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Nobivac Lepto 2

  • Single Dose Lepto 2 for injection £3.10

Nobivac Lepto 2

Species:

Dogs

Therapeutic indication:

Immunological veterinary medical products: For dogs

Active ingredient:

Vaccine Antigens

Product:

Nobivac® Lepto 2

Product index:

Nobivac Lepto 2

Qualitative and quantitative composition

Active ingredient per dose of 1 ml Inactivated Leptospira interrogans serogroup - Canicola; strain Ca-12-000: 957 - 1676 ELISA Units* - Icterohaemorrhagiae; strain 820K: 625 - 1335 ELISA Units * Antigen mass ELISA Units, in vitro potency test according to Ph.Eur. monograph 0477. Excipients Preservative: Thiomersal 0.1 mg. For a full list of excipients see section "Pharmaceutical particulars".

Pharmaceutical form

Aqueous suspension for injection.

Clinical particulars

Target species

Dogs.

Indications for use

For active immunisation of dogs to reduce infection with Leptospira interrogans serogroup canicola and Leptospira interrogans serogroup icterohaemorrhagiae. Specific claims: The duration of immunity induced by the vaccine was established as at least one year. 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.

Contra-indications

Only healthy dogs should be vaccinated.

Special warnings for each target species

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

Special precautions for use

None. Operator warnings: None.

Adverse reactions

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 rabies vaccines of the Nobivac series 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.

Use during pregnancy, lactation or lay

The vaccine has been shown to be safe for use in pregnant bitches which have previously been vaccinated with Nobivac Lepto 2.

Interactions

Safety and/or efficacy data are available which demonstrate that this vaccine can be mixed with live vaccines from the Nobivac range containing Canine distemper virus (strain Onderstepoort), Canine adenovirus type 2 (strain Manhattan LPV3), Canine parvovirus (strain 154) and/or Canine parainfluenza virus (strain Cornell). Safety and/or efficacy data are available which demonstrate that this vaccine can be administered the same day but not mixed with the inactivated rabies (strain Pasteur RIV) vaccine for the Nobivac range.

Amounts to be administered and administration route

The contents of one vial (1 ml) should be administered by subcutaneous injection. Allow the vaccine to reach room temperature (15 °C - 25 °C) before use. Sterile injection equipment should be used. 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, DHP, Pi or Parvo-C as indicated in the appropriate package leaflets. For more detailed advice on vaccination programmes and how the product may be used in conjunction with other Nobivac dog vaccines in specific circumstances contact the company direct or refer to the support literature.

Overdose

No particular symptoms at double dose (see section “ Adverse reactions”).

Withdrawal periods

Not applicable.

Pharmacological particulars

Immunological properties: ATC Vet code: QI07AB01 Strains of Leptospira interrogans serogroups Canicola and Icterohaemorrhagiae are responsible for leptospirosis in dogs. The active ingredients of the vaccine Leptospira interrogans Canicola; strain Ca-12-000 and Leptospira interrogans Icterohaemorrhagiae; strain 820K stimulate active immunity against these serogroups.

Pharmaceutical particulars

Excipients

Stabiliser solution and thiomersal.

Major incompatibilities

Do not mix with any other medicinal product except with the vaccines indicated in section “ Interactions”.

Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 21 months. Shelf life after first opening of the immediate packaging: 10 hours.

Special precautions for storage

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

Immediate packaging

Carton box with 1, 10 or 50 vials of glass type I (Ph.Eur.) containing 1 ml or 10 ml or plastic box with 10 or 50 vials of glass type I (Ph.Eur.) containing 1 ml closed with a halogenobutyl rubber stopper and sealed with a coded aluminium cap. Not all presentations may be marketed.

Disposal

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

Marketing Authorisation Number

Vm 01708/4360

Significant changes

Date of the first authorisation or date of renewal

31 May 2002.

Date of revision of the text

20 January 2016.

Any other information

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

Legal category

Legal category: POM-V

GTIN

GTIN description:Nobivac Lepto 2 10x1ds: GTIN:08713184144133, GTIN description:Nobivac Lepto 2 50x1ds: GTIN:08713184027665

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.

Need help or advice? Contact us:

  • Landline: 01582 842096
  • Mon - Fri: 8:30am - 5:30pm
  • Sat: 9:00am - 1:00pm
  • Email: support@viovet.co.uk

All prices include VAT where applicable.

Questions & Answers for Nobivac Lepto 2

Below are some recent questions we've received regarding Nobivac Lepto 2, 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

  • Non-Executive Director

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

  • Non-Executive Director

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.