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Fortrans 4’s 64g powder for oral solution




The instruction for medical use of Fortrans® medicine the Trade name of Fortrans® the International unlicensed name Is not present the Dosage form Powder for preparation of solution for intake Structure One one-dose package contains active agents: a macrogoal of 4000 – 64.0, potassium chloride – 0.75 g, sodium chloride – 1.46 g, sodium sulfate anhydrous – 5.70 g, Natrii hydrocarbonas – 1.68 g, excipients: sodium saccharin – 0.1 g the Description the Powder of white color easily soluble in water, bitter and salty taste Pharmacotherapeutic group Laxatives. Osmotic laxatives. The macrogoal the ATX A06AD15 Code the Pharmacological Makrogol Pharmacokinetics properties 4000 is not absorbed from digestive tract and is not exposed to metabolism. A pharmacodynamics Action of Fortrans is based on a combination of high-molecular polymer to isotonic solution of electrolytes. The macrogoal 4000 interferes with absorption of water from a stomach and intestines and promotes the accelerated evacuation of intestinal contents by frequent defekation. The electrolytes which are contained in Fortrans interfere with disturbance of water and electrolytic balance of an organism. – preparation for endoscopic or radiological researches of a large intestine – preparation for surgeries on a large intestine the Route of administration and doses to Accept indications inside. Drug is intended only for adults. Each bag gets divorced in 1 liter of water. To stir slowly before full dissolution of powder in water. The approximate dose makes 1 liter of solution on 15 – 20 kg of body weight that corresponds, on average, to 3 – 4 liters of solution. Route of administration. Administration of drug both in a single dose, and in a separate dosage is possible provided that the full dose of the restored solution will be accepted (on average, from 3 to 4 liters of solution depending on the body weight of the patient). – At a separate dosage: To accept 2 liters of solution on the eve of the procedure and 1 or 2 liters – in the morning in day of the procedure. The last reception of Fortrans has to be in 3-4 hours prior to the procedure. Or to accept 3 liters of solution on the eve of the procedure and 1 liter in the morning in day of the procedure. The last reception of Fortrans has to be in 3-4 hours prior to the procedure. – At a single dosage: To accept 3-4 liters of solution on the eve of the procedure. The break after reception of the first two liters is possible at 1 o’clock. The recommended rate of reception – 1-1.5 liters in 1 hour (i.e. approximately on 250 ml each 10-15 minutes). The doctor can regulate the recommended rate of administration of drug according to a clinical condition of the patient and potential associated diseases. Side effects Diarrhea is the expected effect of Fortrans use. It was reported about nausea and vomiting at the beginning of administration of drug which usually passed at the continuing reception. The table lists below the adverse reactions observed during clinical trials and also the adverse events received from post-marketing sources. Frequency is defined according to the following scale: very often (≥ 1/10), it is frequent (from ≥1/100 to & lt, 1/10), is not frequent (from ≥ 1/1000 to & lt, 1/100), is rare (from ≥ 1/10000 to & lt, 1/1000), is very rare (& lt, 1/10000), it is unknown (it is impossible to estimate on the basis of the available data). The systems of bodies and the classes Frequency Adverse Reactions Gastrointestinal disturbances Very often Nausea the Abdominal pain the Abdominal distension Often Disorder Vomiting from the immune system is not known Hypersensitivity (acute anaphylaxis, a Quincke’s disease (Quincke), a small tortoiseshell, rash, an itching) of the Contraindication – hypersensitivity to active agent or to any of excipients – heavy disturbances of the general state, such as dehydration or heavy heart failure – the started form of cancer or other diseases of a large intestine resulting in excessive weakness mucous – tendency ment of intestinal impassability or gastrointestinal obstruction – perforation of a digestive tract or risk of perforation – gastric emptying disturbance (for example, gastroparez) – toxic colitis or toxic megacolon Medicinal interactions the Doctor has to be informed on any other medicines taken by the patient inside. Because of gastric emptying as a result of Fortrans action, other oral means cannot be absorbed. It is necessary to accept them more, than in 2 hours prior to Fortrans introduction. It is necessary to avoid the use of oral drugs before intake of laxative before full completion of medical examination. Especially it matters for drugs with the narrow therapeutic index or with short elimination half-life. Special instructions Elderly people with the weakened general state should use this drug only under observation of the doctor. The diarrhea caused by Fortrans use can lead to considerable disturbance of absorption of at the same time taken drugs. This drug contains a macrogoal (polyethyleneglycol or PEG). It was reported about allergic reactions to drugs on the basis of a macrogoal: acute anaphylaxis, rash, angiootek (Quincke). Electrolytic disturbances are not expected at reception of Fortrans because of its isotonic structure, nevertheless was exclusively seldom reported about disturbances of water and electrolytic balance at patients from risk group. The electrolytic disturbances which are available for patients have to be corrected before administration of drug for cleaning of intestines. Фортранс® it has to be applied with care at patients with electrolytic disturbances or at the patients who are taking the accompanying drugs increasing risk of disturbance of water and electrolytic balance, including a hyponatremia and a hypopotassemia or increasing risk of possible complications (for example, at patients with renal failures, heart failure or at the same time accepting diuretics). Such patients have to be under the corresponding observation. Drug has to be used with care and only under observation of the doctor at patients with a tendency to aspiration, or at bed patients, or at patients with the changed neurologic function and/or with motive disturbances in connection with risk of aspiration pneumonia. To such patients the drug has to be administered in a sitting position via the nazogastralny probe. Patients with a heart or renal failure have a risk of an acute fluid lungs because of an overload water. Фортранс® contains sodium. Drug contains 1.967 g of sodium in each package. It is necessary to take into account at patients on a rigid diet with salt restriction. Use in pediatrics Drug is intended only for adults. Safety and efficiency of Fortrans at children are younger than 18 years is not established. Pregnancy and a lactation Data on Fortrans use by pregnant women are absent or are very limited. Researches on animals concerning reproductive toxicity are insufficient. Use of Fortrans during pregnancy should be considered, only if the expected advantage exceeds risk. Data on use of Fortrans during breastfeeding are absent or are very limited. It is not known whether Makrogol 4000 with breast milk is allocated. Use of Fortrans during breastfeeding should be considered, only if the expected advantage exceeds risk. Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms of the Research on influence on ability to run the vehicle and/or to use mechanisms were not carried out. Overdose Symptoms: diarrhea. Treatment: drug withdrawal. In case of overdose with heavy diarrhea it is necessary to carry out monitoring of narusheniiya of water and electrolytic balance and level of hydration. The form of release and packing place Drug in bags from the paper laminated by aluminum foil and polyethylene. 4 bags together with the instruction for medical use in the state and Russian languages place Storage conditions in a cardboard box to Store at a temperature not above 25 °C to Store out of children’s reach! 3 years not to use a period of storage after the expiration date specified on packing. Prescription status Without prescription the Producer Bofur Ipsen Indastri of 28100 Dryo, France the Owner of the registration certificate Ipsen of Pharm, France the Address of the organization in the territory of the Republic of Kazakhstan, the accepting claim (offer) on quality of medicines from consumers and responsible for post-registration observation of safety of medicine: 050040 Almaty, Al-Farabi Ave., 45, office 2
representative office of JSC IPSEN PHARMA (IPSEN FARMA) in RK

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