or Rebif therapy.
Zaradi potencialne nevarnosti resnih neželenih učinkov za dojence, se mora sprejeti odločitev bodisi o prekinitvi dojenja ali pa prenehanju zdravljenja z zdravilom Rebif.
Central nervous system-related adverse events associated with the use of interferon beta (e. g. dizziness) might influence the patient's ability to drive or use machines (see section 4.8).
Neželeni dogodki v povezavi z uporabo interferona beta, vezani na osrednji živčni sistem (npr. omotica), lahko vplivajo na bolnikovo sposobnost za vožnjo ali upravljanje strojev (glejte poglavje 4. 8).
Approximately 70% of patients treated with Rebif can expect to experience the typical interferon flu-like syndrome within the first six months after starting treatment.
Približno 70% bolnikov zdravljenih z zdravilom Rebif lahko pričakuje pojav za interferon značilnega gripi podobnega sindroma v prvih šestih mesecih po začetku zdravljenja.
Approximately 30% of patients will also experience reactions at the injection site, predominantly mild inflammation or erythema.
Približno 30% bolnikov bo tudi izkusilo reakcije na mestu injiciranja, pretežno blago vnetje ali eritem.
Asymptomatic increases in laboratory parameters of hepatic function and decreases in white blood cells (WBC) are also common.
Asimptomatsko povečanje laboratorijskih vrednosti parametrov jetrne funkcije in zmanjšanje števila belih krvnih celic sta tudi pogosta.
The majority of adverse reactions observed with IFN beta-1a are usually mild and reversible, and respond well to dose reductions.
Večina neželenih učinkov, opaženih pri IFN- beta- 1a je običajno blagih in reverzibilnih in se dobro odzivajo na zmanjšanje odmerka.
The adverse reactions reported below are classified according to frequency of occurrence as follows:
Spodaj navedeni neželeni učinki so razdeljeni glede na pogostnost pojavljanja kot sledi:
Very Common Common Uncommon Rare
Zelo pogosti Pogosti Občasni Redki Zelo redki Neznana
≥ 1/ 10 ≥ 1/ 100 to < 1/ 10 ≥ 1/ 1,000 to < 1/ 100 ≥ 1/ 10,000 to < 1/ 1,000
≥ 1/ 10 ≥ 1/ 100 do < 1/ 10 ≥ 1/ 1. 000 do < 1/ 100 ≥ 1/ 10. 000 do < 1/ 1. 000 < 1/ 10. 000 Ni mogoče oceniti iz razpoložljivih podatkov
Cannot be estimated from the available data
V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Predstavljeni podatki so zbrani iz kliničnih študij z multiplo sklerozo (placebo = 824 bolnikov; zdravilo Rebif 22 mikrogramov trikrat na teden (TIW) =398 bolnikov; zdravilo Rebif 44 mikrogramov TIW=
The data presented is obtained from pooled clinical studies in multiple sclerosis (placebo=824 patients; Rebif 22 micrograms three times per week (TIW)=398 patients; Rebif 44 micrograms TIW=727 patients) and shows the frequency of adverse reactions observed at six months (excess over
5 727 bolnikov) in kažejo pogostnost neželenih učinkov opaženih v šestih mesecih (presežek glede na placebo).
Adverse reactions are listed below by frequency of occurrence and by MedDRA System Organ Class.
Neželeni učinki so našteti po pogostnosti pojavljanja in po MedDRA razvrstitvi organskih sistemov.
System Organ Class Infections and infestations
Organski sistem
Uncommon Injection site abscess
Občasni
Not known* Injection site infections, including cellulitis
okužbe mesta injiciranja, vključno s celulitisom
Neutropenia, lymphopenia, leucopenia, thrombocytopenia, anaemia
nevtropenija, limfopenija, leukopenija, trombocitopen ija, anemija
Thyroid dysfunction most often presenting as hypothyroidism or hyperthyroidism
motnje delovanja ščitnice, najpogosteje v obliki hipotireoidizma ali hipertireoidizma
Seizures
epileptični napadi
Diarrhoea, vomiting, nausea
driska, bruhanje, slabost
Pruritus, rash, erythematous rash, maculo-papular rash
srbenje, izpuščaj,
Angioedema, urticaria, erythema multiforme, erythema multiforme-like skin reactions, Stevens-Johnson syndrome, hair loss
urtikarija,
Musculoskeletal and connective tissue disorders
podkožja Bolezni mišično - skeletnega sistema in vezivnega tkiva
Myalgia, arthralgia
eritematozni izpuščaj, makulopapulozni izpuščaj mialgija, artralgija bolečina na mestu
General disorders and administration site conditions
multiformni eritem, multiformne mu eritemu podobne kožne reakcije, Stevens - Johnsonov sindrom, izguba las
Injection site inflammation, injection site reaction, influenza-like symptoms
vnetje na mestu Splošne težave in injiciranja, bula na injiciranja, spremembe na mestu injiciranja, mestu injiciranja utrujenost, reakcija na aplikacije drgetanje, zvišana mestu telesna injiciranja, gripi temperatura podoben simptom Preiskave Bolezni dihal, prsnega koša in mediastinalnega prostora
Injection site pain, fatigue, rigors, fever
asimptomatsko zvečanje ravni transaminaz
Injection site necrosis, injection site mass
6
Investigations
Organski sistem
Asymptomatic transaminase increase
Zelo pogosti
Respiratory, thoracic and mediastinal disorders
Občasni
Dyspnoea
Neznana *
Immune system disorders Vascular disorders
Bolezni imunskega sistema Žilne bolezni
Anaphylactic reactions Thromboembolic events
anafilaktične reakcije tromboembol ični dogodki
Hepatitis with or without icterus
hepatitis z ali brez zlatenice.