Ledaga
Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
11-09-2023
Fachinformation
(SPC)
11-09-2023
Öffentlichen Beurteilungsberichts
(PAR)
16-03-2017
Wirkstoff:
Chlormethine
Verfügbar ab:
Helsinn Birex Pharmaceuticals Ltd.
ATC-Code:
L01AA05
INN (Internationale Bezeichnung):
chlormethine
Therapiegruppe:
Antineoplastic agents
Therapiebereich:
Mycosis Fungoides
Anwendungsgebiete:
Ledaga is indicated for the topical treatment of mycosis fungoides-type cutaneous T-cell lymphoma (MF-type CTCL) in adult patients.
Produktbesonderheiten:
Revision: 9
Berechtigungsstatus:
Authorised
Berechtigungsdatum:
2017-03-03
Gebrauchsinformation
21
B. PACKAGE LEAFLET
22
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LEDAGA 160
MICROGRAMS/G GEL
chlormethine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Ledaga is and what it is used for
2.
What you need to know before you use Ledaga
3.
How to use Ledaga
4.
Possible side effects
5.
How to store Ledaga
6.
Contents of the pack and other information
1.
WHAT LEDAGA IS AND WHAT IT IS USED FOR
Ledaga contains the active substance chlormethine. This is an
anti-cancer medicine used on the skin to
treat mycosis fungoides-type cutaneous T-cell lymphoma (MF-type CTCL).
MF-type CTCL is a condition in which certain cells of the body’s
immune system called
T-lymphocytes become cancerous and affect the skin. Chlormethine is a
type of anti-cancer medicine
called an ‘alkylating agent’. It attaches to the DNA of dividing
cells, like cancer cells, which stops
them from multiplying and growing.
Ledaga is for use in adults only.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE LEDAGA
DO NOT USE LEDAGA
-
if you are allergic
(hypersensitive) to chlormethine or any of the other ingredients of
this
medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Ledaga.
-
Contact with your eyes must be avoided. Do not apply the medicine near
the eyes, to the inside
of the nostrils, the inside of the ear or on the lips.
-
If Ledaga gets in your eyes, it can cause pain, burning, swelling,
redness, sensitivity to light, and
blurred vision. It may also cause blindness and severe perm
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Fachinformation
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Ledaga 160 micrograms/g gel
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of gel contains chlormethine hydrochloride equivalent to 160
micrograms of chlormethine.
Excipients with known effect
Each tube contains 10.5 grams of propylene glycol and 6 micrograms of
butylhydroxytoluene.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gel.
Clear, colourless gel.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ledaga is indicated for the topical treatment of mycosis
fungoides-type cutaneous T-cell lymphoma
(MF-type CTCL) in adult patients (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Ledaga should be initiated by an appropriately
experienced physician.
Posology
A thin film of Ledaga should be applied once daily to affected areas
of the skin.
Treatment with Ledaga should be stopped for any grade of skin
ulceration or blistering, or moderately
severe or severe dermatitis (e.g., marked skin redness with oedema).
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 1 week, the frequency of
application can be increased to every other
day for at least 1 week and then to once-daily application if
tolerated.
_Elderly_
The dosing recommendation for elderly patients (
65 years old) is the same as for younger adult
patients (see section 4.8).
_Paediatric population_
The safety and efficacy of Ledaga in children aged 0 to 18 years have
not been established. No data
are available.
3
Method of administration
Ledaga is for topical application to the skin.
The following instructions should be followed by patients or
caregivers when applying Ledaga:
•
Patients must wash hands thoroughly with soap and water immediately
after handling or
applying Ledaga. Patients should apply Ledaga to affected areas of the
skin. In case of Ledaga
exposure to non-affected areas of the skin, patients s
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