Intell Minoxidil 2% 60 ml solution for external use in vial

The instruction for medical use of Minoksidil Inteli medicine the Trade name Minoksidil Inteli Mezhdunarodnoye the unlicensed name Minoksidil Lekarstvennaya a form Solution for external use of 2% and 5% Structure of 1 ml of solution contains active agent – minoksidit 20 mg or 50 mg excipients: 96% ethanol, propylene glycol, water purified. Vodno's description - spirtovy transparent, colourless solution with an alcohol smell (for concentration of 2%). Vodno is spirtovy transparent, from colourless to slightly painted (zheltovato - brown) colors solution with an alcohol smell (for concentration of 5%). Pharmacotherapeutic group Other drugs for treatment of diseases of skin. Minoksidil. ATH code: D11AX01 external use minoksidit the Pharmacological Pharmacokinetics Absorption At properties is absorbed in the minimum quantities (on average 1.4% (0.3%-4.5%) come to a system blood stream). Distribution and metabolism of Concentration of a minoksidil in serum after external use correspond to extent of transdermalny absorption. About 60% of the minoksidil absorbed after topical administration are metabolized to a glucuronide of a minoksidil, mainly in a liver. Removal After phase-out of drug about 95% of the minoksidil which came to a system blood stream is removed within 96 hours (four days). Minoksidil and his metabolites are allocated almost completely with urine, with very insignificant extent of removal with excrements. The pharmacodynamics Minoksidil at topical administration has promoting effect on growth of hair at persons with an androgenic alopecia. Emergence of signs of growth of hair is noted approximately in 4 months of use of a minoksidil 2 times a day and can fluctuate at different patients. After the drug treatment termination growth of hair can stop and within 3-4 months to return to level before treatment. The exact mechanism of action of a minoksidil at treatment of an androgenetichesky alopecia is unknown. After topical administration of a minoksidil both at persons with normal, and at patients with the increased arterial blood pressure the system side effects connected with absorption of a minoksidil were not noted. The mechanism of action by means of which minoksidit stimulates growth of hair up to the end is not found out, but minoksidit can turn process of the baldness caused by an androgenetichesky alopecia by means of the following: − − stimulation of a phase of an anagen − lengthening of a phase of an anagen − stimulation of restoration of an anagen after a phase of a telogen as a peripheral vazodilatator minoksidit increase in diameter of a core of a hair strengthens microcirculation in hair follicles. The Vascular Endothelial Growth Factor (VEGF) is stimulated under the influence of a minoksidil. SEFR presumably is responsible for the increased windowing of capillaries that it indicates the high metabolic activity noted during a phase of an anagen. Indications the Androgenetichesky alopecia of moderate intensity at men and women (2% solution) and only at men (5% solution). The route of administration and doses Minoksidil of 2% and 5% solution is intended only for external use. 2% solution of a minoksidil are applied at the first signs of an alopecia, stop a hair loss and stimulate growth of new. The effect occurs in 3-4 months. Minoksidil, 5% solution, is applied to treatment of an androgenetichesky alopecia only at men. This treatment is intended for patients at whom use of 2% of solution within 4 months does not provide growth recovery of hair. 5% solution of a minoksidil provide high probability of growth recovery of hair, than 2% solution. The effect can be observed in two months of daily two times use of drug. Minoksidil, 5% solution, is intended for men at whom baldness or a poredeniye of hair in a parietal part of the head is observed. Drug is not intended for treatment of baldness in the field of frontal zones or in the field of front border of growth of hair. It is not recommended to apply 5% solution of a minoksidil to men if the androgenic alopecia has hereditary or focal character. The daily recommended dose makes 1 ml / 12 hours that corresponds to 10 pressing, is applied to head skin, since the center of field of drawing. The daily recommended dose has to be observed regardless of alopecia degree. The maximum recommended daily dose makes 2 ml. A route of administration Extent of treatment response minoksidily is individual for each patient. To apply to dry skin of a hairy part of the head, since the center of field of drawing (it is rubbed to problem sites of the head in baldness zones). Not to apply solution of a minoksidil on other parts of a body. After putting drug it is recommended to wash up hands carefully. Perhaps, use of drug within 4 months before emergence of evidence of growth of hair will be required. After the termination of treatment for 3-4 months there is a probability that the patient will return to a state prior to medicine use. Maintenance of stable effect requires constant use of drug. It is necessary to stop drug use if in one year the improvement is not noted. Children Use of a minoksidil is not recommended at children and teenagers up to 18 years as safety and efficiency of use of drug for such patients was not studied. Elderly patients Use of a minoksidil is not recommended at aged people 65 years as safety and efficiency of use of drug for such patients was not studied are more senior. Side effects during placebo - controlled clinical trials the general frequency of emergence of the undesirable phenomena at women was approximately five times higher on all categories of a system of a body in comparison with men. Dermatological reactions (for example, irritation, an itching) were noted at the patients using both solutions. It was explained with presence of propylene glycol in active and inactive solution. Frequency of emergence of undesirable reactions at use of solution of a minoksidil for topical administration is defined, using the following symbols: Very often ≥1/10), it is frequent (≥1/100, & lt, 1/10), infrequently (≥1/1,000, & lt, 1/100), is rare (≥1/10,000, & lt, 1/1,000), is very rare (& lt, 1/10,000), it is not known (it is impossible to estimate on the basis of the available data). Disturbances from nervous system Often: headache Seldom: Disturbance dizziness from the vascular system Infrequently: hypotension Seldom: cardiopalmus, increase in pulse rate, stethalgia Respiratory, thoracic and mediastinal disturbances Infrequently: asthma Seldom: hypersensitivity reactions (including a face edema, an erythema, a Quincke's disease (including swelled lips, a mucous oral cavity, a throat, language) Disturbances from skin and hypodermic cellulose Often: a hypertrichosis (undesirable growth of hair not on head skin, including growth of hair on the face of women), an itching (including pruritic rash and an itching in the site of application, a generalized itching and an itching of eyes) Infrequently: temporary baldness (see the section Special Instructions), changes of texture and hair color, skin exfoliation (including exfoliative rash in the site of application and exfoliative dermatitis), rash (including pustular, papular in the site of application, generalized vesicular and macular rash), an acne (acne rash), dermatitis (including contact, in the site of application, atypical, atopic and seborrheal dermatitis) and xeroderma (including dryness in the site of application) the General disturbances and disturbances in the site of application Infrequently: nausea, vomiting, xeroderma, increase in weight, peripheral swelled, irritation in the site of application (including irritation of skin, an ulceration, including ears, a face), an erythema in the site of application (including an erythema and erythematic rash, including ears, a face) Contraindications Children's and teenage age up to 18 years. The known hypersensitivity to a minoksidil, ethanol, propylene glycol. Pregnancy and period of feeding by a breast. Hypertension. Use of occlusive bandages or other medications for topical administration. Any injuries of head skin (including psoriasis and a sunblister). Drug should not be applied during the reddening, inflammation, infection, skin soreness of the head. Drug should not be applied to the shaved head skin. Medicinal interactions Though it was not shown clinically, there is a probability that minoksidit can increase risk of lowering of blood pressure at orthostatic patients at simultaneous use with vazodilatator and antihypertensive medicines, such as guanetidin and its derivatives (see the section Special Instructions) It is impossible to apply together with such products to external use as kortikoida, retinoids or the blocking ointments as it can increase their absorption. Special instructions women should not apply 5% solution of a minoksidil to growth recovery of hair as at women it is not more effective, than 2% solution. Besides, at some women it can lead to growth of hair in the person. At patients with a dermatosis of head skin the transdermalny absorption of medicinal substance therefore it is necessary to exclude a dermatosis prior to drug use is possible. As the product contains propylene glycol, it can cause irritation of skin. Several cases of contact dermatitis which are associated with propylene glycol which is the vehicle in this product are known. Though system absorption of a minoksidil was not registered, it cannot be excluded therefore it is recommended to carry out regular monitoring of blood pressure, pulse rate and also regular control of presence of hypostases. Patients with cardiovascular pathology in the anamnesis or with a cardiopathy of any type have to observe extra care because of possibility of systemic action. At emergence of system side effects (retrosternal pains, heartbeat, dizziness, decrease in the ABP, sudden increase in body weight, hypostases of hands and/or legs) and also reddenings and irritations in the place of rubbing in drug should be cancelled and if necessary to appoint the corresponding therapy in case of hit of drug in eyes, on the injured skin or mucous membranes it is necessary to wash out an affected area a large amount of flowing cold water at once. It is necessary to avoid inhalation of drug at dispersion. At some patients after use of drug the discoloration and structures of hair was observed. It is necessary to avoid drug washing off, hair can be wetted not earlier than in 4 h after use. In case of systemic action or heavy dermatological reactions the use of a minoksidil needs to be stopped. To avoid contact with eyes. In case of contact with sensitive surfaces it is necessary to wash out their large number waters. Minoksidil is applied only to treatment of an androgenetichesky alopecia and should not be used in other types of baldness, for example, when in the family anamnesis there is no baldness, baldness is sudden and/or focal, baldness is caused by the birth of the child or the cause of baldness is unknown. The patient has to stop use of drug MINOKSIDIL-INTELI and see a doctor in case of detection of hypotension or in case of emergence in the patient of a stethalgia, a cardiopalmus, weakness or dizziness, the sudden not explained increase in weight, hypostasis of hands or legs or permanent erubescence. Patients with the known cardiovascular diseases or arrhythmia of heart have to consult with the doctor before use of drug MINOKSIDIL-INTELI. MINOKSIDIL-INTELI is intended only for external use. Not to apply on any parts of the body besides head skin. Some patients reported about increase in a hair loss at the beginning of use of drug MINOKSIDIL-INTELI. It, most likely, is caused by the action of a minoksidil promoting transition of hair from a telogenny resting phase in a phase of an anagen (old hair drop out in process of growth of new hair on their place). Such temporary strengthening of a hair loss is usually noted during two - six week after an initiation of treatment and gradually decreases within several weeks. In case of loss continuation (& gt, 2 weeks) users have to stop use of drug MINOKSIDIL-INTELI and consult with the doctor. The accidental ingestion can cause the serious undesirable phenomena from heart. Therefore drug has to be stored out of children's reach. Pregnancy and the period of a lactation Though during the researches conducted on animals the direct or mediated harmful impact on a pregnancy course, development of an embryo/fruit, childbirth or post-natal development was not revealed. There are no data on use of a minoksidil by pregnant women therefore it is not necessary to use drug at pregnancy. Because minoksidit gets into breast milk, its use during feeding is not recommended by a breast. The feature of influence of medicine on ability to run the vehicle or potentially dangerous Minoksidil mechanisms does not influence ability to control of motor transport and work with mechanisms. The overdose Accidental or deliberate overdose at external use of a minoksidil will lead to increase in intensity of adverse dermatological reactions, especially the nagger, xeroderma, irritation and eczema. Also, system absorption will increase that will increase the probability of emergence of system effects. Signs and symptoms of accidental and deliberate oral administration of a minoksidil are consequences of fast and almost full absorption which happens in digestive tract. Hypotension, tachycardia, a liquid delay can be observed that leads to hypostases, a pleural exudate or stagnant heart failure. Treatment: it is necessary to carry out symptomatic and maintenance therapy. Adrenomimetiki, such as adrenaline and noradrenaline, is not recommended to use. A form of release and packing On 60 ml of drug in bottles from polyethylene with the measured pump. On 1 bottle together with the instruction for medical use in the state and Russian languages put in a cardboard pack. To Store storage conditions at a temperature not above 25 °C. To store out of children's reach. Period of storage 3 years. The use period after packing opening 1 month. Not to apply after an expiration date. Prescription status Without prescription the Kantabria Pharmasyyutik's Industrial Producer, S.A., Carretera de Cazona-Adarzo, with/N 39011 – Santander, Spain the Name and the country of the Pharmasyyutik's Industrial organization packer of Kantabria, S.A., Spain the Name and the country of the owner of the registration certificate of CJSC Inteli Generix Nord, Sheyminishkyu 3 St., LT-09312, Vilnius, the Republic of Lithuania the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) and responsible for post-registration observation of safety medicinal means. TV-Pharma LLP, Almaty, mdt. Zhetysu 3, 1, quarter 7 Ph. / fax: (727) 376-8082 Электр.адрес:Valera.tv.pharma@gmail.com
to Develop