Faglucid (Solvent) Instructions for Use

Marketing Authorization Holder

Sintez PJSC (Russia)

ATC Code

V07AC (Auxiliary agents for blood transfusion)

Dosage Form

Faglucid

Solution for hemopreservative: 50 ml, 75 ml, 100 ml, 113 ml, or 120 ml containers

Dosage Form, Packaging, and Composition

Hemopreservative solution is transparent, colorless or slightly yellowish.

Excipients: water for injections up to 1 L.

50 ml – polymeric containers (1) “Gemasin” with a capacity of 250 ml – bags – group packaging.
75 ml – polymeric containers (1) “Gemasin” with a capacity of 375 ml – bags – group packaging.
100 ml – polymeric containers (1) “Gemasin” with a capacity of 500 ml – bags – group packaging.
113 ml – polymeric containers (1) “Gemasin” with a capacity of 575 ml – bags – group packaging.
50 ml – two-chamber polymeric containers (1) “Gemasin” with a capacity of 250 ml (empty container capacity 200 ml) – bags – group packaging.
75 ml – two-chamber polymeric containers (1) “Gemasin” with a capacity of 375 ml (empty container capacity 300 ml) – bags – group packaging.
100 ml – two-chamber polymeric containers (1) “Gemasin” with a capacity of 500 ml (empty container capacity 400 ml) – bags – group packaging.
113 ml – two-chamber polymeric containers (1) “Gemasin” with a capacity of 575 ml (empty container capacity 400 ml) – bags – group packaging.
120 ml – two-chamber polymeric containers (1) “Gemasin” with a capacity of 600 ml (empty container capacity 400 ml) – bags – group packaging.
100 ml – two-chamber polymeric containers (1) for plasmapheresis with a capacity of 500 ml (empty container capacity 400 ml) – bags – group packaging.
113 ml – two-chamber polymeric containers (1) for plasmapheresis with a capacity of 575 ml (empty container capacity 400 ml) – bags – group packaging.
50 ml – three-chamber polymeric containers (1) “Gemasin” with a capacity of 250 ml (2 empty container capacities of 200 ml each) – bags – group packaging.
75 ml – three-chamber polymeric containers (1) “Gemasin” with a capacity of 375 ml (2 empty container capacities of 300 ml each) – bags – group packaging.
100 ml – three-chamber polymeric containers (1) “Gemasin” with a capacity of 500 ml (2 empty container capacities of 400 ml each) – bags – group packaging.
113 ml – three-chamber polymeric containers (1) “Gemasin” with a capacity of 575 ml (2 empty container capacities of 400 ml each) – bags – group packaging.
120 ml – three-chamber polymeric containers (1) “Gemasin” with a capacity of 600 ml (2 empty container capacities of 400 ml each) – bags – group packaging.
100 ml – three-chamber polymeric containers (1) for plasmapheresis with a capacity of 500 ml (2 empty container capacities of 400 ml each) – bags – group packaging.
113 ml – three-chamber polymeric containers (1) for plasmapheresis with a capacity of 575 ml (2 empty container capacities of 400 ml each) – bags – group packaging.
100 ml – four-chamber polymeric containers (1) “Gemasin” with a capacity of 500 ml (2 empty container capacities of 400 ml each and one 100 ml) – bags – group packaging.
113 ml – four-chamber polymeric containers (1) “Gemasin” with a capacity of 575 ml (2 empty container capacities of 400 ml each and one 100 ml) – bags – group packaging.
120 ml – four-chamber polymeric containers (1) “Gemasin” with a capacity of 600 ml (2 empty container capacities of 400 ml each and one 100 ml) – bags – group packaging.
100 ml – four-chamber polymeric containers (1) for plasmapheresis into two chambers with a capacity of 500 ml (2 empty container capacities of 400 ml each) – bags – group packaging.
113 ml – four-chamber polymeric containers (1) for plasmapheresis into two chambers with a capacity of 575 ml (2 empty container capacities of 400 ml each) – bags – group packaging.

Clinical-Pharmacological Group

Donor blood preservative preparation

Pharmacotherapeutic Group

Hemopreservative-auxiliary substance

Pharmacological Action

Hemopreservative.

It ensures the preservation of the morphofunctional integrity of blood for 50 days by maintaining the physiological level of ATP in erythrocytes, the rheological properties of blood, and the pH value at a physiological level.

Indications

Blood preservation.

ICD codes

Dosage Regimen

Use Faglucid solution exclusively as a hemopreservative for donor blood collection and storage.

Prepare the container and connecting system using aseptic technique immediately prior to blood collection.

Mix the hemopreservative solution with blood in a strict ratio of 1:4 (one volume of solution to four volumes of blood).

Ensure the final volume of the blood-preservative mixture corresponds to the total capacity of the selected container system.

Agitate the container gently after filling to achieve homogeneous mixing of blood and preservative solution.

Store the collected blood unit at a temperature of +2°C to +6°C for up to 50 days from the date of collection.

Inspect the solution visually for particulate matter and discoloration prior to use; do not use if the solution is not clear or colorless to slightly yellow.

Select the appropriate container volume (50 ml, 75 ml, 100 ml, 113 ml, or 120 ml) based on the intended blood collection volume.

Do not use the solution if the container is damaged or the tamper-evident seal is broken.

Discard any unused portion of the solution remaining in the primary container after the blood collection procedure is complete.

Adverse Reactions

Possible allergic reactions.

Contraindications

Hypersensitivity to the components of the combination.

Special Precautions

Do not administer hypotonic or hypertonic saline solutions, dextrose solutions, and other medicinal products simultaneously with blood using the same device.

Storage Conditions

Store at 8°C (46°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx 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.