Cryomarex Rispens

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Marek's disease virus

Available from:

Boehringer Ingelheim Animal Health UK Ltd

ATC code:

QI01AD03

INN (International Name):

Marek's disease virus

Pharmaceutical form:

Suspension for injection

Prescription type:

POM-VPS -Prescription Only Medicine – Veterinarian, Pharmacist, Suitably Qualified Person

Therapeutic group:

Chickens

Therapeutic area:

Live Viral Vaccine

Authorization status:

Authorized

Authorization date:

1994-08-30

Summary of Product characteristics

Revised: May 2020
AN: 01998/2019
Page 1 of 5
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.
Revised: May 2020
AN: 01998/2019
Page 2 of 5
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 its 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.
F