Priorix, powder and solvent in pre-filled syringe for solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

Measles, mumps and rubella vaccine (live)

Read all of this leaflet carefully before you are given this vaccine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This vaccine has been prescribed only for you; do not pass it on to other people.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

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

Contents of this leaflet

1. What Priorix is and what it is used for
2. What you need to know before you are given Priorix
3. How Priorix is administered
4. Possible side effects
5. How to store Priorix

Pack contents and additional information

1. What Priorix is and what it is used for

Priorix is a vaccine given to children from 9 months of age, 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 defence system) will produce antibodies to protect the person against infection by measles, mumps and rubella viruses.

Although Priorix contains live viruses, they are so weakened that they cannot cause measles, mumps or rubella in healthy individuals.

2. What you need to know before you receive Priorix

Do not administer Priorix if

• you are allergic to the active substances or to any of the other components of this vaccine (listed in section 6). Signs of an allergic reaction may include itchy rash, difficulty breathing, and swelling of the face or tongue;
• you are allergic to neomycin (an antibiotic). Although known contact dermatitis (skin rash caused by direct skin contact with allergens such as neomycin) should not be a problem, consult your doctor first;
• you have a severe infection with high fever. In such cases, vaccination will be postponed until you recover. However, a mild infection such as a cold should not be a problem, but consult your doctor first;
• you have an illness (such as Human Immunodeficiency Virus (HIV) or Acquired Immunodeficiency Syndrome (AIDS)) or have recently received or are still taking any medication that weakens the immune system (except low-dose corticosteroid treatment for asthma or replacement therapy). Whether you should receive the vaccine depends on the level of your immune defenses;
• you are pregnant. In addition, pregnancy should be avoided for 1 month after vaccination.

Warnings and precautions

Consult your doctor or pharmacist before receiving Priorix if:

• you have central nervous system disorders, a history of febrile seizures, or a family history of seizures. If you develop a high fever after vaccination, consult your doctor immediately;
• you have ever had a severe allergic reaction to egg proteins;
• you have previously experienced an adverse reaction after measles, mumps, or rubella vaccination involving easy bruising or prolonged bleeding (see section 4);
• you have a weakened immune system (e.g., due to HIV infection) or are about to take a medication that weakens the immune system. You should be closely monitored, as the response to vaccination may not be sufficient to ensure protection against the disease (see section 2 “Do not administer Priorix if”).

Fainting (especially in adolescents) may occur before or after any injection. Inform your doctor or nurse if you have previously fainted after receiving an injection.

If you are vaccinated within 72 hours following exposure to someone with measles, Priorix may provide some protection against the disease.

Children under 12 months

Children vaccinated during their first year of life may not be fully protected. Your doctor will advise whether additional vaccine doses are needed.

As with all vaccines, Priorix may not fully protect all vaccinated individuals.

Use of Priorix with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines (or other vaccines).

Priorix may be given 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, group B meningococcal vaccines, meningococcal group C vaccines, meningococcal groups A, C, W-135, Y vaccines, and pneumococcal conjugate vaccine. Consult your doctor or nurse for further information.

A separate injection site should be used for each vaccine.

If not administered simultaneously, an interval of at least one month is recommended between 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 skin test is required, it should be performed before vaccination, simultaneously with vaccination, or 6 weeks after Priorix vaccination.

Pregnancy, breastfeeding, and fertility

Priorix must not be given to pregnant women.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before receiving this vaccine. It is also important that you do not become pregnant during the month following vaccination. An effective contraceptive method should be used during this period to prevent pregnancy.

Priorix contains sorbitol, para-aminobenzoic acid, phenylalanine, polysorbate 80, proline, sodium, and potassium

This vaccine contains 9 mg of sorbitol per dose.

This vaccine contains para-aminobenzoic acid. It may cause allergic reactions (possibly delayed) and, rarely, bronchospasm.

This vaccine contains 334 micrograms of phenylalanine per dose. Phenylalanine may be harmful in patients with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

This vaccine contains 0.65 micrograms of polysorbate 80 per dose. Polysorbates may cause allergic reactions. Inform your doctor if you have any known allergies.

This vaccine contains 407 micrograms of proline per dose. Proline may be harmful in patients with hyperprolinemia, a rare genetic disorder in which proline accumulates in the body. If you have hyperprolinemia, do not use this medicine unless recommended by your doctor.

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

This vaccine contains less than 39 mg (1 mmol) of potassium per dose and is therefore considered essentially “potassium-free”.

3. How Priorix is administered

Priorix is administered subcutaneously or intramuscularly, either in the upper arm or in the outer thigh.

Priorix is intended for children from 9 months of age, adolescents, and adults.

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

The vaccine must never be administered intravenously.

4. Possible adverse effects

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

The adverse effects observed in clinical trials with Priorix were as follows:

Very common (may occur in more than 1 in every 10 doses of the vaccine): redness at the injection site, fever of 38°C or higher.

Common (may occur in up to 1 in every 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 every 100 doses of the vaccine): middle ear infection, swollen lymph nodes (in the neck, armpit, or groin), loss of appetite, restlessness, 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 every 1,000 doses of the vaccine): seizures accompanied by high fever, allergic reactions.

Following the marketing of Priorix, the following adverse effects have been reported in some cases:

• joint and muscle pain
• appearance of small blood spots or pinpoint skin rashes, or bruising more easily than normal due to a reduced platelet count
• sudden, life-threatening allergic reaction
• infection or inflammation of the brain, spinal cord, and peripheral nerves, causing temporary difficulty walking (instability) and/or temporary loss of control over body movements, inflammation of certain nerves, possibly with tingling or loss of normal sensation or movement (Guillain-Barré syndrome)
• narrowing or blockage of blood vessels
• erythema multiforme (symptoms include red spots, often itchy, resembling a measles-like rash, starting on the limbs and sometimes on the face and rest of the body)
• symptoms resembling measles and mumps (including painful, temporary swelling of the testicles and swelling of neck glands)

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines at www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Priorix

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

Do not use this vaccine after the expiry date stated on the carton, after EXP.

Store and transport refrigerated (between 2°C and 8°C).

Do not freeze.

Keep in the original packaging to protect from light.

Use the vaccine promptly after reconstitution. If this is not possible, it must be stored in the refrigerator (between 2°C and 8°C) and used within 8 hours after reconstitution.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Priorix

The active substances are:

After reconstitution, 1 dose (0.5 ml) contains:

Live attenuated measles virus1 (Schwarz strain) not less than 103.0 CCID503

Live attenuated mumps virus1 (RIT 4385 strain, derived from Jeryl Lynn strain) not less than 103.7 CCID503

Live attenuated rubella virus2 (Wistar RA 27/3 strain) not less than 103.0 CCID503

1produced in chicken embryo cells; 2produced in human diploid cells (MRC-5); 350% cell culture infectious dose

The other components are:

Powder: amino acids (containing phenylalanine and proline), lactose (anhydrous), mannitol, sorbitol (E-420), Medium 199 (contains phenylalanine, para-aminobenzoic acid, polysorbate 80 (E-433), proline, sodium and potassium).

Solvent: water for injections.

See section 2 "Priorix contains sorbitol, para-aminobenzoic acid, phenylalanine, polysorbate 80, proline, sodium and potassium".

Appearance of the product and contents of the pack

Powder and solvent for injectable solution in a pre-filled syringe. The powder is white to slightly pinkish, with part of it possibly yellowish to slightly orange. The solvent is a clear, colourless solution.

Priorix consists of:

• Powder for 1 dose in a glass vial.
• Solvent for 1 dose in a pre-filled syringe.

Pack sizes of 1 or 10, with 2 separate needles or without needles. Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

GlaxoSmithKline, S.A.

P.T.M. C/ Severo Ochoa, 2

28760 Tres Cantos (Madrid)

Tel: +34 900 202 700

[email protected]

Manufacturer:

GlaxoSmithKline Biologicals S.A.

Rue de l'Institut 89; 1330 Rixensart

Belgium

Date of latest review of this leaflet: 04/2026

Up-to-date detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.

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This information is intended for healthcare professionals only:

As with all injectable vaccines, appropriate medical treatment and supervision must be readily available at all times to manage the rare possibility of an anaphylactic reaction following vaccine administration.

Since alcohol and other disinfectants may inactivate the live attenuated viruses in the vaccine, they should be allowed to fully evaporate from the skin before vaccine administration.

Under no circumstances should Priorix be administered intravenously.

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

Before reconstitution or administration, both the solvent and the reconstituted vaccine should be inspected visually for any extraneous particulate matter and/or abnormal physical appearance. If such conditions are observed, the solvent or reconstituted vaccine should not be used.

Due to minor variations in pH, the color of the reconstituted vaccine may range from light orange to rose-pink without affecting the vaccine's potency.

The vaccine should be reconstituted by adding the entire contents of the pre-filled syringe containing the solvent to the vial containing the powder, using an appropriate needle (21G to 25G).

Refer to the instructions for detailed guidance on how to insert the needle into the syringe.

1. Add the solvent to the powder. Shake well until the powder is completely dissolved in the solvent.

2. Withdraw all the contents of the vial.

3. Use a new needle for vaccine administration. Unscrew the needle from the syringe and attach the injection needle, repeating the previous steps.

Use the vaccine promptly after reconstitution. If this is not possible, it must be stored between 2°C and 8°C and used within 8 hours after reconstitution.

Disposal of unused medicine and of all materials that have come into contact with it must be carried out in accordance with local regulations.