Lactovac Suspension for injection

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

Inactivated bovine rotavirus, strain 1005/78; Inactivated bovine rotavirus, strain holland; Inactivated bovine coronavirus, strain 800; Inactivated e.coli k99/f41, strain s1091/83

थमां उपलब्ध:

Zoetis Belgium S.A.

ए.टी.सी कोड:

QI02AL01

INN (इंटरनेशनल नाम):

Inactivated bovine rotavirus, strain 1005/78; Inactivated bovine rotavirus, strain holland; Inactivated bovine coronavirus, strain 800; Inactivated e.coli k99/f41, strain s1091/83

डोज़:

strain 1005/78  at least 107.4

फार्मास्यूटिकल फॉर्म:

Suspension for injection

प्रिस्क्रिप्शन प्रकार:

LM: Licensed Merchant as defined in relevant national legislation

चिकित्सीय समूह:

Cattle

चिकित्सीय क्षेत्र:

bovine rotavirus + bovine coronavirus + escherichia

चिकित्सीय संकेत:

Immunological - Inactivated Vaccine

प्राधिकरण का दर्जा:

Authorised

प्राधिकरण की तारीख:

2013-12-09

उत्पाद विशेषताएं

Health Products Regulatory Authority
16 April 2021
CRN009Y3S
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Lactovac Suspension for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml dose contains:
​
​
ACTIVE SUBSTANCES:
​
​
Inactivated bovine rotavirus, strain 1005/78 > 1 RPU*
​
​
Inactivated bovine rotavirus, strain Holland > 1 RPU*
​
​
Inactivated bovine coronavirus, strain 800 > 1 RPU*
​
​
Inactivated _E.coli_ K99/F41, strain S1091/83 > 1 RPU*
* Relative potency unit; RPU = antibody response in rabbit
potency test not significantly lower than that obtained with a
reference batch shown efficacious in cattle. ​
​
ADJUVANTS:
​
​
Aluminium hydroxide
60​
mg
Quil A (_Quillaja saponaria _saponin extract)
1 mg​
​
EXCIPIENTS:
​
​
Thiomersal
0.05 mg​
​
For the full list of excipients, see section 6.1.
​
3 PHARMACEUTICAL FORM
Suspension for injection.
Pinkish liquid suspension which might contain loose sediment which is
easily resuspended.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle (cows and heifers).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the active immunisation of pregnant cows and heifers in order to
confer passive protection to their calves (via colostrum) to
reduce the severity and duration of neonatal diarrhoea caused by
rotavirus, coronavirus and _E. coli_ (K99/F41) infections.
Protection is conferred only while the calves are fed colostrums from
vaccinated cows.
4.3 CONTRAINDICATIONS
Do not use in animals which have intercurrent infection or are in poor
nutritional status.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
Protection of the herd.
Neonatal diarrhoea in calves is caused by pathogens which are
constantly present in the herd. For this reason proper control
measures require that all pregnant cows and heifers in a herd must be
included in the programme of immunisation. This is the
only way in which the pressure of infection can be reduced.
Health Produc