Antitoksina iadu zhmii

Leaflet attached to the packaging: information for the user

Viper venom antitoxin, 500 LD units, solution for injection

Immunoserum contra venena viperarum europaearum

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 specifically for you. 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 tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Viper venom antitoxin and what is it used for
• 2. Important information before using Viper venom antitoxin
• 3. How to use Viper venom antitoxin
• 4. Possible side effects
• 5. How to store Viper venom antitoxin
• 6. Contents of the packaging and other information

1. What is Viper venom antitoxin and what is it used for

Viper venom antitoxin contains specific horse immunoglobulin G, which, by binding to the venom of the adder ( Vipera berus), neutralizes its toxic properties. This medicine is obtained from the serum of horses immunized with the venom of the adder.
Viper venom antitoxin is used in people bitten by the adder.
The person bitten should be transported to a medical care unit as soon as possible, preferably to a hospital, and should be kept calm and provided with assistance. The medicine should be administered as soon as possible after the bite. Administration of antitoxin against viper venom is most appropriate in cases of severe poisoning.

2. Important information before using Viper venom antitoxin

When not to use Viper venom antitoxin

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 poisoning and the need to administer antitoxin, it can be administered using a desensitization method or under the cover of medications, i.e. after the administration of anti-shock agents, in accordance with the description in section 3.

Warnings and precautions

Before using Viper venom antitoxin, a medical history of allergic conditions in the patient and their previous administration of horse antitoxin, as well as the use of antihistamine medications within 48 hours, should be taken.
Administration of antitoxin should be carried out by personnel with experience in treating anaphylactic shock, with access to an anti-shock kit.
A sensitivity test should never be performed or the medicine administered without an anti-shock kit ready for use.
If the patient is allergic to horse protein or has previously received horse antitoxin, or is an allergy sufferer, Viper venom antitoxin should be administered using a desensitization method, as described in section 3.

Viper venom antitoxin and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
There is insufficient data on the use of Viper venom antitoxin in pregnant and breastfeeding women.
Caution should be exercised when prescribing the medicine to pregnant and breastfeeding women.

Driving and using machines

Viper venom antitoxin has no effect on the ability to drive vehicles and operate machines.

Viper venom antitoxin contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per 1 ml of solution, which means the medicine is considered "sodium-free".

3. How to use Viper venom antitoxin

Viper venom antitoxin should always be used in accordance with the doctor's recommendations.
Before deciding to use the medicine, a medical history of allergic conditions in the patient, their previous administration of horse antitoxin, and the use of antihistamine medications within 48 hours, should be taken.

Before administering antitoxin, a skin sensitivity test for horse antitoxin (horse protein) should always be performed.

Taking antihistamine medications 48 hours before the sensitivity test may inhibit the occurrence of an allergic reaction.
A negative test result does not guarantee that the patient is not sensitive to the antitoxin, therefore, before each administration of the medicine, special caution should be exercised and an anti-shock kit should be available.
In case of a need for rapid administration of Viper venom antitoxin, if there is no time for a sensitivity test, it is recommended to administer the medicine under the cover of medications, i.e. after the administration of anti-shock agents, the decision to proceed with this method is made by the doctor.

Dosage:

Children and adults
The contents of one ampoule should be administered immediately after the bite.
If necessary, the dose can be repeated.
Route of administration: intramuscular.
If possible, Viper venom antitoxin should be administered in the area of the bite.
Sensitivity test (intradermal)
Before performing the intradermal test and before administering the antitoxin, an anti-shock kit should be prepared.
Due to the need for rapid medical intervention within 1 to 2 hours after the bite, the intradermal test should provide a rapid response as to whether the patient is allergic to horse protein.
0.1 ml of antitoxin diluted 1:10 with sterile 0.9% sodium chloride solution should be injected intradermally.
The occurrence of redness and a blister at the injection site within 10 to 20 minutes is evidence of an allergy to horse protein.
In case of no reaction to the sensitivity test, the entire dose, i.e. the contents of one ampoule, can be administered once, intramuscularly.
If, after 1 to 2 hours, there is no observation of the disappearance of clinical symptoms of poisoning, the dose can be repeated (the contents of one ampoule of the medicine).
In case of a positive sensitivity test (the occurrence of a blister and redness at the injection site of the diluted antitoxin) and simultaneous indications for the use of Viper venom antitoxin, it is recommended to administer the medicine using a desensitization method.
Desensitization method of administering horse antitoxin
The antitoxin diluted 1:10 (as in the sensitivity test) with sterile 0.9% sodium chloride solution should be injected subcutaneously every 30 minutes to 1 hour in amounts of 0.1 ml to 0.5 ml.
Then, the undiluted antitoxin should also be injected subcutaneously in amounts of 0.2 ml and 0.5 ml.
The rest of the dose should be administered intramuscularly.
It should also be considered at what time after the bite it is necessary to administer the antitoxin to the patient.
The duration of the desensitization method may have a negative impact on the patient's condition, up to and including a threat to their life, especially in cases of severe poisoning by the viper's venom.
An alternative is to administer the antitoxin under the cover of anti-shock agents.
Depending on the patient's condition, sedatives, anti-anxiety medications, painkillers, and in the case of patients in a severe and very severe condition with pronounced allergic reactions, corticosteroids, antibiotics, non-steroidal anti-inflammatory drugs, and if necessary, parenteral rehydration, are also administered.

Use of a higher dose of Viper venom antitoxin than recommended

The dose size depends on the patient's condition. The decision on its size is made by the doctor.
Higher doses than necessary should be avoided.
Larger doses may cause an exacerbation of the side effects listed in section 4.

Discontinuation of Viper venom antitoxin

In case of any further doubts related to the use of the medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Viper venom antitoxin can cause side effects, although they may not occur in every patient.
The possibility of side effects after the administration of animal antitoxin in cases of viper bites is secondary to saving a life.
The frequency of possible side effects listed below is defined as follows:

• Very common (occurring in 1 or more people out of 10);
• Common (occurring in 1 or more people out of 100 and less than 1 person out of 10);
• Uncommon (occurring in 1 or more people out of 1,000 and less than 1 person out of 100);
• Rare (occurring in 1 or more people out of 10,000 and less than 1 person out of 1,000);
• Very rare (occurring in less than 1 person out of 10,000);
• Frequency not known (frequency cannot be determined based on available data).

General disorders and administration site conditions
Uncommonly, anaphylactic shock (a severe allergic reaction of the entire body) may occur.
Serum sickness may also occur, usually between 7 and 20 days after the administration of Viper venom antitoxin. Uncommonly, the following symptoms of serum sickness may occur: swelling at the injection site, lymph node enlargement, elevated body temperature, joint swelling, and urticaria.
Renal and urinary disorders
Serum sickness may occur, which in rare, severe cases may manifest as kidney damage.
Nervous system disorders
Very rarely, complications in the form of brachial plexus neuritis, cranial nerves, and peripheral nerves (i.e. encephalopathy) or Guillain-Barre syndrome (acute, idiopathic, i.e. spontaneous polyneuritis) may occur. The symptoms of the disease disappear after the removal of the antigen from the body.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor or pharmacist, or nurse.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Viper venom antitoxin

Store in a refrigerator (2°C – 8°C). Do not freeze.
Store in the original packaging to protect from light.
The medicine should be stored in a place that is out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste. 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 Viper venom antitoxin contains

• The active substance of the medicine is antibodies neutralizing the venom of the adder ( Vipera berus). 1 ml contains antibodies neutralizing at least 130 LD units of the venom of the adder ( Vipera berus). 1 ampoule of the medicine contains antibodies neutralizing at least 500 LD units of the venom of the adder ( Vipera berus).
• Excipients: sodium chloride, phenol, water for injections, and sodium hydroxide and hydrochloric acid - in small amounts to adjust the pH.

What Viper venom antitoxin looks like and what the packaging contains

The medicine is a solution for injection, containing antibodies neutralizing at least 500 LD units of the venom of the adder ( Vipera berus), in a glass ampoule type I in a cardboard box - packaging of 1 piece.

Marketing authorization holder and manufacturer

BIO-MED Serum and Vaccine Production Plant Ltd.
Chełmska 30/34 Street
00-725 Warsaw
phone: +48 22 841 40 71
(logo)
Date of last revision of the leaflet:January 2021