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GLAXOSMITHKLINE GLYCINE BUFFER DILUENT

Active substance(s): NOT SPECIFIED

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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

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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