Land: Australien
Språk: engelska
Källa: Department of Health (Therapeutic Goods Administration)
oxybuprocaine hydrochloride, Quantity: 4 mg/mL
Bausch & Lomb Australia Pty Ltd
Eye Drops, solution
Excipient Ingredients: purified water; hydrochloric acid
Ophthalmic
20 X 0.5mL
Medicine Registered
(S4) Prescription Only Medicine
To produce local anaesthesia in the eye.
Visual Identification: A clear, colourless solution, reasonably free from visible particulate matter; Container Type: Tube; Container Life Time: 30 Months; Container Temperature: Store at 2 to 8 degrees Celsius
Registered
1991-10-30
MINIMS ® OXYBUPROCAINE EYE DROPS _Oxybuprocaine hydrochloride Eye Drops_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Minims Oxybuprocaine. 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 you using Minims Oxybuprocaine 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 OXYBUPROCAINE IS USED FOR Minims Oxybuprocaine 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 OXYBUPROCAINE _WHEN YOU MUST NOT BE GIVEN_ _IT_ DO NOT USE MINIMS OXYBUPROCAINE IF YOU HAVE AN ALLERGY TO: • Any medicine containing Oxybuprocaine • 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 HAVE AN INFECTION IN YOUR EYE. DO NOT USE THIS MEDICINE IF YOU ARE PREGNANT OR BREAST-FEEDING. Your doctor will discuss the risks and benefits involved. 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 H Läs hela dokumentet
Minims Oxybuprocaine PI-A20190813 v4 1 AUSTRALIAN PRODUCT INFORMATION – MINIMS OXYBUPROCAINE HYDROCHLORIDE (OXYBUPROCAINE HYDROCHLORIDE) EYE DROPS 1 NAME OF THE MEDICINE Oxybuprocaine Hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Minims Oxybuprocaine Hydrochloride Eye Drops contain oxybuprocaine hydrochloride 0.4% (4 mg/mL). No preservatives are included 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 Oxybuprocaine Hydrochloride Eye Drops are clear, colourless sterile ophthalmic solution. No preservatives are included in the formulation. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS To produce local anaesthesia in the eye for short opthalmological procedures. 4.2 D OSE AND METHOD OF ADMINISTRATION ALL PATIENTS One drop of 0.4% oxybuprocaine solution instilled into each eye has been shown sufficient for tonometry after one minute. Addition of a further drop after 90 seconds provides adequate anaesthesia for fitting of a contact lens. To obtain a deeper anaesthetic effect, further drops may be instilled at intervals of no less than 90 seconds. For most procedures one to two drops is sufficient, however for removal of foreign bodies or minor surgery, three to six drops is suggested. One drop a minute for 10 minutes was shown to provide adequate anaesthesia for patients undergoing pterygium surgery. One drop instilled in each eye of a 0.2% oxybuprocaine solution prior to tonometry, was shown to be sufficient in patients over 40 years, suggesting that older patients may achieve sufficient anaesthetic effect with a lower dose of drug. Corneal sensitivity is normal again after about 1 hour. Minims Oxybuprocaine PI-A20190813 v4 2 Each Minims unit should be discarded after a single use. 4.3 C ONTRAINDICATIONS Known hypersensitivity to anaesthetics in this group. Concomitant infection of the eye. Patient instillation of drug. To be given only by a clinician. 4.4 S PECIAL WARNINGS AND PRECAUTIONS FOR US Läs hela dokumentet