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PHYSIONEAL is a brand name for Sodium Bicarbonate. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: PHYSIONEAL 40 is indicated whenever peritoneal dialysis is employed, including: • Acute and chronic renal failure; • Severe water retention; • Severe electrolyte imbalance; • Drug intoxication with dialysable substances, when a more adequate therapeutic alternative is not available. PHYSIONEAL 40 hydrogen…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology The mode of therapy, frequency of treatment, exchange volume, duration of dwell and length of dialysis should be selected by the physician. To avoid the risk of severe dehydration, hypovolaemia and to minimise the loss of proteins, it is advisable to select the peritoneal dialysis solution with the lowest osmolarity consistent with fluid removal requirements for each exchange.
Adults Patients on continuous ambulatory peritoneal dialysis (CAPD) typically perform 4 cycles per day (24 hours). Patients on automated peritoneal dialysis (APD) typically perform 4-5 cycles at night and up to 2 cycles during the day.
5 litres. Elderly As for adults. Paediatric population The safety and efficacy of PHYSIONEAL 40 in paediatric patients have not been established. Therefore the clinical benefits of PHYSIONEAL 40 have to be balanced versus the risks of side effects in this patient category.
The use of PHYSIONEAL 40 in the Clear-Flex container is not recommended in children requiring a fill volume < 1600 ml due to the risk of not detecting a possible misinfusion (administration of the small chamber only). See section
Adverse reactions (occurring in 1% of patients or more) from the clinical trials and post marketing are listed below. The most commonly reported Adverse Reaction from the controlled clinical trials with PHYSIONEAL 40 was alkalosis, occurring in approximately 10 % of patients.
In most cases, it was based on serum hydrogen carbonate values only and was usually not associated with clinical symptoms. The adverse drug reactions listed in this section are given following the recommended frequency convention: very common: (≥1/10); common: (≥1/100 to <1/10) ; uncommon: (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000) ; very rare (<1/10,000), not known (cannot be estimated from the available data) System Organ Class Preferred Term Frequency System Organ Class Preferred Term Frequency BLOOD AND LYMPHATIC SYSTEM DISORDERS Eosinophilia Not known METABOLISM AND NUTRITION DISORDERS Alkalosis Hypokalaemia Fluid retention Hypercalcaemia Hypervolaemia Anorexia Dehydration Hyperglycaemia Lactic Acidosis Common Common Common Common Uncommon Uncommon Uncommon Uncommon Uncommon PSYCHIATRIC DISORDERS Insomnia Uncommon NERVOUS SYSTEM DISORDERS Dizziness Headache Uncommon Uncommon VASCULAR DISORDERS Hypertension Hypotension Common Uncommon RESPIRATORY, THORACIC, AND MEDIASTINAL DISORDERS Dyspnoea Cough Uncommon Uncommon GASTROINTESTINAL DISORDERS Peritonitis Peritoneal membrane failure Abdominal pain Dyspepsia Flatulence Nausea Sclerosing encapsulating peritonitis Cloudy peritoneal effluent Common Uncommon Uncommon Uncommon Uncommon Uncommon Not known Not known SKIN AND SUBCUTANEOUS TISSUE DISORDERS Angioedema Rash Not known Not known MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Musculoskeletal pain Not known System Organ Class Preferred Term Frequency GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Oedema Asthenia Chills Facial oedema Hernia Malaise Thirst Pyrexia Common Common Uncommon Uncommon Uncommon Uncommon Uncommon Not known INVESTIGATIONS Weight increased PCO2 increased Common Uncommon Other undesirable effects of peritoneal dialysis related to the procedure: bacterial peritonitis, catheter site infection, catheter related complication.
4. Method of administration Precautions to be taken before handling or administering the medicinal product • PHYSIONEAL 40 is intended for intraperitoneal administration only. Not for intravenous administration. • Peritoneal dialysis solutions may be warmed to 37°C to enhance patient comfort.
However, only dry heat (for example, heating pad, warming plate) should be used. Solutions should not be heated in water or in a microwave oven due to the potential for patient injury or discomfort. • Aseptic technique should be employed throughout the peritoneal dialysis procedure.
• Do not administer if the solution is discoloured, cloudy, contains particulate matter, shows evidence of leakage between chambers or to the exterior, or if seals are not intact. • The drained fluid should be inspected for the presence of fibrin or cloudiness, which may indicate the presence of peritonitis.
• For single use only. • After removal of the overpouch, immediately open the long-seal (interchamber seal) to mix the two solutions and then open the short SafetyMoon seal (access seal) to allow administration of the mixed solution.
The intraperitoneal solution must be infused within 24 hours after mixing. 6 Special precautions for disposal and other handling. 1. PHYSIONEAL 40 should not be used in patients with: • uncorrectable mechanical defects that prevent effective PD or increase the risk of infection, • documented loss of peritoneal function or extensive adhesions that compromise peritoneal function.
4 Special warnings and precautions for use Use in patients with abdominal conditions Peritoneal dialysis should be done with caution in patients with: 1) abdominal conditions, including disruption of the peritoneal membrane and diaphragm by surgery, from congenital anomalies or trauma until healing is complete, abdominal tumors, abdominal wall infection, hernias, fecal fistula, colostomy or iliostomy, frequent episodes of diverticulitis, inflammatory or ischemic bowel disease, large polycystic kidneys, or other conditions that compromise the integrity of the abdominal wall, abdominal surface, or intra-abdominal cavity 2) other conditions including recent aortic graft replacement and severe pulmonary disease.
1. PHYSIONEAL 40 should not be used in patients with: • uncorrectable mechanical defects that prevent effective PD or increase the risk of infection, • documented loss of peritoneal function or extensive adhesions that compromise peritoneal function.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme.
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Encapsulating Peritoneal Sclerosis (EPS) Encapsulating Peritoneal Sclerosis (EPS) is considered to be a known, rare complication of peritoneal dialysis therapy. EPS has been reported in patients using peritoneal dialysis solutions including some patients using PHYSIONEAL 40 as part of their PD therapy.
Peritonitis If peritonitis occurs, the choice and dosage of antibiotics should be based upon the results of identification and sensitivity studies of the isolated organism(s) when possible. Prior to identification of the involved organism(s), broadspectrum antibiotics may be indicated.
Hypersensitivity Solutions containing glucose derived from hydrolysed maize starch should be used with caution in patients with a known allergy to maize or maize products. Hypersensitivity reactions such as those due to a corn (maize) starch allergy, including anaphylactic/anaphylactoid reactions, may occur.
Stop the infusion immediately and drain the solution from the peritoneal cavity if any signs or symptoms of a suspected hypersensitivity reaction develop. Appropriate therapeutic countermeasures must be instituted as clinically indicated.
Use in patients with elevated lactate levels Patients with elevated lactate levels should use lactate-containing peritoneal dialysis solutions with caution. , severe hypotension, sepsis, acute renal failure, inborn errors of metabolism, treatment with drugs such as metformin and nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs)] must be monitored for occurrence of lactic acidosis before the start of treatment and during treatment with lactate-based peritoneal dialysis solutions.
General monitoring When prescribing the solution to be used for an individual patient, consideration should be given to the potential interaction between the dialysis treatment and therapy directed at other existing illnesses. Serum potassium levels should be monitored carefully in patients treated with cardiac glycosides.
An accurate fluid balance record must be kept and the body weight of the patient must carefully be monitored to avoid over- or underhydration with severe consequences including congestive heart failure, volume depletion and shock. Protein, amino acids, water soluble vitamins and other medicines may be lost during peritoneal dialysis and may require replacement.
Serum electrolyte concentrations (particularly hydrogen carbonate, potassium, magnesium, calcium and phosphate), blood chemistry (including parathyroid hormone and lipid parameters) and haematological parameters should be monitored periodically.
Metabolic alkalosis In patients with plasma hydrogen carbonate level above 30 mmol/l, the risk of possible metabolic alkalosis should be weighed against the benefits of treatment with this product. 25 mmol/l calcium, such as PHYSIONEAL 40, should be carefully considered as it might worsen hyperparathyroidism.
Overinfusion Overinfusion of PHYSIONEAL 40 solutions into the peritoneal cavity may be characterized by abdominal distension/abdominal pain and/or shortness of breath. Treatment of PHYSIONEAL 40 overinfusion is to drain the solution from the peritoneal cavity.
Use of higher glucose concentrations Excessive use of PHYSIONEAL 40 peritoneal dialysis solution with a higher dextrose (glucose) during a peritoneal dialysis treatment may result in excessive removal of water from […]