Solution for injection, suspension, pre-filled syringe. A vaccine against diphtheria and tetanus, adsorbed, with a reduced antigen content 

Read all of this leaflet carefully before you are vaccinated with this medicine.

  • Save this leaflet, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • 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. See section 4.

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

1. What diTeBooster is and what it is used for

diTeBooster is a vaccine that protects against diphtheria and tetanus.

This booster vaccine is used to vaccinate children (5 years and older) and adults who have already received a primary vaccination against diphtheria and tetanus.

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

You should not be vaccinated with diTeBooster

  If you are allergic to active substances or any of the other ingredients of this vaccine (listed in section 6).If you have experienced serious side effects after previous vaccinations.

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before being vaccinated with diTeBooster:

  suffering from any disease. In acute illness with fever, the vaccination should be postponed. receive medical treatment that affects the immune response (eg corticosteroids ) or if you suffer from a disease that increases the risk of bleeding have any allergy shave experienced discomfort after previous vaccinations allergic to formaldehyde. Formaldehyde is used during manufacture and very small amounts may therefore be present in the vaccine

Other medicines and diTeBooster

diTeBooster can be given at the same time as other vaccines but as a separate injection.

Tell your doctor if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription.

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 diTeBooster

Pregnancy

There is limited experience with the use of diet booster during pregnancy. If you are pregnant, your doctor will decide if the risk of tetanus and diphtheria infection is greater than the potential risk to the unborn baby if you are vaccinated.

Breast-feeding

There is limited experience with the use of diet booster during breastfeeding, but there is no evidence of adverse effects due to the transmission of the vaccine to the baby through breast milk.

Driving and using machines

diTeBooster should not affect your ability to drive and use machines.

diTeBooster contains sodium

diTeBooster contains less than 1 mmol sodium (23 mg) per dose and is therefore essentially ‘sodium-free’.

3. How to be vaccinated with diTeBooster

The doctor or nurse gives the vaccine by injection into a muscle ( intramuscularly ).

The booster dose is 0.5 ml for both children (5 years and older) and adults.

If you have any further questions on the use of this vaccine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

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

Severe allergic reactions (examples of which are difficulty breathing, difficulty swallowing, itching of the hands and feet, swelling around the eyes and face) can occur in rare cases (up to 1 in 1,000 people).

Contact a doctor immediately if you experience any of the above reactions.

Other side effects include

Common: may affect up to 1 in 10 users

General malaise and fever (temperature 38 ° C or higher). Redness and swelling at the injection site.

Uncommon:  may affect up to 1 in 100 people

Pronounced redness and swelling of 6 cm or more at the injection site. Eczema and dermatitis ( dermatitis ).

Rare:  may affect up to 1 in 1,000 users 

High fever (temperature above 40ºC). Prolonged lumpy skin after itching (granuloma) or sterile abscess at the injection site. Hives ( urticaria ).

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

Fainting

Reporting of side effects ar

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. You can also report side effects directly via

The Medical Products Agency

Box 26

751 03 Uppsala

By reporting side effects, you can help increase drug safety information.

5. How to store diTeBooster

  Keep this medicine out of the sight and reach of children. Store in a refrigerator (2 ° C – 8 ° C)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. 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 are:

1 dose (= 0.5 ml) contains at least 2 international units of purified diphtheria toxoid and at least 20 international units of purified tetanus toxoid which are adsorbed to aluminum hydroxide hydrate, corresponding to 0.5 mg of aluminum.

This vaccine contains aluminum as an adjuvant. Adjuvants are ingredients found in certain vaccines to accelerate, improve and/or prolong the protective effect of the vaccine.

Other ingredients are:

sodium hydroxide, sodium chloride, and water for injections

What the medicine looks like and the contents of the pack

diTeBooster is a colorless liquid with white and gray particles.

Each dose is delivered as a single pre-filled syringe.

Pack sizes of 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 available for sale.

Marketing Authorization Holder and Manufacturer

Aj Vaccines A / S

Artillerivej 5

DK-2300 Copenhagen S

Denmark

tel: +45 7229 7000

fax: +45 7229 7999

Email: ajvaccines@ajvaccines.com

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

Agent

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, DK, EL, ES, FI, IE, PT, NO, SE: diTeBooster

DE: Td-IMMUN

Muhammad Nadeem

Leave a Reply