VARILRIX

Maa: Israel

Kieli: englanti

Lähde: Ministry of Health

Aktiivinen ainesosa:

VARICELLA VIRUS, LIVE ATTENUATED

Saatavilla:

GLAXO SMITH KLINE (ISRAEL) LTD

ATC-koodi:

J07BK

Lääkemuoto:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Koostumus:

VARICELLA VIRUS, LIVE ATTENUATED NLT 10^3.3 PFU

Antoreitti:

S.C

Prescription tyyppi:

Required

Valmistaja:

GLAXO SMITH KLINE BIOLOGICALS S.A

Terapeuttinen ryhmä:

VARICELLA ZOSTER VACCINES

Käyttöaiheet:

Varilrix is intended for the active immunization against varicella of the categories of persons listed below, where there is no history of varicella.- Healthy subjects, from the age of 12 months.- Patients at high risk of severe varicella, such as patients with acute leukemia or a chronic condition, those on immunosuppressive therapy or those for whom an organ transplant is being considered.Healthy persons living in close contact with patients with varicella and high-risk patients.

Valtuutus päivämäärä:

2014-07-31

Pakkausseloste

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a physician’s prescription only
VARILRIX
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Each dose (0.5 ml) contains:
Live attenuated varicella virus ≥ 10
3.3
PFU
For a list of inactive and allergenic ingredients in the preparation,
see section
6 – ”Further Information”.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This
leaflet contains concise information about the medicine. If you have
further
questions, refer to the physician or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may
harm them, even if it seems to you that their medical condition is
similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
Active
immunization
against
varicella
(chickenpox)
in
the
following
populations, where there is no history of varicella:
-
Healthy individuals from the age of 12 months.
-
Patients at high risk of severe varicella, such as patients with acute
leukemia or a chronic condition, those on immunosuppressive therapy or
those for whom an organ transplant is being considered.
-
Healthy individuals living in close contact with patients with
varicella and
high-risk patients.
THERAPEUTIC GROUP: Viral vaccines, Varicella zoster vaccines
HOW DOES THE VACCINE WORK?
When a person is vaccinated with Varilrix, the immune system (the
body's
natural defense system) will make antibodies to protect the person
from being
infected by chickenpox (varicella) virus.
Varilrix contains weakened virus that is highly unlikely to cause
chickenpox in
healthy individuals. As with all vaccines, Varilrix may not fully
protect all
individuals who are vaccinated.
2. BEFORE USING THE MEDICINE
DO NOT USE VARILRIX IF:
•
you or your child are sensitive (allergic) to the active ingredient or
any of
the additional ingredients contained in the vaccine (detailed in
section 6).
Signs of an allergic reaction may include: itchy skin rash, shortness
of
breath and swelling o

Valmisteyhteenveto

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Varilrix
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
After reconstitution, one dose (0.5 mL) contains:
Varicella virus
1
Oka strain (live, attenuated)
not less than 10
3.3
PFU
2
1
produced in human diploid cells (MRC-5)
2
plaque forming units
This vaccine contains a trace amount of neomycin (see section 4.3).
Excipients with known effect:
The vaccine contains 6 mg of sorbitol per dose.
The vaccine contains 331 micrograms of phenylalanine per dose (see
section 4.4).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection in pre-filled syringe or
in the ampoule.
Before reconstitution, the powder is slightly cream to yellowish or
pinkish coloured cake and the solvent is a
clear colourless liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Varilrix is intended for the active immunization against varicella of
the categories of persons listed below,
where there is no history of varicella.
-
Healthy subjects, from the age of 12 months.
-
Patients at high risk of severe varicella, such as patients with acute
leukemia or a chronic condition,
those on immunosuppressive therapy or those for whom an organ
transplant is being considered (see
also section 4.4).
-
Healthy persons living in close contact with patients with varicella
and high-risk patients (see also
section 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
HEALTHY SUBJECTS
Children from 12 months up to and including 12 years of age:
It is recommended to administer 2 doses of Varilrix to children from
12 months to 12 years of age in order to
ensure optimal protection against varicella.
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It is preferable to administer the second dose at least 6 weeks, but
under no circumstances less than 4 weeks,
after the first dose.
Adolescents 13 years of age and above and adults:
Two doses are required for subjects 13 years of age and above. An
interval of at least 6 weeks, but under no
circumstances less than