Boostrix-IPV suspension for injection 0.5ml pre-filled syringes

Quốc gia: Vương quốc Anh

Ngôn ngữ: Tiếng Anh

Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)

Thành phần hoạt chất:

Tetanus toxoid; Pertussis antigens; Human poliovirus type 1 inactivated; Human poliovirus type 2 inactivated; Human poliovirus type 3 inactivated; Diphtheria toxoid

Sẵn có từ:

GlaxoSmithKline UK Ltd

Mã ATC:

J07CA02

INN (Tên quốc tế):

Tetanus toxoid; Pertussis antigens; Human poliovirus type 1 inactivated; Human poliovirus type 2 inactivated; Human poliovirus type 3 inactivated; Diphtheria toxoid

Dạng dược phẩm:

Suspension for injection

Tuyến hành chính:

Intramuscular

Lớp học:

No Controlled Drug Status

Loại thuốc theo toa:

Valid as a prescribable product

Tóm tắt sản phẩm:

BNF: 14040000; GTIN: 5000483111472

Tờ rơi thông tin

1
Package leaflet: Information for the user
BOOSTRIX
®
-IPV, SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE
Diphtheria, tetanus, pertussis (acellular component) and poliomyelitis
(inactivated) vaccine (adsorbed,
reduced antigen(s) content)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD START
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 pharmacist.
-
This vaccine has been prescribed for you or your child only. Do not
pass it on to others.
-
If you or your child 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 Boostrix-IPV is and what it is used for
2.
What you need to know before you or your child receive Boostrix-IPV
3.
How Boostrix-IPV is given
4.
Possible side effects
5.
How to store Boostrix-IPV
6.
Contents of the pack and other information
1. WHAT BOOSTRIX-IPV IS AND WHAT IT IS USED FOR
Boostrix-IPV is a vaccine used as a booster dose in children from 3
years onwards, teenagers and
adults to prevent four diseases: diphtheria, tetanus (lockjaw),
pertussis (whooping cough) and
poliomyelitis (polio). The vaccine works by causing the body to
produce its own protection
(antibodies) against these diseases.

DIPHTHERIA: Diphtheria mainly affects the airways and sometimes the
skin. Generally the
airways become inflamed (swollen) causing severe breathing
difficulties and sometimes
suffocation. The bacteria also release a toxin (poison), which can
cause nerve damage, heart
problems, and even death.

TETANUS (Lockjaw): Tetanus bacteria enter the body through cuts,
scratches or wounds in the
skin. Wounds that are especially prone to infection are burns,
fractures, deep wounds or wounds
contaminated with soil, dust, horse manure/dung or wood splinters. The
bacteria release a toxin
(poison), which can cause muscle stiffness, painful muscle spasms,

Đặc tính sản phẩm

OBJECT 1
BOOSTRIX-IPV SUSPENSION FOR INJECTION IN PRE-
FILLED SYRINGE
Summary of Product Characteristics Updated 19-Jan-2018 |
GlaxoSmithKline UK
1. Name of the medicinal product
Boostrix-IPV suspension for injection in pre-filled syringe
Diphtheria, tetanus, pertussis (acellular, component) and
poliomyelitis (inactivated) vaccine (adsorbed,
reduced antigen(s) content)
2. Qualitative and quantitative composition
1 dose (0.5 ml) contains:
Diphtheria toxoid
1
not less than 2 International Units (IU) (2.5 Lf)
Tetanus toxoid
1
not less than 20 International Units (IU) (5 Lf)
_Bordetella pertussis_ antigens
Pertussis toxoid
1
8 micrograms
Filamentous Haemagglutinin
1
8 micrograms
Pertactin
1
2.5 micrograms
Inactivated poliovirus
type 1 (Mahoney strain)
2
40 D-antigen unit
type 2 (MEF-1 strain)
2
8 D-antigen unit
type 3 (Saukett strain)
2
32 D-antigen unit
1
adsorbed on aluminium hydroxide, hydrated
(Al(OH)
3
)
0.3 milligrams Al
3+
and aluminium phosphate (AlPO
4
)
0.2 milligrams Al
3+
2
propagated in VERO cells
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Suspension for injection in pre-filled syringe.
Boostrix-IPV is a turbid white suspension.
4. Clinical particulars
4.1 Therapeutic indications
Boostrix-IPV is indicated for booster vaccination against diphtheria,
tetanus, pertussis and poliomyelitis
of individuals from the age of three years onwards (see section 4.2).
The administration of Boostrix-IPV should be based on official
recommendations.
4.2 Posology and method of administration
Posology
A single 0.5 ml dose of the vaccine is recommended.
Boostrix-IPV may be administered from the age of three years onwards.
The use of Boostrix-IPV may be considered during the third trimester
of pregnancy. For the use of the
vaccine before the third trimester of pregnancy, see section 4.6.
Boostrix-IPV contains reduced content of diphtheria, tetanus and
pertussis antigens in combination with
poliomyelitis antigens. Therefore, Boostrix-IPV should be administered
in accordance with official
recommenda