Description
Packing
1 dose – ampoules (5) complete with horse serum diluted 1: 100 (amp. 1 ml) – packs of cardboard.
Pharmacological action of
Antibodies contained in the preparation neutralize diphtheria exotoxin.
Indications
– diphtheria.
Contraindications
There are no clinical contraindications for the use of anti-diphtheria serum.
Use during pregnancy and lactation
The safety of the use of this medicine during pregnancy and during lactation has not been investigated in a clinical trial.
Special instructions
Precautions for use.
1. Given the possibility of developing anaphylactic shock, each vaccine must be monitored for one hour after administration of serum. Vaccination sites should be provided with anti-shock therapy.
Individuals receiving diphtheria serum, must be warned about the need for immediate medical attention in case of signs characteristic of serum sickness.
2. Before the introduction of the drug, an intradermal test with purified horse serum diluted 1: 100 is required to detect sensitivity to a foreign protein.
3. The drug is not suitable for use in ampoules with impaired integrity or labeling, with a change in physical properties (color, transparency, presence of non-breakable flakes), with an expired Expiration, with improper storage.
Composition
diphtheria antitoxin 10,000 IU
Dosage and administration of
A single dose of serum is: for localized forms of 10000-20000 ME, diphtheria of the larynx 40000-50000 ME, for a subtoxic form of 40000-50000 ME, toxic 1 degree 50 000-70000 ME, toxic 11 degree 60000-80000 ME hemorrhagic 100000-120000 ME.
In the absence of effect, administration of serum can be repeated after 12-24 hours using the same doses.
Serum is administered intramuscularly and subcutaneously. As a rule, the maximum volume of the drug administered in one place should not exceed 10 ml.
Before the first administration of serum, a skin test with horse serum purified diluted 1 is mandatory. 100 (ampoule marked in red) to determine the patient’s sensitivity to horse serum proteins. Purified horse serum diluted 1: 100 is injected in a volume of 0.1 ml intradermally into the flexion surface of the forearm. Accounting for the reaction is carried out after 20 minutes A sample is considered negative if the diameter of the edema and (or) redness appearing at the injection site is less than 1 cm. The sample is considered positive if the swelling and (or) redness reaches 1 cm or more in diameter.
In case of a negative skin test, anti-diphtheria serum (ampoule is marked in blue or black) is injected in a volume of 0.1 ml subcutaneously into the middle third of the shoulder.
In the absence of a local or general reaction, after (45 ± 15) min, the prescribed dose of antidiphtheria serum is administered intramuscularly into the upper third of the anterior-outer thigh or buttock, heated to a temperature of (36 ± 1) ° С. The patient who received the serum should be under the supervision of a doctor for an hour.
In case of a positive intradermal test, serum is administered only for health reasons under the supervision of a physician and with special precautions. First, antidiphtheria serum diluted in doses of 0.5 ml, 2 ml, 5 ml is introduced under the skin (diluted serum is prepared immediately before use, introducing 0.1 ml of antiphtheria serum in 9.9 ml of sterile sodium chloride solution of 0.9%) with an interval of 20 min In the absence of reaction to these doses, 0.1 ml of anti-diphtheria serum is administered subcutaneously. If there is no reaction, after 30 minutes all the prescribed amount of serum is administered intramuscularly. In the case of a positive reaction to one of the above doses, anti-diphtheria serum is not administered or is administered under general anesthesia, having a syringe at the ready with a 0.1% solution of adrenaline hydrochloride or a 0.2% solution of norepinephrine hydrotartrate.
All manipulations are carried out with separate sterile syringes, the opened ampoule is closed with a sterile napkin, stored at a temperature of (20 ± 2) ° С for no more than 1 hour.
An opened ampoule with purified horse serum diluted 1: 100 cannot be stored
Side effects of
Administration of serum can lead to the development of anaphylactic shock and other allergic reactions of the immediate type, as well as a symptom complex of serum sickness (fever, skin rashes, arthralgia) that appear in the early (2-6 days) and long-term (2 week) dates, lasting from several hours to several weeks.
Storage conditions
According to the joint venture 3.3.2.1248-03 at a temperature from 2 0 to 8 0 С out of the reach of children. Freezing is not allowed.
Expiration
2 years.
Conditions of supply of
Pharmacy Prescription
Microgen NGO, Russia
