Allergen brucellous (brucellin)

General characteristics. Structure:

Active ingredient: from 3,8 to 5,4 mkg of a polisakharidno-proteinaceous complex, Brucella abortus 19-BA received from a vaccinal strain in 1 intradermal dose.

Excipients: 0,9% sodium chloride solution.

Pharmacological properties:

Pharmacodynamics. Intradermal administration of allergen causes development of local reaction (hypostasis, a hyperemia, morbidity) in the patient with a brucellosis. At healthy faces local reaction to administration of allergen during 24-48 h has to be absent.

Indications to use:

— specific diagnosis of hypersensitivity to brucellas.

Route of administration and doses:

The allergy test is put on an internal surface of an average third of a forearm. On site administrations of allergen process previously leather 70% alcohol.

Ampoule contents in number of 0.1 ml (1 dose) are gathered the syringe with a fine needle and entered strictly boiled and smoked so that on site introductions the small papule with a diameter of 3-5 mm was formed.

Allergen which integrity of packaging is damaged, with the changed physical properties (foreign impurity, I do not dissolve Russian cabbage soup еся flakes), expired is not subject to use, at disturbance of the mode of storage.

Opening of ampoules and the procedure of administration of drug are carried out at strict observance of rules of an asepsis and antiseptics. The opened ampoule with allergen kept with observance of rules of an asepsis can be used during 2 h.

Administration of brucellous allergen is registered in the established registration forms with the indication of the name of drug, date of statement, a dose, the name of the manufacturing enterprise of drug, number of a series, reaction to introduction.

The accounting of reaction is carried out in 24-48 h after administration of allergen by survey and palpation of skin. In certain cases allergic reaction becomes positive to 72 h.

At positive reaction on site of administration of allergen reddish or pale painful puffiness of the extended or oval form appears. Hypostasis can be good контурирован with a clear eminence over the level of normal skin. At poorly expressed reaction hypostasis is distinguished only at palpation (to compare to the similar site of skin on other hand). The dermahemia in the absence of hypostasis is taken for a negative take. At the accounting of reaction the hypostasis size in centimeters (length and width), morbidity degree in 24 and 48 hours is noted. At a negative take it is necessary to consider reaction and in 72 h.

Existence of the expressed cutaneous dropsy on site of administration of allergen is considered positive allergic reaction. Lack of morbidity and a hyperemia in the presence of hypostasis does not exclude positive assessment of test.

The reaction which appeared and disappeared before six hours after administration of allergen is considered nonspecific.

Reaction assessment:

— poorly positive - hypostasis ие more than 2 cm in the diameter is poorly expressed;

— positive - hypostasis from 2 to 6 cm in size in the diameter;

— sharply positive - the hypostasis over 6 cm which sometimes is followed by lymphadenitis and the general reaction of an organism.

Features of use:

Use at pregnancy and feeding by a breast. Data on safety of use at pregnancy and during breastfeeding are absent.

Special instructions. For the purpose of identification of contraindications the doctor (or the paramedic) in day of statement of test performs inspection and the patient's poll with obligatory thermometry.

Considering a possibility of development of an acute anaphylaxis in separate highly sensitive lindens, inspected has to be under medical observation not less than 30 min. Venues of an intracutaneous test have to be provided with means of antishock therapy.

Maintaining allergen and reception of patients in one room is not allowed.

Claims for quality of drug, and it is also necessary to send information on cases of the increased reactogenicity or development of complications to Federal Service on Surveillance in Healthcare and Social Development (Roszdravnadzor) and to the manufacturing enterprise with the indication of number of a series of drug and a period of validity with the subsequent submission of medical documentation.

Influence on ability to driving of motor transport and to control of mechanisms. Data are absent.

Side effects:

After statement of an allergy test in 20-30 min. on site administrations of allergen can arise allergic reactions of immediate type in the form of hypostasis (infiltrate), a hyperemia and a dermatalgia.

At persons, highly sensibilized to brucellous antigen, development of the general reaction (temperature increase, a headache, a fever, an indisposition), sometimes lymphadenitis, joint pains, morbidity on site administrations of allergen, temperature increase is possible (to 38 °C).

Interaction with other medicines:

It is strictly forbidden to carry out statement of an allergy test along with introduction of vaccines.

Contraindications:

— hypersensitivity to brucellous antigen;

— existence of contraindications to introduction of a vaccine brucellous live dry;

— existence of a hyperthermia.

Overdose:

Symptoms of overdose, measure for assistance at overdose are not established.

Storage conditions:

To store and transport according to the joint venture 3.3.2.1248-03 at a temperature from 2 to 8 °C in the place, unavailable to children. A period of validity - 2 years. Drug is not subject to expired use.

Issue conditions:

According to the recipe

Packaging:

Ampoules on 1 ml, on 10 ampoules in cardboard packs.