Ringer lactate - instructions for use, dose, side effects, contraindications

Active substances:
Sodium chloride	6.00 g
Potassium chloride	0.40 g
Calcium chloride hexahydrate (in terms of anhydrous)	0.20 g
Sodium lactate 50% solution (in terms of sodium lactate)	3.20 g
Excipient:
Water for injections	up to 1 liter
Ionic composition:
Sodium ion	131 mmol / l
Potassium ion	5 mmol / l
Calcium ion	2 mmol / l
Chloride ion	111 mmol / l
Lactate ion	29 mmol / l
Theoretical osmolality	278 mOsm / l

Description:Transparent colorless liquid.

Pharmacotherapeutic group:Electrolyte balance recovery agent

ATX: & nbsp

B.05.B.B.01 Electrolytes

Pharmacodynamics:

Rehydrating agent, has a detoxification effect. Normalizes the acid-base state, replenishes the deficiency of the volume of circulating blood, stabilizes the water-electrolyte composition of the blood. The solution is close to isotonic.The main effect of the drug is to compensate for extracellular interstitial and intravascular fluid exchange.

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.

Pharmacokinetics:

After intravenous administration, the solution passes into the tissues for 30 minutes.

Primarily excreted in the urine.

Sodium chloride

Sodium chloride after administration quickly spreads throughout the body, is not metabolized significantly, is primarily excreted in the urine, to a lesser extent with sweat, tears and saliva.

Potassium Chloride

The potassium ion is excreted mainly in urine, in small amounts with feces, as well as with saliva, bile and pancreatic juices.

Calcium chloride

Most of the calcium is excreted in the urine, as well as the nonabsorbable part of calcium is excreted with feces, some is secreted through bile and with pancreatic juice. A small amount of calcium is excreted with sweat and breast milk.

Sodium Lactate

The lactate ion is distributed throughout the body and is metabolized in the liver to sodium bicarbonate and promotes alkalinizationplasma.

Indications:Hypovolemia, isotonic dehydration, metabolic acidosis.

Contraindications:

Hypersensitivity, extracellular hyperhydration or hypervolemia, severe renal failure (with oliguria / anuria), decompensated heart failure, hyperkalemia, hypercalcemia, metabolic alkalosis, ascites in cirrhosis, severe metabolic acidosis, conditions associated with elevated levels lactate (hyperlactatemia), including lactic acidosis, or with impaired lactate assimilation, for example, severe hepatic insufficiency, concomitant therapy with cardiac glycosides, concomitant use with ceftriaxone in neonates (up to 28 days of age), even with separate infusion systems (risk of complication calcium salts of ceftriaxone in the bloodstream with a fatal outcome).

Carefully:Hypernatremia, including diabetes insipidus, extensive tissue damage, chronic heart failure; hyperchloremia, including renal tubular necrosis, diabetes insipidus, with urine diversion, with the concomitant use of diuretics-inhibitors of carbonic anhydrase, steroid hormones; with severe dehydration; states that promote the development of hyperkalemia.including renal insufficiency, adrenocortical insufficiency, acute dehydration, extensive tissue damage, including due to burns; conditions that promote the development of hypercalcemia: renal failure, granulomatosis associated with increased calcitrol synthesis (eg, sarcoidosis), calcium kidney stones at present or in the anamnesis; impaired renal function; hypervolemia or hyperhydration (primary and secondary aldosteronism (due, for example, arterial hypertension, congestive heart failure, renal artery stenosis or nephrosclerosis) or preeclampsia); children under 6 months; simultaneous application with ceftriaxone in patients older than 28 days (including adults) through the same infusion system. If the same infusion system is used for sequential administration, it should be thoroughly rinsed between infusions with a suitable liquid.

Pregnancy and lactation:

The purpose of the drug during pregnancy and during breastfeeding is possible if the intended use of the mother exceeds the potential risk to the fetus.It should be remembered that calcium passes through the placenta and penetrates into breast milk.

When adding medicines to the solution, their properties and the possibility of application during pregnancy and breastfeeding should be assessed separately.

Dosing and Administration:

Intravenously (drip). Doses, speed and duration of administration should be individual and depend on the indication for use, age, body weight, clinical and acid-base status, concomitant treatment of the patient, and clinical and laboratory response of the patient to treatment. The amount of the drug required to restore normal blood volume is 3-5 times the volume of blood loss.

The recommended dose for adults is from 500 ml to 3 liters per day (infusion rate - 40 ml / kg per day).

The recommended dose for children is 20 to 100 ml / kg per day (infusion rate - 5 ml / kg / h) can vary depending on age: for children aged 28 days to 1 year, 6-8 ml / kg / h; for children aged 1 to 6 years - 4-6 ml / kg / h; for children aged 6 to 11 years - 2-4 ml / kg / h. The total volume of the injected solution depends on the age of the child and is determined at the physician's discretion.For children with burns, the average dose is 3.4 ml / kg per 1% of the burn area on the first day after the burn and 6.3 ml / kg per 1% of the burn area for 48 hours. In severe head injury, the dose in children is 2850 ml / m².

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

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

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

Dispose of the containers after a single use. Dispose of each unused dose.

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

Side effects:

Adverse adverse reactions recorded during postmarketing use are grouped according to systems and organs in accordance with the vocabulary MedDRA.

From the immune system: hypersensitivity reactions or infusion reactions, including anaphylactic or anaphylactoid reactions, possibly manifested by one or more of the following symptoms: angioedema, chest pain, chest discomfort, decreased heart rate, tachycardia, lowering blood pressure, respiratory failure. bronchospasm, dyspnea, cough, urticaria, rash, itching, erythema, hot flashes, irritation in the throat, paresthesia, oral cavity hyposeusia, taste disorder, anxiety, fever, headache.

From the side of metabolism and nutrition: hyperkalemia.

General disorders and disorders at the site of administration: reactions at the infusion site, manifested by one or more of the following symptoms: phlebitis, inflammation in the infusion site, swelling in the infusion site, rash at the infusion site, itching at the infusion site, erythema at the infusion site, pain in the infusion site, burning in the infusion site. Spontaneous reports of the following adverse reactions have been reported with other solutions containing sodium lactate: hypersensitivity: laryngeal edema (Quincke's edema), skin swelling,nasal congestion, sneezing; violation of electrolyte balance; hypervolemia; a panic attack; other reactions at the infusion site: infection at the injection site, flowing into surrounding tissue, loss of sensation (numbness) at the site of infusion. Adverse adverse reactions may be associated with drugs added to the solution; The likelihood of any other side effects will be determined by the nature of the added drugs.

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 arrhythmia of the heart and coma. Too rapid intravenous injection of calcium salts can lead to the development of symptoms of hypercalcemia, as well as to lime aftertaste, "hot flashes" and peripheral vasodilation. An easy degree of asymptomatic hypercalcemia. as a rule, is allowed when discontinuing the administration of calcium and other predisposing drugs to it, for example, vitamin D. With severe hypercalcemia, urgent treatment is required (such as "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: mood changes, fatigue, shortness of breath, muscle weakness, arrhythmia. They can develop, especially in patients with hypocalcemia - hypertonus, 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. Also replenishment of calcium, chloride and potassium.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 added drug. 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 measures are taken.

Interaction:

The 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.

The interaction associated with the presence of calcium: cardiac glycosides, whose effects are enhanced in the presence of calcium and can lead to a serious fatal cardiac arrhythmia. Thiazide diuretics, vitamin D 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 bicarbonate): drugs that have an acidic reaction, such as salicylates, barbiturates and lithium, whose renal clearance is increased due to alkalization of urine by the 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. The doctor must determine the incompatibility of the drugs to be added with 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 medications to the Ringer lactate preparation, the resulting solution should be administered immediately. Drugs that are incompatible with Ringer Lactate: aminocaproic acid, amphotericin B, metamninol tartrate, cefamandol, cortisone acetate, diethylsilbestrol, etamivan, ethyl alcohol, phosphate and carbonate solutions, oxytetracycline, sodium thiopental, sodium versenate.

Medicinal preparations partially incompatible with the drug Ringer lactate: tetracycline - the solution is stable for 12 hours; ampicillin sodium - a 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 hours.

Do not use medicines with a known incompatibility.

Special instructions:

The solution is intended for intravenous administration using sterile, pyrogen-free equipment while observing aseptic rules.

Before use, inspect the solution visually for mechanical inclusion and discoloration. Apply only clear solution, without visible inclusions, and if the package is not damaged. To avoid air embolism, remove air from the equipment with a solution.

Enter the solution directly after connecting to the infusion system.

Do not use a series connection of plastic containers. This can lead to air embolism due to sucking in the air left in the first container, which can occur before the solution from the next container arrives.

Additional drugs can be administered via the appropriate port before infusion or during the infusion.Add to the solution of the drug other medicines should only under aseptic conditions. A solution containing added medicines should not be stored, the resulting solution should be added immediately after preparation.

The use of other medicines or infringement of technique of introduction can cause a fever owing to possible hit in an organism of pyrogens. If unwanted reactions develop, stop the solution immediately.

Hypersensitivity reactions

If signs of suspected hypersensitivity appear, the infusion should immediately stop and take the necessary therapeutic measures according to the indications.

Balance of electrolytes

Hypernatremia

- The drug should be used in patients with hypernatremia only after a thorough study of the root cause and consideration of alternative means 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 contribute to 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 control the chloride content in 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 urinary diversion 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 lactate preparation is close to its concentration in the plasma, it is not enough to compensate for the severe potassium deficiency, so the drug should not be used for this purpose.

Use in patients at risk of developing hyperkalemia

Ringer lactate should be used with caution 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. 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 is irritating, so with its intravenous administration, care should be taken not to let it flow into surrounding tissues, and intramuscular administration 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 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.

The risk of excess fluid and / or solutes and the imbalance of electrolytes

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

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

- clinically significant violations of electrolyte and acid-base balance.

In patients with cardiac or pulmonary insufficiency, large-volume infusions should be monitored continuously.

Use in patients with hypervolemic conditions, causing sodium retention and swelling

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

In view of the sodium chloride content, the drug should be used with extreme caution in conditions that cause sodium retention, hypervolemia and edema,as primary and secondary aldosteronism (due, for example, to 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 the Ringer's preparation, lactate can not be added to citrated (preserved) blood stabilized 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:

Data are not available, as the drug is used in a hospital.

Form release / dosage:

Solution for infusion.

Packaging:

For 250 or 500 ml in polyethylene bottles with Eurosheet.

By 250 or 500 ml into containers of multi-layer film made of polypropylene or polyolefin.

A single container is packaged in an individual polymer bag made of a polypropylene or polyethylene film, or without an individual polymer bag.

For 16 bottles of 250 or 500 ml with an equal number of instructions for medical use are placed in boxes of corrugated cardboard (for hospitals).

For 18 500 ml containers or 32 250 ml containers each packed in a polymer bag or without a polymer bag, with an equal number of instructions for medical use placed in a box ofcorrugated cardboard (for hospitals).

Storage conditions:

Store in a dark place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

Shelf life:

2 years. Do not use after expiry date.

Terms of leave from pharmacies:For hospitals

Registration number:LP-004560

Date of registration:27.11.2017

Expiration Date:27.11.2022

The owner of the registration certificate:Sphera-Pharm, OOOSphera-Pharm, OOO Russia

Manufacturer: & nbsp

Sphera-Pharm, OOO Russia

Illustrated instructions

Instructions

Ringer lactate (Ringer lactici)