Alkaline Bicarbonate Haemodialysis Concentrate 8.4 % Solution
Clinical Summary
Quick overview from the medicine insert
Indication
Used in haemodialysis to maintain acid-base balance and electrolyte levels in patients with renal failure.
Dosage (summary)
Administered as per dialysis protocol; typically, 8.4% solution is used during the dialysis process.
Onset of Action / Duration
Immediate onset during dialysis session; duration of effect is dependent on dialysis duration.
Special Populations
- Elderly patients
- Patients with renal impairment
- Patients with cardiovascular disease
Pregnancy & Breastfeeding
Use during pregnancy and lactation should be based on a risk-benefit assessment; consult a healthcare professional.
Key Drug Interactions
- May interact with other medications affecting electrolyte balance.
- Caution with concurrent use of potassium-sparing diuretics.
Contraindications
- Severe metabolic alkalosis
- Hypersensitivity to sodium bicarbonate or sodium chloride
- Severe renal impairment without dialysis
Common side effects
- Metabolic alkalosis
- Fluid overload
- Electrolyte imbalances
Counselling Points
- Inform patients about the importance of adherence to dialysis schedule.
- Advise on signs of electrolyte imbalance, such as muscle cramps or weakness.
- Encourage patients to report any unusual symptoms during treatment.
Serious warnings
- Monitor electrolyte levels regularly during treatment.
- Use with caution in patients with heart failure or hypertension due to sodium content.
Important Disclaimer
The Alkaline Bicarbonate Haemodialysis Concentrate 8.4 % Solution professional information leaflet below is the property of B Braun Medical and is provided on Medinsert exactly as issued, with no.. alterations or editorial changes. We make every effort to keep content current by updating documents as soon as new versions become available. Medinsert serves as a trusted access point for healthcare professionals, but does not replace official sources or clinical judgement. For more details, please read our full disclaimer. read more>>
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Clinical Particulars
Section 4 of the official insert — extracted exactly as issued, no alterations
4.1.Therapeutic indications
The indications below apply exclusively to the ready-to-use bicarbonate haemodialysis solution prepared from alkaline and acidic bicarbonate haemodialysis concentrates diluted as directed:
- Acute renal failure
- Chronic renal failure
- Hyperhydration
- Intoxication
- Compensation of the acid-base and electrolyte balances
- Adjustment of the blood/plasma/body temperature
4.2. Posology and method of administration
Posology
The details for dialysis session, the duration of dialysis, dialyser used, rate of fluid removal, etc. must be specified by the attending nephrologist per patient, in line with the patientu2019s condition.
Method of administration
Unless otherwise prescribed, mix alkaline and acidic bicarbonate haemodialysis concentrate with water of a suitable grade (see section 2). The machine automatically proportions the alkaline bicarbonate, acidic concentrate and water to produce the bicarbonate dialysis fluid (ready to use solution). Instructions for use on haemodialysis machines: Follow manufactureru2019s instructions according to the operating manual of the specific haemodialysis machine in use. Notes: Do not use ACIDIC BICARBONATE HAEMODIALYSIS CONCENTRATE SW after the expiry date printed on the container. Use immediately after opening. Discard any surplus. Do not use if concentrate is not clear. The concentration of the ready-to-use bicarbonate haemodialysis solution must be monitored carefully.
4.3 Contraindications
- Hyperkalaemia with the use of a potassium-containing acidic bicarbonate haemodialysis concentrate;
- Hypokalaemia with the use of a potassium-free acidic bicarbonate haemodialysis concentrate;
- Intractable coagulopathy
4.4 Special warnings and precautions for use
In patients with unstable circulation and/or unstable blood pressure, a different extracorporeal method of treatment may be indicated.
Special precautions
If the removal of ultra filtrate exceeds the recommended rate, hypovolaemic shock may occur. Patients with high blood pressure and chronic uremia should be treated with care as the removal of large volumes may result in hypotension and significantly higher plasma dopamine- u03b2 - hydroxylate activity.
4.5 Interaction with other medicines and other forms of interaction
The effects of dialysis and filtration procedures on drug concentrations in the body can be complex. More medicine may be removed by one dialysis technique than another. In general, medicines of low molecular weight, high water solubility, low volume of distribution, low protein binding, and high renal clearance are most extensively removed by dialysis. For example, aminoglycosides are extensively removed by dialysis procedures, and extra doses may be needed to replace losses, usually guided by serum-drug concentrations. Specific drug dosage adjustments for dialysis procedures may be used where these are known. For medicine where the effect of dialysis is unknown, it is usual to give maintenance doses after dialysis. Dialysis-induced changes in fluids and electrolytes have the potential to alter the effects of some medicine. For example, hypokalaemia predisposes to digoxin toxicity.
4.6 Fertility, pregnancy and lactation
Safety in pregnancy and lactation has not been established. Haemodialysis treatment should be used with particular caution and under the close doctoru2019s supervision.
4.7 Effects on ability to drive and use machines
No data available.
4.8 Undesirable effects
System Organ Class Frequency Adverse reactions
- Vascular disorders Uncommon Hypotension and air embolism
- Gastrointestinal disorders Uncommon Nausea and vomiting (as symptoms of hypotension).
- Nervous system disorders Uncommon Dizziness and convulsion (as symptoms of hypotension).
- Musculoskeletal, connective tissue and bone disorders Uncommon Muscle cramps.
- Blood and the lymphatic system disorders Uncommon Thrombosis and haemorrhage (related to vascular access). Accelerated atherosclerosis (long-term complications in dialysed patients)
- Renal and urinary disorders Uncommon Acquired cystic kidney diseases (long-term complications in dialysed patients).
- Infection and infestation Uncommon Infection (related to vascular access).
- Other Uncommon Amyloidosis (long-term complications in dialysed patients).
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 to SAHPRA via the u20186.04 Adverse Drug Reactions Reporting Formu2019 found under SAHPRAu2019s publications: https://www/sahpra.org.za/Publications/Index/8
4.9 Overdose
Treatment is symptomatic and supportive.
