Mikrazim caps. 25tys.ed 50 pc

Description

Composition
Active substance:
1, capsule 10 000 units comprises: pancreatin in the form of enteric pellets 168 mg containing powder pancreatin 125 mg, corresponding to an activity corresponding to an activity: protease 520 U, amylase 7500 units lipase 10,000 U 1 capsule 25 000 U comprises: pancreatin in the form of enteric 420 mg pellets containing 312 mg of pancreatin powder, corresponding to an activity corresponding to an activity: 1300 units protease, amylase 19,000 IU, 25,000 IU of lipase.
Excipients:
Methacrylic acid-ethyl acrylate copolymer [1: 1] (as a 30% dispersion, further comprising polysorbate 80, sodium lauryl sulfate) – 25.3 mg / 63.2 mg triethyl citrate – 5.1 mg / 12.6 mg Simethicone emulsion 30% dry weight (32.6%) – 0.1 mg / 0.3 mg including dimethicone – 27.8%; precipitated colloidal silicon – 1.3%; colloidal silicon weighted – 0.9%; methylcellulose – 2.5%; Sorbic Acid – 0.1%; Water – 67.4% talc – 12.6 mg / 31.6 mg.
Capsule shell composition: a housing: gelatin – 100% Water – 13-16% Cap: gelatin – 100% Water – 13-16% carmine dye (Ponceau 4R) – 0,6666% / 0,7999%, quinoline yellow dye – 0.1000% / 0.3166% patent blue dye – 0.0200% / 0.0053% titanium dioxide – 1.2999% / 2.9574%.
Description:
Hard gelatin capsules № 2 transparent housing cover with brown (for a dosage of 10,000 U) and № 0el transparent body with a dark orange cover (for dosing 25,000 IU). The contents of capsules – cylindrical pellets or spherical or irregular shape from light brown to brown color with a characteristic smell. Heterogeneity of color.
Product form:
Capsules 10,000 IU and 25,000 IU.
3 (for dosing 10,000 IU) or 10 capsules in blisters of PVC film or films of PVC / polyvinylidene chloride and aluminum foil printed patent.
20, 30, 40 or 50 capsules in polymeric jars with screw caps.
Each bank, in the contour cellular packaging 1 to 3 capsules or 1, 2, 3, 4 or 5 contour cell packs of 10 capsules together with instructions for use placed in a pile of cardboard.
Contraindications
Hypersensitivity of pancreatin or individual components of the preparation. Acute pancreatitis, acute exacerbation of chronic pancreatitis.
Indications
Substitution treatment for exocrine pancreatic insufficiency: chronic pancreatitis, pancreatectomy, post-irradiation, indigestion, cystic fibrosis; flatulence, diarrhea non-infectious origin.
Violation of digestion (a condition after resection of the stomach and small intestine) to improve food digestion in patients with normal function of the gastrointestinal tract in the case of errors in the diet (eating fatty foods, large quantities of food, irregular meals) and for violations of the chewing function, sedentary lifestyle, prolonged immobilization. Remhelda syndrome (syndrome gastrocardiac).
Preparing to X-ray examination and ultrasound of the abdomen.
Overdose
Symptoms: increased levels of uric acid in the urine (giperurikuriya) and blood (hyperuricemia). The children – constipation.
Treatment: removal of the drug, symptomatic therapy.
Interactions with other drugs
With simultaneous application of pancreatin with iron supplementation may decrease the absorption of the latter.
pharmachologic effect
Pharmacological group:
Digestive enzymatic means.
Pharmacological properties:
Mikrazim® – pancreatin pellets in capsules. The preparation contains natural enzymes from the pancreas of animals – protease, lipase and amylase provide digesting protein, fat and carbohydrate food.
Upon receiving Mikrazima® capsule dissolves quickly in the stomach, releasing the enteric coated pancreatin pellets. Due to the small size of the pellets quickly and evenly mixed with food and at the same time bolus easily penetrate into the duodenum, and then into the small intestine where pancreatic enzymes are released and begin to be active, contributing to the rapid and complete digestion of protein, fat and carbohydrate foods.
Rapid stirring of pancreatin pellets from the stomach contents, their uniform distribution therein, simultaneous passage with chyme, as well as preservation of enzymes prior to their work in the intestine (due to enteric coating pellets), providing better digestive activity and maximum approaching of the drug to the natural process of digestion. Enzymatic activity is manifested Mikrazima® maximum 30 minutes after ingestion, which provides quick onset of effect.
After reaction with substrates protease, lipase and amylase in the lower intestine and lose activity with intestinal contents excreted. Mikrazim® not absorbed from the gastro – intestinal tract and is valid only in the intestinal lumen.
Pregnancy and breast-feeding
Data on the potential risks of use of pancreatin during pregnancy and lactation are not available, so the drug should be administered to pregnant and lactating women only if the expected effect of therapy exceeds potential risks.
Conditions of supply of pharmacies
Without recipe.
side effects
Allergic reactions to components of the formulation. When using high doses are rarely observed: diarrhea, nausea, constipation, discomfort in the epigastric region. With prolonged use at high doses possible development of hyperuricosuria, hyperuricemia.
special instructions
Children and adults receiving long-term therapy with pancreatin in large doses, should be monitored by a specialist.
The main reasons for the ineffectiveness of the enzyme treatment are: inactivation of enzymes in the duodenum due to acidification of its contents; related intestinal diseases (helminthic infestations dysbiosis); failure to comply with the recommended treatment regimen of patients; the use of enzymes that have lost their activity.
Information on the possible impact of the drug on the ability to drive vehicles, mechanisms: No specific data.
Storage conditions
In dry and dark place at a temperature not higher than 25 C.
Keep out of the reach of children.
Dosing and Administration
Dose selected individually depending on the age, severity of symptoms and diet composition. dose selection is performed using the registered medicines Mikrazim® 10,000 IU and 25,000 IU Mikrazim®.
The capsules taken orally, drinking plenty of non-alkaline liquid (water, fruit juices). If a single dose greater than 1 capsule should be taken half of the total number of capsules immediately before a meal, and the other half – during meal time. If a single dose – 1 capsule, it should be taken at meal time.
If difficulty swallowing (e.g., children or elderly), the capsule can be opened and taking the drug directly into the pellet previously mixing them with a fluid or liquid food (pH
The duration of the pancreatin can vary from a few days (indigestion), to several months or years (long-term replacement therapy).
Replacement therapy for different types of exocrine pancreatic insufficiency.
The dose is adjusted individually and depends on the severity of exocrine insufficiency of individual eating habits and age of the patient.
Steatorrhea (more than 15 grams of fat in faeces per day).
In the presence of diarrhea, reduction in body weight and no effect of diet administered 25,000 IU of lipase at every meal. If necessary, and good endurance increase the dose to 30 000 – 35 000 units of lipase at a time. Further increase of a dose in most cases, does not improve the results of treatment and diagnosis require revision, lower fat content in the diet and / or additional prescribing – proton pump inhibitors.
When expressed mild steatorrhea, not accompanied by diarrhea and weight loss, appointed from 10 000 units to 25 000 units of lipase at the reception.
Cystic fibrosis.
The initial calculated dose for children under 4 years of age – 1000 lipase units per kilogram of body weight at each feeding for children over 4 years old – 500 units of lipase per kilogram of body weight at every meal. The dose should be individualized depending on the severity of the disease, the severity of steatorrhea and nutritional status. Maintenance dose for most patients should not exceed 10 000 units of lipase per kilogram of body weight per day.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist