Miostat intraocular

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Carbachol 0.01%{relative}

Available from:

Alcon Laboratories (New Zealand) Limited

INN (International Name):

Carbachol 0.01% w/v

Dosage:

0.01 %

Pharmaceutical form:

Solution for injection

Composition:

Active: Carbachol 0.01%{relative} Excipient: Calcium chloride dihydrate Hydrochloric acid Magnesium chloride hexahydrate Potassium chloride Sodium acetate trihydrate Sodium chloride Sodium citrate dihydrate Sodium hydroxide Water for injection

Units in package:

Vial, glass, 1x1.5ml Type I Ph Eur, 1.5 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Siegfried Ltd

Product summary:

Package - Contents - Shelf Life: Vial, glass, 1x1.5ml Type I Ph Eur - 1.5 mL - 36 months from date of manufacture stored at or below 25°C - Vial, glass, 12x1.5ml Type I Ph Eur - 18 mL - 36 months from date of manufacture stored at or below 25°C

Authorization date:

1977-10-20

Patient Information leaflet

Internal document code
1
MioS080920cNZ
MIOSTAT™ INTRAOCULAR SOLUTION FOR INJECTION 150 ΜG IN 1.5 ML
_Carbachol_
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
PLEASE
READ
THIS
LEAFLET
CAREFULLY BEFORE YOU ARE GIVEN
MIOSTAT
TM
.
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.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 expected benefits of
using Miostat against the risks
this
medicine
could
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
this medicine, ask your doctor or
pharmacist.
KEEP
THIS
LEAFLET
WITH
THE
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 which a

Summary of Product characteristics

Internal document code
1
MioS170820iNZ
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
MIOSTAT
TM
(carbachol) Intraocular Injection 150 µg/1.5 mL.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
MIOSTAT
TM
injection contains carbachol 150 µg in 1.5 mL.
3.
PHARMACEUTICAL FORM
Sterile solution for 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 used in those persons showing hypersensitivity to
any of
the
components of this preparation. 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.
Internal document code
2
MioS170820iNZ
Paediatric population
Safety and efficacy in paediatric patients have not been established.
4.5
INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTIONS
No clinically relevant interactions have been described with
intraocu