Infanrix

Država: Nova Zelandija

Jezik: angleščina

Source: Medsafe (Medicines Safety Authority)

Aktivna sestavina:

Diphtheria toxoid, adsorbed 30 [iU]; Pertactin 8ug; Pertussis filamentous haemagglutinin 25ug; Pertussis toxoid, adsorbed 25ug; Tetanus toxoid, adsorbed 40 [iU]; Diphtheria toxoid, adsorbed 30 [iU]; Pertactin 8ug; Pertussis filamentous haemagglutinin 25ug; Pertussis toxoid, adsorbed 25ug; Tetanus toxoid, adsorbed 40 [iU]

Dostopno od:

GlaxoSmithKline NZ Limited

INN (mednarodno ime):

Detoxified pertussis toxin 25 µg

Odmerek:

0.5 mL

Farmacevtska oblika:

Suspension for injection

Sestava:

Active: Diphtheria toxoid, adsorbed 30 [iU] Pertactin 8ug Pertussis filamentous haemagglutinin 25ug Pertussis toxoid, adsorbed 25ug Tetanus toxoid, adsorbed 40 [iU] Excipient: Aluminium as Aluminium hydroxide & phosphate Sodium chloride Water for injection Active: Diphtheria toxoid, adsorbed 30 [iU] Pertactin 8ug Pertussis filamentous haemagglutinin 25ug Pertussis toxoid, adsorbed 25ug Tetanus toxoid, adsorbed 40 [iU] Excipient: Aluminium as Aluminium hydroxide & phosphate Phenoxyethanol Polysorbate 80 Sodium chloride Water for injection

Enote v paketu:

Syringe, glass, 0.5mL, 1 dose unit

Razred:

Prescription

Tip zastaranja:

Prescription

Izdeluje:

GlaxoSmithKline Biologicals SA

Terapevtske indikacije:

INFANRIX (DTPa) is indicated for active primary immunisation against diptheria, tetanus and pertussis. INFANRIX is indicated as fourth and/or fifth dose for children from 15 months of age up to and including 6 years of age who have previously been immunised with three or four doses of diphtheria, tetanus and pertussis (whole cell or acellular) vaccine.

Povzetek izdelek:

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) - Syringe, glass, 0.5mL - 10 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

Datum dovoljenje:

1994-06-10

Navodilo za uporabo

1
INFANRIX
®
Combined diphtheria, tetanus, acellular pertussis (DTPa) vaccine
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
This leaflet answers some of the common questions about INFANRIX
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 your child
having INFANRIX against the expected benefits.
IF YOU HAVE ANY CONCERNS ABOUT INFANRIX TALK TO YOUR DOCTOR, NURSE OR
PHARMACIST.
KEEP THIS LEAFLET WITH THIS VACCINE. You may need to read it again.
WHAT IS INFANRIX USED FOR
INFANRIX is a vaccine used to immunise against diphtheria, tetanus and
pertussis (whooping cough). The
vaccine is sometimes called DTPa vaccine.
INFANRIX is not intended for use in adults.
Diphtheria, pertussis and tetanus are three life-threatening diseases
caused by bacterial infection. The
vaccine works by causing the body to produce its own protection
(antibodies) against the disease.
DIPHTHERIA
Diphtheria is a bacterium that lives in the airways of humans and can
also affect the skin. Generally, the
airways become inflamed (swollen) causing severe breathing
difficulties and sometimes suffocation. The
bacteria 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
burn wounds, fractures, deep wounds or wounds contaminated with soil,
dust, horse manure or wood
splinters. The bacteria release toxins, which can cause muscle
stiffness, painful spasms, fits and death. The
spasm can be strong enough to cause bone fractures of the spine.
PERTUSSIS (Whooping cough)
Pertussis is highly infectious. It affects the breathing tract causing
severe spells of coughing that may
interfere with normal breathing. The coughing is often accompanied

Lastnosti izdelka

NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
INFANRIX diphtheria-tetanus-acellular pertussis (DTPa) vaccine
suspension for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
INFANRIX contains diphtheria toxoid, tetanus toxoid and three purified
pertussis antigens
[pertussis toxoid (PT), filamentous haemagglutinin (FHA) and pertactin
(PRN)] adsorbed onto
aluminium salts.
A 0.5 mL dose of the vaccine contains:
Diptheria toxoid
not less than 30 International Units (IU)
Tetanus toxoid
not less than 40 International Units (IU)
Bordetella pertussis antigens
Pertussis toxoid (PT)
25 micrograms (

g)
Pertussis Filamentous Haemagglutinin (FHA)
25 micrograms (

g)
Pertactin (PRN) (69 kiloDalton (kDa) outer membrane protein)
8 micrograms (

g)
The diphtheria and tetanus toxins are obtained from cultures of
Corynebacterium diphtheriae and
Clostridium tetani and are then detoxified and purified. The acellular
pertussis vaccine
components (PT, FHA and PRN) are prepared by growing phase I
Bordetella pertussis from which
the PT and FHA and PRN are extracted, purified and treated with
formaldehyde; PT is irreversibly
detoxified.
The diphtheria toxoid, tetanus toxoid and acellular pertussis vaccine
components are adsorbed on
aluminium salts. The final vaccine is formulated in saline.
INFANRIX meets the World Health Organisation requirements for
manufacture of biological
substances and for diphtheria and tetanus vaccines. No substances of
human origin are used in
its manufacture.
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Suspension for injection.
INFANRIX is presented as a turbid white suspension in a glass
prefilled syringe. Upon storage, a
white deposit and clear supernatant is observed.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
INFANRIX (DTPa) is indicated for active primary immunisation against
diptheria, tetanus and
pertussis.
INFANRIX is indicated as fourth and/or fifth dose for children from 15
months of age up to and
including 6 years of age who have previous