Minims Povidone Iodine 5% w/v Eye Drops, Solution

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

Iodinated povidone

Commercializzato da:

Bausch & Lomb UK Limited

Codice ATC:

S01AX; S01AX18

INN (Nome Internazionale):

Iodinated povidone

Dosaggio:

5 percent weight/volume

Forma farmaceutica:

Eye drops, solution

Tipo di ricetta:

Product subject to prescription which may not be renewed (A)

Area terapeutica:

Other antiinfectives; povidone-iodine

Stato dell'autorizzazione:

Marketed

Data dell'autorizzazione:

2012-12-14

Foglio illustrativo

Graphics&Packing
Technology Section
ICN POLFA RZESZÓW S.A.
ULOTKA PIL
Nazwa produktu
Product Name
MINIMS POVIDONE IODINE
5% W/V
DRP SOL 20 SINGLE DOSE
UNITS
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
76920
Nr korekty
Proof No
5
Data
Date
19.05.2016
Kod farmaceutyczny
Pharmacode
-
Kod wersji
Valeant version code
P1UKIE01
Inny kod
Other code
-
Rozmiar czcionki
Font size
MINIMUM 8 PT
Wymiar ulotki
PIL size
160 X 240 MM
Krój czcionki
Font used
Nobel BL Font family
Gramatura papieru
Paper weight
60 G/M
2
Komentarze Comments (Reason for the change)
NATIONAL REGISTRATION OF TEXT FOLLLOWING - SAFETY VARIATION AND QRD
UPDATE
PMR_ICN-15-1289-A
PACKING SITE: LABORATOIRE CHAUVIN, AUBENAS, FRANCE
Akceptacja Techniczna Technical Approval
Akceptacja Działu ds. Rejestracji Regulatory Affairs Dept. Approval
MINIMS
® POVIDONE IODINE 5% W/V EYE DROPS, SOLUTION
Iodinated Povidone
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 or your pharmacist.
–
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same
as yours.
–
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. See
section 4.
WHAT IS IN THIS LEAFLET
1.
What Minims Povidone Iodine is and what it is used for
2. What you need to know before you use Minims Povidone Iodine
3. How to use Minims Povidone Iodine
4. Possible side effects
5. How to store Minims Povidone Iodine
6. Contents of the pack and other information
1. WHAT MINIMS POVIDONE IODINE IS AND WHAT IT IS USED FOR
Minims Povidone Iodine is a solution that contains an antiseptic known
as Iodinated Povidone in an eye wash solution.
It is used for cleani

Scheda tecnica

HealthProductsRegulatoryAuthority
27February2019
CRN008L5X
Page1of5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
MinimsPovidoneIodine5%w/vEyeDrops,Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Eachsingledosecontainerprovides20mgofIodinatedPovidonein0.4mlofsolution.Onemlofsolutioncontains50mg
IodinatedPovidone
Excipientwithknowneffect:disodiumphosphateanhydrous(seesection4.8).
Forafulllistofexcipients,seesection6.1.
3 PHARMACEUTICAL FORM
EyeDrops,Solution
Deepbrown-redcolouredsolution
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
MinimsPovidoneIodine5%w/vEyeDrops,Solutionisindicatedforcutaneousperi-ocularandconjunctivalantisepsispriorto
ocularsurgerytosupportpost-operativeinfectioncontrol.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults (including the elderly): _
Instiltwotothreedropsofthesolutionontotheeye/eyesandleavefortwominutes.
See“MethodofAdministration”forfurtherdetails.
_Paediatric population: _
Theadultdosemaybeusedinneonates,infants,childrenandadolescents
_Method of administration_:

-Washhandsthoroughlybeforeuse.

-Cleantheareaaroundtheeyeswithasterilecottonswab

-Twistoffthecapofthecontainertoopenit

-Donottouchtheeyewiththesingle-dosecontainernozzle.

-Gentlyinstil2to3dropsofthesolutionontotheeye/eyes

-Allowthesolutiontospread,byaskingthepatienttoclosetheireyesandrolltheireyesaround

-Leavethedropsontheeye/eyesfortwominutesbeforerinsing:Usinga