Dufalac syrup 667mg / ml fl.p 500ml / e bundled glass mer with plum flavor

Description

Composition
Active substance:
1 ml contains: lactulose liquid 667 g / L – 0.999 ml ;.
Excipients:
Plum natural flavoring 0.001 ml.
Description:
Transparent viscous liquid from colorless to brownish-yellow.
Product form:
Syrup [with plum flavor], 667 mg / ml.
200 ml, 500 ml or 1000 ml vial of high density polyethylene with a white polypropylene screw cap with tamper-evident.
Atop the cover cap is put on (polypropylene) serving measured glass. Per vial glued label with instructions for use.
15 ml of a disposable bag made of polyethylene and aluminum foil.
10 bags together with instructions for use in a cardboard pack.
Contraindications
– galactosemia; – obstruction, perforation or risk of perforation of the gastrointestinal tract; – hypersensitivity to any component of the formulation; – galactose or fructose intolerance, lactase deficiency or glucose-galactose malabsorption.
Be wary – undiagnosed rectal bleeding; – colostomy, ileostomy.
Dosage
667 mg / ml
Indications
Constipation: regulation of the physiological rhythm of emptying the colon.
Softening chair for medical purposes (hemorrhoids, post-surgery on the colon and in the anal area).
Hepatic encephalopathy in adults: treatment and prevention of hepatic coma or precoma.
Interaction with other drugs
for interaction studies have been performed with other drugs.
Overdose
Symptoms: When receiving very high doses may be abdominal pain, and diarrhea.
Treatment: drug discontinuation or dose reduction. In the case of a high fluid loss due to diarrhea or vomiting may require correction of water and electrolyte balance.
pharmachologic effect
Pharmacological group:
Laxative.
Pharmacodynamics:
Has hyperosmotic laxative effect, stimulates intestinal motility, improve the absorption of Ca2 + and phosphate salts, contributes to the removal of ammonium ions. Lactulose is cleaved by the intestinal flora of the colon to low molecular weight organic acids, which leads to a decrease in pH and increase the osmotic pressure and, as a consequence, increase the volume of the intestinal contents. These effects stimulate the peristalsis and affect stool consistency. As a result of recovering the physiological rhythm of the colon emptying.
In hepatic encephalopathy effect attributed to suppression of proteolytic bacteria by increasing the number of acidophilic bacteria (e.g., lactobacillus), conversion of ammonia into the ionic form due to acidification of the contents of the colon, bowel movement due to decreased pH in the colon and the osmotic effect and the reduction of nitrogen containing toxic substances by stimulation of bacteria utilizing ammonia for synthesis of bacterial protein.
Lactulose as a prebiotic substance enhances the growth of beneficial bacteria such as bifidobacteria and lactobacilli, whereas it becomes possible to suppress the growth of potentially pathogenic bacteria such as Clostridium and Escherichia coli, which provides a more favorable balance of intestinal flora.
Pharmacokinetics:
Absorption is low. After ingestion reaches the colon unaltered, where split intestinal flora. Completely metabolized at doses up to 40-75 ml. When applied at higher doses partially excreted unchanged.
Pregnancy and breast-feeding
Not expected to have any impact on the fetus or infant, since systemic exposure to lactulose on pregnant or lactating women is negligible.
Dyufalak® can be administered during pregnancy and lactation. Not expected to have any impact on reproductive function, as systemic exposure to lactulose is negligible.
Conditions of supply of pharmacies
Without recipe.
side effects
In the early days of taking lactulose may cause flatulence. It generally disappears after a few days.
In the case of high doses for long time in the treatment of hepatic encephalopathy patient can develop disorders of water and electrolyte balance due to diarrhea.
Disorders of the gastrointestinal tract
Very common (> 1/10): diarrhea.
Often (> 1/100,
other violations
Infrequently (> 1/1000,
In the application in children is expected a similar safety profile as compared with that in adults.
special instructions
In the case of abdominal pain of unknown origin before the start of treatment or lack of therapeutic effect within a few days after receiving the drug should consult a doctor.
It should be borne in mind that Dyufalak® may contain minor amounts of bound sugars (e.g., lactose, galactose, fructose and epilaktoza).
When receiving the doses recommended for the treatment of constipation, the sugar content should not be a problem for patients with diabetes. In the treatment of hepatic encephalopathy usually prescribed higher doses, and its content of sugar should be considered for patients with diabetes.
The content of residual sugars present in the formulation Dyufalak® is about 0.075 XE in 5 ml of syrup.
Prolonged use of doses exceeding recommended in the instructions, or improper use can lead to diarrhea and disturbance of water-electrolyte balance.
When treating children laxatives should be used in exceptional cases and under medical supervision. Please be aware that during the treatment may occur reflex emptying disorders.
Impact on the ability to drive a car and other mechanisms
Use of the drug Dyufalaka no effect or has little effect on the ability to drive a car and mechanisms.
Storage conditions
Store at a temperature not higher than 25 ° C.
Keep out of the reach of children!.
Dosing and Administration
The drug is intended for oral administration.
A solution of lactulose can be taken both in diluted and undiluted. It is necessary to immediately swallow received a single dose without delaying the mouth.
All dosage should be individualized.
In case of appointment of a single daily dose, it must be taken at one and the same time, for example at breakfast time.
During therapy, laxatives are advised to take plenty of fluids (1.5-2 liters, equal to 6-8 glasses) per day.
For accurate dosing of the drug in vials should use the supplied measuring cup. In applying the drug in bags need to tear off corner bag and immediately take the contents.
The dosage for the treatment of constipation or stool softener for medical purposes:
Lactulose daily dose can be administered once or by dividing it into two, using a measuring cup.
After several days of initial dose can be adjusted to a maintenance dose, depending on the reaction to the drug. The laxative effect may appear after 2-3 days after initiation of treatment.
The initial daily dose:
Adults and adolescents 15-45 ml (1-3 sachet)
Children aged 7-14 years, 15 ml (1 bag)
Children 1-6 years old, 5-10 ml
Children up to year-to 5 mL
Supportive daily dose:
Adults and adolescents 15-30 ml (1-2 sachet)
Children aged 7-14 years, 10-15 ml (1 bag)
Children 1-6 years old, 5-10 ml
Children up to year-to 5 mL
If the maintenance daily dose is less than 15 ml, and for accurate dosing in children of 7 years, it is recommended to apply the preparation in vials.
The dose in the treatment of hepatic encephalopathy (adults):
Initial dose 3-4 times a day for 30-45 ml.
Then move on individually tailored maintenance dose so that the upholstered chair was the most 2-3 times a day.
The safety and efficacy of the drug in children (under 18 years) in hepatic encephalopathy has not been established due to lack of data.
Elderly patients and patients with renal or hepatic impairment:
There are no special recommendations for dosing, since systemic exposure to lactulose is negligible.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist