BOOSTRIX POLIO

Nazione: Israele

Lingua: inglese

Fonte: Ministry of Health

Principio attivo:

DIPHTHERIA TOXOID; FILAMENTOUS HAEMAGGLUTININ (FHA); INACTIVATED POLIO VIRUS (IPV) TYPE 1; INACTIVATED POLIO VIRUS (IPV) TYPE 2; INACTIVATED POLIO VIRUS (IPV) TYPE 3; PERTACTIN (PRN OR 69 KDA OMP); PERTUSSIS TOXOID VACCINE; TETANUS TOXOID

Commercializzato da:

GLAXO SMITH KLINE (ISRAEL) LTD

Codice ATC:

J07CA

Forma farmaceutica:

SUSPENSION FOR INJECTION

Composizione:

PERTACTIN (PRN OR 69 KDA OMP) 2.5 MCG / 0.5 ML; DIPHTHERIA TOXOID NLT 2 IU / 0.5 ML; TETANUS TOXOID NLT 20 IU / 0.5 ML; FILAMENTOUS HAEMAGGLUTININ (FHA) 8 MCG / 0.5 ML; PERTUSSIS TOXOID VACCINE 8 MCG / 0.5 ML; INACTIVATED POLIO VIRUS (IPV) TYPE 3 32 DU / 0.5 ML; INACTIVATED POLIO VIRUS (IPV) TYPE 1 40 DU / 0.5 ML; INACTIVATED POLIO VIRUS (IPV) TYPE 2 8 DU / 0.5 ML

Via di somministrazione:

I.M

Tipo di ricetta:

Required

Prodotto da:

GLAXO SMITH KLINE BIOLOGICALS S.A

Gruppo terapeutico:

BACTERIAL AND VIRAL VACCINES, COMBINED

Indicazioni terapeutiche:

For booster vaccination against diphtheria, tetanus and pertusis and poliomyelitis of individuals from the age of three years onwards. The administration of Boostrix Polio should be based on official recommendations.

Data dell'autorizzazione:

2022-06-30

Foglio illustrativo

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed according to a physician’s prescription
only
Boostrix Polio
Suspension for injection in pre-filled syringe
Each dose (0.5 ml) contains:
diphtheria toxoid – NLT 2 IU
tetanus toxoid – NLT 20 IU
pertussis toxoid (PT) – 8 mcg
filamentous hemagglutinin (FHA) – 8 mcg
pertactin (PRN, or 69kDa OMP) – 2.5 mcg
inactivated poliovirus type 1 – 40 DU
inactivated poliovirus type 2 – 8 DU
inactivated poliovirus type 3 – 32 DU
For the list of the inactive and allergenic ingredients in the
medicine, see section
2 – “Important information about some of the ingredients in the
medicine” and
section 6 – “Additional information”.
Read the leaflet carefully in its entirety before using the medicine.
This leaflet
contains concise information about the medicine. If you have further
questions, refer to the physician or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may
harm them even if it seems to you that their medical condition is
similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
For booster vaccination against diphtheria, tetanus and pertussis and
poliomyelitis of individuals from the age of three years onwards.
The administration of Boostrix Polio should be based on official
recommendations.
Therapeutic group: Bacterial and viral vaccines combined.
How this vaccine works?
The vaccine works by causing the body to produce its own protection
(antibodies) against these diseases (diphtheria, tetanus, pertussis,
and
poliomyelitis).
None of the ingredients in the vaccine can cause these diseases.
2. BEFORE USING THE MEDICINE
Do not use Boostrix Polio if:
• you or your child have previously had any allergic reaction to
Boostrix
Polio or to any of the additional ingredients contained in this
vaccine
(listed in section 6), or neomycin, polymyxin (antibiotics) or to
formaldehyde. Signs of an allergic reaction may include itchy skin
rash,
shortness of breath,

Scheda tecnica

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Boostrix Polio
1.
NAME OF THE MEDICINAL PRODUCT
Boostrix
Polio
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
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 vaccine may contain traces of formaldehyde, neomycin and polymyxin
which
are used during the manufacturing process (see section 4.3).
Excipients with known effect
The vaccine contains para-aminobenzoic acid < 0.07 nanograms per dose
and phenylalanine 0.0298
micrograms per dose (see section 4.4).
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Suspension for injection in pre-filled syringe.
Boostrix Polio is a turbid white suspension.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Boostrix Polio is indicated for booster vaccination against
diphtheria, tetanus, pertussis and
poliomyelitis of individuals from the age of three years onwards (see
section 4.2).
The administration of Boostrix Polio should be based on official
recommendations.
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14
4.2
Posology and method of administration
Posology
A single 0.5 ml dose of the vaccine is recommended.
Boostrix Polio may be administered from the age of three years
onwards.
The use of Boostrix-IPV may be considered during the third trimester
of pregnancy. For the use of the
vaccine before the third trimester of pregnancy, see section 4.6.
Boostrix Polio contains reduced content of diphtheria, tetanus and
pertussis antigens in combination
with poliomyelitis antigens. Therefore, Boostrix Polio should be
administered in acc