natgillin/translations-raw huggingface dataset:
When first starting treatment with Rebif, in order to allow tachyphylaxis to develop thus reducing adverse reactions, it is recommended that 8.8 micrograms be administered by subcutaneous injection three times per week during the initial 2 weeks of therapy.
Na začetku prvega zdravljenja z zdravilom Rebifse odmerek postopno viša namenom razvoja tahifilaksije in s tem zmanjšanja neželenih učinkov se priporoča dajanje 8, 8 mikrogramov trikrat na teden subkutano v obliki injekcije prva 2 tedna zdravljenja.
Thereafter, 22 micrograms be administered
Nato 22 mikrogramov subkutano v obliki injekcije trikrat na teden 3. in 4. teden in od petega tedna naprej dajanje celotnih 44 mikrogramov.
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.
18 Način uporabe Pred injiciranjem in še naslednjih 24 ur po vsaki injekciji je priporočena uporaba antipiretičnega analgetika z antipiretičnim delovanjem za zmanjševanje gripi podobnih simptomov povezanih z uporabo zdravila Rebif.
Safety and efficacy with Rebif have not been demonstrated beyond 4 years of treatment.
Varnost in učinkovitost zdravljenja z Rebifom, ki traja več kot štiri leta, nista dokazani.
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.
Zato se priporoča, da lečeči zdravnik bolnika pregleda najmanj vsako drugo leto v 4- letnem obdobju od začetka zdravljenja z Rebifom in na individualni osnovi sprejme odločitev o dolgoročnem zdravljenju.
19 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 19 oteklina ali odtekanje tekočine iz mesta injiciranja, posvetuje s svojim zdravnikom, preden nadaljuje z uporabo injekcij zdravil Rebif.
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 (zlasti alanin- aminotransferaze (ALT)) in 1- 3% bolnikov je razvilo povečanje jetrnih transaminaz, ki je preseglo 5- kratne vrednosti zgornje meje normalne ravni (ULN).
This medicinal product contains 1.0 mg benzyl alcohol per dose of 0.2 ml and 2.5 mg benzyl alcohol per dose of 0.5 ml.
To zdravilo vsebuje 1, 0 mg benzilalkohola na odmerek 0, 2 ml in 2, 5 mg benzilalkohola na odmerek 0, 5 ml.
20 4.5 Interaction with other medicinal products and other forms of interaction
20 4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
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. antiepileptiki in nekatere vrste antidepresivov.
Because of the potential for serious adverse reactions in breast-fed infants, a decision should be made either to discontinue nursing or to discontinue 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.
21 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:
≥ 1/ 10 ≥ 1/ 100 to < 1/ 10 ≥ 1/ 1,000 to < 1/ 100 ≥ 1/ 10,000 to < 1/ 1,000 < 1/ 10,000
≥ 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
Not known
21
Cannot be estimated from the available data
razpoložljivih podatkov
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 placebo).
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= 727 bolnikov) in kažejo pogostnost neželenih učinkov opaženih v šestih mesecih (presežek glede na placebo).
Very common
Zelo pogosti nevtropenija, limfopenija, leukopenija, trombocitope nija, anemija
Pruritus, rash, erythematous rash, maculo-papular rash
srbenje, izpuščaj, eritematozni izpuščaj, makulopapulozni izpuščaj
Myalgia, arthralgia
mialgija, artralgija bolečina na mestu
22 System Organ Class General disorders and administration site conditions
22
Very common Injection site inflammation, injection site reaction, influenza-like symptoms
Organski sistem Bolezni dihal, prsnega koša in mediastinalnega prostora
Common Injection site pain, fatigue, rigors, fever
Zelo pogosti
Not known*
Pogosti
Dyspnoea
Neznana * dispneja
Anaphylactic reactions Thromboembolic events
anafilaktične reakcije tromboembolični dogodki
*Adverse reactions identified during post marketing surveillance (frequency not known)
* Neželeni učinki, opaženi v času spremljanja zdravila na trgu po pridobitvi dovoljenja za promet (pogostnost ni znana)
Interferon beta has a potential for causing severe liver injury.
Zdravilo Rebif ima, tako kot drugi interferoni beta, potencial za povzročanje hudih jetrnih poškodb.
Rebif (interferon beta-1a) shares the same amino acid sequence with endogenous human interferon beta.
Zdravilo Rebif (interferon beta- 1a) ima enako zaporedje aminokislin kot človeški endogeni beta interferon.
At licensed posology, Rebif 22 micrograms has been demonstrated to decrease the incidence (approximately 30% over 2 years) and severity of clinical relapses in patients with at
Pri odobrenem odmerjanju zdravila Rebif 22 mikrogramov dokazano zmanjšuje pogostnost (približno 30% v dveh letih) in intenziteto kliničnih zagonov bolezni pri bolnikih, ki so imeli najmanj dva zagona v predhodnih dveh letih in izhodiščni EDSS 0 do 0, 5.
Over 4 years, the reduction in the mean exacerbation rate was 22% in patients treated with Rebif 22 micrograms, and 29% in patients treated with Rebif 44 micrograms group compared with a group of patients treated with placebo for 2 years and then either Rebif 22 or Rebif 44 micrograms for 2 years.
Tekom 4 let se je povprečna pogostnost zagonov zmanjšala za 22% pri bolnikih, ki so prejemali zdravilo Rebif 22 mikrogramov in za 29% pri bolnikih, ki so prejemali zdravilo Rebif 44 mikrogramov, v primerjavi s skupino bolnikov, 23 ki so 2 leti prejemali placebo in nato še 2 leti zdravilo Rebif 22 mikrogramov ali zdravilo Rebif 44 mikrogramov.
If the patient population was divided into 2 subgroups (those with and those without relapses in the 2-year period prior to study entry), there was no effect on disability in patients without relapses, but in patients with relapses, the proportion with progression in disability at the end of the study was reduced from 70% (placebo) to 57% (Rebif 22 micrograms and 44 micrograms combined).
Če so razdelili populacijo bolnikov v dve podskupini (na bolnike z in brez pojava zagonov v 2 letih pred vključitvijo v študijo), ni bilo pomembnega učinka na razvoj nesposobnosti pri bolnikih brez zagonov, vendar pa se je pri bolnikih z zagoni delež tistih z napredovalo nesposobnostjo na koncu študije zmanjšal iz 70% (placebo) na 57% (zdravilo Rebif 22 mikrogramov v kombinaciji z zdravilom Rebif 44 mikrogramov).
Subcutaneous and intramuscular administrations of Rebif produce equivalent exposure to interferon beta.
Izpostavljenost interferonu beta je ekvivalentna po subkutani ali intramuskularni uporabi zdravil Rebif.
For patients initiating treatment with Rebif, Rebif 8.8 micrograms and Rebif 22 micrograms are available in an initiation pack composed of 6 individual doses of a 1 ml type 1 glass syringe with a stainless steel needle containing 0.2 ml of Rebif 8.8 micrograms solution for injection and 6 individual doses of a 1 ml type 1 glass syringe with a stainless steel needle containing 0.5 ml of Rebif 22 micrograms solution for injection.
Za bolnike, ki začenjajo zdravljenje z zdravilom Rebif, sta na voljo Rebif 8, 8 mikrogramov in Rebif 22 mikrogramov v začetnem pakiranju, ki vsebuje 6 posameznih odmerkov po 0, 2 ml Rebif 8, 8 mikrogramov raztopine za injiciranje v enomililitrskih tip I steklenih injekcijskih brizgah z iglo iz nerjavečega jekla in 6 posameznih odmerkov po 0, 5 ml Rebif 22 mikrogramov raztopine za injiciranje v enomililitrskih tip I steklenih injekcijskih brizgah z iglo iz nerjavečega jekla.
4th May 2003 Date of latest renewal:
4. maj 2003 Datum zadnjega podaljšanja dovoljenja za promet:
Rebif 22 micrograms/ 0.5 ml solution for injection in cartridge
Rebif 22 mikrogramov/ 0, 5 ml raztopina za injiciranje v vložku.
Each pre-filled cartridge contains 66 micrograms (18 MIU*) of interferon beta-1a** in 1.5 ml solution, corresponding to 44 micrograms/ ml.
En napolnjen vložek vsebuje 66 mikrogramov (18 milijonov i. e. *) interferona beta- 1a ** v 1, 5 ml raztopine, kar ustreza 44 mikrogramov/ ml.
Excipient:7.5 mg benzyl alcohol For a full list of excipients, see section 6.1.
Za celoten seznam pomožnih snovi glejte poglavje 6. 1.
Solution for injection in cartridge.
Raztopina za injiciranje v vložku.
Clear to opalescent solution, with pH 3.7 to 4.1 and osmolarity 250 to 450 mOsm/ l.
Bistra do opalescentna raztopina, s pH 3, 7 do 4, 1 in osmolarnostjo 250 do 450 mOsm/ l.
Method of Administration Rebif solution for injection in cartridge is intended for multidose use and should only be used with the RebiSmart autoinjector device following adequate training of the patient and/ or carer.
Način uporabe Zdravilo Rebif raztopina za injiciranje v vložku je namenjeno za večkratno odmerjanje in se sme uporabljati samo s pripomočkom za samoinjiciranje RebiSmart po ustreznem izobraževanju bolnika in/ ali negovalca.
For administration, the instructions provided in the package leaflet and in the instruction manual provided with the RebiSmart autoinjector device should be followed.
Za uporabo je treba upoštevati navodila za uporabo zdravila in navodila za uporabo, priložena pripomočku za samoinjiciranje RebiSmart.
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.
Pred injiciranjem in še naslednjih 24 ur po vsaki injekciji je priporočena uporaba antipiretičnega analgetika z antipiretičnim delovanjem za zmanjševanje gripi podobnih simptomov povezanih z uporabo zdravila Rebif.
27 At the present time, it is not known for how long patients should be treated.
27 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.
Zato se priporoča, da lečeči zdravnik 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.
Patients with single lesions may continue provided that the necrosis is not too extensive.
Bolniki, ki imajo eno samo lezijo, lahko z zdravljenjem nadaljujejo pod pogojem, da 28 nekroza ni preobširna.
28 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 (zlasti alanin- aminotransferaze (ALT)) in 1- 3% bolnikov je razvilo povečanje jetrnih transaminaz, ki je preseglo 5- kratne vrednosti zgornje meje normalne ravni (ULN).
This medicinal product contains 2.5 mg benzyl alcohol per dose of 0.5 ml.
To zdravilo vsebuje 2, 5 mg benzilalkohola na odmerek 0, 5 ml.
Interferons have been reported to reduce the activity of hepatic cytochrome P450-dependent enzymes in humans and animals.
29 Poročali so, da interferoni zmanjšajo aktivnost od jetrnega citokroma P450 odvisnih encimov pri človeku in živalih.
29 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. antiepileptiki in nekatere vrste antidepresivov.
≥ 1/ 10 ≥ 1/ 100 to < 1/ 10 ≥ 1/ 1,000 to < 1/ 100 ≥ 1/ 10,000 to < 1/ 1,000 < 1/ 10,000
≥ 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
30 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 placebo).
30 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= 727 bolnikov) in kažejo pogostnost neželenih učinkov opaženih v šestih mesecih (presežek glede na placebo).
*Not known Injection site infections, including cellulitis
okužbe mesta injiciranja, vključno s celulitisom
Pruritus, rash, erythematous rash, maculo-papular rash
eritematozni izpuščaj, makulopapulozni izpuščaj
Angioedema, urticaria, erythema multiforme, erythema multiforme-like skin reactions, Stevens-Johnson syndrome, hair loss
multiformni eritem, multiformne mu eritemu podobne kožne reakcije, Stevens - Johnsonov sindrom, izguba las
Injection site inflammation, injection site reaction, influenza-like symptoms
Splošne težave in vnetje na mestu injiciranja, bula na injiciranja, spremembe na mestu injiciranja, mestu injiciranja utrujenost, aplikacije
Injection site pain, fatigue, rigors, fever
reakcija na mestu injiciranja, gripi podoben simptom
Injection site necrosis, injection site mass
drgetanje, zvišana telesna temperatura
Respiratory, thoracic and mediastinal disorders
Bolezni dihal,
Anaphylactic reactions Thromboembolic events
Organski sistem
System Organ Class Hepatobiliary disorders
Zelo pogosti
Uncommon
Neznana *
*Not known Hepatitis with or without icterus
Bolezni jeter, žolčnika in žolčevodov
Immunostimulants, Interferon, ATC code:
Farmakoterapevtska skupina: zdravila za spodbujanje imunske odzivnosti, interferoni, oznaka ATC:
Over 4 years, the reduction in the mean exacerbation rate was 22% in patients treated with Rebif 22 micrograms, and 29% in patients treated with Rebif 44 micrograms group compared with a group of patients treated with placebo for 2 years and then either Rebif 22 or Rebif 44 micrograms for 2 years.
Tekom 4 let se je povprečna pogostnost zagonov zmanjšala za 22% pri bolnikih, ki so prejemali zdravilo Rebif 22 mikrogramov in za 29% pri bolnikih, ki so prejemali zdravilo Rebif 44 mikrogramov, v primerjavi s skupino bolnikov, 32 ki so 2 leti prejemali placebo in nato še 2 leti zdravilo Rebif 22 mikrogramov ali zdravilo Rebif 44 mikrogramov.
In a 3-year study in patients with secondary progressive multiple sclerosis (EDSS 3-6.5) with evidence of clinical progression in the preceding two years and who had not experienced relapses in the preceding 8 weeks, Rebif had no significant effect on progression of disability, but relapse rate was reduced by approximately 30%.
V 3 letni študiji z bolniki, ki imajo sekundarno progresivno multiplo sklerozo (EDSS 3 do 6, 5) s potrjenim kliničnim napredovanjem bolezni v predhodnih dveh letih in brez zagonov v predhodnih osmih tednih, zdravivo Rebif ni imelo pomembnega učinka na napredovanje nesposobnosti, vendar pa je zmanjšalo delež zagonov bolezni za približno 30%.
32 Rebif has not yet been investigated in patients with primary progressive multiple sclerosis, and should not be used in such patients.
Uporaba zdravila Rebif pri bolnikih s primarno progresivno multiplo sklerozo še ni raziskana, zato se zdravila Rebif pri teh bolnikih ne sme uporabljati.
Mannitol Poloxamer 188 L-methionine Benzyl alcohol Sodium acetate Acetic acid for pH adjustment Sodium hydroxide for pH adjustment Water for injections
33 ocetna kislina za uravnavanje pH natrijev hidroksid za uravnavanje pH voda za injekcije
The RebiSmart autoinjector device containing a pre-filled cartridge of Rebif must be stored in the device storage box in a refrigerator (2°C – 8°C).
Pripomoček za samoinjiciranje RebiSmart, ki vsebuje napolnjen vložek zdravila Rebif, shranjujte v škatli za pripomoček v hladilniku (2 °C – 8 °C).
Cartridges (type 1 glass) with a plunger stopper (rubber) and crimp cap (aluminium and halobutyl rubber) containing 1.5 ml solution for injection.
Vložki (steklo tipa 1) z batnim zamaškom (guma) in objemno zaporko (aluminij in halogenirana butilna guma), ki vsebujejo 1, 5 ml raztopine za injiciranje.
Pack size of 4 cartridges.
Velikost pakiranja 4 vložki.
The solution for injection in a pre-filled cartridge is ready for use with the RebiSmart autoinjector device.
Raztopina za injiciranje v napolnjenem vložku je pripravljena za uporabo s pripomočkom za samoinjiciranje RebiSmart.
For storage of the autoinjector device with the cartridge, see section 6.4.
Za shranjevanje pripomočka za samoinjiciranje z vložkom glejte poglavje 6. 4.
Rebif 44 micrograms/ 0.5ml solution for injection in cartridge
Rebif 44 mikrogramov/ 0, 5 ml raztopina za injiciranje v vložku
Each pre-filled cartridge contains132 micrograms (36 MIU*) of interferon beta-1a** in 1.5 ml solution, corresponding to 88 micrograms/ ml.
En napolnjen vložek vsebuje 132 mikrogramov (36 milijonov i. e. *) interferona beta- 1a ** v 1, 5 ml raztopine, kar ustreza 88 mikrogramov/ ml.
7.5 mg benzyl alcohol For a full list of excipients, see section 6.1.
Za celoten seznam pomožnih snovi glejte poglavje 6. 1.
Clear to opalescent solution, with pH3.7 to 4.1 and osmolarity 250 to 450 mOsm/ l.
Bistra do opalescentna raztopina, s pH 3, 7 do 4, 1 in osmolarnostjo 250 do 450 mOsm/ l.
Method of administration Rebif solution for injection in cartridge is intended for multidose use and should only be used with the RebiSmart autoinjector device following adequate training of the patient and/ or carer.
Način uporabe Zdravilo Rebif raztopino za injiciranje v vložku je namenjeno za večkratno odmerjanje in se sme uporabljati samo s pripomočkomza samoinjiciranje RebiSmart po ustreznem izobraževanju bolnika in/ ali negovalca.
For administration, the instructions provided in the package leaflet and in the instruction manual provided with the RebiSmart autoinjector device should be followed.
Za uporabo je treba upoštevati navodila za uporabo zdravila in navodila za uporabo, priložena ripomočku za samoinjiciranje RebiSmart.
35 At the present time, it is not known for how long patients should be treated.
36 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.
Zato je se priporoča, da lečeči zdravnik 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.
Patients with single lesions may continue provided that the necrosis is not too extensive.
Bolniki, ki imajo eno samo lezijo, lahko z zdravljenjem nadaljujejo, pod pogojem, da 37 nekroza ni preobširna.
36 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 (zlasti alanin- aminotransferaze (ALT)) in 1- 3% bolnikov je razvilo povečanje jetrnih transaminaz, ki je preseglo 5- kratne vrednosti zgornje meje normalne ravni (ULN).
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.
No interaction studies have been performed with Iinterferon beta-1a in humans.
38 Študij medsebojnega delovanja z drugimi zdravili za interferon beta- 1a pri človeku niso izvedli.
37 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. antiepileptiki in nekatere vrste antidepresivov.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
39 V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti.
38 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 placebo).
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= 727 bolnikov) in kažejo pogostnost neželenih učinkov opaženih v šestih mesecih (presežek glede na placebo).
Seizures
epileptični napadi angioedem,
Gastrointestinal disorders
Bolezni kože in
Diarrhoea, vomiting, nausea
urtikarija,
Skin and subcutaneous tissue disorders
podkožja Bolezni mišično - skeletnega sistema in vezivnega tkiva
Pruritus, rash, erythematous rash, maculo-papular rash
izpuščaj, eritematozni izpuščaj, makulopapul ozni izpuščaj mialgija, artralgija bolečina na
Angioedema, urticaria, erythema multiforme, erythema multiforme-like skin reactions, Stevens-Johnson syndrome, hair loss
multiformni eritem, multiformnemu eritemu podobne kožne reakcije, Stevens - Johnsonov sindrom, izguba las
Musculoskeletal and connective tissue disorders
Splošne težave in
Myalgia, arthralgia
vnetje na mestu
General disorders and administration site conditions
mestu
Injection site inflammation, injection site reaction, influenza-like symptoms
injiciranja, bula na
Injection site pain, fatigue, rigors, fever
injiciranja,
Injection site necrosis, injection site mass
mestu injiciranja
Investigations
mestu aplikacije
39
anafilaktične reakcije tromboembolični
Anaphylactic reactions Thromboembolic events
40
System Organ Class Hepatobiliary disorders
Organski sistem Bolezni jeter, žolčnika in žolčevodov
Not known* Hepatitis with or without icterus
Neznana * dogodki hepatitis z ali brez zlatenice.