Bimatoprost Multichem

देश: न्यूज़ीलैंड

भाषा: अंग्रेज़ी

स्रोत: Medsafe (Medicines Safety Authority)

सक्रिय संघटक:

Bimatoprost 0.3 mg/mL;  ;  

थमां उपलब्ध:

Multichem NZ Limited

INN (इंटरनेशनल नाम):

Bimatoprost 0.3 mg/mL

डोज़:

0.3 mg/mL

फार्मास्यूटिकल फॉर्म:

Eye drops, solution

रचना:

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

प्रिस्क्रिप्शन प्रकार:

Prescription

द्वारा बनाया गया:

Yonsung Fine Chemicals Co. Limited

चिकित्सीय संकेत:

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.

उत्पाद समीक्षा:

Package - Contents - Shelf Life: Bottle, White LDPE bottle & dropper insert; white HDPE tamper-proof screw cap, 3mL - 3 mL - 36 months from date of manufacture stored at or below 25°C 4 weeks opened stored at or below 25°C - Bottle, White LDPE bottle & dropper insert; white HDPE tamper-proof screw cap, 3 x 3mL - 9 mL - 36 months from date of manufacture stored at or below 25°C 4 weeks opened stored at or below 25°C

प्राधिकरण की तारीख:

2015-06-24

उत्पाद विशेषताएं

NEW ZEALAND DATA SHEET
BIMATOPROST MULTICHEM
Page 1 of 11
1. PRODUCT NAME
Bimatoprost multichem 0.3 mg/mL eye drops
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL contains 0.3 mg bimatoprost.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Bimatoprost multichem eye drops are a clear, isotonic, colourless,
sterile ophthalmic solution.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Bimatoprost multichem 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 multichem in the
affected eye(s) once daily,
administered in the evening.
Adjunctive therapy
The recommended dose is one drop of Bimatoprost multichem 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 multichem eye drops.
In order to minimise systemic absorption of Bimatoprost multichem 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 has not
been established.
Use in elderly
No dosage adjustment in elderly patients is necessary.
4.3 Contraindications
Bimatoprost multichem eye drops are contraindicated in patients with
hypersensitivity to
bimatoprost or to any component of the medication.
NEW ZEALAND DATA SHEET
BIMATOPROST MULTICHEM
Page 2 of 11
4.4 Special warnings and precautions for use
General
Bimatoprost multichem eye drops have 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
sponta