PRIORIX 0.5 ML Powder and solvent for injectable solution

Зміст інструкції

1. Priorix Tetra, powder and solvent for injectable solution in pre-filled syringe
   1. What is Priorix Tetra and what is it used for
   2. What you need to know before you receive 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

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

Vaccine (live) against measles, mumps, rubella and varicella

Read this leaflet carefully before you or your child receive this vaccine as 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 effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

It can be administered to adults and children, so you can read it for your child.

Contents of this leaflet:

• 1. What Priorix Tetra is and what it is used for
• 2. What you need to know before you receive 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 is Priorix Tetra and what is it used for

Priorix Tetra is a vaccine used in subjects from 11 months of age for the prevention of diseases caused by the
measles, mumps, rubella and varicella viruses.
In some situations Priorix Tetra can 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 defense system) develops antibodies that protect them from infection by the measles,
mumps, rubella and varicella viruses.
Although Priorix Tetra contains live viruses, these are too weak to cause measles, mumps, rubella or
varicella in healthy people.
Like all vaccines, Priorix Tetra may not completely protect all vaccinated people.

2. What you need to know before you receive Priorix Tetra

Do not use Priorix Tetra:

• if you are allergic to any of the ingredients of this vaccine (listed in section 6). Signs of an allergic reaction can include itchy rash, feeling of shortness of breath, swelling of the face or tongue,
• if you have previously had an allergic reaction to any vaccine against measles, mumps, rubella and/or chickenpox,
• if you have had an allergy to neomycin (an antibiotic agent). A known contact dermatitis (skin rash that appears when the skin is in direct contact with allergens such as neomycin) is not a problem but must be reported to the doctor beforehand,
• if you have a severe infection with a high temperature. In these cases, vaccination should be postponed

until recovery. A mild infection such as a cold does not cause problems, but should be reported to the doctor beforehand,

• if you have a condition such as Human Immunodeficiency Virus (HIV) or Acquired Immunodeficiency Syndrome (AIDS) or are taking medicines that can weaken the immune system. Whether or not to administer the vaccine to your child will depend on the level of immune defenses,
• in case of pregnancy. Furthermore, pregnancy should be avoided in the first month after vaccination.

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

• if you have a personal or family history of convulsions including febrile convulsions. In this case, you must be closely monitored after vaccination as fever may occur, especially 5 to 12 days after vaccination (see also section 4),
• if you have had a severe allergic reaction to egg proteins,
• if you have developed side effects after a vaccination against measles, mumps or rubella that resulted in easy bruising or prolonged bleeding compared to normal (see also section 4),
• if you have a weakened immune system (e.g., due to an HIV infection). You must be closely monitored as the response to the vaccine may not be sufficient to guarantee protection against the disease (see section 2 “Do not use Priorix Tetra”).

If you have been vaccinated within 72 hours of contact with someone with measles or chickenpox, Priorix Tetra may partially protect you from the disease.
Once vaccinated, you should try to avoid close contact for at least 6 weeks after vaccination, as much as possible, with the following individuals:

• individuals with reduced resistance to diseases;
• pregnant women who have not had chickenpox or have not been vaccinated against chickenpox;
• newborns from mothers who have not had chickenpox or have not been vaccinated against chickenpox.

Fainting (especially in adolescents) can occur following, or even before any injection with a needle. Therefore, inform the doctor or nurse if you have fainted with an injection in the past.
Like other vaccines, Priorix Tetra may not completely protect you from chickenpox. However, people who have been vaccinated and who contract chickenpox usually have a very mild illness, compared to people who have not been vaccinated.

Other medicines and Priorix Tetra
Tell your doctor if your child is taking, has recently taken or may take any other medicine or has recently received any other vaccine.
If you have had a blood transfusion or human antibodies (immunoglobulins), your doctor may postpone vaccination for at least 3 months.
If a tuberculin test is to be performed, this should be done before, at the same time or 6 weeks after vaccination with Priorix Tetra.
The use of salicylates (a substance present in many medicines used to lower fever and relieve pain) should be avoided for 6 weeks after vaccination with Priorix Tetra.
Priorix Tetra can be administered simultaneously with other vaccines. A different injection site must be used for each vaccine.

Pregnancy and breastfeeding
Priorix Tetra should not be administered to pregnant women.
If you are pregnant, breastfeeding, suspect or are planning a pregnancy, ask your doctor or pharmacist for advice before receiving this vaccine. It is also important to avoid pregnancy in the first month after vaccination. An effective contraceptive method should be used during this period to avoid pregnancy.

Driving and using machines
There is no information to suggest that Priorix Tetra affects the ability to drive and use machines.

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 (even delayed) and, exceptionally, bronchospasm.
This vaccine contains 583 micrograms of phenylalanine per dose. Phenylalanine may be harmful if you have phenylketonuria (PKU), a rare genetic disease that causes a buildup of phenylalanine because the body cannot eliminate it properly.
The vaccine contains less than 1 mmol of sodium (23 mg) per dose, i.e. essentially “sodium-free”.
The vaccine contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially “potassium-free”.

3. How to use Priorix Tetra

Priorix Tetra is administered subcutaneously or intramuscularly into the upper arm or the outer thigh.
Priorix Tetra is intended for subjects aged 11 months and older. The doctor will determine the timing and number of
injections to be administered based on official recommendations.
The vaccine should never be administered intravenously.

4. Possible side effects

Like all medicines, this vaccine can cause side effects, although not everyone will experience them.
The following side effects may occur with this vaccine:

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

*Higher rates of fever have been observed after the administration of the first dose of Priorix Tetra in
comparison to vaccines for mumps-measles-rubella and varicella administered separately during the same
visit.
In rare cases, the following adverse reactions have been reported during routine use of GlaxoSmithKline Biologicals
vaccines against measles, mumps, rubella or varicella:

• joint and muscle pain
• allergic reactions. Skin rashes that may be itchy or blistered, swelling of the eyes and face, difficulty breathing or
  swallowing, sudden drop in blood pressure and loss of consciousness. These reactions can occur before leaving the
  doctor's office. In any case, if your child experiences any of these symptoms, contact a doctor immediately
• infection or inflammation of the brain, spinal cord and peripheral nerves resulting in temporary difficulty walking
  (instability) and/or temporary loss of body movement control, stroke, inflammation of certain nerves, possibly with
  tingling or loss of sensation or normal movements (Guillain-Barré syndrome)
• narrowing or blockage of blood vessels
• pinpoint or small spot bleeding, or bruising more frequently than normal due to a decrease in platelets
• erythema multiforme (whose symptoms are red spots, often itchy, similar to the measles rash that start on the limbs
  and sometimes on the face and the rest of the body)
• chickenpox-like rash
• shingles (herpes zoster)
• symptoms similar to measles and mumps (including transient painful swelling of the testicles and swelling of the neck
  glands)

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor or pharmacist. You can also report side effects directly through the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects you 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 which is 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.
Store in the original packaging to protect it from light.
After reconstitution, the vaccine must be administered immediately or be stored in a refrigerator
(2  C – 8  C). If it is not used within 24 hours, it must be discarded.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack 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 Priorix Tetra and contents of the pack
Priorix Tetra is supplied as a powder and solvent for injectable solution (powder in a vial for 1 dose and
solvent in a pre-filled syringe (0.5 ml)) with or without separate needles, in the following packs:

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

Priorix Tetra is supplied as a compact powder ranging in colour from whitish to light pink, some of which
may be yellowish, and a clear, colourless solvent (water for injections) for the
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 for healthcare professionals only:
As with all injectable vaccines, in the event of rare anaphylactic reactions following vaccine administration, appropriate supervision and medical treatment must always be immediately available.
Alcohol and other disinfecting agents should be allowed to evaporate from the skin before injecting the vaccine, as they may inactivate the attenuated viruses in the vaccine itself.
Priorix Tetra must not be administered by intravascular or intradermal routes under any circumstances.
In the absence of compatibility studies, the medicinal product should not be mixed with other medicinal products.
The reconstituted (dissolved) vaccine must be visually inspected before administration. The colour of the
reconstituted vaccine may vary from light peach to fuchsia pink due to slight variations in its pH. After reconstitution, it may contain translucent particles related to the product. This is
normal and does not affect the pharmacological characteristics of the vaccine.
I

Do not administer if the vaccine has other colourations or contains other particles.
The vaccine is reconstituted by adding the entire contents of the pre-filled syringe of solvent to the
powder contained in the vial.
To insert the needle into the syringe, carefully read the instructions in Figures 1 and 2. However, the
syringe supplied with Priorix Tetra may be slightly different (without a thread) from the syringe in the
drawing.
In this case, the needle should be inserted without screwing.

Figure 1Figure 2
Always hold the syringe by the body, not by the plunger or the Luer Lock Adapter (LLA), and keep
the needle in line with the syringe (as shown in Figure 2). Otherwise, the LLA may
deform and detach.
If the LLA detaches during syringe assembly, a new dose of
vaccine (new syringe and new vial) must be used.

• 1. Unscrew the syringe protection by rotating counterclockwise (as shown in Figure 1). Whether the LLA is rotating or not, follow the steps below:
• 2. Attach the needle to the syringe by gently connecting the needle hub to the LLA and rotate a quarter turn clockwise until a click is felt (as shown in Figure 2).
• 3. Remove the needle protection, which may be a little difficult.
• 4. Add the solvent to the powder. The mixture should be shaken well until the powder is completely dissolved in the solvent.
• 5. Draw up the entire contents of the vial and administer.

• 6. To administer the vaccine, a new needle must be used. Unscrew the needle from the syringe and attach the injection needle, repeating step 2 above.

After reconstitution, it is recommended to use the vaccine immediately or store it in a refrigerator
(2°C-8°C). If the vaccine is not used within 24 hours, it must be discarded.
Unused medicine and waste derived from this medicine must be disposed of in accordance with
current local regulations.