Galastop 50 μg/ml oral solution
Contra-indications, warnings, etc
Do not use in pregnant animals since Galastop may cause abortion. Do not use in lactating bitches unless suppression of lactation is required.
Galastop may induce transient hypotension in treated animals. Do not use in animals concurrently being treated with hypotensive drugs. Do not use directly after surgery whilst the animal is still under the influence of the anaesthetic agents.
Do not use with dopamine antagonist.
Special warnings for each target species
Additional supportive treatments should involve restriction of water and carbohydrate intake and increase exercise.
Special precautions for use in animals
Cabergoline has the capacity to cause abortion in bitches in the later stages of pregnancy, and under no circumstances should Galastop be used in pregnant bitches.
Cabergoline may induce transient hypotension in treated animals and use of Galastop in animals concurrently being treated with hypotensive drugs, or in animals directly after surgery whilst the animal is still under the influence of anaesthetic agents, might result in more significant hypotension and such usage is contra-indicated.
Use in pregnant animals
Experimental data have shown that cabergoline has the capacity to cause abortion in bitches in the later stages of pregnancy: this effect was seen in all bitches tested. Therefore a contra-indication against use of Galastop in pregnancy is essential.
Induction of hypotension
Experimental data have shown that cabergoline has a hypotensive effect. This side-effect would not be expected to have adverse effects in clinical use because:
- The degree of this effect is not great and would not be expected to have adverse effects in healthy animals;
- In none of the experiments undertaken with cabergoline for whatever purpose and in whatever species has any evidence been observed of any adverse clinical reactions resulting from this hypotensive effect.
Nevertheless if an animal had low blood pressure for other reasons (e.g. concurrent use of hypotensive drugs, influence of anaesthetic agents), cabergoline might have adverse effects, and a warning to prevent usage of Galastop under such conditions is included.
The tolerance data show that cabergoline has emetic activity in the dog. This effect appears to be dose related, and is marked at doses of 10 µg/kg and above (the ED50 – the dose causing emesis in 50% of treated dogs – being calculated at 19 µg/kg).
In the clinical studies vomiting and anorexia was observed is a proportion of bitches treated as recommended for Galastop: in those studies where frequency was recorded, a total of 361 bitches were treated as recommended; of these 28 bitches (8%) vomited and 58 bitches (16%) showed anorexia.
In most cases these adverse effects were transient and of little significance, occurring after the first one or two treatments only. In only 3 bitches in the clinical trials (less that 1%) was treatment stopped because of vomiting.
In a small proportion of cases (qualitative frequency not available), a degree of drowsiness was observed in the first 2 days of treatment.
Interactions between cabergoline and other veterinary medicinal products have not been observed.
Since cabergoline exerts its therapeutic effect by direct stimulation of dopamine receptors, Galastop should not be administered concurrently with drugs which have dopamine antagonist activity (such as phenothiazines, butyrophenones), as these might reduce its prolactin inhibiting effects.
The experimental data indicate that a single overdose with Galastop 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. It is unlikely that the administration of dopamine antagonist drugs would be necessary, but this course of action could be considered.
Special precautions to be taken by the person administering the 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 age should wear gloves when administering the product.
For animal treatment only. Keep out of reach and sight of children.