Minims saline 0.9% eye drops 0.5ml unit dose

Ország: Egyesült Királyság

Nyelv: angol

Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktív összetevők:

Sodium chloride

Beszerezhető a:

Bausch & Lomb UK Ltd

ATC-kód:

S01XA20

INN (nemzetközi neve):

Sodium chloride

Adagolás:

9mg/1ml

Gyógyszerészeti forma:

Eye drops

Az alkalmazás módja:

Ocular

Osztály:

No Controlled Drug Status

Recept típusa:

Valid as a prescribable product

Termék összefoglaló:

BNF: 11080100; GTIN: 5027519002405

Betegtájékoztató

Graphics&Packing
Technology Section
ICN POLFA RZESZÓW S.A.
ULOTKA PIL
Nazwa produktu
Product Name
MINIMS SALINE 0.9 % W/V
SOL DRP 20 SDU
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
76844
Nr korekty
Proof No
5
Data
Date
30.04.2015
Kod farmaceutyczny
Pharmacode
-
Kod wersji
Valeant version code
P1UKIE01
Inny kod
Other code
76844 (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-14-0703-A
PACKING SITE: LABORATOIRE CHAUVIN, AUBENAS, FRANCE
Akceptacja Techniczna Technical Approval
Akceptacja Działu ds. Rejestracji Regulatory Affairs Dept. Approval
MINIMS® SALINE 0.9% W/V
EYE DROPS, SOLUTION
SODIUM CHLORIDE
IN THIS LEAFLET:
1. What Minims
®
Saline 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® SALINE EYE DROPS ARE AND WHAT THEY ARE USED FOR
Minims
®
Saline contains a salt solution. It is used to irrigate (wash out) the
eyes.
Minims
®
Saline is indicated for children, adults and the elderly.
2.
BEFORE YOU USE YOUR EYE DROPS
There are no special precautions which should be taken before using
this product.
IF YOU ARE PREGNANT, MAY BE PREGNANT, OR ARE BREASTFEEDING
You can use Minims
®
Saline as it will not harm your baby, and it is safe to use during
breastfeeding.
DRIVING AND USING MACHINES
As with all eye drops, your vision may be blurred after putting the
drops in. Wait until your vision is clear before driving or using
machines.
3.
HOW TO USE YOUR EYE DROPS
The drops are for single use only and provided in single use Minims
units, to treat both eyes if necess

Termékjellemzők

OBJECT 1
MINIMS SALINE 0.9% W/V EYE DROPS SOLUTION
Summary of Product Characteristics Updated 10-Aug-2015 | Bausch & Lomb
U.K Limited
1. Name of the medicinal product
Minims Saline 0.9% w/v Eye Drops Solution
2. Qualitative and quantitative composition
A clear, colourless liquid containing Sodium Chloride PhEur 0.9% w/v.
3. Pharmaceutical form
Single-use, sterile eye drops.
4. Clinical particulars
4.1 Therapeutic indications
As a topical ocular irrigating solution.
4.2 Posology and method of administration
Adults (including the elderly) and Children:
Adequate solution should be used to irrigate the eye.
4.3 Contraindications
None.
4.4 Special warnings and precautions for use
None.
4.5 Interaction with other medicinal products and other forms of
interaction
None known.
4.6 Pregnancy and lactation
Not applicable.
4.7 Effects on ability to drive and use machines
None known.
4.8 Undesirable effects
None known.
4.9 Overdose
Not applicable.
5. Pharmacological properties
5.1 Pharmacodynamic properties
Minims Saline is an isotonic solution of sodium chloride used for
irrigation of the eye. There are no
pharmacodynamic properties of relevance for this product.
5.2 Pharmacokinetic properties
There are no pharmacokinetic properties which are applicable for this
product.
5.3 Preclinical safety data
There are no preclinical data of relevance to the prescriber which are
additional to that already included in
other sections of the SPC.
6. Pharmaceutical particulars
6.1 List of excipients
Purified Water
6.2 Incompatibilities
None known.
6.3 Shelf life
15 months.
6.4 Special precautions for storage
Store below 25°C. Do not freeze. Protect from light.
6.5 Nature and contents of container
A sealed conical shaped container fitted with a twist and pull off cap
overwrapped in an individual
polypropylene/paper pouch. Each Minims unit contains approximately
0.5ml of solution.
6.6 Special precautions for disposal and other handling
Discard each unit after a single use.
7. Marketing authorisation holder
Bausch & Lomb UK Limited Bausch &