Arepanrix

Country: European Union

Language: Slovenian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
25-10-2011
Summary of Product characteristics Summary of Product characteristics (SPC)
25-10-2011
Public Assessment Report Public Assessment Report (PAR)
25-10-2011

Active ingredient:

split virus influence, inaktivirano, ki vsebujejo antigen*: A/California/7/2009 (H1N1)v, kot sev (X-179A)*razmnožujejo v jajca.

Available from:

GlaxoSmithKline Biologicals S.A.

ATC code:

J07BB02

INN (International Name):

pandemic influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)

Therapeutic group:

Cepiva proti gripi

Therapeutic area:

Influenza, Human; Immunization; Disease Outbreaks

Therapeutic indications:

Preprečevanje gripe v uradno prijavljeni pandemični situaciji. Pandemije gripe cepiva je treba uporabljati v skladu z uradnimi smernice.

Product summary:

Revision: 1

Authorization status:

Umaknjeno

Authorization date:

2010-03-23

Patient Information leaflet

                                Zdravilo nima veā dovoljenja za promet
26
6.
POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN
POGLEDA OTROK
Cepivo shranjujte nedosegljivo otrokom!
7.
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA
Suspenzijo in emulzijo morate pred uporabo zmešati skupaj.
8.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
EXP
9.
POSEBNA NAVODILA ZA SHRANJEVANJE
_ _
Shranjujte v hladilniku.
Ne zamrzujte.
Shranjujte v originalni ovojnini za zagotovitev zaščite pred
svetlobo.
10.
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH
ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
Zavrzite v skladu z lokalnimi predpisi.
11.
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
GlaxoSmithKline Biologicals s.a.
Rue de l’Institut 89
B-1330 Rixensart, Belgija
12.
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET
EU/1/10/624/001
13.
ŠTEVILKA SERIJE
_ _
Lot:
14.
NAČIN IZDAJANJA ZDRAVILA
Izdaja cepiva je le na recept.
15.
NAVODILA ZA UPORABO
16.
PODATKI V BRAILLOVI PISAVI
Zdravilo nima veā dovoljenja za promet
27
Sprejeta je utemeljitev, da Braillova pisava ni potrebna.
Zdravilo nima veā dovoljenja za promet
28
PODATKI NA ZUNANJI OVOJNINI
PAKIRANJE S 50 VIALAMI SUSPENZIJE (ANTIGEN)
1.
IME ZDRAVILA
Suspenzija za emulzijo za injiciranje za cepivo Arepanrix
cepivo proti pandemski gripi (H1N1) z delci virionov, inaktivirano (z
adjuvansom)
2.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN
inaktivirani delci virusa gripe, ki vsebujejo antigene*, ki ustrezajo
3,75 mikrogramom
hemaglutinina/odmerek
*Antigen: sev A/California/7/2009 (X-179A) podoben sevu
A/California/7/2009 (H1N1)v
3.
SEZNAM POMOŽNIH SNOVI
Pomožne snovi: tiomersal, natrijev klorid, natrijev hidrogenfosfat,
kalijev dihidrogenfosfat, kalijev
klorid, voda za injekcije
4.
FARMACEVTSKA OBLIKA IN VSEBINA
suspenzija antigena za injiciranje
50 vial: suspenzija
2,5 ml na vialo
Po premešanju z emulzijo adjuvansa:
10 ODMERKOV
po 0,5 ml
5.
POSTOPEK IN POT(I) UPORABE ZDRAVILA
_ _
intramuskularna uporaba
Pred uporabo pretresite.
Pred uporabo preberite priloženo navodilo.
6.

                                
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Summary of Product characteristics

                                Zdravilo nima veā dovoljenja za promet
1
DODATEK I
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
Zdravilo nima veā dovoljenja za promet
2
1.
IME ZDRAVILA
Arepanrix suspenzija in emulzija za emulzijo za injiciranje
cepivo proti pandemski gripi (H1N1)v z delci virionov, inaktivirano (z
adjuvansom)
2.
KAKOVOSTNA IN KOLIČINSKA SESTAVA
Po premešanju 1 odmerek (0,5 ml) vsebuje:
inaktivirane delce virusa gripe, ki vsebujejo antigene*, ki ustrezajo:
_ _
sevu A/California/7/2009 (X-179A) podobnemu sevu A/California/7/2009
(H1N1)v
3,75 mikrogramov
**
*
namnožen v jajcih
**
hemaglutinin
Cepivo ustreza priporočilu Svetovne zdravstvene organizacije in
odločbi EU za pandemijo.
Adjuvans AS03, ki je sestavljen iz skvalena (10,69 miligramov), DL-
α
-tokoferola (11,86 miligramov)
in polisorbata 80 (4,86 miligramov).
Po premešanju suspenzije in emulzije nastane večodmerno cepivo v
viali. Za število odmerkov v viali
glejte poglavje 6.5.
Pomožne snovi: Cepivo vsebuje 5 mikrogramov tiomersala.
Za celoten seznam pomožnih snovi glejte poglavje 6.1.
3.
FARMACEVTSKA OBLIKA
suspenzija in emulzija za emulzijo za injiciranje
Suspenzija je prozorna do sivo bela opalescentna suspenzija, ki lahko
rahlo sedimentira.
Emulzija je belkasta homogena tekočina.
4.
KLINIČNI PODATKI
4.1
TERAPEVTSKE INDIKACIJE
Preprečevanje gripe v uradno razglašenih pandemskih razmerah (glejte
poglavji 4.2 in 5.1).
Cepivo proti pandemski gripi je treba uporabljati v skladu z uradnimi
priporočili.
4.2
ODMERJANJE IN NAČIN UPORABE
Odmerjanje
Priporočila za odmerjanje upoštevajo dostopne podatke iz:
•
potekajočih kliničnih študij pri zdravih preiskovancih, ki so
dobili en odmerek cepiva
Arepanrix (H1N1),
•
kliničnih študij pri zdravih preiskovancih(vključno s starejšimi),
ki so dobili dva odmerka
različice cepiva Arepanrix z vsebnostjo 3,75 µg HA (HA -
hemaglutinin) pridobljenega iz
A/Indonesia/05/2005 (H5N1).
Zdravilo nima veā dovoljenja za promet
3
In tudi iz:
•
potekajočih kliničnih študij pri zdravih preiskovancih, ki so
dobili en odmere
                                
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Similar products

Active ingredient split virus influence, inaktivirano, ki vsebujejo antigen*: A/California/7/2009 (H1N1)v, kot sev (X-179A)*razmnožujejo v jajca.

split virus influence, inaktivirano, ki vsebujejo antigen*: A/California/7/2009 (H1N1)v, kot sev (X-179A)*razmnožujejo v jajca.

ATC code J07BB02

J07BB02

Marketed by GlaxoSmithKline Biologicals S.A.

GlaxoSmithKline Biologicals S.A.

INN (International Name) pandemic influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)

pandemic influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)

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Patient Information leaflet Patient Information leaflet Bulgarian 25-10-2011
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Arepanrix