Minims Saline 0.9% w/v Eye Drops, Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Sodium chloride

Available from:

Bausch Health Ireland Limited

ATC code:

S01AX; S01AX03

INN (International Name):

Sodium chloride

Dosage:

0.9 percent weight/volume

Pharmaceutical form:

Eye drops, solution

Therapeutic area:

Other antiinfectives; zinc compounds

Authorization status:

Marketed

Authorization date:

1983-04-01

Summary of Product characteristics

Health Products Regulatory Authority
10 May 2019
CRN008VQ1
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.
Health Products Regulatory Authority
10 May 2019
CRN008VQ1
Page 2 of 3
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
Not applicable.
6.3 SHELF LIFE
15 months
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Store below 25
o
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 a