Summary of medicine characteristics - Poulvac Flufend H5N3 RG
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose of 0.5 ml contains:
Active substance :
Inactivated recombinant avian influenza virus
of H5N3 subtype (strain rg-A/ck/VN/C58/04) > 1:40 HI units per dose
Adjuvants:
White Oil
Sorbitan sesquioleate
Polysorbate 80
Excipients:
Thiomersal
Phosphate Buffer Saline
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Emulsion for injection.
4. CLINICAL PARTICULARS
4.1 Target species
Chickens and ducks.
4.2 Indications for use, specifying the target species
ens and ducks against avian influenza virus type A, subtype H5.
Chickens: Reduction of mortality and virus excretion after challenge.
Onset of immunity: 3 weeks after the second injection.
Duration of immunity in chickens has not been established yet.
Ducks: Reduct Onset of immu Duration of im
of clinical signs and virus excretion after challenge.
: 3 weeks after the second injection.
ity in ducks : 14 weeks after the second injection.
4.3
N
4.4 Special warnings for each target species
The level of efficacy attained may vary depending on the degree of antigenic homology between t vaccine strain and circulating field strains.
No information is available on the interference of maternally derived antibodies on vaccination both target species.
4.5 Special precautions for use
Special precautions for use in animals
Avoid stress in the birds around the time of vaccination.
Special precautions to be taken by the person administering the veterinar animals
cinal product to
To the user:
This product contains mineral oil. Accidental injection/self injecti result in severe pain and swelling, particularly if injected into a joint or finger, and in rare c ould result in the loss of the
affected finger if prompt medical attention is not given. If you cidentally injected with this
product, seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you. If pain persists for more than 12 hours after medical examination, seek medical advice again.
To the physician:
This product contains mineral oil. Even if small amounts have been injected, accidental injection with this product can cause intense swelling, which may, for example, result in ischaemic necrosis and even the loss of a digit. Expert, PROMPT, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.
4.6 Adverse reactions (frequency and
A transient local site reaction (swelling vaccines.
ccasionally occur as is normal with oil adjuvanted
4.7 Use during pregnancy, lactation or lay
No information is available
fety of this vaccine for birds in lay.
4.8 Interactions with
medicinal products and other forms of interaction
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
4.9 Amo
e administered and administration route
Chicken
3 weeks of age or older: 0.5 ml intramuscularly in the breast muscle. Revaccinate after 3 weeks.
The vaccination schedule should be completed at least 4 weeks before the start of laying.
e day old: 0.2 ml subcutaneously in the neck.
accinate after 3 weeks: 0.5 ml subcutaneously in the neck
e vaccination schedule should be completed at least 4 weeks before the start of laying.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Following the administration of a double dose in chickens and ducks, no adverse reactions other t those described in section 4.6 have been observed.
4.11 Withdrawal period
Zero days
5. IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: Inactivated recombinant vaccine, ATC vet code:
To stimulate active immunity in chickens and ducks against avian influenza vi To induce serological response against N3 neuraminidase which can act a Infected from Vaccinated Animals (DIVA strategy).
ype.
o Differentiate
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
White Oil
Sorbitan sesquioleate
Polysorbate 80
Thiomersal
Sodium chloride
Sodium phosphate dibasic
Potassium phosphate monobasic
6.2. Incompatibilities
Do not mix with any other medici
6.3 Shelf life
1 year.
The entire content
hould be used within 2 hours after broaching the container.
6.4 Special precautions for storage
Store and transport refrigerated (2° to 8°C).
Store in the original container in order to protect from light. Do not freeze.
6.5 Nat
composition of immediate packaging
500 ml of vaccine in high-density polyethylene bottles, closed with a nitrile rubber stopper and aluminium cap.
ine is presented in boxes of 1 or 10 bottles of 500 ml.
6.6 Special precautions for the disposal of unused veterinary medicinal products or waste
material derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicin products should be disposed of in accordance with the local requirements.
7. MARKETING AUTHORISATION HOLDER
Pfizer Limited Ramsgate Road Sandwich, Kent CT13 9NJ United Kingdom
8. MARKETING AUTHORISATION NUMBER
EU/2/06/060/001–002
9. DATE OF FIRST AUTHORISATION/RENEWAL O
01/09/2006