Ringer's lactate FKI

Italy
Brand name Ringer's lactate FKI
Form solution for infusion
Active substance / Dosage
SODIUM CHLORIDE
POTASSIUM CHLORIDE
CALCIUM CHLORIDE DIHYDRATE
SODIUM LACTATE 50%
Prescription type Prescription only
ATC code
B05BB01
Registration number 030773
Manufacturer FRESENIUS KABI ITALIA S.R.L.
Ringer's lactate FKI solution for infusion

Table of Contents

Package leaflet: Information for the user

RINGER LACTATE FRESENIUS KABI ITALIA infusion solution

Generic Medicine
Please read this leaflet carefully before using this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, ask your doctor, pharmacist or nurse.
  • This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
  • If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

  1. What RINGER LACTATE FRESENIUS KABI ITALIA is and what it is used for
  2. What you need to know before using RINGER LACTATE FRESENIUS KABI ITALIA
  3. How to use RINGER LACTATE FRESENIUS KABI ITALIA
  4. Possible side effects
  5. How to store RINGER LACTATE FRESENIUS KABI ITALIA
  6. Contents of the pack and other information

1. What RINGER LACTATE FRESENIUS KABI ITALIA is and what it is used for

RINGER LACTATE FRESENIUS KABI ITALIA is an infusion solution to be injected directly into a vein, containing a combination of active substances: sodium chloride, potassium chloride, calcium chloride dihydrate and sodium lactate.
This medicinal product is indicated:

  • to provide water and electrolytes to the body following losses of extracellular fluids and electrolytes, thereby restoring normal electrolyte levels necessary for proper body function, and to restore normal blood pH when mild or moderate acidosis (increased acidity) occurs;
  • to restore normal blood pressure following shock caused by significant blood loss (mild or moderate haemorrhagic shock).

2. What you need to know before using RINGER LACTATE FRESENIUS KABI ITALY

Do not use RINGER LACTATE FRESENIUS KABI ITALY

  • if you are allergic to sodium chloride, potassium chloride, calcium chloride dihydrate, sodium lactate, or any of the other components of this medicine (listed in section 6);
  • if you have severe kidney problems (renal failure);
  • if you have high levels of calcium in the blood (hypercalcemia) and in the urine (hypercalciuria), or suffer from severe kidney diseases;
  • if you have high levels of sodium in the blood (hypernatremia) or of other electrolytes (water-electrolyte overload);
  • if you have high levels of potassium in the blood (hyperkalemia) or reduced ability to eliminate potassium (potassium retention);
  • if you have a heart rhythm disorder called ventricular fibrillation, because calcium chloride may increase the risk of cardiac arrhythmias;
  • if you have kidney stones, which may worsen with calcium administration;
  • if you suffer from a chronic systemic disease called sarcoidosis, which may enhance the increase in blood calcium levels (hypercalcemia);
  • if you have circulatory problems due to a high tendency of blood to clot (hypercoagulability);
  • if you are taking heart medications called cardioactive glycosides (see section “Other medicines and RINGER LACTATE FRESENIUS KABI ITALY”);
  • if you have an increased blood pH (metabolic and respiratory alkalosis);
  • if you suffer from a disease of the adrenal glands (Addison's disease) and are not receiving treatment for it;
  • if you experience painful, brief muscle cramps (heat cramps);
  • if the patient is a newborn (≤ 28 days of age), RINGER LACTATE FRESENIUS KABI ITALY (or other calcium-containing solutions) must not be administered simultaneously with ceftriaxone (an antibiotic), even if separate infusion lines are used. There is a risk of fatal particle formation in the newborn's bloodstream.

During blood transfusions, this solution must not be administered through the same infusion catheter as whole blood due to the possible risk of blood coagulation.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before using RINGER LACTATE FRESENIUS KABI ITALY infusion solution.

This medicine must be administered via a very slow infusion , as potassium intoxication may occur, potentially leading to death due to loss of heart function (cardiac depression), cardiac rhythm disturbances (arrhythmias), up to cardiac arrest (see section “How to use RINGER LACTATE FRESENIUS KABI ITALY”).

If signs or symptoms of suspected hypersensitivity occur, the infusion must be stopped immediately.

Due to its sodium content, this medicine must be administered with caution in the following cases:

  • if you have heart problems (congestive heart failure, cardiac insufficiency);
  • if you have kidney problems (renal failure);
  • if you have fluid accumulation (edema with salt retention), either in the lungs (pulmonary edema) or associated with swelling of the ankles and legs (peripheral edema);
  • if you are taking heart medications (cardiotonic inotropic drugs), steroid anti-inflammatory drugs (corticosteroids), or hormonal medicines (corticotropins);
  • if you have high blood pressure (hypertension);
  • if you suffer from a condition called pre-eclampsia, characterized by high blood pressure, swelling due to fluid accumulation, and presence of proteins in the urine, or other conditions caused by sodium accumulation.

This medicine should not be administered to:

  • patients with conditions that may cause sodium retention, fluid overload, and edema, such as patients with primary hyperaldosteronism, secondary hyperaldosteronism (e.g., associated with hypertension, congestive heart failure, renal artery stenosis, or nephrosclerosis), or pre-eclampsia; if strictly necessary, it should be administered with particular caution;
  • patients with conditions predisposing to hyperkalemia (such as severe kidney damage or adrenal insufficiency, severe dehydration, or extensive tissue injury), and in patients with heart failure; if strictly necessary, it should be administered with particular caution.

Due to its potassium content, this medicine must be administered with caution in the following cases:

  • if you have kidney problems (renal failure), as it may cause potassium retention;
  • if you have heart problems (cardiac insufficiency) and are taking other heart medications (digitalis);
  • if you have an adrenal gland disorder (adrenal insufficiency);
  • if you have liver problems (hepatic insufficiency);
  • if someone in your family suffers from a disorder characterized by sudden episodes of muscle weakness (familial periodic paralysis);
  • if you suffer from a condition characterized by muscle stiffness (congenital myotonia);
  • if you have recently undergone surgery (early post-operative phase). Although Ringer Lactate has a potassium concentration similar to plasma levels, it is insufficient to produce a therapeutic effect in cases of severe potassium deficiency; therefore, it should not be used for this purpose.

Due to its calcium content, this medicine must be administered with particular caution in the following cases:

  • if you have kidney (renal failure) or heart problems, as it may increase the risk of cardiac arrhythmias;
  • if you have received a blood transfusion, as calcium ion concentrations may differ from expected levels;
  • if you suffer from lung problems that may cause heart enlargement (cor pulmonale);
  • if you have breathing difficulties (respiratory failure) or a decreased blood pH (respiratory acidosis);
  • if you have low body water levels (dehydration) or an electrolyte imbalance; if you have low blood pressure, because calcium chloride administration may cause vasodilation leading to further blood pressure reduction.

Calcium-containing solutions must be used carefully in patients with a history of kidney stones.

Calcium chloride solution is irritating and therefore must not be administered by intramuscular injection, subcutaneous injection, or peri-vascular injection, as tissue damage and death (necrosis) may occur.

Due to its lactate content, this medicine must be used cautiously in patients with lactic acidosis or impaired oxidative processes preventing lactate utilization (e.g., shock, hypoxemia).

Ringer Lactate should not be administered to patients at risk of alkalosis; if strictly necessary, it must be administered with particular caution. Since lactate is metabolized into bicarbonate, administration may cause or worsen metabolic alkalosis.

Ringer Lactate should not be administered to patients with conditions associated with increased lactate levels or impaired lactate utilization, such as severe hepatic insufficiency; if strictly necessary, it must be administered with particular caution.

In patients with severe hepatic insufficiency, hyperlactatemia may develop due to impaired lactate metabolism.

Lactate is a substrate for gluconeogenesis. This should be taken into account when Ringer Lactate is used in patients with type 2 diabetes.

During treatment with this medicine, your doctor must periodically monitor heart function via serial electrocardiograms and check electrolyte levels, fluid balance, osmolarity, and blood pH.

Serum and urinary calcium levels must be frequently monitored to prevent hypercalciuria (high calcium levels in urine), which may lead to increased blood calcium levels (hypercalcemia).

Hypersensitivity

The infusion must be stopped immediately if signs or symptoms of suspected hypersensitivity occur. Appropriate therapeutic countermeasures must be initiated as clinically indicated.

  • Pay particular attention if you are in any of the following conditions that may cause elevated vasopressin hormone levels:
  • acute illness
  • pain
  • recent surgery
  • infections, burns
  • brain diseases
  • liver, heart, or kidney diseases

These conditions may increase the risk of low sodium levels in the blood (hyponatremia), with symptoms such as headache, nausea, seizures, drowsiness, vomiting, cerebral edema, which may be fatal. Individuals at increased risk of cerebral edema include:

  • children
  • women (especially those of childbearing age)
  • individuals with altered brain fluid levels (e.g., due to meningitis, intracranial bleeding, or brain trauma).

This medicine must be used immediately after opening the container. The solution must be clear, colorless, and free of visible particles, and is intended for single, uninterrupted administration. Any remaining solution must not be used.

Children

In children, the safety and efficacy of this medicine have not been established.

As with other calcium-containing solutions, concomitant treatment with ceftriaxone is contraindicated in neonates (under 28 days of age) due to the risk of fatal precipitation of ceftriaxone-calcium salt in the neonatal bloodstream (see section “Possible side effects”).

Children are particularly at risk of life-threatening cerebral edema caused by acute hyponatremia.

Other medicines and RINGER LACTATE FRESENIUS KABI ITALY

Inform your doctor if you are currently using, have recently used, or might use any other medicines, especially if you are taking:

  • drugs that stimulate vasopressin release: chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxy-N-methamphetamine, ifosfamide, antipsychotics, narcotics
  • drugs that enhance vasopressin action: chlorpropamide, NSAIDs, cyclophosphamide
  • vasopressin analogs: desmopressin, oxytocin, vasopressin, terlipressin
  • other drugs that increase the risk of hyponatremia, including diuretics in general and antiepileptic drugs such as oxcarbazepine.

Contraindicated combinations

Concomitant therapy with cardioactive glycosides (digitalis), digoxin, and digitoxin is contraindicated, as their combined use may increase the risk of arrhythmias due to synergistic inotropic and toxic effects (see Contraindications).

Combinations requiring caution

Angiotensin II receptor antagonists
Immunosuppressants such as tacrolimus and cyclosporine
Due to potassium content and the risk of hyperkalemia, administer with caution.
Corticosteroids
Corticosteroids are associated with sodium and water retention, leading to edema and hypertension; therefore, caution is required when administering sodium salts together with corticosteroids (see Precautions for use).
Thiazide diuretics, vitamin D
Hypercalcemia may occur due to reduced renal calcium excretion.
Medicines containing magnesium
Risk of hypercalcemia or hypermagnesemia may increase, especially in patients with renal disorders.
ACE inhibitors
The use of ACE inhibitors, which reduce aldosterone levels, may lead to potassium retention. Therefore, serum potassium levels must be closely monitored.
Potassium-sparing diuretics
The use of drugs such as potassium-sparing diuretics may increase the risk of hyperkalemia, especially in the presence of renal dysfunction. Therefore, in such cases, serum potassium levels must be closely monitored.

Effects of Ringer Lactate on other medicines

Caution is advised when administering Ringer Lactate to patients treated with drugs whose renal elimination depends on pH. Due to the alkalinizing effect of lactate (bicarbonate formation), Ringer Lactate may interfere with the elimination of such drugs:

  • renal clearance of acidic drugs such as salicylates, barbiturates, and lithium may be increased
  • renal clearance of basic drugs, such as sympathomimetics (e.g., ephedrine, pseudoephedrine), dexamfetamine sulfate, and phenylfluramine hydrochloride, may be decreased.

Calcium chloride solution may interact with the following medicines:

  • verapamil (and other calcium channel blockers), as concomitant use may reduce verapamil's antihypertensive effect;
  • neuromuscular blockers: calcium salts may counteract the effects of non-depolarizing neuromuscular blockers; in some cases, an increased and prolonged effect of tubocurarine has also been observed.
  • ceftriaxone (an antibiotic) due to the risk of particle formation.

Pregnancy and breastfeeding

If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before this medicine is administered.

Ringer Lactate Fresenius Kabi Italia must be administered with particular caution in pregnant women during labor, especially if administered in combination with oxytocin (a hormone that may induce labor and control bleeding), due to the risk of hyponatremia.

This medicine must not be used during pregnancy or breastfeeding unless absolutely necessary.

Driving and using machines

This medicine does not affect the ability to drive vehicles or operate machinery.

3. How to use RINGER LACTATE FRESENIUS KABI ITALIA

This medicine will be prepared by a doctor, pharmacist, or nurse and must not be mixed or administered simultaneously with injections containing ceftriaxone.
This medicine must be administered directly into a vein (intravenous infusion) by trained medical personnel. It must not be injected via other routes of administration (intramuscular, subcutaneous, or into perivascular tissues).
This medicine must only be administered if your kidney function is normal and at a rate not exceeding 10 mEq of potassium per hour.
After administration of the medicine, remain lying down for a short period.
The dose will be adjusted according to your age, body weight, health condition, concomitant treatments, and the patient's clinical and laboratory response to therapy.

Adults
The recommended dose in adults is approximately 20–30 ml of solution per kg of body weight per day, which may be increased up to a maximum of 40 ml of solution per kg of body weight per day.
Administration must be stopped if you experience pain or redness at the injection site, as this may be due to leakage of the medicine from the vein (drug extravasation).
When choosing the volume/infusion rate, care must be taken regarding existing diseases and concomitant therapies (see Precautions for use and Interactions).

Children
Infusions that are too rapid may cause local pain; the infusion rate must be adjusted according to tolerance.
Administration must be stopped if you experience pain or redness at the injection site, as this may be due to leakage of the medicine from the vein (drug extravasation).

Preparation of the medicine: Use the solution immediately after opening the container. The container is intended for single, uninterrupted administration and any remaining solution must not be used.
Shake well before administration. Do not use the medicine if the solution is not clear and colourless or if it contains particles.
Ensure all precautions are taken to maintain sterility before and during intravenous infusion.

If you use more RINGER LACTATE FRESENIUS KABI ITALIA than you should
This medicine will be administered by a doctor or trained healthcare professional; therefore, it is unlikely that you will receive an excessive dose. However, if you think you have been given too much RINGER LACTATE FRESENIUS KABI ITALIA, inform your doctor immediately or go to the nearest hospital.

Following administration of an excessive dose of this medicine, the following may occur:

  • Increased levels of potassium in the blood (hyperkalaemia), which may lead to death due to heart damage (cardiac depression, arrhythmias, or arrest);
  • Increased levels of sodium (hypernatraemia) and increased blood volume (hypervolaemia). If sodium levels in the blood rise too much, loss of fluids from internal organs (dehydration), particularly from the brain, may occur, along with fluid accumulation affecting the cerebral, pulmonary, and peripheral circulation, leading to fluid buildup around the lungs (pulmonary oedema) or swelling in the legs and ankles (peripheral oedema);
  • Increased levels of chloride, resulting in a reduction of blood pH (acidosis) due to decreased bicarbonate ion concentration;
  • Increased levels of calcium in the blood (hypercalcaemia), leading to thirst, nausea, vomiting, constipation, increased urine production (polyuria), abdominal pain, muscle weakness, mental disturbances, and in severe cases, heart problems (cardiac arrhythmia) and coma.

If you have any doubts about the use of RINGER LACTATE FRESENIUS KABI ITALIA, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects may occur, especially in case of inappropriate administration or administration that is too rapid (see section “Warnings and precautions”).

Not known (frequency cannot be estimated from the available data):

  • Stomach and intestinal disturbances and irritation (gastrointestinal disorders), nausea, vomiting, diarrhoea, abdominal pain, constipation;
  • Thirst, reduced salivation, metallic taste, chalky taste;
  • Muscle and nerve disturbances (neuromuscular), muscle stiffness, altered sensation in limbs (paraesthesia), loss of muscle tone (flaccid paralysis), weakness;
  • Mental confusion, headache, dizziness, restlessness, irritability;
  • Seizures, coma, death;
  • Drowsiness, confusional states, mental disorders;
  • Irregular heartbeat (arrhythmias), tachycardia, bradycardia, conduction disorders, disappearance of the P wave, widening of the QRS complex on the electrocardiogram, syncope, ventricular fibrillation, cardiac arrest;
  • Decrease or increase in blood pressure (hypotension, hypertension), swelling of limbs (peripheral oedema), vasodilation, hot flushes;
  • Increase or decrease in blood levels of sodium (hypernatraemia/hyponatraemia), chloride (hyperchloraemia), and blood volume (hypervolaemia);
  • Breathing difficulties (dyspnoea, respiratory arrest);
  • Fluid accumulation in the lungs (pulmonary oedema) and air around the lung (pneumothorax);
  • Reduced tear production;
  • Kidney problems (renal failure), increased urine production (polyuria);
  • Increased calcium levels in the blood (hypercalcaemia);
  • Burnett’s syndrome (also known as milk-alkali syndrome), a condition caused by excessive intake of milk or alkaline compounds, characterised by symptoms such as nausea, vomiting, headache, and muscle weakness;
  • Muscle weakness;
  • Fever, infection and inflammation at the infusion site, pain or local reaction, redness, rash, burning, itching, swelling at the infusion site;
  • Circulatory problems due to blood clot formation in veins (thrombosis);
  • Inflammation of veins extending from the infusion site (phlebitis);
  • Leakage of medicine into surrounding tissues at the injection site (extravasation);
  • Tissue damage and tissue death (tissue necrosis);
  • Abscess formation and calcium deposits in the skin (cutaneous calcification);
  • Kidney problems caused by calcium-ceftriaxone deposits, especially in children. Pain during urination may occur or urine output may decrease (see section Warnings and precautions). In preterm and full-term neonates (age < 28 days), serious, even fatal, reactions may occur when ceftriaxone and calcium are administered concomitantly;
  • Immune system disorders: hypersensitivity reactions to infusion, including anaphylactic/anaphylactoid reactions.
  • Low levels of sodium in the blood (hospital-acquired hyponatraemia**);
  • Cerebral oedema (hyponatraemic encephalopathy**)

** Hospital-acquired hyponatraemia may cause irreversible brain damage and death due to the development of acute hyponatraemic encephalopathy.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store RINGER LACTATE FRESENIUS KABI ITALIA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after “Exp.”.
The expiry date refers to the last day of that month.
Store in the original packaging and in a tightly closed container. Do not refrigerate or
freeze.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What RINGER LACTATE FRESENIUS KABI ITALIA contains

  • The active substances are: sodium chloride, potassium chloride, calcium chloride dihydrate and sodium lactate. 1000 ml of solution contain 6.0 g of sodium chloride, 0.4 g of potassium chloride, 0.27 g of calcium chloride dihydrate, 6.34 g of 50% sodium lactate. Each litre of solution contains 130.9 mEq of sodium, 5.4 mEq of potassium, 3.68 mEq of calcium, 111.7 mEq of chloride and 28.3 mEq of lactate.
    pH: 5.5–7.0.

  • The other components are: water for injections, hydrochloric acid and sodium hydroxide (as pH regulators).

Description of the appearance of RINGER LACTATE FRESENIUS KABI ITALIA and contents of the
package
Infusion solution, sterile and pyrogen-free.
Glass vial 50 ml, 100 ml, 250 ml, 500 ml, 20x500 ml, 1000 ml
PE vial 250 ml, 20x250 ml, 30x250 ml, 500 ml, 10x500 ml,
20x500 ml
PP glass vial 250 ml, 500 ml, 24x500 ml
Flexible bag 100 ml, 250 ml, 500 ml, 1000 ml
Freeflex bag with overpouch 50 ml, 100 ml
Freeflex bag 250 ml, 500 ml, 1000 ml, 10x1000 ml
Freeflex bag with overpouch and ship shape ports 50 ml, 100 ml
Freeflex bag with ship shape ports 250 ml, 500 ml, 1000 ml, 10x1000 ml

Marketing Authorisation Holder and Manufacturer responsible for batch release:
Marketing Authorisation Holder:
Fresenius Kabi Italia S.r.l.
Via Camagre, 41
37063 Isola della Scala (VR)
Italy

Manufacturer
Fresenius Kabi Italia S.r.l. – Via Camagre, 41 – 37063 Isola della Scala (VR) – Italy
Fresenius Kabi France – 6, rue du Rempart BP 611 – 27400 Louviers Cedex - France
Fresenius Kabi Deutschland GmbH – Friedberg – Germany
Fresenius Kabi Polska Sp. z o.o – Kutno – Poland
Fresenius Kabi España SA - Dr. Ferran, 12 - E-08339 Vilassar de Dalt – Barcelona – Spain
S.M. Farmaceutici S.r.l – Industrial Zone – 85050 Tito (PZ) – Italy

Stylized icon of a pair of open scissors with blades pointing to the left and circular handles on the right

The following information is intended exclusively for physicians or healthcare professionals

CLINICAL INFORMATION
Dosage and Administration
The solution is isotonic with blood and must be administered with caution by intravenous infusion at a controlled infusion rate, using sterile and pyrogen-free equipment.
Electrolyte balance, serum electrolytes, and acid-base balance may need to be monitored before and during administration, with particular attention to serum sodium in patients with non-osmotic release of vasopressin (syndrome of inappropriate antidiuretic hormone secretion, SIADH) and in patients receiving concomitant therapy with vasopressin agonists, due to the risk of hospital-acquired hyponatremia (see sections 4.4, 4.5, and 4.8 of the Summary of Product Characteristics).
Monitoring of serum sodium is particularly important for hypotonic solutions.
Tonicity of Ringer Lactate Fresenius Kabi Italia: 278 mOsm/l.
The infusion rate and volume depend on age, body weight, and clinical condition (e.g., burns, surgical procedures, head injuries, infections).
For pediatric patients, the dose and rate of administration should be determined by a physician experienced in pediatric fluid therapy. Concomitant therapy must be determined by a physician experienced in pediatric intravenous fluid therapy (see sections 4.4 and 4.8 of the Summary of Product Characteristics).
Infusion of large volumes should be used under specific monitoring conditions in patients with cardiac or pulmonary insufficiency and in patients with non-osmotic vasopressin release (including SIADH), due to the risk of hospital-acquired hyponatremia (see below).

Hyponatremia
Patients with non-osmotic vasopressin release (e.g., during acute illness, pain, postoperative stress, infections, burns, and central nervous system disorders), patients with cardiac, hepatic, or renal diseases, and patients treated with vasopressin agonists (see section 4.5) are particularly at risk of acute hyponatremia following infusion of hypotonic solutions.
Acute hyponatremia may cause acute hyponatremic encephalopathy (cerebral edema), characterized by headache, nausea, seizures, lethargy, and vomiting. Patients with cerebral edema are at particularly high risk of severe, irreversible, and life-threatening brain injury.
Children, women of childbearing age, and patients with reduced cerebral compliance (e.g., meningitis, intracranial hemorrhage, cerebral contusion, and cerebral edema) are particularly at risk of severe and life-threatening cerebral edema caused by acute hyponatremia.

Management of Overdose
Immediately discontinue the infusion and initiate corrective therapy to reduce plasma levels of excess ions and restore, if necessary, acid-base balance (see section 4.4).
The patient should be closely observed for the emergence of any signs and symptoms related to the administered drug, with appropriate symptomatic and supportive measures provided as needed.
In cases of severe hypernatremia, loop diuretics may be used.
In cases of hyperkalemia, intravenous glucose (with or without insulin) or sodium bicarbonate may be administered.
In cases of mild calcium chloride overdose, treatment includes immediate discontinuation of the infusion and of any other calcium-containing medications. In cases of severe overdose (plasma concentrations >2.9 mmol/l), the following measures should be taken:

  • Rehydration by administration of 0.9% sodium chloride solution;
  • Use of non-thiazide diuretics to promote calcium excretion;
  • Monitoring of plasma potassium and calcium levels, with immediate correction to normal values;
  • Monitoring of cardiac function, and use of beta-blockers to reduce the risk of cardiac arrhythmias;
  • Hemodialysis if necessary. Elevated plasma levels of electrolytes may require dialysis.

Incompatibilities
If used to dilute medications, consult a pharmacist, if available, before adding any additive drugs; always consider the characteristics of the products to be added; use aseptic techniques; do not store.
Due to the presence of calcium chloride, the solution is incompatible with:

  • Magnesium sulfate: formation of a precipitate;

  • Medications containing phosphate: formation of calcium phosphate precipitate;

  • Medications containing carbonate: formation of calcium carbonate precipitate;

  • Medications containing tartrate: formation of calcium tartrate precipitate.
    Incompatibilities of calcium chloride have been observed with:

  • Aminophylline: due to precipitate formation;

  • Amphotericin B: due to development of turbidity;

  • Cefamandole: due to presence of sodium carbonate in the cefamandole formulation;

  • Ceftriaxone sodium: due to precipitate formation; therefore, calcium-containing solutions must not be administered within 48 hours following ceftriaxone administration;

  • Cephalothin: due to physical incompatibility;

  • Cefradine: due to presence of sodium carbonate in the cefradine formulation;

  • Chlorpheniramine: due to physical incompatibility;

  • Dobutamine: due to development of turbidity;

  • Fat emulsion: due to presence of flocculation;

  • Sodium heparin;

  • Indomethacin: due to precipitate formation;

  • Sodium nitrofurantoin;

  • Promethazine: due to precipitate formation;

  • Propofol: due to precipitate formation;

  • Streptomycin: because calcium may inhibit streptomycin activity;

  • Tetracyclines: calcium salts may complex with tetracyclines.

For further information, refer to the Summary of Product Characteristics