Poulvac Flufend H5N3 RG
recombinant inactivated avian influenza virus
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Medicinal product no longer authorised
authorised
Marketing Authorisation Holder:
Pfizer Limited Ramsgate Road Sandwich, Kent CT13 9NJ
United Kingdom
Manufacturer for the batch release: Pfizer Global Manufacturing Weesp CJ van Houtenlaan 36
1381 CP Weesp The Netherlands
no
Poulvac FluFend H5N3 RG
Emulsion for injection for chickens and ducks
One dose of 0.5 ml contains:
Inactivated recombinant avian influenza virus
of H5N3 subtype (strain rg-A/ck/VN/C58/04) > 1:40 HI Units
White Oil
Medicinal
Sorbitan sesquioleate Polysorbate 80
Thiomersal
Phosphate Buffer Saline
For active immunisation of chickens and ducks against avian influenza virus type A, subtype H5.
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.
authorised
Reduction of clinical signs and virus excretion after challenge. Onset of immunity: 3 weeks after the second injection.
Duration of immunity in ducks : 14 weeks after the second injection.
None
A transient local site reaction (swelling) may occasionally occur as is normal with oil adjuvanted vaccines.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Chickens and ducks
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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.
At one day old: 0.2 ml subcutaneously in the neck. Revaccinate after 3 weeks: 0.5 ml subcutaneously in the neck
The vaccination schedule should be completed at least 4 weeks before the start of laying.
Medicinal
Do not mix with any other medicinal product.
Withdrawal period: Zero days
Keep out of the reach and sight of children.
Store and transport refrigerated (2ºC - 8ºC). Keep in the original container in order to protect from light. Do not freeze.
The entire content of the bottle should be used within 2 hours after broaching the container.
authorised
The level of efficacy attained may vary depending on the degree of antigenic homology between the vaccine strain and circulating field strains.
No information is available on the interference of maternally derived antibodies on vaccination for both target species.
No information is available on the safety of this vaccine for birds in lay. For animal treatment only
Avoid stress in the birds around the time of vaccination.
This product contains mineral oil. Accidental injection/self injection may result in severe pain and swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss of the affected finger if prompt medical attention is not given. If you are accidentally 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.
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
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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.
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
Following the administration of a double dose in chickens and ducks, no adverse reactions other than those described in section 6 have been observed.
Medicinal
Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.
13/12/2010
Detailed information on this product is available on the website of the European Medicines Agency
The vaccine is presented in boxes of 1 or 10 bottles of 500 ml.
The use of this veterinary medicinal product is only allowed under the particular conditions established by European Community legislation on the control of Avian Influenza.
authorised
Pfizer Animal Health s.a., Tél.: + 32 (0)2 554 62 11
Pfizer Kft.
Tel: +361 488 3695
Agrimed Limited Tel: +356 21 465 797
Pfizer Oy Animal Health, Tlf: +358 (0)9 4300 40
Pfizer Animal Health B.V., Tel: +31 (0)10 4064 600
Pfizer GmbH
Tel: +49 30-5500 5501
Pfizer Oy Animal Health, Tlf: +358 (0)9 4300 40
Pfizer Animal Health Tel: +370 5 269 17 96
Pfizer Corporation Austria Ges.m.b.H. Tel: +43 (0)1 52 11 57 20
Pfizer Hellas A.E.
Τηλ.: +30 210 6785800
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Pfizer Trading Polska Sp. z.o.o. Tel: +48 22 335 62 00
Pfizer S.A.
Tel: +34 91 4909900
Laboratórios Pfizer, Lda. Tel: +351 21 423 55 00
Pfizer
Tél: +33 (0)1 58 07 46 00
Pfizer Romania SRL Tel: + 0040 21 207 28 93
Pfizer Healthcare Ireland, Trading As: Pfizer Animal Health
Medicinal
Tel: +353 (0) 1 467 6500
Pfizer Luxembourg SARL Tel: +386 (0) 1 52 11 670
Pfizer Oy Animal Health, Tel: +358 (0)9 4300 40
Pfizer Luxembourg SARL o.z. Tel: + 421 2 3355 5500
Pfizer Italia S.r.l.,
Tel: +39 06 3318 2933
Pfizer Oy Animal Health, Puh/Tel: +358 (0)9 4300 40
Pfizer Hellas A.E.
Τηλ.: +30 210 6785800
Pfizer Oy Animal Health, Tel: +358 (0)9 4300 40
Pfizer Animal Health Tel: +370 5 269 17 96
authorised
Pfizer Ltd
Tel: +44 (0) 1304 616161
Medicinal
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Pfizer Animal Health Tel: +370 5 269 17 96