XALACOM EYE DROPS

Maa: Singapore

Kieli: englanti

Lähde: HSA (Health Sciences Authority)

Aktiivinen ainesosa:

LATANOPROST; TIMOLOL MALEATE 6.83mg/ml EQV TIMOLOL

Saatavilla:

VIATRIS PRIVATE LIMITED

ATC-koodi:

S01ED51

Annos:

50 mcg/ml

Lääkemuoto:

SOLUTION

Koostumus:

LATANOPROST 50mcg/ml; TIMOLOL MALEATE 6.83mg/ml EQV TIMOLOL 5mg/ml

Antoreitti:

OPHTHALMIC

Prescription tyyppi:

Prescription Only

Valmistaja:

Pfizer Manufacturing Belgium N.V.

Valtuutuksen tilan:

ACTIVE

Valtuutus päivämäärä:

2002-05-11

Pakkausseloste

XALACOM
®
OPHTHALMIC SOLUTION
1.
NAME OF THE MEDICINAL PRODUCT
Xalacom
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml solution contains 50 mcg of latanoprost and 6.8 mg of timolol
maleate equivalent to
5 mg timolol.
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 who are insufficiently responsive to another
topical IOP lowering agent.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Use in adults (including the elderly):
One drop in the affected eye(s) once daily.
The use of Xalacom may be considered in patients who require both
timolol and latanoprost,
but it is unknown whether patients who are adequately controlled with
timolol given twice
daily plus latanoprost given once daily will be as well controlled
with Xalacom given once
daily. Xalacom should be used for the reduction of intraocular
pressure in patients with open
angle glaucoma and ocular hypertension who are insufficiently
responsive to another
intraocular lowering pressure medication.
Xalacom should not be used more than once daily because latanoprost is
most effective when
given once daily. If there is an insufficient response to Xalacom,
then consideration should be
given to using the individual agents with timolol dosed twice daily.
If one dose is missed, treatment should continue with the next dose as
planned. The dose
should not exceed one drop in the affected eye(s) daily.
If more than one topical ophthalmic drug is being used, they 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).
When using nasolacrimal occlusion or closing the eyelids for 2
minutes, the systemic
absorption is reduced. This may result in a decrease in systemic side
effects and an increase in
local activity.
Use in children:
Safety and effectiveness in children and adolescents have not bee

Valmisteyhteenveto

XALACOM
®
(LATANOPROST, TIMOLOL MALEATE)
OPHTHALMIC SOLUTION
1.
NAME OF THE MEDICINAL PRODUCT
Xalacom
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml solution contains 50 mcg of latanoprost and 6.8 mg of timolol
maleate equivalent to
5 mg timolol.
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 who are insufficiently responsive to another
topical IOP lowering agent.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Use in adults (including the elderly):
One drop in the affected eye(s) once daily.
The use of Xalacom may be considered in patients who require both
timolol and latanoprost,
but it is unknown whether patients who are adequately controlled with
timolol given twice
daily plus latanoprost given once daily will be as well controlled
with Xalacom given once
daily. Xalacom should be used for the reduction of intraocular
pressure in patients with open
angle glaucoma and ocular hypertension who are insufficiently
responsive to another
intraocular lowering pressure medication.
Xalacom should not be used more than once daily because latanoprost is
most effective when
given once daily. If there is an insufficient response to Xalacom,
then consideration should be
given to using the individual agents with timolol dosed twice daily.
If one dose is missed, treatment should continue with the next dose as
planned. The dose
should not exceed one drop in the affected eye(s) daily.
If more than one topical ophthalmic drug is being used, they 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
).
When using nasolacrimal occlusion or closing the eyelids for 2
minutes, the systemic
absorption is reduced. This may result in a decrease in systemic side
effects and an increase
in local activity.
Use in children:
Safety and effectiveness in child