Varilrix

Package leaflet: Information for the user

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

Varicella vaccine (live)
Please read this leaflet carefully before receiving this medicine as it contains
important information.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This vaccine has been prescribed for you only. Do not give it to other people.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

1. What Varilrix is and what it is used for
2. What you need to know before you/your child are given Varilrix
3. How Varilrix is administered
4. Possible side effects
5. How to store Varilrix
6. Contents of the pack and other information

1. What Varilrix is and what it is used for

Varilrix is a vaccine used from the age of 12 months onwards to protect against disease caused by the varicella virus. In certain circumstances, Varilrix may also be administered to children from 9 months of age.
Vaccination within 3 days after exposure to varicella may help prevent the onset of varicella or reduce the severity of the disease.
How Varilrix works
When a person is vaccinated with Varilrix, the immune system (the body's natural defence system) will develop antibodies to protect the person against infection by the varicella virus.
Varilrix contains weakened viruses that are highly unlikely to cause varicella in healthy individuals.
As with all vaccines, Varilrix may not fully protect all vaccinated individuals.

2. What you should know before you/your child receives Varilrix

Varilrix must not be given if:

• you or your child has any serious illness (such as blood disorders, cancer, human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)), or if you are taking medicines (including high-dose corticosteroids) that may weaken the immune system. The decision whether or not to administer the vaccine to you or your child will depend on the level of immune defenses. See also section 2 “Warnings and precautions”

• you or your child is allergic to any of the ingredients of this vaccine (listed in section 6). Signs of an allergic reaction may include itchy rash, difficulty breathing, and swelling of the face or tongue

• you or your child has previously had an allergic reaction to neomycin (an antibiotic). Known contact dermatitis (skin reaction after direct skin contact with allergens such as neomycin) should not be a reason to avoid vaccination, but speak to your doctor first

• you or your child has previously had an allergic reaction to any varicella vaccine

• you are pregnant. In addition, pregnancy must be avoided during the first month following vaccination.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before you or your child receive Varilrix

• if you or your child has a severe infection with high fever. Vaccination may need to be postponed until recovery. A minor infection, such as a cold, does not require postponement of vaccination, but speak to your doctor first
• if you or your child has a weakened immune system (for example due to HIV infection and/or treatment). You or your child should be closely monitored as the response to the vaccine may not be sufficient to ensure protection against the disease (see section 2 “Varilrix must not be given if”)
• if you or your child has bleeding problems or bruises easily.

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, Varilrix may not provide complete protection against varicella infection.
However, people who have been vaccinated and still contract varicella usually develop a much milder form of the disease compared to unvaccinated individuals.
In rare cases, the weakened virus may be transmitted from a vaccinated person to an unvaccinated person. This has occurred when the vaccinated person developed spots or blisters. Healthy individuals who contract the disease in this way generally develop a mild rash which is not harmful.
For up to 6 weeks after vaccination, you or your child should avoid, if possible, close contact with the following individuals:

• individuals with weakened immune systems;
• 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.

Other medicines and Varilrix
Tell your doctor or pharmacist if you or your child is taking, has recently taken, or might take any other medicines.
Inform your doctor if you or your child needs to undergo a skin test for possible tuberculosis. If this test is performed within 6 weeks after administration of Varilrix, the result may not be reliable.
Vaccination with Varilrix should be postponed for at least 3 months if you or your child has recently received a blood transfusion or human immunoglobulins.
The use of aspirin or other salicylates (substances found in some medicines used to reduce fever or relieve pain) should be avoided for 6 weeks after vaccination with Varilrix, as this could cause a serious illness called Reye's syndrome, which can affect all organs of the body.
Varilrix may be administered simultaneously with other vaccines. Each vaccine should be administered at a different injection site.

Pregnancy and breastfeeding
Varilrix must not be given to pregnant women.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before receiving the vaccine.
In addition, it is important to avoid pregnancy during the first month following vaccination. During this period, you must use an effective contraceptive method to prevent pregnancy.
Inform your doctor if you are breastfeeding or intend to breastfeed. Your doctor will decide whether to administer Varilrix to you.

Driving and using machines
Varilrix does not affect or affects negligibly the ability to drive vehicles and use machines.
However, some of the side effects mentioned in section 4 "Possible side effects" may temporarily affect the ability to drive or use machines.

Varilrix contains sorbitol and phenylalanine
This vaccine contains 6 mg of sorbitol per dose.
This vaccine contains 331 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.

3. How Varilrix is given

Varilrix is administered as a subcutaneous or intramuscular injection into the upper arm or the outer side of the thigh.
Individuals aged 12 months and older will receive 2 doses of Varilrix, with an interval of at least 6 weeks between doses. The interval between the first and second dose must not be less than 4 weeks.
In certain circumstances, the first dose of Varilrix may be given to children from 9 to 11 months of age. In these cases, two doses are required, to be administered at least 3 months apart.
Individuals at risk of severe varicella, such as those receiving cancer treatment, may receive additional doses. The interval between doses must not be less than 4 weeks.
The appropriate timing and number of doses will be determined by the doctor based on official recommendations.
If you or your child have been given more Varilrix than you should have
Overdose is highly unlikely because the vaccine comes in a single-dose vial and is administered by a doctor or nurse. A few cases of accidental administration have been reported, and abnormal drowsiness and seizures were reported in only some of these cases.
If you think you or your child have missed a dose of Varilrix
Contact your doctor, who will decide whether a dose is needed and when it should be given.

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 (may affect more than 1 in 10 people)
  • pain and redness at the injection site.
• Common (may affect up to 1 in 10 people)
  • rash (spots and/or blisters)
  • swelling at the injection site*
  • fever of 38°C or higher (measured rectally).
• Uncommon (may affect up to 1 in 100 people)
  • upper respiratory tract infection
  • sore throat and difficulty swallowing (pharyngitis)
  • swollen lymph glands
  • irritability
  • headache
  • drowsiness
  • cough
  • itchy, blocked or runny nose, sneezing (rhinitis)
  • nausea
  • vomiting
  • chickenpox-like rash
  • itching
  • joint pain
  • muscle pain
  • fever above 39.5°C (measured rectally)
  • fatigue (tiredness)
  • general feeling of being unwell.
• Rare (may affect up to 1 in 1,000 people)
  • inflammation of the eyes (conjunctivitis)
  • stomach pain
  • diarrhoea
  • itchy and irregular skin rash (urticaria).

*Swelling at the injection site and fever have been reported as very common in adolescents and adults. Swelling after the second dose has been reported as very common in children under 13 years of age.
During routine use of Varilrix, the following side effects have been reported occasionally:

• infection or inflammation of the brain (encephalitis) has been observed after vaccination with live attenuated varicella vaccines. In some cases, this condition has been fatal, particularly in people with a weakened immune system (as stated in section 2, Varilrix must not be used in patients with a weakened immune system). Seek immediate medical advice if you or your child develops 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 a live attenuated varicella vaccine.
• infection or inflammation of the spinal cord and peripheral nerves, resulting in temporary difficulties with walking (instability) and/or temporary loss of control of body movements
• stroke (brain damage caused by interruption of blood supply)
• seizures or convulsions
• shingles (herpes zoster)
• increased tendency to bleed or bruise easily due to a decrease in a type of blood cell called platelets
• allergic reactions. Skin rashes which may be itchy or blistering, 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. However, if you or your child experiences any of these symptoms, you must contact a doctor urgently
• inflammation, narrowing or blockage of blood vessels. This may include unusual bleeding or bruising under the skin (Schönlein-Henoch purpura) or fever lasting more than five days, associated with a rash on the trunk sometimes followed by peeling of the skin on the hands and fingers, red eyes, lips, throat and tongue (Kawasaki disease)
• erythema multiforme (symptoms are red spots, often itchy, resembling measles rash, starting on the limbs and sometimes on the face and rest of the body).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via
adverse-reactions.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Varilrix

Keep this medicine 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 that month.
Store and transport in a refrigerator (2°C – 8°C).
Keep in the original packaging to protect from light.
After reconstitution, the vaccine should be administered immediately. If this is not possible, the reconstituted vaccine may be kept for up to 90 minutes at room temperature (25°C) and up to 8 hours in the refrigerator (2°C – 8°C). If not used within these time limits and storage conditions, the reconstituted vaccine must be discarded.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Varilrix contains

• The active substance is live attenuated varicella virus (Oka strain, produced in human diploid cells MRC-5). Each 0.5 mL dose of reconstituted vaccine contains not less than 10 PFU (Plaque Forming Units) of varicella virus.
• The other components are:
  Powder: amino acids (containing phenylalanine), anhydrous lactose, sorbitol (E 420), mannitol (E 421).
  Solvent: water for injections.

Description of the appearance of Varilrix and package contents
Varilrix 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 needles separately included in the following pack sizes:

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

Varilrix is provided as a whitish to yellowish or pinkish powder and a clear, colourless solvent (water for injections) for reconstitution of the vaccine.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: GlaxoSmithKline Biologicals s.a. - Rue de l’Institut 89 - Rixensart (Belgium)
Local Representative: GlaxoSmithKline S.p.A. – Viale dell’Agricoltura, 7 - 37135 Verona - Italy
Manufacturer: GlaxoSmithKline Biologicals s.a. - Rue de l’Institut 89 - Rixensart (Belgium)

This medicinal product is authorised in the European Economic Area Member States under the following names:

Other sources of information
More detailed information on this vaccine is available on the website of the Italian Medicines Agency (aifa.gov.it).

The following information is intended exclusively for physicians or healthcare professionals.
As with all injectable vaccines, in the event of a rare anaphylactic reaction following administration of the vaccine, appropriate medical supervision and treatment must always be immediately available.
Allow alcohol and other disinfectants to evaporate completely from the skin before injecting the vaccine, as these agents may inactivate the virus.
Do not inject intravenously or intradermally.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
The solvent and the reconstituted vaccine must be inspected visually before administration.
The colour of the reconstituted vaccine may vary from light peach to fuchsia pink due to minor pH variations. The reconstituted vaccine may contain translucent particles related to the product. This is normal and does not affect the pharmaceutical characteristics of the vaccine.
Do not administer if the vaccine has any other colour or contains other particles.
The vaccine must be reconstituted by adding the entire contents of the prefilled syringe of solvent provided to the vial containing the powder.
To insert the needle into the syringe, carefully read the instructions shown in Figure 1 and 2. However, the syringe supplied with Varilrix may be slightly different (without threading) compared to the syringe illustrated.
In this case, the needle must be attached without screwing.
Needle

Syringe

Figure 1 Figure 2
Always hold the syringe by its body, 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 deform and leak.
If the LLA detaches during syringe assembly, a new dose of vaccine (new syringe and new vial) must be used.

1. Unscrew the syringe cap by turning it counterclockwise (as shown in Figure 1).

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

2. Attach the needle to the syringe by gently connecting the needle hub to the Luer Lock adapter and rotate one-quarter turn clockwise until it locks (as shown in Figure 2).
3. Remove the needle protective cap, which may be difficult.
4. Add the solvent to the powder. The mixture must be shaken well until the powder is completely dissolved in the solvent.
5. Aspirate the entire contents of the vial.
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 that the vaccine be administered as soon as possible. However, it has been shown that the reconstituted vaccine can be stored for up to 90 minutes at room temperature (25°C) and up to 8 hours in the refrigerator (2°C – 8°C). If not used within these time limits and storage conditions, the reconstituted vaccine must be discarded.
Any unused medicine and waste material derived from this medicine must be disposed of in accordance with local regulations.