Bioestrovet Swine 0.0875 mg/ml Solution for Injection – SPC change
The SPC for Bioestrovet Swine 0.0875 mg/ml Solution for Injection has been updated with new guidance, including a prohibition on use in cases of bronchospasm or gastrointestinal dysmotility. The induction of parturition may be influenced by the physiological state of the animal, with about 95% of sows/gilts starting farrowing within 36 hours and most responses occurring within 24 ± 5 hours after injection, unless spontaneous parturition is imminent. To reduce risks, injections should not be given into contaminated skin and adipose tissue injections may lead to incomplete absorption; do not administer intravenously; premature induction can lower piglet birth weight and increase stillbirths, so gestation length should be calculated from farm records and not anticipated by more than two days. Other notes include that pregnancy should only be terminated if intended, fertility effects on progeny are neutral, progestogen co-administration may reduce cloprostenol response, and SPC updates are available via the UK Product Information Database with further updates published in VMD Connect.
Change to the information provided in the Summary of Product Characteristics for Bioestrovet Swine 0.0875 mg/ml Solution for Injection for Pigs.
The Summary of Product Characteristics (SPC) for Bioestrovet Swine 0.0875 mg/ml Solution for Injection for Pigs has been updated.
Additions and/or changes are listed below:
- Section 3.3: Do not use in cases of bronchospasm or gastrointestinal dysmotility.
- Section 3.4: The response of sows and gilts to induction of parturition may be influenced by the physiological state at 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.
- Section 3.5: 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.
- Section 3.7: Pregnancy: Do not administer to pregnant animals unless the objective is to terminate the 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.
- Section 3.8: In animals to which a progestogen is being administered, a decrease in the response of cloprostenol can be expected.
Any veterinary medicinal product which is authorised for marketing in the United Kingdom will have its Summary of Product Characteristics (SPC) available on our Product Information Database.
No medicine is 100% risk free, information on contraindications, special warnings and precautions for use, adverse events and potential interactions with other medicinal products is presented across the various sections of the SPC.
All updates to SPCs other than template changes, are published in the medicine updates section of VMD Connect.
https://www.gov.uk/government/news/bioestrovet-swine-00875-mgml-solution-for-injection-spc-change
