PegIntron

Country: European Union

Language: Slovenian

Source: EMA (European Medicines Agency)

Buy It Now

Patient Information leaflet Patient Information leaflet (PIL)
03-06-2021
Summary of Product characteristics Summary of Product characteristics (SPC)
03-06-2021
Public Assessment Report Public Assessment Report (PAR)
03-06-2021

Active ingredient:

peginterferon alfa-2b

Available from:

Merck Sharp & Dohme B.V.

ATC code:

L03AB10

INN (International Name):

peginterferon alfa-2b

Therapeutic group:

Immunostimulants,

Therapeutic area:

Hepatitis C, kronični

Therapeutic indications:

Adults (tritherapy)PegIntron in combination with ribavirin and boceprevir (tritherapy) is indicated for the treatment of chronic-hepatitis-C (CHC) genotype-1 infection in adult patients (18 years of age and older) with compensated liver disease who are previously untreated or who have failed previous therapy. Prosimo, da ribavirin in boceprevir povzetkov glavnih značilnosti zdravila (SmPCs), ko PegIntron se uporablja v kombinaciji s temi zdravili. Adults (bitherapy and monotherapy)PegIntron is indicated for the treatment of adult patients (18 years of age and older) with CHC who are positive for hepatitis-C-virus RNA (HCV-RNA), including patients with compensated cirrhosis and / or co-infected with clinically stable HIV. PegIntron v kombinaciji z ribavirin (bitherapy) je indiciran za zdravljenje CHC okužbe pri odraslih bolnikih, ki so predhodno nezdravljenih vključno z bolniki s klinično stabilno HIV co-okužbe in pri odraslih bolnikih, ki niso predhodnem zdravljenju z interferonom-alfa (pegylated ali ne-pegylated) in ribavirin kombinacija terapije ali interferonom-alfa monotherapy. Interferon monotherapy, vključno z PegIntron, je indicirana predvsem v primeru, nestrpnosti ali contraindication za ribavirin. Prosimo, glejte povzetek glavnih značilnosti Zdravila ribavirin, ko PegIntron se uporablja v kombinaciji z ribavirin. Paediatric population (bitherapy)PegIntron is indicated in a combination regimen with ribavirin for the treatment of children three years of age and older and adolescents who have CHC, previously untreated, without liver decompensation, and who are positive for HCV-RNA. Ko se odločate, da ne odloži zdravljenje do odrasle dobe, je pomembno upoštevati, da je kombinacija terapije povzročile zaviranja rasti, ki so lahko nepopravljive v nekaterih bolnikih, ki. Odločitev za zdravljenje mora biti od primera do primera. Prosimo, glejte povzetek glavnih značilnosti Zdravila ribavirin za kapsule ali peroralna raztopina, ko PegIntron se uporablja v kombinaciji z ribavirin.

Product summary:

Revision: 36

Authorization status:

Umaknjeno

Authorization date:

2000-05-24

Patient Information leaflet

                                79
9.
POSEBNA NAVODILA ZA SHRANJEVANJE
SHRANJUJTE V HLADILNIKU.
10.
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH
ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
Po dajanju odmerka morate morebitno preostalo raztopino zavreči.
11.
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
Nizozemska
12.
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET
EU/1/00/131/001 (1 viala praška, 1 ampula vehikla)
EU/1/00/131/002 (1 viala praška, 1 ampula vehikla, 1 injekcijska
brizga, 2 injekcijski igli, 1 čistilni
tampon)
EU/1/00/131/003 (4 viale praška, 4 ampule vehikla)
EU/1/00/131/004 (4 viale praška, 4 ampule vehikla, 4 injekcijske
brizge, 8 injekcijskih igel, 4 čistilni
tamponi)
EU/1/00/131/005 (6 vial praška, 6 ampul vehikla)
EU/1/00/131/026 (12 vial praška, 12 ampul vehikla, 12 injekcijskih
brizg, 24 injekcijskih igel, 12
čistilnih tamponov)
13.
ŠTEVILKA SERIJE
Lot
14.
NAČIN IZDAJANJA ZDRAVILA
15.
NAVODILA ZA UPORABO
16.
PODATKI V BRAILLOVI PISAVI
PegIntron 50 mcg
17.
EDINSTVENA OZNAKA – DVODIMENZIONALNA ČRTNA KODA
Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.
Zdravilo nima več dovoljenja za promet
80
18.
EDINSTVENA OZNAKA – V BERLJIVI OBLIKI
PC:
SN:
NN:
Zdravilo nima več dovoljenja za promet
81
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
OVOJNINAH
PEGINTRON 50 MIKROGRAMOV – VIALA PRAŠKA
1.
IME ZDRAVILA IN POT(I) UPORABE
PegIntron 50 mikrogramov prašek za injekcijo
peginterferon alfa-2b
s.c.
2.
POSTOPEK UPORABE
Pred uporabo preberite priloženo navodilo!
3.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
EXP
4.
ŠTEVILKA SERIJE
Lot
5.
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT
50 mcg/0,5 ml
6.
DRUGI PODATKI
Zdravilo nima več dovoljenja za promet
82
PODATKI NA ZUNANJI OVOJNINI
ŠKATLA 80 MIKROGRAMOV
1.
IME ZDRAVILA
PegIntron 80 mikrogramov prašek in vehikel za raztopino za
injiciranje
peginterferon alfa-2b
2.
NAVEDBA ENE ALI VEČ UČINKOVIN
Ena viala praška vsebuje 80 mikrogramov peg
                                
                                Read the complete document

Summary of Product characteristics

                                1
PRILOGA I
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
Zdravilo nima več dovoljenja za promet
2
1.
IME ZDRAVILA
PegIntron 50 mikrogramov prašek in vehikel za raztopino za
injiciranje
PegIntron 80 mikrogramov prašek in vehikel za raztopino za
injiciranje
PegIntron 100 mikrogramov prašek in vehikel za raztopino za
injiciranje
PegIntron 120 mikrogramov prašek in vehikel za raztopino za
injiciranje
PegIntron 150 mikrogramov prašek in vehikel za raztopino za
injiciranje
2.
KAKOVOSTNA IN KOLIČINSKA SESTAVA
PegIntron 50 mikrogramov prašek in vehikel za raztopino za
injiciranje
Ena viala vsebuje 50 mikrogramov peginterferona alfa-2b, merjeno glede
na beljakovine.
Po rekonstituciji v skladu z navodili vsebuje vsaka viala 50
mikrogramov/0,5 ml peginterferona alfa-2b.
PegIntron 80 mikrogramov prašek in vehikel za raztopino za
injiciranje
Ena viala vsebuje 80 mikrogramov peginterferona alfa-2b, merjeno glede
na beljakovine.
Po rekonstituciji v skladu z navodili vsebuje vsaka viala 80
mikrogramov/0,5 ml peginterferona alfa-2b.
PegIntron 100 mikrogramov prašek in vehikel za raztopino za
injiciranje
Ena viala vsebuje 100 mikrogramov peginterferona alfa-2b, merjeno
glede na beljakovine.
Po rekonstituciji v skladu z navodili vsebuje vsaka viala 100
mikrogramov/0,5 ml peginterferona alfa-2b.
PegIntron 120 mikrogramov prašek in vehikel za raztopino za
injiciranje
Ena viala vsebuje 120 mikrogramov peginterferona alfa-2b, merjeno
glede na beljakovine.
Po rekonstituciji v skladu z navodili vsebuje vsaka viala 120
mikrogramov/0,5 ml peginterferona alfa-2b.
PegIntron 150 mikrogramov prašek in vehikel za raztopino za
injiciranje
Ena viala vsebuje 150 mikrogramov peginterferona alfa-2b, merjeno
glede na beljakovine.
Po rekonstituciji v skladu z navodili vsebuje vsaka viala 150
mikrogramov/0,5 ml peginterferona alfa-2b.
Učinkovina zdravila je kovalentni konjugat rekombinantnega
interferona alfa-2b* z monometoksi
polietilenglikolom. Jakosti tega zdravila se ne sme primerjati z
jakostjo drugih pegiliranih ali
nepegiliranih beljakovi
                                
                                Read the complete document

Similar products

Active ingredient peginterferon alfa-2b

peginterferon alfa-2b

ATC code L03AB10

L03AB10

Marketed by Merck Sharp & Dohme B.V.

Merck Sharp & Dohme B.V.

INN (International Name) peginterferon alfa-2b

peginterferon alfa-2b

Documents in other languages

Patient Information leaflet Patient Information leaflet Bulgarian 03-06-2021
Summary of Product characteristics Summary of Product characteristics Bulgarian 03-06-2021
Public Assessment Report Public Assessment Report Bulgarian 03-06-2021
Patient Information leaflet Patient Information leaflet Spanish 03-06-2021
Summary of Product characteristics Summary of Product characteristics Spanish 03-06-2021
Public Assessment Report Public Assessment Report Spanish 03-06-2021
Patient Information leaflet Patient Information leaflet Czech 03-06-2021
Summary of Product characteristics Summary of Product characteristics Czech 03-06-2021
Public Assessment Report Public Assessment Report Czech 03-06-2021
Patient Information leaflet Patient Information leaflet Danish 03-06-2021
Summary of Product characteristics Summary of Product characteristics Danish 03-06-2021
Public Assessment Report Public Assessment Report Danish 03-06-2021
Patient Information leaflet Patient Information leaflet German 03-06-2021
Summary of Product characteristics Summary of Product characteristics German 03-06-2021
Public Assessment Report Public Assessment Report German 03-06-2021
Patient Information leaflet Patient Information leaflet Estonian 03-06-2021
Summary of Product characteristics Summary of Product characteristics Estonian 03-06-2021
Public Assessment Report Public Assessment Report Estonian 03-06-2021
Patient Information leaflet Patient Information leaflet Greek 03-06-2021
Summary of Product characteristics Summary of Product characteristics Greek 03-06-2021
Public Assessment Report Public Assessment Report Greek 03-06-2021
Patient Information leaflet Patient Information leaflet English 03-06-2021
Summary of Product characteristics Summary of Product characteristics English 03-06-2021
Public Assessment Report Public Assessment Report English 03-06-2021
Patient Information leaflet Patient Information leaflet French 03-06-2021
Summary of Product characteristics Summary of Product characteristics French 03-06-2021
Public Assessment Report Public Assessment Report French 03-06-2021
Patient Information leaflet Patient Information leaflet Italian 03-06-2021
Summary of Product characteristics Summary of Product characteristics Italian 03-06-2021
Public Assessment Report Public Assessment Report Italian 03-06-2021
Patient Information leaflet Patient Information leaflet Latvian 03-06-2021
Summary of Product characteristics Summary of Product characteristics Latvian 03-06-2021
Public Assessment Report Public Assessment Report Latvian 03-06-2021
Patient Information leaflet Patient Information leaflet Lithuanian 03-06-2021
Summary of Product characteristics Summary of Product characteristics Lithuanian 03-06-2021
Public Assessment Report Public Assessment Report Lithuanian 03-06-2021
Patient Information leaflet Patient Information leaflet Hungarian 03-06-2021
Summary of Product characteristics Summary of Product characteristics Hungarian 03-06-2021
Public Assessment Report Public Assessment Report Hungarian 03-06-2021
Patient Information leaflet Patient Information leaflet Maltese 03-06-2021
Summary of Product characteristics Summary of Product characteristics Maltese 03-06-2021
Public Assessment Report Public Assessment Report Maltese 03-06-2021
Patient Information leaflet Patient Information leaflet Dutch 03-06-2021
Summary of Product characteristics Summary of Product characteristics Dutch 03-06-2021
Public Assessment Report Public Assessment Report Dutch 03-06-2021
Patient Information leaflet Patient Information leaflet Polish 03-06-2021
Summary of Product characteristics Summary of Product characteristics Polish 03-06-2021
Public Assessment Report Public Assessment Report Polish 03-06-2021
Patient Information leaflet Patient Information leaflet Portuguese 03-06-2021
Summary of Product characteristics Summary of Product characteristics Portuguese 03-06-2021
Public Assessment Report Public Assessment Report Portuguese 03-06-2021
Patient Information leaflet Patient Information leaflet Romanian 03-06-2021
Summary of Product characteristics Summary of Product characteristics Romanian 03-06-2021
Public Assessment Report Public Assessment Report Romanian 03-06-2021
Patient Information leaflet Patient Information leaflet Slovak 03-06-2021
Summary of Product characteristics Summary of Product characteristics Slovak 03-06-2021
Public Assessment Report Public Assessment Report Slovak 03-06-2021
Patient Information leaflet Patient Information leaflet Finnish 03-06-2021
Summary of Product characteristics Summary of Product characteristics Finnish 03-06-2021
Public Assessment Report Public Assessment Report Finnish 03-06-2021
Patient Information leaflet Patient Information leaflet Swedish 03-06-2021
Summary of Product characteristics Summary of Product characteristics Swedish 03-06-2021
Public Assessment Report Public Assessment Report Swedish 03-06-2021
Patient Information leaflet Patient Information leaflet Norwegian 03-06-2021
Summary of Product characteristics Summary of Product characteristics Norwegian 03-06-2021
Patient Information leaflet Patient Information leaflet Icelandic 03-06-2021
Summary of Product characteristics Summary of Product characteristics Icelandic 03-06-2021
Patient Information leaflet Patient Information leaflet Croatian 03-06-2021
Summary of Product characteristics Summary of Product characteristics Croatian 03-06-2021

Search alerts related to this product

Alerts PegIntron peginterferon alfa-2b

PegIntron peginterferon alfa-2b

View documents history

Documents history Documents history

PegIntron