Tardak 10 Mg/Ml Suspension For Injection
Revised: June 2013
SUMMARY OF PRODUCT CHARACTERISTICS
NAME OF THE VETERINARY MEDICINAL PRODUCT
Tardak 10 mg/ml Suspension for Injection
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient mg/ml
Delmadinone Acetate 10.0
Benzalkonium Chloride (preservative) 0.2
For a full list of excipients, see Section 6.1
Suspension for injection.
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).
Tardak should not be used in dogs already receiving progestogens.
Special warnings for each target species
4.5 Special precautions for use
Special precautions for use in animals
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.
Special precautions to be taken by the person administering the veterinary medicinal product to 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
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)
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
Polyethylene glycol 4000
Citric acid monohydrate
Sodium citrate dehydrate
Hydrochloric acid (pH adjustment)
Sodium hydroxide (pH adjustment)
Water for injections
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.
MARKETING AUTHORISATION HOLDER
Zoetis UK Limited
5th Floor, 6 St. Andrew Street
MARKETING AUTHORISATION NUMBER
DATE OF THE FIRST AUTHORISATION
Date: 23rd April 1992
DATE OF REVISION OF THE TEXT
Date: June 2013
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