Ganfort® 0.3/5

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Bimatoprost 0.3 mg/mL;  ; Timolol maleate 6.8 mg/mL equivalent to 5 mg/mL timolol;  

Available from:

AbbVie Limited

INN (International Name):

Bimatoprost 0.3 mg/mL

Pharmaceutical form:

Eye drops, solution

Composition:

Active: Bimatoprost 0.3 mg/mL   Timolol maleate 6.8 mg/mL equivalent to 5 mg/mL timolol   Excipient: Benzalkonium chloride Citric acid monohydrate Dibasic sodium phosphate heptahydrate Hydrochloric acid Purified water Sodium chloride Sodium hydroxide

Units in package:

Bottle, plastic, 1, 3 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Kyowa Pharma Chemical Co. Ltd.

Product summary:

Package - Contents - Shelf Life: Bottle, plastic, 1 - 3 mL - 24 months from date of manufacture stored at or below 25°C 4 weeks opened stored at or below 25°C

Authorization date:

2005-11-02

Patient Information leaflet

GANFORT® 0.3/5 bimatoprost 0.3 mg per mL & timolol (as maleate) 5.0
mg per mL Eye Drops CMI v8-PIv7 30aug23
1
GANFORT® 0.3/5 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 GANFORT® 0.3/5 EYE DROPS?
GANFORT® 0.3/5 eye drops contains the active ingredients bimatoprost
and timolol (as maleate). GANFORT® 0.3/5 eye drops are
used to lower raised pressure in the eye and to treat glaucoma.
For more information, see Section 1. Why am I using GANFORT® 0.3/5
eye drops?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE GANFORT® 0.3/5 EYE DROPS?
Check the list of ingredients at the end of the CMI. Do not use
GANFORT® 0.3/5 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
GANFORT® 0.3/5 eye drops?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with GANFORT® 0.3/5 eye drops and affect
how it works, or GANFORT® 0.3/5 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 GANFORT® 0.3/5 EYE DROPS?
•
Use one drop in your affected eye(s), according to your doctor's
instructions.
•
Use the drops each morning.
•
Please refer to the full instructions which can be found in Section 4.
How do I use GANFORT® 0.3/5 eye drops?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING GANFORT® 0.3/5 EYE DROPS?
THINGS YOU SHOULD
DO
•
Remind any doctor, dentist, pharmacist, or optometrist you visit that
you are using GANFORT®
0.3/5 eye drops.
•
Continue to use GANFORT® 0.3/5 eye drops every day unless your doctor
te

Summary of Product characteristics

GANFORT DSv8 CCDSv4 24 April 2023
NEW ZEALAND DATA SHEET
GANFORT
® - EYE DROPS
1
PRODUCT NAME
GANFORT
®
0.3/5 - Eye drops
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Bimatoprost 0.3 mg/mL and timolol (as maleate) 5.0 mg/mL
For a full list of excipients, see section 6.1 List of excipients
3
PHARMACEUTICAL FORM
Eye drops
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
GANFORT
®
0.3/5 eye drops are indicated for the reduction of intraocular
pressure (IOP) in
patients with chronic open-angle glaucoma or ocular hypertension who
are insufficiently
responsive to monotherapy.
4.2
DOSE AND METHOD OF ADMINISTRATION
The recommended dose is one drop of GANFORT
®
0.3/5 in the affected eye(s) once daily,
administered in the morning.
In order to minimise systemic absorption of GANFORT
®
0.3/5 eye drops, apply pressure to
the tear duct immediately following administration of the drug.
As with all eye drops containing benzalkonium chloride as a
preservative, there is potential
for incompatibility with other topical ophthalmic medications. If more
than one topical
ophthalmic medicinal product is to be used, other eye drops should not
be used within five to
ten minutes of using GANFORT
®
0.3/5 eye drops.
INFORMATION FOR PATIENTS - USE WITH CONTACT LENSES
The preservative in GANFORT
®
0.3/5 eye drops, benzalkonium chloride, may be absorbed
by and cause discolouration of soft contact lenses. Patients wearing
soft (hydrophilic) contact
lenses should be instructed to remove them prior to administration and
wait at least 15
minutes after instilling GANFORT
®
0.3/5
eye drops before reinserting soft contact lenses.
SPECIAL POPULATIONS
_Paediatric Use: _
Safety and effectiveness in paediatric patients have not been
established.
GANFORT DSv8 CCDSv4 24 April 2023
4.3
CONTRAINDICATIONS
GANFORT
®
0.3/5
eye drops are contraindicated in patients with hypersensitivity to any
component of this medication, in patients with bronchospasm, bronchial
asthma or patients
with a history of bronchial asthma, or severe chronic obstructive
pulmona