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(Levamisole Hydrochloride; Oxyclozanide) (Norbrook Laboratories Limited)
Authorised for use in cattle and sheep
Addition of the following warnings to section 4.5i of the SPC: ‘Animals should be dosed according to their individual weight, and not dosed as per the heaviest animal in the group, otherwise signs of overdose may occur (see section 4.10).’
It is important that the container is shaken thoroughly before use to ensure that the two active substances are homogeneously resuspended and therefore the animals receive the correct dose.’
The warning ‘After treatment, animals should be moved to clean pasture in order to prevent re infection’ has been removed from section 4.5i as it is not consistent with current principles of responsible use (i.e. it does not promote the maintenance of a parasite population in refugia).
Section 4.6: Rarely, animals may also display signs of ataxia, incoordination, recumbency and depression.
Additionally, rarely, sheep may show an allergic reaction such as submandibular oedema, ear flap oedema and swelling of the head. If such a reaction occurs, appropriate treatment should be administered without delay. Such reactions may evolve to a more severe condition (anaphylaxis), which may be life-threatening.
Addition of the following warnings to section 4.10: ‘Do not overdose. If recommended dosages are exceeded animals may exhibit signs of overdosage and toxicity. The effects of levamisole overdosage include impaired motor function, i.e. muscle tremors, head shaking, increased salivation, facial swelling, oedema, scouring and in most severe cases, death.’