Serum the antidiphtherial horse cleared concentrated

General characteristics. Structure:

Active ingredient: not less than 1500 international anti-toxic activity units (ME) in 1 ml of serum.

Pharmacological properties:

Pharmacodynamics. The antibodies which are contained in drug neutralize diphtheritic exotoxin.

Indications to use:

Treatment of patients with diphtheria.

Route of administration and doses:

The single dose of serum makes: at the localized forms 10000 – 20000 ME, diphtherias of a throat of 40000 - 50000 ME, at a subtoxic form 40000 – 50000 ME, toxic Istepeni of 50000 - 70000 ME, toxic II degree of 60000 - 80000 ME, hemorrhagic 100000 – 120000 ME.

In the absence of effect administration of serum can be repeated in 12-24 h with use of the same doses. Serum is entered intramusculary and subcutaneously. As a rule, the maximum volume of drug entered into one place should not exceed 10 ml.

Before the first administration of serum without fail put skin test with serum horse cleared divorced 1:100 (the ampoule is marked in red color) for definition of sensitivity of the patient to proteins of serum of a horse. Serum horse cleared divorced 1:100 is entered of 0,1 ml vnutrikozhno into the flexion surface of a forearm. The accounting of reaction is carried out in 20 min. Test is considered negative if diameter of the hypostasis and (or) reddening appearing on site introductions is less than 1 cm. Test is considered positive if hypostasis and (or) reddening have a diameter of 1 cm and more.

At negative skin test serum antidiphtherial (the ampoule is marked in blue or black color) is entered of 0,1 ml subcutaneously into the area of an average third of a shoulder.

In the absence of local or general reaction in (45±15) min. enter intramusculary into the area of an upper third of a front-outside surface of a hip or a buttock the appointed dose of serum antidiphtherial, warmed up up to the temperature (36±1) of °C. The patient who received serum has to be under observation of the doctor within an hour.

At a positive intracutaneous test serum is entered only according to vital indications under observation of the doctor and with special precautions. In the beginning enter under skin serum antidiphtherial divorced in doses of 0,5 ml, 2 ml, 5 ml (divorced serum is prepared just before use, bringing 0,1 ml of serum antidiphtherial in 9,9 ml of sterile sodium of chloride of solution of 0,9%) with an interval of 20 min. In the absence of reaction to these doses enter subcutaneously 0,1 ml of serum antidiphtherial. In the absence of reaction in 30 min. enter all appointed amount of serum intramusculary. In case of positive reaction to one of above-mentioned doses, serum antidiphtherial do not enter or enter under anesthetic, having the syringe from 0,1% solution of Adrenalinum hydrochloricum or 0,2% hydrotartrate noradrenaline solution.

All manipulations carry out by separate sterile syringes, close the opened ampoule a sterile napkin, store at a temperature (20±2) ºС no more than 1 hour.

The opened ampoule with serum horse cleared to divorced 1:100 storage is not subject.

Features of use:

Considering a possibility of development of an acute anaphylaxis, behind everyone vaccinated it is necessary to provide medical observation within one hour after administration of serum. Venues of inoculations have to be provided with means of antishock therapy.

The persons who received serum antidiphtherial have to be warned about need of the immediate request for medical care in case of the signs characteristic of a serum disease.

Before administration of drug surely put an intracutaneous test with serum horse cleared divorced 1:100 for detection of sensitivity to a foreign protein.

Drug in ampoules with the broken integrity or marking is not suitable for use, at change of physical properties (color, transparency, existence of not breaking flakes), at the expired period of validity, at the wrong storage.

Use at pregnancy and during breastfeeding. Safety of use of this medical supply at pregnancy and during feeding by a breast in the course of clinical tests was not investigated.

Side effects:

Administration of serum can lead to development of an acute anaphylaxis and other allergic reactions of immediate type, and also symptom complex of a serum disease (temperature increase, skin rashes, arthralgias) appearing in early (for 2-6 days) and remote (on the 2nd week) terms, lasting from several hours up to several weeks.

Interaction with other medicines:

It is not established.

Contraindications:

Clinical contraindications for use of serum antidiphtherial are absent.

Storage conditions:

Period of validity - 2 years. The opened ampoule with serum horse cleared to divorced 1:100 storage is not subject.

Issue conditions:

According to the recipe

Packaging:

Serum antidiphtherial horse cleared concentrated, solution for intramuscular and hypodermic introduction – on 10000 ME in ampoules. Serum horse cleared divorced 1:100, solution for intradermal introduction – on 1 ml in ampoules. Release in a set. The set consists of 1 ampoule of serum antidiphtherial horse cleared concentrated (marking is put in blue or black color) and 1 ampoules of serum horse cleared divorced 1:100 (marking is put in red color). On 5 sets in a pack from a cardboard together with a knife ampoule or the scarificator ampoule and the application instruction. When packaging ampoules with notches, a ring of a break and a point for opening the knife ampoule or the scarificator ampoule is not put.