Varivax vaccine powder and solvent for suspension for injection 0.5ml vials

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktívna zložka:

Varicella-Zoster virus live attenuated (Oka/Merck strain)

Dostupné z:

Merck Sharp & Dohme (UK) Ltd

ATC kód:

J07BK01

INN (Medzinárodný Name):

Varicella-Zoster virus live attenuated (Oka/Merck strain)

Forma lieku:

Powder and solvent for suspension for injection

Spôsob podávania:

Intramuscular; Subcutaneous

Trieda:

No Controlled Drug Status

Typ predpisu:

Valid as a prescribable product

Prehľad produktov:

BNF: 14040000; GTIN: 5015973643012

Príbalový leták

PACKAGE LEAFLET: INFORMATION FOR THE USER
VARIVAX® POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION
VARICELLA VACCINE (LIVE)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD IS
VACCINATED BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
−
Keep this leaflet. You may need to read it again.
−
If you have any further questions, ask your doctor or your pharmacist.
−
This vaccine has been prescribed for you or your child. Do not pass it
on to others. It may harm
them, even if their signs of illness are the same as yours.
−
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
_ _
WHAT IS IN THIS LEAFLET:
1.
What VARIVAX is and what it is used for
2.
What you need to know before you or your child receives VARIVAX
3.
How VARIVAX is given
4.
Possible side effects
5.
How to store VARIVAX
6.
Contents of the pack and other information
1.
WHAT VARIVAX IS AND WHAT IT IS USED FOR
VARIVAX is a vaccine to help protect adults and children against
varicella (chickenpox). Vaccines
are used to protect you or your child against infectious diseases.
VARIVAX can be administered to persons 12 months of age or older.
VARIVAX may also be administered to infants from 9 months of age under
special circumstances,
such as to conform with national vaccination schedules or in outbreak
situations.
It may also be given to persons who have no history of chickenpox, but
who have been exposed to
someone who has chickenpox.
Vaccination within 3 days of exposure may help prevent chickenpox or
reduce the severity of disease,
resulting in fewer skin lesions and shorter duration of illness. In
addition, there is limited information
that being vaccinated up to 5 days after exposure may reduce disease
severity.
As with other vaccines, VARIVAX does not completely protect all
individuals from naturally acquired
varicella.
2.
WHAT YOU NEED TO KNOW BEFORE YOU OR YOUR CHILD RECEIVES VARIVAX
DO NOT USE VARIVAX IF:
−
you or your child are allergic to

Súhrn charakteristických

OBJECT 1
VARIVAX
Summary of Product Characteristics Updated 02-Jan-2018 | Merck Sharp &
Dohme Limited
1. Name of the medicinal product
VARIVAX® powder and solvent for suspension for injection
Varicella Vaccine (live)
2. Qualitative and quantitative composition
After reconstitution, one dose (0.5 mL) contains:
Varicella virus* Oka/Merck strain (live, attenuated) ≥1350 PFU**
* Produced in human diploid cells (MRC-5)
** PFU = Plaque-forming units
This vaccine may contain a trace amount of neomycin (see sections 4.3
and 4.4).
Excipients:
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder and solvent for suspension for injection.
White to off-white powder and clear, colourless liquid solvent.
4. Clinical particulars
4.1 Therapeutic indications
VARIVAX is indicated for vaccination against varicella in individuals
from 12 months of age (see
sections 4.2 and 5.1).
VARIVAX can be administered to infants from 9 months of age under
special circumstances, such as to
conform with national vaccination schedules or in outbreak situations
(see sections 4.2, 4.5, and 5.1).
VARIVAX may also be administered to susceptible individuals who have
been exposed to varicella.
Vaccination within 3 days of exposure may prevent a clinically
apparent infection or modify the course of
the infection. In addition, there are limited data that indicate that
vaccination up to 5 days after exposure
may modify the course of the infection (see section 5.1).
4.2 Posology and method of administration
_Posology_
The use of VARIVAX should be based on official recommendations.
Individuals less than 9 months of age
VARIVAX should not be administered to individuals less than 9 months
of age.
Individuals from 9 months of age
Individuals should receive two doses of VARIVAX to ensure optimal
protection against varicella (see
section 5.1).
• Individuals from 9 to 12 months of age
In settings in which vaccination is initiated between 9 and 12 months
of age, a second dose is needed and
should be given after a minimum interval of 3