Introduction
Company name: Fort Dodge Animal Health
Address: Flanders Road
Hedge End
Southampton SO30 4QH
Telephone: 01489 781711
Fax: 01489 788306
Duramune Pi + L
Introduction
Company name: Fort Dodge Animal Health
Address: Flanders Road
Hedge End
Southampton SO30 4QH
Telephone: 01489 781711
Fax: 01489 788306
Presentation
Duramune Pi + L is a combination vaccine presented as a lyophilisate and diluent for suspension for injection. Each dose comprises: one vial of a freeze dried fraction containing live attenuated canine parainfluenza virus, strain FDL (105.1 to 107.4 TCID50*); and one vial of liquid diluent fraction, an inactivated adjuvanted suspension of Leptospira canicola outer membrane coat protein (potency as per Ph.Eur) and Leptospira icterohaemorrhagiae outer membrane coat protein (potency as per Ph.Eur).
* Tissue Culture Infective Dose.
Uses
For active immunisation of dogs to reduce clinical signs due to infection with canine parainfluenza virus and reduce shedding of canine parainfluenza virus; to prevent mortality and reduce clinical signs due to Leptospira interrogans, serogroups canicola and icterohaemorrhagiae. The onset of immunity is from two weeks after the second vaccination. The duration of immunity is one year; after one year, only a reduction of oculonasal discharge has been demonstrated following a canine parainfluenza challenge.
Dosage and administration
The vaccine is to be administered by subcutaneous injection to dogs of the age of 6 weeks or older. Aseptically reconstitute the contents of the freeze-dried fraction using the contents of the vial of liquid diluent fraction. Shake the vial well and immediately administer all of the reconstituted vaccine using aseptic technique.
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 + L 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.
Contra-indications, warnings, etc
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 (<2cm) 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 1-2 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. If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Special warnings
No information is available on the effects 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.
Animals that have received immunosuppressive drugs (e.g. glucocorticoids) should not be vaccinated until an interval of at least 4 weeks has elapsed.
The canine parainfluenza virus strain, strain FDL, present in the vaccine may spread to unvaccinated animals, but does not cause disease.
In the case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Withdrawal period
Not applicable.
Pharmaceutical precautions
Keep out of reach and sight of children.
Store and transport refrigerated (+2ºC to +8ºC). Do not freeze. Protect from light.
Do not use after the expiration date shown on the vial labels.
Reconstituted vaccine should be used immediately.
FOR ANIMAL TREATMENT ONLY
Legal category
POM-V
Packaging Quantities
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. Not all pack sizes may be marketed.
Further information
Disposal
Dispose of waste materials by boiling, incineration or immersion in an appropriate disinfectant in accordance with national requirements.
Marketing authorisation number
Vm 01596/4350.
Significant Changes
new product | 05/07/2007 |