Twinrix Paediatric vaccine suspension for injection 0.5ml pre-filled syringes

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)

מרכיב פעיל:

Hepatitis B virus surface antigen; Hepatitis A virus inactivated

זמין מ:

GlaxoSmithKline UK Ltd

קוד ATC:

J07BC20

INN (שם בינלאומי):

Hepatitis B virus surface antigen; Hepatitis A virus inactivated

טופס פרצבטיות:

Suspension for injection

מסלול נתינה (של תרופות):

Subcutaneous; Intramuscular

סיווג:

No Controlled Drug Status

סוג מרשם:

Valid as a prescribable product

leaflet_short:

BNF: 14040000; GTIN: 5000483223106

עלון מידע

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
TWINRIX
® PAEDIATRIC, SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE
Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine
(adsorbed)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START/ YOUR CHILD STARTS
RECEIVING 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 or your pharmacist.
-
This vaccine has been prescribed for you/ your child only. Do not pass
it on to others.
-
If you get / your child gets any side effects, talk to your doctor or
pharmacist. This includes any
possible side effects not listed in this leaflet. See section 4.
This leaflet has been written assuming the person receiving the
vaccine is reading it, but it can be
given to adolescents and children so you may be reading it for your
child.
WHAT IS IN THIS LEAFLET
1.
What Twinrix Paediatric is and what it is used for
2.
What you need to know before you receive Twinrix Paediatric
3.
How Twinrix Paediatric is given
4.
Possible side effects
5.
How to store Twinrix Paediatric
6.
Contents of the pack and other information
1.
WHAT TWINRIX PAEDIATRIC IS AND WHAT IT IS USED FOR
Twinrix Paediatric is a vaccine used in infants, children and
adolescents from 1 year up to and
including 15 years to prevent two diseases: hepatitis A and hepatitis
B. The vaccine works by causing
the body to produce its own protection (antibodies) against these
diseases.

HEPATITIS A: Hepatitis A is an infectious disease, which can affect
the liver. This disease is
caused by the hepatitis A virus. The hepatitis A virus can be passed
from person to person in
food and drink, or by swimming in water contaminated by sewage.
Symptoms of hepatitis A
begin 3 to 6 weeks after coming into contact with the virus. These
consist of nausea (feeling
sick), fever and aches and pains. After a few days the whites of eyes
and skin may become
yellowish (jaundice). The severity and type of symptoms can vary.
Young children m

מאפייני מוצר

OBJECT 1
TWINRIX PAEDIATRIC VACCINE SUSPENSION FOR
INJECTION
Summary of Product Characteristics Updated 24-Nov-2016 |
GlaxoSmithKline UK
1. Name of the medicinal product
Twinrix
®
Paediatric, suspension for injection
Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine
(adsorbed).
2. Qualitative and quantitative composition
1 dose (0.5 ml) contains:
Hepatitis A virus (inactivated)
1,2
360 ELISA Units
Hepatitis B surface antigen
3,4
10 micrograms
1
Produced on human diploid (MRC-5) cells
2
Adsorbed on aluminium hydroxide, hydrated
0.025 milligrams Al
3+
3
Produced in yeast cells (_Saccharomyces_ _cerevisiae_) by recombinant
DNA technology
4
Adsorbed on aluminium phosphate
0.2 milligrams Al
3+
The vaccine may contain traces of neomycin which is used during the
manufacturing process (see section
4.3).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Suspension for injection
Turbid white suspension.
4. Clinical particulars
4.1 Therapeutic indications
Twinrix Paediatric is indicated for use in non immune infants,
children and adolescents from 1 year up to
and including 15 years who are at risk of both hepatitis A and
hepatitis B infection.
4.2 Posology and method of administration
Posology
- Dosage
The dose of 0.5 ml (360 ELISA Units HA/10 µg HBsAg) is recommended
for infants, children and
adolescents from 1 year up to and including 15 years of age.
- Primary vaccination schedule
The standard primary course of vaccination with Twinrix Paediatric
consists of three doses, the first
administered at the elected date, the second one month later and the
third six months after the first dose.
The recommended schedule should be adhered to. Once initiated, the
primary course of vaccination
should be completed with the same vaccine.
- Booster dose
In situations where a booster dose of hepatitis A and/or hepatitis B
is desired, a monovalent or combined
vaccine can be given. The safety and immunogenicity of Twinrix
Paediatric administered as a booster
dose following a three dose primary course