Land: Australien
Sprache: Englisch
Quelle: Department of Health (Therapeutic Goods Administration)
apraclonidine hydrochloride, Quantity: 5.75 mg/mL
Clinect Pty Ltd
Eye Drops, solution
Excipient Ingredients: benzalkonium chloride; sodium acetate; sodium chloride; hydrochloric acid; sodium hydroxide; purified water
Ophthalmic
1 x 10mL, 1 x 5mL, 1 x 2.5mL
(S4) Prescription Only Medicine
To control intraocular pressure in glaucoma patients on maximally tolerated glaucoma therapy for a period of 3 months. In clinical studies the drop in intraocular pressure (IOP) appeared to decrease after Day 60 which may be associated with a progression of the disease or loss of effect of the drug. This phenomenon appears to be an individual occurence with a variable time of onset. As with any patient on maximally tolerated therapy (See Dosage & Administration), patients using apraclonidine 0.5% eye drops to delay surgery should have frequent follow-up examinations and treatment should be discontinued if IOP rises significantly. In patients who have maintained a response to apraclonidine 0.5% eye drops for 3 months and a decision is made to continue treatment, safety aspects, including any evidence of corneal changes (see Warnings and Precautions), and IOP control should be closely monitored.
Visual Identification: A clear colourless to pale yellow solution.; Container Type: Bottle; Container Material: LDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Registered
1992-06-29
IOPIDINE ® EYE DROPS 0.5% _Apraclonidine hydrochloride_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you use Iopidine Eye Drops. This leaflet answers some common questions about Iopidine 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.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 Iopidine Eye Drops against the risks this medicine could have for you. The information in this leaflet applies to Iopidine 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 IOPIDINE IS USED FOR Iopidine Eye Drops are used to lower raised pressure in the eye and to treat glaucoma. Glaucoma is usually caused by a build-up of the fluid which flows through the eye. This build up occurs because the fluid drains out of your eye more slowly than it is being pumped in. Since new fluid continues to enter the eye, joining the fluid already there, the pressure continues to rise. This raised pressure may damage the back of the eye resulting in gradual loss of sight. Damage can progress so slowly that the person is not aware of this gradual loss of sight. Sometimes even normal eye pressure is associated with damage to the back of the eye. There are usually no symptoms of glaucoma. The only way of knowing that you have gl Lesen Sie das vollständige Dokument
1 AUSTRALIAN PRODUCT INFORMATION – IOPIDINE (APRACLONIDINE HYDROCHLORIDE) EYE DROPS SOLUTION 1 NAME OF THE MEDICINE Apraclonidine hydrochloride. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION IOPIDINE Eye Drops 0.5% contains 5.75 mg/mL apraclonidine hydrochloride equivalent to 5.0 mg of apraclonidine in a sterile isotonic base. May contain potential allergens: benzoates, sulfites and hydroxybenzoates from the manufacturing process For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Eye drops, solution. Clear colourless to pale yellow solution. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS IOPIDINE 0.5% is indicated to control intraocular pressure in glaucoma patients on maximally tolerated glaucoma therapy for a period of 3 months. In clinical studies the drop in intraocular pressure appeared to decrease after Day 60 which may be associated with a progression of the disease or loss of effect of the drug. This phenomenon appears to be an individual occurrence with variable time of onset. As with any patient on maximally tolerated therapy (see Section 4.2 Dosage and Method of Administration), patients using IOPIDINE 0.5% to delay surgery should have frequent follow-up examinations and treatment with IOPIDINE 0.5% should be discontinued if IOP rises significantly. In patients who have maintained a response to IOPIDINE 0.5% for 3 months and a decision is made to continue treatment, safety aspects, including any evidence of corneal changes (see Section 4.4 Speical Warnings and Precautions for Use), and IOP control should be closely monitored. 4.2 D OSE AND METHOD OF ADMINISTRATION One drop of IOPIDINE 0.5% should be instilled into the affected eye(s) three times per day. Since IOPIDINE 0.5% will be used with other ocular glaucoma therapies, an approximate five minute interval between instillation of each medication should be observed to prevent washout of the previous dose (see Section 4.1 Therapeutic Indications). Clinical studies to establish safety and efficacy in children Lesen Sie das vollständige Dokument