资料单张
Page 1 of 16
_ _
SUM M ARY OF PRODUCT CHARACTERISTICS
2
1.
NAM E OF THE VETERINARY M EDICINAL PRODUCT
AviProSALMONELLA VAC E
Lyophilisate for suspension for chickens
2.
QUALITATIVE AND QUANTITATIVE COM POSITION
Active substance:
1 dose contains:
1 x 10
8
CFU to 6 x 10
8
CFU attenuated Salmonella Enteritidis-bacteria, strain
Sm24/Rif12/Ssq.
EXCIPIENTS:
For a full list of excipients, see section 6.1.
3.
PHARM ACEUTICAL FORM
Lyophilisate for suspension
White to greyish/ brownish lyophilised cake
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Chickens (future breeders and layers), from one day old.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Active immunisation of chickens to reduce the number of Salmonella Enteritidis field
strains excreting birds.
Immunity develops within 14 days of first vaccination: after 15 days the faecal excretion is
reduced up to 70 %.
The immunity lasts until 52. week of life.
4.3
CONTRAINDICATIONS
Do not use in sick birds. Do not use in birds in lay and within 3 weeks before onset o f lay._ _
4.4
SPECIAL WARNINGS
Not tested in ornamental and pure-bred poultry.
Not to be used in chickens during lay.
The vaccine may spread to susceptible birds in contact with vaccinates. Vaccinated birds
shed the vaccine strain for up to 14 days.
Bell drinkers are preferred during first days of life, the use of nipple drinkers for one day
old chickens can only be recommended if used according to national regulations.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
The vaccine strain is highly sensitive to quinolone antibiotics and has inc
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产品特点
Page 1 of 15
_[TEM-006 Version 01/2006] _
_ _
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
AviPro
®
SALMONELLA VAC E
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 dose contains:
1 x 10
8
CFU to 6 x 10
8
CFU attenuated Salmonella Enteritidis-bacteria, strain
Sm24/Rif12/Ssq.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral lyophilisate, (for reconstitution in drinking water).
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Chickens (future breeders and layers), from one day old.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Active immunisation of chickens to reduce the number of Salmonella Enteritidis field
strains excreting birds.
Immunity develops within 14 days of first vaccination: after 15 days the faecal excretion
is reduced up to 70 %.
The immunity lasts until 52. week of life.
4.3
CONTRAINDICATIONS
Do not use in sick birds. Do not use in birds in lay and within 3 weeks before onset of
lay._ _
4.4
SPECIAL WARNINGS
Not tested in ornamental and pure-bred poultry.
Not to be used in chickens during lay.
The vaccine may spread to susceptible birds in contact with vaccinates. Vaccinated
birds shed the vaccine strain for up to 14 days.
Bell drinkers are preferred during first days of life, the use of nipple drinkers for one day
old chickens can only be recommended if used according to national regulations.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
3
The vaccine strain is highly sensitive to quinolone antibiotics and has increased
sensitivity
to
erythro
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