Eurican Dhppi
Revised: May 2012
AN: 02063/2011
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SUMMARY OF PRODUCT CHARACTERISTICS |
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1. |
NAME OF THE VETERINARY MEDICINAL PRODUCT |
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EURICAN DHPPi |
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2. |
QUALITATIVE AND QUANTITATIVE COMPOSITION |
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Each 1-ml dose of vaccine contains: Freeze-dried pellet Attenuated canine distemper virus, at least 104.0 CCID50 Attenuated canine adenovirus (CAV2), at least 102.5 CCID50 Attenuated canine parvovirus, at least 104.9 CCID50 Attenuated canine parainfluenza type 2 virus, at least 104.7 CCID50 For full list of excipients, see section 6.1. |
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3. |
PHARMACEUTICAL FORM |
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Lyophilisate for suspension. |
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4. |
CLINICAL PARTICULARS |
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4.1 |
Target species |
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Dogs and puppies from 8 weeks of age. |
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4.2 |
Indications for use specifying the target species |
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In the dog: Active immunization against distemper to reduce mortality and clinical signs; against infectious canine hepatitis to prevent clinical signs; against parvovirus to prevent clinical signs and reduce mortality and viral excretion; and against parainfluenza type 2 infections to reduce clinical signs and viral excretion. Onset of immunity: 2 weeks after completion of the primary vaccination course. Duration of immunity: 1 year. |
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4.3 |
Contra-indications |
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None. |
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4.4 |
Special warnings for each target species |
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None |
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4.5 |
Special precautions for use, including special precautions to be taken by the person administering the medicinal product to animals |
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i. Special precautions for use in animals |
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The CAV 2 and CPV vaccinal strains may be shed from vaccinated animals for a number of days following vaccination. However, due to the absence of demonstrable pathogenicity of these strains, it is not necessary to keep vaccinated animals separated from non-vaccinated animals. |
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ii. Special precautions to be taken by the person administering the medicinal product to animals |
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In case of accidental self-injection, seek medical advice immediately and show this package insert or the label to the physician. |
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4.6 |
Adverse reactions (frequency and seriousness) |
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Vaccination may occasionally cause hypersensitivity reactions in some animals. In such cases, symptomatic treatment should be provided. In rare cases, immediately after the injection, slight and transient pain may occur at the injection site. Slight swelling (<4cm) at the injection site may be observed after vaccination. Such swellings will resolve in most animals within 4-5 days. Some animals may also show slight dullness during the first three days post vaccination. |
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4.7 |
Use during pregnancy, lactation or lay |
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Can be used during pregnancy. In the absence of data from studies in seronegative bitches, the vaccine should only be used in pregnant bitches which have previously been vaccinated before pregnancy. |
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4.8 |
Interaction with other medicinal products and other forms of interaction |
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Safety and efficacy data are available which demonstrate that this vaccine can be reconstituted in Eurican L. No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the product mentioned above. A decision to use this vaccine before and after any other veterinary medicinal product therefore needs to be made on a case by case basis. |
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4.9 |
Amounts to be administered and administration route |
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Reconstitute the vaccine with Eurican L using a clean, sterile syringe. Use the vaccine immediately after reconstitution of the freeze-dried pellet. Apply usual aseptic procedures. Use sterile and/or disinfectant free equipment for injection purposes. Administer by subcutaneous injection. The following vaccination schedule is recommended: |
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Primary vaccination: 1st injection: from 8th week of age. 2nd injection: 3 to 5 weeks later, from 12th week of age. Re-vaccination: Booster injections should be given annually thereafter. |
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4.10 |
Overdose (symptoms, emergency procedures, antidotes), if necessary |
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No signs other than those described under 4.6 have been observed after administration of a vaccine overdose. |
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4.11 |
Withdrawal periods |
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Not applicable. |
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5. |
IMMUNOLOGICAL PROPERTIES |
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The vaccine induces an immune response against distemper, infectious canine hepatitis, parvovirosis and parainfluenza type 2 infections in the dog. |
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ATC Vet Code: QI07AD04 |
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6. |
PHARMACEUTICAL PARTICULARS |
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6.1 |
List of excipients |
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Freeze drying substrate |
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6.2 |
Major incompatibilities |
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Do not mix with any other veterinary medicinal product except Eurican L. |
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6.3 |
Shelf-life |
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Shelf-life of the veterinary medicinal product as packaged for sale: 2 years. Shelf-life after reconstitution: Use immediately after reconstitution. |
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6.4 |
Special precautions for storage |
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Store and transport between +2oC and +8oC, protected from light. Do not freeze. |
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6.5 |
Nature and composition of immediate packaging |
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The vaccine is filled in 1 dose vials glass type I (Ph.Eur.) which are closed with a butyl elastomer rubber stopper and a varnished aluminium cap. Pack of 10 single dose 1ml bottles containing one freeze-dried pellet. Pack of 5x10 single dose 1ml bottles containing one freeze-dried pellet. Not all pack sizes may be marketed. |
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6.6 |
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products |
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Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant approved for use by the competent authorities. |
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7. |
MARKETING AUTHORISATION HOLDER |
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Merial Animal Health Limited PO Box 327 Sandringham House Sandringham Avenue Harlow Business Park Harlow Essex CM19 5TG UK |
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8. |
MARKETING AUTHORISATION NUMBER(S) |
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Vm 08327/4126 VPA 10857/36/1 |
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9. |
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION |
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Date: UK:19th June 1997 Date: IE: 28th October 2005 |
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10. |
DATE OF REVISION OF THE TEXT |
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Date: May 2012 |
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PROHIBITION OF SALE, SUPPLY AND/OR USE |
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Not applicable |
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