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-15%
Bioprojet Pediapax Food Supplement Powder 400g
19.19€
22.58€
- Brand: BIOPROJET ITALIA Srl
- Product Code: 935543470
- EAN:
- Availability: In Stock
- Purchase 3 items for 18.81€ each
- Purchase 4 items for 18.42€ each
- Purchase 5 items for 18.04€ each
Pedia pax
MACROGOL 3350
pure, without electrolytes, without flavorings, without excipients
Gluten free
Useful for the treatment of constipation
and of fecaloma in the pediatric age
For a more targeted management of the dosage Ideal in the initial and final phase of the therapy of chronic constipation
Recommended dosage by ESPGHAN / NASPGHAN 2014 guidelines: 0.2-0.8 g / kg day
A teaspoon = 5 g of macrogol to be dissolved in half a glass of still water
• The dose can be increased or decreased according to individual response.
1. IDENTIFICATION, COMPOSITION AND PURPOSE OF USE OF THE MEDICAL DEVICE
1.1 Description and indications for use
Pediapax is a powdered medical device for extemporaneous oral suspension, suitable for:
• 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, defined as refractory constipation with fecal load in the rectum and / or colon.
1.2 Composition
Each bottle contains 400 g of Macrogol 3350. The Pediapax product does not contain gluten .
1.3 Validity
36 months.
1.4 Mechanism of action
The effectiveness of the device is due to the characteristics of polyethylene glycol (PEG), a high molecular weight polymer, metabolically inert, not degraded by the intestinal bacterial flora; on the long linear polymeric chains, by means of hydrogen bonds, the water molecules are retained, which hydrate the fecal mass by stimulating peristalsis. Pediapax is not absorbed in the intestine and is excreted unchanged.
2. METHOD OF USE
2.1 Chronic constipation
Unless otherwise prescribed by a doctor, it is advisable to use Pediapax in the following ways.
The dose can be increased or decreased according to the individual response to treatment. The most correct daily dosage is to be decided on the basis of the child's weight and the severity of constipation.
In any case, it is advisable to consult a doctor.
Use the product in pediatric children only after medical advice.
The maximum dose needed does not normally exceed 30 g of product per day.
Based on the dosage indicated above, take the quantity of product with the aid of the measuring cup with notches that allow you to dose 2.5 g (primatacca) and 5 g (level measuring cup) of product.
Dissolve a level measuring spoon (equal to 5 g) in 62.5 ml of still water (about ½ glass).
It is possible to divide the daily dose into several administrations.
2.2 Fecaloma
The diagnosis of fecal impaction / fecal load in the rectum should be confirmed by a physical or radiological examination of the abdomen and rectum.
The dosage recommended by the ESPGHAN and NASPGHAN guidelines is 1-1.5 g per body kg per day.
Therefore the posology for the treatment of fecaloma with Pediapax is the following:
The daily dosage must be taken divided into doses of 5 g (level measuring spoon) to be left in about 62.5 ml of water (about half a glass) to be consumed entirely over 12 hours, for a correct intake of the product we recommend that you contact the attending physician . The treatment must be interrupted once the occlusion is resolved, but in any case it must last a maximum of 6 consecutive days. An indicator of this resolution is the passage of a large amount of stool. After resolution, it is recommended to have the child follow an appropriate treatment program for the intestine, to prevent the onset of a new fecaloma (the dosage to prevent relapse of the faecaloma is that for patients with chronic constipation - Ref. § 2.1) .
NOTE: A larger volume of ready-to-use solution can be prepared. In this case, the solution can be stored covered in the refrigerator for up to 24 hours, and then discarded.
3. KNOWN SIDE EFFECTS
Gastrointestinal disturbances (abdominal pain, borborygia, diarrhea or loose stools), as well as nausea, mild vomiting, abdominal distension, flatulence, inflammation and perianal irritation may appear especially in the initial phase of use, effects which usually improve by reducing the dose. . Allergic reactions, including anaphylaxis, have been observed very rarely. Other symptoms of allergic reactions such as itching, hives and wheezing. If the side effects persist, suspend the treatment and contact your pediatrician for a consultation.
4. METHOD OF STORAGE
Store the unopened package in a dry place away from direct light or heat sources. Store the device below 25 ° C.
5. WARNINGS AND PRECAUTIONS
Keep the device and any solution obtained away from children.
Do not use the device after the expiry date stated on the package.
Do not use in case of damaged packaging.
Absolutely do not exceed the recommended doses: in case of overdose, intense pains, abdominal distension may occur.
Induced diarrhea can also occur, with electrolyte disturbances caused by possible excessive evacuation.
If overdose is suspected, contact your pediatrician immediately.
When Pediapax is used in high dosages to treat fecal impaction, it should be administered with caution in patients with impaired swallowing reflex, reflux esophagitis or reduced levels of consciousness. In case 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 adequate diet, accompanied by the administration of an oral rehydration solution (ORS) to avoid dehydration, however, it is advisable to consult your doctor.
6. CONTRAINDICATIONS AND LIMITATIONS OF USE
Do not use under 2 years for the treatment of chronic constipation and under 3 years for the treatment of fecal impaction. The use of the device is not recommended in case of: intestinal perforation or obstruction due to structural or functional disorders of the intestinal wall, ileus, serious inflammatory pathologies of the intestinal tract, such as Crohn's disease, ulcerative colitis and toxic. Known hypersensitivity to PEG. Do not take the medical device while using other oral devices or medicinal specialties: the osmotic power of the PEG and the induced increase in gastrointestinal transit speed can adversely affect their effectiveness. In any case, consult your doctor before taking Pediapax in case of other therapies in progress. Do not use in case of known gastric or intestinal lesions.
7. INTERACTIONS WITH DRUGS AND FOOD SUPPLEMENTS
To date, no drug interactions are known but it is advisable that the product be taken at least 2 hours from that of the drugs administered orally since the osmotic power of the macrogol and the increase in the gastrointestinal transit speed induced can negatively affect their efficacy. However, consult your doctor before taking Pediapax in case of other therapies in progress.
8. DISPOSAL
The expired device or in any case to be eliminated must be managed in accordance with the waste management regulations of the Local Managing Authority. Never dispose of the product or its packaging in the environment.
Format
400 g bottle with 5 g measuring spoon with half dose notch.
MACROGOL 3350
pure, without electrolytes, without flavorings, without excipients
Gluten free
Useful for the treatment of constipation
and of fecaloma in the pediatric age
For a more targeted management of the dosage Ideal in the initial and final phase of the therapy of chronic constipation
Recommended dosage by ESPGHAN / NASPGHAN 2014 guidelines: 0.2-0.8 g / kg day
A teaspoon = 5 g of macrogol to be dissolved in half a glass of still water
• The dose can be increased or decreased according to individual response.
1. IDENTIFICATION, COMPOSITION AND PURPOSE OF USE OF THE MEDICAL DEVICE
1.1 Description and indications for use
Pediapax is a powdered medical device for extemporaneous oral suspension, suitable for:
• 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, defined as refractory constipation with fecal load in the rectum and / or colon.
1.2 Composition
Each bottle contains 400 g of Macrogol 3350. The Pediapax product does not contain gluten .
1.3 Validity
36 months.
1.4 Mechanism of action
The effectiveness of the device is due to the characteristics of polyethylene glycol (PEG), a high molecular weight polymer, metabolically inert, not degraded by the intestinal bacterial flora; on the long linear polymeric chains, by means of hydrogen bonds, the water molecules are retained, which hydrate the fecal mass by stimulating peristalsis. Pediapax is not absorbed in the intestine and is excreted unchanged.
2. METHOD OF USE
2.1 Chronic constipation
Unless otherwise prescribed by a doctor, it is advisable to use Pediapax in the following ways.
| Weight kg) | Maximum daily dose registered mail |
| 10-12 kg | 2 tsp |
| 13-20 kg | 2 ½ tsp |
| 21-25 kg | 3 tsp |
| 26-30kg | 4 tsp |
| > 30 kg | 5 teaspoons |
The dose can be increased or decreased according to the individual response to treatment. The most correct daily dosage is to be decided on the basis of the child's weight and the severity of constipation.
In any case, it is advisable to consult a doctor.
Use the product in pediatric children only after medical advice.
The maximum dose needed does not normally exceed 30 g of product per day.
Based on the dosage indicated above, take the quantity of product with the aid of the measuring cup with notches that allow you to dose 2.5 g (primatacca) and 5 g (level measuring cup) of product.
Dissolve a level measuring spoon (equal to 5 g) in 62.5 ml of still water (about ½ glass).
It is possible to divide the daily dose into several administrations.
2.2 Fecaloma
The diagnosis of fecal impaction / fecal load in the rectum should be confirmed by a physical or radiological examination of the abdomen and rectum.
The dosage recommended by the ESPGHAN and NASPGHAN guidelines is 1-1.5 g per body kg per day.
Therefore the posology for the treatment of fecaloma with Pediapax is the following:
| Weight kg) | Recommended maximum daily dose |
| 14-17 kg | 4 tsp |
| 18-22 kg | 5 tsp |
| 23-27kg | 6 tsp + half |
| 28-34 kg | 8 teaspoons |
| 35-39 kg | 9 tsp |
| > 40 kg | 10 tsp + half |
The daily dosage must be taken divided into doses of 5 g (level measuring spoon) to be left in about 62.5 ml of water (about half a glass) to be consumed entirely over 12 hours, for a correct intake of the product we recommend that you contact the attending physician . The treatment must be interrupted once the occlusion is resolved, but in any case it must last a maximum of 6 consecutive days. An indicator of this resolution is the passage of a large amount of stool. After resolution, it is recommended to have the child follow an appropriate treatment program for the intestine, to prevent the onset of a new fecaloma (the dosage to prevent relapse of the faecaloma is that for patients with chronic constipation - Ref. § 2.1) .
NOTE: A larger volume of ready-to-use solution can be prepared. In this case, the solution can be stored covered in the refrigerator for up to 24 hours, and then discarded.
3. KNOWN SIDE EFFECTS
Gastrointestinal disturbances (abdominal pain, borborygia, diarrhea or loose stools), as well as nausea, mild vomiting, abdominal distension, flatulence, inflammation and perianal irritation may appear especially in the initial phase of use, effects which usually improve by reducing the dose. . Allergic reactions, including anaphylaxis, have been observed very rarely. Other symptoms of allergic reactions such as itching, hives and wheezing. If the side effects persist, suspend the treatment and contact your pediatrician for a consultation.
4. METHOD OF STORAGE
Store the unopened package in a dry place away from direct light or heat sources. Store the device below 25 ° C.
5. WARNINGS AND PRECAUTIONS
Keep the device and any solution obtained away from children.
Do not use the device after the expiry date stated on the package.
Do not use in case of damaged packaging.
Absolutely do not exceed the recommended doses: in case of overdose, intense pains, abdominal distension may occur.
Induced diarrhea can also occur, with electrolyte disturbances caused by possible excessive evacuation.
If overdose is suspected, contact your pediatrician immediately.
When Pediapax is used in high dosages to treat fecal impaction, it should be administered with caution in patients with impaired swallowing reflex, reflux esophagitis or reduced levels of consciousness. In case 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 adequate diet, accompanied by the administration of an oral rehydration solution (ORS) to avoid dehydration, however, it is advisable to consult your doctor.
6. CONTRAINDICATIONS AND LIMITATIONS OF USE
Do not use under 2 years for the treatment of chronic constipation and under 3 years for the treatment of fecal impaction. The use of the device is not recommended in case of: intestinal perforation or obstruction due to structural or functional disorders of the intestinal wall, ileus, serious inflammatory pathologies of the intestinal tract, such as Crohn's disease, ulcerative colitis and toxic. Known hypersensitivity to PEG. Do not take the medical device while using other oral devices or medicinal specialties: the osmotic power of the PEG and the induced increase in gastrointestinal transit speed can adversely affect their effectiveness. In any case, consult your doctor before taking Pediapax in case of other therapies in progress. Do not use in case of known gastric or intestinal lesions.
7. INTERACTIONS WITH DRUGS AND FOOD SUPPLEMENTS
To date, no drug interactions are known but it is advisable that the product be taken at least 2 hours from that of the drugs administered orally since the osmotic power of the macrogol and the increase in the gastrointestinal transit speed induced can negatively affect their efficacy. However, consult your doctor before taking Pediapax in case of other therapies in progress.
8. DISPOSAL
The expired device or in any case to be eliminated must be managed in accordance with the waste management regulations of the Local Managing Authority. Never dispose of the product or its packaging in the environment.
Format
400 g bottle with 5 g measuring spoon with half dose notch.