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Advice for veterinarians in NSW treating coccidiosis in sheep and ...

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FACTSHEET<br />

<strong>Advice</strong> <strong>for</strong> <strong>veter<strong>in</strong>arians</strong> <strong>in</strong> <strong>NSW</strong><br />

treat<strong>in</strong>g <strong>coccidiosis</strong> <strong>in</strong> <strong>sheep</strong> <strong>and</strong><br />

lambs, goats <strong>and</strong> kids<br />

Lee Cook, Technical Specialist Stock Foods <strong>and</strong> Medic<strong>in</strong>es, Orange<br />

Introduction<br />

Sulfonamides have traditionally been used as an<br />

effective treatment <strong>for</strong> <strong>coccidiosis</strong> <strong>in</strong> lambs <strong>and</strong><br />

calves. There are now no sulfonamide products<br />

registered specifically <strong>for</strong> treatment of <strong>coccidiosis</strong><br />

<strong>in</strong> <strong>sheep</strong> follow<strong>in</strong>g the 2000 review of sulfonamides<br />

by the Australian Pesticides <strong>and</strong> Veter<strong>in</strong>ary<br />

Medic<strong>in</strong>es Authority (APVMA).<br />

All such uses were removed from labels, largely<br />

because the <strong>sheep</strong> <strong>in</strong>dustry was apparently not<br />

will<strong>in</strong>g to fund residue studies or obta<strong>in</strong> data to set<br />

withhold<strong>in</strong>g periods (WHP) at the time the APVMA<br />

undertook the review. Some of the deleted uses<br />

also lacked efficacy studies. In most cases, the<br />

affected products are no longer available.<br />

There are still some sulfonamide products<br />

registered <strong>for</strong> use <strong>in</strong> <strong>sheep</strong> or other species, all of<br />

which are prescription animal remedies (Schedule<br />

4 poisons).<br />

Given that the oral <strong>sheep</strong> sulfonamide registrations<br />

were mostly withdrawn because of lack of residue<br />

data at <strong>coccidiosis</strong> dose rates, <strong>veter<strong>in</strong>arians</strong> us<strong>in</strong>g<br />

these products to treat lambs or kids should only<br />

do so <strong>in</strong> situations where an appropriately longer<br />

WHP can be recommended <strong>and</strong> implemented after<br />

treatment.<br />

Restra<strong>in</strong>ts: all off-label use by <strong>veter<strong>in</strong>arians</strong> is<br />

subject to any restrictions imposed under a<br />

“Restra<strong>in</strong>t” or “Restra<strong>in</strong>ts” head<strong>in</strong>g. Such<br />

restrictions cannot be over-ridden by <strong>veter<strong>in</strong>arians</strong>.<br />

Sheep may only be treated off-label with products<br />

registered <strong>in</strong> cattle, <strong>sheep</strong>, pigs or chickens.<br />

Products registered <strong>for</strong> horses or dogs <strong>and</strong> cats<br />

may not be used <strong>for</strong> food produc<strong>in</strong>g animals.<br />

February 2012, http://www.dpi.nsw.gov.au/factsheets <strong>for</strong> updates<br />

Primefact 1241 first edition<br />

Sulfonamide Treatment Options<br />

<strong>for</strong> Coccidiosis<br />

1. Registered <strong>in</strong>jectable products<br />

2. Registered <strong>sheep</strong> products (oral <strong>and</strong> <strong>in</strong>trauter<strong>in</strong>e)<br />

used off-label<br />

3. Off-label sulfadimid<strong>in</strong>e products <strong>for</strong> other food<br />

produc<strong>in</strong>g species<br />

4. Off-label comb<strong>in</strong>ation sulfonamide/trimethoprim<br />

products <strong>for</strong> other FP species<br />

5. Off-label toltrazuril products <strong>for</strong> other food<br />

produc<strong>in</strong>g species<br />

6. Preventive products (on <strong>and</strong> off-label)<br />

1 Registered <strong>in</strong>jectables<br />

The APVMA has set Maximum Residue Limits<br />

(MRLs) <strong>for</strong> sulfadimid<strong>in</strong>e, sulfadiaz<strong>in</strong>e, sulfadox<strong>in</strong>e<br />

<strong>and</strong> trimethoprim <strong>in</strong> mammalian meat <strong>and</strong> offal,<br />

which <strong>in</strong>cludes <strong>sheep</strong> <strong>and</strong> goat (meat <strong>and</strong> offal)<br />

products. These relate to the <strong>in</strong>jectable<br />

comb<strong>in</strong>ation products conta<strong>in</strong><strong>in</strong>g one of these<br />

sulfonamides plus trimethoprim. These <strong>in</strong>jectables<br />

may have a place <strong>in</strong> <strong>coccidiosis</strong> treatment <strong>in</strong> some<br />

cases.<br />

The existence of these MRLs also helpfully means<br />

that trace residues <strong>in</strong> <strong>sheep</strong> or goats follow<strong>in</strong>g<br />

treatment with other products conta<strong>in</strong><strong>in</strong>g these<br />

actives are not illegal.<br />

2 Off-label <strong>sheep</strong> products<br />

One sulfonamide product is still registered <strong>for</strong> oral<br />

treatment of <strong>sheep</strong>. The product is Keymix®<br />

Sulphatrim TM Oral Sulfadiaz<strong>in</strong>e <strong>and</strong> Trimethoprim<br />

Medication. It comes <strong>in</strong> 500g <strong>and</strong> 25kg packs <strong>and</strong><br />

is marketed by International Animal Health<br />

Products of Hunt<strong>in</strong>gwood <strong>NSW</strong>. It conta<strong>in</strong>s<br />

400g/kg sulfadiaz<strong>in</strong>e <strong>and</strong> 80g/kg trimethoprim <strong>and</strong><br />

Biosecurity <strong>NSW</strong>


is registered <strong>for</strong> treatment of bacterial <strong>in</strong>fections <strong>in</strong><br />

<strong>sheep</strong> at a dose of 62.5mg product / kg<br />

bodyweight. For the sulfadiaz<strong>in</strong>e this dose rate<br />

works out at 250mg /10 kg bodyweight, which is<br />

the lower range of those recommended <strong>for</strong><br />

<strong>coccidiosis</strong> treatment (see below). MRLs exist <strong>in</strong><br />

<strong>sheep</strong> tissues <strong>for</strong> sulfadiaz<strong>in</strong>e <strong>and</strong> trimethoprim,<br />

thus reduc<strong>in</strong>g the problem of residues. The label<br />

WHP at this dose is 14 days. This product could<br />

be used off-label to treat <strong>coccidiosis</strong>.<br />

Please note that this product is only manufactured<br />

to order <strong>and</strong> may not be readily available. Stocks<br />

could be purchased <strong>in</strong> advance of anticipated<br />

needs.<br />

Although there are two products, registered as<br />

<strong>in</strong>tra-uter<strong>in</strong>e treatments <strong>for</strong> <strong>sheep</strong> but <strong>for</strong> oral<br />

treatments <strong>in</strong> other species, these appear to no<br />

longer be available (as at February 2012).<br />

The first, Trimaz<strong>in</strong>e Bolus A Sulphonamide<br />

Trimethoprim Preparation (<strong>in</strong> packs of 50 tablets<br />

manufactured by Apex Laboratories) conta<strong>in</strong>s<br />

1000mg of sulfadiaz<strong>in</strong>e <strong>and</strong> 200mg of<br />

trimethoprim. The second, VR Tribactral® Duals<br />

antibacterial pessary/bolus (<strong>in</strong> packs of 20 tablets<br />

manufactured by Intervet) conta<strong>in</strong>s the same<br />

actives. They are registered <strong>for</strong> treatment of<br />

uter<strong>in</strong>e <strong>in</strong>fections <strong>in</strong> <strong>sheep</strong> at a dose of one tablet /<br />

40 kg bodyweight (BWt). For the sulfadiaz<strong>in</strong>e this<br />

dose rate works out at 250mg /10 kg BWt, as<br />

above. The label WHP at this dose is 14 days. If<br />

available these products could potentially be used<br />

off-label to treat <strong>coccidiosis</strong> but the relative degree<br />

of absorption follow<strong>in</strong>g their oral use is unknown.<br />

3 Off-label sulfadimid<strong>in</strong>e products <strong>for</strong><br />

other species<br />

Three pure sulfadimid<strong>in</strong>e products are registered<br />

<strong>for</strong> other species, <strong>and</strong> they could also be legally<br />

prescribed by a veter<strong>in</strong>arian to treat <strong>sheep</strong> or goats<br />

off-label <strong>for</strong> <strong>coccidiosis</strong>. MRLs exist <strong>for</strong><br />

mammalian tissues <strong>for</strong> sulfadimid<strong>in</strong>e, thus reduc<strong>in</strong>g<br />

the problem of residues. There are three products<br />

conta<strong>in</strong><strong>in</strong>g only sulfadimid<strong>in</strong>e:<br />

1. Sulfa FG Premix medication <strong>for</strong> pigs conta<strong>in</strong><strong>in</strong>g<br />

200g/kg sulfadimid<strong>in</strong>e<br />

(<strong>in</strong> 25kg packs from Agribus<strong>in</strong>ess (Lienert) of<br />

Macclesfield, South Australia).<br />

2. SD333 sulfadimid<strong>in</strong>e solution conta<strong>in</strong><strong>in</strong>g<br />

333g/L sulfadimid<strong>in</strong>e<br />

(<strong>in</strong> 500mL bottles from Cattlekare of<br />

D<strong>and</strong>enong, Victoria).<br />

3. CCD Sulfadimid<strong>in</strong>e sodium soluble conta<strong>in</strong><strong>in</strong>g<br />

1000g/kg sulfadimid<strong>in</strong>e<br />

(<strong>in</strong> 1kg <strong>and</strong> 25kg packs from CCD Animal<br />

Health, Girraween, New South Wales).<br />

The second product is similar to the old Coccee<br />

Drench.<br />

One problem the APVMA review found was that<br />

historically recommended dose rates <strong>for</strong> oral<br />

treatment of <strong>coccidiosis</strong> <strong>in</strong> <strong>sheep</strong> with sulfadimid<strong>in</strong>e<br />

have varied markedly. For example:<br />

• 110 mg / kg BWt / day <strong>for</strong> 3 days<br />

(previously registered Coccee solution)<br />

• 25mg / kg BWt daily <strong>for</strong> 7 days<br />

(Veter<strong>in</strong>ary Medic<strong>in</strong>e, Radostits et al)<br />

• 150 mg / kg BWt daily <strong>for</strong> 3 days<br />

(Antimicrobial Prescrib<strong>in</strong>g Guidel<strong>in</strong>es)<br />

• 5-10 mL of 333g/L solution (1665-3330 mg) per<br />

lamb per day (Hunger<strong>for</strong>d).<br />

The current label <strong>for</strong> the Cattlekare product above<br />

has a cattle WHP of 14 days. The (oral) cattle<br />

dose is 740 mg / 10kg BWt <strong>for</strong> three days.<br />

4 Off-label comb<strong>in</strong>ation<br />

sulfonamide/trimethoprim products <strong>for</strong><br />

other species<br />

There are a number of other oral (liquid <strong>and</strong> solid)<br />

sulfonamide products registered <strong>for</strong> other food<br />

produc<strong>in</strong>g species which could also be legally<br />

prescribed by a veter<strong>in</strong>arian to treat <strong>sheep</strong> off-label<br />

<strong>for</strong> <strong>coccidiosis</strong>. These products conta<strong>in</strong> both a<br />

sulfonamide (sulfadimid<strong>in</strong>e <strong>and</strong>/or sulfadiaz<strong>in</strong>e)<br />

<strong>and</strong> trimethoprim. Products <strong>for</strong> calves conta<strong>in</strong><strong>in</strong>g<br />

streptomyc<strong>in</strong> or neomyc<strong>in</strong> are not recommended<br />

as they provide unnecessary antibiotics.<br />

Appropriate WHPs must still be provided by the<br />

prescrib<strong>in</strong>g veter<strong>in</strong>arian.<br />

Example products (this list may not be complete)<br />

<strong>in</strong>clude:<br />

1. GAH Formula Trimethosul Dispersible Powder<br />

conta<strong>in</strong><strong>in</strong>g sulfadiaz<strong>in</strong>e <strong>and</strong> trimethoprim<br />

(<strong>in</strong> ½, 1, 5, 10 <strong>and</strong> 20kg packs).<br />

2. Agrotech Trimethosol<br />

(<strong>in</strong> 500g packs).<br />

3. AFS Trimsul conta<strong>in</strong><strong>in</strong>g sulfadiaz<strong>in</strong>e <strong>and</strong><br />

trimethoprim<br />

(<strong>in</strong> 500 g packs or 500mL solution).<br />

4. Trimetsulpha Water Soluble® conta<strong>in</strong><strong>in</strong>g<br />

sulfadiaz<strong>in</strong>e <strong>and</strong> trimethoprim<br />

(<strong>in</strong> 15 <strong>and</strong> 30kg packs).<br />

5. Trimid<strong>in</strong>e Powder conta<strong>in</strong><strong>in</strong>g sulfadimid<strong>in</strong>e <strong>and</strong><br />

trimethoprim<br />

(<strong>in</strong> 250g packs).<br />

6. Sulprim Oral Powder conta<strong>in</strong><strong>in</strong>g sulfadimid<strong>in</strong>e<br />

<strong>and</strong> trimethoprim<br />

(<strong>in</strong> 250g <strong>and</strong> 1 kg packs).<br />

A literature review <strong>in</strong> 1982 suggested that a s<strong>in</strong>gle<br />

dose of a sulphonamide was as effective as repeat<br />

p 2 <strong>Advice</strong> <strong>for</strong> <strong>veter<strong>in</strong>arians</strong> <strong>in</strong> <strong>NSW</strong> treat<strong>in</strong>g <strong>coccidiosis</strong> <strong>in</strong> <strong>sheep</strong> <strong>and</strong> lambs, goats <strong>and</strong>


doses <strong>in</strong> produc<strong>in</strong>g cl<strong>in</strong>ical recovery (though not <strong>in</strong><br />

reduc<strong>in</strong>g shedd<strong>in</strong>g of oocysts). Dos<strong>in</strong>g with<br />

sulfadimid<strong>in</strong>e at 150 mg/kg Bwt as a s<strong>in</strong>gle dose<br />

has been reported as effective.<br />

(Medication Aga<strong>in</strong>st Ov<strong>in</strong>e Coccidiosis – A Review<br />

Gregory MW, Joyner LP & Catchpole J, Veter<strong>in</strong>ary<br />

Research Communications, 5 (1981/1982) 307-<br />

325).<br />

5 Other Chemical Products - toltrazuril<br />

Toltrazuril is a very effective coccidiostat which has<br />

been registered <strong>for</strong> some time <strong>for</strong> use <strong>in</strong> poultry<br />

<strong>and</strong> more recently <strong>for</strong> use <strong>in</strong> piglets <strong>and</strong> now<br />

calves. In order <strong>for</strong> it to be used <strong>in</strong><br />

lambs/<strong>sheep</strong>/kids there would need to be an<br />

official Maximum Residue Limit (MRL) set <strong>for</strong> the<br />

residues <strong>in</strong> <strong>sheep</strong>/goat tissue <strong>and</strong> no such MRL<br />

exists. Even <strong>in</strong> calves there are still relatively high<br />

residues after the 56 day label WHP but an MRL<br />

has been set to cover this. Only if a prescrib<strong>in</strong>g<br />

veter<strong>in</strong>arian can supply a WHP sufficiently long to<br />

ensure that no detectable residue rema<strong>in</strong>s should<br />

they recommend its use off-label <strong>for</strong> lambs/<strong>sheep</strong><br />

or other meat produc<strong>in</strong>g animals.<br />

An Export Slaughter Interval (ESI) <strong>and</strong> a retreatment<br />

<strong>in</strong>terval of 75 days is provided <strong>for</strong> calves.<br />

Literature references suggest no residues above<br />

the limit of quantification are present by this time <strong>in</strong><br />

calves, but this may not apply to <strong>sheep</strong> or goats.<br />

6 Coccidiosis Prevention<br />

Rumens<strong>in</strong>® 100 (monens<strong>in</strong>) is now registered by<br />

Elanco <strong>for</strong> <strong>coccidiosis</strong> prevention <strong>in</strong> cattle, <strong>sheep</strong><br />

<strong>and</strong> goats, <strong>and</strong> MRLs have been established <strong>for</strong><br />

<strong>sheep</strong>. It is not prescription only.<br />

Bovatec® <strong>and</strong> Avatec ® (lasalocid) products <strong>in</strong><br />

various concentrations <strong>and</strong> pack sizes are<br />

registered by Pfizer <strong>for</strong> add<strong>in</strong>g to <strong>sheep</strong> fed “<strong>in</strong><br />

conf<strong>in</strong>ement” to prevent <strong>coccidiosis</strong>. As a result<br />

MRLs exist <strong>for</strong> use <strong>in</strong> <strong>sheep</strong> (but also meat<br />

mammalian generally).<br />

If <strong>sheep</strong> are at pasture, rather than <strong>in</strong> conf<strong>in</strong>ement,<br />

then lasalocid would strictly require written<br />

directions from a veter<strong>in</strong>arian <strong>for</strong> use while at<br />

pasture, s<strong>in</strong>ce the use would be off-label.<br />

Off-label use of monens<strong>in</strong> or lasalocid as a s<strong>in</strong>gle<br />

dose treatment may also be useful but<br />

<strong>veter<strong>in</strong>arians</strong> would have to satisfy themselves<br />

regard<strong>in</strong>g the efficacy <strong>and</strong> residue profile <strong>for</strong> this<br />

use.<br />

Further, most lasalocid products specifically restrict<br />

s<strong>in</strong>gle dose treatments as a label restra<strong>in</strong>t. This<br />

prevents such off-label use by a veter<strong>in</strong>arian.<br />

Off-label Directions<br />

In <strong>NSW</strong>, users who are not <strong>veter<strong>in</strong>arians</strong> must<br />

follow the label directions. Written off-label<br />

directions can be provided to a client by a<br />

veter<strong>in</strong>arian <strong>and</strong> these must <strong>in</strong>clude animal<br />

species, dose rate, frequency of treatment, length<br />

of treatment <strong>and</strong> manner of adm<strong>in</strong>istration, as well<br />

as a WHP. S<strong>in</strong>ce there are no WHPs <strong>for</strong> off-label<br />

uses the period should be equal to, <strong>and</strong> advised to<br />

the potential user as, an ESI. The written<br />

directions must be signed <strong>and</strong> dated by the<br />

direct<strong>in</strong>g veter<strong>in</strong>arian. This is dealt with <strong>in</strong> Sections<br />

39, 39A, 39C <strong>and</strong> 39D of the Stock Medic<strong>in</strong>es Act<br />

1989.<br />

Us<strong>in</strong>g any product off-label is at the discretion of<br />

the prescrib<strong>in</strong>g veter<strong>in</strong>arian. If any problems result<br />

such as treatment failure or illegal residue<br />

detections, the prescrib<strong>in</strong>g veter<strong>in</strong>arian may be<br />

held liable (see Section 40(2) of the Stock<br />

Medic<strong>in</strong>es Act <strong>in</strong> relation to illegal residue issues).<br />

© State of New South Wales through Department of Trade <strong>and</strong><br />

Investment, Regional Infrastructure <strong>and</strong> Services 2012. You<br />

may copy, distribute <strong>and</strong> otherwise freely deal with this<br />

publication <strong>for</strong> any purpose, provided that you attribute the<br />

Department of Trade <strong>and</strong> Investment, Regional Infrastructure<br />

<strong>and</strong> Services as the owner.<br />

ISSN 1832-6668<br />

Disclaimer: The <strong>in</strong><strong>for</strong>mation conta<strong>in</strong>ed <strong>in</strong> this publication is<br />

based on knowledge <strong>and</strong> underst<strong>and</strong><strong>in</strong>g at the time of writ<strong>in</strong>g<br />

(February 2012). However, because of advances <strong>in</strong> knowledge,<br />

users are rem<strong>in</strong>ded of the need to ensure that <strong>in</strong><strong>for</strong>mation upon<br />

which they rely is up to date <strong>and</strong> to check currency of the<br />

<strong>in</strong><strong>for</strong>mation with the appropriate officer of the Department of<br />

Primary Industries or the user’s <strong>in</strong>dependent adviser.<br />

Recognis<strong>in</strong>g that some of the <strong>in</strong><strong>for</strong>mation <strong>in</strong> this document is<br />

provided by third parties, the State of New South Wales, the<br />

author <strong>and</strong> the publisher take no responsibility <strong>for</strong> the accuracy,<br />

currency, reliability <strong>and</strong> correctness of any <strong>in</strong><strong>for</strong>mation <strong>in</strong>cluded<br />

<strong>in</strong> the document provided by third parties.<br />

The product trade names <strong>in</strong> this publication are supplied on the<br />

underst<strong>and</strong><strong>in</strong>g that no preference between equivalent products<br />

is <strong>in</strong>tended <strong>and</strong> that the <strong>in</strong>clusion of a product name does not<br />

imply endorsement by the Department of Primary Industries<br />

over any equivalent product from another manufacturer.<br />

Any decision to treat animals <strong>and</strong> provide WHPs based on<br />

these considerations is made entirely at the decision of the<br />

attend<strong>in</strong>g veter<strong>in</strong>arian. No recommendation is made that any<br />

such use is or will be effective or that it will be safe to either the<br />

animals or humans consum<strong>in</strong>g food produced by treated<br />

animals.<br />

Published by the Department of Primary Industries, a part of the<br />

Department of Trade <strong>and</strong> Investment, Regional Infrastructure<br />

<strong>and</strong> Services.<br />

PUB12/118<br />

<strong>Advice</strong> <strong>for</strong> <strong>veter<strong>in</strong>arians</strong> <strong>in</strong> <strong>NSW</strong> treat<strong>in</strong>g <strong>coccidiosis</strong> <strong>in</strong> <strong>sheep</strong> <strong>and</strong> lambs, goats <strong>and</strong> kids p 3

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