Minims Saline 0.9% w/v Eye Drops, Solution

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

Sodium chloride

Commercializzato da:

Bausch + Lomb Ireland Limited

Codice ATC:

S01AX; S01AX03

INN (Nome Internazionale):

Sodium chloride

Forma farmaceutica:

Eye drops, solution

Area terapeutica:

Other antiinfectives; zinc compounds

Stato dell'autorizzazione:

Marketed

Data dell'autorizzazione:

1983-04-01

Foglio illustrativo

Bausch & Lomb
MINIMS® SALINE 0.9% W/V
EYE DROPS, SOLUTION
SODIUM CHLORIDE
Read all this leaflet carefully before you start using your medicine.
It contains a summary of the
information available on your medicine. If you have any questions or
are not sure about anything, ask
your doctor or pharmacist. Remember this medicine is for you. Do not
give it to someone else.
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
necessary. Once opened, use immediately. Discard any unused portion.
DOSAGE
The amount of solution used should be enough to irrigate the eye
properly.
METHOD OF ADMINISTRATION
If you are putting the eye drops in yourself, then follow these
instructions carefully:
1.
Wash your hands.
2.
Use a mirror, this will help you to see what you are doing.
3.
Twist off the cap from the Minims body of the unit.
4.
Pull your lower eyelid down gently, and then gently squeeze until some
liquid falls inside your
lower eyelid. Make sure the dropper does not touch any parts of your
eye.
5.
Close the eyelids.
6.
Repeat steps 4 and 5 for the other eye if necessary, then throw

Scheda tecnica

Health Products Regulatory Authority
03 June 2022
CRN00CTZ8
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Minims Saline 0.9% w/v Eye Drops, Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium Chloride 0.9% w/v.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Eye drops, solution
Single use, clear, colourless, sterile eye drops, solution
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
INTERACTIONS
None known.
4.6 FERTILITY, 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.
Health Products Regulatory Authority
03 June 2022
CRN00CTZ8
Page 2 of 3
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
Not applicable.
6.3 SHELF LIFE
15 months
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Store below 25°C. Do not freeze. Store in the original container to
protect from light.
6.5 NATURE AND CONTENTS OF CONTAINER
A sealed conical shaped container fitted with a twist and pull off cap
made from Ph. Eur. grade polypropylene for containers
and closures for parenteral and opthalmic preparations. Each Minims
unit contains