VacPertagen – Package Leaflet: InfoCons – Consumer Protection presents, in an accessible format, the official package leaflet of the medicine VacPertagen, as authorised in the European Union and published in the Union Register of medicinal products.
Before anything else
Read all of this leaflet carefully before you receive this vaccine 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.
- 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.
ℹ️ 1. What VacPertagen is and what it is used for
VacPertagen is a vaccine use d to prevent pertussis . It is used as a booster vaccination in adolescents (12 years and older) and adults who were previously vaccinated against the disease (active vaccination). It is also used as a passive vaccination to protect infants in the first few months of life by vaccinating mothers during pregnancy.
Pertussis (often called whooping cough) is a highly infectious disease that can occur at any age. The disease affects the airways causing severe episodes of coughing that may interfere with normal breathing and can last for several weeks. Pertussis can also cause ear infections, chest infections (bronchitis), lung infections (pneumonia), fits, brain damage and even death.
VacPertagen activates the immune system (the body’s natural defences) to make antibodies , against the infecting bacterium that protect against pertussis disease. Most people will have received pertussis vaccines earlier in their life, but these may not provide life -long protection.
An active vaccination helps your body to produce new antibodies . Passive vaccination in the second or third trimester of pregnancy allows the body to make antibodies that are passed to the infant through the placenta before birth. This helps provide immediate protection to the infant in the first few months of life before the baby is given their own pertussis vaccine.
⚠️ 2. What you need to know before you receive VacPertagen
Do not use VacPertagen
- if you are allergic (hypersensitive) to the active substances or any of the other ingredients of this vaccine (listed in section 6) or to formaldehyde.
- if you have had an allergic reaction after receiving a pertussis vaccine.
- if you have suffered from a severe allergic reaction or a re action affecting the brain (encephalopathy) within 7 days after receiving a pertussis containing vaccine.
- if you have an unstable or progressive medical condition affecting the brain and nervous system , such as uncontrolled epilepsy or progressive encephalopathy .
Warnings and precautions
Talk to your doctor, pharmacist or nurse before you are given V acPertagen if you:
- have experienced any of the following problems after getting a pertussis -containing vaccine in the past :
- a high body temperature (40 ° C or higher ) within 48 hours after vaccination
- a collapse or shock -like state within 48 hours after vaccination
- persistent crying lasting 3 hours or more within 48 hours of vaccination during childhood
- had a fit (convulsion) with or without fever within 3 days of vaccination.
- are feeling nervous about getting the vaccine or have ever fainted after any injection. This can help your doctor or nurse take precautions in case you may faint .
- have an infection with a high fever. If this is the case, vaccination will be postponed. There is no need to delay vaccination for a minor infection such as a cold but talk to your doctor first.
- have a bleeding problem or bruise easily, or if you are receiving anti -blood clotting medicines .
- have a weakened immune system , due to another medical condition or certain treatments. This may prevent you getting the full benefit from VacPertagen .
- are pregnant and in the first trimester of pregnancy If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before you are given V acPertagen .
As with any vaccine, V acPertagen may not fully protect all those who receive it.
Children
VacPertagen is not recommended in children under 12 years of age .
Other medicines and VacPertagen
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines, or have recently received any other vaccine.
Pregnancy and breast -feeding If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advi ce before you are given th is vaccine. Talk to your doctor or nurse for advice before getting this vaccine if you are breast -feeding.
Driving and using machines
Some of the effects of vaccination mentioned in section 4 (Possible side effects) such as muscle pain (myalgia) or feeling tired (fatigue) , may temporarily reduce your ability to drive and use machines.
Wait until these effects have worn off before you drive or use machines.
VacPertagen contains sodium
This vaccine contains less than 1 mmol sodium (1.7 mg) per dose, that is to say essentially ‘sodium free’.
💊 3. How VacPertagen is given
You will be given one injection of 0.5 mL into the muscle of your upper arm (deltoid muscle) .
If you have any questions on the use of V acPertagen , ask your doctor, pharmacist or nurse.
❗ 4. Possible side effects
Like all medicines, this vaccine can cause side effects, although not everyone gets them.
Serious side effects
- Severe allergic reactions may occur very rarely (may affect up to 1 in 10 000 people).
Signs of an allergic reaction include difficulty breathing, blueness of the tongue or lips, rash, swelling of the face or throat, and low blood pressure causing dizziness or collapse.
Such symptoms usually develop quickly after the injection is given. Tell your doctor immediately if you notice any of these symptoms after vaccination.
Other side effects
Very common (may affect more than 1 in 10 people)
- headache
- feeling sick (nausea)
- muscle pain (myalgia)
- joint pain (arthralgia)
- pain where the injection is given
- feeling tired (fatigue)
- generally feeling unwell/discomfort (malaise)
Common (may affect up to 1 in 10 people)
- swollen or painful lymph nodes (lymphadenitis and lymphadenopathy)
- vomiting
- digestive problems such as diarrhoea and gut inflammation (enteritis)
- rash
- urticaria
- itching (pruritus) where the injection is given
- hard mass/lump (induration) where the injection is given
- bruising where the injection is given (injection site haematoma)
- chills
- fever
Uncommon (may affect up to 1 in 100 people)
- redness (erythema) and swelling where the injection is given
Rare (may affect up to 1 in 1 000 people)
- a forceful heartbeat that may be rapid or irregular ( palpitation s)
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V . By reporting side effects, you can help provide more information on the safety of this medicine.
🌡️ 5. How to store VacPertagen
Keep this vaccine out of sight and reach of children. Store in a refrigerator (2 ° C – 8 ° C). Do not freeze. Store in the original package in order to protect from light .
Do not use this vaccine if you notice the packaging is torn or damaged.
Do not use VacPertagen after the expiry date which is stated on the carton and the pre -filled syringe label after “EXP ”.
Unopened vaccine is stable for a total of 3 days when kept at temperatures between 8 °C and 25 °C. At the end of this period VacPertagen should be discarded.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
📦 6. Contents of the pack and other information
What VacPertagen contains
The active substances per dose (0.5 mL) are:
Purified Bordetella pertussis antigens Recombinant Pertussis Toxin (PT gen)1,2 5 micrograms Filamentous Haemagglutinin (FHA)1 5 micrograms 1adsorbed on aluminium hydroxide, hydrated 0. 3 milligrams Al3+ 2produced in Bordetella pertussis as a genetically detoxified PT (PT gen) by recombinant DNA technology The other ingredients are :
Sodium chloride (see section 2) and water for injections.
Alumin ium hydroxide is included in this vaccine as an adjuvant. Adjuvants are often included in vaccines to improve the body’s production of protective responses.
What VacPertagen looks like and contents of the pack
VacPertagen is a whitish, cloudy uniform suspension, provided in a single -dose (0.5 mL) pre -filled syringe.
VacPertagen is supplied in a pack containing one pre -filled syringe with needle .
Marketing Authorisation Holder
BioNet Europe 41 Quai Fulchiron, Lyon 69005 France
Manufacturer
MIAS Pharma Limited Suite 1 First Floor, Stafford House, Strand Road, Portmarnock, D13 WC83, Ireland
This leaflet was last revised in
Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu .
📄 Package Leaflet – official source
This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information VacPertagen (PDF, ec.europa.eu).
You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/25/1999).
⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.