Translation of the instruction Mose

ZERKALIN solution skin 1%

Instruction

For medical use of medicine

Zerkalin®

(zerkalin®)

Ingredients:

Active ingredient: clindamycin;

1 ml of solution;

excipients: ethanol of 96%, propylene glycol, the water purified.

Dosage form.

Solution skin.

Main physical and chemical properties: colourless transparent liquid with an ethanol smell.

Pharmacotherapeutic group.

Antimicrobial means for treatment of an acne. clindamycin.

ATX D10A F01 Code.

Pharmacological properties.

Pharmacodynamics.

Klindamitsin is to semi-synthetic derivatives of lincomycin, the antibiotic received from the culture of Streptomyces lincolensis. It has bacteriostatic and bactericidal properties depending on concentration in the scene of action and sensitivity of microorganisms. Clindamycin suppresses synthesis of protein at sensitive bacteria by linking with 50S a subedinitsa of ribosomes of bacteria, interrupting early stages of protein synthesis. It is known that the spectrum of action of in vitro and in Vivo clindamycin covers the majority of gram-positive bacteria, interrupting early stages of protein synthesis. It is known that the spectrum of action of in vitro and in Vivo clindamycin covers the majority of gram-positive bacteria, the majority of anaerobic pathogens and protozoa. Drug is inefficient to Enterobacteriaceae, mushrooms and viruses. After local drawing on skin of 1% of solution of clindamycin of a hydrochloride growth of sensitive bacteria, especially anaerobe bacterias of Propionibacterium acnes who are in sebaceous glands and follicles is suppressed and also concentration of the free fatty acids (FFA) in skin fat decreases. Such decrease in concentration of SZhK in skin fat is a consequence of indirect suppression of the microorganisms producing a lipase which is necessary for transformation of triglycerides on SZhK, or a direct consequence of decrease in development of a lipase microorganisms. Except lipases of Propionibacterium acnes produce proteases, hyaluronidases and chemotactic factors which together with komedogenny SZhK are responsible for development of inflammatory defeats (papules, pustules, nodes, cysts) at acne rash. Therefore both antibacterial, and anti-inflammatory actions (in which important role is played by oppression of a chemotaxis of leukocytes) are important for development of effect at local putting clindamycin at patients with an acne.

Pharmacokinetics.

Knows that in specially created model of human skin in vitro after putting clindamycin of a hydrochloride (pomecheneny a radioisotope) nearly 10% of a dose are absorbed by a corneal layer of skin. Clindamycin well gets into inflammatory defeats after local drawing. The bioavailability of clindamycin after drawing on skin is about 7.5%.

Clinical characteristics.

Indication.

Treatment of eels usual.

Contraindication.

It is contraindicated to the patients having in the anamnesis hypersensitivity to means, containing clindamycin or lincomycin, Crohn's disease, the ulcer colitis or colitis connected with application of antibiotics.

Interaction with other medicines and other types of interactions.

Klindamitsin has property to block neuromuscular transmission that can lead to strengthening of effect of other medicines with similar properties. therefore it should be applied with care to patients who receive such medicines. there is a cross stability between clindamycin and lincomycin. also the antagonism between erythromycin and clindamycin was noted.

Feature of application.

At topical administration of clindamycin the absorption of an antibiotic from the surface of skin happens. at external and system use of clindamycin reported about development of diarrhea, diarrhea with impurity of blood and colitis (in particular pseudomembranous colitis).

Knows that the main reason of development of the colitis connected with application of antibiotics is the toxin produced by clostridiums. Usually colitis is characterized by heavy persistent diarrhea and heavy gripes in a stomach and can be followed by discharge of blood and slime. Pseudomembranous colitis can be revealed by means of endoscopic inspection. Crops a calla on Clostridium difficile (S. of difficile) and the analysis a calla on availability of C. difficile toxin can help at diagnosis of this disease.

in case of development of considerable diarrhea of use of medicine should be stopped. In cases of heavy diarrhea it is necessary to consider the possibility of carrying out endoscopic inspection of a large intestine for establishment of the exact diagnosis. Use of the means oppressing a vermicular movement such as opiates and diphenoxylate with atropine, can prolong and/or worsen this state. It was defined that Vancomycinum is effective in treatment of the pseudomembranous colitis connected with application of antibiotics which reason C.difficile is. The usual dose for adult patients makes from 500 mg to 2 g of Vancomycinum the day orally divided into 3–4 receptions within 7–10 days. It is known that pitches of a holestiramin or a kolestipol connect Vancomycinum in the conditions of in vitro. In case of need simultaneous use of pitch and Vancomycinum it is desirable to use each of these medicines at different times. It is necessary to avoid hit of medicine on a mucous membrane of eyes and in an oral cavity. When putting solution it is necessary to wash up hands carefully. At accidental contact with sensitive surfaces (eyes, grazes on skin, mucous membranes) it is necessary to wash this site with cool water carefully. Oral and parenteral administration of clindamycin was connected with development of heavy colitis which can lead to a lethal outcome. There are no data on use of medicine to patients with a renal and/or liver failure. It is necessary to appoint with care dosage forms of clindamycin for external use to patients with an atopy.

Use during pregnancy or feeding by a breast.

Pregnancy.

does not have information on well controlled researches of congenital malformations at topical administration of clindamycin at pregnant women. This medicine should be applied to pregnant women only in case of obvious need taking into account advantage/risk.

Feeding by a breast.

whether clindamycin gets into breast milk after topical administration. However it was reported about availability of clindamycin in breast milk after oral and parenteral administration of medicine. It is necessary or cancel use of medicine, or to stop feeding by a breast for treatment, considering importance of use of medicine for mother.

Ability to influence speed of response at control of motor transport or other mechanisms.

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Route of administration and doses.

Solution зеркалин® are applied on an affected area of pure leather by 2 times a day. duration of application is determined by the doctor individually.

Children.

Safety and efficiency of medicine at children was not investigated by age up to 12 years.

Overdose.

in the quantities sufficient for development of system effects (see the section of "feature of application").

Side reactions.

Knows that in dosage forms of clindamycin for external use, side reactions in the form of diarrhea, diarrhea with impurity of blood and colitis, including pseudomembranous colitis (were occasionally observed see. section of "feature of application"). the abdominal pain and gastrointestinal frustration, nausea, vomiting and also a folliculitis caused by gram-negative microorganisms, irritation of skin, burning, an itch, dryness, an erythema, fat content / the oily skin, contact dermatitis, urticaria, burning of eyes connected with application of the dosage forms of clindamycin intended for topical administration were noted. reactions of hypersensitivity. oral and parenteral administration of clindamycin was connected with development of heavy colitis which can have a lethal outcome.

Expiration date.

3 years.

Storage conditions.

at a temperature not above 25 °C.

out of children's reach.

Packing.

On 30 ml of solution in a glass bottle; 1 glass bottle in a cardboard box.

Category of a holiday.

Without recipe.

Producer.

Yadran-galensky of laboratories of of

Location of the producer and address of the place of implementation of its activity.

, 51000 Rijeka, Croatia.