Apart from these considerations experience has shown that, when used correctly, Ovarid Tablets do not produce undesirable side-effects since oral administration allows the duration of effect to be more accurately controlled than is the case with depot injections.

In the prevention of oestrus in bitches, the timing of administration is of great importance if best results are to be obtained. If Ovarid Tablets are given once ovulation has occurred, they may aid conception.

ii.

Special precautions for the person administering the veterinary medicinal product to animals

None.

4.6

Adverse reactions (frequency and seriousness)

Occasionally, lethargy and increased appetite with consequent weight gain may be seen in treated animals.

As with all prostagens there is the possibility of endometrial changes. However, at the recommended doses there should be no adverse effects.

Very occasionally, following long term use of megestrol acetate in cats to prevent recurrence of miliary eczema, mammary hypertrophy may occur. This effect is quite distinct from mammary neoplasia and may regress on cessation of dosing. In such cases medication should be withdrawn.

4.7

Use during pregnancy, lactation or lay

Prostagens may inhibit parturition. Therefore, if Ovarid is given (to cats) during pregnancy, it should be withdrawn 2-3 weeks prior to parturition. (Ovarid is not recommended for use in pregnant bitches.)

Experience has shown that bitches conceive normally at the heat following the withdrawal of megestrol acetate. Ovarid can be given to bitches to prevent the oestrus which occurs after cessation of dosing with a postponement course.

In breeding queens it is advisable that mating should be allowed at the second or subsequent call rather than the first call after cessation of mating.

4.8

Interaction with other medicinal products and other forms of interaction

None known.

4.9

Amounts to be administered and administration route

Postponement of oestrus (Bitches): 0.5 mg/kg daily for a maximum period of forty days. The course of tablets should commence preferably fourteen but at least seven days before the effect is required. A series of postponement courses may be given provided the bitch is not medicated more than twice in any 12 month period.

The following table may be used to help in dispensing tablets:

Prevention of oestrus (suppression of heat) (Bitches):

(a) Normal dosage regimen: 2 mg/kg daily for eight days. The course of tablets should commence at the onset of pro-oestrus as indicated by the presence of both haemorrhage and vulval swelling. The stage of the oestrus cycle may be confirmed by the examination of vaginal smears.

(b) Extended dosage regimen: 2 mg/kg daily for four days followed by 0.5 mg/kg daily for 16 days.

The use of this prolonged prevention course is advised in first season bitches, and may also be beneficial in bitches with a history of false pregnancy, in some cases where other abnormalities of the oestrous cycle are known to occur and when the animal to be medicated is housed with other bitches.

Oestrus control in cats:

(i) Postponement of oestrus -- 2.5 mg per cat once weekly for up to 30 weeks. Dosage should commence in anoestrus (the non-breeding season).

(ii) Prevention of oestrus -- 5 mg per cat daily for three days commencing as soon as the signs of calling are seen.

Treatment of miliary eczema (miliary dermatitis) and eosinophilic granuloma (rodent ulcer) in cats: The recommended dosage is 2.5 to 5 mg per cat every two to three days until the lesions begin to regress then once weekly until a satisfactory response is obtained. In some cases it may be necessary to give a maintenance dosage of 2.5 mg per cat weekly or fortnightly to prevent recurrence of the condition. Alternatively, repeat courses of treatment may be given as required.

Undesirable behaviour in dogs: The dosage should be adjusted according to response and the following is offered as a guide:

In a minority of animals, it may be necessary to prescribe a low maintenance dose on a once weekly basis or to give repeat short courses of medication as required.

Treatment with Ovarid in conjunction with re-training appears to increase the level of success in cases of undesirable behaviour.

4.10

Overdose (symptoms, emergency procedures, antidotes), if necessary

The effects of overdose of Ovarid have not been investigated, however effects consistent with its progestational activity could be expected.

4.11

Withdrawal period(s)

Not applicable.

5.

PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Progestogens

ATC Vet Code: QG03AC05

5.1

Pharmacodynamic properties

Megestrol acetate is a potent progestagen with marked anti-oestrogenic properties. It is recommended for administration by the oral route in bitches for the postponement or prevention of oestrus and the treatment of hypersexuality which may be manifest as undesirable behaviour in male dogs.

In cats it is recommended for prevention or postponement of oestrus and the treatment of military dermatitis and eosinophilic granulomata.

Megestrol acetate is an established pharmacopoeial progestagen which is of greater potency than progesterone both as a progestational agent and as an inhibitor of ovulation.

5.2

Pharmacokinetic properties

Absorption of megestrol acetate from the gastro-intestinal tract is variable following oral administration; peak drug concentrations in plasma occur 1 to 3 hours after a dose by mouth. It is excreted in urine, mainly as unchanged drug; metabolites account for only about 5 to 8% of the dose administered.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Calcium phosphate

Maize starch

Dried yeast

6.2

Incompatibilities

Not applicable

6.3

Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.

6.4

Special precautions for storage

None.

6.5

Nature and composition of immediate packaging

Aluminium foil/polyethylene strips.

Packaged in cartons of: 200 x 5mg tablets

Packaged in cartons of: 16 x 5mg tablets

6.6

Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if appropriate

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

7.

MARKETING AUTHORISATION HOLDER

Virbac

1 ere avenue

2065M – LID

06516 Carros

France

8.

MARKETING AUTHORISATION NUMBER

Vm 05653/4161

9.

DATE OF FIRST AUTHORISATION

Date: 30^th October 1992

10.

DATE OF REVISION OF THE TEXT

Date: May 2010