BOOSTRIX 0.5 mL injection pre-filled syringe

Země: Austrálie

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktivní složka:

Pertussis toxoid, Quantity: 16 microgram/mL; Pertussis filamentous haemagglutinin, Quantity: 16 microgram/mL; Pertactin, Quantity: 5 microgram/mL; Diphtheria toxoid, Quantity: 4 IU/mL; Tetanus toxoid, Quantity: 40 IU/mL

Dostupné s:

GlaxoSmithKline Australia Pty Ltd

INN (Mezinárodní Name):

Diphtheria toxoid,Pertactin,Pertussis filamentous haemagglutinin,Pertussis toxoid,Tetanus toxoid

Léková forma:

Injection, suspension

Složení:

Excipient Ingredients: aluminium hydroxide hydrate; aluminium phosphate; sodium chloride; water for injections

Podání:

Intramuscular

Jednotky v balení:

10 x 0.5mL prefilled syringe, 1 x 0.5mL prefilled syringe

Druh předpisu:

(S4) Prescription Only Medicine

Terapeutické indikace:

BOOSTRIX is indicated for booster vaccination against diphtheria, tetanus and pertussis of individuals aged four years and older (see Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,BOOSTRIX is also indicated for passive protection against pertussis in early infancy following maternal immunisation during pregnancy (see Section 4.2 DOSE AND METHOD OF ADMINISTRATION, Section 4.6 FERTILITY, PREGNANCY AND LACTATION and 5.1 PHARMACODYNAMIC PROPERTIES).,The use of BOOSTRIX should be in accordance with official recommendations.

Přehled produktů:

Visual Identification: Turbid liquid with slow settling white deposit, and a colourless supernatant. The precipitate is easily resuspended when shaken.; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 48 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Stav Autorizace:

Licence status A

Datum autorizace:

2009-04-20

Informace pro uživatele

BOOSTRIX
1
BOOSTRIX
_Combined Diptheria-Tetanus acellular Pertussis (dTpa) Vaccine _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions about
BOOSTRIX 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 against the expected
benefits.
IF YOU HAVE ANY CONCERNS ABOUT
RECEIVING BOOSTRIX TALK TO YOUR
DOCTOR, NURSE OR PHARMACIST
KEEP THIS LEAFLET WITH THIS VACCINE.
You may need to read it again.
WHAT BOOSTRIX IS
USED FOR
BOOSTRIX is a vaccine used as a
booster to prevent three diseases:
diphtheria, tetanus and pertussis
(whooping cough) 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.
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% of
cases.
PERTUSSIS (WHOOPING COUGH)
Pertussis is a highly infectious
illness. The disease affects the
breathing tract causing severe spells

Charakteristika produktu

1
AUSTRALIAN PRODUCT INFORMATION
BOOSTRIX (COMBINED DIPHTHERIA, TETANUS, ACELLULAR PERTUSSIS
(DTPA)) SUSPENSION FOR INJECTION
1
NAME OF THE MEDICINE
Combined diphtheria-tetanus-acellular pertussis (dTpa) vaccine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
BOOSTRIX dTpa vaccine is a sterile suspension which contains
diphtheria toxoid, tetanus
toxoid and three purified antigens of _ Bordetella pertussis_
[pertussis toxoid (PT), pertussis
filamentous haemagglutinin (FHA) and pertactin (PRN)] adsorbed onto
aluminium salts.
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
1
adsorbed on aluminium hydroxide hydrate (Al(OH)3)
0.3 milligrams Al3+
and aluminium phosphate (AlPO4)
0.2 milligrams Al3+
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.
No substances of human origin are used in its manufacture.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
This medicine contains less than 1 mmol (39 mg) per dose of potassium
and less than 1
mmol (23 mg) per dose of sodium, i.e., essentially
‘potassium-free’ and ‘sodium-free’.
2
3
PHARMACEUTICAL FORM
BOOSTRIX is a turbid white suspension for injection.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
BOOSTRIX is indicated for booster vaccination against diphtheria,
tetanus and pertussis of
individuals
aged
four
years
and
older
(see
Section
4.2
DOSE
AND
METHOD
OF
ADMINISTRATION).
BOOSTRIX is also indicated for passive protection against pertussis in
early infancy following
maternal
immunisation
during
pregnancy
(see
Section
4.2
DOSE
AND
METHOD
OF
ADMINISTRATION,
Section
4.6
FERTILITY, PREGNANCY
AND
LACTATION
an