Ernaph (Solution) Instructions for Use

Marketing Authorization Holder

Sintez PJSC (Russia)

ATC Code

V07AC (Auxiliary agents for blood transfusion)

Dosage Form

Ernaph

Solution for blood preservation 100 ml: bags

Dosage Form, Packaging, and Composition

Hemopreservative solution transparent, slightly colored.

Excipients : water for injections up to 1 L.

100 ml – polymeric containers (1) three-chamber or four-chamber with a capacity of 400 ml – bags (1) inner – Multilayer bags.
100 ml – polymeric containers (1) three-chamber or four-chamber with a capacity of 400 ml – bags (2) inner – Multilayer bags.
100 ml – polymeric containers (1) three-chamber or four-chamber with a capacity of 400 ml – bags (3) inner – Laminated bags.
100 ml – polymeric containers (1) three-chamber or four-chamber with a capacity of 400 ml – bags (4) inner – Multilayer bags.
100 ml – polymeric containers (1) three-chamber or four-chamber with a capacity of 400 ml – bags (5) inner – Multilayer bags.

Clinical-Pharmacological Group

Donor blood preservative preparation

Pharmacotherapeutic Group

Hemopreservative-auxiliary substance

Pharmacological Action

Ernaph solution is a phosphate-saline solution with adenine and nicotinamide.

Ernaph solution is intended for the preservation and resuspension of red blood cell mass and red blood cell mass on the day of blood collection from donors or no later than 7 days from the time of its preparation.

Resuspension of red blood cell mass and red blood cell mass in Ernaph solution allows for the normalization of rheological parameters and the preservation of the morphofunctional integrity and therapeutic efficacy of the red blood cell suspension for up to 35 days.

Ernaph solution is mixed with red blood cell mass or red blood cell mass in a ratio of 1 volume of solution to 2 volumes of red blood cell mass or red blood cell mass.

Indications

• As a hemopreservative for red blood cell mass or red blood cell mass during its storage and transfusion.

ICD codes

Dosage Regimen

Resuspension of red blood cell mass using Ernaph solution is performed in a sterile closed system – in three-chamber or four-chamber polymeric containers for blood and its components by transferring the solution from the polymeric container where it is stored into the polymeric container with the red blood cell mass.

The shelf life of the preserved red blood cell mass and red blood cell mass is 35 days.

Before use, check the integrity of the consumer packaging and the tightness of the container.

Contraindications

• Hemoglobin above 90 g/L with bleeding stopped;
• Hemoglobin above 70 g/L with chronic anemia;
• Hemoglobin above 80 g/L in the presence of concomitant cardiovascular pathology;
• Individual intolerance to nicotinic acid;

With “massive” transfusion of blood prepared on the basis of Ernaph, in patients with chronic renal failure, deterioration of kidney function and intoxication of the body with accumulated adenine metabolism products are possible.

Use in Renal Impairment

With “massive” transfusion of blood prepared on the basis of Ernaph, in patients with chronic renal failure, deterioration of kidney function and intoxication of the body with accumulated adenine metabolism products are possible.

Special Precautions

Freezing during transportation is allowed.

Cloudiness of the polymeric container and the presence of moisture in the bag with containers, provided the containers are sealed, is not a contraindication to the use of the drug.

Storage Conditions

The drug should be stored in a dry place, protected from light and aggressive environments and out of the reach of children, at a temperature from 5°C (41°F) to 20°C (68°F).

Shelf Life

Shelf life – 2 years – when using polyethylene film for the outer packaging bags of medical devices;

2.5 years – when using a combined multilayer material based on aluminum foil for the outer packaging bags of medical devices.

Do not use after the expiration date stated on the packaging.

Dispensing Status

For blood transfusion departments and stations only.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.