SUMMARY OF PRODUCT CHARACTERISTICS

BE, CY, CZ, DE, EL, FR, HU, LU, NL, PT, SK, UK:

KELACTIN 50 microgram/ml oral solution for dogs and cats

DK, FI, IS, NO, SE:

KELACTIN vet 50 microgram/ml oral solution for dogs and cats

1 ml of product contains:

Active ingredient

Cabergoline 50 microgram

For full list of excipients, see 6.1.

Oral Solution.

Pale yellow, viscous oily solution.

4.1 Target species

Dog and cat.

4.2 Indications for use specifying the target species

The product is indicated for the following uses:

• Treatment of false pregnancy in bitches

• Suppression of lactation in bitches and queens

4.3 Contra-indications

• Do not use in pregnant animals since the product may cause abortion.

• Do not use with dopamine antagonist.

4.4 Special warnings for each target species

Additional supportive treatments should involve restriction of water and carbohydrate intake and increase exercise.

4.5 Special precautions for use, including special precautions to be taken by the person administering the medicinal product to the animals

i) Special precautions for use in animals

(ii)Special precautions to be taken by the person administering the veterinary medicinal product to animals

Wash hand after use. Avoid contact with skin and eyes. Wash of any splashes immediately.

Care should be taken to avoid contact between the solution and women of childbearing age.

Women of childbearing potential and breast-feeding woman should not handle the product or should wear disposable gloves when administering the product.

If you know you are hypersensitive to cabergoline or any of the other ingredients in the product, you should avoid contact with the product.

Do not leave unattended filled syringes in presence of children. In the event of accidental ingestion, particularly by a child, seek medical attention immediately.

4.6 Adverse reactions (frequency and seriousness)

Cabergoline may induce transient hypotension in treated animals and might result in more significant hypotension in animals concurrently being treated with hypotensive drugs, or directly after surgery whilst the animal is under the influence of anaesthetic agents.

Possible adverse effects are:

• sleepiness

• anorexia

• vomiting

These adverse effects are usually of a moderate and transient nature.

Vomiting usually only occurs after the first administration. In this case treatment should not be stopped, since the vomiting will not reoccur after the following administrations.

In very rare cases allergic reactions occurred, such as oedema, urticaria, dermatitis and pruritus.

In very rare cases a transient hypotension may occur.

In very rare cases neurological symptoms occurred, such as sleepiness, muscle tremor, ataxia, hyperactivity and convulsions.

4.7 Use during pregnancy, lactation or lay

• Cabergoline has the capacity to cause abortion in the later stages of pregnancy and should not be used in pregnant animals. Differential diagnosis between pregnancy and false pregnancy should be made correctly.

• The product is indicated for the suppression of lactation: inhibition of prolactin secretion by cabergoline results in a rapid cessation of lactation and a reduction in the size of the mammary glands. The product should not be used in lactating animals unless suppression of lactation is required.

4.8 Interaction with other medicinal products and other forms of interaction

Since cabergoline exerts its therapeutic effect by direct stimulation of dopamine receptors, the product should not be administered concurrently with drugs which have dopamine antagonist activity (such as phenothiazines, butyrophenones, metoclopramide), as these might reduce its prolactin inhibiting effects.

Since cabergoline may induce transient hypotension, the product should not in animals concurrently treated with hypotensive drugs.

4.9 Amounts to be administered and administration route

The product should be administered orally either directly into the mouth or by mixing with food.

The dosage is 0.1 ml/kg bodyweight (equivalent to 5 microgram/kg bodyweight of cabergoline) once daily for 4-6 consecutive days, depending on the severity of the clinical condition.

If the signs fail to resolve after a single course of treatment, or if they recur after the end of treatment, then the course of treatment may be repeated.

How to withdraw the recommended volume from the vial?

It is recommended to rinse and dry the syringe following each application.

a. b. c. d. e. f. g.

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

The experimental data indicate that a single overdose with cabergoline might result in an increased likelihood of post-treatment vomiting, and possibly an increase in post-treatment hypotension.

General supportive measures should be undertaken to remove any unabsorbed drug and maintain blood pressure, if necessary. As an antidote, the parental administration of dopamine antagonist drugs such as metoclopramide might be considered.

4.11 Withdrawal periods

Not applicable.

5 PHARMACOLOGICAL PROPERTIES:

Pharmacotherpeutic group:prolactin inhibitor belonging to the ergoline derivative group which acts by dopamine agonist activity.

ATC vet Code: QG02CB03.

5.1 Pharmacodynamic properties

The pharmacodynamics of cabergoline have been investigated in various in-vitroand in-vivosystem. The most significant findings can be summarised as follows:

• Cabergoline is a potent inhibitor of prolactin secretion by the pituitary, and as a consequence inhibits prolactin secretion dependent processes such as lactation.

• The mechanism of action of cabergoline is via direct interaction with the D-2 dopaminergic receptor on pituitary lactotroph cells; this interaction is a persistent effect.

• Cabergoline has some affinity for noradrenergic receptors, but does not affect noradrenaline or serotonin metabolism.

• As for other ergoline derivatives, cabergoline has emetic effects (equivalent in potency to those of pergolide and bromocriptine).

• At high doses orally, cabergoline causes a reduction in blood pressure.

No pharmacokinetic data are available for the recommended dosing regimen in dogs and cats.

Pharmacokinetic studies in dogs were performed with a daily dose of 80 µg/kg bodyweight (16 times the recommended dose). Dogs were treated for 30 days; pharmacokinetic assessments made on day 1 and 28.

Absorption:

• T_max = 1 hour on day 1 and 0.5-2 hours (mean 75 minutes) on day 28;

• C_max ranged from 1140 to 3155 pg/ml (mean 2147 pg/ml) on day 1 and from 455 to 4217 pg/ml (mean 2336 pg/ml) on day 28;

• AUC _{(0-24 h)} on day 1 ranged from 3896 to 10216 pg.h.ml^-1 (mean 7056 pg.h.ml^-1) and on day 28 from 3231 to 19043 pg.h.ml^-1 (mean 11137 pg.h.ml^-1) .

Elimination:

Triglycerides, medium-chain.

Nitrogen

6.2 Incompatibilities

Do not mix the product with an aqueous solution (e.g. milk)

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

6.3 Shelf-life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years

Shelf-life after first opening of the immediate packaging: 14 days.

6.4 Special precautions for storage

As packaged for sale: store in a refrigerator (2-8°C).

After first opening: store below 25°C.

Store in upright position.

Keep bottle in outer carton in order to protect from light.

Do not freeze.

6.5 Nature and contents of immediate packaging

Immediate packaging:

Amber glass type III vials of 15 ml capacity (containing 7 or 15 ml) or type II vials of 30 ml capacity (containing 24 ml) with grey coated bromobutyl rubber closure, supplied with vial adapter and HDPP dosing syringe (1 ml syringe with 7 ml packaging, and 3 ml syringe with 15 and 24 ml packagings).

Secondary packaging:

Cardboard box containing a single vial of 7 ml, 15 ml or 24 ml.

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products 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.

7. Marketing authorisation holder

KELA N.V.,

St. Lenaartseweg 48,

2320 Hoogstraten,

Belgium

8. Marketing authorisation number

Vm 06126/4002

9. Date of the first authorisation

4 July 2012

10. Date of revision of the text

July 2012

PROHIBITION OF SALE, SUPPLY AND/OR USE

To be supplied only on veterinary prescription.