GLAXOSMITHKLINE GLYCINE BUFFER DILUENT
Active substance(s): NOT SPECIFIED
NAME OF THE MEDICINAL PRODUCT
GlaxoSmithKline Glycine Buffer Diluent
QUALITATIVE AND QUANTITATIVE COMPOSITION
No active ingredient present
Liquid for reconstitution of Flolan
Glaxo Welicome Glycine Buffer Diluent is used to reconstitute Flolan.
Posology and Method of Administration
The reconstitution injection is administered by infusion, either intravascularly or into the
blood supply of the dialyser.
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
Pregnancy and Lactation
Effects on Ability to Drive and Use Machines
Pre-clinical Safety Data
List of Excipients
Sodium Chloride Ph Eur
Sodium Hydroxide BP
Water For Injections Ph Eur
Special Precautions for Storage
Store below 25°C.
Protect from light.
Do not freeze.
Nature and Content of Container
Clear neutral glass vials with a fluororesin faced butyl rubber stopper and aluminium collar.
Pack size: 50ml
Instructions for Use, Handling and Disposal
MARKETING AUTHORISATION HOLDER
GlaxoWellcome UK Ltd
Trading as GlaxoSmithKline UK
Stockley Park West
MARKETING AUTHORISATION NUMBER(S)
DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
18th May 1998
DATE OF (PARTIAL) REVISION OF THE TEXT
Source: Medicines and Healthcare Products Regulatory Agency
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