Boostrix

Country: নিউ জিলণ্ড

ভাষা: ইংরেজি

সূত্র: Medsafe (Medicines Safety Authority)

সক্রিয় উপাদান:

Diphtheria toxoid, adsorbed 2 [iU] (Lower fiducial limit); Pertactin 2.5ug; Pertussis filamentous haemagglutinin 8ug; Pertussis toxoid, adsorbed 8ug; Tetanus toxoid, adsorbed 20 [iU] (Lower fiducial limit); Diphtheria toxoid, adsorbed 2 [iU] (Lower fiducial limit); Pertactin 2.5ug; Pertussis filamentous haemagglutinin 8ug; Pertussis toxoid, adsorbed 8ug; Tetanus toxoid, adsorbed 20 [iU] (Lower fiducial limit)

থেকে পাওয়া:

GlaxoSmithKline NZ Limited

INN (International Name):

Diphtheria toxoid, adsorbed 2 IU (Lower fiducial limit)

ডোজ:

0.5 mL

ফার্মাসিউটিকাল ফর্ম:

Suspension for injection

রচনা:

Active: Diphtheria toxoid, adsorbed 2 [iU] (Lower fiducial limit) Pertactin 2.5ug Pertussis filamentous haemagglutinin 8ug Pertussis toxoid, adsorbed 8ug Tetanus toxoid, adsorbed 20 [iU] (Lower fiducial limit) Excipient: Aluminium hydroxide Aluminium phosphate Formaldehyde Glycine Phenoxyethanol Polysorbate 80 Sodium chloride Water for injection Active: Diphtheria toxoid, adsorbed 2 [iU] (Lower fiducial limit) Pertactin 2.5ug Pertussis filamentous haemagglutinin 8ug Pertussis toxoid, adsorbed 8ug Tetanus toxoid, adsorbed 20 [iU] (Lower fiducial limit) Excipient: Aluminium hydroxide Aluminium phosphate Sodium chloride Water for injection

প্যাকেজ ইউনিট:

Syringe, glass, 1 x 0.5mL single dose, 1 dose unit

শ্রেণী:

Prescription

প্রেসক্রিপশন টাইপ:

Prescription

Manufactured by:

GSK Vaccines GmbH

থেরাপিউটিক ইঙ্গিত:

BOOSTRIX is indicated for booster vaccination against diphtheria, tetanus and pertussis of individuals aged four years and older.

পণ্য সারাংশ:

Package - Contents - Shelf Life: Syringe, glass, 0.5mL single dose - 1 dose units - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 7 days not refrigerated stored stored below 37°C - Syringe, glass, 0.5mL dose - 10 dose units - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 7 days not refrigerated stored stored below 37°C

অনুমোদন তারিখ:

1999-03-11

তথ্য লিফলেট

1
BOOSTRIX
Combined diphtheria, 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
your child having BOOSTRIX against the expected benefits.
IF YOU HAVE ANY CONCERNS ABOUT BOOSTRIX TALK TO YOUR DOCTOR, NURSE OR
PHARMACIST.
KEEP THIS LEAFLET WITH THIS VACCINE. You may need to read it again.
WHAT IS BOOSTRIX USED FOR
BOOSTRIX is a vaccine used for booster vaccination against diphtheria,
tetanus and pertussis
(whooping cough). The vaccine is sometimes called dTpa vaccine.
BOOSTRIX is intended for use in children aged 4 years and older and
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 bre

পণ্য বৈশিষ্ট্য

1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
BOOSTRIX Combined diphtheria-tetanus-acellular pertussis (dTpa)
suspension for injection
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 pertussis 69 kilodalton (kDa) outer membrane
protein (OMP)] 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, hydrated (Al(OH)
3
)
0.3 milligrams Al
3+
and aluminium phosphate (AlPO
4
)
0.2 milligrams Al
3+
The diphtheria toxoid, tetanus toxoid and acellular pertussis vaccine
(dTpa) components are
adsorbed on 0.5 mg aluminium and suspended in isotonic sodium
chloride.
For the full list of excipients, see section 6.1 List of excipients._
_
3.
PHARMACEUTICAL FORM
BOOSTRIX is a turbid white suspension for injection.
Upon storage a white deposit and clear supernatant can be observed.
This is a normal finding.
4.
CLINICAL PARTICULARS
4.1
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 and 5.1 Pharmacodynamic
properties).
The use of BOOSTRIX should be in accordance with official
recommendations.
2
4.2
DOSE AND METHOD OF ADMINISTRATION
Dose
Each dose consists of a 0.5 mL ready to use sterile suspension.
BOOSTRIX can be administered to pregnant women during the