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SUMMARY OF PRODUCT CHARACTERISTICS B OTTJLISM-ANTITOXIN BEHRIN G

1.    Name of the medicinal product

Botuiism-Antitoxin Behring

2. Qualitative and quantitative composition 1 ml contains:

Equine protein

with antitoxin against Cl. botulinum

Type A Type B Type E

3. Pharmaceutical form

Botuiism-Antitoxin Behring is a clear, colourless to pále yellow solution for infusion.

4.    Clinical particulars

4.1    Therapentic indications

Treatment of botulism

Botuiism-Antitoxin Behring must be given immedialely on suspicion of botulism. Under no circumstances sliould the treatment be delayed by vvaiting for results of lengthy clinical observations or of bacteriological / serological tests.

4.2    Posology and method of administration

4.2.1    Dosage

Adults and children receive the same dose.

Initial dose: 500 ml

First infiuse 250 ml slowly vvhile observing the circulatory effects. Foilow with a continuous drip infusion of a further 250 ml.

Depending on the degree of clinical improvement, a further 250 ml may be advisable 4-6 hours Jater.

Novartis Vaccines and    Botulismus-Antitoxin Behring,

Diagnostics GmbH & Co. KG Revision: 12.09.06 name change

Revision: 30.08.04 Update ofthe dossier Revision: 13.11.2003 / new Suffix „KG“

4.2.2 Method of administration

The antitoxin is to be administered slowly intravenously and preferably at body temperature.

The application of immune sera must be recorded by the physician with batch no. and name of the preparation (trade name) in the International Vaccination Record.

4.3 Contraindications

None (vital indication!)

4.4 Speciál warnings and speciál precautions for use

Precautions:

Before administering Botulism-Antitoxin Behring the patienťs history

should be carefully reviewed whether the patient has been sensitised to

equine protein.

General rules for injections of Heterologous Immune Sera

1.    Administer immune sera only when clearly necessary.

2.    Use only clear and particle free immune sera.

3.    Be prepared to treat shock.

4.    Administration of immune sera to patients with a history of allergic reactions to equine proteine, may only be doně together with a medication for the prevention of shock reactions.

5.    The patient must be monitored closely for signs of the onset of shock and be kept under medical supervision for 2 hours after the administration of the immune sérum.

Novartis Vaccines and    Botulismus-Antitoxin Behring,

Diagnostics GmbH & Co. KG Revision: 12.09.06 name change

Revision: 30.08.04 Update of the dossier Revision: 13.11.2003 / new Suffix „KG“

Management of adverse drug reactions

Clinical manifestation,	Measures
symptoms and signs
Anaphylaxis, anaphylactoid reactions: Onset within minutes to hours after
administration
Symptoms such as urticaria, nausea, *	Immediate intemiption of
headache, bronchospasm, symptoms of	administration of the antigenic
shock may occur	materiál
■	Shock recovery position
M	Administration of oxygen
■	Rapid intravenous volume substitution (CAVE: antigenic plasma expanders!)
■	If necessary, intravenous administration of catecholamines +
	corticosteroids + Hi- + EF-receptor antagonists
■	Monitoring of vital signs (respiraíion, puise, blood pressure)
Pyretic reactions: Onset 1 to 2 hours after start of therapy
Fever, chills, arterial hypertension ■	Monitoring of the circulatory systém
■	Antipyretic treatment, including, if appropriate, physical measures (wet compresses)
m	In čase of severe chills Pethidine may be administered, if necessary
Latě reactions (e.g. sérum sickness): Onset 7 (5 to 24) days after start of therapy
Pruritus, urticaria, fever, arthralgia, “	Determination of clinical status
neurological disorders m	Determination of involvement of organs and any symptoms
K	Administration of corticosteroids, if necessary
m	Check potential indication for plasma separation

Novartis Vaccines and    Botulismus-Antitoxin Behring,

Diagnostics GmbH & Co. KG Revision: 12.09.06 name change

Revision: 30.08.04 Update of the dossier Revision: 13.11.2003 / new Suffix „KG“

4.5 Interactions with other medicaments and other forms of interaction

None known.

4.6    Pregnancy and lactation

Pregnancy or lactation period are no contraindication to the use of Botulism-Antitoxin Behring (vital indication!).

4.7    Effects on ability to drive and use machines

None known

4.8    Undesirable effects

Transient elevations in temperature may occur.

Allergic and anaphylactic reactions occur occasionally and, in very rare cases, may extend as far as a shock.

Immediate measures depend on the nátuře and degree of the clinical symptoms: see “Speciál warnings and speciál precautions for use”

Sérum sickness occurs occasionally. Delayed allergic reactions such as serogenetic polyneuritis rarely occur and usually the prognosis is good.

The application ofheterologous sera involves a risk of allergic sensitisation.

4.9    Overdose

No symptoms of oyerdosage are known

5.    Pharmacological properties

Pharmacodynamic properties

Botulism-Antitoxin Behring is a Fermo-Serum®.

Fermo-Serum® is enzymatically treated (with pepsin) „purifíed“ sérum. This proceduře reduces the risk of sensitisation and allergic reactions are persistently reduced.

The proceduře is based on the fact that antibody molecules are more resistant to pepsin as the remáining sérum proteins. As the latter are readily splitted to peptides and peptones, the antibody globulines (7S) are degraded only about one third of their size (Fc-fragment) to F(ab)2-fragment(5S) and they keep their activity to a large extent.

Botulism-Antitoxin Behring is a clear, colourless to pále yellow solution and is obtained from horses immunised with the toxins of Cl. botulinum Types A, B and E. The antibodies react specifically with the botulism toxins and neutralise them.

Novartis Vaccines and    Botulismus-Antitoxin Behring,

Diagnostics GmbH & Co. KG Revision: 12.09.06 name change

Revision: 30.08.04 Update of the dossier _ Revision: 13.11.2003 / new Suffix „KG“

To verify the clinical diagnosis, the patienťs sérum (collected before the administration of antitoxin), vomit, stool, or stomach contents is tested for toxin in the laboratory animal test. After administering the antitoxin a further sample of the patienťs sérum should be collected and tested for toxin by the same method in order to ensure that all the toxin has been neutralised.

In infant botulism antitoxin is not ušed.

Pharmacokinetic properties

When administered intravenously, the antibodies také immmediate effect.

6.    Pharmaceutical particulars

6.1    List of excipients

Sodium chloride, water for injections.

In traces: Phenol

6.2    Incompatibilities

Botulism-Antitoxin Behring must not be mixed with other drugs in a single syringe.

6.3    Shelflife

The shelflife of Botulism-Antitoxin Behring is 48 months.

This preparation should not be ušed after the expiry dáte printed on the package and Container.

Once the bottle has been opened, its contents is to be ušed immediately.

6.4    Speciál precautions for storage

Botulism-Antitoxin Behring should be stored at +2 to +8°C.

6.5    Nátuře and contents of Container

250 ml infusion bottle

6.6    Instructions for use/handling

Dispose any unused solution appropiately.

Novartis Vaccines and    Botulismus-Antitoxin Behring,

Diagnostics GmbH & Co. KG Revision: 12.09.06 name change

Revision: 30.08.04 Update of the dossier Revision: 1.3.11.2003 / new Suffix „KG“

7.    Marketing authoršsation holder

Novartis Vaccines and Diagnostics GmbH & Co. KG PO Box 1630 D-35006 Marburg Germany

8.    Marketing authorisation number

9.    Dáte of first authorisation/renewal of the authorisation

10. Dáte of (partial) revision of the text.

September 2006

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Letzte Bearbeitung: 12.09.06

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