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MUTAFLOR Suspension 25X5 ml

Ardeypharm GmbH

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MUTAFLOR Suspension

MUTAFLOR ® is an agent for the treatment of intestinal diseases.

MUTAFLOR suspension Active ingredient:
Escherichia coli strain Nissle 1917

MUTAFLOR suspension Areas of application:
Diarrhea in babies, toddlers and children; Diarrhea in infants, toddlers, and tube-fed children; Colonization prophylaxis in premature and full term infants; Increase in postnatal immune competence in premature and full term infants

Warning:

Shake before use.
Store at 2 ° C to 8 ° C (in the refrigerator)!


For information on risks and side effects, read the package insert and ask your doctor or pharmacist!

MUTAFLOR suspension

Mutaflor ® suspension

To support intestinal health
• Easy to administer
• Relieves symptoms
• Shortens the duration of illness
• For babies from the first day of life


Against diarrhea in infants and children
In children, diarrhea is mostly caused by a gastrointestinal infection by viruses and bacteria, but also by drugs such as antibiotics. The infections damage the intestinal mucosa, and the intestine also loses water and minerals that are necessary for a functioning metabolism. Especially with smaller children, dehydration can occur after a few hours due to the heavy loss of water, which is why medical advice should be sought quickly. Mutaflor ®Suspension with natural intestinal bacteria can support the intestine in combating diarrhea pathogens. Thanks to the practical drinking ampoule, the suspension can be easily administered even to infants.


Natural protection of the intestines
Mutaflor ®Suspension is a means of treating diarrheal diseases in infants, toddlers and children. The medicinal product contains a high concentration of the natural bacterial culture E. coli strain Nissle 1917. Among other things, the intestinal bacterium forms antimicrobial substances that support the intestine in defending itself against diarrhea pathogens. The intestinal flora is stabilized and the natural balance in the intestine is restored. This increases the protection of the intestine against the colonization of pathogenic germs. Studies show that the duration of the diarrheal illness can be shortened significantly by using Mutaflor ® .


RECOMMENDED USE:
Drinking ampoule Mutaflor ®Tear off the suspension from the block, shake vigorously and remove the cap by twisting it. The suspension can be instilled directly into the mouth from the ampoule. In infants, the medicine is given before drinking, in young children after a meal.

Unless otherwise prescribed by a doctor, the recommended dose for infants, toddlers and children is 1 to 3x 1ml per day for diarrhea. Please always store Mutaflor ® Suspension at 2 ° C to 8 ° C in the refrigerator.

IN CASE OF FAILURE

IN CASE OF FAILURE

With diarrhea, more water and electrolytes are released into the intestines than usual. The stool becomes more fluid and the amount of stool increases. This natural defense reaction of the body causes pathogenic substances to be excreted as quickly as possible. At the same time, there is also an excretion of bacteria that are necessary for intestinal health. The supply of natural intestinal bacteria can rebalance the intestine and restore its normal function.

DEFENSE STRENGTHENING

Although newborns received antibodies in the womb, their own immune system only develops after a few days or weeks. The earlier the antibodies are formed, the more difficult it is for pathogens to settle in the infant's intestines. The E. coli bacterial strain Nissle 1917 can prevent the spread of harmful bacteria in the intestine and activate the immune system in a targeted manner. So the body is better protected against unwanted germs.


FREQUENT QUESTIONS & ANSWERS:

How should I feed my child if I have diarrhea?
Since the body loses a lot of water and minerals with diarrhea, the loss of fluid should be compensated for quickly so that it does not lead to dehydration. Therefore give your child plenty of fluids in the form of mineral water or tea with glucose. Cold drinks and fruit juices are to be avoided. If you are breastfeeding your baby, you should also do so if you have diarrhea.

After the fluid loss has been compensated for, you can start building your diet. Bottle-fed infants receive normal, undiluted infant formula. Initially, toddlers and children can eat small portions of easily digestible foods such as rusks, mashed potatoes, pasta, grated apples and carrots, or ripe bananas.

How long can Mutaflor ®Suspension to be used for diarrhea?
In the case of acute diarrhea, you can give your child Mutaflor ® suspension for up to 5 days; if the diarrhea has persisted for a long time, it can be used for up to 15 days. Please discuss the dosage and duration of use with the treating pediatrician.

How can my baby's immune system be increased?
Harmony and loving care are particularly important for the well-being of babies. Babies who are comfortable have better immune defenses. Fresh air - both outdoors and at home - increases the body's defenses. Regular ventilation of closed rooms prevents bacteria and viruses from spreading. To ward off viruses and bacteria, hygiene must of course also be observed. However, excessive hygiene can be harmful and promote diseases such as hay fever and neurodermatitis.

active ingredients

  • 100000000 germs Escherichia coli; Trunk Nissle 1917

excipients

  • water, purified
  • sodium chloride
  • potassium chloride
  • Magnesium Sulfate-7 Water
  • calcium chloride-2 water
  • Magnesium chloride-6 water
  • Sodium hydroxide for pH adjustment

indication

  • Substance group and mode of action:
    • The drug is used to treat diarrhea in infants, toddlers and children. In addition, it promotes the development of the body's own defenses. The bacterium E. coli strain Nissle 1917 contained as an active ingredient acts in the intestine against pathogenic microorganisms and prevents them from settling (colonization prophylaxis).
    • In addition, the E. coli strain Nissle 1917 releases substances into the intestine that strengthen the intestinal mucosa and support it in its natural function.
  • The medicine is used for:
    • Diarrhea in infants, toddlers and children
    • Diarrhea in infants, young children, and tube-fed children
    • To prevent harmful germs from settling in the intestines of premature and full-term babies (colonization prophylaxis)
    • To increase the body's own defenses in premature and full-term babies

dosage

  • Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
  • Dosage:
    • The recommended dose is:
      • In case of diarrhea:
        • Babies, toddlers and children: 1 - 3 x 1 ml per day
      • Diarrhea with tube feeding:
        • Infants, toddlers and children: 1 x 5 ml per day
      • To prevent harmful germs from settling in the intestine (colonization prophylaxis):
        • Premature and term babies: 1 x 1 ml per day
      • To increase the body's defenses:
        • Premature and term babies: 1st week of life 1 x 1 ml per day; 2nd - 3rd week 1 ml per day 3 times a week
  • Please talk to your doctor or pharmacist if you have the impression that the effect is too strong or too weak.

 

  • Duration of use:
    • Diarrhea; acute:
      • up to 5 days
    • Diarrhea; existing for a long time:
      • up to 15 days
    • Diarrhea with tube feeding:
      • up to 5 days per diarrhea period
      • The treatment should be continued for a few days after the onset of treatment success.
    • Colonization prophylaxis:
      • at least 5 days
    • Strengthening of the body's defences:
      • 1st - 3- week of life

 

  • What to do if you give your child more than you should
    • No special measures are required even if excessive amounts are taken.

 

  • What do you have to consider if you have administered too little or forgotten to take a dose?
    • Do not apply the double amount if you have forgotten the previous application.
    • The intake should be continued while maintaining the previous dosage - regardless of the missed intake.

 

  • If you stop taking it?
    • No precautions are necessary here.

 

  • If you have any further questions on the use of the medicine, ask your doctor or pharmacist.

way

  • The suspension can be dripped directly into the mouth, in infants before drinking, in small children after a meal.
  • For more information, see the instructions for use!

side effects

  • Like all medicines, this medicine can cause side effects, although not everybody gets them.
  • The evaluation of side effects is based on the following frequency information:
    • very common: more than 1 in 10 people treated
    • Common: less than 1 in 10 but more than 1 in 100 people treated
    • uncommon: less than 1 in 100 but more than 1 in 1,000 people treated
    • rare: less than 1 in 1,000 but more than 1 in 10,000 people treated
    • very rare: less than 1 in 10,000 people treated, or unknown
    • Not known: frequency cannot be estimated from the available data
  • Flatulence occurs very rarely at the beginning of the intake. Adverse effects in the gastrointestinal tract such as abdominal pain, diarrhea or vomiting have also been reported very rarely.
  • Furthermore, hives or allergic reactions can also occur in very rare cases.
  • Sepsis has been observed occasionally in very premature infants. The frequency cannot be estimated from the available data.
  • Please tell your doctor or pharmacist if any of the listed side effects gets serious for your child, or if you notice any side effects that are not listed.
  • What countermeasures should be taken in the event of side effects?
    • If flatulence occurs at the beginning of therapy, the daily dose should not be given all at once, but distributed evenly throughout the day, with meals.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not specified.

 

interactions

  • When taken with other medicines:
    • Please tell your doctor or pharmacist if your child is taking/using any other medicines, has recently taken/used any other medicines or intends to use any other medicines in your child.
    • Certain antibiotics and sulfonamides can make this medicine less effective. Therefore, please tell your doctor or pharmacist which antibiotics or sulphonamides your child is taking.

Contraindications

  • This medicine must not be taken
    • if your child is allergic to E. coli strain Nissle 1917 or any of the other ingredients of this medicine.

pregnancy and breast feeding period

  • The contained bacterium E. coli strain Nissle 1917 is a natural intestinal resident. If the active ingredient E. coli is used as intended, there are no known risks during pregnancy and breastfeeding. However, the medicine is only intended for the treatment of infants, young children and children.

patient notes

  • Warnings and Precautions:
    • Please talk to your doctor or pharmacist before using this medicine.
    • If your child experiences intolerance reactions, please contact your doctor or pharmacist.
    • With diarrhea there is a risk of dehydration. Therefore, even during treatment with this drug, care should be taken to ensure adequate fluid intake and electrolyte intake.