Package Insert: Information for the User

Qdenga Powder and Diluent for Pre-filled Injectable Solution

Tetravalent Live, Attenuated Dengue Vaccine

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. You can help us by reporting any side effects you experience. The final part of section 4 includes information on how to report these side effects.

Read this package insert carefully before you or your child is vaccinated, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.
• This medicinal product has been prescribed to you or your child only, and should not be given to others.
• If you or your child experience side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this package insert. See section 4.

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

Qdenga is administered to adults, young people, 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 defenses (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 transmitted through mosquitoes (Aedes mosquitoes).
• If a mosquito bites a person with dengue, it can transmit the virus to the next people it bites.

Dengue is not transmitted directly from person to person.

The symptoms of dengue include fever, headache, pain behind the eyes, muscle and joint pain, sensitivity or discomfort (nausea and vomiting), inflammation of the lymph nodes or skin rash. Dengue symptoms usually last from 2 to 7 days. You can also be infected with the dengue virus without showing symptoms of illness.

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

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

Do not use Qdenga if you or your child

• are allergic to the active ingredients or to any of the other components of Qdenga (listed in section 6).
• have had an allergic reaction after receiving Qdenga previously. Signs of an allergic reaction may include a prickling rash, difficulty breathing, and inflammation of the face and tongue.
• have a weakened immune system (the body's natural defenses). This may be due to a genetic defect or an HIV infection.
• are taking a medicine that affects the immune system (such as high doses of corticosteroids or chemotherapy). Your doctor will not use Qdenga until 4 weeks after you have stopped treatment with this medicine.
• are pregnant or breastfeeding.

Do not use Qdenga if any of the above cases apply.

Warnings and precautions

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

Important information about the protection provided

Like any vaccine, Qdenga may not protect all those who receive it, and the protection may decrease over time. You may still contract dengue fever from mosquito bites, including severe dengue fever. You should 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 believe you may have dengue fever and experience any of the following symptoms: high fever, intense abdominal pain, persistent vomiting, rapid breathing, bleeding gums, fatigue, restlessness, and blood in the vomit.

Other protective measures

You should take precautions to avoid mosquito bites. This includes the use of insect repellents, protective clothing, and mosquito nets.

Children under 4 years old

Children under 4 years of age should not receive Qdenga.

Other medicines and Qdenga

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

Inform your doctor or pharmacist if you or your child are using, have used recently, or may need to use any other medicine or vaccine.

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

• Medicines that affect your body's natural defenses (immune system) such as high doses of 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 hemoderivatives that contain immunoglobulins, such as blood or plasma. In this case, your doctor will not use Qdenga until 6 weeks have passed 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 a month after vaccination with Qdenga.
• believe you may be pregnant or are planning to have a baby, ask your doctor, pharmacist, or nurse before using Qdenga.

Driving and operating machinery

Qdenga has a small effect on the ability to drive and operate machinery 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; it is essentially "sodium-free".

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

Qdenga is administered by a doctor or nurse as a subcutaneous injection in the upper arm. It should not be injected into a blood vessel.

You or your child will receive 2 injections.

The second injection is administered 3 months after the first.

There are no data available for adults over 60 years of age. Consult your doctor to see if Qdenga is beneficial for you.

Qdenga should be used in accordance with official recommendations.

The instructions for preparing the vaccine for doctors and healthcare professionals are listed at the end of the prospectus.

If you or your child miss a Qdenga injection

• If you or your child miss a scheduled injection, the doctor will decide when to administer the missed injection. It is essential that you or your child follow the instructions from your doctor, pharmacist, or nurse regarding the follow-up injection.
• If you forget or are unable to return at the scheduled time, ask your doctor, pharmacist, or nurse for advice.

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

Like all medicines, Qdenga can cause side effects, although not everyone will experience them.

The following side effects have occurred 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 feeling of discomfort
• weakness
• nasal or throat infections
• fever

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

• inflammation at the injection site
• pain or inflammation of the nose or throat
• hematomas at the injection site
• itching at the injection site
• inflammation of the throat and tonsils
• joint pain
• influenza-like illness

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

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

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

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

Other side effects in children aged 4 to 5 years:

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

• decreased appetite
• sensation of sleepiness
• irritability

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep Qdenga out of sight and reach of children.

Do not use Qdenga after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

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

Do not freeze.

Store the vaccine in the outer packaging.

After mixing (reconstitution) with the solvent provided, Qdenga must be used immediately. If not used immediately, Qdenga should be used within a period of 2 hours.

Medicines should not be thrown down the drains or in the trash. Ask your pharmacist how to dispose of the containers and medicines that you no longer need. In this way, you will help to protect the environment.

What Qdenga contains

• After reconstitution, a dose (0.5 ml) contains:

Dengue virus serotype 1 (live, attenuated)*: ≥ 3.3 log10 UFP**/dose

Dengue virus serotype 2 (live, attenuated)#: ≥ 2.7 log10 UFP**/dose

Dengue virus serotype 3 (live, attenuated)*: ≥ 4.0 log10 UFP**/dose

Dengue virus serotype 4 (live, attenuated)*: ≥ 4.5 log10 UFP**/dose

* Produced in Vero cells using recombinant DNA technology. Genes of specific surface proteins of each serotype, insertedin the skeleton of dengue type 2. This product contains genetically modified organisms (GMOs).

# Produced in Vero cells using recombinant DNA technology.

** UFP = 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 injection.

Appearance of Qdenga and contents of the pack

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

The powder and diluent must be mixed before use.

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

Only some pack sizes may be marketed.

The powder is compact for suspension of white to off-white color.

The diluent (0.22% sodium chloride solution) is a colorless and transparent liquid.

After reconstitution, Qdenga is a transparent, colorless to pale yellow solution, essentially free of foreign particles.

Marketing authorization holder and responsible person for manufacturing

Marketing authorization holder

Takeda GmbH

Byk-Gulden-Str. 2

78467 Konstanz

Germany

Responsible person for manufacturing

Takeda GmbH

Production site Singen

Robert-Bosch-Str. 8

78224 Singen

Germany

For more information about this medicinal product, please contact the local representative of the marketing authorization holder:

Last update of the summary of product characteristics: month YYYY.

Other sources of information

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

This information is intended for healthcare professionals only:

• Qdenga must not be mixed with other medicinal products or vaccines in the same syringe.
• Qdenga must not be administered as an intravascular injection under any circumstances.
• The vaccination must be performed by subcutaneous injection, preferably in the upper arm, in the deltoid region. Qdenga must not be administered as an intramuscular injection.
• Syncope (fainting) may occur after, or even before, any vaccination as a psychogenic response to the needle injection. Procedures should be established to prevent falls and manage syncopal reactions.

Instructions for reconstitution of the vaccine with the diluent presented in the pre-filled syringe:

Qdenga is a 2-component vaccine consisting of a vial containing the lyophilized vaccine and diluent supplied in the pre-filled syringe. The lyophilized vaccine must be reconstituted with the diluent before administration.

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

To reconstitute Qdenga, use only the diluent (0.22% sodium chloride solution) in the pre-filled syringe supplied with the vaccine, as it does not contain 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 vial of the lyophilized vaccine and the diluent from the refrigerator and leave them at room temperature for approximately 15 minutes.

After reconstitution, the resulting solution must be transparent, colorless to pale yellow, and essentially free of foreign particles. Discard the vaccine if particles or color changes are observed.

Qdenga must be administered immediately after reconstitution. Its physical and chemical stability has been demonstrated for a period of 2 hours at room temperature (up to 32.5°C) from the moment of reconstitution of the vial of the vaccine. Once this period has elapsed, the vaccine must be discarded. Do not return it to the refrigerator. From a microbiological point of view, Qdenga must be used immediately. If not used immediately, the storage times and conditions will be the responsibility of the user.

The disposal of unused medicinal product and all disposable materials will be carried out in accordance with local regulations.