Innovative products and services

Характеристики

Description:

 White with a yellow tint or yellow wipes of knitted fabric.

Composition:

Active substance – Cisplatin (1±0.15 mg in 1 сm2 of the wipe). 

Oxidized cellulose

Release form:

The wipes:

• 1.5 х 1.5 сm in package № 10 or № 20
• 3.0 х 5.0 сm in package № 5

Pharmacotherapeutic group: 

Alkylating agent

The medicine “Cisplacel” (absorbable wipes) provides a local cytostatic antitumor effect and is intended for implantation in the bed of a removed supratentorial neuroepithelial or metastatic brain tumor, in postoperative cavities and/or soft tissues at the site of removal of malignant tumors of the spine and paravertebral soft tissues, as well as in soft tissues and cavities at the site of a removed tumor of the head and neck organs (upper jaw resection, orbit tumors, cervical lymphadenectomy, removal of soft tissue tumors, etc.).

ATC index:

L01AX

Pharmacological action:

The pharmacological effect of the medicine is because of the cytostatic effect of cisplatin immobilized on oxidized cellulose (pharmacological group of alkylating agents) which bifunctionally alkylates DNA strands, suppresses the biosynthesis of nucleic acids, causes cell death. Cisplatin is not specific to the cell cycle, it acts in the G0 phase. Two-stage turns into an active form. At the first stage, it inhibits the synthesis of DNA, RNA and protein, and at the second stage, it forms metabolic products that act only on DNA synthesis. Platinum complexes with a cis-arrangement of halogen atoms can form stable chelates with purine and pyrimidine components of the nucleic acid molecule and thus form bonds within a single strand or parallel strands of the DNA double helix. Blocking of DNA strands persists for several days after cisplatin administration.

Indications and usage:

"Cisplacel" is used for local chemotherapy after complete or partial removal of supratentorial neuroepithelial brain tumors, regardless of their malignancy, for local chemotherapy after removal of malignant neoplasms of the cervical, thoracic, lumbar, sacral spine and paravertebral soft tissues, brain metastases, as well as after removal of malignant neoplasms of the head and neck (upper jaw resection, orbit tumors, cervical lymphadenectomy, removal of soft tissue tumors, etc.).

Dosage and administration:

The medicine “Cisplacel” is intended only for local implantation use:

• during operations on the brain after partial or complete removal of the supratentorial tumor, its bed is tiled with 20 “Cisplacel” wipes so that all the walls of the wound are completely covered with the drug. The napkins are impregnated with a sucre separated from the walls of the brain wound and stick to it, initially contributing to implementing the final hemostasis. The optimal effective dose of the drug is 45 mg (20 napkins measuring 1.5 (± 0.1) x 1.5 (± 0.1) cm № 20). It may reduce the dose with a small surface area of the brain wound. If the specified surface area of the napkins does not cover the wound, the drug is placed in the places of the most likely localization of the residual tumor (on the vessels, the area of the “leg” of the tumor, etc.);
• when removing malignant neoplasms of the head and neck on the walls of the postoperative cavity or on soft tissues, in the place of an insufficiently radically removed tumor, “Cisplacel” wipes are stacked one on top of the other or tiled, in the required amount, so that the total dose is 60-80 mg, the wound is sutured tightly.
• when removing malignant tumors of the spine and paravertebral soft tissues on the walls of the postoperative cavity and/or on soft tissues, in the place of an insufficiently radically removed tumor, “Cisplacel” wipes are stacked one on top of the other or tiled, in the required amount, so that the total dose of cisplatin is 45-80 mg. It may reduce the dose with a small surface area of the walls of the postoperative cavity. It is necessary to avoid the application of the medicine “Cisplacel” on the thinned dura mater, as well as in the suture area of the dura mater. If the specified surface area of the napkins does not cover the wound, the medicine is placed in the places of the most likely localization of the residual tumor.

Adverse reaction: 

During clinical trials, no adverse reactions and complications were registered, no toxic effects of the medicine on remote areas of the central nervous system were noted. However, because the composition of the medicine contains cisplatin, the possibility of allergic reactions is not excluded.

Overdose:

Considering the dosage form of the medicine and implantation use, an overdose of the medicine is excluded.

Contraindications:

• pregnancy (for women of childbearing age, a urinary pregnancy test is performed);
• individual intolerance to the medicine (in the severe course of the early postoperative period with the development of toxic aseptic meningitis, it may be necessary to remove napkins from the brain wound);
• the presence of a polyvalent allergy;
• intraoperative complications requiring time reduction or termination of surgical manipulations.

Drug interactions

When applied topically, the interaction with other drugs is insignificant. It is compatible in combination with other anticancer drugs.

Storage:

At the temperature from 5 ° C to 15 ° C. Keep out of the reach of children.

Shelf life:

2.5 years. Do not use it after the expiration date.

Package:

10 or 20 wipes of 1.5x1.5 cm in size or 5 napkins of 3.0x5.0 cm in size are placed in a plastic or transparent polymer film bag which is placed in a metalized film bag. The package made of metalized film, together with the instructions, is placed in a pack of cardboard.

Release conditions:

On medical prescription.

Created by:

UE «UNITEHPROM BSU»

220045, Republic of Belarus,

Minsk, Kurchatov str. 1

Phone/fax: +375 (17) 272-09-26

e-mail: unitehprombgu@gmail.com