Bovilis Ringvac lyophilisate and solvent for suspension for injection for cattle

国: アイルランド

言語: 英語

ソース: HPRA (Health Products Regulatory Authority)

即購入

ダウンロード 製品の特徴 (SPC)
18-06-2019

有効成分:

Attenuated micronidia of trichophyton verrucosum strain ltf-130; Attenuated micronidia of trichophyton verrucosum strain ltf-130; Attenuated micronidia of trichophyton verrucosum strain ltf-130

から入手可能:

Intervet International BV

ATCコード:

QI02AP01

INN(国際名):

Attenuated micronidia of trichophyton verrucosum strain ltf-130; Attenuated micronidia of trichophyton verrucosum strain ltf-130; Attenuated micronidia of trichophyton verrucosum strain ltf-130

投薬量:

.

医薬品形態:

Lyophilisate and solvent for suspension for injection

処方タイプ:

POM: Prescription Only Medicine as defined in relevant national legislation

治療群:

Cattle

治療領域:

trichophyton

適応症:

Immunological

認証ステータス:

Authorised

承認日:

2017-04-21

製品の特徴

                                Health Products Regulatory Authority
18 June 2019
CRN0094DC
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Bovilis Ringvac lyophilisate and solvent for suspension for injection
for cattle
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Per 1 ml of vaccine:
ACTIVE SUBSTANCE:
Attenuated _Trichophyton verrucosum_, strain LTF - 130 ≥9 x 10
6
and ≤21 x 10
6
viable microconidia.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Lyophilisate and solvent for suspension for injection.
Lyophilisate: off white to light brown coloured pellet.
Solvent: clear colourless solution. Reconstituted product: off white
to grey homogenous suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Active immunisation of calves and cattle at risk of infection, or
calves and cattle suffering from dermatophytosisinduced by
_Trichophyton verrucosum_. The prophylactic vaccination reduces
clinical signs of _Trichophyton verrucosum_induced
dermatophytosis while the therapeutic use results in a 2-foldfaster
recovery of animals which already show clinical signs of
disease.
Onset of immunity: 3 weeks after vaccination.
Duration of immunity: at least one year as demonstrated in a
laboratory study.
4.3 CONTRAINDICATIONS
Do not use in animals with fever and / or with
dermatophytosis-independent symptoms of an infectious disease.
Do not use in animals that are treated with corticosteroids.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
_Trichophyton verrucosum_can survive in the environment for 6 - 8
years. It is recommended to combine a vaccination program
with a cleaning and disinfection protocol.
Preparations with antifungal activity should not be given while
immunization is ongoing until three weeks after completion of
vaccination.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Vaccinated animals should not be housed among non-vaccinated animals
showing clinical signs of _Trichophyton _
_verrucosum_infecti
                                
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