Medicinal Products

DIALYSIS PERITO CONTINUES AMBUL3

Generic drug of the therapeutic class: Anesthesia, resuscitation, analgesics
active ingredients: BEFORE RECONSTITUTION: Acid solution, Sodium chloride, Calcium chloride, Magnesium chloride, Glucose, Alkaline solution of lactate: Sodium lactate (E325), AFTER RECONSTITUTION: Neutral solution ready to use: Sodium chloride, Sodium lactate (E325), Calcium chloride, Magnesium chloride, Glucose
laboratory: Fresenius MC Deutsch Gmbh

Solution for peritoneal dialysis
Carton of 2 pockets bicompartimentées (sleepsafe) of 5000 ml
All forms

Indication

Chronic end stage renal failure (decompensated) irrespective of the origin treated by peritoneal dialysis.

Dosage DIALYSE PERITO CONTINUE AMBUL3 Solution for peritoneal dialysis Carton of 2 pockets bicompartimentées (sleepsafe) of 5000 ml

This solution is exclusively reserved for the intraperitoneal route.

Dosage

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

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.

The dosage, volume and number of exchanges must be adapted 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 will be required. For these patients or for patients who can tolerate larger volumes, a dose of 2500 ml - 3000 ml per exchange may be administered.

If a cycler is used for continuous cyclic or intermittent peritoneal dialysis, it is recommended to use larger volume bags.

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

There are no particular recommendations in the elderly subject.

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.

The treatment must be done every day respecting the prescribed doses. Peritoneal dialysis is a long-term treatment involving repeated administrations of solutions.

PERITONEAL DIALYSIS CONTINUES AMBULATORY 3 contains 42.5 grams of glucose in 1000 ml.

Mode and duration of administration

For the STAY SAFE BALANCE system

Preheat the solution bag 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.

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

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, PERITONEAL DIALYSIS CONTINUES AMBULATORY 3 can be used alternately with a peritoneal dialysis solution containing more glucose (lower osmolarity).

Before starting a peritoneal dialysis treatment at home, the patient must have been trained, practice the technique and be considered capable of using the technique. The training must be conducted by a qualified person.

The doctor must ensure that the patient is sufficiently proficient in the handling technique before performing his home treatment. If there is a problem or uncertainty, the doctor should be contacted.

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

Against indications

For this solution of peritoneal dialysis:

PERITONEAL DIALYSIS CONTINUES AMBULATORY 3 should not be used in patients with severe hypokalemia and severe hypercalcemia, hypovolemia and 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)

· Peritonitis;

· Internal or external abdominal fistula

· Umbilical hernia, inguinal or other abdominal hernia;

· Intra-abdominal tumors

Ileus;

· Pulmonary diseases (especially pneumonia);

Septicemia;

· Lactic acidosis;

· 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.

Side effects Dialysis Perito Continue Ambul3

PERITONEAL DIALYSIS CONTINUES AMBULATORY 3 is a solution of electrolytes whose composition is close to that of blood. In addition, the solution has a neutral pH, similar to the physiological pH.

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

Metabolic and nutritional disorders

Hyperglycemia, hyperlipidemia, increased body weight due to continuous glucose intake in the peritoneal dialysis solution.

Cardio-vascular disorders

Tachycardia, hypotension, hypertension.

Respiratory, thoracic and mediastinal disorders

Dyspnea.

Renal and urinary disorders

Electrolyte imbalances, such as hypokalemia (very common (> 10%)), hyperkalemia associated with increased calcium intake (eg, when calcium-containing phosphorus chelators are administered).

General disorders

Dizziness, edema, hydration problems highlighted by either rapid weight loss (dehydration) or rapid weight gain (hyperhydration).

Severe dehydration may occur when using a solution with a high glucose concentration.

Potential side effects of peritoneal dialysis treatment:

Infections and infestations

Peritonitis (very common (> 10%)); infection of the catheter or tunnel emergence site (very common (> 10%)); in rare cases, sepsis (£ 0.01%).

Respiratory, thoracic and mediastinal disorders

Dyspnoea caused by elevation of the diaphragm, scapular pain.

Gastrointestinal disorders

Diarrhea or constipation, hernias (very common (> 10%)); abdominal distension and feeling of satiety.

General disorders and conditions of the administration site

Discomfort, redness, edema, suppuration, crusts and pain at the site of catheter emergence.

Problems with the peritoneal dialysis technique

Effluent cloudiness, difficulties in infusion and drainage of the solution.

Peritonitis is evidenced by a turbid drainage effluent. Abdominal pain, fever and feeling of discomfort may occur or, in very rare cases, sepsis. The patient should consult the doctor immediately. The bag containing the drainage solution should be closed with a sterile stopper and subjected to microbiological testing and counting of white blood cells.

In case of infection of the emergence site or tunnel, the doctor should be consulted as soon as possible.

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