Galastop 50 ug/ml Oral Solution

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Cabergoline

Available from:

Ceva Salute Animale S.p.A

ATC code:

QG02CB03

INN (International Name):

Cabergoline

Pharmaceutical form:

Oral solution

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Dogs

Therapeutic area:

Anti Hormone Agent

Authorization status:

Authorized

Authorization date:

1996-04-22

Summary of Product characteristics

Revised: December 2023
AN: 02509/2023
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Galastop 50 µg/ml
Oral solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of product contains:
_1.1_
_ACTIVE INGREDIENT_
Cabergoline
50
µg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral Solution.
A
pale
yellow,
viscous
non
aqueous
solution
for
oral
administration
containing 50 µg/ml cabergoline in a miglyol base.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Galastop is indicated for the following uses:
•
_Treatment _
_of _
_false _
_pregnancy _
_in _
_bitches_:
Inhibition
of
prolactin
secretion by cabergoline results in a rapid resolution of the signs of
false
pregnancy, including lactation and behavioural changes.
•
_Suppression of lactation in bitches_: Suppression of lactation in the
bitch may be required under certain clinical circumstances (for
example
following removal of puppies soon after birth, or following early
weaning).
Inhibition of prolactin secretion by cabergoline results in a rapid
cessation of
lactation and a reduction in the size of the mammary glands.
4.3
CONTRAINDICATIONS
•
Do not use in pregnant animals since Galastop may cause abortion.
Revised: December 2023
AN: 02509/2023
Page 2 of 8
•
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.
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
i)
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 (