Dengue tetravalent vaccine (live, attenuated).
After reconstitution, one dose (0.5 mL) contains 4.5-6.0 log10 CCID50* of each serotype of the CYD dengue virus** (1, 2, 3 and 4).
* CCID50: 50% Cell Culture Infectious Dose.
** Produced in serum-free Vero cells by recombinant DNA technology.
The powder is a white, homogenous, freeze-dried powder with possible retraction at the base, and may form a ring-shaped cake.
The solvent (0.4% sodium chloride solution) is a clear, colorless liquid.
After reconstitution with the solvent provided, Dengvaxia is a clear, colorless liquid with the possible presence of white to translucent particles.
Excipients/Inactive Ingredients: Essential amino acids including L-Phenylalanine, non-essential amino acids, L-Arginine hydrochloride, Sucrose, D-Trehalose dihydrate, D-Sorbitol, trometamol, urea, sodium chloride, water for injections.
Pharmacology: Pharmacodynamics: Mechanism of Action: Dengvaxia contains live attenuated viruses. Following administration, the viruses replicate locally and elicit neutralizing antibodies and cell-mediated immune responses against the four dengue virus serotypes.
No pharmacokinetic studies have been performed on Dengvaxia.
Dengvaxia is a vaccine used to help protect adult or child against dengue disease caused by dengue virus serotypes 1, 2, 3 and 4. Dengvaxia is given to adults, adolescents and children 9 through 45 years of age living in endemic areas (where dengue infections regularly occur).
Dengvaxia contains dengue virus serotypes 1, 2, 3 and 4 that have been weakened. Dengvaxia works by stimulating the body's natural defenses (immune system), which produces its own protection (antibodies) against the viruses that cause dengue disease.
Dengue is a viral infection transmitted to humans through the bite of an infected Aedes mosquito.
Dengue is not transmitted directly from person-to-person. Nevertheless the virus which replicates in an infected individual can be transmitted to other humans through mosquito bites for 4-5 days (maximum 12 days) after the first symptoms appear.
Dengue disease results in a wide range of symptoms including fever, headache, pain behind the eyes, muscle and joint pain, nausea, vomiting, swollen glands or skin rash. Symptoms usually last for 2-7 days. Dengue disease can also be asymptomatic.
However, occasionally dengue can be severe and potentially lead to hospitalization and in rare cases to death. Severe dengue is characterized by high fever and any of the following symptoms: severe abdominal pain, persistent vomiting, rapid breathing, severe bleeding, bleeding in stomach, bleeding gums, fatigue, restlessness, coma, seizure and organ failure.
Dengvaxia is given by the doctor or nurse as an injection underneath the skin (subcutaneous route) in the upper arm.
Adults or children will receive 3 injections of 0.5 mL each at 6-month intervals. The first injection will occur at the chosen or scheduled date; the second injection, 6 months after the first injection; and the third injection, 6 months after the second injection. Dengvaxia should be used according to the local vaccination schedule.
Reconstitution instructions intended for medical and healthcare professionals are included under Caution for Usage.
If the Patient Forget an Injection of Dengvaxia: If the patient miss a scheduled injection, the physician will decide when to give the missed injection.
It is important that the patient follow the instructions of the physician, pharmacist or nurse regarding return visits for the follow-up injection. If the patient forgets or is not able to go back to the physician, pharmacist or nurse at the scheduled time, ask him/her for advice.
If the patient has any further questions on the use of Dengvaxia, ask the physician, pharmacist or nurse.
No case of overdose have been reported in clinical studies with Dengvaxia.
Do not use Dengvaxia if the patient is allergic (hypersensitive) to the active substances or any of the other ingredients of Dengvaxia listed in Description (see Description); has developed an allergic reaction after prior administration of Dengvaxia. Signs of an allergic reaction may include an itchy rash, shortness of breath and swelling of the face and tongue; is suffering from a disease with mild to high fever or acute disease. In this case, the physician will postpone the administration of Dengvaxia until the patient has recovered; has a weakened immune system, for example due to a genetic defect, HIV infection or therapies that affect the immune system (for example, high-dose corticosteroids or chemotherapy); pregnant; breastfeeding.
Tell the physician, pharmacist or nurse before receiving Dengvaxia if the patient has never been infected by dengue virus before or if he/she don't know whether he/she has ever been infected by dengue virus. The physician will consider prescribing vaccination after having carefully considered the benefits and the risks of vaccination.
Dengvaxia is not recommended for individuals who have never been infected by dengue virus before vaccination because the patient may have an increased risk of a severe dengue illness that may lead to hospitalization if he/she is later bitten by a dengue-infected mosquito (see Precautions).
Tell the physician, pharmacist or nurse before receiving Dengvaxia if the patient: Has never been infected by dengue virus before or if the patient don't know whether he/she has ever been infected by dengue virus. Doctor will consider prescribing vaccination after having carefully considered the benefits and the risks of vaccination. Dengvaxia is not recommended for individuals who have never been infected by dengue virus before vaccination because he/she may have an increased risk of a more severe dengue illness that may lead to hospitalization if later bitten by a dengue-infected mosquito.
Is taking an immunosuppressive treatment (prednisone or equivalent 20 mg or 2 mg/kg body weight for 2 weeks or more). The doctor will postpone administration of Dengvaxia until 4 weeks after stopping the treatment.
Has experienced any health problems after prior administration of any vaccines. The doctor will carefully consider the risks and the benefits of vaccination.
As with all vaccines, Dengvaxia may not protect 100% of persons who have been vaccinated.
Vaccination with Dengvaxia is not a substitute for protection against mosquito bites. The patient should take appropriate precautions to prevent mosquito bites, including the use of repellents, adequate clothing, and mosquito nets.
Consult a doctor if he/she believes that he/she 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.
Fainting, sometimes accompanied by falling, can occur (mostly in adolescents) following, or even before, any injection with a needle. Therefore the patient should tell the doctor, pharmacist or nurse if he/she fainted with a prior injection.
Travelers: The patient should tell the doctor if he/she is currently live in an area where dengue infections do not regularly occur. Unless he/she has been previously infected by dengue, vaccination is not recommended if he/she plans to travel to an area where dengue infections regularly occur.
Using Other Medicines and Dengvaxia: Dengvaxia may not have an optimal effect if it is used at the same time as medicines that suppress the immune system such as corticosteroids or chemotherapy.
Inform the physician, pharmacist or nurse if the patient is taking or has recently tajen any other vaccines or any other medicines, including medicines obtained without a prescription.
Effects on the Ability to Drive or Operate Machinery: No data are available on the effects of Dengvaxia on the ability to drive or use machines.
Use in Children: Dengvaxia should not be administered in children less than 9 years of age.
Dengvaxia must not be given to pregnant or breastfeeding women.
If the patient is of child-bearing age, the patient should take the necessary precautions to avoid pregnancy for 1 month following administration of Dengvaxia.
If the patient is pregnant or breastfeeding, the patient is may be pregnant or is planning to have a baby, ask the doctor, pharmacist or nurse for advice before receiving Dengvaxia.
Like all medicines, Dengvaxia can cause side effects, although not all patients get them.
Serious Allergic Reactions:
If any of these symptoms occur after leaving the place where the patient received an injection, consult a doctor IMMEDIATELY: Difficulty in breathing, blueness of the tongue or lips, a rash, swelling of the face or throat, low blood pressure causing dizziness or collapse, sudden and serious malaise with drop in blood pressure causing dizziness and loss of consciousness, accelerated heart rate associated with respiratory disorders.
When these signs and symptoms (signs or symptoms of anaphylactic reactions) occur they usually develop quickly after the injection is given and while the patient is still in the clinic or doctor's surgery. They can also happen very rarely after receiving any vaccine (may affect up to 1 user in 10,000 people).
Other Undesirable Effects:
The following side effects were reported during clinical studies in children, adolescents and adults.
Most of the reported side effects occurred within 3 days after the injection of Dengvaxia.
Very Common: (may affect more than 1 user in 10):
Headache, muscle pain (myalgia), generally feeling unwell (malaise), feeling of weakness (asthenia), injection site pain, fever.
Common (may affect up to 1 user in 10):
Injection site reactions: redness (erythema), bruising (hematoma), swelling, and itching (pruritus).
Uncommon (may affect up to 1 user in 100):
Infections of the upper respiratory tract, dizziness, sore throat (oropharyngeal pain), cough, runny nose (rhinorrhea), nausea, skin eruption (rash), neck pain, hardening of skin at the injection site (injection site induration).
Very rare (may affect up to 1 user in 10 000):
Additional Undesirable Effects in Adults: Uncommon (may affect up to 1 user in 100):
Swollen glands (lymphadenopathy), migraine, joint pain (arthralgia), flu-like symptoms (influenza-like illness).
Additional Undesirable Effects in Children and Adolescents (from 9 to and including 17 years of age): Uncommon (may affect up to 1 user in 100):
Itchy rash (urticaria).
For some people who have not been infected by dengue before vaccination, there may be an increased risk of getting a severe dengue illness requiring hospitalization if they become bitten by a dengue-infected mosquito later. By monitoring subjects 9 years of age or older in a 5 year follow-up clinical trial, it was estimated that there were 5 additional hospitalized dengue cases or 2 additional severe dengue cases per 1000 vaccinees with no previous dengue infection could occur following vaccination. This increased risk may mainly occur during the third year following the first injection and was not observed in people who have been previously infected by dengue before vaccination.
If the patient get any side effects, talk to the doctor, pharmacist or nurse. This includes any possible side effects not listed on the leaflet.
The following information is intended for doctors, pharmacists or nurses only: Before administering any biological, the person responsible for administration must take all precautions to prevent allergic or other reactions. As with all injectable vaccines, appropriate medical treatment and supervision must always be readily available in the event of an anaphylactic reaction following the administration of Dengvaxia.
Epinephrine (1:1000) and other appropriate agents used to control immediate allergic reactions must be available to treat unexpected events such as anaphylaxis.
Once Dengvaxia has been completely reconstituted using the solvent provided, it is administered by subcutaneous (SC) injection. The recommended injection site is the deltoid region.
Dengvaxia must not be mixed with other medicinal products in the same syringe.
Dengvaxia must not be administered by intravascular injection under any circumstances.
Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to injection with a needle. Procedures should be in place to prevent injury from falling and to manage syncopal reactions.
Separate syringes and needles, separate injection sites and preferably separate limbs must be used if any other vaccine(s) or medicinal product(s) is/are concomitantly administered.
Dengvaxia is reconstituted by transferring all of the solvent (0.4% sodium chloride solution) provided in the blue-labeled pre-filled syringe into the vial of freeze dried powder with a yellowish green flip-off cap. The pre-filled syringe is fitted with a sterile needle for this transfer. The vial is then gently swirled. After complete dissolution, a 0.5 mL dose of the reconstituted suspension is withdrawn into the same syringe. For injection, the syringe should be fitted with a new sterile needle.
The suspension should be visually inspected prior to administration. After reconstitution, Dengvaxia is a clear, colorless liquid with the possible presence of white to translucent particles (of endogenous nature).
After reconstitution with the solvent provided, Dengvaxia must be used immediately.
Any unused product or waste material should be disposed of, preferably by heat inactivation or incineration, in accordance with local regulations.
Store in a refrigerator (2°C-8°C).
Do not freeze.
Keep the vaccine in the outer carton in order to protect it from light.
Do not throw away any medicines via wastewater or household waste. Ask a pharmacist how to throw away medicines no longer used. These measures will help to protect the environment.
J07B - VIRAL VACCINES ; Used for active immunizations.
Powd for inj (vial + solvent in single-dose pre-filled syringe) 0.5 mL x 1's.