Composition:
Each 1 ml contains Proligestone 100mg, Methyl parahydroxy benzoate 0,12 %, Propyl parahydroxy benzoate 0,014 %.

Pharmacological Classification:
20.4 Ovulation controlling agents and prostaglandins.

Pharmacological Action:
Delvosteron is a long acting progestational agent which has good antigonadotrophic properties but is weakly progestogenic and has no androgenic properties. Proligesterone has therefore hardly any effect on the endometrium even if it is already sensitised by oestrogens.

Indications:

• For the delay and suppression of oestrus in the dog and cat
• Treatment of dermatitis of hormonal origin
• Feline miliary eczema
• False pregnancy in bitches

Contra-Indications:
Do not use the agent during pro-oestrus.

Warnings:

The dose and duration of Delvosteron treatment should not exceed the recommendations for use set out under Dosage and Administration.

Although Delvosteron is a safe product, high doses or prolonged use of progestagens may promote the development of cystic endometrial hyperplasia and subsequent pyometra.

• In cats few cases of mammary hyperplasia following the use of Delvosteron have been recorded.
• Atrophy of the skin and underlying tissue have been observed in rare cases.
• In view of the considerable variation in age at which signs of the first pro-oestrus occur, it is advisable to postpone treatment until these signs are actually noted. Alternatively the treatment may be postponed until the following anoestrus phase.
• It should be born in mind that in spite of the disappearance of oestrus signs, dogs and cats treated in pro-oestrus may remain fertile for as long as one week.
• A small percentage of animals may not come on heat after treatment has stopped but the number is not much greater than in bitches left to cycle normally.
• Cats will normally come into oestrus approximately six months after the last injection.
• Uterine pathology may develop especially after long-term use.
• Permanent anoestrus may occur in treated bitches.
• Dystocias may develop in bitches that are treated during early or late pregnancy.

Withdrawal Period:
Not applicable. For use in dogs and cats only.

Route of Administration:
Delvosteron should be given by subcutaneous injection taking care 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 cleaned and swabbed with alcohol. It is helpful to massage the injection site following administration to promote dispersion of the product.

Dosage Schedule:

Bitches: Used for: 

1. Permanent postponement of heat:
   It is recommended that injections are given as follows:
2. • 1st injection: in pro-oestrus (see suppression of heat below) or in anoestrus (see temporary postponement of heat below).
   • 2nd injection: 3 months after 1st injection.
   • 3rd injection: 4 months after 2nd injection.
   • Subsequent injections at 5 monthly intervals.
     
     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 4 months later and 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 the 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 when a permanent postponement course is terminated.
3. 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.
4. 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.
5. 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.
6. Prevention of false pregnancy: Medication for permanentpostponement of oestrus as advocated above.

Queens: Used for:

1. 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 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.
2. Treatment and prevention of feline miliary dermatitis / eczema: 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.

Side-Effects and Special Precautions:
See warnings. Brief pain reaction immediately after injection, discolouration and loss of hairs at the injection site and endometritis have rarely been observed.

Known symptoms of overdosage and particulars of its treatment:
See warnings. Overdosage will delay the period before return to a normal cycle. Treatment is symptomatic.

Identification:
White injectable aqueous suspension in a clear glass bottle.

Storage Instructions:
Store at room temperature between 20 ºC to 25 ºC.

Presentation:
20 ml multidose vials.

Registration holder:
Intervet S.A. (Pty) Ltd
Co. Reg. No. 1991/006580/07