Expiration date: 05/2027

The composition and form of issue:

Powder lyophilized for solution preparation for injections. 1 vial contains:

hydrocortisone (as hydrocortisone sodium succinate) 100 mg

(monohydrate monobasic sodium phosphate secondary acid phosphate sodium) 

pack of 1 vial.

Powder lyophilized for solution preparation for injections in vial 2-vol. ACT-O-VIAL. 1 vial contains:

I. lower capacity: 

hydrocortisone (as hydrocortisone sodium succinate) 100 mg

(monohydrate monobasic sodium phosphate secondary acid phosphate sodium) 

II. Top capacity: 

benzyl alcohol 18 mg

water for injection 2 ml

in the paper cartons 1 a bottle dvuhyakornaya (dried powder of hydrocortisone sodium succinate sterile water and the solvent in 2 separated from each other containers of one bottle).

Method of application and dose:

In/in, in/in infusion, in/m. as the emergency treatment of acute conditions it is recommended to assign the I/O. At the end of the acute period or appoint a parenteral dosage form of the drug with a longer effect or oral forms of the drug. The treatment begins with the/in the introduction of over 30 (e.g., 100 mg) and 10 min (e.g., 500 mg or more) depending on the severity of the patient's condition.

High-dose corticosteroids should be prescribed only until the stabilization of the patient, but generally not more than 48-72 h. adverse events with high doses of corticosteroids for a short period of time are rare, but may develop peptic ulcers.

Perhaps the appointment of prophylactic antacid therapy.

At appointment of high doses of hydrocortisone for longer than 48-72 h, may develop hypernatremia. In this case, it is recommended to replace solu Cortef to another corticosteroid drug such as methylprednisolone sodium succinate which causes little or does not cause sodium retention in the body.

Dose re-appointed every 2-4-6 h depending on the response of the patient and the clinical picture of the disease. Sentencing children dose is correspondingly reduced, at the same assigned dose should depend on the severity of the disease and reactions to therapy, you also need to take into account the age and weight of the child. The assigned dose should be 25 mg/day and 15 mg/kg.

If after the corticosteroid therapy in patients, there is a stressful situation, such patients should be under strict supervision due to the possible development of insufficiency of the adrenal cortex.

Corticosteroid therapy does not replace standard therapy, and is designated as optional.

Preparation of solutions.

Preparations for parenteral administration should be inspected visually for changes in color or appearance of the particles in all cases when the solution and the glassware allowed to do it.

Bottle 100 mg

For in/in or/m injection, prepare solution by adding in a bottle (following the rules of antisepsis) is not more than 2 ml of bacteriostatic water for injection or sodium chloride for injection with bacteriostatic additive and shaking the vial until the powder is completely dissolved. For in/infusion, first prepare solution by adding the vial of not more than 2 ml of bacteriostatic water for injection, then this solution may be added to 100 or 1000 ml of 5% dextrose in water (or physiological saline or 5% dextrose solution in saline, if the patient does not need to limit sodium).

Two-anchors vial ACT-O-VIAL

1. Click on plastic activator to the solvent poured into the lower container.

2. Caution ' s the bottle until until the powder is dissolved.

3. Remove the plastic disk covering the centre of the tube.

4. Treat the tube surface with the appropriate antiseptic.

5. Puncture needle tube center so that I could see the tip of the needle. Turn the vial and syringe collect the required amount of solution.

For in/in or/m injection, further dilution is not required. For in/infusion, first prepare solution as described above. Further, this solution was added to 100 or 1000 ml of 5% dextrose in water (or physiological saline or 5% dextrose solution in saline, if the patient does not need to limit sodium). In cases where it is desirable to introduce a small volume of liquid, from 100 to 3000 mg of hydrocortisone (equivalent to hydrocortisone sodium succinate) can be added to 50 ml of the above solutions used for dilution. The resulting solutions are stable during 4 hours and can be entered in/in, directly or through a second bag.

If the drug solutions prepared as indicated above, the pH will be from 7 to 8 and osmolality — 0.36 osmol (saline = 0.28 osmol).