Država: Novi Zeland
Jezik: engleski
Izvor: Medsafe (Medicines Safety Authority)
Lodoxamide trometamol 1.78 mg/mL equivalent to 1 mg/mL Lodoxamide
Novartis New Zealand Ltd
Lodoxamide trometamol 1.78 mg/mL (Equiv to 1 mg/mL Lodoxamide)
1 mg/mL
Eye drops, solution
Active: Lodoxamide trometamol 1.78 mg/mL equivalent to 1 mg/mL Lodoxamide Excipient: Benzalkonium chloride Citric acid monohydrate Disodium edetate dihydrate Hydrochloric acid Hypromellose Mannitol Purified water Sodium citrate dihydrate Sodium hydroxide Tyloxapol
Bottle, plastic, Droptainer, 5mL, 5 mL
Pharmacy only
Pharmacy only
Carbogen Amcis AG
LOMIDE Eye Drops 0.1% are indicated in the treatment of non-infectious allergic conjunctivitis (vernal conjunctivitis, giant papillary conjunctivitis and seasonal allergic conjunctivitis). The aetiologic factors are unknown, but common airborne allergens and contact lenses have been implicated. Lodoxamide trometamol may be effective against other ocular diseases where Type-I, IgE-mediated hypersensitivity (or mast cells) play a major role in the inflammatory process. Prophylactic use of LOMIDE Eye Drops will assist in minimising the allergic symptoms associated with Seasonal Allergic Conjunctivitis.
Package - Contents - Shelf Life: Bottle, plastic, Droptainer - 5 mL - 24 months from date of manufacture stored at or below 25°C 4 weeks opened stored at or below 25°C - Bottle, plastic, Droptainer - 10 mL - 24 months from date of manufacture stored at or below 25°C 4 weeks opened stored at or below 25°C
1995-05-03
1 CONSUMER MEDICINE INFORMATION LOMIDE EYE DROPS 0.1% LODOXAMIDE TROMETAMOL WHAT IS IN THIS LEAFLET PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU USE LOMIDE EYE DROPS. This leaflet answers some common questions about Lomide Eye Drops. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date listed on the final page. More recent information on the medicine may be available. You should ensure that you speak to your pharmacist or doctor to obtain the most up to date information on the medicine. You can also download the most up to date leaflet from www.medsafe.govt.nz. The updates may contain important information about the medicine and its use of which you should be aware. All medicines have risks and benefits. Your doctor has weighed the expected benefits of you using Lomide against the risks this medicine could have for you. The information in this leaflet applies to Lomide only. This information does not apply to similar products, even if they contain the same ingredients. If you have any concerns about using this medicine, ask your doctor or pharmacist. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT LOMIDE IS USED FOR Lomide Eye Drops are used to treat seasonal allergic conjunctivitis, an allergic condition of the eye that is commonly caused by pollens or other agents that produce an allergic response in the eye. Seasonal allergic conjunctivitis, as suggested by its name, normally occurs in line with seasonal increases in pollens. Lomide Eye Drops may also be used to treat a severe allergic condition of the eye (commonly known as vernal keratoconjunctivitis) that is associated with redness, itching, pain and swelling in or around the eye(s) and/or eyelid(s). Lomide Eye Drops contain the active ingredient lodoxamide trometamol which belongs to a class of medicines known as “Mast Cell Stabilisers” which have a direct effect on Mast Cells preventing them from s Pročitajte cijeli dokument
1 NEW ZEALAND DATA SHEET 1. PRODUCT NAME LOMIDE TM Lodoxamide trometamol 0.1% Eye Drops 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of Lomide Eye Drops contains the active ingredient lodoxamide trometamol 0.178%w/v equivalent to lodoxamide 0.1%. Excipient with known effect Benzalkonium chloride 0.007% as a preservative. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Sterile preserved eye drops, solution. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Lomide Eye Drops 0.1% are indicated in the treatment of non-infectious allergic conjunctivitis (vernal conjunctivitis, giant papillary conjunctivitis and seasonal allergic conjunctivitis). The aetiologic factors are unknown, but common airborne allergens and contact lenses have been implicated. Lodoxamide trometamol may be effective against other ocular diseases where Type-I, IgE-mediated hypersensitivity (or mast cells) play a major role in the inflammatory process. Prophylactic use of Lomide Eye Drops will assist in minimising the allergic symptoms associated with seasonal allergic conjunctivitis. 4.2. DOSE AND METHOD OF ADMINISTRATION Adults and children of 4 years and older One drop in each eye four times a day at regular intervals. Patients should be advised that the effect of therapy with Lomide Eye Drops is dependent upon its administration at regular intervals, as directed. Improvements in signs and symptoms in response to therapy with Lomide Eye Drops (decreased discomfort, itching, foreign body sensation, photophobia, acute ocular pain, tearing, discharge, erythema/swelling, conjunctival redness, limbal reaction, epithelial disease, ptosis) are usually evident within a few days, however, longer treatment for up to four weeks is sometimes required. Further, continued treatment may result in ongoing improvement in signs and symptoms for at least 3 months. Once symptomatic improvement has been established, therapy should be continued for as long as needed to sustain improvement. Patients should be advised to wait 10 minu Pročitajte cijeli dokument