Anivac VHD Suspension for injection for rabbits

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

Rabbit haemorrhagic disease, strain RHDV PHB 98

थमां उपलब्ध:

Pharmagal Bio s.r.o

ए.टी.सी कोड:

QI08AA01

INN (इंटरनेशनल नाम):

Rabbit haemorrhagic disease, strain RHDV PHB 98

डोज़:

minimum 1 PD90

फार्मास्यूटिकल फॉर्म:

Suspension for injection

प्रिस्क्रिप्शन प्रकार:

POM: Prescription Only Medicine as defined in relevant national legislation

चिकित्सीय समूह:

Rabbits

चिकित्सीय क्षेत्र:

rabbit haemorrhagic disease virus

चिकित्सीय संकेत:

Immunological - Inactivated Vaccine

प्राधिकरण का दर्जा:

Authorised

प्राधिकरण की तारीख:

2008-11-10

उत्पाद विशेषताएं

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Anivac VHD Suspension for injection for rabbits
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose of vaccine (0.5 ml) contains:
_Active substances:_
Inactivated Rabbit Haemorrhagic Disease Virus strain RHDV PHB98
…… min. 1 PD
90
*
_Adjuvant:_
Aluminium hydroxide gel
.................................................................................
1.3 mg
_Excipients:_
Formaldehyde
………………………………………………………………
0.55 mg
Thiomersal
………………………………………………………………
0.05 mg
For a full list of excipients, see section 6.1.
* Protective dose for minimum 90 % of vaccinated animals
3 PHARMACEUTICAL FORM
Suspension for injection.
Suspension of red-brown colour with easily shakeable sediment of
inactivated RHDV adsorbed on aluminium
hydroxide gel that forms 40-60 % of the vaccine if left undisturbed.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Rabbit.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of rabbits to prevent mortality caused by RHD
virus
Onset of immunity: 7 days
Duration of immunity: 1 year based on field data without controlled
challenge
4.3 CONTRAINDICATIONS
None.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
No information is available on the use of the vaccine in seropositive
animals including those with maternally derived
antibodies; therefore in situations where high antibody levels are
expected the vaccination protocol should be planned
accordingly.
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