03. Ecoflor – immobilized probiotic of a new generation

1. Instructions for medications
2. Dialek

Scientific and Production Unitary Enterprise Dialek, Republic of Belarus INSTRUCTIONS (information for specialists) on the medical use of the drug

1. Compound
2. Pharmacotherapeutic group
3. Pharmacological properties
4. Indications for use
5. Directions for use and dosage regimen
6. Side effect
7. Contraindications
8. Overdose
9. Precautionary measures
10. Interaction with other drugs

A07.
ANTIDIARRHEAL, ANTI-INFLAMMATORY/ANTI-INFECTIVE INTESTINE Antidiarrheal microorganisms General characteristics: Grayish-white suspension with a specific odor and taste. During storage, the formation of a loose amorphous sediment is allowed, which breaks down when shaken.

Directions for use and dosage regimen

Bioflor is used to treat adults and children. The medicine can be used in a mixture with water (50-100 ml), with natural juices, decoctions of vegetables and fruits, compotes and other liquid products. The greatest effect is achieved when Bioflor is used separately 30 minutes before meals or 1.5 hours after meals.

Bioflor is used:

• for chronic diseases of the gastrointestinal tract: 1 dessert spoon 3 times a day for 1-3 months;
• for dysbacteriosis of various etiologies, 1 dessert spoon 2-3 times a day for 1-3 months;
• after acute intestinal infections: 1-3 dessert spoons 3 times a day for 3-5 days. The duration of treatment and dose are determined by the doctor. In individual cases, it is possible to increase the dosage of the drug as prescribed by the doctor.

Treatment of children should be carried out as prescribed and under the supervision of a physician.

For children, the dose of the drug is reduced in proportion to the child’s age:

• from 6 months to 1 year – up to ½ teaspoon (2-3 ml) 2-3 times a day until recovery;
• from 1 year to 5 years – ¼ of the adult norm;
• from 6 years to 10 years – ½ adult norm;
• from 11 years old – corresponds to the intake norm for an adult

If symptoms persist for a long time and/or the patient’s condition worsens, and/or new symptoms appear, you should immediately consult a doctor.

Side effects

Bioflor is well tolerated by patients and causes side effects in isolated cases (in the presence of hypersensitivity to the drug). A negative reaction of the body may manifest itself in the form of increased gas formation and intestinal pain, but such symptoms indicate the need to adjust the treatment regimen (in the first days of therapy, the drug is taken in minimal quantities).

The reason for discontinuing Bioflora is the appearance of a rash on the skin, indicating an allergy and intolerance to the drug.

Overdose

There have been no cases of overdose of Bioflor in medical practice. The drug is not addictive and does not have a negative effect on the body if the dosages specified in the instructions or prescribed by a specialist are exceeded. This feature is not a basis for uncontrolled use of Bioflor. Changing the drug regimen on your own may negatively affect the effectiveness of therapy.

Contraindications

Bioflor has no contraindications. The drug can be used for children from a very early age. The only limitation to therapy is the presence of increased sensitivity of the body to the components of its composition. A doctor can recognize drug intolerance based on a comprehensive examination of the patient or by conducting special tests.

During pregnancy

Bioflor can be used during pregnancy and lactation, but only after consultation with a doctor and a comprehensive examination. The drug does not have a negative effect on the fetus and the body of a newborn child.

The use of Bioflora during pregnancy and lactation implies special adjustments to the dosage regimen.

Pregnant women can use the drug only after a complete diagnosis of the body and permission from a doctor.

Precautionary measures

• The patient has a severe allergy.
• If the allergy is caused by dysbiosis of the gastrointestinal tract, then the use of Bioflor eliminates it. However, it is difficult to determine all allergenic factors. Therefore, you should start taking Bioflor with a small amount - 1 teaspoon once a day and, in the absence of allergic reactions, gradually increase its volume.
• In very rare cases, with severe changes in the small intestine, the use of Bioflora in the first days can increase gas formation and the resulting intestinal pain. In this case, it is advisable to discontinue the drug until the symptoms stop or stop treatment with the drug if the above symptoms reoccur.
• For dysfunctions and diarrhea caused by worms and other parasites, as well as protozoa (amoeba, lamblia, etc.), specific treatment must be carried out as prescribed by a doctor. The use of Bioflora in these diseases eliminates concomitant microflora disorders and resulting dysfunctions, improves immunity, which promotes recovery.
• Bioflor is ineffective in exacerbations of necrotizing ulcerative colitis and Crohn's disease. It is recommended to start taking it during periods between exacerbations of the disease. It is not advisable to use Bioflora simultaneously with taking hormonal medications for these diseases.
• Impact on the ability to drive vehicles and operate machinery
• Does not affect the ability to drive vehicles or operate dangerous machinery.

Use during pregnancy and breastfeeding The safety of the drug during pregnancy and breastfeeding has not been studied in controlled clinical trials.

Use in children Use in children is permitted.

Bioflor solution for oral administration 100ml No. 1

Name

Bioflor solution.

Release forms

Suspension.

INN

E. coli.

FTG

Mybp is a eubiotic.

general characteristics

A grayish-white suspension with a specific odor and taste. During storage, the formation of a loose amorphous sediment is allowed, which breaks down when shaken.

Compound

Composition per 100 ml: Active substance: E. coli M-17* - at least 100×108 live cells at the time of manufacture and at least 100×107 live cells at the end of the shelf life Excipients: Sodium chloride - 0.7 g (GF RB II volume 2, p. 740) Purified water - up to 100 ml (GF RB II volume 2, p. 309) A mixture of vegetable extracts (soybean, - 0.8 g of dill, beets, mint, garlic, parsley, cabbage) and propolis (STP-OS-029) *100 ml of an aqueous solution of sodium chloride and a mixture of vegetable and propolis extracts ensure the maintenance of the viability of E. coli M-17 in an amount of at least 100 × 107 living cells at the end of the shelf life Composition per 250 ml: Active substance : E. coli M-17 * - no less than 250×108 live cells at the time of manufacture and no less than 250×107 live cells at the end of the shelf life Excipients: Sodium chloride - 1.6 g (SP RB II volume 2, p. 740) Purified water - up to 250 ml (GF RB II volume 2, p. 309) A mixture of vegetable extracts (soybean, - 2.1 g of dill, beets, mint, garlic, parsley, cabbage) and propolis (STP-OS-029 ) *250 ml of an aqueous solution of sodium chloride and a mixture of vegetable and propolis extracts ensure the maintenance of the viability of E. coli M-17 in an amount of at least 250 × 107 living cells at the end of the shelf life.

Pharmacotherapeutic group

Antidiarrheal microorganisms.

Pharmacological properties

The pharmacological properties of Bioflora are determined by the live Escherichia coli contained in it - strain E. coli M-17. Escherichia coli E. coli M-17 has antagonistic activity against a wide range of pathogenic and opportunistic microorganisms, including Shigella, Salmonella, Proteus, Staphylococcus, Klebsiella, which in turn contributes to the normalization of intestinal microflora.

Indications for use

Bioflor is used in complex therapy of: chronic diseases of the gastrointestinal tract (nonspecific and specific chronic colitis and enterocolitis, accompanied by diarrhea syndrome); gastrointestinal disorders caused by an imbalance of intestinal microflora; in convalescents after acute intestinal infections. Use in children The liquid dosage form of Bioflor is intended for use in children from 6 months of age.

Directions for use and dosage

The medicine can be used in a mixture with water or liquid food (50-100 ml). The greatest effect is achieved when Bioflor is used separately 30 minutes before meals or 1.5 hours after meals. To achieve a therapeutic effect, the drug should be taken for at least 3-5 days. 1 dose is 10 ml of the drug and contains about 109 live Escherichia coli bacteria E. coli M-17. Graduated syringes or spoons should be used for dosing. The volume of one dessert spoon is 10 ml; the volume of one teaspoon is 5 ml. Children: from 6 months to 1 year - 1 dose per day (10 ml) in 2-3 divided doses; from 1 year to 3 years - 2 doses per day (20 ml) in 2-3 divided doses; from 3 years to 6 years - 4 doses per day (40 ml) in 2-3 divided doses. Due to the presence of plant extracts in the drug, use in children should be started with small amounts, gradually increasing the dose. When used against the background of antibiotic therapy, a 2-3 hour interval is recommended between the use of antibacterial agents and Bioflor solution. The use of the drug in children over 6 years of age and in adults is possible after medical consultation to clarify the single, daily doses and duration of treatment, depending on the severity of the symptoms of dyspepsia. If symptoms persist for a long time and/or the patient’s condition worsens, and/or new symptoms appear, it is necessary to stop taking the Bioflor solution and consult a doctor.

Side effect

In rare cases, there may be a slight increase in the severity of dyspeptic disorders, which usually resolve on their own and do not require cessation of treatment. In case of a severe reaction, use of the drug should be discontinued. There is a risk of developing an allergic reaction to the components of the drug. If undesirable effects not described in the instructions occur, you should consult your doctor.

Contraindications

hypersensitivity to the components of the drug; specific and nonspecific ulcerative colitis; children under 6 months.

Overdose

There are currently no reports of adverse effects in case of overdose.

Precautionary measures

The patient has a severe allergy. If the allergy is caused by an imbalance of the gastrointestinal microflora, then the use of Bioflor will help eliminate it. However, it is difficult to determine all allergenic factors. Therefore, taking Bioflor should start with a small amount of the drug and, in the absence of allergic reactions, gradually increase it to the recommended dose. In very rare cases, with severe symptoms of dyspepsia, the use of Bioflor solution in the first days can increase gas formation and resulting intestinal pain. In this case, it is advisable to discontinue the drug until the symptoms stop or stop treatment with the drug if these symptoms recur. In case of dysfunctions and diarrhea, against the background of helminthic infestations, parasitic diseases caused by protozoa (amoeba, giardia, etc.), specific treatment must be carried out as prescribed by a doctor. Use in children Use in children from 6 months of age is permitted.

Impact on the ability to drive vehicles and operate machinery

Does not affect the ability to drive vehicles or operate dangerous machinery.

Use during pregnancy and breastfeeding

The safety of the drug during pregnancy and breastfeeding has not been studied in controlled clinical trials.

Interaction with other drugs

With the simultaneous use of Bioflor and antimicrobial drugs for oral administration, the clinical effectiveness of Bioflor is reduced.

Storage conditions

Store away from light at temperatures between 2 °C and 8 °C.

Best before date

1 year. Do not use after the expiration date stated on the package. Keep out of the reach of children. After opening the bottle, use the medicine within 10 days.

Vacation conditions

Over the counter.

Buy Bioflor solution for external use in bottle or bottle 100 ml in pack No. 1 in the pharmacy

Price for Bioflor solution for internal use in bottle or bottle 100 ml in pack No. 1

Instructions for use for Bioflor solution for ext. in bottle or bottle 100 ml in pack No. 1

Interaction with other drugs

With the simultaneous use of Bioflor and antimicrobial drugs for oral administration, the clinical effectiveness of Bioflor is reduced.

Conditions and shelf life Store in a place protected from light at a temperature of 2 oC to 8 oC. Shelf life – 1 year. Do not use after the expiration date stated on the package. Keep out of the reach of children. After opening the bottle, use the medicine within 10 days.

in bottles or vials 100ml in packaging No. 1; in bottles or vials 250ml in packaging No. 1

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Analogs

Analogs of Bioflor are considered to be drugs with an antidiarrheal effect and normalizing the digestive process by affecting the intestinal microflora. When selecting a replacement, it is important to take into account possible differences in the instructions for use and composition of such medications. The best option for finding an analogue of Bioflor is consultation with a specialist.

Reviews

The effectiveness of Bioflor is confirmed by positive reviews from patients who used the drug for their own treatment or in the treatment of children. An improvement in the body's condition is observed within a short period of time after taking the suspension. This nuance is of particular importance in the presence of diarrhea or other intestinal disorders that cause significant discomfort when they occur.

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