Vizo-PF Bimatoprost

Negara: Selandia Baru

Bahasa: Inggris

Sumber: Medsafe (Medicines Safety Authority)

Bahan aktif:

Bimatoprost 0.3 mg/mL

Tersedia dari:

AFT Pharmaceuticals Ltd

Dosis:

0.3 mg/mL

Bentuk farmasi:

Eye drops, solution

Komposisi:

Active: Bimatoprost 0.3 mg/mL Excipient: Citric acid monohydrate Dibasic sodium phosphate heptahydrate Hydrochloric acid Sodium chloride Sodium hydroxide Water for injection

Jenis Resep:

Prescription

Indikasi Terapi:

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.

Ringkasan produk:

Package - Contents - Shelf Life: Bottle, plastic, 5 mL white LDPE bottle with HDPE dose nozzle and HDPE cap - 3 mL - 24 months from date of manufacture stored at or below 25°C 4 weeks opened stored at or below 25°C

Tanggal Otorisasi:

2020-06-19

Karakteristik produk

NEW ZEALAND DATA SHEET
1.
VIZO-PF BIMATOPROST (300 MICROGRAM/ML EYE DROP SOLUTION)
Vizo-PF Bimatoprost (bimatoprost) 300 microgram/mL eye drop solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Vizo-PF Bimatoprost eye drops contains 300 microgram of bimatoprost
per 1 mL solution.
For the full list of excipients, see section 6.1 List of Excipients.
3.
PHARMACEUTICAL FORM
Eye drop solution.
Vizo-PF Bimatoprost eye drops are a clear, isotonic, colourless,
sterile ophthalmic solution and is
practically free from visible particles.
The solution has a pH of 6.8 – 7.8, and an osmolality of
approximately 290 mOsmol/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Vizo-PF 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.
4.2
DOSE AND METHOD OF ADMINISTRATION
Monotherapy:
The recommended dose is one drop of Vizo-PF Bimatoprost eye drops in
the affected eye(s) once daily,
administered in the evening.
Adjunctive therapy:
The recommended dose is one drop of Vizo-PF Bimatoprost eye drops 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 Vizo-PF Bimatoprost eye drops.
In order to minimise systemic absorption of Vizo-PF Bimatoprost eye
drops, patients should be
instructed to apply pressure to the tear duct immediately following
administration of the medicine.
For individual patient use only.
Special populations:
_USE IN HEPATIC IMPAIRMENT _
Vizo-PF Bimatoprost eye drops has not been studied in patients with
hepatic impairment and should
therefore be used with caution in such patients.
_USE IN RENAL IMPAIRMENT _
Vizo-PF Bimatoprost eye drops has not been studied in patients with
renal impairment and should
therefore be u