ILEVRO nepafenac 0.3% eye drops, suspension, oval bottle

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

nepafenac, Quantity: 3 mg/mL

Tilgængelig fra:

Novartis Pharmaceuticals Australia Pty Ltd

Lægemiddelform:

Eye Drops, suspension

Sammensætning:

Excipient Ingredients: carbomer 974P; carmellose sodium; benzalkonium chloride; boric acid; sodium hydroxide; hydrochloric acid; sodium chloride; propylene glycol; guar galactomannan; purified water; disodium edetate

Indgivelsesvej:

Ophthalmic

Enheder i pakken:

3mL

Recept type:

(S4) Prescription Only Medicine

Terapeutiske indikationer:

ILEVRO is indicated for the:,- prevention and treatment of postoperative pain and inflammation associated with cataract surgery,- reduction in risk of postoperative macular oedema associated with cataract surgery in patients with non proliferative diabetic retinopathy.

Produkt oversigt:

Visual Identification: Light yellow to yellow uniform suspension; Container Type: Bottle; Container Material: LDPE; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Autorisation status:

Registered

Autorisation dato:

2019-08-30

Indlægsseddel

ILEVRO
®
_EYE DROPS SUSPENSION_
_Nepafenac 0.3%_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you use Ilevro Eye Drops.
This leaflet answers some common
questions about Ilevro Eye Drops. It
does not contain all 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
Ilevro Eye Drops against the risks
this medicine could have for you.
The information in this leaflet applies
to Ilevro 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 ILEVRO IS USED
FOR
Ilevro is used to:
- prevent and treat pain and
inflammation of the eye associated
with cataract surgery
- reduce risk of postoperative
macular oedema associated with
cataract surgery in patients with non
proliferative diabetic retinopathy.
Ilevro contains the active substance
nepafenac. It belongs to a group of
medicines called non-steroidal anti-
inflammatory drugs (NSAIDs).
NSAIDs relieve pain and reduce
inflammation (e.g. swelling, redness
and throbbing).
Your doctor may have prescribed
Ilevro for another reason. Ask your
doctor if you have any questions
about why Ilevro has been prescribed
for you.
There is no evidence that Ilevro is
addictive.
_USE IN CHILDREN_
Ilevro Eye Drops are not
recommended in children and young
adults aged under

Produktets egenskaber

1
AUSTRALIAN PRODUCT INFORMATION – ILEVRO
® (NEPAFENAC) EYE
DROPS SUSPENSION
1
NAME OF THE MEDICINE
Nepafenac.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient in ILEVRO EYE DROPS is Nepafenac 3 mg/mL (0.3%).
May contain potential allergens: benzoates, sulfur dioxide/sulfites
and hydroxybenzoates from the
manufacturing process.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
ILEVRO is a light yellow to yellow, uniform suspension for
multiple-dose topical ophthalmic use.
Nepafenac is a yellow crystalline powder which is poorly soluble in
water.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
ILEVRO is indicated for the:
-prevention and treatment of postoperative pain and inflammation
associated with cataract surgery
-reduction in risk of postoperative macular oedema associated with
cataract surgery in patients with
non proliferative diabetic retinopathy.
4.2
D
OSE AND METHOD OF ADMINISTRATION
For ophthalmic use only.
For individual patient use only.
Shake the bottle well before use. After cap is removed, if a tamper
evident snap collar is present
and loose, remove before using ILEVRO.
If more than one topical ophthalmic medicinal product is being used,
the medicinal products must
be administered at least 5 minutes apart. Eye ointments should be
administered last.
To prevent contamination of the dropper tip and solution, care must be
taken not to touch the
eyelids surrounding areas or other surfaces with the dropper tip of
the bottle. Instruct patients to
keep the bottle tightly closed when not in use.
For the prevention and treatment of pain and inflammation, the dose is
1 drop of ILEVRO in the
conjunctival sac of the affected eye(s) once a day beginning 1 day
prior to cataract surgery and
2
continued on the day of surgery. In clinical studies, the
effectiveness of ILEVRO was demonstrated
for up to 14 days of the postoperative period. Treatment durations
greater than two weeks and a
dosing frequency of more than once daily have not been assessed. An