Priorix

Patient Information Leaflet: Information for the User

Priorix, powder and solvent for solution for injection
Measles, mumps and rubella vaccine, live
Please read all of this leaflet carefully before this vaccine is administered, as it
contains important information for you.

• Keep this leaflet for future reference.
• If you have any further questions, please consult your doctor or pharmacist.
• This vaccine has been prescribed for a specific individual only. Do not pass it on to others.
• If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist immediately. See section 4. The content of this leaflet has been prepared with the assumption that it will be read by the person receiving the vaccine. However, since this vaccine may also be administered to children, it is possible that a parent or guardian will be reading this information.

Table of contents:

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

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

Priorix is a vaccine given to children from 9 months of age, adolescents and adults to help protect against measles, mumps and rubella.
How Priorix works
The immune system (the body's natural defence system) of the person receiving Priorix vaccine will produce antibodies, which will protect the individual against infection caused by measles, mumps and rubella viruses.
Although Priorix contains live viruses, they are too weakened to cause measles, mumps or rubella in healthy individuals.

2. Important information before using Priorix vaccine

When not to use Priorix vaccine:

• if there has ever been an allergic reaction to any component of this vaccine (listed in section 6). Symptoms of allergy include itchy skin rash, difficulty breathing, swelling of the face or tongue,
• if there has ever been an allergic reaction to neomycin (an antibiotic). Contact dermatitis caused by neomycin (skin rash occurring when there is direct contact with the allergen such as neomycin) does not constitute a contraindication to vaccination, but you should inform your doctor about it,
• if there is an acute, severe illness with fever. In such a case, vaccination will be postponed until recovery. A mild infection, such as a cold, should not be a reason to avoid 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 if the patient has recently taken or is still taking medications that may weaken the immune system (except for low-dose corticosteroids used in asthma treatment or replacement therapy). Whether the patient receives the vaccine will depend on the level of immunity,
• if pregnancy has been confirmed. In addition, pregnancy should be avoided for 1 month after vaccination.

Warnings and precautions
Before administering Priorix vaccine, discuss with your doctor or pharmacist if:

• the patient suffers from disorders of the central nervous system, febrile seizures, or if there has ever been a history of seizures in the family. If high fever occurs after vaccination, medical advice should be sought immediately,
• the patient has ever had a severe allergic reaction to chicken egg protein,
• the patient experienced adverse reactions after vaccination against measles, mumps or rubella involving easy bruising or prolonged bleeding (see section 4),
• the patient has a weakened immune system (e.g. due to HIV infection) or is about to start taking a medication that weakens the immune system. Close monitoring is required, as the response to vaccination may not be sufficient to provide protection against disease (see section 2 "When not to use Priorix vaccine").

Fainting may occur after or even before any injectable vaccine is administered (particularly in adolescents). Therefore, inform your doctor or nurse if the patient has ever fainted during an injection.
If the patient is vaccinated within 72 hours of exposure to someone with measles, Priorix vaccine may provide some protection against developing the disease.
Children under 12 months of age
Children vaccinated during the first year of life may not be fully protected. If additional doses of the vaccine are needed, your doctor will advise on their administration.
As with all vaccines, Priorix may not fully protect all vaccinated individuals.

Priorix and other medicines
Tell your doctor about all vaccines and any medicines the patient is currently taking, has recently taken, or plans to take.
Priorix vaccine may be given at the same time as other vaccines, such as: diphtheria, tetanus, acellular pertussis vaccine, Haemophilus influenzae type b vaccine, oral or inactivated poliomyelitis vaccine, hepatitis A vaccine, hepatitis B vaccine, varicella vaccine, meningococcal group B vaccine, conjugated meningococcal group C vaccine, conjugated meningococcal vaccine against groups A, C, W135 and Y, and conjugated pneumococcal vaccine. For additional information, please consult your doctor or nurse.
Each vaccine should be administered at a different injection site.
If Priorix cannot be given simultaneously with other vaccines containing live attenuated viruses, an interval of at least one month should be maintained between vaccinations.
Vaccination may be delayed for at least 3 months if the patient has recently received blood transfusion or human immunoglobulin.
If a tuberculin test (skin test for tuberculosis) is planned, it should be performed before or simultaneously with vaccination, or at least 6 weeks after vaccination.

Pregnancy, breastfeeding and effects on fertility
Priorix vaccine should not be given to pregnant women.
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before receiving this vaccine.
In addition, it is important that the patient does not become pregnant for one month after vaccination. During this time, an effective method of contraception should be used to avoid 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 (including delayed-type reactions) and, very rarely, bronchospasm.
The vaccine contains 334 micrograms of phenylalanine per dose. Phenylalanine may be harmful for patients with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates in the body because the body cannot eliminate it properly.
This vaccine contains less than 1 mmol (23 mg) of sodium per dose, meaning the vaccine is considered "sodium-free".
This vaccine contains potassium, less than 1 mmol (39 mg) of potassium per dose, meaning the vaccine is considered "potassium-free".

3. How to use the Priorix vaccine

The Priorix vaccine is administered subcutaneously or intramuscularly into the upper arm or the outer part of the thigh.
Priorix is intended for use in children from the age of 9 months, adolescents, and adults.
The appropriate timing of vaccination and the number of doses to be administered will be determined by a physician according to official recommendations.
Under no circumstances should the vaccine be administered intravenously.

4. Possible adverse reactions

Like any medicine, this vaccine may cause adverse reactions, although not everyone will experience them.
The following adverse reactions have been reported with Priorix vaccine during clinical trials:

♦ Very common (may occur in more than 1 in 10 doses):

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

♦ Common (may occur in less than 1 in 10 doses):

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

♦ Uncommon (may occur in less than 1 in 100 doses):

• Otitis media (middle ear infection)
• Lymphadenopathy (swollen lymph nodes in the neck, armpits, or groin)
• Loss of appetite
• Irritability
• Unusual crying
• Insomnia
• Redness, irritation, or watering of the eyes (conjunctivitis)
• Bronchitis
• Cough
• Swelling of the parotid glands (lymph nodes near the cheek)
• Diarrhea
• Vomiting

♦ Rare (may occur in less than 1 in 1000 doses):

• Seizures associated with high fever
• Allergic reactions

Very rarely, the following adverse reactions have been reported after the vaccine was placed on the market:

• Joint and muscle pain
• Bleeding or bruising more easily than usual due to a low platelet count
• Sudden life-threatening allergic reactions
• Infection or inflammation of the brain, spinal cord, and peripheral nerves leading to transient difficulties in walking (unsteadiness) and/or transient loss of motor coordination, or inflammation of certain nerves possibly causing tingling sensations, loss of sensation, or movement disorders (Guillain-Barré syndrome)
• Narrowing or blockage of blood vessels
• Erythema multiforme (characterized by red, often itchy spots, similar to the rash seen in measles, appearing first on the limbs and sometimes on the face and other parts of the body)
• Measles- and mumps-like symptoms (including transient painful swelling of the testicles and swollen glands in the neck)

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Priorix vaccine

Keep 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 in a refrigerated state (2°C – 8°C).
Do not freeze.
Store in the original packaging to protect from light.
After reconstitution, the vaccine should be administered 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 must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

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

What Priorix vaccine looks like and contents of the pack
Priorix vaccine is supplied as a powder and solvent for the preparation of a solution for injection (powder in a single-dose vial and solvent in an ampoule (0.5 ml)) – pack size 100 units.
Priorix is supplied as a white to slightly pinkish powder, part of which may be yellowish to slightly orange, and a clear, colourless solvent (water for injections), which after reconstitution form the vaccine.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
GlaxoSmithKline Biologicals S.A.
rue de l’Institut 89
1330 Rixensart, Belgium

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.

Information intended exclusively for medical professionals:

As with all injectable vaccines, there is a possibility of a rare anaphylactic reaction; therefore, appropriate medical support must be available immediately after vaccination.
Alcohol and other disinfectants should be allowed to evaporate completely from the skin before administering the vaccine, as they may inactivate the attenuated viruses contained in the vaccine.
Priorix vaccine must never be administered intravenously.
Due to lack of compatibility studies, the vaccine should not be mixed with other medicinal products.
The solvent and the reconstituted vaccine should be inspected visually before reconstitution and before administration for the presence of foreign particles and/or any physical changes. If any abnormalities in appearance are observed, the solvent or the prepared vaccine must not be used.
The vaccine should be reconstituted by adding the entire volume of solvent from the ampoule to the vial containing the powder. The mixture should then be shaken vigorously until the powder is completely dissolved.
Due to minor pH fluctuations, the reconstituted vaccine may range in color from peach to pinkish-fuchsia; this does not affect its efficacy.
The entire contents of the vial should be withdrawn.
A new needle should be used for administration of the vaccine.
After reconstitution, the vaccine should be used immediately. If this is not possible, it should be stored at 2 °C – 8 °C and used within 8 hours of reconstitution.
Any unused product or waste material should be disposed of in accordance with local regulations.

Package leaflet: information for the user

Priorix, powder and solvent for solution for injection
Measles, mumps and rubella vaccine (live)
Please read all of this leaflet carefully before receiving the vaccine, because it contains important information for you.

• Keep this leaflet; you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This vaccine has been prescribed for a specific individual. Do not pass it on to others.
• If you experience any adverse reactions after vaccination, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4. The text of this leaflet has been prepared with the assumption that it will be read by the person receiving the vaccine. However, since this vaccine may be administered to both adults and children, it is possible that the leaflet will be read by a parent or guardian.

Contents of the leaflet:

1. What Priorix vaccine is and what it is used for
2. What you need to know before receiving Priorix
3. How to use Priorix
4. Possible side effects
5. How to store Priorix
6. Contents of the pack and other information

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

Priorix is a vaccine used in children after they have completed 9 months of life, adolescents, and adults to prevent measles, mumps, and rubella.
How Priorix works
The immune system (the body's natural defense system) of the person receiving the Priorix vaccine will produce antibodies, thus protecting the patient against infection with measles, mumps, and rubella viruses.
Although the Priorix vaccine contains live viruses, they are too weakened to cause measles, mumps, or rubella in healthy individuals.

2. Information before using Priorix vaccine

When not to use Priorix vaccine:

• if there has ever been an allergic reaction to any component of this vaccine (listed in section 6). Symptoms of allergy may include itchy skin rash, difficulty breathing, swelling of the face or tongue,
• if there has ever been an allergic reaction to neomycin (an antibiotic). Contact dermatitis caused by neomycin (skin rash occurring upon direct contact with allergens such as neomycin) does not constitute a contraindication to vaccination, but you should inform your doctor about it,
• if there is an acute, severe illness with fever. In such cases, vaccination will be postponed until recovery. A mild infection, such as a cold, should not be a reason to avoid vaccination, but you should discuss this with your doctor first,
• if the patient has any condition (e.g. human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)) or if the patient has recently taken or is still taking medications that may weaken the immune system (except for low-dose corticosteroids used for asthma treatment or replacement therapy). Whether the patient receives the vaccine will depend on the level of immunity,
• if pregnancy has been confirmed. In addition, pregnancy should be avoided for 1 month after vaccination.

Warnings and precautions
Before administering Priorix vaccine, discuss with your doctor or pharmacist if:

• the patient suffers from disorders of the central nervous system, febrile seizures, or if there has ever been a history of seizures in the family. If high fever occurs after vaccination, consult a doctor immediately,
• the patient has previously experienced a severe allergic reaction to chicken egg protein,
• the patient has had adverse reactions after measles, mumps, or rubella vaccination involving easy bruising or prolonged bleeding (see section 4),
• the patient has a weakened immune system (e.g. due to HIV infection) or is about to start taking a medication that weakens the immune system. Close monitoring is required, as the response to the vaccine may not be sufficient to provide protection against disease (see section 2 "When not to use Priorix vaccine").

Fainting may occur after or even before any injectable vaccine is administered
(especially in adolescents). Therefore, inform your doctor or nurse if the
patient has ever fainted during an injection.
If the patient is vaccinated within 72 hours of exposure to someone with measles,
Priorix vaccine may provide some protection against developing the disease.
Children under 12 months of age
Children vaccinated during the first year of life may not be fully protected. If
additional vaccine doses are needed, your doctor will advise on their administration.
As with all vaccines, Priorix may not fully protect all vaccinated individuals.
Priorix vaccine and other medicines
Tell your doctor about all vaccines and any medicines currently used, recently used,
or planned to be used by the patient.
Priorix vaccine may be administered at the same time as other vaccines, such as:
diphtheria, tetanus, acellular pertussis vaccine, Haemophilus influenzae type b vaccine, oral or inactivated polio vaccine, hepatitis A vaccine, hepatitis B vaccine, varicella vaccine, meningococcal group B vaccine, conjugated meningococcal serogroup C vaccine, conjugated meningococcal vaccine against groups A, C, W135 and Y, and conjugated pneumococcal vaccine. For additional information, contact your doctor or nurse.
Each vaccine should be administered at a different injection site.
If Priorix cannot be given simultaneously with other vaccines containing live, attenuated viruses, at least one month should elapse between vaccinations.
Vaccination may be delayed for at least 3 months if the patient has recently received blood transfusion or human immunoglobulin.
If a tuberculin test (skin test for tuberculosis) is planned for the patient,
it should be performed before or simultaneously with vaccination, or at least 6 weeks after
vaccination.
Pregnancy, breastfeeding and fertility
Priorix vaccine should not be given to pregnant women.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant,
she should consult her doctor or pharmacist before using this vaccine.
Moreover, it is important not to become pregnant for one month after vaccination. During this time,
an effective method of contraception should be used to avoid 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 (including delayed-type reactions) and, rarely, bronchospasm.
The vaccine contains 334 micrograms of phenylalanine per dose. Phenylalanine may be harmful for patients with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates in the body because the body cannot eliminate it properly.
This vaccine contains less than 1 mmol (23 mg) of sodium per dose, meaning the vaccine is considered "sodium-free".
This vaccine contains potassium, less than 1 mmol (39 mg) of potassium per dose, meaning the vaccine is considered "potassium-free".

3. How to administer Priorix vaccine

The Priorix vaccine is administered subcutaneously or intramuscularly, into the upper arm or the outer part of the thigh.
Priorix is intended for use in children after completion of the 9th month of life, adolescents, and adults.
The appropriate timing of vaccination and the number of doses to be administered will be determined by a physician according to official recommendations.
Under no circumstances should the vaccine be administered intravenously.

4. Possible adverse reactions

Like any medicine, this vaccine may cause adverse reactions, although not everybody will experience them.
The following adverse reactions have been reported during clinical trials with Priorix vaccine:

♦ Very common (may occur in more than 1 in 10 doses):

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

♦ Common (may occur in less than 1 in 10 doses):

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

♦ Uncommon (may occur in less than 1 in 100 doses):

• Otitis media (middle ear infection)
• Lymphadenopathy (enlarged lymph nodes in the neck, armpit or groin)
• Loss of appetite
• Irritability
• Unusual crying
• Insomnia
• Redness, irritation or watering of the eyes (conjunctivitis)
• Bronchitis
• Cough
• Swelling of the parotid glands (lymph nodes in the cheek area)
• Diarrhoea
• Vomiting

♦ Rare (may occur in less than 1 in 1000 doses):

• Convulsions associated with high fever
• Allergic reactions

After marketing of the vaccine, the following adverse reactions have been very rarely reported:

• Joint and muscle pain
• Bleeding or bruising more easily than usual due to a low platelet count
• Sudden life-threatening allergic reactions
• Infection or inflammation of the brain, spinal cord and peripheral nerves leading to transient difficulties in walking (unsteadiness) and/or transient loss of motor coordination, inflammation of certain nerves with possible tingling sensation, loss of sensation or movement disorders (Guillain-Barré syndrome)
• Narrowing or blockage of blood vessels
• Erythema multiforme (characterized by red, often itchy spots, similar to the rash seen in measles, appearing first on limbs and sometimes on the face and other parts of the body)
• Measles- and mumps-like symptoms (including transient painful swelling of the testes and swollen glands in the neck)

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warszawa
Tel.: 22 49 21 301
Fax: 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Priorix vaccine

Keep the vaccine out of the sight and reach of children.
Do not use this vaccine after the expiry date stated on the outer packaging.
Store and transport in a refrigerated state (2°C – 8°C).
Do not freeze.
Keep in the original packaging to protect from light.
After reconstitution, the vaccine should be administered 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 must not be disposed of via the sewage system or household waste. Ask a pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

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

What Priorix vaccine looks like and contents of the pack
Priorix vaccine is supplied as a powder and solvent for the preparation of a 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 units,
• without needles: packs of 1 or 10 units.

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

Marketing Authorisation Holder and Manufacturer
GlaxoSmithKline Biologicals S.A.
rue de l’Institut 89
1330 Rixensart, Belgium

Other sources of information
Detailed information about this medicinal product is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.

Information intended exclusively for healthcare professionals:

As with all injectable vaccines, there is a possibility of a rare anaphylactic reaction; therefore, appropriate medical care must be available immediately after vaccination.
Alcohol and other disinfectants should be allowed to evaporate completely from the skin before administering the vaccine, as they may inactivate the attenuated viruses contained in the vaccine.
The Priorix vaccine must never be administered intravenously.
Due to lack of compatibility studies, the vaccine should not be mixed with other medicinal products.
The solvent and the reconstituted vaccine should be inspected visually before reconstitution and before administration for the presence of foreign particles and/or any physical changes. If any abnormalities are observed, the solvent or the prepared vaccine should not be used.
The vaccine should be reconstituted by adding the entire contents of the solvent from the prefilled syringe to the vial containing the powder.
To attach the needle to the prefilled syringe, carefully follow the instructions shown in Figures 1 and 2. The prefilled syringe supplied with the PRIORIX vaccine may differ slightly from the one illustrated (it may lack a threaded end for screwing on the needle). In such a case, the needle should be attached without screwing.

Needle

Prefilled syringe
Figure 1. Figure 2.
Always hold the prefilled syringe by its barrel, not by the plunger or the Luer Lock adapter (Luer Lock Adaptor, LLA), and keep the needle aligned with the syringe (as shown in Figure 2). Failure to follow these instructions may cause misalignment of the LLA and leakage from the prefilled syringe.
If the LLA becomes detached during attachment of the needle to the prefilled syringe, a new dose of the vaccine (a new prefilled syringe and vial) must be used.

1. Unscrew the cap of the prefilled syringe by turning 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 prefilled syringe by gently placing the needle hub onto the LLA and turning it a quarter turn clockwise until a click is felt, indicating the needle is locked (as shown in Figure 2).
3. Remove the needle cap, which may require some force.
4. Add the solvent to the powder. Then shake vigorously until the powder is completely dissolved.

Depending on minor pH variations, the reconstituted vaccine may range in color from peach to pinkish-fuchsia, which does not affect its efficacy.

5. Withdraw the entire contents of the vial.
6. For administration of the vaccine, use a new needle. To do this, unscrew the current needle from the prefilled syringe and attach a new injection needle, following the instructions in point 2.

The vaccine should be used immediately after reconstitution. If this is not possible, it should be stored at 2°C–8°C and used within 8 hours of reconstitution.
Any unused product or waste material should be disposed of in accordance with local regulations.