TRAVATAN OPHTHALMIC SOLUTION 0.004%

Страна: Сингапур

Язык: английский

Источник: HSA (Health Sciences Authority)

Активный ингредиент:

TRAVOPROST

Доступна с:

NOVARTIS (SINGAPORE) PTE LTD

код АТС:

S01EE04

дозировка:

0.04 mg/ml

Фармацевтическая форма:

SOLUTION

состав:

TRAVOPROST 0.04 mg/ml

Администрация маршрут:

OPHTHALMIC

Тип рецепта:

Prescription Only

Производитель:

SA ALCON-COUVREUR NV

Статус Авторизация:

ACTIVE

Дата Авторизация:

2002-02-22

тонкая брошюра

1. NAME OF THE MEDICINAL PRODUCT
TRAVATAN®
40 micrograms/ml eye drops, solution
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 40 micrograms of travoprost.
Excipients: each ml of solution contains polyquaternium-1 (POLYQUAD®)
10 microgram (as a preservative), 
propylene glycol 7.5 mg, polyoxyethylene hydrogenated castor oil 40
(HCO-40) 2 mg (see section 4.4.)
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Eye drops, solution.
Clear, colourless solution.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Decrease of elevated intraocular pressure in patients with ocular 
hypertension or open-angle glaucoma (see section 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Use in adults, including the elderly population
The dose is one drop of TRAVATAN® eye drops in the conjunctival sac
of the affected eye(s) once daily. Optimal effect 
is obtained if the dose is administered in the evening.
Nasolacrimal occlusion or gently closing the eyelid after
administration is recommended. This may reduce the 
systemic absorption of medicinal products administered via the ocular
route and result in a decrease in systemic 
adverse reactions.
If more than one topical ophthalmic medicinal product is being used,
the medicinal products must be administered 
at least 5 minutes apart (see section 4.5).
If a dose is missed, treatment should be continued with the next dose
as planned. The dose should not exceed one 
drop in the affected eye(s) daily.
When substituting another ophthalmic antiglaucoma agent
with TRAVATAN® eye drops, the other agent should be 
discontinued and TRAVATAN® eye drops should be started the following
day.
Paediatric population
The efficacy and safety of TRAVATAN® eye drops in patients below the
age of 18 years have not been established and 
its use is not recommended in these patients until further data become
available.
Hepatic and renal impairment
TRAVATAN® eye drops has been studied in patients with mild to severe
hepatic impairment and in

Характеристики продукта

1.
NAME OF THE MEDICINAL PRODUCT
TRAVATAN
®
40 micrograms/ml eye drops, solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution contains 40 micrograms of travoprost.
Preservative: 1 ml of solution contains 10 microgram polyquaternium-1
(POLYQUAD
®
)
Excipients with known effect: 1 ml of solution contains 7.5 mg
propylene glycol, 2 mg polyoxyethylene
hydrogenated castor oil 40 (HCO-40) (see section 4.4.).
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye drops, solution.
Clear, colourless to light yellow solution .
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TRAVATAN
®
eye drops contains travoprost, a prostaglandin analogue.
TRAVATAN eye drops is indicated for the decrease in elevated
intraocular pressure in patients with
ocular hypertension or open-angle glaucoma (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Use in adults, including the elderly population
The dose is 1 drop of TRAVATAN eye drops in the conjunctival sac of
the affected eye(s) once daily.
Optimal effect is obtained if the dose is administered in the evening.
TRAVATAN should not be administered more than once daily since it has
been shown that more
frequent administration of prostaglandin analogues may decrease the
intraocular pressure lowering
effect.
If a dose is missed, treatment should be continued with the next dose
as planned. The dose should not
exceed 1 drop in the affected eye(s) daily.
TRAVATAN may be used concomitantly with other topical ophthalmic drug
products to lower intraocular
pressure.
When substituting another ophthalmic antiglaucoma agent with TRAVATAN
eye drops, the other agent
should be discontinued and TRAVATAN eye drops should be started the
following day.
Use in children
The efficacy and safety of TRAVATAN eye drops in patients below the
age of 18 years have not been
established and its use is not recommended in these patients until
further data become available.
Use in patients with Hepatic and renal impairment
TRAVATAN eye drops has been studied in