TAFLOTAN ophthalmic solution 0.0015%

देश: मलेशिया

भाषा: अंग्रेज़ी

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

सक्रिय संघटक:

Tafluprost

थमां उपलब्ध:

SANTEN PHARMA MALAYSIA SDN. BHD.

INN (इंटरनेशनल नाम):

Tafluprost

पैकेज में यूनिट:

2.5ml mL

द्वारा बनाया गया:

Santen Pharmaceutical Co., Ltd., Shiga Plant

उत्पाद विशेषताएं

Santen PI Blue
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SGK is a Matthews International Corporation
COMMERCIAL
ARTWORK
752821
Taflotan 0.0015% (MY) 2.5 ml Leaflet
CAW-5614-01
N/A
DIMENSION:
420 X 120 mm
PHARMA CODE:
000612
N/A
04-04-2023
MY
ARTWORK VERSION NUMBER:
SCHAWK JOB NO.:
108525975/403251250
07
CMO SPEC NUMBER:
N/A
CMO ITEM NUMBER:
N/A
Product description
Taflotan ophthalmic solution is a clear, colorless, sterile aqueous
ophthalmic solution. Each mL
contains 15µg of tafluprost. It also contains Polysorbate 80,
concentrated glycerin, disodium edetate
hydrate, sodium dihydrogen phosphate dihydrate, benzalkonium chloride
and pH adjuster as
additives. Its pH is 5.7-6.3 and its osmolar ratio is 1.0-1.1.
Indications
Reduction of intraocular pressure in patients with primary open-angle
glaucoma or ocular
hypertension.
Dosage and Administration
Instill 1 drop in the affected eye(s) once daily.

Do not use more than once daily because more frequent administration
may lessen the intraocular
pressure (IOP) lowering effect.
Data regarding concomitant use of Taflotan ophthalmic solution 0.0015%
with other topical
ophthalmic drug products to lower intraocular pressure is limited.
Contraindications (Taflotan ophthalmic solution is contraindicated in
the following patients.)
1)
Patients with combination with products containing omidenepag
isopropyl.
2)
Patients with a history of hypersensitivity to any of the ingredients
of this product.
Precautions
1.
Careful administration (This product should be administered with care
to the following patients.)
1)
Patients with aphakia or pseudophakia [this product may induce macular
oedema including
cystoid macular oedema, and the associated visual acuity reduced.]
2) Patients with bronchial asthma or a history of bronchial asthma
[this product may aggravate or
induce asthmatic attack.]
3)
Patients with endophthalmitis (iritis, uveitis) [other drugs in this
catego