Translation of the instruction Mose

HLORGEKSIDIN-KR solution for external use of 0.05%

Instruction

On medical use of medicine

Ingredients:

Active ingredient: chlorhexidina digluconate;

100 ml of solution 20% of solution, in terms of 100% contain a chlorhexidin of a digluconate, substance — 0.05 g;

excipient: the water purified.

Dosage form.

Solution for external use.

Main physical and chemical properties: colourless transparent liquid.

Pharmacotherapeutic group.

Antiseptic and disinfectants. code atkh d08a s02.

Pharmacological properties.

Pharmacodynamics.

Chlorhexidin's

digluconate is cationic biguanide. The chlorhexidin has amino groups of cellular proteins. Gets into intracellular membranes of bacterial cages, settles on cytoplasm and changes function of a membrane, interfering with oxygen consumption that causes decrease in level of adenosine triphosphoric acid (ATP) and death of cages. Destroys DNA and breaks synthesis of DNA at microorganisms. Provides the long persistent antimicrobic activity interfering reproduction of microorganisms at least within 6 hours after use of medicine.

Chlorhexidin's

digluconate has the fast and expressed effect on gram-positive and gram-negative bacteria (Treponema pallidum, Chlamidia spp., Ureaplasma spp., Neisseria gonorrhoeae, Gardnerella vaginalis, Bacteroides fragilis), simplest (Trichomonas vaginalis), viruses (Herpes virus). In the presence of blood and other organic substances the antimicrobic activity of a chlorhexidin of a digluconate does not decrease.

Pharmacokinetics.

Through intact skin does not get. Practically it is not soaked up from digestive tract. After accidental ingestion of 300 mg the maximum concentration is reached in 30 minutes and makes 0.206 mkg/l. It is removed mainly with stool (90%), less than 1% are allocated with kidneys.

Clinical characteristics.

Indication.

For prevention of infections, sexually transmitted (syphilis, gonorrhea, trichomoniasis, clamidiosis, ureaplasmosis, genital herpes).

For disinfection of the purulent wounds infected burn surfaces; for treatment of infections of skin and mucous membranes in surgery, obstetrics, gynecology, urology (uretrita, uretroprostatita), stomatology (rinsing and irrigation — an ulitis, stomatitis, afta, a periodontal disease, an alveolitis).

Contraindication.

Hypersensitivity to medicine components. tendency to allergic reactions and allergic diseases, dermatitis, viral diseases of skin.

is not recommended to apply

to processing of a conjunctiva and washing of a cavity, on wounds with a big surface, at operations in the central nervous system and an ear canal, in ophthalmology, to introduction to an ear canal.

Interaction with other medicines and other types of interactions.

at the same time it is undesirable to apply

in order to avoid development of dermatitis chlorhexidin and medicines of iodine.

Chlorhexidin's

digluconate is cationic substance and is incompatible with soap and other anion substances (saponins, sodium lauryl sulfate, sodium carboxymethylcellulose, colloids, arabic gum).

It is compatible to the medicines containing cationic group (a benzalkoniya chloride, a tsetrimoniya bromide).

Ethanol strengthens effect of medicine.

digluconate is incompatible

In concentration of 0.05% of a chlorhexidin with borates, carbonates, chlorides, citrates, phosphates, sulfates as almost insoluble precipitation is formed.

Feature of application.

Should avoid hit of medicine in a wound to patients with an open craniocereberal injury, injury of a spinal cord, perforation of a tympanic membrane. at hit of solution on mucous membranes of their eye it is necessary to wash quickly and carefully with water. hit of hypochloride bleaches on the fabrics staying earlier in contact with the medicines containing chlorhexidin can promote emergence of spots of brown color on them. bactericidal effect of medicine amplifies with temperature increase. at a temperature over 100 °C medicine partially decays.

Drug is practically not absorbed by

in a stomach. At accidental ingestion of means it is necessary to wash out a stomach, using raw milk, crude egg, gelatin. In case of need to carry out symptomatic therapy.

not to part

with hard water. It is possible to sterilize in the autoclave at a temperature of 116 °C within 30 min. Not to sterilize by means of ionizing radiation.

should not violate rules of use of medicine — it can do much harm to health.

Use during pregnancy or feeding by a breast.

during pregnancy or feeding by a breast to use medicament only when the expected advantage for mother exceeds potential risk for the fruit/child. not to process the surface of mammary glands before feeding.

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

does not influence.

Route of administration and doses.

to Apply

outwardly. at microtraumas to process leather around a wound solution then on a wound to impose the napkin moistened with solution and to fix it a bandage or a plaster.

For prevention of infections, sexually transmitted, medicine is effective if to apply it not later than in 2 hours after sexual intercourse. Before use of medicine for the purpose of prevention of venereal diseases it is necessary to empty a bladder, to wash up hands and genitals. After that a stream of solution to process leather of a pubis, the internal surfaces of hips, genitals. To enter bottle contents by means of a nozzle into an urethra: to men — 2–3 ml, to women — 1–2 ml (to women in a vagina of 5-10 ml and to detain for 2–3 minutes). To process solution leather of internal surfaces of hips, a pubis, genitals. After the procedure it is not necessary to empty a bladder within 2 hours.

Complex treatment of uretrit and uretroprostatit to carry out by

by injection to an urethra 2–3 ml of solution of a chlorhexidin of a digluconate 1–2 times a day, a course of treatment — 10 days. To appoint procedures every other day.

Solution of medicine to apply

in the form of irrigations, rinsings and appliques — to apply 5–10 ml of solution on the struck surface of skin or mucous membranes with exposure 1–3 minutes 2–3 times a day (on a tampon or by irrigation).

a breast medicine to apply

during pregnancy or feeding in the usual recommended doses.

Children.

not to apply

to children up to 12 years.

Overdose.

overdose Cases at external use are unknown to

.

Wrong application in a large amount of substance (300 ml of a chlorhexidin) leads

to a lethal outcome with signs of hepatonephric insufficiency.

inside medicine is practically not adsorbed by

At hit — it is necessary to wash out a stomach with use of milk, gelatin or crude egg. Symptomatic therapy is in case of need carried out.

Side reactions.

In some cases at the increased individual sensitivity reactions of hypersensitivity, dryness and an itch of skin, dermatitis, stickiness of skin of hands which is observed within 3–5 minutes, a photosensitization are possible

. at treatment of ulites — coloring of enamel of teeth, adjournment of a dental calculus, violation of taste.

in case of any undesirable phenomena should stop use of medicine and it is obligatory to see a doctor.

Expiration date.

3 years.

not to apply

after the expiration date specified on packing.

Storage conditions.

to Store

in original packing at a temperature not above 25 °C.

to Store

out of children's reach.

Packing.

On 100 ml in a container with a nozzle for the directed administration of medicine, in a pack from cardboard.

On 100 ml in a container with a nozzle for the directed administration of medicine, without pack.

Category of a holiday.

Without recipe.

Producer.

Public joint stock company "chemical pharmaceutical plant "red star".

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

61010, Ukraine, Kharkiv, st. gordiyenkovsky, 1.