Medicinal Products


Generic drug of the therapeutic class: Oncology and Hematology
active ingredients: After reconstitution, one vial contains: BCG
laboratory: Medac

Powder and solvent for suspension for intravesical administration
Box of 1 bottle of powder + 50 ml solvent bag
All forms


Treatment of non-invasive urothelial carcinoma of the bladder:

· Curative treatment of carcinoma in situ

· Prophylactic treatment of recurrence of:

o Urothelial carcinoma limited to the mucosa:

§ pTa G1-G2 if it is a multifocal and / or recurrent tumor

§ pTa G3

o Urothelial carcinoma invading the lamina propria but not the muscularis of the bladder (pT1)

o carcinoma in situ.

Dosage BCG-MEDAC Powder and solvent for suspension for intravesical administration Box of 1 vial of powder + 50 ml solvent bag


The contents of a vial are required for bladder instillation. The instructions for reconstitution are given in the Instructions for Use, Handling and Disposal section .


Carcinoma in situ

The standard treatment regimen includes intravesical instillation of BCG-medac weekly for six consecutive weeks in induction therapy. BCG treatment should only begin 2 to 3 weeks after transurethral resection (RTU). After a 4-week therapeutic window, intravesical administration should be resumed as part of a maintenance treatment for at least one year. The maintenance treatment diagrams are described below.

Induction treatment (prophylactic treatment of recurrence)

BCG treatment should be started approximately 2 to 3 weeks after RTU or after bladder biopsy without traumatic catheterization and should be repeated weekly for 6 weeks. This therapy should be followed by maintenance therapy for intermediate and high risk tumors.

Maintenance treatment

One pattern includes a monthly therapy of 12 months. Another maintenance regimen consists of 1 instillation per week for 3 weeks in the 3 rd, 6 th, 12 th, 18 th, 24 th, 30 th and 36 th months. As part of this scheme, a total of 27 instillations are administered for a period of three years.

The treatment regimens mentioned with different BCG strains have been studied in clinical studies involving a large number of patients. At present, it is not possible to indicate which of these diagrams is the best.


BCG-medac should be administered under the conditions required for intravesical endoscopy.

The patient should not drink within 4 hours before instillation and for 2 hours after instillation. The bladder must be emptied before instillation of BCG. BCG-medac is introduced into the bladder by means of a catheter and at low pressure. The instilled BCG-medac suspension should remain in the bladder for 2 hours if possible. During this time, the suspension should remain in sufficient contact with the entire surface of the bladder mucosa. Therefore, the patient should be mobilized as much as possible. Two hours later, the patient should eliminate the instilled suspension preferably in a sitting position.

If there is no specific medical contraindication, hyperhydration is advised to the patient for 48 hours after each instillation.

BCG-medac should not be given to the child as its safety and efficacy have not been established.

There are no specific recommendations regarding the use of the product in the elderly patient.

Against indications

· Hypersensitivity to any of the components.

· BCG-medac should not be used in immunocompromised patients or persons with congenital or acquired immune deficiency caused by concomitant pathology (eg HIV positive serodiagnosis, leukemia or lymphoma), cancer treatment (eg by cytostatics, radiotherapy) or immunosuppressive therapy (eg by corticosteroids).

· BCG-medac should not be given to people with active TB. The presence of active tuberculosis should be excluded by means of an appropriate history and, if indicated, by diagnostic tests performed in accordance with local recommendations.

· History of radiotherapy of the bladder.

· BCG-medac is contraindicated in breastfeeding women (see section Pregnancy and breastfeeding ).

· BCG-medac should only be instilled 2 to 3 weeks after RTU, bladder biopsy or traumatic catheterization.

· Bladder perforation (see section Warnings and precautions for use ).

· Acute urinary tract infection (see Warnings and Precautions section ).

Side effects Bcg-Medac

Within each group frequency, adverse effects should be presented in order of decreasing severity.

Class of organ system

Frequency of adverse effects

Infections and infestations

Very common (> 1/10):

Cystitis and inflammatory reactions (granulomas) of the bladder

Uncommon (> 1/1000, <1/100):

Urinary tract infection, orchitis, infection / severe systemic BCG reaction, BCG sepsis, miliaria, skin abscess, Reiter's syndrome (conjunctivitis, asymmetric oligoarthritis and cystitis)

Rare (> 1/10 000, <1/1000):

Vascular infection (eg infected aneurysm), renal abscess

Very rare (<1 / 10, 000):

BCG infection of surrounding implants and tissues (eg, aortic graft, cardiac defibrillator, hip or knee prosthesis), cervical lymphadenitis, local lymph node infection, osteomyelitis, bone marrow, psoas abscess, penile glans infection, orchitis or epididymitis resistant to antituberculous treatment

Blood and lymphatic system disorders

Uncommon (> 1/1000, <1/100):

Cytopenia, anemia

Immune system disorders

Very common (> 1/10):

Systemic reaction to transient BCG (fever <38.5 ° C, flu-like syndrome including malaise, fever, chills, general discomfort)

Very rare (<1 / 10, 000):

Hypersensitivity reaction (eg eyelid edema, coughing)

Eye disorders

Very rare (<1 / 10, 000):

Chorioretinitis, conjunctivitis, uveitis

Vascular disorders

Very rare (<1 / 10, 000):

Vascular fistula

Respiratory, thoracic and mediastinal disorders

Uncommon (> 1/1000, <1/100):

Pulmonary granuloma

Gastrointestinal disorders

Very common (> 1/10):


Very rare (<1 / 10, 000):

Vomiting, intestinal fistula, peritonitis

Hepatobiliary disorders

Uncommon (> 1/1000, <1/100):


Skin and subcutaneous tissue disorders

Uncommon (> 1/1000, <1/100):

Skin rash

Musculoskeletal and systemic disorders:

Uncommon (> 1/1000, <1/100):

Arthritis, arthralgia

Renal and urinary disorders

Very common (> 1/10):

Frequent urination with discomfort and pain

Uncommon (> 1/1000, <1/100):

Macroscopic hematuria, bladder retraction, urinary obstruction, bladder contracture

Disorders of reproductive organs and breast

Very common ( > 1/10):

Asymptomatic granulomatous prostatitis

Uncommon (> 1/1000, <1/100):

Epididymitis, symptomatic granulomatous prostatitis

Not known (can not be estimated from the available data):

Genital disorders (eg vaginal pain, dyspareunia)

General disorders and administration site conditions

Frequent (> 1/100, <1/10):

Fever> 38.5 ° C

Uncommon (> 1/1000, <1/100):


Adverse effects of BCG treatment are common but generally mild and transient. Adverse reactions usually increase with the number of BCG instillations.

Infrequent arthritis / arthralgia and rash may occur. In the majority of cases of arthritis, arthralgia and skin rash, they can be attributed to BCG hypersensitivity reactions. In some cases, it may be necessary to discontinue the administration of BCG-medac.

Local adverse reactions:

Discomfort, painful urination and excessive voiding frequency occur in up to 90% of patients. Cystitis and an inflammatory reaction (granulomas) may be an essential part of anti-tumor activity. Other side effects not commonly observed include gross hematuria, urinary tract infection, bladder retraction, urinary obstruction, bladder contracture, symptomatic granulomatous prostatitis, orchitis and epididymitis. Renal abscesses are rarely seen. In addition, genital disorders (eg vaginal pain, dyspareunia) may occur at an indeterminate rate.

Systemic reaction to transient BCG:

A subfebrile condition, flu-like symptoms and a general feeling of discomfort may occur. These symptoms disappear within 24 to 48 hours and should be treated with standard symptomatic treatment. These reactions are signs of the onset of an immune response. All patients receiving the product should be closely monitored and advised to report any occurrence of fever and other than urinary manifestations.

Severe systemic infections / adverse reactions:

Infections / systemic adverse reactions are defined as follows: fever> 39.5 ° C for at least 12 hours, fever> 38.5 ° C for at least 48 hours, BCG miliary, granulomatous hepatitis, liver enzyme abnormalities, dysfunction organic (outside the urogenital tract) with granulomatous inflammation at biopsy, Reiter's syndrome. Severe BCG infection / systemic reaction may result in potentially life-threatening BCG sepsis.

Therapeutic recommendations, see the table below.

Treatment of symptoms, signs and syndromes

Symptoms, signs or syndrome


1) Symptoms of bladder irritation lasting less than 48 hours

Symptomatic treatment

2) Symptoms of bladder irritation for at least 48 hours

Stop BCG-medac and start treatment with quinolones. If symptoms do not completely disappear after 10 days, administer isoniazid (INH) * for 3 months.

In the case of antituberculous treatment, treatment with BCG-medac must be permanently discontinued.

3) Concurrent bacterial infection of the urinary tract

Postpone BCG-medac treatment until a negative urine culture is obtained and until the end of antibiotic therapy.

4) Other genitourinary side effects: symptomatic granulomatous prostatitis, epididymitis and orchitis, urethral obstruction and renal abscess

Stop BCG-medac treatment.

Administer isoniazid (INH) * and rifampicin * for 3 to 6 months depending on the severity of the symptoms.

In the case of antituberculous treatment, treatment with BCG-medac must be permanently discontinued.

5) Fever less than 38.5 ° C for less than 48 hours

Symptomatic treatment with paracetamol.

6) Rash, arthralgia or arthritis or Fiessinger-Leroy-Reiter syndrome.

Stop BCG- medac treatment .

Administer an antihistamine or nonsteroidal anti-inflammatory drugs.

If no response, administer isoniazid * for 3 months.

In the case of antituberculous treatment, treatment with BCG-medac must be permanently discontinued.

7) Infection / Systemic BCG reaction ** without signs of septic shock

** see definition of infection / systemic BCG reaction

Permanently abort treatment with BCG-medac.

Schedule a consultation with an infectious disease specialist.

Give triple antituberculous therapy * for 6 months.

8) Infection / Systemic BCG reaction with signs of septic shock

Permanently abort treatment with BCG-medac.

Immediately administer triple antituberculous therapy * with fast-acting high-dose corticosteroids.

Seek advice from an infectious disease specialist.

* Caution: BCG bacteria are sensitive to all currently used anti-TB drugs except pyrazinamide. If triple anti-tuberculosis therapy is needed, the normally recommended combination is isoniazid (INH), rifampicin and ethambutol.

** See the definition of an infection / systemic BCG reaction.

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