LACTOFIN 3ML | Suppression of lactation in dogs and cats

LACTOFIN, 50 mcg/ml oral solution, for dogs and cats.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance:
Cabergoline…………………………………..………50 µg
Excipient, csp. ………………………………..………….1ml
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Oral solution.
4. CLINICAL DATA
4.1 Target species
Dogs and cats.
4.2 Indications for use, specifying the target species
Treatment of pseudopregnancy in bitches.
Suppression of lactation in bitches and cats.
As an adjuvant in the treatment of eclampsia and mastitis accompanied by discharge
dairy in bitches and cats.
4.3 Contraindications
None.
4.4 Special warnings for each target species
As additional supportive measures, during treatment the
intake of water and carbohydrates, as well as increasing the exercise of the animals
treaties.
4.5 Special precautions for use
Special precautions for use in animals
Cabergoline can cause abortions in bitches in the final phase of pregnancy and in

Cabergoline may cause transient hypotension in treated animals and its use
concomitant with other hypotensive drugs or in animals under the influence of
anesthetic agents after surgical procedures can lead to hypotension
significant. In these cases, cabergoline is contraindicated..
Special precautions to be taken by the person administering the medicinal product
to the animals
Administer the drug with caution.
It is convenient to wash your hands after use.
Avoid contact with skin and eyes. In case of accidental contact with the skin, it must be
be washed immediately with soap and water.
People with a known hypersensitivity to cabergoline should avoid all contact
with the veterinary drug.
The drug should be handled with care by pregnant women or women in
childbearing age who are taking contraceptives. Disposable gloves are recommended
when handling the medication.
In case of accidental ingestion, consult a doctor immediately and show him the
leaflet or label.
4.6 Adverse reactions (frequency and seriousness)
Occasionally there have been some cases of vomiting taking place
generally within one to two hours after the first dose is administered. He
treatment should not be interrupted, as this phenomenon does not usually occur in
subsequent treatments.
During treatment a slight loss of appetite may occur.
4.7 Use during pregnancy, lactation or lay
The indication of the veterinary medicinal product excludes its use during pregnancy.
Inhibition of prolactin release causes rapid cessation of secretion
of milk and the consequent reduction in the volume of the breast.
Do not use in lactating bitches or cats unless discontinuation of dosing is necessary.
lactation.
4.8 Interaction with other medicinal products and other forms of interaction
None known.
4.9 Amounts to be administered and administration route
Lactofin can be administered orally directly into the animal's mouth or mixed
with the feed
Bitches: 0,1 ml/kg body weight (equivalent to 5 µg/kg body weight) once
once a day for 4-6 days, depending on the severity of the condition
clinical.

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In case of recurrence, the treatment can be repeated according to the forms of
administration described above.
The drug should be used under the direct supervision of a veterinarian.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
In case of overdose, the first symptom to appear is vomiting. Saying
effect can be antagonized by parenteral administration of an agent
antidopaminergic such as metoclopramide
The emetic effect is dose-dependent. It has been observed in dogs treated with doses of
10 µg/kg and above. The dose that causes emesis in 50% of the treated animals
(ED50) is 19 µg/kg. In cats, the dose with emetic effects is 15 µg/kg.
4.11 Wait times
Not applicable.
5 PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: Other gynecological drugs. Prolactin inhibitors.
ATCvet code: QG02CB03.
5.1 Pharmacodynamic properties
Cabergoline is a derivative of ergotamine that possesses dopaminergic activity.
It inhibits the release of prolactin in the anterior pituitary and thus interferes with all
processes that depend on that hormone, such as lactation. The maximum inhibition is
it reaches 4-8 hours and lasts several days, depending on the dose administered.
The mechanism of action of cabergoline is exerted by stimulation of receptors
dopaminergic agents present in the lactotroph cells of the pituitary gland; such action persists in
time.
Cabergoline acts as a dopamine agonist, selectively binding to
dopaminergic D2 receptors in the central nervous system, and has some affinity for
noradrenergic receptors, but does not interfere with noradrenaline metabolism
nor with that of serotonin.
Like other derivatives of ergotamine, cabergoline possesses emetic activity (with a
potency similar to that of bromocriptine and pergolide).
5.2 Pharmacokinetic data
In dogs administered a daily dose of 80 µg/kg bw of cabergoline
for 30 days (pharmacokinetic determinations were carried out on day 1 and on
28), the following pharmacokinetic parameters were found:
Tmax of 1 hour on day 1 and 0,5-2 hours (mean 75 minutes) on day 28;
Cmax between 0,001 µg/ml and 0,003 µg/ml (mean 0,002 µg/ml) on day 1 and
between 0,0004 and 0,004 µg/ml (mean 0,002 µg/ml) on day 28;
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AUC(0-24 h) between 0,004 and 0,010 µg.h.ml-1 on day 1 (mean 0,007 µg.h.ml-1) and between
0,003 and 0,02 µg.h.ml-1 (mean 0,011 µg.h.ml-1) on day 28.
plasma t½ of 19 hours on day 1 and 10 hours on day 28
6 PHARMACEUTICAL DATA
6.1 List of excipients
Medium chain triglycerides (Miglyol 812).
6.2 Incompatibilities
None known.
6.3 Validity period
Shelf life of the veterinary medicinal product packaged for sale: 3 years.
Shelf-life after first opening the immediate package: 12 days.
6.4 Special precautions for storage
Store in the original box and keep the bottle tightly closed in order to
protect it from light.
6.5 Nature and composition of immediate packaging
Box with:
a type III topaz glass vial, with a low-density polyethylene spout
(LDPE) to attach the syringe and a composite child-resistant closure
by an external closure and an internal polypropylene closure, an LDPE seal and a
tamper-evident ring.
syringe for oral use composed of a cylindrical body of polypropylene, a plunger
of high density polyethylene and a silicone sealing ring. The syringe has a
volume of 3 ml and is graduated (with indications of 1, 2 and 3 ml and intervals
intermediates of 0,1 ml).
The formats are the following:
3 ml bottle + 3 ml oral syringe (for animals weighing up to 5 kg)
7 ml bottle + 3 ml oral syringe (for animals weighing up to 11 kg)
15 ml bottle + 3 ml oral syringe (for animals weighing up to 25 kg)
24 ml bottle + 3 ml oral syringe (for animals weighing up to 40 kg)
Not all formats may be marketed.

Any unused veterinary medicinal product or residues derived from it must be
disposed of in accordance with local regulations.
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7 MARKETING AUTHORIZATION HOLDER
Fatro Ibérica SL
Constitution 1, ground floor 3
08960 Sant Just Desvern (Barcelona)
8 MARKETING AUTHORIZATION NUMBER
2328 ESP
9 DATE OF THE FIRST AUTHORIZATION OR RENEWAL OF THE
AUTHORIZATION
July 20, 2011
10 DATE OF REVISION OF THE TEXT
January 11, 2012
PROHIBITION OF SALE, DISPENSATION AND/OR USE
Dispensing conditions: Medicine subject to a veterinary prescription
Administration conditions: Administration under control or supervision of the veterinarian

See technical sheet

LACTOFIN