Cryomarex Rispens

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Marek disease virus (rispens strain)

Available from:

Boehringer Ingelheim Vetmedica GmbH

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 area:

avian herpes virus (marek's disease)

Authorization status:

Authorised

Authorization date:

2006-12-15

Summary of Product characteristics

Health Products Regulatory Authority
15 July 2020
CRN009VN8
Page 1 of 4
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.
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 with gloves and a visor. Protective
clothing should be worn that leaves no areas of the skin exposed. In
the event of accidental splashing of liquid nitrogen,
immediate and copious irrigation of the eye with water is very
important. Special care must be taken if finger rings are worn, as
these will freeze rapidly.
First aid treatment of f