Linex Forte caps. # 14

Release form, composition and packaging

?

Opaque capsules, white body, yellow cap

the contents of the capsules are light beige powder interspersed with yellow.

1 caps.

powder Probio-tec AB Blend 64 (Probio-tec® AB Blend 64) 60 mg,

incl.

Lactobacillus acidophilus (LA-5) 13.8 mg

Bifidobacterium animalis subsp.

lactis (BB-12) 4.2 mg

Auxiliary components of the active ingredient: anhydrous dextrose - 29.1 mg, microcrystalline cellulose - 6 mg, potato starch - 6 mg, magnesium stearate - 0.9 mg.

Beneo Synergy 1 (Beneo® Synergy 1) - 171.5 mg (powder contains 90-94% inulin and 6-10% oligofructose (dextrose + fructose + sucrose)), magnesium stearate - 3.5 mg.

The composition of the capsule body: hypromellose - 33.149 mg, titanium dioxide (E171) - 0.691 mg.

The composition of the capsule cap: hypromellose - 22.08 mg, titanium dioxide (E171) - 0.24 mg, iron dye yellow oxide (E172) - 0.24 mg.

7 pcs.

- blisters (1) - cardboard packs.

7 pcs.

- blisters (2) - cardboard packs.

pharmachologic effect

The drug normalizes the intestinal microflora. One capsule of Linex Forte contains 2 × 109 colony-forming units of live lyophilized lactic acid bacteria: Lactobacillus acidophilus (LA-5) and Bifidobacterium animalis subsp. lactis (BB-12). Live lactic acid bacteria are a normal component of the natural intestinal microflora. Lactic acid bacteria perform a protective function, synthesizing substances with antibacterial activity, producing enzymes, under the influence of which hydrolysis of fiber, proteins, fats, starch and deconjugation of bile acids occurs, and also participate in the synthesis of vitamins of group B, C, K, amino acids, organic acids. Lactic acid bacteria LA-5 and BB-12 inhibit the growth of pathogenic bacteria by:- shift of intestinal pH to the acidic side (the result of the ability of LA-5 to synthesize lactic acid and BB-12 to synthesize acetic and succinic acids in addition to lactic acid) - production of metabolites that have a toxic effect on pathogenic bacteria (formation of H2O2) - the formation of antimicrobial substances, bacteriocins (LA-5 secretes acidocin, a broad-spectrum bacteriocin that prevents the growth of bacteria and fungi) - competition with pathogenic bacteria for nutrients - interactions with adhesion receptors, thus preventing the colonization of other, potentially pathogenic microorganisms.- the formation of antimicrobial substances, bacteriocins (LA-5 secretes acidocin, a broad-spectrum bacteriocin that prevents the growth of bacteria and fungi) - competition with pathogenic bacteria for nutrients - interactions with adhesion receptors, thus preventing the colonization of other, potentially pathogenic microorganisms.- the formation of antimicrobial substances, bacteriocins (LA-5 secretes acidocin, a broad-spectrum bacteriocin that prevents the growth of bacteria and fungi) - competition with pathogenic bacteria for nutrients - interactions with adhesion receptors, thus preventing the colonization of other, potentially pathogenic microorganisms.

Pharmacokinetics

Lactic acid bacteria, such as LA-5 and BB-12, act directly in the gastrointestinal tract when taken orally, the drug does not undergo systemic absorption.

Routine pharmacokinetic studies are therefore not applicable.

The resistance of LA-5 and BB-12 to the effects of gastric juice and bile allows the strains in large quantities to remain viable when passing through the stomach and duodenum.

Both strains attach to the intestinal mucosa.

Like other microorganisms, it is gradually excreted from the gastrointestinal tract with feces.

Indications for use

- treatment and prevention of intestinal dysbiosis.

Intestinal dysbiosis is manifested by the following symptoms: diarrhea, dyspepsia, constipation, flatulence, nausea, belching, vomiting, abdominal pain, allergic skin reactions are possible.

- Relief of constipation in adults and children over 12 years old

- an addition to the standard eradication therapy of Helicobacter pylori in adults and children over 12 years old.

Contraindications for use

- hereditary fructose intolerance, sucrase-isomaltase deficiency or glucose / galactose malabsorption syndrome

- hypersensitivity to drug components.

The drug should be used with caution in diabetes mellitus (it contains simple sugars), deficiency of the immune system (for example, HIV infection).

Dosage regimen

The drug is taken orally, preferably during or after meals.

The capsules should be taken with a small

Name ENG

LINEX FORTE

Clinical and pharmacological group

A drug that regulates the balance of intestinal microflora (probiotic)

ATX code

Preparations containing microorganisms that produce lactic acid in combination with other drugs

Dosage

60mg

Structure

1 capsule contains: Active ingredient: Probio-tec AB Blend 64 powder - 60,000 mg (powder contains active ingredients: Lactobacillus acidophilus (LA-5) - 13.8 mg and Bifidobacterium animalis subsp.lactis ( BB-12) - 4.2 mg auxiliary components: anhydrous dextrose - 29.1 mg, microcrystalline cellulose - 6 mg, potato starch 6 - mg, magnesium stearate - 0.9 mg).

Excipients: Beneo Synergy 1 - 171,500 mg (powder contains 90-94% inulin and 6-10% oligofructose (dextrose + fructose + sucrose))

magnesium stearate - 3,500 mg.

The composition of the capsule body: hypromellose - 33.149 mg, titanium dioxide (E 171) - 0.691 mg.

The composition of the capsule cap: hypromellose - 22.080 mg, titanium dioxide dye (E 171) - 0.240 mg, iron dye yellow oxide (E 172) - 0.240 mg.

Indications

treatment and prevention of intestinal dysbiosis.

Intestinal dysbiosis is manifested by the following symptoms: diarrhea, dyspepsia, constipation, flatulence, nausea, belching, vomiting, abdominal pain, allergic skin reactions are possible.

relief of constipation in adults and children over 12 years of age

addition to standard eradication therapy of Helicobacter pylori in adults and children over 12 years old.

Storage conditions and periods

At a temperature not higher than 25 degrees.

Expiration date: 2 years

Contraindications

hereditary fructose intolerance, sucrase-isomaltase deficiency or glucose / galactose malabsorption syndrome

hypersensitivity to drug components.

The drug should be used with caution in diabetes mellitus (it contains simple sugars), deficiency of the immune system (for example, HIV infection).

INN / Active ingredient

Lactobacillus acidophilus, Bifidobacterium animalis subsp.

lactis

Specifications

Category

Preparations for the gastrointestinal tract

Scope of the drug

Gastrointestinal tract

Release form

Capsules

Manufacturer country

Slovenia

Package quantity, pcs

14

Scope of application

Gastroenterology

Minimum age from

From birth

Way of introduction

Through the mouth

Vacation conditions

Without recipe

Brand name

Sandoz

The amount of the dosage form in the primary package

7 pcs.

Primary packaging type

Blister

Type of consumer packaging

Pack of cardboard

Pharmaco-therapeutic group

Eubiotic

Dosage form

Capsules

The target audience

Children

Dosage (volume) of the substance in the preparation

60mg

Expiration date in days

730

Package weight, g

45

Mode of application

:

Linex Forte capsules are preferably taken with or after meals, with a little liquid. < br> < br> Adults and adolescents over 12 years old: 1 capsule 1-3 times a day. < br> < br> Children from 2 to 12 years: 1 capsule 1-2 times a day. < br> < br> Newborns and children under 2 years of age: 1 capsule once a day. < br> < br> Diarrhea in children under 6 years old should be treated under medical supervision. < br> < br> When Linex Forte is prescribed to children and patients who cannot swallow a whole capsule, it must be opened, the contents are poured into a spoon and mixed with a small amount of liquid. < br> < br> The duration of treatment depends on the cause development of dysbiosis and individual characteristics of the organism. Linex Forte can be taken until the symptoms of dysbiosis disappear. < br> < br> Do not exceed the recommended daily dose of the drug.

Anatomical and therapeutic characteristics

:

A07FA51 Microorganisms producing lactic acid, in combination with other drugs

Information on technical characteristics, delivery set, country of manufacture