Translation of the instruction Mose

PANTENOL PLUS

cream the Instruction

On medical use of medicine

Pantenol plus

Ingredients:

Active ingredient: chlorhexidina dihydrochloride, dekspantenol;

chlorhexidina of dihydrochloride of 5 mg, a dekspantenola of 50 mg contains

1 g of cream;

excipients: DL пантолактон, cetyl alcohol, stearyl alcohol, paraffin white soft, oil mineral, lanolin, polyethyleneglycol stearate, water purified.

Dosage form.

Cream.

Main physical and chemical properties: uniform cream from almost white till pale yellow color.

Pharmacotherapeutic group.

Dermatological means. antiseptic and disinfectants. chlorhexidin, combinations.

ATX D08A C52 Code.

Pharmacological properties.

Pharmacodynamics.

Chlorhexidin's

dihydrochloride — an antiseptic agent which has bactericidal effect in relation to gram-positive bacteria, especially to sensitive strains of Staphylococcus aureus — microorganisms which are most often connected with skin infections. To a lesser extent a chlorhexidina dihydrochloride is active rather gram-negative pathogenic microorganisms. Some types of Pseudomonas and Proteus are resistant to a chlorhexidin. It has weak activity concerning mushrooms and is inactive concerning viruses.

Dekspantenol, active component of medicine of Pantenol Plus, in cages quickly turns into pantothenic acid and acts as vitamin. But dekspantenol has advantage as quicker, than pantothenic acid, is absorbed at topical administration. Pantothenic acid is a component of vital coenzyme A (CoA). Acetyl coenzyme A (CoA) plays the leading role in metabolism of each cell in this form. Thus, pantothenic acid is necessary for formation and healing of injuries of skin and mucous membranes.

Pharmacokinetics.

Absorption of a chlorhexidin through the uninjured skin is not revealed by

. At babies who were bathed in washing 4% solution of a chlorhexidin of a gluconate low concentration of a chlorhexidin in blood (1 mkg/ml) were observed. Is known of distribution of a chlorhexidin in bodies and fabrics a little as dermal absorption is minimum. At oral purpose of 300 mg at healthy adult C _max in blood plasma, making 0.2 mkg/ml, it is possible to define in 30 min. Chlorhexidin after topical skin administration actually is not soaked up.

After oral administration chlorhexidin is almost completely allocated with a stake.

Dekspantenol is quickly absorbed by skin. In skin cells quickly turns into pantothenic acid and fills up endogenous reserves of this vitamin.

In blood pantothenic acid contacts proteins of blood plasma (mainly β-globulin and albumine). At healthy adults the concentration makes about 500-1000 mkg/l and 100 mkg/l in blood and blood serum respectively.

Pantothenic acid does not break up in an organism and is removed in not changed look. 60–70% of an oral dose are removed with urine, the rest — with a stake. At adults with urine 2–7 mg are excreted, children have 2–3 mg/days

Clinical characteristics.

Indication.

Superficial injuries of skin of any origin at which there is a risk of infection: scratches, cuts, raschesa, skin cracks, burns, abscesses, dermatitis. chronic injuries of skin, such as trophic ulcers of legs and decubituses. skin infections, for example the secondary infected eczema and neurodermatitis. treatment of nipple cracks at women who nurse. in low-invasive surgery: injuries and surgical wounds.

Contraindication.

Hypersensitivity to a dekspantenol and/or a chlorhexidin or any other components of medicine. it is impossible to apply on a perforated tympanic membrane.

Interaction with other medicines and other types of interactions.

Chlorhexidin is incompatible

with omylivayushchy substances and other anion connections. panthenol plus is not recommended to be applied along with other antiseptic agents to prevention of their mutual influence (counteraction or an inactivation).

Feature of application.

Should avoid contact with eyes, ears and mucous membranes. at hit of medicine in eyes they need to be washed with water carefully.

is not recommended to apply

Pantenol Plus to processing of irritations of skin which probability of infection is low (for example, at a sunblister). Not to apply at allergic diseases of skin without infectious complications.

Big on the areas which are strongly polluted and deep wounds and also the wounds which arose from stings and punctures demand medical intervention (there is a danger of development of tetanus). If the wound sizes within 10–14 days remain big or the wound does not heal, it is necessary to revise expediency of prescribing of medicine. It is also necessary if severe perifocal hyperaemia takes place, the wound swells, there is severe pain, purulent exudation amplifies or damage is followed by fever (danger of development of sepsis).

not to use Drug for treatment of contaminated wounds with plentiful purulent exudation.

If symptoms remain or the state worsens, it is necessary to see a doctor.

Use during pregnancy or feeding by a breast.

by

At a research of reproductive function at animals did not reveal any risk for a fruit. however during pregnancy it is not necessary to use medicament panthenol plus on the big surfaces of skin as data on controlled researches with the assistance of pregnant women are absent.

women can use Drug during feeding by a breast, but it is necessary to abstain from application on the big surfaces of skin. If medicament is used for treatment of nipple cracks, before feeding by a breast it should be washed away.

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

does not influence.

Route of administration and doses.

to Adults and children 1 years medicine are more senior than

to apply one or several times in day, depending on requirement, on previously cleaned affected areas of skin.

Daily dose at repeated application not has to exceed 5 g

If necessary can apply bandages.

Frequency of putting medicine and duration of treatment are determined by

by the recommendation of the doctor individually, depending on clinical signs of injury of skin. It is necessary to avoid application on big sites of skin.

Children.

to use Drug to children 1 years are more senior.

Overdose.

cases of overdose are unknown to

At topical administration of medicine.

Dekspantenol, even in high doses, is well had and it is considered non-toxic. The hypervitaminosis is unknown.

by

described increase in level of aminotransferase after self-poisoning chlorhexidiny.

Often after repeated topical administration on the same sites of skin her irritation can arise. Drug is intended for treatment of superficial injuries of skin. It is necessary to avoid application on big sites of skin.

Side reactions.

Disturbance from the immune system, leather and hypodermic fabric. allergic reactions, including allergic reactions of skin, such as contact dermatitis, allergic dermatitis, itch, erythema, eczema, rash, small tortoiseshell, hypostasis, irritation of skin, bubbles. hypersensitivity, anaphylactic reactions and acute anaphylaxis (potentially life-threatening) with the corresponding laboratory and clinical manifestations including a syndrome of asthma, reaction from easy to moderate severity which potentially affect skin, a respiratory system, digestive tract, a cardiovascular system, including cardiorespiratory insufficiency.

Expiration date.

2 years.

Storage conditions.

to Store

at a temperature not over 25 ºс.

to Store

out of children's reach.

Packing.

On 30 g in a tuba, in a pack from cardboard.

Category of a holiday.

Without recipe.

Producer/applicant.

LLC ternofarm.

Location of the producer and its address of the place of implementation activity/location of the applicant.

Ukraine, 46010, Ternopil, st. factory, 4.

Ph./fax: (0352) 521-444, www.ternopharm.com.ua