Miochol-E

देश: ऑस्ट्रेलिया

भाषा: अंग्रेज़ी

स्रोत: Department of Health (Therapeutic Goods Administration)

सक्रिय संघटक:

Mannitol; Acetylcholine chloride

थमां उपलब्ध:

Bausch & Lomb Australia Pty Ltd

वर्ग:

Medicine Registered

सूचना पत्रक

MIOCHOL
®
-E

_acetylcholine chloride_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Miochol-E.
It does not contain all 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.
Those 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 risk of you being given Miochol-
E against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN MIOCHOL-E, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT MIOCHOL-E IS
USED FOR
Miochol-E is used to constrict the
pupil of the eye during cataract
surgery and other types of eye
surgery.
It belongs to a group of medicines
called parasympathomimetics.
It works by mediating nerve impulse
transmission.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
It is available only with a doctor's
prescription.
There is not enough information to
recommend the use of this medicine
for children.
BEFORE YOU ARE GIVEN
MIOCHOL-E
_WHEN YOU MUST NOT BE GIVEN_
_IT_
YOU MUST NOT BE GIVEN MIOCHOL-E
IF YOU HAVE AN ALLERGY TO:
•
any medicine containing
acetylcholine chloride
•
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.
YOU MUST NOT BE GIVEN MIOCHOL-E
AFTER THE EXPIRY DATE PRINTED O

उत्पाद विशेषताएं

MIOCHOL
®
-E  
(ACETYLCHOLINE CHLORIDE)  

NAME OF THE DRUG  
Active ingredient: acetylcholine chloride  
Chemical name: 2-acetoxyethyltrimethylammonium chloride  
Molecular formula: C
7
H
16
ClNO
2

CAS number: 60-31-1  
Molecular weight: 181.7  
Structural formula:  

DESCRIPTION  

Miochol-E is a parasympathomimetic preparation for intraocular
use presented in a blister 
pack containing one vial and
one ampoule: the vial contains acetylcholine chloride 20 
mg; the ampoule contains 2 mL of diluent.  
Excipients: Vial mannitol. Ampoule sodium acetate, magnesium chloride,
potassium 
chloride, calcium chloride, water for injections.  

PHARMACOLOGY  

Acetylcholine is a naturally occurring neurohormone which
mediates nerve impulse 
transmission
at all cholinergic sites involving somatic and autonomic nerves. After 
release from the nerve ending,
acetylcholine is rapidly inactivated by the enzyme 
acetylcholinesterase by hydrolysis to
acetic acid and choline.  
Direct application of acetylcholine to
the iris will cause rapid miosis of short duration. 
Topical ocular instillation of acetylcholine to
the intact eye causes no discernible 
responses as cholinesterase destroys the molecule more rapidly than
it can penetrate the 
cornea.  
CLINICAL TRIALS  
Clinical studies with Miochol-E have shown it to
be clinically and statistically superior to 
placebo in inducing miosis following cataract surgery when
administered at doses of 0.5-
2.0mL:  
HORIZONTAL PUPIL DIAMETER (MM) FOR INTENTION TO TREAT
SUBJECTS (MEAN ± SD) 

Post IOL 
Post Injection  
+45 secs  
Post Injection  
+ 5-10 mins  
Miochol-E (n=62)  
Change from post 
IOL  
P value - within 
treatment  
7.4 ± 1.5  
5.1 ± 1.5  
-2.3 ± 1.2  
<0.001  
4.6 ± 1.4  
-2.8 ± 1.2  
<0.001  
Placebo (n=31)  
Chang