מדינה: אוסטרליה
שפה: אנגלית
מקור: Department of Health (Therapeutic Goods Administration)
atropine sulfate monohydrate, Quantity: 0.1027 mg/mL (Equivalent: atropine sulfate, Qty 0.1 mg/mL)
Aspen Pharmacare Australia Pty Ltd
Eye Drops, solution
Excipient Ingredients: citric acid monohydrate; sodium chloride; hydrochloric acid; water for injections; sodium hydroxide
Ophthalmic
90, 60, 30, 5
(S4) Prescription Only Medicine
EIKANCE 0.01% is indicated as a treatment to slow the progression of myopia in children aged from 4 to 14 years. Atropine treatment may be initiated in children when myopia progresses greater than or equal to -1.0 D per year.
Visual Identification: EIKANCE 0.01% eye drops are a clear, colourless solution packed in transparent polyethylene single-dose containers, which are sealed in aluminium laminated foil sachets; Container Type: Ampoule; Container Material: LDPE; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2021-09-13
EIKANCE 0.01% -cmi 1 ▼ This medicine is new or being used differently. Please report side effects. See the full CMI for further details EIKANCE 0.01% EYE DROPS 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. ▼ This medicine is new or being used differently. Please report side effects. See the full CMI for further details. 1. WHY AM I USING EIKANCE 0.01%? EIKANCE 0.01% Eye Drops contain the active ingredient atropine sulfate monohydrate. They are used as a treatment for near sightedness in children aged from 4 to 14 years. For more information, see Section 1. Why am I using EIKANCE 0.01% ? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE EIKANCE 0.01%? Do not use if you have ever had an allergic reaction to atropine or any of the ingredients of the Eye Drops listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, USE 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 EIKANCE 0.01% ? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with EIKANCE 0.01% and affect how it works. 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 EIKANCE 0.01%? • Use as directed by your Doctor. Do not use more than the number of drops he/she advises or use them more frequently than directed. • Gently pull out the lower eyelid to form a sac. Allow one drop to fall into the sac without touching the eye with the dropper end of the container. To minimise absorption of the drug other than into the eye, close eyes and then apply gentle pressure to the tear duct for approximately one minute immediately after application. More instructions can be found in Section 4. How do I use EIKANCE 0.01% ? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING EIKANCE 0.01%? THINGS YOU SHOUL קרא את המסמך השלם
EIKANCE 0.01%-pi Page 1 of 12 ▼ 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 https://www.tga.gov.au/reporting-problems. AUSTRALIAN PRODUCT INFORMATION EIKANCE 0.01% EYE DROPS (ATROPINE SULFATE MONOHYDRATE 0.01%) STERILE OPHTHALMIC SOLUTION 1 NAME OF THE MEDICINE Atropine sulfate monohydrate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION EIKANCE 0.01% eye drops is a preservative-free ophthalmic solution containing 100 micrograms of atropine sulfate in 1 mL (0.01%). For the full list of excipients, see 6.1 List of excipients. 3 PHARMACEUTICAL FORM EIKANCE 0.01% eye drops are a clear, colourless solution packed in transparent polyethylene single-dose containers, which are sealed in aluminium laminated foil sachets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS EIKANCE 0.01% is indicated as a treatment to slow the progression of myopia in children aged from 4 to 14 years. Atropine treatment may be initiated in children when myopia progresses ≥-1.0 D per year. 4.2 DOSE AND METHOD OF ADMINISTRATION Treatment should be supervised by a paediatric ophthalmologist. Instil one drop into the eye as required for treatment. To minimise the risk of systemic absorption, gentle pressure should be applied to the tear duct for one minute after application. EIKANCE 0.01%-pi Page 2 of 12 EIKANCE 0.01% eye drops should be administered as one drop to each eye at night. The maximum benefit of treatment may not be achieved with less than a 2 year continued administration period. The duration of administration should be based on regular clinical assessment. The maximum duration of treatment in the clinical studies was 5 years. There is very little data in support of treatment beyond the age of 14 years. Each container is for single use and should be discarded after administration of the dose (See Section 6.5 Nature and contents of container). 4.3 CONTRAINDICATIONS EIK קרא את המסמך השלם