LATANOPROST SANDOZ EYE DROPS 0.005%

Pays: Singapour

Langue: anglais

Source: HSA (Health Sciences Authority)

Ingrédients actifs:

Latanoprost

Disponible depuis:

NOVARTIS (SINGAPORE) PTE LTD

Code ATC:

S01EE01

Dosage:

0.05mg/ml

forme pharmaceutique:

SOLUTION

Composition:

Latanoprost 0.05mg/ml

Mode d'administration:

OPHTHALMIC

Type d'ordonnance:

Prescription Only

Fabriqué par:

Alcon Manufacturing Ltd., ASPEX (Alcon Sterile Products Expansion) Manufacturing Facility

Statut de autorisation:

ACTIVE

Date de l'autorisation:

2013-07-19

Résumé des caractéristiques du produit

LATANOPROST SANDOZ EYE DROPS 0.005%
1.
NAME OF THE MEDICINAL PRODUCT
LATANOPROST SANDOZ EYE DROPS 0.005%
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml Latanoprost contains 50 microgram of latanoprost (equivalent to
0.005% w/v).
One drop contains approximately 1.5 micrograms latanoprost.
Excipient: 1 ml contains 0.2 mg Benzalkonium chloride and is included
as a preservative (equivalent to
0.02% w/v).
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye drops, solution.
Appearance: colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Reduction of elevated intraocular pressure in patients with open angle
glaucoma and ocular
hypertension.
Reduction of elevated intraocular pressure in paediatric patients with
elevated intraocular pressure and
paediatric glaucoma.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For ocular use.
Recommended dosage for adults (including the elderly):
Recommended therapy is 1 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.
To reduce possible systemic absorption, it is recommended that the
lachrymal sac be compressed at the
medial canthus (punctal occlusion) for one minute. This should be
performed immediately following
the instillation of each drop.
Contact lenses should be removed before instillation of the eye drops
and may be reinserted after 15
minutes.
If more than one topical ophthalmic agent is being used, the agents
should be administered at least five
minutes apart.
Patients should be informed of the correct handling of Latanoprost eye
drops solution. Please see
section 6.6 Instructions for use/handling.
Paediatric population:
Latanoprost eye drops may be used in paediatric patients at the same
posology as in ad ults. No data are
availabl