Bovilis Ringvac

Land: Storbritannien

Sprog: engelsk

Kilde: VMD (Veterinary Medicines Directorate)

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Hent Produktets egenskaber (SPC)
14-04-2020

Aktiv bestanddel:

Trichophyton verrucosum

Tilgængelig fra:

Intervet International BV

ATC-kode:

QI02AP01

INN (International Name):

Trichophyton verrucosum

Lægemiddelform:

Lyophilisate and solvent for suspension for injection

Recept type:

POM-V - Prescription Only Medicine – Veterinarian

Terapeutisk gruppe:

Cattle

Terapeutisk område:

Live Fungal Vaccine

Autorisation status:

Authorized

Autorisation dato:

2005-09-23

Produktets egenskaber

                                Revised 08 June 2010
AN. 01546/2009
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE VETERINARY MEDICINAL PRODUCT
Bovilis Ringvac
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active substance(s)_
Per ml of reconstituted product:
_Trichophyton verrucosum_

7 x 10
6
and

21 x 10
6
viable
microconidia strain LTF-130.
3
PHARMACEUTICAL FORM
Lyophilisate for suspension for injection
4
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle
4.2
INDICATIONS FOR USE SPECIFYING THE TARGET SPECIES
For active immunisation of cattle to reduce clinical signs of ringworm
caused by
_Trichophyton verrucosum_. (prophylactic dose) and to shorten the
recovery time of
infected cattle showing clinical signs of ringworm (therapeutic dose).
Onset of immunity has been demonstrated at 3 weeks after completion of
the
recommended course.
The duration of protection has not been determined but experience of
use in the field
suggests that after the recommended course has been completed cattle
continue to be
protected without re-vaccination.
4.3
CONTRAINDICATIONS
Do not vaccinate cattle already infected with or in the incubation of
an infection with
_Trichophyton verrucosum_ with the prophylactic dose. In such cases,
animals show signs
of the disease which could be severe.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE, INCLUDING SPECIAL PRECAUTIONS TO BE TAKEN
BY THE PERSON
ADMINISTERING THE MEDICINAL PRODUCT TO ANIMALS.
4.5.1 Special precautions for use in animals
Occasional hypersensitivity reactions may occur. In such cases
appropriate
treatment with e.g. adrenaline should be given without delay.
Use fresh sterilised equipment for each injection.
Revised 08 June 2010
AN. 01546/2009
4.5.2Special precautions to be taken by the person administering the
veterinary
medicinal product to animals
Immuno-suppressed individuals should not use the product.
In case of accidental self-injection, seek medical advice and show the
package
insert or label to the physician.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Thr
                                
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