Minims lidocaine and fluorescein eye drops 0.5ml unit dose

Pajjiż: Ingilterra

Lingwa: Ingliż

Sors: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredjent attiv:

Lidocaine hydrochloride; Fluorescein sodium

Disponibbli minn:

Bausch & Lomb UK Ltd

INN (Isem Internazzjonali):

Lidocaine hydrochloride; Fluorescein sodium

Dożaġġ:

40mg/1ml ; 2.5mg/1ml

Għamla farmaċewtika:

Eye drops

Rotta amministrattiva:

Ocular

Klassi:

No Controlled Drug Status

Tip ta 'preskrizzjoni:

Valid as a prescribable product

Sommarju tal-prodott:

BNF: 11070000; GTIN: 5027519001309

Fuljett ta 'informazzjoni

Graphics&Packing
Technology Section
ICN POLFA RZESZÓW S.A.
ULOTKA PIL
Nazwa produktu
Product Name
MINIMS LIDOCAINE
HYDROCHLORIDE 4% W/V
AND FLUORESCEIN SODIUM
0.25%
DRP SOL
Kolor nadruku Colours
Black
Kraj
Country (ISO)
UNITED KINGDOM (UK),
IRELAND (IE)
Nr wykrojnika
Spec No
5338
Opracowane przez
Designed by
Kod Wytwórcy
Manufacturer code
76862
Nr korekty
Proof No
5
Data
Date
09.04.2015
Kod farmaceutyczny
Pharmacode
-
Kod wersji
Valeant version code
P1UK01
Inny kod
Other code
76862 (DATA MATRIX)
Rozmiar czcionki
Font size
MINIMUM 8 PT
Wymiar ulotki
PIL size
160 X 240 MM
Krój czcionki
Font used
Frutiger Neue LT W1G
Condensed
FRUTIGER NEUE LT W1G
CONDENSED BOLD
Gramatura papieru
Paper weight
- G/M
2
Komentarze Comments (Reason for the change)
MAH TRANSFER FROM CHAUVIN PHARMACEUTICALS LTD UK TO B+L UK LTD
PMR_ICN-14-0806-A
PACKING SITE: LABORATOIRE CHAUVIN, AUBENAS, FRANCE
Akceptacja Techniczna Technical Approval
Akceptacja Działu ds. Rejestracji Regulatory Affairs Dept. Approval
MINIMS® LIDOCAINE HYDROCHLORIDE 4% W/V
AND FLUORESCEIN SODIUM 0.25% W/V
EYE DROPS, SOLUTION
LIDOCAINE HYDROCHLORIDE AND FLUORESCEIN SODIUM
IN THIS LEAFLET:
1.
What Minims® Lidocaine Hydrochloride and Fluorescein Sodium eye drops
are and what they are used for
2.
Before you use your eye drops
3.
How to use your eye drops
4.
Possible side effects
5.
How to store your eye drops
6.
Further information
1. WHAT MINIMS®
LIDOCAINE HYDROCHLORIDE AND FLUORESCEIN SODIUM EYE DROPS ARE AND WHAT
THEY ARE USED FOR
Minims® Lidocaine Hydrochloride and Fluorescein Sodium contains a
local anaesthetic (lidocaine) and a diagnostic agent (fluorescein).
Lidocaine Hydrochloride is a local anaesthetic which temporarily numbs
the surface of the eye.
Fluorescein sodium is a temporary dye which helps the doctor or eye
specialist to examine your eye.
Your eye drops are used to:
•
numb and stain the surface of the eye, for a short time only, to help
the doctor or eye specialist to examine your eye .
•
help your doctor or eye specialist to measure the pressur

Karatteristiċi tal-prodott

OBJECT 1
MINIMS LIDOCAINE & FLUORESCEIN
Summary of Product Characteristics Updated 23-Oct-2017 | Bausch & Lomb
U.K Limited
1. Name of the medicinal product
Minims Lidocaine & Fluorescein
2. Qualitative and quantitative composition
Clear, slightly yellow, slightly viscous eye drops containing
Lidocaine Hydrochloride PhEur 4% w/v and
Fluorescein Sodium PhEur 0.25% w/v.
3. Pharmaceutical form
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 Posology 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 medicinal products and other forms of
interaction
None known.
4.6 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
adm