Intestiphage® bacteriophage polyvalent

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT INTESTIFAG® POLIVALENT BACTERIOPHAGE

Composition:

Active substance: 1 ml of the preparation contains specific bacteriophages at a concentration of not less than 1×10⁵ phage particles against the following microorganisms: Shigella flexneri, Shigella sonnei, Salmonella enterica, Escherichia coli, Proteus vulgaris, Proteus mirabilis, Enterococcus faecalis, Staphylococcus aureus, Pseudomonas aeruginosa;

Excipients: sodium chloride; magnesium chloride hexahydrate; sodium hydroxide; diluted hydrochloric acid; water for injections.

Medicinal form. Solution.

Main physicochemical properties: clear liquid, a yellowish tint is permissible.

Pharmacotherapeutic group. Antibacterial agents. Other antibacterial agents.

ATC code J01XX.

Immunobiological and biological properties.

The preparation has the ability to specifically lyse the following bacteria: Shigella flexneri, Shigella sonnei, Salmonella enterica, Escherichia coli, Proteus vulgaris, Proteus mirabilis, Enterococcus faecalis, Staphylococcus aureus, Pseudomonas aeruginosa. Bacteriophages specifically infect bacterial cells, multiply inside the bacterial cell, and destroy it via lysis. The antibacterial effect of the preparation is due to the specific lysis of pathogenic bacteria, while the preparation does not disturb the normal microflora. Under the influence of bacteriophages, phagocytosis is activated, neutrophil activity and their metabolic activity increase, which prevents the recurrence of infectious disease and chronic inflammation. The number of leukocytes and neutrophils decreases, while the level of lymphocytes increases, primarily due to T-lymphocytes. Bacteriophages rapidly penetrate into the blood and lymph and are excreted by the kidneys with urine.

Clinical characteristics.

Indications.

Treatment and prevention of the following diseases:

• shigellosis;
• salmonellosis;
• dysbiosis;
• infectious enterocolitis, colitis of mixed etiology.

Contraindications.

Hypersensitivity to the components of the drug.

Special precautions.

An essential condition for effective phage therapy is prior determination of the phage sensitivity of the causative agent of the disease. The drug should be administered as early as possible. The drug must not be used if it becomes turbid.

Interaction with other medicinal products and other forms of interaction.

The drug may be used in combination with other antibacterial agents, as well as monotherapy—in cases of patient intolerance to antibiotic therapy or resistance of pathogen strains to antibiotics.

Instructions for use.

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

Use during pregnancy or breastfeeding.

Safety and efficacy have not been established; therefore, use is contraindicated.

Ability to affect reaction speed when driving or operating machinery.

The use of this medicinal product does not affect reaction speed when driving or operating machinery.

Dosage and Administration.

The drug is intended for oral use.

For therapeutic purposes, bacteriophage is taken orally 4 times a day, 1 hour before meals. The treatment duration is 7–10 days. The recommended dosage for oral administration is specified in Table 1.

Table 1

When dosing the drug, the recommendations of the medical instructions should be followed. The required amount of the medicinal product should be drawn from the vial using a sterile syringe. When using low doses of the drug, the dropper cap may be used, assuming that one milliliter of the drug contains 20 drops of bacteriophage solution.

Rectal administration of bacteriophage once daily as enemas after bowel evacuation is possible instead of one oral dose.

The recommended dosage regimen for rectal administration is specified in Table 2.

Table 2

For prophylactic purposes, the optimal regimen is daily oral administration of a single age-appropriate dose. The duration of use is determined by the epidemiological situation.

Children.

The drug is intended for use in children aged 2 months and older.

Overdose.

Cases of overdose have not been reported.

Adverse reactions.

Cases of adverse reactions have not been reported.

Shelf life.

3 years.

Storage conditions.

Store at a temperature from 2 to 8 °C in the original packaging. After the first opening of the vial, the product can be stored for no more than 10 days at a temperature from 2 to 8 °C. Transportation is permitted at a temperature not exceeding 25 °C for up to 30 days; thereafter, the medicinal product must be stored at a temperature from 2 to 8 °C.

Packaging.

Solution in 10 ml vials, 4 vials per cardboard pack with dropper caps or without dropper caps; 20 ml vials, 4 vials per cardboard pack; 50 ml vials, 1 vial per cardboard pack.

Prescription status.

By prescription only.

Manufacturer.

LLC "FARMEKS GROUP", Ukraine, for NEO PROBIO CARE INC., Canada.

Location of manufacturer and its address of business activity.

100, Shevchenka Street, city of Boryspil, Kyiv region, 08301, Ukraine

or٭

Manufacturer.

LIMITED LIABILITY COMPANY "NEOPROBIOCARE-UKRAINE".

Location of manufacturer and address of its business activity.

154 Akademika Zabolotnoho Street, Kyiv, 03143, Ukraine

or٭

Manufacturer.

Private Joint-Stock Company "Infuziya", Ukraine, for NEO PROBIO CARE INC., Canada.

Location of manufacturer and its address of business activity.

84A Nemirovskе Highway, Vinnytski Khutory village, Vinnytsia district, Vinnytsia region, 23219, Ukraine.

٭ The instruction leaflet inside the cardboard pack will indicate only one manufacturer (the one responsible for the batch production).

Marketing Authorization Holder.

NEO PROBIO CARE INC., Canada.

Address of Marketing Authorization Holder.

599 Suncherry Drive, Burlington, Ontario, L7T 4L7, Canada