Agrippal

1. Name Of The Medicinal Product

AGRIPPAL, Suspension for injection in pre-filled syringe

Influenza vaccine (surface antigen, inactivated)

(2010/2011 SEASON)

2. Qualitative And Quantitative Composition

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

A/California/07/2009 (H1N1) - derived strain used NYMC X-181

15 micrograms HA**

A/Perth/16/2009 (H3N2) - like strain used NYMC X-187 derived from A/Victoria/210/2009

15 micrograms HA**

B/Brisbane/60/2008

15 micrograms HA**

Per 0.5 ml dose

* propagated in fertilized hens' eggs from healthy chicken flocks

** haemagglutinin

This vaccine complies with the WHO recommendations (northern hemisphere) and EU decision for the 2010/2011 season.

For a full list of excipients see section 6.1

3. Pharmaceutical Form

Suspension for injection in pre-filled syringe.

The vaccine appears as a clear liquid.

4. Clinical Particulars

4.1 Therapeutic Indications

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

The use of AGRIPPAL should be based on official recommendations.

4.2 Posology And Method Of Administration

Adults and children from 36 months: 0.5 ml

Children from 6 months to 35 months: Clinical data are limited. Dosages of 0.25 ml or 0.5 ml have been used.

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

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

For instructions for preparation, see section 6.6.

4.3 Contraindications

Hypersensitivity to the active substances, to any of the excipients and to residues, e.g. eggs, chicken proteins, such as ovalbumin.

The vaccine may contain residues of the following substances, e.g. kanamycin and neomycin sulphate, formaldehyde, cetyltrimethylammonium bromide (CTAB) and polysorbate 80.

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.

AGRIPPAL should under no circumstances be administered intravascularly.

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

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

AGRIPPAL 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 results. The transient false positive reactions could be due to the IgM response by the vaccine.

4.6 Pregnancy And Lactation

The limited data from vaccinations in pregnant women do not indicate that adverse foetal and maternal outcomes were attributable to the vaccine. The use of this vaccine may be considered from the second trimester of pregnancy. For pregnant women with medical conditions that increase their risk of complications from influenza, administration of the vaccine is recommended, irrespective of their stage of pregnancy.

AGRIPPAL may be used during lactation.

4.7 Effects On Ability To Drive And Use Machines

The vaccine is unlikely to produce an effect 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 (

Nervous system disorders

Common (:

Headache*

Skin and subcutaneous tissue disorders

Common (:

Sweating*

Musculoskeletal and connective tissue disorders

Common (:

Myalgia, arthralgia*

General disorders and administration site conditions

Common (:

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, paraesthesiae, febrile convulsions, neurological disorders, such as encephalomyelitis, neuritis and Guillain-Barré 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

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.

5.2 Pharmacokinetic Properties

Not applicable

5.3 Preclinical Safety Data

Not applicable

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sodium chloride

Potassium chloride

Potassium dihydrogen phosphate

Disodium phosphate dihydrate

Magnesium chloride hexahydrate

Calcium chloride dihydrate

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 – 8°C). Do not freeze. Keep the syringe in the outer carton in order to protect from light.

6.5 Nature And Contents Of Container

0.5 ml of suspension in pre-filled syringe (type I glass) with needle (23 G, 1” or 25 G, 1” or 25 G, 5/8”), equipped with a rubber plunger stopper – pack size of 1 or 10.

0.5 ml of suspension in pre-filled syringe (type I glass) without needle, equipped with a rubber plunger stopper – pack size of 1 or 10.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

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

Shake before use.

If half a dose (0.25 ml) is to be administered, discard half the contained volume (up to the mark indicated on the syringe barrel), before injection.

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

7. Marketing Authorisation Holder

Novartis Vaccines and Diagnostics S.r.l., Via Fiorentina 1, SIENA, Italy

8. Marketing Authorisation Number(S)

PL 13767/0004

9. Date Of First Authorisation/Renewal Of The Authorisation

22 December 1998

22 January 2009

10. Date Of Revision Of The Text

06/2010