LEDAGA

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

CHLORMETHINE AS HYDROCHLORIDE

متاح من:

RAFA LABORATORIES LTD

ATC رمز:

L01AA05

الشكل الصيدلاني:

GEL

تركيب:

CHLORMETHINE AS HYDROCHLORIDE 160 MCG/G

طريقة التعاطي:

TOPICAL

نوع الوصفة الطبية :

Required

المصنعة من قبل:

HELSINN BIREX PHARMACEUTICALS, LTD., IRELAND

المجال العلاجي:

CHLORMETHINE

الخصائص العلاجية:

Topical treatment of Stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma in patients who have received prior skin-directed therapy

تاريخ الترخيص:

2021-08-31

نشرة المعلومات

PATIENT PACKAGE INSERT ACCORDING TO PHARMACISTS’ REGULATIONS
(PREPARATIONS) – 1986
This medicine can be sold with a doctor’s prescription only
LEDAGA
®
THE ACTIVE INGREDIENT:
Each gram of gel contains:
Chlormethine (as hydrochloride) 160 mcg
For the list of the additional ingredients, please see section 6.
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This
leaflet contains
concise information about the medicine. If you have any further
questions, ask the doctor
or pharmacist.
This medicine has been prescribed for the treatment of your illness.
Do not pass it on to
others. It may harm them, even if you think that their illness is
similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
Local treatment for patients with stage
I
A and
I
B mycosis fungoides-type cutaneous T-
cell lymphoma who have received previous skin treatment.
THERAPEUTIC GROUP: Nitrogen mustard analog.
2. BEFORE USING THIS MEDICINE:
DO NOT USE THE MEDICINE IF:
You are hypersensitive (allergic) to the active ingredient
(chlormethine) or to any of the
additional ingredients in the medicine (for a list of the additional
ingredients, see section
6). Tell your doctor if you have ever had an allergic reaction to
chlormethine.
SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE
Soft tissue or eye injury:
•
If the gel comes into contact with the eyes it may cause eye pain,
burning, swelling,
redness, inflammation, sensitivity to light and blurred vision. The
gel may even
cause permanent damage to the eyes, including blindness. If the gel
gets in the
eyes, rinse the eyes right away for at least 15 minutes with a large
amount of water,
saline or an eye wash solution, AND SEEK MEDICAL HELP IMMEDIATELY
(INCLUDING AN
OPHTHALMOLOGIST EXAMINATION).
•
If the gel comes into contact with mucous membranes such as the mouth
or the
nose it may cause pain, redness and ulcers, which may be severe. Rinse
the
affected area right away for at least 15 minutes with a large amount
of water, AND
SEEK MEDICAL HELP IMMEDIATELY.
•
Skin inflammation (Dermatit

خصائص المنتج

LEDAGA®
PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
Ledaga®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient in LEDAGA is chlormethine. Each tube of LEDAGA
contains 60g of 0.016% w/w
(160mcg/g) chlormethine clear gel (equivalent to 0.02% chlormethine
HCl).
For the full list of excipients, see section 4.8.
3.
PHARMACEUTICAL FORM
Gel
4.
CLINICAL PARTICULARS
4.1
INDICATIONS AND USAGE
Topical treatment of Stage IA and IB mycosis fungoides-type cutaneous
T-cell lymphoma in patients who
have received prior skin-directed therapy. _ _
4.2
DOSAGE AND ADMINISTRATION
4.2.1
DOSING AND DOSE MODIFICATION
_ _
_FOR TOPICAL DERMATOLOGICAL USE ONLY_
Apply a thin film of LEDAGA gel once daily to affected areas of the
skin.
Stop treatment with LEDAGA for any grade of skin ulceration,
blistering, or moderately-severe or severe
dermatitis (_i.e._, marked skin redness with edema) [_see Warnings and
Precautions (4.4.3)_]_. _ Upon
improvement, treatment with LEDAGA can be restarted at a reduced
frequency of once every 3 days. If
reintroduction of treatment is tolerated for at least one week, the
frequency of application can be
increased to every other day for at least one week and then to once
daily application if tolerated.
4.2.2
APPLICATION INSTRUCTIONS
LEDAGA is a cytotoxic drug. Follow applicable special handling and
disposal procedures.
Patients must wash hands thoroughly with soap and water after handling
or applying LEDAGA.
Caregivers must wear disposable nitrile gloves when applying LEDAGA to
patients and wash hands
thoroughly with soap and water after removal of gloves. If there is
accidental skin exposure to LEDAGA,
caregivers must immediately wash exposed areas thoroughly with soap
and water for at least 15
minutes and remove contaminated clothing [_see Warnings and
Precautions (4.4.2)_].
Patients or caregivers should follow these instructions when applying
LEDAGA:
•
Apply immediately or within 30 minutes after removal from the
refrigerator. Return LEDAGA to
the refrigerator immediately after