ЦФДА-1 - instructions for use, doses, side effects, contraindications

Active substanceAdenine + Dextrose + Citric acid + Sodium dihydrogen phosphate + Sodium citrateAdenine + Dextrose + Citric acid + Sodium dihydrogen phosphate + Sodium citrate

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Terumo Corporation Japan

Dosage form: & nbsphemoconvant solution

Composition:

Citric acid (monohydrate) 0.327g

Sodium citrate (dihydrate) 2.63 g

Single-substituted sodium phosphate (dihydrate) 0.251 g

Glucose (anhydrous) 2.9 g

Adenine 0.0275g

Water for injection up to 100ml

Description:Sterile, non-pyrogenic, colorless, clear solution, in two-port containers (single, double, staged and quadruple to store whole blood or its components). Each container has connecting tubes with valves to separate blood components, which can be hermetically sealed and output ports with removable covers. Each package is intended for single use and should be used only in procedures for the collection, storage and transfusion of human blood.

Pharmacotherapeutic group:Anticoagulant solution for whole blood

ATX: & nbsp

V.07.A.C Aids for blood transfusion

Pharmacodynamics:The addition of CFDA-1 to whole blood prevents its coagulation due to the binding of calcium ions and promotes storage.

Indications:As an anticoagulant and hemoconvant for human blood and its components in the process of blood sampling, storage and transfusion.

Contraindications:Not known.

Dosing and Administration:

1. Form a free node on the donor tube about 10 cm from the needle for intravenous injection, without tightening it.

2. Take the donor tube to the clamp.

3. Suspend the blood collection bag below the donor's arm level by at least 60 cm.

4. Apply the cuff to measure blood pressure, or a tourniquet. Disinfect the venipuncture site. Inflate the cuff to 60 mm Hg. Art.

5. Remove the protective cap from the needle and perform venipuncture.

6. Remove the clamp to start taking blood

7. Stir blood and anticoagulant at regular intervals throughout the blood sampling.

8. Collect blood by weight according to the table.

9. Tighten the previously applied knot (see item 1) after collection of blood. Attach the clamp between the knot and the needle. Cut the donor tube between the knot and the clamp. Collect the test samples.

10. After collecting blood immediately turn the bag several times, as follows, mixing the blood and anticoagulant.

11. Pump the blood out of the donor tube into the bag. Mix and refill the donor tube with blood.

12. Using a sealer or aluminum rings, close the donor tube between the numbers. A warning. Start overlapping the donor tube from the side of the needle, and then from the side of the bag.

13. Store the filled bag at a temperature of 1-6 ° C.

Warning: Use in within 24 hours after opening blister packaging. Clear easily separating protective film blister packaging for 4/5 length and after removing the kit, attach it back.

Overdose:

When used in accordance with the instruction, the possibility of adverse reactions is negligible. The most important symptom of overdose is the appearance of paresthesia, which requires the cessation or reduction of the rate of administration.

When blood paresthesia or its components, paresthesias, muscle spasms and convulsions in the limbs appear during the transfusion, it is necessary to stop the anticoagulated blood product immediately and prescribe calcium preparations.

Interaction:

Not known.

Special instructions:

Do not use: for intravenous administration, if the solution is opaque, if the integrity of the package is compromised.

If after inspection of the container contents it is established that the solution is transparent and does not contain any particles,The container is checked for leaks, for which it is strongly compressed by hand. If a leak is detected, the container is considered unfit because its sterility is impaired.

Form release / dosage:Solution anticoagulant ЦФДА-1.

Packaging:

Solution anticoagulant TsFDA-1 in plastic containers, packed in polypropylene cuvettes with a transparent blister cap. Containers contain 35 ml, 49 ml or 63 ml of the anticoagulant TSFDA-1 solution. Plastic containers containing the CFDA-1 solution are represented by a system of single, double, stacked and quadruple containers containing containers with solutions and portable blood bags (one or two or three).

Single containers 49ml / 350ml and 63ml / 450ml - 10 pcs. in orange blister trays, 6 blisters in a cardboard box.

Double containers 35 ml / 250 ml (empty container 150 ml), 49 ml / 350 ml (empty container 200 ml) and 63 ml / 450 ml (empty container 300 ml) - 5 pcs. in green blister trays, 6 blisters in a cardboard box.

Structural containers 49ml / 350ml (2 empty containers of 400ml) - 4 pcs. in pink blister trays, 6 blisters each in a cardboard box.

Quadruple containers 63 ml / 450 ml (3 empty containers of 400 ml) - 4 pcs.in purple blister trays, 6 trays in a cardboard box.

Storage conditions:

Store at a temperature of no higher than 25 degrees, avoid freezing, in a place protected from light and inaccessible to children.

Shelf life:

2.5 years. Do not use after the date shown on the package.

Terms of leave from pharmacies:For hospitals

Registration number:П N015952 / 01

Date of registration:14.08.2009

The owner of the registration certificate:Terumo CorporationTerumo Corporation Japan

Manufacturer: & nbsp

TERUMO CORPORATION Japan

Representation: & nbspDELRUS CJSCDELRUS CJSCRussia

Information update date: & nbsp18.09.2015

Illustrated instructions

Instructions

ЦФДА-1 (CFDA-1)