Last Updated on eMC 12-01-2018 View medicine  | Baxter Healthcare Ltd Contact details

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC.  For each version, we show the dates it was published on the eMC and the reasons for change.

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:12-12-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 2 - deletion of

Theoretical Osmolarity:                                        287 mOsm/l

 

Section 3 - added text:

Theoretical Osmolarity:                                        287 mOsm/l

 

                Section 4.2 - changed text as shown in red and green   

The rate at which Hemosol B0 is administered depends on the blood concentration of electrolytes, acid-base balance, fluid balance and overall clinical condition of the patient. The volume of substitutionreplacement solution and/or dialysate to be administered will also depend on the desired intensity (dose) of the treatment performed and on the amount of. The solution, which has to should be replaced in order to achieve the target fluid balance. The doseprescribed and administration (dose, infusion rate, and cumulative volume is therefore at the discretion of the responsible) should be established only by a physician. experienced in critical care medicine and CRRT (Continuous Renal Replacement Therapy).

 

Commonly used flow rates for the substitution solution in haemofiltration and haemodiafiltration are:

Adult:               500 - 1500 ml3000 mL/hour

 

Commonly used flow rates for the dialysis solution (dialysate) in continuous haemodialysis are:

Adult:               500 - 2000 ml2500 mL/hour

 

Commonly used flow rates in adults are approximately 2000 to 2500 ml/h which correspond to a daily fluid volume of approximately 48 to 60 L.

 

Special population:

 

Elderly population

Evidence from clinical studies and experience suggests that use in the elderly population is not associated with differences in safety or effectiveness.

 

Paediatric population:

 

Commonly usedThe range of flow rates for the substitution solution in haemofiltration and haemodiafiltration are:

Adolescents (12-18 years of age):                  500 - 1500 ml/hour

Neonates, infants, children (0-12 years of age):         15 – 20 ml/kg/hour

 

Commonly used flow ratesand for the dialysis solution (dialysate) in continuous haemodialysis are:

Adolescents (12-Children (from neonates to adolescents to 18 years of age):                 500 -): 1000 to 2000 ml/hourmL/h/1.73 m2

Neonates, infants, children (0-12 years of age):         15 – 20 ml/kg/hour

 

Flow rates up to 4,000 mL/h/1.73 m2 may be needed, especially in younger children (≤10 kg). The absolute flow rate (in mL/h) in the paediatric population should generally not exceed the maximum adult flow rate.

 

Method of administration:

Intravenous use and for haemodialysis.

 

Hemosol B0, when used as a substitution solution is administered into the extracorporeal circuit before (pre-dilution) or after the haemofilter or haemodiafilter (post-dilution).

 

 Section 4.4 changed text as shown in red and green

The substitution solution Hemosol B0 is potassium-free. The serum potassium concentration must be monitored before and during hemofiltration and/or hemodialysis.

 

Check that the solutions are clear and that all seals are intact before mixing. Carefully follow the instructions for use.

The electrolyte solution must be mixed with the buffer solution before use to obtain the final solution suitable for haemofiltration/haemodiafiltration/continuous haemodialysis.

 

Do not administerUse only with appropriate extracorporeal renal replacement equipment.

 

Because the solution unless it is clear. Aseptic technique must be used during connection / disconnection of the line sets.

 

When used with a monitor, only monitors for Continuous Renal Replacement Therapies must be used. Do not use with a haemodialysis monitor.

 

Precautions for use:

 

The heating of this substitution solutioncontains no glucose, administration may lead to body temperature (37°C) must be carefully controlled.

hypoglycemia. Blood glucose levels

Before and during treatment, haemodynamic status, fluid balance, electrolyte and acid-base balance should be closely monitored throughout the procedure. Special attention should be given to potassium levels. Phosphate substitution and potassium supplement might be necessary. regularly.

 

Hemosol B0 contains hydrogen carbonate (bicarbonate), and lactate (a hydrogen carbonate precursor) which can influence the patient’s acid–base balance. If metabolic alkalosis develops or worsens during therapy with the solution, the administration rate may need to be decreased, or the administration stopped.

 

The use of contaminated haemofiltration solution may cause sepsis, shock and fatal conditions.

 

Precautions for use:

 

Hemosol B0 may be warmed to 37 °C to enhance patient comfort. Warming of the solution prior to use should be done before reconstitution with dry heat only. Solutions should not be heated in water or in a microwave oven. The solution should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer unless the solution is clear and the seal is intact.

 

Before and during treatment, electrolyte and acid-base balance should be closely monitored throughout the procedure.

Phosphate up to 1.2 mmol/L may be added to the solution. If potassium phosphate is added, the total potassium concentration should not exceed 4 mEq/L (4 mmol/L). Potassium supplement might be necessary.

 

The patient’s hemodynamic status and fluid balance should be monitored throughout the procedure and corrected as needed.

 

Section 4.5 changed text as shown in red and green

The blood concentration of filterable/dialysable drugs may be reduced during treatment. Corresponding corrective therapy should be instituted if necessary to establish the desired blood concentrations for drugs removed during treatment.

Interactions with other medications due to electrolyte and/or acid-base imbalances can be avoided by correct dosage of the solution for haemodialysis/haemofiltration and precise monitoring.

 

However, the following interactions are conceivable:

·         The risk of digitalis-induced cardiac arrhythmia is increased during hypokalaemia;

·         Vitamin D and vitamin D analogues, as well as medicinal products containing calcium,  (e.g. calcium chloride or calcium gluconate used for maintenance of calcium homeostasis, in CRRT patients receiving citrate anticoagulation and calcium carbonate as phosphate binder,) can increase the risk of hypercalcaemia;

·         Additional sodium bicarbonate substitutionhydrogen carbonate (or other buffer source) contained in the CRRT fluids or in other fluids administered during therapy may increase the risk of metabolic alkalosis.;

·         When citrate is used as an anticoagulant, it contributes to the overall buffer load and can reduce plasma calcium levels.

Section 4.6 changed text as shown in red and green

Pregnancy and breastfeeding

No effects on fertility or during pregnancy or on the breast-fed newborn/infant are anticipated. There is no report on Hemosol B0 during pregnancy or lactation but literature on renal replacement therapy during acute kidney injury does not suggest risks associated with solutions. The prescriber should consider the benefit/risk relationship before administering Hemosol B0 to pregnant or breast feeding women.

 

Fertility

There are no clinical data on fertility. However no effects on fertility are anticipated

 

Section 4.8 - changed text shown in red and green and Table added

SomeThe following undesirable effects relatedare reported from post-marketing experience. The table presented below is according to the dialysis treatment can occur, such as nausea, vomiting, muscle crampsMedDRA system organ classification (SOC and hypotension.Preferred Term Level).

Electrolyte disturbances may occur. Frequencies: Not known (cannot be estimated from the available data).

Section 4.9 - changed text shown in red and green

Overdose with Hemosol B0 substitution fluid should not occur if the procedure is carried out correctly and the fluid balance, electrolyte and acid-base balance of the patient are carefully monitored.

However, overdose will result in fluid overload in patients with renal failure.

Continued application of haemofiltration will remove excess fluid and electrolytes. In case of hyperhydration, the ultrafiltration must be increased and the rate of administration of the solution for haemofiltration reduced. In the case of a severe dehydration it is necessary to cease ultrafiltration and to increase the inflow of solution for haemofiltration appropriately.

Overdose could lead to severe consequences, such as congestive heart failure, electrolyte or acid-base disturbances.

If hypervolaemia or hypovolaemia occur, this should be corrected immediately.

If electrolyte imbalance and acid-base balance abnormalities (e.g., metabolic alkalosis, hypophosphatemia, hypokalemia, etc.) occur, stop administration promptly. There is no specific antidote for overdose. The risk can be minimized by close monitoring and adequate supplementation during treatment (see section 4.4).

 

section 5.1 - changed text shown in red and green

Pharmacotherapeutic group: Hemofiltrates, ATC code: B05ZB.

 

Pharmacodynamic effects

Hemosol B0 is pharmacologically inactive. The sodium, calcium, magnesium and chloride ions are present at concentrations similar to physiological levels in plasma.

 

Mechanism of action

The solution is used to replace water and electrolytes removed during haemofiltration or to serve as a suitable exchange medium for use during haemodiafiltration or continuous haemodialysis.

BicarbonateHydrogen carbonate is used as an alkalising buffer.

 

Section 6.6 - changes shown in red and green

The electrolyte solution (small compartment A) is added to the buffer solution (large compartment B) after breaking the frangible pin or opening the peel seal andimmediately before administrationuse to obtain the patientreconstituted solution.

 

A patient information leaflet with detailed instruction for use is enclosed in the box.

Aseptic technique should be used throughout the handling and administration to the patient:

Use only if the overwrap is not damaged, all seals are intact, frangible pin or peel seal is not broken, and the solution is clear. Press bag firmly to test for any leakage. If leakage is discovered, discard the solution immediately since sterility can no longer be assured.

 

The large compartment is fitted with an injection port for the possible addition of other necessary drugs after reconstitution of the solution.

Before adding a substance or medication, verify that it is soluble and stable in Hemosol B0, and that the pH range is appropriate (pH of reconstituted solution is 7.0 to 8.5).

Additives may be incompatible. The instructions for use of the medication to be added and other relevant literature must be consulted. After addition, if there is a color change and/or the appearance of precipitates, insoluble complexes, or crystals, do not use.

 

Mix the solution thoroughly when additives have been introduced.

 

The reconstituted solution is for single use only.

Do not use if container is damaged or if solution is not clear.

Discard any unused solution.

 

The solution should be used immediately after removal of the over wrap and after addition of solution A to solution B. If not used immediately, the reconstituted solution should be used within 24 hours after addition of the electrolyte solution to the buffer solution.

 

The reconstituted solution is for single use only.

Do not use if container is damaged or if solution is not clear.

 

 

Discard any unused solution.

 

If a peel seal separates the two compartments of the bag and a frangible pin is located in the luer connector the following instructions for use should be followed:

I           Immediately before use remove the overwrap from the bag and mix the solutions in the two different compartments. Hold the small compartment with both hands and squeeze it until an opening is created in the peel seal between the two compartments.

II         Push with both hands on the large compartment until the peel seal between the two compartments is entirely open.

III        Secure complete mixing of the solution by shaking the bag gently. The solution is now ready for use, and can be hung on the equipment.

IV        The dialysis or replacement line may be connected to either of the two access ports.

IVa      If the luer access is used, remove the cap and connect the male luer lock on the dialysis or replacement line to the female luer receptor on the bag; tighten. Using thumb and fingers, break the coloured frangible pin at its base, and move it back and forth. Do not use a tool. Verify that the pin is completely separated and that the fluid is flowing freely. The pin will remain in the luer port during the treatment.

IVb     If the injection port is used, first remove the snap-off cap. Then introduce the spike through the rubber septum. Verify that the fluid is flowing freely.

 

The solution should be used immediately after removal of the over wrap and after addition of solution A to solution B. If not used immediately, the reconstituted solution should be used within 24 hours, including the duration of the treatment.

 

The reconstituted solution is for single use only. Do not use if container is damaged or if solution is not clear. Discard any unused portion immediately after use.

 

The solution should be used immediately after removal of the over wrap and after addition of solution A to solution B.. If not used immediately, the reconstituted solution should be used within 24 hours, including the duration of the treatment, after addition of the electrolyte solution to the buffer solution.

The reconstituted solution is for single use only. Do not use if container is damaged or if solution is not clear. Discard any unused portion immediately after use.

 

No special requirements for disposal.

The reconstituted solution is for single use only. Do not use if container is damaged or if solution is not clear. Discard any unused portion immediately after use.

 

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

 

Section 7 address change

 

 

Reasons for adding or updating:

  • Change to section 1 - Name of the medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:15-10-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



The following sections of the SPC are revised

 

1 – Name of the Medicinal Product

2 - Qualitative and Quantitative Composition

3 - Pharmaceutical form

4.1 – Therapeutic indications

4.2 - Posology and method of administration

4.3 - Contraindications

4.4 - Special warnings and precautions for use

4.5 - Interaction with other medicinal products and other forms of interaction

4.6 - Fertility, pregnancy and lactation

4.8 - Undesirable effects

6.2 – Incompatibilities

6.4 – Special precautions for storage

6.6 - Special precautions for disposal and other handling

9 – Date of first authorisation/Renewal of the authorisation

10 - Date of revision of the text

Reasons for adding or updating:

  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Date of revision of text on the SPC:01-01-0001

Legal Category:POM

Black Triangle (CHM): NO