PORCILIS COLI 6C
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
12-05-2024
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Active ingredient:
E.COLI K88AB ANTIGEN E.COLI K88AC ANTIGEN E.COLI K99 ANTIGEN E.COLI 987P ANTIGEN CLOSTRIDIUM PERFRINGENS TYP B CLOSTRIDIUM PERFRINGENS TYPE C TOXOID
Available from:
Intervet Ireland Limited
ATC code:
QI09AB08
Pharmaceutical form:
Suspension for Injection
Therapeutic group:
Immunological - Inactivated vaccine
Therapeutic area:
Porcine
Authorization date:
2011-11-04
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Porcilis Coli 6C.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
For a full list of excipients, see section 6.1.
*
relative to the potency of the reference batch in accordance with Ph. Eur. 962
**
IU = International Unit
3 PHARMACEUTICAL FORM
Suspension for injection.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs (sows and gilts).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
A combined _E. coli _and _Cl. perfringens _Types B, C and D vaccine for pigs.
For the passive protection of piglets by the active immunisation of breeding sows and gilts, to reduce mortality and
clinical signs due to neonatal colibacillosis and enteritis.
4.3 CONTRAINDICATIONS
None.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate only healthy animals.
4.5 SPECIAL PRECAUTIONS FOR USE
ACTIVE SUBSTANCES
PER 5 ML DOSE
Cell-free pilus antigen of _E.coli _K88ab
100 – 135 Units*
Cell-free pilus antigen of _E.coli _K88ac
100 – 135 Units*
Cell-free pilus antigen of _E.coli _K99
190 – 250 Units*
Cell-free pilus antigen of _E.coli _987p
2900 – 3100 units*
Purified toxoids of _Cl. Perfringens _Type B
and purified toxoids of Types C and D
Together contributing not less than 300 IU**
equivalents beta toxoid and not less than 200
IU** equivalents of epsilon toxoid.
ADJUVANT
Aluminium hydroxide
Less than 15 mg aluminium
PRESERVATIVE
Thiomersal
0.01% w/v
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 07/11/2011_
_CRN 7011588_
_page number: 1_
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
None.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS
None.
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Occasio
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