Cryomarex Rispens

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Marek disease virus (rispens strain)

Available from:

Merial Animal Health Limited

ATC code:

QI01AD03

INN (International Name):

Marek disease virus (rispens strain)

Dosage:

.

Pharmaceutical form:

Suspension for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Chickens

Therapeutic area:

avian herpes virus (marek's disease)

Therapeutic indications:

Immunological - Live Vaccine

Authorization status:

Authorised

Authorization date:

2006-12-15

Summary of Product characteristics

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.
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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