Medine.co.uk

Out of date information, search another

Magnesium Sulphate Paste B.P.

Out of date information, search another
Informations for option: Magnesium Sulphate Paste B.P., show other option

SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Magnesium Sulphate Paste BP.

2.    Qualitative and Quantitative Composition

Name of ingredient_Quantity

Dried Magnesium Sulphate (78.8 - 85.8%) 47.762g Phenol    0.497g

Phenol is of BP quality.

3.    Pharmaceutical Form

Paste.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

As an adjunct to the management of superficial skin infections, including boils.

4.2. Posology and Method of Administration

Method of Administration External application to the affected area.

Posology

Adults, elderly and children


External paste applied directly.

There is no difference in the quantity required for affected areas or for children, adults or the elderly.

Contra-indications

4.3.


None known.

4.4.    Special Warnings and Precautions for Use

Do not use repeatedly.

Use as directed on medical advice.

4.5.    Interactions with other Medicaments and other forms of Interaction

No significant clinical interactions known.

4.6.    Pregnancy and Lactation

As with all medicines it may be used during this period if the benefits outweigh the risks.

4.7.    Effects on Ability to Drive and Use Machines

Not applicable.

4.8.    Undesirable Effects

None known.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9.    Overdose

Should accidental ingestion occur, treat symptomatically.

PHARMACOLOGICAL PROPERTIES

5


5.1    Pharmacodynamic properties

Topical application of the ingredients of the paste help to draw infected wounds and reduce inflammation.

5.2.    Pharmacokinetic Properties

Not applicable.

5.3.    Preclinical Safety Data

Not applicable.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Name of ingredient    Quantity

Glycerol    51 .7g

6.2.    Incompatibilities

None known.

6.3.    Shelf Life

3 years.

6.4. Special Precautions for Storage

Store below 25°C.

6.5.    Nature and Contents of Container

Polypropylene tub and lid with tie sealed tamper evident top containing 25g or 50g.

HDPE tub and lid with tie sealed tamper evident top containing 25g or 50g.

6.6.    Instruction for Use/Handling

Stir well before use and apply liberally to the affected area.

Cover with a dressing.

Administrative Data

7. Marketing Authorisation Holder

KL Pharmaceutical Limited

21 Macadam Place

South Newmoor Industrial Estate

Irvine

Ayrshire

KA11 4HP

8. Marketing Authorisation Number

PL 03436/0002

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION 29/05/2008

10 DATE OF REVISION OF THE TEXT

23/03/2007