Calcium Chloride

End-stage (decompensated) chronic renal failure of any origin which can be treated with peritoneal dialysis.

Posology This solution is indicated exclusively for intraperitoneal use. The mode of therapy, frequency of administration, and dwell time required will be specified by the attending physician.

Continuous ambulatory peritoneal dialysis (CAPD) Adults:

Unless otherwise prescribed, patients will receive an infusion of 2000 ml solution per exchange four times a day. After a dwell time between 2 and 10 hours the solution will be drained. Adjustment of dosage, volume and number of exchanges will be necessary for individual patients.

If dilation pain occurs at the commencement of peritoneal dialysis, the solution volume per exchange should be temporarily reduced to 500-1500 ml. In large patients, and if residual renal function is lost, an increased volume of dialysis solution will be necessary.

In these patients, or patients who tolerate larger volumes, a volume of 2500-3000 ml solution per exchange may be given.

Paediatric population:

In children the solution volume per exchange should be prescribed according to age and body surface area (BSA). For initial prescription, the volume per exchange should be 600-800 ml/m2 BSA with 4 (sometimes 3 or 5) exchanges per day.

It can be increased up to 1000- 1200 ml/m2 BSA depending on tolerance, age and residual renal function. Automated peritoneal dialysis (APD) A machine (cycler) is used for intermittent or continuous cyclic peritoneal dialysis. The use of larger bags is recommended providing more than one solution exchange.

The cycler performs the solution exchanges according to the medical prescription stored in the cycler.

Adults:

Typically, patients spend 8-10 hours a night cycling. Dwell volumes range from 1500 to 3000 ml and the number of cycles usually varies from 3 to 10 per night. The amount of fluid used is typically between 10 and 18 l but can range from 6 to 30 l.

The cycler therapy at night is usually combined with 1 or 2 exchanges during the daytime.

Paediatric population:

The volume per exchange should be 800-1000 ml/m2 BSA with 5-10 exchanges overnight. It can be increased up to 1400 ml/m2 BSA depending on tolerance, age and residual renal function. There are no special dosage recommendations for the elderly.

25%) are used when the body weight is above the desired dry weight. The withdrawal of fluid from the body increases in relation to the glucose concentration of the peritoneal dialysis solution. These solutions should be used cautiously to handle the peritoneal membrane with care, to prevent dehydration and in order to keep the glucose burden as low as possible.

Peritoneal dialysis is a long-term therapy involving repeated administrations of single solutions. 75 mmol/l calcium contains 15 g glucose in 1000 ml solution. Method of administration Before performing peritoneal dialysis at home, the patient must be trained appropriately, must practice the technique and be shown to be proficient.

The training should be performed by qualified personnel. The attending physician must ensure that the patient masters the handling techniques sufficiently before being discharged to carry out peritoneal dialysis at home. In case of any problems or uncertainty the attending physician should be contacted.

Dialysis using the prescribed doses should be performed daily and should be continued for as long as renal function substitution therapy is required. Continuous ambulatory peritoneal dialysis (CAPD): stay•safe bag The solution bag is first warmed up to body temperature.

6. The appropriate dose is infused in the peritoneal cavity using a peritoneal catheter over 5 - 20 minutes. Depending on physician's instructions, the dose should dwell in the peritoneal cavity for 2 to 10 hours (equilibrium time), and then be drained.

Automated peritoneal dialysis (APD): sleep•safe bag The connectors of the prescribed sleep•safe solution bags are inserted in the free tray ports and then automatically connected to the tubing set by the cycler. The cycler checks the bar codes of the solution bags and gives an alarm when the bags do not comply with the prescription stored in the cycler.

After this check the tubing set can be connected to the patient’s catheter extension and the treatment be started. The sleep•safe solution is automatically warmed up to body temperature by the cycler during the inflow into the abdominal cavity.

Dwell times and selection of glucose concentrations are carried out according to the medical prescription stored in the cycler (for more details please refer to the operating instructions of the cycler).

Automated peritoneal dialysis (APD):

Safe•Lock bag The connectors of the prescribed Safe•Lock solution bags are connected manually to the tubing set of the cycler. The Safe•Lock solution is placed on the heater plate of the cycler for warming of the solution that will be transferred to the abdominal cavity of the patient during the treatment.

Dwell times and selection of glucose concentrations are carried out according to the medical prescription stored in the cycler (for more details please refer to the operating instructions of the cycler). , with higher osmolarity).

75 mmol/l calcium is an electrolyte solution the composition of which is similar to blood. In addition, the solution has a neutral pH which is similar to the physiological pH value. Possible adverse reactions may result from the peritoneal dialysis itself or may be induced by the peritoneal dialysis solution.

g. g. by the administration of calcium-containing phosphate binders (common) General disorders - Dizziness (uncommon) - Oedema (uncommon) - Disturbances in hydration (uncommon) indicated either by a rapid decrease (dehydration) or increase (overhydration) in body weight.

Severe dehydration might occur when using solutions of higher glucose concentration. Potential adverse reactions of the treatment mode Infections and infestations - Peritonitis (very common) indicated by a cloudy effluent. Later abdominal pain, fever, and general malaise may develop or, in very rare cases, sepsis.

The patient should seek medical advice immediately. The bag with the cloudy effluent should be closed with a sterile cap and assessed for microbiological contamination and white blood cell count. - Skin exit site and tunnel infections (very common).

In case of skin exit site and tunnel infections the attending physician should be consulted as soon as possible. - Sepsis (very rare) Respiratory, thoracic and mediastinal disorders - Shoulder pain (common) - Dyspnoea caused by the elevated diaphragm (not known) Gastrointestinal disorders - Hernia (very common) - Abdominal distension and sensation of fullness (common) - Diarrhoea (uncommon) - Constipation (uncommon) - Encapsulating peritoneal sclerosis (not known) General disorders and administration/catheter site conditions - Redness, oedema, exudations, crusts and pain at the catheter exit site (very common) - In- and outflow disturbances of the dialysis solution (common) - General malaise (not known) Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

25 mmol/l calcium must not be used in patients with lactic acidosis, severe hypokalaemia and severe hypocalcaemia. 25 mmol/l calcium must not be used in patients with lactic acidosis, severe hypokalaemia, severe hypocalcaemia, hypovolaemia and arterial hypotension.

75 mmol/l calcium must not be used in patients with lactic acidosis, severe hypokalaemia and severe hypercalcaemia. 75 mmol/l calcium must not be used in patients with lactic acidosis, severe hypokalaemia, severe hypercalcaemia, hypovolaemia and arterial hypotension.

For peritoneal dialysis in general Peritoneal dialysis should not be commenced if any of the following are present: - recent abdominal surgery or injury, a history of abdominal operations with fibrous adhesions, severe abdominal burns, bowel perforation, - extensive inflammatory conditions of the abdominal skin (dermatitis), - inflammatory bowel diseases (Crohn's disease, ulcerative colitis, diverticulitis), - peritonitis, - internal or external abdominal fistula, - umbilical, inguinal or other abdominal hernia, - intra-abdominal tumours, - ileus, - pulmonary disease (especially pneumonia), - sepsis, - extreme hyperlipidaemia,in rare cases of uraemia, which cannot be managed by peritoneal dialysis, - cachexia and severe weight loss, particularly in cases where ingestion of adequate protein is not guaranteed, - patients who are physically or mentally incapable of performing peritoneal dialysis as instructed by the physician.

If any of the above mentioned disorders develops during the peritoneal dialysis, the attending physician will have to decide on how to proceed.

08/2025 4 DOSAGE AND ADMINISTRATION 02/2026 7 WARNINGS AND PRECAUTIONS 02/2026 Table of Contents Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ............................................................................................

2 Table of Contents ................................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION ......................................................................

4 1 Indications .................................................................................................................. 4 2 Contraindications ........................................................................................................

4 4. Dosage and Administration ......................................................................................... 5 5. Overdose.....................................................................................................................

6 6. Dosage Forms, Strengths, Composition, and Packaging ............................................... 6 7. Warnings and Precautions........................................................................................... 9 8. Adverse Reactions .......................................................................................................

10 9. Drug Interactions ...................................................................................................... 12 10. Clinical Pharmacology ...............................................................................................

12 11. Storage, Stability and Disposal .................................................................................. 13 12. Special Handling Instructions ....................................................................................

13 PART II: SCIENTIFIC INFORMATION .............................................. Error! Bookmark not defined. 13. Pharmaceutical Information...................................................................................... 14 14. Clinical Trials .............................................................................................................

14 15. Microbiology ............................................................................................................. 15 16. Non-Clinical Toxicology […]

02/2026 7 WARNINGS AND PRECAUTIONS 02/2026 Table of Contents Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ............................................................................................

2 Table of Contents ................................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION ......................................................................

4 1 Indications .................................................................................................................. 4 2 Contraindications ........................................................................................................

4 4. Dosage and Administration ......................................................................................... 5 5. Overdose.....................................................................................................................

6 6. Dosage Forms, Strengths, Composition, and Packaging ............................................... 6 7. Warnings and Precautions........................................................................................... 9 8. Adverse Reactions .......................................................................................................

10 9. Drug Interactions ...................................................................................................... 12 10. Clinical Pharmacology ...............................................................................................

12 11. Storage, Stability and Disposal .................................................................................. 13 12. Special Handling Instructions ....................................................................................

13 PART II: SCIENTIFIC INFORMATION .............................................. Error! Bookmark not defined. 13. Pharmaceutical Information...................................................................................... 14 14. Clinical Trials .............................................................................................................

14 15. Microbiology ............................................................................................................. 15 16. Non-Clinical Toxicology […]

). For the most recent information in the management of a suspected drug overdose, contact your regional poison control centre or Health Canada's toll-free number, 1-844 POISON-X (1-844-764- 7669). 6. Dosage Forms, Strengths, Composition, and Packaging Table 1 – Dosage Forms, Strengths, and Composition Route of Administration Dosage Form/ Strength/Composition Non-Medicinal Ingredients Intravenous or intraventricular cavity injection 10 mL Calcium Chloride solution in a pre-filled, single use syringe (see Table 2 Dosage Forms) / 100 mg/mL / Calcium Chloride Dihydrate Hydrochloric Acid and/or Sodium Hydroxide for pH adjustment, Water for Injection USP Calcium Chloride Injection USP is supplied in single-use containers as follows: Table 2 – Dosage Forms & Packaging Container Volume Needle LifeShield® Abboject® Syringe1 10 mL 20-gauge Pre-filled Abboject® Syringe2 10 mL 20-gauge Pre-filled Ansyr® Syringe3 10 mL Needle-free, with luer lock adapter 1: LifeShield® Abboject® Syringe: Flexible and reliable, the ready-to-use LifeShield® Abboject® syringe minimizes errors and protects caregivers and patients alike.

It can be used for needle-free or shrouded Calcium Chloride Injection USP Page 7 of 18 Protected B / Protégé B needle access. The design features two pieces - a calibrated glass drug vial and a matching plastic syringe barrel with integral injector needle.

Medication, fluid path, and needle are sterile and nonpyrogenic if caps and needle cover are undisturbed and package intact. 2.

Abboject® Syringe:

Flexible and reliable, the ready-to-use Abboject® syringe minimizes errors and protects caregivers and patients alike. It can be used for needle-free access. The design features two pieces - a calibrated glass drug vial and a matching plastic luer lock syringe barrel.

Medication, fluid path, and needle are sterile and nonpyrogenic if caps and luer end cover are undisturbed and package intact. 3: Ansyr® Syringe: The Ansyr® syringe is a proprietary delivery option offering one-piece, polypropylene plastic construction with a needle-free male luer lock adapter.

Ansyr® syringes are available prefilled with a wide range of emergency medications. Graduated markings on the syringe barrel conform to ISO standards and clearly show any drug remaining. Medication and fluid path are sterile and nonpyrogenic if protective cover is undisturbed and package intact.

7. Warnings and Precautions General Risk of Ceftriaxone-Calcium Precipitation Do not mix or administer Calcium Chloride Injection simultaneously with ceftriaxone, even if using different infusion lines or different infusion sites as it can lead to precipitation of ceftriaxone-calcium (see2 CONTRAINDICATIONS).

. Calcium Chloride Injection and ceftriaxone intravenous solutions may be administered sequentially one after another if infusion lines at different sites are used, or if the infusion lines are replaced or infusion lines are thoroughly flushed between infusions with physiological salt solution to avoid precipitation.

Aluminum Toxicity Calcium Chloride Injection contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Research indicates that patients with impaired kidney function, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day can accumulate aluminum at levels associated with central nervous system and bone toxicities.

Tissue loading may occur at even lower amounts of aluminum. Exposure to aluminum from Calcium Chloride Injection at the recommended dose is not more than 10 mcg. When prescribing Calcium Chloride Injection in patients receiving parenteral nutrition solutions, limit the total daily patient exposure to aluminum to no more than 5 mcg/kg/day.

Hypotension, Bradycardia, Arrhythmias and Syncope with Rapid Administration Rapid injection of Calcium Chloride Injection may cause vasodilation, decreased blood pressure, bradycardia, arrhythmias, syncope, and cardiac arrest. It is particularly important to prevent a high concentration of calcium from reaching the heart because of the danger of cardiac syncope.

Too rapid an injection exceeding 1 mL/min may lead to hypotension and cardiac syncope (see 4 DOSAGE AND ADMINISTRATION). If injected into the ventricular cavity in cardiac resuscitation, it must not be injected into the myocardial tissue.

Arrhythmias with Concomitant Digoxin Use Calcium Chloride Injection USP Page 8 of 18 Protected B / Protégé B Arrhythmias may occur if Calcium Chloride Injection and digoxin are administered together. Hypercalcemia resulting from an overdose of Calcium Chloride Injection increases the risk of digoxin toxicity.

Avoid the use of Calcium Chloride Injection in patients receiving digoxin. If concomitant therapy is necessary, closely monitor ECG and calcium levels (see 9. 4 DRUG-DRUG INTERACTIONS). Tissue Necrosis and Calcinosis Administration of Calcium Chloride Injection in patients with local trauma may result in calcinosis cutis due to transient increase in local calcium concentration.

Calcinosis cutis can occur with or without extravasation of Calcium Chloride Injection, is characterized by abnormal dermal deposits of calcium salts, and clinically manifests as papules, plaques, or nodules that may be associated with erythema, swelling, or induration.

Tissue necrosis, ulceration, and secondary infection are the most serious complications. Calcium Chloride Injection USP is irritating to veins and must not be injected into tissues, since severe necrosis and sloughing may occur (see 2 CONTRAINDICATIONS).

4 Administration). Avoid extravasation or accidental injection into perivascular tissues. Should perivascular infiltration occur, immediately discontinue intravenous administration at that site and treat as needed. Local infiltration of […]

). . Calcium Chloride Injection and ceftriaxone intravenous solutions may be administered sequentially one after another if infusion lines at different sites are used, or if the infusion lines are replaced or infusion lines are thoroughly flushed between infusions with physiological salt solution to avoid precipitation.

Aluminum Toxicity Calcium Chloride Injection contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Research indicates that patients with impaired kidney function, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day can accumulate aluminum at levels associated with central nervous system and bone toxicities.

Tissue loading may occur at even lower amounts of aluminum. Exposure to aluminum from Calcium Chloride Injection at the recommended dose is not more than 10 mcg. When prescribing Calcium Chloride Injection in patients receiving parenteral nutrition solutions, limit the total daily patient exposure to aluminum to no more than 5 mcg/kg/day.

Hypotension, Bradycardia, Arrhythmias and Syncope with Rapid Administration Rapid injection of Calcium Chloride Injection may cause vasodilation, decreased blood pressure, bradycardia, arrhythmias, syncope, and cardiac arrest. It is particularly important to prevent a high concentration of calcium from reaching the heart because of the danger of cardiac syncope.

Too rapid an injection exceeding 1 mL/min may lead to hypotension and cardiac syncope (see

1 INDICATIONS AND USAGE Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection is indicated for use as a source of water, electrolytes, and calories or as an alkalinizing agent in adults and pediatric patients. Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection is indicated for use as a source of water, electrolytes, and calories or as an alkalinizing agent in adults and pediatric patients.

( 1 )

2 DOSAGE AND ADMINISTRATION • The recommended dosage and duration are based on the patient’s age, weight, clinical condition, and concomitant therapy. 1 ) • To reduce the risk of air embolism, adhere to the preparation instructions.

2 ) • Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection is for intravenous use. 3 ) • Use a peripheral vein to administer if the final dextrose concentration is 5% or less, and the osmolarity is less than 900 mOsm/L.

3 ). • Consider using a central vein to administer hypertonic solutions with osmolarity of 900 mOsm/L or more to avoid venous irritation, including phlebitis. 3 ) • Do not administer Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection simultaneously with ceftriaxone in neonates (28 days of age or younger) due to serious risks.

4 ) • See full prescribing information for information dosage considerations, preparation, administration, and drug incompatibilities. 1 Dosage Considerations The recommended dosage and duration of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection is based on the patient’s age, weight, clinical condition, and concomitant therapy.

Evaluate the patient’s clinical status and monitor changes in blood glucose and electrolyte concentrations especially during prolonged use of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection to optimize clinical status.

2 Important Preparation Instructions Visually inspect the Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection solution for particulate matter and discoloration. Do not administer Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection unless the solution is clear and the container seals are intact.

If additives are determined to be compatible with Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection then using aseptic technique, mix thoroughly; do not store solutions containing additives. After mixing, do not use if there is discoloration or formation of precipitates.

2) ] : • Use a non-vented infusion set or close the vent on a vented set. • Use a dedicated line without any connections (do not connect flexible containers in series). • The use of pressure infusion is not recommended as a method to increase flow rates.

However, if pressure infusion is required, ensure that any air within the bag is fully evacuated prior to initiation of infusion. • If using a pumping device to administer Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection, turn off the pump before the container is empty.

Preparation Instructions 1. Tear overwrap downside at slit and remove solution container. 2. Visually inspect the container. o If the outlet port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired.

o Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. 3. Check for minute leaks by squeezing inner bag firmly.

If leaks are found, discard solution as sterility may be impaired. 4. 3) ] . Preparation for Administration 1. Suspend container from eyelet support. 2. Remove protector from outlet port at bottom of container. 3. Attach administration set according to its accompanying directions.

3 Important Administration Instructions Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection is for intravenous use. Use immediately after removing the overwrap. Discard the unused portion. • Use a peripheral vein to administer Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection if the final dextrose concentration is 5% or less, and the osmolarity is less than 900 mOsm/L.

7) ]. 4) and Contraindications (4) ] . To Add Medication Before Solution Administration 1. Prepare medication site. 2. Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject. 3. Mix solution and medication thoroughly.

For high density medication such as potassium chloride, squeeze ports while ports are upright and mix thoroughly. To Add Medication During Solution Administration 1. Close clamp on the set. 2. Prepare medication site. 3. Using syringe with19 to 22 gauge needle, puncture resealable medication port and inject.

4. Remove container from IV pole and/or turn to an upright position. 5. Evacuate both ports by squeezing them while container is in the upright position. 6. Mix solution and medication thoroughly. 7. Return container to in use position and continue administration.

1) ] . 1) ] . Do not administer Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection simultaneously with citrate anticoagulated/preserved blood through the same administration set because of the likelihood of coagulation precipitated by the calcium content of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection.

10) ] The following adverse reactions have been identified during postapproval use of Lactated Ringer’s products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: General Disorders and Administration Site Conditions: Phlebitis, extravasation, infusion site inflammation, infusion site swelling, infusion site rash, infusion site pruritus, infusion site erythema, infusion site pain, infusion site burning, and infusion site hypoaesthesia.

Hypersensitivity Reactions and Infusion Reactions:

Angioedema, chest pain/discomfort, bradycardia or tachycardia, hypotension, respiratory distress, bronchospasm, dyspnea, cough, urticaria, rash, pruritus, erythema, flushing, throat irritation, paresthesia, oral hypoesthesia, dysgeusia, nausea, anxiety, pyrexia, and headache, laryngeal edema, sneezing, injection site infection.

Metabolism and Nutrition Disorders:

Hyperkalemia, hyponatremia, and hypervolemia.

Nervous System Disorders:

Hyponatremic encephalopathy. , pruritus, dyspnea, urticaria, rash, cough). gov/medwatch.

4) ] . 3) ] . 4) ] . 7) ] . • Concomitant treatment with ceftriaxone in neonates (28 days of age or younger). ( 4 ) • Patients with known hypersensitivity to any of the components of Potassium Chloride in Lactated Ringer’s solution and Dextrose (5%) Injection ( 4 ) • Patients with clinically significant hyperkalemia ( 4 ).

• Patients with clinically significant hyperglycemia ( 4 ).