资料单张
Dokument1
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobilis Reo ERS inac
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Per dose of 0.5 ml:
Inactivated Reovirus strain ERS inducing
6.7 log
2
and ≤ 10.0 log
2
antibody ELISA units
Light liquid paraffin (215 mg)
3.
PHARMACEUTICAL FORM
Emulsion for injection
4.
PACKAGE SIZE
1000 doses (500 ml)
12 x 1000 doses (500 ml)
5.
TARGET SPECIES
Chicken
6.
INDICATION
Vaccination against enteric Reovirus infections
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
i.m. injection of 0.5 ml
Read the package leaflet before use.
8.
WITHDRAWAL PERIOD
Zero days
9.
SPECIAL WARNING(S), IF NECESSARY
Accidental self-injection is dangerous – see package leaflet before use.
10.
EXPIRY DATE
EXP {month/year}
Once broached use within 3 hours
Dokument1
11.
SPECIAL STORAGE CONDITIONS
Store between 2°C and 8°C. Do not freeze. Protect from light.
12.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Dispose of waste material in accordance with local requirements.
13.
THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE
For animal treatment only
14.
THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Keep out of the reach and sight of children
15.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Intervet International B.V.
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands
As represented by the national company
16.
MARKETING AUTHORISATION NUMBER(S)
17.
MANUFACTURER’S BATCH NUMBER
Lot {number}
Dokument
阅读完整的文件
产品特点
NOBILIS® REO E
I. SUMMARY OF PRODUCT CHARACTERISTICS
Dokument1
NOBILIS® REO ERS INAC
FEHLER! VERWEISQUELLE KONNTE NICHT GEFUNDEN WERDEN.
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobilis Reo ERS inac
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Per dose of 0.5 ml:
ACTIVE SUBSTANCE: Inactivated Reovirus strain ERS inducing
6.7 log
2
and ≤10.0 log
2
antibody ELISA units
ADJUVANT: Light liquid paraffin, 215 mg
For a list of excipients see section 6.1
3. PHARMACEUTICAL FORM
Emulsion for injection, white to nearly white (after shaking)
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Chicken
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Active immunisation of chickens as an aid in the protection of their progeny against
weight gain losses due to enteric reovirus (ERS) infection, and reduction of virus
replication in target organs.
Onset of immunity: 4 weeks after two vaccinations
Duration of immunity: 47 weeks after two vaccinations
4.3
CONTRAINDICATIONS
None
4.4
SPECIAL WARNINGS
None
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Vaccinate healthy birds only. For birds in lay please see section 4.7.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL
PRODUCT TO ANIMALS
To the user:
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 advic
阅读完整的文件
资料单张 