MINIMS tetracaine (amethocaine) hydrochloride 1.0% 10 mg/mL eye drops tube

Country: Ավստրալիա

language: անգլերեն

source: Department of Health (Therapeutic Goods Administration)

active_ingredient:

tetracaine (amethocaine) hydrochloride, Quantity: 10 mg/mL

MAH:

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_indication:

To produce local anaesthesia in the eye.

leaflet_short:

Visual Identification: Clear solution reasonably free from visible particulate matter; Container Type: Tube; Container Material: PP; Container Life Time: 30 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

authorization_status:

Registered

authorization_date:

1991-10-30

PIL

MINIMS
® AMETHOCAINE
(TETRACAINE) EYE DROPS
_Tetracaine (Amethocaine) hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Minims
Amethocaine Eye Drops.
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 your using Minims
Amethocaine Eye Drops 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
AMETHOCAINE EYE
DROPS IS USED FOR
Minims Amethocaine Eye Drops
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 AMETHOCAINE
EYE DROPS
_WHEN YOU MUST NOT BE GIVEN_
_IT_
DO NOT USE MINIMS AMETHOCAINE
EYE DROPS IF YOU HAVE AN ALLERGY
TO:
•
Any medicine containing
tetracaine
•
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 ARE
BEING TREATED WITH A GROUP OF
MEDICINES CALLED SULPHONAMIDES.
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 HAS BEEN DEVELOPED
FOR USE IN

SPC

Minims Amethocaine PI-A20200429 v4
Page 1 of 7
AUSTRALIAN PRODUCT INFORMATION – MINIMS
® AMETHOCAINE
[TETRACAINE (AMETHOCAINE) HYDROCHLORIDE] EYE DROPS
1
NAME OF THE MEDICINE
Tetracaine (Amethocaine) Hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Minims Amethocaine Eye Drops contain tetracaine hydrochloride 0.5% or
1% w/v. No
preservatives are contained 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 Amethocaine Eye Drops are clear, colourless sterile eye drops
reasonably free from
visible particulate matter. No preservatives are contained in the
formulation.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Minims Amethocaine Eye Drops are indicated to produce local
anaesthesia in the eye
4.2
D
OSE AND METHOD OF ADMINISTRATION
ADULTS AND CHILDREN
One drop as required.
Further drops may be needed to achieve a complete anaesthetic effect;
if this is required,
instillation must be strictly as recommended and supervised by the
treating physician.
Normal corneal sensitivity can be expected after approximately 1 hour.
Although unlikely, due
to the small volume in each unit dose, systemic absorption of local
anaesthetics is rapid from
mucosal membranes (see Section 4.9 Overdose). Systemic absorption of
tetracaine may be
reduced by compressing the lacrimal sac at the medial canthus for a
minute during and
following the instillation of the drops. (This blocks the passage of
the drops via the naso-
lacrimal duct to the wide absorptive area of the nasal and pharyngeal
mucosa. It is especially
advisable in children.)
Each Minims Amethocaine Eye Drop unit should be discarded after a
single use.
Minims Amethocaine PI-A20200429 v4
Page 2 of 7
4.3
C
ONTRAINDICATIONS
Minims Amethocaine Eye Drops are contraindicated in patients with
hypersensitivity to any of
the components of the preparation.
Tetracaine is hydrolysed in the body to p-amino benzoic acid and
should therefore not be used
in patients being treated w