Typhoid bacteriophage (Tablets) Instructions for Use

Marketing Authorization Holder

Microgen NPO, JSC (Russia)

ATC Code

V03A (Other therapeutic agents)

Dosage Form

Bacteriophage typhoid

Enteric-coated tablets: 100, 200, 250, 400, 500, 800 or 1000 pcs.

Dosage Form, Packaging, and Composition

25 pcs. – bottles (4) – carton packs.
25 pcs. – bottles (10) – carton packs.
50 pcs. – bottles (4) – carton packs.
50 pcs. – bottles (10) – carton packs.
100 pcs. – bottles (4) – carton packs.
100 pcs. – bottles (10) – carton packs.
25 pcs. – jars (8) – carton packs.
50 pcs. – jars (8) – carton packs.
100 pcs. – jars (8) – carton packs.

Clinical-Pharmacological Group

Antibacterial drug

Pharmacotherapeutic Group

MIBP-bacteriophage

Indications

• For the treatment and prevention of diseases caused by Salmonella Typhi in adults and children.
• Treatment of typhoid fever and paratyphoid fever as part of complex therapy.
• For the purpose of bacterial carriage sanitation in individuals with a history of typhoid fever.
• Prevention of typhoid fever in individuals at increased risk of infection, including during epidemic outbreaks and in endemic regions.
• Use for intestinal dysbiosis associated with the presence of Salmonella Typhi susceptible to the bacteriophage, as directed by a physician.

Contraindications

• Hypersensitivity to any component of the drug. The drug is generally well-tolerated; however, individual intolerance to the auxiliary components of the tablet formulation is possible.
• There are no other absolute contraindications identified. The drug can be used in children from the neonatal period, pregnant women, and breastfeeding mothers, but strictly under medical supervision after a careful assessment of the benefit-risk ratio.

Dosage Regimen

The dosage and duration of treatment are set individually by the attending physician, depending on the age of the patient, the severity of the condition, and the goals of therapy (treatment or prevention).

For the treatment of typhoid fever and paratyphoid fever, the drug is usually prescribed 3 times a day, 1-2 hours before meals. The course of treatment is 7-10 days, but can be extended according to clinical indications. For children under 6 years of age, the dosage is determined by the doctor based on body weight and clinical picture.

For the sanitation of bacteria carriers and for preventive purposes, the drug is taken on an empty stomach 2-3 times a day for 5-7 days. The specific regimen and the need for repeated courses are determined by the physician. The tablets must be swallowed whole, without chewing, with a sufficient amount of water.

Adverse Reactions

Adverse reactions when using Typhoid bacteriophage are extremely rare due to the high specificity of the drug’s action.

In isolated cases, in patients with individual hypersensitivity to the excipients of the drug, mild allergic reactions (such as skin rash, urticaria) may occur. These reactions are usually transient and resolve quickly after discontinuation of the drug.

No other systemic adverse reactions have been reported. The safety profile of bacteriophages is one of their key advantages, allowing their use in vulnerable patient groups.

Drug Interactions

No clinically significant interactions of Typhoid bacteriophage with other drugs have been established.

The drug can be used in combination with antibiotics, including in the treatment of severe forms of typhoid fever. In some cases, a combined approach enhances the therapeutic effect and reduces the risk of developing bacterial resistance.

It is recommended to inform your doctor about all medications you are taking, including over-the-counter drugs and dietary supplements. The simultaneous use of enterosorbents, antacids and drugs containing alcohol may reduce the titer of active bacteriophages; therefore, it is recommended to maintain an interval of 1-2 hours between taking Typhoid bacteriophage and these drugs.

Overdose

Cases of overdose with Typhoid bacteriophage have not been described in medical literature. Given the mechanism of action and high specificity, the risk of acute toxic effects in case of accidental or intentional excess of the recommended dose is assessed as negligible.

In case of taking a dose significantly higher than prescribed, it is recommended to consult a doctor for observation and symptomatic measures, although the development of any specific pathological conditions is not expected. The main recommendation is to strictly adhere to the dosage regimen prescribed by the doctor.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.