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Duramune Pi, Lyophilisate and diluent for suspension for injection for dogs
- Provides protection against canine parainfluenza virus as part of the Duramune Range of canine vaccines.
- Bioreactor technology for production improves product consistency and helps ensure the Duramune range presents antigenically relevant material in all fractions.
- Duramune is better tolerated than older broad spectrum canine vaccines and its primary vaccination can be completed at 10 weeks of age, facilitating earlier socialization.
Description
Duramune Pi is a combination vaccine presented as a lyophilisate and diluent for suspension for injection for dogs.Each dose comprises:
Freeze-dried fraction
| Active substances | Per 1 ml dose |
|---|---|
| Canine parainfluenza virus, strain FD | 105.1 to 107.4 TCID50* |
| Sterile solvent fraction | |
| Sterilised water for injections (Ph. Eur) | 1 ml |
INDICATIONS
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
Do not use in pregnant or lactating bitches.
ADVERSE REACTIONS
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.
Overdose
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.
TARGET SPECIES
Dogs
DOSAGE, ROUTE AND METHOD OF ADMINISTRATION
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 solvent provided. Shake
well before use. The entire contents of the reconstituted vial should be administered as a
single dose.
Primary vaccination
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.
ADVICE ON CORRECT ADMINISTRATION
- Sterile needles and syringes should be used for administration.
- Syringes and needles should not have been sterilised chemically or be above ambient temperature. Do not use chemicals to disinfect or sterilise skin.
- Shake well before use.
- Aseptic precautions should be observed.
- Reconstituted vaccine should be used immediately.
WITHDRAWAL PERIOD
Not applicable.
SHELF LIFE
Shelf-life of the veterinary medicinal product as packaged for sale: 2 years
Use immediately after reconstitution of the freeze-dried vaccine.
SPECIAL STORAGE PRECAUTIONS
Store and transport refrigerated (+2°C to +8°C).
Do not freeze.
Protect from light.
SPECIAL WARNINGS
Only healthy dogs should be vaccinated.
Do not use in pregnant or lactating bitches.
No information is available on the safety and efficacy of the concurrent use of this vaccine
with any other. It is therefore recommended that no other vaccine should be administered
within 14 days before or after vaccination with this product.
The live virus strains present in the vaccine may spread to unvaccinated animals, but do not
cause disease.
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.
Dispose of waste materials by boiling, incineration or immersion in an appropriate
disinfectant in accordance with national requirements.
OTHER INFORMATION
ATC Code: QI07AD08
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
Solvent Fraction
Vial: Type I (Ph.Eur.) glass. 3 ml capacity
Contents: 1 ml in a 3 ml injection vial.
Closure: Type I (Ph.Eur.) grey or red bromobutyl rubber stoppers sealed with aluminium
crimp caps
Pack sizes: Packs with 10 or 25 x 1 ml doses. Each dose is a combination of one vial of the
freeze-dried fraction and one vial of solvent fraction.
