Country: Малезија
Језик: Енглески
Извор: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DEXAMETHASONE SODIUM PHOSPHATE; Levofloxacin hemihydrate
SANTEN PHARMA MALAYSIA SDN. BHD.
DEXAMETHASONE SODIUM PHOSPHATE; Levofloxacin hemihydrate
1 x 5 ml
Tubilux Pharma S.p.A.
DUCRESSA ® 1MG/ML + 5MG/ML EYE DROPS SOLUTION Dexamethasone/Levofloxacin 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What DUCRESSA is used for 2. How DUCRESSA works 3. Before you use DUCRESSA 4. How to use DUCRESSA 5. While you are using it 6. Side effects 7. Storage and Disposal of DUCRESSA 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT DUCRESSA IS USED FOR Ducressa is an eye drops solution that contains levofloxacin and dexamethasone. Ducressa is used to prevent and treat inflammation and prevent possible infection of the eye after cataract surgery in adults. HOW DUCRESSA WORKS Levofloxacin is an antibiotic of the type called fluoroquinolones (sometimes shortened to quinolones). It works by killing some types of bacteria that can cause infections. Dexamethasone is a corticosteroid, it has an anti-inflammatory action (stopping symptoms like pain, heat, swelling and redness). BEFORE YOU USE DUCRESSA - _When you must not use it_ - if you are allergic to levofloxacin (or other quinolones) or dexamethasone (or other corsticosteroids) or any of the other ingredients of this medicine. - if you are suffering from an eye infection that you are not using medicine for including viral (like herpes simplex keratitis or varicella), fungal infections and tuberculosis of the eye. You could have an infection if you have a sticky discharge from your eye or if you have a red eye that has not been seen by a doctor. - _Before you start use it_ Talk to your doctor before using Ducressa: • If you are using any other antibiotic treatment, including oral antibiotics. As with other anti-infectives, prolonged use may induce antibiotic resistance with the result of overgrowth of pathogenic microrganisms. • If you suffer from high pressure in the eye or if you have already had high pressure in the eye after using an eye steroid medicine. You are at risk of having this again if you use Ducressa. If you suffer from high pressure in the eye tell your doc Прочитајте комплетан документ
1. NAME OF THE MEDICINAL PRODUCT Ducressa 1 mg/ml + 5 mg/ml, eye drops, solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ml of eye drops solution contains dexamethasone sodium phosphate equivalent to 1 mg of dexamethasone and levofloxacin hemihydrate equivalent to 5 mg of levofloxacin. One drop (about 30 microliter) contains about 0.03 mg of dexamethasone and 0.150 mg of levofloxacin. 3. PHARMACEUTICAL FORM Eye drops solution (eye drops). A clear, greenish-yellow, sterile aqueous ophthalmic solution practically free from particles with a pH of 7.0- 7.6 and osmolality of 270-330 mOsm/Kg. The expelled drops appear clear and colorless. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ducressa eye drops solution is indicated for prevention and treatment of inflammation, and prevention of infection associated with cataract surgery in adults. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology One drop instilled into the conjunctival sac after surgery every 6 hours. Duration of treatment is 7 days. Care should be taken not to discontinue therapy prematurely. If one dose is missed, treatment should continue with the next dose as planned. Re-evaluation of the patient to assess the need to continue the administration of corticosteroid eye drops as monotherapy is recommended after the completion of one week of therapy with Ducressa eye drops. The length of this treatment can depend on the patient’s risk factors and outcome of surgery and must be determined by the doctor according to slit-lamp microscopic findings and depending on the severity of the clinical picture. A follow-up treatment with steroid eye drops should not normally exceed 2 weeks. However, care should be taken not to discontinue therapy prematurely._ _ _ _ _Paediatric population: _ The safety and efficacy of Ducressa in children and adolescents below the age of 18 years have not been established. No data are available. Ducressa is not recommended f Прочитајте комплетан документ