MUTAFLOR® oral suspension
MUTAFLOR®
Composition
Active substance: 1 ml of suspension contains 1917 ≥ 108 Escherichia coli Nissle strain.
Excipients: purified water, sodium chloride, potassium chloride, magnesium sulfate heptohydrate, calcium chloride dihydrate, magnesium chloride hexahydrate, sodium hydrochloride solution 32%.
Description
It is a beige, cloudy suspension.
Pharmacotherapeutic group
Probiotic.
ATC : A07EF01.
Pharmacological properties
Pharmacodynamics
E.coli is the first saprophytic bacteria to start working in the intestine. It creates conditions for the activity of other saprophytic bacteria in the intestine and destroys the pathogenic flora. Since these bacteria are aerobic, they respire with free oxygen in the gut, which creates conditions for the establishment and regeneration of anaerobic bacteria, especially bifidobacteria. E.coli breaks down the carbohydrates in the gut, resulting in a drop in pH and the growth of lactobacilli and normalization of intestinal kinetics. In addition, the metabolites of E.coli eliminate inflammation in the intestine and serve as an energetic substrate for enterocytes. E.coli antagonizes pathogenic bacteria, destroying them and preventing their invasion of the intestinal wall. At the same time, E.coli increases the synthesis of local antibacterial proteins in the intestine, and also stimulates the synthesis of anti-inflammatory cytokines by affecting the macrophages located in the intestine.
Pharmacokinetics
E.coli strains are found in the patient’s feces starting from the first day and up to 8 weeks after admission..
Instructions for use
- Diarrhea in tube-fed children
- Diarrhea in formula-fed children
- Increase of the body’s natural defense system in premature and newborns (prevention of infection)
- Prevention of intestinal colonization of pathogenic bacteria in premature and newborn infants
Contraindications
- Hypersensitivity to the component in the composition of the preparation.
- Premature children weighing up to 1000 grams.
Special instructions and precautions
It should be prescribed with caution to patients with immunodeficiency. Dehydration of the body and electrolyte imbalance should be taken into account during diarrhea.
Interaction with other drugs
Use together with antibiotics can reduce the effect of the drug, so it is not recommended to use it together with antibiotics.
Use during pregnancy and lactation
The component of the Mutaflor drug is a bacteria that lives in the intestine. The drug is not intended for use by pregnant and lactating women.
Effects on the ability to drive vehicles and other potentially dangerous mechanisms
No adverse effects have been detected in cases requiring attention.
Method of use and dosage
- Tear off the block to open the single-dose container. Shake well and open cap before use. The suspension can be given directly from the containers to the mouth, before feeding to babies, after feeding to small children.
- Diarrhea: 1 ml/day for 1-3 days in infants and children. 1 ml/day for 5 days in acute diarrhea, 1 ml/day for 15 days in chronic diarrhea.
- Diarrhea in tube-fed children: 1 ml/day from 1-5 ml for 5 days depending on the period of diarrhea.
- Boosting the natural defense system in newborns: 1 ml 1 time a day in the 1st week of life, 1 ml/day 3 times a week in the 2nd and 3rd week.
- Prophylaxis of intestinal colonization by pathogenic bacteria: 1 ml/day to neonates for at least 5 days.
Expiry date
Not less than 5 days in acute diarrhea.
Not less than 15 days in chronic diarrhea.
5 days during tube feeding.
1-3 weeks during the rise of the natural defense system in newborns.
It is taken for no less than 5 days during the prophylaxis of the colonization of pathogenic bacteria in the intestine.
If you have any further questions, it is recommended that you consult your doctor.
Opened ampoule should be used within 3 months.
Side effects
Diarrhea can be observed on the first day of taking the drug. In addition, in rare cases, abdominal pain, bloating, transient dyspeptic disorders, rash, nausea, and vomiting may occur. Very rarely, allergies and sepsis can be observed in premature babies weighing less than 1000 g.
If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.
Overdose
- If you give your child more MUTAFLOR® suspension than prescribed
- No special measures are required.
- If you forget to use MUTAFLOR® Suspension
- Do not take a double dose to make up for a missed dose.
- If you stop using MUTAFLOR® suspension
- No special precautions are required.
- If you have any further questions about the use of this product, ask your doctor or pharmacist.
Packing form
1 ml solution in a polyethylene ampoule. 5 ampoules in a sachet. 1 sachet is packed in a cardboard box with a leaflet.
Store condition
It should be stored at a temperature between 2-8°C, in a refrigerator, in a dry place, protected from light and out of the reach of children.
Shelf life
1 year.
Prescription
Manufacturer
Pharma- Zentrale GmbH, Germany.
Loerfeldstrasse 20, 58313 Herdecke, Germany.