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Nobivac Lepto Injection for Dogs

  • Single Dose Lepto 2 for injection £2.88
  • Single Vial Lepto 4 for Injection £6.89

Selection of 2 products from

£2.88 to £6.89

Description

Nobivac Lepto 4 is a liquid vaccine supplied in single dose bottles to protect dogs against Leptospirosis infection. It can be used as the diluent for Nobivac DHPPi in order to provide protection against additional diseases (Canine Distemper, Hepatitis, Parvo virus and Paranifluenza). Two injections given 4 weeks apart are needed for the first vaccination, which can start from 6 weeks of age. After that, a single booster vaccination needs to be given annually. (It is not necessary to boost for Distemper, Parvo and Hepatitis every year. These can be done on alternate years, or such longer period as advised by your veterinary surgeon.)

Nobivac Lepto 2

Presentation

Inactivated, bacterial vaccine a liquid suspension of Leptospira interrogans serogroups

-Canicola (strain Ca-12-000) ≥ 40 PD80 /dose

-Icterohaemorrhagiae (strain 820K) ≥ 40 PD80 /dose

Also contains 0.1 mg/ml Thiomersal as a preservative. Each vial contains a single dose.

Uses

For active immunisation of dogs to reduce infection with Leptospira interrogans serovar canicola and Leptospira interrogans serovar icterohaemorrhagiae.

Specific claims

Nobivac Lepto 2 significantly reduces the number of animals which develop a urinary tract infection which can predispose to development of a carrier condition after L. canicola and L. icterohaemorrhagiae infection.

The duration of immunity induced by the vaccine was established as at least one year. Nobivac Lepto 2 can be used alone or as a diluent for other freeze dried Nobivac dog vaccines.

Dosage and administration

The contents of one vial (1 ml) should be administered by subcutaneous injection. Sterile equipment should be used for administration.

Primary course vaccination: All dogs not previously vaccinated should be vaccinated twice 2-4 weeks apart. Puppies should be at least 6 weeks of age before they receive the first vaccination.

Booster vaccination: A single annual booster dose is recommended.

Nobivac Lepto 2 may be used to reconstitute Nobivac DHPPi, Nobivac DHP, Nobivac Pi and Nobivac Parvo-C as indicated in the appropriate package leaflet.

The product may be used in pregnant bitches which have previously been vaccinated with Nobivac Lepto.

Contra-indications, warnings, etc

Only healthy dogs should be vaccinated.

A good immune response is reliant on the reaction of an immunogenic agent and a fully competent immune system. Immunogenicity of the vaccine antigen will be reduced by poor storage or inappropriate administration. Immunocompetence of the animal may be compromised by a variety of factors including poor health, nutritional status, genetic factors, concurrent drug therapy and stress.

A local reaction of limited size may occur during the first few days after vaccination.

After subcutaneous administration with the DHPPi, Pi, Parvo-C and/or Nobivac Rabies a diffuse swelling may be observed at the injection site in most puppies. Occasionally this swelling may be hard and painful but this will diminish gradually and will disappear after 2-3 weeks.

In the rare event of a hypersensitivity reaction following vaccination, administer an antihistamine, corticosteroid or adrenaline, without delay and by the most immediate route.

The vaccine may not be effective in dogs incubating the disease at the time of vaccination.

Some animals may be immunologically incompetent and fail to respond to vaccination. Animals that have received the corresponding anti-serum or immunosuppressive drugs should not be vaccinated until an interval of at least 4 weeks has elapsed.

Safety and/or efficacy data are available which demonstrate that this vaccine can be mixed with Nobivac DHPPi, DHP, Pi and/or Parvo-C.

Safety and/or efficacy data are available which demonstrate that this vaccine can be administered the same day but not mixed with Nobivac Rabies.

Do not mix with any other medicinal product except with the vaccines listed above.

For animal treatment only. Keep out of reach and sight of children.

Pharmaceutical precautions

Store at 2 to 8°C. Do not freeze. Protect from light.

In-use shelf life : 10 hours.

Disposal advice

Any unused veterinary medicinal product or waste material derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

Legal category

POM-V

Packaging Quantities

Cartons of 10 and 50 single dose vials or carton with one 10 ml vial.

Not all pack sizes may be marketed.

Further information

Nil.

Marketing authorisation number

Vm 01708/4360.

Nobivac L4, suspension for injection for dogs

Qualitative and quantitative composition

Each dose of 1 ml contains:

Active substances:

Inactivated Leptospira strains:

L. interrogans serogroup Canicola

serovar Portland-vere (strain Ca-12-000)

3550-7100 U*

L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni

(strain Ic-02-001)

290-1000 U*

L. interrogans serogroup Australis

serovar Bratislava (strain As-05-073)

500-1700 U*

L. kirschneri serogroup Grippotyphosa serovar Dadas strain

Gr-01-005)

650-1300 U*

* Antigenic mass ELISA units.

Excipient: Thiomersal 0.1 mg.

For a full list of excipients, see section "Pharmaceutical particulars".

Pharmaceutical form

Suspension for injection. Colourless suspension.

Clinical particulars

Target species

Dogs.

Indications for use

For active immunisation of dogs against:

- L. interrogans serogroup Canicola serovar Canicola to reduce infection and urinary excretion.

- L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni to reduce infection and urinary excretion.

- L. interrogans serogroup Australis serovar Bratislava to reduce infection.

- L. kirschneri serogroup Grippotyphosa serovar Bananal/Lianguang to reduce infection and urinary excretion.

Onset of immunity: 3 weeks.

Duration of immunity: 1 year.

Contra-indications

None.

Special warnings for each target species

None.

Special precautions for use

Vaccinate only healthy animals.

Adverse reactions

A mild and transient increase in body temperature (≤ 1°C) may occur for a few days after vaccination, with some pups showing less activity and/or a reduced appetite. A small transient swelling (≤ 4 cm), which can occasionally be firm and painful on palpation, may be observed at the site of injection. Any such swelling will either have disappeared or be clearly diminished by 14 days post-vaccination. An occasional transient acute hypersensitivity (anaphylaxis) reaction may occur.

Use during pregnancy, lactation or lay

Can be used during pregnancy.

Interactions

Safety and efficacy data are available which demonstrate that this vaccine can be mixed with vaccines of the Nobivac series containing distemper, canine adenovirus type 2 and/or parvovirus components for subcutaneous administration.

Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but not mixed with vaccines of the Nobivac series containing Bordetella bronchiseptica and/or parainfluenza virus components for intranasal administration.

No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the products mentioned above. 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.

Amounts to be administered and administration route

Subcutaneous use.

Before use, allow the vaccine to reach room temperature.

Administer two vaccinations of 1 dose (1 ml) of vaccine with an interval of 4 weeks to dogs from 6 weeks of age onwards.

Vaccination scheme:

Basic vaccination: The first vaccination can be administered from 6 to 9(*) weeks of age and the second vaccination from 10 to 13 weeks of age.

Revaccination: Dogs should be re-vaccinated annually with one dose (1 ml) of vaccine.

(*) In case of high level of MDA, first vaccination is recommended at 9 weeks of age.

For simultaneous use, 1 dose of a Nobivac vaccine containing distemper, canine adenovirus type 2 and/or parvovirus components should be reconstituted with 1 dose (1 ml) of Nobivac L4. The mixed vaccines will be administered by subcutaneous injection.

Overdose

No adverse reactions other than those mentioned in section "Adverse Reactions" were observed after the administration of a double dose of vaccine. However, these reactions may be more severe and/or last longer. For example, local swelling, which can be up to 5 cm in diameter and which may take over 5 weeks to completely disappear, may be observed at the site of injection.

Withdrawal periods

Not applicable.

Pharmacological particulars

Immunological properties

Pharmacotherapeutic group: Inactivated bacterial vaccine.

ATC vet code QI07AB01.

To stimulate active immunity in dogs against L. interrogans serogroup Canicola serovar Canicola, L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni, L. interrogans serogroup Australis serovar Bratislava, and L. kirschneri serogroup Grippotyphosa serovar Bananal/Lianguang.

In vitro and in vivo data in non-target species suggests that the vaccine may provide a degree of cross-protection against L. interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae and L. kirschneri serogroup Grippotyphosa serovar Grippotyphosa.

Pharmaceutical particulars

Excipients

Thiomersal

Sodium chloride

Potassium chloride

Disodium phosphate dihydrate

Potassium dihydrogen phosphate

Water for injections

Major incompatibilities

Do not mix with any other veterinary medicinal products except those mentioned in section "Interactions".

Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.

Shelf life after first opening the immediate packaging: 10 hours.

Shelf life after reconstitution of Nobivac vaccines: 45 min.

Special precautions for storage

Store in a refrigerator (2 °C – 8 °C). Do not freeze. Protect from light.

Immediate packaging

Glass type I vial of 1 ml (1 dose) or 10 ml (10 doses) closed with a halogenobutyl rubber stopper and sealed with a coded aluminium cap.

Pack size:

Box with 5, 10, 25 or 50 vials of 1 ml (1 dose).

Box with 1 vial of 10 ml (10 doses).

Not all pack sizes may be marketed.

Disposal

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

Marketing Authorisation Holder (if different from distributor)

Intervet International B.V, The Netherlands.

Marketing authorisation number

EU/2/12/143/001-005.

Date of the first authorisation or date of renewal

16 July 2012.

Date of revision of the text

16 July 2012.

Any other information

For animal treatment only. Keep out of the sight and reach of children.

Legal category

POM-V

GTIN (Global Trade Item No)

Nobivac L4 10x1ds:

08713184125491

Nobivac L4 50x1ds:

08713184125507

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Questions & Answers for Nobivac Lepto Injection for Dogs

Below are some recent questions we've received regarding Nobivac Lepto Injection for Dogs, including answers from our team.

Ask Your Own Question

Do I get card to put batch etc on for use in kennels

1st Mar 2016
Ruth

Will I get card to prove dosage and batch for proof of cover for kennels

John Cousins
  • Veterinary Surgeon

If you ask separately for a vaccine card we can send one with your order at no extra charge. You have to do this or you will not get one. The vaccine itself comes in small bottles with a peel-off label which you can stick on the vaccine card. It states the name of the vaccine, the batch number and the expiry date (= use-by date for giving the vaccine, not how long the immunity lasts for). There is a place on the card for the person who gave the vaccine to sign. Normally your vet would sign here, but a vet should not sign if they did not give the vaccine. You can sign it yourself and as long as you do not put any false qualifications there, then the vaccine record card is correct, genuine and can be used. You must not pretend to be a vet, or that is actually against the law. It would be up to the kennels to decide if they wanted to accept a record card signed by you, though they might well not notice who signed it in fact.

Nobivac l4

12th Aug 2015
lesey michael

does lepto4 have to be given 4weeks apart. what time scale is there between injections

John Cousins
  • Veterinary Surgeon

Ideally it should be 4 weeks between injections which is on the data sheet. Some vets still use the same protocol as for Lepto 2, ie a minimum of 2 weeks and a maximum of 4 weeks between the two injections for an initial course. My guess is that this would be effective but it is not on the data sheet. early completion of the course to facilitate early socialisation and habituation is a factor to consider.