Description
Pediapax
Description
Medical device in powder form for extemporaneous oral suspension useful in:
- Treatment of chronic constipation in children over 2 years of age and weighing 10 kg or more.
- Treatment of fecal impaction in children from the age of 3 years, defined as refractory constipation with fecal loading in the rectum and/or colon.
How to use
Chronic constipation : the usual starting dose in children between 2 and 6 years is half (1/2) sachet per day, in children aged 7 years and over one (1) sachet per day, dissolved:
- In 125 ml of still water (about 1 glass) for the whole sachet.
- In 62.5 ml of still water (about ½ glass) for the half sachet.
It is possible to dissolve the product in a liquid other than water (tea, milk, broth or fruit juice).
The dose can be increased or decreased to allow regular evacuation of soft stools. If it is necessary to increase the dose, it is best to do so every 2 days. The maximum dose required does not normally exceed 2 sachets per day. In the case of prolonged treatment, proceed with gradual interruption and a resumption of the same in the event of recurrence of constipation. Do not use the product for more than 30 consecutive days, if the symptoms persist consult your doctor.
PEDIAPAX can also be used on children under 2 years of age, starting from 6 months: for this age group, in order to define the dosage more precisely, the formulation in a bottle equipped with a measuring spoon is available.
Fecaloma : The diagnosis of fecaloma/fecal loading in the rectum must be confirmed by a physical or radiological examination of the abdomen and rectum. A treatment cycle for fecaloma with PEDIAPAX should last from 3 up to a maximum of 6 consecutive days, in the following manner:
A sachet means a whole sachet of 13.125 g (2 half sachets). The daily number of sachets must be taken divided into doses of 6.563 g (1/2 sachet) to be dissolved in 62.5 ml of water (about half a glass), all consumed within 12 hours. It is possible to dissolve the product in a liquid other than water (tea, milk, broth or fruit juice). The time interval between one intake and the next is calculated based on the number of sachets to be taken in 12 hours, so:
For a personalized dosage, a dosage of 1-1.5 g/kg/day can be considered (and therefore also use half a dose of PEDIAPAX). The indicated treatment regimen must be interrupted once the obstruction has resolved. An indicator of such resolution is the passage of a large amount of stool. After resolution, it is recommended that the child follow an appropriate treatment program for the intestine, to prevent the onset of a new fecaloma (the dosage to prevent the recurrence of fecaloma is that for patients with chronic constipation).
Note : It is possible to prepare a larger volume of ready-to-use solution, for example by dissolving 6 sachets in 750 ml of water. In this case the solution can be stored covered in the refrigerator for up to 24 hours, and then discarded.
Warnings
Keep the device and any solution obtained out of the reach of children; Do not use the device after the expiry date shown on the package and sachet; Do not use if the package is damaged; Each sachet is for single use only and must be opened immediately before use: do not reuse sachets that have been partially used or opened at unknown times, as this method of use could lead to risks of contamination of the product. Do not exceed the recommended doses: in the event of an overdose, intense pain and abdominal distension may occur. Induced diarrhoea may also occur, with electrolyte disturbances caused by possible excessive evacuation. In the event of suspected overdose, contact your paediatrician immediately. When PEDIAPAX is used in high doses to treat fecal impaction, it should be administered with caution in patients with an altered swallowing reflex, reflux esophagitis or reduced levels of consciousness. If you forget to take a dose, do not take a double dose to catch up. During treatment with PEDIAPAX it is advisable to follow an appropriate diet, accompanied by the administration of an oral rehydration solution (ORS) to avoid dehydration. However, it is advisable to consult your doctor.
Known side effects : gastrointestinal disorders (abdominal pain, rumbling, diarrhea or loose stools) may appear especially in the initial phase of use, in addition to nausea, mild vomiting, abdominal distension, flatulence, inflammation and irritation of the perianal area, effects that normally improve by reducing the dose. Allergic reactions, including anaphylaxis, have been observed very rarely. Other symptoms of allergic reactions such as itching, urticaria and dyspnea. If side effects persist, stop treatment and contact your pediatrician for advice.
Contraindications and limitations of use : do not use in children under 2 years of age for the treatment of chronic constipation and in children under 3 years of age for the treatment of fecal impaction. For use under this age group, the use of the bottle with measuring spoon is recommended. Taking the device is not recommended in the case of: intestinal perforation or obstruction due to structural or functional disorders of the intestinal wall, ileum, serious inflammatory diseases of the intestinal tract, such as Crohn's disease, ulcerative colitis and toxic megacolon. Known hypersensitivity to PEG. Do not take the medical device while using other devices or oral medicinal products: the osmotic power of PEG and the increase in gastrointestinal transit speed induced may negatively affect their effectiveness. In any case, consult your doctor before taking PEDIAPAX in the case of other therapies in progress. Do not use in the presence of known gastric or intestinal lesions.
Disposal : the expired device or in any case to be disposed of must be managed in accordance with the waste management regulations of the Local Management Authority. Do not under any circumstances dispose of the product or its packaging in the environment.
Conservation
Store the intact package in a dry place away from direct light or heat sources: remove and open the sachets only just before using them. Store the device below 25°C.
Format
20 divisible sachets of 13.125 g of powder for oral suspension.
Medical device in powder form for extemporaneous oral suspension useful in:
- Treatment of chronic constipation in children over 2 years of age and weighing 10 kg or more.
- Treatment of fecal impaction in children from the age of 3 years, defined as refractory constipation with fecal loading in the rectum and/or colon.
How to use
Chronic constipation : the usual starting dose in children between 2 and 6 years is half (1/2) sachet per day, in children aged 7 years and over one (1) sachet per day, dissolved:
- In 125 ml of still water (about 1 glass) for the whole sachet.
- In 62.5 ml of still water (about ½ glass) for the half sachet.
It is possible to dissolve the product in a liquid other than water (tea, milk, broth or fruit juice).
The dose can be increased or decreased to allow regular evacuation of soft stools. If it is necessary to increase the dose, it is best to do so every 2 days. The maximum dose required does not normally exceed 2 sachets per day. In the case of prolonged treatment, proceed with gradual interruption and a resumption of the same in the event of recurrence of constipation. Do not use the product for more than 30 consecutive days, if the symptoms persist consult your doctor.
PEDIAPAX can also be used on children under 2 years of age, starting from 6 months: for this age group, in order to define the dosage more precisely, the formulation in a bottle equipped with a measuring spoon is available.
Fecaloma : The diagnosis of fecaloma/fecal loading in the rectum must be confirmed by a physical or radiological examination of the abdomen and rectum. A treatment cycle for fecaloma with PEDIAPAX should last from 3 up to a maximum of 6 consecutive days, in the following manner:
| 3-6 years: | 2 sachets of PEDIAPAX |
| 7-10 years: | 3 sachets of PEDIAPAX |
| >10 years: | 4 sachets of PEDIAPAX |
A sachet means a whole sachet of 13.125 g (2 half sachets). The daily number of sachets must be taken divided into doses of 6.563 g (1/2 sachet) to be dissolved in 62.5 ml of water (about half a glass), all consumed within 12 hours. It is possible to dissolve the product in a liquid other than water (tea, milk, broth or fruit juice). The time interval between one intake and the next is calculated based on the number of sachets to be taken in 12 hours, so:
| N. sachets per day | N. of ½ sachets | 1 ½ sachets each |
| 2 | 4 | 3 hours |
| 3 | 6 | 2 hours |
| 4 | 8 | 1 hour and 30 min. |
For a personalized dosage, a dosage of 1-1.5 g/kg/day can be considered (and therefore also use half a dose of PEDIAPAX). The indicated treatment regimen must be interrupted once the obstruction has resolved. An indicator of such resolution is the passage of a large amount of stool. After resolution, it is recommended that the child follow an appropriate treatment program for the intestine, to prevent the onset of a new fecaloma (the dosage to prevent the recurrence of fecaloma is that for patients with chronic constipation).
Note : It is possible to prepare a larger volume of ready-to-use solution, for example by dissolving 6 sachets in 750 ml of water. In this case the solution can be stored covered in the refrigerator for up to 24 hours, and then discarded.
Warnings
Keep the device and any solution obtained out of the reach of children; Do not use the device after the expiry date shown on the package and sachet; Do not use if the package is damaged; Each sachet is for single use only and must be opened immediately before use: do not reuse sachets that have been partially used or opened at unknown times, as this method of use could lead to risks of contamination of the product. Do not exceed the recommended doses: in the event of an overdose, intense pain and abdominal distension may occur. Induced diarrhoea may also occur, with electrolyte disturbances caused by possible excessive evacuation. In the event of suspected overdose, contact your paediatrician immediately. When PEDIAPAX is used in high doses to treat fecal impaction, it should be administered with caution in patients with an altered swallowing reflex, reflux esophagitis or reduced levels of consciousness. If you forget to take a dose, do not take a double dose to catch up. During treatment with PEDIAPAX it is advisable to follow an appropriate diet, accompanied by the administration of an oral rehydration solution (ORS) to avoid dehydration. However, it is advisable to consult your doctor.
Known side effects : gastrointestinal disorders (abdominal pain, rumbling, diarrhea or loose stools) may appear especially in the initial phase of use, in addition to nausea, mild vomiting, abdominal distension, flatulence, inflammation and irritation of the perianal area, effects that normally improve by reducing the dose. Allergic reactions, including anaphylaxis, have been observed very rarely. Other symptoms of allergic reactions such as itching, urticaria and dyspnea. If side effects persist, stop treatment and contact your pediatrician for advice.
Contraindications and limitations of use : do not use in children under 2 years of age for the treatment of chronic constipation and in children under 3 years of age for the treatment of fecal impaction. For use under this age group, the use of the bottle with measuring spoon is recommended. Taking the device is not recommended in the case of: intestinal perforation or obstruction due to structural or functional disorders of the intestinal wall, ileum, serious inflammatory diseases of the intestinal tract, such as Crohn's disease, ulcerative colitis and toxic megacolon. Known hypersensitivity to PEG. Do not take the medical device while using other devices or oral medicinal products: the osmotic power of PEG and the increase in gastrointestinal transit speed induced may negatively affect their effectiveness. In any case, consult your doctor before taking PEDIAPAX in the case of other therapies in progress. Do not use in the presence of known gastric or intestinal lesions.
Disposal : the expired device or in any case to be disposed of must be managed in accordance with the waste management regulations of the Local Management Authority. Do not under any circumstances dispose of the product or its packaging in the environment.
Conservation
Store the intact package in a dry place away from direct light or heat sources: remove and open the sachets only just before using them. Store the device below 25°C.
Format
20 divisible sachets of 13.125 g of powder for oral suspension.
