solution for injection, suspension in pre-filled syringe
Vaccine against diphtheria, tetanus, and pertussis (acellular, component), adsorbed, with reduced antigen content
What Triaxis is and what it is used for
Triaxis (Tdap) is a vaccine. Vaccines are used to protect against infectious diseases. They work by causing the body to produce its protection against the bacteria that cause these diseases.
This vaccine is used to boost protection against diphtheria, tetanus, and pertussis in children from 4 years of age, adolescents, and adults, after a complete basic immunization.
The use of Triaxis during pregnancy provides protection that can be transferred to the baby in the womb and protect the baby against whooping cough during the first months of life.
Limitations of Coverage
Triaxis prevents these diseases only if they are caused by the bacteria that the vaccine targets. You or your child can still get similar illnesses if they are caused by other bacteria or viruses.
Triaxis does not contain any live bacteria or viruses and it cannot cause any of the infectious diseases it protects against.
Remember that no vaccine can provide complete, lifelong protection to all people vaccinated.
What you need to know before Triaxis is given to you or your child
To be sure that Triaxis is suitable for you or your child, you must tell the doctor or nurse if any of the points below apply to you or your child. If there is something you do not understand, ask the doctor or nurse to explain it.
Do not use Triaxis if you or your child
- have had an allergic reaction:
- against vaccines against diphtheria, tetanus, or whooping cough
- against any of the other ingredients (specified in section 6)
- against any residual substance from manufacturing (formaldehyde, glutaraldehyde), of which there may be trace amounts.
- ever had a serious reaction affecting the brain within a week of a previous dose of a pertussis vaccine
- has an acute severe febrile illness. Vaccination should be postponed until you or your child has recovered. A mild illness without a fever is usually not a reason to postpone vaccination. The doctor decides whether you or your child should receive Triaxis.
Warnings and precautions
Talk to a doctor or nurse before the vaccination if you or your child have
- received a booster dose of a vaccine against diphtheria and tetanus within the last 4 weeks. In this case, you or your child should not receive Triaxis and your doctor will decide based on official recommendations when you or your child can receive another injection.
- had Guillain-Barré syndrome (temporary loss of movement and feeling in all or part of the body) within 6 weeks of a previous dose of a tetanus vaccine. The doctor decides whether you or your child should receive Triaxis.
- an uncontrolled disease affecting the nervous system or uncontrolled epileptic seizures. The doctor only starts treatment and vaccinates when the condition has stabilized.
- weak or impaired immune system due to
- medication (eg steroids, chemotherapy, or radiotherapy).
- HIV infection or AIDS. _
- any other disease.
The vaccine may not protect as well as it protects people with healthy immune systems. If possible, vaccination should be postponed until such illness or treatment has ceased.
- any problem with the blood that makes bruising easy, or bleeding for a long time after a minor injury (for example, due to a blood disorder such as hemophilia or thrombocytopenia or treatment with blood-thinning medicines).
Fainting may occur after, or even before, any needle injection. Therefore, tell the doctor or nurse if you or your child has fainted during a previous injection.
Tell your doctor, pharmacist, or nurse before using Triaxis if you or your child have had an allergic reaction to latex. The tip covers of the pre-filled syringes contain a derivative of natural rubber (latex), which can cause an allergic reaction.
Other medicines and Triaxis
Tell the doctor, nurse, or pharmacist if you or your child are taking, have recently taken, or might take any other medicines.
As Triaxis does not contain live bacteria, it can generally be given at the same time as other vaccines or immunoglobulins but a different injection site. Studies have shown that Triaxis can be used at the same time as any of the following vaccines: a hepatitis B vaccine, a polio vaccine (injected or taken by mouth), an inactivated influenza vaccine, and a recombinant human papillomavirus vaccine. Injection of several vaccines at the same time must be done in different parts of the body.
If you or your child are receiving drug treatment that affects your or your child’s blood or immune system (such as blood-thinning drugs, corticosteroids, or chemotherapy ), read the section “Warnings and precautions” above.
Pregnancy, breastfeeding, and fertility
Tell the doctor or nurse if you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby. The doctor will help you decide if you should receive Triaxis during pregnancy.
Driving ability and use of machinery
It has not been studied whether the vaccine affects the ability to drive or use machines. The vaccine has no or negligible effect on the ability to drive and use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased 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. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with a doctor or pharmacist if you are unsure.
How and when Triaxis is given
When you or your child is given the vaccine
The doctor will decide whether Triaxis is suitable for you or your child depending on:
- which vaccines you or your child have received in the past
- how many doses of similar vaccines you or your child have received before
- when you or your child received the last dose of one of the similar vaccines
The doctor decides how long you should wait 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 gives you Triaxis?
Triaxis should be given by healthcare professionals trained in giving vaccines and in a clinic or practice equipped to manage any rare serious allergic reaction to the vaccine.
Dosage
All age groups for which Triaxis is intended receive one injection (half a milliliter).
If you or your child suffers an injury that requires preventive measures against tetanus, the doctor may decide to give Triaxis with or without tetanus immunoglobulin.
Triaxis can be used for booster vaccination. The doctor will advise you about booster vaccination.
Mode of administration
The doctor or nurse will give you the vaccine into a muscle in your upper arm (the deltoid muscle).
The doctor or nurse will not give you the vaccine in a blood vessel, in the buttocks, or under the skin. In the case of a disturbance in the clotting ability of the blood, they may decide to inject under the skin, but this can cause more local side effects, including a small lump under the skin.
If you have any further questions about the use of this medicine, contact your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Severe allergic reactions
If any of these symptoms occur after you leave the place where you or your child received an injection, you must IMMEDIATELY contact a doctor:
- breathing difficulties
- bluing of the tongue or lips
- rash
- swelling of the face or neck
- low blood pressure that causes dizziness or collapse
If these signs or symptoms occur, they usually develop very quickly after the injection has been given and while you or your child are still in the clinic or doctor’s office. As with all vaccines, in very rare cases (in 1 in 10,000 patients) serious allergic reactions may occur.
Other side effects are
The following side effects were observed during clinical trials conducted in specific age groups.
Children aged 4 to 6 years
Very common (may affect more than 1 in 10 people):
- decreased appetite
- headache
- diarrhea
- fatigue
- pain
- redness
- swelling in the area where the vaccine was injected.
Common (may affect up to 1 in 10 people):
- nausea
- vomiting
- rash
- aches (in the whole body) or muscle weakness
- aching or swollen joints
- fever
- overindulge
- complaints from lymph nodes in the armpit.
Young people aged 11 to 17 years
Very common (may affect more than 1 in 10 people):
- headache
- diarrhea
- nausea
- aches (in the whole body) or muscle weakness
- aching or swollen joints
- fatigue/weakness
- general malaise
- overindulge
- pain
- redness and swelling in the area where the vaccine was injected.
Common (may affect up to 1 in 10 people):
- vomiting
- rash
- fever
- complaints from lymph nodes in the armpit.
Adults aged 18 to 64 years
Very common (may affect more than 1 in 10 people):
- headache
- diarrhea
- aches (in the whole body) or muscle weakness
- fatigue/weakness
- general malaise
- pain
- redness and swelling in the area where the vaccine was injected.
Common (may affect up to 1 in 10 people):
- nausea
- vomiting
- rash
- aching or swollen joints
- fever
- overindulge
- complaints from lymph nodes in the armpit.
The following additional side effects have been reported in the various recommended age groups during the commercial use of Triaxis. The frequency of these side effects cannot be calculated precisely, as it would be based on voluntary reporting about an estimated number of vaccinated persons.
- Allergic/severe allergic reactions (you can read about how to recognize such a reaction at the beginning of section 4), tingling or numbness, paralysis of part or the whole body ( Guillain-Barré syndrome ), nerve inflammation in the arm (brachial neuritis ), loss of function of the nerve that controls the facial muscles (facial paralysis), seizures (convulsions), fainting, inflammation of the spinal cord ( myelitis ), inflammation of the heart muscle ( myocarditis ), itching, hives, inflammation of a muscle (myositis), extensive swelling of the arm with redness, warmth and tenderness or pain in the area where the vaccine was injected, bruising or boils in the area where the vaccine was injected.
How to store Triaxis
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the label after “EXP”. The expiration date is the last day of the specified month.
Store in a refrigerator (2°C-8°C). Do not freeze. The frozen vaccines must be discarded.
Store the syringe in the outer carton. Light sensitive.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
| 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 hemagglutinin | 5 micrograms |
| Pertactin | 3 micrograms |
| Fimbria types 2 and 3 | 5 micrograms |
| Adsorbed on aluminum phosphate | 1.5 mg (0.33 mg Al 3+ ) |
| This vaccine contains aluminum phosphate as an adjuvant. Adjuvants are ingredients found in some vaccines to accelerate, enhance and/or prolong the protective effect of the vaccine. Other ingredients are: phenoxyethanol, water for injections |
Appearance and package sizes of the medicine
Triaxis is available as a suspension for injection in a pre-filled syringe (0.5 ml):
- without needle – packs of 1 or 10
- with 1 or 2 separate needles – packs of 1 or 10
Not all pack sizes may be marketed.
The normal appearance of the vaccine is a cloudy white suspension that may settle on storage. After thorough shaking, it is a homogeneous white liquid.
Marketing Authorisation Holder:
Sanofi Pasteur Europe
14 Espace Henry Vallée
69007 Lyon
France
Manufacturer:
Sanofi Pasteur
14 Espace Henry Vallée
69007 Lyon
France
Local representative:
Sanofi AB
Box 30052
104 25 Stockholm
Phone: +46 8-634 50 00