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