A white, aqueous, sterile injectable suspension containing 100 mg/ml proligestone. Preservatives methylhydroxybenzoate 1 mg/ml and propylhydroxybenzoate 0.12 mg/ml.

The safety of progestagens is related to their molecular structure. Proligestone has a unique molecular configuration which makes it possible to administer Delvosteron at any stage of the oestrous cycle with little risk of undesirable effects on the endometrium.

1.Oestrus control

(i) Bitches

Permanent postponement of heat

Repeat injections given in anoestrus/metoestrus induced by the previous administration of Delvosteron.

Temporary postponement of heat

A single injection given in anoestrus.

Suppression of heat

A single injection given at the beginning of pro-oestrus.

(ii) Queens

Permanent postponement of calling

Repeat injections given in anoestrus/dioestrus induced by the previous administration of Delvosteron

Temporary postponement of calling

A single injection given during dioestrus or anoestrus.

Suppression of calling

A single injection given at the onset of calling.

(iii) Ferrets

To prevent the problems, such as vaginal and uterine infection and bone marrow depression associated with prolonged oestrus and persistently high oestrogen levels.

2.False pregnancy: treatment and prevention.

It has been shown that in most bitches, a single injection of Delvosteron will effectively alleviate both the nervous signs and lactation associated with false pregnancy. Trial results have indicated that the incidence of false pregnancy is markedly reduced following the use of Delvosteron for oestrus control irrespective of the bitch's previous history in respect of this condition.

3.Feline miliary dermatitis (miliary eczema): treatment and prevention.

Dosage

Bitches: 10–33 mg/kg bodyweight. The recommended average doses are as follows:

Cats:Oestrus control – 1 ml for the average 3 kg cat. Feline miliary dermatitis – 33–50 mg/kg, or 1.5 ml for the average 3 kg cat.

Ferrets:0.5 ml per jill.

Route of administration

Delvosteron should be given by subcutaneous injection taking special care to ensure that the product is not deposited intradermally or into a pad of subcutaneous fat or scar tissue. The usual aseptic precautions should be observed, i.e. the site to be used should be cleansed and swabbed with spirit. It is helpful to massage the injection site following administration to promote dispersion of the product.

Dosage schedule

Bitches

Permanent postponement of heat

It is recommended that injections are given as follows:

An injection of Delvosteron may be given to maintain permanent postponement of heat in bitches that are presented late, provided that postponement has not been interrupted by heat.

If anoestrus is not fully maintained, i.e. a `breakthrough' oestrus occurs in bitches on the permanent postponement regime described above, then immediate re-injection is suggested followed by dosing at intervals described above, but starting one step back in the duration of intervals between injections. For example, if a breakthrough heat occurs in a bitch being given injections at 5 monthly intervals, an immediate dose is given, the next dose 4 months later and the subsequent doses at 5 monthly intervals.

Following termination of a permanent postponement course, the next oestrus will occur generally 6–7 months after the last injection. In approximately 4% of cases the interval may be less than 5 months and in 7% it may be longer than 12 months. Up to 3% of bitches may fail to come on heat again when a permanent postponement course is terminated.

Temporary postponement of heat

A single injection given at any time in anoestrus but preferably not more than one month before the effect is required. The subsequent oestrus will occur on average 6 months after the injection. In about 3% of cases the interval will be shorter than 3 months and in up to 4% of bitches the delay will be longer than 12 months.

Suppression of heat

A single injection as soon as possible after the onset of pro-oestrus is seen. Following the injection, bleeding, vulval swelling and attractiveness to dogs should gradually decrease and stop within 5–7 days. The time for return to oestrus in the majority of bitches will be 5–6 months on average, but in approximately 3% of bitches the interval will be shorter than 3 months and in 1% it will be longer than 12 months.

Treatment of false pregnancy

A single dose, given preferably as soon as the signs are seen. In most cases nervous signs will disappear within 6 days and lactation will have stopped or be much reduced by day 9 after injection. In approximately 20% of cases the signs will recur within one month of treatment, about 70% of these cases will respond to a second dose.

Prevention of false pregnancy

Medication for permanent postponement of oestrus as advocated above.

Queens

Oestrus control

Dosage regimes similar to those given for bitches are advised for permanent postponement, temporary postponement or the suppression of calling, except that for temporary postponement of calling the injections may be given in either dioestrus or anoestrus. Following injection at the onset of calling, the signs will usually abate within 1–4 days, but in a few cases such a response may not be seen for 7 days. As cats are seasonally polyoestrus, the recurrence of calling after treatment is very variable. However in one study 11% and 30% of cats called within 5 months after medication in anoestrus and pro-oestrus respectively. The return to calling will be further delayed if the non breeding season (anoestrus) intervenes.

Treatment and prevention of feline miliary dermatitis

A single injection is often sufficient but a second dose may be given 14 days later if the clinical response is not adequate. Dosing may need to be repeated 4 monthly, or more frequently if necessary depending on the clinical response obtained.

Jills

Oestrus control

Delvosteron can be used to suppress or postpone heat in jills during the breeding season usually March to September. Following injection in jills showing prolonged oestrus (suppression) the signs will usually abate within 10–11 days. Injections given just before the onset of the breeding season (postponement) or during the breeding season (suppression or postponement) will usually maintain the jill in anoestrus for the remainder of the breeding season.

1.As with all progestagens, the possibility exists that the Cystic Endometrial Hyperplasia/pyometra complex may be seen as a side effect of the medication. In the clinical trials carried out with Delvosteron, however, the incidence of uterine disorders including pyometra, was only 0.3% overall and no cases occurred in bitches injected in pro-oestrus. The incidence of uterine changes was higher (1.4%) in animals which had previously received depot progestagens containing medroxyprogesterone acetate.

2.A transient increased appetite, lethargy and weight gain may be seen in some animals medicated with Delvosteron, but these side effects occur less frequently than with the first generation progestagens such as medroxyprogesterone acetate or megestrol acetate.

3.When using Delvosteron for the suppression of heat, it is important to ensure that the bitch is still in the early stages of pro-oestrus as an injection given in the later stages of pro-oestrus is unlikely to be effective at suppressing heat.

4.Bitches may accept the male for some days after medication with Delvosteron in pro-oestrus (suppression of heat). Thus contact with dogs should be prevented, wherever possible, until the signs of heat, vulval swelling and bleeding have fully regressed. This usually occurs within 5 days of dosing.

In bitches, the duration of postponement of oestrus following a dose of Delvosteron may on occasion be shorter than expected where the medicated animal is housed with other bitches. In such cases contact the Company for advice on possible alternative dosage regimes.

5.Delvosteron has been used to control heat in diabetic animals without altering insulin requirement. However, in other animals, the administration of Delvosteron has led to an increased insulin requirement. It is advised therefore that the product is used with caution in such animals and that urine sugar levels are observed carefully during the month after dosing.

6.A brief pain reaction may be seen immediately after injection. Since a slight local reaction, skin thinning and `pitting' together with some discolouration and loss of hair may occur very occasionally, it is advisable to inject Delvosteron subcutaneously on the medial side of the flank fold in thin skinned or show animals.

7.Very occasionally a local or systemic allergic/anaphylactic reaction may occur, necessitating immediate treatment with an appropriate corticosteroid, antihistamine or adrenaline.

8.Cases of false pregnancy that recur after a second dose of Delvosteron are better treated conservatively (restricted water intake, low carbohydrate diet, increased exercise, etc.) rather than being given further hormone medication. Delvosteron should not be administered to bitches which have been treated previously with oestrogens or other progestagens for the current false pregnancy.

9.A few cases of mammary hypertrophy following the use of Delvosteron in entire and neutered queens have been recorded, but proligestone appears less likely to induce the condition than first generation progestagens.

10.Delvosteron, in common with other progestagens, may cause adrenal suppression in some animals. It may be sensible therefore to administer glucocorticoids to animals being given the product for the permanent postponement of heat if they are subjected to excessive trauma, stress or require major surgery. However no problems have been reported by veterinary surgeons in practice in this respect.

For animal treatment only. Keep out of reach of children.

Store below 25°C. Shake well before use. Use a sterile needle and syringe for administration.

Following withdrawal of the first dose use within 28 days. Discard unused material. Avoid the introduction of contamination.

20 ml multidose vials.

Although Delvosteron may be used to medicate bitches at their first oestrus, this regime is not normally recommended. Similarly medication before a bitch's first oestrus is not generally advised. Delvosteron may be safely used in breeding bitches, queens or jills; fecundity at the oestrus following the cessation of medication is not adversely affected. Delvosteron is not contra-indicated in bitches with a history of abnormal cycles or those which have shown or are showing signs of urogenital tract disorders. Indeed there is an indication that the product may be used beneficially in such caes; for example the permanent postponement of oestrus with Delvosteron may prevent the recurrence of endometritis.

Delvosteron generally has little effect on the performance of racing greyhounds.

In trials, 65% of cases of allergic skin conditions in dogs responded well to a single dose of 10–33 mg/kg, as recommended for oestrus control in bitches, although not unexpectedly the response was only maintained in just over one third of the cases. Cases of flea hypersensitivity responded particularly well. Dosing with Delvosteron may thus be a useful alternative to medication with glucocorticoids whilst the underlying case is being eliminated.