Infanrix-IPV

Pays: Nouvelle-Zélande

Langue: anglais

Source: Medsafe (Medicines Safety Authority)

Ingrédients actifs:

Diphtheria toxoid, adsorbed 60 IU/mL; Pertactin 16 µg/mL;  ; Pertussis filamentous haemagglutinin 50 µg/mL;  ; Pertussis toxoid, adsorbed 50 µg/mL;  ; Polio virus type 1 80 DAgU/mL;  ; Polio virus type 2 16 DAgU/mL;  ; Polio virus type 3 64 DAgU/mL;  ; Tetanus toxoid, adsorbed 80 IU/mL

Disponible depuis:

GlaxoSmithKline NZ Limited

DCI (Dénomination commune internationale):

Detoxified pertussis toxin 50 µg/mL

Dosage:

0.5 mL

forme pharmaceutique:

Suspension for injection

Composition:

Active: Diphtheria toxoid, adsorbed 60 IU/mL Pertactin 16 µg/mL   Pertussis filamentous haemagglutinin 50 µg/mL   Pertussis toxoid, adsorbed 50 µg/mL   Polio virus type 1 80 DAgU/mL   Polio virus type 2 16 DAgU/mL   Polio virus type 3 64 DAgU/mL   Tetanus toxoid, adsorbed 80 IU/mL Excipient: Aluminium hydroxide Neomycin sulfate Polymyxin B sulfate Sodium chloride Water for injection

Unités en paquet:

Syringe, glass, single dose, prefilled (not marketed), 0.5 mL

classe:

Prescription

Type d'ordonnance:

Prescription

Fabriqué par:

GlaxoSmithKline Biologicals SA

indications thérapeutiques:

INFANRIX®-IPV is indicated for active primary immunisation against diphtheria, tetanus, pertussis, and poliomyelitis. INFANRIX®-IPV is also indicated as a booster dose for children who have previously been immunised with DTP and polio antigens.

Descriptif du produit:

Package - Contents - Shelf Life: Syringe, glass, single dose, prefilled, 0.5 mL - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Syringe, glass, 0.5ml single dose, prefilled - 10 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

Date de l'autorisation:

2000-05-10

Notice patient

INFANRIX-IPV
1
INFANRIX-IPV
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this vaccine, speak to your doctor or pharmacist.
1.
WHY IS MY INFANT OR CHILD BEING GIVEN INFANRIX-IPV?
INFANRIX-IPV contains the active ingredients diphtheria toxoid,
tetanus toxoid, pertussis toxoid, filamentous haemagglutinin,
pertactin, poliovirus Type 1, poliovirus Type 2 and poliovirus Type 3.
INFANRIX-IPV is a vaccine used in infants to prevent four
diseases, diphtheria, tetanus, pertussis (whooping cough) and
poliomyelitis (polio).
For more information, see Section 1. Why is my infant or child being
given INFANRIX-IPV? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE MY INFANT OR CHILD IS GIVEN INFANRIX-IPV?
Do not use if your infant or child has ever had an allergic reaction
to INFANRIX-IPV or any of the ingredients listed at the end of
the CMI.
TALK TO YOUR DOCTOR IF YOUR INFANT OR CHILD HAS ANY OTHER MEDICAL
CONDITIONS OR TAKES ANY OTHER MEDICINES.
For more information, see Section 2. What should I know before my
infant or child is given INFANRIX-IPV? in the full CMI.
3.
WHAT IF MY INFANT OR CHILD IS TAKING OTHER MEDICINES?
Some medicines may interfere with INFANRIX-IPV and affect how it
works.
A list of these medicines is in Section 3. What if my infant or child
is taking other medicines? in the full CMI.
4.
HOW IS INFANRIX-IPV GIVEN?

INFANRIX-IPV will be injected into the thigh muscle in children over
12 months of age, and into the upper leg muscle/thigh
muscle in infants under 12 months of age.

INFANRIX-IPV is usually given as a total of three doses in the first
year of life from the age of 2 months.
More instructions can be found in Section 4. How is INFANRIX-IPV
given? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE MY INFANT OR CHILD IS BEING GIVEN
INFANRIX-IPV?
THINGS YOU
SHOULD DO

Remind any doctor, dentist or pharmacist that your infant or child
visits that they have been given
INFANRIX-IPV.

Tell your doctor immediately if you notice

Résumé des caractéristiques du produit

1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
INFANRIX-IPV Combined diphtheria-tetanus-acellular pertussis (DTPa)
and enhanced
inactivated polio suspension for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 dose (0.5 mL) contains:
Diphtheria toxoid
1
not less than 30 International Units (IU) (25 Lf)
Tetanus toxoid
1
not less than 40 International Units (IU) (10 Lf)
_Bordetella pertussis_ antigens
Pertussis toxoid (PT)
1
25 micrograms
Filamentous Haemagglutinin (FHA)
1
25 micrograms
Pertactin (PRN)
1
8 micrograms
Poliovirus (inactivated) (IPV)
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
)
0.5 milligrams Al
3+
2
propagated in VERO cells
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
INFANRIX-IPV is a sterile, turbid white suspension for injection.
Upon storage, a white deposit and clear supernatant can be observed.
This is not a sign of
deterioration.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
INFANRIX-IPV is indicated for active primary immunisation in infants
from the age of 2 months
against diphtheria, tetanus, pertussis, and poliomyelitis.
INFANRIX-IPV is also indicated as a booster dose for children up to 13
years of age who have
previously been immunised with diphtheria, tetanus, pertussis (DTP)
and polio antigens.
2
4.2
DOSE AND METHOD OF ADMINISTRATION
Dose
The primary vaccination schedule consists of three doses in the first
year of life. An interval
of at least 1 month should be respected between doses.
In order to maintain protection a booster dose is recommended. An
interval of at least 6
months after completion of primary vaccination schedule should be
adhered to. Local
immunisation schedule recommendations should be followed for primary
and booster doses.
Data on the use of the vaccine as a booster has been obtained for
children up to 13 years of
age.
Instructions for the pre-filled syringe
Hold the syringe