Description
50 mg/ml, contraceptive suspension for injection for dogs and cats
Active substance and excipient content
Active substance:
Medroxyprogesterone acetate – 50 mg/ml
Excipients:
Methyl parahydroxybenzoate – 1.2 mg/ml
Propyl parahydroxybenzoate – 0.2 mg/ml
Therapeutic indications
Preventing heat in bitches and queens.
Treating hypersexuality in queens, not associated with polycystic ovaries.
Contraindications
Do not use:
– in proestrus, oestrus, metoestrus phases,
– in pregnant and lactating animals,
– in case of diagnosed mammary gland tumours,
– in immature and growing animals,
– before occurrence of the first heat cycle,
– in diabetic animals,
– in reproductive tract inflammations,
– in English Whippet bitches,
– in cases of hypersensitivity to the active substance or any of the excipients.
Adverse reactions
Administration of medroxyprogesterone for more than 2 years is conducive to uterus and mammary gland disorders. It may cause endometritis pyometra complex in bitches, growth of endometrial tissue, cystic endometrial hyperplasia, polycystic ovaries, acromegaly and mammary gland tumours. Administration of MPA may cause adrenal suppression and diabetes.
Transitory changes in animal temperament and increased appetite may occur during treatment.
In rare cases, skin and fur discolouration or hyperpigmentation may occur at the injection site. Any adverse reactions emerged after administration of the product or any observed symptoms not listed in the leaflet (including symptoms reported in humans following exposure to the product) should be reported to the competent veterinarian, Marketing Authorization Holder or the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. The report form should be downloaded from https://www.urpl.gov.pl (Department of Veterinary Medicinal Products).
Amount to be administered per species, method and route of administration
Depogeston should be administered subcutaneously or intramuscularly in the following doses:
bitches: 50 – 100 mg of medroxyprogesterone acetate per animal, subcutaneously or intramuscularly, i.e.
– small animals (up to 10 kg of b.w.) – 1.0 ml of the product per animal;
– medium (10-25 kg of b.w.) – 1.5 ml of the product per animal;
– large (25-45 kg of b.w.) – 2.0 ml of the product per animal;
queens: 50 mg of medroxyprogesterone acetate per animal, subcutaneously, i.e. 1.0 ml of the product per animal.
First administration of the product should occur not earlier than after 2 months after parturition and not later than 1 month before expected heat.
In order to permanently block the heat cycle, apply this product regularly every 5 months in bitches and every 3-4 months in queens, however not longer than for the period of 2 years. Inform the animal owner that occurrence of the first heat is animal-specific and it usually occurs after about 5-6 months in bitches and 3-4 months in queens, although in some cases this period may be considerably extended.
Instructions for use
Shake the product before use to obtain homogeneous suspension.
Withdrawal period
Not applicable
Special precautions for storage
Keep out of the sight and reach of children.
Store below 25°C. Do not freeze.
Do not use this product after the use-by date given on the label.
Shelf life after first opening the immediate packaging: 14 days
Special warnings
Special warnings per target species:
Relevant laboratory tests to determine the phase of the cycle should be run before use.
Special precautions for use in animals:
First administration of the product should occur not earlier than after 2 months after parturition and not later than 1 month before expected heat.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Pregnant women and women of childbearing potential should avoid exposure to the product. In case of accidental spilling on skin or contact with eyes, rinse the affected site with water. In case of accidental self-injection, immediately seek doctor’s assistance and present the doctor with the information leaflet or package.
Pregnancy:
Do not use during pregnancy.
Lactation:
Do not use while breastfeeding. If administered during breastfeeding, the product suppresses milk secretion by inhibiting secretion of pituitary gonadotropins.
Interaction with other medicinal products and other forms of interaction:
Administration of gonadotropins (LH, FSH) and estrogens for purposes of recovering the heat cycle after product use may increase the risk of pathological lesions of the endometrium.
Overdose (symptoms, emergency procedures, antidotes):
Overdose may cause transitory changes in animal temperament, increased appetite, lactation.
Pharmaceutical incompatibilities:
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Medicines should not be disposed of via wastewater or household waste.
Ask your veterinary surgeon how to dispose of medicines no longer required. These
measures should help to protect the environment.
Other information
For more information about this veterinary medicinal product, contact the Marketing Authorization Holder.
Pack size
One glass bottle containing 5 ml of the product, wrapped in a cardboard box.
Shelf life of the veterinary medicinal product as packaged for sale
3 years
For animal treatment only.
Subject to medical prescription – prescription drug
Tobe administered under veterinary supervision.
2015-09-30 SPC
CPLW 2015-09-30
27.07.2015 r.
