Antitoksina botulinova A B E

Leaflet included in the packaging: information for the user

Botulinum antitoxin ABE

500 IU + 500 IU + 100 IU/ml, solution for injection
Immunoserum botulinicum
You should carefully read the contents of the leaflet before using the medicine, as it contains
important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you for a specific reason. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Botulinum antitoxin ABE and what is it 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 packaging and other information

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

Botulinum antitoxin ABE contains a mixture of specific immunoglobulin G, which binds to and neutralizes the toxic properties of botulinum toxins A, B, and E.
The medicine is obtained from the serum of horses immunized with toxoid and botulinum toxin type A, B, or E.

Indications

The medicine is used to neutralize botulinum toxin or botulinum toxins type A, B, and E in botulism poisoning.

2. Important information before using Botulinum antitoxin ABE

When not to use Botulinum antitoxin ABE

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

In case of allergy to horse protein, in situations of severe botulism poisoning, botulinum antitoxin can be administered using a desensitization method or under the cover of anti-anaphylactic agents.

Warnings and precautions

Before deciding to use this medicine, a medical history should be taken (if the patient's condition allows) regarding allergies in the patient and previous administration of horse antitoxin, as well as the use of antihistamines within 48 hours.
Administration of antitoxin should be carried out by personnel experienced in working with anaphylactic shock and with access to an anti-anaphylactic kit.
A skin test should never be performed or the medicine injected without a ready-to-use anti-anaphylactic kit.
If the patient is allergic to horse protein or has previously received horse antitoxin, or is an allergist, Botulinum antitoxin ABE should be administered using a desensitization method described in section 3.

Botulinum antitoxin ABE and other medicines

The patient should inform their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan 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.
Cautious use of the medicine is recommended in pregnant and breastfeeding women.

Driving and using machines

Botulinum antitoxin ABE does not affect the ability to drive and use machines.

3. How to use Botulinum antitoxin ABE

The decision to use the medicine is made by a doctor.
This medicine should always be used in accordance with the doctor's recommendations. In case of doubts, the patient should consult their doctor.
Before deciding to use this medicine, a medical history should be taken regarding allergies in the patient and previous administration of horse antitoxin, as well as the use of antihistamines within 48 hours.

Before using this medicine, a sensitivity test to horse antitoxin (horse protein) should always be performed.

Taking antihistamines 48 hours before the sensitivity test may inhibit the occurrence of an allergic reaction.
A negative result of the sensitivity test does not guarantee that the patient is not sensitive to the antitoxin; therefore, when administering the medicine, special caution should be exercised, and an anti-anaphylactic kit should be available.
If the patient is allergic to horse protein or has previously received horse antitoxin, or is an allergist, Botulinum antitoxin ABE should be administered using a desensitization method described in section 3.
Route of administration: intramuscularly or intravenously.
Recommended dose
Prophylactically/preventively:
The medicine is administered intramuscularly.
Dose: 10 ml to 20 ml (one to two vials).
Therapeutically:
The medicine is administered intramuscularly, and in life-saving situations, intravenously.
Dose: 50 ml to 100 ml (five to ten vials).
Note: Before administering the medicine intravenously, it should be warmed to a temperature of 37°C.
Sensitivity test
One of the following sensitivity tests should be performed (taking into account the medical history):

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

If after 30 minutes of intradermal administration, no local or general reaction is observed, then 0.2 ml of undiluted antitoxin should be injected subcutaneously.
If after 30 minutes of subcutaneous injection of undiluted antitoxin, no local or general reaction occurs, then the antitoxin can be administered intramuscularly or intravenously.
Intramuscular administration:
To ensure slow release of the medicinal product, the antitoxin should be administered intramuscularly. When administering intramuscularly, it is recommended to inject the medicine into different parts of the body.
Intravenous administration:
To ensure the fastest possible neutralization of botulinum toxins in all tissues and body fluids, slow intravenous infusion of antitoxin is recommended.
Note: Before administering the antitoxin intravenously, it should be warmed to a temperature of 37°C.
The occurrence of redness and swelling at the injection site within 30 minutes of the sensitivity test indicates an allergy to horse protein.
If the result is positive or uncertain, and the administration of botulinum antitoxin is necessary, it should be administered using a desensitization method.
Desensitization method of administering Botulinum antitoxin ABE
Desensitization involves injecting small amounts of the medicine, from 0.1 to 0.5 ml, subcutaneously, at intervals of 30-40 minutes. It is often necessary to repeat the same doses due to uncertain reactions.
Method one:
The antitoxin diluted 1:10 with sterile 0.9% sodium chloride solution should be injected subcutaneously, at intervals of 30 minutes to 1 hour, from 0.1 to 0.5 ml, and then undiluted Botulinum antitoxin ABE, 0.2 ml and 0.5 ml.
The remaining planned dose should be administered intramuscularly. It is recommended to inject the medicine into different parts of the body.
Method two:
The smallest tolerated dose in the intradermal test should be injected subcutaneously.
If within 30 minutes, no reaction occurs, the dose should be increased every 30 minutes until 0.2 ml of undiluted antitoxin is injected subcutaneously.
The remaining planned dose should be administered intramuscularly. It is recommended to inject the medicine into different parts of the body.

Using a higher dose of Botulinum antitoxin ABE than recommended

A higher dose than necessary should be avoided.
A higher dose may cause exacerbation of side effects listed in section 4, such as allergic reactions or neurological symptoms.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Similarly, after the administration of other animal-derived antitoxins, not very common severe general reactions of an allergic nature, such as anaphylactic shock and/or serum sickness, are observed.
Serum sickness begins between 7 and 20 days after administration of the medicine and is characterized by swelling at the injection site, enlarged lymph nodes, elevated body temperature, joint swelling, urticaria, and in severe cases, kidney damage.
Very rarely, neurological complications may occur, such as brachial plexus neuritis, cranial nerve neuritis, and peripheral nerve neuritis (i.e., encephalopathy) or Guillain-Barré syndrome (acute idiopathic polyneuritis). The symptoms of the disease disappear after the removal of the antigen from the body.
Very rarely, swelling and pain may occur at the injection site.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: ndl@urpl.gov.pl
Thanks to the reporting of side effects, more information can be collected on the safety of the use of the medicine.

5. How to store Botulinum antitoxin ABE

The medicine should be stored out of sight and reach of children.
Store in a 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 is the last day of the given month.
The medicine should be used immediately after opening.
Medicines should not be disposed of via wastewater or household waste containers. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Botulinum antitoxin ABE contains

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

What Botulinum antitoxin ABE looks like and what the packaging contains

A glass vial containing 10 ml of solution for injection, in a cardboard box.
The packaging contains 1 or 5 vials.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Biomed S.A.
Chełmska 30/34
00-725 Warsaw
phone: 22 841 40 71
(logo)

Date of last revision of the leaflet: