Ringer lactici Viaflo (Solution) Instructions for Use

Marketing Authorization Holder

Bieffe Medital S.p.A. (Italy)

ATC Code

B05BB01 (Electrolytes)

Active Substance

Compound solution of sodium lactate (Rec.INN registered by WHO)

Dosage Forms

	Ringer lactici Viaflo	Solution for infusion: 250 ml container 30 pcs.
		Solution for infusion: 500 ml container 20 pcs.
		Solution for infusion: 1000 ml container 10 pcs.

Dosage Form, Packaging, and Composition

250 ml – plastic containers (30) Viaflo – cardboard boxes.

500 ml – plastic containers (20) Viaflo – cardboard boxes.

1000 ml – plastic containers (10) Viaflo – cardboard boxes.

Clinical-Pharmacological Group

Drug for rehydration and detoxification for parenteral use

Pharmacotherapeutic Group

Electrolyte balance restoring agent

Pharmacological Action

Rehydrating agent, has a detoxifying effect. It normalizes the acid-base state, replenishes the circulating blood volume deficit, and stabilizes the water and electrolyte composition of the blood. The solution is close to isotonic, osmolarity is approximately 278 mOsm/L.

The pharmacological properties of the solution are due to the presence of lactate and other components of the solution (sodium, potassium, calcium, chloride), corresponding to the level in plasma. The main effect of the drug is to compensate for the extracellular exchange of interstitial and intravascular fluid. Lactate is metabolized to bicarbonate primarily in the liver and promotes plasma alkalinization.

An increase in central venous pressure leads to an increase in the production of natriuretic peptide. The drug causes a decrease in blood osmolarity and an increase in pH. When using the solution as a base for diluting and transporting substances administered parenterally, the pharmacological properties are determined by these substances.

Indications

• Hypovolemia;
• Isotonic dehydration;
• Metabolic acidosis.

ICD codes

Dosage Regimen

IV drip.

Recommended doses for adults are from 500 ml to 3 L/day (40 ml/kg/day).

For children and newborns – from 20 ml to 100 ml/kg/day.

The infusion rate for children (usually 5 ml/kg/h) may vary depending on age: 6-8 ml/kg/h for newborns (up to 28 days), 4-6 ml/kg/h – for children over 1 year old, 2-4 ml/kg/h – for school-age children. For children with burns, the average dose is 3.4 ml/kg/% of burn area on the first day after the burn and 6.3 ml/kg/% of burn area within 48 hours. For severe traumatic brain injury in children, the dose is 2850 ml/m².

The infusion rate and total volume may be increased during surgery.

Opening the package

1. Remove the Viaflo container from the polyamide-polypropylene plastic bag immediately before use.
2. Check the container for leaks within one minute by firmly squeezing the container; if a leak is found, the container should be discarded because sterility may be compromised.
3. Check the solution for clarity and the absence of inclusions. The container should be discarded if clarity is impaired or if inclusions are present.

Preparation for use

Use sterile materials to prepare and administer the solution.

1. Hang the container by the loop.
2. Remove the plastic protector from the outlet port located at the bottom of the container. With one hand, grasp the small wing on the neck of the outlet port. With the other hand, grasp the large wing on the cap and twist. The cap will open.
3. When setting up the system, aseptic technique should be followed.
4. Set up the system in accordance with the instructions for connecting, priming the system, and administering the solution contained in the system instructions.

Adding other drugs to the solution

Added drugs may be incompatible with the solution.

For addition before administration it is necessary

1.. Disinfect the medication injection area on the container (medication addition port).

1. Using a 19-22 gauge syringe, puncture this area and inject the drug.
2. Thoroughly mix the drug with the solution. For drugs with high density (e.g., potassium chloride), carefully inject the drug through the syringe while holding the container so that the medication addition port is at the top (upside down), then mix.

Do not store containers to which drugs have been added.

For addition during administration it is necessary

1. Move the system clamp regulating the solution flow to the “Closed” position.
2. Disinfect the medication injection area on the container (medication addition port).
3. Using a 19-22 gauge syringe, puncture this area and inject the drug.
4. Remove the container from the stand and/or turn it upside down.
5. In this position, carefully remove air from both ports.
6. Thoroughly mix the drug with the solution.
7. Return the container to the operating position, move the system clamp to the “Open” position and continue administration.

Adverse Reactions

Thrombophlebitis, hypervolemia, hyperhydration, hyperchloremia, anxiety, allergic reactions.

Contraindications

• Hypervolemia;
• Hypertensive hyperhydration;
• Hyperkalemia;
• Hypernatremia;
• Arterial hypertension;
• Heart and/or renal failure;
• Hyperchloremia;
• Alkalosis;
• Hepatic failure (reduced bicarbonate formation from lactate);
• Hyperlactacidemia;
• Hypersensitivity.

With caution: respiratory failure, acute dehydration, simultaneous treatment with glucocorticosteroids, diseases associated with increased vitamin D levels (e.g., sarcoidosis).

Use in Pregnancy and Lactation

The solution can be used during pregnancy and lactation.

Use in Hepatic Impairment

Contraindicated in hepatic failure.

Use in Renal Impairment

Contraindicated in renal failure.

Pediatric Use

For children and newborns – from 20 ml to 100 ml/kg/day.

The infusion rate for children (usually 5 ml/kg/h) may vary depending on age: 6-8 ml/kg/h for newborns (up to 28 days), 4-6 ml/kg/h – for children over 1 year old, 2-4 ml/kg/h – for school-age children. For children with burns, the average dose is 3.4 ml/kg/% of burn area on the first day after the burn and 6.3 ml/kg/% of burn area within 48 hours. For severe traumatic brain injury in children, the dose is 2850 ml/m².

Special Precautions

Regular monitoring of electrolytes, pH, pCO₂, and circulating blood volume is necessary. The solution can only be used if it is clear, free of visible inclusions, and its packaging is intact.

Use immediately after connecting the infusion system to the solution bag. Do not use serially connected bags, as this may lead to air embolism due to suction of air remaining in the first bag, which may occur before the solution from the next bag arrives.

The solution should be administered through a sterile system using aseptic technique. To avoid air entering the system, it should be primed with the solution.

Other drugs can be added to the solution before or during infusion by injection into the specially designated area of the container (bag).

When adding a drug, it is necessary to determine the isotonicity of the resulting solution before infusion. Thorough aseptic mixing of all drugs added to the solution is necessary. Do not store the solution containing added drugs; the resulting solution should be administered immediately after preparation.

The use of other drugs or violation of the administration technique may cause fever due to the possible entry of pyrogens into the body. If adverse reactions occur, the administration of the solution should be stopped immediately.

The set should be discarded after a single use. Any started set should be discarded.

Do not connect partially used containers (regardless of the amount of solution remaining).

Before starting use, the container should not be removed from the polyamide-polypropylene plastic bag in which it is placed, as it maintains the sterility of the product.

Calcium chloride has a locally irritating effect, so the solution should be prevented from entering the tissues surrounding the vein during IV administration, and IM administration should be avoided.

In the case of concomitant blood transfusion, it is not recommended to prescribe Ringer’s Lactate solution due to the risk of coagulation.

Drug Interactions

NSAIDs, androgens, anabolic steroids, estrogens, corticotropin, corticosteroids, vasodilators and ganglion blockers increase the risk of hypernatremia.

Potassium-sparing diuretics, potassium preparations increase the risk of hyperkalemia.

Alkalizes urine and inhibits the excretion of drugs with an alkaline reaction.

Accelerates the excretion of lithium and salicylates.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F). Do not freeze.

Shelf Life

Shelf life – 36 months for 1000 ml containers, 20 months – for 250 ml and 500 ml containers.

Dispensing Status

The drug is dispensed by prescription.

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.