Do not use in pregnant animals unless the objective is to terminate the pregnancy.
Do not administer to animals with spastic disease of the respiratory or gastrointestinal tract.
Do not use in animals with cardiovascular, gastro-intestinal or respiratory disturbances.
Do not use to induce parturition in sows with suspected dystocia due to mechanical obstruction or if problems are expected because of an abnormal position of the foetus.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Do not use intravenously.
Special warnings for each target species
The response of sows and gilts to induction of parturition may be influenced by the physiological state at the time of treatment. Responses to treatment are not uniform either across herds or across individuals within herds.
Special precautions for use
Special precautions for use in animals
Induction of farrowing too early in pregnancy can lead to non-viable piglets being born. An increase in the number of non-viable piglets may result if used more than two days prior to the average gestation length calculated from farm records.
To reduce the risk of anaerobic infections, potentially related to the pharmacological properties of prostaglandins, avoid injecting through an area of contaminated skin. Clean and disinfect carefully the injection sites before administration.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Prostaglandins of the F2-α type, such as cloprostenol, can be absorbed through the skin and mucous membranes 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 child-bearing age, asthmatics and people with bronchial or other respiratory problems must avoid any contact with the product.
This veterinary medicinal product may cause hypersensitivity (allergic) reactions. People with known hypersensitivity to benzyl alcohol should avoid contact with the product.
Wear disposable impervious gloves when administering the product.
Wash hands after use.
Accidental spillage on the skin should be washed off immediately with soap and water.
In case of accidental self-injection or spillage onto the skin, seek medical advice and show the package leaflet or label to the physician.
Should shortness of breath occur, seek medical advice immediately and show the package leaflet or label to the physician. Do not eat, drink or smoke while handling the product.
Adverse reactions (frequency and seriousness)
An anaerobic infection can occur when anaerobic bacteria enter the injection site, particularly following intramuscular injection.
When used in sows and gilts for induction of parturition and dependent on the time of treatment relative to the date of conception, the incidence of retained placenta may be increased.
In very rare cases transient erythema and pruritus, urination and defecation, ataxia, hyperpnea, dyspnea, nest-building behaviors, abdominal muscle spasms, vocalization and salivation may occur following the administration of prostaglandin F2α.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Use during pregnancy and lactation
Do not use in pregnant animals when parturition induction is not intended.
Overdose
Overdose can lead to the following symptoms: increased heart and respiratory rates, bronchoconstriction, increased body temperature, increased urine and faeces quantity, salivation, nausea and vomiting, restless behaviour.
There is no antidote.