powder and liquid for intravesical suspension 
(Bacillus Calmette-Guérin)

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What BCG-medac is and what it is used for 
2. What you need to know before you use BCG-medac 
3. How to use BCG-medac 
4. Possible side effects 
5. How BCG-medac must be stored 
6. Package contents and other information

1. What BCG medac is and what it is used for

The complete name of this medicine is BCG ‑ medac, powder, and liquid for intravesical suspension. Hereinafter referred to as BCG ‑ medac in this leaflet.

BCG medac contains attenuated (attenuated) Mycobacterium Bovis bacteria with little potential for infection.

BCG-medac stimulates the immune system and is used to treat several types of bladder cancer. It is effective if the cancer is confined to the cells that make up the lining of the bladder (urothelium) and has not invaded the bladder’s internal tissue.

BCG-medac is given directly into the bladder by instillation (treatment with a fluid in a limited area).

For the form of bladder cancer with a flat tumor (cancer in situ ), BCG-medac is used to treat a disease that is limited to the inner lining of the bladder. There are different degrees of cancer that can affect the inner lining of the bladder and the cell layers closest to the lining (lamina propria).

BCG-medac is also used to prevent cancer from returning ( prophylactic treatment).

BCG contained in BCG medac may also be approved for the treatment of other diseases not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions and always follow their instructions.

2. What you need to know before using BCG medac

Do not use BCG-medac

  • if you are allergic to live BCG‑ bacteria (Bacillus Calmette ‑ Guérin) or any of the other ingredients of this medicine (listed in section 6).
  • if the activity of your immune system is impaired or if you suffer from immunodeficiency, whether it is due to a concomitant disease (eg positive HIVologi serology, leukemia, or lymphoma ), cancer therapy (eg chemotherapy, radiation), or immunosuppressive ( immunosuppressive) treatment (eg corticosteroids ).
  • if you suffer from active tuberculosis.
  • if your bladder or nearby areas have previously been treated with radiation.
  • if you are breast-feeding.
  • if you have undergone urethral surgery (TUR, transurethral resection ), sampling of the bladder tissue (bladder biopsy), or if you have been injured when inserting the catheter (traumatic catheterization) during the previous 2-3 weeks.
  • if you have a hole in your bladder.
  • if you have visible blood in the urine (macrohematuria).
  • If you suffer from an acute infection of the urinary tract.

BCG-medac must not be given under the skin or into the skin, in a muscle or vein, or for vaccination. It must be given directly into the bladder by instillation.

Warnings and cautions

Your doctor will give you a patient card, which you should always have with you (see also section 4).

Talk to your doctor or pharmacist before using BCG  medac

  • if you have a fever or blood in your urine. In this case, treatment with BCG ‑ medac should be postponed.
  • if you have a low bladder capacity as it may decrease even more after treatment.
  • if you are HLA ‑ B27 ‑ positive (human leukocyte antigen B27) as you may have an increased incidence of inflammation in the joints (reaction arthritis).
  • if you have arthritis with inflammation of the skin, eyes, and urinary tract (Reiter’s syndrome).
  • if you have a limited dilation of a blood vessel ( aneurysm ) or prosthesis. You can get an infection in the implant or graft.
  • if you have liver problems or are taking medicines that may affect your liver. This is especially important if treatment with three antibiotics and so-called antituberculous drugs is being considered.

General hygiene

After installation , sit down on the toilet seat before urinating so as not to spread the urine and to prevent contamination of the toilet seat and the toilet with BCG bacteria.

We recommend that you wash your hands and genitals after urinating. This is especially true during the first urination after BCG treatment. If damaged skin becomes contaminated, use a suitable disinfectant (ask a doctor or pharmacist).

Discovered by Bacillus Calmette ‑ Guérin

It is generally difficult to detect BCG bacteria. A negative test result does not rule out an infection with BCG outside the bladder.

Urinary tract infection

Your doctor must determine that you do not have an acute urinary tract infection before each bladder treatment with BCG. If an acute urinary tract infection is diagnosed during treatment with BCG, treatment should be discontinued until the urine test is normal and antibiotic treatment is completed.

Patients who have contact with people with weakened immune systems

If you are being treated with BCG ‑ medac, you must follow the general hygiene advice given above. This is extremely important when in contact with people with weakened immune systems as BCG bacteria can be harmful to patients with a weak immune system. However, a transmission of the bacterium between humans has not yet been reported.

Sexual transmission

You should use condoms during intercourse for one week after BCG treatment to be sure that no sexual transmission of BCG bacteria takes place.

Other medicines and BCG ‑ medac

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

This is especially important with the following medicines, as BCG bacteria are sensitive to

  • drugs against tuberculosis (eg ethambutol, streptomycin, β-aminosalicylic acid (PAS), isoniazid (INH) and rifampicin)
  • antibiotics (fluoroquinolones, doxycycline, or gentamicin)
  • bactericidal
  • Lube.

BCG bacteria are resistant to pyrazinamide and cycloserine.

Pregnancy, breastfeeding, and fertility

Pregnancy

Do not use BCG-medac if you are pregnant or think you may be pregnant.

Breast-feeding

Do not take BCG-medac while breast-feeding.

Fertility

BCG has been shown to have a negative effect on the production of sperm and can lead to low concentrations or lack of sperm in the semen. This effect was reversible in animals. However, men should seek advice on the possibility of preserving sperm before starting treatment.

Driving and using machines

This medicine may affect your ability to drive or use machines. Do not drive or use machines until you know what effect BCG ‑ medac has on you.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance.

If you are not sure, talk to your doctor, nurse, or pharmacist.

3. How to use BCG ‑ medac

Dosage

BCG ‑ medac is prepared and given only by trained health care professionals. The contents of one vial are sufficient for blister treatment.

Administration

The BCG medac is inserted into the bladder at low pressure using a catheter.

If possible, the medicine should remain in the bladder for two hours. To allow for this, do not drink anything for four hours before treatment and two hours after treatment.

While suspension one remains in the bladder, it must come into adequate contact with the entire surface of the mucosa. By moving, you facilitate the treatment. After two hours, empty the bladder, in a sitting position, to avoid spillage.

Unless you are on treatment with limited fluid intake, you should drink plenty for 48 hours after each treatment.

Use for children

The safety and efficacy of BCG Medac in children have not been established.

Use for the elderly

There are no specific instructions for use in the elderly, but liver function should be considered before administering BCG.

Length of treatment

As a standard treatment regimen (induction therapy), you will receive an intravesical(bladder delivery) treatment with BCG-medac per week for six consecutive weeks. After a period of four weeks without treatment, you may receive additional intravesical administration called maintenance treatment for at least one year as described below. Your doctor will talk to you about this.

Induction treatment

  • BCG treatment should be started approximately 2–3 weeks after urethral surgery (TUR, transurethral resection ) or bladder tissue sampling (bladder biopsy) and without damage occurring when a catheter is inserted (traumatic catheterization). This is repeated at one-week intervals for six weeks.
  • After this, many people receive maintenance treatment. This means that you can get more doses.

Maintenance treatment

  • Maintenance treatment consists of three treatments at one-week intervals for at least 1 year up to 3 years during months 3, 6, 12, 18, 24, 30, and 36. With this schedule, you receive a total of 15 to 27 treatments for 1 to 3 years.

If necessary, your doctor will discuss the need for maintenance treatment with you every 6 months after the first year of treatment.

Although maintenance treatment reduces the risk of cancer returning and may slow its progression, the side effects and discomfort of treatment may outweigh the benefits for some patients. It is therefore important that you and the doctor discuss the disadvantages of the treatment and your own wishes before starting or continuing the treatment.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects of BCG treatment are common but generally mild and temporary. Side effects usually increase with the number of BCG treatments.

The most serious side effect is a severe systemic infection. Tell your doctor immediately if you get the following symptoms, which can occur at any time and sometimes be delayed, and may develop weeks, months, or even years after your last dose.

Show your patient card to the attending physician.

  • Fever above 39.5 ° C for at least 12 hours or fever above 38 ° C for several weeks, night sweats
  • Weight loss of unknown origin
  • The increasing feeling of illness
  • Signs of inflammation can be different and show up as
    • difficulty breathing or coughing that does not feel like a common cold (miliary pneumonia )
    • liver problems: a feeling of pressure in the right upper abdomen, or abnormal liver function tests (especially an enzyme called alkaline phosphatase), or
    • pain and redness in the eyes, vision problems or blurred vision, eye inflammation (“pink eye”)
  • A so-called granulomatous inflammation that can show up in a biopsy

Systemic BCG infection / reaction

If the bladder is accidentally damaged during treatment with BCG medac or if BCG medac is given into a muscle or vein, this can lead to a severe general BCG‑ infection. Severe systemic BCG‑ infection may lead to BCG‑ sepsis. BCG sepsis is a life-threatening condition. Talk to a doctor immediately if you get a symptom or sign that worries you or contact an infection doctor! However, infection one is not virulent (pathogenic). Your doctor will prescribe medication for your side effects and BCG treatment may be discontinued.

In contrast to a BCG infection, the BCG response often manifests as low-grade fever, flu-like symptoms, and general discomfort for 24-48 hours as the onset of an immune response. Your doctor may prescribe certain medicines to treat your symptoms. Talk to your doctor if symptoms worsen.

Delayed BCG‑ infection

In some cases, BCG bacteria can remain in the body for several years. This infection can appear at any time and sometimes symptoms and signs of an infection may appear later, even years after the last dose of one of the BCG medac has been administered. Signs of inflammation may be similar to those of severe BCG infection/reaction mentioned above. Problems with implants or grafts can also be a side effect of BCG treatment and require urgent treatment.

Thus, it is very important that you have your patient card with you and show it to all doctors who treat you to ensure an appropriate treatment in the event of a delayed BCG‑ infection. Your doctor will also be able to assess whether the symptoms are a side effect of your BCG treatment or not.

The following is a complete list of side effects that may occur:

Very common:  may affect more than 1 user in 10

  • Nausea
  • Cystitis ( cystitis ), inflammatory responses (granuloma) in the bladder. These side effects can be a significant part of antitumor activity.
  • Frequent urination with discomfort and pain. This can occur in up to 90% of patients.
  • Inflammatory reactions in the prostate gland ( asymptomatic granulomatous prostatitis )
  • Temporary systemic BCG reactions such as fever below 38.5 ° C, flu-like symptoms(malaise, fever, chills), and general discomfort

Common: may affect up to 1 in 10 users

  • Fever higher than 38.5 ° C
  • Muscle pain ( myalgia )
  • Diarrhea

Uncommon: may affect up to 1 in 100 people

  • Severe systemic BCG reaction/infection, BCG blood poisoning (see below for details)
  • Lack of cells in the blood (cytopenia)
  • Anemia ( anemia, decreased hemoglobin in the blood)
  • Reiter’s syndrome ( arthritis with inflammation of the skin, eyes, and urinary tract)
  • Inflammation of the lungs (miliary pneumonitis )
  • Inflammatory reactions in the lung (pulmonary granuloma)
  • Inflammation of the liver ( hepatitis )
  • Skin rash
  • Skin rash, arthritis ( arthritis ), joint pain ( arthralgia ). In most cases, these side effects are a sign of an allergic reaction (hypersensitivity) to BCG. In some cases, it may be necessary to discontinue treatment.
  • Urinary tract infection, presence of blood in the urine ( microscopic hematuria )
  • Abnormally small bladder (bladder retraction), abnormally low urine flow (urinary obstruction), bladder contraction (bladder contracture)
  • Inflammation of the testicles (orchid)
  • Inflammation of the epididymis (epididymitis)
  • Inflammatory reaction in the prostate gland ( symptomatic granulomatous prostatitis )
  • Low blood pressure ( hypotension )

Rare:  may affect up to 1 in 1,000 users

  • Vascular infection (eg infected limited dilation of a blood vessel)
  • Kidney fever

Very rare: may affect up to 1 in 10,000 people

  • BCG‑ infection of implants and surrounding tissue (eg infection of aortic graft, cardiac defibrillator, hip or knee joint prosthesis)
  • Inflammation of the lymph nodes in the throat (cervical lymphadenitis), regional lymph node infection
  • Allergic reaction (hypersensitivity) (eg eyelid edema, cough)
  • Inflammation of the interior of the eye (chorioretinitis)
  • Conjunctivitis (red and infected eye), uveitis ( inflammation of the grape membrane of the eye)
  • Vascular fistula (an abnormal connection between blood vessels)
  • Vomiting, intestinal fistula (an abnormal connection between the intestine and nearby organs or skin), peritonitis ( peritonitis )
  • Bacterial infection of bone and bone marrow (osteomyelitis)
  • Bone marrow infection
  • Psoas abscess ( abscess in the lumbar muscle)
  • Inflammation of the testes (orchid) or epididymis (epididymitis) resistant to (insensitive to) tuberculosis treatment
  • Infection of the glans

Has been reported: occurs in an unknown number of users

  • Genital disorders (eg vaginal pain)
  • Pain during intercourse (dyspareunia)
  • Severe immunological reaction with fever, enlarged liver, enlarged spleen and enlarged lymph nodes, jaundice, and rash (haemophagocytic syndrome)
  • Renal failure, inflammation of renal tissue, renal calcification and pelvis ( pyelonephritis, nephritis [including tubulointerstitial nephritis, interstitial nephritis, and glomerulonephritis])
  • Absence of or a small number of sperm in the semen ( azoospermia, oligospermia)

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. Postal address

5. How to store BCG medac

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and carton after EXP.

Store in a refrigerator (2-8 ° C).

Do not freeze.

Store in the original package. Sensitive to light.

After reconstitution, the product should be used immediately.

6. Contents of the packaging and other information

Content declaration

The active substance is live BCG bacteria (Bacillus Calmette ‑ Guérin) (strain RIVM derived from strain 1173 ‑ P2).

After reconstitution, a vial contains:

BCG ‑ strain RIVM derived from strain 1173 ‑ P2 2 x 10 8 to 3 x 10 9 living units

The other ingredients in the powder are: polygeline, anhydrous glucose, and polysorbate 80.

The other ingredients in the liquid are: sodium chloride and water for injections.

What the medicine looks like and the contents of the pack

BCG ‑ medac consists of a white powder and a colorless, clear solution used as a liquid. There are packs of 1, 3, 5, or 6 vials. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

medac

Society for

clinical specialties mbH

Theaterstr. 6

22880 Wedel

Germany

Muhammad Nadeem

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