| ABBREVIATED PRESCRIBING INFORMATION |
| Influvac suspension for injection 0.5 ml |
| Therapeutic indications |
Influvac is indicated for active immunization for the prevention of influenza disease in adults and children from 6 months of age.
The use of influvac should be based on official recommendations. |
| Contraindications |
| Hypersensitivity to the active substances, to (any of) the excipients or to any component that may be present as traces such as eggs (ovalbumin, chicken proteins), formaldehyde, cetyltrimethylammonium bromide, polysorbate 80 or gentamicin. |
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.
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine.
Immunisation shall be postponed in patients with febrile illness or acute infection.
Influvac should under no circumstances be administered intravascularly.
As with other vaccines administered intramuscularly, influvac should be given with caution to individuals with thrombocytopenia or any coagulation disorder since bleeding may occur following an intramuscular administration to these subjects.
Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress-related reactions can occur following, or even before, any vaccination as a psychogenic response to the needle injection. This can be accompanied by several neurological signs such as transient visual procedures are in place to avoid injury from faints.
Influvac is not effective against all possible strains of influenza virus. Influvac is intended to provide protection against those strains of virus from which the vaccine is prepared and to closely related strains.
As with any vaccine, a protective immune response may not be elicited in all vaccinees.
Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient. Interference with serological testing.
This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially 'sodium-free” This medicine contains potassium, less than 1 mmol (39 mg) per dose,i.e. essentially "potassium- free". |
| Interactions with other medicinal products and other forms of interaction |
No interaction studies have been performed. If Influvac is given at the same time as other vaccines, immunisation should be carried out on separate limbs. It should be noted that the adverse reactions may be intensified.
The immunological response may be diminished if the patient is undergoing immunosuppressant treatment.
Following influenza vaccination, false positive results in serology tests using the ELISA method to detect antibodies against HIV1, Hepatitis C and especially HTLV1 have been observed. The Western Blot technique disproves the false-positive ELISA test results. The transient false-positive reactions could be due to the IgM response by the vaccine. |
Fertility, pregnancy and lactation
Pregnancy |
| Inactivated influenza vaccines can be used in all stages of pregnancy. Larger datasets on safely are available for the second and third trimester, compared with the first trimester; however, data from worldwide use of influenza vaccine do not indicate any adverso foetal and maternal outcomes attributable to the vaccine. |
| Breastfeeding |
| Influvac may be used during breastfeeding. |
| Fertility |
| No human fertility data are available |
| Effects on ability to drive and use machines |
| Influvac has no or negligible influence on the ability to drive and use machines. |
| Undesirable effects |
| Data for quadrivalent Influvac Tetra are relevant to trivalent influvac because both vaccines are manufactured using the same process and have overlapping compositions. |
| Summary of safety profile |
Safety data regarding use of Influvac are based on data from (3) clinical studies using trivalent Influvac or the quadrivalent Influvac Tetra.
In two clinical studies, healthy adults 18 years of age and older, and healthy children 3 to 17 years of age were administered with quadrivalent influenza vaccine Influvac Tetra or trivalent Influvac. In a third study, the safety was assessed in healthy children from 6 months to 35 months of age administered quadrivalent influenza vaccine Influvac Tetra or a non-influenza vaccine control.
In both children studies, children from 6 months to 8 years of age received one or two doses depending on their influenza vaccination history.
Most reactions usually occurred within the first 3 days following vaccination and resolved spontaneously within 1 to 3 days after onset. The intensity of these reactions was generally mild, In all age groups, the most frequently reported local adverse reaction was vaccination site pain, The most frequently reported systemic adverse reactions in adults and children from 6 to 17 years of age were fatigue and headache, and for children from 3 to 5 years of age drowsiness, irritability and loss of appetite,
The most frequently reported systemic adverse reactions in children from 6 months to 35 months of age were irritability/fussiness.
In addition, overall data from clinical trials and post-marketing experience have demonstrated that the safety and tolerability profile for QIV and TIV is comparable. |
| Adverse Reactions Reported (Adults, Elderly, and Pediatric Populations) |
