Minims povidone iodine 5% eye drops 0.4ml unit dose

国家: 英国

语言: 英文

来源: MHRA (Medicines & Healthcare Products Regulatory Agency)

有效成分:

Povidone-Iodine

可用日期:

Bausch & Lomb UK Ltd

ATC代码:

S01AX18

INN（国际名称）:

Povidone-Iodine

剂量:

50mg/1ml

药物剂型:

Eye drops

给药途径:

Ocular

类:

No Controlled Drug Status

处方类型:

Valid as a prescribable product

產品總結:

BNF: 11080200; GTIN: 5027519008858

资料单张

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

产品特点

OBJECT 1
MINIMS POVIDONE IODINE 5% W/V EYE DROPS,
SOLUTION
Summary of Product Characteristics Updated 14-Nov-2017 | Bausch & Lomb
U.K Limited
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 milliliter of
solution contains 50 mg Iodinated Povidone
Excipient with known effect: disodium phosphate anhydrous ( see
section 4.8).
For the 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 for
cutaneous 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)_
Instill 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 instill 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 suitable syringe, irrigate the
eye / eyes thoroughly with sterile saline 0.9% w/v solution until the
characteristic colour of the iodine
solution disappears
4.3 Contraindications
- Hypersensitivity to iodinated povidone, to iodine or to any of the
excipients listed in section 6.1
- Minims® Povidone Iodine 5% w/v eye drops, solution is
contraindicated for intra-ocular or peri-oc