Summary of Product Characteristics (SmPC) - Minims saline 0.9% w/v eye drops solution
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 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.
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 pre-clinical 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
Discard each unit after a single use.
7 MARKETING AUTHORISATION HOLDER
Bausch & Lomb UK Limited
Bausch & Lomb House
106 London Road
Kingston-Upon-Thames
Surrey, UK
KT2 6TN
8 MARKETING AUTHORISATION NUMBER(S)
PL 03468/0081
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
16/04/2007
10 DATE OF REVISION OF THE TEXT
22/04/2015