Porcilis Lawsonia lyophilisate and solvent for emulsion for injection for pigs

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Inactivated Lawsonia intracellularis strain SPAH-08

Tilgjengelig fra:

Intervet Ireland Limited

ATC-kode:

QI09AB

INN (International Name):

Inactivated Lawsonia intracellularis strain SPAH-08

Dosering :

.

Legemiddelform:

Lyophilisate and solvent for emulsion for injection

Resept typen:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutisk område:

Inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia)

Autorisasjon status:

Authorised

Autorisasjon dato:

2019-11-08

Preparatomtale

Health Products Regulatory Authority
15 February 2022
CRN00CKFS
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Porcilis Lawsonia lyophilisate and solvent for emulsion for injection
for pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 2 ml reconstituted vaccine contains:
​
ACTIVE SUBSTANCE (LYOPHILISATE):
​
​
Inactivated_ Lawsonia intracellularis _strain SPAH-08
​
≥ 5323 U
1
1
Antigenic mass units as determined in the _in vitro_ potency test
(ELISA).
​
ADJUVANT (SOLVENT):
​
​
Light mineral oil
​
222.4 mg
​
Aluminium(as hydroxide)
​
2.0 mg
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Lyophilisate and solvent for emulsion for injection.
Lyophilisate: white/nearly white pellet/powder.
Solvent: homogenous white to nearly white emulsion after shaking.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
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.
4.3 CONTRAINDICATIONS
None.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Not applicable.
Health Products Regulatory Authority
15 February 2022
CRN00CKFS
Page 2 of 5
Special precautions to be taken by the person administering the
veterinary medicinal product to animals
To the user:
This veterinary medicinal product contains mineral oil. Accidental
injection/self-injection may result in severe pain and swelling,
particularly if injected into a joint or finger, and in rare cases
could result in the loss of the affected finger if prompt medical
attention is not given. If you are accidentally injected with this
veterinary medicinal product, seek prompt medical advic