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

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

Tropicamide; Phenylephrine hydrochloride; Lidocaine Hydrochloride Monohydrate

Inapatikana kutoka:

Laboratoires Thea

ATC kanuni:

S01FA; S01FA56

INN (Jina la Kimataifa):

Tropicamide; Phenylephrine hydrochloride; Lidocaine Hydrochloride Monohydrate

Kipimo:

0.2 mg/ml + 3.1 mg/ml + 10 milligram(s)/millilitre

Dawa fomu:

Solution for injection

Dawa ya aina:

Product subject to prescription which may be renewed (B)

Eneo la matibabu:

Anticholinergics; tropicamide, combinations

Idhini hali ya:

Marketed

Idhini ya tarehe:

2015-08-28

Taarifa za kipeperushi

2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FYDRANE 0.2 MG/ML + 3.1 MG/ML + 10 MG/ML SOLUTION FOR INJECTION
_ _
tropicamide / phenylephrine hydrochloride / lidocaine hydrochloride
monohydrate
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 FYDRANE is and what it is used for
2.
What you need to know before you are given MYDRANE
3.
How FYDRANE is administered
4.
Possible side effects
5.
How to store FYDRANE
6.
Contents of the pack and other information
1.
WHAT FYDRANE IS AND WHAT IT IS USED FOR
WHAT FYDRANE 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 monohydrate) 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 FYDRANE
YOU SHOULD NOT BE GIVEN FYDRANE:
•
if
you
are
allergic
to
tropicamide,
phenylephrine
hydrochloride
and/or
lidocaine
hydrochloride
monohydrate or to any of the other ingredients of this medicine
(listed in se

Tabia za bidhaa

Health Products Regulatory Authority
22 September 2023
CRN00D4ZF
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fydrane 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 monohydrate.
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 monohydrate.
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
Fydrane is indicated for cataract surgery to obtain mydriasis and
intraocular anaesthesia, during the surgical procedure.
Fydrane is indicated in adults only.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Intracameral use. One ampoule for single eye use.
Fydrane must be administered by an ophthalmic surgeon.
Posology
Fydrane 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 Fydrane in only one
injection, at the start of the surgical procedure.
Special population
_Elderly:_
No dose adjustment is necessary.
_Paediatric population:_
The safety and efficacy of Fydrane 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.
Health Products Regulatory Authority
22 S