Antitoxin botulinum a b e

Package leaflet: Information for the user

Botulinum Antitoxin ABE
500 IU + 500 IU + 100 IU/ml, solution for injection
Immunoserum botulinicum

Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm someone else, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Botulinum Antitoxin ABE is and what it is used for
2. Important information before using Botulinum Antitoxin ABE
3. How to use Botulinum Antitoxin ABE
4. Possible side effects
5. How to store Botulinum Antitoxin ABE
6. Contents of the pack and other information

1. What Botulinum Antitoxin ABE is and what it is used for

Botulinum Antitoxin ABE contains a mixture of specific immunoglobulins G which bind to
botulinum toxins A, B and E, neutralizing their toxic properties.
The product is obtained from serum of horses immunized with the appropriate toxoid and toxin of botulism types A, B or E.
Indications
The medicine is used to neutralize botulinum toxins of types A, B and E in botulism poisoning.

2. Information before using Botulinum Antitoxin ABE

When not to use Botulinum Antitoxin ABE

• if the patient is allergic to the active substance (equine protein) or to any of the other ingredients of this medicine (listed in section 6).

In case of allergy to equine protein, in severe poisoning situations, botulinum antitoxin may be administered by desensitization method or under cover (i.e. after administration) of antianaphylactic agents.
Warnings and precautions
Before deciding to use this medicine, a medical interview should be conducted (if the patient's condition allows) regarding any allergies the patient may have, previous administration of equine antitoxin, and use of antihistamines within the past 48 hours.
Administration of antitoxin should be performed by personnel experienced in managing anaphylactic shock and with immediate access to an emergency anaphylaxis kit.
A skin test must never be performed, nor should the medicine be injected, without an anaphylaxis kit ready for immediate use.
If the patient is allergic to equine protein, has previously received equine antitoxin, or is an allergic individual, Botulinum Antitoxin ABE should be administered by the desensitization method described in section 3.
Botulinum Antitoxin ABE and other medicines
Inform the doctor about all medicines currently or recently taken by the patient, as well as any medicines the patient intends to take.
No studies have been conducted on the interactions of Botulinum Antitoxin ABE with other medicines.
Pregnancy and breastfeeding
There is insufficient data on the use of Botulinum Antitoxin ABE in pregnant and breastfeeding women.
Caution should be exercised when prescribing this medicine to pregnant women and during lactation.
Driving and operating machinery
Botulinum Antitoxin ABE has no influence on the ability to drive or operate machinery.

3. How to use the medicine Botulinum Antitoxin ABE

The decision on using this medicine is made by a physician.
This medicine should always be used according to the physician's instructions. In case of doubt, consult your physician.

Before deciding to use this medicine, a medical history should be taken, including information about any allergies the patient may have, previous administration of equine antitoxin, and use of antihistamines within the last 48 hours.

Before administering this medicine, a hypersensitivity test for equine antitoxin (equine protein) must always be performed.

Taking antihistamines within 48 hours before the hypersensitivity test may suppress the occurrence of an allergic reaction.

A negative result of the hypersensitivity test does not completely guarantee the absence of patient sensitivity to antitoxin; therefore, extreme caution must be exercised during each administration of the medicine, and an anaphylaxis emergency kit must be available.

In cases of positive or uncertain hypersensitivity test results, if there are still medical indications for using the medicine, Botulinum Antitoxin ABE may be administered using a desensitization method.

Route of administration: Intramuscularly or intravenously.

Recommended dose

Prophylactic/preventive use:
The medicine is administered intramuscularly.
Dose: 10 ml to 20 ml (one to two vials).

Therapeutic use:
The medicine is administered intramuscularly, or intravenously in life-saving situations.
Dose: 50 ml to 100 ml (five to ten vials).

Note: Before intravenous administration, the medicine should be warmed to 37°C.

Hypersensitivity test

One of the following hypersensitivity tests should be performed (taking into account the patient's medical history):

• inject 0.2 ml of the medicine intradermally, diluted 1:1,000 in sterile 0.9% sodium chloride solution, or
• inject 0.2 ml of the medicine intradermally, diluted 1:100 in sterile 0.9% sodium chloride solution, or
• inject 0.1 ml of the medicine intradermally, diluted 1:10 in sterile 0.9% sodium chloride solution.

If, after 30 minutes, no local or systemic reaction occurs, inject 0.2 ml of undiluted antitoxin subcutaneously.

If, 30 minutes after subcutaneous injection of undiluted antitoxin, no local or systemic reaction occurs, the antitoxin may be administered intramuscularly or intravenously.

Intramuscular administration:
To ensure slow release of the medicinal product, administer the antitoxin intramuscularly. When administering intramuscularly, it is recommended to inject the antitoxin at different body sites.

Intravenous administration:
To achieve the fastest possible neutralization of botulinum toxins in all tissues and body fluids, slow intravenous infusion of the antitoxin is indicated.

Note: Before intravenous administration, the antitoxin must be warmed to 37°C.

Redness and wheal formation at the injection site within 30 minutes after the hypersensitivity test indicate hypersensitivity to equine protein.

If the test result is positive or uncertain, but administration of botulinum antitoxin is necessary, the medicine should be administered by desensitization.

Desensitization method for administering Botulinum Antitoxin ABE

Desensitization consists of subcutaneous injections of small volumes of the medicine, from 0.1 to 0.5 ml, at intervals of 30–40 minutes. The same doses may need to be repeated due to uncertain reactions.

Method one:
Dilute the antitoxin 1:10 with sterile 0.9% sodium chloride solution and administer subcutaneously every 30 minutes to 1 hour, starting with doses from 0.1 to 0.5 ml. Then administer 0.2 ml and subsequently 0.5 ml of undiluted Botulinum Antitoxin ABE.

The remaining part of the planned dose should be administered intramuscularly. It is recommended to inject the medicine at different body sites.

Method two:
Subcutaneously inject the smallest dose tolerated in the intradermal test.
If no reaction occurs within 30 minutes, increase the dose every 30 minutes until 0.2 ml of undiluted antitoxin has been administered subcutaneously.

The remaining part of the planned dose should be administered intramuscularly. It is recommended to inject the medicine at different body sites.

Use of higher than recommended dose of Botulinum Antitoxin ABE

Administration of higher doses than necessary should be avoided.
Higher doses may intensify the adverse reactions listed in section 4, such as allergic reactions or neurological symptoms.

4. Possible adverse reactions

Like any medicine, this product may cause adverse reactions, although not everyone experiences them.

As with administration of other animal-derived antitoxins, serious allergic reactions such as anaphylactic shock and/or serum sickness may occur, although not very frequently.

Serum sickness typically begins between the 7th and 20th day after administration of the medicine and is manifested by swelling at the injection site, lymph node enlargement, fever, joint swelling, urticaria, and in severe cases, kidney damage.

Very rarely, neurological complications may occur, such as inflammation of the brachial plexus nerves, cranial nerves, and peripheral nerves (i.e. encephalopathy) or Guillain-Barré syndrome (acute idiopathic polyneuritis). Symptoms of the disease resolve after removal of the antigen from the body.

Very rarely, swelling and pain at the injection site may occur.

Reporting of adverse reactions

If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 4921 301
Fax: +48 22 4921 309
e-mail: [email protected]

Reporting adverse reactions enables better collection of information on the safety of this medicinal product.

5. How to store the medicine Antytoksyna botulinowa ABE

Keep the medicine out of the sight and reach of children.
Store in the refrigerator. Do not freeze. Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the packaging after: Expiry date. The expiry date refers to the last day of the stated month.
The medicine should be used immediately after opening.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Antytoksyna botulinowa ABE contains

• The active substances are: botulinum antitoxin type A 500 IU, botulinum antitoxin type B 500 IU, botulinum antitoxin type E 100 IU/ml.
• The other components are: phenol, sodium chloride, water for injections, and small amounts of sodium hydroxide and hydrochloric acid to adjust pH.

What Antytoksyna botulinowa ABE looks like and contents of the pack
A glass vial containing 10 ml of injection solution, in a cardboard box.
The pack contains 1 or 5 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
BIOMED S.A. Institute of Serums and Vaccines
ul. Chełmska 30/34
00-725 Warsaw
tel. 22 841 40 71
(logo)