Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
Recombinant human nerve growth factor
Dompe farmaceutici s.p.a.
S01
cenegermin
Ophthalmologicals
Keratitis
Treatment of moderate (persistent epithelial defect) or severe (corneal ulcer) neurotrophic keratitis in adults
Revision: 2
Authorised
2017-07-06
19 B. PACKAGE LEAFLET 20 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT OXERVATE 20 MICROGRAMS/ML EYE DROPS, SOLUTION cenegermin 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 OXERVATE is and what it is used for 2. What you need to know before you use OXERVATE 3. How to use OXERVATE 4. Possible side effects 5. How to store OXERVATE 6. Contents of the pack and other information 1. WHAT OXERVATE IS AND WHAT IT IS USED FOR OXERVATE contains the active substance cenegermin. Cenegermin is a type of nerve growth factor (a human protein) which is naturally present on the eye surface. OXERVATE is used to treat adults with moderate or severe ‘neurotrophic keratitis’. This is a disease affecting the cornea (the transparent layer in the front part of the eye) which causes defects on the outer surface of the cornea that do not heal naturally or corneal ulcers. OXERVATE is intended to allow the healing of the cornea. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE OXERVATE DO NOT USE OXERVATE : - if you are allergic to cenegermin or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Only use this medicine in your affected eye(s). Talk to your doctor BEFORE using this medicine: - if you have an infection in your eye, as the infection should be treated first. If you get an eye infection WHILST using OXERVATE, you should stop your treatment and consult your doctor for advice straightaway. - if you have an eye cancer, because this medicine might worsen your cancer. - if you a Lestu allt skjalið
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT OXERVATE 20 micrograms/ml eye drops, solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ml of solution contains 20 micrograms of cenegermin*. * Recombinant form of human nerve growth factor produced in _Escherichia Coli_ . For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Eye drops, solution (eye drops). Clear, colourless solution. pH 7.0-7.4 and osmolarity 280-320 mOsm/kg. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of moderate (persistent epithelial defect) or severe (corneal ulcer) neurotrophic keratitis in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be initiated and supervised by an ophthalmologist or a healthcare professional qualified in ophthalmology. Posology _Adults _ The recommended dose is one drop of OXERVATE in the conjunctival sac of the affected eye(s), 6 times a day at 2 hourly intervals, starting from the morning and within 12 hours. Treatment should be continued for eight weeks. Patients with an eye infection should be treated before starting therapy with OXERVATE (see section 4.4). If a dose is missed, treatment should be continued as normal, at the next scheduled administration. The missed dose can be administered later, within the 12 hours shelf-life of the daily vial. Patients should be advised not to instil more than one drop in the affected eye(s) during any administration. _Special populations _ _ _ _Elderly _ No dose adjustment is required in patients 65 years of age and older. _ _ _ _ _Hepatic and renal impairment _ 3 The medicinal product has not been studied in patients with hepatic or renal impairment. However, no dose adjustment is considered necessary in these populations. _Paediatric population _ The safety and efficacy of this medicinal product in children and adolescents below the age of 18 years have not been established. No data are available. _ _ Method of administration For ocular use only. _Precautions to be taken before admin Lestu allt skjalið