Država: Malezija
Jezik: engleski
Izvor: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Ketoconazole
JOHNSON & JOHNSON SDN BHD
Ketoconazole
100ml mL
JANSSEN PHARMACEUTICA N.V.
NIZORAL ® SHAMPOO 2% Ketoconazole (20mg/g) _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ _ _ _ _ _ _ WHAT IS IN THIS LEAFLET 1. What Nizoral Shampoo is used for 2. How Nizoral Shampoo works 3. Before you use Nizoral Shampoo 4. How to use Nizoral Shampoo 5. While you are using it 6. Side effects 7. Storage and Disposal of Nizoral Shampoo 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT NIZORAL SHAMPOO IS USED FOR Nizoral Shampoo is used to treat and prevent skin infections caused by fungi or yeasts. Both skin and scalp can be treated with the shampoo. HOW NIZORAL SHAMPOO WORKS Nizoral Shampoo rapidly relieves scaling and pruritis, which are usually associated with seborrheic dermatitis, pityriasis capitis (dandruff) and pityriasis versicolor. BEFORE YOU USE NIZORAL SHAMPOO - _When you must not use it_ If you know you are hypersensitive (allergic) to the formulation of this product. Symptoms of hypersensitivity include itching and red skin, occurring after application. _Pregnancy and lactation_ There is no known risk with the use of Nizoral Shampoo in pregnancy or breast- feeding. - _Before you start use it_ Tell your healthcare professional (doctor or pharmacist) if you have allergies to any other medicines, foods, preservatives or dyes. - _Taking other medicines_ _ _ If you are using Corticosteroids (cortisone-type medicines) in creams, ointment or lotion. If you are using such a medicine, check with your doctor or pharmacist before starting treatment with Nizoral Shampoo. You may start with Nizoral Shampoo right away, but do not stop using the corticosteroid from one day to the next. The skin might react by redness and itching. It is recommended that the steroid therapy be gradually withdrawn over a period of 2 – 3 weeks, while using Nizoral Shampoo to prevent any potential rebound effect. If in doubt, please consult your healthcare professional. HOW TO USE NIZORAL SHAMPOO - _How much to use_ Wash the infected parts of the skin or scalp with Nizoral Shampoo Pročitajte cijeli dokument
LCN NIZORAL SHAMPOO 2% FOR TOPICAL USE ONLY DESCRIPTION NIZORAL Shampoo 2% contains the synthetic broad spectrum antifungal agent, ketoconazole. One gram contains 20mg ketoconazole. The shampoo formulation consists of sodium lauryl ether sulphate, disodium monolauryl ether sulphosuccinate, coconut fatty acid diethanolamide, laurdimonium hydrolyzed animal collagen, macrogol 120 methyl glucose diolaete, sodium chloride, hydrochloric acid, imidurea, perfume bouquet, sodium hydroxide, erythrosine sodium and purified water. PROPERTIES _Pharmacodynamics _ Ketoconazole, a synthetic imidazole dioxolane derivative, has a potent antifungal activity against dermatophytes, such as _Trichophyton_ spp., _Epidermophyton _ spp., _Microsporum _ spp., and yeasts, such as _Candida _ spp. and _Malassezia_ spp. ( _Pityrosporum _ spp.) _._ NIZORAL Shampoo 2% rapidly relieves scaling and pruritus, which are usually associated with seborrhoeic dermatitis, pityriasis capitis (dandruff) and pityriasis versicolor. _Pharmacokinetics _ Plasma concentrations of ketoconazole were not detectable after topical administration of NIZORAL Shampoo 2% on the scalp. Plasma levels were detected after topical administration of NIZORAL Shampoo 2% on the whole body. INDICATIONS Treatment and prophylaxis of infections in which the yeast _Malassezia_ (previously called _ _ _Pityrosporum_ ) is involved, such as pityriasis versicolor (localised), seborrhoeic dermatitis and pityriasis capitis (dandruff). CONTRAINDICATIONS NIZORAL Shampoo 2% is contraindicated in individuals with a known hypersensitivity to any of its ingredients. WARNINGS & PRECAUTIONS In patients who have been on prolonged treatment with topical corticosteroids, it is recommended that the steroid therapy be gradually withdrawn over a 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 bathed with cold water. ® PREGNANCY & LACTATION There are no adequate and wel Pročitajte cijeli dokument