ILEVRO

País: Indonésia

Língua: indonésio

Origem: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Ingredientes ativos:

NEPAFENAC

Disponível em:

NOVARTIS INDONESIA - Indonesia

DCI (Denominação Comum Internacional):

NEPAFENAC

Dosagem:

3 MG

Forma farmacêutica:

TETES MATA

Unidades em pacote:

DUS, 1 BOTOL PLASTIK @ 3 ML

Fabricado por:

ALCON COUVREUR, NV - Belgium

Data de autorização:

2020-11-04

Características técnicas

Page 1 of 11
1
NAME OF THE MEDICINAL PRODUCT
Ilevro 0.3% Eye Drops, Suspension
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active: 1 mL of suspension contains 3 mg nepafenac.
Preservative: benzalkonium chloride 0.005%
For excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Eye drops, suspension
Light yellow to dark orange uniform suspension, pH 6.8
(approximately).
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Nepafenac Eye Drops, Suspension 0.3% is indicated in adults for:
•
Prevention and treatment of postoperative pain and inflammation
associated with
cataract surgery
•
Reduction in risk of postoperative macular edema associated with
cataract surgery in
non-proliferative diabetic retinopathy patients.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
RECOMMENDED DOSE AND DOSAGE ADJUSTMENT
_For _
_prevention _
_and treatment _
_of postoperative pain and inflammation _
_associated with _
_cataract surgery: _
•
1 drop applied to the conjunctival sac of the affected eye(s) once a
day beginning 1
day prior to cataract surgery and continuing on the day of surgery and
for the first 2
weeks (14 days) of the postoperative period.
•
An additional drop should be administered 30 to 120 minutes prior to
surgery.
DISETUJUI OLEH BPOM : 09/06/2021
ID : EREG100005VR12100065
Page 2 of 11
•
Treatment can be extended to the first 3 weeks (21 days) of the
postoperative period
as directed by the clinician.
_For _
_reduction _
_in _
_the _
_risk _
_of _
_macular _
_edema _
_associated _
_with _
_cataract _
_surgery _
_in _
_nonproliferative diabetic retinopathy patients:_
•
The dose of Ilevro is 1 drop in the conjunctival sac of the affected
eye(s) once (1)
time daily. Dosing begins 1 day prior to surgery, continues 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.
PEDIATRIC PATIENTS
•
The
safety
and
effectiveness
of
nepafenac
in
pediatric
patients
have
not
been
established.
•
Its use