Derbac M Liquid

1. Name Of The Medicinal Product

Derbac M Liquid

2. Qualitative And Quantitative Composition

Malathion 0.5% w/w

For excipients, see 6.1.

3. Pharmaceutical Form

Liquid emulsion.

4. Clinical Particulars

4.1 Therapeutic Indications

For the eradication of head lice, pubic lice and their eggs. Treatment of scabies.

4.2 Posology And Method Of Administration

For topical external use only.

Adults, the elderly and children aged 6 months and over:

As this product does not contain alcohol, it may be more suitable for those with asthma or eczema.

1. Treatment of head lice:

Rub the liquid into the scalp until all the hair and scalp is thoroughly moistened. Leave the hair to dry naturally in a warm but well ventilated room. After 12 hours, or the next day if preferred, shampoo the hair in the normal way.

Rinse the hair and comb whilst wet to remove the dead lice and eggs (nits) using the Derbac Nit Comb.

Treatment should be repeated after 7 days.

2. Treatment of crab (pubic) lice:

Apply Derbac M Liquid to the entire skin surface. Pay particular attention to all hairy areas including beards and moustaches.

Avoid any other areas above the neck. Leave on for at least one hour before washing but preferably Derbac M Liquid should be left on overnight. Wash off in the usual manner.

Treatment should be repeated after 7 days.

3. Treatment of scabies:

Apply Derbac M Liquid to the entire skin surface. In adults it may not be necessary to apply above the neck but children under the age of two years should have a thin film of Derbac M Liquid applied to the scalp, face and ears, avoiding the eyes and mouth.

Do not wash off or bathe for 24 hours. If hands or any other parts must be washed during this period, the treatment must be reapplied to those areas immediately.

Treatment should be repeated after 7 days.

No special sterilisation of clothing is necessary: ordinary laundering or dry cleaning with hot iron pressing are sufficient.

The infestation is cleared by the treatment. However, the itching and rash may persist for up to 7 days. An anti-irritant cream can be applied if necessary.

Family members and close contacts should also be treated simultaneously.

Children aged 6 months and under:

Under medical supervision only.

4.3 Contraindications

Known sensitivity to malathion. Not to be used on infants less than 6 months except on medical advice.

4.4 Special Warnings And Precautions For Use

Avoid contact with the eyes. For external use only. Keep out of the reach of children. If inadvertently swallowed, a doctor or casualty department should be contacted at once.

When Derbac M Liquid is used by a school nurse or other health officer in the mass treatment of large numbers of children, it is advisable that protective plastic or rubber gloves be worn.

Continued prolonged treatment with this product should be avoided. It should be used not more than once a week and for not more than 3 consecutive weeks.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None stated.

4.6 Pregnancy And Lactation

No known effects in pregnancy and lactation. However, as with all medicines, use with caution.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

Skin irritation and hypersensitivity reactions such as anaphylaxis, angioedema, and swollen eyes have been reported with malathion products. Chemical burns have also been reported.

4.9 Overdose

It is most unlikely that a toxic dose of malathion will be ingested. Treatment consists of gastric lavage, assisted respiration and, if necessary in the event of massive ingestion, administration of atropine together with pralidoxime.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Malathion, ATC code: P03AX03

Derbac M Liquid contains malathion, a widely used organophosphorus insecticide which is active by cholinesterase inhibition. It is effective against a wide range of insects, but is one of the least toxic organophosphorus insecticides since it is rapidly detoxified by plasma carboxylesterases.

5.2 Pharmacokinetic Properties

None stated. Derbac M Liquid is applied topically to the affected area.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Methyl hydroxybenzoate

Propyl hydroxybenzoate

Lanette Wax SX

Potassium citrate

Citric acid

Perfume HT 52

Water

6.2 Incompatibilities

None stated

6.3 Shelf Life

Two and a half years unopened

6.4 Special Precautions For Storage

Store at or below 25^oC. Protect from light.

6.5 Nature And Contents Of Container

Cartoned, clear or amber glass bottles with polyethylene caps and polypropylene faced wads containing either 50, 2 x 50, 55, 100, 200 or 210 ml of product.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

None stated.

7. Marketing Authorisation Holder

Seton Products Limited, Tubiton House, Oldham, OL1 3HS.

8. Marketing Authorisation Number(S)

PL 11314/0046.

9. Date Of First Authorisation/Renewal Of The Authorisation

13/10/95 / 11/09/00

10. Date Of Revision Of The Text

February 2008