Minims Tetracaine Hydrochloride

Country: Նոր Զելանդիա

language: անգլերեն

source: Medsafe (Medicines Safety Authority)

active_ingredient:

Tetracaine hydrochloride 0.5%

MAH:

Bausch & Lomb (NZ) Ltd

INN:

Tetracaine hydrochloride 0.5%

dosage:

0.5 %

pharmaceutical_form:

Eye drops, solution

composition:

Active: Tetracaine hydrochloride 0.5% Excipient: Hydrochloric acid Purified water

units_in_package:

Single use dropper, 0.5ml, 20 dose units

class:

Prescription

prescription_type:

Prescription

manufactured_by:

Siegfried Evionnaz SA

therapeutic_indication:

Latest Regulatory Activity

leaflet_short:

Package - Contents - Shelf Life: Single use dropper, 0.5ml - 20 dose units - 30 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

authorization_date:

1988-12-01

PIL

MINIMS
® AMETHOCAINE (TETRACAINE)
EYE DROPS
_Amethocaine hydrochloride Eye Drops _
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
amethocaine
*
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 THE EYE ONLY.

SPC

NEW ZEALAND DATA SHEET
1
MINIMS Tetracaine Hydrochloride, eye drops solution 0.5%
MINIMS Tetracaine Hydrochloride, eye drops solution 1%
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 0.5 mL contains 5 mg or 10 mg of Tetracaine Hydrochloride.
For full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Clear, colourless, single-use, sterile eye drops.
4
CLINICAL PARTICULARS
4.1
Therapeutic indications
Ocular anaesthetic for topical instillation into the conjunctival sac.
4.2
Dose and method of administration
Adults and children
One drop or as required. Each Minims unit should be discarded after
use.
4.3
Contraindications
Not to be used in patients with a known hypersensitivity to the
product.
Tetracaine is hydrolysed in the body to p-amino-benzoic acid and
should not therefore be
used in patients being treated with sulphonamides.
In view of the immaturity of the enzyme system which metabolises the
ester type
local
anaesthetics in premature babies, tetracaine should be avoided in
these
patients.
4.4
Special warnings and precautions for use
The
anaesthetised
eye
should
be
protected
from
dust
and
bacterial
contamination.
Tetracaine may give rise to dermatitis in hypersensitive patients.
On instillation an initial burning sensation may be experienced. This
may last for up to 30
seconds.
The cornea may be damaged by prolonged application of anaesthetic eye
drops.
Systemic absorption 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.)
NEW ZEALAND DATA SHEET
4.5
Interaction with other medicaments and other forms of interaction
Tetracaine
should
not
be
used
in
patients
being
treated
with
sulphonamides
(see
contraindications above).
4.6
Fertility, pregnancy and lactation
Safety for use in pregnancy and lactation has not been established,
therefore, use
only
when consi