Zostavax

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

varicella-zoster virus (live, attenuated)

Saatavilla:

Merck Sharp & Dohme B.V.

ATC-koodi:

J07BK02

INN (Kansainvälinen yleisnimi):

shingles (herpes zoster) vaccine (live)

Terapeuttinen ryhmä:

Viral vaccines

Terapeuttinen alue:

Herpes Zoster; Immunization

Käyttöaiheet:

Zostavax is indicated for prevention of herpes zoster ('zoster' or shingles) and herpes-zoster-related post-herpetic neuralgia. Zostavax is indicated for immunisation of individuals 50 years of age or older.,

Tuoteyhteenveto:

Revision: 33

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2006-05-19

Pakkausseloste

34
B. PACKAGE LEAFLET
35
PACKAGE LEAFLET: IN
FORMATION F
OR THE USER
ZOSTAVAX
POWDER AND SOLV
E
NT FOR SUSPENSION FOR INJECTION
shingles (herpes zoster) vaccine (live)
READ ALL OF THIS LEAFLET CAREFULLY
BEFORE YOU ARE VAC
CINATED BECA
USE IT CONT
AINS IMPOR
TANT
INFORMATION FOR YOU
.
-
Keep this leafle
t. You
may need t
o read it again.
-
If you have any furt
h
er questions, ask your doctor or pharmacist.
-
This vaccine has been prescribed for you only.
Do not pass it on to others.
-
If you get any of the side effects, talk to
your doctor or pharm
acist. This incl
udes any possible
side effects not listed in this leaf
let. See section 4.
WHAT IS IN
THIS LEAFLET
1.
What
ZOSTAVAX
is and what it is used fo
r
2.
What you need to know be
fore y
ou receive
ZOSTAVAX
3.
How to use ZOSTAVAX
4.
Possible side eff
ects
5.
How to store ZOSTAVAX
6.
Contents of the pack and other inform
ation
1.
WHAT ZOSTAVAX
IS AND WHAT IT IS USED FOR
ZOSTAVAX
is a vaccine
used t
o prevent shingles (zoster) and zoster
-related post-herpetic neuralgia
(PHN), the long-
lasting nerve pain
that follows sh
ingles.
ZOSTAVAX
is used to vaccinate individuals 50
y
ears of age or older.
ZOSTAVAX
cannot be used to treat
exist
ing shingles or the pain associated with existing shingles.
DISEASE INFORM
ATION ON SHINGLES:
What is shingles?
Shingles is a painful, blistering rash. It
usually occurs in one part of the bod
y
and can last for several
w
eeks. It may lead to severe
and long-
lasting pain and scarring. Less commonly, bacterial skin
infections, wea
kness, musc
le paralysis, l
oss of hearing or visio
n can occur
. Shingles is caused by the
same virus that causes chickenp
o
x. After you have had chic
k
enpox, the virus that caused
it stays in
your body in nerve cells. Sometimes, after many years, the virus bec
omes active
again and causes
shingles.
What is PHN?
After the shingles blister
s heal, pain can last for months or ye
a
rs and may be severe. Thi
s long-lasting
nerve pain is
called post-
herpetic neuralgia or PHN.
2.
WHAT YOU NEED TO KNOW BEFORE

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
ZOSTAVAX
powder and solvent
for suspension for injection
ZOSTAVAX
powder and
solvent for suspension for injecti
on in a pre-filled syringe
shingles (herpe
s zoster) vaccine (live)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
After reconstitution,
one dose (0.65 mL) contains:
Varicella-zoster virus
1
, Oka/Merck strain, (live,
att
enuated) not less than 19
,400 PFU
2
1
produced in human diploid (MRC-5) cells
2
PFU = Plaque
-
forming units
This vaccine may contain
traces
of neomycin
. See sections 4.3 and 4.4.
For the full
list of excipient
s, see section
6.1.
3.
PHARMACEUTICAL
FORM
Pow
der and solvent for suspension for
injection.
T
he powder is a wh
ite to off-w
hite compact crystalline
plug.
The solvent is a clear, colourless liquid.
4.
CLINI
CAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ZOSTAVAX
is indicated for prevention of herpe
s zo
ster (“zoster” or shingles) and her
pes
zoster-related post-herpetic neuralgia (PHN).
ZOSTAVAX
is indicated for i
mmu
nization of individua
ls 50
years of age or older.
4.2
POSOLOGY AND METHOD OF ADMINISTRATIO
N
Posology
Individuals should receive a sin
gle dose (0.65 mL).
The need for a boo
ster dose is
not known. S
ee sections 4.8 and 5.1.
Paediatric population
The saf
ety and efficacy of
ZOSTAVAX
in children and adolescents have not been established. No
data are available.
There is no relevant use of
ZOSTAVAX
in children and adolescents fo
r
prevention
of primary
varicella infectio
n (chickenpox).
3
Method of administr
ation
The vaccine can be injected
subcutaneously (SC)
or intramuscularly (IM)
, preferably in
the deltoid
region
(see sections
4.8 and 5.1)
.
T
he vaccine should be administered s
ub
cutaneously
in patients with severe thro
mbocytopenia or any
coagulation disorder (see section 4.4).
THE V
ACCINE SHOULD UNDER NO CIRCUMSTANCES BE INJECTED INTRAVASCULARLY
.
For precautions to be taken
before handlin
g or
administering the medicinal produc
t, see section 6.6.
For instructions on r
econ