Nevanac

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Nepafenac 1 mg/mL

Available from:

Novartis New Zealand Ltd

INN (International Name):

Nepafenac 1 mg/mL

Dosage:

0.1 %

Pharmaceutical form:

Eye drops, suspension

Composition:

Active: Nepafenac 1 mg/mL Excipient: Benzalkonium chloride Carbomer Disodium edetate dihydrate Hydrochloric acid Mannitol Purified water Sodium chloride Sodium hydroxide Tyloxapol

Units in package:

Bottle, dropper, 1.5mL physician's sample in a 4 mL bottle, 1.5 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Carbogen Amcis AG

Therapeutic indications:

Inhibition and treatment of pain and inflammation associated with cataract surgery

Product summary:

Package - Contents - Shelf Life: Bottle, dropper, physician's sample in a 4 mL bottle - 1.5 mL - 18 months from date of manufacture stored at or below 25°C 4 weeks opened stored at or below 25°C - Bottle, dropper, in a 4 mL bottle - 3 mL - 24 months from date of manufacture stored at or below 25°C 4 weeks opened stored at or below 25°C

Authorization date:

2006-05-27

Patient Information leaflet

Internal document code
1
Nev061117cNZ, based on DS Nev061117iNZ
NEVANAC
TM 0.1% EYE DROPS
_Nepafenac _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
PLEASE READ THIS LEAFLET
CAREFULLY BEFORE YOU USE
NEVANAC EYE DROPS.
This leaflet answers some
common questions about
Nevanac 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.medsafe.govt.nz.
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 Nevanac against the
risks this medicine could have
for you.
The information in this leaflet
applies to Nevanac 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 NEVANAC IS USED
FOR
Nevanac Eye Drops contain the
active ingredient nepafenac
which 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).
Nevanac
Eye Drops are used
to
treat the pain and inflammation
of the eye associated with
cataract
surgery.
Nevanac
Eye
Drops
are
also
used to reduce the risk of the
swelling of the macula, which
is the centre of the retina, after
cataract
surgery
in
diabetic
patients.
Your doctor may have
prescribed it for another reason.
This medicine is only available
with a doctor’s prescription.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY THIS
MEDICINE HAS B

Summary of Product characteristics

Internal document code
1
Nev061117iNZ
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
NEVANAC
TM
(nepafenac) Eye Drops 0.1%
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Nevanac contains 1 mg in 1 mL of nepafenac.
Excipient with known effect
Benzalkonium chloride 0.05 mg in 1 mL as a preservative.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye drops, suspension. Physiological pH of approximately 7.4.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Nevanac Eye Drops 0.1% are indicated for:

inhibition and treatment of pain and inflammation associated with
cataract surgery

reduction in the risk of post-operative macular oedema associated with
cataract
surgery in diabetic patients.
4.2.
DOSE AND METHOD OF ADMINISTRATION
For ocular use only.
Shake well before use. One drop of Nevanac Eye Drops 0.1% should be
applied to the
affected eye(s) three-times-daily beginning 1 day prior to cataract
surgery and continued
on the day of surgery and through the first 2 weeks of the
postoperative period.
For the reduction in the risk of postoperative macular oedema
associated with cataract
surgery in diabetic patients, the dose is 1 drop of Nevanac in the
conjunctival sac of the
affected eye(s) 3 times daily beginning 1 day prior to cataract
surgery, continued on the
day of surgery and up to 60 days of the postoperative period as
directed by the clinician.
An additional drop should be administered 30 to 120 minutes prior to
surgery.
If more than one topical ophthalmic medical product is being used, the
medicinal products
must be administered at least 5 minutes apart. Eye ointments should be
administered last.
If a dose is missed, a single drop should be applied as soon as
possible before reverting
to regular routine. Do not use a double dose to make up for the one
missed.
After the cap is removed, if the tamper evident snap collar is loose,
remove before using
Nevanac Eye Drops 0.1%.
To prevent contamination of the dropper tip and solutions, care must
be taken not to touch
the eyelids, surrounding ar