VANGUARD CPV-L.

Ireland - English - HPRA (Health Products Regulatory Authority)

Active ingredient:
Live canine parvovirus strain NL-35-D; Inactivated leptospira canicola; Inactivated leptospira icterohaemorrhagiae
Available from:
Zoetis Belgium S.A.
ATC code:
QI07AI05
INN (International Name):
Live canine parvovirus strain NL-35-D; Inactivated leptospira canicola; Inactivated leptospira icterohaemorrhagiae
Dosage:
.
Pharmaceutical form:
Solution for injection
Prescription type:
POM: Prescription Only Medicine as defined in relevant national legislation
Therapeutic group:
Dogs
Therapeutic area:
live canine parvovirus + inactivated leptospira
Therapeutic indications:
Immunological - Mixed Vaccine (L & A)
Authorization status:
Authorised
Authorization number:
VPA10387/084/001
Authorization date:
2014-09-12

Read the complete document

Health Products Regulatory Authority

23 October 2017

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1 NAME OF THE VETERINARY MEDICINAL PRODUCT

VANGUARD CPV-L

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Quantity per 1 ml dose

Active substance(s):

Live attenuated canine Parvovirus, strain NL-35-D, low passage, minimum :

CCID

Inactivated Leptospira canicola, at least 40 hamster protective doses and inactivated

Leptospira icterohaemorrhagiae, at least 40 hamster protective doses.

*Cell culture infectious dose-50

For a full list of excipients see section 6.1.

3 PHARMACEUTICAL FORM

Solution for injection.

A clear to slightly turbid liquid.

4 CLINICAL PARTICULARS

4.1 Target Species

Dogs from 6 weeks of age.

4.2 Indications for use, specifying the target species

Active immunisation of dogs to prevent mortality and clinical signs including

leucopenia and reduce viral shedding caused by canine parvovirus (types 2a, 2b and

2c) and to reduce infection caused by Leptospira canicola and Leptospira

icterohaemorrhagiae.

Onset of immunity occurs by approximately two weeks after the last dose of the

basic vaccination scheme. Onset of immunity for the canine parvovirus component

(type 2b) occurs 7 days after a single dose when animals are vaccinated from 9 weeks

of age. The duration of immunity is 12 months, after the last dose of the basic

vaccination scheme based on serology/challenge data.

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4.3 Contraindications

Do not use in unhealthy animals.

4.4 Special warnings for each target species

None.

4.5 Special precautions for use

Special precautions for use in animals

The canine parvovirus vaccinal strain may be shed from vaccinated animals for a

number of days following vaccination. However, due to the low pathogenicity of this

strain, it is not necessary to keep vaccinated animals separated from non-vaccinated

animals.

Due to the presence of maternally derived antibodies, a small percentage of pups

may fail to mount an adequate immune response to vaccination and may be at risk

from disease when the local disease challenge is sufficiently high. The percentage of

puppies that fail to mount an adequate immune response to vaccination is greater

when the final vaccination is given at 10 weeks of age than it is when the final

vaccination is given at 12 weeks or older, when the amounts of maternally derived

antibodies will be lower. Therefore, where the circumstances of the individual case

permit, consideration should be given to administering the final vaccination at 12

weeks of age, even in pups that are first presented at 6 to 8 weeks of age.

Special precautions to be taken by the person administering the veterinary

medicinal product to animals

In case of accidental self-injection, wash the area immediately with water. If

symptoms develop, seek medical advice immediately and show the package leaflet

or the label to the physician.

4.6 Adverse reactions (frequency and seriousness)

Vaccinated dogs may have a transient swelling 4-6 hours after vaccination, which

resolves after approximately 7days.

In the rare event of a systemic anaphylactic reaction following vaccination, administer

appropriate treatment such as adrenaline or an equivalent without delay.

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4.7 Use during pregnancy, lactation or lay

Do not use during pregnancy.

4.8 Interaction 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 needs to be made on a case by case basis.

4.9 Amounts to be administered and administration route

Dosage and route of administration:

Shake well and immediately inject the entire contents of the vial (1 ml)

subcutaneously. Do not use chemically sterilised syringes or needles, as these will

interfere with the effectiveness of the vaccine.

Basic Vaccination Scheme:

Puppies between 6 and 12 weeks of age:

Two doses of Vanguard CPV-L at least 14 days apart. The second dose should not be

given until at least 10 weeks of age.

Puppies 12 weeks of age or older:

A single 1 ml dose of Vanguard CPV-L followed by a single 1 ml dose of Vanguard

Lepto ciat least 14 days later.

Re-vaccination Scheme:

A single 1 ml dose of Vanguard CPV-L to be given annually thereafter.

Annual booster vaccinations are recommended. However, should veterinary

practitioners conduct a risk:benefit analysis for individual animals to determine the

frequency of re-vaccination, they should be aware of the following information.

Serological data has indicated that most dogs, when given at least the first annual

booster, can maintain protective levels of immunity to the CPV component of

Vanguard CPV-L for at least 4 years.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

No reactions other than those listed in Section 4.6 are observed after an overdose.No

treatment is necessary in most cases of overdose. However, if a systemic anaphylactic

reaction occurs (e.g. vomiting), administer adrenaline or an equivalent.

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4.11 Withdrawal period(s)

Not applicable.

5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: Immunologicals for canidae, dog, live viral and

inactivated bacterial vaccines, live canine parvovirus + inactivated leptospira.

ATC vet code: QI07AI05

The vaccine is intended for the active immunization of healthy puppies and dogs

against canine parvovirus disease and against Leptospira canicola and Leptospira

icterohaemorrhagiae.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Modified Eagles medium

6.2 Incompatibilities

Do not mix with any other veterinary medicinal product.

6.3 Shelf-life

Shelf-life of the veterinary medicinal product as packaged for sale: 4 years

6.4 Special precautions for storage

Store and transport refrigerated (2°C – 8°C). Do not freeze.

6.5 Nature and composition of immediate packaging

The vaccine is filled in 1 dose vials glass type I (Ph.Eur.). Pack contains 1, 10, 25 or 100

vials of 1 ml liquid VanguardCPV-L. Not all pack sizes may be marketed.

6.6 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 authority.

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7 MARKETING AUTHORISATION HOLDER

Zoetis Belgium S.A.

2nd Floor, Building 10

Cherrywood Business Park

Loughlinstown

Co Dublin

Ireland

8 MARKETING AUTHORISATION NUMBER(S)

VPA10387/084/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 11

October 2004

Date of last renewal: 4

November 2009

10 DATE OF REVISION OF THE TEXT

May 2017

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