国: ニュージーランド
言語: 英語
ソース: Medsafe (Medicines Safety Authority)
Ingenol mebutate 0.015%{relative} ((70 µg per tube))
LEO Pharma Limited
Ingenol mebutate 0.015% w/w ((70 µg per tube))
0.015% w/w
Topical gel
Active: Ingenol mebutate 0.015%{relative} ((70 µg per tube)) Excipient: Benzyl alcohol Citric acid monohydrate Hyetellose Isopropyl alcohol Purified water Sodium citrate dihydrate
Tube, 1mL Aluminium/HDPE, with HDPE cap, 3 dose units
Prescription
Prescription
LEO Pharma Southport Pty Ltd
Topical treatment of solar (actinic) keratoses in adults
Package - Contents - Shelf Life: Tube, 1mL Aluminium/HDPE, with HDPE cap - 3 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)
2012-05-23
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 完全なドキュメントを読む
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 完全なドキュメントを読む