VASTREKA ivermectin 10 mg/g cream tube

国: オーストラリア

言語: 英語

ソース: Department of Health (Therapeutic Goods Administration)

即購入

ダウンロード 公開評価報告書 (PAR)
23-11-2017

有効成分:

ivermectin, Quantity: 10 mg/g

から入手可能:

Galderma Australia Pty Ltd

INN(国際名):

Ivermectin

医薬品形態:

Cream

構図:

Excipient Ingredients: glycerol; isopropyl palmitate; carbomer copolymer (type B); dimeticone 20; disodium edetate; citric acid monohydrate; cetyl alcohol; stearyl alcohol; ceteareth-20; sorbitan stearate; methyl hydroxybenzoate; propyl hydroxybenzoate; phenoxyethanol; propylene glycol; oleyl alcohol; sodium hydroxide; purified water

投与経路:

Topical

パッケージ内のユニット:

60 g, 15 g, 30 g, 2 g, 45 g

処方タイプ:

(S4) Prescription Only Medicine

適応症:

VASTREKA is indicated for the topical treatment of inflammatory lesions of rosacea (papulo-pustular) in adult patients 18 years and over.

製品概要:

Visual Identification: White to pale yellow cream; Container Type: Tube; Container Material: PP/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

認証ステータス:

Licence status A

承認日:

2015-09-14

情報リーフレット

                                VASTREKA
1
VASTREKA
® CREAM
_ _
_Ivermectin 10mg/g (1% w/w) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about VASTREKA.
It does not contain all the available
information. It does not use the place
of talking to your doctor or pharmacist.
All medicines have risks and benefits.
Your doctor has weighed the risks of
you using VASTREKA against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH YOUR MEDICINE.
YOU MAY NEED TO READ IT AGAIN.
WHAT VASTREKA IS
USED FOR
VASTREKA contains the active
substance ivermectin that belongs to a
group of medicines called avermectins.
VASTREKA is used to treat pimples
and spots found with rosacea.
Your doctor, however may prescribe it
for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY VASTREKA
HAS BEEN PRESCRIBED FOR YOU.
This medicine is available only with a
doctor’s prescription.
VASTREKA is not addictive.
BEFORE YOU USE
VASTREKA
_WHEN YOU MUST NOT USE IT _
DO NOT USE VASTREKA:

if you have an allergy to any
medicine containing ivermectin

if you have an allergy to any of the
ingredients listed at the end of this
leaflet

for any children under 18 years of
age
Some of the symptoms of an allergic
reaction may include:

shortness of breath

wheezing or difficulty breathing

swelling of the face, lips, tongue or
other parts of the body

rash, itching or hives of the skin
DO NOT USE VASTREKA AFTER THE
USE BY (EXPIRY) DATE PRINTED ON THE
PACK OR IF THE PACKAGING IS TORN OR
SHOWS SIGNS OF TAMPERING.
If it has expired or is damaged, return
it to your pharmacist for disposal.
_BEFORE YOU START TO USE IT_
TELL YOUR DOCTOR IF YOU HAVE ALLERGIES
TO ANY OTHER MEDICINES, FOODS,
PRESERVATIVES OR DYES.
VASTREKA contains cetyl alcohol
and stearyl alcohol which may cause
local skin reactions (e.g. contact
dermatitis), methyl hydroxybenzoate
(E218) and propyl hydroxybenzoate
(E217) which may cause allergi
                                
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