Apo-Bimatoprost

Nchi: Nyuzilandi

Lugha: Kiingereza

Chanzo: Medsafe (Medicines Safety Authority)

Viambatanisho vya kazi:

Bimatoprost 0.3 mg/mL;  

Inapatikana kutoka:

Apotex NZ Ltd

INN (Jina la Kimataifa):

Bimatoprost 0.3 mg/mL

Kipimo:

0.3 mg/mL

Dawa fomu:

Eye drops, solution

Tungo:

Active: Bimatoprost 0.3 mg/mL   Excipient: Benzalkonium chloride Citric acid Dibasic sodium phosphate Hydrochloric acid Sodium chloride Sodium hydroxide

Dawa ya aina:

Prescription

Viwandani na:

Chirogate International Inc.

Matibabu dalili:

Apo-Bimatoprost is indicated as a 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.

Bidhaa muhtasari:

Package - Contents - Shelf Life: Bottle, polypropylene - 3 mL - 24 months from date of manufacture stored at or below 25°C 28 days opened stored at or below 25°C

Idhini ya tarehe:

2014-04-03

Tabia za bidhaa

NEW ZEALAND DATA SHEET
APO-BIMATOPROST
BIMATOPROST 0.3MG/ML EYE DROPS
Please refer to Medsafe website (www.medsafe.govt.nz) for the most
recent datasheet
Page 1 of 10
PRESENTATION
APO-BIMATOPROST is a clear colourless solution.
INDICATIONS
APO-BIMATOPROST 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.
DOSAGE AND ADMINISTRATION
Monotherapy: The recommended dose is one drop of APO-BIMATOPROST in
the affected
eye(s) once daily, administered in the evening.
Adjunctive Therapy: The recommended dose is one drop of
APO-BIMATOPROST 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 APO-BIMATOPROST eye drops.
In order to minimise systemic absorption of APO-BIMATOPROST 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.
MAXIMUM TOLERATED DAILY DOSE
One drop per eye daily
CONTRAINDICATIONS
APO-BIMATOPROST eye drops are contraindicated in patients with
hypersensitivity to
bimatoprost or to any component of the medication.
WARNINGS AND PRECAUTIONS
GENERAL:
Bimatoprost has not been studied in patients with heart block more
severe than first degree
or uncontrolled congestive heart failure. There have been a limited
number of spontaneous
APO-BIMATOPROST
BIMATOPROST 0.3MG/ML EYE DROPS
Please refer to Medsafe website (www.medsafe.govt.nz) for the most
recent datasheet
Page 2 of 10
reports of bradycardia or hypotension with Bimatoprost
eye drops. APO-BIMATOPROST
should be used with caution in patients p