XALATAN EYE DROPS 0.005%

Țară: Singapore

Limbă: engleză

Sursă: HSA (Health Sciences Authority)

Ingredient activ:

LATANOPROST

Disponibil de la:

VIATRIS PRIVATE LIMITED

Codul ATC:

S01EE01

Dozare:

50 mcg/ml

Forma farmaceutică:

SOLUTION

Compoziție:

LATANOPROST 50 mcg/ml

Calea de administrare:

OPHTHALMIC

Tip de prescriptie medicala:

Prescription Only

Produs de:

Pfizer Manufacturing Belgium N.V.

Statutul autorizaţiei:

ACTIVE

Data de autorizare:

1997-11-21

Prospect

XALATAN
®

LATANOPROST 0.005% SOLUTION 

1. 
NAME OF THE MEDICINAL PRODUCT 

XALATAN
® 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each ml contains 50 mcg of latanoprost. 
One drop contains approximately 1.5 mcg of latanoprost. 

3. PHARMACEUTICAL 
FORM 

Ophthalmic solution. 

4. CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 

Reduction of elevated intraocular pressure (IOP) in patients with
open-angle 
glaucoma and ocular hypertension. It may also be used for the
reduction of elevated 
intraocular pressure as an adjunct medical therapy in patients
with primary chronic 
angle closure glaucoma.  

Reduction of elevated intraocular pressure in
paediatric patients with elevated 
intraocular pressure and paediatric glaucoma. 

4.2  POSOLOGY AND METHOD OF ADMINISTRATION 

Use in adults (including the elderly): 
One drop in the affected eye(s) once daily. Optimal effect is
obtained if latanoprost is 
administered in the evening. 

The dosage of latanoprost should not exceed once daily since it has
been shown that 
more frequent administration decreases the intraocular pressure
lowering effect. 

If one dose is missed, treatment should continue with the next dose
as normal. 

Latanoprost may be used concomitantly with other classes of topical
ophthalmic drug 
products to lower IOP. If more than one topical ophthalmic drug is
being used, the drugs 
should be administered at least five minutes apart. 

XAL-SIN-0913/1 
Date of last revision: Jan 2014    1 of 
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XAL-SIN-0913/1 
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Contact lenses should be removed before instillation of the eye drops
and may be 
reinserted after fifteen minutes (see section 4.4 SPECIAL WARNINGS
AND SPECIAL 
PRECAUTIONS FOR USE – GENERAL). 

Pediatric Population 
Xalatan eye drops may be used in paediatric patients at the same
posology as in 
adults. N

Caracteristicilor produsului

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XALATAN
LATANOPROST 0.005% SOLUTION
1.
NAME OF THE MEDICINAL PRODUCT
XALATAN
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL contains 50 mcg of latanoprost.
One drop contains approximately 1.5 mcg of latanoprost.
Excipient with known effect: benzalkonium chloride.
3.
PHARMACEUTICAL FORM
Ophthalmic solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Reduction of elevated intraocular pressure (IOP) in patients with
open-angle glaucoma
and ocular hypertension. It may also be used for the reduction of
elevated intraocular
pressure as an adjunct medical therapy in patients with primary
chronic angle closure
glaucoma.
Reduction
of
elevated
intraocular
pressure
in
paediatric
patients
with
elevated
intraocular pressure and paediatric glaucoma.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Use in adults (including the elderly)
One drop in the affected eye(s) once daily. Optimal effect is obtained
if latanoprost is
administered in the evening.
The dosage of latanoprost should not exceed once daily since it has
been shown that
more frequent administration decreases the IOP lowering effect.
If one dose is missed, treatment should continue with the next dose as
normal.
Latanoprost may be used concomitantly with other classes of topical
ophthalmic drug
products to lower IOP. If more than one topical ophthalmic drug is
being used, the drugs
should be administered at least five minutes apart.
Contact lenses should be removed before instillation of the eye drops
and may be
reinserted after fifteen minutes (see section
4.4
).
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11
Paediatric population
Xalatan eye drops may be used in paediatric patients at the same
posology as in adults.
No data are available for preterm infants (less than 36 weeks
gestational age). Data in
the age group <1 year (4 patients) are limited (see section
5.1
).
4.3
CONTRAINDICATIONS
Known hypersensitivity to latanoprost or any other component of the
product.
4.4
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
_Iris pigmentation changes_
Latanoprost may gradually chan