A vaccine against diphtheria, tetanus, and pertussis ( acellular component) ( adsorbed, reduced antigen content)

Read this leaflet carefully before you are vaccinated

– Save this information, you may need to read about it.

– If you have any further questions, ask your doctor, pharmacist, or nurse.

– If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. This also applies to any side effects not mentioned in this information. See section 4.

This leaflet contains information about: 
1. What diTekiBooster is and what it is used for 
2. What you need to know before you are vaccinated with diTekiBooster 
3. How to be vaccinated with diTekiBooster 
4. Possible side effects 
5. How diTekiBooster be stored 
6. Package Contents and other information

1. What diTekiBooster is and what it is used for

What is diTekiBooster used for?

• diTekiBooster is used to vaccinate children, adolescents, and adults.

• diTekiBooster is a vaccine that protects against diphtheria, tetanus, and pertussis.

• diTekiBooster stimulates the body to produce antibodies against diphtheria, tetanus, and pertussis bacteria.

You will only receive diTekiBooster if you have already been vaccinated against diphtheria, tetanus, and pertussis.

2. What you need to know before you are vaccinated with diTekiBooster

You should not be vaccinated with diTekiBooster

  • if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6) or to formaldehyde which may be present in very small amounts.
  • if you suffer from progressive neurological diseases.
  • if you are ill with a high fever, then the vaccination should be postponed.
  • if you have experienced problems with the nervous system ( encephalopathy ) within 7 days after previous vaccination with a vaccine against pertussis (pertussis).

Warnings and cautions

Your doctor or nurse will be extra careful when it comes to vaccinating with diTekiBooster

  • if your immune response is weakened or if you are receiving immunosuppressive drugs. You can still be vaccinated with diTekiBooster, but your immune response may be weakened.
  • if you suffer from an illness or receive medical treatment that increases the risk of bleeding.
  • if you have experienced any of the following side effects after previous pertussis vaccinations:

General:

If you have had a fever (temperatures above 40 ° C) within 48 hours of the vaccination which is not due to any other known reason.

Children:

  • if the child has had a collapse or a shock-like condition within 48 hours of vaccination.
  • if the child has had persistent, inconsolable crying that lasts for at least 3 hours within 48 hours after vaccination.
  • if the child has had seizures with or without fever within 3 days after vaccination.

Other medicines and diTekiBooster

Tell your doctor if you are taking, have recently taken, or might take any other medicines.

diTekiBooster can be given at the same time as other vaccines without reducing the effect of diTekiBooster.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before getting vaccinated with diTekiBooster.

Driving and using machines:

diTekiBooster should not affect your ability to drive and use machines. You are responsible for assessing whether you are fit to drive motor vehicles or perform work that requires sharp attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

diTekiBooster contains sodium chloride

The vaccine contains less than 1 mmol sodium (23 mg) per dose and is essential ‘sodium-free’.

3. How to be vaccinated with diTekiBooster

Dosage instructions

As a rule, the doctor or nurse gives the vaccine by injection into a muscle ( intramuscularly ). It can also be given as an injection under the skin if there is a risk of bleeding.

Dose

Dose one is 0.5 ml for both children, adolescents, and adults.

Ask your doctor or pharmacist if you are unsure.

If you need to be vaccinated

Ask your doctor or nurse if you think you need to be vaccinated.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects are

Very rare side effects: may affect up to 1 in 10,000 people

– Severe allergic reactions ( hypersensitivity reaction within minutes to hours), e.g. skin rash, difficulty breathing, and fainting ( anaphylactic reaction ). Can be fatal.

Other side effects are

Very common side effects: may affect more than 1 in 10 people

Pain, itching, redness,s or swelling at the injection site

– Headache

– Fatigue

Common side effects: may affect up to 1 in 10 people

– General malaise, irritability, and fever (temperature 38 ° C or more)

– Redness and swelling of 5 cm or more at the injection site

– Muscle pain ( myalgia )

Rare side effects: may affect up to 1 in 1,000 people

– High fever (temperature above 40 ° C)

– Long-lasting lumpy skin with itching (granuloma) or sterile abscess at the injection site

– Hives ( urticaria )

Reporting of side effects ar

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to side effects that are not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects, you can help increase drug safety information.

The Medical Products Agency

Box 26

SE-751 03 Uppsala

5. How to store diTekiBooster

• Keep this medicine out of the sight and reach of children.

• Store in a refrigerator (2ºC-8ºC)

• Store in the original package. Sensitive to light.

• Do not freeze.

• The vaccine should not be used if it has been frozen.

• Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiration date is the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substances per dose are:

Diphtheria toxoid, purified 1: not less than 2 international units

Tetanus toxoid, purified 1: not less than 20 international units

Pertussis toxoid, purified 1: 20 micrograms

1 absorbed on aluminum hydroxide, hydrated, EQUIVALENT 0.5 mg aluminum.

Other excipients are:

Sodium chloride, sodium hydroxide, and water for injections

What the medicine looks like and the contents of the pack

Appearance

diTekiBooster is a colorless liquid with white or gray particles after shaking.

Pack sizes

diTekiBooster is delivered as a pre-filled syringe.

1 x 0.5 ml, 5 x 0.5 ml, 10 x 0.5 ml and 20 x 0.5 ml.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

AJ Vaccines A / S 
Artillerivej 5 
DK-2300 Copenhagen S 
Denmark 
tel .: +45 7229 7000 
fax: +45 7229 7999 
e-mail: ajvaccines@ajvaccines.com

Further information on this medicine can be obtained from the representative of the marketing authorization holder:

Representative 
Scandinavian Biopharma Distribution AB

Industrivägen 1

171 48 Solna

Phone: 08-470 56 00

Email: info@sbdistribution.se

This medicinal product is authorized under the European Economic Area under the names:

AT: DTaP Booster SSI injection suspension in a ready-made syringe

BE: BoosterTdaP 0.5ml Suspension for injection into the pre-filled syringe

DE: TdaP-IMMUN

DK, FI, NL, NO, SE: diTekiBooster

IE, IS: TdaPBooster

PL: Tdap Szczepionka SSI

IT: Tribaccine

Muhammad Nadeem

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