Medicinal Products

BICAVERA GLUCOSE 4.25%

Generic drug of the therapeutic class: Anesthesia, resuscitation, analgesics
Active Ingredients: BEFORE RECONSTITUTION: Acid Solution: Sodium Chloride, Calcium Chloride, Magnesium Chloride, Glucose, Alkaline Solution: [Sodium Bicarbonate (E550i), 651], AFTER RECONSTITUTION: Ready-to-Use Solution: Sodium Chloride, [Sodium Bicarbonate (E550i), 651], Calcium Chloride, Magnesium Chloride, Glucose
laboratory: Fresenius MC Deutsch Gmbh

Solution for peritoneal dialysis
Box of 4 pockets bicompartimentées (sleepsafe) of 3000 ml
All forms

Indication

End-stage decompensated chronic renal failure, irrespective of origin, treated with peritoneal dialysis.

Dosage BICAVERA GLUCOSE 4.25% Solution for peritoneal dialysis Box of 4 pockets bicompartimentées (sleepsafe) of 3000 ml

Dosage

Bicavera4, 25% Glucose, is exclusively reserved for the intraperitoneal route.

The dosage, the frequency of administration and the stasis time are defined by the doctor.

Continuous Ambulatory Peritoneal Dialysis (CAPD)

Unless otherwise indicated, use 2000 ml of solution per exchange, 4 times a day.

After a stasis time of 2 to 10 hours, the solution is drained.

Bicavera 4.25% Glucose contains 42.5 grams of glucose in 1000 ml. According to the prescription, a maximum of 85 grams of glucose per bag can be brought to the patient.

The dosage should be appropriate for each patient.

In case of pain due to abdominal distension at the beginning of peritoneal dialysis, the volume per exchange must be temporarily reduced (500 - 1500 ml per exchange).

In large patients, and if residual renal function is lost, a larger dose may be administered. For these patients or for patients who can tolerate larger volumes, a dose of 2500 ml per exchange can be administered.

In children, the volume per exchange should be reduced, depending on age, height and weight
(30 - 40ml / kg).

Automated Peritoneal Dialysis (APD)

If a machine (Sleepsafe cycler) is used for continuous cyclic or intermittent peritoneal dialysis, larger volume (3000 ml) bags for more than one solution exchange are used. The cycler carries out the exchange of solutions according to the medical prescription recorded in the Sleepsafe cycler.

Peritoneal dialysis solutions with a high glucose concentration (2.3% or 4.25%) will be used when the body weight is above the desired dry weight.

The fluid loss increases with the glucose concentration of the peritoneal dialysis solution. These solutions should be used with care to preserve the peritoneal membrane and prevent dehydration, as well as to keep glucose load as low as possible.

Peritoneal dialysis is a long-term treatment involving repeated administrations of solutions.

Mode and duration of administration

Patients must master the peritoneal dialysis technique before performing peritoneal dialysis at home. They must be trained by qualified personnel. Before performing dialysis at home, the attending physician will ensure that patients have sufficient knowledge of the technique. In case of difficulty or doubt, the doctor should be contacted.

Repeat the infusions every day.

Peritoneal dialysis should be continued as long as renal replacement therapy is necessary.

Continuous Ambulatory Peritoneal Dialysis (CAPD)

For instructions on use, refer to the Instructions for Use, Handling and Disposal section .

The solution bag is first warmed to body temperature. Warming should be done by means of a suitable heater. The warming time of a 2, 000 ml bag, with an initial temperature of 22 ° C, is about 120 minutes. Additional information can be obtained in the heater's operating instructions. The use of a microwave oven is not recommended because of the risk of overheating.

Solutions in both compartments must be mixed before use.

To do this, wrap the pocket from one of the upper corners until the central weld opens. The solutions of the two compartments mix instantly. Then wrap the pocket from the top edge until the weld at the triangle at the bottom of the pocket, opens fully.

According to the doctor's prescription, the solution remains in the peritoneal cavity for 2 to 10 hours (equilibrium time) and is drained.

Depending on the desired osmotic pressure, Bicavera 4.25% Glucose may be used alternately with a lower glucose composition peritoneal dialysis solution (lower osmolarity).

Automated Peritoneal Dialysis (APD)

The Sleepsafe solution bag connectors are inserted into the available Sleepsafe cycler ports and are automatically connected to the Sleepsafe set tubing by the cycler.

The cycler checks the barcode of the solution pockets and triggers an alarm if the pocket does not match the prescription stored in the machine. After this check, the set tubing can be connected to the patient's catheter extension and treatment can begin. The Sleepsafe solution is automatically heated by the cycler to body temperature during infusion. The duration of the stasis phases and the selection of the glucose concentrations are carried out according to the prescription recorded in the cycler (for more details, refer to the instructions for use of the cycler).

Against indications

For this solution of peritoneal dialysis:

Bicavera 4.25% Glucose should not be used in the following situations:

· Severe hypokalemia,

· Severe hypercalcemia,

· Hypovolemia,

· Hypotension.

For peritoneal dialysis in general:

Peritoneal dialysis should not be used if:

· Abdominal surgery or recent abdominal injury, history of abdominal operations with fibrous adhesions, severe abdominal burns, perforation of the bowel;

· Extensive inflammatory skin conditions in the abdomen (dermatitis)

· Inflammatory bowel diseases (Crohn's disease, ulcerative colitis, diverticulitis)

· Localized peritonitis;

· Internal or external abdominal fistula

· Umbilical hernia, inguinal or other abdominal hernia;

· Intra-abdominal tumors

Ileus;

· Pulmonary diseases (especially pneumonia);

Septicemia;

· Severe hyperlipidemia;

· Rare cases of uremia not treated with peritoneal dialysis;

· Cachexia and significant weight loss, especially when adequate protein intake is not guaranteed;

· Where the patient is unable physically or mentally to undergo peritoneal dialysis treatment as prescribed by the physician.

If any of these occur during peritoneal dialysis, the doctor must make the necessary decisions.

This peritoneal dialysis solution should not be used as an intravenous infusion.

Side effects Bicavera Glucose

Bicavera 4.25% Glucose is a solution of electrolytes whose composition is close to that of blood. In addition, a physiological buffer based on bicarbonate is used. The solution is generally well tolerated.

Potential adverse effects may arise from the peritoneal dialysis process or may be induced by the solution itself.

Potential side effects caused by the solution itself:

· Electrolyte imbalances, such as hypokalemia, hypercalcemia associated with increased calcium intake (eg, when administering phosphorus-containing calcium chelators).

· Water imbalances. Rapid weight loss, a drop in blood pressure and / or tachycardia may indicate dehydration. Edema, hypertension and dyspnea may indicate hyperhydration.

· Hyperglycemia.

· Hyperlipidemia.

· Increased body weight

Potential side effects of peritoneal dialysis treatment:

Peritonitis, evidenced by a turbid drainage effluent. Abdominal pain, fever, and feeling of discomfort may occur or, in very rare cases, a generalized infection of the blood may occur (sepsis). The patient should consult the doctor immediately. The bag containing the drainage solution must be closed with a sterile stopper and checked.

· Infection of the site of emergence of the catheter or tunnel, highlighted by redness, edema, pain, suppuration or crusts. The doctor should be consulted as soon as possible.

· Difficulties with infusion and drainage of the solution.

· Diarrhea or constipation.

· Dyspnoea caused by the elevation of the diaphragm

· Hernia.

· Sensation of abdominal bloating and satiety.

· Scapular pain.

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