País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
Inactivated leptospira canicola; Inactivated leptospira icterohaemorrhagiae
Boehringer Ingelheim Vetmedica GmbH
QI07AB01
Inactivated leptospira canicola; Inactivated leptospira icterohaemorrhagiae
.
Suspension for injection
POM: Prescription Only Medicine as defined in relevant national legislation
leptospira
Authorised
2004-11-05
Health Products Regulatory Authority 29 May 2020 CRN009PHD Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Eurican L 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Inactivated_ Leptospira canicola................................. _} > 80% protection* Inactivated_ Leptospira icterohaemorrhagiae............. _} Excipient..................................................................... qs 1 dose of 1 ml *According to Ph. Eur. hamster potency test For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Suspension for injection. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs from 8 weeks of age. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES In dogs: Active immunisation against _Leptospira canicola_ and _Leptospira icterohaemorrhagiae_ to prevent mortality and to reduce clinical symptoms of Leptospira infections caused by these agents. Onset of immunity: 14 days after primary vaccination. The duration of immunity is one year. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. Health Products Regulatory Authority 29 May 2020 CRN009PHD Page 2 of 4 4.5 SPECIAL PRECAUTIONS FOR USE (I) SPECIAL PRECAUTIONS FOR USE IN ANIMALS: Vaccinate only healthy animals (II) SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE MEDICINAL PRODUCT TO THE ANIMALS: In the case of accidental self-injection, wash the area immediately with water. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) In rare cases, immediately after injection, transient pain may occur at the injection site. A temperature increase of approximately 1°C lasting no more than a day, may occur in rare cases. In rare circumstances, a hypersensitivity reaction may occur, which may require appropriate symptomatic treatment. 4.7 USE DURING PREGNANCY, LACTATION OR LAY In the absence of data from studies in seronegative bitches, the vaccine should only be used in pregnant bitches which have been vaccinated before pregnancy. 4.8 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTH Llegiu el document complet