NEVANAC EYEDROPS

מדינה: דרום אפריקה

שפה: אנגלית

מקור: South African Health Products Regulatory Authority (SAHPRA)

זמין מ:

Novartis South Africa (Pty) Ltd

כמות:

See ingredients

טופס פרצבטיות:

EYEDROPS

הרכב:

EACH 1,0 ml SUSPENSION CONTAINS NEPAFENAC 1,0 mg

מצב אישור:

Registered

תאריך אישור:

2012-03-04

עלון מידע

Page 1 of 8
NOVARTIS
SA
(PTY)
LTD
NEVANAC Eye Drops, suspension
Nepafenac 1 mg/ml
_ _
PIL Approved: 20 March 2018
SCHEDULING STATUS:
NEVANAC® EYE DROPS, SUSPENSION
Nepafenac 1 mg/ml eye drops, suspension
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING NEVANAC®
EYE DROPS.

Keep this leaflet. You may need to read it again.

This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their
symptoms are the same as yours.
1.
WHAT NEVANAC® EYE DROPS CONTAINS
The active substance is nepafenac.
Preservatives are: disodium edetate and benzalkonium chloride.
Other ingredients are: carbomer 974P, tyloxapol, mannitol and sodium
chloride. Tiny amounts of sodium
hydroxide or hydrochloric acid are sometimes added to keep the acidity
levels (pH levels) normal.
Contains sugar: mannitol
2.
WHAT NEVANAC® EYE DROPS IS USED FOR
NEVANAC® Eye drops is used to prevent and relieve pain and
inflammation and to reduce the risk of swelling
in the back of the eye (macular oedema) following cataract surgery on
the eye.
NEVANAC® Eye drops belongs to a group of medicines called
non-steroidal anti-inflammatory drugs
(NSAIDS).
3.
BEFORE YOU USE NEVANAC® EYE DROPS
S3
Page 2 of 8
NOVARTIS
SA
(PTY)
LTD
NEVANAC Eye Drops, suspension
Nepafenac 1 mg/ml
_ _
PIL Approved: 20 March 2018
Do not use NEVANAC® Eye drops if you are allergic (hypersensitive) to
nepafenac or any of the other
ingredients in NEVANAC® Eye drops or to other non-steroidal
anti-inflammatory drugs. Examples of NSAIDs
are: aspirin, ibuprofen, ketoprofen, piroxicam, diclofenac.
•Do not use NEVANAC® Eye drops if you have a history of heart
failure.
•Do not wear contact lenses whilst being treated with NEVANAC® Eye
drops. (NEVANAC® Eye drops
contains benzalkonium chloride which may discolour soft contact
lenses.)
•Do not use in children less than 18 years old.
Tell your doctor and do not use NEVANAC® Eye drops if the above
applies to you.
TAKE SPECIAL CARE WITH NEVANAC® EYE DROPS:
•If you bruise easily or have ble

מאפייני מוצר

Page 1 of 11
NOVARTIS
SA
(PTY)
LTD
NEVANAC Eye Drops, suspension
Nepafenac 1 mg/ml
_ _
PI Approved: 20 March 2018
SCHEDULING STATUS
PROPRIETARY NAME AND DOSAGE FORM
NEVANAC® Eye drops, suspension
COMPOSITION
1 ml of suspension contains 1 mg nepafenac.
Preservatives: benzalkonium chloride 0.005 % (m/v) and disodium
edetate 0.01 % (m/v).
Excipients are: Carbomer 974P, tyloxapol, mannitol, sodium chloride,
sodium hydroxide, hydrochloric acid.
Contains sugar: mannitol
PHARMACOLOGICAL CLASSIFICATION
A.15.4 Ophthalmic preparations, Anti-inflammatory agents, non-steroids
ATC code: S01BC10
PHARMACOLOGICAL ACTION
PHARMACODYNAMIC PROPERTIES
Nepafenac is a non-steroidal anti-inflammatory and analgesic prodrug.
After topical ocular dosing, nepafenac
penetrates the cornea and is converted by ocular tissue hydrolases to
amfenac, a non-steroidal anti-
inflammatory drug. Amfenac inhibits the action of prostaglandin H
synthase (cyclooxygenase), an enzyme
required for prostaglandin production.
PHARMACODYNAMIC EFFECTS
The majority of hydrolytic conversion is in the retina/choroid
followed by the iris/ciliary body and cornea,
consistent with the degree of vascularised tissue.
S3
Page 2 of 11
NOVARTIS
SA
(PTY)
LTD
NEVANAC Eye Drops, suspension
Nepafenac 1 mg/ml
_ _
PI Approved: 20 March 2018
PHARMACOKINETIC PROPERTIES
ABSORPTION
Following three-times-daily dosing of nepafenac eye drops in both
eyes, low but quantifiable plasma
concentrations of nepafenac and amfenac were observed in the majority
of subjects 2 and 3 hours post-dose,
respectively. The mean steady-state plasma Cmax for nepafenac and for
amfenac were 0,310 ± 0,104 ng/ml and
0,422 ± 0,121 ng/ml, respectively, following ocular administration.
DISTRIBUTION
Amfenac has a high affinity toward serum albumin proteins. In vitro,
98,4 %, 95,4 % and 99,1 % was bound to rat
albumin, human albumin and human serum, respectively.
METABOLISM
Nepafenac undergoes bioactivation to amfenac via intraocular
hydrolases. Subsequently, amfenac undergoes
extensive metabolism to more polar met