Package leaflet: Information for the user

Priorix-Tetra, powder and solvent for solution for injection
Vaccine against measles, mumps, rubella and varicella, live
Please read all of this leaflet carefully before the vaccine is administered, because it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others.
If any side effects occur in the patient, including any side effects not listed in this leaflet, inform your doctor or pharmacist. 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 be administered to both adults and
children, it is possible that the leaflet will be reviewed by a parent or guardian of a child.

Table of contents

What Priorix-Tetra vaccine is and what it is used for
Important information before receiving Priorix-Tetra
How to use Priorix-Tetra
Possible side effects
How to store Priorix-Tetra
Contents of the pack and other information

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

Priorix-Tetra is a vaccine used in individuals aged 11 months and older to prevent diseases caused by the measles, mumps, rubella and varicella viruses. Under certain circumstances, Priorix-Tetra may also be given to children after they have completed 9 months of life.

How Priorix-Tetra vaccine works
After administration of Priorix-Tetra vaccine, the immune system (the body's defence system) of the vaccinated person will start producing antibodies designed to protect against infection with the measles, mumps, rubella and varicella viruses.

Although Priorix-Tetra contains live viruses, they have been attenuated to such an extent that they cannot cause measles, mumps, rubella or varicella 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 allergy to any of the components of this vaccine (listed in section 6). Symptoms of an allergic reaction may include itchy rash, difficulty breathing, or swelling of the face or tongue;
if the patient has previously experienced an allergic reaction after receiving any vaccine against measles, mumps, rubella, and/or varicella;
if the patient is allergic to neomycin (an antibiotic). Contact dermatitis caused by neomycin (skin rash occurring due to direct skin contact with an allergen such as neomycin) should not be a major concern, but you should consult a doctor first;
if the patient has a severe infection accompanied by fever. In such cases, vaccination should be postponed until recovery. A mild infection, such as a common cold, should not prevent vaccination, but you should inform the doctor;
if the patient has any medical condition (e.g. human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)) or is taking medications that may weaken the immune system. Whether the patient should receive the vaccine will depend on their level of immunity;
if pregnancy is confirmed. In addition, pregnancy should be avoided for 1 month after vaccination.

Warnings and precautions
Talk to your doctor or pharmacist before receiving Priorix-Tetra vaccine if:

the patient, or their family history, includes a history of seizures, including febrile seizures. In such cases, careful observation after vaccination is recommended, as fever associated with vaccination may occur, particularly 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 previously experienced adverse reactions after measles, mumps, or rubella vaccination, such as easy bruising or prolonged bleeding (see section 4);
if the patient has a weakened immune system (e.g. due to HIV infection). Close monitoring is advised, as the immune response to the vaccine may be insufficient to provide protection against disease (see section 2 "When not to use Priorix-Tetra vaccine").

If the patient is vaccinated within 72 hours of exposure to someone with measles or varicella, the Priorix-Tetra vaccine may provide some protection against developing the disease.
After vaccination, the patient should, for at least 6 weeks, try to avoid close contact with:

individuals with weakened immunity to infections,
pregnant women who have never had varicella or have not been vaccinated against varicella,
newborn infants of mothers who have never had varicella or have not been vaccinated against varicella.

Fainting may occur after, or even before, any injectable vaccine is administered (particularly in adolescents). Therefore, inform the doctor or nurse if the patient has ever fainted during an injection.
As with other vaccines, Priorix-Tetra may not fully protect all vaccinated individuals. However, in vaccinated individuals, the disease course is usually much milder than in unvaccinated individuals.
Priorix-Tetra and other medicines
Inform the doctor about all medicines currently taken or recently taken, medicines planned for future use, and any vaccines recently received.
Vaccination may be postponed by the doctor for at least 3 months if the patient recently received a blood transfusion or human antibodies (immunoglobulins).
If a tuberculin skin test (for tuberculosis) is required, it should be performed before or simultaneously with vaccination, or at least 6 weeks after vaccination.
Avoid taking salicylates (substances found in many antipyretic and analgesic medicines) for 6 weeks after vaccination.
Priorix-Tetra may be administered at the same time as other vaccines. Each vaccine should be administered at a different injection site.
Pregnancy and breastfeeding
Priorix-Tetra vaccine should not be given to pregnant women.
During pregnancy, breastfeeding, or if pregnancy is suspected or planned, consult a doctor or pharmacist before using this vaccine. It is also important that the patient avoids becoming pregnant for one month after vaccination. An effective method of contraception should be used during this time to prevent pregnancy.
Driving and using machines
There are no data suggesting that Priorix-Tetra vaccine affects the ability to drive or operate machinery.
Priorix-Tetra contains sorbitol
This vaccine contains 14 mg of sorbitol per dose.

3. How to use Priorix-Tetra vaccine

Priorix-Tetra is administered subcutaneously or intramuscularly, into the upper arm or the outer
part of the thigh.
Priorix-Tetra is intended for individuals aged 11 months and older. The vaccination schedule and the number
of doses a patient will receive will be determined by the physician based on official recommendations.
Under no circumstances should the vaccine be administered intravenously.

4. Possible adverse reactions

As with any medicinal product, adverse reactions may occur following this
vaccine, although they do not affect everyone.
The following adverse reactions may occur after vaccination:
♦ Very common (may occur in more than 1 in 10 doses of vaccine):

pain and redness at the injection site
fever of 38°C or higher*
swelling at the injection site when the vaccine is administered to adolescents and adults

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

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

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

unusual crying, restlessness, insomnia
general malaise, lethargy, fatigue
swelling of the parotid glands (salivary glands in the cheek area)
diarrhoea, vomiting
loss of appetite
upper respiratory tract infection
runny nose
swelling of lymph nodes

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

middle ear infection
febrile convulsions
cough
bronchitis

* Fever has been observed more frequently after administration of the first dose of Priorix-
Tetra vaccine compared to separate administration of measles, mumps, rubella vaccine and
varicella vaccine during the same visit.
The following adverse reactions have been reported during routine use of measles, mumps and
rubella vaccine or varicella vaccine manufactured by GlaxoSmithKline Biologicals:

joint and muscle pain
allergic reactions. Such reactions may include 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 even before leaving the doctor's office. If any of the above symptoms occur in a patient, medical advice should be sought immediately
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, stroke, inflammation of certain nerves with possible tingling sensation or loss of sensation or movement disorders (Guillain-Barré syndrome)
narrowing or blockage of blood vessels
local bleeding or easier than usual bruising due to reduced platelet count
erythema multiforme (symptoms include red, often itchy spots similar to the rash seen in chickenpox, appearing on limbs and sometimes on the face and other parts of the body)
rash resembling chickenpox
shingles
symptoms resembling measles and mumps (including transient painful swelling of testes and swollen neck lymph nodes)

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: 22 49 21 301
Fax: 22 49 21 309
e-mail: [email protected]
Adverse reactions may also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicinal product.

5. How to store Priorix-Tetra vaccine

Keep the vaccine out of the 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 stated month.
The abbreviation "Lot" indicates the vaccine batch number.
Store and transport under refrigerated conditions (2°C - 8°C).
Do not freeze.
Keep in the original packaging to protect from light.
After reconstitution, the vaccine should be administered immediately or stored
in a refrigerator (2°C - 8°C). If not used within 24 hours, it must be discarded.
Medicines must 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. 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 varicella viruses.
Other components 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 supplied as a powder and solvent for solution for injection (the powder is contained in a single-dose vial, the solvent in a 0.5 ml ampoule).
Pack sizes of 1, 10 or 100.
Priorix-Tetra vaccine is a white to slightly pinkish powder and a clear, colourless solvent (water for injections) used to reconstitute the powder.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
GlaxoSmithKline Biologicals S.A.
Rue de l’Institut 89
B-1330 Rixensart
Belgium

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.

Information intended exclusively for healthcare professionals:

As with all injectable vaccines, appropriate medical treatment and supervision must always be available in case of rare anaphylactic reactions following vaccination.
Alcohol and other disinfectants should be allowed to evaporate from the skin before administering the vaccine, as they may inactivate the attenuated viruses present in the vaccine.
Priorix-Tetra vaccine must never under any circumstances be administered intravenously or intradermally.
Since compatibility studies have not been conducted, the medicinal product must not be mixed with other medicinal products.
After reconstitution, the vaccine should be visually inspected for the presence of particulate matter and/or abnormal physical appearance. If such are observed, the vaccine must not be administered.
Reconstitute the vaccine by adding the entire contents of the ampoule containing the solvent to the vial containing the powder. Then shake vigorously until the powder is completely dissolved in the solvent.
Due to minor changes in pH, the reconstituted vaccine may range in color from light peach to magenta-pink. This is a normal phenomenon and does not affect the vaccine's efficacy. If any other changes are observed, the vaccine must not be administered.
The entire contents of the vial should be administered.
A new needle should be used for vaccine administration.
After reconstitution, the vaccine should be administered immediately or stored in a refrigerator (2°C–8°C). If not used within 24 hours, it must be discarded.
Any unused medicinal product or waste material should be disposed of in accordance with local regulations.