Diphtheria, Tetanus, Poliomyelitis vaccine, suspension for injection (vial)

Država: Malta

Jezik: engleski

Izvor: Medicines Authority

Dostupno od:

Bilthoven Biologicals B.V. Antonie van Leeuwenhoeklaan 9 3721 MA, Bilthoven, Netherlands

ATC koda:

J07CA01

INN (International ime):

POLIOVIRUS (INACTIVATED) TYPE 3 (SAUKETT STRAIN) 7.5 DAgU DIPHTHERIA TOXOID >5 IU TETANUS TOXOID >20 IU POLIOVIRUS (INACTIVATED) TYPE 1 (MAHONEY STRAIN) 40 DAgU POLIOVIRUS (INACTIVATED) TYPE 2 (MEF-1 STRAIN) 4 DAgU

Farmaceutski oblik:

SUSPENSION FOR INJECTION

Sastav:

POLIOVIRUS (INACTIVATED) TYPE 3 (SAUKETT STRAIN) 7.5 DAgU DIPHTHERIA TOXOID >5 IU TETANUS TOXOID >20 IU POLIOVIRUS (INACTIVATED) TYPE 1 (MAHONEY STRAIN) 40 DAgU POLIOVIRUS (INACTIVATED) TYPE 2 (MEF-1 STRAIN) 4 DAgU

Tip recepta:

POM

Područje terapije:

VACCINES

Status autorizacije:

Authorised

Datum autorizacije:

2024-02-09

Uputa o lijeku

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PACKAGE LEAFLET: INFORMATION FOR THE USER
DIPHTHERIA, TETANUS, POLIOMYELITIS VACCINE, SUSPENSION FOR INJECTION
Diphtheria toxoid, tetanus toxoid, polio trivalent bulk
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What DT-IPV vaccine is and what is it used for
2.
When you need to know before you use DT-IPV vaccine
3.
How should to use DT-IPV vaccine
4.
Possible side effects
5.
How to store DT-IPV vaccine
6.
Contents of the pack and other information
1.
WHAT DT-IPV VACCINE IS AND WHAT IS IT USED FOR
Diphtheria, Tetanus, Poliomyelitis (DT-IPV) vaccine belongs to the
drug group known as
vaccines. Most medicines combat the effects of a disease. A vaccine,
on the other hand, is
given to healthy individuals and helps to protect them against
infectious diseases and the
problems they cause. DT-IPV vaccine is intended for protection against
diphtheria, tetanus
and polio.
Each of these diseases is caused by a specific bacterium or, in the
case of polio, a virus. The
vaccine contains each of these pathogens in an inactivated and
therefore harmless form. In
response to contact with the inactivated pathogens, the cells of the
immune system begin to
produce antibodies that render the pathogens harmless. What’s more,
the immune system
remembers the characteristics of the pathogens and how they can be
fought against. In this
way, vaccination creates long-term protection against diphtheria,
tetanus and polio. The
moment a person who is vaccinated against DT-IPV comes into contact
with the

Svojstava lijeka

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Diphtheria, Tetanus, Poliomyelitis vaccine, suspension for injection
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 dose (1 mL) contains:
-
Diphtheria toxoïd*
≥ 5 international units
-
Tetanus toxoïd*
≥ 20 international units
-
Polio trivalent bulk
•
Type I inactivated poliovirus (Mahoney)**
40 D-antigen units
•
Type 2 inactivated poliovirus (MEF 1)**
4 D-antigen units
•
Type 3 inactivated poliovirus (Saukett)**
7.5 D-antigen units
*) Adsorbed onto 1.5 mg of hydrated aluminium phosphate, equivalent to
12.3 micromoles of
Al
3+
**) Grown on Vero cells.
For a full list of excipients, see Section 6.1.
3
PHARMACEUTICAL FORM
Suspension for injection
The colour of the vaccine is orange-red.
4
CLINICAL DATA
4.1
THERAPEUTIC INDICATIONS
Active immunisation against diphtheria, tetanus and poliomyelitis.
Diphtheria, Tetanus,
Poliomyelitis vaccine (DT-IPV) is indicated for use in children from 5
years of age, for
adolescents and for adults for primary vaccination and as a
re-vaccination after primary
vaccination against diphtheria, tetanus and poliomyelitis.
The use of DT-IPV must be based on official recommendations.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Dosage
One dose contains 1 mL.
_Primary vaccination _
Basic immunisation is given by a primary series of two doses, at least
1 month apart, followed
by a third dose at least 6 months after the second dose.
_Re-vaccination _
A single 1 mL dose
_Paediatric patients _
Due to its composition, DT-IPV is not suitable for primary
immunisation in children under 5
years of age.
Method of administration
For instructions of the medicinal product before administration, see
section 6.6
The vaccine must be swirled before use. This makes the vaccine cloudy.
DT-IPV is administered intramuscularly, preferably in the deltoid
muscle
4.3
CONTRAINDICATIONS
-
Hypersensitivity to the active substances or to (any of) the
excipients listed in Section
6.1.
-
DT-IPV administration should be postponed if someone suffers fr