Porcilis Lawsonia lyophilisate and solvent for emulsion for injection for pigs

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Inactivated Lawsonia intracellularis strain SPAH-08

Tersedia dari:

Intervet Ireland Limited

Kode ATC:

QI09AB

INN (Nama Internasional):

Inactivated Lawsonia intracellularis strain SPAH-08

Dosis:

.

Bentuk farmasi:

Lyophilisate and solvent for emulsion for injection

Jenis Resep:

POM: Prescription Only Medicine as defined in relevant national legislation

Area terapi:

Inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia)

Status otorisasi:

Authorised

Tanggal Otorisasi:

2019-11-08

Karakteristik produk

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