Summary of Product Characteristics (SmPC) - Glaxosmithkline Glycine Buffer Diluent
1. NAME OF THE MEDICINAL PRODUCT
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
Not applicable.
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.
7. MARKETING AUTHORISATION HOLDER
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