IOPIDINE apraclonidine 5mg/mL (as hydrochloride) eye drops bottle

Država: Australija

Jezik: engleski

Izvor: Department of Health (Therapeutic Goods Administration)

Aktivni sastojci:

apraclonidine hydrochloride, Quantity: 5.75 mg/mL

Dostupno od:

Clinect Pty Ltd

Farmaceutski oblik:

Eye Drops, solution

Sastav:

Excipient Ingredients: benzalkonium chloride; sodium acetate; sodium chloride; hydrochloric acid; sodium hydroxide; purified water

Administracija rute:

Ophthalmic

Jedinice u paketu:

1 x 10mL, 1 x 5mL, 1 x 2.5mL

Tip recepta:

(S4) Prescription Only Medicine

Terapijske indikacije:

To control intraocular pressure in glaucoma patients on maximally tolerated glaucoma therapy for a period of 3 months. In clinical studies the drop in intraocular pressure (IOP) appeared to decrease after Day 60 which may be associated with a progression of the disease or loss of effect of the drug. This phenomenon appears to be an individual occurence with a variable time of onset. As with any patient on maximally tolerated therapy (See Dosage & Administration), patients using apraclonidine 0.5% eye drops to delay surgery should have frequent follow-up examinations and treatment should be discontinued if IOP rises significantly. In patients who have maintained a response to apraclonidine 0.5% eye drops for 3 months and a decision is made to continue treatment, safety aspects, including any evidence of corneal changes (see Warnings and Precautions), and IOP control should be closely monitored.

Proizvod sažetak:

Visual Identification: A clear colourless to pale yellow solution.; Container Type: Bottle; Container Material: LDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Status autorizacije:

Registered

Datum autorizacije:

1992-06-29

Uputa o lijeku

IOPIDINE
® EYE DROPS
0.5%
_Apraclonidine hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you use Iopidine Eye Drops.
This leaflet answers some common
questions about Iopidine Eye Drops.
It does not contain all of the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
final page. More recent information
on the medicine may be available.
You should ensure that you speak to
your pharmacist or doctor to obtain
the most up to date information on
the medicine.
You can also download the most up
to date leaflet from
www.novartis.com.au.
The updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the expected benefits of you using
Iopidine Eye Drops against the risks
this medicine could have for you.
The information in this leaflet applies
to Iopidine only. This information
does not apply to similar products,
even if they contain the same
ingredients.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT IOPIDINE IS USED
FOR
Iopidine Eye Drops are used to lower
raised pressure in the eye and to treat
glaucoma.
Glaucoma is usually caused by a
build-up of the fluid which flows
through the eye. This build up occurs
because the fluid drains out of your
eye more slowly than it is being
pumped in. Since new fluid continues
to enter the eye, joining the fluid
already there, the pressure continues
to rise. This raised pressure may
damage the back of the eye resulting
in gradual loss of sight. Damage can
progress so slowly that the person is
not aware of this gradual loss of
sight. Sometimes even normal eye
pressure is associated with damage to
the back of the eye.
There are usually no symptoms of
glaucoma. The only way of knowing
that you have gl

Svojstava lijeka

1
AUSTRALIAN PRODUCT INFORMATION – IOPIDINE (APRACLONIDINE
HYDROCHLORIDE) EYE DROPS SOLUTION
1
NAME OF THE MEDICINE
Apraclonidine hydrochloride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
IOPIDINE Eye Drops 0.5% contains 5.75 mg/mL apraclonidine
hydrochloride equivalent to 5.0 mg of
apraclonidine in a sterile isotonic base.
May contain potential allergens: benzoates, sulfites and
hydroxybenzoates from the manufacturing
process
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Eye drops, solution.
Clear colourless to pale yellow solution.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
IOPIDINE 0.5% is indicated to control intraocular pressure in glaucoma
patients on maximally
tolerated glaucoma therapy for a period of 3 months.
In clinical studies the drop in intraocular pressure appeared to
decrease after Day 60 which may be
associated with a progression of the disease or loss of effect of the
drug. This phenomenon appears
to be an individual occurrence with variable time of onset.
As with any patient on maximally tolerated therapy (see Section 4.2
Dosage and Method of
Administration), patients using IOPIDINE 0.5% to delay surgery should
have frequent follow-up
examinations and treatment with IOPIDINE 0.5% should be discontinued
if IOP rises significantly.
In patients who have maintained a response to IOPIDINE 0.5% for 3
months and a decision is made
to continue treatment, safety aspects, including any evidence of
corneal changes (see Section 4.4
Speical Warnings and Precautions for Use), and IOP control should be
closely monitored.
4.2
D
OSE AND METHOD OF ADMINISTRATION
One drop of IOPIDINE 0.5% should be instilled into the affected eye(s)
three times per day. Since
IOPIDINE 0.5% will be used with other ocular glaucoma therapies, an
approximate five minute
interval between instillation of each medication should be observed to
prevent washout of the
previous dose (see Section 4.1 Therapeutic Indications).
Clinical studies to establish safety and efficacy in children