PROPES

INSTRUCTION
for medical use of medicinal product

PROPOS®
(PROPESUM)

Composition:

active substance: 1 ml of solution contains not less than 5 mg of propes (regulatory peptides derived from bovine embryonic tissue);

excipients: sodium chloride, water for injections, chinosis.

Pharmaceutical form. Solution for injection.

Main physico-chemical properties: clear light-brown liquid.

Pharmacotherapeutic group.

Antineoplastic agents. ATC code L01X.

Pharmacological properties.

Pharmacodynamics.

Propes® has antitumor activity. The medicinal product exhibits pronounced antitoxic effects, improves liver function, suppresses development of tumor processes, promotes tumor regression through their resorption. The drug stimulates functional activity of mononuclear phagocytes and natural killer cells, thus activating nonspecific immune responses of the body. It inhibits production of pro-inflammatory cytokines in allergic diseases.

Clinical characteristics.

Indications.

In complex therapy of malignant neoplasms (lung cancer, kidney cancer, liver cancer, esophageal cancer, rectal cancer, duodenal cancer, small and large intestine cancer, soft tissue and bone sarcomas, melanomas), and also indicated for treatment of diseases associated with immunological status disorders.

Contraindications.

Increased individual sensitivity to any component of the drug.

Interaction with other medicinal products and other types of interactions.

No interactions have been observed.

Special precautions.

Use with caution in patients with a history of allergies.

This medicinal product contains less than 1 mmol (23 mg)/dose of sodium, i.e. practically sodium-free.

Use during pregnancy or breastfeeding.

Due to lack of studies on toxic effects on human reproductive function, Propes® is contraindicated in women during pregnancy or breastfeeding.

Ability to influence reaction rate when driving or operating machinery.

Clinical trials did not reveal any effect of Propes® on the ability to drive or operate machinery.

Method of administration and dosage.

The drug is administered intramuscularly to adults. In case of surgical treatment of malignant neoplasms, patients should be given 2 ml twice daily for 5 days before surgery and 2 ml once daily for 10 days after surgery. For conservative treatment, the drug is used in two dosage regimens (I, II):

I – 2 ml once daily for 10 days during combined chemotherapy and during subsequent courses;

II – in long-term radical radiotherapy of patients with systemic tumor diseases or palliative irradiation of bone metastases – administer identically to the regimen used in surgical treatment; in this case, the drug may be administered up to 20 ml per day for 3 days.

For treatment of diseases associated with immunological status disorders, the drug is administered 2 ml once daily for 10 days, or 2 ml every other day for 20 days.

Children.

Experience in use in children is lacking; therefore, the drug should not be used in pediatric practice.

Overdose.

No cases of overdose have been observed.

Adverse reactions.

During medical use to date, no adverse reactions have been identified; however, individual intolerance to the drug is possible. Allergic reactions may occur in individuals with increased hypersensitivity.

Shelf life.

2 years.

Storage conditions.

Store in original packaging at a temperature from +2°C to +8°C, in a place inaccessible to children. Do not freeze!

Incompatibility.

Do not mix in the same syringe with other medicinal products.

Packaging.

2 ml in an ampoule, 5 or 10 ampoules per cardboard box with polymer blister insert.

Prescription status.

By prescription only.

Manufacturer.

LLC "NIR".

Manufacturer's address and place of business.

50 Kharkivske Shose, Kyiv, 02155, Ukraine.