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MYDRANE 0.2 MG/ML + 3.1 MG/ML + 10 MG/ML SOLUTION FOR INJECTION.

Active substance(s): LIDOCAINE HYDROCHLORIDE / PHENYLEPHRINE HYDROCHLORIDE / TROPICAMIDE

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Mydrane

0.2 mg/ml + 3.1 mg/ml
+ 10 mg/ml solution for injection

tropicamide / phenylephrine hydrochloride /
lidocaine hydrochloride
Read all of this leaflet carefully before you are
given this medicine because it contains important
information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor,
pharmacist or nurse.
- If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.

Dose and method of administration
• MYDRANE injection will be administered by an
ophthalmic surgeon, under local anaesthesia, at the
beginning of cataract surgery.
• The recommended dose is 0.2 ml of solution, in only
one injection. No additional dose should be injected as
no additional effect has been shown and as increased
loss of endothelial cells (cells of a layer covering the
posterior surface of the cornea) has been observed.
• The same dose is used for both adults and the elderly.
If you are given too much, or too little, MYDRANE:
Your medication will be given by an ophthalmic surgeon.
It is unlikely that you will be given an overdose.
If you have any further questions on the use of this
medicine, ask your doctor, or pharmacist or nurse.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects,
What is in this leaflet
although not everybody gets them.
1. What MYDRANE is and what it is used for
Most serious well known complications occurring during
2. What you need to know before you are given
or after cataract surgery:
MYDRANE
Uncommon: may affect up to 1 in 100 people
3. How MYDRANE is administered
• Injury to the lens (posterior capsule rupture),
4. Possible side effects
• Swelling of the retina (cystoid macular oedema).
5. How to store MYDRANE
Please seek urgent medical advice in this case.
6. Contents of the pack and other information
Other side effects:
1. WHAT MYDRANE IS AND WHAT IT IS USED FOR
Uncommon: may affect up to 1 in 100 people
What MYDRANE is
• Headache,
This medicine is a solution which is injected into the eye. • Swelling of the cornea (keratitis), increased pressure in
It contains three active substances:
the eye, redness of the eye (ocular hyperaemia),
• tropicamide which belongs to a group of medicines
• High blood pressure (hypertension).
blocking the passage of impulses through particular
Reporting of side effects
nerves (known as anticholinergics),
If you get any side effects, talk to your doctor, pharmacist
• phenylephrine (as phenylephrine hydrochloride)
or nurse. This includes any possible side effects not listed
which belongs to a group of medicines mimicking the in this leaflet. You can also report side effects directly via
effects of impulses conveyed through particular nerves the Yellow Card Scheme.
(known as alpha sympathomimetics),
Website: www.mhra.gov.uk/yellowcard
• lidocaine (as lidocaine hydrochloride) which belongs to By reporting side effects you can help provide more
a class of drugs called amide type local anaesthetics.
information on the safety of this medicine.
What it is used for
5. HOW TO STORE MYDRANE
This medicine is used in adults only.
Keep this medicine out of the sight and reach of children.
It will be administered by your ophthalmic surgeon by
injection into the eye at the beginning of cataract surgery Do not use this medicine after the expiry date which is
stated on the carton, blister and ampoule. The expiry date
(cloudiness of the lens), in order to enlarge the pupil of
refers to the last day of that month.
your eye (mydriasis) and to obtain anaesthesia in your
This medicinal product does not require any special
eye during the surgical procedure.
storage conditions.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE
For single eye use only. This medicine should be used
GIVEN MYDRANE
immediately after first opening of the ampoule.
You should not be given MYDRANE:
Do not throw away any medicines via wastewater or
• if you are allergic to tropicamide, phenylephrine
household waste. Ask your pharmacist how to throw
hydrochloride and/or lidocaine hydrochloride or to
any of the other ingredients of this medicine (listed in away medicines you no longer use. These measures will
help protect the environment.
section 6),

3. HOW MYDRANE IS ADMINISTERED
You should only be given this medicine if you have
demonstrated, at a previous visit, a satisfactory pupil
dilation with topical mydriatic therapy.

The following information is intended for medical or
healthcare professionals only:
Incompatibilities
No incompatibility with most commonly used products
in cataract surgery was reported in literature with the
active ingredients, and during clinical trials. For usual
viscoelastics, this was also confirmed by pharmaceutical
interaction test.
Warning
Do not use if the blister is damaged or broken. Open
under aseptic conditions only. The content of the
unopened blister is guaranteed to be sterile.
How to prepare and administer MYDRANE
Single-eye use solution for intracameral use only.
MYDRANE must be administered by intraocular injection
into the anterior chamber of the eye (intracameral
injection), by an ophthalmic surgeon, in the
recommended aseptic conditions of cataract surgery.
Before intracameral injection, the solution should be
visually inspected and should only be used if it is clear,
slightly brownish-yellow and practically free from visible
particles.
The recommended dose is 0.2 ml of MYDRANE; no
additional dose should be injected as no significant
add-on effect has been demonstrated and as increased
endothelial cell loss was observed.
The product should be used immediately after opening of
the ampoule and not be reused for the other eye or any
other patient.
To prepare MYDRANE for intracameral administration,
please adhere to the following instructions:
1. Inspect unopened blister to
ensure that it is intact. Peel open
blister.

6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What MYDRANE contains
• The active substances are tropicamide 0.04 mg,
phenylephrine hydrochloride 0.62 mg and lidocaine
hydrochloride 2 mg for each 0.2 ml dose, equivalent
to 0.2 mg of tropicamide, 3.1 mg of phenylephrine
hydrochloride and 10 mg of lidocaine hydrochloride for
1 ml.
• The other ingredients are: sodium chloride, disodium
phosphate dodecahydrate, disodium phosphate
dihydrate, disodium edetate and water for injections.
What MYDRANE looks like and contents of the pack
MYDRANE is a clear, slightly brownish-yellow solution
for injection, practically free from visible particles and
supplied in a 1 ml brown glass ampoule. Each ampoule
contains 0.6 ml of solution for injection and is presented
in a sealed paper/PVC blister.
Each box contains 1 or 20 or 100 ampoules (with
5 micrometers filter needle(s) to be used only for the
withdrawal of the vial contents). All components are for
single-use only.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
LABORATOIRES THEA
12, RUE LOUIS BLERIOT
63017 CLERMONT-FERRAND CEDEX 2
FRANCE
Manufacturer
DELPHARM TOURS
RUE PAUL LANGEVIN
37170 CHAMBRAY LES TOURS
FRANCE
This medicinal product is authorised in the Member
States of the EEA under the following names:
Austria, Belgium, Bulgaria, Cyprus, Czech Republic,
Germany, Denmark, Greece, Finland, France, Croatia,
Iceland, Italy, Luxembourg, The Netherlands, Poland,
Portugal, Romania, Sweden, Slovenia, Slovak Republic,
United Kingdom .................................................................Mydrane
Ireland, Spain........................................................................ Fydrane
Norway ...................................................................................Mydane
This leaflet was last revised in 07/2015
If you would like any more information, or would like
the leaflet in a different format, please contact Medical
Information at THEA Pharmaceuticals Ltd, telephone
number 0870 192 3283.

2. Break open the ampoule
containing the drug product.
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 cut under the point.

5-µm filter
needle

3. Assemble the 5-micron filter
sterile needle (provided) onto
a sterile syringe. Remove the
5-micron filter sterile needle
protector and withdraw at
least 0.2 ml of the solution for
injection from the ampoule into
the syringe.
4. Disconnect the needle from
the syringe and assemble the
syringe with an appropriate
anterior chamber cannula.

0.2 ml

5. Carefully expel the air from the
syringe. Adjust to 0.2 ml. The
syringe is ready for injection.
6. Inject slowly the 0.2 ml syringe
volume into the anterior
chamber of the eye, in only one
injection, through the side port
or principal port.

After use, discard the remaining solution.
Do not keep it for subsequent use.
Any unused product or waste material should be
disposed of in accordance with local requirements.
Discard used needles in a sharps container.

N2380A20L03/0715 - 0000000

• if you are allergic to anaesthetics of the amide type,
• if you are allergic to atropine derivatives.
Warnings and precautions
MYDRANE is not recommended:
• in combined cataract surgery with a certain type of eye
surgery (vitrectomy),
• if the anterior part (anterior chamber) of your eye is
shallow,
• if you have a history of acute increase of eye pressure
(acute narrow angle glaucoma).
You should talk to your doctor in particular if you have:
• high blood pressure (hypertension),
• thickening of the arterial wall (atherosclerosis),
• any heart disease and particularly if it affects the heart
rate,
• a contraindication to medicines that increased blood
pressure (pressor amines) by general route,
• overactive thyroid gland (hyperthyroidism),
• prostate gland disorders,
• fits (epilepsy),
• any liver diseases or kidney problems,
• any problems with your breathing,
• loss of muscle function and weakness (myasthenia
gravis).
Other medicines and MYDRANE
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
Pregnancy, breast-feeding and fertility
This medicine should not be used:
• during pregnancy,
• during breast-feeding.
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor
or pharmacist for advice before taking any medicine.
Driving and using machines
Mydrane has a moderate influence on the ability to drive
and use machines. Consequently, you should not drive
and/or use machines until vision is normal.
MYDRANE contains sodium
This medicinal product contains less than 1 mmol
sodium (23 mg) per dose, i.e. essentially “sodium-free”.

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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.

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