natgillin/translations-raw huggingface dataset:
Med undtagelse af pyreksi var frekvensen for størstedelen af de rapporterede bivirkninger markant mindre for patienter med kronisk hepatitis B, der blev behandlet med Pegasys- monoterapi sammenlignet med HCV - patienter, der blev behandlet med Pegasys- monoterapi (se tabel 4).
With the exception of pyrexia the frequency of the majority of the reported adverse reactions was notably less in CHB patients treated with Pegasys monotherapy compared with HCV patients treated with Pegasys monotherapy (see Table 4).
88% af de patienter, der blev behandlet med Pegasys oplevede uønskede hændelser sammenlignet med 53% af patienterne i sammenligningsgruppen behandlet med lamivudin.
Adverse events were experienced by 88% of Pegasys-treated patients as compared with 53% of patients in the lamivudine comparator group, while 6% of the Pegasys-treated and 4% of the lamivudine-treated patients experienced serious adverse events during the studies.
6% af de patienter, der blev behandlet med Pegasys, oplevede alvorlige uønskede hændelser under forsøget sammenlignet med 4% af patienterne, der blev behandlet med lamivudin.
Adverse events or laboratory abnormalities led to 5% of patients withdrawing from Pegasys treatment, while less than 1% of patients withdrew from lamivudine treatment for these reasons.
Uønskede hændelser eller laboratorie- abnormaliteter medførte, at 5
The percentage of patients with
Seponeringsraterne for patienter med cirrose svarede til raterne i hele populationen i hver behandlingsgruppe.
64 cirrhosis who withdrew from treatment was similar to that of the overall population in each treatment group.
63 Tabel 4:
Table 4:
Immunsystemet
65 Body system
Anafylaksi, systemisk lupus erytematosus, rheumatoid arthritis
Anaphylaxis, systemic lupus erythematosus rheumatoid arthritis
Koma, konvulsioner,, facialisparese
Coma, convulsions, facial palsy
Optisk neuropati, Synstab papilødem, retinal vaskulær lidelse, retinopati, sår på cornea
Optic neuropathy, Papilledema, retinal vascular disorder, retinopathy, corneal ulcer
Luftveje, thorax og mediastinum
66 Body system
Dyspnø, hoste
Very Common ≥ 1/ 10
Dyspnø under anstrengelser, epistaxis, nasopharyngitis, sinuskongestion, nasal kongestion, rhinitis, ondt i halsen
Common ≥ 1/ 100 to < 1/ 10
Hiven efter vejret
Uncommon ≥ 1/ 1000 to < 1/ 100
Interstitiel pneumonitis inklusiv fatal udgang, lungeemboli
Rare ≥ 1/ 10,000 to < 1/ 1000
Mave- tarmkanalen
Very rare < 1/ 10,000
Diarré *, kvalme *, abdominalsmerter *
Respiratory, thoracic and mediastinal disorders
Opkastning, dyspepsi, dysfagi, sår i munden, gingival blødning, glossitis, stomatitis, flatulens, mundtørhed
Dyspnoea, cough
Gastrointestinal blødning
Dyspnoea exertional, epistaxis, nasopharyngitis, sinus congestion, nasal congestion, rhinitis, sore throat
Mavesår, pancreatitis
Wheezing
64 System - organklasse
Interstitial pneumonitis including fatal outcome, pulmonary embolism
Uønskede hændelser efter markedsføring
67 Post marketing adverse events
65 Moderat (absolut neutrofillocyttal:
Moderate (ANC:
Som for andre interferoner blev der set en høj incidens af neutraliserende antistoffer ved kronisk hepatitis B, dette var imidlertidigt ikke korreleret med fravær af terapeutisk respons hos nogen af sygdommene.
However in neither disease was this correlated with lack of therapeutic response.
20. 000.
Interferon alfa-2a is conjugated with bis-[monomethoxy polyethylene glycol] at a degree of substitution of one mole of polymer/ mole of protein. The average molecular mass is approximately 60,000 of which the protein moiety constitutes approximately 20,000.
Faldets første fase indtræffer indenfor 24 til 36 timer efter den første Pegasys- dosis, og efterfølges af anden fase, som fortsætter de næste 4 til 16 uger hos patienter med varigt respons.
The first phase of decline occurs 24 to 36 hours after the first dose of Pegasys is followed by and the second phase of decline which continues over the next 4 to 16 weeks in patients who achieve a sustained response.
66 Kronisk hepatitis B:
Chronic hepatitis B:
Tabel 5:
69 Table 5:
67 Kronisk Hepatitis C:
Chronic hepatitis C
Behandlingsregimer, behandlingsvarighed og studieudfald for HCV- monoinficerede patienter og hiv- HCV- co- inficerede patienter.
For HCV monoinfected patients and HIV-HCV co-infected patients, for treatment regimens, duration of therapy and study outcome see Tables 6, 7, 8 and Table 14, respectively.
Tabel 6:
70 Table 6:
Pegasys 180 µg
Interferon alfa-2a
Interferon alfa- 2a 6 MIE/ 3 MIE & 3 MIE
Pegasys Interferon Pegasys Pegasys 180 mcg alfa-2a 180 mcg 180 mcg
Pegasys Interferon 180 µg alfa- 2ª 3 MIE
180 mcg 6 MIU/
Samlet vedvaren - de respons
Overall Sustained Response
68 ved baseline samt viral belastning i relation til genotype, viral belastning ved baseline og hurtig virologisk respons ved uge 4, er opsummeret i hhv. tabel 7 og 8.
The virological responses of HCV monoinfected patients treated with Pegasys monotherapy and with Pegasys and ribavirin combination therapy in relation to genotype and pre-treatment viral load and in relation to genotype, pre-treatment viral load and rapid virological response at week 4 are summarised in Table 7 and Table 8, respectively.
Tabel 7:
71 Table 7:
Lav viral bel.
Low viral load= ≤ 800,000 IU/ mL; High viral load= > 800,000 IU/ mL *Pegasys 180 mcg ribavirin 1000/ 1200 mg, 48 w vs.
69 Tabel 8:
Table 8:
- - 92% (22/ 24))
Genotype 4 non RVR
Lav viral belastning = ≤800. 000 IE/ ml; Høj viral belastning = > 800. 000 IE/ ml Hurtig viral respons (HCV- RNA ikke- målelig) ved uge 4 og HCV- RNA ikke- målelig ved uge 24
Low viral load= ≤ 800,000 IU/ mL; High viral load= > 800,000 IU/ mL RVR = rapid viral response (HCV RNA undetectable) at week 4 and HCV RNA undetectable at week 24
En begrænset mængde data viser, at en forkortelse af behandlingen til 24 uger kan være forbundet med højere risiko for recidiv (se tabel 9).
72 Although limited, data indicated that shortening treatment to 24 weeks might be associated with a higher risk of relapse (see Table 9).
I studie NV17317 med patienter smittet med virologisk genotype 2 eller 3, modtog alle patienter Pegasys 180 μg s. c. én gang ugentlig og 800 mg ribavirin, og patienterne blev randomiceret til 16 eller 24 ugers behandling. Behandling i 16 uger resulterede i lavere vedvarende virologisk respons (65%) end behandling i 24 uger (76%) (p < 0, 0001).
Overall treatment for 16 weeks resulted in lower sustained viral response (65%) than treatment for 24 weeks (76%) (p < 0.0001).
70 Tabel 10:
Table 10:
Data indikerer, at afkortning af behandlingsvarighed til 16 uger er forbundet med højere risiko for relaps (se tabel 11).
73 The data indicated that shortening treatment to 16 weeks is associated with a higher risk of relapse (see Table 11).
Genotype 2 or 3 RVR
Genotype 2 or 3
15
RVR
% (67/ 439)
(67/ 439)
6
6%
% (23/ 386)
9% (21/ 245)
Lav viral belastning
High viral load
5% [0, 6%; 10, 3%]
10.3%]
71 Tabel 12:
74 Table 12:
72 Tabel 13 Vedvarende virologisk respons i HALT- C ved tidligere behandling hos ikke - responderende population Pegasys 180 µg & Ribavirin 1000/ 1200 mg Tidligere behandling
Table 13 Sustained Virological Response in HALT-C by Previous Treatment Regimen in Non-responder Population Previous Treatment
Det virologiske respons for patienter behandlet med Pegasys monoterapi og med Pegasys og ribavirin kombinationsbehandling i relation til genotype og viral belastning ved baseline for hiv- HCV- co - inficerede patienter er angivet i tabel 14.
75 HIV-HCV co-infected patients The virological responses of patients treated with Pegasys monotherapy and with Pegasys and ribavirin combination therapy in relation to genotype and pre-treatment viral load for HIV-HCV co- infected patients are summarised below in Table 14.
Interferon alfa- 2ª 3 MIE &
Pegasys 180 mcg &
I henhold til studier på rotter om massebalance, vævsdistribution og helkrops - autoradioluminografi fordeles peginterferon alfa- 2a, udover at opkoncentreres i blodet, til lever, nyrer og knoglemarv.
From mass balance, tissue distribution and whole body autoradioluminography studies performed in rats, peginterferon alfa-2a is distributed to the liver, kidney and bone marrow in addition to being highly concentrated in the blood.
Hos raske forsøgspersoner og hos patienter med kronisk hepatitis B eller C er der set dosisproportional stigning i ekspositionen for Pegasys efter behandling én gang ugentlig.
76 Dose-proportional increases in exposure of Pegasys are seen in healthy subjects and in patients with chronic hepatitis B or C after once-weekly dosing.
74 5. 3 Prækliniske sikkerhedsdata
5.3 Preclinical safety data
0, 5 ml af opløsning til injektion i en fyldt injektionssprøjte (type I silikoniseret glas) med en stempelprop og en tophætte (butylgummi lamineret med fluororesin på den side, der vender mod indholdet) med en kanylw.
0.5 ml of solution for injection in pre-filled syringe (siliconised Type I glass) with a plunger stopper and tip cap (butyl rubber laminated on the product facing side with fluororesin) with a needle.
Findes i pakninger med 1, 4 eller 12.
Available in packs of 1, 4 or 12.
76 1.
79 1.
Pegasys 180 mikrogram injektionsvæske, opløsning i en fyldt injektionssprøjte
Pegasys 180 micrograms solution for injection in pre-filled syringe
En fyldt sprøjte indeholder peginterferon alfa- 2a *..................................................................................... 180 mikrogram Hvert hætteglas på 0, 5 ml opløsning indeholder 180 mikrogram peginterferon alfa- 2a *.
One pre-filled syringe contains peginterferon alfa-2a*.................................................................................... .180 micrograms Each syringe of 0.5 ml solution contains 180 micrograms peginterferon alfa-2a*.
77 4. 2 Dosering og indgivelsesmåde
80 4.2 Posology and method of administration
Den anbefalede dosis og behandlingsvarighed af Pegasys til såvel HbeAg- positiv og HbeAg- negativ kronisk hepatitis B er 180 mikrogram én gang ugentlig i 48 uger, administreret subkutant i abdomen eller lår.
The recommended dosage and duration of Pegasys for both HBeAg-positive and HBeAg-negative chronic hepatitis B is 180 micrograms once weekly for 48 weeks by subcutaneous administration in the abdomen or thigh.
78 Tabel 1:
81 Table 1:
RVR = hurtig virologisk respons (ikke- målelig HCV- RNA) ved uge 4 og HCV- RNA ikke- målelig ved uge 24 ** RVR = hurtigt virologisk respons (HCV- RNA- negativ) ved uge 4 Lav viral belastning = ≤800. 000 IE/ ml; høj viral belastning = > 800. 000 IE/ ml
*RVR = rapid viral response (HCV RNA undetectable) at week 4 and HCV RNA undetectable at week 24; **RVR = rapid viral response (HCV RNA negative) by week 4 LVL= ≤ 800,000 IU/ mL; HVL= > 800,000 IU/ mL
Den endelige kliniske betydning af en kortere initial behandling på 16 uger i stedet for 24 uger er ikke kendt tagende hensyn til behovet for at genbehandle patienter, som ikke reagerer på behandling, og patienter, som recidiverer.
The ultimate clinical impact of a shortened initial treatment of 16 weeks instead of 24 weeks is unknown, taking into account the need for retreating non-responding and relapsing patients.
79 Tabel 2:
82 Table 2:
Genotype 1 og genotype 2/ 3 hiv- HCV- co- inficerede patienter i kombinationsbehandling.
Positive predictive values of 45% (50/ 110) and 70% (59/ 84) were observed for genotype 1 and genotype 2/ 3 HIV-HCV co-infected patients receiving combination therapy.
Hvis et af følgende indtræffer skal ribavirindosis reduceres til 600 mg/ dag (200 mg om morgenen og 400 mg om aftenen):
Specific recommendations for management of treatment-emergent anaemia are as follows: ribavirin should be reduced to 600 milligrams / day (200 milligrams in the morning and 400 milligrams in the evening) if either of the following apply:
Et lægeligt skøn.
If the abnormality is reversed, ribavirin may be restarted at 600 milligrams daily, and further increased to 800 milligrams daily at the discretion of the treating physician.
80 Tabel 3:
83 Table 3:
Child- Pugh A).
84 Patients with hepatic impairment In patients with compensated cirrhosis (eg, Child-Pugh A), Pegasys has been shown to be effective and safe.
INR * graduering iht.
INR
< 1, 7 1, 7- 2, 3 > 2, 3 Burns og Saunders (1966)
< 1.7 1.7- 2.3> 2.3
82 4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen
85 4.4 Special warnings and precautions for use
Efter påbegyndelse af behandlingen skal der tages hæmatologiske prøver efter 2 og 4 uger og biokemiske prøver efter 4 uger.
Haematological tests should be repeated after 2 and 4weeks and biochemical tests should be performed at 4weeks.
83 I de kliniske studier om kombineret behandling af Pegasys med ribavirin er der set anæmi (hæmoglobin < 10 g/ dl) hos op til 15% af patienterne med kronisk hepatitis C.
86 The occurrence of anaemia (haemoglobin < 10 g/ dl) has been observed in up to 15% of chronic hepatitis C patients in clinical trials on the combined treatment of Pegasys with ribavirin.
Halvdelen af de tilfælde, hvor stigningen oversteg 10 gange øvre referencegrænse, blev Pegasys- dosis reduceret eller seponeret, indtil transaminasestigningerne var forsvundet, hvorimod behandlingen fortsatte uændret i de resterende tilfælde.
In approximately half the case of flares exceeding 10 times the upper limit of normal, Pegasys dosing was reduced or withheld until the transaminase elevations subsided, while in the rest therapy was continued unchanged.
84 Autoimmune sygdomme Der er rapporteret om udvikling af autoantistoffer og autoimmunsygdomme under behandling med alfa- interferoner.
Autoimmune disease The development of auto-antibodies and autoimmune disorders has been reported during treatment with alpha interferons.
Øjenforandringer Som tilfældet er for andre interferoner, er der efter behandling med Pegasys i sjældne tilfælde rapporteret om retinopati, inklusive retinal hæmoragi, ekssudater, papilødem, optisk neuropati og obstruktion af arterier og vener i retina, som kan medføre synstab. Alle patienter skal have foretaget en øjenundersøgelse inden start af behandling.
All patients should have a baseline eye examination.
Pegasys skal anvendes med forsigtighed hos patienter med psoriasis, og hvis der kommer udbrud eller forværring af psoriasislæsioner, skal det overvejes at stoppe behandlingen.
Pegasys must be used with caution in patients with psoriasis, and in cases of onset or worsening of psoriatic lesions, discontinuation of therapy should be considered.
Hiv- HCV- co- infektion Der henvises til produktresuméerne for de retrovirale lægemidler, som skal gives samtidig med HCV - behandling vedrørende opmærksomhed på og håndtering af toksicitet specifikt for hvert produkt samt for potentielt overlap af toksicitet med Pegasys med eller uden ribavirin.
HIV/ HCV coinfection Please refer to the respective Summary of Product Characteristics of the antiretroviral medicinal products that are to be taken concurrently with HCV therapy for awareness and management of toxicities specific for each product and the potential for overlapping toxicities with Pegasys with or without ribavirin.
4. 5).
The concomitant use of ribavirin with zidovudine is not recommended due to an increased risk of anaemia (see section 4.5)
Hos patienter, der er co- inficeret med hiv- HCV, er begrænsede effekt - og sikkerhedsdata (N = 51) tilgængelige hos personer med CD4- tal mindre end 200 celler/ µl.
88 In patients co-infected with HIV-HCV, limited efficacy and safety data (N = 51) are available in subjects with CD4 counts less than 200 cells/ uL.
86 Samtidig administration af ribavirin og didanosin anbefales ikke.
Co-administration of ribavirin and didanosine is not recommended.
Forværring af anæmi pga. ribavirin er rapporteret, når zidovudin anvendes som del af hiv- behandling, dog er den eksakte mekanisme stadig ikke belyst.
89 Exacerbation of anaemia due to ribavirin has been reported when zidovudine is part of the regimen used to treat HIV although the exact mechanism remains to be elucidated.
88% af de patienter, der blev behandlet med Pegasys oplevede uønskede hændelser sammenlignet med 53% af patienterne i sammenligningsgruppen behandlet med lamivudin.
Adverse events or laboratory abnormalities led to 5% of patients withdrawing from Pegasys treatment, while less than 1% of patients withdrew from lamivudine treatment for these reasons.
6% af de patienter, der blev behandlet med
The percentage of patients with
Seponeringsraterne for patienter med cirrose svarede til raterne i hele populationen i hver behandlingsgruppe.
90 cirrhosis who withdrew from treatment was similar to that of the overall population in each treatment group.
88 Tabel 4:
Table 4:
Øvre luftvejsinfektioner, bronkitis, oral candidiasis, herpes simplex, svampeinfek - tioner, virale eller bakterielle infektioner
Upper respiratory infection, bronchitis, oral candidiasis, herpes simplex, fungal, viral and bacterial infections
Immunsystemet
91 Body system
Idiopatisk eller trombotisk trombocyto - penisk purpura
, Idiopathic or thrombotic thrombocytopenic purpura
Rretinal blødning
Retinal hemorrhage
89 System - organklasse
Hepato-biliary disorders
Almene symptomer Pyreksi, og reaktioner på kulderystelser *, administrationsstedet smerter, asteni, træthed, reaktioner på injektionsstedet *, irritabilitet *
General disorders Pyrexia, and rigors*, administration pain*, site conditions asthenia, fatigue, injection site reaction*, irritability*
Uønskede hændelser efter markedsføring
93 Post marketing adverse events
90 Moderat (absolut neutrofillocyttal:
Moderate (ANC:
91 Kronisk hepatitis B:
Chronic hepatitis B:
Tabel 5:
95 Table 5:
92 Kronisk Hepatitis C:
Chronic hepatitis C
Tabel 6:
96 Table 6:
Studie NV15495 S
Study NV15495 Study
Interferon Pegasys Interferon alfa- 2a 180 µg alfa- 2a 6 MIE/ 3 3 MIE
Pegasys Interferon Pegasys Pegasys 180 mcg alfa-2a 180 mcg 180 mcg
Interferon alfa- 2b 3 MIE
180 mcg 6 MIU/
3% til 16% p- værdi (stratificeret Cochran- Mantel- Haenszel test) = 0, 003
p-value (stratified Cochran-Mantel-Haenszel test) = 0.001 p-value (stratified Cochran-Mantel-Haenszel test)=0.003
Resultaterne fra studie NV15942
The virological responses of HCV monoinfected patients treated with Pegasys monotherapy and with Pegasys and ribavirin combination therapy in relation to genotype and pre-treatment viral load and in relation to genotype, pre-treatment viral load and rapid virological response at week 4 are summarised in Table 7 and Table 8, respectively.
93 udgør rationalet for at anbefale behandling baseret på genotype, viral belastning ved baseline og virologisk respons ved uge 4 (se tabel 1, 7 og 8).
The results of study NV15942 provide the rationale for recommending treatment regimens based on genotype, baseline viral load and virological response at week 4 (see Tables 1, 7 and 8).
Forskellen mellem behandlingsregimerne var generelt ikke påvirket forekomst/ fravær af cirrose; derfor er behandlingsanbefalingerne for genotype 1, 2 og 3 uafhængige af denne baselinekarakteristika.
The difference between treatment regimens was in general not influenced by presence/ absence of cirrhosis; therefore treatment recommendations for genotype 1, 2 or 3 are independent of this baseline characteristic.
Tabel 7:
97 Table 7:
94 Tabel 8:
Table 8:
En begrænset mængde data viser, at en forkortelse af behandlingen til 24 uger kan være forbundet med højere risiko for recidiv (se tabel 9).
98 Although limited, data indicated that shortening treatment to 24 weeks might be associated with a higher risk of relapse (see Table 9).
Samlet Behandling i 16 uger resulterede i lavere vedvarende virologisk respons (65%) end behandling i 24 uger (76%) (p < 0, 0001).
Overall treatment for 16 weeks resulted in lower sustained viral response (65%) than treatment for 24 weeks (76%) (p < 0.0001).
Det vedvarende virologiske respons opnået efter 16 uger og 24 ugers behandling blev også undersøgt i en retrospektiv undergruppe- undersøgelse af patienter, som var HC - RNA- negative ved uge 4, og som havde en lav virologisk belastning ved baseline (se tabel 10).
The sustained viral response achieved with 16 weeks of treatment and with 24 weeks of treatment was also examined in a retrospective subgroup analysis of patients who were HCV RNA negative by week 4 and had a LVL at baseline (see Table 10)
95 Tabel 10:
Table 10:
Data indikerer, at afkortning af behandlingsvarighed til 16 uger er forbundet med højere risiko for relaps (se tabel 11).
99 The data indicated that shortening treatment to 16 weeks is associated with a higher risk of relapse (see Table 11).
96 Tabel 12:
100 Table 12:
97 Tabel 13 Vedvarende virologisk respons i HALT- C ved tidligere behandling hos ikke - responderende population Pegasys 180 µg & Ribavirin 1000/ 1200 mg Tidligere behandling
Table 13 Sustained Virological Response in HALT-C by Previous Treatment Regimen in Non-responder Population Previous Treatment
Det virologiske respons for patienter behandlet med Pegasys monoterapi og med Pegasys og ribavirin kombinationsbehandling i relation til genotype og viral belastning ved baseline for hiv- HCV- co - inficerede patienter er angivet i tabel 14.
101 HIV-HCV co-infected patients The virological responses of patients treated with Pegasys monotherapy and with Pegasys and ribavirin combination therapy in relation to genotype and pre-treatment viral load for HIV-HCV co- infected patients are summarised below in Table 14.
Vedvarende virologisk respons baseret på genotype og viral belastning ved baseline efterbehandling med Pegasys i kombination med ribavirin hos hiv- HCV- co- inficerede patienter Studie NR15961
Sustained Virological Response based on Genotype and Pre-treatment Viral Load after Pegasys Combination Therapy with Ribavirin in HIV-HCV Co-infected Patients Study NR15961
Lav viral belastning= ≤800. 000 IE/ ml; Høj viral belastning = > 800. 000 IE/ ml * Pegasys 180 μg ribavirin 800 mg vs.
Low viral load= ≤ 800,000 IU/ mL; High viral load= > 800,000 IU/ mL * Pegasys 180 mcg ribavirin 800 mg vs.
Hos raske forsøgspersoner og hos patienter med kronisk hepatitis B eller C er der set dosisproportional stigning i ekspositionen for Pegasys efter behandling én gang ugentlig.
102 Dose-proportional increases in exposure of Pegasys are seen in healthy subjects and in patients with chronic hepatitis B or C after once-weekly dosing.
99 5. 3 Prækliniske sikkerhedsdata
5.3 Preclinical safety data
0, 5 ml af opløsning til injektion i en fyldt injektionssprøjte (type I silikoniseret glas) med en stempelprop og en tophætte (butylgummi lamineret med fluororesin på den side, der vender mod indholdet) med en kanyle.
0.5 ml of solution for injection in pre-filled syringe (siliconised Type I glass) with a plunger stopper and tip cap (butyl rubber laminated on the product facing side with fluororesin) with a needle.
100 7.
7.
101 BILAG II
105 ANNEX II
FREMSTILLERE AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
102 A.
106 A.
Navn og adresse på fremstillerne af det biologisk aktive stof
Name and address of the manufacturer(s) of the biological active substance
1 D- 79639 Grenzach - Wyhlen Tyskland
1 D-79639 Grenzach- Wyhlen Germany
Indehaveren af markedsføringstilladelsen skal fortsat indsende årlige periodiske sikkerhedsopdateringer (PSUR).
The marketing authorisation holder should continue to submit yearly periodic safety update (PSUR) reports.
103 BILAG III
107 ANNEX III
104 A.
108 A.
105 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
109 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
YDRE KARTON – 1 x 135 μg HÆTTEGLAS
OUTER CARTON – 1 x 135 μ g VIAL
Pegasys 135 mikrogram injektionsvæske, opløsning Peginterferon alfa- 2a
Pegasys 135 micrograms solution for injection Peginterferon alfa-2a
1 hætteglas indeholder 135 mikrogram peginterferon alfa- 2a.
1 vial contains 135 micrograms of peginterferon alfa -2a.
Indeholder også natriumchlorid, polysorbat 80, benzylalkohol (se indlægssedlen for yderligere information), natriumacetat, eddikesyre, og vand til injektionsvæsker.
Also contains sodium chloride, polysorbate 80, benzyl alcohol (see the package leaflet for further information), sodium acetate, acetic acid and water for injections.
1 hætteglas 135 mikrogram i 1 ml
1 vial 135 micrograms in 1 ml