Poulvac Flufend H5N3 RG - patient leaflet, side effects, dosage

A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer of the biological active substance(s)

Pfizer Global Manufacturing Weesp

CJ van Houtenlaan 36

1381 CP Weesp

The Netherlands

Pfizer Animal Health 2000 Rockford Road Charles City, Iowa 50616 USA

Name and address of the manufacturer responsible for batch release

Pfizer Global Manufacturing Weesp

CJ van Houtenlaan 36

1381 CP Weesp

The Netherlands

• B. CONDITIONS OR RESTRICTIONS OF T REGARDING SUPPLY OR USE

  To be supplied only on veterinary prescription.

  According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, Member States prohibit or may prohibit the import, sale, supply and/or use of the veterinary medicinal product on the whole or part of

  
  

  a)

  
  

  b)

  
  

  The

  
  

  et

  
  

  the administration of the veter implementation of nationa diseases, or will cause diffi

  
  

  in foodstuffs or other pro the disease to which th absent from the territ

  
  

  use of this veteri

  
  

  established by European

  
  

  medicinal product to animals will interfere with the

  
  

  ammes for the diagnosis, control and eradication of animal in certifying the absence of contamination in live animals or tained from treated animals

  inary medicinal product is intended to confer immunity is largely

  
  

  edicinal product is only allowed under the particular conditions unity legislation on the control of Avian Influenza.

  
  

  The holder of this plans for the medi

  
  

ting authorisation must inform the European Commission about the marketing roduct authorised by this decision.

NS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH TO SAFE AND EFFECTIVE USE

within the scope of Regulation (EC) No 470/2009.

The following constituents of Poulvac FluFend H5N3 RG are included in Table 1 (Allow substances) of the annex to Commission Regulation (EU) No 37/2010 as follows:

Pharmacologically active substance	Marker residue	Animal species	MRLs	Target tissues	Other provisions	Therapeutics < classification
Sodium chloride	Not applicable	All food producing species	No MRL required	Not applicable	No Entry	No entry
Thiomersal	Not applicable	All food producing species	No MRL required	Not applicable	For use only as a preservative in multidose vaccines at a concentration ^oj bxceeding 0,02 %.	No entry
White oil is a mineral hydrocarbon, Arlacel 83V is sor sorbitan monooleate, sodium phosphate dibasic (E33 are substances with E numbers. These constituents Table 1 (Allowed substances) of the annex to Commis				bitan sesquioleate, Tween 80 is polyoxyethylene 9) and potassium phosphate monobasic (E340) of Poulvac FluFend H5N3 RG are included in sion Regulation (EU) No 37/2010 as follows:
Pharmacologically active substance	Marker residue	Animal species	MRLsf	Target tissues	Other provisions	Therapeutic classification
Mineral hydrocarbons, low to high viscosity including microcrystalline waxes, approximately C10-C60, aliphatic, branched aliphatic and alicyclic compounds	Not applicable	All food ( producing species C	No MRL required	Not applicable	Excludes aromatic and unsaturated compounds	No entry
Sorbitan sesquioleate	Not applicable	All food producing species	No MRL required	Not applicable	No entry	No entry
Polyoxyethylen e sorbitan monooleate and trioleate, -A	'Not applicable	All food producing species	No MRL required	Not applicable	No entry	No entry
Food additives (substances with a valid E number approved as additives in	Not applicable	All food producing species	No MRL required	Not applicable	Only substances approved as additives in foodstuffs for human	No entry

Pharmacologically active substance	Marker residue	Animal species	MRLs	Target tissues	Other provisions	Therapeutic classification^
foodstuffs for human consumption)					consumption, with the exception of preservatives listed in part C of Annex III to European Parliament and Council Directive 95/2/EC.	<¿

E. SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING AUTHORISATION HOLDER

The Marketing Authorisation Holder shall complete the following programme of studies, the results of which shall form the basis of the annual reassessment of the benefit/risk profile. More detailed information on the specific obligations is set out in the CVMP assessment report.

QUALITY ASPECTS

1) There are important outstanding issues regarding the differences of production and control between the manufacturing sites (including the nature of the eggs used) and the lack of a validation study for the potency test on finished product (it appears that final product tests are only done at Weesp but in-process tests such as titration and HA quantification need to be equivalent too). With regard to the differences in production and control, harmonization of the production process and the controls between both manufacturing site is strongly suggested. An alternative solution could be to retain only one production site. In particular, a rationalization of the nature of eggs used (taking into consideration the problem of the possible presence of extraneous agents in conventional eggs and the possibility to inactivate them during the inactivation process of the Influenza virus, supported by a corresponding validation study). The Applicant is asked to commit to take appropriate measures to harmonise the productions and/or to provide the adequate demonstrations/data to solve the issues.

• 1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Poulvac FluFend H5N3 RG

Emulsion for injection for chickens and ducks

• 2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES

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

Chickens :

Reduction of mortal Onset of immunit Duration of im ical signs and virus excretion after challenge.

nity: 3 weeks after the second injection.

mmunity in ducks : 14 weeks after the second injection.

7. METHOD AND ROUTES OF ADMINISTRATION

Chickens

3 weeks of age or older: 0.5 ml intramuscularly in the breast muscle. Revaccinate after 3 wee The vaccination schedule should be completed at least 4 weeks before the start of laying.

Ducks

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 lay

Read the package leaflet before use

Withdrawal period – Zero days

9. SPECIAL WARNINGS, IF NECESSARY

Accidental injection is dangerous.

Once broached, use within 2 hours.

11. SPECIAL STORAGE CONDI

Store and transport refrigerated ( light. Do not freeze.

NS FOR THE DISPOSAL OF UNUSED PRODUCTS OR IF ANY

For disposal read the package leaflet.

13. THE WORDS ‘FOR ANIMAL TREATMENT ONLY’ AND CONDITIONS OF RES

E WORDS ‘KEEP OUT OF THE REACH AND SIGHT OF CHILDREN’

ep out of the reach and sight of children

PACKAGE LEAFLET FOR:

Poulvac FluFend H5N3 RG

Emulsion for injection for chickens and ducks

• 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

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

• 2. NAME OF THE VETERINARY MEDICINA

Poulvac FluFend H5N3 RG

Emulsion for injection for chickens and ducks

• 3. STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS

  One dose of 0.5 ml contains:

  4.

  Fo

  Excipients:

  Thiomersal Phosphate

  ATIONS

  irus 8/04)

  Duration of immunity in chickens has not been established yet.

  
  

Active substance :

Inactivated recombinant avian infl of H5N3 subtype (strain rg-A/c

Adjuvants:

White Oil

Sorbitan sesquioleate

Polysorbate 80

ens :

uction of mortality and virus excretion after challenge. nset of immunity: 3 weeks after the second injection.

Ducks:

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.

• 5. CONTRAINDI­CATIONS

None

• 6. ADVERSE REACTIONS

  ith oil adjuvanted

  
  

A transient local site reaction (swelling) may occasionally occur as is no vaccines.

If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.

• 7. TARGET SPECIES

Chickens and ducks

• 8. DOSAGE FOR EACH SPECIES, ROUTES AND METHOD OF ADMINISTRATION

  
  

Chickens

• 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.

  Ducks

  At one day old: 0.2 ml subcutaneously

  Revaccinate after 3 weeks: 0.5 ml subcut

  
  

  9. ADVICE ON CORR

  The vaccination schedule should b

  MINISTRATION

  
  

  neck.

  ously in the neck

  ted at least 4 weeks before the start of laying.