SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Juramate 250 µg/ml Solution for Injection

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active substance:

Cloprostenol Sodium equivalent to 250 µg/ml cloprostenol

Excipients:

Preservative: Chlorocresol 1 mg/ml

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Solution for Injection

Clear, colourless solution

4. CLINICAL PARTICULARS

4.1 Target species

Cattle, horses.

4.2 Indications for use, specifying the target species

Cattle

Horses

• Induction of luteolysis following early foetal death and resorption

• Termination of persistent dioestrus

• Termination of pseudopregnancy

• Treatment of lactation anoestrus

• Establishing oestrous cycles in barren/maiden mares

• As an aid to stud management

4.3 Contraindications

None

4.4 Special warnings for each target species

Due to the possibility of post-injection bacterial infections, careful aseptic techniques should be employed.

4.5 Special precautions for use

Not applicable.

Prostaglandins of the F_2type can be absorbed through the skin and may cause bronchospasm or miscarriage.

Care should be taken when handling the product to AVOID SELF-INJECTION OR SKIN CONTACT.

Women of child-bearing age, asthmatics and persons with bronchial or other respiratory problems should avoid contact with the product, and should wear disposable plastic gloves when administering the product.

The possible incidence of bronchospasm with the product is unknown. Should shortness of breath result from accidental inhalation of injection, seek urgent medical advice and show the doctor this warning.

Accidental spillage on the skin should be washed off immediately with soap and water.

4.6 Adverse reactions (frequency and seriousness)

On rare occasions severe life-threatening local bacterial infections may occur associated with clostridial proliferation at the injection site. It is important to keep treated animals under observation and, if such infection occurs aggressive antibiotic therapy, particularly covering clostridial species, should be employed as a matter of urgency. Careful aseptic techniques should be employed to decrease the possibility of these infections.

4.7 Use during pregnancy, lactation or lay

Do not administer to pregnant animals unless the objective is to terminate pregnancy.

4.8 Interaction with other medicinal products and other forms of interaction

None known.

4.9 Amounts to be administered and administration route

Do not administer intravenously.

CATTLE

(Single or repeated 2mL doses (equivalent to 500 µg. of cloprostenol) by intramuscular injection).

Therapeutic indications

Sub-oestrus (or non detected oestrus)

After diagnosing the presence of a corpus luteum – by rectal palpation – treat with the product and inseminate those animals showing heat. Those animals which do not show heat to be re-examined 11 days later and may receive a second injection and be bred at oestrus or at fixed times; once at 72-84 hours or twice at 72 and 96 hours.

Induction of parturition

Induces parturition in the period around normal term. Induction should take place as close to the predicted calving date as possible and not more than 10 days before. Induction should not be attempted before day 270 of gestation measured from the confirmed day of conception, except in pathological conditions. All treated animals must receive adequate supervision. In common with other methods of shortening the gestation period a higher than usual incidence of retention of the foetal membranes is to be expected.

Termination of normal pregnancy

Normal pregnancy can be terminated in cattle from one week after conception until the 150^thday of gestation. Best results are obtained during the first 100 days. Treated animals should be kept under observation until expulsion of the foetus and placenta is complete.

Termination of abnormal pregnancy

Mummified foetus – induction of luteolysis at any stage of pregnancy will result in the expulsion of the mummified foetus from the uterus into the vagina from which manual removal may be necessary. Normal cyclical activity should then follow.

Hydrops of the foetal membrane – Pathological accumulation of placental fluids can cause severe physiological complications and death. Surgical drainage is not usually successful in alleviating the condition. In such cases, a single dose may be used to induce parturition.

Chronic endometritis (Pyometra)

Treat with a single dose. In long-standing cases treatment may be repeated after 10-14 days.

Ovarian luteal cysts

Where cystic ovaries associated with persistent luteal tissue and absence of heat are diagnosed, the product has proved to be effective in correcting the condition and bringing about a return to cyclicity.

Other indications:

Controlled breeding

Examples of programmes which have been used are:

Cattle which respond to a single prostaglandin injection will normally do so within 6 days of treatment. The response time after two injections is more rapid. Animals may be inseminated on detection of oestrus in any of the breeding programmes. However, fixed time insemination should only be used following the second of a two injection programme (i.e. examples iii) and iv)). In the latter case insemination should be performed either once at 72-84 hours or twice at 72 and 96 hours after the second injection, as preferred.

Double ‘fixed-time’ insemination may give superior results to a single insemination. However, economic factors in the particular herd may outweigh such a benefit.

For successful treatment, animals should be cycling normally. Rectal examination before treatment should avoid the disappointment of treating non-cycling (an-oestrus) or pregnant animals.

Attention should be directed to the diet and condition of the treated animals. Sudden changes in feeding levels, in feed constituents and in housing, etc should be avoided around the time of the breeding programme, as should any other factor, such as regrouping, which could reasonably be expected to lead to stress.

If artificial insemination is to be used, the quality of semen and insemination technique should be assured beforehand.

A recommended guideline for use of the product in dairy cows would be as follows:

After the first injection, inseminate any cows showing signs of heat.

Animals that do not show signs of heat should be injected 11 days after the first injection and then inseminated 72-96 hours later.

Control of the oestrous cycle is of value in:-

1) The dairy herd:

HORSES

Ponies and donkeys: single dose of 0.5-1.0 ml (equivalent to 125-250 µg of cloprostenol) by intramuscular injection. Thoroughbreds, hunters and heavy horses:
1-2 mL (equivalent to 250-500 µg of cloprostenol) by intramuscular injection).

Induction of luteolysis following early foetal death and resorption: about 8-10% of all mares which conceive lose the conceptus during the first 100 days of pregnancy. Persistence of luteal function in the ovary precludes an early return to oestrus.

Termination of persistent dioestrus: non-pregnant mares frequently and spontaneously go to and out of periods of prolonged dioestrus. A very high proportion of mares in this category i.e. not cycling, are in prolonged dioestrus rather than anoestrus, particularly in the latter part of the breeding season.

Termination of pseudopregnancy: some mares which are covered at normal oestrus and subsequently found to be empty (but not having lost or resorbed a conceptus) display clinical signs of pregnancy. These animals are said to be “pseudopregnant”.

Treatment of lactation anoestrus: failure of lactating mares to cycle again for several months after exhibiting an early ‘foal heat’ can be avoided.

Establishing oestrous cycles in barren/maiden mares: some of these animals will be found, on examination, to have a functional corpus luteum and are suffering from abnormal persistence of luteal function or are simply failing to exhibit normal oestrous behaviour (“silent heat”) while ovarian cyclicity continues.

As an aid in stud management: mares may be brought into oestrus on a planning timing schedule (singly or in groups), to facilitate more efficient use and management of stallions during the breeding season.

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

Cattle: At x5 to x10 overdose the most frequent side effect is increased rectal temperature. This is usually transient, however, and not detrimental to the animal. Limited salivation may also be observed in some animals.

Horses: The most frequently observed side effects are sweating and decreased rectal temperatures. These are usually transient, however, and not detrimental to the animal. Other possible reactions are increased heart rate, increased respiratory rate, abdominal discomfort, locomotor incoordination and lying down. If these occur, they are likely to be seen within 15 minutes of injection and disappear within 1 hour. Mares usually continue to eat throughout.

4.11 Withdrawal period(s)

Cattle should not be slaughtered for human consumption within 24 hours after administering the product.

It is not necessary to discard milk from treated cattle.

Do not administer to horses intended for human consumption.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group:

ATCvet code: QG02AD90

5.1 Pharmacodynamic properties

Cloprostenol is a synthetic prostaglandin analogue structurally related to Prostaglandin F_2(PGF_2). As a potent luteolytic agency it causes functional and morphological regression of the corpus luteum (luteolysis) in cattle and horses followed by return to oestrus and normal ovulation.

Note:There is a refractory period of four to five days after ovulation when cattle and horses are insensitive to the luteolytic effect of prostaglandins. Juramate has a good safety margin and does not impair fertility. No deleterious effects have been reported on the progeny conceived at the oestrus following treatment.

5.2 Pharmacokinetic particulars

After its administration by injection, cloprostenol is metabolised to acid 9, 11, dihydroxy-15-ceto prost-5-enoic and 9,11, 15-trihydroxyprost-5-enoic which rapidly disappear from the blood, being excreted via the urine in 5-6 hours.

Radiolabelled studies show blood levels between 0.0014 and 0.002 g per ml at 20 minutes – 2 hours after its administration.

Subsequently, blood levels fall rapidly, having an apparent half life of 1-3 hours, falling below 0.00004 g/ml at 8 hours. No significant concentrations are found at 24 hours in the liver, muscle, heart, kidneys, uterus, ovaries, skin, brain and fat, or in milk after 4 hours.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Chlorocresol

Sodium Chloride

Sodium Citrate

Citric Acid Anhydrous

Sodium Hydroxide (for pH adjustment)

Water for Injections

6.2 Incompatibilities

Strong acid/alkaline products

6.3 Shelf life

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

Shelf-life after first opening the immediate packaging: 28 days.

6.4. Special precautions for storage

Following withdrawal of the first dose, use the product within 28 days.

Protect from light.

6.5 Nature and composition of immediate packaging

Cardboard box containing one clear glass (type I) vial of 20 ml, closed with a chlorobutyl rubber stopper and aluminium cap.

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

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

Jurox (UK) Limited

Second Floor, Richmond House

105 High Street, Crawley

West Sussex RH10 1DD

United Kingdom

8. MARKETING AUTHORISATION NUMBER

Vm 25296/4001

9. DATE OF FIRST AUTHORISATION

14 August 2008

10. DATE OF REVISION OF THE TEXT

September 2016

16 September 2016