Sporobacterin (Suspension) Instructions for Use

Marketing Authorization Holder

Bakoren, LLC (Russia)

ATC Code

A07FA (Antidiarrheal microorganisms)

Active Substance

Bacillus subtilis (Grouping name)

Dosage Form

Sporobacterin

Oral suspension 1 billion CFU/1 ml: vials 1 dose 5 pcs. or 10 pcs., 2 doses 5 or 10 pcs., 5 doses 1, 2, 5 or 10 pcs., 10 doses 1 or 2 pcs.

Dosage Form, Packaging, and Composition

Oral suspension in the form of a white or slightly yellowish suspension with a specific odor and salty taste; upon settling, a loose sediment of various shades from white to light brown forms, which breaks up upon shaking.

Excipients: sodium chloride 70 mg/ml, purified water up to 1 ml.

1 dose – vials (5) – carton packs.
1 dose – vials (10) – carton packs.
10 doses – polymer dropper bottles (1) – carton packs.
10 doses – polymer dropper bottles (2) – carton packs.
2 doses – vials (5) – carton packs.
2 doses – vials (10) – carton packs.
5 doses – vials (5) – carton packs.
5 doses – vials (10) – carton packs.
5 doses – polymer dropper bottles (1) – carton packs.
5 doses – polymer dropper bottles (2) – carton packs.

Clinical-Pharmacological Group

Drug regulating the balance of intestinal microflora (probiotic)

Pharmacotherapeutic Group

MIBP-eubiotic

Pharmacological Action

Bacteria of Bacillus subtilis strain 534 secrete broad-spectrum antibacterial substances that suppress the development of a number of pathogenic and opportunistic bacteria. The growth of saprophytes, including normal intestinal microflora, is not suppressed by Sporobacterin.

The Bacillus subtilis strain 534 culture also produces other biologically active substances, such as proteolytic enzymes, lysozyme, lipases, amylases, and others, which promote the breakdown of carbohydrates, fats, and proteins, participating in the digestion and absorption of food. Furthermore, bacterial enzymes help cleanse wounds and inflammatory foci from necrotized tissues. The drug has a pronounced immunostimulating effect, including on the absorptive and digestive activity of phagocytic blood cells, and has a moderate anti-allergic effect.

Indications

Sporobacterin is used for the treatment of

• Acute bacterial intestinal infections, including acute dysentery, salmonellosis, etc.;
• Dysbacteriosis of various etiologies;
• Surgical infection of soft tissues;
• Osteomyelitis (in the absence of large sequestra);
• For the prevention and treatment of complications caused by pathogenic and opportunistic microorganisms during surgical and obstetric-gynecological operations.

Sporobacterin is prescribed for children over 6 months of age and adults.

ICD codes

Dosage Regimen

The prescribed dose of the drug is diluted 10-15 times with cooled boiled water. Sporobacterin is prescribed 30-40 minutes before meals.

for the treatment of gastrointestinal diseases

CHILDREN

• For the treatment of acute bacterial intestinal infections, including acute dysentery, salmonellosis: for children aged from 6 months to 3 years, prescribe orally 0.5 ml (8-10 drops) 2 times a day for 7-10 days; for children over 3 years old – 1 ml (17-20 drops) 2 times a day for 7-10 days;
• For the treatment of dysbacteriosis after past bacterial infections or antibiotic use: for children aged from 6 months to 3 years, prescribe orally 0.5 ml (8-10 drops) 2 times a day for 20 days, for children over 3 years old – 1 ml (17-20 drops) 2 times a day for 20 days. If a nursing mother has dysbacteriosis, she is recommended to take the drug 1 ml 2 times a day during the period of the child’s treatment.

ADULTS

• For the treatment of acute bacterial intestinal infections, including acute dysentery, salmonellosis: the drug is prescribed orally 1 ml (17-20 drops) 2 times a day for 7-10 days;
• For the treatment of dysbacteriosis after past bacterial infections or antibiotic use: the drug is prescribed orally 1 ml 2 times a day for 20 days.

in surgical practice

• For the treatment and prevention of surgical infection of soft tissues: the drug is prescribed orally 1 ml 2 times a day for 7-10 days;
• For the prevention of purulent-septic complications in the postoperative period: the drug is prescribed orally 5 ml once a day (at night) for 5 days before surgery and 5 ml once a day (at night) for 5 days after surgery or trauma.

If necessary, treatment courses can be repeated.

! An opened vial with the drug, closed with a cap, can be stored for no more than 10 days at a temperature from 4 to 8°C (46.4°F).

Adverse Reactions

In rare cases, adverse events such as chills, skin rash, abdominal pain, diarrhea may occur. When the dosage is reduced or the drug is discontinued, these phenomena are completely relieved within a day.

Contraindications

No contraindications for the use of Sporobacterin have been identified. The drug should be used with caution in case of drug allergy. The effect of the drug on pregnant women has not been studied.

Not suitable for use: a drug with compromised packaging integrity; a drug without labeling; a drug with altered physical properties and the presence of foreign impurities.

Use in Pregnancy and Lactation

The effect of the drug on pregnant women has not been studied.

Pediatric Use

Sporobacterin is prescribed for children over 6 months of age.

Special Precautions

Ability to influence driving vehicles and working with mechanisms. The use of the drug does not affect the ability to drive vehicles and work with mechanisms.

Drug Interactions

Concomitant use of antibiotics and sulfonamides may reduce the therapeutic efficacy of Sporobacterin.

Storage Conditions

The drug should be stored and transported in accordance with SP 3.3.2.1248-03 at a temperature up to 10°C (50°F), in a place inaccessible to children. Transportation at temperatures up to 25°C (77°F) for no more than 14 days is permissible.

Shelf Life

Shelf life. 2 years. The drug with an expired shelf life must not be used.

Dispensing Status

The drug is approved for use as an over-the-counter product.

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.