Target species
Horses, sheep and dogs.
Indications for use
This veterinary medicinal product is intended for prophylactic use in horses, sheep and dogs to reduce the risk of tetanus infection, as a result of accidental injury or as a preoperative precaution.
This veterinary medicinal product is intended for therapeutic use in horses and dogs to enhance recovery rates in animals showing clinical signs of tetanus, when combined with other treatments.
Onset of immunity: After subcutaneous and intramuscular injection: 2 days after administration.
After intravenous or intramuscular injection to horses: 1 – 4 hours.
After subarachnoidal injection: straight after application.
Duration of immunity: 2 – 3 weeks.
The duration of effective antibody titres has not been investigated in the central nervous system. The intravenous and subarachnoidal application routes are recommended for therapeutic use of this veterinary medicinal product in horses only.
Contraindications
Administration to cats is contraindicated. Cats are unable to metabolise the preservative phenol as rapidly as other species due to the absence of a specific enzyme.
Special warnings for each target species
After repeated administration at longer intervals sensitisation may occur, leading to hypersensitivity reactions/anaphylactic shock.
Administering repeat doses at longer intervals is therefore not recommended.
Especially if a (repeated) intravenous application is intended in heterologous animals a biological pre-testing (1 ml, subcutaneous, 30 - 40 minutes observation) should be performed.
Special precautions for use
None.
Adverse reactions
Horses, dogs:
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Injection site swelling1 Hyperthermia2 Hypersensitivity reaction3 |
1 Transient
2 Transient. May occur on the day of application and the day after.
3 Especially after repeated administration. Especially heterologous animals are susceptible.
Sheep:
Rare (1 to 10 animals / 10,000 animals treated): | Hyperthermia1 |
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Injection site swelling2 Hypersensitivity reaction3 |
1 Transient. May occur on the day of application and the day after.
2 Transient
3 Especially after repeated administration. Especially heterologous animals are susceptible.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy or lactation
The safety of the veterinary medicinal product has not been established during pregnancy and lactation. However, with regard to use in horses, on the basis of experience from field use in mares and from published data employing the administration of a different tetanus hyperimmune serum in pregnant mares it is concluded that it is unlikely to cause any reaction other than that described in section "Adverse reactions".
Interactions
Safety and efficacy data are available which demonstrate that this immunological veterinary medicinal product can be administered on the same day but not mixed with Equilis Te and Equilis Prequenza Te (for proper use, refer to the package leaflets).
No information is available on the safety and efficacy of this immunological veterinary medicinal product when used with any other veterinary medicinal product except the products mentioned above. A decision to use this immunological veterinary medicinal product 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
I. Dosage and method of administration in horses
I.a Prophylaxis:
Method of administration:
Subcutaneous or intramuscular injection.
Dosage for preoperative treatment or after injury:
Horse | 7 500 – 10 000 IU = 7.5 – 10 ml |
Foal with body weight up to 100 kg | 3 000 IU = 3.0 ml |
If the operation wound or the injury has not improved after 10 – 14 days the serum application has to be repeated (see section 3.4).
Simultaneous with vaccination
Subcutaneous or intramuscular injection.
This veterinary medicinal product and vaccines* against tetanus are to be applied at different parts of the body.
*Equilis Prequenza Te and Equilis Te. For proper use please refer to the relevant package leaflets.
Dosage see 'prophylaxis'.
I.b Therapeutic:
Method of administration:
Preferably intravenous injection, otherwise subcutaneous or intramuscular injection.
To supply the central nervous system with antitoxin the administration of this veterinary medicinal product into the subarachnoid space is recommended (see section 3.6).
Dosage:
Horse | 20 000 – 50 000 IU = 20 – 50 ml |
Foal with body weight up to 100 kg | 30 000 IU = 30 ml |
The given doses should be applied in an as early as possible stage of the disease. A repeated administration on the two following days can be useful.
II. Dosage and method of administration in sheep
Method of administration:
Subcutaneous application.
The dosage for preoperative treatment or after injury should contain:
Sheep (subcutaneous) | 3 000 IU = 3.0 ml |
Lamb (subcutaneous) | 1 500 IU = 1.5 ml |
III. Dosage and method of administration in dogs
Method of administration:
Subcutaneous or intramuscular application.
a. The dosage for preoperative treatment or after injury should contain:
Dog depending on the body weight (80 IU/kg) | Min 500 – max 2 500 IU = 0.5 – 2.5 ml |
b. The therapeutical dosage should contain:
Dog depending on the body weight (1 000 IU/kg) | Min 10 000 – max 20 000 IU = 10 – 20 ml |
Overdose
Do not administer more than the dose indicated to horses or dogs. In sheep the administration of an overdose of 6 ml/6 000 IU may result in an increase in body temperature of up to 2 °C and local reactions, but no ulceration or abscess formation should be observed.
Withdrawal periods
Zero days.