Nazione: Australia
Lingua: inglese
Fonte: Department of Health (Therapeutic Goods Administration)
gentamicin sulfate, Quantity: 3 mg/mL (Equivalent: gentamicin, Qty 3 mg/mL)
Abbvie Pty Ltd
Eye Drops, solution
Excipient Ingredients: polyvinyl alcohol; dibasic sodium phosphate heptahydrate; sodium chloride; disodium edetate; benzalkonium chloride; sodium hydroxide; purified water; hydrochloric acid
Ophthalmic
5mL
(S4) Prescription Only Medicine
GENTOPIC eye drops are indicated in the topical treatment of infections of the external eye and its adnexa caused by susceptible bacteria. Such infections include conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharoconjunctivits, acute meibomianitis and dacryocystitis.
Visual Identification: Clear colourless solution; Container Type: Bottle; Container Material: LDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Registered
1991-10-14
GENOPTIC ® Gentamicin Sulfate Eye Drops- CMI Version 2.0 GENOPTIC ® EYE DROPS _ _ [gentamicin sulfate] CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about GENOPTIC ® eye drops, (including how to use the eye drops). It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using GENOPTIC ® eye drops against the benefits they expect it will have for you. If you have any concerns about using/taking this medicine, ask your doctor or pharmacist. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT GENOPTIC ® EYE DROPS ARE USED FOR GENOPTIC ® eye drops are used for the treatment of infections of the eye caused by bacteria. These include conjunctivitis (an infection of the transparent skin that covers the inner surface of the eyelid and the surface of the eye which causes the eye to produce discharge, to be itchy and to form crusty eyelids); infection of the cornea (the front layer of the eyeball); corneal ulcers; infection of the edges of the eyelids including hair follicles and glands; infection of the oil producing gland that covers the inner surface of the eyelid and infection of the tear sac. _Mechanism of action: _ The active ingredient in GENOPTIC ® eye drops, gentamicin sulfate, belongs to a chemical group called the aminoglycosides which have an antibiotic activity against a wide range of bacteria. Your doctor may have prescribed GENOPTIC ® eye drops for another reason. Ask your doctor if you have any questions about why GENOPTIC ® eye drops have been prescribed for you. BEFORE YOU TAKE GENOPTIC ® EYE DROPS _ _ _WHEN YOU MUST NOT USE IT _ Do not use GENOPTIC ® eye drops if: 1. you have an allergy to GENOPTIC ® eye drops or any of the ingredients listed at the end of this leaflet. Check with your doctor if: you are pregnant or have the intention of becoming pregnant. Like some medicines, Leggi il documento completo
GENOPTIC Product Information Version 3 1 AUSTRALIAN PRODUCT INFORMATION – GENOPTIC ® (GENTAMICIN SULFATE) EYE DROPS 1 NAME OF THE MEDICINE Gentamicin sulfate. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of GENOTIC ® eye drops contains gentamicin sulfate (equivalent to 3 mg gentamicin). For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Eye drops, solution. GENOPTIC ® eye drops are a sterile, aqueous solution buffered to approximately pH 7.0 for use in the eye. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS GENOPTIC eye drops are indicated in the topical treatment of infections of the external eye and its adnexa caused by susceptible bacteria. Such infections include conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharoconjunctivitis, acute meibomianitis and dacryocystitis. 4.2 DOSE AND METHOD OF ADMINISTRATION Instil one or two drops of GENOPTIC eye drops into the affected eye(s) every four hours. In severe infections, dosage may be increased to a maximum of 2 drops once every hour. In order to minimise systemic absorption of GENOPTIC eye drops, apply pressure to the tear duct immediately following administration of the drug. 4.3 CONTRAINDICATIONS Hypersensitivity to gentamicin sulfate, benzalkonium chloride or any of the other constituents. GENOPTIC Product Information Version 3 2 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE IDENTIFIED PRECAUTIONS GENOPTIC eye drops are not for injection. It should never be injected subconjunctivally, nor should it be introduced directly into the anterior chamber of the eye. Prolonged use of topical antibiotics may give rise to overgrowth of nonsusceptible organisms, such as fungi. Bacterial resistance to gentamicin may also develop. Should this occur, or if irritation or hypersensitivity to any component of the product develops, or purulent discharge, inflammation or pain becomes aggravated, discontinue use of the preparation and institute appropriate therapy. Patien Leggi il documento completo