MIOSTAT carbachol 0.15mg/1.5mL intraocular injection

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

carbachol, Quantity: 100 microgram/mL

Available from:

Alcon Laboratories Australia Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: sodium citrate dihydrate; potassium chloride; hydrochloric acid; sodium acetate; sodium hydroxide; calcium chloride dihydrate; sodium chloride; magnesium chloride hexahydrate; water for injections

Administration route:

Intraocular

Units in package:

1 x 1.5 mL vial, 12 x 1.5 mL vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Intraocular use for miosis during surgery.

Product summary:

Visual Identification: A clear, colourless solution; Container Type: Vial; Container Material: Glass; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1992-06-29

Patient Information leaflet

MIOSTAT® INTRAOCULAR SOLUTION FOR INJECTION
1
MIOSTAT
™ INTRAOCULAR
SOLUTION FOR INJECTION
_ Carbachol 150 microgram/1.5 mL (0.01%) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
YOU ARE GIVEN MIOSTAT.
This leaflet answers some common
questions about Miostat Solution for
Injection. 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.ebs.tga.gov.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 risks of you using Miostat against
the benefits they expect it will have
for you.
The information in this leaflet applies
to Miostat only. This information
does not apply to similar products,
even if they contain the same
ingredients.
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 MIOSTAT IS USED
FOR
Miostat contains carbachol which
belongs to a group of medicines
called parasympathomimetics.
This medicine works by stimulating
the muscles inside the eye that are
responsible for the contraction of the
pupils.
Your doctor will inject Miostat into
your to eye to constrict your pupils
during surgery.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
IS BEING USED.
_USE IN CHILDREN _
The safety and effectiveness of
Miostat Solution for Injection has not
been established.
BEFORE YOU ARE GIVEN
MIOSTAT
_WHEN YOU MUST NOT BE GIVEN _
_IT _
MIOSTAT SHOULD NOT BE GIVEN TO YOU
IF YOU HAVE AN ALLERGY TO:
•
Carbachol
•
Any of the ingredients in Miostat

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – MIOSTAT
TM (CARBACHOL)
INTRAOCULAR INJECTION
1
NAME OF THE MEDICINE
Carbachol.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
MIOSTAT
TM
Intraocular injection contains carbachol 150 microgram/1.5 mL (
0.01%).
For a full list of excipients see Section 6.1. List of Excipients.
3
PHARMACEUTICAL FORM
Solution for injection.
Sterile, balanced salt solution of carbachol for intraocular
injection.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Intraocular use for miosis during surgery.
4.2 DOSE AND METHOD OF ADMINISTRATION
This is not a multi-dose container and should not be used for more
than one patient.
Contains no antimicrobial agent. Use once only and discard any
residue.
Aseptically remove the sterile vial from the blister package by
peeling the backing
paper and dropping the vial onto a sterile tray.
Withdraw
the
contents into a
dry sterile
syringe
and
replace
the
needle
with
an
atraumatic cannula prior to intraocular irrigation. No more than
one-half mL should be
gently instilled into the anterior chamber for the production of
satisfactory miosis.
It
may be instilled before or after securing sutures. Miosis is usually
maximal within two
to five minutes after application.
4.3 CONTRAINDICATIONS
Should not be in those persons showing hypersensitivity to any of the
components of this
medicine (see Section 6.1. List of Excipients).
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
FOR SINGLE-DOSE INTRAOCULAR USE ONLY.
DISCARD UNUSED PORTION.
Intraocular carbachol 0.01% should be used with caution in patients
with acute
cardiac
failure,
bronchial
asthma,
peptic
ulcer,
hyperthyroidism,
G.I.
spasm,
urinary
tract
obstruction and Parkinson’s disease.
The use of intraocular carbachol may increase surgically induced
intraocular
inflammation.
The
vial
stopper
contains
natural
rubber
(latex) which
may
cause
severe
allergic
reactions.
USE IN THE ELDERLY
No data available.
PAEDIATRIC USE
Safety and efficacy in paediatric patients have not been established.
EFFECTS ON LABORATORY TESTS
No data avai