Heptavac P Plus

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

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Summary of Product characteristics (SPC)

27-08-2021

DSU (DSU)

20-10-2023

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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 chauvoei cells and equivalent toxoid of strain 1048; Formalin pasteurella haemolytica strain a1 (s1006/77); Formalin pasteurella haemolytica strain a2 (s1126/92); Formalin pasteurella haemolytica strain a6 (s1084/81); Formalin pasteurella haemolytica strain a7 (s1078/81); Formalin pasteurella haemolytica strain a9 (s994/77); Formalin pasteurella trehalosi strain t3 (s1109/84); Formalin pasteurella trehalosi strain t4 (s1085/81); Formalin pasteurella trehalosi strain t10 (s1075/81); Formalin pasteurella trehalosi strain t15 (s1105/84)

Available from:

Intervet Ireland Limited

ATC code:

QI04AB05

INN (International Name):

Dosage:

Pharmaceutical form:

Suspension for injection

Prescription type:

LR: Licensed Retailer as defined in national legislation

Therapeutic group:

Sheep

Therapeutic area:

clostridium + pasteurella

Therapeutic indications:

Immunological - Inactivated Vaccine

Authorization status:

Authorised

Authorization date:

2003-03-21

Summary of Product characteristics

Health Products Regulatory Authority
26 August 2021
CRN00CDL6
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Heptavac P Plus
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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
For the full list of excipients see section 6.1
3 PHARMACEUTICAL FORM
Suspension for injection
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Sheep and lambs from 3 weeks of age.
Health Products Regulatory Authority
26 August 2021
CRN00CDL6
Page 2 of 4
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 mortality and clinical
signs of lamb dysentery, pulpy kidney, tetanus and pasteurellosis in
their lambs provided that the lambs receive sufficient
colostrum during the first 1 �

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