Summary of the Product Characteristics

1. Trade Name of the Medicinal Product

Manorapid

2. Qualitative and quantitative composition

100 g contain:

63.14 g Propan-2-ol, 14.3 g Propan-1-ol

For excipients, see section 6.1.

3. Pharmaceutical Form

Cutaneous solution

Clear, colourless solution.

4. Clinical Particulars

4.1 Therapeutic indications

Hygienic and surgical hand disinfection.

4.2 Posology and method of administration

Route of administration:

Cutaneous use

For hygienic hand disinfection a sufficient amount of Manorapid is to be rubbed undiluted in the hands to keep the whole palm wet for 30 seconds, including the problem areas (interdigital area, nail fold). In case of contamination with HBV apply analogously, the hands have to be kept wet for 5 minutes by repeated application.

For surgical hand disinfection Manorapid is to be rubbed undiluted in the hands to keep the whole palm wet for 1,5 minutes including the problem areas (interdigital area, nail fold).

4.3 Contra-indications

• Hypersensitivity to the active substances or to any of the excipients

• Manorapid should not be used on mucous membranes or open wounds

4.4 Special warnings and precautions for use

Only for cutaneous use.

Manorapid must not be swallowed or get into the blood circulation. Manorapid contains alcohols and is inflammable. Prior to use of electrical devices skin areas treated with Manorapid should be rubbed dry.

Lanolin poly(oxyethylen)-75 may cause local skin reactions (e. g. contact dermatitis).

4.5 Interaction with other medicinal products and other forms of interaction

Not known.

4.6 Pregnancy and lactation

Appropriate use of Manorapid has no influence on pregnancy or breast feeding.

4.7 Effects on ability to drive and use machines

Not relevant

4.8 Undesirable effects

Due to the high content of alcohols multiple administration may result in a demoisturizing effect on the skin (peeling, reddening, tension, itching).

Due to the content of fragrances and wool wax (lanolin)contact allergy may occur.

4.9 Overdose

After inadvertent oral uptake of higher amounts of Manorapid (from 0.5 ml/kg bw on) symptoms of intoxication due to the alcohols contained can be expected.

Exerting similar toxic effects, Propan-1-ol is 1.5 to 2 times more toxic than Ethanol. The clinical manifestation of the combined intoxication is supposed to correspond to the manifestation of intoxication with Ethanol alone. Emergency treatment has to be initiated employing the common principles of intoxication treatment (e.g. possibly entire primary elimination of toxins and prevention of further absorption). In contrast to a combined Methanol/Ethanol intoxication, besides symptomatic measures a rapid decrease of the blood level of ethanol needs to be achieved with first priority (e.g. by infusions of Glucose or Levulose, if necessary by dialysis) since high blood levels of ethanol inhibit the enzymatic metabolism of Propanol.

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Other antiseptics and disinfectans

ATC-code: D08AX53

Propan-1-ol and Propan-2-ol are bactericidal and fungicidal within a broad range of concentrations. If used as directed no absorption of Manorapid through the intact skin and therefore no systemic effects due to the two alcohols are expected.

6. Pharmaceutical particulars

Purified water

Parfum Fresh PH 799 982 MF (Haarmann & Reimer)

Butan-1,3-diol

Lanolin poly(oxyethylen)-75.

6.2 Incompatibilities

Not applicable.

6.3 Shelf-life

3 years

Shelf-life after first opening: 6 months

6.4 Special precautions for storage

Do not store above 25 °C.

Danger of explosion in case of extreme heating.

Store in the original package

Keep container tightly closed

6.5 Nature and contents of container

Plastic bottles (PE) with snap-on lid (PP) resp. can (PE) with safety screw cap (PE).

Pack sizes: 150 ml, 500 ml, 1000 ml and 5000 ml.

Please note: Pouring into another sterile container is only allowed under aseptic conditions (sterile bank).

6.6 Instructions for use and handling

Larger quantities of the liquid are not to be disposed with waste water. Employ liquid absorbing material. Do not dispose with the normal waste. Smaller amounts can be diluted with water and disposed with waste water. Do not pour larger quantities into the sink or the W.C., but give these to hazardous waste collecting points.

7. Marketing authorisation holder

Antiseptica

chem. pharm. Produkte GmbH

Carl-Friedrich-Gauß-Str. 7

D – 50259 Pulheim-Brauweiler

Tel.: 0049 / (0) 2234 / 98466 0

Fax: 0049 / (0) 2234 / 98466 11

8. Marketing authorisation number

9. Date of first authorisation / Renewal of authorisation

10. Date of (partial) revision of the text: May 2007

11. Prescription status / Distribution