Special Warning : אזהרת שימוש

4.4       Special warnings and precautions for use

Traceability

In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.

General recommendations

Anaphylaxis
Anaphylaxis has been reported in individuals who have received Qdenga. As with all injectable vaccines, appropriate medical treatment and supervision must 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 individual’s 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 section 5.1). 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.

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 sections 4.6 and 4.3).

Other
Qdenga must not be administered by intravascular, intradermal or intramuscular injection.

Excipients
Qdenga contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

Qdenga contains less than 1 mmol potassium (39 mg) per dose, that is to say essentially ‘potassium- free’.

Effects on Driving

4.7    Effects on ability to drive and use machines

Qdenga has minor influence on the ability to drive and use machines.