The instruction for medical use
of Nayz® medicine
the Trade name
of Nayz®
the International unlicensed name
Is not present
the Dosage form
Gel of 1%,
Structure
of 1 g
active agent contains 20 g: Nimesulide of 10 mg, methyl salicylate of 100 mg, menthol of 50 mg, capsaicin of 0.250 mg
excipients: diethyl phthalate, diethylene glycol monoethyl ether, the polioksilovy castor oil hydrogenated (40), propylene glycol, Natrium benzoicum, dinatrium edetat, bottled hydroxytoluene, carbomer-980, trometamol, the water purified.
The description
White or almost white gel
Pharmacotherapeutic group
Other drugs for topical treatment of diseases of the musculoskeletal system
the Code of automatic telephone exchange M02AX10
the Pharmacological
Pharmacokinetics Distribution properties in fabrics in the field of putting gel – 70%, bioavailability – 30%. Time necessary for achievement of the maximum concentration (TCmax) is 1.5 - 2.5 hours, the maximum concentration (Cmax) makes 3.5 - 6.5 mg/ml. communication with proteins of plasma – 95%, with erythrocytes – 2%, with lipoproteids – 1%. Change of a dose does not influence extent of binding. The share of free fraction in blood makes 1%. Distribution volume – 0.19 - 0.35 l/kg. Well gets into acidic environment of the center of inflammation (40%), synovial fluid (43%). Easily gets through gistogematichesky barriers.
The pharmacodynamics
Nimesulide – non-steroidal anti-inflammatory drug (NPVS) from a class of sulfonanilid, possesses anti-inflammatory, analgeziruyushchy and antiagregantny action. Nimesulide – selection inhibitor of cyclooxygenase 2, the mechanism of effect of Nimesulide is connected with protein kinase inhibition With, IV phosphodiesterase and proteinases, with inhibition of a histamine and release (TNF-α), with synthesizing of the factor of activation of thrombocytes (FAT).
Nayz the gel containing methyl salicylate, menthol, capsaicin is effective as analgeziruyushchy means.
The capsaicin which is a part drug exhausts substance P which is a neurotransmitter for transfer of pain and feeling of an itching from peripheral nervous system to the central nervous system. Then synthesis and transport of substance P without neuron is blocked.
Methyl salicylate is derivative salicylic acid and possesses irritant action that leads to release of substance P of neurons. Reduction of accumulation of substance P in nerve terminations leads to reduction of pain. Methyl salicylate when drawing on skin causes analgetic effect and decrease in muscular tension at the expense of the receptors which are in muscle tissue irrespective of influence of efferent nerve terminations. Methyl salicylate slows down synthesis of prostaglandins as a result of oppression of cyclooxygenases that reduces hypostasis and infiltration of the inflamed fabrics.
Menthol possesses the cooling action, at the expense of irritation of cold receptors.
At external use, Nimesulide, methyl salicylate, capsaicin, menthol are quickly absorbed and get into hypodermic cellulose, muscle tissue, the articulate capsule and directly into a joint cavity.
The clinical effect at topical administration occurs in 4 weeks.
Indications
- an ankylosing spondylarthritis - osteochondrosis with a radicular syndrome - sciatica
- a sciatica - a lumbago - an osteoarthrosis - arthritises of various etiology (including rheumatoid,
psoriasis) - an arthralgia (including in rheumatism and gout) - myalgia of rheumatic and not rheumatic genesis - inflammation of ligaments, sinews, a bursitis - posttraumatic inflammation of soft tissues and the musculoskeletal system (damages and ruptures of sheaves, bruises)
- a pain syndrome of various genesis (including in the postoperative period, in injuries, algodismenoreya)
the Route of administration and doses
Is appointed locally. Nayz gel is evenly applied, without rubbing, on the struck area a column of gel 3 cm long 3 – 4 times a day. Gel is applied on the clean and dry surface of skin.
The amount of gel and frequency of use can vary depending on the size of the processed site and reaction of the patient, no more than 4 times a day.
The maximum daily dose makes 5 mg/kg (1 tuba a day). Duration of use of drug is 10 days.
Side effects
local reactions
- irritation of skin, skin rash, peeling, a skin itching, tranzitorny discoloration of skin, an erythema, peeling of skin, contact dermatitis
system reactions
- heartburn, nausea, vomiting, diarrhea, a gastralgia, an ulceration of a mucous membrane of digestive tract
- a liquid delay
- thrombocytopenia, a leukopenia, an agranulocytosis, anemia
- increase in activity of hepatic transaminases
- lengthening of a bleeding time
- a hamaturia
- an acute anaphylaxis
- disturbance of breath in the presence of bronchial asthma
of the Contraindication
- hypersensitivity to Nimesulide and other components of drug, acetylsalicylic acid and other NPVS
- a dermatosis, injuries of epidermis, a skin infection in a scope (for gel)
- pregnancy and the period of a lactation
- children's age up to 18 years
Medicinal interactions
Interaction with other medicines is practically not observed because of extremely low concentration of active agent. Pharmacokinetic interaction happens at the level of linking with proteins of plasma: nayz gel increases concentration of the medicines competing for communication with proteins of plasma – digoxin, Phenytoinum, lithium drugs, diuretics, hypotensive drugs, other NPVS, anticoagulants, cyclosporine, a methotrexate, oral hypoglycemic drugs.
Miyelotoksichny medicines cause strengthening of a gematoksichnost.
Special instructions
At emergence of local irritation the use of gel has to be symptomatic therapy is stopped and is appointed.
Not to apply gel around eyes, on a mucous surface, on other open parts of the body, on wound surfaces, in dermatitis. It is impossible to touch by hands with gel of sensitive areas of a surface of skin. It is necessary to avoid use of gel with air-tight bandages. After putting gel it is necessary to wash up hands with soap. The tuba should be closed densely after gel use.
Burns can be after full rubbing in of drug. Burns usually pass in several days after drug withdrawal.
It is necessary to apply with care Nimesulide gel at patients with the increased risk of development of the side effects connected with intake of salicylates.
At prolonged use the systematic control of functions of kidneys is necessary. The active capsaicin which is a part of gel in concentration of 1% and more can cause neurotoxicity and a thermal hyperalgesia. The burning sensation, reddening which appeared later uses of gel are connected with the capsaicin which is a part of gel.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
Topical administration of drug in the form of gel does not influence ability to driving of motor transport and to control of mechanisms.
Overdose
Symptoms: strengthening of side effects.
Treatment: drug withdrawal, symptomatic therapy.
A release form
On 20 g of gel of drug place in the laminated aluminum tubas.
Each tuba together with the instruction for medical use in the state and Russian languages is put in a pack from cardboard
by
Storage conditions
to Store at a temperature not above 25 °C.
To store out of children's reach!
A period of storage
2 years
After an expiration date not to apply
Prescription status
Without prescription
Dr. of Reddi's Laboratoris Limited Producer
7-1-27 Amiirpert, Hayderabad-500,016, India
the Name of the Owner of the registration certificate:
The Dr. of Reddi's Laboratoris Limited, India
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products
Representative office Dr. of Reddi's Laboratoris Limited in the Republic of Kazakhstan:
050057 Almaty, st. 22 line, 45
ph. 8 (727) 3941688
fax: 8 (727) 3941294
of Nayz® medicine
the Trade name
of Nayz®
the International unlicensed name
Is not present
the Dosage form
Gel of 1%,
Structure
of 1 g
active agent contains 20 g: Nimesulide of 10 mg, methyl salicylate of 100 mg, menthol of 50 mg, capsaicin of 0.250 mg
excipients: diethyl phthalate, diethylene glycol monoethyl ether, the polioksilovy castor oil hydrogenated (40), propylene glycol, Natrium benzoicum, dinatrium edetat, bottled hydroxytoluene, carbomer-980, trometamol, the water purified.
The description
White or almost white gel
Pharmacotherapeutic group
Other drugs for topical treatment of diseases of the musculoskeletal system
the Code of automatic telephone exchange M02AX10
the Pharmacological
Pharmacokinetics Distribution properties in fabrics in the field of putting gel – 70%, bioavailability – 30%. Time necessary for achievement of the maximum concentration (TCmax) is 1.5 - 2.5 hours, the maximum concentration (Cmax) makes 3.5 - 6.5 mg/ml. communication with proteins of plasma – 95%, with erythrocytes – 2%, with lipoproteids – 1%. Change of a dose does not influence extent of binding. The share of free fraction in blood makes 1%. Distribution volume – 0.19 - 0.35 l/kg. Well gets into acidic environment of the center of inflammation (40%), synovial fluid (43%). Easily gets through gistogematichesky barriers.
The pharmacodynamics
Nimesulide – non-steroidal anti-inflammatory drug (NPVS) from a class of sulfonanilid, possesses anti-inflammatory, analgeziruyushchy and antiagregantny action. Nimesulide – selection inhibitor of cyclooxygenase 2, the mechanism of effect of Nimesulide is connected with protein kinase inhibition With, IV phosphodiesterase and proteinases, with inhibition of a histamine and release (TNF-α), with synthesizing of the factor of activation of thrombocytes (FAT).
Nayz the gel containing methyl salicylate, menthol, capsaicin is effective as analgeziruyushchy means.
The capsaicin which is a part drug exhausts substance P which is a neurotransmitter for transfer of pain and feeling of an itching from peripheral nervous system to the central nervous system. Then synthesis and transport of substance P without neuron is blocked.
Methyl salicylate is derivative salicylic acid and possesses irritant action that leads to release of substance P of neurons. Reduction of accumulation of substance P in nerve terminations leads to reduction of pain. Methyl salicylate when drawing on skin causes analgetic effect and decrease in muscular tension at the expense of the receptors which are in muscle tissue irrespective of influence of efferent nerve terminations. Methyl salicylate slows down synthesis of prostaglandins as a result of oppression of cyclooxygenases that reduces hypostasis and infiltration of the inflamed fabrics.
Menthol possesses the cooling action, at the expense of irritation of cold receptors.
At external use, Nimesulide, methyl salicylate, capsaicin, menthol are quickly absorbed and get into hypodermic cellulose, muscle tissue, the articulate capsule and directly into a joint cavity.
The clinical effect at topical administration occurs in 4 weeks.
Indications
- an ankylosing spondylarthritis - osteochondrosis with a radicular syndrome - sciatica
- a sciatica - a lumbago - an osteoarthrosis - arthritises of various etiology (including rheumatoid,
psoriasis) - an arthralgia (including in rheumatism and gout) - myalgia of rheumatic and not rheumatic genesis - inflammation of ligaments, sinews, a bursitis - posttraumatic inflammation of soft tissues and the musculoskeletal system (damages and ruptures of sheaves, bruises)
- a pain syndrome of various genesis (including in the postoperative period, in injuries, algodismenoreya)
the Route of administration and doses
Is appointed locally. Nayz gel is evenly applied, without rubbing, on the struck area a column of gel 3 cm long 3 – 4 times a day. Gel is applied on the clean and dry surface of skin.
The amount of gel and frequency of use can vary depending on the size of the processed site and reaction of the patient, no more than 4 times a day.
The maximum daily dose makes 5 mg/kg (1 tuba a day). Duration of use of drug is 10 days.
Side effects
local reactions
- irritation of skin, skin rash, peeling, a skin itching, tranzitorny discoloration of skin, an erythema, peeling of skin, contact dermatitis
system reactions
- heartburn, nausea, vomiting, diarrhea, a gastralgia, an ulceration of a mucous membrane of digestive tract
- a liquid delay
- thrombocytopenia, a leukopenia, an agranulocytosis, anemia
- increase in activity of hepatic transaminases
- lengthening of a bleeding time
- a hamaturia
- an acute anaphylaxis
- disturbance of breath in the presence of bronchial asthma
of the Contraindication
- hypersensitivity to Nimesulide and other components of drug, acetylsalicylic acid and other NPVS
- a dermatosis, injuries of epidermis, a skin infection in a scope (for gel)
- pregnancy and the period of a lactation
- children's age up to 18 years
Medicinal interactions
Interaction with other medicines is practically not observed because of extremely low concentration of active agent. Pharmacokinetic interaction happens at the level of linking with proteins of plasma: nayz gel increases concentration of the medicines competing for communication with proteins of plasma – digoxin, Phenytoinum, lithium drugs, diuretics, hypotensive drugs, other NPVS, anticoagulants, cyclosporine, a methotrexate, oral hypoglycemic drugs.
Miyelotoksichny medicines cause strengthening of a gematoksichnost.
Special instructions
At emergence of local irritation the use of gel has to be symptomatic therapy is stopped and is appointed.
Not to apply gel around eyes, on a mucous surface, on other open parts of the body, on wound surfaces, in dermatitis. It is impossible to touch by hands with gel of sensitive areas of a surface of skin. It is necessary to avoid use of gel with air-tight bandages. After putting gel it is necessary to wash up hands with soap. The tuba should be closed densely after gel use.
Burns can be after full rubbing in of drug. Burns usually pass in several days after drug withdrawal.
It is necessary to apply with care Nimesulide gel at patients with the increased risk of development of the side effects connected with intake of salicylates.
At prolonged use the systematic control of functions of kidneys is necessary. The active capsaicin which is a part of gel in concentration of 1% and more can cause neurotoxicity and a thermal hyperalgesia. The burning sensation, reddening which appeared later uses of gel are connected with the capsaicin which is a part of gel.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
Topical administration of drug in the form of gel does not influence ability to driving of motor transport and to control of mechanisms.
Overdose
Symptoms: strengthening of side effects.
Treatment: drug withdrawal, symptomatic therapy.
A release form
On 20 g of gel of drug place in the laminated aluminum tubas.
Each tuba together with the instruction for medical use in the state and Russian languages is put in a pack from cardboard
by
Storage conditions
to Store at a temperature not above 25 °C.
To store out of children's reach!
A period of storage
2 years
After an expiration date not to apply
Prescription status
Without prescription
Dr. of Reddi's Laboratoris Limited Producer
7-1-27 Amiirpert, Hayderabad-500,016, India
the Name of the Owner of the registration certificate:
The Dr. of Reddi's Laboratoris Limited, India
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products
Representative office Dr. of Reddi's Laboratoris Limited in the Republic of Kazakhstan:
050057 Almaty, st. 22 line, 45
ph. 8 (727) 3941688
fax: 8 (727) 3941294
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