CRYOMAREX RISPENS
Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Vara einkenni
(SPC)
04-05-2024
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Senda beiðni.
Senda beiðni.
Virkt innihaldsefni:
MAREK DISEASE VIRUS (RISPENS STRAIN)
Fáanlegur frá:
Merial Animal Health Limited
ATC númer:
QI01AD03
INN (Alþjóðlegt nafn):
MAREK DISEASE VIRUS (RISPENS STRAIN)
Skammtar:
Unknown
Lyfjaform:
Suspension for Injection
Gerð lyfseðils:
POM
Meðferðarhópur:
Fowl - Chicken
Lækningarsvæði:
Avian herpes virus vaccine (Mareks disease)
Ábendingar:
Immunological - Live Vaccine
Leyfisstaða:
Authorised
Leyfisdagur:
2006-12-15
Vara einkenni
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Cryomarex Rispens
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose contains:
ACTIVE INGREDIENT:
Marek’s disease virus, Rispens strain, attenuated, at least
1000 PFU
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Suspension for injection
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Chickens.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of chickens to reduce mortality, clinical signs and lesions linked to Marek’s disease. The onset
of protection is from 5 days following vaccination. While the duration of immunity has not been investigated under
laboratory conditions, a single vaccine dose is considered sufficient to provide protection throughout the risk period.
4.3 CONTRAINDICATIONS
None.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 13/01/2014_
_CRN 7014907_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Only healthy birds should be vaccinated.
Rispens strain virus is excreted by vaccinates and may spread to in-contact birds. Safety and reversion to virulence
trials have shown that the spread to in-contact birds can be considered as safe.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS
The operator should be aware of the general precautions to be taken when handling liquid nitrogen. Due to it's very low
temperature, liquid nitrogen will cause severe injury if it is in contact with the body. Ampoules may explode with
considerable violence on sudden temperature changes; therefore the operator should protect himself
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