Poulvac Marek CVI + HVT
Country: France
Language: English
Source: HMA (Heads of Medicines Agencies)
Patient Information leaflet
(PIL)
09-10-2013
Summary of Product characteristics
(SPC)
09-10-2013
Active ingredient:
Mareks Disease Virus 0 -, Mareks disease virus - Rispens strain Cvi 988 0 -
Available from:
Pfizer Animal Health BV
ATC code:
QJ57GA0
Pharmaceutical form:
Lyophilisate and Solvent
Therapeutic group:
mareks disease
Therapeutic area:
Chicken Food
Authorization date:
2011-08-26
Patient Information leaflet
1
ANNEX II
A.
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S)
AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE
FOR BATCH RELEASE
B.
CONDITIONS OR RESTRICTIONS OF THE MARKETING
AUTHORISATION REGARDING SUPPLY OR USE
C.
CONDITIONS OR RESTRICTIONS OF THE MARKETING
AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE
D.
STATEMENT OF THE MRLS
E.
SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING
AUTHORISATION HOLDER
2
A.
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturer(s) of the biological active substance(s)
Pfizer Global Manufacturing Weesp
C.J. van Houtenlaan 36
1381 CP Weesp
The Netherlands
or
Pfizer Animal Health
2000 Rockford Road
Charles City
Iowa 50616
USA
Name and address of the manufacturer(s) responsible for batch release
Pfizer Global Manufacturing Weesp
C.J. van Houtenlaan 36
1381 CP Weesp
The Netherlands
or
Pfizer Olot, S.L.U.
Carretera Camprodon s/n - La Riba
17813 - Vall de Bianya
Girona
Spain
B.
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
REGARDING SUPPLY OR USE
To be supplied only on veterinary prescription.
C.
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT
Not applicable.
D.
STATEMENT OF THE MRLS
Not applicable.
E.
SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING
AUTHORISATION HOLDER
3
Not applicable.
4
ANNEX III
LABELLING AND PACKAGE LEAFLET
5
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Summary of Product characteristics
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Poulvac Marek CVI + HVT
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 dose of 0.2 ml contains:
Active substances:
Live Marek’s disease virus, strain CVI 988, cell associated: not less than 10
2.9
CCID
50
, not more than
10
3.5
CCID
50
*.
Live Marek HVT strain F#126, cell associated: not less than 1000 PFU, not more than 6000 PFU**
*CCID
50
= cell culture 50% infective dose
**PFU = plaque forming units
Excipient(s):
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Frozen virus-infected cell suspension, after thawing to be diluted in Poulvac Marek Diluent.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Chicken.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Active immunisation of healthy day-old chicks against Marek’s Disease to reduce mortality, clinical
signs and lesions of the disease.
Onset of immunity: 9 days post vaccination.
4.3
CONTRAINDICATIONS
Do not use in unhealthy chickens.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
The vaccine viruses have the potential to spread. After 10 passages, the vaccine showed an increase in
virulence in the highly susceptible pure bred Rhode Island Red bird. Maternal antibodies may have
some negative influence on vaccination.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
3
Exposure to heat and direct sunlight must be avoided.
Contact with disinfectants makes the vaccine ineffective.
Use clean materials for vaccination.
Avoid v
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