Wartec

Страна: Новая Зеландия

Язык: английский

Источник: Medsafe (Medicines Safety Authority)

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Активный ингредиент:

Podophyllotoxin 0.15%{relative}

Доступна с:

GlaxoSmithKline NZ Limited

ИНН (Международная Имя):

Podophyllotoxin 0.15% w/w

дозировка:

0.15% w/w

Фармацевтическая форма:

Topical cream

состав:

Active: Podophyllotoxin 0.15%{relative} Excipient: Butylated hydroxyanisole Cetyl alcohol Emulsifying wax Isopropyl myristate Liquid paraffin Medium-chain triglycerides Methyl hydroxybenzoate Phosphoric acid Propyl hydroxybenzoate Purified water Sorbic acid Stearyl alcohol

Штук в упаковке:

Tube, aluminium, with HDPE screw cap, 5 g

класс:

Prescription

Тип рецепта:

Prescription

Производитель:

Analytecon SA

Терапевтические показания :

For the topical treatment of external condylomata acuminata (anogenital warts).

Обзор продуктов:

Package - Contents - Shelf Life: Tube, aluminium, with HDPE screw cap - 5 g - 36 months from date of manufacture stored at or below 30°C - Tube, aluminium, with HDPE screw cap - 10 g - 36 months from date of manufacture stored at or below 30°C

Дата Авторизация:

2000-01-19

тонкая брошюра

                                WARTEC CREAM
®
 
1 
WARTEC CREAM
®
 
_0.15% w/v podophyllotoxin _
CONSUMER MEDICINE INFORMATION 
  
WHAT IS IN THIS LEAFLET 
This leaflet answers some common 
questions about Wartec Cream. It 
does not contain all the available 
information. 
It does not take the place of talking to 
your doctor or pharmacist. 
All medicines have benefits and 
risks. Your doctor has weighed the 
benefits of you using Wartec Cream 
against the risks they expect it may 
have for you. 
IF YOU HAVE ANY CONCERNS ABOUT THIS 
MEDICINE, ASK YOUR DOCTOR. 
KEEP THIS LEAFLET WITH YOUR 
MEDICINE. 
You may need to read it again. 
WHAT WARTEC CREAM IS 
USED FOR 
Wartec Cream contains 
podophyllotoxin, a plant extract that 
has antiwart properties. It works by 
destroying the skin of the wart. 
Wartec Cream is used on the skin to 
treat warts that are found in the 
external genital region (penis or 
vulva) or around the anus. 
It should not be used to treat warts 
that are found inside the anus or 
urinary canals of the penis or the 
vulva. 
These types of warts are commonly 
referred to as anogenital or venereal 
warts. 
They are caused by the Human 
Papilloma Virus (HPV). Up to half of 
sexually active adults are infected 
with HPV but only a small 
percentage will show outward signs 
of the virus. 
Anogenital warts are usually soft and 
skin coloured with a fleshy 
appearance. 
They are contagious and infection 
can occur through direct skin-to-skin 
contact. In adults, infection 
commonly occurs through sexual 
contact. 
Anogenital warts generally appear 
about 3 months after infection 
occurs; however they may not show 
themselves for over a year. 
Wartec Cream is not addictive. 
Wartec Cream is only available with 
a doctor's prescription. 
 
BEFORE YOU USE 
WARTEC CREAM  
DO NOT USE WARTEC
                                
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Характеристики продукта

                                NEW ZEALAND DATA SHEET 
 
WARTEC
®
 
CREAM 
    
 
Podophyllotoxin 0.15% w/w 
PRESENTATION 
Wartec Cream contains podophyllotoxin 0.15% w/w in a white cream base
for topical 
application. 
 
INDICATIONS 
Wartec Cream is indicated for the topical treatment of external
condylomata acuminata 
(anogenital warts). 
 
DOSAGE AND ADMINISTRATION 
Wartec Cream is for topical application only. 
 
The affected area should be thoroughly washed with soap and water,
and dried prior to 
application. 
 
Using a fingerstall or disposable glove, the cream is applied twice
daily morning and 
evening (every 12 hours) for 3 consecutive days and then withheld for
the next 4 
consecutive days, using only enough cream to just cover each wart.
  
 
Hands should be washed thoroughly after application. 
  
Application to the surrounding normal tissue should be avoided.  
 
Residual warts should be treated with further courses of twice
daily applications for 
three days at weekly intervals, if necessary for a total of 4 weeks of
treatment. 
 
Where lesions are greater than 4cm², it is recommended that
treatment takes place 
under the direct supervision of medical staff. 
1 
There is a possibility of relapse following treatment and in the
event that this does 
occur, alternative treatment may need to be considered. 
 
RENAL IMPAIRMENT 
 
No dosage adjustment is necessary.  
As there is very limited percutaneous absorption of podophyllotoxin
with the 
recommended dosage, renal impairment is not expected to result in
systemic exposure 
of clinical significance. 
 
HEPATIC IMPAIRMENT 
 
No dosage adjustment is necessary.  
As there is very limited percutaneous absorption of podophyllotoxin
with the 
recommended dosage, hepatic impairment is not expected to result in
systemic 
exposure of clinical significance. 
CONTRAINDICATIONS 
Do not use: 
−  on open or bleeding wounds (e.g. following surgical
procedures) 
− in 
children 
−  if there is hypersensitivity to 
                                
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