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Important Medical Disclaimer

This section contains technical information intended for healthcare professionals only.

  • The information provided here is not intended to replace professional judgment or serve as a standard of medical care.
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Advanced
Therapy for Ulcerative Colitis

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What is TRUD™?

TRUD™ is a white enema bottle containing a thick suspension that includes sodium hyaluronate. Ulcerative colitis is a disease of the colon and rectum in which the mucosal lining becomes inflamed. Symptoms include rectal bleeding, frequent diarrhoea and abdominal pain.

TRUD™ is applied via the rectum and forms a protective coat over the lining of the distal colon and rectum. This allows the mucosal tissue to heal naturally which reduces the symptoms of ulcerative colitis.

  • Fast-Acting Relief
  • Clinically Proven
  • Easy-to-Administer Injectable

Warnings about the use of TRUD™

TRUD™ is for rectal administration only. Do not use for children. Do not use TRUD™ if you are
allergic to parabens preservatives or sodium hyaluronate. Do not use if you are pregnant or breast feeding. Use each enema bottle of TRUD™ once only. Throw the bottle away after you have used it even if you have not emptied the bottle. If you use a TRUD™ bottle for a second time it may become contaminated with micro-organisms which would cause you harm.

Clinical trial And results

A clinical study was conducted in Istituto Clinico Humanitas, (Milan) Italy on patients suffering from mild to moderate UC in the acute phase (active flare-ups). This was conducted to show the safety and effectiveness of TRUD™ in UC. Statistically significant results described below were seen in patients who used TRUD™ at the end of the study (week 4). TRUD™ was shown to be effective in reducing the clinical symptoms and improving endoscopic scores of patients that suffer from UC.

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Healing

Almost a quarter of the patients showed complete mucosal healing in the colon demonstrating that TRUD™ is effective in facilitating the healing of the affected colon of patients with mild to moderate UC in the acute phase.

Side effects

No serious adverse events were seen in any patient during the course of the trial. Some mild transient side effects (e.g. flatulence,nausea,headache, etc.) were seen which could be due to the procedure of using an enema.

Ease of use

TRUD™ was found to be well tolerated as a form of treatment for patients with mild to moderate UC. A patient can administer it by himself.

Adverse
effects

Rarely an allergic reaction can occur. Tell your doctor if you get a rash after using TRUD™, any shortness of breath, palpitations or chest pains. These effects should disappear when you stop using TRUD™. Common side effects are bloating, flatulence, nausea and pain. If you have a serious side effect or you notice side effects not listed in this leaflet please tell your doctor.

How to store TRUD™

Keep out of reach of children. Store TRUD™ between 2°C and 30°C. Protect the TRUD™ enema bottle from direct sunlight. Do not pierce or burn the TRUD™ bottle even if it is empty. Do not use TRUD™ after the expiry date printed on the bottle and box. Do not dispose of TRUD™ via wastewater or household waste. Dispose of TRUD™ according to local regulations. Ask your pharmacist how to dispose of used bottles.

Further Information

TRUD™ is intended to be used to supplement the intestinal mucosa of patients suffering from mild to moderate distal ulcerative colitis. TRUD™ provides a soft barrier to minimise the effects of continuous immune stimulation by triggers from the contents of the colon on the colonic mucosa and thereby provide the ideal environment for the regeneration of the intestinal mucosa. TRUD™ is composed of high molecular weight sodium hyaluronate 1.8 x 106 Daltons and low molecular weight sodium hyaluronate 0.35 x 106 Daltons together with other ingredients, which ensure that the enema solution adheres to the mucosa of the distal left side colon when administered via the rectum.

FAQs

01

What is the treatment regimen of TRUD™?

The patient should use one TRUD™ enema every day at bedtime for 28 days.

02

At what severity can TRUD™ be used?

TRUD™ is indicated for mild to moderate distal Ulcerative Colitis.

03

Can TRUD™ be used both in chronic and acute phase?

Yes, TRUD™ can be used both in chronic and acute phases.

04

How long should the patient keep it?

The enema suspension should be retained in the bowel for as long as possible so as to maintain the longest possible contact time with the colon. It is recommended that the patient should remain in the administration position for 5 to 10 minutes. It is also recommended to empty the bowels before administration, as to keep the product until the next day.

05

Can TRUD™ be used straight from the bottle ?

Yes, but we highly recommend that the patient warms it up in water for 1 minute and shake it well for approximately 30 seconds.

06

Can TRUD™ be used concomitantly with other treatments ?

Patients can use TRUD™ rectally in concomitant to oral treatment such as 5-ASA, in order to maximise the therapeutic efficacy. Please note there has been no study performed specifically to assess the interaction with other treatments.

07

How soon can the effects of TRUD™ be seen?

Generally, patients start to have improvements after several days or up to two weeks of TRUD™ treatment.

08

What are the side effects of TRUD™ Vs other treatments?

Similar to other rectal treatments, common side effects of TRUD™ are bloating, flatulence, nausea, diarrhea and abdominal pain which is partly believed to be due to the route of administration.

The latest treatment available for mild to moderate Ulcerative Colitis (UC) patients.

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Get in Touch

+41 22 704 05 45 info@mdtsa.ch

location

Rue du 31 Décembre, 36,
1207 Geneva, Switzerland

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