Instruction Normacor

A set of two solutions for blood cardioplegia – protection of the myocardium from ischemic and reperfusion damage during cardiac surgery

Instruction

Normacor

®

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01

General information

NORMACOR® is a cardioplegic agent for blood cardioplegia, a set of two solutions for myocardial protection during cardiac surgery.

Registration number

LP-No.(015032)-(RG-RU)

Trade name

NORMACOR®

INN

potassium chloride + magnesium sulfate + mannitol

Dosage form

set of solutions for cardioplegia

Description

transparent colorless liquid

Pharmacotherapeutic group

cardioplegic agent

ATX code

B05XA16

pH

7,6–8,0

02

Pharmacological properties

The drug NORMACOR® is a set of two solutions:

Solution No. 1 (high potassium) - to achieve rapid asystole

Solution No. 2 (low potassium) - to maintain asystole

The drug prolongs myocardial resistance to hypoxia, reducing its energy consumption, and provides protection against ischemic and reperfusion injury under conditions of normothermia or moderate hypothermia

Components

Potassium ions reduce myocardial excitability and conductivity

Magnesium ions are involved in neuromuscular excitation

Mannitol has an anti-edematous, diuretic effect

Trometamol - eliminates acidemia and intracellular acidosis

03

Indications for use

Cardiac surgeries:

in patients with preserved and reduced contractility of the heart

in chronic cardiac dysfunction, severe damage to the coronary bed and myocardium

in urgent or emergency interventions due to unstable angina or acute myocardial infarction

in case of emergency transition to IR during minimally invasive surgery

04

Contraindications, special instructions

Contraindications

Individual intolerance to components

Efficacy and safety in children under 18 years of age have not been established

The solution NORMACOR® is not used for injections or infusions (except for cardioplegia).

Use during pregnancy and lactation

No studies have been conducted. Use is only possible if the benefit to the mother outweighs the potential risk to the fetus and child

05

Method of administration and dosage

Auxiliary equipment

perfusion set for blood cardioplegia;

cardioplegic cannulas (Ø 2.5–6 mm);

tube clamps;

Cardioplegic ICU attachment with two roller pumps.

Temperature regime: normothermia (36–37 °C) or moderate hypothermia (30–35 °C).
Routes of administration: antegrade (through the aortic root), retrograde (through the coronary sinus), or mixed.

Cardioplegia administration scheme

Doses · Achieving asystole

Immediately after clamping the aorta, perfusion of a mixture of Solution No. 1 with oxygenated blood in a ratio of 1:2, rate 300 ml/min.

Asystole occurs within 1–2 minutes.

After reaching asystole, administer the remaining volume up to 400 ml, reducing the rate to 250 ml/min.

If asystole is absent within 3 minutes, increase the rate to 350 ml/min, if necessary, add an additional container of Solution No. 1.

If asystole is absent within 5 minutes, switch to retrograde delivery (100 ml/min, pressure no more than 50 mmHg).

Maintenance of asystole

It is carried out in one of three equivalent ways:

1

With the heart stopped, perfuse with a mixture of Solution No. 2 and oxygenated blood in a 1:4 ratio at a rate of 150 ml/min antegrade or 100 ml/min retrograde, with repeated interruptions of 15 minutes and resumption of 2–3 minutes between intervals. The pressure during retrograde administration should not exceed 50 mmHg. Upon resumption of ventricular activity, switch to a 1:2 mixture of Solution No. 1 and blood until asystole is achieved.

2

Upon resumption of ventricular activity, perfuse a mixture of Solution No. 1 and oxygenated blood in a 1:2 ratio (antegrade at 150 ml/min or retrograde at 100 ml/min) only if ventricular activity is observed until stable asystole is achieved. The pressure during retrograde administration should not exceed 50 mmHg.

3

If signs of resumption of ventricular activity appear, perfuse with a 1:2 mixture of Solution No. 1 and blood for 2–3 minutes (possibly multiple times) to prevent resumption of ventricular activity. The pressure during retrograde administration should not exceed 50 mmHg.

End of cardioplegia: perfusion is stopped and the clamp is removed from the aorta

Антеградная кардиоплегия

Ретроградная кардиоплегия

06

Side effects, overdose and interactions

Side effects

Allergic reactions are possible. No adverse reactions were identified in clinical trials

Overdose

Hyperkalemia (a longer rhythm recovery after aortic clamp removal) is possible. This resolves spontaneously with the Mannitol contained in the medication. No additional treatment is required.

Interaction with other drugs

None. Mannitol may accelerate the elimination of other drugs

07

Release form and storage conditions

Release form

A set of solutions in glass bottles (250 ml or 450 ml) or polymer containers (200 ml or 400 ml). Solution No. 1 and Solution No. 2 are packed in a cardboard box.

Storage conditions

Protect from light, at a temperature not exceeding 25°C. Keep out of reach of children. Expiration date: 3 years. Do not use after the expiration date.

Conditions of dispensation: for hospitals.