Riik: Armeenia
keel: inglise
Allikas: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
minoxidil
Bosnalijek d.d.
D11AX01
minoxidil
50mg/ml
spray cutaneous,solution
60ml plastic vial
OTC
Registered
2018-06-27
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT PILFUD ® 5% cutaneous spray, solution minoxidil 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of the solution contains 50,00 mg of minoxidil. For excipients see_ section_ 6.1. 3. PHARMACEUTICAL FORM Cutaneous spray, solution. Clear, pale yellow to orange coloured solution. 4. CLINICAL PARTICULARS 4.1.THERAPEUTIC INDICATIONS Pilfud is indicated for the treatment of androgenic alopecia in men aged between 18 and 65. The onset and degree of hair growth may vary among users. Although in general younger patients, those who have been balding for a shorter period of time, or who have a smaller area of baldness on the head surface better respond to the therapy with Pilfud, individual responses cannot be predicted. 4.2.POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY (MEN AGED 18-65) Hair and scalp must be thoroughly dry prior to application of Pilfud. A dose of 1 ml of Pilfud should be applied twice daily on the affected area of the scalp. The total daily dosage should not exceed 2 ml. If fingertips are used to facilitate drug application, hands should be washed afterwards. In order to achieve the expected therapeutic effect, the solution should be applied twice daily for at least two months. Once a clinical improvement is achieved, one should continue to apply Pilfud as usual, in 1.3.1 Summary of Product Characteristics SmPCD002925/1 PILFUD 5% _ cutaneous spray, solution Page: 1 / 12 Page: 71 / 146 MODULE 1 order to maintain the hair growth process. There are reports indicating that 3-4 months after discontinuation of Pilfud the balding process continues. The treatment should be discontinued if there is no improvement after one year. SPECIAL POPULATIONS There are no specific recommendations for use in patients with renal or hepatic impairment. PAEDIATRIC AND ELDERLY POPULATIONS Not recommended. The safety and effectiveness of Pilfud in children and adolescents below the age of 18 years or adults over the age of 65 years has not been established. ME Lugege kogu dokumenti