EIKANCE 0.01% atropine sulfate monohydrate 100 microgram/1 mL eye drops solution packed in single-dose ampoules

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Toimeaine:

atropine sulfate monohydrate, Quantity: 0.1027 mg/mL (Equivalent: atropine sulfate, Qty 0.1 mg/mL)

Saadav alates:

Aspen Pharmacare Australia Pty Ltd

Ravimvorm:

Eye Drops, solution

Koostis:

Excipient Ingredients: citric acid monohydrate; sodium chloride; hydrochloric acid; water for injections; sodium hydroxide

Manustamisviis:

Ophthalmic

Ühikuid pakis:

90, 60, 30, 5

Retsepti tüüp:

(S4) Prescription Only Medicine

Näidustused:

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.

Toote kokkuvõte:

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

Volitamisolek:

Registered

Loa andmise kuupäev:

2021-09-13

Infovoldik

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

Toote omadused

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