HEPTAVAC P PLUS

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CLOSTRIDIUM PERFRINGENS BETA TOXOID (STRAINS 554 AND 578), CLOSTRIDIUM PERFRINGENS EPSILON TOXOID (STRAIN 603), CLOSTRIDIUM SEPTICUM TOXOID (STRAIN 505), CLOSTRIDIUM TETANI TOXOID (STRAIN S1123/91), CLOSTRIDIUM NOVYI TOXOID (STRAIN 754), CLOSTRIDIUM CHAUVOEI CELLS AND EQUIVALENT TOXOID OF STRAIN 655, CLOSTRIDIUM CHAUVOEI CELLS AND EQUIVALENT TOXOID OF STRAIN 656, CLOSTRIDIUM CHAUVOEI CELLS AND EQUIVALENT TOXOID OF STRAIN 657, CLOSTRIDIUM CHAUVOEI CELLS AND EQUIVALENT TOXOID OF STRAIN 658, CLOSTRIDIUM CHAUVO

Available from:

Intervet Ireland Limited

ATC code:

QI04AB05

INN (International Name):

CLOSTRIDIUM PERFRINGENS BETA TOXOID (STRAINS 554 AND 578), CLOSTRIDIUM PERFRINGENS EPSILON TOXOID (STRAIN 603), CLOSTRIDIUM SEPT

Dosage:

Unknown

Pharmaceutical form:

Suspension for Injection

Prescription type:

LM-Licensed Merchant

Therapeutic group:

Ovine

Therapeutic area:

Clostridium vaccine + Pasteurella vaccine

Therapeutic indications:

Immunological - Inactivated vaccine

Authorization status:

Authorised

Authorization date:

2003-03-21

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Heptavac P Plus
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
For the full list of excipients see section 6.1.
ACTIVE SUBSTANCES
per ml
_Clostridium perfringens _beta toxoid
inducing
10 IU
_Clostridium perfringens _epsilon toxoid
inducing
5 IU
_Clostridium septicum _toxoid
inducing
2.5 IU
_Clostridium tetani _toxoid
inducing
2.5IU
_Clostridium novyi _toxoid
inducing
3.5 IU
_Clostridium chauvoei _cells and equivalent toxoid of strains 655,656,657,658,
1048.
inducing
0.5 guinea pig PD
90
Formalin killed cells of _Mannheimia haemolytica _serotypes:
A1
5 x 10
8
cells
A2
5 x 10
8
cells
A6
5 x 10
8
cells
A7
5 x 10
8
cells
A9
5 x 10
8
cells
Formalin killed cells of _Pasteurella trehalosi _serotypes:
T3
5 x 10
8
cells
T4
5 x 10
8
cells
T10
5 x 10
8
cells
T15
5 x 10
8
cells
ADJUVANT
Aluminium hydroxide gel
400
mg
EXCIPIENTS
Thiomersal (preservative)
0.067 - 0.15 mg
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 29/09/2016_
_CRN 7024719_
_page number: 1_
3 PHARMACEUTICAL FORM
Suspension for injection
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Sheep and lambs from 3 weeks of age.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the active immunisation of sheep to reduce mortality and clinical signs of lamb dysentery, pulpy kidney, struck,
tetanus, braxy, blackleg and black disease, caused by _Clostridium perfringens _types B, C and D, _Cl. septicum, Cl._
_novyi, Cl. chauvoei _and _Cl. tetani_. The vaccine may also be used for the active immunisation of sheep to reduce
mortality and clinical signs of pneumonic and systemic pasteurellosis.
The vaccine may be used in pregnant ewes to provide passive immunisation of their lambs to reduce