Monopost Unidose 50 micrograms/ml eye drops, solution in single-dose container

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Latanoprost

Tilgjengelig fra:

Lexon (UK) Ltd

ATC-kode:

S01EE; S01EE01

INN (International Name):

Latanoprost

Dosering :

50 microgram(s)/millilitre

Legemiddelform:

Eye drops, solution in single-dose container

Terapeutisk område:

Prostaglandin analogues1); latanoprost

Autorisasjon dato:

2020-07-10

Informasjon til brukeren

WHAT MONOPOST UNIDOSE LOOKS LIKE AND
CONTENTS OF THE PACK
This medicine is an eye drops, solution in
single-dose container. The solution looks slightly
yellow and cloudy. It contains no preservative.
The single-dose containers are packed in a sachet
of 10 units, each single-dose container holding 0.2
ml of solution. Each pack contains 30 (3 sachets
of 10) single dose containers.
Product procured from within the EU, repackaged
and distributed by the PARALLEL PRODUCT
AUTHORISATION HOLDER: Lexon (UK) Limited, Unit
18, Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE, UK.
Manufacturer
LABORATOIRE UNITHER
ZI de la Guérie
50211 Coutances Cedex
France
Monopost is a
registered trademark of
Laboratoires
Théa
PPA1097/071/001
THIS MEDICINAL PRODUCT IS AUTHORISED IN
THE MEMBER STATES OF THE EEA UNDER THE
FOLLOWING NAMES:
Belgium, Bulgaria, Cyprus, Denmark, Finland,
France, Estonia, Germany, Greece, Iceland,
Italy, Latvia, Luxembourg, The Netherlands,
Norway, Poland, Portugal, Spain,
Sweden ..........................................MONOPROST
Ireland ..............................MONOPOST UNIDOSE
Austria, Czech Republic, Lithuania, Romania,
Slovak Republic, Slovenia,
United Kingdom ................................MONOPOST
THIS LEAFLET WAS LAST REVISED IN JANUARY 2021
Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: [phone]
for help.
WARNINGS AND PRECAUTIONS
Talk to your doctor, or pharmacist or nurse
before using MONOPOST UNIDOSE if you
think any of the following apply to you:
•
If you are about to have or have had eye surgery
(including cataract surgery).
•
If you suffer from eye problems (such as eye
pain, irritation or inflammation, blurred vision).
•
If you know that you suffer from dry eyes.
•
If you have severe asthma or your asthma is not
well controlled.
•
If you wear contact lenses. You can still use
MONOPOST UNIDOSE, but follow the
instruction for contact lens wearers in Section 3.
•
If you have suffered or are currently sufferin

Preparatomtale

Health Products Regulatory Authority
03 February 2021
CRN00C04K
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Monopost Unidose 50 micrograms/ml eye drops, solution in single-dose
container
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml eye drops solution contains 50 micrograms of latanoprost.
One drop contains approximately 1.5 micrograms of latanoprost.
Excipient with known effect
Macrogolglycerol hydroxystearate 40
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution in single-dose container.
_ _
_Product imported from Greece_
The solution is a slightly yellow and opalescent solution.
pH: 6.5 – 7.5
Osmolality: 250-310 mosmol/kg
4 CLINICAL PARTICULARS
As per PA1107/007/001
5 PHARMACOLOGICAL PROPERTIES
As per PA1107/007/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Macrogolglycerol hydroxystearate 40
Sorbitol
Carbomer 974P
Macrogol 4000
Disodium edetate
Sodium hydroxide (for pH-adjustment)
Water for injections
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
container and outer package of the product on the market in
the country of origin.
After first opening of the sachet: use the single-dose containers
within 10 days.
After first opening of the single-dose container: use immediately and
discard the single-dose container after use.
Health Products Regulatory Authority
03 February 2021
CRN00C04K
Page 2 of 2
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Store below 25°C.
6.5 NATURE AND CONTENTS OF CONTAINER
10 single-dose containers containing 0.2 ml of eye drops solution
packed in a sachet.
Each pack contains 30 single-dose containers.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
No special requirements
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Lexon (UK) Limited
Unit 18, Oxleasow Road
East Moons Moat
Redditch
Worcestershire
B98 0RE
United Kingdom
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1097/071/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATIO