Prescribing information for BCG-medac https://emc.link/pi44239

Prescribing information for Mitomycin medac https://www.emcpi.com/pi/33668

Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk.  Adverse events should also be reported to medac drug safety at: drugsafety@medac.de

Bladder Cancer Care

As part of their continued bladder cancer care programme, medac Pharma has developed an all in one instillation system supplied as standard with Mitomycin medac and BCG-medac, for the treatment of non-muscle invasive bladder cancer (NMIBC).

Mitomycin medac and BCG-medac are both licensed for intravesical use.

Educational information

Visit our Educational information page with videos on best practice for managing NMIBC and bladder cancer care, as well more information on medac Academy, an education platform for Healthcare Professionals with CPD certified eLearning and other educational content.

Education page
Mitomycin medac
BCG-medac

Each kit contains:

  • An all in one instillation system
  • Mitomycin medac 40mg vial
  • A Catheter
  • A Connector
  • Disposal bag

Ordering Mitomycin medac:

Mitomycin medac is available from Alloga:
Tel: +44 (0)1773 441702

Mitomycin medac product code:
USP4527

Mitomycin medac has several key features:

  • Rapidly dissolving formulation1
  • Formulation with urea to reduce irritation. Unlike sodium and chloride ions, urea can freely pass through cell membranes resulting in very little effect on tonicity of the reconstituted solution2
  • Easy to use closed instillation system speeds up the process of Mitomycin medac instillation therapy and prevents cytotoxic contamination3

Therapeutic indication4

Mitomycin medac is indicated for intravesical administration to prevent relapse in adult patients with superficial urinary bladder carcinoma following transurethral resection.

Available in a 40mg vial complete with instillation set, Mitomycin medac can be administered as both induction and maintenance therapy.

Mitomycin medac Summary of Product Characteristics
Mitomycin medac Prescribing Information

Each kit contains:

  • A closed instillation system
  • BCG-medac vial

Ordering BCG-medac:

BCG-medac is available from Alloga:
Tel: +44 (0)1773 441702

BCG-medac product code:

  • APC2339 – GB Customers
  • APC2668 – NI Customers

BCG-medac has several key features:

  • Licensed in Great Britain and Northern Ireland
  • BCG-medac is the RIVM strain of BCG – a strain with proven efficacy6
  • First choice of BCG in Europe2

Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk

Adverse events should also be reported to medac drug safety at: drugsafety@medac.de

Therapeutic indication5

  • The treatment of primary or concurrent carcinoma-insitu of the urinary bladder.
  • The prevention of recurrence of high-risk nonmuscle invasive urothelial bladder carcinoma (pTaG3, pT1G2, pT1G3) after transurethral resection.
  • The treatment and/ or the prevention of recurrence of aggressive variants of urothelial carcinoma, for example micropapillary or nested variants.
BCG-medac Summary of Product Characteristics
BCG-medac Prescribing Information

Patient information – Please visit our patients page for information you can share with your patients

Step 1

To prepare the instillation system, firstly tear open the protective cover, but do not remove it completely. This will protect the tip of the instillation system from contamination. Then, remove the caps from both the BCG-medac/ Mitomycin medac vial and the instillation system. Whilst holding the vial on a hard surface, press the connecter of the instillation system firmly, and in a straight manner, onto the BCG-medac/ Mitomycin medac vial. Turn the vial three times completely in one direction, to establish a connection.

Step 2

Holding the tube, break the upper valve by bending it backwards and forwards.

Step 3

Then, gently squeeze some liquid into the vial, but do not fill the vial completely. Dissolve the BCG-medac/ Mitomycin medac by gently agitating the solution.

Step 4

Invert the entire system and by gently squeezing some air from the bag into the vial, draw the reconstituted BCG-medac/ Mitomycin medac back into the instillation system. Do not remove the vial.

Step 5

Whilst holding the instillation system vertically, remove the protective cover completely and connect the system to the patient’s catheter.

Step 6

Now, break the sealing mechanism in the tube section by bending backwards and forwards, and instil the solution. Once the instillation is complete, free the catheter by pressing air through, then simply dispose of the empty system and packaging in the bag provided.

Note: BCG-medac solution is colourless. Mitomycin medac solution is blue-purple.

References
  1. medac GmbH (2016). Video showing dissolving speeds of two Mitomycin medac vials.
  2. Data on file.
  3. Lyvén B. Investigation of sealing properties of a system intended for safe mixing of drugs. SP Technical Research Institute of Sweden. January 2009.
  4. Mytomicin medac Summary of Product Characteristics (SmPC).
  5. BCG-medac Summary of Product Characteristics (SmPC).
  6. Del Giudice et al, 2023, Efficacy of Different Bacillus of Calmette-Guérin (BCG) Strains on Recurrence Rates among Intermediate/High-Risk Non-Muscle Invasive Bladder Cancers (NMIBCs): Single-Arm Study Systematic Review, Cumulative and Network Meta-Analysis

Copyright © medac Pharma LLP 2022. All rights reserved.

medac Code: D074/02/2026.
Date of Preparation: March 2026

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