Nazione: Australia
Lingua: inglese
Fonte: Department of Health (Therapeutic Goods Administration)
tetracaine (amethocaine) hydrochloride, Quantity: 5 mg/mL
Bausch & Lomb Australia Pty Ltd
Eye Drops, solution
Excipient Ingredients: purified water; hydrochloric acid
Ophthalmic
20 X 0.5mL single dosage units
Medicine Registered
(S4) Prescription Only Medicine
To produce local anaesthesia in the eye.
Visual Identification: Clear, colourless solution reasonably free from visible particulate matter; Container Type: Tube; Container Material: PP; Container Life Time: 30 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
1991-10-30
MINIMS ® AMETHOCAINE (TETRACAINE) EYE DROPS _Tetracaine (Amethocaine) hydrochloride_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Minims Amethocaine 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 benefits and risks. Your doctor has weighed the risks of your using Minims Amethocaine Eye Drops against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT THIS MEDICINE, ASK YOUR DOCTOR. KEEP THIS LEAFLET IN A SAFE PLACE. You may need to read it again. WHAT MINIMS AMETHOCAINE EYE DROPS IS USED FOR Minims Amethocaine Eye Drops belongs to a group of medicines called local anaesthetics. It is used to numb or block the feeling of pain in your eye(s) during short term medical procedures. These procedures may include, measuring the pressure in your eye, inserting contact lenses, removing foreign bodies from your eye(s) and other minor operations on your eye(s). ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED TO YOU. Your doctor may have prescribed it for another reason. BEFORE YOU ARE GIVEN MINIMS AMETHOCAINE EYE DROPS _WHEN YOU MUST NOT BE GIVEN_ _IT_ DO NOT USE MINIMS AMETHOCAINE EYE DROPS IF YOU HAVE AN ALLERGY TO: • Any medicine containing tetracaine • Any other local anaesthetic • Any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: • Shortness of breath • Wheezing or difficulty breathing • Swelling of the face, lips, tongue or other parts of the body • Rash, itching or hives on the skin DO NOT USE THIS MEDICINE IF YOU ARE BEING TREATED WITH A GROUP OF MEDICINES CALLED SULPHONAMIDES. DO NOT USE THIS MEDICINE AFTER THE EXPIRY DATE PRINTED ON THE PACK OR IF THE PACKAGING IS TORN OR SHOWS SIGNS OF TAMPERING. If it has expired or is damaged, return it to your pharmacist for disposal. THIS MEDICINE HAS BEEN DEVELOPED FOR USE IN Leggi il documento completo
Minims Amethocaine PI-A20200429 v4 Page 1 of 7 AUSTRALIAN PRODUCT INFORMATION – MINIMS ® AMETHOCAINE [TETRACAINE (AMETHOCAINE) HYDROCHLORIDE] EYE DROPS 1 NAME OF THE MEDICINE Tetracaine (Amethocaine) Hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Minims Amethocaine Eye Drops contain tetracaine hydrochloride 0.5% or 1% w/v. No preservatives are contained in the formulation. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM A single-use eye drops, solution. Minims Amethocaine Eye Drops are clear, colourless sterile eye drops reasonably free from visible particulate matter. No preservatives are contained in the formulation. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Minims Amethocaine Eye Drops are indicated to produce local anaesthesia in the eye 4.2 D OSE AND METHOD OF ADMINISTRATION ADULTS AND CHILDREN One drop as required. Further drops may be needed to achieve a complete anaesthetic effect; if this is required, instillation must be strictly as recommended and supervised by the treating physician. Normal corneal sensitivity can be expected after approximately 1 hour. Although unlikely, due to the small volume in each unit dose, systemic absorption of local anaesthetics is rapid from mucosal membranes (see Section 4.9 Overdose). Systemic absorption of tetracaine may be reduced by compressing the lacrimal sac at the medial canthus for a minute during and following the instillation of the drops. (This blocks the passage of the drops via the naso- lacrimal duct to the wide absorptive area of the nasal and pharyngeal mucosa. It is especially advisable in children.) Each Minims Amethocaine Eye Drop unit should be discarded after a single use. Minims Amethocaine PI-A20200429 v4 Page 2 of 7 4.3 C ONTRAINDICATIONS Minims Amethocaine Eye Drops are contraindicated in patients with hypersensitivity to any of the components of the preparation. Tetracaine is hydrolysed in the body to p-amino benzoic acid and should therefore not be used in patients being treated w Leggi il documento completo