Translation of the instruction Mose

DERMABIN ointment

Instruction

On medical use of medicine

Dermabin

(dermabin)

Ingredients:

Active ingredients: betamethasone, salicylic acid;

0.64 mg contain

1 g of ointment betamethasone of Dipropionas that is equivalent betamethasone of 0.5 mg, and salicylic acid of 30 mg;

excipients: vaseline, liquid paraffin.

Dosage form.

Ointment.

Main physical and chemical properties: uniform ointment of soft consistence of white color without foreign inclusions.

Pharmacotherapeutic group.

Corticosteroids for application in dermatology. active corticosteroids in a combination with other medicines.

ATH Code. D07X C.

Pharmacological properties.

Pharmacodynamics.

Betamethasone Dipropionas — the synthetic fluorinated corticosteroid which possesses anti-inflammatory, antipruritic and vasoconstrictive action. At topical administration, salicylic acid possesses keratolytic action.

Pharmacokinetics.

Absorption by Dipropionas betamethasone organism perhaps mainly after prolonged use on the extensive surface of skin.

Clinical characteristics.

Indication.

For topical treatment of a dermatosis sensitive to corticosteroids, such as chronic, erythematic or giperkeratozny psoriasis and other dermatosis erythematic skvamatoznogo character, in particular, seborrheal dermatitis (eczema), dry eczema in a desquamative phase, lichenification.

Contraindication.

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Drug is contraindicated to patients with hypersensitivity to active agents or to any other component of medicine. and also at pink eels, an acne, skin reactions after vaccination, perioral dermatitis, widespread blyashechny psoriasis, a perianal and genital itching, a varicosity, a diaper dermatitis, skin manifestations of syphilis, chicken pox, a tuberculosis cutis, other bacterial and fungal infections of skin without appropriate antibacterial and anti-fungal therapy, at shingles, herpes a usual, contagious mollusk, dermatomycoses.

Interaction with other medicines and other types of interactions.

to

does not know Interaction.

Feature of application.

Drug is not intended to

for application in ophthalmology. it is necessary to avoid hit of medicine in eyes, on mucous membranes, wound surfaces and ulcers.

If during use of medicine there were irritations or hypersensitivity, treatment should be stopped.

should appoint by

in the presence of an infection the corresponding therapy.

At disappearance of dandruff or an orogovelost treatment is continued only by corticosteroids.

by

Any side effects which are observed at application of system corticosteroids including oppression of function of bark of adrenal glands, can be noted also at topical administration of glucocorticosteroids, especially at children.

System absorption of corticosteroids or salicylic acid at topical administration will be higher than

if treatment is carried out on big body surfaces or when using occlusive bandages. It is necessary to observe the appropriate measures of precaution in such cases or at prolonged use, especially at treatment of children.

At development of excessive dryness or increase in irritation of skin should stop use of medicine.

Corticosteroids for external use for a number of reasons can cause psoriasis, including resumption of symptoms with the subsequent development of tolerance, risk of developing of pustulous psoriasis and local system toxicity owing to decrease in protective function of skin. Patients with abnormal liver functions are more sensitive to system influence. Careful observation of the patient is necessary.

Local corticosteroids can distort a clinical picture.

recurrence at treatment interruption Is possible

and also exacerbation of an infection and delay of healing are possible.

putting medicine on sites with atrophied skin Is contraindicated to

.

Use during pregnancy or feeding by a breast.

As safety of application of local corticosteroids is not established to pregnant women by

, prescribing of these medicines is possible only if the expected advantage for future mother obviously exceeds potential threat for a fruit. medicines of this group are contraindicated to pregnant women in high doses and for a long time.

it is not clear For today whether corticosteroids at topical administration as a result of system absorption can get into breast milk therefore at making decision on the feeding termination by a breast or medicament withdrawal it is necessary to consider need of prescribing of medicine.

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

Usually medicine does not influence speed of response at control of motor transport or other mechanisms.

Route of administration and doses.

Ointment is applied a thin layer on an affected area of skin by 2 times a day, in the morning and in the evening. for some patients for achievement of satisfactory result can be rather single daily drawing.

Maximum daily dose should be reduced to minimum which would allow to control symptoms gradually.

Drug is appointed to children 2 years are more senior. Treatment duration for children of 2 years it has to be limited up to 5 days.

Children.

Drug is appointed to children 2 years are more senior.

in case of application to children needs to consider possibility of signs of oppression gipotalamo - a hypophysial and adrenal system which arise at children more often than at adult patients that is connected with bigger absorption of medicine at children through bigger value of the relation of the area of integuments to body weight.

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At the children receiving corticosteroids for topical administration noted oppression of function of adrenal glands, Cushing's syndrome, a growth inhibition, insufficient gain of body weight, increase in intracranial pressure.

Manifestation of oppression of function of bark of adrenal glands: low level of cortisol in blood plasma and lack of reaction to test on stimulation of adrenal glands using medicines of adrenocorticotropic hormone (AKTG). Increase in intracranial pressure is shown by protrusion of a fontanel, a headache, a bilateral papilledema.

Use of this medicine is only possible

if the expected advantage exceeds potential risk of development of side reactions.

Overdose.

At prolonged or excessive use of local glucocorticosteroids the oppression of hypophysial and adrenal function with development of secondary adrenal insufficiency and emergence of symptoms of a hypercorticoidism, including Cushing's disease is possible

. excessive or prolonged use of topical medicines with salicylic acid can cause emergence of symptoms of a salitsilizm.

Treatment. Appoint the corresponding symptomatic therapy. Symptoms of a sharp hypercorticoidism are usually reversible. If it is necessary, carry out correction of electrolytic balance. In case of chronic toxic action the gradual cancellation of corticosteroids is recommended.

Treatment of a salitsizlim symptomatic. Take measures for faster removal of salicylates from an organism. In case of the excess growth of resistant microorganisms recommend to stop medicament treatment and appoint necessary therapy. Orally apply Natrii hydrocarbonas to alkalization of urine and strengthening of a diuresis.

Side reactions.

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At application of local corticosteroids such side reactions can be observed: burning, itch, irritation, xeroderma, folliculitis, hypertrichosis, akneobrazny rash, hypopigmentation, perioral dermatitis and allergic contact dermatitis.

Following side reactions can arise more often at application of occlusive bandages: skin maceration, consecutive infection, atrophy of skin, striya and heat rash.

Striya's

and vasodilatation, generally on a face, can be result of long continuous putting medicine.

Expiration date.

3 years.

Storage conditions.

to Store

out of children's reach at a temperature not above 25 °C.

Packing.

On 15 g in tubas. on 1 tuba in a cardboard box.

Category of a holiday.

According to the prescription.

Producer.

LLC fz «biofarma, Ukraine.

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

Ukraine, 09100, Kiev region, white church, st. Kiev, 37.