Leucogen

Health Products Regulatory Authority 18 July 2017 CRN000VVS Page 1 of 4 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Leucogen 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose (1.0 ml) contains: Active substance: FeLV recombinant p45 antigen Minimum: 97 micrograms Target 102 micrograms Adjuvant: Aluminium hydroxide gel (3%) 0.1 ml Quil A 10 micrograms Excipients: For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Suspension for injection 4 CLINICAL PARTICULARS 4.1 Target Species Cats. 4.2 Indications for use, specifying the target species For active immunisation of healthy cats to prevent persistent feline leukaemia-virus viraemia and any associated clinical signs of feline leucocis. The onset of protection begins 2 weeks after immunisation and the duration of protection lasts one year after the basic vaccination. Health Products Regulatory Authority 18 July 2017 CRN000VVS Page 2 of 4 4.3 Contraindications Refer to Section 4.7. 4.4 Special warnings for each target species None. 4.5 Special precautions for use Special precautions for use in animals The vaccine should be administered in accordance with the usual aseptic conditions for vaccination. Vaccinate only healthy animals. It is recommended that animals be treated for intestinal parasites at least 10 days prior to vaccination. Special precautions to be taken by the person administering the veterinary medicinal product to animals In the case of accidental self-injection, seek medical advice immediately and show the package insert or the label to the physician. 4.6 Adverse reactions (frequency and seriousness) Transient and small thickening or nodule, approximately 5-10 mm in size, may be observed at the injection site and disappear within 2 to 6 weeks without treatment. Occasionally, systemic reactions (hyperthermia, anorexia, lethargy) may occur within one or two days after vaccine administration. 4.7 Use during pregnancy, lactation or lay In the absence of supporting data, the vaccine should not be used in pregnant or lactating cats. 4.8 Interaction with other medicinal products and other forms of interaction No information is available on the safety and efficacy from the concurrent use of this vaccine with any other except Feligen RCP, where this vaccine is authorised. It is therefore recommended that no other vaccine than Feligen RCP should be administered within 14 days before or after vaccination with Leucogen. Health Products Regulatory Authority 18 July 2017 CRN000VVS Page 3 of 4 4.9 Amounts to be administered and administration route Shake the vial before use. Administer Leucogen via the subcutaneous route to cats according to the following regimen of vaccination: Basic Vaccination Scheme: Dose 1: A single 1 ml dose from a minimum of 8 weeks of age. Dose 2: A single 1 ml dose 3 to 4 weeks later. Re-vaccination Scheme: Administer a single 1 ml dose on an annual basis thereafter. 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary No undesirable effects have been seen after the administration of an overdose of Leucogen except those indicated in Section 4.6 Adverse Effects. 4.11 Withdrawal period(s) Not applicable 5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES To stimulate active immunity to feline leucosis ATC Vet code: QI06AA01 6 PHARMACEUTICAL PARTICULARS 6.1 List of excipients Disodium phosphate anhydrous Potassium dihydrogen phosphate Sodium chloride Water for injection 6.2 Incompatibilities Do not mix with any other vaccine / immunological product except Feligen RCP, where this vaccine is authorised. Health Products Regulatory Authority 18 July 2017 CRN000VVS Page 4 of 4 6.3 Shelf-life Shelf life of the veterinary medicinal product as packaged for sale: 2 years. 6.4 Special precautions for storage Store and transport refrigerated (2°C - 8°C). Protect from light. Do not freeze. 6.5 Nature and composition of immediate packaging Glass vial containing the vaccine and closed with a 13 mm diameter rubber stopper and sealed with an aluminium seal. 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, where appropriate Any unused product or waste material should be disposed of in accordance with national requirements. 7 MARKETING AUTHORISATION HOLDER Virbac S.A. 1ère avenue 2065 M LID 06516 Carros France 8 MARKETING AUTHORISATION NUMBER(S) VPA 10988/40/1 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21st September 2007 10 DATE OF REVISION OF THE TEXT