MIOCHOL-E 20MG POWDER AND SOLVENT FOR INSTILLATION SOLUTION FOR INTRAOCULAR USE

Active substance: ACETYLCHOLINE CHLORIDE

View full screen / Print PDF » Download PDF ⇩

Transcript
FPO
In this leaflet:

Miochol -E
®

20mg Powder and
Solvent for instillation
solution for intraocular use
acetylcholine chloride

1.

2.

What Miochol-E is and what it’s used for

2. Things to consider before you are given
Miochol-E

Some people MUST NOT have Miochol-E.
Talk to your doctor if:


3. How Miochol-E is used
4. Possible side effects
5. How to store Miochol-E
6. Further information

Patient Information Leaflet

Please read this leaflet carefully before you are
treated. It contains important information. Keep
the leaflet in a safe place because you may want to
read it again. If you have any other questions, or if
there is something you don’t understand, please ask
your doctor or nurse.
If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or nurse.
This product will usually be referred to as Miochol-E
in this leaflet.

1.

What Miochol-E is and what it’s used for

The Miochol-E pack includes a vial containing the
Miochol-E powder, and an ampoule containing
a liquid which is used to make up the irrigation
solution. There is also a small filter hub device.
The active ingredient in Miochol-E is called
acetylcholine chloride. This is one of a group
of medicines called parasympathomimetics
(neurohormones). It is involved with the transmission
of nerve impulses in the body.
Miochol-E is used during cataract surgery and other
types of eye surgery. It is used to make the pupil (at
the front of the eye) contract. This helps the surgeon
carry out the operation.



You think you may be allergic to acetylcholine
chloride or to any of the other ingredients.
(These are listed at the end of the 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 are pregnant or breastfeeding.

Are you taking other medicines?
Some medicines can interfere with the way
Miochol-E works. Tell your doctor or nurse if you are
applying preparations containing NSAIDs (nonsteroidal anti-inflammatory drugs, e.g. ibuprofen or
diclofenac) to your skin to treat pain and swelling.
Always tell your doctor or pharmacist about all the
medicines you are taking. This means medicines
you have bought yourself as well as medicines on
prescription from your doctor.

Will there be any problems with driving or
using machinery?

INFORMATION FOR THE
HEALTHCARE PROFESSIONAL

Your vision may be affected both by the eye surgery
and by the use of Miochol-E. You should not drive or
use machinery while you have any problems.

Warning: Do not use if blister or peelable backing is
damaged or broken. Open under aseptic conditions
only. The contents of the unopened blister are
guaranteed to be sterile.

3. How Miochol-E is used

Your surgeon will work out the correct dose of
Miochol-E for you. In most cases between 0.5 and
2 ml will be a suitable dose. The same dose is used
both for adults and the elderly.
Your surgeon will determine when to use Miochol-E.
In cataract surgery Miochol-E should only be used
after the replacement lens has been inserted into
the eye.
Miochol-E is applied drop by drop into the eye
during surgery. (This is called intraocular irrigation.)
The solution will be made up just before it is needed
by a healthcare professional. The use of Miochol-E
in children has not been studied, and therefore it is
not recommended.

How to prepare Miochol-E
1.

Inspect unopened blister
to ensure that it is intact.
Peel open blister.

2. Aseptically transfer
the ampoule, vial and
filter hub to sterile
field. Maintain asepsis
during preparation of
the solution.
3. Aseptically attach a
sterile 18 to 20 gauge,
bevelled needle to
the luer tip of a sterile
disposable syringe with
twisting motion to ensure
a secure fit.

4. Break open the ampoule
containing the solvent.
The One Point Cut
(OPC) ampoule must
be opened as follows:
Hold the bottom part
of the ampoule with the
thumb pointing to the
coloured point. Grasp the top of the ampoule
with the other hand, positioning the thumb at
the coloured point and press back to break at
the existing etched mark under the point.
5. Remove the needle protector and withdraw
the solvent from the ampoule into the syringe.
Discard the empty ampoule.
6. Remove and discard the plastic cap from the
top of vial.
7.

Insert the needle
through the centre of the
vial stopper.

8. Transfer the solvent from
the syringe to the vial.
9.

Shake gently to
dissolve drug.

9225602

FPO

Your doctor has decided to use Miochol-E to help
treat your condition.

Things to consider before you are
given Miochol-E

XXXXXXX GB

10. Slowly withdraw the solution from the vial
through the needle into the syringe.
11. Discard needle.
12. Aseptically open the
filter hub pouch.
13. Aseptically attach the
filter hub to the luer
tip of syringe with a
twisting motion to assure
secure fit.
14. Aseptically attach
a sterile blunt tip
irrigation cannula to
male luer of filter prior
to intraocular irrigation.
15. Discard appropriately
after use. Do not reuse
the filter hub.
The solution must be
mixed just before use, since aqueous solutions of
acetylcholine are unstable. Do not use unless a clear
and colourless solution is produced.
For single use only. Discard any unused solution.

What if you are given too much?

5.

Keep all medicines out of the reach and sight
of children.

How to store Miochol – E

If you are given more Miochol-E than you need, your
doctor may need to give you an injection of either
atropine sulphate or adrenaline to control symptoms.
Symptoms of overdose may include slow heart rate,
low blood pressure, flushing, breathing difficulties
and sweating.



Do not store Miochol-E above 25°C. Do
not freeze.

4.



Do not use any Miochol-E after the expiry date
printed on the box.

Miochol-E should not be re-sterilised. The filter
hub is recommended only for use with Miochol-E.
Aspiration through the filter is not recommended.
However, if utilised, discard needle and syringe filter
to prevent recontamination of fluids during injection.
Do not aspirate and inject through the same filter.



Do not use any Miochol-E pack that is damaged
or shows signs of tampering.



Keep Miochol-E out of the reach and sight
of children.

Possible side effects

Miochol-E is suitable for most people, but, like all
medicines, it can sometimes cause side effects.
In isolated cases it has been reported that using
Miochol-E has made the cornea (the transparent
layer which protects the front of the eye) become
cloudy or swollen. This may affect your vision.
The following symptoms which are due to Miochol-E
being absorbed into the body’s circulation from the
eye, have also been reported rarely:


slow heart rate, dizziness or lightheadedness
due to low blood pressure, flushing, breathing
difficulties and sweating.

If any of these side effects are severe or last for
more than a few days, or if you notice anything
else not mentioned here, please tell the doctor
or nurse.

How to store Miochol-E

Miochol-E should not be stored above 25°C. It
should not be frozen.
It should not be used after the expiry date which is
printed beside the letters “EXP” on the carton and
the blister. The expiry date refers to the last day of
that month.
It should not be used if the blister or peelable
backing is damaged or broken.
The re-constituted solution should be
used immediately.
6.

Further Information

Each pack of Miochol-E contains a blister and a
filtering hub device.
The blister contains a vial of white powder and
an ampoule of clear, colourless solvent. The vial
contains 20 mg of acetylcholine chloride as active
ingredient and the inactive ingredient, mannitol. The
ampoule contains 2 ml of solvent which contains
sodium acetate trihydrate, magnesium chloride
hexahydrate, potassium chloride, calcium acetate
trihydrate, magnesium chloride hexahydrate,
potassium chloride, calcium chloride dihydrate and
water for injections.

The Miochol-E powder must be reconstituted with
the solvent before it is used. The reconstituted
solution is a clear, colourless solution providing
10 mg/ml of acetylcholine chloride (20 mg/2 ml).
The filtering hub device has a 5 micron filter and a
luer lock.
Marketing Authorisation holder is
Dr. Gerhard Mann
Chem.-pharm. Fabrik GmbH
Brunsbüetteler Damm 165-173
13581 Berlin
Germany
Authorisation Number:
UK - PL 13757/0017 (powder)
- PL 13757/0018 (diluent)
Republic of Ireland - PA 1245/2/1
The manufacturer responsible for release to the
market is
Dr. Gerhard Mann
Chem.-pharm. Fabrik GmbH
Brunsbüetteler Damm 165-173
13581 Berlin
Germany
This leaflet was revised in December 2011.
If you would like any more information, or would like
the leaflet in a different format, please contact +44
(0) 1748 828864 (UK) or +44 (0) 1748 828849
(Republic of Ireland).
Miochol®-E is a registered trademark of Bausch & Lomb Incorporated.
©Bausch & Lomb Incorporated.

9225602

XXXXXXX GB

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web3)