Mydrane 0.2mg/ml / 3.1mg/ml / 10mg/ml solution for injection 0.6ml ampoules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Tropicamide; Phenylephrine hydrochloride; Lidocaine hydrochloride

Available from:

Thea Pharmaceuticals Ltd

INN (International Name):

Tropicamide; Phenylephrine hydrochloride; Lidocaine hydrochloride

Dosage:

200microgram/1ml ; 3.1mg/1ml ; 10mg/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Intracameral

Class:

No Controlled Drug Status

Prescription type:

Never Valid To Prescribe As A VMP

Product summary:

BNF: 11080200; GTIN: 3662042003462

Patient Information leaflet

N2380A20L03/X1217
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.
What is in this leaflet
1. What MYDRANE is and what it is used for
2. What you need to know before you are given
MYDRANE
3. How MYDRANE is administered
4. Possible side effects
5. How to store MYDRANE
6. Contents of the pack and other information
1. WHAT MYDRANE IS AND WHAT IT IS USED FOR
What MYDRANE is
This medicine is a solution which is injected into the eye.
It contains three active substances:
•
tropicamide which belongs to a group of medicines
blocking the passage of impulses through particular
nerves (known as anticholinergics),
•
phenylephrine (as phenylephrine hydrochloride)
which belongs to a group of medicines mimicking the
effects of impulses conveyed through particular nerves
(known as alpha sympathomimetics),
•
lidocaine (as lidocaine hydrochloride) which belongs to
a class of drugs called amide type local anaesthetics.
What it is used for
This medicine is used in adults only.
It will be administered by your ophthalmic surgeon by
injection into the eye at the beginning of cataract surgery
(cloudiness of the lens), in order to enlarge the pupil of
your eye (mydriasis) and to obtain anaesthesia in your
eye during the surgical procedure.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE
GIVEN MYDRANE
You should not be given MYDRANE:
•
if you are allergic to tropicamide, phenylephrine
hydrochloride and/or lidocaine hydrochloride or to
any of the other ingredients of this medicine (listed in
section 6),
•
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 surge

Summary of Product characteristics

OBJECT 1
MYDRANE
Summary of Product Characteristics Updated 05-Jun-2018 | Thea
Pharmaceuticals Ltd
1. Name of the medicinal product
Mydrane 0.2 mg/ml + 3.1 mg/ml + 10 mg/ml solution for injection.
2. Qualitative and quantitative composition
1 ml of solution for injection contains 0.2 mg of tropicamide, 3.1 mg
of phenylephrine hydrochloride and
10 mg of lidocaine hydrochloride.
One dose of 0.2 ml solution contains 0.04 mg of tropicamide, 0.62 mg
of phenylephrine hydrochloride
and 2 mg of lidocaine hydrochloride.
Excipient with a known effect: sodium (0.59 mg per dose; see section
4.4).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection.
Clear and slightly brownish-yellow solution practically free from
visible particles.
pH: 6.9 - 7.5
Osmolality: 290 – 350 mosmol/kg
4. Clinical particulars
4.1 Therapeutic indications
Mydrane is indicated for cataract surgery to obtain mydriasis and
intraocular anaesthesia during the
surgical procedure.
Mydrane is indicated in adults only.
4.2 Posology and method of administration
Intracameral use. One ampoule for single eye use.
Mydrane must be administered by an ophthalmic surgeon.
Posology
Mydrane should only be used in patients who have already demonstrated,
at pre-operative assessment, a
satisfactory pupil dilation with topical mydriatic therapy.
_Adults:_
Slowly inject, by intracameral route, 0.2 ml of Mydrane in one
injection, at the start of the surgical
procedure.
Special population
_Elderly:_
No dose adjustment is necessary.
_Paediatric population:_
The safety and efficacy of Mydrane in children aged 0 to 18 years have
not been established.
_Patients with renal impairment:_
Considering the low dose and the very low systemic exposure (see
section 5.2), no dose adjustment is
necessary (see section 4.4).
_Patients with hepatic impairment:_
Considering the low dose and the very low systemic exposure (see
section 5.2), no dose adjustment is
necessary.
Method of administration
Intracameral use.
The following procedure should be foll