Heptavac P Plus
Country: Greece
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
24-01-2013
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Active ingredient:
Cl.chauvoei and equivalent toxoid 0 , Cl.novyi 0 , Cl.perfringens type B 0 TCP units, Cl.perfringens type C 0 , Cl.perfringens type D 0 , Cl.septicum 0 , Cl.tetani 0
Available from:
Intervet Intenational BV
ATC code:
QI04AB05
Pharmaceutical form:
Suspension for injection
Therapeutic group:
Clostridium vaccine + Pasteurella vaccine
Therapeutic area:
Sheep Food
Authorization date:
2010-07-14
Summary of Product characteristics
Revised: July 2010
AN: 01235/2009
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Heptavac P Plus (IT: Heptavac P)
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 ≥ 2.5 IU
_Clostridium novyi_
toxoid inducing ≥ 3.5 IU
_Clostridium chauvoei_
cells and equivalent toxoid inducing ≥ 0.5 guinea pig PD
90
Formalin killed cells of the epidemiologically most important serotypes of
_Mannheimia haemolytica_ and _Pasteurella_ _trehalosi _grown under iron restricted
conditions: 5x10
8
cells per strain
ADJUVANT:
Aluminium hydroxide gel 400 mg
EXCIPIENT:
Thiomersal 0.13 mg (preservative)
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Sheep.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the active immunisation of sheep as an aid in the control of lamb dysentery,
pulpy kidney, struck, tetanus, braxy, blackleg, black disease, clostridial metritis
caused by _Clostridium perfringens_ types B, C and D, _Cl.septicum_, _Cl.novyi_,
_Cl.chauvoei_ and _Cl.tetani_. The vaccine may be used as an aid in the control of
Revised: July 2010
AN: 01235/2009
Page 2 of 6
pneumonic pasteurellosis in sheep of all ages from a minimum age of 3 weeks
and in the control of systemic pasteurellosis in weaned fattening and breeding
sheep.
The vaccine may be used in pregnant ewes as an aid in the control
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