SUMMARY OF PRODUCT CHARACTERISTICS

Duramune Pi + LC

Qualitative composition

Combined canine parainfluenza virus vaccine (live), lyophilisate, canine leptospirosis vaccine (inactivated) and canine coronavirus vaccine (inactivated).

Quantitative composition

1. Lyophilisate 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 solvent fraction:

Active Substances	Per 1 ml dose
Inactivated Leptospira interrogans bacteria (outer membrane coat)
Serogroup canicola, Serovar canicola	Potency according to Ph.Eur.*
Serogroup icterohaemorrhagiae, serovar icterohaemorrhagiae	Potency according to Ph.Eur.*
Canine coronavirus, strain TN449 (inactivated)	RP** 1.0-2.0
Adjuvants
Ethylene/Maleic anhydride (EMA-31)	0.1 mg
Neocryl	0.015 ml
Excipients
For a full list of excipients, see section 6.1.

* hamster 80% protective dose according to Ph.Eur.

** RP = Relative Potency

Lyophilisate and solvent for suspension for injection.

Lyophilisate: Cream-yellow colour powder

Solvent: Opaque White liquid

Reconstituted vaccine: orange or yellowish colour with light opalescence

4.1 Target Species

Dogs

4.2 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; to prevent mortality and reduce clinical signs due to Leptospira interrogans, serovars canicolaand icterohaemorrhagiae; and to reduce infection at the intestinal level caused by canine coronavirus.

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 oculo-nasal discharge has been demonstrated following a canine parainfluenza challenge.

4.3 Contraindications

See section 4.7.

4.4 Special warnings

The canine parainfluenza virus strain, strain FDL, present in the vaccine may spread to unvaccinated animals, but does not cause disease.

Animals that have received immunosuppressive drugs (e.g. glucocorticoids) should not be vaccinated until an interval of at least 4 weeks has elapsed.

4.5 Special precautions for use

None.

(ii) 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.

4.6 Adverse reactions (frequency and seriousness)

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.

4.7 Use during pregnancy, lactation and 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 efficacy of this vaccine when used with any other veterinary medicinal product. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.

See section 4.4.

4.9 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 lyophilisate vial using the liquid vaccine. 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 + LC is recommended.

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 (<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 very commonly be seen in of dogs given an overdose.

4.11 Withdrawal period

Not applicable.

To stimulate active immunity against canine parainfluenza virus, Leptospira interrogans serogroup canicola,Leptospira interrogans serogroup icterohaemorrhagiae and canine coronavirus.

ATCVet Code: QI07AJ12

1. Lyophilisate fraction:

Sucrose
Gelatin
Bactopeptone
Potassium phosphate dibasic
Potassium phosphate monobasic
Sodium hydroxide
Eagle’s Earle’s medium with HEPES
May contain Hydrogen Chloride or Sodium hydroxide for pH correction

2. Liquid solvent fraction:

Ethylene/Maleic anhydride (EMA-31)

Neocryl

Sodium chloride
Sodium phosphate dibasic
Potassium phosphate monobasic
Water for injections

Do not mix with any other veterinary medicinal product, except the solvent vaccine supplied for use with the product.

Shelf life of the veterinary medicinal product as packaged for sale: 18 months.
Shelf life after reconstitution according to directions: Use immediately.

Store and transport refrigerated (+2°C - +8°C).

Protect from light.

Do not freeze.

Lyophilisate Fraction

Vial: Type I (Ph.Eur.) glass.

Closure: Bromobutyl rubber stoppers sealed with aluminium caps

Liquid solvent 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 lyophilisate vaccine and one vial of liquid vaccine.

Not all pack sizes may be marketed

Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.

Zoetis UK Limited

5th Floor, 6 St Andrew Street

London

EC4A 3AE

Vm42058/4052

Date:02 April 2007

Date:October 2015

Approved: 30/10/2015