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Duramune Puppy DP+C, Lyophilisate and diluent for suspension for injection for dogs.

Description

Duramune Puppy DP+C 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 distemper virus, strain Onderstepoort102.5 to 104.8 TCID50*
Canine parvovirus, strain SAH104.7 to 106.5 TCID50*
*TCID50 = tissue culture 50% infective dose
Liquid diluent fraction
Active substances:Per 1 ml dose
Canine coronavirus, strain TN449 (inactivated)RP* 1.0-2.0**
Adjuvants:
Ethylene/Maleic anhydride (EMA)0.01 m
Neocryl XK-62 (50% solution)0.03 ml
* hamster 80% protective dose according to Ph.Eur.
** RP = Relative Potency

INDICATIONS

The onset of immunity is from two weeks after the second vaccination. The duration of immunity is at least one year for all antigens.

CONTRAINDICATIONS

None.

ADVERSE REACTIONS

Following the first vaccination, up to 80% of puppies develop a small visible swelling (<2 cm) lasting for generally only two days. Following the second vaccination, occasionally a small visible swelling (up to 5 cm) may be seen at the injection site, which may last for up to five days. The swelling may be painful for one to two days.
In most cases these small and transient injection site reactions resolve with no need for treatment.
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.

TARGET SPECIES

Dogs.

DOSAGE, ROUTE AND METHOD OF ADMINISTRATION

The vaccine is to be administered by subcutaneous injection to dogs aged 6 weeks and above.
Aseptically reconstitute the contents of the freeze-dried fraction using the liquid vaccine. 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 Puppy DP + C is recommended.

ADVICE ON CORRECT ADMINISTRATION

WITHDRAWAL PERIOD

Not applicable.

SHELF LIFE

Shelf-life of the veterinary medicinal products as packaged for sale: 18 months.
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

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. This product should not be used concurrently or simultaneously with any other immunological product.
Do not mix with any other vaccine or immunological product except the diluent vaccine supplied.
The live virus strains present in the vaccine may spread to unvaccinated animals, but do not cause disease.
The efficacy of the CDV and CPV components of the vaccine may be reduced due to maternal antibody (MDA) interference. However, the vaccine has been proven to be of benefit against virulent challenge in the presence of maternal antibody levels to CDV and CPV that are likely to be encountered under field conditions. In situations where higher MDA levels are expected, the vaccination protocol should be planned accordingly.
Any unused vaccine or waste material should be disposed of in accordance with local requirements.

OTHER INFORMATION

ATC Code: QI07AH04
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
Liquid diluent Fraction
Vial: High-density polypropylene.
Closure: Chlorobutyl snap-on rubber stoppers with centre hole caps sealed with aluminium crimp caps.
Contents: 1 ml in a 3 ml injection vial.
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 diluent fraction.

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