국가: 영국
언어: 영어
출처: VMD (Veterinary Medicines Directorate)
Lawsonia intracellularis
MSD Animal Health UK Limited
Lawsonia intracellularis
Lyophilisate and solvent for emulsion for injection
POM-V - Prescription Only Medicine – Veterinarian
Pigs
Inactivated Bacterial Vaccine
Authorized
2020-12-23
Issued: December 2020 AN: 01307/2019 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Porcilis Lawsonia ID lyophilisate and solvent for emulsion for injection for pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 0.2 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): Paraffin, light liquid 8.3 mg Dl-α-tocopheryl acetate 0.6 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. Issued: December 2020 AN: 01307/2019 Page 2 of 6 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Vaccinate healthy animals only. This vaccine is intended for intradermal administration only. The lyophilisate must be reconstituted in the dedicated “Solvent for Porcilis Lawsonia ID” or in Porcilis PCV ID following the instructions given in section 4.9. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Not applicable. 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 전체 문서 읽기