Panzinorm p fort 20000 tab / v kish.rastv. 30 pc

Description

Composition
Active substance:
1 tablet contains: Pancreatin (pig) 1 mg 269.12 – 279.44 mg 2 with enzymatic activity: 20,000 IU of lipase. Heb.
Pharm., 12 000 units of amylase. Heb.
Pharm., Protease 900 units. Heb.
Pharm.
Excipients:
Lactose monohydrate 53.90 mg – 64.22 mg Microcrystalline cellulose 72.66 mg Crospovidone 10.40 mg, colloidal silicon dioxide, anhydrous 1.60 mg Magnesium stearate 2.00 mg shell: 6.25 mg of hypromellose, methacrylic acid-ethyl acrylate copolymer (1: 1) 15.89 mg triethyl citrate 5.07 mg titanium dioxide (E171) 6.58 mg talc 9.60 mg simethicone emulsion 0.43 mg, vanilla flavor (54286 C) 0 , 34 mg, bergamot flavor (54253 T) 0.16 mg macrogol 6000 0.25 mg, 0.55 mg sodium carmellose, polysorbate 80 0.88 mg.
Description:
Smooth, round, biconvex tablets, film-coated white or light gray in color with a smell of vanilla and bergamot.
Product form:
The tablets coated with enteric coating.
10 tablets in a blister composite material OPA / Al / PVC and aluminum foil. 1, 3 or 10 blisters together with instructions for use placed into cardboard pack.
Contraindications
Hypersensitivity to the active substance (porcine pancreatin), or to any subsidiary component of the drug, lactase deficiency, lactose intolerance, glucose-galactose malabsorption syndrome (Preparation Panzinorm® forte 20000 contains lactose), children under 3 years (for a given dosage form).
Indications
Substitution treatment of exocrine (enzyme) pancreatic insufficiency in children and adults caused by a decrease in the enzymatic activity of the pancreas due to violation of products, regulation of secretion, delivering pancreatic enzymes or increased their destruction in the intestinal lumen, which is caused by a variety of diseases of the gastrointestinal tract, and is most often occurring at: cystic fibrosis, chronic pancreatitis, surgery on the pancreas, after gastrectomy, pancreatic cancer gland, partial gastrectomy (e.g. Billroth II), ductal obstruction of the pancreas or common bile duct (e.g., due to tumors), Shvahmana Diamond syndrome, condition after the onset of acute pancreatitis and power resumption.
To avoid complications be used only after consulting a doctor.
Interaction with other drugs
Interaction studies have been conducted.
Overdose
Symptoms: hyperuricosuria and hyperuricemia.
Treatment: removal of the drug, symptomatic therapy, to ensure adequate rehydration.
pharmachologic effect
Pharmacological group:
Digestive enzymatic means.
Pharmacodynamics:
Enzyme preparation improves the process of digestion of food for adults and children, and thus reducing the symptoms of the enzyme pancreatic insufficiency (bloating, changes in the frequency and stool consistency). Pancreatic enzymes included in the formulation, facilitate cleavage of proteins, fats, carbohydrates, leading to their complete absorption in the small intestine.
Preparation Panzinorm® forte 20000 is a tablet containing porcine pancreatin coated with enteric (acid resistant) coating. When the tablet reaches the small intestine, the enteric coat dissolves quickly (at pH> 5,5), is released enzymes with lipolytic, proteolytic and amylolytic activity that leads to the splitting of fats, carbohydrates and proteins. The resulting cleavage agent then either are absorbed directly or are further digested by intestinal enzymes.
Pharmacokinetics:
In animal studies it has been demonstrated the absence of absorption of undigested enzymes, resulting in classical pharmacokinetic studies have not been conducted. Preparations containing pancreatic enzymes, suction is not required for the manifestation of their effects. Conversely, the therapeutic activity of said drugs is fully implemented in the lumen of the gastrointestinal tract. According to their chemical structure, they are proteins and, therefore, the passage through the gastrointestinal tract enzyme preparations to split until no absorption occurs in the form of peptides and amino acids.
Pregnancy and breast-feeding
Pregnancy
Clinical data on the treatment of pregnant women with drugs containing pancreatic enzymes are lacking. Studies in animals have not revealed absorption of pancreatic enzymes swine origin, so the toxic effects on reproduction and fetal development is not expected.
Prescribed the drug to pregnant women should be cautious if the expected benefit to the mother outweighs the potential risk to the fetus.
Breastfeeding
Based on animal studies, during which revealed no systematic negative impact of pancreatic enzymes, is not expected any harmful effects of the drug on the child through breast milk.
Pancreatic enzymes can be administered to women during breast-feeding.
If necessary reception during pregnancy or lactation preparation Panzinorm® forte 20000 should be taken in dosages sufficient to maintain adequate nutritional status.
Conditions of supply of pharmacies
Available without prescription.
side effects
Disorders of the gastrointestinal tract: very common (> 1/10): abdominal pain; common (> 1/100,
Gastrointestinal disorders are mainly related to the underlying disease. The frequency of occurrence of adverse reactions such as an abdominal pain and diarrhea was lower or similar to that with placebo.
Stricture of the ileum, cecum and colon (fibrosing colopathy) were observed in patients with cystic fibrosis who received high doses of pancreatin preparations (see. Section “Special Instructions”).
Violations of the skin and subcutaneous tissue disorders: uncommon (> 1/1000,
Disorders of immune system: the frequency is unknown: hypersensitivity (anaphylactic response).
Allergic reactions were observed mainly on the part of the skin, but were also noted and other manifestations of allergy. Reports of these adverse events were received during post-marketing use and were spontaneous. For an accurate assessment of the incidence of insufficient data are available.
In the application in children has not been noted any specific adverse reactions. Frequency, type and severity of adverse reactions in children with cystic fibrosis were similar to those in adults.
special instructions
Patients with cystic fibrosis treated with high doses of pancreatin preparations (over 10,000 IU. Lipase / kg / day), described stricture ileum, caecum and colon (fibrosing colonopathy).
Impact on the ability to drive a car and other mechanisms
Use of the drug Panzinorm® forte 20 000 have no or negligible effect on the ability to drive a car and mechanisms.
Storage conditions
At a temperature of not higher than 30 C.
Keep out of the reach of children.
Dosing and Administration
Inside, take at meal time. Tablets drug Panzinorm® forte 20000 should be taken not liquid with a sufficient amount of liquid.
The dose and duration of treatment is determined individually depending on the age and degree of pancreatic insufficiency.
Adults Panzinorm® forte preparation of 20 000 recommend taking (in the absence of other requirements) in the early treatment of 1 tablet 3 times a day during each main meal. You can receive the drug Panzinorm® forte 20 000 during the reception of a light snack. If necessary, a single dose increased by 2 times. The average daily dose – 1-2 tablets 3 times a day.
In children, the drug is used by a physician. Children under the age of 3 – 100 000 units. / Day (based on the lipase).
The duration of treatment may vary from single dose or several days (at disturbance due to the digestion process errors in the diet) to several months or years (permanent replacement therapy, if necessary).
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist