化疣敵乳膏

Ülke: Tayvan

Dil: Çince

Kaynak: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)

Aktif bileşen:

PODOPHYLLOTOXIN

Mevcut itibaren:

荷商葛蘭素史克藥廠股份有限公司台灣分公司 台北市中正區忠孝西路一段66號23-24樓 (86927438)

ATC kodu:

D06BB04

Farmasötik formu:

乳膏劑

Kompozisyon:

PODOPHYLLOTOXIN (9200041700) 1.5MG

Paketteki üniteler:

鋁管裝

Sınıf:

製　劑

Reçete türü:

須由醫師處方使用

Tarafından üretildi:

STIEFEL LABORATORIES (IRELAND) LTD. FINISKLIN BUSINESS PARK, SLIGO, IRELAND IE

Terapötik alanı:

podophyllotoxin

Terapötik endikasyonlar:

生殖器疣（包括外生殖器及肛門附近的疣）。

Ürün özeti:

註銷日期: 2017/04/10; 註銷理由: 屆期未申請展延; 有效日期: 2016/01/30; 英文品名: WARTEC CREAM 0.15% W/W

Yetkilendirme durumu:

已註銷

Yetkilendirme tarihi:

2001-01-30

Bilgilendirme broşürü

[Pharmacodynamics]
ATC code
PHARMACOTHERAPEUTIC GROUP: ANTIVIRALS - PODOPHYLLOTOXIN
ATC CODE: D06BB04
Mechanism of action
PODOPHYLLOTOXIN BINDS TO CELLULAR MICROTUBULES AND INHIBITS MITOTIC
DIVISION.
Pharmacodynamic effects
PODOPHYLLOTOXIN INVADES INFECTED CELLS AND INHIBITS GROWTH, THEREBY
INDUCING NECROSIS OF THE CELLS AND THUS THE CONDYLOMAS.
[Pharmacokinetics]
SYSTEMIC ABSORPTION OF PODOPHYLLOTOXIN AFTER TOPICAL APPLICATION OF
100 MG OF 0.3% CREAM OR 100 ΜL OF 0.5% SOLUTION
HAS BEEN STUDIED (EXTRAVAGINALLY IN 10 FEMALES, AND WITHIN THE
PREPUTIAL CAVITY IN 10 MALES, EACH ON 2 OCCASIONS
SEPARATED BY 8 HOURS). C
MAX WAS AT OR BELOW 4.7 NG/ML FOLLOWING ALL DOSES AND T
MAX RANGED FROM 0.5 TO 36 HRS; IN SOME
SUBJECTS CONCENTRATIONS WERE BELOW THE LIMIT OF DETECTION. C
MAX AND T
MAX WERE COMPARABLE FOR THE 0.3% CREAM AND
0.5% SOLUTION IN BOTH MALES AND FEMALES. IT CAN BE CONCLUDED THAT
SYSTEMIC ABSORPTION OF RECOMMENDED DOSES OF
PODOPHYLLOTOXIN CREAM OR SOLUTION IS EXPECTED TO BE LOW.
Special patient populations
•Children
SAFETY AND EFFICACY OF TOPICAL PODOPHYLLOTOXIN HAVE NOT BEEN
ESTABLISHED IN CHILDREN UNDER THE AGE OF 12.
•Elderly
NO ADDITIONAL INFORMATION.
NON-CLINICAL INFORMATION
Carcinogenesis/Mutagenesis
PODOPHYLLOTOXIN WAS NOT MUTAGENIC IN AN AMES TEST, USING SALMONELLA
TYPHIMURIUM STRAINS TA1535, TA1537, TA98 AND
TA100 UP TO 5000 ΜG/PLATE, THE MAXIMUM CONCENTRATION IN ACCORDANCE
WITH CURRENT GUIDELINES, AND WAS NEGATIVE IN AN
IN VITRO HUMAN CHROMOSOME ABERRATION ASSAY USING HUMAN LYMPHOCYTES AND
AN IN VIVO MOUSE MICRONUCLEUS TEST WHEN
TESTED UP TO 20 MG/KG.
ASSESSMENT OF MUTATIONS AT THE HPRT LOCUS USING CHINESE HAMSTER OVARY
(CHO) CELLS IN VITRO SHOWED EVIDENCE OF
MUTAGENICITY, BUT THE RESULTS WERE INCONSISTENT WITH REGARD TO THE
DOSE RESPONSE OBSERVED ACROSS REPLICATE CULTURES.
NO ONCOGENIC EFFECTS WERE OBSERVED WITH PODOPHYLLOTOXIN WHEN ASSESSED
IN TWO 80-WEEK MOUSE CARCINOGENICITY STUDIES
FOLLOWING DERMAL OR DIETARY ADMINISTRATION, AND IN A 2-YEAR RAT
DIETARY CARCINOGENICITY STUDY. ANIMAL STUDIES