Prospect: information for the user

Priorix, powder and diluent in pre-filled syringe for injectable solution

Measles, mumps, and rubella (live) vaccine

Read this prospect carefully before you receive this vaccine, as it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any questions, consult your doctor or pharmacist.

-This vaccine has been prescribed only for you, and you must not give it to other people.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

This prospect has been written assuming that the person reading it is the one receiving the vaccine, but it may be administered to adults and children, so you may be reading it for your child.

Contents of the package and additional information

Priorix is a vaccine administered to children from 9 months old, adolescents, and adults to protect them against diseases caused by measles, mumps, and rubella viruses.

How Priorix works

When a person is vaccinated with Priorix, the immune system (the body's natural defense system) will produce antibodies to protect the person from infection by measles, mumps, and rubella viruses.

Although Priorix contains live viruses, they are too weakened to produce measles, mumps, or rubella in healthy individuals.

Do not administer Priorix if

• You are allergic to the active ingredients or any of the other components of this vaccine (listed in section 6). Signs of an allergic reaction may include skin rash with itching, difficulty breathing, and swelling of the face or tongue;
• You are allergic to neomycin (an antibiotic). Although a known contact dermatitis (skin rash produced when the skin comes into direct contact with allergens such as neomycin) should not be a problem, consult your doctor first;
• You have a severe infection with a high fever. In these cases, vaccination will be postponed until you recover. Although a mild infection, such as a cold, should not be a problem, consult your doctor first;
• You have any disease (such as Human Immunodeficiency Virus (HIV) or Acquired Immune Deficiency Syndrome (AIDS)) or are taking any medication that may weaken the immune system. Whether you receive the vaccine will depend on the level of your defenses;
• You are pregnant. Additionally, pregnancy should be avoided for 1 month after vaccination.

Warnings and precautions

Consult your doctor or pharmacist before you are vaccinated with Priorix if:

• You have central nervous system disorders, a history of seizures accompanied by high fever, or a family history of seizures. If high fever occurs after vaccination, consult your doctor immediately;
• You have ever had a severe allergic reaction to egg proteins;
• You have had an adverse reaction after vaccination against measles, mumps, or rubella that involved the appearance of rashes with ease or prolonged bleeding (see section 4);
• You have a weakened immune system (e.g., HIV infection). You should be closely monitored as the response to the vaccine may not be sufficient to ensure protection against the disease (see section 2 “Do not administer Priorix if”).

Before or after any injection, dizziness may occur (especially in adolescents), so inform your doctor or nurse if you have fainted on previous occasions after receiving an injection.

If you are vaccinated within 72 hours of contact with someone who has measles, Priorix will provide some protection against the disease.

Children under 12 months

It is possible that children vaccinated during their first year of life may not be fully protected. Your doctor will advise if additional doses of the vaccine are required.

As with all vaccines, it is possible that Priorix may not provide complete protection for all vaccinated individuals.

Use of Priorix with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication (or other vaccines).

Priorix can be administered to you at the same time as other vaccines such as diphtheria, tetanus, pertussis, Haemophilus influenzae type b, oral or inactivated polio, hepatitis A, hepatitis B, varicella, meningococcal group B vaccines, as well as meningococcal group C vaccines, meningococcal group A, C, W-135, Y vaccines, and the pneumococcal conjugate vaccine. Consult your doctor or nurse for more information.

A different injection site should be used for each vaccine.

If not administered at the same time, it is recommended to have an interval of at least one month between the administration of Priorix and other live attenuated vaccines.

Your doctor may delay vaccination for at least 3 months if you have received blood transfusions or human antibodies (immunoglobulins).

If a tuberculin test is required, it should be performed before, simultaneously with, or 6 weeks after vaccination with Priorix.

Pregnancy, lactation, and fertility

Priorix should not be administered to pregnant women.

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before receiving the vaccine. It is also important that you do not become pregnant for one month after vaccination. During this time, an effective contraceptive method should be used to avoid pregnancy.

In the event of unintended vaccination of pregnant women with Priorix, it should not be a reason to terminate the pregnancy.

Priorix contains sorbitol, para-aminobenzoic acid, phenylalanine, sodium, and potassium

This vaccine contains 9 mg of sorbitol per dose.

Priorix contains para-aminobenzoic acid. It may cause allergic reactions (possibly delayed) and, exceptionally, bronchospasm.

This vaccine contains 334 micrograms of phenylalanine per dose. Phenylalanine may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

This vaccine contains less than 23 mg of sodium (1 mmol) per dose; it is essentially “sodium-free”.

This vaccine contains less than 39 mg (1 mmol) of potassium per dose, making it essentially “potassium-free”.

Priorix is administered under the skin or into the muscle, either in the upper arm or in the outer thigh.

Priorix is intended for children aged 9 months and older, adolescents, and adults.

Your doctor will determine the appropriate time and number of injections for you based on official recommendations.

The vaccine should never be administered into a vein.

Like all medicines, this vaccine may cause side effects, although not everyone will experience them.

The side effects that occurred in clinical trials with Priorix were the following:

• Very common (may occur in more than 1 in 10 doses of the vaccine):

• Redness at the injection site
• Fever of 38°C or higher.

• Common (may occur in up to 1 in 10 doses of the vaccine):

• Pain and swelling at the injection site
• Fever above 39.5°C
• Skin rash (spots)
• Upper respiratory tract infection.

• Uncommon (may occur in up to 1 in 100 doses of the vaccine):

• Middle ear infection
• Swelling of the lymph nodes (lymph nodes in the neck, armpit, or groin)
• Loss of appetite
• Nervousness
• Abnormal crying
• Inability to sleep (insomnia)
• Red, irritated, and watery eyes (conjunctivitis)
• Bronchitis
• Cough
• Swelling of the parotid glands (glands in the cheeks)
• Diarrhea
• Vomiting.

• Rare (may occur in up to 1 in 1,000 doses of the vaccine):

• Seizures accompanied by high fever
• Allergic reactions.

After the commercialization of Priorix, the following side effects have been reported on some occasions:

• Muscle and joint pain
• Appearance of small or pinpoint blood spots on the skin or bruising more easily than normal due to a decrease in platelet count
• Sudden allergic reaction with life-threatening risk
• Infection or inflammation of the brain, spinal cord, and peripheral nerves, causing temporary difficulty walking (instability) and/or temporary loss of control of body movements, inflammation of some nerves, possibly with tingling or loss of sensation or normal movement (Guillain-Barré syndrome)
• Narrowing or obstruction of blood vessels
• Erythema multiforme (symptoms are red spots, often accompanied by itching similar to the skin rash caused by measles, which begins on the limbs and sometimes on the face and the rest of the body)
• Symptoms similar to measles and parotiditis (including painful and temporary swelling of the testicles and swelling of the glands in the neck)

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use,www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this vaccine out of sight and reach of children.

Do not use this vaccine after the expiration date that appears on the box, after CAD.

Store and transportrefrigerated(between 2°C and 8°C).

Do not freeze.

Store in the original packaging to protect it from light.

The vaccine must be administered quickly after reconstitution. If this is not possible, it must be stored in the refrigerator (between2°Cand8°C) and used before 8 hours after reconstitution.

Medicines should not be disposed of through drains or in the trash. Dispose of containers and medicines you no longer need at the SIGREcollection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. By doing so,,you will help protect the environment.

Composition of Priorix

• The active principles are: attenuated live measles, mumps and rubella viruses.

• The other components are:

Dry substance: amino acids(containing phenylalanine), lactose (anhydrous), mannitol(E-421), sorbitol(E-420),medium 199(contains phenylalanine, para-aminobenzoic acid, sodium and potassium).

Vehicle: water for injection.

Appearance of the product and contents of the container

Priorix is presented as a powder and vehicle for injectable solution (powder in a vial for 1 dose and vehicle in a pre-filled syringe (0.5 ml)), with or without needles, in the following container sizes:

• with 2 separate needles: containers of 1 or 10
• without needle: containers of 1 or 10.

Priorix is supplied as a white to slightly pink powder and a transparent and colourless (water for injection) vehicle to reconstitute the vaccine.

Only some container sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

GlaxoSmithKline, S.A.

PTM - C/ Severo Ochoa, 2

28760 Tres Cantos, Madrid

Telephone: 900 202 700

Fax:91 807 03 10

e-mail: [email protected]

Manufacturer:

GlaxoSmithKline Biologicals S.A.

Rue de l'Institut 89; 1330 Rixensart

Belgium

Last review date of this leaflet:October 2023

The detailed and updated information on this medicine is available on the website ofthe Spanish Agencyof Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.

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This information is intended solely for healthcare professionals:

As with all injectable vaccines, appropriate medical treatment and supervision should always be available in case of a rare anaphylactic reaction following administration of the vaccine.

Since alcohol and other disinfectants can inactivate the attenuated live viruses in the vaccine, the skin should be allowed to dry before administration of the vaccine.

Priorix should not be administered intravascularly under any circumstances.

Without compatibility studies, this medicinal product should not be mixed with other medicinal products.

Before reconstitution or administration, the vehicle and the reconstituted vaccine should be visually inspected for any particulate matter and/or physical aspect variation. If any of them are observed, the vehicle or the reconstituted vaccine should not be used.

The vaccine should be reconstituted by adding the entire contents of the pre-filled syringe to the vial containing the powder.

To learn how to insert the needle into the syringe, please read the instructions provided with images 1 and 2 carefully. However, the syringe provided with Priorix may be slightly different (without a screw thread) from the syringe in the image. In this case, the needle should be inserted without screwing.

Always hold the syringe by the body, not by the plunger or the Luer lock adapter (LLA), and keep the needle in the syringe axis (as shown in image 2). Otherwise, the LLA may be deformed and cause leaks.

If the LLA comes loose during syringe assembly, use a new dose of the vaccine (new syringe and vial).

1. Remove the syringe cap by turning it counterclockwise (as shown in image 1).

Please follow the next steps, regardless of whether the LLA turns or not:

1. Insert the needle into the syringe by gently engaging the needle cone with the LLA and turning it a quarter of a turn clockwise until it locks (as shown in image 2).

1. Remove the needle cap (it may be difficult).

1. Add the vehicle to the powder. The mixture should be shaken well until the powder is completely dissolved.

Due to minor pH variations, the colour of the reconstituted vaccine may vary from light orange to fuchsia pink without affecting the potency of the vaccine.

1. Remove the entire contents of the vial.

1. A new needle should be used to administer the vaccine. Remove the needle from the syringe and insert the injection needle, repeating step 2 above.

The vaccine should be administered as quickly as possible after reconstitution. If this is not possible, it should be stored between2°Cand 8°C and used within 8 hours of reconstitution.

The unused medicine and all materials that have come into contact with it will be disposed of in accordance with local regulations.