Qdenga Special Precautions

Anaphylaxis: Events of anaphylaxis have been reported post authorization.
Appropriate medical treatment and supervision should always be readily available in the event of a rare anaphylactic reaction following administration of the vaccine.
Review of medical history: Vaccination should be preceded by a review of the medical history (especially with regard to previous vaccination and possible hypersensitivity reactions which occurred after vaccination).
Concurrent illness: Vaccination with Qdenga should be postponed in subjects suffering from an acute severe febrile illness. The presence of a minor infection, such as a cold, should not result in a deferral of vaccination.
Limitations of vaccine effectiveness: A protective immune response with Qdenga may not be elicited in all vaccinees against all serotypes of dengue virus and may decline over time (see Pharmacology: Pharmacodynamics under Actions). It is currently unknown whether a lack of protection could result in an increased severity of dengue. It is recommended to continue personal protection measures against mosquito bites after vaccination. Individuals should seek medical care if they develop dengue symptoms or dengue warning signs.
There are no data on the use of Qdenga in subjects above 60 years of age and limited data in patients with chronic medical conditions.
Anxiety related reactions: Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress‐related reactions may occur in association with vaccination as a psychogenic response to the needle injection. It is important that precautions are in place to avoid injury from fainting.
Other: Qdenga must not be administered by intravascular, intradermal or intramuscular injection.
Drug Abuse and Dependence: Qdenga has no known potential for abuse or dependence.
Effects on ability to drive and use machines: No studies on the effects of Qdenga on the ability to drive and use machines have been performed. Some of the effects mentioned under Adverse Reactions may temporarily have a minor influence on the ability to drive and use machines.
Use in Pregnancy: Women of childbearing potential: As with other live attenuated vaccines, women of childbearing potential should avoid pregnancy for at least one month following vaccination (see Use in Pregnancy & Lactation).