The instruction
for medical use
of LikopidÒ medicine,
Trade name
Likopid
Mezhdunarodnoye the unlicensed name
Is not present
the Dosage form
of the Tablet 1 mg and 10 mg
Structure
One tablet contains
active agent - glyukozaminilmuramildipeptid (GMDP)
of 1.0 mg or 10.0 mg,
excipients: lactoses monohydrate, sugar (sucrose), potato starch, methyl cellulose, calcium stearate.
The description
Round ploskotsilindrichesky tablets of white color with a facet (for a dosage of 1 mg). Round ploskotsilindrichesky tablets of white color with a facet and risky (for a dosage of 10 mg).
The pharmacotherapeutic
Immunomodulator ATX LO3A Code Pharmacological Pharmacokinetics Bioavailability Properties group of drug at oral administration makes 7-13%. Extent of linking with blood albumine weak. Time of achievement of the maximum concentration (tmax) 1.5 hours after reception. Elimination half-life (t1/2) 4.29 hours. Does not form active metabolites, it is removed generally through kidneys in not changed look.
The pharmacodynamics
Active ingredient of the tablets LikopidÒ, glyukozaminilmuramildipeptid (GMDP) represents a synthetic analog of a structural fragment of a cover (peptidoglikan) of bacterial cells. Glyukozaminilmuramildipptid is the activator of congenital and artificial immunity, strengthens protection of an organism against viral, bacterial and fungal infections, renders adjuvant effect in development of immunological reactions.
The biological activity of drug is implemented by means of binding glyukozaminilmuramildipeptid with the intracellular receptor protein NOD2 localized in cytoplasm of phagocytes (neutrophils, macrophages, dendritic cells). Drug stimulates functional (bactericidal, cytotoxic) the activity of phagocytes, strengthens the presentation them antigens, proliferation of T - and V-lymphocytes, is increased by synthesis of specific antibodies, contributes to normalization of balance of Th1/Th2-lymphocytes towards prevalence of Th1. Pharmacological action is carried out by means of strengthening of production of key interleukins (interleukin-1, interleukin-6, interleukin-12), a factor of necrosis of tumors an alpha, gamma interferon, colony stimulating factors. Drug increases activity of natural killer cells.
ЛикопидÒ, has hypotoxicity (LD50 exceeds a therapeutic dose by 106,000 times and more for 1 mg and by 49,000 times and more for 10 mg). In an experiment at an oral method of administration in the doses, by 100 times exceeding therapeutic drug has no toxic effect on the central nervous and cardiovascular systems, does not cause pathological changes from internals. ЛикопидÒ, has no embriotoksichesky and teratogenic effect, does not cause chromosomal, genovariations. In the pilot studies conducted on animals data on antineoplastic activity of LikopidaÒ, (glyukozaminilmuramildipeptid) are obtained.
Indications
Drug is used at children since 3 years and at adults in complex therapy of the diseases which are followed by secondary immunodeficiency.
To children aged from the 3rd up to 18 years Likopid is appointed only in a dosage of 1 mg.
The adult Likopid is appointed in a dosage of 1 mg and 10 mg.
For a dosage of 1 mg
Children since 3 years and adult:
persistent, recurrent infections of upper and lower airways in stages of aggravation and in remission stages
acute and chronic pyoinflammatory diseases of skin and soft tissues (a pyoderma, a furunculosis and others)
a herpes infection
Preventive reception (adult)
prevention and decrease in seasonal incidence of ORZ and frequency of exacerbations of chronic diseases of ENT organs, upper and lower airways
For a dosage of 10 mg
Adult (is more senior than 18 years)
acute and chronic pyoinflammatory diseases of skin and soft tissues of a heavy course, including it is purulent - septic postoperative complications
of an infection, sexually transmitted (the human papillomavirus infection, chronic trichomoniasis
a herpes infection (including oftalmogerpes)
psoriasis (including psoriasis arthritis)
a pulmonary tuberculosis
Likopid in a dosage of 1 mg apply the Route of administration and doses inside or sublingual on an empty stomach, LikopidÒ, in a dosage of 10 mg apply inside on an empty stomach, in 30 minutes prior to food.
At the admission of administration of drug if there passed no more than 12 hours from the planned time, it is possible to accept the passed dose if there passed more than 12 hours from the planned reception time, it is necessary to accept only the dose following according to the scheme and not to accept passed.
At reception of LikopidaÒ, in a dosage of 10 mg the patients of advanced age are recommended to begin treatment with half doses (1/2 from therapeutic), in the absence of side effects raising a drug dose to necessary therapeutic.
For a dosage of 1 mg:
Children (since 3 years) and adult:
Acute and chronic pyoinflammatory diseases of skin and soft tissues (pyoderma, furunculosis and others): to children on 1 mg of 1 times a day under language within 10 days, the adult on 2 mg 2-3 times a day under language within 10 days.
Persistent, recurrent infections of upper and lower airways (in a stage of aggravation and in a remission stage): to children of LikopidÒ, appoint 3 courses on 1 mg of 1 times a day under language within 10 days, with a break between courses in 20 days, the adult 2 mg of 1 times a day under language within 10 days.
Herpes infection: to children on 1 mg 3 times a day under language within 10 days, the adult on 2 mg 3 times a day under language within 10 days.
Prevention:
Adults (is more senior than 18 years):
for prevention or decrease in seasonal incidence of ORZ and frequency of exacerbations of diseases of ENT organs, upper and lower airways of LikopidÒ, accept 1 mg 3 times a day under language within 10 days.
For a dosage of 10 mg:
Adults (is more senior than 18 years):
Pyoinflammatory diseases of skin and soft tissues sharp and chronic, a heavy course, including it is purulent - septic postoperative complications: on 10 mg of 1 times a day within 10 days.
Herpes infection (recurrent course, severe forms): on 10 mg of 1 times a day within 6 days.
- at an oftalmogerpesa: on 10 mg 2 times a day within 3 days. After a break in 3 days the course of treatment is repeated.
Infections, sexually transmitted (human papillomavirus infection, chronic trichomoniasis): on 10 mg of 1 times a day within 10 days.
Psoriasis: on 10-20 mg of 1 times a day within 10 days and further five receptions every other day on 10-20 mg of 1 times a day.
At a heavy course of psoriasis and extensive defeat (including psoriasis arthritis): on 10 mg 2 times a day within 20 days.
Pulmonary tuberculosis: on 10 mg of 1 times a day within 10 days.
Side effects
Often (1-10%)
for a dosage of 1 mg and 10 mg
- in an initiation of treatment the short-term fervescence to subfebrile values can be noted (up to 37.9C) that is not the indication to drug withdrawal, most often the above side effect is observed at reception of the tablets LikopidÒ, in high doses (20 mg)
for a dosage of 10 mg
- arthralgias (joint pain), myalgias (muscle pains)
short-term fervescence to febrile values is rare (0.01-0.1%) for a dosage of 1 mg and 10 mg (& gt, 38.0C). At fervescence more than 38.0C intake of febrifuges is possible that it does not reduce pharmacological effects of the tablets LikopidÒ,
It is very rare (less than 0.01%)
for a dosage of 1 mg and 10 mg
Contraindication diarrhea
individual hypersensitivity to drug
the pregnancy and a lactation
an autoimmune thyroiditis in a phase of aggravation
of a state which are followed by febrile temperature (& gt, 38C) at the time of administration of drug
seldom found inborn disbolism: alaktaziya, galactosemia, sprue of glucose and galactose, intolerance of sucrose, intolerance of fructose, deficit of a sukraizomaltaza.
Medicinal interactions
Drug increases efficiency of antimicrobial drugs, synergism concerning antiviral and antifungal drugs is noted. Antacids and sorbents considerably reduce bioavailability of drug. Glucocorticosteroids reduce biological effect of LikopidaÒ.
Special instructions
Each tablet Likopid of 1 mg and 10 mg contains sucrose in number of 0.00042 x. e. and 0.001 x. e. (grain units) respectively that should be considered to patients with diabetes.
Each tablet Likopid of 1 mg and 10 mg contains 0.074 grams and 0.184 grams of lactose respectively that should be considered the patient suffering from a gipolaktaziya (lactose intolerance at which in an organism the decrease in level of lactase of the enzyme necessary for lactose digestion is observed).
At the beginning of reception of LikopidaÒ, 10 mg the aggravation of symptoms of the chronic and latent proceeding diseases connected with the main pharmacological effects of drug is possible.
ЛикопидÒ, 10 mg are applied with care at elderly people, is strict under control of the doctor. Patients of advanced age are recommended to begin treatment with half doses (1/2 from therapeutic), in the absence of side effects raising a drug dose to necessary therapeutic.
The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
does not affect ability to drive the car and/or potentially dangerous mechanisms.
Overdose
Symptoms: cases of overdose of drug are unknown. Proceeding from pharmacological properties of drug, in case of its overdose the temperature rise of a body to subfebrile (up to 37.9C) values can be observed.
Treatment: if necessary symptomatic therapy (febrifuges) is carried out, sorbents are appointed. Specific antidote is unknown.
Form of release and packing
of the Tablet of 1 mg and 10 mg.
On 10 tablets in blister strip packaging from a film of the polyvinylchloride and printing aluminum foil varnished. On 1 blister strip packaging together with the instruction for medical use in the state and Russian languages put in a pack from cardboard.
To Store storage conditions in the dry place protected from light at a temperature not over 25C.
To store out of children's reach!
Not to apply a period of storage of 5 years after expiry date
Prescription status
According to the prescription
CJSC Peptek Producer, Russia.
Legal and actual address: 117997, Moscow, Miklukho-Maclay St., 16/10. Ph./fax: (495) 330-74-56.
Owner of the registration certificate
of CJSC Peptek,
Russia. 117997, Moscow, Miklukho-Maclay St., 16/10.
Ph./fax: (495) 330-74-56
The address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products
of CJSC Peptek,
Russia. 117997, Moscow, Miklukho-Maclay St., 16/10.
Ph./fax: (495) 330-74-56
www.licopid.ru www.peptek.ru,
e-mail: peptek@peptek.ru
med_dir@peptek.ru
To the specified address, the e-mail address, phone can obtain, if necessary, additional data on drug, to report about undesirable side reactions at administration of drug (side effects) or to direct the claim for its quality.
To develop
for medical use
of LikopidÒ medicine,
Trade name
Likopid
Mezhdunarodnoye the unlicensed name
Is not present
the Dosage form
of the Tablet 1 mg and 10 mg
Structure
One tablet contains
active agent - glyukozaminilmuramildipeptid (GMDP)
of 1.0 mg or 10.0 mg,
excipients: lactoses monohydrate, sugar (sucrose), potato starch, methyl cellulose, calcium stearate.
The description
Round ploskotsilindrichesky tablets of white color with a facet (for a dosage of 1 mg). Round ploskotsilindrichesky tablets of white color with a facet and risky (for a dosage of 10 mg).
The pharmacotherapeutic
Immunomodulator ATX LO3A Code Pharmacological Pharmacokinetics Bioavailability Properties group of drug at oral administration makes 7-13%. Extent of linking with blood albumine weak. Time of achievement of the maximum concentration (tmax) 1.5 hours after reception. Elimination half-life (t1/2) 4.29 hours. Does not form active metabolites, it is removed generally through kidneys in not changed look.
The pharmacodynamics
Active ingredient of the tablets LikopidÒ, glyukozaminilmuramildipeptid (GMDP) represents a synthetic analog of a structural fragment of a cover (peptidoglikan) of bacterial cells. Glyukozaminilmuramildipptid is the activator of congenital and artificial immunity, strengthens protection of an organism against viral, bacterial and fungal infections, renders adjuvant effect in development of immunological reactions.
The biological activity of drug is implemented by means of binding glyukozaminilmuramildipeptid with the intracellular receptor protein NOD2 localized in cytoplasm of phagocytes (neutrophils, macrophages, dendritic cells). Drug stimulates functional (bactericidal, cytotoxic) the activity of phagocytes, strengthens the presentation them antigens, proliferation of T - and V-lymphocytes, is increased by synthesis of specific antibodies, contributes to normalization of balance of Th1/Th2-lymphocytes towards prevalence of Th1. Pharmacological action is carried out by means of strengthening of production of key interleukins (interleukin-1, interleukin-6, interleukin-12), a factor of necrosis of tumors an alpha, gamma interferon, colony stimulating factors. Drug increases activity of natural killer cells.
ЛикопидÒ, has hypotoxicity (LD50 exceeds a therapeutic dose by 106,000 times and more for 1 mg and by 49,000 times and more for 10 mg). In an experiment at an oral method of administration in the doses, by 100 times exceeding therapeutic drug has no toxic effect on the central nervous and cardiovascular systems, does not cause pathological changes from internals. ЛикопидÒ, has no embriotoksichesky and teratogenic effect, does not cause chromosomal, genovariations. In the pilot studies conducted on animals data on antineoplastic activity of LikopidaÒ, (glyukozaminilmuramildipeptid) are obtained.
Indications
Drug is used at children since 3 years and at adults in complex therapy of the diseases which are followed by secondary immunodeficiency.
To children aged from the 3rd up to 18 years Likopid is appointed only in a dosage of 1 mg.
The adult Likopid is appointed in a dosage of 1 mg and 10 mg.
For a dosage of 1 mg
Children since 3 years and adult:
persistent, recurrent infections of upper and lower airways in stages of aggravation and in remission stages
acute and chronic pyoinflammatory diseases of skin and soft tissues (a pyoderma, a furunculosis and others)
a herpes infection
Preventive reception (adult)
prevention and decrease in seasonal incidence of ORZ and frequency of exacerbations of chronic diseases of ENT organs, upper and lower airways
For a dosage of 10 mg
Adult (is more senior than 18 years)
acute and chronic pyoinflammatory diseases of skin and soft tissues of a heavy course, including it is purulent - septic postoperative complications
of an infection, sexually transmitted (the human papillomavirus infection, chronic trichomoniasis
a herpes infection (including oftalmogerpes)
psoriasis (including psoriasis arthritis)
a pulmonary tuberculosis
Likopid in a dosage of 1 mg apply the Route of administration and doses inside or sublingual on an empty stomach, LikopidÒ, in a dosage of 10 mg apply inside on an empty stomach, in 30 minutes prior to food.
At the admission of administration of drug if there passed no more than 12 hours from the planned time, it is possible to accept the passed dose if there passed more than 12 hours from the planned reception time, it is necessary to accept only the dose following according to the scheme and not to accept passed.
At reception of LikopidaÒ, in a dosage of 10 mg the patients of advanced age are recommended to begin treatment with half doses (1/2 from therapeutic), in the absence of side effects raising a drug dose to necessary therapeutic.
For a dosage of 1 mg:
Children (since 3 years) and adult:
Acute and chronic pyoinflammatory diseases of skin and soft tissues (pyoderma, furunculosis and others): to children on 1 mg of 1 times a day under language within 10 days, the adult on 2 mg 2-3 times a day under language within 10 days.
Persistent, recurrent infections of upper and lower airways (in a stage of aggravation and in a remission stage): to children of LikopidÒ, appoint 3 courses on 1 mg of 1 times a day under language within 10 days, with a break between courses in 20 days, the adult 2 mg of 1 times a day under language within 10 days.
Herpes infection: to children on 1 mg 3 times a day under language within 10 days, the adult on 2 mg 3 times a day under language within 10 days.
Prevention:
Adults (is more senior than 18 years):
for prevention or decrease in seasonal incidence of ORZ and frequency of exacerbations of diseases of ENT organs, upper and lower airways of LikopidÒ, accept 1 mg 3 times a day under language within 10 days.
For a dosage of 10 mg:
Adults (is more senior than 18 years):
Pyoinflammatory diseases of skin and soft tissues sharp and chronic, a heavy course, including it is purulent - septic postoperative complications: on 10 mg of 1 times a day within 10 days.
Herpes infection (recurrent course, severe forms): on 10 mg of 1 times a day within 6 days.
- at an oftalmogerpesa: on 10 mg 2 times a day within 3 days. After a break in 3 days the course of treatment is repeated.
Infections, sexually transmitted (human papillomavirus infection, chronic trichomoniasis): on 10 mg of 1 times a day within 10 days.
Psoriasis: on 10-20 mg of 1 times a day within 10 days and further five receptions every other day on 10-20 mg of 1 times a day.
At a heavy course of psoriasis and extensive defeat (including psoriasis arthritis): on 10 mg 2 times a day within 20 days.
Pulmonary tuberculosis: on 10 mg of 1 times a day within 10 days.
Side effects
Often (1-10%)
for a dosage of 1 mg and 10 mg
- in an initiation of treatment the short-term fervescence to subfebrile values can be noted (up to 37.9C) that is not the indication to drug withdrawal, most often the above side effect is observed at reception of the tablets LikopidÒ, in high doses (20 mg)
for a dosage of 10 mg
- arthralgias (joint pain), myalgias (muscle pains)
short-term fervescence to febrile values is rare (0.01-0.1%) for a dosage of 1 mg and 10 mg (& gt, 38.0C). At fervescence more than 38.0C intake of febrifuges is possible that it does not reduce pharmacological effects of the tablets LikopidÒ,
It is very rare (less than 0.01%)
for a dosage of 1 mg and 10 mg
Contraindication diarrhea
individual hypersensitivity to drug
the pregnancy and a lactation
an autoimmune thyroiditis in a phase of aggravation
of a state which are followed by febrile temperature (& gt, 38C) at the time of administration of drug
seldom found inborn disbolism: alaktaziya, galactosemia, sprue of glucose and galactose, intolerance of sucrose, intolerance of fructose, deficit of a sukraizomaltaza.
Medicinal interactions
Drug increases efficiency of antimicrobial drugs, synergism concerning antiviral and antifungal drugs is noted. Antacids and sorbents considerably reduce bioavailability of drug. Glucocorticosteroids reduce biological effect of LikopidaÒ.
Special instructions
Each tablet Likopid of 1 mg and 10 mg contains sucrose in number of 0.00042 x. e. and 0.001 x. e. (grain units) respectively that should be considered to patients with diabetes.
Each tablet Likopid of 1 mg and 10 mg contains 0.074 grams and 0.184 grams of lactose respectively that should be considered the patient suffering from a gipolaktaziya (lactose intolerance at which in an organism the decrease in level of lactase of the enzyme necessary for lactose digestion is observed).
At the beginning of reception of LikopidaÒ, 10 mg the aggravation of symptoms of the chronic and latent proceeding diseases connected with the main pharmacological effects of drug is possible.
ЛикопидÒ, 10 mg are applied with care at elderly people, is strict under control of the doctor. Patients of advanced age are recommended to begin treatment with half doses (1/2 from therapeutic), in the absence of side effects raising a drug dose to necessary therapeutic.
The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
does not affect ability to drive the car and/or potentially dangerous mechanisms.
Overdose
Symptoms: cases of overdose of drug are unknown. Proceeding from pharmacological properties of drug, in case of its overdose the temperature rise of a body to subfebrile (up to 37.9C) values can be observed.
Treatment: if necessary symptomatic therapy (febrifuges) is carried out, sorbents are appointed. Specific antidote is unknown.
Form of release and packing
of the Tablet of 1 mg and 10 mg.
On 10 tablets in blister strip packaging from a film of the polyvinylchloride and printing aluminum foil varnished. On 1 blister strip packaging together with the instruction for medical use in the state and Russian languages put in a pack from cardboard.
To Store storage conditions in the dry place protected from light at a temperature not over 25C.
To store out of children's reach!
Not to apply a period of storage of 5 years after expiry date
Prescription status
According to the prescription
CJSC Peptek Producer, Russia.
Legal and actual address: 117997, Moscow, Miklukho-Maclay St., 16/10. Ph./fax: (495) 330-74-56.
Owner of the registration certificate
of CJSC Peptek,
Russia. 117997, Moscow, Miklukho-Maclay St., 16/10.
Ph./fax: (495) 330-74-56
The address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products
of CJSC Peptek,
Russia. 117997, Moscow, Miklukho-Maclay St., 16/10.
Ph./fax: (495) 330-74-56
www.licopid.ru www.peptek.ru,
e-mail: peptek@peptek.ru
med_dir@peptek.ru
To the specified address, the e-mail address, phone can obtain, if necessary, additional data on drug, to report about undesirable side reactions at administration of drug (side effects) or to direct the claim for its quality.
To develop
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