Posterisan

INSTRUCTIONS
for medical use of medicinal product

POSTERIZAN

Composition:

active substance: 1 suppository contains 387.10 mg of standardized bacterial culture suspension (containing 6.6 × 10⁸ E. coli, killed and preserved in 6.6 mg of liquid phenol);

excipients: hard fat, polyoxylated hydrogenated castor oil.

Pharmaceutical form. Suppositories.

Basic physicochemical properties: homogeneous suppositories from white to beige in color with a characteristic phenol odor.

Pharmacotherapeutic group.

Agents for the treatment of hemorrhoids and anal fissures for local use.

ATC Code C05AX.

Pharmacological properties.

Pharmacodynamics.

The active substance of the medicinal product is a standardized bacterial culture suspension (SBC) obtained from E. coli.

For SBC production, bacteria are inactivated with phenol. The aqueous suspension is then processed into a galenical form. Thus, the final product contains intact cells, cellular degradation products, and metabolites, but no live bacteria.

After rectal administration (in rats and dwarf pigs), SBC is rapidly absorbed through the intestinal mucosa. When applied to the skin and mucous membranes, SBC stimulates both non-specific and specific immune mechanisms. In vitro tests and animal models have shown that SBC induces proliferation of T-lymphocytes and production of immunoglobulins (IgA and IgG). This triggers polyclonal stimulation of the immune response, enhances natural immune defense, and reduces tissue susceptibility to infections.

In in vitro models using human cell systems, lymphocyte proliferation is induced in an antigen-specific manner by Langerhans antigen-presenting cells. In vitro, SBC lyophilisates inhibit histamine release from mast cells and basophilic granulocytes, demonstrating anti-inflammatory properties. Induction of various cytokines in vitro suggests a potential role in tissue regeneration and thus supports wound healing.

Animal and human studies also demonstrate immunogenic effects on inflammatory skin changes and wound-healing activity. Swelling decreases more rapidly when therapy includes SBC.

Pharmacokinetics.

Studies on absorption, systemic presence, and excretion are not feasible following local application of SBC. However, penetration of immunogenic components of SBC has been demonstrated in immunohistochemical studies of the rectal mucosa in animals (rats and dwarf pigs).

Clinical characteristics.

Indications.

Local treatment of hemorrhoid symptoms.

Contraindications.

Increased sensitivity to the active substance or to any component of the drug.

Interaction with other medicinal products and other forms of interaction.

Unknown.

Special precautions.

In case of fungal infections, a topical antifungal medicinal product should be used simultaneously.

Posterezan contains macrogolglycerol hydroxystearate, a component of castor oil. May cause skin reactions.

Use during pregnancy or breastfeeding.

There are no contraindications for the use of the drug during pregnancy or breastfeeding.

Ability to affect reaction speed when driving or operating machinery.

Data not available.

Method of administration and dosage.

Hygienic procedures of the anal area should be performed before application.

Rectal use in adults: 1 suppository twice daily (in the morning and evening), preferably after defecation.

The duration of treatment is determined by the physician depending on the nature and course of the disease. Usually the treatment lasts 5–7 days.

Children.

Do not use in children.

Overdose.

No cases of overdose or intoxication have been reported. In case of accidental oral intake of suppositories (e.g., by children), gastrointestinal disturbances (abdominal pain, nausea) are possible.

Adverse reactions.

In individual cases, patients with increased sensitivity to the components of Posterezan suppositories may experience hypersensitivity reactions, including itching and burning.

May cause contact dermatitis (e.g., due to hypersensitivity to phenol).

Shelf life. 3 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C, in a dry, light-protected place, out of reach of children.

Packaging.

5 suppositories per strip.

2 strips per cardboard box.

Prescription status.

Over-the-counter.

Manufacturer.

Dr. Kade Pharmazeutische Fabrik GmbH.

Manufacturer's location and address of place of business.

Riethstraße 2, 12277 Berlin, Germany.