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Since Tri-Solfen® was commercially launched, over 80 million lambs have been treated and over 80% of Australian wool growers are now using Tri-Solfen for their sheep. Here’s what some of them have to say…

‘We have used pain relief for two years now and seen real production gains. We are concerned for the welfare of our animals and will continue to use pain relief to ensure they get the best care.’

Clinton Wise– Wililoo Merino Stud, Woodanilling, W.A.

'It easy to see the difference pain relief makes. Before, lambs would walk away hunched up, even taking a couple of hours to walk back to the paddock. Now they run straight back to Mum and start suckling,” says Rod. “My wool is now sold under the Better Choices brand. I see this as a definite advantage. I think it will be an advantage in the long run, to both me and the industry as a whole.'

Rod Miller– Glenpaen Merino Stud, Horsham, Vic

'After being treated with pain relief my lambs were more content and less stressed. As farmers we are sincere in looking after the welfare of our animals and using pain relief demonstrates this.'

Richard Coole– Frankland, W.A.

'We have been using pain relief for the past three years. We’re impressed by reduced bleeding in the mulesing wound immediately after application. Lambs run straight back to find the ewe, which has dramatically reduced our mortality rates. Flock management, post lamb marking is easier due to the effect of pain relief and the scab healing faster.'

Ryan & Malcom O’Dea– Peepingee Merino Stud, Narrogin, W.A.

'Using pain relief eases the stress and allows lambs to mother up and move back to the paddock easier with faster weight gains.'

Kent Lummis– Waverley Downs, Gilgandra, NSW


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Advisory Board

Ian Page

Non-Executive Director

Ian is Chief Executive Officer of Dechra Pharmaceuticals, which has a 33% shareholder in Medical Ethics. He joined National Veterinary Services, Dechra’s former services business in 1989 and joined the Board of Dechra in 1997. In October 2010, Ian was appointed as Non-Executive Chairman of Sanford DeLand Asset Management.

Dr Chris Roberts

Human Wound and Regulatory Advisor

Chris has over 20 years’ line management experience of heading clinical research teams. He was previously global head of Smith & Nephew clinical support and market development, where he managed global clinical Phase II and III programmes in the management of venous and pressure ulcers.

Lieutenant Colonel Professor Steven Jeffery

Medical Specialist Advisor

Steve has over 15 years’ experience in military plastic surgery. In 2011 he was awarded the Military Civilian Partnership Award for ‘Regular of the Year’, as well as receiving the Wounds UK ‘Key Contribution’ award and the Smith and Nephew ‘Customer Pioneer of the Year’ award. He has also been awarded Fellowship of the Royal College of Surgeons of England ad eundum. He is an expert adviser to NICE Medical Technologies Evaluation Programme. Steve co-founded the Woundcare 4 Heroes charity, which is already making a big difference to the wound care of both serving and veteran personnel.

Dr Matthew Bayfield

Medical Specialist Scientific Director

Dr Matthew Bayfield, Head of Cardiothoracic Surgery, Strathfield Private Hospital and VMO Cardiothoracic Surgeon, Royal Prince Alfred Hospital.

Professor Peter Windsor

Veterinarian Research Advisor

Peter is a registered specialist veterinary surgeon in New South Wales and an emeritus Professor at Sydney University. He holds a BVSc (Hons), PhD, DVSc and diploma from the European College of Small Ruminant Health Management.

Dr Julian Braidwood

Global Regulatory Affairs Advisor

Julian has held leadership roles and managed international clinical projects with Grampian. He was previously Regulatory Affairs Manager at Novartis Animal Health. He is the Founder and Managing Director of Triveritas, where he is responsible for a team of 40 animal health specialists across the EU and the US.


Tri-Solfen® no Risk to Humans, Animals or Trade Report

February 7, 2013

Letter by Prof J G McLean  BVSc, PhD, HDA(Hons), Comp IE Aust, Professor Emeritus –  13 August 2009


Mr James Suter

Acting Program Manager

Veterinary Medicines


Symonston ACT 2609


Dear Mr Suter

Tri-Solfen Topical Solution

Thank you for the opportunity to review the residue requirements for Tri-Solfen (TS)

for registration. I believe the new information submitted by Dr Ruth Davis is well

argued and worthy of consideration.


The major issues are food safety and trade. The active constituents are lignocaine

LIG), bupivicaine (BUP and cetrimide (CET), all of which have been used for many

years in human and animal medicine. They are formulated together in TS and used as

a post-mulesing dressing in lambs. The recommended age for mulesing is 2-12 weeks.

with the maximum allowed under the Commonwealth Government Model Code of

Practice for Welfare of Animals (Code) being 12 months.


Mulesing is only carried out on young sheep that are destined for wool production. In

reality, the three actives would have disappeared long before the sheep ever entered

the human food chain. The interval is likely to be many years, with some sheep

actually dying beforehand and others being used for pet food.


The three actives are used topically in humans, and LIG and BUP are also

administered parenterally. The ingestion of resides from TS are of no consideration in

human health.


In relation to trade issues, it is stated that over 5 million sheep have been treated under

an APVMA permit with a meat WHP of 90 days, and there have been no reported

residue violations. The EU has considered CET and found it not necessary to establish

an MRL but rather included it Annex II of it regulations, which is an equivalent to

the Australian residue standard entry on Table 5. The Australian Office of Chemical

Safety has found that if any residues of CET in meat would be of no toxicological

concern. LIG and BUP are metabolised rapidly and the breakdown products do not

represent a hazard.


There was a suggestion that the CET concentration be reduced so as to decrease the

possibility of resides. I do not believe this reduction to be necessary and would not

support it because it decreases the efficacy of the product as a post-mulesing dressing.



In relation difficulties in making a suitable radio-labelled CET for residue studies, I

do not fully accept that it is not possible. However, I concede that it would be

technically difficult because it would involve purifying CET before radio-labelling the

major component. The absence of adequate facilities to conduct radio-labelled residue

studies is also noted, as is the worldwide shortage of such facilities. This may present

the opportunity for the establishment of such facilities in Australia, with some

government assistance.


In summary, I do not believe there is any human health, food safety or trade issues

related to the use of CET, LIG or BUP formulated into a post-mulesing dressing for

wool producing sheep, as they are formulated in TS.


Accordingly, I would recommend that cetrimide, lignocaine and bupivacaine each be

given a Table 5 entry in the Maximum Residue Limit Standard, with the qualifier

“when used as a post-mulesing treatment in sheep intended for wool production”. I

would further restrict their use to formulation into a specified product, such as TriSolfen.


In addition, any animals treated with TS should be identified in the National

Livestock Identification Scheme (NLIS). Furthermore, if a withholding period of 90

days is specified for TS, this will result in the requirement when animals are sold, for

the vendor to make a declaration related to treatment. Therefore, any animals treated

with TS, will then be able to be traced.


Finally, I would recommend that it be specified that all mulesing be carried according

to the Code of Practice for the Welfare of Animals. This will ensure that sheep

subsequently dressed with Tri-Sulfen fulfil all the guidelines specified in the Code

relating to mulesing. These include such matters as key indicators for mulesing, age

for mulesing and post-mulesing management. This requirement would mean that the

use pattern for TS is further defined and regulated.


I trust that this report will enable you to make progress in this registration. Please do

not hesitate to get back to me if I can be of any further assistance.


Yours sincerely

J G (Jock) McLean

BVSc, PhD, HDA(Hons), Comp IE Aust

Professor Emeritus