Ganfort PF 0.3/5

Nchi: Nyuzilandi

Lugha: Kiingereza

Chanzo: Medsafe (Medicines Safety Authority)

Viambatanisho vya kazi:

Bimatoprost 300 µg/mL;  ; Timolol maleate 5 mg/mL;  

Inapatikana kutoka:

AbbVie Limited

INN (Jina la Kimataifa):

Bimatoprost 300 µg/mL

Kipimo:

300mcg/mL & 5mg/mL

Dawa fomu:

Eye drops, solution

Tungo:

Active: Bimatoprost 300 µg/mL   Timolol maleate 5 mg/mL   Excipient: Citric acid monohydrate Dibasic sodium phosphate heptahydrate Hydrochloric acid Purified water Sodium chloride Sodium hydroxide

Dawa ya aina:

Prescription

Viwandani na:

Kyowa Pharma Chemical Co. Ltd.

Matibabu dalili:

Indicated for the reduction of intraocular pressure (IOP) in patients with chronic open-angle glaucoma or ocular hypertension who are insufficiently responsive to monotherapy.

Bidhaa muhtasari:

Package - Contents - Shelf Life: Ampoule, plastic, LDPE, 0.4 mL; packed into an Al foil pouch - 5 dose units - 24 months from date of manufacture stored at or below 25°C protect from light and moisture. Do not freeze. - Ampoule, plastic, LDPE, 0.4 mL; packed into an Al foil pouch - 30 dose units - 24 months from date of manufacture stored at or below 25°C protect from light and moisture. Do not freeze.

Idhini ya tarehe:

2012-12-05

Taarifa za kipeperushi

GANFORT® PF 0.3/5 bimatoprost 0.3 mg per mL & timolol (as maleate)
5.0 mg per mL Eye Drops CMI v6-PIv8 30aug23
1
GANFORT® PF 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® PF 0.3/5 EYE DROPS?
GANFORT® PF 0.3/5 eye drops contains the active ingredients
bimatoprost and timolol (as maleate). GANFORT® PF 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® PF 0.3/5
eye drops?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE GANFORT® PF 0.3/5 EYE DROPS?
Check the list of ingredients at the end of the CMI. Do not use
GANFORT® PF 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® PF 0.3/5 eye drops?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with GANFORT® PF 0.3/5 eye drops and
affect how it works, or GANFORT® PF 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® PF 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® PF 0.3/5 eye drops?
in the full
CMI.
5.
WHAT SHOULD I KNOW WHILE USING GANFORT® PF 0.3/5 EYE DROPS?
THINGS YOU SHOULD DO
•
Remind any doctor, dentist, pharmacist, or optometrist you visit that
you are using GANFORT®
PF 0.3/5 eye drops.
•
Continue to use GANFORT® PF

Tabia za bidhaa

GANFORT
®
PF DS v5 CCDS v4 24 April 2023
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1
of
16
NEW ZEALAND DATA SHEET
GANFORT
® PF - EYE DROPS
1
PRODUCT NAME
GANFORT
®
PF 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
®
PF 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
®
PF 0.3/5
in the affected eye(s) once daily,
administered in the morning.
In order to minimise systemic absorption of GANFORT
®
PF 0.3/5 eye drops, apply pressure
to the tear duct for at least 2 minutes immediately following
administration of the drug (see
see section 4.4 Special warnings and precautions for use).
If more than one topical ophthalmic medicinal product is to be used,
each one should be
instilled at least 5 minutes apart.
The unit dose container is for single use only; one container is
sufficient to treat both eyes.
Any unused solution should be discarded immediately after use. If one
dose is missed,
treatment should continue with the next dose as planned. The dose
should not exceed one
drop in the affected eye(s) daily.
INFORMATION FOR PATIENTS - USE WITH CONTACT LENSES
Patients wearing soft (hydrophilic) contact lenses should be
instructed to remove them prior
to administration of GANFORT
®
PF 0.3/5 and wait at least 15 minutes after instilling
GANFORT
®
PF 0.3/5 before reinserting soft contact lenses.
SPECIAL POPULATIONS
_Paediatric Use: _
Safety and effectiveness in paediatric patients have not been
established.
_Geriatric Use:_
No overall differences in safety and effectiveness have been observed
between
elderly and other adult patients.
GANFORT
®
PF DS v5 CCDS v4 24 April 2023
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2
of
16
4.3
CONTRAINDICATIO