البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
MERCAPTAMINE AS HYDROCHLORIDE
MEDISON PHARMA LTD
A16AA04
OPHTHALMIC SOLUTION
MERCAPTAMINE AS HYDROCHLORIDE 3.8 MG
OCULAR
Required
RECORDATI RARE DISEASES, FRANCE
MERCAPTAMINE
Cystadrops is indicated for the treatment of corneal cystine crystal deposits in adults and children from 2 years of age with cystinosis.
2020-05-20
Cystadrops-3.8mg_ml-PIL-ENG-D12-F Patient leaflet in accordance with the Pharmacists Regulations (Preparations) - 1986 This medicine is dispensed with a doctor's prescription only Cystadrops 3.8 mg/ml Eye drops Active ingredient and quantity: Each 1 ml contains 3.8 mg cysteamine (mercaptamine) Inactive ingredients and allergens in the preparation - see section 6 ‘Additional information’. See also ‘Important information about some of this medicine’s ingredients’ in section 2. Read the entire leaflet carefully before you start using this medicine. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. This medicine has been prescribed to treat your illness. Do not pass it on to others. It may harm them, even if it seems to you that their illness is similar to yours. 1. What is this medicine intended for? Cystadrops is indicated for the treatment of corneal cystine crystal deposits in adults and children from 2 years of age with cystinosis. Therapeutic group - eye preparations Cystinosis is a rare hereditary disease in which the body is unable to remove excess cystine (an amino acid). This causes cystine crystals to accumulate in various organs (such as kidney and eyes). Accumulation of crystals in the eye can lead to increased sensitivity to light (photophobia), corneal deterioration (keratopathy) and loss of vision. 2. Before using the medicine Do not use this medicine if: you are sensitive (allergic) to the active ingredient (cysteamine) or to any of the other ingredients in this medicine (see section 6 - “Additional information”). Special warnings about using this medicine Contact lenses - Contact of the medicine with contact lenses should be avoided. You should remove contact lenses before using this medicine and put them back 15 minutes afterwards. Children and adolescents Cystadrops may be used in children from 2 years of age at the same dose as in adults. Drug interactions If you are taking, have recently taken or اقرأ الوثيقة كاملة
_ _ 1 1. NAME OF THE MEDICINAL PRODUCT CYSTADROPS 3.8 MG/ML eye drops solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL contains mercaptamine hydrochloride equivalent to 3.8 mg mercaptamine (cysteamine). Excipient with known effect: Each mL of eye drops solution contains 0.1 mg of benzalkonium chloride. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Eye drops solution. Viscous, clear solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cystadrops is indicated for the treatment of corneal cystine crystal deposits in adults and children from 2 years of age with cystinosis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with Cystadrops should be initiated under the supervision of a physician experienced in the management of cystinosis. Posology The recommended dose is one drop in each eye, 4 times a day during waking hours. The recommended interval between each instillation is 4 hours. The dose could be decreased progressively (to a minimum total daily dose of 1 drop in each eye) depending on the results of ophthalmic examination (such as, corneal cystine crystal deposits, photophobia). If the patient misses an instillation, the patient should be told to continue the treatment with the next instillation. The dose should not exceed 4 drops a day in each eye. The accumulation of corneal cystine crystals increases if Cystadrops is discontinued. The treatment should not be stopped. _Paediatric population _ Cystadrops may be used in paediatric patients from 2 years of age at the same dose as in adults (see section 5.1). The safety and efficacy of Cystadrops in children aged less than 2 years has not been established. No data are available. 2 Method of administration For ocular use. Before the first admnistration, in order to facilitate the administration, the patient should be told to bring back Cystadrops at room temperature. After first opening, the patient should be told to keep the dropper bottle at room temperature. To avoid sticky eyes in the morning, the patient s اقرأ الوثيقة كاملة