Descrizione Clinica
Foods Pediapax powder 20bust
Pediapa
Description
Medical device in powder for oral suspension useful in:
- Treatment of chronic constipation in children over 2 years and weighing more than 10 kg.
- Treatment of fecaloma in children aged 3, defined as refractory stips with fecal load in rectum and/or colon.
Mode of use
Chronic stipsis: the usual initial dose in children between 2 and 6 years is half (1/2) sachet per day, in children from 7 years on of one (1) sachet per day, dissolved:
- In 125 ml of non-carbonated water (about 1 glass) for the whole bag.
- In 62.5 ml of non-carbonated water (about 1⁄2 glass) for the half sachet.
You can dissolve the product in a liquid other than water (tea, milk, broth or fruit juice).
The dose can be increased or decreased so as to allow a regular evacuation of soft feces. If you need to increase the dose, it is better to do it every 2 days. The maximum dose required does not normally exceed 2 sachets per day. In the case of prolonged treatment, proceed with the gradual interruption and a recovery of the same in case of reappearance of constipation. Do not use the product for more than 30 consecutive days, if symptoms persist to consult your doctor.
PEDIAPAX can also be used under 2 years, starting from 6 months: for this age group, in order to make a more precise definition of the dosage, the bottle formulation is available with a dosage spoon.
Fecaloma: the diagnosis of fecaloma/caric in the rectum must be confirmed by a physical or radiological examination of the abdomen and rectum. A fecaloma treatment cycle with PEDIAPAX will last from 3 to a maximum of 6 consecutive days, in the following mode:
The whole sachet is 13.125 g (2 half sachets). The daily number of sachets must be taken in doses of 6,563 g (1/2 sachet) to dissolve in 62.5 ml of water (about half a glass), all consumed within 12 hours. You can dissolve the product in a liquid other than water (tea, milk, broth or fruit juice). The time interval between one intake and the other is calculated according to the number of envelopes to be taken in the 12 hours, so:
The dosage of 1-1.5 g/Kg/die (and then use the half dose of PEDIAPAX). The indicated treatment scheme must be interrupted once the occlusion has been resolved. An indicator of this resolution is the passage of a large amount of feces. After the resolution, it is recommended to follow the child 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).
Note: you can prepare a greater volume of solution ready for use, for example by melting 6 sachets in 750 ml of water. 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 and the bag; Do not use in case of damaged packaging; Each envelope is disposable and must be opened only immediately before taking: do not reuse partially used or open envelopes in unknown times, as this way of use may result in the risk of contamination of the product. 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 take a double dose 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 dishydration, it is however recommended to consult your doctor.
Known side effects: 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.
Contraindications and limitations of use: do not use below 2 years for the treatment of chronic constipation and below 3 for the treatment of fecaloma. For use below this band, the bottle with spoon dispenser is recommended. 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.
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: extract and open the envelopes just before using them. Store the device below 25°C.
Format
20 sachets divided by 13,125 g oral suspension powder.
Medical device in powder for oral suspension useful in:
- Treatment of chronic constipation in children over 2 years and weighing more than 10 kg.
- Treatment of fecaloma in children aged 3, defined as refractory stips with fecal load in rectum and/or colon.
Mode of use
Chronic stipsis: the usual initial dose in children between 2 and 6 years is half (1/2) sachet per day, in children from 7 years on of one (1) sachet per day, dissolved:
- In 125 ml of non-carbonated water (about 1 glass) for the whole bag.
- In 62.5 ml of non-carbonated water (about 1⁄2 glass) for the half sachet.
You can dissolve the product in a liquid other than water (tea, milk, broth or fruit juice).
The dose can be increased or decreased so as to allow a regular evacuation of soft feces. If you need to increase the dose, it is better to do it every 2 days. The maximum dose required does not normally exceed 2 sachets per day. In the case of prolonged treatment, proceed with the gradual interruption and a recovery of the same in case of reappearance of constipation. Do not use the product for more than 30 consecutive days, if symptoms persist to consult your doctor.
PEDIAPAX can also be used under 2 years, starting from 6 months: for this age group, in order to make a more precise definition of the dosage, the bottle formulation is available with a dosage spoon.
Fecaloma: the diagnosis of fecaloma/caric in the rectum must be confirmed by a physical or radiological examination of the abdomen and rectum. A fecaloma treatment cycle with PEDIAPAX will last from 3 to a maximum of 6 consecutive days, in the following mode:
| 3-6 years: | 2 bags of PEDIAPAX |
| 7-10 years: | 3 bags of PEDIAPAX |
| >10 years: | 4 bags of PEDIAPAX |
The whole sachet is 13.125 g (2 half sachets). The daily number of sachets must be taken in doses of 6,563 g (1/2 sachet) to dissolve in 62.5 ml of water (about half a glass), all consumed within 12 hours. You can dissolve the product in a liquid other than water (tea, milk, broth or fruit juice). The time interval between one intake and the other is calculated according to the number of envelopes to be taken in the 12 hours, so:
| No sachets per day | No. of 1⁄2 bags | 1 1⁄2 envelope each |
| 2 | 4 | 3 hours |
| 3 | 6 | 2 hours |
| 4 | 8 | 1 hour and 30 min. |
The dosage of 1-1.5 g/Kg/die (and then use the half dose of PEDIAPAX). The indicated treatment scheme must be interrupted once the occlusion has been resolved. An indicator of this resolution is the passage of a large amount of feces. After the resolution, it is recommended to follow the child 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).
Note: you can prepare a greater volume of solution ready for use, for example by melting 6 sachets in 750 ml of water. 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 and the bag; Do not use in case of damaged packaging; Each envelope is disposable and must be opened only immediately before taking: do not reuse partially used or open envelopes in unknown times, as this way of use may result in the risk of contamination of the product. 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 take a double dose 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 dishydration, it is however recommended to consult your doctor.
Known side effects: 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.
Contraindications and limitations of use: do not use below 2 years for the treatment of chronic constipation and below 3 for the treatment of fecaloma. For use below this band, the bottle with spoon dispenser is recommended. 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.
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: extract and open the envelopes just before using them. Store the device below 25°C.
Format
20 sachets divided by 13,125 g oral suspension powder.
