Target species
Cattle
Indications for use, specifying the target species
Cattle:
- Oestrus induction and synchronisation in cows and heifers with a functional corpus luteum.
- Induction of oestrus as an aid to management of suboestrus (‘silent heat’).
- Treatment of clinical and subclinical endometritis in the presence of a functional corpus luteum.
- Treatment of ovarian luteal cysts.
- Induction of abortion until day 150 of pregnancy.
- Induction of parturition after day 270 of gestation.
Contraindications
Do not administer the veterinary medicinal product to pregnant cows in which the induction of abortion or parturition is not intended.
Do not administer to induce parturition in animals with suspected dystocia due to mechanical obstruction or abnormal position, presentation and/or posture of the foetus.
Do not administer to animals with known hypersensitivity to the active substance or one of the excipients.
Do not use in animals with compromised cardiovascular function, bronchospasm or gastro-intestinal dysmobility. Do not administer intravenously.
Special warnings for each target species
There is a refractory period of four to five days after ovulation when cattle are insensitive to the luteolytic effect of prostaglandins.
Special precautions for use
Special precautions for safe use in the target species:
Do not administer intravenously.
In case of oestrus induction: from the 2nd day after injection, adequate heat detection is necessary.
Induction of parturition and abortion may cause dystocia, stillbirth and/or metritis. The incidence of retained placenta may be increased depending on the time of treatment relative to the date of conception.
Premature induction of farrowing will reduce the piglet’s birth weight and increase the number of stillborn piglets and non-viable and immature born piglets. It is essential that the mean length of gestation is calculated on each farm from past records and not to anticipate the term of gestation by more than two days.
To reduce the risk of anaerobic infections arising from vasoconstriction at the injection site, injections into contaminated (wet or dirty) skin areas should be. Clean and disinfect injection sites thoroughly before administration.
All animals should receive adequate supervision after treatment. Injection into adipose tissue can result in incomplete absorption of the veterinary medicinal product.
Cloprostenol may cause effects related to Prostaglandin F2α activity in the smooth muscles, such as increased frequency of urination and defecation.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Prostaglandins of the F2α type, such as cloprostenol, 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 avoid contact when handling this veterinary medicinal product. Personal protective equipment consisting of disposable impervious gloves should be worn when handling the veterinary medicinal product.
Accidental spillage on the skin should be washed immediately with soap and water. In case of accidental self-injection or spillage onto the skin seek medical advice immediately, particularly as shortness of breath may occur, and show the package leaflet or label to the physician.
This veterinary medicinal product may cause hypersensitive reactions. People with known hypersensitivity to benzyl alcohol should avoid contact with the veterinary medicinal product.
Wash hands after use.
Special precautions for the protection of the environment:
Not applicable.
Adverse reactions (frequency and seriousness)
Rare (1 to 10 animals / 10,000 animals treated) | Injection site infection1 |
Very rare (<1 animal / 10,000 animals treated, including isolated reports) | Anaphylaxis2 Increased respiratory rate3 Increased heart rate3 Abdominal pain3 Diarrhoea3,5 Incoordination3 Lying down3 Retained placenta4 Metritis4 Dystocia4 Stillbirth4 Restlessness Frequent urination3,5 |
1 May occur if anaerobic bacteria enter the injection site, especially following intramuscular injection, and may become generalized. Aggressive antibiotic therapy, particularly covering clostridial species, should be employed at the first sign of infection. Careful aseptic techniques should be employed to decrease the possibility of these infections.
2 Requiring immediate medical attention. Can be life-threatening.
3 Cloprostenol may cause effects similar to Prostaglandin F2α activity in the smooth muscles.
4 May be caused by induction of parturition or abortion. As part of induction of parturition, depending on the date of treatment versus the date of conception, the incidence of placental retention may be increased.
5 In case of occurrence, these effects are observed within 15 minutes post-injection and usually disappear after one hour.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
Do not use in pregnant animals in which the induction of abortion or parturition is not intended.
Lactation:
The product can be used during lactation.
Fertility:
Cloprostenol has a large safety margin and does not negatively affect fertility in cattle. Nor have any harmful effects been reported in the offspring of an insemination or mating following treatment with this veterinary medicinal product for conception products obtained after treatment.
Interactions with other medicinal products and other forms of interaction
The concomitant use of oxytocin and cloprostenol increases the effects on the uterus.
The concomitant use of progestogens decreases the effect of cloprostenol.
Do not administer the veterinary medicinal product together with non-steroidal anti-inflammatory drugs (NSAIDS) since they inhibit endogenous prostaglandin synthesis.
Amounts to be administered and administration route
Intramuscular use.
Cattle (cows and heifers)
One dose equals 500 micrograms of cloprostenol/animal corresponding to 2 ml of the veterinary medicinal product per animal.
Oestrus induction and synchronisation
Administer one dose per animal. When no oestrus symptoms are observed, a second dose can be administered after 11 days.
Treatment of clinical and subclinical endometritis in the presence of a functional corpus luteum
Administer one dose of the veterinary medicinal product per animal. If necessary, repeat the treatment 10-14 days later.
Treatment of ovarian luteal cysts
Administer a single dose per animal
Induction of abortion up to day 150 of gestation
Administer a single dose of the veterinary medicinal product per animal, between the 5th and the 150th day of gestation .
Induction of parturition
Administer a single dose per animal not earlier than10 days before the expected date of calving.
Overdose (symptoms, emergency treatment, antidotes), if necessary
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.
There are no antidotes available, treatment should be symptomatic, assuming that prostaglandin F2α influences the smooth muscle cells.
Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance
Not applicable
Withdrawal periods
Cattle:
Meat: 1 day
Milk: zero hours