Universal reference book for medicines
Product name: KEVRAVT (KERAVORT)

Active substance: imiquimod

Type: Immunomodulator for topical application.
Interferon synthesis inducer
Manufacturer: GLENMARK PHARMACEUTICALS (India)
Composition, form of production and packaging
The cream for external use is
white or almost white, homogeneous, soft.

100 g

imiquimod 5 g

Excipients: isostearic acid (Emersol 874) 25 g, cetyl alcohol (Speziol C15 Pharma) 2.2 g, stearyl alcohol (Speziol C18 Pharma) 3.1 g, myristyl alcohol (Speziol C14) 7 g, soft white wax 3 g, polysorbate 60 (Tween 60) 3.4 g, sorbitan monostearate (Motane 60 PHA) 0.6 g, methyl parahydroxybenzoate 0.2 g, propyl parahydroxybenzoate 0.02 g, glycerol 2 g, xanthane gum 0.5 g, benzyl alcohol - 2 g, purified water - up to 100 g.

0.25 g - single-use bags made of laminate (12) - packs of cardboard.

0.25 g - single-use bags made of laminate (24) - packs of cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2016.

PHARMACHOLOGIC EFFECT

Immunomodulating drug for external use.
Imiimod - the active substance of the Keravort preparation - is a compound - a modifier of the immune response. Imiximod does not have a direct antiviral effect, its effect is due to the induction of interferon alpha (IFN?) And other cytokines.
PHARMACOKINETICS

Less than 0.9% of the radiolabeled imiquimod is absorbed through the human skin after a single dose.

A small amount of the drug that enters the systemic bloodstream is excreted from the body by the kidneys and through the intestine at a ratio of approximately 3: 1.Concentration of the drug in the blood serum after a single or multiple external application did not reach the level that can be quantified (> 5 ng / ml).

INDICATIONS

- treatment of external genital warts in the place of localization on the external genitalia or in the perianal region in adults.

DOSING MODE

Outwardly.

The cream is applied a thin layer on the previously cleaned surface of the affected areas of the skin and gently rubbed until completely absorbed.
Cream should be applied only to the affected area, avoiding contact with internal surfaces. Keravort Cream should be applied 3 times a week before bedtime and left on the skin for 6-10 hours, during this time, do not use a shower or bath.
On the site of application of the cream should not be applied bandage.

After the specified time, the cream should be washed off with warm water and soap.

Treatment should be continued until the disappearance of visible genital or perianal condylomas, but no more than 16 weeks.

The cream is packed in disposable sachets containing the required amount of cream to apply to the affected area of ​​the skin in 20 cm 2 .

If the patient forgot to apply the cream on schedule, you should apply the missed dose as soon as he remembers it, then follow the usual schedule.

Do not use the cream more than 1 time per day.

Do not use excess cream.

SIDE EFFECT

The incidence of side effects is defined as follows: very often (> 1/10);
often (<1/10> 1/100); infrequently (<1/100> 1/1000); rarely (<1/1000> 1/10 000); very rarely (<1/10 000).
Local skin reactions: very often - itching and pain in the place of application of the cream;
often - infection, erythema, erosion, excoriation / scaling and edema;infrequently - itchy skin, dermatitis, folliculitis, erythematous rash, eczema, urticaria; rarely - induration, ulceration, scabbing and the appearance of vesicles, local hypopigmentation and hyperpigmentation.
From the digestive system: infrequently - pain in the anus, lesions of the rectum.

From the genitourinary system: infrequently - fungal and bacterial infection, herpes simplex, vaginitis, vulvitis, painful intercourse, pain in the penis, vagina, atrophic vaginitis.

If there are local side effects, the cream should be removed by rinsing it with soap and water.
Treatment can be resumed after a skin reaction has been stopped.
CONTRAINDICATIONS

- hypersensitivity to imichimod or other components of the cream;

- Children under 18 years of age (due to lack of data).

PREGNANCY AND LACTATION

Use in pregnancy is possible by strict indications, if the intended benefit to the mother exceeds the potential risk to the fetus.

If you need to use the drug during lactation, breastfeeding should be discontinued.

SPECIAL INSTRUCTIONS

The cream is applied only to the affected areas.

Avoid getting the cream on the mucous membranes.

Avoid contact with eyes.
In case of contact with eyes, rinse with water.
Keravort Cream is applied before bedtime.
The use of excessive amounts of cream or a prolonged contact of the cream with the skin can cause a pronounced local reaction.
You can not reuse the cream from a previously opened sachet!

Before and after applying the cream, you should wash your hands with warm water and soap.

Men who did not have circumcision, when treating genital warts, located under the foreskin, should daily rinse the affected area, pulling the foreskin.
It is recommended to immediately stop treatment if early signs of phimosis are detected.
If a local reaction to the drug causes serious discomfort for the patient, or in the area of ​​application of the cream there is an infection, you can take a break in the treatment for several days.
In the event of infection, the necessary measures are taken.
Keravort Cream can cause exacerbation of inflammatory skin diseases.

It is not recommended to use Keravort cream before healing of the skin after other types of medicamentous or surgical treatment.

Do not start treatment with Keravort cream on areas with open sores or wounds before healing.

Fillers methyl parahydroxybenzoate, propyl parahydroxybenzoate, cetyl spitter and stearyl alcohol can cause an allergic reaction.

When detecting a hypersensitivity reaction, it is recommended to stop therapy.

It is not recommended to use occlusive dressing during treatment with Keravort.

The use of imiquimod in doses exceeding the recommended levels may lead to an increased risk of developing severe local reactions.

During the application period Keravort cream should avoid or minimize exposure to sunlight (including sunlight), since there is a danger of getting sunburn.

Because
imiquimod does not have direct antiviral and cytotoxic effects, after the treatment, new genital warts and perianal areas may appear.
Based on the current knowledge, the treatment of urethral, ​​intravaginal, cervical, rectal, or intra-anal genital warts with Keravort cream is not recommended.

Keravort Cream should be washed off the skin before sexual intercourse.

Keravort Cream can weaken the effect of condoms or vaginal diaphragms, therefore it is not recommended to use these contraceptives when using Keravort cream.You should choose an alternative method of contraception.

In patients with immunodeficiency it is not recommended to use Keravort cream repeatedly.

Impact on the ability to drive vehicles and manage mechanisms

Studies of the effect of the drug on the ability to drive a car and work with mechanisms have not been carried out.

OVERDOSE

Overdose is unlikely because of low absorption of the drug.
If you randomly ingest 200 mg of imiquimod, which corresponds to the contents of approximately 16 sachets, nausea, vomiting, headache, myalgia, and fever may occur. The most serious clinical side effect of oral administration of several doses of 200 mg is a decrease in blood pressure.
In case of an overdose, the patient should immediately consult a doctor for symptomatic therapy.

DRUG INTERACTION

Interaction with other medicinal products

Studies of the interaction of imiquimod with other drugs, including immunosuppressants, have not been conducted.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored in a dark place at a temperature of 2 В° to 25 В° C.
Shelf life - 2 years. Do not use the drug after the expiration date.
Keep out of the reach of children.

Alphabetical index of medicines:
A  B  V  G  D  E  J
Z  I  Y  K  L  M  N
O  P  R  S  T  U  F
H  C  CH  SH  E  U  Y

Privacy policy:
Copyright 2009 - 2017. Universal reference book of medicines. All rights reserved.
When using site materials, an active hyperlink is required!