ViATIM vaccine suspension for injection 1ml pre-filled syringes

Država: Velika Britanija

Jezik: engleski

Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivni sastojci:

Hepatitis A virus (GBM strain) inactivated; Salmonella typhi (Ty2 strain) Vi capsular polysaccharide

Dostupno od:

Sanofi

ATC koda:

J07BC20

INN (International ime):

Hepatitis A virus (GBM strain) inactivated; Salmonella typhi (Ty2 strain) Vi capsular polysaccharide

Farmaceutski oblik:

Suspension for injection

Administracija rute:

Intramuscular; Subcutaneous

Razred:

No Controlled Drug Status

Tip recepta:

Valid as a prescribable product

Proizvod sažetak:

BNF: 14040000; GTIN: 5015973541011

Uputa o lijeku

PACKAGE LEAFLET: INFORMATION FOR THE USER
VIATIM, SUSPENSION AND SOLUTION FOR SUSPENSION FOR INJECTION IN
PRE-FILLED SYRINGE
Hepatitis A (inactivated, adsorbed) and Typhoid polysaccharide vaccine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE USING THIS VACCINE 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, nurse or
pharmacist.
-
This vaccine has been prescribed for you only. Do not pass it on to
others.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What ViATIM is and what it is used for
2.
What you need to know before you use ViATIM
3.
How to use ViATIM
4.
Possible side effects
5.
How to store ViATIM
6.
Contents of the pack and other information
1.
WHAT VIATIM IS AND WHAT IT IS USED FOR
ViATIM is a vaccine. Vaccines are used to protect you against
infectious diseases. This
vaccine helps to protect against both typhoid fever and hepatitis A
infection in people 16
years of age and older.
Typhoid fever is an infectious disease that may be caught from food
and drink that contain the
bacteria (called _Salmonella enterica, _subtype _typhi_) that cause
the illness. It is a serious
infection that may be fatal if not treated promptly.
Hepatitis A infection is due to a virus that attacks the liver. It may
be caught from food or
drink that contains the virus. Symptoms include jaundice and feeling
generally unwell.
When you are given an injection of ViATIM, your body’s natural
defences will produce
protection against typhoid fever and hepatitis A infection.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE VIATIM
To make sure that ViATIM is suitable for you, it is important to tell
your doctor or nurse if
any of the points below apply to you. If there is anything you do not
understand, ask your
doctor or nurse to explain.
DO NOT USE VIATIM

If you are allergic to the active substances or to

Svojstava lijeka

OBJECT 1
VIATIM
Summary of Product Characteristics Updated 05-Jan-2018 | Sanofi
Pasteur
1. Name of the medicinal product
ViATIM, Suspension and solution for suspension for injection in
pre-filled syringe.
Hepatitis A (inactivated, adsorbed) and Typhoid polysaccharide vaccine
2. Qualitative and quantitative composition
The dual-chamber syringe contains 0.5 millilitre of inactivated
hepatitis A vaccine and 0.5 millilitre of
typhoid polysaccharide vaccine which are mixed prior to
administration.
After reconstitution, 1 dose (1ml) contains:
Originally contained in the suspension:
Hepatitis A virus, GBM strain (inactivated)
1,2
………….160 U
3
1
produced in human diploid (MRC-5) cells
2
adsorbed on aluminium hydroxide, hydrated (0.3 milligrams Al)
3
In the absence of an international standardised reference, the antigen
content is expressed using an in-
house reference
Originally contained in the solution:
Salmonella typhi (Ty 2 strain) capsular Vi polysaccharide………25
micrograms
For the full list of excipients, see section 6.1.
ViATIM may contain traces of neomycin, which is used during the
manufacturing process (see section
4.3).
3. Pharmaceutical form
Suspension and solution for suspension for injection in pre-filled
syringe.
The inactivated hepatitis A vaccine is a cloudy and white suspension
and the typhoid polysaccharide
vaccine is a clear and colourless solution.
4. Clinical particulars
4.1 Therapeutic indications
ViATIM is indicated for simultaneous active immunisation against
typhoid fever and hepatitis A virus
infection in subjects from 16 years of age.
ViATIM should be given in accordance with official recommendations.
4.2 Posology and method of administration
Posology
The recommended dosage for subjects of at least 16 years of age is 1
millilitre of the mixed vaccine.
Initial protection is achieved with one single dose of ViATIM.
Protective levels of antibody may not be
reached until 14 days after administration of the vaccine.
In order to provide long-term protection against infection caused by
t