The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 46602/0006.
Suspension for injection in pre-filled syringe
Diphtheria, Tetanus and Poliomyelitis (inactivated)
Vaccine (adsorbed, reduced antigen(s) content)
1. What REVAXIS is and what it is used for
2. What you need to know before you use REVAXIS
3. How to use REVAXIS
4. Possible side effects
5. How to store REVAXIS
6. Contents of the pack and other information
REVAXIS (Td-IPV) is a vaccine Vaccines are used to protect against infectious diseases. This vaccine helps boost protection against diphtheria, tetanus and poliomyelitis (polio). When an injection of REVAXIS is given, the body’s natural defenses will produce protection against these different diseases.
This booster vaccination is for children from the age of 6 years, teenagers and adults who have received this vaccine or a similar vaccine in the past. REVAXIS should not be given as the first vaccination (primary course) against diphtheria, tetanus and poliomyelitis (polio).
REVAXIS will be given according to national recommendations and/or local practice.
To make sure that REVAXIS is suitable for you or your child, it is important that you tell your doctor, nurse or pharmacist if any points below apply to you or your child. If there is anything you do not understand, ask your doctor, nurse or pharmacist to explain.
Talk to your doctor, pharmacist or nurse before using REVAXIS
Fainting can occur following, or even before, any needle injection.
Therefore, tell your doctor or nurse if you or your child fainted with a previous injection.
REVAXIS can be given at the same time as other vaccines or immunoglobulins but in different injection sites (e.g. the other arm or leg).
If you or your child are receiving medical treatment that affects the immune system (such as steroids, chemotherapy or radiotherapy), refer to the section „Take special care with REVAXIS“.
Tell your doctor, nurse or pharmacist if you are using or have recently used any other medicines
If you or your child are pregnant or breast-feeding, think you or your child may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice whether you or your child should receive the vaccine.
REVAXIS can be given to women who are breast-feeding.
Dizziness (vertigo) has been reported after vaccination. If you feel dizzy after having the vaccine, you should not drive or operate machinery.
REVAXIS contains 10 microgram phenylalanine in each 0.5 ml dose which is equivalent to 0.17 microgram/kg for a 60 kg person.
Phenylalanine may be harmful for people with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
REVAXIS contains less than 1mmol of potassium (39 mg) and sodium (23 mg) per dose, that is to say essentially ‘potassium-free’ and ‘sodium-free’.
REVAXIS contains 2 mg of alcohol (ethanol) in each 0.5 ml dose. The small amount of alcohol in this medicine will not have any noticeable effects.
REVAXIS is for children from the age of 6 years, teenagers and adults.
This vaccine is not suitable for children who are under 6 years old.
REVAXIS is used to boost protection in someone who has received this vaccine or a similar vaccine in the past. Remember that the polio vaccine you had in the past may have been given by injection or by mouth.
This vaccine will be given according to national recommendations and/ or local practice.
After an injury, you may need a tetanus vaccination. Your doctor or nurse will give you REVAXIS in case you also need a booster against diphtheria and polio at the same time.
The vaccination will be given by a doctor or nurse who is trained in the use of vaccines and at a clinic or surgery that is equipped to deal with any uncommon severe allergic reaction to the injection.
Children from the age of 6 years, teenagers and adults will receive one injection (0.5 ml dose).
Method of administration
REVAXIS is given as an injection into a muscle, usually in the upper outer part of the arm.
The vaccine is not to be injected directly into any blood vessel or into the skin. In case of blood clotting disorders your doctor may decide to inject deep under the skin.
If you have any further questions on the use of this vaccine, ask your doctor, nurse or pharmacist.
Like all medicines and vaccines, this vaccine can cause side effects, although not everybody gets them.
These reactions are always a rare possibility after receiving a vaccine and may include:
When these signs or symptoms occur they usually develop very quickly after the injection is given and while the person affected is still in the clinic or doctor’s surgery.
If any of these symptoms occur after leaving the place where you or your child received the injection, you must consult a doctor IMMEDIATELY.
If you or your child experience any of the following side effects and it gets serious, tell your doctor, nurse or pharmacist.
During clinical studies, the following side effects were observed:
Very common side effects (reported in more than 1 out of 10 people):
Common side effects (reported by less than 1 in 10 people):
Uncommon side effects (reported by less than 1 in 100 people):
Rare side effects (reported by less than 1 in 1,000 people):
Additionally, the following side effects with unknown frequency (exact incidence rates cannot be precisely calculated) have been reported during the commercial use of REVAXIS
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517; Website: www.hpra.ie; E-mail: [email protected]. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this vaccine out of the sight and reach of children.
Store in a refrigerator between 2°C and 8°C. Do not freeze. Discard the vaccine if it has been frozen. Do not use this vaccine after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.
Do not throw away any medicines via waste water or household waste.
Ask your pharmacist how to throw away medicines you no longer use.
These measures will help protect the environment.
The active substances in each dose (0.5 ml) of vaccine are:
Purified Diphtheria Toxoid not less than 2 IU¹
Purified Tetanus Toxoid not less than 20 IU¹
Inactivated Poliomyelitis virus (cultivated on Vero cells)
Type 1 29 D antigen units²
Type 2 7 D antigen units²
Type 3 26 D antigen units²
The adsorbent is: aluminium hydroxide 0.35 mg as aluminium
¹ IU is an international unit for measuring vaccine activity
² These antigen quantities are strictly the same as those previously expressed as 40-8-32 D-antigen units, for virus type 1, 2 and 3 respectively, when measured by another suitable immunochemical method.
Aluminium hydroxide is included in this vaccine as an adsorbent.
Adsorbents are substances included in certain vaccines to accelerate, improve and/or prolong the protective effects of the vaccine.
The other ingredients are:
Phenoxyethanol, ethanol anhydrous, formaldehyde, acetic acid (pH adjuster), sodium hydroxide (pH adjuster), Medium 199 (a mixture of amino acids including phenylalanine, mineral salts, vitamins, polysorbate 80, hydrochloric acid (pH adjuster), sodium hydroxide (pH adjuster) and other substances) and water for injections.
The vaccine’s normal appearance is a cloudy white suspension for injection that may sediment during storage. It is available as a single dose (0.5 ml) pre-filled syringe
Not all pack sizes may be marketed.
The manufacturer responsible for batch release is:
This medicinal product is authorised in the following Member States of the EEA under the name REVAXIS: Austria, Belgium, Germany, Italy, Ireland, Luxembourg, Portugal, The Netherlands, United Kingdom.
This leaflet was last revised in March 2023.