Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

Tetravalent dengue vaccine (live, attenuated)

This medicinal product is subject to additional monitoring, which will allow for faster detection of new safety information. You can help by reporting any adverse reactions you may experience. Information on how to report adverse reactions is included at the end of section 4.

Read all of this leaflet carefully before you or your child are vaccinated, as 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, pharmacist, or nurse.
• This medicine has been prescribed only for you or your child and must not be given to other people.
• If you or your child experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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 administered
4. Possible side effects
5. How to store Qdenga
6. Contents of the pack and other information

1. What Qdenga is and what it is used for

Qdenga is a vaccine. It is used to help protect you or your child against dengue. Dengue is a disease caused by serotypes 1, 2, 3 and 4 of the dengue virus. Qdenga contains weakened forms of these 4 dengue virus serotypes, so it cannot cause the disease.

Qdenga is given to adults, adolescents and children (from 4 years of age).

Qdenga should be used in accordance with official recommendations.

How the vaccine works

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

What is dengue

Dengue is caused by a virus.

• The virus is spread through mosquitoes (Aedes mosquitoes).
• If a mosquito bites a person with dengue, it can transmit the virus to other people it bites later.

Dengue is not passed directly from person to person.

Signs of dengue include fever, headache, pain behind the eyes, muscle and joint pain, sensitivity or discomfort (nausea and vomiting), swollen lymph nodes or skin rash. Dengue symptoms usually last from 2 to 7 days. You may also be infected with the dengue virus but not show any signs of illness.

Sometimes, dengue can be severe enough to require hospitalisation for you or your child, and in rare cases, it can cause death. Severe dengue may cause high fever and any of the following symptoms: severe abdominal pain, persistent nausea (vomiting), rapid breathing, severe bleeding, bleeding in the stomach, bleeding from the gums, feeling tired, restlessness, coma, seizures (convulsions) and organ dysfunction.

2. What you need to know before you or your child receive Qdenga

To ensure that Qdenga is suitable for you or your child, it is important that you inform your doctor, pharmacist, or nurse if any of the following apply to you or your child. If there is anything you do not understand, ask your doctor, pharmacist, or nurse to explain it.

Do not use Qdenga if you or your child

• are allergic to the active substances or to any of the other components of Qdenga (listed in section 6).
• have had an allergic reaction after previously receiving Qdenga. Signs of an allergic reaction may include an itchy rash, difficulty breathing, and swelling of the face and tongue.
• have a weakened immune system (the body's natural defenses). 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 breastfeeding.

Do not use Qdenga if any of the above apply.

Warnings and precautions

• Inform your doctor, pharmacist, or nurse before receiving Qdenga if you or your child:
• have an infection with fever. Vaccination may need to be postponed until recovery.
• have ever had health problems after receiving a vaccine. Your doctor will carefully consider the risks and benefits of vaccination.
• have ever fainted after an injection. Dizziness, fainting, and sometimes falls (especially in young people) may occur after or even before any needle injection.

Important information about protection provided

As with any vaccine, Qdenga may not protect all individuals who receive it, and protection may decrease over time. You may still contract dengue from mosquito bites, including severe dengue disease. You must continue to protect yourself or your child from mosquito bites even after vaccination with Qdenga.

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

Other protective measures

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

Young children

Children under 4 years of age must not receive Qdenga.

Other medicines and Qdenga

Qdenga may be administered at the same visit as the hepatitis A vaccine, yellow fever vaccine, or human papillomavirus (HPV) vaccine, provided each is given at a different injection site (a different part of the body, usually the other arm).

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

Specifically, inform your doctor or pharmacist if you or your child are taking any of the following:

• Medicines that affect the body's natural defenses (immune system), such as high-dose corticosteroids or chemotherapy. In this case, your doctor will not use Qdenga until 4 weeks after stopping treatment. This is because Qdenga may not work as well.
• Medicines called “immunoglobulins” or blood-derived products containing immunoglobulins, such as blood or plasma. In this case, your doctor will not use Qdenga until at least 6 weeks, and preferably 3 months, after stopping treatment. This is because Qdenga may not work as well.

Pregnancy and breastfeeding

Do not use Qdenga if you or your daughter are pregnant or breastfeeding. If you or your daughter:

• are of childbearing age, you should take necessary precautions to avoid pregnancy for one month after vaccination with Qdenga.
• think you might be pregnant or are planning to have a baby, consult your doctor, pharmacist, or nurse before using Qdenga.

Driving and use of machines

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

Qdenga contains sodium and potassium

This medicine contains less than 1 mmol of sodium (23 mg) per 0.5 ml dose; this is essentially “sodium-free”.

This medicine contains less than 1 mmol (39 mg) of potassium per 0.5 ml dose; this is essentially “potassium-free”.

3. How Qdenga is administered

Qdenga is administered by a doctor or nurse as an injection under the skin (subcutaneous injection) in the upper arm. It must not be injected into a blood vessel.

You or your child will receive 2 injections.

The second injection is given 3 months after the first one.

There is no data available for adults over 60 years of age. Please consult your doctor to determine whether Qdenga is beneficial for you.

Qdenga should be used in accordance with official recommendations.

Instructions for vaccine preparation for doctors and healthcare professionals are provided at the end of the leaflet.

If you or your child miss a Qdenga injection

• If you or your child miss a scheduled injection, the doctor will decide when the missed dose should be administered. It is important that you or your child follow the instructions provided by your doctor, pharmacist, or nurse regarding the follow-up injection.
• If you forget or are unable to attend the scheduled appointment, please consult your doctor, pharmacist, or nurse for advice.

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

4. Possible adverse effects

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

Severe allergic (anaphylactic) reaction

If any of the following symptoms occur after leaving the place where you or your child received the injection, contact a doctor immediately:

• difficulty breathing
• blue tongue or lips
• rash
• swelling of the face or throat
• low blood pressure causing dizziness or fainting
• sudden and severe feeling of discomfort or restlessness, accompanied by a drop in blood pressure causing dizziness and loss of consciousness, along with rapid heartbeat associated with difficulty breathing

These signs or symptoms (anaphylactic reactions) usually occur shortly after the injection is administered and while you or your child are still at the medical center or doctor's office. They may also very rarely occur after receiving any vaccine.

The following adverse effects have been reported during studies in children, adolescents, and adults.

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

• pain at the injection site
• headache
• muscle pain
• redness at the injection site
• general malaise
• weakness
• nose or throat infections
• fever

Common (may affect up to 1 in 10 people):

• swelling at the injection site
• pain or inflammation of the nose or throat
• bruising at the injection site
• itching at the injection site
• inflammation of the throat and tonsils
• joint pain
• flu-like illness

Uncommon (may affect up to 1 in 100 people):

• diarrhea
• nausea
• stomach pain
• vomiting
• bleeding at the injection site
• dizziness
• skin itching
• skin rash, including rashes with spots or itchy skin
• hives
• fatigue
• change in skin color at the injection site
• inflammation of the respiratory tract
• runny nose

Very rare (may affect up to 1 in 10,000 people):

• rapid swelling under the skin in areas such as the face, throat, arms, and legs

Frequency not known (cannot be estimated from available data):

• sudden and severe allergic (anaphylactic) reaction, with difficulty breathing, swelling, fainting, rapid heartbeat, sweating, and loss of consciousness

Other adverse effects in children aged 4 to 5 years:

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

• decreased appetite
• drowsiness
• irritability

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, 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 Qdenga

Keep Qdenga out of the sight and reach of children.

Do not use Qdenga after the expiry date stated on the carton after EXP. The expiry date is the last day of the month indicated.

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

Do not freeze.

Keep the vaccine in its outer packaging.

After mixing (reconstitution) with the solvent supplied, Qdenga must be used immediately. If not used immediately, Qdenga must be used within 2 hours.

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

6. Contents of the pack and other information

What Qdenga contains

• 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 using recombinant DNA technology. Genes encoding serotype-specific surface proteins inserted into a dengue type 2 backbone. This product contains genetically modified organisms (GMOs).

Produced in Vero cells using recombinant DNA technology.

** PFU = plaque-forming units

• The other ingredients are: a ,a -trehalose dihydrate, poloxamer 407, human serum albumin, potassium dihydrogen phosphate, sodium dihydrogen phosphate, potassium chloride, sodium chloride, water for injections.

What Qdenga looks like and contents of the pack

Qdenga is a powder and solvent for injectable solution. Qdenga is supplied as a powder in a single-dose vial and solvent in a pre-filled syringe with 2 needles supplied separately or without needle.

The powder and solvent must be mixed before use.

Qdenga powder and solvent for injectable solution in pre-filled syringe is available in pack sizes of 1 or 5.

Only certain pack sizes may be marketed.

The powder is a white to off-white compact pellet for suspension.

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

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

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Takeda GmbH

Byk-Gulden-Str. 2

78467 Konstanz

Germany

Manufacturer

Takeda GmbH

Production site Singen

Robert-Bosch-Str. 8

78224 Singen

Germany

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

Date of the most recent review of this leaflet: October 2024.

Other sources of information

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.

This information is intended for healthcare professionals only:

• Qdenga must not be mixed with other medicines or vaccines in the same syringe.
• Qdenga must not be administered by intravenous injection under any circumstances.
• Vaccination should be given by subcutaneous injection, preferably in the upper arm at the deltoid region. Qdenga must not be administered by intramuscular injection.
• Syncope (fainting) may occur after, or even before, any vaccination as a psychogenic response to needle injection. Procedures should be in place to prevent injury from falls and to manage syncopal reactions.

Instructions for reconstituting the vaccine with the solvent provided in the pre-filled syringe:

Qdenga is a two-component vaccine consisting of a vial containing the lyophilized vaccine and solvent supplied in a pre-filled syringe. The lyophilized vaccine must be reconstituted with the solvent prior to administration.

Qdenga must not be mixed with other vaccines in the same syringe.

To reconstitute Qdenga, use only the solvent (0.22% sodium chloride solution) in the pre-filled syringe supplied with the vaccine, as it contains no preservatives or other antiviral substances. Contact with preservatives, antiseptics, detergents, and other antiviral substances should be avoided, as they may inactivate the vaccine.

Remove the vaccine vial and the solvent in the pre-filled syringe from the refrigerator and allow them to reach room temperature for approximately 15 minutes.

After reconstitution, the resulting solution should be clear, colorless to pale yellow, and essentially free from foreign particles. Discard the vaccine if particles or changes in color are observed.

Qdenga must be administered immediately after reconstitution. Its physicochemical stability has been demonstrated for up to 2 hours at room temperature (up to 32.5°C) following reconstitution of the vaccine vial. After this period, the vaccine must be discarded. Do not return it to the refrigerator. From a microbiological standpoint, Qdenga should be used immediately. If not used immediately, the storage times and conditions shall be the responsibility of the user.

Disposal of unused medication and all disposable materials must be carried out in accordance with local regulations.