Skinoren 15% 15g of the gel for the face for problems. skin

The instruction for medical use of Skinoren Torgovoye medicine a name Skinoren Mezhdunarodnoye the unlicensed name Azelaic acid the Dosage form Gel of 15% Structure of 100 g of gel contain active agent – the azelaic acid micronized 15.0 g excipients: propylene glycol, polysorbate 80, lecithin, polyacrylic acid, triglycerides with an average length of a chain, sodium hydroxide, dinatrium edetat, the benzoic acid, water purified. The description Opaque gel from color, white to white with a yellowish shade. Pharmacotherapeutic group Drugs for treatment of eels. Other drugs for topical treatment of acne rash. Azelaic acid. The ATX D10AX03 code the Pharmacological Pharmacokinetics Later properties of local putting gel azelaic acid gets into all layers of skin. Penetration happens quicker in the injured skin, than in healthy. After single topical administration of 1 g of azelaic acid about 3.6% of the put dose are soaked up. In clinical trials the patients with an acne had an identical extent of absorption of Skinoren of gel and Skinoren of cream. A part of the soaked-up acid is removed by kidneys in not changed look. The rest in the form of the dicarboxylic acids from the chain (C7, C5) shortened by length which are formed as a result of beta oxidation is removed also by kidneys. Patients from a rozatse at Skinoren's use gel 2 times a day in 8 weeks had a similar equilibrium concentration of azelaic acid to that that was observed at volunteers and at patients with an acne at a normal diet. It indicates that extent of hypodermic absorption when putting azelaic acid 2 times a day does not influence system loading of the azelaic acid received from endogenous sources and as a result of meal. Acne pharmacodynamics: The therapeutic effectiveness of Skinoren gel at treatment of an acne is caused by its antimicrobic action and direct influence on a follicular hyperkeratosis. In vitro and in Vivo azelaic acid inhibits proliferation of keratinotsit and normalizes the broken processes of a final differentiation of epidermis at formation of an acne. Considerable decrease in density of colonization of Propionibacterium acnes and significant reduction of fraction of free fatty acids in superficial lipids of skin is clinically observed. In two double blind randomized clinical trials Skinoren's efficiency of gel considerably exceeded efficiency of a basis without Azelaic acid (placebo) concerning reduction of total number of papules, pustules, and was 6% less, than at 5% peroxide benzoyl (r =0.056). In these researches Skinoren's efficiency of gel concerning comedones was estimated as secondary parameter. Skinoren gel was more effective, than a basis without Azelaic acid (placebo) concerning reduction of quantity of comedones, but less, than 5% benzoyl peroxide. Rozatsea: The mechanism owing to which azelaic acid influences pathogenetic links of development of a rozatse finally is not found out. Several researches in vitro and ex Vivo indicate that azelaic acid can have anti-inflammatory effect, reducing formation of pro-inflammatory active forms of oxygen. In two placebos - controlled clinical trials lasting 12 weeks at treatment papulo-pustular a rozatsea in comparison with 0.75% metronidazole gel, Skinoren gel statistically considerably exceeded a basis without Azelaic acid (placebo) concerning reduction of inflammatory manifestations, according to global assessment of efficiency the researcher (Investigators Global Assessment, IGA) including improvement of an erythema. In clinical trials at treatment papulo-pustular a rozatsea, Skinoren gel showed considerable efficiency in reduction of inflammatory elements in comparison with 0.75% metronidazole gel (72.7% for 55.8%), the general assessment of improvement of a state, including at treatment of an erythema (56% for 42%). Degree of local side effects generally was from easy to moderate, 25.8% at use Skinoren of gel, and 7.1% at use of 0.75% gel metronidazole. In three clinical trials of noticeable effect on a telangiectasia it was not observed. Indications - easy and moderate degrees of a papulo-pustular form of an acne disease (acne vulgaris) on face skin, - topical treatment papulo-pustular a rozatsea the Route of administration and doses Outwardly. Gel is applied on affected areas of skin and slightly rubbed 2 times a day (in the morning and in the evening). About 0.5 g (2.5 cm) of gel are enough for all surface of a face. Before drug Skinoren use the skin should be cleaned with water or the soft cleaning cosmetic, then to dry up. It is necessary to avoid use of occlusive bandages, and after putting gel it is necessary to wash hands. In case of excessive irritation of skin it is necessary to reduce either amount of the gel applied Skinoren, or frequency rate of use of drug to 1 time a day before disappearance of symptoms of irritation. If necessary it is possible to interrupt temporarily treatment for several days. It is important that Skinoren gel was used regularly during the entire period of treatment. Duration of a course of treatment can change depending on an individual picture of a disease and is defined by degree of its weight. Acne: generally notable improvement is observed, as a rule, in 4 weeks. Skinoren gel should be applied to achievement of the best results continuously for several months depending on clinical effect. If after 1 month of use Skinoren of gel of improvement there is no exacerbation of an acne disease it is necessary to stop use of drug and to consider other ways of treatment. Rozatsea: notable improvement is observed, as a rule, in 4 weeks. Skinoren gel should be applied to achievement of the best results continuously for several months depending on clinical effect. If after 2 months of use Skinoren of gel of improvement does not come or vonikat aggravation of a rozatse it is necessary to stop use of drug and to consider other ways of treatment. Use in pediatrics Use at teenagers of 12-18 years at treatment of an acne disease is not required dose adjustment of drug from teenagers of 12-18 years. Safety and efficiency of use Skinoren of gel at treatment of an acne disease at children are younger than 12 years is not established. Safety and efficiency of use Skinoren of gel at treatment papulo-pustular a rozatse at children are younger than 18 years is not established. Side effects according to clinical trials and post-marketing observation by the most frequent side effects were an itching, burning and hyperaemia in the site of application of drug. Frequency of the side effects observed in clinical trials and in post-marketing observation is distributed on classes of a system of bodies according to MedDRA – the Medical dictionary for regulatory activity: Very often (≥1/10), it is frequent (≥1/100 & lt, 1/10), Infrequently (≥1/1000 & lt, 1/100), is rare (≥1/10000 & lt, 1/1000), Is very rare (& lt, 1/10000), with an unknown frequency (it cannot be calculated from the available data). Very often (≥1/10) - burning, an itching and pain on the site of application of drug Often (≥1/100 & lt, 1/10) - dryness, rash and paresthesias on the site of application of drug (at treatment of an acne disease) - dryness, rash, paresthesias also swelled on the site of application of drug (at treatment papulo-pustular a rozatsea) Infrequently (≥1/1000 & lt, 1/100) - contact dermatitis, an erythema, peeling of skin, feeling of warmth and change of coloring of skin on the site of application of drug (at treatment of an acne disease) - rash, contact dermatitis (at treatment papulo-pustular a rozatsea) - discomfort, an erythema and a small tortoiseshell on the site of application of drug (at treatment papulo-pustular a rozatsea) is rare (≥1/10000 & lt, 1/1000): - reactions of hypersensitivity (are noted in the course of post-marketing observations) With an unknown frequency: - cases of deterioration in bronchial asthma at the patients receiving treatment by azelaic acid (are noted in the course of post-marketing observations). Generally the irritation of skin decreases against the background of treatment Skinoren gel. Contraindications - hypersensitivity to drug components. Medicinal interactions are not established the Special instructions Drug is intended only for external use. Skinoren cream contains benzoic acid which renders moderate irritant action on skin, eyes and mucous and also propylene glycol which can cause irritation of skin. Patsiyentov it is necessary to inform that when using Skinoren's of gel it is necessary to avoid hit of drug in eyes, in a mouth and on mucous membranes. At accidental hit it is necessary to wash out carefully eyes, a mouth and mucous membranes with a large amount of water. If the irritation of eyes remains it is necessary to consult with the doctor. Hands should be washed after each putting drug. When using drug for treatment papulo-pustular the rozatsea is recommended to avoid use of the alcohol cleaning means, tinctures, astringents, abrasive substances and means for a peeling. It was seldom reported about cases of deterioration in bronchial asthma at the patients receiving treatment by azelaic acid in the course of post-marketing observation. Pregnancy and the period of a lactation Adequate and controlled researches at topical administration of azelaic acid at women during pregnancy were not conducted. Researches on animals did not reveal straight lines and the mediated adverse effects concerning pregnancy, development of an embryo/fruit, childbirth and post-natal development. It is necessary to be careful when assigning Skinoren of gel to pregnant women. It is unknown whether azelaic acid with breast milk in issledovaniyay in vivo is emitted. Nevertheless, experience with equilibrium dialysis of in vitro showed that penetration of drug into breast milk is possible. However, it is not expected that penetration of azelaic acid promotes a significant change in its basal level in breast milk. Azelaic acid does not concentrate in breast milk and less than 4% of the azelaic acid applied outwardly are absorbed systemically, without increasing its endogenous influence above physiological level. Nevertheless, the feeding women should be careful when prescribing drug. Babies should not contact to the breast leather processed by this drug. Use in pediatrics Safety and efficiency Skinoren of gel at treatment of an acne disease at children is younger than 12 years is not established. Safety and efficiency of drug at treatment papulo-pustular a rozatse at children are younger than 18 years is not established. Features of influence of medicine on ability to run motor transport and potentially dangerous mechanisms. Use of drug does not affect ability to run motor transport and potentially dangerous mechanisms. Overdose In view of very low local and general toxicity of azelaic acid the development of intoxication is extremely improbable. The form of release and packing On 5 g, 15 g and 30 g of drug place in a tuba aluminum with internal coating epoxy varnish, with a protective membrane and the twisting cover from polyethylene of high density. On 1 tuba together with the instruction for medical use in the state and Russian languages put in a pack from cardboard. To Store storage conditions at a temperature not above 25 °C. To store in places inaccessible for children! 3 years not to use a period of storage after an expiration date. Prescription status Without prescription the Producer/packer: The buyer Helsker Manufacturing of Neuter of l., Segreyt, Italy the Holder of the registration certificate of Bayer Pharm AG, Germany the Address of the organization in the territory of the Republic of Kazakhstan, the accepting claim (offer) on quality of medicines from consumers: TOO Bayer KAZ Timiryazev St., 42, pavilion 15, office 301 Address of the organization in the territory of the Republic of Kazakhstan responsible for post-registration observation of safety of medicine of Bayer of KAZ LLP, st. Timiryazeva 42, pavilion 15, pavilion 15, office 301 050057, Almaty, the Republic of Kazakhstan
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