Repevax | Diphtheria vaccine , tetanus, pertussis ( acellular component) and (inactivated) polio | uses, dose and side effects

Repevax (Tdap-IPV) is a vaccine. Vaccines are used to protect against infectious diseases. They work by getting the body to produce its protection ( antibodies ) against bacteria and viruses that cause the diseases to be fought.

This vaccine is used for children over 3 years of age, adolescents, and for adults as a booster dose to protect against diphtheria, tetanus, pertussis, and polio after a complete basic vaccination (primary vaccination series).

The use of Repevax during pregnancy provides protection that can be transmitted to the baby in the womb and protect the baby against whooping cough during the first months of life.

Restrictions on the protection afforded by the vaccine

Repevax protects against the mentioned diseases only if they are caused by the bacteria and viruses for which the vaccine is intended. You or your child can still get similar diseases if they are caused by other bacteria and viruses.

Scratch wax does not contain live bacteria or viruses, and it can not cause any of the infectious diseases that it protects against.

Note that no vaccine gives all vaccinated people complete, lifelong protection.

What you need to know before giving Repevax to you or your child

To make sure that Repevax is suitable for you or your child, inform your doctor or nurse if any of the following apply to you or your child. If there is anything you do not understand in this leaflet, ask your doctor or nurse to explain it.

Do not use Repevax if you or your child

previously had an allergic reaction
- of a vaccine against diphtheria, tetanus, pertussis, or polio
- against any of the excipients of the vaccine (listed in section 6)
- against any residues from the manufacture (formaldehyde, glutaraldehyde, streptomycin, neomycin, polymyxin B, and bovine serum albumin), the residues of which may be present in the vaccine
previously received
- a serious brain disease within 7 days after a previous vaccination against whooping cough
have an acute severe febrile illness. The vaccine should not be given until you or your child have recovered. A mild illness, which has not caused a fever, generally does not mean that vaccination has to be postponed. Your doctor will decide if you or your child should receive Repevax.

Warnings and cautions

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

received a booster dose of a vaccine against diphtheria and tetanus during the last 4 weeks. In this case, you or your child should not take Repevax and your doctor will decide based on official recommendations when you or your child can receive the next vaccine dose.
had Guillain-Barré syndrome (temporary loss of mobility and sensation in all or part of the body) within 6 weeks after a previous dose of tetanus vaccine. Your doctor will decide if you or your child should receive Repevax.
a progressive disease affecting the brain/nerves or seizures ( epilepsy ) that are out of control. The doctor will start treatment and only vaccinate when the condition has stabilized.
weak or weakened immune system due to the following:
- medication (eg steroids, chemotherapy, or radiation therapy)
- HIV infection or AIDS _
- or any other disease. The vaccine then does not necessarily protect as well as it protects people with a healthy immune system. If possible, the vaccination should be postponed until you or your child has recovered from such an illness or until the treatment has ended.
bleeding disorders that easily cause bruising or that small wounds bleed for a long time (eg blood diseases, such as hemophilia or platelet deficiency, or medication with blood-thinning drugs).

Fainting may occur after, or even before, any needle injection. Therefore, tell your doctor or nurse if you or your child have fainted from a previous injection.

Other medicines and Repevax

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Because Repevax does not contain any live bacteria or viruses, it can generally be given at the same time as other vaccines or immunoglobulins, but in a different place. According to studies, Repevax can be given concomitantly with the following vaccines: an inactivated influenza vaccine, a hepatitis B vaccine, or a recombinant human papillomavirus vaccine. The vaccines should be given to different extremities.

If you or your child are being treated with a medicine that affects your or your child’s blood or immune system (such as blood thinners, steroids, chemotherapy drugs ), read the instructions given above in the section “Warnings and Precautions”.

Pregnancy, breastfeeding, and fertility

Tell your doctor or nurse if you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby. Your doctor will help you decide if you should receive Repevax during pregnancy.

Driving and using machines

No studies have been performed on 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 sharpened 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. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Scratch wax contains ethanol

Repevax contains 1.01 mg of alcohol ( ethanol ) per dose of 0.5 ml. The low amount of alcohol in this medicine does not produce any noticeable effects.

How and when Repevax is given

When is the vaccine given to you or your child?

Your doctor will decide based on the following information if Repevax is suitable for you or your child:

which vaccines you or your child have received in the past
how many doses of the corresponding vaccines you or your child have received before
when you or your child last received a corresponding vaccine.

Your doctor will decide how long it should be between vaccinations.

If you are pregnant, your doctor will help you decide if you should receive Repevax during pregnancy.

Administration and method of administration

Who gives you the Repevax vaccine?

The Repevax vaccine should only be given by healthcare professionals who have been trained to give vaccines and who work in a clinic or clinic that has equipment for the treatment of very rare acute, severe allergic reactions.

Dosage

For all age groups, Repevax is intended for receiving an injection (half a milliliter).

If you or your child suffers from an injury that requires preventative measures against tetanus, your doctor may decide to give Repevax, with or without tetanus immunoglobulin.

Scratch wax can be used for revaccination. Your doctor will advise you on re-vaccination.

Method of administration

The doctor or nurse injects the vaccine into the muscle on the outside of the upper arm (deltoid muscle).

The doctor or nurse does not inject the vaccine into a blood vessel, into the gluteal muscle, or under the skin. If you or your child has a blood clotting disorder, your doctor or nurse may decide to inject the vaccine under your skin, although it may cause a stronger local reaction, such as a small lump under your skin.

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

Possible side effects

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

Severe allergic reactions

If any of these symptoms first appear after you have left the vaccination site, contact your doctor IMMEDIATELY:

breathing difficulties
the tongue or lips turn blue
rash
the face or neck swells up
low blood pressure, which causes dizziness or fainting.

These symptoms generally appear within a very short time after vaccination, ie when you or your child is still in the clinic or doctor’s office. Severe allergic reactions are very rare (may affect up to 1 in 10,000 people) regardless of the vaccine used.

Other side effects are

In clinical trials, the following side effects have been observed in certain age groups.

Children from 3 to 6 years of age

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

injection site pain
swelling and redness at the injection site
fatigue
fever (37.5 ° C or higher)
diarrhea

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

bruises at the injection site
itching and irritated skin at the injection site
headache
nausea
vomiting
rash
pain or swelling in joints
irritability.

Adolescents (from 11 years of age) and adults

It is a little more likely that young people get side effects than adults. Most side effects occur within 3 days after vaccination.

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

injection site pain
swelling and redness at the injection site
headache
nausea
joint pain or swollen joints
muscle pain
impotence
frostbite.

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

vomiting
diarrhea
fever (38.0 ° C or higher)

The following side effects have also been reported in different age groups during the time that Repevax has been on the market. How common these side effects are cannot be stated exactly, as the data are based on voluntary reporting and the number of vaccinated persons is only an estimate.

Lymph node disorders, allergic/severe allergic reactions, seizures, fainting, paralysis of the whole body or a part of the body (Guillain-Barré syndrome), paralysis of the face, spinal cord inflammation, nerve inflammation in the arm (brachial neuritis), temporary decreased or altered sensation in the vaccinated body part, dizziness, pain in the vaccinated body part, extensive swelling in extremity one (often in combination with redness and sometimes with blisters), general malaise, pallor, hard lump (hardening) at the injection site, abdominal pain.

How to store Repevax

Keep out of sight and reach of children.

Scratch wax should be used before the expiry date which is 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. Discard the vaccine if it has been frozen.

Store the syringe in the outer carton. Sensitive to light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Contents of the pack and other information

Content declaration

Diphtheria toxoid	at least 2 IU (2 Lf)
Tetanus toxoid	at least 20 IU (5 Lf)
Pertussis antigens:
Pertussis toxoid	2.5 micrograms
Filamentous hemagglutinin	5 micrograms
Pertactin	3 micrograms
Fimbria type 2 and 3	5 micrograms
Inactivated poliovirus (grown in Vero cells):
Type 1 (Mahoney)	40 D antigen units
Type 2 (MEF1)	8 D antigen units
Type 3 (Sackett)	32 D antigen units
Adsorbed to an aluminum embossed	1.5 mg (0.33 mg Al3 +)

This vaccine contains aluminum phosphate as an adjuvant. Adjuvants are ingredients found in some vaccines to accelerate, improve and/or prolong the protective effect of the vaccine. Other ingredients are: phenoxyethanol, ethanol, polysorbate 80, water for injections

What the medicine looks like and the contents of the pack

Repevax is a solution for injection, a suspension supplied in a pre-filled syringe (0.5 ml):

where the syringe is not provided with a needle-pack size of 1, 10 or 20
where 1 or 2 separate needles are included – pack size 1 or 10

Not all pack sizes may be marketed.

The vaccine is normally a uniform, cloudy white suspension in which a precipitate may form during storage. Once shaken, the vaccine is a smooth, white solution.

Marketing Authorisation Holder

Sanofi Pasteur

14 Henry Vallée Space

69007 Lyon

France

Manufacturer