MEDICAL POSITION PAPER Management Guidelines of Eosinophilic Esophagitis A. Papadopoulou, yS. Koletzko, zR. Heuschkel, J.A. Dias, jjK.J. Allen, S.H. Murch, S. Chong, F. Gottrand, yyS. Husby, zzP. Lionetti, M.L. Mearin, jjjjF.M. Ruemmele, M.G. Scha¨ppi, A. Staiano, M. Wilschanski, and yyyY. Vandenplas, for the ESPGHAN Eosinophilic Esophagitis Working Group and the Gastroenterology Committee
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Bi-peglyte enIMPORTANT: PLEASE READ
Sodium Sulphate……………5.74 g Sodium Bicarbonate……….1.69 g Sodium Chloride……………1.46 g Bowel Prep Kit
Potassium Chloride…………0.76 g Each blister-pack of Bisacodyl delayed release tablets, USP Polyethylene Glycol 3350 and Electrolytes for Oral Solution USP and contains: three (3) tablets of bisacodyl 5 mg each. Bisacodyl Delayed Release Tablets USP What the nonmedicinal ingredients are:
This leaflet is part III of a three-part "Prescribing
PEG/Electrolytes powder sachets (in alphabetical order): Fruit
Information" published when Bi-PEGLYTE® was approved
flavours and Sodium Saccharin. for sale in Canada and is designed specifically for Consumers.
This leaflet is a summary and will not tell you everything about
Bisacodyl tablets (in alphabetical order): D&C Yellow No.10
Bi-PEGLYTE®. Contact your doctor or pharmacist if you
Aluminum Lake, FD&C Yellow No.6 Aluminum Lake, have any questions about the drug.
Hypromellose, Lactose Monohydrate, Magnesium Stearate, Methylated Silica, Methylcellulose, Microcrystalline Cellulose, ABOUT THIS MEDICATION
Polydextrose, Polydimethylsiloxane, Polyethylene Glycol, Polyvinyl Acetate Phthalate, Silica, Sodium Alginate, Sodium What the medication is used for:
Bicarbonate, Sodium Carboxymethylcellulose, Sorbic Acid, Bi-PEGLYTE® is used for cleansing of the colon as a preparation Stearic Acid, Sulphuric Acid, Talc, Titanium Dioxide, Triacetin, for colonoscopy in adults. Triethyl Citrate. What it does:
What dosage forms it comes in:
Bi-PEGLYTE® produces a watery stool which cleanses the bowel Bi-PEGLYTE® is a kit containing two sachets of before colonoscopy examination. The bisacodyl component of PEG/Electrolytes powder for reconstitution (each sachet is Bi-PEGLYTE® acts as a stimulant laxative directly on the bowel to dissolved into 1 L of water – see "Proper use of this Medication") induce muscle contractions and to promote fluid accumulation in and one blister-pack containing 3 tablets of 5 mg each of the bowel, and the polyethylene glycol binds to the water to help bisacodyl. The entire contents of the kit should be used for the laxation and together the ingredients speed bowel emptying. The product to be effective. electrolytes help maintain the salt balance in this process. WARNINGS AND PRECAUTIONS
When it should not be used:
Do not use if you are hypersensitive (allergic) to any ingredient in BEFORE you use Bi-PEGLYTE® talk to your doctor or
this formulation (see "What the nonmedicinal ingredients are"). pharmacist if:
You have taken any other medication within two hours Do not take if you have any of the following stomach/intestine of when you plan to start the PEG/Electrolyte solution conditions (ask your doctor if you are unsure): (you may be removing this medication from your Ileus (blockage in the bowel) gastrointestinal tract by taking the PEG/Electrolyte Gastric retention (problems with food and fluid emptying You have abdominal pain, nausea, or vomiting Gastrointestinal (GI) obstruction (a blockage in bowel) You have a history of electrolyte imbalance (e.g., change Bowel perforation (an opening in the wall of your in blood salts (low blood sodium)) or are using diuretics stomach or intestine) You have ulcerative colitis or any other inflammatory Toxic colitis (inflamed large bowel with damage to the bowel disease (e.g., Crohn's disease) intestinal wall) You are pregnant or nursing Toxic megacolon (acute swelling of the large bowel) You have difficulty swallowing or have a pronounced Acute surgical abdomen gag reflex or are prone to vomiting Appendicitis (painful swelling and infection of the You have any allergies to this drug or its ingredients appendix, a small pouch attached to the large intestine) Talk to your doctor if you have kidney or heart problems. Renal Gastroenteritis (inflammation in the gastrointestinal tract) impairment (kidney problems )or heart failure (heart problems), Diverticulitis (a digestive disease found in the large increase the tendency to bring up the stomach contents into the esophagus and increase the tendency to bring food down or fluid What the medicinal ingredients are:
Each sachet of PEG/Electrolytes powder gastrointestinal lavage Inform your doctor immediately if you experience severe
preparation contains: abdominal pain or rectal bleeding.
Polyethylene Glycol 3350…59.55 g Bi-PEGLYTE® Prescr b IMPORTANT: PLEASE READ
INTERACTIONS WITH THIS MEDICATION
Oral medications taken within 2 hours of the start of administration In case of drug overdose, contact a health care practitioner, of the PEG/Electrolytes powder may be flushed from the hospital emergency department or regional Poison Control Centre gastrointestinal tract and not absorbed. immediately, even if there are no symptoms.
Tell your doctor and pharmacist about all the medicines you are taking, including prescription and non-prescription medications, SIDE EFFECTS AND WHAT TO DO ABOUT THEM
vitamins, nutritional supplements, and herbal products. Nausea, abdominal fullness and bloating are the most frequent PROPER USE OF THIS MEDICATION
side effects occurring in up to half of patients taking PEG/Electrolytes powder. Abdominal cramps, vomiting and anal No solid food or milk (clear liquids only) should be taken on the irritation occur less frequently. These side effects normally do day of the preparation. No antacids should be taken within one hour of taking the bisacodyl tablets. Your physician will tell you what time of the day to start your treatment. Mild cramping has occurred in some patients after bisacodyl Step 1: Take the 3 bisacodyl tablets (total of 15 mg) with water at
a time recommended by your physician. Do not chew or crush
Bi-PEGLYTE® may cause loss of body fluid (dehydration) and the tablets.
changes in blood salts (electrolytes) in your blood. These changes Step 2: Prepare the PEG/Electrolyte solution as follows:
- Dissolve the entire contents of one sachet in 1 L
- kidney problems
(32 ounces) of water and mix rapidly until a clear solution - abnormal heartbeats
forms. No additional ingredients, e.g. flavouring, should be added to the solution. Drink sufficient amount of balance salt-containing fluid as - Refrigerate the solution as chilling improves the taste.
directed by your doctor to prevent loss of body fluid and related - Use the freshly-made solution within 48 hours and
discard unused portion.
Step 3: Wait for a bowel movement.
SERIOUS SIDE EFFECTS, HOW OFTEN THEY
HAPPEN AND WHAT TO DO ABOUT THEM
Do not worry if no bowel movement occurs within 6 hours of taking the bisacodyl tablets. After 6 hours (with or without a
Symptom / effect
Talk with your
bowel movement), begin to drink the solution as follows:
- Rapidly drink a glassful (240 mL) of the PEG/Electrolyte
solution every 10 minutes until the 1 L solution is doctor or
finished. Repeat Step 2 with the other PEG/Electrolytes pharmacist
powder sachet, drinking 240 mL of the solution every 10 minutes, or as directed by a physician. Make sure to
drink all of the solution.
You will begin to have a watery bowel movement within 1 hour bleeding
and continue to have loose bowel movements for 1 to 2 hours after finishing the solution. Lavage is complete when fecal discharge is Isolated
such as skin
Abdominal bloating or distention may occur before the first bowel rash, hives
movement. If your abdominal distention or discomfort continues, and runny
stop drinking the PEG/Electrolyte solution temporarily or drink each portion at longer intervals until your symptoms disappear. If you experience severe bloating, distention or abdominal pain, This is not a complete list of side effects. For any unexpected
administration of the solution should be slowed or temporarily effects while taking Bi-PEGLYTE®, contact your doctor or
discontinued until the symptoms abate. Report these events to your physician. Inform your doctor immediately if you
experience severe abdominal pain or rectal bleeding.
Bi-PEGLYTE® Prescr b IMPORTANT: PLEASE READ
HOW TO STORE IT
Store the contents of the Bi-PEGLYTE® carton at room temperature (15-30°C). The freshly-reconstituted PEG/Electrolyte solution should be used within 48 hours if stored at room temperature. Discard unused portion. Keep out of reach of children. REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected adverse reactions associated
with the use of health products to the Canada Vigilance
Program by one of the following 3 ways:
• Report online at www.healthcanada.gc.ca/medeffect
• Call toll-free at 1-866-234-2345
• Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Postal Locator 0701E
Postage paid labels, Canada Vigilance Reporting Form
and the adverse reaction reporting guidelines are available
on the MedEffect™ Canada Web site at
NOTE: Should you require information on the management of
side effects, contact your health professional. The Canada
Vigilance Program does not provide medical advice.
This document plus the full prescribing information, prepared for health professionals can be found by contacting the sponsor This leaflet was prepared by PENDOPHARM, Division of Pharmascience Inc. Last revised: July 13, 2012 ® Registered trademark of Pharmascience Inc. Bi-PEGLYTE® Prescr b
LYMPHATIC FILARIASIS MORBIDITY PROJECT SURGICAL HANDBOOK An Aid to District Hospital Surgeons 2nd edition, Summer 2007 LF -Filaricele surgery handbook* IMPORTANT NOTICE: Techniques described in this Handbookare only for treating LF patients who have normal scrotal skin! Surgical techniques described here and during The West Africa LF-Morbidity Project's training workshops are contraindicated inpatients with significant lymphoedema of the scrotal skin,elephantiasis of the scrotum, or lymph-scrotum. Such conditionsmay generally require reconstructive surgery.