Bimatoprost Actavis

Valsts: Jaunzēlande

Valoda: angļu

Klimata pārmaiņas: Medsafe (Medicines Safety Authority)

Aktīvā sastāvdaļa:

Bimatoprost 0.1 mg/mL;  

Pieejams no:

Teva Pharma (New Zealand) Limited

SNN (starptautisko nepatentēto nosaukumu):

Bimatoprost 0.1 mg/mL

Deva:

0.1 mg/mL

Zāļu forma:

Eye drops, solution

Kompozīcija:

Active: Bimatoprost 0.1 mg/mL   Excipient: Benzalkonium chloride Citric acid monohydrate Dibasic sodium phosphate heptahydrate Hydrochloric acid Sodium chloride Sodium hydroxide Water for injection

Receptes veids:

Prescription

Ražojis:

Yonsung Fine Chemicals Co. Limited

Ārstēšanas norādes:

Bimatoprost Actavis is indicated as monotherapy for the reduction of elevated intraocular pressure (IOP) in patients with chronic glaucoma or ocular hypertension; or as adjunctive therapy in patients not adequately controlled on other agents.

Produktu pārskats:

Package - Contents - Shelf Life: Bottle, plastic, LDPE with LDPE dropper nozzle and HDPE cap - 3 mL - 24 months from date of manufacture stored at or below 25°C 28 days opened stored at or below 25°C

Autorizācija datums:

2014-06-30

Lietošanas instrukcija

CONSUMER MEDICINE INFORMATION
BIMATOPROST ACTAVIS
BIMATOPROST EYE DROPS, SOLUTION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about BIMATOPROST ACTAVIS.
It does not
contain all the available information. It does not take the place of
talking to your doctor or
pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you using
BIMATOPROST ACTAVIS against the benefits they expect it will have for
you.
If you have any concerns about using this medicine, ask your doctor or
pharmacist.
Keep this leaflet with the medicine. You may need to read it again.
WHAT BIMATOPROST ACTAVIS IS USED FOR
BIMATOPROST ACTAVIS eye drops are used to lower raised pressure in the
eye and to
treat glaucoma.
Glaucoma is a condition in which the pressure of fluid in the eye may
be high. However,
some people with glaucoma may have normal eye pressure. Glaucoma is
usually caused by
a build up of the fluid which flows through the eye. This build up
occurs because the fluid
drains out of your eye more slowly than it is being pumped in. Since
new fluid continues to
enter the eye, joining the fluid already there, the pressure continues
to rise.
This raised pressure may damage the back of the eye resulting in
gradual loss of sight.
Damage can progress so slowly that the person is not aware of this
gradual loss of sight.
Sometimes even normal eye pressure is associated with damage to the
back of the eye.
There are usually no symptoms of glaucoma. The only way of knowing
that you have
glaucoma is to have your eye pressure, optic nerve and visual field
checked by an eye
specialist or optometrist. If glaucoma is not treated it can lead to
serious problems, including
total blindness. In fact, untreated glaucoma is one of the most common
causes of blindness.
BIMATOPROST ACTAVIS eye drops lower the pressure in the eye by helping
the flow of fluid
out of the eye chamber.
BIMATOPROST ACTAVIS eye drops can be used alone or together with other
eye
drops/medicines to lower raised pressure within your eyes. Al

Produkta apraksts

Version 1.0
1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
BIMATOPROST ACTAVIS, Eye drops, solution, 0.1 mg/mL and 0.3 mg/mL
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL contains 0.1 mg or 0.3 mg of bimatoprost.
Excipient with known effect:
benzalkonium chloride
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye drops, solution.
BIMATOPROST ACTAVIS is a clear, colourless ophthalmic solution.
Bimatoprost is a white to off-
white powder and is very soluble in ethyl alcohol and methyl alcohol
and slightly soluble in water.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
BIMATOPROST ACTAVIS
is indicated as monotherapy for the reduction of elevated intraocular
pressure (IOP) in patients with chronic glaucoma or ocular
hypertension; or as adjunctive therapy in
patients not adequately controlled on other agents.
4.2
DOSE AND METHOD OF ADMINISTRATION
MONOTHERAPY
The recommended dose is one drop of BIMATOPROST ACTAVIS
in the affected eye(s) once daily,
administered in the evening.
ADJUNCTIVE THERAPY
The recommended dose is one drop of BIMATOPROST ACTAVIS
in the affected eye(s) once daily,
administered in the evening.
More frequent administration has not been shown to provide increased
efficacy.
If more than one topical ophthalmic medication is to be used, the
other medication should not be used
within 5 minutes of using BIMATOPROST ACTAVIS
eye drops.
In order to minimise systemic absorption of BIMATOPROST ACTAVIS
eye drops, patients should
be instructed to apply pressure to the tear duct immediately following
administration of the drug.
PAEDIATRIC USE
Safety and effectiveness in patients below 18 years of age have not
been established.
USE IN ELDERLY
No dosage adjustment in elderly patients is necessary.
INFORMATION FOR PATIENTS
BIMATOPROST ACTAVIS
eye drops contain the preservative benzalkonium chloride, which may
be absorbed by soft contact lenses. Contact lenses should be removed
prior to instillation of
BIMATOPROST ACTAVIS
and may be reinserted 15 minutes following administration.
BIMATO