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Powder for oral suspension

Escherichia coli cryodesiccata

1. What the product COLINFANT NEW BORN is and what it is used for

The product COLINFANT NEW BORN is immunopreparation (probiotic).
The product COLINFANT NEW BORN is designed for newborns and breast-fed infants up to 1 year of age and for premature babies, especially those who are not breast-fed, especially for prevention of hospital infections, gastrointestinal diseases of various origin, disorders of intestinal microflora composition e.g. after treatment with antibiotics and in carriers enteropathogenic strains (strains causing intestinal disease).
Escherichia coli strain contained in the product is a representative of bacteria group that is the part of normal intestinal microflora. It very well colonizes intestinal tract and its long-term presence in the intestine stimulates the production of specific and nonspecific antibodies, both local, in the intestine and saliva, and overall in blood circulation. It has a positive effect on the composition of intestinal microflora, extrudes enteropathogenic strains and helps to regulate intestinal flora in patients with intestinal diseases. It also has a positive effect on carriers of enteropathogenic strains.

2. What you need to know before your child use the product COLINFANT NEW BORN

Do not use the product COLINFANT NEW BORN:

  • if your child is allergic to active substance or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor before administration of the product COLINFANT NEW BORN to the child.
In patients with immunodeficiency is advised increased attention of a doctor during application of preparation. Before and after administration of the product, a bacteriological examination of stools may be performed in order to check the capture of Escherichia coli strain.

Other medicines and the product COLINFANT NEW BORN
Tell your doctor if your child is using, have recently used or might use any other medicines.
Escherichia coli strain contained in the vaccine is sensitive to common antibiotics therefore it is useless to administer it along with antibiotics.

The product COLINFANT NEW BORN with food and drink.
The product is administered before food and drink.

Pregnancy, breast-feeding and fertility
The product is designed for children up to 1 year of age.

Driving and using machines
The product is designed for children up to 1 year of age.

The product COLINFANT NEW BORN contains sucrose
If your doctor told you that your child does not tolerate some sugars, talk to your doctor before administering this product to the child.
This product contains less than 1 mmol (23 mg) of sodium in one dose, i.e. basically “sodium-free”.

3. How to use the product COLINFANT NEW BORN

Always administer this medicine to the child exactly as your doctor has told you.  Check with your doctor if you are not sure.

The recommended dose of the product is content of one medicinal bottle dissolved according to instructions indicated in this leaflet.

The product should be administered orally (by mouth) once daily prior to meal, three times weekly for a period of 4 weeks.

The content of one bottle should be dissolved by addition of 1 ml of sterile distilled water by means of syringe, whereas the bottle stopper should be pierced with a needle after removal of aluminium closure. In newborns and premature babies, the product should be administered by a syringe without the needle directly at the root of tongue to avoid its spitting out by the infant and, thereafter, tea should be given to drink down. If a premature infant is nourished parenterally (into a vein), the administration is conducted by means of a gastric tube. In children from 1 week to 1 year of age, the syringe content should be transferred to 5-10 ml of tea and given to the child to drink.

If you administered to a child more COLINFANT NEW BORN than you should
Overdose is not known. If it occurred, there could be loose stools for 1-2 days and then spontaneous adjustment.

If you forget to use the product COLINFANT NEW BORN
Do not take a double dose to make up for a forgotten dose and inform your doctor.

If you stop using the product COLINFANT NEW BORN
If you have any further questions on the use of this medicine, ask your doctor

4. Possible side effects

Like all medicines, this product can cause side effects, although not everybody gets them.
On the first day of administration of the product, more frequent loose stool may be recorded in sporadic cases. Other adverse drug reactions are not known.

Reporting of side effects

If your child gets any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly to the address:

State Institute for Drug Control, Šrobárova 48, 100 41 Praha 10

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store the product COLINFANT NEW BORN

Keep this product out of the sight and reach of children.
Store in a refrigerator (2 °C – 8 °C). Store in the original package and in the box to protect the product from light and humidity.
The product must be used immediately after opening and reconstitution.
Do not use this product after the expiry date which is stated on the label and carton after “Usable until:”. The expiry date refers to the last day of that month.
Do not use this medicine if you notice a damage of bottle closure.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What the product COLINFANT NEW BORN contains
One dose contains Escherichia coli criodesiccata (O83:K24:H31) at an amount of 0.8 x 108 to 1.6 x 108 bacteria.
Excipients: 100 mg sucrose, 150 mg non-fat dried milk
Other ingredients are sodium hydrogen phosphate, potassium dihydrogen phosphate, sodium chloride, ammonium chloride.

What the product COLINFANT NEW BORN looks like and contents of the pack
The product COLINFANT NEW BORN is whitish to slightly yellowish porous mass stored in the vast of majority in a compact unit at the bottom of the medicinal bottle. After reconstitution is created whitish, slightly cloudy liquid.
The carton box contains 12 glass medicinal bottles with lyophilized product closed with rubber stopper and aluminium cap and this package leaflet.

Intended for:

Human medicaments