OVIVAC P PLUS

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

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Summary of Product characteristics (SPC)

12-06-2017

DSU (DSU)

20-10-2023

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Active ingredient:

Clostridium perfringens type d, strain 603 epsilon toxoid; Clostridium septicum s1110/85 toxoid; Clostridium tetani, strain 51123/91 toxoid; Clostridium chauvoei strain no. 655; Clostridium chauvoei strain no. 656; Clostridium chauvoei strain no. 657; Clostridium chauvoei strain no. 658; Clostridium chauvoei strain no. 1048; Formalin killed cells of mannheimia haemolytica serotypes a1; Formalin killed cells of mannheimia haemolytica serotypes a2; Formalin killed cells of mannheimia haemolytica serotypes a6; Formalin killed cells of mannheimia haemolytica serotypes a7; Formalin killed cells of mannheimia haemolytica serotypes a9; Formalin killed cells of pasteurella trehalosi serotypes t3; Formalin killed cells of pasteurella trehalosi serotypes t4; Formalin killed cells of pasteurella trehalosi serotypes t10; 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

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
OVIVAC P PLUS
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
ACTIVE SUBSTANCES
per ml
_Clostridium perfringens_ type D_,_ strain 603 epsilon toxoid
inducing
5 IU
_Clostridium septicum_ S1110/85 toxoid
inducing
2.5 IU
_Clostridium tetani,_ strain 51123/91 toxoid
inducing
2.5IU
_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
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4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the active immunisation of sheep to reduce mortality and clinical
signs of pulpy kidney, tetanus, braxy and blackleg
caused by_ Clostridium perfringens_ type D,_ Cl. tetani, Cl.
septicum_, and_ Cl. chauvoei_ and to reduce mortality and
clinic

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