Երկիր: Միացյալ Թագավորություն
Լեզու: անգլերեն
Աղբյուրը: MHRA (Medicines & Healthcare Products Regulatory Agency)
Dexamethasone
Waymade Healthcare Plc
S01BA01
Dexamethasone
1mg/1ml
Eye drops
Ocular
No Controlled Drug Status
Valid as a prescribable product
BNF: 11040100
PACKAGE LEAFLET - INFORMATION FOR THE USER MAXIDEX ® 0.1%W/V, EYE DROPS, SUSPENSION (dexamethasone) 1. WHAT MAXIDEX IS AND WHAT IT IS USED FOR 2. BEFORE YOU USE MAXIDEX 3. HOW TO USE MAXIDEX 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE MAXIDEX 6. FURTHER INFORMATION MAXIDEX belongs to a group of medicines known as corticosteroids. IT IS USED TO TREAT inflammation of the eye surface and the front portion inside the eye (anterior segment) and to prevent or treat inflammation following surgery to the eye. It helps to relieve the symptoms of inflammation such as redness, soreness and swelling. DO NOT USE MAXIDEX... If you think that you have ANY TYPE OF INFECTION, including viral, fungal, untreated parasitic eye infections and tuberculosis of the eye. If you are ALLERGIC to dexamethasone or any of the other ingredients listed in section 6. If any of these apply, ask your doctor for advice. TAKE SPECIAL CARE... Only use Maxidex in your eye(s). Maxidex should be used WITH CAUTION IN CHILDREN UNDER 2 YEARS of age. Maxidex should not be used for more than one week, unless advised by your doctor. Use of Maxidex for long periods of time, may cause: o Increased pressure in your eye(s). If you already have high pressure in your eye(s) or an eye disease such as glaucoma. You should have your eye pressure checked regularly while using Maxidex.. Ask your doctor for advice. This is especially important in paediatric patients, as the risk of corticosteroid- induced increased pressure in the eye may be greater in children and may occur earlier than in adults. The risk of increase in eye pressure and/or cataract formation is higher in susceptible patients(e.g. patients with diabetes) using steroids. o The development of Cataracts. You should see your doctor regularly if using on a long term basis. Use of steroids MAY MAKE EYE INFECTIONS WORSE and DELAY HEALING of an eye wound. If you have an infection, your doctor will prescribe another medicine to treat it. Topical NSAIDs (Non- Steroidal Anti Inflammatory Drugs-Me Կարդացեք ամբողջական փաստաթուղթը
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT MAXIDEX 0.1% w/v, eye drops, suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Dexamethasone 0.1% w/v Excipient with known effect in suspension: Benzalkonium Chloride 0.01% w/v. For the full list excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye drops, suspension 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Indicated for treatment of steroid responsive inflammatory conditions of the conjunctiva, cornea and anterior segment of the eye such as: anterior uveitis, iritis, cyclitis, allergic and vernal conjunctivitis, herpes zoster keratitis, superficial punctate keratitis and non-specific superficial keratitis. Also indicated for the treatment of corneal injury from chemical, radiation or thermal burns or following penetration by foreign bodies. Indicated for post- operative use to reduce inflammatory reactions and suppress graft reaction. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults, adolescents, and children (2 years of age and above) The frequency of instillation of drops and the duration of treatment will vary depending upon the severity of the underlying condition and the response to treatment. Severe inflammations require one to two drops instilled into the eye every thirty to sixty minutes until a satisfactory response occurs. Subconjunctival or systemic steroid therapy should be considered if there is no response. When a favourable response has been observed reduce the dosage towards one drop every four hours. Method of Administration For ocular use only. Shake the bottle well before use. After cap is removed, if tamper evident snap collar is loose, remove before using product. Do not let the tip of the dropper touch the eye. Nasolacrimal occlusion or gently closing the eyelid after administration is recommended. This may reduce the systemic absorption of medicinal products administered via the ocular route and result in a decrease in systemic adverse reactions. Paediatric patients The safety and efficacy of this product has Կարդացեք ամբողջական փաստաթուղթը