Medine.co.uk

Liquid Paraffin Bp

Document: spc-doc_PL 02021-5004R change

SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Light Liquid Paraffin - BP

2.    QUALITATIVE AND QUANTITATIVE COMPOSITION

Light Liquid Paraffin - BP 100%w/w

3.    PHARMACEUTICAL FORM

Liquid

4    CLINICAL PARTICULARS

4.1.    Therapeutic Indications

Not applicable.

4.2.    Posology and Method of Administration

Not applicable.

4.3.    Contra-Indications

Not applicable.

4.4 Special warnings and precautions for use

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

PHARMACEUTICAL PARTICULARS

6


6.1.    List of Excipients

The product is 100% excipients.

6.2.    Incompatibilities

Water, Alcohol’s.

6.3.    Shelf Life

36 months.

6.4.    Special Precautions for Storage

At ambient temperature under dry conditions and away from direct sunlight.

6.5.    Nature and Content of Container

Bulk Tanker approx. 20 tonnes.

205 Litre Metal Containers.

25 Litre Metal Containers 5 Litre Metal Containers

6.6.    Instructions for Use, Handling and Disposal

No special instructions.

7. MARKETING AUTHORISATION HOLDER

Fuchs Lubricants (UK) Plc New Century Street Hanley

Stoke on Trent ST1 5HU

8.    MARKETING AUTHORISATION NUMBER(S)

PL 02021/5004R

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

21 December 1972 / 22 May 1997

10. DATE OF (PARTIAL) REVISION OF THE TEXT

13 February 1996