Target Audience:
Veterinary practitioners, pharmacists and farmers.
Problem Or Issue:
Cydectin 1% injectable solution for sheep is indicated for the treatment of a range of parasite infections in sheep. The product is administered by subcutaneous injection at a dose of 0.2 mg moxidectin/kg bodyweight (equivalent to 0.1 ml/5 kg bodyweight).
The HPRA has received a report of adverse reactions following the administration of Cydectin 1% injectable solution to sheep with a history of previous vaccination against footrot. In animals that reacted, one, or a number, of the following effects were noted: difficulty breathing, poor co-ordination, depression, death or abortions.
As a result of these reports, the marketing authorization holder has recently updated the wording of the product information of Cydectin 1% injectable solution for sheep with a warning that the product should not be used in sheep with a history of previous vaccination against footrot,
This warning only applies to Cydectin 1% injectable solution for sheep and not to the rest of the Cydectin range.
Background Information Or Related Documents:
Important additions have been made to the summary of product characteristics (SPCs), product labelling and leaflet to increase the awareness of users to the potential for adverse effects resulting from the use of Cydectin 1% Solution for injection for sheep in animals previously vaccinated against footrot and to highlight measures that will reduce the occurrence of such effects. The following warning statements have been added to the product information:
- SPC: Section 4.3 Contraindications
Not to be used in animals with a history of previous vaccination against footrot. Such use may result in anaphylactic-type reactions, including dyspnoea, ataxia, depression, death and abortions.
- Outer package: Section 9 Special warnings
Not to be used in animals with a history of previous vaccination against footrot.
- Leaflet: Section 5 Contraindications
Not to be used in animals with a history of previous vaccination against footrot. Such use may result in anaphylactic-type reactions, including dyspnoea, ataxia, depression, death and abortions.
Actions To Be Taken:
Veterinary practitioners and other health care professionals should take note of the new information and advise the user when prescribing or dispensing veterinary medicines.
Users should take note of the new information and use the product accordingly.