1.

GlaxoSmithKline Glycine Buffer Diluent

2.    QUALITATIVE AND QUANTITATIVE COMPOSITION

No active ingredient present

3.    PHARMACEUTICAL FORM

Liquid for reconstitution of Flolan

4.    CLINICAL PARTICULARS

4.1.    Therapeutic Indications

Glaxo Welicome Glycine Buffer Diluent is used to reconstitute Flolan.

4.2.    Posology and Method of Administration

The reconstitution injection is administered by infusion, either intravascularly or into the blood supply of the dialyser.

4.3.    Contra-Indications

Not applicable

4.4.    Special Warnings and Special Precautions for Use

The label for this product will contain the following statements:

Keep out of reach of children Store below 25°C Do not freeze Protect from light

Use the content of this vial to reconstitute one vial of Flolan.

Use once only, then discard any unused solution.

No Data Held

4.5.    Interactions with other Medicinal Products and other Forms of Interaction

Not applicable.

4.6.    Pregnancy and Lactation

Not applicable.

4.7.    Effects on Ability to Drive and Use Machines

Not applicable.

4.8.    Undesirable Effects

Not applicable.

4.9.    Overdose

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

5.1.    Pharmacodynamic Properties

Not applicable.

5.2.    Pharmacokinetic Properties

Not applicable.

5.3.    Pre-clinical Safety Data

6. PHARMACEUTICAL PARTICULARS

6.1.    List of Excipients

Glycine BP

Sodium Chloride Ph Eur Sodium Hydroxide BP Water For Injections Ph Eur

6.2.    Incompatibilities

None known.

6.3.    Shelf Life

36 months.

6.4.    Special Precautions for Storage

Store below 25°C.

Protect from light.

Do not freeze.

6.5.    Nature and Content of Container

Clear neutral glass vials with a fluororesin faced butyl rubber stopper and aluminium collar. Pack size: 50ml

6.6.    Instructions for Use, Handling and Disposal

Not applicable.

GlaxoWellcome UK Ltd Trading as GlaxoSmithKline UK Stockley Park West Uxbridge UB11 1BT

8.    MARKETING AUTHORISATION NUMBER(S)

PL 10949/0311

9.    DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION

18th May 1998

10.    DATE OF (PARTIAL) REVISION OF THE TEXT

Sept 2003