Triaxis

Package Leaflet: Information for the User

TRIAXIS

Injectable Suspension in Pre-filled Syringe
Diphtheria, Tetanus, Pertussis (acellular components) Vaccine
(adsorbed, reduced antigen content)
Please read all of this leaflet carefully before you or your child are vaccinated because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This vaccine has been prescribed only for you or your child. Do not give it to others.
• If you or your child experience any adverse reactions, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What Triaxis is and what it is used for
2. What you need to know before Triaxis is given to you or your child
3. How and when to use Triaxis
4. Possible side effects
5. How to store Triaxis
6. Contents of the pack and other information

1. What Triaxis is and what it is used for

Triaxis (dTpa) is a vaccine. Vaccines are used to protect against infectious diseases. They work by stimulating the body's natural defences to produce protection against bacteria that cause certain diseases.
This vaccine is used to stimulate protection against diphtheria, tetanus, and pertussis (whooping cough) in children from four years of age, adolescents, and adults, following a complete primary vaccination course.
The use of Triaxis during pregnancy allows the transfer of protection to the unborn child in the womb, thereby protecting the baby from pertussis during the first months of life.
Limitations in the protection provided
Triaxis will prevent these diseases only if they are caused by the same bacteria against which the vaccine acts. You or your child may still contract similar illnesses if they are caused by other bacteria or viruses.
Triaxis does not contain any live bacteria or viruses and cannot cause any of the infectious diseases against which it provides protection.
Please remember that no vaccine can provide complete, lifelong protection in all vaccinated individuals.

2. What you should know before Triaxis is administered to you or your child

To ensure that Triaxis is suitable for you or your child, it is important that you inform your doctor or
nurse if any of the points listed below apply to you or your child. If there is anything you do not
understand, ask your doctor or nurse for clarification.
Do not use Triaxis if you or your child:

• have had an allergic reaction to:
• diphtheria, tetanus, or pertussis vaccines,
• any of the other components (listed in Section 6),
• any residual components from manufacturing (formaldehyde, glutaraldehyde) that may be present in trace amounts.
  • have had a severe reaction affecting the brain within one week after receiving a previous dose of a pertussis-containing vaccine.
  • have a serious febrile illness in its acute phase. Vaccination should be postponed until you or your child have recovered. A minor illness not accompanied by fever generally does not justify postponing vaccination. Your doctor will decide whether to administer Triaxis to you or your child.

Warnings and precautions
Talk to your doctor or nurse before vaccination if you or your child:

• have 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, based on official recommendations, when you or your child can receive another injection.
• have experienced Guillain-Barré syndrome (temporary loss of movement and sensation in part or all of the body) within 6 weeks after a previous dose of a vaccine containing tetanus toxoid. Your doctor will decide whether to administer Triaxis to you or your child.
• have a progressive neurological disorder or uncontrolled seizures. Your doctor will first initiate treatment and proceed with vaccination once the condition has stabilized.
• have a weakened or suppressed immune system due to:
  • medications (e.g., steroids, chemotherapy, or radiotherapy)
  • HIV infection or AIDS
  • any other disease.

The vaccine may not be as effective as in individuals with a healthy immune system. If possible,
vaccination should be postponed until recovery from these conditions or completion of treatment.

• have any blood disorder causing you to bruise easily or bleed for prolonged periods after minor cuts (e.g., a blood disorder such as hemophilia or thrombocytopenia, or treatment with anticoagulant medications).

Fainting may occur following, or even before, any injection with a needle. Therefore, inform your
doctor or nurse if you or your child have fainted after a previous injection.
Inform your doctor, pharmacist, or nurse before using Triaxis if you or your child have had
allergic reactions to latex. The pre-filled syringes (1.5 mL) with soft caps contain a derivative of natural rubber latex, which may cause an allergic reaction.
Other medicines, vaccines, and Triaxis
Inform your doctor, nurse, or pharmacist if you or your child are taking, have recently taken, or might take any other medicines.
Since Triaxis does not contain live bacteria, it can generally be administered simultaneously with other
vaccines or immunoglobulins, but at a different injection site. Studies have shown that Triaxis can
be administered simultaneously with any of the following vaccines: hepatitis B vaccine,
poliomyelitis vaccine (injectable or oral), and inactivated influenza vaccine, respectively. In addition,
Triaxis can be administered simultaneously with the human papillomavirus vaccine and/or
polysaccharide conjugate meningococcal vaccines (serogroups A, C, Y, and W) (all three vaccines or in pairs). Simultaneous administration of more than one vaccine should be performed in different limbs.
If you or your child are receiving medical treatment affecting the blood or immune system (such as blood-thinning medications, steroids, chemotherapy), refer to the section “Warnings and precautions” above.
Pregnancy, breastfeeding, and fertility
If you are pregnant, breastfeeding, suspect you may be pregnant, or are planning to become pregnant,
inform your doctor or nurse. 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 of Triaxis on the ability to drive vehicles or operate machinery.
Triaxis has no or negligible effect on the ability to drive vehicles and operate machinery.

3. How to use Triaxis

When you or your child will receive the vaccine
The doctor will determine whether Triaxis is suitable for you or your child 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

The doctor will decide 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 will administer Triaxis to you?
Triaxis must be administered by a healthcare professional trained in the use of vaccines and in a hospital or clinic equipped to manage any rare, severe allergic reactions to the vaccine that may occur after injection.

Dosage
All age groups for which Triaxis is indicated will receive 1 injection (0.5 millilitres).

If you or your child has sustained an injury requiring preventive action against tetanus disease, the doctor may decide to administer Triaxis with or without tetanus immunoglobulins.

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 by intramuscular injection into the upper outer part of the arm (deltoid muscle).

The doctor or nurse will not inject the vaccine into a blood vessel, into the buttock, or under the skin. In case of blood coagulation disorders, they may decide to administer the injection under the skin, although this may lead to additional local adverse effects, including the formation of a small nodule under the skin.

If you have any doubts about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Triaxis can cause side effects, although not everyone will experience them.
Severe allergic reactions
If any of the following symptoms occur after you or your child have left the place where the vaccine was administered, you must consult a doctor IMMEDIATELY:

• difficulty breathing,
• bluish discoloration of the tongue or lips,
• skin rash,
• swelling of the face or throat,
• low blood pressure causing dizziness or collapse.

When these signs or symptoms occur, they usually develop immediately after administration of the vaccine and while you or your child are still in the hospital or medical office.
Other side effects
The following side effects were observed during clinical studies 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 at the injection site

Common (may affect up to 1 in 10 people):

• nausea
• vomiting
• rash
• body pain or muscle weakness
• joint pain or swelling
• fever
• chills
• axillary lymph node disorders

Adolescents aged 11 to 17 years
Very common (may affect more than 1 in 10 people):

• headache
• diarrhea
• nausea
• body pain or muscle weakness
• joint pain or swelling
• fatigue/weakness
• malaise
• chills
• pain
• redness and swelling at the injection site

Common (may affect up to 1 in 10 people):

• vomiting
• rash
• fever
• axillary lymph node disorders

Adults aged 18 to 64 years
Very common (may affect 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 affect up to 1 in 10 people):

• nausea
• vomiting
• rash
• joint pain or swelling
• fever
• chills
• axillary lymph node disorders

The following additional adverse events have been reported in the different age groups indicated during commercial use of Triaxis. The frequency of these adverse events cannot be precisely determined, as it is based on voluntary reporting relative to the estimated number of vaccinated individuals.

• Allergic reactions/serious allergic reactions (you can find an explanation on how to recognize such reactions at the beginning of Section 4), tingling or numbness, partial or complete body paralysis (Guillain-Barré syndrome), inflammation of the nerves in the arm (brachial neuritis), loss of function of the nerve controlling facial muscles (facial paralysis), seizures, fainting, inflammation of the spinal cord (myelitis), inflammation of the muscular component of the heart (myocarditis), itching, hives, inflammation of a muscle (myositis), extensive limb swelling accompanied by redness, warmth, tenderness or pain at the injection site, bruising, abscess, or a small lump at the injection site.
  Reporting of side effects
  If you or your child experience any side effect, including those not listed in this leaflet, please contact your doctor, pharmacist, or nurse. You may also report side effects directly via the national reporting system at the following website:
  https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
  By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to Store Triaxis

Keep this medicinal product out of the sight and reach of children.
Do not use Triaxis after the expiry date stated on the label after the word “Exp.”. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C - 8°C). Do not freeze. If frozen, the vaccine must be discarded.
Keep the vaccine in its outer packaging to protect it from light.
Do not dispose of any medicinal product via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the Pack and Other Information

What Triaxis Contains
The active substances in each dose (0.5 ml) of the 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
Type 2 and 3 fimbriae 5 micrograms
Adsorbed on Aluminium Phosphate 1.5 mg (0.33 mg of Al)
Aluminium phosphate is included in this vaccine as an adjuvant. Adjuvants are substances included in some vaccines to accelerate, enhance, and/or prolong the protective effects of the vaccine.

Other components are: phenoxyethanol, water for injections.

Description of the Appearance of Triaxis and Contents of the Pack
Triaxis is a 0.5 ml injectable suspension supplied in a pre-filled syringe:

• 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.

Not all pack sizes may be marketed.
The vaccine is a white, cloudy suspension which may sediment during storage and form clumped or fragmented aggregates. After thorough shaking, the vaccine appears as a uniformly white liquid. If aggregates are present, the product may be shaken again until a uniform suspension is obtained.

Marketing Authorization Holder:
Sanofi Winthrop Industrie
82 avenue Raspail
94250 Gentilly
France
Representative in Italy
Sanofi S.r.l. - Viale L. Bodio, 37/B – 20158 Milano

Responsible Manufacturers for Batch Release:
Sanofi Winthrop Industrie
Voie de l’Institut - Parc Industriel d’Incarville
B.P 101
27100 Val de Reuil
France
Sanofi-Aventis Zrt.
Building Dc5
Campona Utca 1
Budapest XXII, 1225
Hungary

This medicinal product is authorized in the European Economic Area member states under the following names:
Austria, Germany: Covaxis
Belgium, Denmark, Finland, France, Greece, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden: Triaxis
Bulgaria, Cyprus, Croatia, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Malta, Poland, Romania, Slovakia, Slovenia, United Kingdom (Northern Ireland): Adacel

The following information is intended exclusively for physicians or 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 featuring a soft cap (Figure A) or a rigid cap (Figure B). The syringe containing the injectable suspension should be inspected visually before administration. If particulate matter, leakage, premature plunger activation, or a defective tip seal are observed, discard the pre-filled syringe. The syringe is for single use only and must not be reused.

Instructions for use of the pre-filled Luer Lock syringe:
Figure A: Luer Lock Syringe with Soft Cap

Step 1: Holding the syringe cap in one hand (avoid touching the plunger or the syringe barrel), remove the cap.
Step 2: To attach the needle to the syringe, gently rotate the needle clockwise into the syringe until slight resistance is felt.

Figure B: Luer Lock syringe with rigid cap

Step 1: Holding the Luer Lock adapter in one hand (avoid touching the plunger or the syringe barrel), remove the cap by twisting it.
Step 2: To attach the needle to the syringe, gently twist the needle into the syringe's Luer Lock adapter until slight resistance is felt.

Instructions for using the safety needle with pre-filled syringe with Luer Lock:
Follow steps 1 and 2 above to prepare the Luer Lock syringe and needle for attachment

Figure C: Safety needle (inside the housing)	Figure D: Components of the safety needle (ready for use)
Step 3: Remove the safety needle from its housing. The needle is covered by the safety shield and the needle cap.
Step 4: A: Pull the safety shield away from the needle and tilt it toward the syringe barrel at the angle shown. B: Remove the needle cap.
Step 5: After completing the injection, lock (activate) the safety shield using one of the three (3) illustrated one-handed activation techniques: surface, thumb, or fingers. Note: Activation is confirmed by an audible and/or tactile "click".
Step 6: Visually inspect the activation of the safety shield. The safety shield must be fully locked (activated), as shown in Image C.
Image D indicates that the safety shield is NOT fully locked (not activated).
Warning: Do not attempt to unlock (deactivate) the safety device by forcing the needle out of the safety shield.

Unused medicine and waste materials derived from this medicine must be disposed of in accordance with
local regulations.
Needles must not be recapped.