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April 2006 Galaxy DAPPi + LC 46J9.27 PART IB Summary of Product Characteristics TIA 50161 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Galaxy DAPPi + LC 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Qualitative composition Combined canine distemper virus vaccine (live), freeze dried; canine adenovirus vaccine (live), freeze dried; canine parainfluenza virus vaccine (live), freeze dried; canine parvovirosis vaccine (live), freeze dried; canine leptospirosis vaccine (inactivated); and canine coronavirus vaccine (inactivated). Quantitative composition 1. Freeze-dried fraction: Active Ingredients Canine Distemper virus, strain Onderstepoort Canine Adenovirus type 2, strain V197 Canine Parainfluenza virus, Strain FDL Canine Parvovirus, strain SAH Per 1 ml dose ≥102.5 to ≤104.8 TCID50 ≥103.6 to ≤107.0 TCID50 ≥104.6 to ≤107.4 TCID50 ≥104.7 to ≤106.5 TCID50 2. Liquid diluent fraction: Active Ingredients Per 1 ml dose Canine coronavirus, strain TN449 (inactivated) RP* 1.0-2.0 Inactivated Leptospira interrogans bacteria (outer membrane coat) Serogroup canicola, Serovar canicola Serogroup icterohaemorrhagiae, serovar icterohaemorrhagiae Potency according to Ph.Eur.** Potency according to Ph.Eur.** Adjuvant Ethylene/Maleic anhydride (EMA) Neocryl XK-62 * ** Relative potency hamster 80% protective dose according to Ph.Eur. Excipients: For a full list of excipients, see section 6.1. D:\582679610.doc 0.01 ml 0.03 ml April 2006 Galaxy DAPPi + LC PART IB Summary of Product Characteristics 3. 46J9.27 TIA 50161 PHARMACEUTICAL FORM Lyophilisate and solvent for suspension for injection. 4. CLINICAL PARTICULARS 4.1 Target Species Dogs 4.2 Indications for use specifying the target species For the active immunisation of dogs to prevent mortality and disease caused by canine distemper virus and canine parvovirus; to prevent mortality and reduce clinical signs due to infectious canine hepatitis and Leptospira; to reduce clinical signs and infection caused by canine adenovirus 2; to reduce shedding of canine parainfluenza virus and to reduce infection at the intestinal level caused by canine coronavirus. The onset of immunity is from two weeks after the final vaccination. The duration of immunity is at least one year for all antigens except the canine parainfluenza component, which is not known but may be less than a year. 4.3 Contraindications See section 4.7. 4.4 Special warnings <for each target species> The live vaccine strains may spread to unvaccinated animals, but do not cause disease. 4.5 Special precautions for use Special precautions for use in animals The efficacy of the CDV, CAV and CPV components of the vaccine may be reduced due to maternal antibody (MDA) interference. Nonetheless, the vaccine has been proved to be of benefit against virulent challenge in the presence of levels of maternal antibody to CDV, CAV and CPV that are likely to be encountered under field conditions. Animals that have received immunosuppressive drugs (e.g. glucocorticoids) should not be vaccinated until an interval of at least 4 weeks has elapsed. D:\582679610.doc April 2006 Galaxy DAPPi + LC PART IB Summary of Product Characteristics 46J9.27 TIA 50161 Special precautions to be taken by the person administering the veterinary medicinal product to animals None. 4.6 Adverse reactions (frequency and seriousness) Very commonly reported reactions include: Following the first vaccination, transient pain at the injection site lasting up to 4 hours and small visible swelling (not more than 2 cm across) at the injection site lasting for up to two days. Following the second vaccination, small visible swelling (up to 5 cm) may be seen at the injection site, which may last for up to five days. The swelling may be painful for 1 to 2 days. Following the third vaccination, a small visible swelling (not more than 2 cm across) lasting for up to 5 days and, less frequently, a larger swelling or localised oedema lasting for up to 2 days. In most cases, these small and transient injection site reactions resolve with no need for treatment. 4.7 Use during pregnancy, lactation or lay Do not use in pregnant or lactating bitches. 4.8 Interactions with other medicinal products and other forms of interaction No information is available on the safety and the efficacy from the concurrent use of this vaccine with any other. This product should not be used concurrently or simultaneously with any other immunological product. 4.9 Amounts to be administered and administration route The vaccine is to be administered by subcutaneous injection to dogs aged 6 weeks and older. Aseptically reconstitute the contents of the freeze-dried vial using the liquid vaccine. Shake well before use. The entire contents of the reconstituted vial should be administered as a single dose. Puppies aged between 6 and 8 weeks: The initial vaccination course consists of three vaccinations. The first vaccination should be given between 6-8 weeks of age and the next two vaccinations given at three-week intervals thereafter. D:\582679610.doc April 2006 Galaxy DAPPi + LC PART IB Summary of Product Characteristics 46J9.27 TIA 50161 Puppies aged at least 8 weeks: Two vaccinations should be given with an interval of 2-4 weeks between doses. The second vaccination should be given to puppies aged at least 12 weeks. Booster vaccination: An annual booster vaccination with one dose of Galaxy DAPPi + LC is recommended. The duration of protection of the CPI component has not been determined and an annual booster may not be sufficient if exposure to a high-risk environment is expected. 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary Some puppies may exhibit a transient lethargy by 4 hours post vaccination but recover by two days post vaccination. Occasionally a small visible swelling (<2 cm) may be seen at the injection site, which may last for up to 17 days. 4.11 Withdrawal period(s) Not applicable. 5. IMMUNOLOGICAL PROPERTIES To stimulate active immunity against canine distemper virus, canine adenovirus, infectious canine hepatitis, canine parainfluenza virus, canine parvovirus, Leptospira interrogans serogroup canicola and Leptospira interrogans serogroup icterohaemorrhagiae and canine coronavirus. ATCVet Code: QI07AJ10 Environmental properties Not applicable. 6. PHARMACEUTICAL PARTICULARS 6.1 List of excipients 1. Freeze-dried fraction: Sucrose Gelatin Bactopeptone Potassium phosphate dibasic Potassium phosphate monobasic Potassium hydroxide D:\582679610.doc April 2006 Galaxy DAPPi + LC PART IB Summary of Product Characteristics 46J9.27 TIA 50161 Eagle’s Earle’s medium with HEPES May contain HCl or NaOH for pH correction 2. Liquid diluent fraction: Sodium chloride Sodium phosphate dibasic Potassium phosphate monobasic Water for injections May contain HCl or NaOH for pH correction 6.2 Incompatibilities Do not mix with any other vaccine or immunological product except the diluent vaccine supplied. 6.3 Shelf life 24 months. Use immediately after reconstitution. 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 Freeze-dried Fraction Vial: Type I (Ph.Eur.) glass. 3 ml capacity Closure: Type I (Ph.Eur.) grey or red bromobutyl rubber stoppers sealed with aluminium crimp caps Liquid diluent Fraction D:\582679610.doc Vial: High-density polypropylene. Contents: 1 ml in a 3 ml injection vial. Closure: Chlorobutyl snap-on rubber stoppers with centre hole caps sealed with aluminium crimp caps. Pack Sizes: Packs with 10, 25, 50 or 100 x 1 ml doses. Each dose is a combination of one vial of freeze-dried vaccine and one vial of liquid vaccine. April 2006 Galaxy DAPPi + LC PART IB Summary of Product Characteristics 6.6 46J9.27 TIA 50161 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products Any unused vaccine or waste material should be disposed of in accordance with local requirements. 7. MARKETING AUTHORISATION HOLDER Fort Dodge Animal Health Limited Flanders Road Hedge End Southampton SO30 4QH United Kingdom 8. MARKETING AUTHORISATION NUMBERS Vm 01596 / 4326 9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION <{DD/MM/YYYY}> <{DD month YYYY}> 10. DATE OF REVISION OF THE TEXT April 2006 PROHIBITION OF SUPPLY, SALE AND/OR USE D:\582679610.doc