Moviprep powder for solution inside the sachet and 111.896g 2 pc + b sachet 10.600g 2 pieces

Description

Composition
Active substance:
A sachet contains: macrogol-3350 100.00 g anhydrous sodium sulfate 7,500 g, 2,691 g of sodium chloride, potassium chloride 1.015 g
Bytes sachet contains: ascorbic acid 4.700 g Sodium ascorbate 5.900 g
Excipients:
A sachet contains: aspartame (E951) 0.233 g, 0.117 g acesulfame potassium, a flavoring lemon V3938-1 N1 0,340 g
Description:
Sachet A: Powder from white to yellow in color with a characteristic lemon smell.
Sasha B: Powder from white to light brown.
Product form:
powder for solution for oral administration. By 111.896 grams of the drug in laminated sachets A. At 10,600 g in laminated sachets B. One sachet A and sachet B in a plastic bag. By two pack is placed in a cardboard box, together with instructions for use.
Contraindications
Hypersensitivity to any component of the drug violation gastric emptying (gastroparesis) ileus perforation or risk of perforating gastrointestinal phenylketonuria bodies (because of the content in the composition aspartame) deficiency of glucose-6-phosphate dehydrogenase (because of the content in the composition of ascorbic acid), toxic megacolon, It is a complication of severe inflammatory bowel disease, including Crohn’s disease and ulcerative colitis age 18 years unconsciousness
Precautions impaired gag reflex, a tendency to aspiration or regurgitation impaired consciousness dehydration severe heart failure (III-IV NYHA functional class classification) severe renal failure (creatinine clearance
If you have one of these diseases, before taking MOVIPREPP ® P product should consult a doctor.
Indications
Preparation for diagnostic tests (endoscopy, X-ray and other examinations of the intestine) and surgical interventions that require a bowel movement.
Interaction with other drugs
Diarrhea caused by reception MOVIPREPP ® P drug may impair the absorption of other concomitant medication. Medications taken orally one hour prior to the laxative effect of the drug (e.g., oral contraceptives) can be derived from the blood, not absorbing.
Overdose
Symptoms: severe diarrhea, which can lead to disruption of water and electrolyte balance. Treatment: usually sufficient to use a large amount of liquid, preferably fruit juices. If necessary – intravenous infusion solutions to restore water and electrolyte balance.
pharmachologic effect
Pharmacological group:
Laxative.
Pharmacodynamics:
Oral administration of electrolyte solution based on macrogol, causes mild diarrhea which result becomes rapid emptying of the contents of the colon. Macrogol 3350, sodium sulphate and ascorbic acid exert an osmotic effect, causing a laxative effect. Macrogol-3350 increases the volume of stool that leads to increased intestinal motility. Electrolytes that are part of the drug, as well as additional fluids prevent disruption of water-electrolyte balance.
Pharmacokinetics:
Macrogol-3350 is not changed while in the intestine. It is practically not absorbed from the gastrointestinal tract (GIT). Absorbed amount of macrogol 3350 eliminated via the kidneys. Ascorbic acid is absorbed mainly in the small intestine by active sodium-dependent saturable transport. There is an inverse relationship between the dose received and the percentage of absorbed dose. At an oral dose of 30 to 180 mg of absorbed about 70-85% of the dose. Upon subsequent oral administration of ascorbic acid in the amount of up to 12 g total 2 g absorbed after oral administration of large doses of ascorbic acid and in case of exceeding its plasma concentration of 14 mg / L ascorbic acid absorbed derived mainly as unchanged via the kidneys.
Pregnancy and breast-feeding
Experience of using MOVIPREP® drug during pregnancy and lactation is limited. MOVIPREP® drug should be used only in cases where the expected benefit to the mother outweighs the potential risk to the fetus or child (consult your doctor).
Conditions of supply of pharmacies
Without a prescription.
side effects
Diarrhea is an expected effect of the preparation of the bowel. Due to the nature of the effects of the drug during the bowel preparation procedure undesirable effects have been reported in most patients. Despite some differences in specific cases, the most common adverse effects for macrogol-containing drugs are: nausea, vomiting, bloating, abdominal pain, irritation of the anus, and sleep disorders. As a result of diarrhea and / or vomiting may develop dehydration. As with the reception of other products, which include macrogol, various allergic reaction including rash, hives, itching, dyspnea, angioedema, and anaphylaxis.
Undesirable effects are classified according to frequency of occurrence:
Very common:> 1/10
Common:> 1/100,
special instructions
Patients elderly, debilitated or malnourished patients with different comorbidities patients prone to regurgitation or aspiration, with disturbance of consciousness, particularly if the drug is administered through a nasogastric tube, the drug should be used under medical supervision. Cooked MOVIPREP® drug solution does not replace the regular liquid intake, so it is necessary to maintain a sufficient liquid level in the body. In malnourished, debilitated patients, patients with various diseases associated with clinically significant renal dysfunction, arrhythmia and the risk of electrolyte imbalance should consider the need to determine the level of electrolytes at baseline and after treatment, assessment of renal function and performance of the ECG research. In rare cases it observed serious arrhythmias, including atrial fibrillation associated with ionic osmotic laxative for bowel preparation. These phenomena occur predominantly in patients with existing cardiac risk factors and electrolyte imbalance. In case of patients of any symptoms indicative of arrhythmia or shifts of water / electrolyte balance (e.g., edema, dyspnea, fatigue, heart failure), determine the level of electrolytes in the blood plasma, perform an electrocardiogram and proper treatment of all discovered abnormalities. If the patient has symptoms such as pronounced flatulence, bloating, abdominal pain or any other reaction, further complicating the drug, you need to slow down or temporarily stop taking the drug and consult a doctor. In treating patients who are dieting controlled sodium, it should be considered that the product contains 56.2 mmol of sodium absorbed in 1 liter of solution. When treating patients with impaired kidney function or patients who are dieting controlled potassium, one should consider that the product contains 14.2 mmol of potassium per 1 liter of solution.
Effect on the ability to drive mechanisms and
During the course of preparation for medical procedures MOVIPREP® drug is recommended to refrain from driving and other mechanisms (see. Section “Side effects”).
Storage conditions
At a temperature of not higher than 25 C.
The reconstituted solution stored at temperatures below 8 C.
Keep out of the reach of children.
Dosing and Administration
Before carrying out the diagnostic study (endoscopic, radiologic and other bowel studies) and surgical intervention is necessary to pass an important bowel preparation process that includes 3 stages: 1. Compliance with special diets; 2. Selection of drug reception circuits depending on the time of the study or surgery; 3. Conduct bowel cleaning process using MOVIPREP® preparation. Detailed information for each step is shown below.
1. Compliance with special diets: 3 days prior to the study or surgery is recommended to follow a special diet according to the list of authorized products:
Allowed: All protein foods, boiled meat and poultry (except sausage), lean fish, low-fat dairy products, and eggs. Jelly, sugar, honey. Fluid-clear broth, tea without milk, coffee without milk, fruit drinks without fruit juice without pulp, soft drinks unpainted water.
Forbidden: the whole plant foods – vegetables, fruits, berries, herbs, cereals, nuts, cereal, bread. Fluid-colored juices, alcohol, carbonated drinks. All the products not included in the approved list.
2. Selection of the drug is MOVIPREP® schemes depending on the time of the survey or operation: You must choose a doctor the most appropriate scheme for admission of the drug MOVIPREP® depending on the time of the diagnostic study and the daily activity of the patient. Before use the single-stage surgery evening reception circuit MOVIPREP® preparation
colonoscopy Time from 8-00 to 10-00
Diet for 3 days prior to colonoscopy: according to the list of authorized products. Diet 2 days prior to colonoscopy: according to the list of authorized products. Diet the day before the colonoscopy: Breakfast: according to the list of approved products; lunch and dinner: only allowed clear liquids.
One-step part scheme: day before colonoscopy: 19: 00 – 20: 00 to take the first liter solution of the drug; 21: 00 – 22: 00 to receive a second solution preparation liter. After each liter of the drug to drink 500 ml of liquid permitted.
colonoscopy Time from 10-00 to 14-00
Diet for 3 days prior to colonoscopy: according to the list of authorized products. Diet 2 days prior to colonoscopy: according to the list of authorized products. Diet the day before the colonoscopy: breakfast and a light lunch and 13: 00: According to the list of approved products; Dinner: only allowed clear liquids.
Two-stage scheme: day before colonoscopy: 20: 00 – 21: 00 to take the first liter drug solution. Colonoscopy: 06: 00 – 07: 00 to take the second liter of the drug solution. After each liter of the drug to drink 500 ml of liquid permitted.
colonoscopy Time from 14-00 to 19-00
Diet for 3 days prior to colonoscopy: according to the list of authorized products. Diet 2 days prior to colonoscopy: according to the list of authorized products. Diet the day before the colonoscopy: breakfast, lunch and light dinner 18: 00: According to the list of authorized products. On the day of the colonoscopy in the morning: only allowed clear liquids
Single-Stage morning scheme: Day colonoscopy: 08: 00 – 09: 00 to take the first liter solution of the drug; 10: 00 – 11: 00 to receive a second solution preparation liter. After each liter of the drug to drink 500 ml of liquid permitted.
If necessary, while taking the drug MOVIPREP® adjusted by the attending physician in compliance with specified time intervals.
3. Conduct bowel cleaning process using MOVIPREP® preparation: Packing MOVIPREP® preparation A comprises two sachets and two sachets B, from which solution is prepared for oral administration. Regardless of the weight of the patient MOVIPREP® total dose of drug to the intestine cleaning quality is 2 liters of solution of the drug. 1) Preparation of first solution liter MOVIPREP® preparation: It is necessary the content of one sachet A sachet and one B is completely dissolved in a small amount of non-carbonated drinking water at room temperature, the solution with water to bring the volume to 1 liter and mix. 2) Preparation of second solution liter MOVIPREP® preparation: repeated cooking algorithm drug solution in step 1 (see above) using the remaining sachet A sachet and B. The prepared solution MOVIPREP® drug should drink within 1-2 hours, such as 1. glass every 15-30 minutes.
IMPORTANT: while taking the drug MOVIPREP® is highly recommended to use an additional 1 liter of another liquid: non-carbonated water, broth, fruit juice without pulp, soft drinks, tea or coffee without milk (can be with sugar or honey). should not eat solid food since the beginning of reception of the drug solution MOVIPREP® until the end of the diagnostic studies or surgical intervention. When a two-stage (one liter overnight and one liter morning) and single-stage evening and morning dosing schemes (regardless of destination drugs having a sedative action), the drug should be stopped at least 2 hours, but not more than 4 hours before the starting the procedure, and other fluids reception (according to the list of authorized products) should be discontinued at least 1 hour, but not more than 4 hours before the procedure. The criterion readiness for diagnostic testing or surgery is the appearance of the liquid transparent or almost transparent, slightly colored chair. When receiving the drug solution MOVIPREP® home must be considered an appropriate time period for the trip to the clinic for the procedure. Loose stools appear usually within 1 hour after the beginning of reception of each liter of the preparation and ends MOVIPREP® usually 1-2 hours. During defecation dosing frequency can be increased to 12-15 times. If you are taking any medication, be sure to tell your doctor before taking the drug MOVIPREP®.
If you have any questions, be sure to ask their doctor.
Features of the application in selected groups of patients
Patients with impaired renal function Use caution when taking this drug in patients with severe renal impairment (creatinine clearance
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist