Šalis: Izraelis
kalba: anglų
Šaltinis: Ministry of Health
CHLORMETHINE AS HYDROCHLORIDE
RAFA LABORATORIES LTD
L01AA05
GEL
CHLORMETHINE AS HYDROCHLORIDE 160 MCG/G
TOPICAL
Required
HELSINN BIREX PHARMACEUTICALS, LTD., IRELAND
CHLORMETHINE
Topical treatment of Stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma in patients who have received prior skin-directed therapy
2021-08-31
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 Perskaitykite visą dokumentą
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 Perskaitykite visą dokumentą