Tetanus Toxoid Concentrated Data Sheet

Presentation

Tetanus Toxoid Concentrated is an inactivated vaccine containing >150 I.U. per dose (1 ml) purified tetanus toxoid. To enhance the immunogenicity the toxoid is adsorbed onto aluminium hydroxide. 0.05 mg/dose sodium timerfonate is added as preservative.

Uses

-        For the active immunisation of horses, to reduce mortality and clinical signs of the disease caused by infection with Clostridium tetani. 

         About 10-14 days after basic immunisation (two vaccinations) the antibodies against tetanus toxoid reach an interim maximum and protective immunity is obtained that lasts for at least one year. The first booster immunisation (third vaccination) leads to a rapid increase of the antitoxin titre.

         For horses it has been shown that the protection resulting after the third vaccination lasts for at least two years.

-        For concurrent administration with Intervet’s Tetanus Antitoxin serum to injured horses that have not been vaccinated or are not completely immunised against tetanus, to reduce mortality and reduce clinical signs of the disease caused by infection with Clostridium tetani.  

-        For the active immunisation of pregnant mares in order to provide passive immunity to the progeny against mortality and clinical disease caused by infection with Clostridium tetani. 

-        For the active immunisation of cattle, sheep, pigs and dogs against disease caused by infection with Clostridium tetani in situations where a tetanus threat has been experienced or is expected and for the active immunisation of pregnant cows, ewes, sows and bitches to provide passive immunity to the progeny.

Dosage and administration

For horses, cattle, sheep, pigs and dogs: intramuscular injection of 1 ml per animal.

Can be used during pregnancy and lactation.

Allow the vaccine to reach room temperature (15-25°C) before use.

Shake the vial before use.

Sterile injection equipment should be used.

HORSES
Basic immunisation:
All horses not previously vaccinated should be vaccinated twice at an interval of 4-8 weeks. Foals can be vaccinated from 4 months of age. In foals from mares vaccinated during pregnancy (see below) maternally derived immunity may interfere with vaccination. These animals should not be vaccinated before 6 months of age. If levels of maternally derived antibodies are unknown, it is advised to vaccinate foals at 4 months of age, followed by a complete basic immunisation from 6 months of age.

Revaccination:

A third vaccination should be given about 12 months after the basic immunisation.

Thereafter booster vaccinations can be given at 2 years’ interval.

Active immunisation of animals during pregnancy:

A booster vaccination of pregnant mares 4-8 weeks prior to foaling leads, via the colostrum, to passive immunisation of the foals for their first 4-6 months of life. 

Particularly when vaccinating pregnant animals, stress should be avoided.

Foals from fully vaccinated mares should take up colostrum within the first 24 hours of life.

Concurrent active and passive immunisation:

For effective immunisation of injured horses that have not been vaccinated or are not completely immunised against tetanus, animals should receive two doses with an interval of 4-8 weeks. At the first vaccination Intervet’s Tetanus Antitoxin Behring is administered simultaneously but at a separate injection site, using separate syringes and needles.

Animals not vaccinated earlier with Tetanus Toxoid Concentrated should receive a further dose after approximately 12 months with a re-vaccination dose being given every 2 years thereafter. 

CATTLE, SHEEP, PIGS AND DOGS
Tetanus Toxoid Concentrated should not be used for routine vaccination in these animal species and its use is normally restricted to situations where a tetanus threat is suspected or has been experienced.   The following general guidance can be given:

Basic vaccination:

All animals not previously vaccinated should be vaccinated twice at an interval of 4-8 weeks. Animals can be vaccinated from 3 months of age. In young animals born to dams that were vaccinated during pregnancy (see below) maternally derived immunity may interfere with the vaccination. The age of initial vaccination should be adjusted accordingly. Although no direct data are available, it is advised that calves   are not   vaccinated before 5 months of age. At the minimum age (3 months) recommended for vaccinating lambs, piglets and pups, interference by maternally derived immunity is not to be expected.

Revaccination:

If further vaccinations are found necessary, booster vaccinations must be given at intervals of about 12 months.

Active immunisation of animals during pregnancy:

A booster vaccination of pregnant animals 4-6 weeks prior to parturition leads, via the colostrum, to passive immunisation of the young for their first months of life. 

Particularly when vaccinating pregnant animals, stress should be avoided.

Animals born to fully vaccinated dams should take up colostrum within the first 24-36 hours of life.

Contra-indications, warnings, etc.

Do not use in sick animals or in animals that have intercurrent disease, heavy parasitic infestation or are in poor general condition, since in these cases no satisfactory immune response can be expected.

Adverse reactions are very rare. A transient swelling at the injection site up to 3 cm in diameter, lasting for 2 to 3 days, may occur. A slight increase in body temperature, up to 1.5°C, may be observed the day following vaccination.

The vaccine has been shown to be safe when administered at twice the recommended dose. Effects other than those described above are not to be expected.

Interactions:

Horses

No information is available on the safety and efficacy from the concurrent use of this vaccine with any other immunological veterinary medicinal product in horses except Intervet’s equine influenza vaccine and Intervet’s combined vaccine against equine influenza and equine herpesvirus. These products should be administered at a separate injection site, using a separate syringe plus needle. 

Field experience suggests that the product may be used at the same time but at a separate site with Intervet’s tetanus antitoxin serum   for prophylactic purposes in injured horses that have not been vaccinated or are not completely immunised against tetanus.

It is therefore recommended that no other vaccines than these should be administered within 14 days before or after vaccination with the product.

Cattle, sheep, pigs and dogs

No information is available on the safety and efficacy from the concurrent use of this vaccine with any other immunological veterinary medicinal product in cattle, sheep, pigs and dogs. 

It is therefore recommended that no other vaccines than these should be administered within 14 days before or after vaccination with the product.

Do not mix with any other medicinal product.

Only vaccinate healthy animals.

In any group of animals a small number of individuals may fail to respond to vaccination as a result of immunological incompetence or for some other reasons.

Limited information is available on the safety and efficacy of the vaccine in animal species other than horses.

Operator warning:

In the case of accidental self-injection, wash the area with water, seek medical advice and show the package insert or the label to the physician.

Withdrawal periods:

Zero days.

FOR ANIMAL TREATMENT ONLY.  KEEP OUT OF REACH AND SIGHT OF CHILDREN.

Pharmaceutical precautions

Store between +2°C and+ 8°C (in a refrigerator). Keep the container in the outer carton.

Disposal advice:

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

Legal Category 

POM-V                        To be supplied only on veterinary prescription.

Package quantities

Cardboard box with 10 glass vials of 1 ml with a rubber stopper and aluminium cap.

Further information

Nil.

Marketing Authorisation number

Vm 01708/4510                       UK authorised veterinary medicinal product.

Marketing Authorisation holder

Intervet UK Ltd.

Walton Manor

Walton

Milton Keynes

Bucks. MK7 7AJ

Distributed in Northern Ireland by:

Intervet Ireland Ltd.

Magna Drive

Magna Business Park

Citywest Road

Dublin 24

Date of text preparation

15/08/06