TETRAVAC 0 Suspension for Injection

দেশ: আয়ার্লণ্ড

ভাষা: ইংরেজি

সূত্র: HPRA (Health Products Regulatory Authority)

সক্রিয় উপাদান:

PURIFIED TETANUS TOXOID, PURIFIED DIPHTHERIA TOXOID PH. EUR., ADSORBED PURIFIED PERTUSSIS TOXOID, ADSORBED PURIFIED FILAMENTOUS HAEMAGGLUTININ, INACTIVATED POLIOMYELITIS VIRUS PH. EUR, INACTIVATED TYPE 1 POLIOVIRUS, INACTIVATED TYPE 2 POLIOVIRUS, INACTIVATED TYPE 3 POLIOVIRUS

থেকে পাওয়া:

Sanofi Pasteur MSD Ltd

এটিসি কোড:

J07CA02

INN (আন্তর্জাতিক নাম):

PURIFIED TETANUS TOXOID, PURIFIED DIPHTHERIA TOXOID PH. EUR., ADSORBED PURIFIED PERTUSSIS TOXOID, ADSORBED PURIFIED FILAMENTOUS

ফার্মাসিউটিকাল ফর্ম:

Suspension for Injection

প্রেসক্রিপশন টাইপ:

Product subject to prescription which may not be renewed (A)

থেরাপিউটিক এলাকা:

Bacterial and viral vaccines, combined

অনুমোদন অবস্থা:

Authorised

অনুমোদন তারিখ:

2001-03-23

তথ্য লিফলেট

PACKAGE LEAFLET: INFORMATION FOR THE USER 

TETRAVAC, SUSPENSION FOR INJECTION 
DIPHTHERIA, TETANUS, PERTUSSIS (ACELLULAR, COMPONENT) AND
POLIOMYELITIS (INACTIVATED) VACCINE, 
ADSORBED. 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOUR CHILD IS VACCINATED
BECAUSE IT CONTAINS IMPORTANT 
INFORMATION. 
- 
Keep this leaflet. You may need to read it again. 
- 
If you have any further questions, ask your doctor, nurse or
pharmacist. 
- 
This medicine has been prescribed only for your child. Do not pass it
on to others. 
- 
If your child gets any side effects, talk to  your doctor, nurse
or pharmacist. This includes any 
possible side effects not listed in this leaflet. See section 4. 

WHAT IS IN THIS LEAFLET  
1. 
What Tetravac is and what it is used for 
2. 
What you need to know before Tetravac is given to your child 
3. 
How to use Tetravac 
4. 
Possible side effects 
5. 
How to store Tetravac 
6. 
Contents of the pack and other information 

1. 
WHAT TETRAVAC IS AND WHAT IT IS USED FOR  

Tetravac is a vaccine. Vaccines are used to protect against
infectious diseases. 
This vaccine helps to protect your child against diphtheria,
tetanus, pertussis (whooping cough) and 
poliomyelitis (polio). 
It is given as a primary series vaccination in babies and as a
booster vaccination in children who 
received this vaccine or a similar vaccine when they were younger. 

When an injection of Tetravac is given, the body’s natural
defences will produce protection against 
these different diseases. 
 
Diphtheria is an infectious disease that usually first affects the
throat. In the throat, the infection 
causes pain and swelling which can lead to suffocation. The bacteria
that cause the disease also 
produce a toxin (poison) that can damage the heart, kidneys and
nerves. 
 
Tetanus (often called lock jaw) is caused by the tetanus bacteria
entering a deep wound. The 
bacteria produce a toxin (poison) that causes spasms of

পণ্য বৈশিষ্ট্য

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tetravac, suspension for injection
Diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine, adsorbed.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 0.5 mL dose of vaccine contains:
Purified diphtheria toxoid
1
not less than 30 I.U. #
Purified tetanus toxoid
1
not less than 40 I.U. *
Purified pertussis toxoid (PTxd)
1
25 µg 
Purified filamentous haemagglutinin (FHA)
1
25 µg 
Inactivated type 1 poliovirus
2
D antigen**: 40 units
Inactivated type 2 poliovirus
2
D antigen**: 8 units
Inactivated type 3 poliovirus
2
D antigen**: 32 units
#
As mean value
*
As lower confidence limit (p = 0.95).
**
Quantity of antigen in the final bulk product, in accordance with WHO recommendations.
1
adsorbed on aluminium hydroxide (expressed as Al
3+
) 0.30 mg
2
produced on Vero cells
Excipient(s) with known effect: The vaccine contains phenylalanine and small amounts of ethanol (alcohol) (see
section 4.4).
For the full list of excipients, see section 6.1.
The vaccine may contain traces of glutaraldehyde, neomycin, streptomycin and polymyxin B (see section 4.4).
3 PHARMACEUTICAL FORM
Suspension for injection.
Tetravac is a sterile and whitish turbid suspension.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Active immunisation against diphtheria, tetanus, pertussis and poliomyelitis
•
for primary vaccination in infants,
•
for booster in children who have previously received a primary vaccination with a diphtheria-tetanus-whole-cell
or acellular pertussis-poliomyelitis vaccine.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Primary vaccination:_
Primary immunisation can be given as 3 doses at an interval of 1-2 months starting at the age of 2 or 3 months or as 2
doses at an interval of 2 months starting at t