Duramune Pi
Revised: 01 December 2014
AN: 00723/2014
SUMMARY OF PRODUCT CHARACTERISTICS
NAME OF THE IMMUNOLOGICAL VETERINARY MEDICINAL PRODUCT
Duramune Pi
QUALITATIVE AND QUANTITATIVE COMPOSITION
Qualitative composition
Combined canine parainfluenza virus vaccine (live), freeze dried.
Quantitative composition
1. Freeze-dried fraction:
-
Active Substances
Per 1 ml dose
Canine Parainfluenza virus, Strain FDL
104.5 to 106.8 TCID50*
*TCID50= tissue culture 50% infective dose
-
Excipients
For a full list of excipients, see section 6.1.
2. Liquid diluent fraction:
-
Water for injection
ml
PHARMACEUTICAL FORM
Lyophilisate and solvent for suspension for injection.
CLINICAL PARTICULARS
Target Species
Dogs.
Indications for use, specifying the target species
For the active immunisation of dogs to reduce clinical signs due to infection with canine parainfluenza virus and reduce shedding of canine parainfluenza virus.
The onset of immunity is from two weeks after the second vaccination. The duration of immunity is one year.
Contraindications
See section 4.7.
Special warnings
The live vaccine strain may spread to unvaccinated animals, but does not cause disease.
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
In the case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Following the first vaccination, it is very common for puppies to develop a small visible swelling (<2 cm) lasting for generally only two days. Following the second vaccination, it is common for a small visible swelling (up to 5 cm) to be seen at the injection site, which may last for up to five days. The swelling may be painful for 1 to 2 days.
In most cases, these small and transient injection site reactions resolve with no need for treatment.
In very rare cases, type I hypersensitivity reactions (facial oedema, urticaria, anaphylactic reaction), vomiting and diarrhoea may be observed after vaccination. In the event of an allergic or anaphylactic reaction, immediate appropriate symptomatic treatment should be given.
Do not use in pregnant or lactating bitches.
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. It is therefore recommended that no other vaccines should be administered within 14 days before or after vaccination with the product.
Amounts to be administered and administration route
The vaccine is to be administered subcutaneously to dogs of the age of 6 weeks and older.
Aseptically reconstitute the contents of the freeze-dried vial using the diluent provided. Shake well before use. The entire contents of the reconstituted vial should be administered as a single dose. Syringes and needles should not have been sterilised chemically or be above ambient temperature. Do not use chemicals to disinfect or sterilise skin.
Puppies 6-10 weeks of age
The initial vaccination course consists of two vaccinations. The first vaccination should be given between 6-8 weeks of age and the second vaccination should be given from 10 weeks of age.
Puppies of at least 10 weeks of age
Two vaccinations should be given with an interval of 2-4 weeks between doses.
Booster vaccination
An annual booster vaccination with one dose of Duramune Pi is recommended.
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 (<5 cm) may be seen at the injection site, which may last for up to 17 days. Transient mild hyperthermia lasting not more than 24 hours may be seen in up to 20% of dogs given an overdose.
Withdrawal period(s)
Not applicable.
IMMUNOLOGICAL PROPERTIES
To stimulate active immunity against canine parainfluenza virus.
ATCVet Code: QI07AD08
PHARMACEUTICAL PARTICULARS
List of excipients
1. Freeze-dried fraction:
Sucrose
Gelatin
Bactopeptone
Potassium phosphate dibasic
Potassium phosphate monobasic
Sodium hydroxide
Eagle’s Earle’s medium with HEPES
2. Liquid diluent fraction:
None.
Incompatibilities
Do not mix with any other vaccine or immunological product except the diluent supplied.
Shelf life
2 years.
Use immediately after reconstitution.
Special precautions for storage
Store and transport refrigerated (+2 °C - +8 °C).
Protect from light.
Do not freeze.
Nature and composition of immediate packaging
Freeze-dried Fraction
Vial: Type I (Ph.Eur.) glass.
Closure: Bromobutyl rubber stoppers sealed with aluminium caps
Liquid diluent Fraction
Vial: Type I (Ph.Eur.) glass.
Closure: Chlorobutyl rubber stoppers sealed with aluminium 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 water for injections.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.
MARKETING AUTHORISATION HOLDER
Zoetis UK Limited
5th Floor, 6 St Andrew Street
London
EC4A 3AE
MARKETING AUTHORISATION NUMBER
Vm: 42058/4051
DATE OF FIRST AUTHORISATION
Date:19 February 2007
DATE OF REVISION OF THE TEXT
Date:01 December 2014
Approved: 17 March 2015
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