Lumigan

Страна: Нова Зеландия

Език: английски

Източник: Medsafe (Medicines Safety Authority)

Активна съставка:

Bimatoprost 0.3 mg/mL;  

Предлага се от:

AbbVie Limited

INN (Международно Name):

Bimatoprost 0.3 mg/mL

дозиране:

0.3 mg/mL

Лекарствена форма:

Eye drops, solution

Композиция:

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

Броя в опаковка:

Bottle, dropper, LDPE, 3ml, 1 dose unit

Клас:

Prescription

Вид предписание :

Prescription

Произведено от:

Kyowa Pharma Chemical Co. Ltd.

Терапевтични показания:

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.

Каталог на резюме:

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

Дата Оторизация:

2001-03-30

Листовка

LUMIGAN® eye drops bimatoprost 0.3 mg per mL CMI v9 PI v8 30aug23
1
LUMIGAN® EYE DROPS
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING LUMIGAN® EYE DROPS?
LUMIGAN® eye drops contains the active ingredient bimatoprost.
LUMIGAN® eye drops is used to lower raised pressure in the
eye and to treat glaucoma.
For more information, see Section 1. Why am I using LUMIGAN® eye
drops?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE LUMIGAN® EYE DROPS?
Check the list of ingredients at the end of the CMI. Do not use
LUMIGAN® eye drops if you have ever had an allergic reaction to
any of them.
TALK TO YOUR DOCTOR BEFORE YOU USE THIS MEDICINE IF HE/SHE IS NOT
AWARE THAT YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE
BREASTFEEDING.
For more information, see Section 2. What should I know before I use
LUMIGAN® eye drops?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with LUMIGAN® eye drops and affect how
it works, or LUMIGAN® eye drops may interfere with
other medicines and affect how they work.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I USE LUMIGAN® EYE DROPS?
•
Use one drop in your affected eye(s), according to your doctor's
instructions
•
Use the drops each evening.
More instructions can be found in Section 4. How do I use LUMIGAN®
eye drops?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING LUMIGAN® EYE DROPS?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist, pharmacist, or optometrist you visit that
you are using LUMIGAN® eye
drops
•
Continue to use LUMIGAN® eye drops every evening unless your doctor
tells you to stop
•
Keep all your appointments so your condition can be checked.
THINGS YOU
SHOULD NOT DO
•
Do not touch the dropper tip against your eye, eye lid or any surface
•
Do

Данни за продукта

LUMIGAN
®
DS v9 CCDS v13 3 May 23
1
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
LUMIGAN
®
(bimatoprost) 0.3 mg/mL eye drops
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
LUMIGAN
®
eye drops contains bimatoprost 0.3 mg/mL
For full list of excipients, see section 6.1 List of Excipients.
3. PHARMACEUTICAL FORM
LUMIGAN
®
(bimatoprost) eye drops are a clear, isotonic, colourless, sterile
ophthalmic solution.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
LUMIGAN
®
eye drops 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 LUMIGAN
®
eye drops in the affected eye(s) once daily,
administered in the evening.
ADJUNCTIVE THERAPY:
The recommended dose is one drop of LUMIGAN
®
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 LUMIGAN
®
eye drops.
In order to minimise systemic absorption of LUMIGAN
®
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.
4.3 CONTRAINDICATIONS
LUMIGAN
®
eye drops are contraindicated in patients with hypersensitivity to
bimatoprost or to any
component of the medication.
LUMIGAN
®
DS v9 CCDS v13 3 May 23
2
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
GENERAL:
LUMIGAN
®
eye drops 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 reports of
bradycardi