Fortrans powder for solution inside 64g pack. 4 things

Description

Composition
Active substance:
Macrogol 4000 64.0.
Excipients:
Sodium chloride 1.46
Potassium chloride 0.75
Sodium bicarbonate 1.68
Anhydrous sodium sulfate 5.70
Sodium saccharin 0.10.
Description:
White powder, readily soluble in water.
Product form:
powder for solution for oral administration, 64 g.
By 73.69 g of the formulation was put in bags made of paper laminated with aluminum foil and polyethylene. 4 bags were placed together with instructions in a cardboard box.
Contraindications
– hypersensitivity to active substances or any other component of the formulation; – severe general condition of the patient, e.g., dehydration, or severe heart failure; – a stomach ulcer; – a common malignant tumor, or other disease of the colon, accompanied by extensive lesions of the intestinal mucosa; – gastro-intestinal obstruction; – obstruction of the gastrointestinal tract; – the risk of perforation or perforation of the gastrointestinal tract; – violation of gastric emptying (including gastroparesis); – Toxic colitis or toxic megacolon; – Children up to age 18 years (effectiveness and safety have not been established in this population).
CAREFULLY
With impaired renal function, heart failure, in patients with concomitant diuretic therapy; in patients who are prone to the development of water and electrolyte imbalance, including hypokalemia and hyponatremia; in patients with neurological disorders, in bedridden patients and / or in patients with impaired motor functions in patients with a tendency to aspiration and / or under the floor / unconscious (see. “Special Instructions” section).
Dosage
64 g
Indications
Colon Cleansing in the preparation of the patient to: – endoscopy or X-ray examinations of the colon, – surgical interventions that require the lack of content in the colon.
Interaction with other drugs
Diarrhea caused by drug intake Fortrans® may possibly impair the absorption of other concomitant medication.
Efficacy of drugs having a narrow therapeutic index or short half-life may be reduced. In this regard, the doctor, the appointing Fortrans® should be informed about all the concomitant patient specimen.
Overdose
Previous drug overdose treatment Fortrans® limited. In case of overdose may experience nausea, vomiting, diarrhea, and electrolyte imbalances. For the treatment of symptoms of overdose symptomatic therapy is recommended, including the intake of fluids. In rare cases of overdose associated with severe metabolic disorders, conducting intravenous rehydration is recommended.
pharmachologic effect
Pharmacological group:
Osmotic laxative.
Pharmacodynamics:
Fortrans® is an osmotic laxative, which is composed of Macrogol 4000 (polyethylene glycol) and electrolytes (sodium, potassium, chloride and bicarbonate).
Macrogol 4000 high-molecular compound is a long linear polymers that via hydrogen bonds are capable of holding water molecules. After oral drug increases the volume of fluid in the intestine. The volume of unabsorbed fluid contained in the intestine provides the laxative effect of the drug solution.
Included in the product provide electrolytes to maintain the composition of the blood plasma. The concentration of electrolytes in solution preparation
Fortrans® such that the electrolyte exchange between the contents of the intestine and the blood plasma is practically reduced to zero. Thus, the presence of electrolytes in the preparation Fortrans® prevents their loss from the body during the passage of a large amount of liquid through the gastrointestinal tract during treatment with the drug.
Pharmacokinetics:
A solution prepared by dissolving one bag of the drug in 1 liter of water, isotonic electrolyte composition and content izoosmotichen colon.
The results of pharmacokinetic studies confirm the absence of absorption and biotransformation Macrogol 4000 after ingestion.
Pregnancy and breast-feeding
Pregnancy
Experience of using the drug in pregnant Fortrans® limited. These preclinical reproductive toxicity studies are not sufficient.
The drug can be used during pregnancy only after careful assessment of the risk to the fetus ratio and benefits for the mother.
Breastfeeding
Previous applications Fortrans® drug during breastfeeding limited. It is not known whether the Macrogol 4000 in breast milk is released.
It is impossible to eliminate the risk to the newborn / infant.
The drug can be used during breast-feeding only if the resulting benefit to the mother outweighs the potential risk to the baby.
Conditions of supply of pharmacies
Without a prescription.
side effects
At the beginning of the drug may develop nausea and vomiting. These side effects usually disappear with continued dosing.
The table below summarizes the most common adverse drug reactions (ADRs), registered in clinical trials and post-marketing surveillance.
NLR frequency determined next gradation, respectively: very often (> 1/10); common (> 1/100,
special instructions
The elderly, have poor health, it is recommended to use the drug only under medical supervision.
It is necessary to avoid taking solid food for at least two hours before application of the drug and to Fortrans® closure survey. Allowed reception beverages such as tea and coffee (without milk) and other soft drinks.
The patient must withstand interval of at least 1 hours between drug intake Fortrans® and other drugs.
The preparation contains Macrogol 4000 (polyethylene glycol). Allergic reactions (anaphylaxis, angioedema, urticaria, skin rashes) have been reported after administration of preparations containing polyethylene glycol.
Caution should be exercised when administering the drug to patients with Fortrans® intestinal mucosal inflammation, including the rectum.
The drug should be used with caution and only under medical supervision in patients with a tendency to aspiration in bedridden patients, patients with neurological disorders and / or in patients with impaired motor functions due to the risk of aspiration pneumonia. Thus the drug is administered to patients in a “sitting” and through a nasogastric tube.
Patients in the floor / unconscious, must be carefully monitored during the use of the drug. When symptoms of pain or bloating should reduce the rate of drug administration or to suspend the application until the disappearance of the symptoms.
Due to the isotonic composition Fortrans® drug, patients are expected development of electrolyte imbalance after his admission, except in patients at risk of water and electrolyte balance disorders. Patients with impaired water and electrolyte balance is necessary to carry out the appropriate treatment to eliminate them before the bowel cleansing procedure. The drug should be used with caution in patients prone to the development of water-electrolyte imbalances, including hyponatremia and hypokalemia, and patients in whom the risk of side effects above (in patients with impaired renal function, heart failure, or in patients with concomitant diuretic therapy). Use of the drug in such patients should be carefully monitored.
Particular caution should be observed in patients with heart and kidney failure patients, since due to fluid overload they are at risk of acute pulmonary edema. Previous medical use the drug in patients with impaired renal function is limited.
The efficacy and safety Fortrans® the drug in children under the age of 18 years have not been established.
Effects on ability to drive and operate machinery
Not installed.
However, given the pharmacological action of the drug and the possibility of the appearance of adverse reactions, should be careful when driving and operating machinery.
Storage conditions
At a temperature of not higher than 30C.
Keep out of the reach of children.
Dosing and Administration
The drug should only be used in adult patients.
The drug is intended for oral administration.
Preparation of drug solution: The contents of one sachet poured into 1 liter of water and stir well until dissolved. The resulting solution should be clear and colorless. Similarly prepare the required amount of the solution (4.3 l) using only integer (unbroken) sachets. For 4 liters of solution Fortrans® drug to dissolve contents bags 4 in 4 liters of water.
To improve the taste of the solution is better to accept cooled.
The recommended dose is one sachet / 1 L solution of 15-20 kg body weight or, on average, 3 to 4 l of the resulting solution.
Recommended drinking one full glass (250 ml), the resulting solution of the drug every 15 minutes until complete consumption of the prepared solution volume. Typically, the drug takes 4-6 hours. Full dose can be divided into two doses (2 liters evening and from 1 to 2 liters of the following morning). It is usually recommended to complete the last dose no later than 3 hours before the examination or surgery. In single dose total dose of 3-4 liters of solution taken the evening before the designated procedure.
When administered by gavage drug administration rate should be 15-20 ml per min.
Fortrans® for cleansing the gastrointestinal tract and promotes the evacuation of bowel contents like diarrhea. The first liquid stool should appear within 1-2 hours after the procedure.
Features of the application in selected groups of patients
Patients with impaired renal function
Use caution when taking this drug in patients with altered renal function.
elderly patients
Changing the dose is not required.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist