Descrizione Clinica
Foods Pediapax powder 400g
Pediapa
DUST
Description
Medical device in powder for oral suspension useful in:
- Treatment of chronic constipation in children from 6 months of age.
- Treatment of fecaloma in children aged 3, defined as refractory stips with fecal load in rectum and/or colon.
Mechanism of action: the effectiveness of the device is due to the characteristics of polyethyleneglycol (PEG), polymer with high molecular weight, metabolically inert, not degraded by the intestinal bacterial flora; on long linear polymer chains, through hydrogen bonds, water molecules are retained, hydrating the fecal mass by stimulating peristalsis. PEDIAPAX is not absorbed at the intestinal level and is expelled in unaltered form.
Components
Each bottle contains 400 g of Makropur (Macrogol 3350 purified).
Without gluten and without lactose.
Mode of use
You can dissolve the product in a liquid other than water (tea, milk, broth or fruit juice).
Chronic stipsis: Unless otherwise prescribed, it is advisable to use PEDIAPAX according to the following methods.
The dose may be increased or decreased depending on the individual response to treatment. The most correct daily posology is to be decided according to the weight of the child and the severity of the stypsis. It is recommended in any case to feel the advice of the doctor. Use the product in children under pediatric age only after medical advice. The maximum dose required does not normally exceed 30 g of the product per day. Do not use the product for more than 30 consecutive days, if symptoms persist to consult your doctor. On the basis of the above mentioned posology, take the quantity of product with the aid of the mesurino equipped with heels that allow to dose 2,5 g (before notch) and 5 g (mixed) of product. Melt a satin scoop (equal to 5 g) into 62.5 ml of ungased water (about 1⁄2 glass) or other liquid. You can split the daily dose into multiple administrations.
Fecaloma: the diagnosis of fecaloma/caric in the rectum must be confirmed by a physical or radiological examination of the abdomen and rectum. The recommended dosage from ESPGHAN and NASPGHAN guidelines is 1-1.5 g per body per die. Then the posology for the treatment of the fecaloma with PEDIAPAX is as follows:
The daily dosage must be taken in doses of 5 g (mixurine satin) to dissolve in about 62.5 ml of non-gassed water (approximately half a glass) or other liquid, to be consumed entirely within the 12 hours, for proper intake of the product we recommend to contact the doctor. The treatment must be interrupted once the occlusion is resolved, but in any case it will have to last up to 6 consecutive days. An indicator of this resolution is the passage of a large amount of feces. After the resolution, it is recommended to have the child follow an appropriate treatment program for the intestine, to prevent the occurrence of a new fecaloma (the dosage to prevent relapse of the fecaloma is that for patients with chronic constipation - Ref. § 2.1). NOTE: you can prepare a greater volume of solution ready for use. In this case the solution can be kept covered in the refrigerator for maximum 24 hours, and then eliminated.
Warnings
Store the device and any solution obtained away from the reach of children; Do not use the device after the expiry date shown on the package; Do not use in case of damaged packaging; Do not exceed the recommended doses: in case of overdose, intense pain, abdominal distension may occur. Induced diarrhea may also occur, with electrolytic disorders caused by excessive evacuation. If you suspect overdosing, please contact your pediatrician immediately. When PEDIAPAX is used in high doses to treat fecaloma, it should be administered carefully in patients with altered swallowing reflex, esophagi by reflux or reduced consciousness levels. If you forget to take a dose, do NOT BE A DOWN TO recover. During treatment with PEDIAPAX it is advisable to follow an adequate diet, accompanied by the administration of a solution for oral rehydration (ORS) in order to avoid dehydration, it is recommended to consult your doctor.
Contraindications and limitations of use: do not use below 6 months for the treatment of chronic constipation and below 3 years for the treatment of fecaloma. The intake of the device is not recommended in case of: perforation or intestinal obstruction due to structural or functional disorders of the intestinal wall, of the ileo, severe inflammatory pathologies of the intestinal tract, such as Crohn's disease, ulcerative colitis and toxic megacolons. Hypersensitivity known to PEG. Do not take the medical device during the use of other oral medicinal devices or specialities: the osmotic power of the PEG and the increase in the gastrointestinal transit speed may adversely affect their effectiveness. Consult your physician in any case before taking PEDIAPAX in case of other therapies in place. Do not use in case of gastric or intestinal lesions known.
Interactions with drugs and dietary supplements: to date no known interactions with drugs but it is appropriate that the intake of the product be spaced of at least 2 hours from that of the drugs administered by mouth since the osmotic power of the macrogol and the increase in the rate of gastrointestinal transit induced can adversely affect their effectiveness. However, consult your physician before taking PEDIAPAX in case of other therapies in place.
Side effects: known They may appear mainly in the initial phase of use gastro-intestinal disorders (abdominal pain, borborigmas, diarrhea or loss of feces), as well as nausea, mild vomiting, abdominal distension, flatulence, inflammation and perianal irritation, effects that normally improve by reducing the dose. Very rarely allergic reactions have been observed, including anaphylaxis. Other symptoms of allergic reaction such as itching, hives and dispnea. If the side effects persist, suspend the treatment and apply to your pediatrician for a consult.
Disposal: the expired device or otherwise to be eliminated must be managed as a waste management regulation of the Local Manager. Do not disperse in any case the product or its packaging in the environment.
Conservation
Store the package in a dry place and sheltered from light sources or direct heat. Store the device below 25°C.
Format
400 g of powder for oral suspension.
Medical device in powder for oral suspension useful in:
- Treatment of chronic constipation in children from 6 months of age.
- Treatment of fecaloma in children aged 3, defined as refractory stips with fecal load in rectum and/or colon.
Mechanism of action: the effectiveness of the device is due to the characteristics of polyethyleneglycol (PEG), polymer with high molecular weight, metabolically inert, not degraded by the intestinal bacterial flora; on long linear polymer chains, through hydrogen bonds, water molecules are retained, hydrating the fecal mass by stimulating peristalsis. PEDIAPAX is not absorbed at the intestinal level and is expelled in unaltered form.
Components
Each bottle contains 400 g of Makropur (Macrogol 3350 purified).
Without gluten and without lactose.
Mode of use
You can dissolve the product in a liquid other than water (tea, milk, broth or fruit juice).
Chronic stipsis: Unless otherwise prescribed, it is advisable to use PEDIAPAX according to the following methods.
| From 6 months to 2 years (up to 12 kg) | 0.8 g product per kg body weight per day |
| From 2 to 11 years (from 12 kg to 20 kg) | 1 g of product per kg body weight per day |
| Over 11 years (or >20 kg) | 10-30 g product per day |
The dose may be increased or decreased depending on the individual response to treatment. The most correct daily posology is to be decided according to the weight of the child and the severity of the stypsis. It is recommended in any case to feel the advice of the doctor. Use the product in children under pediatric age only after medical advice. The maximum dose required does not normally exceed 30 g of the product per day. Do not use the product for more than 30 consecutive days, if symptoms persist to consult your doctor. On the basis of the above mentioned posology, take the quantity of product with the aid of the mesurino equipped with heels that allow to dose 2,5 g (before notch) and 5 g (mixed) of product. Melt a satin scoop (equal to 5 g) into 62.5 ml of ungased water (about 1⁄2 glass) or other liquid. You can split the daily dose into multiple administrations.
Fecaloma: the diagnosis of fecaloma/caric in the rectum must be confirmed by a physical or radiological examination of the abdomen and rectum. The recommended dosage from ESPGHAN and NASPGHAN guidelines is 1-1.5 g per body per die. Then the posology for the treatment of the fecaloma with PEDIAPAX is as follows:
| Weight (kg) | Recommended maximum daily dose |
| 14-17 kg | 4 teaspoons |
| 18 kg | 5 spoons |
| 23-27 kg | 6 teaspoons + half |
| 28-34 kg | 8 spoons |
| 35-39 kg | 9 spoons |
| > 40 kg | 10 teaspoons + half |
The daily dosage must be taken in doses of 5 g (mixurine satin) to dissolve in about 62.5 ml of non-gassed water (approximately half a glass) or other liquid, to be consumed entirely within the 12 hours, for proper intake of the product we recommend to contact the doctor. The treatment must be interrupted once the occlusion is resolved, but in any case it will have to last up to 6 consecutive days. An indicator of this resolution is the passage of a large amount of feces. After the resolution, it is recommended to have the child follow an appropriate treatment program for the intestine, to prevent the occurrence of a new fecaloma (the dosage to prevent relapse of the fecaloma is that for patients with chronic constipation - Ref. § 2.1). NOTE: you can prepare a greater volume of solution ready for use. In this case the solution can be kept covered in the refrigerator for maximum 24 hours, and then eliminated.
Warnings
Store the device and any solution obtained away from the reach of children; Do not use the device after the expiry date shown on the package; Do not use in case of damaged packaging; Do not exceed the recommended doses: in case of overdose, intense pain, abdominal distension may occur. Induced diarrhea may also occur, with electrolytic disorders caused by excessive evacuation. If you suspect overdosing, please contact your pediatrician immediately. When PEDIAPAX is used in high doses to treat fecaloma, it should be administered carefully in patients with altered swallowing reflex, esophagi by reflux or reduced consciousness levels. If you forget to take a dose, do NOT BE A DOWN TO recover. During treatment with PEDIAPAX it is advisable to follow an adequate diet, accompanied by the administration of a solution for oral rehydration (ORS) in order to avoid dehydration, it is recommended to consult your doctor.
Contraindications and limitations of use: do not use below 6 months for the treatment of chronic constipation and below 3 years for the treatment of fecaloma. The intake of the device is not recommended in case of: perforation or intestinal obstruction due to structural or functional disorders of the intestinal wall, of the ileo, severe inflammatory pathologies of the intestinal tract, such as Crohn's disease, ulcerative colitis and toxic megacolons. Hypersensitivity known to PEG. Do not take the medical device during the use of other oral medicinal devices or specialities: the osmotic power of the PEG and the increase in the gastrointestinal transit speed may adversely affect their effectiveness. Consult your physician in any case before taking PEDIAPAX in case of other therapies in place. Do not use in case of gastric or intestinal lesions known.
Interactions with drugs and dietary supplements: to date no known interactions with drugs but it is appropriate that the intake of the product be spaced of at least 2 hours from that of the drugs administered by mouth since the osmotic power of the macrogol and the increase in the rate of gastrointestinal transit induced can adversely affect their effectiveness. However, consult your physician before taking PEDIAPAX in case of other therapies in place.
Side effects: known They may appear mainly in the initial phase of use gastro-intestinal disorders (abdominal pain, borborigmas, diarrhea or loss of feces), as well as nausea, mild vomiting, abdominal distension, flatulence, inflammation and perianal irritation, effects that normally improve by reducing the dose. Very rarely allergic reactions have been observed, including anaphylaxis. Other symptoms of allergic reaction such as itching, hives and dispnea. If the side effects persist, suspend the treatment and apply to your pediatrician for a consult.
Disposal: the expired device or otherwise to be eliminated must be managed as a waste management regulation of the Local Manager. Do not disperse in any case the product or its packaging in the environment.
Conservation
Store the package in a dry place and sheltered from light sources or direct heat. Store the device below 25°C.
Format
400 g of powder for oral suspension.
