Boostrix-IPV

国家: 新西兰

语言: 英文

来源: Medsafe (Medicines Safety Authority)

有效成分:

Diphtheria toxoid, adsorbed 2 [iU] (2.5LfU); Pertactin 2.5ug;  ; Pertussis filamentous haemagglutinin 8ug;  ; Pertussis toxoid, adsorbed 8ug;  ; Polio virus type 1 40 DAgU;  ; Polio virus type 2 8 DAgU;  ; Polio virus type 3 32 DAgU;  ; Tetanus toxoid 20 [iU] (5LfU)

可用日期:

GlaxoSmithKline NZ Limited

INN（国际名称）:

Diphtheria toxoid, adsorbed 2.5 Lf U (2IU)

剂量:

0.5 mL

药物剂型:

Suspension for injection

组成:

Active: Diphtheria toxoid, adsorbed 2 [iU] (2.5LfU) Pertactin 2.5ug   Pertussis filamentous haemagglutinin 8ug   Pertussis toxoid, adsorbed 8ug   Polio virus type 1 40 DAgU   Polio virus type 2 8 DAgU   Polio virus type 3 32 DAgU   Tetanus toxoid 20 [iU] (5LfU) Excipient: Aluminium Medium 199 Sodium chloride Water for injection

每包单位数:

Syringe, glass, 0.5mL, 1 dose unit

类:

Prescription

处方类型:

Prescription

厂商:

GSK Vaccines GmbH

疗效迹象:

BOOSTRIX®-IPV is indicated for booster vaccination against diphtheria, tetanus, pertussis and poliomyelitis of individuals from the age of four years onwards. BOOSTRIX®-IPV is not intended for primary immunisation.

產品總結:

Package - Contents - Shelf Life: Syringe, glass, 0.5mL - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 8 hours not refrigerated stored below 21°C - Syringe, glass, 10 x 0.5mL doses - 10 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 8 hours not refrigerated stored below 21°C

授权日期:

2003-07-18

资料单张

1
BOOSTRIX
®
-IPV
Combined diphtheria-Tetanus-acellular pertussis (dTpa) and Inactivated
Poliovirus
Vaccine
CONSUMER MEDICINE INFORMATION LEAFLET
WHAT IS IN THIS LEAFLET
This leaflet answers some of the common questions about BOOSTRIX-IPV
vaccine. It does not
contain all the available information. It does not take the place of
talking to your doctor, nurse or
pharmacist.
All medicines and vaccines have risks and benefits. Your doctor has
weighed the possible
risks of having BOOSTRIX-IPV against the expected benefits.
IF YOU HAVE ANY CONCERNS ABOUT RECEIVING BOOSTRIX-IPV TALK TO YOUR
DOCTOR, NURSE OR
PHARMACIST.
KEEP THIS LEAFLET WITH THIS VACCINE. You may need to read it again
WHAT BOOSTRIX-IPV IS USED FOR
BOOSTRIX-IPV is a vaccine used as a booster to prevent four diseases,
diphtheria, tetanus,
pertussis (whooping cough) and poliomyelitis (polio) in adults and
children aged 4 years and older
who have been previously vaccinated against these diseases. The
vaccine works by causing the
body to produce its own protection (antibodies) against these
diseases.
Diphtheria, tetanus, and pertussis are all serious life-threatening
diseases caused by bacterial
infection. Poliomyelitis is an infectious diseases caused by viral
infection.
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
death. The risk of serious complications and death is greater in the
very young and elderly.
TETANUS (Lockjaw)
Tetanus bacteria enter the body through wounded skin. Wounds that are
especially prone to
infection are burns, fractures, deep wounds or wounds contaminated
with soil, dust, horse
manure or wood splinters. The bacteria release a toxin (poison), which
can cause muscle
stiffness, painful muscle spasms, fits and death. The spasms can be
strong enough to cause
bone fractures of the spine. The death rate is 10%

产品特点

1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
BOOSTRIX-IPV Combined diphtheria-tetanus-acellular pertussis (dTpa)
and enhanced
inactivated polio suspension for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
BOOSTRIX-IPV contains diphtheria toxoid, tetanus toxoid, and three
purified pertussis
antigens

pertussis toxoid (PT), filamentous hemagglutinin (FHA) and pertactin
(PRN/69
kiloDalton outer membrane protein)

adsorbed on aluminium salts. It also contains three
types of inactivated polio viruses (type 1: Mahoney strain; type 2:
MEF-1 strain; type 3:
Saukett strain).
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
The final vaccine also contains aluminium hydroxide and aluminium
phosphate as adjuvants,
sodium chloride, Medium 199, water for injections, and traces of
neomycin sulfate and
polymyxin sulfate.
The manufacture of this product includes exposure to bovine derived
materials. No
evidence exists that any case of vCJD (considered to be the human form
of bovine
spongiform encephalopathy) has resulted from the administration of any
vaccine product.
For the full list of excipients, see section 6.1 List of excipients.
2
3.
PHARMACEUTICAL FORM
Suspension for injection.
BOOSTRIX-IPV is a turbid white suspension presented in a prefilled
syringe. Upon storage, a
white deposit and clear supernatant can be observed. This is a normal
finding.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
BOOSTRIX-IPV is indicated for booster vaccination against diphtheria,