Target species
Pigs (sows and gilts).
Indications for use
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 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 cases of 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
The response of sows and gilts to induction of parturition may be influenced by the physiological state and the time of treatment. The vast majority of the animals, 95%, will commence farrowing within 36 hours of treatment. The majority of animals can be expected to respond within the period of 24+/- 5 hours following the injection, except in those cases where spontaneous parturition is imminent.
Special precautions for use
To reduce the risk of anaerobic infections arising from vasoconstriction at the injection site, injections into contaminated (wet or dirty) skin areas should be avoided. Thoroughly clean and disinfect injection sites prior to administration.
Injection into adipose tissue may lead to incomplete absorption of the veterinary medicinal product.
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.
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 child-bearing 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 label or leaflet to the physician.
This veterinary medicinal product may cause hypersensitivity reactions. People with known hypersensitivity to benzyl alcohol should avoid contact with the veterinary medicinal product.
Wash hands after use.
Adverse Reactions
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): | | Restlessness2, Frequent urination2; Diarrhoea2 Retained placenta3, Metritis3, Dystocia3, Stillbirth3 |
1 May occur if anaerobic bacteria enter the injection site and may become generalized. Careful aseptic techniques should be employed to decrease the possibility of these infections.
2 May be observed within 15 minutes post-injection and usually disappears after one hour.
3 May be caused by induction of parturition with any exogenous compound.
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 administer to pregnant animals unless the objective is to terminate pregnancy.
Fertility:
There is no effect on the subsequent reproductive performance of sows treated with cloprostenol and of gilts or boars born from treated animals.
Interactions
The concomitant use of oxytocin and cloprostenol increases the effects on the uterus.
Do not administer with non-steroidal anti-inflammatory drugs (NSAIDs) since they inhibit endogenous prostaglandin synthesis.
In animals to which a progestogen is being administered, a decrease in the response of cloprostenol can be expected.
Amounts to be administered and administration route
To be administered by deep intramuscular route with a needle at least 4 cm long.
Administer a single dose of 2 ml per animal (equivalent to 175 micrograms of cloprostenol).
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
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.
No antidotes are available: treatment should be symptomatic, assuming Prostaglandin F2α acts on smooth muscle cells.
Withdrawal periods
Meat and offal: 1 day.