PORCILIS LAWSONIA IDAL INACTIVATED VACCINE FOR PIGS

Kraj: Australia

Język: angielski

Źródło: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Składnik aktywny:

LAWSONIA INTRACELLULARIS STRAIN SPAH-08

Dostępny od:

INTERVET AUSTRALIA PTY LIMITED

Forma farmaceutyczna:

MISC. VACCINES OR ANTI SERA

Skład:

LAWSONIA INTRACELLULARIS STRAIN SPAH-08 VACCINE Active 0.0 U

Sztuk w opakowaniu:

1 x 100 doses (Porcilis Lawsonia IDAL lyophilisate) + 1 x 20 mL solvent (X-Solve 12); 1 x 50 doses (Porcilis Lawsonia IDAL lyophilisate) + 1 x 10 mL solvent (X-Solve 12); 10 x 100 doses (Porcilis Lawsonia IDAL lyophilisate) + 10 x 20 mL solvent (X-Solve 12); 10 x 50 doses (Porcilis Lawsonia IDAL lyophilisate) + 10 x 10 mL solvent (X-Solve 12)

Klasa:

VM - Veterinary Medicine

Dziedzina terapeutyczna:

IMMUNOTHERAPY

Podsumowanie produktu:

Poison schedule: 0; Withholding period: Zero (0) days ESI: Zero (0) days. Befor e using this product, confirm the curren t ESI from Intervet Australia Pty Limite d 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 ]

Status autoryzacji:

Registered

Data autoryzacji:

2023-07-01

Ulotka dla pacjenta

PORCILIS LAWSONIA IDAL INACTIVATED VACCINE FOR PIGS
91825/133595
Product Name:
APVMA Approval No:
Label Name:
PORCILIS LAWSONIA IDAL INACTIVATED VACCINE FOR PIGS
Signal Headings:
FOR ANIMAL TREATMENT ONLY
Constituent
Statements:
[Lyophilisate]
Each 0.2 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 0.2 mL:
8.3 mg paraffin, light liquid (adjuvant)
0.6 mg dl-α-tocopheryl acetate (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 10 ml solvent
1 x 100 doses and 1 x 20 ml solvent
10 x 50 doses and 10 x 10 ml solvent
10 x 100 doses and 10 x 20 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 ID” or
Porcilis PCV IDAL Emulsion
for Injection for Pigs (APVMA No. 84901).
Contraindications:
Precautions:
Use with caution in pregnant or lactating sows as the safety of this
product has not been
established. RLP APPROVED
Side Effects:
An increase in body temperature very commonly occurs (mean 0.1°C, in
individual pigs up
to 1.4°C). The animals return to normal temperature within 1 day
after vaccination. Local
injection site reactions in the form of swelling may very commonly
occur (mean diameter
of approximately 1cm, in individual pigs up to 5cm). Local reactions
resolve within 4 weeks
after vaccination.
Dosage and
Administration:
USE ALL PRODUCT WITHIN 6 HOURS OF RECONSTITUTION. Discard the unused
portion.
For intradermal administration only.
Reconstitute the freeze-dried vaccine pellet in the solvent or
Porcilis PCV IDAL Emulsion
for Injection