Depo-promone 50mg/ml ,3 ml , injectable suspension

DEPO-PROMONE 50*3ML

NAME OF THE VETERINARY MEDICINAL PRODUCT
DEPO PROMONE 50, 3ml,
Injectable suspension for bitches.
Medroxyprogesterone acetate.

STATEMENT OF THE ACTIVE SUBSTANCES AND OTHER INGREDIENTS (INGREDIENTS)
Active substances:
Each ml contains:
Medroxyprogesterone acetate – 50mg.

Excipient(s):
Methyl parahydroxybenzoate
Propyl parahydroxybenzoate
Water for injections
Sodium chloride
Polysorbate 80
Macrogol3335
Sodium hydroxide (pH adjustment)
Hydrochloric acid (pH adjustment)

INDICATION(S)
Prevention of estrus in bitches in heat in accordance with the following recommendations:
1. DOG for whom mating or giving birth involves a very high risk to the animal’s life;
2. DOG presenting a high surgical risk in the case of ovariohysterectomy.
It must be taken into account that some of these bitches may require surgery later. (see the contraindications, warnings, etc. section).
Depo Promone 50 can offer these DOG the possibility of several months of extended longevity without causing estrus disorders or undesirable consequences on pregnancy.
3. DOG in whom pregnancy is not desired.
4. DOG in whom pregnancy is optional.
An administration of Depo Promone 50 is recommended to extend the date of installation of a new pregnancy.

CONTRAINDICATIONS
Not recommended for bitches from whom it is desired to obtain puppies, intended for kennels.
It is recognized that progesterone stimulates the proliferation and secretory activity of the endometrium in the bitch. In many bitches, both treated and untreated with Depo Promone 50, this response is of a transient nature, but in some females, it may persist causing uterine enlargement or an unacceptable accumulation of mucus in the uterus or vaginal discharge and may be linked to the occurrence of pyometra. Otherwise, Depo Promone 50 (medroxyprogesterone acetate) is contraindicated in dog in the following situations:
1. Pro-estrus, estrus or metestrus;
2. dog before their first estrus;
3. Pregnant dogs;
4. History of genitourinary disorders;
5. Abnormal and persistent vaginal discharge;
6. Nymphomania or abnormal estrus periods;
7. False pregnancy;
8. Mammary tumors that can be stimulated under the influence of progesterone activity;
9. Other detectable abnormalities of the endocrine or reproductive system.

Otherwise, clinical studies have shown that Depo Promone 50 can induce lactation and mammary gland enlargement in some dogs; In this case, this product should not be re-administered to dogs that have shown such manifestations.
The degree of mammary gland enlargement varies from very little to some cases in which the process may be undesirable. The effect is undesirable in bitches of greyhound breeds that participate in racing.
Depo Promone 50 alone or in combination with estrogens should not be administered to animals showing abnormal uterine bleeding, mammary tumors or mammary gland enlargement until a definitive diagnosis has been established and the possibility of neoplasia has been excluded.
Some effects of skin thinning and/or hair discoloration have been reported at the subcutaneous injection site. These localized effects are probably due to the anti-inflammatory effect of medroxyprogesterone acetate.
For this reason, Depo Promone 50 should be inoculated in a less visible area such as the inner thigh.
In some dogs exposed to high doses of progestational steroids, the appearance of mammary nodules has been observed.
Animals under therapy with Depo Promone 50 should be examined periodically to observe whether mammary nodules have appeared, in which case a different therapy will be instituted on a case-by-case basis.
Some individuals may be predisposed to obesity when treated with Depo Promone 50. These individuals should be examined for other possible causes and appropriate measures should be taken.
Dietary management should also be considered.
Depo Promone 50 should not be used in animals under treatment for diabetes without close observation to observe the occurrence or not of these effects.
Cystic endometrial hyperplasia has been observed in some animals when using Depo Promone 50. It has been demonstrated that the ovaries must be present in order for the uterus to have a gestational response when using Depo Promone 50. It can be speculated that these dogs with marked ovarian activity or a more reactive uterus are the ones that respond with varying degrees of endometrial hyperplasia or uterine enlargement. Dogs that respond negatively cannot be detected before Depo Promone 50 is administered. Those that show an extreme increase inuterine or persistent vaginal discharge should usually be treated with ovariohysterectomy to correct this condition. Infections, as evidenced by histological signs of inflammation, are only occasionally found. The contents of the enlarged uterus are generally mucoid in nature but may range to the presence of purulent material. However, Depo Promone 50 should not be used in dogs whose owners wish to use them for breeding without the owner’s consent and without informing the owner of the risk of cystic endometrial hyperplasia, pyometra and the need for hysterectomy. Owners should be advised to promptly notify their veterinarian of any abnormal vaginal discharge or abdominal enlargement in order to reduce the possibility of systemic toxemia or pyometra.

ADVERSE REACTIONS
None known.

TARGET SPECIES
Bitches.

DOSAGE FOR EACH SPECIES, ROUTE(S) OF ADMINISTRATION AND METHOD OF ADMINISTRATION
Prevention of estrus – 1ml (50 mg medroxyprogesterone acetate), administered subcutaneously during anestrus, with repetition after an interval of 6 months, administered in a place out of sight due to the possibility of changing hair color, thinning of the skin, etc. It will be administered only in the form of aseptic injections.
In dogs, the recommended period for administering the product for the prevention of estrus is 3-5 months after estrus. It is recommended that the period of the estrus cycle be determined either by the animal’s history and/or by performing a vaginal smear before administering the product.
In animals in which estrus prevention is desired for a longer period of time, repeated subcutaneous injections should be carried out at the recommended intervals. Omission of re-administration of the product may cause the reappearance of estrus after a variable period of time.

RECOMMENDATIONS ON CORRECT ADMINISTRATION
In dogs, the recommended period for administering the product to prevent estrus is 3-5 months after estrus.
It is recommended that the period of the estrus cycle be determined either by the animal’s history and/or by performing a vaginal smear before administering the product.
In animals in which estrus prevention is desired for a longer period of time, repeated subcutaneous injections should be made at the recommended intervals. Omission of re-administration of the product may cause the recurrence of estrus after a variable period of time.

WITHDRAWAL TIME
Not applicable.

SPECIAL STORAGE PRECAUTIONS
Store at temperatures up to 25°C.
Do not freeze.
Do not use after the expiry date stated on the label.

SPECIAL WARNING(S)
For animal use only
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
Any unused veterinary medicinal product or waste materials derived from the use of such veterinary medicinal products should be disposed of in accordance with local requirements.