País: Unió Europea
Idioma: anglès
Font: EMA (European Medicines Agency)
Canine herpesvirus (F205 strain) antigens
Boehringer Ingelheim Vetmedica GmbH
QI07AA
Canine herpes vaccine (inactivated subunit)
Dogs
Immunologicals for canidae
Active immunisation of bitches to prevent mortality, clinical signs and lesions in puppies resulting from canine herpes virus infections acquired in the first few days of life.
Revision: 12
Authorised
2001-03-26
14 B. PACKAGE LEAFLET 15 PACKAGE LEAFLET: EURICAN HERPES 205 POWDER AND SOLVENT FOR EMULSION FOR INJECTION 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder: Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein GERMANY Manufacturer responsible for batch release: Boehringer Ingelheim Animal Health France SCS Laboratoire Porte des Alpes Rue de l’Aviation 69800 Saint Priest FRANCE 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Eurican Herpes 205 powder and solvent for emulsion for injection 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Per 1 ml dose: Lyophilisate : ACTIVE SUBSTANCE: Canine herpesvirus (F205 strain) antigens 0.3 to 1.75 µg* *expressed in µg of gB glycoproteins Solvent: ADJUVANT : Light paraffin oil 224.8 to 244.1 mg Lyophilisate: white pellet. Solvent: homogeneous white emulsion 4. INDICATIONS Active immunisation of pregnant bitches to prevent mortality, clinical signs and lesions in puppies resulting from canine herpes virus infections acquired in the first few days of life through passive immunity. 5. CONTRAINDICATIONS None. 16 6. ADVERSE REACTIONS The vaccine may commonly cause transient oedema at the site of injection. These reactions usually regress within one week. Hypersensitivity reactions may rarely occur. Appropriate symptomatic treatment should be administered. The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports). If you notice any serious effects or other effects, even those not already listed in this package leaflet, or you think that Llegiu el document complet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Eurican Herpes 205 powder and solvent for emulsion for injection. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Per 1 ml dose: Lyophilisate : ACTIVE SUBSTANCE: Canine herpesvirus (F205 strain) antigens 0.3 to 1.75 µg* *expressed in µg of gB glycoproteins Solvent : ADJUVANT: Light paraffin oil 224.8 to 244.1 mg EXCIPIENTS: For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for emulsion for injection Lyophilisate : white pellet. Solvent: homogeneous white emulsion. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Active immunisation of pregnant bitches to prevent mortality, clinical signs and lesions in puppies resulting from canine herpes virus infections acquired in the first few days of life through passive immunity. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Vaccinate healthy animals only. Abortion and premature parturition can occur as a result of CHV infection in bitches, the protection of the bitch against infection has not been studied for this vaccine. In order for immunity to be conferred to the puppies, sufficient intake of colostrum is required. 3 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals None. 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 product, seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you. If pain persists for more than 12 hours after medical examination, seek medical advice again. To the physician: Llegiu el document complet