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Alamycin LA 200 mg/ml Solution for Injection (VPA 22664/016/001) - change in withdrawal periods (milk, meat and offal) and change in dosing instructions for sheep and pigs

Notice type: Advisory

Date: 15/01/2021

The withdrawal periods for meat and offal derived from cattle, pigs and sheep and milk derived from cattle and sheep treated with Alamycin LA 200 mg/ml Solution for Injection (Norbrook) have been increased. The maximum injection volume for pigs at each administration site has been restricted and the recommendation for the 48 hour repeat dose for sheep has been removed.

Product name or type:
Alamycin LA 200 mg/ml Solution for Injection

Authorisation Number:
VPA22664/016/001

Active Substance:
Oxytetracycline

Product Classification:
The product concerned is supplied in Ireland under the ‘Prescription Only Medicine’ (POM) category.

Authorisation Holder:
Norbrook Laboratories (Ireland) Limited

Prescription Required:
Yes

Target Audience:
Veterinary practitioners, pharmacists, farmers.

Problem Or Issue:
Following the approval of a change in the formulation, the withdrawal periods for Alamycin LA 200 mg/ml Solution for Injection have been increased for all species. The milk withdrawal period has also been increased for cows and ewes. The maximum injection volume for pigs per injection site has been reduced. A recommendation for the 48 hour repeat dose for sheep has been removed.

Background Information Or Related Documents:
Withdrawal periods are established based on the maximum residue limit established by the European Medicines Agency (EMA) for the relevant drug residues in meat.

The withdrawal periods are established in line with EU guidelines.

Actions To Be Taken:
The following revised withdrawal periods have been established:

Cattle:
Meat and offal: 35 days
Milk: 8 days

Pigs:
Meat and offal: 20 days

Sheep:
Meat and offal: 20 days
Milk: 8 days

In addition, the maximum injection volume has been restricted to 5.5 ml per injection site in pigs. The maximum injection volume for cattle and sheep remains unchanged at 20 and 5 ml, respectively.
The 48 hour repeat dose for sheep is no longer approved.

The HPRA advises veterinary practitioners and users to follow the withdrawal periods of the product as stated on the product labelling. Existing stock can continue to be used as long as it is within the expiry date for use. New stock with updated labelling reflecting the revised withdrawal periods and dosing instructions will be introduced to the market in the coming period. Veterinary practitioners and users should note this change and apply the new withdrawal periods as indicated on the new stock. The product details on HPRA website (www.hpra.ie), have been updated in line with this development.

As with all veterinary medicines, any adverse events occurring following use of the product should be reported to the HPRA via the online reporting form available at https://www.hpra.ie/homepage/about-us/report-an-issue/veterinary-medicines-adverse-reaction or to the marketing authorisation holder of the relevant product(s), at the earliest opportunity.

Further Information:

Extent of change to withdrawal periods

Species	Withdrawal Period
	Previous		New
Meat and offal Cattle Sheep Pigs	28 days 7 days 14 days		35 days 20 days 29 days
Milk Cattle Sheep		7 days 6 days	8 days 8 days

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