ERAVAC Emulsion for Injection for Rabbits

देश: यूनाइटेड किंगडम

भाषा: अंग्रेज़ी

स्रोत: VMD (Veterinary Medicines Directorate)

सक्रिय संघटक:

Rabbit haemorrhagic disease virus

थमां उपलब्ध:

Laboratorios Hipra SA

ए.टी.सी कोड:

QI08AA01

INN (इंटरनेशनल नाम):

Rabbit haemorrhagic disease virus

फार्मास्यूटिकल फॉर्म:

Emulsion for injection

प्रिस्क्रिप्शन प्रकार:

POM-V - Prescription Only Medicine – Veterinarian

चिकित्सीय समूह:

Rabbits

चिकित्सीय क्षेत्र:

Inactivated Viral Vaccine

प्राधिकरण का दर्जा:

Authorized

प्राधिकरण की तारीख:

2016-09-22

उत्पाद विशेषताएं

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