Nizoral shampoo 20 mg \ g, 60 ml

Red-orange liquid

Pharmaco-therapeutic group

N4 Treatment and prevention of infections caused by the yeast Malassezia spp.

(Pityrosporum spp.) Such as pityriasis versicolor (localized), seborrheic dermatitis and dandruff.

Application during pregnancy and during breastfeeding

Although when using Nizoral® shampoo, ketoconazole does not penetrate the skin, there have been no adequate and well-controlled studies in pregnant and lactating women.

Plasma concentrations of ketoconazole were not detected after topical application of Nizoral® Shampoo to the skin of non-pregnant women.

There are no known risks associated with the use of Nizoral® 2% shampoo during pregnancy and during breastfeeding.

Since the absorption of ketoconazole into the systemic circulation is negligible, no effects are expected on pregnant women and breastfed children.

During pregnancy and during breastfeeding, it is used only if the intended benefit to the mother outweighs the potential risk to the fetus and child.

Dosage form

Shampoo 2%.

25, 60 or 120 ml of the drug in a high density polyethylene bottle with a screw cap.

Each bottle together with instructions for use in a cardboard box.

Shelf life

3 years.

Do not use after the expiration date.

Category

External use

Name ENG

NIZORAL

Clinical and pharmacological group

Antifungal drug for external use

ATX code

Ketoconazole

Dosage

2% x 60ml

Structure

Shampoo contains: ketoconazole 21 mg.

Excipients: macrogol methyldextrose dioleate, imidourea, cocoyl diethanolamide, collagen hydrolyzate, sodium hydroxide, sodium lauryl sulfate, sodium lauryl sulfosuccinate, sodium chloride, hydrochloric acid, flavor.

Indications

Treatment and prevention of skin lesions caused by the yeast-like microorganisms Malassezia furfur (Pityrosporum ovale), such as dandruff and pityriasis versicolor (localized).

Contraindications

Known hypersensitivity to any component of the shampoo.

INN / Active ingredient

Ketoconazole

Storage conditions and periods

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Specifications

Category

Antifungal

Scope of the medicinal product

Leather

Release form

Shampoo

Manufacturer country

Belgium

Package quantity, pcs

one

Scope of application

Dermatology

Way of introduction

Locally

,

Outwardly

Vacation conditions

Without recipe

Volume, ml.

60 ml

Brand name

Janssen-Pharmaceutica NV

The amount of the dosage form in the primary package

60 ml

Primary packaging type

Bottle

Type of consumer packaging

Pack of cardboard

Pharmaco-therapeutic group

Antifungal agent

Anatomical and therapeutic characteristics

D01AC08 Ketoconazole

Dosage form

Medicinal shampoo

Packaging

Box

Dosage (volume) of the substance in the preparation

ketoconazole, 20 mg

Expiration date in days

1095

The target audience

Adult

Package weight, g

one hundred

Mode of application

:

Teenagers from 12 years old and adults.

Apply NISORAL® shampoo 2% to the affected skin areas for 3-5 minutes, then rinse with water.

Treatment: pityriasis versicolor: once a day for 5 days / li> seborrheic dermatitis and dandruff: twice a week for 2-4 weeks. / Li> Prevention: pityriasis versicolor: once a day for 3 days ( one-time course of treatment before summer) ./ li> seborrheic dermatitis and dandruff: weekly or once every two weeks.

There is no information about the presence of any adverse effects in children.

The safety and efficacy of Nizoral® Shampoo 2% in children under 12 years of age have not been established.