1. Name Of The Medicinal Product
Inactivated Influenza Vaccine (Split Virion) BP, suspension for injection in prefilled syringe.
Influenza vaccine (split virion, inactivated).
2. Qualitative And Quantitative Composition
Influenza virus (inactivated, split) of the following strains*:
• A/California/7/2009 (H1N1) – derived strain used NYMC X-179A | 15 micrograms HA** |
• A/Perth/16/2009 (H3N2) – like strain used NYMC X-187 derived from | |
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• B/Brisbane/60/2008 | 15 micrograms HA**
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* propagated in fertilised hens' eggs from healthy chicken flocks
** haemagglutinin
This vaccine complies with the WHO recommendations (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 in prefilled syringe.
The vaccine, after shaking gently, is a slightly whitish and opalescent 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 Inactivated Influenza Vaccine (Split Virion) BP 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, such as ovalbumin, chicken proteins.
The vaccine may contain other residues of the following substances: neomycin, formaldehyde and octoxinol 9.
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.
Inactivated Influenza Vaccine (Split Virion) BP 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
Inactivated Influenza Vaccine (Split Virion) BP 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 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.
Inactivated Influenza Vaccine (Split Virion) BP 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 (
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* These reactions usually disappear within 1-2 days without treatment.
ADVERSE REACTIONS REPORTED FROM POST
Adverse reactions reported from post
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, febril 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:
Generalized skin reactions including pruritus, urticaria or non
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 homologuous 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
Buffer solution:
• Sodium chloride
• Potassium chloride
• Disodium phosphate dihydrate
• Potassium dihydrogen phosphate
• 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 prefilled syringe (type I glass) with attached needle, equipped with a plunger stopper (elastomer chlorobromobutyl or chlorobutyl or bromobutyl) – pack size of 1, 10, 20 or 50.
0.5 ml of suspension in prefilled syringe (type I glass) without needle, equipped with a plunger stopper (elastomer chlorobromobutyl or chlorobutyl or bromobutyl) – pack size of 1, 10, 20 or 50.
6.6 Special Precautions For Disposal And Other Handling
The vaccine should be allowed to reach room temperature before use.
Shake before use.
The vaccine should not be used if foreign particles are present in the suspension.
For children, when one dose of 0.25 ml is indicated, push the plunger stopper exactly to the edge of the mark so that the half of the volume is eliminated. 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
Sanofi Pasteur MSD Limited
Mallards Reach
Bridge Avenue
Maidenhead
Berkshire
SL6 1QP
8. Marketing Authorisation Number(S)
PL 06745/0095
9. Date Of First Authorisation/Renewal Of The Authorisation
First authorization: 9 December 1968.
Renewal of authorization: 30 December 2007.
10. Date Of Revision Of The Text
07/2011
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