GLETVAX 6

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

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, CLOSTRIDIUM PERFRINGENS TYPE D TOXOID

Disponibil de la:

Zoetis Ireland Limited

Codul ATC:

QI09AB08

INN (nume internaţional):

E.COLI K88AB ANTIGEN, E.COLI K88AC ANTIGEN, E.COLI K99 ANTIGEN, E.COLI 987P ANTIGEN, CLOSTRIDIUM PERFRINGENS TYP B, CLOSTRIDIUM

Forma farmaceutică:

Suspension for Injection

Tip de prescriptie medicala:

LM: Licensed Merchant as defined in relevant national legislation

Grupul Terapeutică:

Porcine

Zonă Terapeutică:

escherichia + clostridium

Indicații terapeutice:

Immunological - Inactivated vaccine

Statutul autorizaţiei:

Authorised

Data de autorizare:

2013-08-29

Caracteristicilor produsului

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
GLETVAX 6
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
For a full list of excipients, see section 6.1.
*
Antibody titre obtained in the potency test in mice 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.
ACTIVE SUBSTANCES
PER 5 ML DOSE
Cell-free pilus antigen of_ E.coli_ K88ab
14.6 log
2
antibody titre*
Cell-free pilus antigen of_ E.coli_ K88ac
15.5 log
2
antibody titre *
Cell-free pilus antigen of_ E.coli_ K99
12.2 log
2
antibody titre *
Cell-free pilus antigen of_ E.coli_ 987p
13.1 log
2
antibody titre *
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
Less than 0.575 mg
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