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Bausch & Lomb U.K Limited
Bausch & Lomb House, 106 London Road, Kingston-upon-Thames, Surrey, KT2 6TN, UK Telephone: +44 (0) 1748 82 8864 Need to contact this company?

Summary of Product Characteristics last updated on the eMC: 15/09/2003

SPC	Minims Saline

Table of Contents

1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT

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1. NAME OF THE MEDICINAL PRODUCT

Minims Saline (Astromins, Ultra Saline Minims).

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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

A clear, colourless liquid containing Sodium Chloride PhEur 0.9% w/v.

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3. PHARMACEUTICAL FORM

Single-use, sterile eye drops.

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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

As a topical ocular irrigating solution.

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4.2 Posology and method of administration

Adults (including the elderly) and Children:

Adequate solution should be used to irrigate the eye.

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4.3 Contraindications

None.

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4.4 Special warnings and precautions for use

None.

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4.5 Interaction with other medicinal products and other forms of interaction

None known.

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4.6 Pregnancy and lactation

Not applicable.

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4.7 Effects on ability to drive and use machines

None known.

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4.8 Undesirable effects

None known.

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4.9 Overdose

Not applicable.

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5. PHARMACOLOGICAL PROPERTIES

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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.

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5.2 Pharmacokinetic properties

There are no pharmacokinetic properties which are applicable for this product.

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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.

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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

Purified Water

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6.2 Incompatibilities

None known.

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6.3 Shelf life

15 months.

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6.4 Special precautions for storage

Store below 25°C. Do not freeze. Protect from light.

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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.

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6.6 Special precautions for disposal and other handling

Discard each unit after a single use.

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7. MARKETING AUTHORISATION HOLDER

Chauvin Pharmaceuticals Ltd

106 London Road

Kingston-upon-Thames

Surrey

KT2 6TN

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8. MARKETING AUTHORISATION NUMBER(S)