Twinrix Pediatric, injectable suspension in pre-filled syringe

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Twinrix Pediatric, Injectable suspension in pre-filled syringe

Vaccine (HAB) (adsorbed) against hepatitis A (inactivated) and against hepatitis B (recombinant DNA)

Read the entire leaflet carefully before you/your child is vaccinated, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, consult your doctor or pharmacist.

• This vaccine has been prescribed for you/your child only, and must not be passed on to others.

• If you/your child experience any adverse reactions, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

This leaflet is written assuming that the person receiving the vaccine is the one reading it. However, the vaccine may be administered to children and adolescents, so you may be reading it on behalf of your child.

Leaflet contents

1. What Twinrix Pediatric is and what it is used for
2. What you need to know before receiving Twinrix Pediatric
3. How Twinrix Pediatric is administered
4. Possible adverse effects
5. How to store Twinrix Pediatric
6. Contents of the pack and other information

1. What Twinrix Pediatric is and what it is used for

Twinrix Pediatric is a vaccine used in children and adolescents from 1 year up to and including 15 years of age to prevent two diseases: hepatitis A and hepatitis B. The vaccine works by causing the body to produce its own protection (antibodies) against these diseases.

• Hepatitis A: Hepatitis A is an infectious disease that can affect the liver. This disease is caused by the hepatitis A virus. Hepatitis A can be spread from person to person through food and drinks, or by swimming in water contaminated with sewage. Symptoms of hepatitis A begin 3 to 6 weeks after exposure to the virus. These include nausea (feeling unwell), fever, and aches. After several days, the whites of the eyes and the skin may turn yellow (jaundice). The severity and type of symptoms may vary. Young children may not develop jaundice. Most people recover completely, but the illness is generally severe enough to prevent patients from working or carrying out normal activities for about a month.

• Hepatitis B: Hepatitis B is caused by the hepatitis B virus. It causes inflammation of the liver. The virus is present in body fluids such as blood, semen, vaginal secretions, or saliva (sputum) of infected individuals.

Vaccination is the best way to protect against these diseases. None of the components of the vaccine are infectious.

2. What you need to know before receiving Twinrix Pediatric

Twinrix Pediatric must not be given if:

• you are allergic to:

• the active substances or to any of the other components of this vaccine (listed in section 6)

• neomycin.

Signs of an allergic reaction may include itchy skin rash, difficulty breathing, and swelling of the face or tongue.

• you previously had an allergic reaction to any hepatitis A or hepatitis B vaccine.

• you have a severe infection with fever (over 38°C). A minor illness, such as a cold, should not be a problem for vaccination, but tell your doctor first.

Warnings and precautions

Talk to your doctor or pharmacist before receiving Twinrix Pediatric if:

• you have experienced any health problems after previous vaccination.
• you have a weakened immune system due to illness or medical treatment.
• you have a bleeding disorder or bruise easily.

Fainting (syncope) may occur before or after any injection (especially in adolescents); therefore, inform your doctor or nurse if you have previously fainted after receiving an injection.

Other medicines and Twinrix Pediatric

Twinrix Pediatric can be administered at the same medical visit as the human papillomavirus (HPV) vaccine, provided that the injections are given at different sites (e.g., the other arm).

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before receiving this vaccine.

It is unknown whether Twinrix Pediatric passes into breast milk; however, the vaccine is not expected to cause problems in breastfed infants.

Twinrix Pediatric contains neomycin and sodium

Inform your doctor if you have had an allergic reaction to neomycin (an antibiotic).

This vaccine contains less than 1 mmol of sodium (23 mg) per dose; essentially "sodium-free".

3. How to administer Twinrix Pediatric

You will receive a total of three injections over a 6-month period. Each injection will be given during a separate visit. The first dose will be administered on the scheduled date. The other two doses will be given one month and six months after the first dose, respectively.

• First dose: on the scheduled date
• Second dose: 1 month later
• Third dose: 6 months after the first dose

Your doctor will inform you whether additional doses or future booster doses are required.

If you miss one of the scheduled injections, consult your doctor to arrange another visit.

Make sure you complete the full three-dose vaccination course. Otherwise, you may not be fully protected against the diseases.

The doctor will administer the Twinrix Pediatric injection into the upper arm muscle or into the thigh muscle of your child.

This vaccine must never be injected into a vein.

If you have any further questions about the use of this vaccine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this vaccine may cause adverse effects, although not everyone experiences them.

The adverse effects that may occur are listed below:

Adverse effects that occurred during clinical trials or during routine use of the vaccine, or with individual hepatitis A and hepatitis B vaccines, or with the adult formulation of Twinrix.

Very common (may occur in more than 1 in every 10 doses of vaccine): pain and redness at the injection site.

Common (may occur in up to 1 in every 10 doses of vaccine): drowsiness, headache, nausea, loss of appetite, swelling or bruising at the injection site, malaise, fatigue, fever equal to or greater than 37.5°C, irritability.

Uncommon (may occur in up to 1 in every 100 doses of vaccine): diarrhea, vomiting, stomach pain, skin rash, muscle aches, upper respiratory tract infection.

Rare (may occur in up to 1 in every 1,000 doses of vaccine): swelling of the glands in the neck, armpit, or groin (lymphadenopathy), dizziness, loss of skin sensitivity to pain or touch (hypoesthesia), tingling sensation (paresthesia), hives, itching, joint pain, low blood pressure, flu-like symptoms such as fever, sore throat, runny nose, cough, and chills.

Very rare (may occur in up to 1 in every 10,000 doses of vaccine): reduction in platelets, increasing the risk of bleeding or bruising (thrombocytopenia), purple or reddish-brown spots visible through the skin (thrombocytopenic purpura), inflammation or infection of the brain (encephalitis), degenerative brain disease (encephalopathy), nerve inflammation (neuritis), numbness or weakness in arms and legs (neuropathy), paralysis, seizures, swelling of the face, mouth, or throat (angioneurotic edema), purple or reddish-purple skin swelling (lichen planus), severe skin rashes (erythema multiforme), joint inflammation, muscle weakness, infection around the brain that may cause severe headache with neck stiffness and light sensitivity (meningitis), inflammation of certain blood vessels (vasculitis), abnormal results of liver laboratory tests, multiple sclerosis, inflammation of the spinal cord (myelitis), drooping eyelids and sinking of the muscles on one side of the face (facial paralysis), temporary nerve inflammation causing pain, weakness, and paralysis of limbs, often progressing to chest and face (Guillain-Barré syndrome), eye nerve disease (optic neuritis), immediate pain at the injection site, stinging, and burning sensation.

Serious allergic reactions (anaphylaxis, anaphylactoid reactions, and serum sickness-like reactions) may also occur very rarely (up to 1 in every 10,000 doses of vaccine). Some signs of serious allergic reactions may include itchy or blistering skin rashes, 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 any of these symptoms appear, seek medical attention immediately.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Twinrix Pediatric

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the month indicated.

Store in a refrigerator (between 2°C and 8°C).

Keep in the original packaging to protect from light.

Do not freeze. Freezing destroys the vaccine.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Twinrix Pediatric

• The active substances are:

Hepatitis A virus (inactivated) 1,2 360 ELISA Units

Hepatitis B surface antigen 3,4 10 micrograms

1Produced on human diploid cells (MRC-5)

2Adsorbed on hydrated aluminium hydroxide 0.025 milligrams Al3+

3Produced by recombinant DNA technology in yeast cells (Saccharomyces cerevisiae)

4Adsorbed on aluminium phosphate 0.2 milligrams Al3+

• The other components of Twinrix Pediatric are: sodium chloride, water for injections.

Appearance of Twinrix Pediatric and contents of the pack

Injectable suspension in a pre-filled syringe.

Twinrix Pediatric is a white, slightly milky liquid.

Twinrix Pediatric is available in 1-dose pre-filled syringes, with or without separate needles, in pack sizes of 1, 10 and 50.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

GlaxoSmithKline Biologicals s.a.

Rue de l’Institut 89

B-1330 Rixensart

Belgium

More information about this medicinal product is available upon request by contacting the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

Other sources of information

Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu, and on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).

This information is intended for healthcare professionals only:

During storage, a fine white deposit may be observed with a translucent, colourless layer above it.

The vaccine must be resuspended before use. Once resuspended, the vaccine will have a white, cloudy, and uniform appearance.

Resuspension of the vaccine to obtain a white, cloudy, and uniform suspension

The vaccine should be resuspended by following the steps outlined below.

1. Hold the syringe upright with the hand closed.
2. Shake the syringe by inverting it upside down and then upright again.
3. Repeat this action vigorously for at least 15 seconds.
4. Inspect the vaccine again:
   1. If the vaccine appears as a white, cloudy, and uniform suspension, it is ready for use (it should not appear translucent).
   2. If the vaccine still does not appear as a white, cloudy, and uniform suspension, continue inverting it upside down and then upright again for at least another 15 seconds, then inspect again.

Before administration, the vaccine should be inspected visually for the presence of foreign particles and/or abnormal physical appearance. If either of these conditions is observed, do not administer the vaccine.

Instructions for the pre-filled syringe after resuspension

Waste disposal

Disposal of unused medicine and of all materials that have come into contact with it must be carried out in accordance with local regulations.