Medine.co.uk

Ovarid 20 Mg Tablets

Revised: 13 May 2010

AN: 00142/2010

SUMMARY OF PRODUCTS CHARACTERISTICS

1.

NAME OF THE VETERINARY MEDICINAL PRODUCT

Ovarid 20mg Tablets

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains:


Active substance(s):

Megestrol acetate


For a full list of excipients, see section 6.1

mg

20.0

3.

PHARMACEUTICAL FORM

Tablets

Buff coloured slightly speckled biconvex uncoated tablet with a break on one surface.

4.

CLINICAL PARTICULARS

4.1

Target species

Cats and dogs

4.2

Indications for use, specifying the target species

Megestrol acetate is a potent prostagen 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 miliary and eosinophilic granulomata.


Postponement of oestrus (Bitches): The product may be used to postpone an anticipated oestrus. Following the recommended course it is not possible to state when the next oestrus period will occur, with any degree of accuracy, as this will depend on the stage of anoestrus when the tablets were administered. It is most likely, however, that it will appear some three months later. It is unlikely that oestrus will be delayed by more than six months.


Prevention of oestrus (suppression of heat) (Bitches): When the tablets are used by the recommended method for the prevention of oestrus, the signs of pro-oestrus usually disappear in two to three days and the subsequent oestrus normally occurs four to six weeks earlier than would have been the case had medication not been given.


Oestrus control in cats: Oestrus can be prevented or postponed by selecting an appropriate dose regime. The occurrence of the next oestrus following treatment may be variable because the cat is seasonally polyoestrus and ovulation does not occur spontaneously.


However, the next call after a prevention course given during the breeding season will probably occur a few days later than normally expected -- on average about four weeks after the last dose is given. Queens given a correctly timed postponement course will not call whilst they are receiving the tablets.


Miliary eczema in cats: Field experience has shown it to be very successful in the treatment of miliary eczema. A clinical response can be expected in most cases within the first few days of commencing treatment.


Eosinophilic granuloma (rodent ulcer) in cats: Clinical experience has shown that the product can be beneficial in this condition.


Undesirable behaviour in dogs: Trials have shown that the product is an effective treatment in 75% of dogs exhibiting the following undesirable behaviour:

Aggression -- either dominant or submissive (fear-induced)

Mounting

Territory marking by urination

Roaming

Excitability

Destructiveness

4.3

Contraindications

Ovarid is not recommended in diabetic animals.

Male dogs intended for breeding should not be treated with Ovarid

4.4

Special warnings for each target species

None

4.5

Special precautions for use

i.

Special precautions for use in animals

It must be remembered that progestagens, like other synthetic hormones, should always be used with care. This is particularly so in bitches treated at their first oestrus. Owners should be advised that this class of bitch, and a small proportion of others which have abnormal oestrous cycles, may show excessive libido, or oestrus may return earlier than expected, because of difficulties which may be encountered with the timing of administration.



Apart from these considerations experience has shown that, when used correctly, the product does 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 the product is given once ovulation has occurred, they may aid conception.

ii.

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

None

iii.

Other precautions

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 the product 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. The product 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

Amount(s) 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:


Weight of bitch

5 mg tablets only

20 mg tablets only

kg

lb

Total daily dose (mg)

No. daily

No. for maximum course

(40 days)

No. daily

No. for maximum course

(40 days)

Up to 5

Up to 11

2.5

½

20

---

---

6--10

12--22

5

1

40

---

---

11--15

23--33

7.5

1½

60

---

---

16--20

34--44

10

2

80

½

20

21--30

45--66

15

3

120

--

31--40

67--88

20

4

160

1

40

41--50

89--110

25

5

200

---

51--60

111--142

30

---

---

1½

60

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.


Weight of bitch

5 mg tablets only

20 mg tablets only

kg

lb

Total daily dose (mg)

No. daily course

No. for complete course

(8 days)

No. daily

No. for complete course

(8 days)

2.5--5

6--11

10

2

16

½

4

6--7.5

12--17

15

3

24

8--10

18--22

20

4

32

1

8

11--15

23--33

30

6

48

1½

12

16--20

34--44

40

---

---

2

16

21--25

45--55

50

---

---

2½

20

26--30

56--66

60

---

---

3

24

31--35

67--77

70

---

---

3½

28

36--40

78--88

80

---

---

4

32

41--50

89--110

100

---

---

5

40

51--60

111--142

120

---

---

6

48

(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:


Initial dosing

Subsequent dosing

Improved -- 1 mg/kg daily for 14 days



2 mg/kg daily for 7 days

Improved -- 1 mg/kg daily for 14 days

Not improved -- 4 mg/kg daily for 7 days


Not improved -- cease treatment
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 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 miliary 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 20mg tablets

Packaged in cartons of: 16 x 20mg 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 the local requirements

7.

MARKETING AUTHORISATION HOLDER

Virbac

1ère avenue

2065M – LID

06516 Carros

France

8.

MARKETING AUTHORISATION NUMBER(S)

Vm 05653/4160

9.

DATE OF FIRST AUTHORISATION

Date: 30 October 1992

10.

DATE OF REVISION OF THE TEXT

Date: May 2010


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