Picato

国: ニュージーランド

言語: 英語

ソース: Medsafe (Medicines Safety Authority)

有効成分:

Ingenol mebutate 0.05%{relative} ((235 µg per tube))

から入手可能:

LEO Pharma Limited

INN（国際名）:

Ingenol mebutate 0.05% w/w ((235 µg per tube))

投薬量:

0.05% w/w

医薬品形態:

Topical gel

構図:

Active: Ingenol mebutate 0.05%{relative} ((235 µg per tube)) Excipient: Benzyl alcohol Citric acid monohydrate Hyetellose Isopropyl alcohol Purified water Sodium citrate dihydrate

パッケージ内のユニット:

Tube, 1mL aluminium/HDPE, with HDPE cap, 2 dose units

クラス:

Prescription

処方タイプ:

Prescription

製:

LEO Pharma Southport Pty Ltd

適応症:

Topical treatment of solar (actinic) keratoses in adults

製品概要:

Package - Contents - Shelf Life: Tube, 1mL aluminium/HDPE, with HDPE cap - 2 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

承認日:

2012-05-23

情報リーフレット

PICATO
®
GEL, 0.05%
1
PICATO
®
GEL, 0.05%
Ingenol (_in' jen ol_) mebutate (_me bue' tate_)
_ _
CONSUMER MEDICINE INFORMATION (CMI)
PLEASE READ THIS LEAFLET CAREFULLY
BEFORE YOU START YOUR TREATMENT.
Picato
®
gel, 0.05% is the brand
name. The generic name of the
active ingredient is ingenol
mebutate.
KEEP THIS LEAFLET. You may want
to read it again.
WHAT IS IN THIS LEAFLET?
This leaflet answers some common
questions about using the medicine
Picato
®
gel, 0.05%. It does not
contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using Picato
®
gel
against the benefits it is expected
to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING PICATO
®
GEL TALK TO YOUR
DOCTOR OR PHARMACIST.
WHAT PICATO
®
GEL, 0.05%
IS USED FOR
Picato
®
gel, 0.05% is used as a
topical treatment of solar keratoses
(sun spots) on the body of adults.
Solar keratoses are thickened,
scaly patches of skin caused by
too much sun exposure. Solar
keratoses are also known as actinic
keratoses.
Picato
®
gel contains the active
ingredient ingenol mebutate.
The ingenol mebutate in Picato
®
gel
treats the lesions in the area where
the gel is applied.
IT IS NOT RECOMMENDED THAT
PICATO
®
GEL, 0.05% IS USED
ON THE FACE OR SCALP – IT IS
TOO STRONG.
_ _
Picato
®
gel, 0.05% is only available
with a doctor’s prescription.
This medicine is not expected to
affect your ability to drive a car or
operate machinery.
This medicine is not addictive.
BEFORE YOU USE PICATO
®
GEL
_WHEN YOU MUST NOT USE _
_PICATO_
_® _
_GEL_
_ _
DO NOT USE PICATO
®
GEL IF YOU are
allergic to ingenol mebutate or any
of the other ingredients listed at the
end of this leaflet (see PRODUCT
DESCRIPTION).
Some of the symptoms of an
allergic reaction include shortness
of breath, wheezing or difficulty
breathing; swelling of the face, lips,
tongue or other parts of the body;
rash, itching or “hives” on the skin.
DO NOT USE PICATO
®
GEL ON BROKEN

製品の特徴

Picato
®
Gel NZ Datasheet
Page 1 of 11
NEW ZEALAND DATA SHEET
1 PICATO
® GEL
Picato
®
gel, 0.015%
Picato
®
gel, 0.05%
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Picato
®
gel 0.015%: Each tube contains 70 mcg of ingenol mebutate in 0.47 g of
gel.
Picato
®
gel 0.05%: Each tube contains 235 mcg of ingenol mebutate in 0.47 g of
gel.
Excipients: For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Clear colourless gel.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Picato
®
gel is indicated for the topical treatment of solar (actinic)
keratoses in adults.
4.2 DOSE AND METHOD OF ADMINISTRATION
Dose
_Solar (actinic) keratoses on face and scalp in adults _
Picato
®
gel 0.015% should be applied to the affected area once daily for 3
consecutive days.
_Solar (actinic) keratoses on the trunk and extremities (body) in
adults _
Picato
®
gel 0.05% should be applied to the affected area once daily for 2
consecutive days.
_Paediatric population _
There is no relevant use of Picato
®
gel in the paediatric population.
_Elderly population _
No dose adjustment is required (see section 5.1).
Method of administration
Picato
®
gel should be applied to the treatment area as defined by the treating
physician.
Each tube contains enough gel to cover an area of approximately 25 cm
2
(e.g. 5 cm x 5 cm).
The gel from the single dose tube should be squeezed onto a fingertip
and spread evenly
over the entire treatment area, allowing it to dry for 15 minutes. One
single dose tube should
be used for the treatment area.
eDoc-000741723 - Version
2. 0
Picato
®
Gel NZ Datasheet
Page 2 of 11
Patients should be instructed to wash their hands with soap and water
immediately after
applying Picato
®
gel. If treating the hands, only the fingertip which is used for
applying the gel
should be washed. Washing and touching the treated area should be
avoided for a period of
6 hours after application of Picato
®
gel. After this period, the treatment area may be washed
using mild soap and water. Picato
®
gel should not be appl