Target species
Cattle (cows and heifers), goats (does), horses (mares), donkeys (jennies), pigs (sows and gilts).
Indications for use
Cattle (cows and heifers):
- 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 parturition after day 270 of gestation.
- Induction of abortion up to day 150 of gestation.
Goats (does):
- Oestrus induction and synchronisation in does with a functional corpus luteum during the breeding season.
Horses (mares):
- Oestrus induction and synchronisation in mares with a functional corpus luteum.
- Termination of early pregnancy between day 5 and day 120 of gestation.
Donkeys (jennies):
- Oestrus induction in jennies with a functional corpus luteum.
Pigs (sows and gilts):
- Induction of farrowing one or two days before the estimated date of parturition.
Contraindications
Do not use in pregnant animals 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 use in animals with compromised cardiovascular function, bronchospasm or gastrointestinal dysmotility.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Special warnings for each target species
Due to the possibility of post-injection bacterial infections, careful aseptic techniques should be employed.
Special precautions for use
Special precautions for use in animals
Do not administer intravenously.
Operator warnings
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 veterinary medicinal 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 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.
Adverse reactions
Cattle (cows and heifers):
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.
Goats (does):
Rare (1 to 10 animals / 10,000 animals treated) | Injection site infection1 |
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Anaphylaxis2; |
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.
Horses (mares):
Uncommon (1 to 10 animals / 1,000 animals treated) | Abnormal oestrus1; |
Rare (1 to 10 animals / 10,000 animals treated) | Injection site infection2 |
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Anaphylaxis3; Increased respiratory rate4; Increased heart rate4; Increased sweating4,5; Abdominal pain4, Colic6, Diarrhoea4,8; Incoordination4, Muscle tremor5; Lying down4, Decreased body temperature4; Retained placenta7, Metritis7, Dystocia7, Stillbirth7; Restlessness, Frequent urination4,8; |
1 Haemorrhagic (anovular) follicles and multiple ovulations are reported in literature for horses treated with cloprostenol.
2 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.
3 Requiring immediate medical attention. Can be life-threatening.
4 Cloprostenol may cause effects similar to Prostaglandin F2α activity in the smooth muscles.
5 Appears to be transient and resolves without any treatment.
6 Mild.
7 May be caused by termination of gestation, depending on the date of treatment versus the date of conception, the incidence of placental retention may be increased.
8 In case of occurrence, these effects are observed within 15 minutes post-injection and usually disappear after one hour.
Donkeys (jennies):
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; Increased sweating3,4; Abdominal pain3, Colic5, Diarrhoea3,7; Incoordination3, Muscle tremor4; Lying down3, Decreased body temperature3, Anorexia; Retained placenta6, Metritis6, Dystocia6, Stillbirth6, Restlessness, Frequent urination3,7; |
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 Appears to be transient and resolves without any treatment.
5 Mild.
6 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.
7 In case of occurrence, these effects are observed within 15 minutes post-injection and usually disappear after one hour.
Pigs (sows and gilts):
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. 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 or lactation
Pregnancy:
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
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 with non-steroidal anti-inflammatory drugs (NSAIDs) since they inhibit endogenous prostaglandin synthesis.
Amounts to be administered and administration route
Cattle (cows and heifers):
One dose equals 500 micrograms of cloprostenol per animal, corresponding to 2 ml of the veterinary medicinal product.
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 per animal. If necessary, repeat the treatment 10-14 days later.
Treatment of ovarian luteal cysts:
Administer a single dose per animal.
Induction of parturition
Administer a single dose per animal, not earlier than 10 days before the expected date of calving.
Induction of abortion up to day 150 of gestation:
Administer a single dose per animal, between the 5th and the 150th day of gestation.
Goats (does):
One dose equals 100 – 125 micrograms of cloprostenol per animal, corresponding to 0.4 – 0.5 ml of the veterinary medicinal product.
Oestrus induction:
Administer one dose per animal.
Synchronisation of oestrus:
Administer a second dose per animal 10 – 12 days after the first dose.
Horses (mares):
Ponies and horses weighing less than 500 kg bodyweight:
One dose equals 125 – 250 micrograms of cloprostenol per animal, corresponding to 0.5 – 1 ml of the veterinary medicinal product.
Horses weighing more than 500 kg bodyweight:
One dose equals 250 – 500 micrograms of cloprostenol per animal, corresponding to 1 – 2 ml of the veterinary medicinal product.
Oestrus induction and synchronisation:
Administer a single dose per animal.
Termination of early gestation between day 5 and day 120:
Administer a single dose per animal, not earlier than 5 days after ovulation.
Donkeys (jennies):
One dose equals 125 - 250 micrograms of cloprostenol per animal, corresponding to 0.5 - 1 ml of the veterinary medicinal product, depending upon bodyweight and size.
A lower dose, down to 37.5 micrograms cloprostenol per animal, corresponding to 0.15 ml of the veterinary medicinal product, might be required for small framed jennies to reduce adverse reactions.
The dose to be applied in general should be as low as possible due to the risk of adverse events (see section 3.6).
Oestrus induction:
Administer a single dose per animal.
Pigs (sows and gilts):
One dose equals 175 micrograms of cloprostenol per animal, corresponding to 0.7 ml of the veterinary medicinal product.
Induction of farrowing:
Administer a single dose per animal one or two days before the estimated date of parturition (see also warnings in section 3.5).
To be administered by deep intramuscular route with a needle at least 4 cm long.
The stopper may be safely punctured up to 10 times. When treating groups of animals in one run, use a draw-off needle that has been placed in the vial stopper to avoid excess broaching of the stopper. The draw-off needle should be removed after treatment.
Overdose
Cattle: At 5x to 10x overdose the most frequent side effect is increased rectal temperature. This is usually transient, however, and not detrimental to the animal. Limited salivation or transient diarrhoea 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.
Pigs: In general, an overdose can lead to the following symptoms: increased heart and respiratory rate, bronchoconstriction, increased body temperature, increased amounts of faeces and urine, salivation, nausea and vomiting. In worse cases transient diarrhoea may occur.
There are no antidotes available, treatment should be symptomatic, assuming that prostaglandin F2α influences the smooth muscle cells.
Withdrawal period(s)
Milk: Zero hours
Goats, horses, donkeys:
Meat and offal: 2 days
Milk: 24 hours
Pigs:
Meat and offal: 1 day