MAXIDEX STERILE OPHTHALMIC SUSPENSION 0.1%

Valsts: Singapūra

Valoda: angļu

Klimata pārmaiņas: HSA (Health Sciences Authority)

Aktīvā sastāvdaļa:

Dexamethasone

Pieejams no:

NOVARTIS (SINGAPORE) PTE LTD

ATĶ kods:

S01BA01

Deva:

0.10%

Zāļu forma:

SOLUTION

Kompozīcija:

Dexamethasone 0.1%

Ievadīšanas:

OPHTHALMIC

Receptes veids:

Prescription Only

Ražojis:

ALCON-COUVREUR NV

Autorizācija statuss:

ACTIVE

Autorizācija datums:

1990-06-22

Produkta apraksts

Maxidex Jul 2023.SIN
Page 1 of 9
1.
NAME OF THE MEDICINAL PRODUCT
MAXIDEX
*
0.1% STERILE OPHTHALMIC SUSPENSION
MAXIDEX
*
0.1
% STERILE OPHTHALMIC OINTMENT (DEXAMETHASONE)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
MAXIDEX
*
OPHTHALMIC SUSPENSION
1 ml of suspension contains 1 mg dexamethasone.
Preservative: 1 ml of suspension contains 0.1 mg benzalkonium
chloride.
For the full list of excipients, see section 6.1.
MAXIDEX
*
OPHTHALMIC OINTMENT
1 g of ointment contains 1 mg dexamethasone.
Preservative: 1 g of ointment contains 0.5 mg methylparaben and 0.1 mg
propylparaben.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
MAXIDEX OPHTHALMIC SUSPENSION
Sterile ophthalmic suspension.
Opaque, white to pale yellow suspension, no agglomerates.
MAXIDEX OPHTHALMIC OINTMENT
Sterile ophthalmic ointment.
A greasy, translucent, white to off-white, homogeneous ointment.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
MAXIDEX contains dexamethasone, a synthetic corticosteroid.
MAXIDEX is indicated in the management of conditions generally
responsive to corticosteroids
such as:
•
Certain inflammatory eye conditions of the anterior segment: acute and
chronic
Maxidex Jul 2023.SIN
Page 2 of 9
anterior uveitis, iridocyclitis, iritis and cyclitis, herpes zoster
ophthalmicus.
•
Certain external diseases such as phlyctenular kerato-conjunctivitis,
nonpurulent
conjunctivitis, including vernal, allergic, catarrhal. It is very
effective where allergy is a
main factor.
•
Recurrent marginal ulceration of toxic or allergic etiology.
•
Thermal and chemical burns.
•
Post-operatively to reduce inflammatory reactions.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
MAXIDEX OPHTHALMIC SUSPENSION
Posology
•
Topical application (1 or 2 drops in the conjunctival sac).
•
FOR SEVERE OR ACUTE INFLAMMATION: drops may be used every 30 to 60
minutes as
initial therapy, being tapered to discontinuation as inflammation
subsides.
•
If favorable response is not obtained in 3 to 4 days, additional
systemic or conjunctival
t