Land: Malaysia
Sprache: Englisch
Quelle: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
KETOCONAZOLE
SPG PHARMA (MALAYSIA) SDN BHD
KETOCONAZOLE
100 mL per BOTTLE
SIAM BHEASACH CO LTD
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ KETAZON SHAMPOO Ketoconazole (20 mg/g) _______________________________________________________________________________________________ 1 WHAT IS IN THIS LEAFLET 1. What KETAZON is used for 2. How KETAZON works 3. Before you use KETAZON 4. How to use KETAZON 5. While you are using KETAZON 6. Side effects 7. Storage and Disposal of KETAZON 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT KETAZON IS USED FOR KETAZON is an antifungal agent used to treat and prevent skin infections. Both skin and scalp can be treated with the shampoo. HOW KETAZON WORKS KETAZON works by preventing the growth of fungi or yeasts and rapidly relieves scaling and pruritus, which are usually associated with your infection. BEFORE YOU USE KETAZON _- When you must not use it _ Do not use KETAZON if you are allergic to ketoconazole or any other ingredients listed at the end of this leaflet. _Pregnancy and lactation _ There is no known risk with the use of KETAZON in pregnancy or breast-feeding. _- Before you start to use it _ Tell your doctor or pharmacist if you have allergies to any other medicines, preservatives or dyes. _- Taking other medicines _ Tell your doctor or pharmacist if you are on a topical corticosteroid treatment. It is recommended that the steroid therapy be gradually withdrawn over a period of 2-3 weeks, while using KETAZON prevent any potential rebound effect. HOW TO USE KETAZON _- How much to use _ For topical use only. Wash the infected areas of the skin or hair with KETAZON and allow the product to soak in for 3-5 minutes before rinsing. Usually, a palmful of shampoo suffice for one wash. _FOR TREATMENT OF: _ Seborrhoeic dermatitis (reddish brown-coloured skin with yellow or white scales) and dandruff: Apply twice weekly for 2-4 weeks Pityriasis versicolor (brown or white-coloured small skin patches): Apply once daily for up to 5 days _FOR PREVENTION: _ Once every 1 or 2 weeks as needs to maintain control _- When to use it Lesen Sie das vollständige Dokument
SCALE: (%) TO TO 01 02 03 04 05 06 07 08 09 10 11 ทะเบียนยา ทะเบียนยา ทะเบียนยา ทะเบียนยา ทะเบียนยา ทะเบียนยา ทะเบียนยา ทะเบียนยา ทะเบียนยา ทะเบียนยา ทะเบียนยา 16/07/19 22/07/19 18/09/2020 24/09/2020 26/01/2021 W 10.5 cm H 27 cm LEAFLET KETAZON SHAMPOO 2 G EXPORT MALAYSIA FM-RD-DE-04-2 KETAZON-SHAMPOO-100-04-L-ENG-MY-A0004 KET-SHAM-100-04-L-ENG-MY-A0004 Drawing No. KET-SHAM-100-04-L-ENG-MY-A0004 Sent date 29/01/2021 26/01/2021 UNDESIRABLE EFFECTS Summary of Safety Profile The adverse reactions tabulated below are classified according to frequency and system organ, from either clinical trial or post marketing experiences. SYSTEM ORGAN FREQUENCY ADVERSE REACTIONS Immune system disorders Rare : Hypersensitivity Nervous system disorders Rare : Dysgeusia Infection and Infestations Uncommon : Folliculitis Eye disorders Uncommon Rare : Increased lacrimation : Eye irritation Skin and subcutaneous tissue disorders Uncommon Rare Not known : Skin burning sensation, alopecia, dry skin, rash, hair texture abnormal : Skin exfoliation, dermatitis contact, skin disorder, acne : Angioedema, urticaria, hair colour changes General disorders and administration site conditions Uncommon Rare : Application site reaction/ pruritus/ irritation/ erythema : Application site hypersensitivity/ pustules OVERDOSE AND TREATMENT In the event of accidental ingestion, supportive and symptomatic measures should be carried out. In order to avoid aspiration, neither eme- sis nor gastric lavage should be instigated. STORAGE CONDITIONS Store below 30 ° C, protect from light and heat SHELF LIFE 3 years DOSAGE FORMS AND PACKAGING AVAILABLE Available in 100 mL per plastic bottle DATE OF REVISION OF PI Date of revision : 22/01/2021 MANUFACTURER :- SIAM BHEASACH CO., LTD. 123 Soi Chokechairuammitr, Vibhavadi-Rangsit Road, Chomphon, Chatuchak, Bangkok 10900 and 9 Lesen Sie das vollständige Dokument