BOVALTO PASTOBOV

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

Mannheimia haemolytica type 1a antigen leucotoxin

थमां उपलब्ध:

Boehringer Ingelheim Vetmedica GmbH

ए.टी.सी कोड:

QI02AB04

INN (इंटरनेशनल नाम):

Mannheimia haemolytica type 1a antigen leucotoxin

डोज़:

.

फार्मास्यूटिकल फॉर्म:

Suspension for injection

प्रिस्क्रिप्शन प्रकार:

POM (E): Prescription Only Exempt as defined in relevant national legislation

चिकित्सीय क्षेत्र:

pasteurella

प्राधिकरण का दर्जा:

Authorised

प्राधिकरण की तारीख:

2000-02-01

उत्पाद विशेषताएं

Health Products Regulatory Authority
14 December 2018
CRN008RJX
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
BOVALTO PASTOBOV
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
_Mannheimia haemolytica*_type A1 antigen: leucotoxin minimum of
68
ELISA.U**
* _Mannheimia haemolytica_was formerly called _Pasteurella _
_haemolytica_
** 1 ELISA.U: q.s. to obtain a _Mannheimia haemolytica_antibody titre
of 1 ELISA unit in mice after two
administrations of vaccine
ADJUVANT(S):
Aluminium (as hydroxide)
4.2
mg
EXCIPIENT(S):
Thiomersal
0.2
mg
Excipient q.s.p. 1 dose of
2
ml
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Suspension for injection – Milky beige.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Active immunisation of cattle to reduce clinical signs and lesions of
_Mannheimia _
_haemolytica_* A1 induced respiratory disease.
Health Products Regulatory Authority
14 December 2018
CRN008RJX
Page 2 of 5
4.3 CONTRAINDICATIONS
None.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS:
Shake well before use.
Apply usual aseptic procedures.
Vaccinate only healthy animals.
Apply usual procedures for the handling of the animals.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY
MEDICINAL PRODUCT TO ANIMALS:
In the case of accidental self-injection, seek medical advice
immediately and show
the package insert or the label to the physician.
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Vaccination by the subcutaneous route is followed by a limited 2-5 cm
local reaction
(oedema developing as a nodule) that regresses within 3 weeks.
Vaccination by the
intramuscular route can cause a transient, diffuse oedema and slight
local reaction
up to 5 cm diameter that regresses within 1-2 weeks. After
subcutaneous and
intramuscular injection granulomas up to 5 cm diameter may occur.
Vaccination (by
the subcu