Nazione: Nuova Zelanda
Lingua: inglese
Fonte: Medsafe (Medicines Safety Authority)
Apraclonidine hydrochloride 5.75 mg/mL equivalent to 5 mg Apraclonidine
Clinect NZ Pty Limited
Apraclonidine hydrochloride 5.75 mg/mL (= 5 mg Apraclonidine)
0.5 %
Eye drops, solution
Active: Apraclonidine hydrochloride 5.75 mg/mL equivalent to 5 mg Apraclonidine Excipient: Benzalkonium chloride Hydrochloric acid Purified water Sodium acetate trihydrate Sodium chloride Sodium hydroxide
Bottle, plastic, 1 x 5.0 mL, 5 mL
Prescription
Prescription
Rohner AG
IOPIDINE Eye Drops 0.5% are indicated for short-term adjunctive therapy in patients on maximally tolerated medical therapy who require additional intraocular pressure reduction. Patients on maximally tolerated medical therapy who are treated with IOPIDINE Eye Drops 0.5% to delay surgery should have frequent follow up examinations and treatment should be discontinued if the intraocular pressure rises significantly.
Package - Contents - Shelf Life: Bottle, plastic, - 5 mL - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, - 10 mL - 36 months from date of manufacture stored at or below 25°C
1993-10-28
Iopidine ® 1 IOPIDINE® CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING IOPIDINE? Iopidine contains the active ingredient apraclonidine hydrochloride. Iopidine is used to lower raised pressure in the eye and to treat glaucoma. For more information, see Section 1. Why am I using Iopidine? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE IOPIDINE? Do not use if you have ever had an allergic reaction to Iopidine, clonidine, pilocarpine or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use Iopidine? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Iopidine and affect how it works or may be affected by Iopidine. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE IOPIDINE? • The usual dose of Iopidine is one drop in the affected eye(s) three times each day. • Follow the instructions provided on ‘How to use’ the Iopidine, and use Iopidine until your doctor tells you to stop. More instructions can be found in Section 4. How do I use Iopidine? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING IOPIDINE? THINGS YOU SHOULD DO • Remind any doctor or pharmacist you visit that you are using Iopidine. • Keep all your doctor's appointments so that your progress can be checked. THINGS YOU SHOULD NOT DO • Do not stop using this medicine or lower the dose without first asking your doctor. If you stop using your medicine your condition may worsen. DRIVING OR USING MACHINES • You should not drive, operate machinery or perform tasks requiring mental alertness and/or physical coordination as you may feel dizzy or tired after using Iopidine. ADDICTION Leggi il documento completo
1 NEW ZEALAND DATA SHEET 1. IOPIDINE 0.5% EYE DROPS IOPIDINE ® (apraclonidine hydrochloride) Eye Drops 0.5%. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of Iopidine Eye Drops 0.5% contains apraclonidine hydrochloride 5.75 mg, equivalent to apraclonidine base 5 mg. Excipient with known effect Benzalkonium chloride 0.1 mg per 1 mL as a preservative. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Eye drops, solution, sterile, isotonic. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Iopidine Eye Drops 0.5% are indicated for short-term adjunctive therapy in patients on maximally tolerated medical therapy who require additional IOP reduction. Patients on maximally tolerated medical therapy who are treated with Iopidine Eye Drops 0.5% to delay surgery should have frequent follow up examinations and treatment should be discontinued if the intraocular pressure rises significantly. The addition of Iopidine Eye Drops 0.5% to patients already using two aqueous suppressing drugs (i.e. beta- blocker plus carbonic anhydrase inhibitor) as part of their maximally tolerated medical therapy may not provide additional benefit. This is because apraclonidine is an aqueous-suppressing drug and the addition of a third aqueous suppressant may not significantly reduce IOP. The IOP-lowering efficacy of Iopidine Eye Drops 0.5% diminishes over time in some patients. This loss of effect, or tachyphylaxis, appears to be an individual occurrence with a variable time of onset and should be closely monitored. The benefit for most patients is less than one month. 4.2 DOSAGE AND METHOD OF ADMINISTRATION _DOSE _ One drop of Iopidine Eye Drops 0.5% should be instilled into the affected eye(s) three times per day. Since Iopidine Eye Drops 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. PAEDIATRIC POPULATION Clinical studies to establish safety and efficacy in children ha Leggi il documento completo