Priorix-tetra

Leaflet attached to the packaging: information for the user

Priorix-Tetra, powder and solvent for solution for injection

Measles, mumps, rubella and chickenpox vaccine, live

Read the leaflet carefully before using the vaccine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

The content of this leaflet has been approved by the competent authorities, assuming it will be read by the person receiving the vaccine. However, since this vaccine may be administered to adults and children, it is possible that the content of the leaflet will be read by the child's parent or guardian.

Table of contents of the leaflet

• 1. What is Priorix-Tetra vaccine and what is it used for
• 2. Important information before using Priorix-Tetra vaccine
• 3. How to use Priorix-Tetra vaccine
• 4. Possible side effects
• 5. How to store Priorix-Tetra vaccine
• 6. Contents of the pack and other information

1. What is Priorix-Tetra vaccine and what is it used for

Priorix-Tetra is a vaccine used in individuals from 11 months of age to prevent diseases caused by measles, mumps, rubella and chickenpox viruses. In certain circumstances, Priorix-Tetra may also be given to children from 9 months of age.

How Priorix-Tetra vaccine works

After administration of Priorix-Tetra vaccine, the immune system (the body's defense system) of the vaccinated person will start producing antibodies that will protect against infection with measles, mumps, rubella and chickenpox viruses.
Although Priorix-Tetra contains live viruses, they have been weakened to such an extent that they cannot cause measles, mumps, rubella and chickenpox in healthy individuals.
As with all vaccines, Priorix-Tetra may not fully protect all vaccinated individuals.

2. Important information before using Priorix-Tetra vaccine

When not to use Priorix-Tetra vaccine

• if the patient has a known hypersensitivity to any of the components of this vaccine (listed in section 6). Symptoms of an allergic reaction include an itchy skin rash, difficulty breathing, swelling of the face or tongue;
• if the patient has had an allergic reaction after previous administration of any measles, mumps, rubella and/or chickenpox vaccine;
• if the patient is allergic to neomycin (an antibiotic). Contact dermatitis caused by neomycin (skin rash appearing as a result of direct skin contact with an allergen such as neomycin) should not be a problem, but you should discuss this with your doctor first;
• if the patient has a severe infection with fever. In this case, vaccination should be postponed until recovery. Mild infections such as a cold should not be a contraindication to vaccination, but you should discuss this with your doctor first;
• if the patient has any disease (e.g. human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)) or is taking medicines that may weaken the immune system. Whether or not the patient will receive the vaccine will depend on the level of immunity;
• if pregnancy is confirmed. Additionally, pregnancy should be avoided for 1 month after vaccination.

Warnings and precautions

You should talk to your doctor or pharmacist before administering Priorix-Tetra vaccine if:

• there is a history of seizures, including febrile seizures. In this case, the patient should be closely monitored after vaccination, as fever associated with vaccination may occur, especially between 5 and 12 days after vaccination (see section 4);
• the patient has ever had a severe allergic reaction to egg protein;
• the patient has had side effects after measles, mumps or rubella vaccination, including easy bruising or bleeding for longer than usual (see section 4);
• the patient has a weakened immune system (e.g. due to HIV infection). The patient should be closely monitored because the response to the vaccine may not be sufficient to provide protection against the disease (see section 2 "When not to use Priorix-Tetra vaccine").

If the patient is vaccinated within 72 hours of contact with a person with measles or chickenpox, Priorix-Tetra vaccine may provide some protection against the disease.
After vaccination, the patient should avoid close contact with:

• people with weakened immune systems,
• pregnant women who have not had chickenpox or have not been vaccinated against chickenpox,
• newborn babies of mothers who have not had chickenpox or have not been vaccinated against chickenpox.

After or even before administration of each injection vaccine, fainting (especially in adolescents) may occur. Therefore, you should inform your doctor or nurse if the patient has ever fainted during injection.
As with other vaccines, Priorix-Tetra vaccine may not fully protect all vaccinated individuals. However, in vaccinated individuals, the course of the disease is usually much milder than in unvaccinated individuals.

Priorix-Tetra vaccine and other medicines

Tell your doctor about all medicines you are taking or have recently taken, medicines you plan to take, and vaccines you have recently received.
Vaccination may be postponed by your doctor for at least 3 months if you have recently received a blood transfusion or human antibodies (immunoglobulin).
If a tuberculin test (skin test for tuberculosis) is to be performed, it should be done before or at the same time as vaccination or after 6 weeks from vaccination.
Salicylates (substances found in many anti-fever and pain-relieving medicines) should be avoided for 6 weeks after vaccination.
Priorix-Tetra vaccine can be given at the same time as other vaccines. Each vaccine should be given at a different injection site.

Pregnancy and breastfeeding

Priorix-Tetra vaccine should not be given to pregnant women.
In pregnancy, during breastfeeding or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this vaccine. Additionally, it is important that for 1 month after vaccination, the patient does not become pregnant. During this time, an effective method of contraception should be used to avoid pregnancy.

Driving and using machines

There are no data suggesting that Priorix-Tetra vaccine affects the ability to drive and use machines.

Priorix-Tetra contains sorbitol

This vaccine contains 14 mg of sorbitol in each dose.

3. How to use Priorix-Tetra vaccine

Priorix-Tetra is given subcutaneously or intramuscularly, in the upper arm or outer thigh.
Priorix-Tetra is intended for individuals from 11 months of age. The vaccination schedule and the number of doses to be given will be determined by your doctor based on official recommendations.
Vaccines should never be given intravascularly.

4. Possible side effects

Like all medicines, side effects may occur after administration of this vaccine, although they may not occur in every individual.
After administration of the vaccine, the following side effects may occur:
♦
Very common (may occur more frequently than 1 in 10 doses of the vaccine):

• pain and redness at the injection site
• fever 38°C or higher*
• swelling at the injection site, in cases where the vaccine is administered to adolescents and adults

♦
Common (may occur no more frequently than 1 in 10 doses of the vaccine):

• swelling at the injection site, in cases where the vaccine is administered to children
• fever higher than 39.5°C*
• irritability
• rash (spots and/or blisters)

♦
Uncommon (may occur no more frequently than 1 in 100 doses of the vaccine):

• abnormal crying, nervousness, insomnia
• general feeling of being unwell, lethargy, fatigue
• swelling of the parotid glands (glands in the cheek area)
• diarrhea, vomiting
• loss of appetite
• upper respiratory tract infection
• runny nose
• swelling of the lymph nodes

♦
Rare (may occur no more frequently than 1 in 1,000 doses of the vaccine):

• middle ear infection
• febrile seizures
• cough
• bronchitis

* More frequent occurrence of fever after administration of the first dose of Priorix-Tetra vaccine compared to separate administration of measles, mumps, rubella and chickenpox vaccines during the same visit.
The following side effects have been reported during routine use of measles, mumps and rubella vaccine or chickenpox vaccine manufactured by GlaxoSmithKline Biologicals:

• joint and muscle pain
• allergic reactions (hypersensitivity). This condition may manifest as an itchy or blistering rash, swelling of the eyelids and face, difficulty breathing or swallowing, sudden drop in blood pressure and loss of consciousness. These reactions may occur before leaving the doctor's office. If any of these symptoms occur, you should immediately consult a doctor
• infection or inflammation of the brain, spinal cord and peripheral nerves resulting in transient difficulties in walking (ataxia) and/or transient loss of coordination, stroke, inflammation of some nerves with possible tingling or loss of sensation or movement disorders (Guillain-Barré syndrome)
• narrowing or obstruction of blood vessels
• small local bleeding or easier bruising due to reduced platelet count
• erythema multiforme (symptoms include red, often itchy spots, similar to a chickenpox-like rash, which appear on the limbs and sometimes on the face and other parts of the body)
• rash similar to chickenpox
• shingles
• symptoms similar to measles and mumps (including transient, painful swelling of the testicles and swollen lymph nodes in the neck)

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Adverse Reaction Monitoring of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Jerozolimskie Avenue 181C
02-222 Warsaw
Tel.: 22 49 21 301
Fax: 22 49 21 309
e-mail: [email protected]
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Priorix-Tetra vaccine

Store the vaccine out of sight and reach of children.
Do not use this vaccine after the expiry date stated on the label after "EXP".
The expiry date refers to the last day of the month.
The abbreviation "Lot" means the batch number of the vaccine.
Store and transport in a cool place (2°C - 8°C).
Do not freeze.
Store in the original packaging to protect from light.
After reconstitution, the vaccine should be used immediately or stored in a refrigerator (2°C - 8°C). If it is not used within 24 hours, it should be discarded.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Priorix-Tetra vaccine contains

• The active substances of the vaccine are: live, attenuated measles, mumps, rubella and chickenpox viruses.
• Other ingredients of the vaccine are: Powder: amino acids, anhydrous lactose, mannitol, sorbitol, medium 199 Solvent: water for injections

What Priorix-Tetra vaccine looks like and contents of the pack

The vaccine is provided as a powder and solvent for solution for injection (powder in a 1-dose vial, solvent in a 0.5 ml ampoule).
Packs of 1, 10 or 100.
Priorix-Tetra vaccine is a white to pale pink powder and a clear, colorless solvent (water for injections) used to dissolve the powder.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

GlaxoSmithKline Biologicals S.A.
Rue de l’Institut 89
B-1330 Rixensart
Belgium
Date of last revision of the leaflet:December 2019

Other sources of information

Detailed information on this vaccine is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products .
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Information intended for healthcare professionals only:
As with all injectable vaccines, it is always necessary to ensure the possibility of appropriate treatment and medical supervision in case of rare post-vaccination anaphylactic reactions.
Alcohol and other disinfectants should evaporate from the skin before administering the vaccine, as they may inactivate the attenuated viruses in the vaccine.
Priorix-Tetra vaccines should never be administered intravascularly or intradermally.
Since compatibility studies have not been performed, the medicinal product should not be mixed with other medicines.
The vaccine should be inspected visually for particulate matter and/or abnormal physical appearance before administration. If any are found, the vaccine should not be administered.
The vaccine should be reconstituted by adding the entire contents of the solvent ampoule to the vial containing the powder. The mixture should then be shaken vigorously until the powder is completely dissolved in the solvent.
Due to minor changes in pH, the vaccine after reconstitution may take on a light apricot to pink color. This is a normal phenomenon and does not affect the efficacy of the vaccine. If other changes are observed, the vaccine should not be administered.
The entire contents of the vial should be administered.
A new needle should be used for administration of the vaccine.
After reconstitution, the vaccine should be used immediately or stored in a refrigerator (2°C - 8°C). If it is not used within 24 hours, it should be discarded.
Any unused product or waste material should be disposed of in accordance with local regulations.