Serum diphtheria horse purified concentrated (Solution) Instructions for Use

Marketing Authorization Holder

Microgen NPO, JSC (Russia)

ATC Code

J06AA01 (Diphtheria antitoxin)

Dosage Form

Serum diphtheria horse purified concentrated

Solution for intramuscular and subcutaneous administration 10 thousand IU/1 dose: amp. 5 pcs. in a kit with diluted horse serum 1:100 (amp. 1 ml)

Dosage Form, Packaging, and Composition

1 dose – ampoules (5) in a kit with diluted horse serum 1:100 (amp. 1 ml) – carton packs.

Clinical-Pharmacological Group

Immunological preparation. Serum

Pharmacotherapeutic Group

MIBP-serum

Pharmacological Action

The antibodies contained in the preparation neutralize the diphtheria exotoxin.

Indications

• Diphtheria.

ICD codes

Dosage Regimen

A single dose of the serum is: for localized forms 10,000-20,000 IU, for laryngeal diphtheria 40,000-50,000 IU, for subtoxic form 40,000-50,000 IU, for toxic grade I 50,000-70,000 IU, for toxic grade II 60,000-80,000 IU, for hemorrhagic form 100,000-120,000 IU.

If there is no effect, the serum administration can be repeated after 12-24 hours using the same doses.

The serum is administered intramuscularly and subcutaneously. As a rule, the maximum volume of the preparation administered at one site should not exceed 10 ml.

Before the first administration of the serum, a skin test with purified diluted horse serum 1:100 (ampoule marked in red) is mandatory to determine the patient’s sensitivity to horse serum proteins. Purified diluted horse serum 1:100 is administered in a volume of 0.1 ml intradermally into the flexor surface of the forearm. The reaction is assessed after 20 minutes. The test is considered negative if the diameter of the swelling and/or redness appearing at the injection site is less than 1 cm. The test is considered positive if the swelling and/or redness reaches a diameter of 1 cm or more.

With a negative skin test, the antidiphtheria serum (ampoule marked in blue or black) is administered in a volume of 0.1 ml subcutaneously in the area of the middle third of the upper arm.

In the absence of a local or general reaction after (45±15) minutes, the prescribed dose of antidiphtheria serum, warmed to a temperature of (36±1)°C, is administered intramuscularly into the area of the upper third of the anterolateral surface of the thigh or the buttock. The patient who received the serum must be under medical supervision for one hour.

With a positive intradermal test, the serum is administered only for vital indications under medical supervision and with special precautions. First, diluted antidiphtheria serum is administered subcutaneously in doses of 0.5 ml, 2 ml, 5 ml (the diluted serum is prepared immediately before use by adding 0.1 ml of antidiphtheria serum to 9.9 ml of sterile 0.9% sodium chloride solution) at 20-minute intervals. If there is no reaction to these doses, 0.1 ml of antidiphtheria serum is administered subcutaneously. If there is no reaction after 30 minutes, the entire prescribed amount of serum is administered intramuscularly. In case of a positive reaction to one of the aforementioned doses, the antidiphtheria serum is not administered or is administered under anesthesia, with a syringe ready containing a 0.1% solution of epinephrine hydrochloride or a 0.2% solution of norepinephrine bitartrate.

All manipulations are performed with separate sterile syringes; the opened ampoule is covered with a sterile napkin and stored at a temperature of (20±2)°C for no more than 1 hour.

An opened ampoule with purified diluted horse serum 1:100 is not subject to storage.

Adverse Reactions

Administration of the serum may lead to the development of anaphylactic shock and other immediate-type allergic reactions, as well as the symptom complex of serum sickness (fever, skin rashes, arthralgias), appearing early (on days 2-6) and delayed (on week 2), lasting from several hours to several weeks.

Contraindications

There are no clinical contraindications for the use of antidiphtheria serum.

Use in Pregnancy and Lactation

The safety of this medical preparation during pregnancy and breastfeeding has not been studied in clinical trials.

Special Precautions

Precautions for use.

1. Considering the possibility of anaphylactic shock development, medical supervision must be ensured for each vaccinated person for one hour after the serum administration. Vaccination sites must be equipped with anti-shock therapy means.

Persons who have received antidiphtheria serum must be warned about the need to immediately seek medical help if signs characteristic of serum sickness appear.

2. Before administration of the preparation, an intradermal test with purified diluted horse serum 1:100 is mandatory to detect sensitivity to foreign protein.

3. The preparation is not suitable for use if the ampoules have damaged integrity or labeling, if physical properties have changed (color, transparency, presence of non-dispersible flakes), if the expiration date has passed, or if stored improperly.

Information on the possible effect of the medicinal product on the ability to drive vehicles and operate machinery.

None.

Overdose

Not established.

Drug Interactions

Not established.

Storage Conditions

In accordance with SP 3.3.2.1248-03 at a temperature from 2°C (35.6°F) to 8°C (46.4°F) in a place inaccessible to children. Freezing is not allowed.

Shelf Life

Shelf life – 2 years.

Dispensing Status

For medical and preventive institutions.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.