국가: 이스라엘
언어: 영어
출처: Ministry of Health
KETOCONAZOLE
J-C HEALTH CARE LTD
D01AC08
SHAMPOO
KETOCONAZOLE 20 MG / 1 G
TOPICAL- SCALP
Required
JANSSEN PHARMACEUTICA N.V.,BELGIUM
KETOCONAZOLE
KETOCONAZOLE
Topical treatment of seborrhoeic dermatitis including dandruff resulting from proven fungal infection including Pityriasis versicolor.
2012-08-31
DO NOT EXCEED THE RECOMMENDED DOSE. For external use only. Do not swallow Nizoral Shampoo. In the event that you accidentally swallowed the preparation, refer to a doctor. If you accidentally swallowed Nizoral Shampoo, or if a child has accidentally swallowed the medicine, refer immediately to a doctor or proceed to a hospital emergency room, and bring the package of the medicine with you. Be sure to adhere to the treatment as recommended by the doctor. Do not take medicines in the dark! Check the label and the dose each time you take medicine. Wear glasses if you need them. If you have further questions regarding use of the medicine, consult a doctor or pharmacist. 4. SIDE EFFECTS: As with any medicine, use of Nizoral Shampoo may cause side effects in some users. Do not be alarmed when reading the list of side effects. You may not suffer from any of them. Stop treatment with Nizoral Shampoo and refer to a doctor immediately in the event that you detect one of the following. It is possible that you will need immediate medical attention: - Allergic reaction, swelling of the face, lips, mouth, tongue or throat that may cause problems with swallowing or breathing. - Severe irritation or reddening of the skin where the shampoo has been used, or other signs of allergy during the first few days of treatment. - Peeling or blistering of the skin. Additional side effects: Uncommon side effects: Infection of the hair follicles, increase in production of tears, hair loss or thinning of the hair, dry skin, skin rash, burning sensation on skin, changes in how your hair feels Rare side effects: Taste impairment, irritation of the eyes, acne, flaking skin Side effects whose frequency is unknown: Urticaria, changes in hair color If a side effect occurs, if one of the side effects worsens or if you suffer from a side effect not mentioned in this leaflet, consult with the doctor. 5. HOW SHOULD THE MEDICINE BE STORED? ∙ Avoid poisoning! This medicine, and any other medicine, should be kept in a safe place out of the reach of chil 전체 문서 읽기
Page 1 of 6 NIZORAL_SHAMPOO_SPC_APPROVED ON JUNE 2015 רשואו קדבנ ונכותו תואירבה דרשמ י"ע עבקנ הז ןולע טמרופ ינויב 2015 NIZORAL SHAMPOO PRODUCT INFORMATION 1. TRADE NAME OF THE MEDICINAL PRODUCT Nizoral Shampoo 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram contains 20 mg ketoconazole For Excipients, see _List of Excipients_ . 3. PHARMACEUTICAL FORM Shampoo for topical application to the scalp or skin 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Topical treatment of Seborrhoeic Dermatitis including dandruff resulting from proven fungal infection including Pityriasis versicolor. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION DOSAGE Usually, a palmful of shampoo suffices for one wash. TREATMENT Adults, Elderly and Adolescence : Pityriasis versicolor: once daily for a maximum of 5 days. Seborrheic dermatitis and dandruff: twice weekly for 2 to 4 weeks. SPECIAL POPULATIONS PEDIATRICS The safe and effective use of Nizoral Shampoo 2% in infants and children under the age of 12 years has not been established. ADMINISTRATION Topical application to the scalp or skin. The infected areas of the skin or the scalp should be thoroughly washed with NIZORAL Shampoo 2%, which should be left on the skin/scalp for 3 to 5 minutes before rinsing. Page 2 of 6 NIZORAL_SHAMPOO_SPC_APPROVED ON JUNE 2015 4.3 CONTRAINDICATIONS NIZORAL Shampoo 2% is contraindicated in individuals with known hypersensitivity to any of its ingredients. 4.4 SPECIAL WARNING AND PRECAUTIONS FOR USE In patients who have been on prolonged treatment with topical corticosteroids, it is recommended that the steroid therapy be gradually withdrawn over the period of 2 to 3 weeks, while using NIZORAL Shampoo 2%, to prevent any potential rebound effect. Avoid contact with the eyes. If the shampoo should get into the eyes, they should be irrigated with water. 4.5 INTERACTIONS WITH OTHER MEDICAMENTS AND OTHER FORMS OF INTERACTION None known. 4.6 PREGNANCY AND LACTATION There are no adequate and well-controlled stu 전체 문서 읽기