1. Name Of The Medicinal Product
VIROFLU
Suspension for injection
Influenza vaccine (surface antigen, inactivated, virosome)
Season 2011/2012
2. Qualitative And Quantitative Composition
Influenza virus surface antigens (haemagglutinin and neuraminidase), virosome, of the following strains*:
A/California/7/2009 (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 fertilised hen's eggs from healthy chicken flocks
** haemagglutinin
Viroflu is an inactivated influenza vaccine formulated with virosomes as carrier/adjuvant system, composed of highly purified surface antigens of strain A and B of the influenza virus propagated in fertilized hen's eggs.
This vaccine complies with the WHO recommendation (Northern hemisphere) and EU decision for the 2011/2012 season.
For a full list of excipients see section 6.1
3. Pharmaceutical Form
Suspension for injection.
Slightly opalescent liquid.
Supplied in a pre-filled syringe.
4. Clinical Particulars
4.1 Therapeutic Indications
Prophylaxis of influenza, especially in those who run an increased risk of associated complications.
The use of Viroflu 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 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. polymyxin B and neomycin.
Immunisation shall be postponed in patients with febrile illness or acute infection.
4.4 Special Warnings And Precautions For Use
Due to the risk of high fever, consideration should be given to the use of alternative seasonal influenza vaccines in children under the age of 5 years.
In case it is used in children, parents should be advised to monitor for fever for 2 -3 days following vaccination.
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.
Viroflu 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
Viroflu may be given at the same time as other vaccines. Immunisations 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 Pregnancy And Lactation
The limited data from vaccinations in pregnant women do not indicate that adverse fetal 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.
Viroflu 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:
Results from one clinical trial conducted with Viroflu in children, during the period May 2010-Apr 2011, showed a percentage of fever up to 18.2%, with a percentage of children who experienced fever 39-40°C of 5.1%. Fever is an already known adverse event that can occur after flu vaccination, but the findings on fever coming from the study are considered higher than those reported previously with other Viroflu studies/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 (
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* 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 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, disodium phosphate dihydrate, potassium dihydrogen phosphate, lecithin, 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: the vaccine must not be used if it is inadvertently frozen.
Protect from the light.
6.5 Nature And Contents Of Container
0.5 ml suspension in pre-filled syringe (type I glass) with plunger stopper (chlorobutyl rubber) with needle in pack sizes 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.
When a dose of 0.25 ml is indicated, the pre-filled syringe should be held in upright position and half of the volume should be eliminated up to the 0.25 ml mark. The remaining volume should be injected.
See also section 4.2.
Any unused product or waste material should be disposed of in accordance with local requirements.
7. Marketing Authorisation Holder
Crucell Italy S.r.l.
Via Zambeletti 25
20021 Baranzate (MI)
Italy
8. Marketing Authorisation Number(S)
PL 15747/0005
9. Date Of First Authorisation/Renewal Of The Authorisation
28. October 2005/20 December 2006
10. Date Of Revision Of The Text
October 2011
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