Gambrosol Trio (Solution) Instructions for Use

Marketing Authorization Holder

Gambro Lundia, AB (Italy)

Manufactured By

Gambro Dasco, S.p.A. (Italy)

ATC Code

B05D (Peritoneal dialysis solutions)

Dosage Forms

	Gambrosol Trio	Solution for peritoneal dialysis (with calcium 1.35 mmol/l): three-chamber bags 2000 ml, 2500 ml, 3000 ml, 5000 ml
		Solution for peritoneal dialysis (with calcium 1.75 mmol/l): three-chamber bags 2000 ml, 2500 ml, 3000 ml, 5000 ml

Dosage Form, Packaging, and Composition

Gambrosol Trio (with calcium content 1.35 mmol/l)

Solution for peritoneal dialysis clear, colorless or light yellow in color.

Component A

Excipients : hydrochloric acid – q.s. pH 3.1, water for injections – 1000 ml.

Component B

Excipients : hydrochloric acid – q.s. pH 3.1, water for injections – up to 1000 ml.

Component C

Excipients : sodium hydroxide – pH 6.6, water for injections – up to 1000 ml.

2000 ml – three-chamber plastic bags (1) – sealed plastic bags.
2500 ml – three-chamber plastic bags (1) – sealed plastic bags.
3000 ml – three-chamber plastic bags (1) – sealed plastic bags.
5000 ml – three-chamber plastic bags (1) – sealed plastic bags.

Gambrosol Trio (with calcium content 1.75 mmol/l)

Solution for peritoneal dialysis clear, colorless or light yellow in color.

Component A

Excipients : hydrochloric acid – q.s. pH 3.1, water for injections – 1000 ml.

Component B

Excipients : hydrochloric acid – q.s. pH 3.1, water for injections – up to 1000 ml.

Component C

Excipients : sodium hydroxide – pH 6.6, water for injections – up to 1000 ml.

2000 ml – three-chamber plastic bags (1) – sealed plastic bags.
2500 ml – three-chamber plastic bags (1) – sealed plastic bags.
3000 ml – three-chamber plastic bags (1) – sealed plastic bags.
5000 ml – three-chamber plastic bags (1) – sealed plastic bags.

Clinical-Pharmacological Group

Solution for peritoneal dialysis

Pharmacotherapeutic Group

Peritoneal dialysis solution

Pharmacological Action

Composition of solutions after mixing components

Gambrosol Trio (with calcium content 1.35 mmol/l)

Gambrosol Trio (with calcium content 1.75 mmol/l)

Gambrosol Trio is an electrolyte solution containing dextrose and a lactate buffer free from bacterial endotoxins, administered for the treatment of chronic renal failure of various origins by the method of peritoneal dialysis (PD).

Fluid balance can be maintained by using solutions with different glucose concentrations, which determine fluid removal (ultrafiltration). The osmolarity of the finished solutions is determined by the glucose concentration.

The electrolyte levels in the solution correspond to the physiological electrolyte levels in blood plasma, with the exception of potassium and lactate. Lactate is used as an alkaline buffer to correct acid-base balance. The isomeric configuration of lactate is S⁺, which is naturally present in human blood plasma.

Dextrose, the lactate buffer, and electrolytes administered intraperitoneally are absorbed into the blood and metabolized in the usual way. When 1 g of dextrose is broken down into carbon dioxide and water, 4 kcal are released. The concentration level of the ingredients corresponds to their physiological level in blood plasma. Lactate is completely metabolized to bicarbonate.

Indications

Solutions for peritoneal dialysis are indicated for

• Acute and chronic renal failure;
• Excessive fluid retention;
• Various types of electrolyte imbalance not amenable to other therapy (including hyperkalemia);
• Intoxication with dialyzable substances.

ICD codes

Dosage Regimen

Solutions for peritoneal dialysis are intended for intraperitoneal use only.

The duration of therapy, frequency of procedures, duration and volume of dialysis are determined by the attending physician.

The solution is prepared in accordance with the doctor’s prescription: after warming to body temperature (37°C (98.6°F)), the outer bag is removed, and to prepare a solution of the required composition, the partition between chamber C with electrolytes and one or both chambers with dextrose A and/or B is broken. The chambers with dextrose are emptied by squeezing them. The prepared solution can be used within 18 hours after mixing.

After treating the skin and hands with a disinfectant, the solution is administered intraperitoneally through a specially surgically placed peritoneal dialysis catheter that provides connection to the plastic bag filled with the solution.

Usually, 3-5 exchanges of 2-2.5 liters each (depending on body weight) are used during the day, with equal time intervals between exchanges of the solution in the abdominal cavity.

To date, there are no data on the use of Gambrosol Trio in pediatrics. For this category of patients, the solution should be used if the benefits outweigh the risk of side effects (based on 20-40 ml/kg body weight/day).

Adverse Reactions

Metabolic disorders: hyperglycemia, hypocalcemia, hypokalemia, decreased ultrafiltration, lactic acidosis, hypervolemia.

Cardiovascular system disorders: increased blood pressure.

Nervous system disorders: syncope.

General effects: abdominal pain, asthenia, headache, peritonitis. Fever is also possible; with catheter infection: signs of inflammation, catheter blockage, ileus; shoulder pain; respiratory disorders associated with pulmonary edema, electrolyte imbalance; cramps; diarrhea or constipation; hernias (ventral, diaphragmatic).

Contraindications

Contraindications for peritoneal dialysis as a method

• Conditions affecting the integrity of the abdominal wall or abdominal cavity, such as: fresh wound, burns or other extensive inflammatory skin lesions in the area of the catheter exit site, peritonitis; perforation of abdominal organs; abdominal surgery with a history of fibrous adhesions, inflammatory bowel diseases (Crohn’s disease, ulcerative colitis, diverticulosis), intra-abdominal tumors, recent abdominal surgery, ileus, abdominal hernias; internal or external abdominal fistulas; dermatitis of the anterior abdominal wall;
• Pulmonary diseases, especially pneumonia;
• Sepsis;
• Lactic acidosis;
• Cachexia and significant weight loss, especially if adequate nutrition is impossible;
• In rare cases, uremia not amenable to peritoneal dialysis therapy;
• Severe hyperlipidemia;
• Use in patients who are physically or mentally (psychosis, dementia, etc.) unable to follow the doctor’s instructions for performing peritoneal dialysis procedures.

Contraindications for these specific solutions

• Severe lactic acidosis and severe hypokalemia, severe hypercalcemia.

Use in Pregnancy and Lactation

Studies of the effect of the peritoneal dialysis solution on reproductive function and on the fetus when used in pregnant women and during lactation have not been conducted. The peritoneal dialysis solution should be used in pregnant women and during lactation only after assessing the benefit/risk ratio.

Use in Renal Impairment

Indicated for acute and chronic renal failure.

Pediatric Use

To date, there are no data on the use of Gambrosol Trio in pediatrics. For this category of patients, the solution should be used if the benefits outweigh the risk of side effects (based on 20-40 ml/kg body weight/day).

Special Precautions

Hemodynamic status and fluid balance should be carefully monitored to avoid hyper- and hypohydration with the subsequent development of congestive heart failure or hypovolemia and shock.

Acid-base and electrolyte balance must also be monitored throughout the procedure. Particular attention should be paid to the timely correction of bicarbonate, potassium, calcium, magnesium, and inorganic phosphate levels. Glycemic levels should be carefully monitored: in patients not suffering from diabetes mellitus, sensitivity to hyperglycemia changes as a result of the combined effect of decreased glucose tolerance due to uremia and transperitoneal absorption of glucose; in patients suffering from diabetes mellitus, the insulin dose should be adjusted according to the level of hyperglycemia, insulin is administered intraperitoneally into the solution in the container.

In case of secondary hyperparathyroidism, serum parathyroid hormone and other bone metabolism parameters should also be monitored and therapy should include the administration of calcium for phosphate binding and/or active vitamin D metabolites to ensure adequate enteral calcium absorption. Mixing of components is carried out immediately before use. It is necessary to strictly observe the rules of asepsis when mixing, connecting, disconnecting the solution bag from the lines. Do not use the solution if the packaging is damaged or the clarity of the solution is impaired.

Warming of solutions to body temperature 37°C (98.6°F) should be carefully monitored. Regular monitoring of physical parameters, electrolyte concentrations, creatinine and urea, plasma protein, blood sugar levels, and in some cases other laboratory parameters (e.g., blood gases, acid-base balance) is mandatory.

User guide.

It is necessary to strictly observe the rules of asepsis when mixing, connecting, disconnecting the solution bag from the lines. Do not use the solution if the packaging is damaged or the clarity of the solution is impaired.

To prepare and assemble the system, carefully read the instructions for use for the peritoneal dialysis accessories.

Before use, the bag with the peritoneal dialysis solution must be warmed to body temperature (37°C (98.6°F)) using dry heat.

Preparation for use.

1. Wash hands;
2. Assemble the accessories for the procedure in accordance with the instructions;
3. Warm the solution bag, sealed in an outer transparent plastic bag, to body temperature (37°C (98.6°F)) using dry heat;
4. Open the outer transparent plastic bag and remove the three-chamber bag with solutions and the drainage bag from the packaging;
5. Prepare the solution of the required composition: break the partitions between chamber C with electrolytes and one or both chambers with dextrose A and/or B. Empty the chambers with dextrose by squeezing them;
6. Place the bag with the prepared solution on the work surface with the connector facing up;
7. Carefully inspect the lines and drainage bag for the presence of fluid (if fluid is found, they must be replaced); the presence of small drops of solution on the walls is allowed.
8. Before the procedure, carefully inspect the condition of the patient’s transfer set and connector.
9. Check the expiration date, the integrity of the solution bag (the presence of leaks or broken plugs leads to a violation of sterility).

Application.

1. Put on a mask and wash your hands thoroughly and disinfect them with an alcohol-based gel;
2. Place the bag with the prepared solution (previously warmed to a temperature of 37°C (98.6°F)) on the work surface with the connector facing up;
3. Separate the lines and close the clamps on the solution flow line and the drain line, break the tube with the partition of the empty drainage plastic bag;
4. Prepare the patient’s transfer set;
5. Remove the protective caps from the connector and from the patient’s transfer set, then connect them by screwing tightly;
6. Hang the bag with the prepared solution at the top, and the empty drainage plastic bag – below the level of the abdominal cavity;
7. Fill: open the clamp on the solution flow line and on the patient’s line, when the solution bag becomes empty, close the clamp on the patient’s line and on the solution flow line;
8. Drain: open the clamp on the patient’s line and on the drain line, when the drain is complete, close the clamp on the patient’s line;
9. Rinse: Open the clamp on the solution flow line and on the drain line, wait three seconds and close the clamps.
10. Completion of the procedure: Wash your hands thoroughly and disinfect them with an alcohol-based gel, open the packaging of the protective cap without touching its inner surface, disconnect the connector of the patient’s transfer set and carefully close it with a new protective cap, secure the patient’s transfer set.

Overdose

Overdose can cause hypovolemia, electrolyte imbalance and acid-base balance disorders, hyperglycemia. Treatment is symptomatic. The excess peritoneal dialysis solution is drained into an empty drainage bag.

Drug Interactions

It should be remembered that medications taken may pass into the dialysate and be eliminated from the body along with it, so dose adjustment of these drugs may be required.

Potassium levels should be monitored especially carefully during concomitant therapy with digitalis preparations, since sensitivity to these drugs increases against the background of hypokalemia.

Storage Conditions

Keep out of reach of children, at a temperature not lower than +4°C (39.2°F).

Shelf Life

Shelf life – 1 year 6 months

Dispensing Status

For hospitals.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.