Instruction for use: Uro-BCG-medac

Dosage form: Lyophilizate for suspension preparation for intravesical administration

Active substance: Vaccinum BCG for immunotherape cancer of vesica urinaria

ATX

L03AX03 BCG vaccine

Pharmacological group:

Immunomodulating agent [Vaccines, serums, phages and toxoids]

The nosological classification (ICD-10)

C67 Malignant neoplasm of bladder: Metastatic bladder cancer; Tumor of the bladder; Bladder cancer; Bladder cancer superficial; Malignant tumor of the bladder; Malignant neoplasms of the bladder; Bladder carcinoma; Transitional cell carcinoma of the bladder; Tumors of the bladder

D09.0 Bladder: Bladder carcinoma

Composition

Lyophilizate for the preparation of a suspension for intravesical administration of 1 vial.

active substance: Viable BCG cells (Mycobacterium bovis, strain RIVM) 2 × 108-8 × 108

Auxiliary substances: poligelin - 250 mg; Glucose anhydrous - 1080 mg; Polysorbate-80 - 0.5 mg

Solvent - sodium chloride solution 0.9%

Pharmachologic effect

Mode action - immunomodulating.

Dosing and Administration

The drug is used in the form of instillations in the bladder.

For 3-11 days before the immunotherapy, the patient is given an intradermal Mantoux test with 2 TE purified tuberculin in standard dilution.

The sample is taken and the response is taken into account in accordance with the instructions for use of tuberculin. The Mantoux test is performed in a tuberculosis dispensary or a person who has a special certificate-admission. The use of the drug is permitted at a papule size of less than 17 mm in diameter.

For one intravesical instillation, the contents of 1 fl.

The drug should be used immediately after the preparation of the suspension. Instructions for preparing the suspension are given in the section "Instructions for use".

Duration of treatment

Treatment of pre-invasive bladder cancer. According to the standard therapy regimen, instillations of Uro-BCG medak are prescribed once a week for 6 consecutive weeks induction. BCG instillation should not be started earlier than 2-3 weeks after transurethral resection (TUR). Then, supportive therapy lasting at least 1 year is performed. The maintenance regimens are listed below.

Prevention of recurrence of bladder cancer. The induction course of BCG therapy should be started 2-3 weeks after transurethral resection (TUR) or bladder biopsy, in the absence of signs of traumatic catheterization, and continue once a week for 6 weeks. In the case of tumors of high and intermediate risk after an induction course, a course of maintenance therapy is necessary. The maintenance regimens are listed below.

Supportive therapy is carried out according to one of the following standard schemes:

- Scheme 1: Uro-BCG medak is used once a month for 12 months, the course begins 4 weeks after the last injection of the drug in the induction course;

- Scheme ¹2: the drug is applied 1 instillation per week for 3 weeks with a weekly interval at the 3rd, 6th, 12th, 18th, 24th, 30th and 36th months from the beginning Induction course of therapy. Under this scheme, taking into account the initial course of induction therapy, a total of 27 drug instillations are performed for 3 years.

The above supportive therapy regimens have been studied in numerous clinical trials involving a large number of patients using various BCG strains. At present, there is no reason to state that any of these schemes is superior to the other.

Application

The use of Uro-BCG medac should be carried out under the same conditions as those for intravesical endoscopy. The patient should not drink for 4 hours before the procedure and 2 hours after instillation. Before instillation of BCG, the bladder should be emptied.

Uro-BCG medak is injected into the bladder under low pressure using an elastic urethral catheter. The introduced suspension of Uro-BCG medak should remain in the bladder, if possible, within 2 hours. During this time, it is necessary to ensure sufficient contact of the suspension of the preparation with the entire mucosa of the bladder. For this, the patient needs to move as much as possible. Lezhachih patients must be turned from the back to the abdomen and vice versa every 15 minutes. 2 hours after instillation, the patient should empty the bladder, preferably in the sitting position.

If the patient has no contraindications, after each instillation for 48 hours it is recommended to perform hyperhydration.

For the treatment of the Uro-BCG medication of elderly patients, special instructions are not provided.

Instructions for use

Before use, the drug Uro-BCG Medak under aseptic conditions should be restored to the state of suspension.

1) in the case of using only a vial of lyophilizate in a cardboard bundle (without a closed system) - using 50 ml of 0.9% sodium chloride solution for injection;

2) in case of using the kit - the vial with the preparation, the solvent, the catheter adapter and the PE bag - using the supplied solvent - 0.9% sodium chloride solution for injection in a polymeric container with a connecting flange and Luer adapter.

The procedure for preparing the suspension and preparing the preparation for instillation

It is necessary to work in gloves.

The reconstituted suspension of the drug should be protected from the effects of daylight and used immediately after preparation. After dissolving the lyophilizate, the preparation should be a coarse-dispersed suspension of light gray color (dissolution time - no more than 3 minutes). Visible particulate matter of the drug does not affect its effectiveness and safety.

1. If only a vial of lyophilizate is used in a cardboard bundle (without a closed system), then any preparation of 0.9% sodium chloride solution for injection is used as a solvent to prepare a suspension of the drug for intravesical administration. Preparation of the suspension and its administration are performed in accordance with the rules of aseptic. Remove the protective plastic cover from the vial with lyophilizate. From the used solvent container with a suitable sterile syringe with a 0.8 mm internal diameter needle, 20 ml of solvent are removed, then puncturing the rubber stopper of the vial with the lyophilizate, slowly injecting the solution from the syringe into the vial. Gently shake the bottle until the lyophilizate is completely dissolved. After that, with the help of a sterile syringe with a needle with an internal diameter of 0.8 mm, transfer the contents of the vial into a sterile container, adjust the volume with 0.9% solution of sodium chloride for injections to 50 ml and mix. The resulting suspension of the drug is injected into the bladder with an elastic urethral catheter.

2. If a kit containing a lyophilisate vial is used, 50 ml of solvent (0.9% sodium chloride solution) in a polymer container with a connecting flange and Luer adapter, an adapter with a Luer adapter for catheter connection and a PE package for disposal of used materials, the order Action should be as follows:

- open the protective bag in which the container containing the solvent is packed, but do not remove the container completely! Thus, the Luer adapter (connector) of the instillation system until the last moment will be protected from contamination by foreign particles and infectious agents;

- break the protective mechanism in the tube of the adapter of the connecting flange, applying a bending force alternately in opposite directions, manipulating the tube, not the bottle. This will ensure the patency of the established connection;

- turn the system so that the bottle is on the bottom and, applying, if necessary, small compressive forces to the container with a solvent, ensure the penetration of the solvent into the bottle until it is filled approximately by half the volume. In this case, it is necessary to avoid excessive pressure on the container in order to avoid depressurization of the system. Do not try to fill the entire volume of the bottle with a solvent! Gently shaking the bottle, it is necessary to achieve complete dissolution of the lyophilizate;

- turn the combined system over so that the bottle is on top and allow the prepared BCG suspension to flow through the joint into the container with the solvent, periodically pressing lightly on the container to help the air fill the inside of the vial. Make sure that the suspension has completely flowed into the instillation system. Do not remove the vial. Keep the instillation system upright;

- completely remove the protective package. In the case of using the urethral catheter with the Luer connector, connect the Luer adapter (connector) of the instillation system with the Luhrer catheter connector. Break the closing mechanism in the tube (applying a bending force alternately in opposite directions), ensuring the patency of the established connection with the catheter, and instill the drug into the bladder. In the case of using a urethral catheter with a conical connector, use the adapter adapter for the catheter included in the kit. Connect the Luerov connector of the instillation system with the Luer connector of the adapter;

- connect the catheter adapter to the catheter. Break the closing mechanism in the tube of the container connector, ensuring the patency of the established connection with the urethral catheter, and instill the drug into the bladder. At the end of instillation, release the catheter from the remnants of the drug, compressing the solvent container, then remove the catheter from the bladder;

- after that place the instillation system with the catheter in the waste package. Disposal of waste and used materials is carried out in accordance with the rules for handling and disposing of infectious materials taken in a medical institution. Methods and treatment regimes for waste and materials must comply with the requirements of the existing sanitary norms and rules for the disinfection of mycobacteria.

Release form

1. Lyophilizate, containing from 2 × 108 to 8 × 108 viable BCG bacteria. In a glass vial with a capacity of 25 ml (type 1 EF). One bottle with lyophilizate in a cardboard bundle.

Set:

1. Lyophilizate containing 2 × 108 to 8 × 108 viable BCG bacteria. In a glass bottle with a capacity of 25 ml (type 1 EF). 1 bottle with lyophilizate in a cardboard package.

2. 50 ml solvent (sodium chloride solution 0.9%) in a polymer container with a connecting flange and Luer adapter, in a sealed transparent PE package.

3. Adapter with Loeer adapter for catheter connection in hermetically sealed PE / paper.

4. PE package for disposal of used materials.

1 pack containing 1 bottle with the preparation, 1 polymer container with a solvent, 1 adapter and 1 PE bag in a cardboard bundle.

Manufacturer

Manufacturer of ready-made dosage form: Bilthoven Biolodicals BV, Antoni Van Leuvenhoeklan 9-13, 3721 MA, Bilthoven, The Netherlands.

The manufacturer that carries out the secondary packaging and issues quality control: Medak GmbH on the production site of Theater Strasse 6, 22880 Wedel, Germany.

Representative of the manufacturer in the Russian Federation: OOO Tirufarm. 121087, Moscow

Conditions of supply of pharmacies

The drug is intended for use in medical and preventive institutions.

Storage conditions of the drug Uro-BCG-medac

In the dark place at a temperature of 2-8 ° C (do not freeze).

Keep out of the reach of children.

Shelf life of the drug Uro-BCG-medac

2 years.

Do not use after the expiry date printed on the package.