VOLTAREN OPHTHA diclofenac sodium 1mg/mL eye drops bottle

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

diclofenac sodium, Quantity: 1 mg/mL

Disponível em:

Novartis Pharmaceuticals Australia Pty Ltd

Forma farmacêutica:

Eye Drops, solution

Composição:

Excipient Ingredients: benzalkonium chloride; disodium edetate; hydroxypropylbetadex; hydrochloric acid; propylene glycol; trometamol; tyloxapol; water for injections

Via de administração:

Ophthalmic

Unidades em pacote:

5mL, 3mL

Tipo de prescrição:

(S4) Prescription Only Medicine

Indicações terapêuticas:

Post-operative inflammation in cataract surgery and other surgical interventions.

Resumo do produto:

Visual Identification: Clear, colourless solution; Container Type: Bottle; Container Material: LDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Status de autorização:

Licence status A

Data de autorização:

2005-07-22

Folheto informativo - Bula

VOLTAREN™ OPHTHA
1MG/ML
_diclofenac sodium_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you use Voltaren Ophtha Eye
Drops.
This leaflet answers some common
questions about Voltaren Ophtha. 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
Voltaren Ophtha against the risks this
medicine could have for you.
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 VOLTAREN OPHTHA
IS USED FOR
This medicine is used to treat
inflammation of the eye e.g.
inflammation which occurs as a
result of surgery.
It belongs to a group of medicines
called non-steroidal anti-
inflammatory drugs (NSAIDs).
NSAIDs relieve pain and reduce
inflammation (i.e. swelling, redness
and throbbing).
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
It is available only with a doctor's
prescription.
_USE IN CHILDREN_
There is not enough information to
recommend the use of this medicine
for children.
BEFORE YOU USE
VOLTAREN OPHTHA
_WHEN YOU MUST NOT USE IT_
DO NOT USE VOLTAREN OPHTHA IF YOU
HAVE EVER HAD AN ALLERGIC REACTION
OR ATTACK OF ASTHMA AFTER TAKING OR
USING:
•
any medicine containing
diclofenac sodium, including
Voltaren tablets or suppositories
•

Características técnicas

This medicinal product is subject to additional monitoring in
Australia. This will allow quick
identification of new safety information. Healthcare professionals are
asked to report any suspected
adverse events at www.tga.gov.au/reporting-problems.
AUSTRALIAN PRODUCT INFORMATION – VOLTAREN* OPHTHA
(DICLOFENAC SODIUM) EYE DROPS SOLUTION
1
NAME OF THE MEDICINE
Diclofenac sodium.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
VOLTAREN* OPHTHA is sterile aqueous solution containing diclofenac
sodium 1.0
mg/mL (0.1% w/v).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Eye drops, solution.
Clear, colourless solution.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Reduction of post-operative inflammation in cataract surgery and other
surgical
interventions.
The single dose units can also be used to inhibit operative miosis
during cataract surgery.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Adults
Pre-operatively: up to 5 drops during 3 hours before surgery.
Post-operatively: 1 drop 3 times on the day of surgery, followed by 1
drop 3 to 5 times daily.
Although systemic absorption of diclofenac sodium has been found to be
minimal following
ocular application, as a general precaution to reduce systemic
absorption, pressure should be
applied to the tear-duct immediately after application.
In clinical studies, effectiveness was demonstrated in patients
treated throughout the first two
weeks of the post-operative period. In some patients with persisting
signs of inflammation,
treatment continued for up to four weeks post-operatively.
To prevent the active substances from being washed out when additional
ophthalmic
medication is used, an interval of at least 5 minutes between each
application should be
adhered to.
The dispenser remains sterile until the original closure is broken.
Patients must be
instructed to avoid allowing the tip of the dispensing container to
contact the eye as this
may contaminate the solution.
▼

4.3
C
ONTRAINDICATIONS
Patients with known hypersensitivity