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Onko BCG 50

TRADE NAME OF THE MEDICINAL PRODUCT

Onko BCG® 50
(Vaccinum BCG)
Prątki BCG do immunoterapii (BCG bacilli for immunotherapy)

QUALITATIVE AND QUANTITATIVE COMPOSITION OF ACTIVE SUBSTANCES

1 ampoule of Onko BCG® 50 contains a freeze-dried suspension of live attenuated BCG bacilli -(Bacillus Calmette Guerin) of the Brazilian substrain Moreau in a 5% solution of sodium glutamate, dried in high-vacuum from the freeze-state. 1 ampoule contains 50 mg of BCG bacilli. 1 ampoule of Onko BCG® 50 contains at least 150 million live BCG particles.

PHARMACEUTICAL FORM

Powder and diluent for the preparation of suspension for administration into the bladder.

CLINICAL PARTICULARS

Indications

The preparation is applied in the treatment of superficial, non-invasive tumours of the urinary bladder (carcinoma urotheliale Ta, Tis, T1).

The preparation should not be used in invasive cancer of the bladder, because the chances of effective treatment are slender, and a suitable moment for introducing another method of treatment may be missed.

The preparation in the dose of 50 mg can be used in the case of recurrent side effects (dysunia, high temperature) or increased tuberculin reaction.

Posology and method of administration

One dose of Onko BCG® 50 equal to 1 intrabladder enema, is contained in 1 ampoule (50 mg) reconstituted in 1ml of isotonic solution of sodium chloride.

Add 1ml of the solvent (sterile isotonic solution of NaCl), using a 5 ml sterile syringe, to the ampoule containing the powder. Aspirate and withdraw the contents of the ampoule gently three times until a fine even suspension results (avoid shaking and foaming the suspension).Then aspirate the suspension from the ampoule to a sterile 50 ml syringe and add 49 ml of sterile isotonic solution of NaCl.

Empty the urine from the bladder with a catheter via the urethra to the bladder. Then administer via the catheter the whole dose (50ml) of the BCG suspension, and add 5ml of the sterile physiological solution of NaCl for the entire empting of the catheter of the BCG suspension. Lubricants used for the initiation of the catheter should not contain tuberculostatic substances.

Patient should not drink any liquids for 3-4 hours before and 2 hours after the administration of the preparation. After the administration of the Onko BCG preparation via catheter the catheter must be removed. The administered BCG suspension must remain in the bladder for 2 hours. During that period the patient should change body position every 15 minutes (on abdomen, back, on sides), and after 2 hours empty the bladder.

Administration into the bladder should be performed 14 days after receiving a biopsy specimen from the tumour or the mucous membrane of the bladder, or after transurethral resection of the tumour (TUR).

The intervention should be applied once a week, for 6 consecutive weeks, and then a maintenance treatment is recommended every 3 months once a week for 3 consecutive weeks.

In the case of recurrence of the tumour a 6 week treatment should be repeated.

Before the beginning of the treatment the patient should undergo an intracutaneous tuberculine test (TT, PPD) for the purpose of estimating the level of immunological reactivity of the individual.

After completing a 6 week treatment the intracutaneous tuberculine test should be repeated to estimate the influence of treatment with the BCG preparation on the general immunological reactivity of the individual. In some treated individuals this reactivity increases.

Contraindications

The intravesical administration of Onko BCG® 50 preparation should not be used in individuals:

  1. with primary or acquired deficiency of the immune system,
  2. undergoing immunosuppressive treatment or radiotherapy,
  3. who are pregnant or breast feeding,
  4. with active tuberculosis or other disease requiring treatment with tuberculostatic medications,
  5. with infections of the urinary system.

Special warnings and special precautions for use

The Onko BCG preparation contains live, attenuated bacilli Mycobacterium bovis, and for that reason after the end of intervention the equipment and materials (syringes, catheters etc.) should be destroyed in accordance with the regulations concerning waste material hazardous to health.

In the case of contamination of the body surface or objects with Onko BCG® 50, the contaminated area should be disinfected with a 70% solution of ethyl alcohol or a 2% solution of septil.

Sexual abstinence is recommended for a period of 48 hours from the administration of the preparation to the bladder.

The Onko BCG preparation must not be administered intravenously, intramuscularly or subcutaneously.

Interactions with other medicinal products and other forms of interactions

The preparation should not be used in individuals undergoing simultaneous treatment with cytostatics or steroids.

During BCG treatment the administration of antibiotics acting against bacilli and the administration of derivatives of acetylsalicylic acid and some antithrombotic medicines should be limited.

Pregnancy and lactation

Treatment with Onko BCG® 50 should not be used in pregnant or breast feeding women.

Effects on ability to drive and use machines

Does not apply.

Undesirable effects

Treatment of superficial bladder cancer with Onko BCG® 50 preparation in intravesical administration is well tolerated by most patients. However, both local and general adverse symptoms may occur.

The most frequent complication is symptoms of urocystitis (cystitis acuta), usually occurring after the second or third administration. Regress usually occurs after several hours. Apart from local reactions general reactions can develop, such as: dysphoria, short-time rise in body temperature (38°-39° C), chill, nausea, myalgia and arthralgia, diarrhoea, local pain in genital organs.

General reactions usually remain for 1-3 days.

Very seldom the above-mentioned symptoms result in the need to cease the treatment and administration of antimycobacterial medicines e.g. in individuals with severe septic symptoms and with gouty symptoms a 4 month schedule of treatment may be accepted for the treatment of tuberculosis of the urinary system, consisting of the administration of:

  1. every day for a period of 2 months three medications: 600 mg of rifampicin , 5 mg/ kg b.w. of isoniazid and 25 mg/ kg b.w. of ethambutol (or 1500 mg of pyrazinamid), and
  2. three times a week days for the following period of 2 months two medications: 600 mg of rifampicin and 10 mg/ kg b.w. isoniazid.

In individuals with tuberculin inflammation of the prostate or with remaining subfebrile states should be applied a 6 week treatment using two-way catheter administration of 600 mg rifampicin every day and 5 mg/kg b.w. of isoniazid.

In gouty symptoms it is sometimes necessary to include steroids.

Adverse results of the therapy, such as semi-tuberculosis inflammation of deeper layers of the bladder wall, prostatitis and/or epididymitis with the formation of foci of caseous necrosis are also well-known.

Foci of semi-tuberculosis granulation in the liver and lungs have also been observed.

All posterior adverse results of the intravesical administration of Onko BCG® 50 preparation usually regress after four months′ antimycobacterial chemotherapy.

In patients with the above-mentioned symptoms of general infection, treatment with Onko BCG® 50 preparation should be unconditionally stopped.

Overdose

When too large a dose of the medication is administered, or medication remains in the bladder longer than the recommended time, the bladder should be flushed several times with a sterile, physiological solution of NaCl. Remove the urine remaining in the bladder with a catheter (in individuals with urine retention), and in the case of occurring septic symptoms use a suitable treatment including tuberculostatics.

PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group in ATC code: L 03 AX

Pharmacodynamic and pharmacokinetic properties

BCG bacilli have found an application as a non-specific immunostimulating agent in the treatment of some types of neoplasm.

The intravesical administration of BCG is aimed at the destruction of a primary tumour, or delay or prevention of its future recurrence. The specific mechanism of BCG activity is not completely understood. It is assumed that the activity of the medication consists of stimulating the basic inflammatory process inside layers of the bladder and stimulation of the immune system, which defends the organism against disease development.

PHARMACEUTICAL PARTICULARS

Composition and list of excipients

  • 1 ampoule with powder contains:

50 mg of monosodium glutamate

  • 1 ampoule with diluent contains

1 ml of isotonic solution of sodium chloride

Incompatibilites

None

Shelf life

Shelf life of Onko BCG® 50 is 18 months. The preparation should be used immediately after dilution.

Special precautions for storage

Onko BCG® 50 should be stored at 2°C to 8°C. Protect from daylight.

Nature and composition of the immediate package

  • 1 ampoule with powder of 50 mg each + 1 ampoule with diluent of 1 ml
  • 5 ampoules with powder of 50 mg each + 5 ampoules with diluent of 1 ml
  • A thick-wall vacuum ampoule made of neutral glass with powder, and the ampoule made of neutral glass in a cardboard box.

Instructions for use and handling and disposal

A suspension of bacilli BCG for intravesical administration should be prepared directly before the intervention.

Actions related to the intervention should be performed in sterile conditions with the staff using sterile gloves, masks and headcoverings. In the case of contamination of the body surface or objects with the BCG suspension, the contaminated surface should be disinfected with a 70% solution of ethyl alcohol or a 2% solution of septil.

After the completed intervention used equipment and materials should be destroyed in accordance with the regulations concerning waste material hazardous to health.