Priorix Tetra

Package leaflet: Information for the user

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

(Measles, mumps, rubella and varicella (live) vaccine)
Please read all of this leaflet carefully before you or your child are given this vaccine because it contains
important information for you.

• Keep this leaflet. 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 or your child. Never give it to others.
• If your child experiences any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

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

1. What Priorix Tetra is and what it is used for
2. What you need to know before receiving Priorix Tetra
3. How to use Priorix Tetra
4. Possible side effects
5. How to store Priorix Tetra
6. 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 from 11 months of age for the prevention of diseases caused by the
measles, mumps, rubella and varicella viruses.
In certain situations, Priorix Tetra may also be administered to children from 9 months of age.
How Priorix Tetra works
When a person is vaccinated with Priorix Tetra, their immune system (the body's natural defence system) produces antibodies that protect them against infection by the measles, mumps, rubella and varicella viruses.
Although Priorix Tetra contains live viruses, these are too weakened to cause measles, mumps, rubella or varicella in healthy individuals.
Like all vaccines, Priorix Tetra may not fully protect all vaccinated individuals.

2. What you should know before receiving Priorix Tetra

Do not use Priorix Tetra:

• if you are allergic to any of the components of this vaccine (listed in section 6). Signs of an allergic reaction may include itchy rash, shortness of breath, swelling of the face or tongue,
• if you have previously had an allergic reaction to any measles, mumps, rubella, and/or varicella vaccine,
• if you are allergic to neomycin (an antibiotic). Known contact dermatitis (a skin rash occurring when the skin is in direct contact with allergens such as neomycin) is not a problem, but you must inform your doctor beforehand,
• if you have a serious infection with high fever. In such cases, vaccination should be postponed until recovery. A mild infection such as a cold does not pose a problem, but you should inform your doctor beforehand,
• if you have a condition such as Human Immunodeficiency Virus (HIV) or Acquired Immunodeficiency Syndrome (AIDS), or are taking medicines that may weaken the immune system. The decision to administer the vaccine to your child will depend on the level of immune defenses,
• during pregnancy. In addition, pregnancy must be avoided during the first month following vaccination.

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

• if you or a family member have a history of seizures, including febrile seizures. In this case, you should be closely monitored after vaccination, as fever may occur, particularly from 5 to 12 days after vaccination (see also section 4),
• if you have had a severe allergic reaction to egg proteins,
• if you have experienced side effects after a measles, mumps, or rubella vaccination involving easy bruising or prolonged bleeding (see also section 4),
• if your immune system is weakened (e.g., due to 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 use Priorix Tetra”).

If you were vaccinated within 72 hours of exposure to someone with measles or varicella, Priorix Tetra may
partially protect you from the disease.
After vaccination, you should try to avoid, as far as possible, close contact with the following individuals for at least 6 weeks:

• individuals with reduced resistance to infections;
• pregnant women who have not had varicella or have not been vaccinated against varicella;
• newborns whose mothers have not had varicella or have not been vaccinated against varicella.

Fainting (especially in adolescents) may occur following, or even before, any needle injection. Therefore, inform your doctor or nurse if you have previously fainted after an injection.
Like other vaccines, Priorix Tetra may not fully protect you against varicella. However, individuals who have been vaccinated and who contract varicella usually experience a very mild form of the disease compared to unvaccinated individuals.
Other medicines and Priorix Tetra
Inform your doctor if your child is taking, has recently taken, or might take any other medicines, or has recently received any other vaccine.
If you have received a blood transfusion or human antibodies (immunoglobulins), your doctor may postpone vaccination by at least 3 months.
If a tuberculin skin test is required, it should be performed before, simultaneously with, or at least 6 weeks after vaccination with Priorix Tetra.
The use of salicylates (a substance present in many medicines used to reduce fever and relieve pain) should be avoided during the 6 weeks following vaccination with Priorix Tetra.
Priorix Tetra may be administered simultaneously with other vaccines. Each vaccine must be administered at a different injection site.
Pregnancy and breastfeeding
Priorix Tetra must not be administered to pregnant women.
If you are pregnant, breastfeeding, suspect you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before receiving this vaccine. In addition, it is important to avoid pregnancy during the first month following vaccination. During this time, an effective contraceptive method must be used to prevent pregnancy.
Driving and using machines
There is no information suggesting that Priorix Tetra affects the ability to drive or operate machinery.
Priorix Tetra contains sorbitol, para-aminobenzoic acid, phenylalanine, sodium, and potassium
This vaccine contains 14 mg of sorbitol per dose.
Priorix Tetra contains para-aminobenzoic acid. It may cause allergic reactions (including delayed reactions) and, rarely, bronchospasm.
This vaccine contains 583 micrograms of phenylalanine per dose. Phenylalanine may be harmful if you have phenylketonuria (PKU), a rare genetic disorder causing accumulation of phenylalanine because the body cannot properly eliminate it.
The vaccine contains less than 1 mmol of sodium (23 mg) per dose, i.e., essentially “sodium-free”.
The vaccine contains less than 1 mmol of potassium (39 mg) per dose, i.e., essentially “potassium-free”.

3. How to use Priorix Tetra

Priorix Tetra is administered under the skin or into the muscle of the upper arm or the outer thigh.
Priorix Tetra is intended for individuals from 11 months of age. Your doctor will determine the timing and number of injections you will receive based on official recommendations.
The vaccine must never be administered intravenously.

4. Possible side effects

Like all medicines, this vaccine may cause side effects, although not everybody gets them.
The following side effects may occur with this vaccine:

• Very common (these may occur in more than 1 case in every 10 doses of vaccine):
  • pain and redness at the injection site
  • fever of 38°C or higher*
  • swelling at the injection site in adolescents and adults
• Common (these may occur in up to 1 case in every 10 doses of vaccine):
  • swelling at the injection site in children
  • fever higher than 39.5°C*
  • irritability
  • rash (spots and/or blisters)
• Uncommon (these may occur in up to 1 case in every 100 doses of vaccine):
  • unusual crying, restlessness, inability to sleep
  • general feeling of being unwell, drowsiness, fatigue
  • swelling of the parotid glands (glands located in the cheek)
  • diarrhoea, vomiting
  • loss of appetite
  • upper respiratory tract infection
• rhinitis
• swelling of the lymph glands
  • Rare (these may occur in up to 1 case in every 1,000 doses of vaccine):
• middle ear infections
• febrile seizures
• cough
• bronchitis

*Higher rates of fever have been observed after administration of the first dose of Priorix Tetra compared to separate administration of measles-mumps-rubella and varicella vaccines during the same visit.
On rare occasions, the following adverse reactions have been reported during routine use of GlaxoSmithKline Biologicals vaccines against measles, mumps, rubella or varicella:

• Infection or inflammation of the brain (encephalitis) has been observed following vaccination with live attenuated measles, mumps, rubella and varicella vaccines. In some cases, this condition has been fatal, particularly in individuals with weakened immune systems (as stated in section 2, Priorix Tetra must not be used in patients with a weakened immune system). Seek immediate medical advice if you or your child experiences loss or reduction in consciousness levels, seizures, or loss of control of body movements, accompanied by fever and headache, as these may be signs of infection or inflammation of the brain. Inform the doctor or pharmacist that you or your child has received Priorix Tetra;
• infection or inflammation of the spinal cord and peripheral nerves, leading to temporary difficulties in walking (instability) and/or temporary loss of control of body movements
• stroke
• inflammation of certain nerves, possibly with tingling sensations or loss of normal sensation or movement (Guillain-Barré syndrome)
• joint and muscle pain
• allergic reactions. Skin rashes which may be itchy or form blisters, swelling of the eyes and face, difficulty breathing or swallowing, sudden drop in blood pressure and loss of consciousness. These reactions may occur before leaving the doctor's office. In any case, if your child experiences any of these symptoms, contact a doctor immediately
• narrowing or blockage of blood vessels
• pinpoint or small-spotted bleeding, or bruising more frequent than normal due to a decrease in platelets
• erythema multiforme (symptoms include red spots, often itchy, resembling measles rash, starting on the limbs and sometimes on the face and rest of the body)
• varicella-like rash
• shingles (herpes zoster)
• measles- or mumps-like symptoms (including transient painful swelling of the testicles and swelling of neck glands)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Priorix Tetra

Keep this vaccine out of the sight and reach of children.
Do not use this vaccine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Store and transport in a refrigerator (2 °C – 8 °C).
Do not freeze.
Keep in the original packaging to protect it from light.
After reconstitution, the vaccine must be administered immediately or stored in a refrigerator (2 °C – 8 °C). If not used within 24 hours, it must be discarded.
Do not dispose of any medicine 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 Tetra contains:
The active substances are: live attenuated measles, mumps, rubella and varicella viruses.
The excipients are:
Powder: amino acids (containing phenylalanine), anhydrous lactose, mannitol (E421), sorbitol (E420), medium
199 (containing phenylalanine, para-aminobenzoic acid, sodium and potassium).
Solvent: water for injections
Description of the appearance of Priorix Tetra and contents of the pack
Priorix Tetra is supplied as a powder and solvent for injectable solution (powder in a vial containing 1 dose and
solvent in a pre-filled syringe (0.5 ml)) with or without separate needles, in the following pack sizes:

• with 2 separate needles: packs containing 1 or 10 doses.
• without needles: packs containing 1 or 10.

Priorix Tetra is supplied as a compact powder ranging in colour from whitish to pale pink, part of which may be yellowish, and a colourless transparent solvent (water for injections) for reconstitution of the vaccine.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
GlaxoSmithKline S.p.A. – Viale dell’Agricoltura, 7 - 37135 Verona - Italy
Manufacturer
GlaxoSmithKline Biologicals s.a., Rue de l’Institut 89, B-1330 Rixensart, Belgium
_____________________________________________________________________________________

The following information is intended exclusively for healthcare professionals:

As with all injectable vaccines, appropriate supervision and immediate medical treatment must always be available in the event of rare anaphylactic reactions following vaccine administration.
Alcohol and other disinfectants must be allowed to evaporate completely from the skin before administering the vaccine, as they may inactivate the attenuated viruses contained in the vaccine.
Under no circumstances must Priorix Tetra be administered intravascularly or intradermally.
In the absence of compatibility studies, the medicinal product must not be mixed with other medicinal products.
The reconstituted (reconstituted) vaccine prior to administration must be inspected visually. The colour of the reconstituted vaccine may vary from light peach to fuchsia pink due to minor variations in its pH level. After reconstitution, it may contain translucent particles related to the product. This is normal and does not affect the pharmacological properties of the vaccine.
Do not administer if the vaccine shows different discoloration or contains other particles.
The vaccine is reconstituted by adding the entire contents of the pre-filled syringe of solvent provided to the powder contained in the vial.
To insert the needle into the syringe, carefully read the instructions shown in Figure 1 and 2. However, the syringe supplied with Priorix Tetra may be slightly different (without threading) compared to the syringe shown in the drawing.
In this case, the needle must be inserted without screwing.

Figure 1 Figure 2
Always hold the syringe by the barrel, not by the plunger or the Luer Lock adapter (LLA), and keep the needle aligned with the syringe (as shown in Figure 2). Otherwise, the LLA may become deformed and leak.
If during syringe assembly the LLA becomes detached, a new dose of vaccine (new syringe and new vial) must be used.

1. Unscrew the syringe cap by turning counterclockwise (as shown in Figure 1). Regardless of whether the LLA rotates or not, proceed with the following steps:
2. Attach the needle to the syringe by gently connecting the needle hub to the LLA and rotate one-quarter turn clockwise until a click is felt (as shown in Figure 2).
3. Remove the needle cap, which may be slightly difficult.
4. Add the solvent to the powder. The mixture must be thoroughly agitated until the powder is completely dissolved in the solvent.
5. Aspirate the entire contents of the vial and administer it.
6. A new needle must be used to administer the vaccine. Unscrew the needle from the syringe and attach the injection needle by repeating step 2 above.

After reconstitution, it is recommended to use the vaccine immediately or store it in the refrigerator (2°C–8°C). If the vaccine is not used within 24 hours, it must be discarded.
Unused medicinal product and waste materials derived from such medicinal product must be disposed of in accordance with local applicable regulations.