Active material: Pancreatin
When ATH: A09AA02
CCF: The enzyme preparation
ICD-10 codes (testimony): K30, K86.1, K86.8, K90.3, K91.2, K91.5
When CSF: 11.05
Manufacturer: KRKA d.d. (Slovenia)
Pharmaceutical form, composition and packaging Panzinorm 10000
◊ Capsules hard gelatin, opaque, body and lid white; contents of capsules – beige-brown pellets.
|pancreatin (in the form of pellets)||96.6 – 123.9 mg,|
|that corresponds to the activity:|
|lipase||10 000 ЕД Ph.Eur.|
|amilazы||no less 7 200 ЕД Ph.Eur.|
|proteases||no less 400 ЕД Ph.Eur.|
Excipients: a copolymer of methacrylic acid and ethyl acrylate (1:1), variance 30%, dry weight (sodium lauryl, polysorbate 80); triэtiltsitrat, talc, simethicone emulsion 20%, dry weight (23%).
Composition of cap and capsule body: gelatin, Titanium dioxide (E171), sodium lauryl.
7 PC. – blisters (3) – packs cardboard.
7 PC. – blisters (12) – packs cardboard.
Panzinorm 10000: pharmachologic effect
The enzyme preparation. The drug compensates for the insufficiency of the exocrine function of the pancreas.
High lipase activity plays an important role in the treatment of maldigestion, due to pancreatic enzyme deficiency. Lipase breaks down fats by hydrolysis into fatty acids and glycerol, thus, promotes their absorption and absorption of fat-soluble vitamins. Amylase breaks down carbohydrates into dextrins and sugars, while protease breaks down proteins.
Included in the pancreatin enzymes lipase, amylase and protease facilitate the digestion of fats, carbohydrates and proteins, which contributes to their more complete absorption in the small intestine. Eliminates symptoms, resulting from indigestion (feeling of heaviness and fullness in the stomach, flatulence, a sense of lack of air, shortness of breath, due to accumulation of gases in the intestines, diarrhea). Improves the process of digestion of food in children; stimulates the secretion of the pancreas' own enzymes, stomach and small intestine, as well as bile.
The capsule has a protective shell, through which active enzymes are released in the small intestine, where do pancreatic enzymes work.
Panzinorm 10000: pharmacokinetics
Panzinorm® 10 000 comes in the form of a capsule, which contains pellets, Film-coated. The film shell of the pellet protects active enzymes from the effects of the acidic environment of the stomach., which allows enzymes to be released in the small intestine. Most of the enzymes are inactivated, as a result of autolysis and proteolysis. A small part of the digestive enzymes is excreted through the intestines..
Panzinorm 10000: testimony
- - Lack of exocrine pancreatic function;
- - To improve food digestion in patients with normal function of the gastrointestinal tract in the case of errors in the diet.
The drug is taken orally with a meal or a light snack.. Capsules should be taken whole, without chewing, drinking plenty of fluids.
The dose and duration of therapy is determined individually depending on age., degree of pancreatic insufficiency and diet.
Adults at the beginning of treatment, it is recommended to take the minimum dose – by 1-2 capsules 3 times / day, at every main meal (breakfast, lunch, dinner) and 1 capsule – during every light meal. If necessary, a single dose is gradually increased. The effective daily dose is 4 to 15 capsules.
The lowest effective dose should be given, especially in patients with cystic fibrosis.
Children over 3 years of age appoint 1-2 capsules with meals or snacks.
The duration of treatment may vary from a single dose or several days (If there is a violation of the digestive process due to errors in the diet) up to several months or years (If you need constant replacement therapy).
Side effects of Panzinorm 10000
Panzinorm® 10 000 rarely causes unwanted effects.
From the digestive system: when taking large doses of the drug – nausea, vomiting, abdominal pain (incl. kišečnaâ how), diarrhea, constipation, perianalnoe irritation, irritation of the mucous membranes of the oral cavity. In cystic fibrosis in case of exceeding the necessary dose of pancreatin (more 10 000 ЕД Ph.Eur. lipases/kg body weight) Rarely, strictures may develop. (fibrous colonopathy) in the ileocecal region and in the ascending colon.
Allergic reactions: hypersensitivity reactions, incl. dermahemia, skin rash, itching; airway obstruction.
Other: hyperuricemia, giperurikozurija, folate deficiency.
Contraindications Panzinorm 10000
- acute pancreatitis;
- exacerbation of chronic pancreatitis;
- Children up to age 3 years (for a given dosage form);
- children with cystic fibrosis under the age of 15 years;
- hypersensitivity to pork protein or other components of the drug.
FROM caution should be prescribed during pregnancy.
Panzinorm 10000: Pregnancy and lactation
Application of Panzinorm® 10 000 Pregnancy and lactation (breast-feeding) possibly only, if the expected benefit of therapy outweighs the potential risk, due to lack of clinical data, confirming the safety of the use of pancreatic enzymes in this category of patients.
Special instructions for taking Panzinorm 10000
In cystic fibrosis in case of exceeding the necessary dose of pancreatin (more 10 000 ЕД Ph.Eur. lipases/kg body weight) Perhaps the strictures (fibrous colonopathy) in the ileocecal region and in the ascending colon. Therefore, in cystic fibrosis, the dose should be adequate to the amount of enzymes, required for fat absorption in terms of quality and quantity of food consumed.
If, while taking Panzinorm capsules® 10 000 there are symptoms of intestinal obstruction, fibrous colonopathy should be ruled out.
With prolonged use, iron preparations are prescribed simultaneously.
Effects on ability to drive vehicles and management mechanisms
It is not known about the negative impact on the ability of driving and operating other machines.
Overdose Panzinorm 10000
Overdose with Panzinorm® 10 000 does not cause systemic toxicity.
Symptoms: nausea, vomiting, diarrhea, giperurikozurija, hyperuricemia, perianalnoe irritation; rarely develops fibrous colonopathy (in cystic fibrosis).
Treatment: removal of the drug, gidratatsiya, simptomaticheskaya therapy.
Drug interaction Panzinorm 10000
With simultaneous long-term use of pancreatin in high doses, a decrease in the absorption of iron preparations is possible. (clinically insignificant) and folic acid. Periodic monitoring of folate levels and/or folic acid administration is recommended..
In an application with cimetidine, bicarbonates, it is also recommended to periodically monitor the level of folate and / or the appointment of folic acid.
Pancreatin may reduce the effectiveness of acarbose and miglitol.
Acid-resistant pellet shell Panzinorm® 10 000 dissolves in the duodenum. At a low pH in the duodenum, pancreatin is not released.. Simultaneous use of histamine H blockers2-receptors (cimetidine), bicarbonates, proton pump inhibitors may increase the effectiveness of pancreatin, which allows you to reduce the dose of Panzinorm® 10 000.
Conditions for dispensing from Panzinorm pharmacies 10000
The drug is resolved to application as an agent Valium holidays.
Conditions and terms of storage Panzinorm 10000
The drug should be stored out of reach of children at or above 30 ° C. Shelf life – 3 year.