ERAVAC Emulsion for Injection for Rabbits

国: イギリス

言語: 英語

ソース: VMD (Veterinary Medicines Directorate)

有効成分:

Rabbit haemorrhagic disease virus

から入手可能:

Laboratorios Hipra SA

ATCコード:

QI08AA01

INN（国際名）:

Rabbit haemorrhagic disease virus

医薬品形態:

Emulsion for injection

処方タイプ:

POM-V - Prescription Only Medicine – Veterinarian

治療群:

Rabbits

治療領域:

Inactivated Viral Vaccine

認証ステータス:

Authorized

承認日:

2016-09-22

製品の特徴

Issued: September 2021
AN: 01737/2020
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
ERAVAC emulsion for injection for rabbits.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 0.5 ml contains:
ACTIVE SUBSTANCE:
Inactivated rabbit haemorrhagic disease type 2 virus (RHDV2), strainV-
1037……≥70% cELISA40*
(*) ≥70 % of vaccinated rabbits shall give cELISA antibody titres
equal to or higher
than 40.
ADJUVANT:
Mineral oil…………104.125 mg
EXCIPIENTS:
Thiomersal…………0.05 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Emulsion for injection.
Whitish emulsion.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Rabbits
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of rabbits from the age of 30 days to reduce
mortality caused
by the rabbit haemorrhagic disease type 2 virus (RHDV2).
Onset of immunity: 1 week.
Duration of immunity: 12 months demonstrated by challenge_ _
4.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance, to
the adjuvant or to
any of the excipients.
Issued: September 2021
AN: 01737/2020
Page 2 of 5
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
The vaccine provides protection only against RHDV2, cross protection
against
classical RHDV has not been demonstrated.
Vaccinate healthy animals only.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Vaccination is recommended where RHDV2 is epidemiologically relevant.
Special precautions to be taken by the person administering the
veterinary medicinal
product to animals
To the user:
This veterinary medicinal product contains mineral oil. Accidental
injection/self-
injection may result in severe pain and swelling, particularly if
injected into a joint or
finger, and in rare cases could result in the loss of the affected
finger if prompt
medical attention is not given. If you are accidentally injected with
this veterinary
medicinal product, seek prompt medical advice even if only a very
small