Qdenga powder and solvent for solution for injection in pre-filled syringe

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you or your child only. Do not pass it on to others.
• If you or your child get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

Qdenga stimulates the body’s natural defences (immune system). This helps to protect against the viruses that cause dengue if the body is exposed to these viruses in the future.

Dengue is caused by a virus.

• The virus is spread by mosquitos (Aedes mosquitos).
• If a mosquito bites someone with dengue it can pass the virus on to the next people it bites.

Dengue is not passed directly from person to person.

Signs of dengue include fever, headache, pain behind the eyes, muscle and joint pain, feeling or being sick (nausea and vomiting), swollen glands or skin rash. Signs of dengue usually last for 2 to 7 days. You can also be infected with dengue virus but show no signs of illness.

Occasionally dengue can be severe enough for you or your child to have to go to hospital and in rare cases it can cause death. Severe dengue can give you a high fever and any of the following: severe abdominal (belly) pain, persistent sickness (vomiting), rapid breathing, severe bleeding, bleeding in the stomach, bleeding gums, feeling tired, feeling restless, coma, having fits (seizures) and organ failure.

• are allergic to the active substances or any of the other ingredients of Qdenga (listed in section 6).
• had an allergic reaction after receiving Qdenga before. Signs of an allergic reaction may include an itchy rash, shortness of breath and swelling of the face and tongue.
• have a weak immune system (the body's natural defences). This may be due to a genetic defect or HIV infection.
• are taking a medicine that affects the immune system (such as high-dose corticosteroids or chemotherapy). Your doctor will not use Qdenga until 4 weeks after you stop treatment with this medicine.
• are pregnant or breast-feeding.

Do not use Qdenga if any of the above applies.

Tell your doctor, pharmacist or nurse before receiving Qdenga if you or your child:

• have an infection with fever. It might be necessary to postpone the vaccination until recovery.
• have ever had any health problems when given a vaccine. Your doctor will carefully consider the risks and benefits of vaccination.
• have ever fainted from an injection. Dizziness, fainting, and sometimes falling, can happen (mostly in young people) following, or even before, any injection with a needle.

As with any vaccine, Qdenga may not protect everybody who receives it and protection might decrease over time. You may still get dengue fever from mosquito bites, including severe dengue illness. You must continue to protect yourself or your child against mosquito bites even after vaccination with Qdenga.

After vaccination, you should consult a doctor if you or your child believe you might have a dengue infection, and develop any of the following symptoms: high fever, severe abdominal pain, persistent vomiting, rapid breathing, bleeding gums, tiredness, restlessness and blood in vomit.

You should take precautions to prevent mosquito bites. This includes using insect repellents, wearing protective clothing, and using mosquito nets.

Children less than 4 years of age must not receive Qdenga.

Qdenga can be given with a hepatitis A vaccine, yellow fever vaccine or human papillomavirus vaccine at a separate injection site (another part of your body, usually the other arm) during the same visit.

Tell your doctor or pharmacist if you or your child are using, have recently used, or might use any other vaccines or medicines.

In particular, tell your doctor or pharmacist if you or your child are taking any of the following:

• Medicines that affect your body’s natural defences (immune system) such as high-dose corticosteroids or chemotherapy. In this case, your doctor will not use Qdenga until 4 weeks after you stop treatment. This is because Qdenga might not work as well.
• Medicines called “immunoglobulins” or blood products containing immunoglobulins, such as blood or plasma. In this case, your doctor will not use Qdenga until 6 weeks, and preferably not for 3 months after you stop treatment. This is because Qdenga might not work as well.

Do not use Qdenga if you or your daughter are pregnant or breast-feeding. If you or your daughter:

• are of child-bearing age, you must take necessary precautions to avoid pregnancy for one month after Qdenga vaccination.
• think you or your daughter may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before using Qdenga.

Qdenga has a minor influence on the ability to drive and use machines in the first days following vaccination.

Qdenga contains less than 1 mmol sodium (23 mg) per 0.5 mL dose, i.e. essentially ‘sodium-free’. Qdenga contains less than 1 mmol potassium (39 mg) per 0.5 mL dose, i.e. essentially ‘potassium-free’.

• If you or your child miss a scheduled injection, your doctor will decide when to give the missed injection. It is important that you or your child follow the instructions of your doctor, pharmacist or nurse about the follow-up injection.
• If you forget or are not able to go back at the scheduled time, ask your doctor, pharmacist or nurse for advice.

Very common (may affect more than 1 in 10 people):

• decreased appetite
• feeling sleepy
• irritability

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

• After reconstitution, one dose (0.5 mL) contains:
  Dengue virus serotype 1 (live, attenuated)*: ≥ 3.3 log10 PFU**/dose
  Dengue virus serotype 2 (live, attenuated)#: ≥ 2.7 log10 PFU**/dose
  Dengue virus serotype 3 (live, attenuated)*: ≥ 4.0 log10 PFU**/dose
  Dengue virus serotype 4 (live, attenuated)*: ≥ 4.5 log10 PFU**/dose
  *Produced in Vero cells by recombinant DNA technology. Genes of serotype-specific surface proteins engineered into dengue type 2 backbone. This product contains genetically modified organisms (GMOs).
  #Produced in Vero cells by recombinant DNA technology.
  **PFU = Plaque-forming units
• The other ingredients are: α,α-Trehalose dihydrate, Poloxamer 407, human serum albumin, potassium dihydrogen phosphate, disodium hydrogen phosphate, potassium chloride, sodium chloride, water for injections.

Qdenga is a powder and solvent for solution for injection. Qdenga is provided as a powder in a single-dose vial and a solvent in pre-filled syringe with 2 separate needles or with no needle.

The powder and the solvent must be mixed together before use.

Qdenga powder and solvent for solution for injection in pre-filled syringe is available in packs of 1 or 5.

Not all pack sizes might be marketed.

The powder is a white to off-white coloured compact cake.

The solvent (0.22% sodium chloride solution) is a clear, colourless liquid.

After reconstitution, Qdenga is a clear, colourless to pale yellow solution, essentially free of foreign particulates.

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