Land: Australien
Språk: engelska
Källa: Department of Health (Therapeutic Goods Administration)
diclofenac sodium, Quantity: 1 mg/mL
Novartis Pharmaceuticals Australia Pty Ltd
Eye Drops, solution
Excipient Ingredients: benzalkonium chloride; disodium edetate; hydroxypropylbetadex; hydrochloric acid; propylene glycol; trometamol; tyloxapol; water for injections
Ophthalmic
5mL, 3mL
(S4) Prescription Only Medicine
Post-operative inflammation in cataract surgery and other surgical interventions.
Visual Identification: Clear, colourless solution; Container Type: Bottle; Container Material: LDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2005-07-22
VOLTAREN™ OPHTHA 1MG/ML _diclofenac sodium_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you use Voltaren Ophtha Eye Drops. This leaflet answers some common questions about Voltaren Ophtha. 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.novartis.com.au 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 Voltaren Ophtha against the risks this medicine could have for you. 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 VOLTAREN OPHTHA IS USED FOR This medicine is used to treat inflammation of the eye e.g. inflammation which occurs as a result of surgery. It belongs to a group of medicines called non-steroidal anti- inflammatory drugs (NSAIDs). NSAIDs relieve pain and reduce inflammation (i.e. swelling, redness and throbbing). ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is not addictive. It is available only with a doctor's prescription. _USE IN CHILDREN_ There is not enough information to recommend the use of this medicine for children. BEFORE YOU USE VOLTAREN OPHTHA _WHEN YOU MUST NOT USE IT_ DO NOT USE VOLTAREN OPHTHA IF YOU HAVE EVER HAD AN ALLERGIC REACTION OR ATTACK OF ASTHMA AFTER TAKING OR USING: • any medicine containing diclofenac sodium, including Voltaren tablets or suppositories • Läs hela dokumentet
This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at www.tga.gov.au/reporting-problems. AUSTRALIAN PRODUCT INFORMATION – VOLTAREN* OPHTHA (DICLOFENAC SODIUM) EYE DROPS SOLUTION 1 NAME OF THE MEDICINE Diclofenac sodium. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION VOLTAREN* OPHTHA is sterile aqueous solution containing diclofenac sodium 1.0 mg/mL (0.1% w/v). For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Eye drops, solution. Clear, colourless solution. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Reduction of post-operative inflammation in cataract surgery and other surgical interventions. The single dose units can also be used to inhibit operative miosis during cataract surgery. 4.2 D OSE AND METHOD OF ADMINISTRATION Adults Pre-operatively: up to 5 drops during 3 hours before surgery. Post-operatively: 1 drop 3 times on the day of surgery, followed by 1 drop 3 to 5 times daily. Although systemic absorption of diclofenac sodium has been found to be minimal following ocular application, as a general precaution to reduce systemic absorption, pressure should be applied to the tear-duct immediately after application. In clinical studies, effectiveness was demonstrated in patients treated throughout the first two weeks of the post-operative period. In some patients with persisting signs of inflammation, treatment continued for up to four weeks post-operatively. To prevent the active substances from being washed out when additional ophthalmic medication is used, an interval of at least 5 minutes between each application should be adhered to. The dispenser remains sterile until the original closure is broken. Patients must be instructed to avoid allowing the tip of the dispensing container to contact the eye as this may contaminate the solution. ▼ 4.3 C ONTRAINDICATIONS Patients with known hypersensitivity Läs hela dokumentet