Voltaren Ophtha

Land: New Zealand

Språk: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv ingrediens:

Diclofenac sodium 1 mg/mL;  ;  

Tilgjengelig fra:

Novartis New Zealand Ltd

INN (International Name):

Diclofenac sodium 1 mg/mL

Dosering :

1 mg/mL

Legemiddelform:

Eye drops, solution

Sammensetning:

Active: Diclofenac sodium 1 mg/mL     Excipient: Benzalkonium chloride Disodium edetate dihydrate Hydrochloric acid Hydroxypropyl gamma-cyclodextrin Propylene glycol Trometamol Tyloxapol Water for injection

Enheter i pakken:

Bottle, dropper, 3 mL Sample Pack white LDPE bottle, LDPE dropper, HDPE cap, 3 mL

Klasse:

Prescription

Resept typen:

Prescription

Produsert av:

Unique Chemicals (A Division of JB Chemicals & Pharmaceuticals Ltd)

Produkt oppsummering:

Package - Contents - Shelf Life: Bottle, dropper, 3 mL Sample Pack white LDPE bottle, LDPE dropper, HDPE cap - 3 mL - 24 months from date of manufacture stored at or below 25°C 4 weeks opened stored at or below 25°C - Bottle, dropper, 5 mL white LDPE bottle, LDPE dropper, HDPE cap - 5 mL - 24 months from date of manufacture stored at or below 25°C 4 weeks opened stored at or below 25°C

Autorisasjon dato:

2003-08-01

Informasjon til brukeren

1
VOLTAREN
OPHTHA
™
EYE DROPS
0.1%_ _
_Diclofenac sodium _
CONSUMER MEDICINE
INFORMATION
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
YOU START TO USE VOLTAREN OPHTHA
EYE DROPS.
This leaflet answers some common
questions about Voltaren Ophtha
Eye Drops. It does not contain all
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.medsafe.govt.nz.
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 risks of you using Voltaren
Ophtha against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT VOLTAREN OPHTHA IS
USED FOR
Voltaren Ophtha contains
diclofenac sodium.
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).
This medicine is used to treat
inflammation of the eye e.g.
inflammation which occurs as a
result of surgery.
Before prescribing Voltaren Ophtha
Eye Drops your doctor will have
examined your eye(s) and decided
that this is the right medicine 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.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY VOLTAREN
OPHTHA HAS BEEN PRESCRIBED_ _FOR
YOU.
_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 _

Preparatomtale

NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
VOLTAREN OPHTHA EYE DROPS 0.1%
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Voltaren Multi Dose Unit Eye Drops contains diclofenac sodium 1.0mg
per 1 mL.
Excipient with known effect
Benzalkonium chloride 50µg per 1 mL as a preservative.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye drops, solution.
Slightly opalescent, slightly yellowish sterile aqueous solution.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Post-operative inflammation in cataract surgery and other surgical
interventions.
Prevention of cystoid macular oedema after cataract extraction with
lens implantation.
Post-traumatic inflammation in non-penetrating wounds.
Inhibition of miosis in cataract surgery.
Relief of pain and photophobia.
Non-infected inflammatory conditions of the anterior segment of the
eye.
4.2.
DOSE AND METHOD OF ADMINISTRATION
Adults
_Ocular surgery and its complications _
Preoperatively, up to 1 drop 5 times during the 3 hours before
surgery.
Postoperatively, 1 drop 3 times on the day of surgery, followed by 1
drop 3 to 5 times
daily for as long as required.
_Relief of pain and photophobia; post-traumatic inflammation _
One drop 4 to 6 hourly.
When pain is due to a surgical procedure (e.g. refractive surgery), 1
to 2 drops in the hour
preceding surgery, 1 to 2 drops within the first 15 minutes after
intervention and 1 drop 4
to 6 hourly for 3 days thereafter.
Elderly
There is no indication that the dosage needs to be modified for the
elderly.
Paediatric use
Voltaren Ophtha is not indicated for use in children. Paediatric
experience is limited to a
few published clinical studies in strabismus surgery.
Instructions for use and handling
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 or
surrounding structures as this may contaminate the solution.
4.3.
CONTRAINDICATIONS
Known hypersensitivity to the active substance or to any of the
excip