SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Imuvac, suspension for injection (influenza vaccine, surface antigen, inactivated).

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Influenza virus surface antigens (haemagglutinin and neuraminidase) of the following strains*:

-    A/California/7/2009 (H1N1)pdm09-like strain    15 micrograms HA**

(A/California/7/2009, X-181)

-    A/Texas/50/2012 (H3N2)-like strain (A/Texas/50/2012,    15 micrograms HA **

X-223A)

-    B/Massachusetts/2/2012-like strain    15 micrograms HA **

(B/Massachusetts/2/2012, BX-51B)

per 0.5 ml dose

* propagated in fertilised hens’ eggs from healthy chicken flocks. ** haemagglutinin.

This vaccine complies with the World Health Organisation (WHO) recommendation (northern hemisphere), and EU recommendation for the 2014/2015 season.

For a full list of excipients see section 6.1.

Imuvac may contain traces of eggs (such as ovalbumin, chicken proteins), formaldehyde, cetyltrimethylammonium bromide, polysorbate 80, or gentamicin, which are used during the manufacturing process (see section 4.3).

3 PHARMACEUTICAL FORM

Suspension for injection in prefilled syringes; a colourless clear liquid, filled in single-dose syringes (glass, type I).

CLINICAL PARTICULARS

4.1 Therapeutic indications

Prophylaxis of influenza, especially those who run an increased risk of associated complications.

Imuvac is indicated in adults and children from 6 months of age.

The use of Imuvac should be based on official recommendations.

4.2    Posology and method of administration

Posology Adults: 0.5 ml.

Paediatric population

Children from 36 months onwards: 0.5 ml.

Children from 6 months to 35 months: Clinical data are limited. Dosages of 0.25 ml or 0.5 ml may be given, for detailed instructions on administering a 0.25ml or 0.5ml dose, see section 6.6. The dose given should be in accordance with existing national recommendations.

For children who have not previously been vaccinated, a second dose should be given after an interval of at least 4 weeks.

Children less than 6 months: the safety and efficacy of Influvac in children less than 6 months have not been established. No data are available.

Method of Administration

Immunisation should be carried out by intramuscular or deep subcutaneous injection.

Precautions to be taken before handling or administrating the medicinal product:

For instructions for preparation of the medicinal product before administration, see section 6.6.

4.3    Contraindications

Hypersensitivity to the active substances, to any of the excipients listed in 6.1 or to any component that may be present as traces such as eggs (ovalbumin, chicken proteins) formaldehyde, cetyltrimethylammonium bromide, polysorbate 80, or gentamicin.

Immunisation shall be postponed in patients with febrile illness or acute infection.

4.4 Special warnings and precautions for use

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.

Imuvac should under no circumstances be administered intravascularly.

Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient.

Interference with serological testing: see section 4.5.

4.5 Interaction with other medicinal products and other forms of interaction

Imuvac may be 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.

4.6 Fertility, pregnancy and lactation

Pregnancy

Inactivated influenza vaccines can be used in all stages of pregnancy. Larger datasets on safety 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 adverse foetal and maternal outcomes attributable to the vaccine.

Breast-feeding

Influvac may be used during breast-feeding.

Fertility

No fertility data are available

4.7 Effects on ability to drive and use machines

Imuvac has no or negligible influence on the ability to drive and use machines.

4.8 Undesirable effects

ADVERSE REACTIONS OBSERVED FROM CLINICAL TRIALS

The safety of trivalent inactivated influenza vaccines is assessed in open label, uncontrolled clinical trials performed as annual update requirement, including at least 50 adults aged 18 - 60 years of age and at least 50 elderly aged 61 years or older. Safety evaluation is performed during the first 3 days following vaccination.

The following undesirable effects have been observed during clinical trials with the following frequencies:

very common (> 1/10); common (> 1/100, < 1/10); uncommon (> 1/1,000, < 1/100).

Tabulated list of adverse reactions:

Organ class	Very common > 1/10	Common > 1/100, < 1/10	Uncommon > 1/1,000, < 1/100
Nervous system disorders		Headache*
Skin and subcutaneous tissue disorders		Sweating*
Musculoskelet al and connective tissue disorders		Myalgia, arthralgia*
General disorders and administration site conditions		fever, malaise, shivering, fatigue Local reactions: redness, swelling, pain, ecchymosis, induration*

* These reactions usually disappear within 1-2 days without treatment

ADVERSE REACTIONS REPORTED FROM POST-MARKETING

SURVEILLANCE

Adverse reactions reported from post marketing surveillance are, next to the reactions which have also been observed during the clinical trials, the following:

Blood and lymphatic system disorders:

Transient thrombocytopenia, transient lymphadenopathy

Immune system disorders:

Allergic reactions, in rare cases leading to shock, angioedema Nervous system disorders:

Neuralgia, paraesthesia, febrile convulsions, neurological disorders, such as encephalomyelitis, neuritis and Guillain Barre syndrome

Vascular disorders:

Vasculitis associated in very rare cases with transient renal involvement Skin and subcutaneous tissue disorders:

Generalised skin reactions including pruritus, urticaria or non-specific rash Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

4.9 Overdose

Overdosage is unlikely to have any untoward effect.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Pharmacotherapeutic group: Influenza vaccine, ATC Code: J07BB02.

Seroprotection is generally obtained within 2 to 3 weeks. The duration of postvaccinal immunity to homologous strains or to strains closely related to the vaccine strains varies but is usually 6-12 months.

Pharmacokinetic properties

Not applicable.

Preclinical safety data

Not applicable.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, sodium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate and water for injections.

6.2 Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3 Shelf life

1 year.

6.4 Special precautions for storage

Store in a refrigerator (+2°C to +8°C).

Do not freeze.

Store in the original package in order to protect from light.

6.5 Nature and contents of container

0.5 ml suspension for injection in prefilled syringe with/without needle (glass, type I), pack of 1 or 10.

6.6 Special precautions for disposal

The vaccine should be allowed to reach room temperature before use.

Shake before use. Inspect visually prior to administration.

For the administration of a 0.25 ml dose from a single dose 0.5 ml syringe, push the front side of the plunger exactly to the edge of the mark so that half of the volume is eliminated; a volume of 0.25 ml of the vaccine remains in the syringe, suitable for administration. See also section 4.2.

Any unused product or waste material should be disposed of in accordance with local requirements.

7 MARKETING AUTHORISATION HOLDER

BGP Products Ltd.

Abbott House

Vanwall Business Park

Vanwall Road

Maidenhead

SL6 4XE

UK.

8    MARKETING AUTHORISATION NUMBER(S)

PL 43900/0042

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

31/03/2005

10 DATE OF REVISION OF THE TEXT

24/03/2015