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Duphalac 667g / l 15ml 10s stick-pack




The instruction for medical use of Dyufalak® medicine the Trade name of Dyufalak® the International unlicensed name Lactulose Dosage Form Syrup of 667 G/l, 15 ml, 200 ml, 500 ml, 1000 ml Structure One bottle contains active agent – lactulose of liquid 667 g/l. The minimum quantities of related sugars (lactose, a galactose, an apilaktoza, a tagatoza, fructose) the Description Transparent viscous liquid from colourless till brownish-yellow color Pharmacotherapeutic group the Digestive tract and a metabolism can contain. Laxatives. Osmotic laxatives. Lactulose the ATX A06AD11 Code the Pharmacological Pharmacokinetics At properties intake lactulose is badly soaked up and in not changed look reaches a large intestine where it is metabolized by indestinal flora. Lactulose is completely metabolized at doses up to 25-50 g or 40-75 ml, at higher dosage can partially be removed in not changed look. The pharmacodynamics In a gleam of a large intestine lactulose by means of indestinal flora is split to low-molecular organic acids. These acids promote lowering rn in a gleam of a large intestine and thanks to osmotic effect to increase in volume of contents of a large intestine. These effects stimulate a vermicular movement of intestines and normalize consistence of a chair. The constipation is eliminated and the physiological rhythm of a large intestine is restored. In hepatic encephalopathy the therapeutic effect is caused: suppression of growth of proteolytic bacteria owing to reproduction of acidophilic bacteria (for example, lactobacilli), binding of ammonia in an ionic form (by means of acidulation of contents of a large intestine), bowel emptying owing to low PH value of contents of a large intestine and osmotic effect and change of bacterial metabolism of nitrogen, by ammonia use stimulation by bacteria for protein synthesis. In this context, however, it should be noted that the giperammoniyemiya in itself cannot be the cause of neuropsychiatric manifestations of hepatic encephalopathy. However ammonia can be considered as model for other nitrogenous compounds. Дюфалак® as prebiotic means strengthens growth of beneficial bacteria, such as bifidobacteria and lactobacilli while growth of conditionally pathogenic bacteriums, such as clostridiums and colibacillus can be suppressed. It can create more favorable balance of indestinal flora. Indications – constipations (regulation of a physiological rhythm of a large intestine) – the states demanding softening of a chair in the medical purposes (hemorrhoids, states after a large intestine surgery and perianal area) – hepatic encephalopathy (treatment and prevention of a hepatic coma or a prekoma) the Route of administration and doses of Dyufalak® syrup for intake can be accepted diluted or undiluted. The dosage of drug is selected depending on individual needs of the patient. The single dose should be swallowed at once and not to hold long time in a mouth. If single dose of drug is recommended, then the daily dose should be accepted at the same time, for example, during a breakfast. During intake of laxatives it is recommended to accept enough liquid, to 1.5-2.0 l, or 6-8 glasses of water a day. For treatment of constipations and softening of a chair in the medical purposes the Daily dose of Duphalac can be accepted once or to divide into two receptions. At intake of Duphalac in bottles it is possible to use a measured cap. In several days from an initiation of treatment the initial dose can be corrected to a maintenance dose depending on therapeutic effect. For development of medical effect 2-3 days can be required. The age the Initial dose, in day the Maintenance dose, a day Adults and teenagers of 15-45 ml 15-30 ml Children of 7-14 years of 15 ml 10-15 ml Children of 1-6 years of 5-10 ml 5-10 ml Babies is younger than 1 year up to 5 ml up to 5 ml For treatment of a hepatic coma and a prekoma (only for adults): For oral use: An initial dose on 30-45 ml 3-4 times a day. This dose can be corrected to a maintenance dose so that the soft chair was 2-3 times a day. For rectal administration: In hard cases (the coming coma or a stage of a coma) Dyufalak® can be entered as the holding enema (300 ml of Duphalac / 700мл waters). The enema has to keep within 30-60 minutes, the procedure has to repeat each 4-6 hours until medicine is able to be applied orally. Safety and efficiency of drug at children (0-18 years) with a hepatic coma and prekomy are not established. Data are absent. Patients of advanced age and patients with a renal or liver failure Are not present special recommendations about dosing as system influence of lactulose is insignificant. Side effects In the first days of treatment the meteorism is possible. As a rule, it passes in several days. At reception of higher doses, than it is recommended in the instruction, the abdominal pain and diarrhea can develop. In such cases the dose decline is necessary. In case of use of the raised doses for a long time at treatment of hepatic encephalopathy at patients disturbances of electrolytic balance owing to diarrhea can develop. It was reported about the following undesirable effects with the specified frequency at the patients receiving treatment by lactulose during placebo – controlled clinical trials: very often (≥1/10), it is frequent (from ≥1/100 to & lt, 1/10), infrequently (from ≥1/1000 to & lt, 1/100), is rare (from ≥1/10000 to & lt, 1/1000), is very rare (& lt, 1/10000), Is very frequent – diarrhea Often – a meteorism, an abdominal pain, nausea, vomiting Infrequently – disturbance of electrolytic balance owing to diarrhea At use of drug for children is expected a similar profile of safety in comparison with that at adults. Contraindications – hypersensitivity to lactulose or any other ingredient – a galactosemia – intestinal impassability, perforation or risk of perforation of digestive tract – to persons with hereditary intolerance of fructose, deficiency of Lapp-lactases enzyme, glucose galactose malabsorption Medicinal interactions of Special researches on studying medicinal interaction it was not carried out. The special instructions Consultation of the Doctor it is recommended in the following cases: – painful symptoms in a stomach of not clear reason prior to treatment – insufficient therapeutic effect after several days of treatment. The dose which is usually used in a constipation should not become a problem for patients with diabetes. The dose used at treatment of a hepatic prekoma and a coma is usually much higher that should be considered to the patients having diabetes. Long reception of not corrected dose and the wrong use of drug can lead to diarrhea and disturbance of electrolytic balance. Дюфалак® contains lactose, a galactose and a small amount of fructose. Thus, the patients having rare hereditary diseases, such as intolerance of a galactose or fructose, syndrome of deficiency of lactase or sprue of glucose galactose should not accept Dyufalak®. At introduction in the form of the holding enema because of strong cleaning effect the incontinence a calla, an involuntary chair and also emergence of perianal irritation because of an acid chair is possible. It is necessary to trace attentively a condition of completion of loss of liquid of the patient. Children At treatment of children depletive have to be applied in exceptional cases and under observation of the doctor. It is necessary to consider that during treatment there can be depletion reflex disorders. Pregnancy and the period of a lactation At intake of Duphalac during pregnancy is not supposed impacts on a fruit because the system effect of lactulose is insignificant. Дюфалак® it can be used during pregnancy. At intake of Duphalac during breastfeeding the impact on the baby is not supposed because the system effect of lactulose is insignificant. Дюфалак® it is possible to apply at the feeding women. Does not render feature of influence of medicine on ability to run the vehicle or potentially dangerous Dyufalak® mechanisms, or has insignificant impact on ability to run transport and potentially dangerous mechanisms. The overdose If a dose is too high, then there can be a following: Symptoms: abdominal pain and diarrhea. Treatment: cancellation or dose decline of drug. The strengthened loss of liquid as a result of diarrhea or vomiting can demand correction of electrolytic balance. The form of release and packing On 200 ml, 500 ml and 1000 ml of drug place in bottles from polyethylene. Over a cover the measured cap from polypropylene is put on. On a bottle paste label c the instruction for medical use in the state and Russian languages. On 15 ml of drug place in stik – packages. On 10 stik – packages together with the instruction for medical use in the state and Russian languages place in a cardboard pack. To Store storage conditions at a temperature not above 25 °C. To store out of children’s reach! A period of storage 3 years After opening of a bottle during an expiration date at observance of storage conditions, in original packing. Not to apply after the expiration date specified on packing. Prescription status Without prescription the Producer Abbott Bayologicalz B.V., Olst, Netherlands Veerveg 12, 8121 AA Olst Naimenovaniye and the country of the organization packer Abbott Bayologicalz B.V., Olst, Netherlands Veerveg 12, 8121 AA Olst Vladelets of the registration certificate B.V. Abbott Helscare Products, Veesp, the Netherlands the Name, the address and a contact information 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: Abbott Kazakhstan LLP 050059, Almaty, Republic of Kazakhstan. Dostyk Ave. 117/6, Business center “Khan Tengri-2”, Ph.: +7 727 244 75 44, fax: +7 727 244 76 44
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