Latanostill 50mcgml Eye Drops Solution

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

LATANOPROST

Boleh didapati daripada:

IMAGE PHARMA SDN BHD

INN (Nama Antarabangsa):

LATANOPROST

Unit dalam pakej:

2.5ml ml

Dikeluarkan oleh:

Bruschettini S.r.l.

Risalah maklumat

1
What is in this leaflet
1.
What Latanostill is used
for
2.
How Latanostill works
3.
Before you use
Latanostill
4.
How to use Latanostill
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
Latanostill
8.
Product description
9.
Manufacturer
10.
Product Registration
Holder
11.
Date of revision
12.
Serial Number
1. WHAT LATANOSTILL IS USED FOR
These eye drops are used for:
-
the
reduction
of
elevated
intraocular
pressure
(IOP)
in
patients
with
open-angle
glaucoma, chronic angle closure
glaucoma
and
ocular
hypertension.
-
reduction of elevated intraocular
pressure
in
paediatric
patients
with elevated intraocular pressure
and paediatric glaucoma.
2.
HOW
LATANOSTILL
WORKS
Latanostill
is
an
ophthalmic
product
(eye
drops)
containing
latanoprost, which belongs to the
group of medicinal products called
prostaglandin analogues.
It works by regulating the flow of
fluid within the eye which results in
lower pressure.
3. BEFORE YOU USE LATANOSTILL
_- When you must not use it _
Do not use Latanostill if: You are
allergic (hypersensitive) to any of the
ingredients of Latanostill.
You are pregnant or you are trying to
become
pregnant.
You
are
breastfeeding
_-Before you start to use it _
Before using Latanostill you should
tell your doctor (or pharmacist) if:
You or your child have an active
swelling process within the eye (e.g.
iritis, uveitis). You or your child have
other
eye
problems
(e.g.
macular
edema, history of iritis/ uveitis, lens
extraction/ aphakia; angle closure,
pigmentary,
inflammatory
and
neovascular
glaucoma;
pseudophakia
with
open-angle
glaucoma,
with rupture
of
the
posterior lens capsule or anterior
chamber lens;
frames
ocular
inflammation
or
congenital
glaucoma).
You or your child have had any
allergies to any medicines
You or your child have had, or are
about
to
have
eye
surgery,
particularly cataract removal.
You or your child have suffered an
eye injury or have an eye infection.
You or your child have severe
asthma or the asthma is not well
controlled. You or your child have
suffered or ar

Ciri produk

ARTWORK
PDF 1.5
DATE
14/07/2022
OPERATOR
017
DRAFT
06
PRODUCT CODE:
IS0779
REV. 02/0322
PRODUCT NAME:
INS LATANOSTILL 50MCG/ML EYE DROPS, SOLUTION
COUNTRY:
ASEAN COUNTRIES
MEASURES (mm): 150X330(150X30)
MATERIAL: CARTA USO MANO
g/sq.mt: 50 GR
CORDONATURA ROMACO 62 MM
Rif. n. Ord. 22000272 del 01/03/2022
FONT TYPE: HELVETICA LT STD
Size: 8 - Spacing: 8
v.07.1-2018
BRUSCHETTINI
S.R.L.
PLEASE ENSURE ARTWORK IS CHECKED WITH THIS SETTINGS: PRINT PRODUCTION
>> OUTPUT PREVIEW >> OVERPRINT PREVIEW TURNED ON AND COLOR PROFILE
SIMULATION SET TO “COATED FOGRA 39”
PHARMACODE N° 99
SEPARATIONS:

BLACK

P. 294
BIANCA/FRONT
LATANOSTILL 50ΜG/ML EYE DROPS, SOLUTION
LATANOPROST 50 ΜG/ML
NAME AND STRENGTH OF ACTIVE SUBSTANCE
Each ml contains 50µg of latanoprost.
DESCRIPTION
Latanostill is a clear, colourless aqueous ophtalmic (eye drops)
buffered, isotonic sterile solution and latanoprost for use
only in your eyes. It is available in sterile bottles with dropper and
plastic lid.
Each vial contains 2.5 ml of solution and is packaged in a carton.
Each bottle with dropper containing 2.5 ml of eye drops.
Each carton contains one vial.
_Inactive ingredients:_ Sodium chloride, Benzalkonium chloride 10% w/w
solution (preservative), Sodium dihydrogen
phosphate dehydrate, Disodium phosphate dodecahydrate, Sodium
hydroxide 10% w/v solution and/or Phosphoric acid
10% w/v solution, Purified water.
PHARMACODYNAMICS/PHARMACOKINETICS
_Pharmacodynamics_
Pharmacotherapeutic classification: 15.4.4. Prostaglandin analogue.
ATC code: S 01E E01.
Mechanism of action:
Latanoprost active substance is an analogue of the prostaglandin F2α,
acting as a selective agoinst to the prostanoid
receptor FP.
Pharmacodynamic effects:
Latanoprost reduces the intraocular pressure by increasing the outflow
of aqueous humor. Decrease of intraocular pressure
starts about 3-4 hours after administration in humans and reaches its
maximum effect after 8-12 hours. The reached value
lasts for at least 24 hours.
_Pharmacokinetics_
Latanoprost (m.w. 432.58) is a pr