Axiron

国家: 新西兰

语言: 英文

来源: Medsafe (Medicines Safety Authority)

有效成分:

Testosterone 2%{relative}

可用日期:

Eli Lilly and Company (NZ) Limited

INN（国际名称）:

Testosterone 2% w/v

剂量:

2% w/v

药物剂型:

Topical solution

组成:

Active: Testosterone 2%{relative} Excipient: Ethanol Isopropyl alcohol Octisalate Povidone

每包单位数:

Bottle, plastic, PP Bottle with internal polyester/aluminium/LDPE pouch, 110 mL

类:

Prescription

处方类型:

Prescription

厂商:

NV Organon

疗效迹象:

Androgen replacement therapy for confirmed testosterone deficiency in males

產品總結:

Package - Contents - Shelf Life: Bottle, plastic, PP Bottle with internal polyester/aluminium/LDPE pouch - 110 mL - 18 months from date of manufacture stored at or below 25°C 60 days opened stored at or below 25°C

授权日期:

2012-12-14

产品特点

 
axiron-ds-v1-19nov12 

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AXIRON
®

(testosterone) 2% w/v transdermal solution 

NAME OF THE MEDICINE 

AXIRON
®
 (testosterone). 

Testosterone AAN is a fragrance free white to practically white
crystalline powder chemically 
described as 17-beta hydroxyandrost-4-en-3-one. Testosterone has the empirical formula C
19
H
28
O
2

representing a molecular weight of 288.43. The CAS number for testosterone is 58-22-0. 

Pharmacotherapeutic group: Androgens, ATC code: G03BA03 

Testosterone has the following structural formula: 

DESCRIPTION 

AXIRON (testosterone)  transdermal
solution is a clear, colourless, fragrance free, single phase 
solution containing 30 mg
of testosterone in 1.5 mL of AXIRON solution for transdermal 
administration through the underarm. The active
pharmacologic ingredient in AXIRON is 
testosterone. The inactive
ingredients are ethanol, isopropyl alcohol, octyl salicylate, and
povidone. 

PHARMACOLOGY 

Testosterone and dihydrotestosterone
(DHT), endogenous androgens, are responsible for the 
normal growth
and development of the male sex organs and for the maintenance of secondary
sex 
characteristics. These
effects include the growth and maturation of the prostate, seminal vesicles, 
penis and scrotum; the
development of male hair distribution on the face, chest, axillae
and pubis; 
laryngeal enlargement, vocal chord thickening, alterations in body musculature
and fat distribution. 

Insufficient secretion of testosterone due to testicular failure, pituitary pathology or gonadotropin 
or luteinising hormone-releasing hormone deficiency results in
male hypogonadism and low serum 
testosterone
concentration. Symptoms associated with low testosterone include
decreased sexual 
desire with or without erectile
dysfunction, fatigue, loss of muscle mass, mood�