Triaxis suspension for injection in pre-filled syringe
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
TRIAXIS injectable suspension in pre-filled syringe
Diphtheria, tetanus, pertussis (acellular component) vaccine
(adsorbed, reduced antigen content)
Read the entire leaflet carefully before you or your child are vaccinated, as it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, consult your doctor, pharmacist or nurse.
- This medicine has been prescribed only for you or your child and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
- If you or your child experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.
Leaflet contents
- What Triaxis is and what it is used for
- What you need to know before you or your child receive Triaxis
- How to use Triaxis
- Possible side effects
- How to store Triaxis
- Contents of the pack and other information
1. What Triaxis is and what it is used for
Triaxis (Tdap) is a vaccine. Vaccines are used to protect against infectious diseases. Vaccines cause the body to produce its own protection against the bacteria that cause these infectious diseases.
This vaccine is used as a booster to protect against diphtheria, tetanus, and pertussis (whooping cough) in children from four years of age, adolescents, and adults after completion of the primary vaccination schedule.
The use of Triaxis during pregnancy allows protection to be passed to the unborn child against whooping cough during the first months of life.
Limitations of the protection provided
Triaxis will only prevent these diseases if they are caused by the bacteria used to produce the vaccine. It is possible that you or your child may develop similar illnesses caused by other bacteria or viruses.
Triaxis does not contain any live bacteria or virus and cannot cause any of the infectious diseases against which it provides protection.
Please remember that no vaccine can provide complete and long-lasting protection for all individuals who are vaccinated.
2. What you need to know before you or your child receive Triaxis
To ensure that Triaxis is suitable for you or your child, it is important to inform your doctor or nurse if any of the following apply to you or your child. If there is anything you do not understand, please consult your doctor or nurse.
Do not use Triaxis if you or your child
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has had an allergic reaction:
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to diphtheria, tetanus, or pertussis (whooping cough) vaccines
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to any other component (listed in section 6)
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to any residual component transferred during manufacturing (formaldehyde, glutaraldehyde) that may be present in small amounts.
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has had a severe reaction affecting the brain within one week after a previous dose of a pertussis-containing vaccine.
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has a serious acute illness. Vaccination should be postponed until you or your child have recovered. A minor illness without fever is usually not a reason to delay vaccination. Your doctor will decide whether you or your child should receive Triaxis.
Warnings and precautions
Talk to your doctor or nurse before vaccination if you or your child
- has received a booster dose of a diphtheria and tetanus vaccine within the past 4 weeks. In this case, you or your child should not receive Triaxis, and your doctor will decide, according to official recommendations, when you or your child can receive another injection.
- has had Guillain-Barré syndrome (temporary loss of movement and sensation in the whole body or part of it) within 6 weeks after receiving a previous dose of a vaccine containing tetanus antigen. Your doctor will decide whether you or your child should receive Triaxis.
- has a progressive disease affecting the brain/nervous system or uncontrolled seizures. Your doctor will initiate treatment and carry out the vaccination once the condition has stabilized.
- has a weakened or compromised immune system due to
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- medications (e.g., steroids, chemotherapy, or radiotherapy).
- HIV infection or AIDS.
- any other disease.
The vaccine may not protect such individuals to the same extent as it protects individuals with a healthy immune system. If possible, vaccination should be postponed until the end of the illness or treatment.
- has blood disorders causing easy bruising or prolonged bleeding after minor cuts (e.g., due to a blood disorder such as hemophilia, thrombocytopenia, or treatment with anticoagulant medications).
Fainting may occur after, or even before, any injection with a needle. Therefore, inform your doctor or nurse if you or your child has previously experienced fainting after an injection.
Talk to your doctor, pharmacist, or nurse before using Triaxis if you or your child have had an allergic reaction to latex. The pre-filled syringes (1.5 ml) with soft stoppers contain a natural rubber latex derivative (latex rubber) that may cause an allergic reaction.
Other medicines, vaccines, and Triaxis
Inform your doctor, nurse, or pharmacist if you or your child are using or have recently used, or might need to use, any other medicines.
Since Triaxis does not contain any live bacteria, it can be administered at the same time as other vaccines or immunoglobulins, although at a different injection site. Studies have shown that Triaxis can be used simultaneously with the following vaccines: hepatitis B vaccine, poliovirus vaccine (oral or injectable), and inactivated influenza vaccine, respectively. In addition, Triaxis can be administered at the same time as the human papillomavirus vaccine and/or meningococcal conjugate polysaccharide vaccines (serogroups A, C, Y, and W) (all three vaccines together or in pairs). Injections of more than one vaccine at the same time will be administered in different limbs.
If you or your child are receiving medical treatment affecting the blood or immune system (such as anticoagulants, steroids, or chemotherapy), refer to the previous section "Warnings and precautions."
Pregnancy, breastfeeding, and fertility
Consult your doctor or nurse if you are pregnant, think you might be pregnant, intend to become pregnant, or are breastfeeding. Your doctor will help you decide whether you should receive Triaxis during pregnancy.
Driving and using machines
No studies have been conducted on the effects on the ability to drive and use machines. The vaccine has no or negligible effect on the ability to drive and use machines.
3. How to use Triaxis
When you or your child will receive the vaccine
Your doctor will decide whether you or your child should receive Triaxis, based on:
- which vaccines you or your child have previously received.
- how many doses of similar vaccines you or your child have previously received.
- when the last dose of a similar vaccine was administered to you or your child.
Your doctor will determine the interval to be observed between vaccinations.
If you are pregnant, your doctor will help you decide whether you should receive Triaxis during pregnancy.
Dosage and method of administration
Who will administer Triaxis?
Triaxis must be administered by healthcare professionals trained in the use of vaccines and in a clinic or outpatient setting equipped to manage any rare severe allergic reactions to the vaccine.
Dosage
All age groups for which it is indicated will receive one injection (0.5 millilitres).
If you or your child experience an injury requiring preventive action against tetanus disease, your doctor may decide to administer Triaxis with or without tetanus immunoglobulin.
Triaxis may be used for booster vaccination. Your doctor will advise you on when to repeat the vaccination.
Method of administration
The doctor or nurse will administer the vaccine into a muscle in the outer upper arm (deltoid muscle).
The doctor or nurse will not administer the vaccine into a blood vessel, into the buttocks, or under the skin. In cases of blood coagulation disorders, they may decide to inject under the skin, although this may cause more local side effects, including a small lump under the skin.
If you have any doubts about the use of this medicine, consult your doctor, pharmacist, or nurse.
4. Possible adverse effects
Like all medicines, Triaxis may cause adverse effects, although not everyone experiences them.
Serious allergic reactions
If any of these symptoms occur after you or your child have left the place where the injection was given, you must consult a doctor IMMEDIATELY.
- difficulty breathing
- blue coloration of the tongue or lips
- rash
- swelling of the face or throat
- low blood pressure causing dizziness or fainting (collapse)
When these signs or symptoms occur, they usually develop very quickly after the injection and while you or your child are still in the doctor's office. Serious allergic reactions are a very rare possibility (may affect 1 in 10,000 people) after receiving any vaccine.
Other adverse effects
The following adverse effects were observed during clinical studies conducted in specific age groups.
In children aged 4 to 6 years
Very common (may occur in more than 1 in 10 people):
- loss of appetite
- headache
- diarrhea
- fatigue
- pain
- redness
- swelling at the injection site
Common (may occur in up to 1 in 10 people):
- nausea
- vomiting
- rash
- body pain or muscle weakness
- painful or swollen joints
- fever
- chills
- lymph node disorder in the armpit
In adolescents aged 11 to 17 years
Very common (may occur in more than 1 in 10 people):
- headache
- diarrhea
- nausea
- body pain or muscle weakness
- painful or swollen joints
- fatigue/weakness
- malaise
- chills
- pain
- redness and swelling at the injection site
Common (may occur in up to 1 in 10 people):
- vomiting
- skin rash
- fever
- lymph node disorder in the armpit
In adults aged 18 to 64 years
Very common (may occur in more than 1 in 10 people):
- headache
- diarrhea
- body pain or muscle weakness
- fatigue/weakness
- malaise
- pain
- redness and swelling at the injection site
Common (may occur in up to 1 in 10 people):
- nausea
- vomiting
- skin rash
- painful or swollen joints
- fever
- chills
- lymph node disorder in the armpit
The following additional adverse events have been reported in the various recommended age groups during commercial use of Triaxis. It is not possible to accurately estimate the frequency of these adverse events, as it would be based on voluntary reporting rates relative to the estimated number of vaccinated individuals.
- Allergic reactions/serious allergic reactions (for information on how to recognize such a reaction, see the beginning of section 4), soreness or numbness, paralysis of part or all of the body (Guillain-Barré syndrome), inflammation of the nerves in the arm (brachial neuritis), loss of function in the nerve transmitting impulses to the facial muscles (facial paralysis), seizures (convulsions), fainting, inflammation of the spinal cord (myelitis), inflammation of the muscular part of the heart (myocarditis), itching (pruritus), hives, inflammation of a muscle (myositis), extensive swelling of the limbs associated with redness, warmth, tenderness to touch or pain at the injection site, bruising, swelling, or a small lump at the injection site.
Reporting of adverse effects
If you or your child experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Triaxis
Keep this medicine out of the sight and reach of children.
Do not use Triaxis after the expiry date which is stated on the packaging and label after CAD/EXP. The expiry date refers to the last day of the month indicated.
Store in a refrigerator (between 2°C and 8°C). Do not freeze. Discard the vaccine if it has been frozen.
Keep the syringe in the outer packaging to protect it from light.
Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be handed over to the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of Triaxis
The active substances in each dose (0.5 ml) of vaccine are:
Diphtheria toxoid not less than 2 International Units (2 Lf)
Tetanus toxoid not less than 20 International Units (5 Lf)
Pertussis antigens:
Pertussis toxoid 2.5 micrograms
Filamentous haemagglutinin 5 micrograms
Pertactin 3 micrograms
Fimbriae types 2 and 3 5 micrograms
Adsorbed on aluminium phosphate 1.5 mg (0.33 mg of Al3+)
Aluminium phosphate is included in the vaccine as an adjuvant. Adjuvants are substances included in certain vaccines to accelerate, enhance, and/or prolong the protective effects of vaccines.
The other components are: phenoxyethanol, water for injections.
Appearance of the product and contents of the pack
Triaxis is presented as an injectable suspension in a pre-filled syringe (0.5 ml):
- without needle – pack of 1 or 10
- with 1 or 2 separate needles – pack of 1 or 10
- with separate safety needle – pack of 1 or 10
Contains a natural rubber latex derivative (latex rubber) in the stopper at the end of the pre-filled syringe.
Only certain pack sizes may be marketed.
The normal appearance of the vaccine is a white, cloudy suspension, which may sediment during storage and form clumpy or flaky aggregates. After proper shaking, the liquid appears uniformly white. If aggregates are present, the product may be shaken again until a uniform suspension is obtained.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder is:
Sanofi Winthrop Industrie
82 avenue Raspail
94250 Gentilly
France
The manufacturer is:
Sanofi Winthrop Industrie
1541 avenue Marcel Mérieux
Marcy l´Etoile - 69280 - France
or
Sanofi Winthrop Industrie
Voie de l’Institut – Parc Industriel d’Incarville
B.P 101
27100 Val de Reuil
France
or
SANOFI-AVENTIS ZRT
Campona U.1 (Harbor Park) - Budapest - 1225 - Hungary
Local representative
sanofi-aventis, S.A.
C/ Rosselló i Porcel, 21
08016 Barcelona
Spain
Tel: +34 93 485 94 00
This medicinal product has been authorised in the Member States of the EEA under the following names:
Austria, Germany: | Covaxis |
Belgium, Denmark, Finland, France, Greece, Ireland, Italy, Luxembourg, Norway, Portugal, Spain, Sweden, Netherlands: | Triaxis |
Bulgaria, Croatia, Cyprus, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Malta, Poland, Romania, Slovakia, Slovenia, United Kingdom (Northern Ireland): | Adacel |
Date of the most recent review of this leaflet: November 2025
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/
This information is intended exclusively for healthcare professionals:
In the absence of compatibility studies, Triaxis must not be mixed with other medicinal products.
Preparation for administration
The pre-filled syringe may be supplied with a Luer Lock tip cap with a soft tip (Image A) or with a rigid tip cap (Image B). The syringe containing the injectable suspension should be visually inspected before administration. If foreign particles, leaks, premature plunger activation, or defective tip sealing are observed, discard the pre-filled syringe. The syringe is for single use only and must not be reused.
Instructions for use of the Luer Lock pre-filled syringe:
Image A: Luer Lock syringe with soft tip cap
Step 1: Holding the syringe cap with one hand (avoid touching the plunger or the syringe barrel), remove the cap from the tip. |
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Step 2: To attach the needle to the syringe, gently rotate it clockwise until you feel slight resistance. |
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Image B: Luer Lock Syringe with Rigid Tip Cap
Step 1: Holding the Luer Lock adapter with one hand (avoid holding the plunger or the syringe barrel), unscrew the tip cap by turning it. |
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Step 2: To attach the needle to the syringe, gently turn the needle in the Luer Lock adapter of the syringe until you feel slight resistance. |
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Instructions for using the safety needle with the Luer Lock pre-filled syringe:
Follow steps 1 and 2 above to prepare the Luer Lock syringe and the needle for attachment.
Image C: Safety Needle (Inside the Case) | Image D: Components of the Safety Needle (Ready for Use) |
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Step 3: Remove the safety shield cover. The needle is protected by the safety shield and the cap. | |
Step 4: A: Slide the safety shield away from the needle and toward the syringe at the indicated angle. B: Remove the cap in a straight line. |
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Step 5: After completing the injection, lock (activate) the safety shield using one of the three single-handed activation techniques illustrated: surface activation, thumb activation, or finger activation. Note: Activation is confirmed by an audible and/or tactile "click." |
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Step 6: Visually inspect the activation of the safety shield. The safety shield must be fully locked (activated) as shown in Figure C. Figure D shows the safety shield is NOT fully locked (not activated). |
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Caution: Do not attempt to unlock (deactivate) the safety device by forcing the needle out of the safety shield. |
Any unused medicine or waste material should be disposed of in accordance with local requirements.
Do not recap needles.