Rezalyut® about 300 mg (30 capsules)
- $22.00
Sku:
4bffa2007a8c
The instruction for medical use
of Rezalyut®Pro medicine
the Trade name
of Rezalyut® of the Missile defense
the International unlicensed name
Is not present
the Dosage form
of the Capsule, 300 mg
Structure
One capsule contains
active agent the - the fat-free, enriched, essential phospholipids from soybeans of 300 mg.
excipients: esters mono - and diglycerides of food fatty acids, triglycerides of average length of a chain, the oil soy refined, a-tocopherol, gelatin, glycerin of 85%.
The description
Soft gelatin capsules of oblong shape, with a colourless transparent cover. Contents of capsules - viscous liquid from golden-yellow till yellowy-brown color.
Pharmacotherapeutic group
Drugs for treatment of diseases of a liver and biliary tract. Drugs for treatment of diseases of a liver.
The ATX A05BA code
the Pharmacological
Research Pharmacokinetics properties of pharmacokinetics with use of marked FH showed that substance is split in intestines to a lizofosfatidilkholin and is soaked up generally in this form. In an intestines wall partially there is a repeated synthesis of phospholipids which then get to a blood stream through absorbent vessels, lizofosfatidilkholin is partially split in a liver to fatty acids, sincaline and the glitserintrifosfat. In blood serum phosphatidylsincaline and other phosphoglycerides are closely connected with lipoproteins and/or with albumine. At intake of phospholipids from soybeans with high content in them (3-sn-fosfatidil) sincalines they probably mostly within several hours are built in in the form of the metabolites endogenous phospholipids. Removal happens as well as endogenous phospholipids or their metabolites.
Pharmacokinetic researches were conducted at the person from marked 3 N and marked 14 C dilinoleoilfosfatidilkholinny and in some researches with marked 3H and with the marked 14 C sincaline placed in linolic acid.
The maximum concentration of isotope 3H was reached within 6-24 hours and made 20% of a dose and thus
was approximately quadruple measured on rats and rabbits.
Elimination half-life of a choline component (marked isotope 3H) makes 66 hours. The maximum concentration of isotope 14C (fatty acids) was reached within 4-12 hours and made 27.9% of a dose. Elimination half-life of this component made 32 hours.
In Calais 2% of isotope 3H and 4,5 of % of isotope 14C, in urine – 6% of isotope 3H and the minimum quantities of isotope 14C were revealed. From this it is possible to draw a conclusion that 90% of both isotopes are soaked up in intestines.
A pharmacodynamics
Vegetable medicine with gipokholisterinemichesky action.
Extract of phospholipids from soybeans consists on average of 76% of phosphatidylsincaline (FH) and almost completely of phosphoglycerides, and fatty acids are provided mostly by linolic acid (omega of 6-62%) and linolenic acid (omega of 3-6%)
the Mechanism of effect of the fat-free enriched phospholipids from soybeans causing decrease in cholesterol is not finalized. Are discussed, among other, the following mechanisms of action:
Fosfatidilkholin (FH) is built in serum lipoproteins, especially in lipoproteins of the high density (LPVP) and increase their ability to return cholesterol from lipoproteins of the low density (LDL) and from fabrics in a liver. The activity of enzyme of a letsitinkholesterinatsiltransferaza (LHAT) which is connected with LPVP and is fosfolipidzavisimy, increases. Thereof more ethers of linolic acid and cholesterol which can be transported with bigger ease by means of LPVP are formed.
Hepatoprotective action is described on numerous experimental models of the intense injury of a liver (caused, e.g., by ethanol, allyl alcohol, phenoxin, paracetamol, galaktozaminy). Moreover, suppression of a steatosis and fibrosis on models of chronic processes (ethanol, acetothioamide, other organic solvents) was observed. The presumable mechanism of action are acceleration of regeneration and stabilization of membranes, inhibition of peroxide oxidation of lipids and synthesis of collagen.
Indications
- fat dystrophy of a liver of various etiology
- toxic damages of a liver
- chronic hepatitis
- an easy form of a hypercholesterolemia if the diet or other non-drug measures (physical activity and weight reduction) do not give sufficient effect
the Route of administration and doses
If other is not offered, then adults and teenagers at the age of 12 years (with body weight more than 43 kg) also are more senior accept inside on 2 Rezalyut® capsules about 3 times a day to food, without chewing and washing down with enough liquid.
Duration of use depends on the course of the disease and is defined by the attending physician.
Side effects
sometimes (less than at 1 patient from 100, but more than at 1 of 1000):
- sensation of discomfort in a stomach
- diarrhea
very seldom (1 case or is 10,000 people less, including isolated cases): and 10,000, but more than at 1 of 1000):
og color and weight reduction) effekta do not give sufficient.
- hypersensitivity reactions (rash or urticaria, an itching)
- dot hemorrhages under skin
- bleedings at women during the period between
Contraindication periods
- the known hypersensitivity to phospholipids, peanut, soy or other components of medicine
- existence of an anti-phospholipidic syndrome
- children's age up to 12 years
Medicinal interactions
is possible interaction of Rezalyut® of the Missile defense with coumarin type anticoagulants (for example, fenprokumon, warfarin). Therefore there can be a need for dose adjustment of this medicine.
The special
instructions Pregnancy and the period of a lactation
No evidence of presence of risk during pregnancy at broad use of soybeans as foodstuff was revealed. However sufficient researches were not conducted. In this regard at pregnancy and in the period of a lactation this drug is not recommended to be used.
The instruction for patients with diabetes: medicine contains less than 0.1 GU (grain unit) on one capsule.
To feature of influence of medicine on ability to control of vehicles and service of potentially dangerous mechanisms
Currently is not present any certificates that against the background of therapy of Rezalyut® about ability to control of vehicles or to service of mechanisms it can be broken.
Overdose
of Messages about overdose and an intoktsikation of Rezalyut® About did not arrive so far.
Strengthening of side effects, such as disturbances from digestive tract is possible.
Treatment - drug withdrawal, consultation of the attending physician, symptomatic therapy.
The form of release and packing
On 10 capsules place in blister strip packaging from a film of polyvinylchloride and aluminum foil.
On 1, 3 or 5 planimetric packs together with the instruction for medical use in the state and Russian languages put in a cardboard box.
To Store storage conditions in the dry place at a temperature not above 25 °C.
To store out of children's reach!
2 years
not to use a period of storage after an expiration date.
Prescription status
Without prescription
AG BERLIN-HEMI Producer
(MENARINI GROUP) Gliniker Weg 125
12489 Berlin, Germany
the Owner of the registration certificate
of Menarini International Opereyshnz the Village of Luxembourg. And., Luxembourg
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods):
Representative office of JSC Berlin-Hemi AG in the Republic of Kazakhstan
ph. +7 727 2446183, 2446184, 2446185
fax: +7 727 2446180
e-mail: Kazakhstan@berlin-chemie.com
of Rezalyut®Pro medicine
the Trade name
of Rezalyut® of the Missile defense
the International unlicensed name
Is not present
the Dosage form
of the Capsule, 300 mg
Structure
One capsule contains
active agent the - the fat-free, enriched, essential phospholipids from soybeans of 300 mg.
excipients: esters mono - and diglycerides of food fatty acids, triglycerides of average length of a chain, the oil soy refined, a-tocopherol, gelatin, glycerin of 85%.
The description
Soft gelatin capsules of oblong shape, with a colourless transparent cover. Contents of capsules - viscous liquid from golden-yellow till yellowy-brown color.
Pharmacotherapeutic group
Drugs for treatment of diseases of a liver and biliary tract. Drugs for treatment of diseases of a liver.
The ATX A05BA code
the Pharmacological
Research Pharmacokinetics properties of pharmacokinetics with use of marked FH showed that substance is split in intestines to a lizofosfatidilkholin and is soaked up generally in this form. In an intestines wall partially there is a repeated synthesis of phospholipids which then get to a blood stream through absorbent vessels, lizofosfatidilkholin is partially split in a liver to fatty acids, sincaline and the glitserintrifosfat. In blood serum phosphatidylsincaline and other phosphoglycerides are closely connected with lipoproteins and/or with albumine. At intake of phospholipids from soybeans with high content in them (3-sn-fosfatidil) sincalines they probably mostly within several hours are built in in the form of the metabolites endogenous phospholipids. Removal happens as well as endogenous phospholipids or their metabolites.
Pharmacokinetic researches were conducted at the person from marked 3 N and marked 14 C dilinoleoilfosfatidilkholinny and in some researches with marked 3H and with the marked 14 C sincaline placed in linolic acid.
The maximum concentration of isotope 3H was reached within 6-24 hours and made 20% of a dose and thus
was approximately quadruple measured on rats and rabbits.
Elimination half-life of a choline component (marked isotope 3H) makes 66 hours. The maximum concentration of isotope 14C (fatty acids) was reached within 4-12 hours and made 27.9% of a dose. Elimination half-life of this component made 32 hours.
In Calais 2% of isotope 3H and 4,5 of % of isotope 14C, in urine – 6% of isotope 3H and the minimum quantities of isotope 14C were revealed. From this it is possible to draw a conclusion that 90% of both isotopes are soaked up in intestines.
A pharmacodynamics
Vegetable medicine with gipokholisterinemichesky action.
Extract of phospholipids from soybeans consists on average of 76% of phosphatidylsincaline (FH) and almost completely of phosphoglycerides, and fatty acids are provided mostly by linolic acid (omega of 6-62%) and linolenic acid (omega of 3-6%)
the Mechanism of effect of the fat-free enriched phospholipids from soybeans causing decrease in cholesterol is not finalized. Are discussed, among other, the following mechanisms of action:
Fosfatidilkholin (FH) is built in serum lipoproteins, especially in lipoproteins of the high density (LPVP) and increase their ability to return cholesterol from lipoproteins of the low density (LDL) and from fabrics in a liver. The activity of enzyme of a letsitinkholesterinatsiltransferaza (LHAT) which is connected with LPVP and is fosfolipidzavisimy, increases. Thereof more ethers of linolic acid and cholesterol which can be transported with bigger ease by means of LPVP are formed.
Hepatoprotective action is described on numerous experimental models of the intense injury of a liver (caused, e.g., by ethanol, allyl alcohol, phenoxin, paracetamol, galaktozaminy). Moreover, suppression of a steatosis and fibrosis on models of chronic processes (ethanol, acetothioamide, other organic solvents) was observed. The presumable mechanism of action are acceleration of regeneration and stabilization of membranes, inhibition of peroxide oxidation of lipids and synthesis of collagen.
Indications
- fat dystrophy of a liver of various etiology
- toxic damages of a liver
- chronic hepatitis
- an easy form of a hypercholesterolemia if the diet or other non-drug measures (physical activity and weight reduction) do not give sufficient effect
the Route of administration and doses
If other is not offered, then adults and teenagers at the age of 12 years (with body weight more than 43 kg) also are more senior accept inside on 2 Rezalyut® capsules about 3 times a day to food, without chewing and washing down with enough liquid.
Duration of use depends on the course of the disease and is defined by the attending physician.
Side effects
sometimes (less than at 1 patient from 100, but more than at 1 of 1000):
- sensation of discomfort in a stomach
- diarrhea
very seldom (1 case or is 10,000 people less, including isolated cases): and 10,000, but more than at 1 of 1000):
og color and weight reduction) effekta do not give sufficient.
- hypersensitivity reactions (rash or urticaria, an itching)
- dot hemorrhages under skin
- bleedings at women during the period between
Contraindication periods
- the known hypersensitivity to phospholipids, peanut, soy or other components of medicine
- existence of an anti-phospholipidic syndrome
- children's age up to 12 years
Medicinal interactions
is possible interaction of Rezalyut® of the Missile defense with coumarin type anticoagulants (for example, fenprokumon, warfarin). Therefore there can be a need for dose adjustment of this medicine.
The special
instructions Pregnancy and the period of a lactation
No evidence of presence of risk during pregnancy at broad use of soybeans as foodstuff was revealed. However sufficient researches were not conducted. In this regard at pregnancy and in the period of a lactation this drug is not recommended to be used.
The instruction for patients with diabetes: medicine contains less than 0.1 GU (grain unit) on one capsule.
To feature of influence of medicine on ability to control of vehicles and service of potentially dangerous mechanisms
Currently is not present any certificates that against the background of therapy of Rezalyut® about ability to control of vehicles or to service of mechanisms it can be broken.
Overdose
of Messages about overdose and an intoktsikation of Rezalyut® About did not arrive so far.
Strengthening of side effects, such as disturbances from digestive tract is possible.
Treatment - drug withdrawal, consultation of the attending physician, symptomatic therapy.
The form of release and packing
On 10 capsules place in blister strip packaging from a film of polyvinylchloride and aluminum foil.
On 1, 3 or 5 planimetric packs together with the instruction for medical use in the state and Russian languages put in a cardboard box.
To Store storage conditions in the dry place at a temperature not above 25 °C.
To store out of children's reach!
2 years
not to use a period of storage after an expiration date.
Prescription status
Without prescription
AG BERLIN-HEMI Producer
(MENARINI GROUP) Gliniker Weg 125
12489 Berlin, Germany
the Owner of the registration certificate
of Menarini International Opereyshnz the Village of Luxembourg. And., Luxembourg
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods):
Representative office of JSC Berlin-Hemi AG in the Republic of Kazakhstan
ph. +7 727 2446183, 2446184, 2446185
fax: +7 727 2446180
e-mail: Kazakhstan@berlin-chemie.com