Minims Oxybuprocaine Hydrochloride 0.4% 4mg/mL eye drops tube

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

oxybuprocaine hydrochloride, Quantity: 4 mg/mL

Available from:

Bausch & Lomb Australia Pty Ltd

Pharmaceutical form:

Eye Drops, solution

Composition:

Excipient Ingredients: purified water; hydrochloric acid

Administration route:

Ophthalmic

Units in package:

20 X 0.5mL

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

To produce local anaesthesia in the eye.

Product summary:

Visual Identification: A clear, colourless solution, reasonably free from visible particulate matter; Container Type: Tube; Container Life Time: 30 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-10-30

Patient Information leaflet

MINIMS
®
OXYBUPROCAINE
EYE DROPS
_Oxybuprocaine hydrochloride Eye Drops_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Minims
Oxybuprocaine.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you using Minims
Oxybuprocaine against the benefits
they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR DOCTOR.
KEEP THIS LEAFLET IN A SAFE PLACE.
You may need to read it again.
WHAT MINIMS
OXYBUPROCAINE IS
USED FOR
Minims Oxybuprocaine belongs to a
group of medicines called local
anaesthetics.
It is used to numb or block the
feeling of pain in your eye(s) during
short-term medical procedures. These
procedures may include, measuring
the pressure in your eye, inserting
contact lenses, removing foreign
bodies from your eye(s) and other
minor operations on your eye(s).
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED TO YOU.
Your doctor may have prescribed it
for another reason.
BEFORE YOU ARE GIVEN
MINIMS
OXYBUPROCAINE
_WHEN YOU MUST NOT BE GIVEN_
_IT_
DO NOT USE MINIMS OXYBUPROCAINE
IF YOU HAVE AN ALLERGY TO:
•
Any medicine containing
Oxybuprocaine
•
Any other local anaesthetic
•
Any of the ingredients listed at
the end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
Shortness of breath
•
Wheezing or difficulty
breathing
•
Swelling of the face, lips,
tongue or other parts of the
body
•
Rash, itching or hives on the
skin
DO NOT USE THIS MEDICINE IF YOU
HAVE AN INFECTION IN YOUR EYE.
DO NOT USE THIS MEDICINE IF YOU ARE
PREGNANT OR BREAST-FEEDING.
Your doctor will discuss the risks and
benefits involved.
DO NOT USE THIS MEDICINE AFTER THE
EXPIRY DATE PRINTED ON THE PACK OR
IF THE PACKAGING IS TORN OR SHOWS
SIGNS OF TAMPERING.
If it has expired or is damaged, return
it to your pharmacist for disposal.
THIS MEDICINE H

Summary of Product characteristics

Minims Oxybuprocaine PI-A20190813 v4
1
AUSTRALIAN PRODUCT INFORMATION – MINIMS OXYBUPROCAINE
HYDROCHLORIDE (OXYBUPROCAINE HYDROCHLORIDE) EYE DROPS
1
NAME OF THE MEDICINE
Oxybuprocaine Hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Minims Oxybuprocaine Hydrochloride Eye Drops contain oxybuprocaine
hydrochloride 0.4%
(4 mg/mL). No preservatives are included in the formulation.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
A single-use eye drops, solution.
Minims Oxybuprocaine Hydrochloride Eye Drops are clear, colourless
sterile ophthalmic solution. No
preservatives are included in the formulation.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
To produce local anaesthesia in the eye for short opthalmological
procedures.
4.2
D
OSE AND METHOD OF ADMINISTRATION
ALL PATIENTS
One drop of 0.4% oxybuprocaine solution instilled into each eye has
been shown sufficient for
tonometry after one minute. Addition of a further drop after 90
seconds provides adequate
anaesthesia for fitting of a contact lens. To obtain a deeper
anaesthetic effect, further drops may be
instilled at intervals of no less than 90 seconds. For most procedures
one to two drops is sufficient,
however for removal of foreign bodies or minor surgery, three to six
drops is suggested.
One drop a minute for 10 minutes was shown to provide adequate
anaesthesia for patients
undergoing pterygium surgery.
One drop instilled in each eye of a 0.2% oxybuprocaine solution prior
to tonometry, was shown to be
sufficient in patients over 40 years, suggesting that older patients
may achieve sufficient anaesthetic
effect with a lower dose of drug.
Corneal sensitivity is normal again after about 1 hour.
Minims Oxybuprocaine PI-A20190813 v4
2
Each Minims unit should be discarded after a single use.
4.3
C
ONTRAINDICATIONS
Known hypersensitivity to anaesthetics in this group.
Concomitant infection of the eye.
Patient instillation of drug. To be given only by a clinician.
4.4
S
PECIAL WARNINGS AND PRECAUTIONS FOR US