SUMMARY OF PRODUCT CHARACTERISTICS

Tardak 10 mg/ml Suspension for Injection

Active ingredient mg/ml

Delmadinone Acetate 10.0

Excipients

Benzalkonium Chloride (preservative) 0.2

EDTA 1.0

For a full list of excipients, see Section 6.1

Suspension for injection.

White suspension

4.1 Target species

Dogs and cats.

4.2 Indications for use, specifying the target species

Tardak is for use in male dogs and cats in the following indications:

The treatment of hypersexuality (including vagrancy).

The relief of prostatic hypertrophy whether benign, carcinomatous or when due to chronic inflammatory processes (in cases of the latter, relief cannot be expected unless appropriate accompanying therapy, such as corticosteroids or antibiotics is also instituted).

For the treatment of circum-anal tumours.

For the treatment of certain forms of aggressiveness, nervousness, epileptiform seizures and corticosteroid-resistant pruritus (developing into dermatoses and accompanied by alopecia).

4.3 Contraindications

Tardak should not be used in dogs already receiving progestogens.

None.

4.5 Special precautions for use

Owners should be clearly warned that an immediate effect cannot be expected following administration of Tardak. In most cases it is necessary to allow two to four days to elapse before the effect of treatment is observed.

Progestogens should not be administered to diabetic animals.

Preparations containing progestogens should be handled with care, particularly by women of childbearing age.

Avoid contact with skin. Impervious gloves should be worn whilst administering this product.

In case of contact with skin, wash off any product with soap and water. If eye exposure occurs, flush immediately with water.

In case of accidental injection, seek medical attention.

4.6 Adverse reactions (frequency and seriousness)

Animals treated with Tardak at stud could show a transient reduction in fertility and libido.

Transient side-effects of increased appetite, polydipsia and polyuria have occasionally been seen. Controlling food intake will prevent an increase in bodyweight. However, where these effects are excessive, therapy should cease.

As some progestogen injections can cause local changes in the hair coat such as lightening of colour and/or hair loss, it is recommended that subcutaneous injections are given at an inconspicuous site e.g. inner surface of the thigh.

4.7 Use during pregnancy, lactation or lay

Not applicable.

4.8 Interaction with other medicinal products and other forms of interaction

This product should be handled with great care when animals are treated by other steroid compounds.

4.9 Amounts to be administered and administration route

Intramuscular or subcutaneous injection. Dose levels should be individually selected, taking into consideration the weight of the animal and the severity of the condition to be treated.

The following dosage recommendations may be taken as a guideline:

Up to 10 kg: 1.5 - 2.0 mg/kg bodyweight

10 to 20 kg: 1.0 - 1.5 mg/kg bodyweight

20 and above: 1.0 mg/kg bodyweight.

In most cases it is necessary to allow two to four days to elapse before the effect of the treatment is observed. Dogs not showing improvement within eight days should be treated a second time with at least the dose level previously given.

Animals showing a favourable response can be expected to require follow-up treatment after a three to four week period. Further treatment in “social indications” is recommended at the first sign of re-appearance of the effectively controlled indication.

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

No specific treatment is indicated.

4.11 Withdrawal period(s)

Not applicable.

Delmadinone acetate is a progestogen whose mechanism of action is to compete with androgens for their receptor sites.

ATC Vet Code: QG03DX91

6.1 List of excipients

Benzalkonium chloride

EDTA

Polyethylene glycol 4000

Citric acid monohydrate

Sodium citrate dehydrate

Polysorbate 80

Sodium chloride

Hydrochloric acid (pH adjustment)

Sodium hydroxide (pH adjustment)

Water for injections

6.2 Incompatibilities

None known.

6.3 Shelf-life

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

Shelf-life after first opening the immediate container: 28 days.

6.4 Special precautions for storage

Do not store above 25°C.

Protect from light.

Shake container before use.

Following withdrawal of the first dose, use the product within 28 days. Discard unused material.

6.5 Nature and composition of immediate packaging

Carton containing 10 ml colourless glass vial with a blue halobutyl (siliconised) rubber bung and aluminium overseal.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if appropriate

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

Zoetis UK Limited

5th Floor, 6 St. Andrew Street

London

EC4A 3AE

Vm42058/4149

Date: 23rd April 1992

Date: June 2013

APPROVED 24/06/13