Minims Lidocaine & Fluorescein

Nazione: Nuova Zelanda

Lingua: inglese

Fonte: Medsafe (Medicines Safety Authority)

Compra

Foglio illustrativo Foglio illustrativo (PIL)
19-04-2020
Scheda tecnica Scheda tecnica (SPC)
04-01-2021

Principio attivo:

Fluorescein sodium 0.25%{relative};  ; Lidocaine hydrochloride monohydrate 4%{relative};  

Commercializzato da:

Bausch & Lomb (NZ) Ltd

INN (Nome Internazionale):

Fluorescein sodium 0.25% w/v

Forma farmaceutica:

Eye drops, solution

Composizione:

Active: Fluorescein sodium 0.25%{relative}   Lidocaine hydrochloride monohydrate 4%{relative}   Excipient: Hydrochloric acid Povidone Water for injection

Confezione:

Single use dropper, 0.5ml, 20 dose units

Classe:

Prescription

Tipo di ricetta:

Prescription

Prodotto da:

ICROM SpA

Dettagli prodotto:

Package - Contents - Shelf Life: Single use dropper, 0.5ml - 20 dose units - 30 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Data dell'autorizzazione:

1981-09-24

Foglio illustrativo

                                MINIMS
® LIGNOCAINE & FLUORESCEIN
EYE DROPS
_Lignocaine Hydrochloride & Fluorescein Sodium Eye Drops _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Minims Lignocaine
& Fluorescein Eye Drops.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you using Minims
Lignocaine & Fluorescein Eye Drops
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR DOCTOR.
KEEP THIS LEAFLET IN A SAFE PLACE.
You may need to read it again.
WHAT MINIMS
LIGNOCAINE &
FLUORESCEIN EYE DROPS
IS USED FOR
Minims Lignocaine & Fluorescein
Eye Drops contains lignocaine
hydrochloride and fluorescein
sodium. Lignocaine (also know as
lidocaine) belongs to a group of
medicines called local anaesthetics,
which temporarily numbs the surface
of the eye. Fluorescein temporarily
colours your eye orange or green and
helps your doctor to examine them.
Minims Lignocaine & Fluorescein
Eye Drops are used to numb and
stain the surface of the your eye(s),
for a short time only, to allow your
doctor to examine your eye. Most
often, the eye drops are used to allow
the pressure inside your eyes to be
measured.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED TO YOU.
Your doctor may have prescribed it
for another reason.
BEFORE YOU ARE GIVEN
MINIMS LIGNOCAINE &
FLUORESCEIN EYE DROPS
_WHEN YOU MUST NOT BE GIVEN _
_IT _
DO NOT USE MINIMS LIGNOCAINE &
FLUORESCEIN EYE DROPS IF YOU HAVE
AN ALLERGY TO:
*
any medicine containing
Lignocaine or Fluorescein
*
any other local anaesthetic
*
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
DO NOT USE THIS MEDICINE AF
                                
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Scheda tecnica

                                NEW ZEALAND DATA SHEET
1 MINIMS Lidocaine & Fluorescein, eye drops solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 0.5 mL contains 20 mg Lignocaine hydrochloride and 1.25 mg of
Fluorescein sodium.
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Clear, slightly-yellow, slightly viscous, single-use, sterile eye
drops.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
As a diagnostic stain and topical anaesthetic combined. Minims
Lidocaine & Fluorescein can be
used in the measurement of intraocular pressure by Goldmann tonometry.
4.2
Dose and method of administration
Adults (including the elderly):
One or more drops, as required.
Children:
As directed by the physician.
4.3
Contraindications
Do not use in patients with a known hypersensitivity to fluorescein or
lidocaine and other
amide-type local anaesthetics.
4.4
Special warnings and precautions for use
The anaesthetised eye should be protected from foreign body
contamination, particularly in
elderly patients in whom the duration of anaesthesia may exceed 30
minutes.
Use
with
caution
in
an
inflamed
eye
as
hyperaemia
greatly
increases
the
rate
of
systemic absorption through the conjunctiva.
Systemic
absorption
may
be
reduced
by
compressing
the
lacrimal
sac
at
the
medial
canthus for a minute during and following the instillation of the
drops. (This blocks
the
passage of the drops via the naso-lacrimal duct to the wide absorptive
area of
the nasal
and pharyngeal mucosa. It is especially advisable in children.)
4.5
Interaction with other medicaments and other forms of interaction
None known.
NEW ZEALAND DATA SHEET
4.6
Fertility, pregnancy and lactation
This combination has been used for a number of years without apparent
ill- consequence.
4.7
Effects on ability to drive and use machines
None known.
4.8
Undesirable effects
ADRs are very rare, (<1/10,000), including isolated reports.
Symptoms of allergic-type reactions and anaphylaxis have been reported
following
topical
ophthalmic administration of fluorescein sodium and may manifest as:
Eye
                                
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