Porcilis Coli 6C

Land: Storbritannia

Språk: engelsk

Kilde: VMD (Veterinary Medicines Directorate)

Aktiv ingrediens:

Clostridium perfringens, Escherichia coli

Tilgjengelig fra:

Intervet UK Ltd

ATC-kode:

QI09AB08

INN (International Name):

Clostridium perfringens, Escherichia coli

Autorisasjon status:

Expired

Preparatomtale

Revised: December 2011
AN: 01181/2011
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Porcilis Coli 6C
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
ACTIVE SUBSTANCES
PER 5 ML DOSE
Cell-free pilus antigen of K88ab
100-135 units
Cell-free pilus antigen of K88ac
100-135 units
Cell-free pilus antigen of K99
190-250 units
Cell-free pilus antigen of 987P
2900-3100 units
Purified toxoids of _Cl. perfringens_ Type B, C and D
together contributing equivalents beta toxoid
and equivalents of epsilon toxoid
≥ 300 IU
≥ 200 IU
Aluminium Hydroxide (Adjuvant)
≤ 15mg A1
Thiomersal (Preservative)
0.01% w/v
For a full list of excipients, see section 6.1.
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 prevent neonatal colibacillosis caused by K99
bearing
strains of _E. coli; _reduce neonatal colibacillosis caused by K88ab,
K88ac and
987P bearing strains of _E.coli_ and _Cl. perfringens_ Type C
necrotising
infectious enteritis.
4.3
CONTRA-INDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate only healthy animals.
Page 1 of 4
Revised: December 2011
AN: 01181/2011
4.5
SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
Occasional hypersensitivity reactions may occur. Prompt
subcutaneous administration of adrenaline may relieve the condition.
Syringes and needles should be sterilised before use and injection
should be made through an area of clean, dry skin, taking precautions
against contamination.
ii.
Special precautions to be taken by the person administering the
veterinary medicinal product to animals
None
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
In most pigs, a slight to moderate swelling (up to 6 cm) may be seen
at the
injection site after vaccination. The