Eziklen concentrate for solution into 176ml vials 2 piece complete with polypropylene cup

Description

Composition
Active substance:
1 bottle contains a drug:
Sodium sulfate, anhydrous 17.510 g;
Magnesium sulfate heptahydrate 3.276;
Potassium Sulfate 3,130.
Excipients:
Sodium benzoate 0.098 g Citric acid anhydrous 0.315 g, malic acid 0.315 g, 0.3025 g sucralose, flavors fruit cocktail 0.7875 g, purified water 169.641 g
Description:
Transparent or slightly opalescent liquid with a fruity odor.
Product form:
Concentrate for oral solution.
176 ml of the concentrate in a transparent bottle made of polyethylene terephthalate dark brown with 180 ml sealed with a screw cap of high density polyethylene, protected from accidental opening by children.
Two vials with the concentrate and another polypropylene beaker for breeding and reception placed together with instruction for use in a cardboard pack.
Contraindications
Hypersensitivity to the active ingredients or to any component of the drug;
Gastrointestinal obstruction or suspected gastrointestinal obstruction;
intestinal perforation;
Violations of gastric emptying (including gastroparesis);
Bowel obstruction;
Toxic colitis, toxic megacolon or;
Profuse vomiting;
Severe dehydration;
Congestive heart failure;
ascites;
Severe renal failure (GFR
The active phase of inflammatory bowel disease (such as Crohn’s disease, ulcerative colitis);
Pregnancy and lactation;
Children up to age 18 years.
Carefully.
Elderly age; disorders of the lung or kidney function moderate; impaired liver function; simultaneous administration of drugs affecting the concentration of electrolytes: calcium channel blockers, diuretics, drugs lithium or other drugs of similar action; simultaneous application of drugs, prolonging the interval QT; decrease gastrointestinal motility (including a history..), the presence of surgical procedures on the gastrointestinal tract, leading to disruption of motility; Patients with impaired gag reflex, prone to regurgitation and aspiration; malnourished, debilitated patients; in patients with clinically significant cardiac dysfunction; in patients who have a high risk of water and electrolyte imbalance (including hyponatraemia and hypokalemia).
Indications
Eziklen® The drug is designed to cleanse the colon in adult patients in preparation for endoscopic and radiological studies of the colon or surgical procedures that require the lack of content in the colon.
Interaction with other drugs
As with any other drugs for bowel cleansing:
With caution in patients receiving drug therapy affecting the concentration of electrolytes blockers “slow” calcium channel blockers, diuretics, drugs lithium or other drugs of similar action.
Caution must be exercised when taking drugs prolonging the interval QT.
Diarrhea is an expected effect, and ingestion of other drugs for 1 – 3 hours after the start of dosing to Eziklen; and bowel cleansing prior to closure process can lead to leaching of their gastrointestinal tract and absorption disturbance. Can be modified therapeutic effect of drugs used regularly inside having a narrow therapeutic range or short half-life (e.g., oral contraceptives, antiepileptic drugs, hypoglycemic drugs, antibiotics, levothyroxine sodium, digoxin and the like. D.).
Overdose
In the case of overdose or misuse (e.g., the use of undiluted preparation and / or receive an insufficient amount of water) may experience nausea, vomiting, diarrhea, and electrolyte abnormalities. Typically, in this case a symptomatic therapy, including fluid intake by mouth.
In rare cases of overdose associated with severe metabolic disorders, conducting intravenous rehydration is recommended.
pharmachologic effect
Pharmacological group:
Osmotic laxative
Pharmacodynamics:
Eziklen is an osmotic laxative. The mechanism of drug action attributable primarily limited by saturable active transport process sulfates. Upon reaching the saturation absorption threshold sulfates remain in the bowel lumen.
Osmotic effect unabsorbed sulfates and ingestion of large volumes of water causes water retention in the gut, which provides a laxative effect, causing a profuse watery diarrhea, and results in a bowel cleansing.
Pharmacokinetics:
Absorption sulfate is limited by saturable active transport process; absorbed sulfates derived mainly kidneys. In clinical studies, after ingestion, similar in content with the drug Eziklen® sulfates, six healthy volunteers (fractional application mode, i.e., receiving two doses with an interval of 12 hours) the maximum concentration (Cmax) in the serum was observed after approximately sulfates 16 hours after the first dose and 5 hours after the second dose and amounted to 499.50 micromol / l compared to baseline 141 – 467 pmol / l, middle – 335 pmol / l. Then, the serum concentration of sulfates decreased with a half-life of 8.5 hours.
The main route of elimination is the excretion of sulfate intestine (about 70% of the amount taken).
Systemic exposure sulfates: AUC (area under the curve “concentration-time”) and the Cmax after administration Eziklen® was investigated in a comparative study in healthy volunteers in 6 patients with impaired renal function moderate severity (creatinine clearance of 30 to 49 ml / min) and 6 patients with impaired liver function mild or moderate severity (according to Child-Pugh: a (N = 5) and B (N = 1), respectively). Impaired renal function decreased the amount of sulfates outputted kidneys. Mean values ​​of AUC and Cmax sulfates were approximately 50% higher in patients with impaired renal function compared with healthy volunteers. Systemic exposure to the drug concentration on the sulphate not dependent on abnormal liver function. In all three treatment groups in serum concentration of sulphates returned to its original value at the 6 th day after taking the drug Eziklen®. In this study, the drug Eziklen® not resulted in clinically significant increase in the blood concentration of sulphate in patients with impaired hepatic or renal function.
Pregnancy and breast-feeding
Pregnancy.
Studies of reproductive function in animals using sodium sulfates, magnesium and potassium were not conducted.
Data on the use of the drug in pregnant women are missing.
The drug Eziklen: not recommended for use during pregnancy.
Breast-feeding.
It is not known whether there is penetration of the drug Eziklen® breast milk.
We can not exclude the risk to the newborn / infant.
Discontinue breastfeeding period Eziklen® ingestion and up to 48 hours after the second dose.
Fertility.
on the impact of data on fertility are not available.
Conditions of supply of pharmacies
Prescription.
side effects
Diarrhea that occurs after taking the drug Eziklen® is the expected effect in intestinal cleansing in preparation before the procedure and occurs in most patients. The most frequently reported adverse reactions in clinical trials and post-registration monitoring were: discomfort, bloating, abdominal pain, nausea and vomiting.
During clinical studies reports of vomiting reported with greater frequency when using a one-time application than with the use of a fractional mode.
The incidence of adverse reactions when applying Eziklen® preparation classified as follows: very often (> 1/10); often (by> 1/100 to
special instructions
Eziklen® drug is not used to treat constipation.
Electrolyte disorder and dehydration:
Given the potential risk of severe electrolyte abnormalities should be carefully weigh the risk / benefit before applying Eziklen® drug in high-risk groups. Before applying Eziklen® drug should be excluded contraindications for its use. Particular attention should be paid to the use of special precautions, including the need to maintain adequate hydration.
All patients should be alerted about the need to maintain adequate hydration before, during and after administration of the drug Eziklen®. If the patient develops a copious vomiting or signs of dehydration after taking the drug should be taken to rehydrate to avoid the potential risk of serious complications associated with the violation of water-electrolyte balance (such as convulsions and cardiac arrhythmia). In addition, it is recommended for preliminary laboratory tests (determination of the concentration of electrolytes, creatinine and blood urea nitrogen). Patients should be encouraged to drink more water as a liquid or transparent as possible to maintain an appropriate level of hydration.
Patients at high risk:
In malnourished, debilitated patients, elderly patients, patients with clinically significant renal impairment, liver or heart disease, as well as in patients who have a high risk of developing electrolyte imbalances, it is necessary to conduct biochemical analyzes of serum electrolyte concentrations and assess renal function before and after of the drug.
Patients with impaired dehydration or water-electrolyte balance must hold the appropriate therapy to correct them prior to receiving the bowel cleansing preparation. In addition, caution should be exercised when using the drug in patients with pathological conditions or in patients receiving drugs that increase the risk of violations of water-electrolyte imbalance (including hyponatraemia and hypokalemia), or increase the risk of potential complications. The need to monitor these patients.
There is a theoretical risk of lengthening the interval QT, which may occur as a result of electrolyte disturbances.
Caution should be exercised when using the drug in the following patient groups:
The drug should be used with caution and only under medical supervision in patients with impaired gag reflex and patients prone to regurgitation and aspiration.
Reduced GI motility, including a history of surgery on the gastrointestinal tract, which led to a decrease in motility.
hyperuricemia:
The drug may cause temporary Eziklen® slight or moderate increase in uric acid concentration. The possibility of increasing concentration of uric acid should be taken into account before prescribing the drug to patients with symptoms of gout or hyperuricemia.
Additional Information:
Prior to receiving the drug must be diluted with water. Acceptance of the undiluted solution may increase the risk of nausea, vomiting, dehydration and electrolyte imbalance. Each vial of the drug should be diluted with water and use the recommended amount of water added to ensure good tolerability of the patient.
The medicament contains 247.1 mmol (or 5,684 g) of sodium per vial. It must be taken into consideration in patients who are on a diet to control sodium intake.
Medicament comprising 35.9 mmol (or 1,405 g) of potassium per vial. It must be taken into account in patients with impaired renal function or in patients who are on a diet with potassium intake control.
Effects on ability to drive vehicles, machinery.
Eziklen the drug has no effect on ability to drive and use machines.
Storage conditions
Keep out of the reach of children.
At a temperature of not higher than 30 ° C.
After opening the bottle and / or dilution with water the solution should be used immediately.
Do not use after the expiration date.
Dosing and Administration
Inside.
Adults.
For proper bowel cleansing requires reception of two bottles Eziklen® preparation.
Before receiving the content of each vial must be diluted with water. The patient has to drink the resulting diluted solution and two cups, filled to the mark with water or permitted a clear liquid (i.e., about 1 L) over the next two hours, as described below in sections and mode of application and use dilution scheme.
Permitted transparent liquids are: water, coffee or tea (without milk or nondairy creamer), carbonated (enriched in carbon dioxide) or non-carbonated soft drinks, clarified fruit juice (no pulp, without red or violet), broths or strained by solid ingredients Soup .
In total, for cleaning the intestine before the procedure need to drink at least 3 liters.
The solution after dilution should be used immediately.
application mode.
The drug is taken or fractional application mode (first vial taken the evening before the procedure, and the second – the next morning), or a one-time application mode (reception day before procedure). Suitable receiving Eziklen® drug regimen may be determined by a physician.
If time permits the designated procedure, the fractional mode of application rather than simultaneous reception mode eve procedure. Regime on the eve of the one-time use of the procedure potentially suitable as an alternative mode.
Fractional application mode.
The day before the procedure:
On the evening before the procedure (eg, 18.00), you must follow these instructions:
-soderzhimoe one vial Eziklen® drug should be poured into the attached beaker and dilute to the mark with water (i.e., to a volume of 0.5 liters);
-to over the next two hours, the patient has to drink the solution and additionally two dimensional water glass or a transparent liquid (i.e., about 1 L).
day of the procedure:
-utrom daily treatments (over 10-12 hours after the evening drug administration) steps must be repeated, according to the instructions for evening before:
-soderzhimoe second drug vial Eziklen® should be poured into the attached beaker and dilute to the mark with water (i.e., to a volume of 0.5 liters).
-to over the next two hours, the patient has to drink the solution and additionally two dimensional water glass or a transparent liquid (i.e., about 1 L).
Receiving the full volume of the diluted solution Eziklen® drug and an additional amount of water or clear liquid is to be terminated at least 2 hours and not later than 4 hours before the procedure.
a one-time application mode (application mode to be used depending on the individual needs of the patient).
The day before the procedure:
-vecherom day before procedure (e.g., 18:00): the contents of one vial Eziklen® drug should be poured into the attached beaker and dilute to the mark with water (i.e., to a volume of 0.5 liters);
-to over the next two hours, the patient has to drink the solution and additionally two dimensional water glass or a transparent liquid (i.e., about 1 L).
After about 2 hours after start of first dose
-soderzhimoe second drug vial Eziklen® should be poured into the attached beaker and dilute to the mark with water (i.e., to a volume of 0.5 liters);
-As for the next two hours, the patient has to drink the solution and additionally two dimensional water glass or a transparent liquid (i.e., about 1 L).
Receiving the full volume of the diluted solution Eziklen® drug and an additional amount of water or clear liquid is to be terminated at least 2 hours and not later than 4 hours before the procedure.
After the procedure.
In order to make up for lost in the process of preparation for the procedure, fluid, patients should drink enough of it, to maintain the appropriate level of hydration.
Dietary restrictions.
On the day before the procedure allowed a light breakfast. Next, the patient may consume only clear liquids as meals until procedure. Should avoid taking liquids red and purple, milk and alcoholic beverages.
Special patient groups.
Elderly patients.
In clinical studies, the drug showed no difference in efficacy and safety Eziklen® in elderly patients and patients in other age groups. For elderly patients do not require dose adjustments, however, caution should be exercised when using the drug in such patients, as well as in any other high-risk populations.
Patients with impaired renal function.
There are limited data on this patient group. No dose adjustment is required for patients with impaired renal mild or moderate severity function, however, caution should be exercised when using the drug in these patients, as well as any other high-risk population. Eziklen® drug contraindicated in patients with severe renal impairment severity.
Patients with impaired liver function.
There are limited data on this patient group. Not careful when applying the drug in such) patients as well as in any other population of high risk is required however, dosage adjustment for patients with impaired liver function, must be observed.
Children population.
The safety and efficacy of the drug in children Eziklen® (ie, patients younger than 18 years) has not been established. Data not available.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist