Porcilis Lawsonia Inactivated Vaccine for Pigs

Land: Australië

Taal: Engels

Bron: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Werkstoffen:

LAWSONIA INTRACELLULARIS STRAIN SPAH-08

Beschikbaar vanaf:

INTERVET AUSTRALIA PTY LIMITED

farmaceutische vorm:

MISC. VACCINES OR ANTI SERA

Samenstelling:

LAWSONIA INTRACELLULARIS STRAIN SPAH-08 VACCINE Active 5323.0 U

Eenheden in pakket:

10x100 doses (Porcilis Lawsonia lyophilisate) + 10x200 mL solvent (Emunade); 10x50 doses (Porcilis Lawsonia lyophilisate) + 10x100 mL solvent (Emunade); 1x100 doses (Porcilis Lawsonia lyophilisate) + 1x200 mL solvent (Emunade); 1x50 doses (Porcilis Lawsonia lyophilisate) + 1x100 mL solvent (Emunade)

klasse:

VM - Veterinary Medicine

Therapeutisch gebied:

IMMUNOTHERAPY

Product samenvatting:

Poison schedule: 0; Withholding period: Zero (0) days. EXPORT SLAUGHTER INTERVA L (ESI): Zero (0) days. Before using t his product, confirm the current ESI fro m Intervet Australia Pty Limited on 1800 033 461 or the APVMA website (www.apvma .gov.au/residues).; Host/pest details: PIG - 3 WEEKS AND OLDER: [ILEITIS, LAWSONIA INTRACELLULARIS , REDUCE LAWSONIA INTRACELLULARIS SHEDDING ]

Autorisatie-status:

Registered

Autorisatie datum:

2023-07-01

Bijsluiter

Porcilis Lawsonia Inactivated Vaccine for Pigs
91351/131935
Product Name:
APVMA Approval No:
Label Name:
Porcilis Lawsonia Inactivated Vaccine for Pigs
Signal Headings:
FOR ANIMAL TREATMENT ONLY
Constituent
Statements:
[Lyophilisate]
Each 2 mL dose of reconstituted vaccine contains
Inactivated Lawsonia intracellularis strain SPAH-08: ≥ 5323 U*
*Antigenic mass units as determined in the in vitro potency test
(ELISA).
[Solvent]
Per 2 mL
222.4 mg Light mineral oil (adjuvant)
2.0 mg Aluminium (adjuvant)
Claims:
For the active immunisation of pigs from 3 weeks of age to reduce
diarrhoea, loss of
daily weight gain, intestinal lesions, bacterial shedding and
mortality caused by Lawsonia
intracellularis infection.
Onset of immunity: 4 weeks after vaccination.
Duration of immunity: 21 weeks after vaccination.
Net Contents:
1 x 50 doses and 1 x 100 mL solvent
1 x 100 doses and 1 x 200 mL solvent
10 x 50 doses and 10 x 100 mL solvent
10 x 100 doses and 10 x 200 mL solvent
Directions for Use:
Restraints:
DO NOT MIX the freeze-dried vaccine pellet with any other veterinary
medicinal product,
except the recommended “Solvent for Porcilis Lawsonia” or Porcilis
PCV M Hyo (APVMA
No. 82241).
Contraindications: RLP APPROVED
Precautions:
Use with caution in pregnant or lactating sows as the safety of this
product has not been
established.
Side Effects:
An increase in body temperature very commonly occurs (mean 0.6°C, in
individual pigs up
to 1.3°C). The animals return to normal temperature within 1 day
after vaccination. Local
injection site reactions in the form of swelling (< 5 cm diameter) may
commonly occur and
resolve within 23 days. Anorexia and lethargy have been reported
uncommonly.
Dosage and
Administration:
USE ALL PRODUCT WITHIN 6 HOURS OF RECONSTITUTION. Discard the unused
portion.
Intramuscular use.
Reconstitute the freeze-dried vaccine pellet in the solvent or in
Porcilis PCV M Hyo
(APVMA No. 82241) as follows:
For proper reconstitution and correct administration, use the
following procedure:
1. Allow the solven