MIOCHOL-E acetylcholine chloride 20mg/2mL powder for solution for intraocular irrigation

国: オーストラリア

言語: 英語

ソース: Department of Health (Therapeutic Goods Administration)

有効成分:

acetylcholine chloride, Quantity: 10 mg/mL

から入手可能:

Bausch & Lomb Australia Pty Ltd

INN（国際名）:

Acetylcholine chloride,Mannitol

医薬品形態:

Diluent, not applicable

構図:

Excipient Ingredients: sodium acetate; magnesium chloride hexahydrate; potassium chloride; calcium chloride dihydrate; water for injections

投与経路:

Intraocular

パッケージ内のユニット:

12 x 20mg/2mL vials with diluent ampoules, 1 x 20mg/2mL vial with diluent ampoule

処方タイプ:

(S4) Prescription Only Medicine

適応症:

Miochol-E is used to obtain complete miosis of the iris in seconds after placement of the intraocular lens (IOL) in cataract surgery; and in penetrating keratoplasty, iridectomy and other anterior segment surgery where rapid miosis may be required.

製品概要:

Visual Identification: Clear colourless solution in glass ampoule; Container Type: Vial; Container Material: Glass; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

認証ステータス:

Licence status A

承認日:

2005-08-31

情報リーフレット

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 ON THE
PACK OR IF THE PACKAGING I

製品の特徴

Miochol-E PI-A-20200921 v4 Page 1 of 7
AUSTRALIAN PRODUCT INFORMATION – MIOCHOL-E
(ACETYLCHOLINE CHLORIDE) POWDER FOR SOLUTION FOR
INTRAOCULAR IRRIGATION
1
NAME OF THE MEDICINE
Acetylcholine chloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of powder contains acetylcholine chloride 20 mg as the
active ingredient. Miochol-E
contains acetylcholine chloride 10 mg/mL upon reconstitution with the
2 mL of diluent in the
ampoule.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Powder for solution for irrigation and diluent.
Powder: white solid or powder in clear glass vials.
Diluent: clear colourless solution in glass ampoules.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Miochol-E is used to obtain complete miosis of the iris in seconds
after placement of the
intraocular lens (IOL) in cataract surgery and in penetrating
keratoplasty, iridectomy and other
anterior segment surgery where rapid miosis may be required.
4.2
D
OSE AND METHOD OF ADMINISTRATION
In most cases 0.5 to 2 mL produces satisfactory miosis.
The syringe containing the reconstituted preparation must be fitted
with a suitable irrigation
cannula for intraocular irrigation.
The Miochol-E solution is instilled into the anterior chamber before
or after securing one or
more sutures. Instillation should be gentle and parallel to the iris
face and tangential to pupil
border.
If there are no mechanical hindrances, the pupil starts to constrict
in seconds and the peripheral
iris is drawn away from the angle of the anterior chamber. Any
anatomical hindrance to miosis,
Miochol-E PI-A-20200921 v4 Page 2 of 7
such as anterior or posterior synechiae, must be released to permit
the desired effect of the
drug.
The solution should be reconstituted immediately before use since
aqueous solutions of
acetylcholine are unstable.
INSTRUCTIONS FOR USE AND HANDLING
Warning: Do not use if blister or peelable backing is damaged or
broken. Open under aseptic
conditions only, at the time of surgery.
DIRECTIONS FOR PREPAR