Instructions for Rofitis solution for infusions bottle 400 ml
Composition
active ingredients: sorbitol, sodium acetate trihydrate, sodium chloride, potassium chloride, magnesium chloride hexahydrate, calcium chloride dihydrate;
1 ml of solution for infusion contains sorbitol 50 mg, sodium acetate trihydrate 5.171 mg, sodium chloride 3.623 mg, potassium chloride 1.342 mg, magnesium chloride hexahydrate 0.61 mg, calcium chloride dihydrate 0.294 mg;
1 ml of solution for infusion contains sorbitol 50 mg, sodium acetate trihydrate 5.171 mg, sodium chloride 3.623 mg, potassium chloride 1.342 mg, magnesium chloride hexahydrate 0.61 mg, calcium chloride dihydrate 0.294 mg
excipient: water for injections.
Dosage form
Solution for infusion.
Main physicochemical properties: clear colorless liquid.
Pharmacotherapeutic group
Solutions that affect electrolyte balance. Electrolytes in combination with other drugs. ATX code B05B B04.
Pharmacological properties
Pharmacodynamics. Rofitis is an electrolyte solution with a total cation content of 123 mmol/l, the composition of which is adapted to the transmineralization of metabolism in a state of stress. The sodium content is reduced compared to electrolyte solutions adapted to plasma in order to counteract the existing tendency to retain sodium and with it to accumulate fluid in this metabolic situation. However, the sodium content is high enough to prevent hyperaldosteronism.
In contrast to plasma-adapted electrolyte solutions, the significantly increased proportion of potassium corresponds to the need for potassium, which increases with adequate administration of replacement fluids in stressful situations.
Electrolytes Na+, K+, Ca2+, Mg2+, and Cl– serve to maintain or correct water-electrolyte homeostasis (including blood volume, osmotic balance, acid-base balance, and the effects of individual ions).
Acetate is oxidized and acts as an alkalizing substance in balance.
Isotonic sorbitol solution has a disaggregant effect and thus improves microcirculation and tissue perfusion.
Pharmacokinetics: The bioavailability of the administered fluid after intravenous infusion is 100%.
Sorbitol is quickly incorporated into the general metabolism, 80-90% of it is utilized in the liver and accumulates in the form of glycogen, 5% is deposited in brain tissues, cardiac muscle and skeletal muscle, 6-12% is excreted in the urine.
Acetate is oxidized to bicarbonate and CO2 and acts as an alkalizing agent in balance. The proportion of anions in its combination of unmetabolized (chloride) and metabolized (acetate) anions is a balanced combination that counteracts the body's tendency to develop increased metabolic acidosis. The concentration of bicarbonate and acetate in the blood plasma is regulated by the kidneys, the concentration of CO2 in the plasma by the lungs.
Sodium is the main cation in the extracellular fluid and, together with various anions, regulates its size. Sodium and potassium are the main carriers involved in bioelectrical processes in the body.
The total sodium content in the body is approximately 80 mmol/kg, of which approximately 97% is extracellular and approximately 3% intracellular. The daily requirement is approximately 100–180 mmol (corresponding to 1.5–2.5 mmol/kg body weight).
The kidneys are the main regulator of water-sodium balance. In interaction with hormonal regulatory mechanisms (renin-angiotensin-aldosterone system, antidiuretic hormone), as well as atrial natriuretic factor, they are mainly responsible for maintaining a constant volume and composition of extracellular fluid.
Chloride is exchanged for bicarbonate in the tubular system and thus participates in the regulation of acid-base balance.
Potassium is the most important cation in the intracellular space. 98% of the available potassium in the body is found inside the cells. The intracellular concentration of potassium is approximately 140–150 mmol/L, the normal value in plasma is 3.5–5 mmol/L.
Plasma potassium levels are closely related to acid-base balance. Alkalosis is often accompanied by hypokalemia, and acidosis by hyperkalemia.
In the case of pre-existing acidosis, a potassium level within the normal range is a sign of potassium deficiency.
During glycogen and protein synthesis, potassium is absorbed by the cell and released during glycogen and protein breakdown (approximately 0.4–1 mmol of potassium per g of glycogen, approximately 2–3 mmol of potassium per g of nitrogen loss).
The kidneys are the main regulator of water balance. Sodium, potassium, and magnesium are largely excreted by the kidneys. 90% of potassium is excreted in the urine and about 10% through the gastrointestinal tract.
Indication
The medicine should be used:
- for pre-, intra- and postoperative maintenance of fluid balance;
- to partially cover carbohydrate needs;
- with hypovolemia and isotonic dehydration.
Use as a carrier solution for electrolyte concentrates and concomitant medications.
Contraindication
Hypervolemia, hypernatremia (in particular due to the use of corticosteroids), hyperkalemia, hypermagnesemia, hyperchloremia, hypercalcemia, extracellular hyperhydration, hypotonic dehydration, alkalosis, lactic acidosis, arterial hypertension, cardiovascular and/or renal failure (in particular acute renal failure), conditions with increased blood clotting, thromboembolism, decompensated heart disease, oliguria and anuria, cerebral edema, cerebral hemorrhage, sorbitol intolerance, hypersensitivity to active substances.
Interaction with other medicinal products and other types of interactions
Ceftriaxone
The simultaneous use of ceftriaxone and Rofitis is contraindicated in neonates (aged ≤ 28 days), even if separate infusion systems are used (life-threatening risk of precipitation of ceftriaxone calcium salt in the newborn's bloodstream).
In patients aged 28 days and older (including adults), ceftriaxone should not be administered simultaneously through the same venous channel (e.g., Y-tube) with calcium-containing solutions, including Rofitis.
If an increase in electrolyte concentration is observed, compatibility with the following substances should be considered:
Sodium
Caution should be exercised when using Rofitis in patients receiving drugs that increase the risk of sodium and fluid retention, such as corticosteroids and carbenoxolone, which may lead to edema and hypertension.
Potassium
Due to its potassium content, Rofitis should be used with caution in patients receiving substances or drugs that increase the risk of hyperkalemia, such as: potassium-sparing diuretics (amiloride, spironolactone, triamterene, alone or in combination), ACE inhibitors [angiotensin-converting enzyme], angiotensin II receptor antagonists, suxamethonium or the immunosuppressants tacrolimus and ciclosporin. The use of potassium with such drugs may lead to severe and potentially fatal hyperkalemia, especially in patients with severe renal insufficiency.
Calcium
Calcium may potentiate the effects of cardiac glycosides and thus lead to serious or life-threatening cardiac arrhythmias. Therefore, patients receiving treatment with cardiac glycosides should be treated with caution with larger infusion volumes or faster infusions. It is recommended that Rofitis be administered with caution to patients taking thiazide diuretics or vitamin D, as these drugs increase the risk of hypercalcemia.
Application features
Rofitis should be used with caution in patients with hypochloremic hypokalemic alkalosis (e.g., due to persistent vomiting, pyloric stenosis, persistent transnasal suctioning).
Although the potassium concentration in Rofitis is similar to that in blood plasma, it does not have a sufficient beneficial effect in severe potassium deficiency. Therefore, the drug should not be used to correct acute potassium deficiency.
Rofitis is not indicated for first-line treatment of severe metabolic acidosis.
Rofitis is not indicated for the treatment of hypomagnesemia.
Rofitis is not indicated for the treatment of hypocalcemia.
Allergic reactions
Allergic reactions/infusion reactions, including anaphylactic/anaphylactoid reactions, have been observed with other electrolyte-containing products.
The infusion should be discontinued immediately if signs and symptoms of an allergic reaction occur. Appropriate therapeutic measures should be initiated when clinically indicated.
Risk of developing fluid and/or solute overload and electrolyte imbalance
Depending on the volume and rate of infusion, intravenous administration of Rofitis may cause:
• fluid overload, which can lead to hyperhydration/hypervolemia and, for example, to congestive states, including pulmonary congestion and edema;
• clinically significant electrolyte disturbances and acid-base imbalance.
In general, the risk of developing a decrease in urine specific gravity is inversely proportional to the electrolyte concentration of Rofitis. The risk of developing solute overload, which can cause congestion, is directly proportional to the electrolyte concentration of Rofitis.
When treatment is prolonged or when the patient's condition or infusion rate requires it, clinical observation and periodic laboratory tests are required to monitor changes in fluid balance, electrolyte concentrations and acid-base balance.
Use in patients with mild to moderate cardiac or respiratory failure
Patients with mild to moderate cardiac or respiratory failure should only be given large volumes of solution under special supervision.
Rofitis should be used with caution in patients with:
• hyponatremia;
• renal failure with a tendency to hyperkalemia.
Use in patients with hypermagnesemia or at risk of developing it
Solutions containing magnesium should be used with caution in patients with:
• hypermagnesemia or conditions that may lead to hypermagnesemia, in particular with severe renal failure or in the case of magnesium therapy for eclampsia;
• myasthenia gravis.
Rofitis should be used with extreme caution in patients with alkalosis or at risk of developing alkalosis. Excessive administration of Rofitis may lead to metabolic alkalosis.
Use in patients with diseases that may lead to sodium retention and edema
Rofitis should be used with caution in patients with conditions that may lead to sodium retention, fluid overload and oedema. In particular, these include patients with primary hyperaldosteronism, secondary hyperaldosteronism (associated, for example, with arterial hypertension, congestive heart failure, renal artery stenosis or nephrosclerosis) or preeclampsia.
Use in patients with hyperkalemia or at risk of hyperkalemia
Rofitis should be used with particular caution in patients with hyperkalemia or conditions that may lead to hyperkalemia (such as severe renal or adrenal insufficiency, acute dehydration, or extensive tissue destruction or burns), as well as in patients with heart disease.
Use in patients with severe renal impairment
Rofitis should be used with extreme caution in patients with severe renal insufficiency. In these patients, the use of the drug may lead to sodium and/or potassium or magnesium retention.
Necessary control
Monitoring the patient's condition depends on the clinical situation and examination results and includes determining water and electrolyte balance, serum osmolarity, acid-base balance, blood sugar levels, as well as liver and kidney function.
Use of citrated blood/preserved blood
Due to the risk of blood clots due to the calcium content, Rofitis should not be added to citrated blood/preserved blood or administered simultaneously with citrated blood/preserved blood through the same infusion line.
Rofitis should not be administered simultaneously with blood products through the same infusion system, as pseudoagglutination or hemolysis is possible.
Risk of air embolism
• Do not connect flexible plastic containers in series to avoid air embolism due to possible residual air contained in the first container.
• If a flexible plastic container containing an intravenous solution is squeezed to increase the flow rate, there is a risk of air embolism if the air in the container is not completely removed before use.
• If a vented infusion set is connected in the open position, it may cause air embolism. Vented infusion sets should not be connected to flexible plastic containers in the open position.
Osmolarity
Rofitis is a hyperosmotic solution with an osmolarity of 500 mosmol/L. Normal physiological serum osmolarity is approximately 280 to 310 mosmol/L.
The administration of hyperosmotic solutions may cause vein irritation, including phlebitis.
Hyperosmotic solutions should be used with caution in patients with hyperosmotic conditions.
Risk of extravasation
Due to its calcium content, Rofitis should be used with caution to avoid extravasation of the solution during infusion.
Use in patients with hypercalcemia or at risk of hypercalcemia
Calcium-containing solutions should be used with caution in patients with:
• hypercalcemia or conditions that may lead to hypercalcemia, such as severe renal impairment and granulomatous diseases (due to increased calcitriol synthesis), e.g. sarcoidosis;
• kidney stones consisting of calcium, or a history of nephrolithiasis.
Additional warnings
For the treatment of hypertensive dehydration, only solutions with a sodium content of at least 70 mmol/L should be used. Depending on the cause and nature of the occurrence, dehydration should be compensated as follows:
• slowly over a period of at least 48 hours — in case of prolonged development (dehydrated elderly patients);
• quickly — in case of acute onset (dehydration associated with heat stress, for example in athletes).
Use in elderly patients
When choosing the infusion solution, infusion volume and infusion rate, it should be taken into account that elderly patients are usually more likely to have cardiac, renal, hepatic and other diseases and receive concomitant medication.
Elderly patients may require a reduction in the indicated dose due to fluid overload.
Patients with hereditary fructose intolerance should not be given this medicine unless clearly necessary. All patients should be informed of the symptoms of hereditary fructose intolerance before prescribing this medicine.
Use during pregnancy or breastfeeding
There is insufficient data on the use of Rofitis in women during pregnancy and breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
Rofitis does not affect the ability to drive vehicles and operate other mechanisms.
Method of administration and doses
Dosage, infusion rate, and duration of use are determined by a specialist physician individually for each patient and depend on the indications, age, weight, clinical and laboratory data, metabolic status, concomitant treatment, and clinical effect of treatment on the patient.
Depending on the type of application, the following dosage is recommended:
Single and daily doses
With physiological metabolism, unless otherwise prescribed by a doctor:
30 ml/kg per day (taking into account the amount of sorbitol 1.5 g/kg per day)
≤ 0.54–0.72 mmol K+ / kg BW [body weight], daily
≤ 3–4 mmol Na+ / kg BW, daily
≤ 2100–2800 ml with a body weight of 70 kg per day
Maximum infusion rate
5 ml/kg body weight per hour
≤ 0.09 mmol K+ / kg BW per hour
≤ 0.5 mmol Na+ / kg MT per hour
≤ 350 ml/h (approximately 117 drops/min) at a body weight of 70 kg
General principles of carbohydrate intake and dosage, as well as recommendations for fluid intake, should be followed.
Method of application
Rofitis should be used as prescribed by a doctor to correct water and electrolyte balance disorders.
Rofitis is intended for intravenous drip administration. Drip administration according to metabolic status.
Due to the non-physiological electrolyte content, prolonged use may lead to electrolyte imbalance. Appropriate correction of electrolyte content is required.
Parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit. Only clear solutions in undamaged containers should be used.
When adding other substances to Rofitis, aseptic techniques should be followed. Mix the solution thoroughly when adding other substances. Do not store solutions containing added substances (see section "Incompatibilities").
Children
The safety and effectiveness of electrolyte solution for children have not been confirmed by adequate and well-controlled studies.
Overdose
Symptoms
Excessive administration of Rofitis may lead to the development of metabolic alkalosis, which may be associated with hypokalemia and decreased serum ionized calcium and magnesium levels.
Excessive volume of Rofitis may cause fluid overload and, as a result, edema (peripheral and/or pulmonary), primarily with impaired renal sodium excretion.
Excessive potassium intake may lead to the development of hyperkalemia, especially in patients with severe renal impairment.
Excessive calcium intake can lead to hypercalcemia.
Excessive magnesium administration can lead to hypermagnesemia.
Treatment
When assessing overdose, possible additives contained in the solution should be taken into account.
The consequences of an overdose require immediate medical attention and treatment.
Treatment includes immediate discontinuation of administration, accelerated renal excretion, appropriate electrolyte balance, and, if necessary, insulin administration.
If oliguria or anuria occurs, fluid removal by hemodialysis or peritoneal dialysis may be necessary.
In case of hyperkalemia, infusion of 200–500 ml of 10–25% glucose solution with the addition of 1–3 units of short-acting insulin / 3–5 g of glucose is recommended.
In case of unsuccessful attempt, additional administration of a cation exchanger that binds potassium is indicated. In dangerous cases, dialysis cannot be avoided.
Adverse reactions
Adverse reactions may occur as symptoms of overdose - see the "Overdose" section.
When used as directed, no side effects were observed.
However, as with all intravenous medicinal products, local reactions due to the route of administration cannot be excluded, the exact frequency of which cannot be estimated from the available data. These may include fever, local pain or reaction, infection at the injection site, vein irritation, venous thrombosis, phlebitis at the injection site, extravasation and hypervolaemia.
The following adverse reactions have been reported in the post-marketing period with the use of other solutions of similar composition.
Adverse reactions are listed by system organ class according to the Medical Dictionary for Regulatory Activities (MedDRA). The frequency of these adverse reactions is unknown (cannot be estimated from the available data).
Immune system disorders: anaphylactoid reaction*, urticaria*, angioedema.
Metabolism and nutrition disorders: hyperkalemia.
Cardiac disorders: tachycardia*, palpitations*.
From the nervous system: headache.
Vascular disorders: hypotension*, hypertension, hyperemia*.
Respiratory, thoracic and mediastinal disorders: dyspnea*, wheezing*.
Skin and subcutaneous tissue disorders: piloerection*, cold sweat*.
General disorders and administration site conditions: hyperthermia, infusion site pain, burning sensation**, peripheral oedema*, chest pain*, chest discomfort*, fever*, chills*, asthenia*, malaise*, flushing*.
Investigation: increased respiratory rate*.
* Manifestations of allergic reaction/infusion reaction.
** May occur during drug administration.
Reporting adverse reactions after registration of a medicinal product is of great importance. This allows monitoring of the benefit/risk ratio when using this medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of efficacy of the medicinal product via the automated pharmacovigilance information system at the link: https://aisf.dec.gov.ua.
Incompatibility
Ceftriaxone
As with other calcium-containing infusion solutions, ceftriaxone should not be administered simultaneously with Rofitis to neonates (aged ≤ 28 days), even if separate infusion systems are used (life-threatening risk of precipitation of ceftriaxone calcium salt in the newborn's bloodstream).
In patients 28 days of age and older (including adults), ceftriaxone should not be administered simultaneously through the same intravenous line (e.g., Y-tube) with calcium-containing solutions, including Rofitis. If the same line is used for sequential administration, it should be thoroughly flushed between infusions with a compatible fluid.
Ceftriaxone must not be mixed with solutions containing calcium, in particular with Rofitis (see section “Interaction with other medicinal products and other types of interactions”).
Use as a carrier solution
When mixing with other drugs, it should be taken into account that Rofitis has an alkaline pH (7.2). This may lead to precipitation in the mixture.
Some medications may be incompatible with Rofitis.
As with all parenteral solutions, the compatibility of the medicinal products with the solution should be checked before addition. Before adding any substance or preparation, it should be ensured that the substance or preparation is water-soluble and stable at the pH of Rofitis. After addition, the solution should be inspected for possible changes in colour and/or precipitate, insoluble complexes or crystals.
When adding medicinal substances to Rofitis, aseptic techniques should be followed. Mix the solution thoroughly when using Rofitis as a carrier. Do not store solutions containing added substances.
For incompatibility of blood products, see the section "Special instructions for use".
The medicinal product contains Ca2+ ions. Addition of inorganic phosphate, bicarbonate/carbonate or oxalate may result in precipitation.
Expiration date
2 years.
Do not use the drug after the expiration date indicated on the package.
Storage conditions
Does not require any special storage conditions. Keep out of the reach of children.
Packaging
100 ml or 200 ml, or 400 ml, or 500 ml in a bottle. 1 bottle in a pack.
Vacation category
According to the recipe.
Producer
JSC "Farmak".
Location of the manufacturer and address of its place of business
Ukraine, 04080, Kyiv, Kyrylivska St., 74.
