Cattle

Cattle:

Do not administer the product to pregnant cows unless you wish to induce parturition or therapeutic abortion, as luteolysis may result in loss of the foetus.

Do not use in animals in cases of dystocic delivery, in case of abnormal position of the foetus or of mechanical obstruction.

Do not administer to animals with known hypersensitivity to the active substance or one of the excipients.

Do not use in animals with cardiovascular, gastro-intestinal or respiratory problems.

Do not administer intravenously.

There is a refractory period of four to five days after ovulation when cattle are insensitive to the luteolytic effect of prostaglandins.

Administer the product intramuscularly by observing normal aseptic rules to reduce the risk of anaerobic infections. Clean and disinfect the injection site prior to administration. Avoid administration through wet or dirty skin. After treatment, the animals must remain under observation to detect any adverse reaction.

In cows when used for induction of pregnancy, abortion at the most advanced stage, complications such as dystocia and increased placental retention are possible.

Direct contact with skin or mucous membranes of the user should be avoided. Prostaglandins of the F2α type may 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. Pregnant women, women of childbearing age, asthmatics and persons with other respiratory tract diseases should exercise caution when handling cloprostenol. Those persons should avoid contact or wear disposable gloves during administration of the product. Accidental spillage on the skin should be washed immediately with soap and water. The possible incidence of bronchospasm with the product is unknown. Should shortness of breath result from accidental inhalation or injection, seek urgent medical advice and show the doctor this warning. Wash hands after use.

In very rare cases, anaphylactic-type reactions can be observed which require immediate medical care. Anaerobic infection may occur if anaerobic bacteria penetrate the tissue of the injection site. Typical local reactions due to anaerobic infection are swelling and crepitus at the injection site. When used for the induction of parturition and dependent on the time of treatment relative to the date of conception, the incidence of retained placenta may be increased.

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

Do not perform the treatment at the same time as non-steroidal anti-inflammatory drugs as non-steroidal anti-inflammatory drugs may inhibit the endogenous prostaglandin synthesis: concomitant administration of these compounds with the product may decrease the luteolytic effects. The activity of other oxytocin agents can be increased after the administration of cloprostenol.

Cattle:

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

Therapeutic indications:

A) Silent heat: This condition is particularly common in heavy producing dairy cows, which have normal ovarian cycles but slightly express or do not express behavioural manifestations. These animals can be treated only after checking the cycle activity and the presence of the corpus luteum. Animals treated with the product may be bred (natural service or artificial insemination) 72 and 96 hours after treatment.If the animal has been treated in the absence of a corpus luteum, another injection of the product is required 11 days after the first injection.

B) Ovarian luteal cysts: The product has demonstrated its efficacy in restoring normal the oestrus cycle in case of absence of heat caused by ovarian cysts (characterized by the presence of persistent luteal tissue).

C) Termination of pregnancy: The condition may occur in case of immature calves.The pregnancy can be interrupted starting from one week after its establishment until day 150 of pregnancy. Before day 100, abortion can be induced quickly and effectively while between day 100 and day 150, results may be less significant because some cows may become progressively less sensitive to the action of corpus luteum maintaining pregnancy. The animals must be kept under observation until foetus and placental membranes complete expulsion.

D) Induction of parturition: From day 270 of pregnancy, the administration of the product induces parturition 30 – 60 hours of treatment. The induction of parturition should take place as close as possible to the expected date of spontaneous parturition. The induction of parturition should not be induced before day 270 day of pregnancy. All treated animals must be kept under observation. As with all other methods of shortening the pregnancy period, placental retention rate may be increased.

E) Removal of mummified foetus: Foetus death may be followed by dehydration and degeneration. The induction of luteolysis at any stage of pregnancy causes the expulsion of mummified foetuses from the uterus to the vagina, from which it is possible to make manual removal. Usually, normal cyclic activity follows.

F) Chronic endometritis (pyometra): Reproduction system lesions caused during parturition or placental retention may cause uterine inflammation and infections known as endometritis. Acute or sub-acute endometritis, which may occur shortly after parturition, may require both local and general antibiotic treatments. This condition is known as pyometra and is characterised by the absence of annual cyclic activity and the presence of a persistent corpus luteum. The condition can be successfully treated by inducing the regression of the corpus luteum. If necessary, the treatment may be repeated after 10-14 days.

Controlled breeding:

A treatment consisting of two injections of the product at 11 days interval is highly effective for oestrus synchronization in healthy cycling cows. Two artificial inseminations at 72 and 96 hours after the second injection, involve a normal fertility rate. For economic reasons, if only one insemination is performed, this must be done after 72-84 hours but this may involve fewer pregnancies. Of cause, such protocol can vary. For example, it is possible to inseminate all animals in heat after the first injection and limit the second treatment, to the cows in which the first had no effect.

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.

Five animals treated with 40 mg cloprostenol (80 times the therapeutic dose) showed only slight symptoms of restlessness: two animals presented a slight sialorrhea and only one had diarrhoea.

These symptoms were moderate and were observed only after careful clinical examination. They disappeared definitively within 8 hours of administration.

One animal treated with 100 mg cloprostenol (200 times the therapeutic dose) by intramuscular injection showed only a slight form of transient diarrhoea, confirming that the drug presents a high safety margin.

In case of signs, a symptomatic treatment is recommended.

Cattle:

Meat: 1 day

Milk: zero hours