Target species
Dogs and cats.
Indications for use for each target species
Treatment of false pregnancy in bitches.
Suppression of lactation in bitches and queens.
Contraindications
Do not use in pregnant animals since the veterinary medicinal product may cause abortion.
Do not use with dopamine antagonists.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Cabergoline may induce transient hypotension in treated animals. Do not use in animals currently being treated with hypotensive drugs. Do not use directly after surgery whilst the animal is still under the influence of anaesthetic agents.
Special warnings
None.
Special precautions for safe use in the target species
Caution is recommended in animals with significantly impaired liver function.
Additional supportive treatments should involve restriction of water and carbohydrate intake and increased exercise.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Wash hands after use.
Avoid contact with skin and eyes. Wash off any splashes immediately.
Women of childbearing potential and breast-feeding women should not handle the veterinary medicinal product or should wear impervious gloves when administering the veterinary medicinal product.
People with known hypersensitivity to cabergoline or any of the other ingredients in the veterinary medicinal product should avoid contact with the veterinary medicinal product.
Do not leave unattended filled syringes in the presence of children. In case of accidental ingestion, particularly by a child, seek medical attention immediately and show the package leaflet or the label to the physician.
Special precautions for the protection of the environment
Not applicable.
Adverse events
Dogs:
Rare (1 to 10 animals / 10,000 animals treated): | Drowsinessa, Anorexia a Vomiting a,b Neurological symptom (e.g. somnolence, muscle tremor, ataxia, hyperactivity, convulsion) |
Very Rare (<1 animal / 10,000 treated, including isolated reports): | Hypotension c Allergic reaction (e.g. allergic oedema, urticaria allergic dermatitis, pruritus) |
a usually moderate and transient.
b usually only occurs after the first administration. In this case treatment should not be discontinued, since the vomiting is unlikely to reoccur after the next administration.
c transient.
Cats:
Very rare (1 animal / 10,000 treated, including isolated reports): | Drowsiness a Allergic reaction (e.g. allergic oedema, urticaria, allergic dermatitis, pruritus) Neurological symptom (e.g. somnolence, muscle tremor, ataxia, hyperactivity, convulsion) Hypotension b |
Undetermined frequency (cannot be estimated from the available data): | Anorexia a Vomiting a,c |
a usually moderate and transient
b transient
c usually only occurs after the first administration. In this case treatment should not be discontinued, since the vomiting is unlikely to reoccur after the next administration.
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, lactation or lay
Pregnancy:
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.
Lactation:
The veterinary medicinal 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 veterinary medicinal product should not be used in lactating animals unless suppression of lactation is required.
Interaction with other medicinal products and other forms of interaction
Since cabergoline exerts its therapeutic effect by direct stimulation of dopamine receptors, the veterinary medicinal 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. See also section Contraindications.
Since cabergoline may induce transient hypotension, the veterinary medicinal product should not be used in animals concurrently treated with hypotensive drugs. See also section Contraindications and Adverse events.
Amounts to be administered and administration route
Oral use.
The veterinary medicinal 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.
To ensure a correct dosage, body weight should be determined as accurately as possible.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
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 parenteral administration of dopamine antagonist drugs such as metoclopramide might be considered.
Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance
Not applicable.
Withdrawal periods
Not applicable.