Ringer Lactate Vaflo - instructions for use, dose, side effects, contraindications

In 1 liter of solution contains: active substances sodium chloride 6.0 g, potassium chloride 0.4 g, calcium chloride, dihydrate 0.27 g, sodium lactate 3.20 g.

Excipients: water for injection up to 1 liter.

Ionic composition:

	Na⁺	to⁺	Ca⁺⁺	SG	FROM3H5ABOUT3- (lactate)
mmol / l	131	5	2	111	29
mEq / l	131	5	4	111	29

The theoretical osmolarity is 278 mOsm / l

Description:Transparent colorless or almost colorless solution.

Pharmacotherapeutic group:Electrolyte balance recovery agent

ATX: & nbsp

B.05.B.B.01 Electrolytes

Pharmacodynamics:

Ringer Lactate Biaflo is an isotonic solution of electrolytes.The components of the solution and their concentrations are selected in such a way as to correspond to the plasma one.

Pharmacological properties are determined by the properties of the components (sodium, potassium, calcium, chloride and lactate). The main effect of the solution is to increase the volume of the extracellular space, including the volume of interstitial fluid and intravascular fluid.

Changes in central venous pressure in healthy volunteers who received Ringer's lactate from Biaflo were associated with the secretion of the atrial natriuretic peptide.

In healthy volunteers, Ringer's lactate Veaflo reduced serum osmolality, increased the pH of the blood and reduced the time to the first urination, compared with 0.9% sodium chloride solution.

Appointment of Ringer's lactated Viflo to patients who underwent an operation on the aorta did not cause significant changes in the concentration of glucagon, noradrenaline, epinephrine, blood glucose and insulin.

When another drug is added to Ringer's lactate, the total pharmacodynamics of the solution will depend on the nature of the drug used.

Pharmacokinetics:

Pharmacokinetic properties are determined by the properties of its components (sodium, potassium, calcium and chloride).

Ringer's infusion of lactated VIAFLO with hemodynamically stable adult patients does not increase the concentration of lactate in the bloodstream.

Pharmacokinetics Dlactate and Llactate are similar. Lactate from Ringer's lactate Vaflo is metabolized predominantly in the liver by both oxidation and gluconeogenesis, both processes lead to the formation of bicarbonate during 1-2 h.

When another drug is added to Ringer's lactate, the total pharmacokinetics of the solution will be determined by the nature of the drug used.

Indications:

Hypovolemia

- Isotonic dehydration

Metabolic acidosis

Contraindications:

Extracellular hyperhydration or hypervolemia

Severe renal insufficiency (with oliguria / anuria)

Decompensated cardiac failure

Hyperkalemia

Hypercalcemia

Metabolic alkalosis

Ascites with cirrhosis

Severe metabolic acidosis

The states associated with increasing the level of lactate (hyperlactatemia), including including lactoacidosis, or with impaired lactate assimilation, for example, severe hepatic impairment

- Hypersensitivity to sodium lactate

- Concomitant therapy with cardiac glycosides (see "Interactions with Other Drugs")

Simultaneous use with ceftriaxone in newborns (up to 28 days of age), even with the use of separate infusion systems (risk of deposition of calcium ceftriaxone salts in the fatal blood flow)

Carefully:

- Hypernatremia, including diabetes insipidus, extensive tissue damage, chronic heart failure

- Hyperchloremia, including renal insufficiency, renal tubular necrosis, diabetes insipidus, with urine diversion, concomitant use of diuretics-inhibitors of carbonic anhydrase, steroid hormones; with severe dehydration.

Conditions that promote the development of hyperkalemia, including renal failure, adrenocortical insufficiency, acute dehydration, extensive damage to tissues, including number due to burns

Conditions conducive to development hypercalcemia, including renal insufficiency, granulomatosis, associated with increased synthesis calcitriol (eg, sarcoidosis), calcium kidney stones in the present time or history

Impaired renal function

Hypervolaemia or hyperhydration (primary and secondary aldosteronism (conditioned, for example, arterial hypertension, congestive heart failure, stenosis of the renal arteries or nephrosclerosis) or preeclampsia)

Children under 6 months of age

Simultaneous application with ceftriaxone in patients older than

28 days (including adults) through the same infusion system.

If the same infusion system used for sequential

introduction, it should be thoroughly rinsed between infusions of a suitable

liquid.

Pregnancy and lactation:

Purpose of the drug during pregnancy and during the breast breastfeeding is possible in the event that The prospective benefit of the mother exceeds potential risk to the fetus or child.

It should be remembered that calcium passes through the placenta and penetrates into the breast milk.

When adding to the solution means of their property and possibility application in pregnancy and breast should be evaluated separately.

Dosing and Administration:

Intravenously (drip). Doses, speed and The duration of administration should be are individual and depend on the indication to application, age, body weight, clinical and acid-base condition, concomitant treatment patient, as well as clinical and laboratory response of the patient to treatment.

The amount of preparation required for restoration of normal blood volume, in 3-5 times exceeds the volume of blood loss. Recommended Adult Dose is from 500 ml to 3 liters per day (the infusion rate is 40 ml / kg per day).

Recommended dose for children is from 20 to 100 ml / kg per day. Speed Infusion for children (usually 5 ml / kg / h) can vary depending on the age:

- for children aged from 28 days to 1 year: 6-8 ml / kg / h;

- for children aged 1 to 2 years: 4-6 ml / kg / h;

- for children aged 2 to 11 years: 2-4 ml / kg / h.

The total volume of the introduced solution depends from the age of the child and is determined by discretion of the doctor. For children with burns average dose of 3.4 ml / kg per 1% of the area burn in the first day after the burn and 6.3 ml / kg per 1% of the burn area during 48 hours In case of severe head injury in children the dose is 2850 ml / m2.

The infusion rate and total volume may be be increased with surgical intervention or in the case of necessity.

When choosing the type of infusion solution and the volume / speed of infusion for the geriatric patient, it is necessary to take into account that in geriatric patients, heart, kidney and liver diseases are usually more common, as well as other disorders, or concomitant medication is used.

Do not remove the container from the protective bag before use; it maintains the sterility of the solution in the container.

Dispose of the container after a single use.

Dispose of each unused dose.

Do not reconnect partially used containers (regardless of the amount of solution left in it).

Side effects:

Adverse adverse reactions recorded during postmarketing use are grouped according to systems and organs according to the dictionary MedDRA.

On the part of the immune system: hypersensitivity reactions or infusion reactions, including anaphylactic and anaphylactoid reactions, possibly manifested by one or more of the following symptoms: angioedema, chest pain, unpleasant sensations in the chest, a decrease in heart rate contractions, tachycardia, decrease arterial pressure, respiratory insufficiency, bronchospasm, dyspnea, cough, urticaria, rash, itching, erythema, hot flashes, irritation in the throat, paresthesia, hypoesthesia of the mouth taste, nausea, anxiety, fever, headache.

From the side of metabolism and nutrition: hyperkalemia.

General disorders and disorders in place introduction: reactions at the site of infusion, manifested by one or more of following symptoms: phlebitis, inflammation at the site of infusion, swelling in place infusion, rash at the infusion site, itching in place infusion, erythema at the site of infusion, pain in the place of infusion, burning in place of infusion.

Spontaneous messages about the following Unwanted reactions occurred at use of other solutions, containing sodium lactate: hypersensitivity: laryngeal edema (edema Quincke), swelling of the skin, nasal congestion, sneezing; violation of electrolyte balance; hypervolemia; a panic attack; other reactions at the infusion site: infection at the injection site, flowing into the surrounding tissue, loss of sensation(numbness) at the site of infusion.

Adverse reactions can be associated with added to the solution medicinal products; probability any other side effects will be determine the nature of the medicines.

Overdose:

Too long or rapid administration of the drug may lead to excessive water or sodium content, which is associated with a risk of edema, especially if there is insufficient renal sodium excretion. In this case, it may be necessary to carry out extrarenal dialysis.

Excessive administration of potassium can lead to the development of hyperkalemia, especially in patients with renal insufficiency. Symptoms include paresthesia of the limbs, muscle weakness, paralysis, arrhythmias and conduction disorders, cardiac arrest and cognitive impairment.

Excessive administration of calcium salts can lead to hypercalcemia. Symptoms of an overdose: anorexia, nausea, vomiting, constipation, abdominal pain, muscle weakness, mental disorders, increased thirst, polyuria, nephrocalcinosis, kidney stones and in severe cases cardiac arrhythmia, and coma.Too rapid intravenous injection of calcium salts can lead to the development of numerous symptoms of hypercalcemia, as well as to limy aftertaste, "hot flashes" and peripheral vasodilation. An easy degree of asymptomatic hypercalcemia, as a rule, is resolved when discontinuation of the administration of calcium and other drugs predisposing to it, for example, vitamin D. With severe hypercalcemia, urgent treatment is required (for example, "loop" diuretics, hemodialysis, calcitonin, bisphosphonates, sodium edetate).

Excessive administration of sodium lactate can lead to hypokalemia and metabolic alkalosis, especially in patients with reduced renal function. Symptoms may include mood changes, fatigue, shortness of breath, muscle weakness and arrhythmia. They can develop, especially in patients with hypocalcemia, hypertension, twitching and muscle cramps. Treatment of metabolic alkalosis, associated with a bicarbonate overdose, mainly consists in adequate correction of the balance of liquid and electrolytes. Calcium, chloride and potassium can be of particular importance.

When the overdose is due to the drugs added to the infusion solution, the signs and symptoms of excessive infusion will depend on the nature of the additives used. When evaluating an overdose, it is necessary to take into account each additional medicinal product added to the solution. In case of unintentional excess infusion, treatment should be discontinued and a patient should be examined for the relevant signs and symptoms associated with the drug used. Reactions resulting from an overdose may require immediate medical attention and treatment.

Ensure that adequate symptomatic and supportive interventions are carried out as required.

Interaction:

Interaction associated with the presence of sodium:

steroid hormones and carbenoxolone, with which sodium and water retention is associated (accompanied by edema and hypertension).

The interaction associated with the presence of potassium:

potassium-sparing diuretics (amiloride, spironolactone, triamterene, alone or in combination).

Angiotensin converting enzyme inhibitors (ACE inhibitors) and angiotensin II receptor antagonists.

Tacrolimus, ciclosporin increase the concentration of sodium in the plasma and can lead to potentially fatal hyperkalemia, especially in the case of renal failure, which enhances the hyperkalemic effect.

Interaction associated with the presence of calcium:

cardiac glycosides, whose effects are enhanced in the presence of calcium and can lead to a serious or fatal cardiac arrhythmia.

Thiazide diuretics or vitamin D, which can lead to hypercalcemia when combined with calcium.

Bisphosphonates, fluorides, some fluoroquinolones and tetracyclines, which are less absorbed (lower bioavailability) when combined with calcium.

The interaction associated with the presence of lactate (which is metabolized to hydro carbonate):

medicines with acid reaction, such as salicylates, barbiturates and lithium, whose renal clearance is increased due to basification of urine by hydrocarbonate formed in the metabolism of lactate.

Drugs that have an alkaline reaction, in particular sympathomimetics (for example, ephedrine, pseudoephedrine) and psychostimulants (eg, dexamphetamine, fenfluramine), in which the half-life is prolonged (slowing of elimination).

Incompatibility

As for all parenteral solutions, the compatibility of the drug with the drug solution should be assessed before adding the medicines. A doctor must determine the incompatibility of the drugs to be added to the drug by checking for possible discoloration and / or the appearance of a possible sediment, insoluble complexes or crystals. The instructions for the use of the added medicines should be taken into account.

Before adding the drug, it is necessary to check its solubility and stability in water at pH values of the preparation (pH from 5.5 to 7.0).

When adding compatible drugs to Ringer's drug, Vaflo lactate, the resulting solution should be injected immediately.

As a guide, the following preparations are incompatible with the drug Ringer Lactate, Viallo (incomplete list): Aminocaproic acid, Amphotericin B, Metamrinol tartrate, Cefamandol, Cortisone acetate, Diethylsilbestrol, Ethamane, Ethyl alcohol, Phosphate and carbonate solutions, Oxytetracycline, Thiopental sodium, Sodium Versaenate.

Medicinal preparations partially incompatible with the drug Ringer lactate Biaflo:

Tetracycline - the solution is stable for 12 hours, Ampicillin sodium solution with a concentration of 2-3% is stable for 4 hours, concentration> 3% should be prescribed no later than 1 hour, Minocycline - the solution is stable for 12 hours, Doxycycline - the solution is stable for 6 h.

Do not use medicines with a known incompatibility.

Special instructions:

The solution is for intravenous administration with a sterile, of pyrogen-free equipment observance of rules of asepsis.

Before use, check solution visually for mechanical inclusions and change colors. Apply only transparent solution, without visible inclusions and if the packaging is intact. To avoid air embolism, remove air from the equipment with solution.

Enter the solution directly afterwards connection to the infusion system.

Do not use sequential connection of plastic containers. it can lead to air embolism due to sucking in air, remaining in the first container, which may occur before solution from the next container.

High pressure feed with to increase the flow rate intravenous solutions contained in plastic containers, can lead to air embolism, in cases, When before the introduction of residual air in container is not completely removed.

Use of the system for intravenous Introduction with a gas outlet can lead to air embolism in the open gas discharge. Do not use plastic containers with systems for intravenous administration with an open gas discharge.

Additional medicines can be introduced through appropriate port before infusion or during the infusion. Add to drug solution other medicinal funds should only be used in aseptic conditions. The solution containing added medicines not store, the resulting solution should be Enter immediately after preparation.

The use of other drugs or infringement of technique of introduction can cause fever due to possible ingress into the body of pyrogens. When development of adverse reactions it is necessary to stop immediately administration of the solution.

- Hypersensitivity reactions

When there are signs of an alleged hypersensitivity infusion should be immediately stop and take necessary therapeutic measures for indications.

Balance of electrolytes

Hypernatremia

- The drug should be used in patients with hypernatremia only after a thorough study of the underlying cause and consideration of alternative agents for intravenous administration. During the period of application it is recommended to monitor the sodium content in the plasma and the degree of hydration of the body.

- the drug should be used with extreme caution in patients with conditions that promote the development of hypernatremia (adrenocortical insufficiency, diabetes insipidus or extensive tissue damage), and in patients with heart disease. Hyperchloremia

- The drug should be used in patients with hyperchloremia only after careful study of the root cause and consideration of alternative intravenous drugs.During the period of application, it is recommended to monitor the chloride content of the plasma and the acid-base balance.

The drug should be used with extreme caution in patients with conditions that contribute to the development of hyperchloremia (eg, renal failure and renal tubular acidosis, diabetes insipidus), in patients with

withdrawal of urine or patients taking certain diuretics (inhibitors of carbonic anhydrase, for example, acetazolamide) or steroids (androgenic agents, estrogenic corticosteroids), and in patients with severe dehydration. Use in patients with potassium deficiency.

Despite the fact that the concentration of potassium in the Ringer formulation of Vaflo lactate is close to its concentration in the plasma, it is not enough to compensate for severe potassium deficiency, so the drug should not be used for this purpose.

Use in patients at risk of developing hyperkalemia

In patients with hyperkalemia or conditions conducive to its development (renal or adrenocortical insufficiency, acute dehydration, extensive tissue damage or burns), as well as in patients suffering from heart disease, Ringer lactate Bioflo should be used with extreme caution.In patients at risk of hyperkalemia, the level of potassium in the plasma should be monitored with particular care.

Use in patients at risk of developing hypercalcemia

Calcium chloride has an irritant effect, so when it is administered intravenously, use caution

and prevent it from flowing into surrounding tissue, and intramuscular injection should be avoided. Solutions containing calcium salts should be used with caution in patients with conditions promoting hypercalcemia, for example, with renal insufficiency and granulomatosis associated with increased calcitriol synthesis (eg, sarcoidosis), calcium kidney stones at present or in the anamnesis.

Fluid balance and renal function

Use in patients with impaired renal function

Ringer lactate Biaflo should be used with extreme caution in patients with impaired renal function. Administration of the drug to such patients can lead to a delay in sodium and / or potassium.

Risk of excess fluid and / or solutes and electrolyte balance disorders

Depending on the volume and speed of infusion against the background of intravenous injection of Ringer's drug, lactate, Biaflo can develop the following conditions:

excess fluid and / or solutes, leading to hyperhydration and, for example, stagnation, including stagnation in the small circulation and pulmonary edema;

clinically significant disorders of electrolyte and acid-base balance.

In patients with cardiac or pulmonary insufficiency, large-volume infusions should be performed under constant supervision.

Use in patients with hypervolemia or conditions that cause retention of sodium and edema

The drug should be used with extreme caution in patients with hypervolemia or hyperhydration.

Due to the sodium chloride content, the drug should be used with extreme caution in conditions that cause sodium retention, hypervolemia and edema, such as primary and secondary aldosteronism (due to, for example, arterial hypertension, congestive heart failure, renal artery stenosis or nephrosclerosis) or preeclampsia.

Acid-base balance

Use in patients at risk of developing alkalosis

It should be used with extreme caution in patients at risk of developing alkalosis.Since lactate is metabolized to bicarbonate, the use of the drug may cause or aggravate metabolic alkalosis.

Against the background of lactate-induced alkalosis, seizures may occur, but infrequently.

- Other instructions

Introduction of citrated (preserved) blood Because of the risk of blood clotting due to the calcium content of Ringer's calcium, Vaflo lactate can not be added to the stabilized citrate (canned) blood or administered simultaneously with it through the same system.

Use in patients with insulin-independent diabetes mellitus Lactate is a substrate for gluconeogenesis, so patients receiving the drug should be carefully monitored for glucose.

Administration of the drug

The use of other medicines or infringement of technique of introduction can cause a fever owing to possible hit in an organism of pyrogens. In this case, the infusion should be stopped immediately.

With prolonged parenteral treatment, the patient needs to ensure a sufficient supply of nutrients.

Effect on the ability to drive transp. cf. and fur:

Not applicable.

Form release / dosage:

Solution for infusions: 250, 500 or 1000 ml in plastic containers

(VIAFLO), made of polyolefin / polyamide coextruded-

plastic.

The container is equipped with a system of ports, which includes a port for additives medicines and port for use the contents of the container.

Containers are placed in protective plastic bags made of

polyamide / polypropylene.

For 30 containers 250 ml, for 20 containers 500 ml, 10 containers each

1000 ml in protective plastic bags together with instructions for use

placed in a cardboard box.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life:

Shelf life 1000 ml: 36 months.

250 ml and 500 ml: 24 months.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:For hospitals

Registration number:LS-001175

Date of registration:12.08.2011

Date of cancellation:2018-03-22

The owner of the registration certificate:Baxter S.L.Baxter S.L. Spain

Manufacturer: & nbsp

BIEFFE MEDITAL, S.A. Spain

Representation: & nbspBaxter Baxter USA

Information update date: & nbsp22.03.2018

Illustrated instructions

Instructions

Ringer Lactate Vaflo (Ringer Lactate Viaflo)