GLETVAX 6

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

E.coli k88ab antigen; E.coli k88ac antigen; E.coli k99 antigen; E.coli 987p antigen; Purified toxoids of Cl. perfringens

Dostopno od:

Zoetis Belgium S.A.

Koda artikla:

QI09AB08

INN (mednarodno ime):

E.coli k88ab antigen; E.coli k88ac antigen; E.coli k99 antigen; E.coli 987p antigen; Purified toxoids of Cl. perfringens

Odmerek:

.

Farmacevtska oblika:

Suspension for injection

Tip zastaranja:

LR: Licensed Retailer as defined in national legislation

Terapevtska skupina:

Pigs

Terapevtsko območje:

escherichia + clostridium

Terapevtske indikacije:

Immunological - Inactivated Vaccine

Status dovoljenje:

Authorised

Datum dovoljenje:

2013-08-29

Lastnosti izdelka

Health Products Regulatory Authority
04 September 2017
CRN000TZN
Page 1 of 5
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
GLETVAX 6
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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
Health Products Regulatory Authority
04 September 2017
CRN000TZN
Page 2 of 5
Thiomersal
Less than 0.575 mg
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.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN IN ANIMALS
None.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY
MEDICINAL PRODUCT TO ANIMALS:
Health Products Regulatory Authority
04 September 2017
CRN000TZN
Page 3 of 5
None.
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Occasional hypersensitivity reactions may occur. Prompt subcutaneous
administration of adrenaline may relieve the condition.
In most pigs, a slight to moderate swellin