Priorix

PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: information for the user

Priorix,powder and solvent for solution for injection
Vaccine against measles, mumps, and rubella, live

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

• This leaflet should be kept in case it needs to be read again.
• In case of any doubts, consult a doctor or pharmacist.
• The vaccine has been prescribed for a specific person. Do not pass it on to others.
• If the patient experiences any side effects, including any not listed in this leaflet, tell the doctor or pharmacist. See section 4. The content of this leaflet has been formulated on the assumption that 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 vaccine and what is it used for
• 2. Important information before using Priorix vaccine
• 3. How to use Priorix vaccine
• 4. Possible side effects
• 5. How to store Priorix vaccine
• 6. Package contents and other information

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

Priorix is a vaccine used in children over 9 months of age, adolescents, and adults to prevent measles, mumps, and rubella.

How Priorix works

The immune system (the body's natural defense system) of the person who received the Priorix vaccine will produce antibodies, which will protect the patient from infection with measles, mumps, and rubella viruses.
Although the Priorix vaccine contains live viruses, they are too weak to cause measles, mumps, and rubella in healthy individuals.

2. Important information before using Priorix vaccine

When not to use Priorix vaccine:

Warnings and precautions

Before administering the Priorix vaccine, discuss with a doctor or pharmacist if:

• the patient has central nervous system disorders, seizures with high fever, or if there have been seizures in their family. In case of high fever after vaccination, consult a doctor immediately,
• the patient has ever had a severe allergic reaction to egg protein,
• the patient has experienced side effects after vaccination against measles, mumps, or rubella, including easy bruising or bleeding 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 vaccine").

After or even before administering any injectable vaccine, fainting (especially in adolescents) may occur. Therefore, inform the doctor or nurse if the patient has ever fainted during injection.
If the patient is vaccinated within 72 hours of contact with a person with measles, the Priorix vaccine may provide some protection against the disease.
Children under 12 months
Children vaccinated in the first year of life may not be fully protected. If additional doses of the vaccine are necessary, the doctor will recommend them.
As with all vaccines, the Priorix vaccine may not fully protect all vaccinated individuals.

Priorix vaccine and other medicines

Tell the doctor about all vaccinations and medicines the patient is currently taking or has recently taken, as well as any medicines or vaccines the patient plans to take.
The Priorix vaccine can be administered at the same time as other vaccines, such as:
pertussis, tetanus, and diphtheria (acellular) vaccine, Haemophilus influenzae type b vaccine, oral or inactivated polio vaccine, hepatitis A vaccine, hepatitis B vaccine, varicella vaccine, meningococcal group B vaccine, and conjugated meningococcal serogroup C vaccine, conjugated meningococcal groups A, C, W135, and Y vaccine, and conjugated pneumococcal vaccine. For more information, consult a doctor or nurse.
Each vaccine should be injected into a different site.
If Priorix cannot be administered at the same time as other live, attenuated vaccines, an interval of at least one month should be maintained between vaccinations.
Vaccination may be postponed for at least 3 months if the patient has recently received blood transfusions or human immunoglobulin.
If a tuberculin test (skin test for tuberculosis) is to be performed on the patient, it should be done before or at the same time as vaccination, or after 6 weeks from vaccination.

Pregnancy, breastfeeding, and fertility

Priorix vaccine should not be administered to pregnant women .
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this vaccine.
Additionally, it is essential to avoid pregnancy for 1 month after vaccination. During this time, an effective method of contraception should be used to prevent pregnancy.
Unintentional administration of the Priorix vaccine to a pregnant woman 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 (possible late reactions) and exceptionally bronchospasm.
The vaccine contains 334 micrograms of phenylalanine per dose. Phenylalanine may be harmful to patients with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates in the body because the body does not eliminate it properly.
This vaccine contains less than 1 mmol (23 mg) of sodium per dose, which means the vaccine is considered "sodium-free".
This vaccine contains potassium, less than 1 mmol (39 mg) of potassium per dose, which means the vaccine is considered "potassium-free).

3. How to use Priorix vaccine

Priorix vaccine is administered subcutaneously or intramuscularly, in the upper arm or outer thigh.
Priorix is intended for use in children over 9 months of age, adolescents, and adults.
The appropriate time for vaccination and the number of doses administered will be determined by the doctor based on official recommendations.
Vaccines should never be administered intravenously.

4. Possible side effects

Like all medicines, this vaccine can cause side effects, although not everybody gets them.
After administration of the Priorix vaccine during clinical trials, the following side effects occurred:
♦ Very common (may occur more often than 1 in 10 doses of the vaccine):

• Redness at the injection site
• Fever (38°C or higher)

♦ Common (may occur less often than 1 in 10 doses of the vaccine):

• Pain and swelling at the injection site
• Fever (higher than 39.5°C)
• Rash
• Upper respiratory tract infection

♦ Uncommon (may occur less often than 1 in 100 doses of the vaccine):

• Otitis media
• Lymphadenopathy (enlarged lymph nodes in the neck, armpits, or groin)
• Loss of appetite
• Nervousness
• Abnormal crying
• Insomnia
• Redness, irritation, or tearing of the eyes (conjunctivitis)
• Bronchitis
• Cough
• Parotid gland swelling (lymph nodes in the cheek area)
• Diarrhea
• Vomiting

♦ Rare (may occur less often than 1 in 1000 doses of the vaccine):

• Febrile seizures
• Allergic reactions

After the vaccine was placed on the market, the following side effects have been reported very rarely:

• Arthralgia and myalgia
• Bleeding or easy bruising due to a decrease in platelet count
• Life-threatening allergic reactions
• Infection or inflammation of the brain, spinal cord, and peripheral nerves resulting in transient walking difficulties and/or transient loss of coordination, inflammation of some nerves with possible tingling or loss of sensation or movement disorders (Guillain-Barré syndrome)
• Narrowing or obstruction of blood vessels
• Exanthema multiforme (characterized by red, often itchy spots, similar to the rash that occurs in measles, appearing first on the limbs and sometimes on the face and other parts of the body)
• Symptoms similar to measles and mumps (including transient, painful swelling of the testicles and swollen glands on the neck)

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: 22 49 21 301
Fax: 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the vaccine.

5. How to store Priorix vaccine

Store the vaccine out of sight and reach of children.
Do not use this vaccine after the expiry date stated on the outer packaging.
Store and transport at 2°C - 8°C.
Do not freeze.
Store in the original packaging to protect from light.
After reconstitution, the vaccine should be used immediately. If this is not possible, it should be stored in a refrigerator (2°C - 8°C) and used within 8 hours of reconstitution.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Priorix vaccine contains

The active substances of the vaccine are live, attenuated viruses: measles, mumps, and rubella.
Other ingredients of the vaccine are:
Powder: amino acids (including phenylalanine), anhydrous lactose, mannitol (E 421), sorbitol (E 420),
medium 199 (including phenylalanine, para-aminobenzoic acid, sodium, and potassium).
Solvent: water for injections.

What Priorix vaccine looks like and what the pack contains

Priorix vaccine is available as a powder and solvent for solution for injection (powder in a single-dose vial and solvent in a pre-filled syringe (0.5 ml) with or without needles) in the following pack sizes:

• with 2 separate needles: packs of 1 or 10,
• without needles: packs of 1 or 10.

Priorix is supplied as a white to slightly pink powder, which may be yellowish to slightly orange, and a clear, colorless solvent (water for injections). These components form the vaccine after reconstitution.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

GlaxoSmithKline Biologicals S.A.
rue de l’Institut 89
1330 Rixensart, Belgium
Date of last update of the leaflet:07/2025

Other sources of information

Detailed information on this medicinal product is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products .
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Information intended exclusively for healthcare professionals:
As with all injectable vaccines, there is a possibility of a rare anaphylactic reaction, so it is essential to ensure the availability of medical care immediately after vaccination.
Alcohol and other disinfectants should evaporate from the skin before administering the vaccine, as they may inactivate the attenuated viruses contained in the vaccine.
Priorix vaccine should never be administered intravenously.
Due to the lack of compatibility studies, the vaccine should not be mixed with other medicinal products.
The solvent and the reconstituted vaccine should be visually inspected for foreign particles and/or physical changes before reconstitution and before administration. If any abnormalities are observed, the solvent or the reconstituted vaccine should not be used.
The vaccine should be reconstituted by adding the entire solvent from the pre-filled syringe to the vial of powder.
To attach the needle to the pre-filled syringe, carefully follow the instructions presented in figures 1 and 2. The pre-filled syringe supplied with the PRIORIX vaccine may differ slightly from the one shown in the figure (it may not have a thread for screwing the needle). In this case, the needle should be attached without screwing.

Needle

Pre-filled syringe

Always hold the pre-filled syringe by its body, not by the plunger or the Luer Lock adapter (LLA), and keep the needle in line with the pre-filled syringe (as shown in figure 2). Failure to follow these instructions may cause the LLA to become misaligned and lead to leakage from the pre-filled syringe.
If the LLA becomes detached from the pre-filled syringe while attaching the needle, a new dose of the vaccine (a new pre-filled syringe and vial) should be used.

Figure 1. Figure 2.

• 1. Remove the cap from the pre-filled syringe by twisting it counterclockwise (as shown in figure 1).

Regardless of whether the LLA rotates or not, follow the instructions below:

• 2. Attach the needle to the pre-filled syringe by gently connecting the needle hub to the LLA and twisting it a quarter turn clockwise until it clicks (as shown in figure 2).
• 3. Remove the needle shield, which may offer some resistance.
• 4. Add the solvent to the powder. Then, shake vigorously until the powder is completely dissolved.

Depending on slight pH variations, the reconstituted vaccine may have a color ranging from peach to pink with a fuchsia tint, which does not affect its efficacy.

• 5. Withdraw the entire contents of the vial.
• 6. Use a new needle for injection. To do this, remove the needle from the pre-filled syringe and attach an injection needle, following the instructions in point 2.

After reconstitution, the vaccine should be used immediately. If this is not possible, it should be stored in a refrigerator (2°C - 8°C) and used within 8 hours of reconstitution.
Any unused product or waste should be disposed of in accordance with local regulations.