Document: leaflet MAH BRAND_PL 06745-0183 change

• leaflet MAH BRAND_PL 06745-0183
• leaflet MAH BRAND_PL 46602-0013

---

PACKAGE LEAFLET

Package leaflet: Information for the user

ADACEL

Suspension for injection in pre-filled syringe

Diphtheria, Tetanus, Pertussis (acellular, component) Vaccine (adsorbed, reduced antigen(s) content)

Read all of this leaflet carefully before you or your child is vaccinated 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 .

-    This vaccine has been prescribed for you or for your child only. Do not pass it on to others.

-    If you or your child 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.

What is in this leaflet:

1.    What ADACEL is and what it is used for

2.    What you need to know before ADACEL is given to you or your child

3.    How and when ADACEL is given

4.    Possible side effects

5.    How to store ADACEL

6.    Contents of the pack and other information

1 What ADACEL is and what it is used for

ADACEL is a vaccine. Vaccines are used to protect against infectious diseases. They work by causing the body to produce its own protection against the bacteria that cause the targeted diseases.

This vaccine is used to boost protection against diphtheria, tetanus and pertussis (whooping cough) in children from the age of 4 years, adolescents and adults, following a complete primary course of vaccination.

Limitations in the protection provided

ADACEL will only prevent these diseases if they are caused by the bacteria targeted by the vaccine. You or your child could still get similar diseases if they are caused by other bacteria or viruses.

ADACEL does not contain any live bacteria or viruses and it cannot cause any of the infectious diseases against which it protects.

Remember that no vaccine can provide complete, life long protection in all people who are vaccinated.

What you need to know before ADACEL is given to you or your child

To make sure that ADACEL is suitable for you or your child, it is important to tell your doctor or nurse if any of the points below apply to you or your child. If there is anything you do not understand, ask your doctor or nurse to explain.

Do not use ADACEL if you or your child

•    has had an allergic reaction:

-    to diphtheria, tetanus or pertussis vaccines

-    to any of the other ingredients (listed in section 6)

-    to any residual component carried over from manufacture (formaldehyde, glutaraldehyde) which may be present in trace amounts.

•    has ever had a severe reaction affecting the brain within one week after a previous dose of a whooping cough vaccine

•    has an acute illness with or without fever. The vaccination should be delayed until you or your child has recovered. A minor illness without fever is not usually a reason to defer vaccination. Your doctor will determine if you or your child should receive ADACEL.

Warnings and precautions

Tell your doctor or nurse before vaccination if you or your child has

•    received a booster dose of a vaccine for diphtheria and tetanus within the last 4 weeks. In this case you or your child should not receive ADACEL and your doctor will decide on the basis of official recommendations when you or your child can receive a further injection.

•    ever had a Guillain-Barre syndrome (temporary loss of movement and feeling in all or part of the body) or brachial neuritis (loss of movement, pain and numbness of the arm and the shoulder) following a previous dose of a tetanus containing vaccine. Your doctor will decide if you or your child should receive ADACEL.

•    a progressive illness affecting the brain/nerves or uncontrolled fits. Your doctor will first start treatment and vaccinate when the condition has stabilized.

•    a poor or reduced immune system, due to

-    medication (e.g., steroids, chemotherapy or radiotherapy)

-    HIV infection or AIDS

-    any other illness.

The vaccine may not protect as well as it protects people whose immune system is healthy. If possible, vaccination should be postponed until the end of such disease or treatment.

•    any problems with the blood that causes easy bruising, or bleeding for a long time after minor cuts (for instance due to a blood disorder such as haemophilia or thrombocytopenia or treatment with blood thinning medicines).

Children and adolescents

ADACEL should not be used in children under 4 years of age.

Other medicines or vaccines and ADACEL

Tell your doctor, nurse or pharmacist if you or your child is taking, has recently taken or might take any other medicines.

As ADACEL does not contain any live bacteria, it can generally be given at the same time as other vaccines or immunoglobulins, but at a different injection site. Studies have demonstrated that ADACEL can be used at the same time as any of the following vaccines: a hepatitis B vaccine, a poliovirus vaccine (injected or oral), an inactivated flu vaccine and a recombinant Human Papillomavirus vaccine respectively. Injections of more than one vaccine at the same time will be given in different limbs.

If you or your child is receiving medical treatment affecting you or your child's blood or immune system (such as blood thinning medicines, steroids or chemotherapy), please refer to the section "Warnings and precautions" above.

Pregnancy, breast-feeding and fertility

Tell your doctor or nurse if you or your child is pregnant or breast-feeding, think you or your child might be pregnant or planning to have a baby. Your doctor or nurse can advise you whether or not vaccination should be delayed.

Driving and using machines

It has not been studied if the vaccine affects the ability to drive or use machines. The vaccine has no or negligible influence on the ability to drive and use machines.

How and when ADACEL is given

When you or your child will be given the vaccine

Vaccination history

Your doctor will determine if ADACEL is suitable for you or your child, depending on:

•    what vaccines have been given to you or your child in the past

•    how many doses of similar vaccines have been given to you or your child in the past

•    when the last dose of a similar vaccine was given to you or your child

You or your child must have had the complete primary courses of diphtheria and tetanus vaccines before having ADACEL.

It is safe to have ADACEL if you or your child have not had the complete primary course of whooping cough vaccines but protection may not be as good as in people who have already had the whooping cough vaccine.

Your doctor will decide how long you have to wait between vaccinations.

Dosage and method of administration

Who will give you ADACEL?

ADACEL should be given by healthcare professionals who have been trained in the use of vaccines and at a clinic or surgery that is equipped to deal with any rare severe allergic reaction to the vaccine.

Dosage

All age groups for whom ADACEL is indicated will receive one injection (half a millilitre).

In case you or your child experience an injury which requires preventive action for tetanus disease, your doctor may decide to give ADACEL with or without tetanus immunoglobulin.

Use in children and adolescents

ADACEL should not be used in children under 4 years of age.

Children from the age of 4 years onwards and adolescents should receive the same dosage as adults.

Method of administration

Your doctor or nurse will give you the vaccine into a muscle in the upper outer part of the arm (deltoid muscle).

Your doctor or nurse will not give you the vaccine into a blood vessel, into the buttocks or under the skin. In case of blood clotting disorders they may decide to inject under the skin, although this might result in more local side effects, including a small lump under the skin.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

Possible side effects

Like all medicines, ADACEL can cause side effects, although not everybody gets them.

Serious allergic reactions

If any of these symptoms occur after leaving the place where you or your child received the injection, you must consult a doctor IMMEDIATELY:

-    difficulty in breathing

-    blueness of the tongue or lips

-    a rash

-    swelling of the face or throat

-    low blood pressure causing dizziness or collapse.

When these signs or symptoms occur they usually develop very quickly after the injection is given and while you or your child is still in the clinic or doctor’s surgery. Serious allergic reactions are a very rare possibility (may affect up to 1 in 10,000 people) after receiving any vaccine.

Other side effects

The following side effects were observed during clinical studies carried out in specific age groups.

In children aged 4 to 6 years

Very common (may affect more than 1 in 10 people):

•    decreased appetite,

•    headache,

•    diarrhoea,

•    tiredness,

•    pain,

•    redness

•    swelling in the area where the vaccine was injected.

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

•    nausea,

•    vomiting,

•    rash,

•    aching (all over the body) or muscular weakness,

•    aching or swollen joints,

•    fever,

•    chills,

underarm lymph node disorder.

In adolescents aged 11 to 17 years

Very common (may affect more than 1 in 10 people):

•    headache,

•    diarrhoea,

•    nausea,

•    aching (all over the body) or muscular weakness,

•    aching or swollen joints,

•    tiredness/weakness,

•    chills,

•    pain,

•    redness and swelling in the area where the vaccine was injected.

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

•    vomiting,

•    rash,

•    fever,

•    underarm lymph node disorder.

In adults aged 18 to 64 years

Very common (may affect more than 1 in 10 people):

•    headache,

•    diarrhoea,

•    aching (all over the body) or muscular weakness,

•    tiredness/weakness,

•    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,

•    chills,

•    underarm lymph node disorder.

The following additional adverse events have been reported in the various recommended age groups during the commercial use of ADACEL. The frequency of these adverse events cannot be precisely calculated, as it would be based on voluntary reporting in relation to the estimated number of vaccinated persons.

- Allergic / serious allergic reactions (how you can recognize such a reaction, you can find in the beginning of section 4), ‘pins and needles’ or numbness, paralysis of part or all the body (Guillain-Barre syndrome), inflammation of the nerves in the arm (brachial neuritis), loss of function in the nerve that supplies the facial muscles (facial palsy), fits (convulsions), fainting, inflammation of the spinal cord (myelitis), inflammation of the muscular part of the heart (myocarditis), itching, hives, inflammation of a muscle (myositis), extensive limb swelling associated with redness, warmth,

tenderness or pain in the area where the vaccine was injected, bruising or abscess in the area where the vaccine was injected.

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 (see details below). By reporting side effects, you can help provide more information on the safety of this medicine.

Ireland

Health Products Regulatory Authority (HPRA): HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

United Kingdom

Medicines and Healthcare products Regulatory Agency (MHRA): Yellow Card Scheme at www.mhra.gov.uk/yellowcard.

How to store ADACEL

Keep this medicine out of the sight and reach of children.

ADACEL must not be used after the expiry date which is stated on the label after “EXP”. The expiry date refers to the last day of that month.

Store in a refrigerator (2°C - 8°C). Do not freeze. Discard the vaccine if it has been frozen.

Keep the syringe in the outer carton in order to protect from light.

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.

Contents of the pack and other information

What ADACEL contains

The active substances in each dose (0.5 mL) of vaccine are:

Diphtheria Toxoid Tetanus Toxoid Pertussis Antigens:

Pertussis Toxoid Filamentous Haemagglutinin Pertactin

Fimbriae Types 2 and 3 Adsorbed on Aluminium Phosphate

The other ingredients are: phenoxyethanol, water for injections

What ADACEL looks like and contents of the pack

ADACEL is presented as a suspension for injection in pre-filled syringe (0.5 mL):

•    without needle - pack size of 1 or 10

•    with 1 or 2 separate needles - pack size of 1 or 10 Not all pack sizes may be marketed.

The normal appearance of the vaccine is a cloudy white suspension, which may sediment during storage. After shaking well it is a uniformly white liquid.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

The manufacturer responsible for batch release is:

Sanofi Pasteur SA

2, avenue Pont Pasteur

69007 Lyon

France

This medicinal product is authorised in the Member States of the EEA under the following names:

Germany:    Covaxis

Austria, Belgium, Finland, France, Greece, Ireland, Italy,

Luxembourg, Norway, Portugal, Spain, Sweden:    Triaxis

Bulgaria, Croatia, Cyprus, Czech Republic, Estonia,

Hungary, Latvia, Lithuania, Malta, Poland, Romania,

Slovakia, Slovenia, United Kingdom:    Adacel

This leaflet was last revised in April 2016.

The following information is intended for healthcare professionals only:

Instructions for use

In the absence of compatibility studies, ADACEL must not be mixed with other medicinal products.

Parenteral biological products should be inspected visually for extraneous particulate matter and/or discolouration prior to administration. If these conditions exist, the product should not be administered.

The needle should be pushed firmly on to the end of the pre-filled syringe and rotated through 90 degrees.

Needles should not be recapped.