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Uromune (MV140)

Guide for Patients

For the prevention of recurrent
Urinary Tract Infections

 

 

 

 

 

 

 

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How to Use

Watch the video below to see the method of administration for the Uromune sublingual (under the tongue) spray

Uromune 1. Dont eat or Drink

1. Do not eat, drink or brush teeth 30mins before and after applying the vaccine

Note: Uromune® works best when your mouth is in as natural a state as possible. For this reason, many prefer to spray Uromune® first thing in the morning
Uromune 2. Remove plastic seal

2. Remove the plastic seal

Uromune 3. Rotate Pipette Sideways

3. If starting a new, unused bottle: 
First prime the bottle by rotating the pipette sideways and pressing the spray button 3 or 4 times to fill the pump mechanism

You will not need to do this again until you start a new bottle
Uromune 4. Shake bottle gently

4. Shake the bottle gently.

5. Spray twice

5. Lift your tongue and spray twice

Press the button quickly and firmly to release the medication as a spray. Pressing the button too slowly will cause the medication to come out in a stream instead, which is less effective.
6. Hold for 1-2 min

6. Hold the dose under your tongue, for approximately 1-2 minutes before swallowing.

7. Rotate pipette down

7. Rotate the pipette back to its downward pointing position.

8. Store refridgerated

8. Store the vaccine in its original packaging and keep it refrigerated (2-8˚C). 

While the vaccine is still viable at room temperature for a few hours, if you need to travel, consider using an insulated container with an ice bag. Freezing deactivates the vaccine. DO NOT FREEZE.
Step-by-Step Instructions
Uromune 1. Dont eat or Drink

Do not eat, drink or brush teeth 30mins before and after applying the vaccine

Uromune® works best when your mouth is in as natural a state as possible. For this reason, many prefer to spray Uromune® first thing in the morning
Uromune 2. Remove plastic seal

Remove the plastic seal

Uromune 3. Rotate Pipette Sideways

If starting a new, unused bottle:
First prime the bottle by rotating the pipette sideways and pressing the spray button 3 or 4 times to fill the pump mechanism

You will not need to do this again until you start a new bottle

Uromune 4. Shake bottle gently

Shake the bottle gently

5. Spray twice

Lift your tongue and spray twice

Press the button quickly and firmly to release the medication as a spray. Pressing the button too slowly will cause the medication to come out in a stream instead, which is less effective.
6. Hold for 1-2 min

Hold the dose under your tongue, for approximately 1-2 minutes before swallowing

7. Rotate pipette down

Rotate the pipette back to its downward pointing position

8. Store refridgerated

Store the vaccine in its original packaging and keep it refrigerated (2-8˚C)

While the vaccine is still viable at room temperature for a few hours, if you need to travel, consider using an insulated container with an ice bag. DO NOT FREEZE.
Uromune 1. Dont eat or Drink

1. Do not eat, drink or brush teeth 30mins before and after applying the vaccine

Note: Uromune® works best when your mouth is in as natural a state as possible. For this reason, many prefer to spray Uromune® first thing in the morning
Uromune 2. Remove plastic seal

2. Remove the plastic seal

Uromune 3. Rotate Pipette Sideways

3. If starting a new, unused bottle: 
First prime the bottle by rotating the pipette sideways and pressing the spray button 3 or 4 times to fill the pump mechanism

You will not need to do this again until you start a new bottle
Uromune 4. Shake bottle gently

4. Shake the bottle gently.

5. Spray twice

5. Lift your tongue and spray twice

Press the button quickly and firmly to release the medication as a spray. Pressing the button too slowly will cause the medication to come out in a stream instead, which is less effective.
6. Hold for 1-2 min

6. Hold the dose under your tongue, for approximately 1-2 minutes before swallowing.

7. Rotate pipette down

7. Rotate the pipette back to its downward pointing position.

8. Store refridgerated

8. Store the vaccine in its original packaging and keep it refrigerated (2-8˚C). 

While the vaccine is still viable at room temperature for a few hours, if you need to travel, consider using an insulated container with an ice bag. Freezing deactivates the vaccine. DO NOT FREEZE.
Uromune adverse event reporting

Got Questions?

If you have clinical-related questions or would like to report an adverse event, please notify us through the form below.

Additional Resources

Summary of Product Characteristics (SmPC)

A technical datasheet on the composition, clinical considerations and pharmacological properties

Download

Dosage Tracking Booklet

Booklet with a calendar to keep track of daily doses and instructions on how to use.

Download

Product Insert Leaflet (PIL)

Leaflet included with the product that contains a short product summary. It includes safety information, storage instructions and the method of administration.

Download
WHO WE ARE
About Company

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Frequently Asked Questions (FAQs)
How many courses are needed?

One 3-month course is sufficient6,20

How long will the treatment effects last for?

Up to 12 months after treatment with some evidence that about 1 in 2 could remain UTI free even after 3 years3,6

Will I still experience UTIs after I have finished the treatment?

Yes. You may still experience UTIs after the treatment has finished, but the number of episodes should reduce6,20

Can I use the bacterial vaccine whilst I have a UTI?

If you experience and infection, continue to use your vaccine as per usual. It is important to treat the infection following direction from your doctor who may prescribe a short-term course of antibiotics

What are the side-effects?

Like all medicines, it can cause side effects. Side effects are typically local, mild and affect less than 2% of patients.6,14
At the start of your treatment you may experience a mild heat sensation, swelling, mouth rash, or slight gastrointestinal tract disturbances.
In very rare incidences you may possibly experience mucosal inflammation, difficulty breathing, or an allergic skin reaction.
Please report any side effects to your doctor and seek medical aid if required.

What do I do if I forget to put the vaccine back in the fridge?

The vaccine is still effective to use if periodically left at room temperature. Refrigeration is best practice and recommended. DO NOT FREEZE.

Clinical Papers

  1. Ramírez Sevilla C;Gómez Lanza E;Puyol Pallàs M;, C. (2024) Immunoactive prophylaxis protocol of uncomplicated recurrent urinary tract infections in a cohort of 1104 women treated with Uromune® vaccine, Life (Basel, Switzerland).
    Available at: https://pubmed.ncbi.nlm.nih.gov/38672735/
  2. Nickel, J.C. et al. (2024) Reducing recurrent urinary tract infections in women with MV140 impacts personal burden of disease: Secondary analyses of a randomized placebo-controlled efficacy study, European Urology Open Science.
    Available at: https://www.sciencedirect.com/science/article/pii/S2666168324003501
  3. Pérez-Sancristóbal, et al. (2023) Long-term benefit of perlingual polybacterial vaccines in patients with systemic autoimmune diseases and active immunosuppression, Biomedicines.
    Available at: https://pubmed.ncbi.nlm.nih.gov/37189785/
  4. Nickel, J.C. and Doiron , R.C. (2023) An effective sublingual vaccine, MV140, safely reduces risk of recurrent urinary tract infection in women, Pathogens (Basel, Switzerland).
    Available at: https://pubmed.ncbi.nlm.nih.gov/36986281/
  5. Sevilla, C.R. et al. (2022) A focus on long-term follow-up of immunoprophylaxis to recurrent urinary tract infections: 10 years of experience with MV140 vaccine in a cohort of 1003 patients support high efficacy and safety, Archivos Españoles de Urología.
    Available at: https://www.aeurologia.com/EN/10.56434/j.arch.esp.urol.20227509.110
  6. Lorenzo-Gómez, M.F. et al (2022) Sublingual MV140 for prevention of recurrent urinary tract infections, NEJM evidence.
    Available at: https://pubmed.ncbi.nlm.nih.gov/38319200/
  7. Martín-Cruz, L. et al. (2022) Candida albicans V132 induces trained immunity and enhances the responses triggered by the polybacterial vaccine MV140 for genitourinary tract infections, Frontiers.
    Available at: https://www.frontiersin.org/journals/immunology/articles/10.3389/fimmu.2022.1066383/full
  8. Sánchez-Ramón, S. et al. (2021) Sublingual bacterial vaccination reduces recurrent infections in patients with autoimmune diseases under immunosuppressant treatment, Frontiers in immunology.
    Available at: https://pmc.ncbi.nlm.nih.gov/articles/PMC8212043/
  9. Lorenzo-Gomez, M.F. et al. (2021) Impact of whole-cell bacterial immunoprophylaxis in the management of recurrent urinary tract infections in the frail elderly.
    Available at: https://www.sciencedirect.com/science/article/pii/S0264410X21011531
  10. Subiza, J.L. et al. (2021) Trained immunity-based vaccines, Frontiers.
    Available at: https://www.frontiersin.org/journals/immunology/articles/10.3389/fimmu.2021.716296/full
  11. Agudo, R.G. et al. (2020) Vacunación sublingual con bacterias inactivadas en pacientes Nefrológicos Con infección urinaria recurrente: Experiencia en un centro de españa, Revista Colombiana de Nefrología.
    Available at: https://revistanefrologia.org/index.php/rcn/article/view/387
  12. Martin-Cruz. L. et al. (2020) A combination of polybacterial MV140 and candida albicans V132 as a potential novel trained immunity-based vaccine for genitourinary tract infections, Frontiers in immunology.
    Available at: https://pubmed.ncbi.nlm.nih.gov/33552074/
  13. Carrión-López, M.F. et al (2020) Analysis of the efficacy of a sublingual bacterial vaccine in the prophylaxis of recurrent urinary tract infection.
    Available at: https://pubmed.ncbi.nlm.nih.gov/31962327/
  14. Nickel, J.C., Saz-Leal, P. and Doiron, R.C. (2020) Could sublingual vaccination be a viable option for the prevention of recurrent urinary tract infection in Canada? A systematic review of the current literature and plans for the future, Canadian Urological Association journal.
    Available at: https://pubmed.ncbi.nlm.nih.gov/33626320/
  15. Sanchez-Ramon, S., Manzanares, M. and Candelas, G. (2020)
    Mucosal anti-infections vaccines: Beyond conventional vaccines, Reumatologia clinica.
    Available at: https://pubmed.ncbi.nlm.nih.gov/30527360/
  16. Ramírez Sevilla, C. et al. (2019)
    Active immunoprophyilaxis with uromune® decreases the recurrence of urinary tract infections at three and six months after treatment without relevant secondary effects, BMC infectious diseases.
    Available at: https://pubmed.ncbi.nlm.nih.gov/31660885/
  17. Yang, B. and Foley, S. (2018)
    First experience in the UK of treating women with recurrent urinary tract infections with the bacterial vaccine Uromune®, BJU international.
    Available at:
    https://pubmed.ncbi.nlm.nih.gov/29171130/
  18. Sihra, N. et al. (2018)
    Nonantibiotic Prevention and management of recurrent urinary tract infection, Nature.
    Available at: https://www.nature.com/articles/s41585-018-0106-x
  19. Benito-Villalvilla, C. et al. (2016) MV140, a sublingual polyvalent bacterial preparation to treat recurrent urinary tract infections, licenses human dendritic cells for generating th1, th17, and IL-10 responses via Syk and myd88, Nature.
    Available at: https://www.nature.com/articles/mi2016112
  20. Lorenzo-Gómez, M.F. et al. (2015) Urinary tract infections in women with stress urinary incontinence treated with transobturator suburethral tape and benefit gained from the sublingual polibacterial vaccine, Sage.
    Available at: https://journals.sagepub.com/doi/full/10.1177/1756287215576648
  21. Lorenzo-Gómez, et al. (2013) Evaluation of a therapeutic vaccine for the prevention of recurrent urinary tract infections versus prophylactic treatment with antibiotics, International urogynecology journal.
    Available at: https://pubmed.ncbi.nlm.nih.gov/22806485/
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