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1. Hospasol 167 Mmol/L Solution For Infusion
2. Hospasol 167 Mmol/L Solution For Infusion

SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Hospasol 167 mmol/l solution for infusion

2.    QUALITATIVE AND QUANTITATIVE COMPOSITION

1000 ml contains:

Sodium hydrogen carbonate 14.0 g

Corresponding to

Na+    167 mmol/l (167 mEq/l)

HCO3 ^- 167 mmol/l (167 mEq/l)

For a full list of excipients, see section 6.1.

3.    PHARMACEUTICAL FORM

Solution for infusion.

Clear and colourless solution.

4.    CLINICAL PARTICULARS

4.1    Therapeutic indications

Hospasol 167 mmol/l is indicated in Acetate-Free Biofiltration or in Acetate-Free Continuous Veno-Venous Haemofiltration in renal-failure patients undergoing dialysis. It is used to replace hydrogen carbonate lost during Acetate-Free Biofiltration or during Acetate-Free Continuous Veno-Venous Haemofiltration and to restore the body’s alkali stores which become depleted in renal failure.

4.2 Posology and method of administration Posology:

The volume, flow rate and duration of dialysis should be determined by the responsible physician.

Commonly used flow rates in Acetate-Free Biofiltration are:

Adults, adolescents and elderly:    from 1 500 to 2 000 ml/hour

Children:    from 30 to 40 ml/kg/hour

Commonly used flow rates in Acetate-Free Continuous Veno-Venous Haemofiltration are:

Adults, adolescents and elderly:    from 85 to 530 ml/hour

Children:    from 1.70 to 10.5 ml/kg/hour

Method of administration:

Intravenous use.

In the Acetate-Free Biofiltration mode of dialysis therapy, Hospasol 167 mmol/l is injected into the venous return line to the patient.

The infusion pump for hydrogen carbonate should be connected to the blood, the ultrafiltration and dialysate pumps.

In Acetate-Free Continuous Veno-Venous Haemofiltration, Hospasol 167 mmol/l is injected into the extracorporeal circuit either in pre or post dilution mode in a location different than the infusion point of the buffer free substitution fluid.

4.3 Contraindications

All dialysis techniques using already a buffer supplementation should be contra-indicated.

4.4 Special warning and precautions for use Special warnings

Hospasol 167 mmol/l should not be used in patients who have metabolic or respiratory alkalosis.

In renal failure patients, serum electrolyte concentrations (particularly bicarbonate, potassium, calcium, magnesium, sodium and phosphate), blood chemistry and haematological parameters should be evaluated periodically.

In cardiac and/or renal insufficient patients, an overdose of sodium may induce hypervolemia and pulmonary oedema.

Thrombophlebitis can be induced if the product is administered to a peripheral vein.

Replacement of proteins, amino acids and water-soluble vitamins may be necessary, as significant losses can occur during dialysis.

Paravenous administration may result in tissue necrosis.

Special precautions for use

Hospasol 167 mmol/l is only intended for use with dialysis machines which are specially designed for carrying out Acetate-Free Biofiltration and Acetate-Free Continuous Veno-Venous Haemofiltration.

The use of a buffer-free dialysate (which does not contain acetate or hydrogen carbonate) is essential. A dialysate with an appropriate composition for acetate-free biofiltration should be selected.

The use of a buffer-free substitution fluid (which does not contain acetate or hydrogen carbonate) is essential. A substitution fluid with an appropriate composition for Acetate-Free Continuous Veno-Venous Haemofiltration should be selected.

The infusion rate should be at least equal to the amount of hydrogen carbonate in the effluent.

Aseptic technique should be used throughout the procedure.

4.5 Interaction with other medicinal products and other forms of interaction

Blood concentration of dialysable medicinal products may be reduced during dialysis. Corrective therapy should be instituted if necessary.

Hospasol 167 mmol/l must be administered alone without addition of any other medicinal products.

4.6 Pregnancy and lactation

There are no adequate data from the use of Hospasol 167 mmol/l in pregnant or lactating women. The prescriber should consider the benefit/risk relationship before administering Hospasol 167 mmol/l to pregnant or breastfeeding women.

4.7 Effects on ability to drive and use machines

Hospasol 167 mmol/l has no influence on the ability to drive or use machines.

4.8 Undesirable effects

Some undesirable effects related to the dialysis treatment procedure can occur rarely and are presented in the following table.

Frequency

4.9 Overdose

Overdose could lead to hypokalaemia and hypoglycaemia.

If overdose occurs, administration of Hospasol 167 mmol/l should be discontinued immediately and dialysis performed with repeated blood-gas monitoring.

5.    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Pharmacotherapeutic group: Hemofiltrates; ATC code: B05Z B

Hospasol 167 mmol/l is pharmacologically inactive.

Sodium hydrogen carbonate is an agent used to maintain the acid-base balance.

Acetate-Free Biofiltration is a haemodialysis technique which uses a buffer-free dialysate (i.e. without sodium hydrogen carbonate or acetate), in combination with the infusion of a sterile and pyrogen-free sodium hydrogen carbonate solution (agent maintaining body acid-base equilibrium). Acetate-Free Continuous Veno-Venous Haemofiltration is a haemofiltration technique which uses a buffer-free substitution fluid (i.e. without sodium hydrogen carbonate or acetate), in combination with the infusion of a sterile and pyrogen-free sodium hydrogen carbonate solution (agent maintaining body acid-base equilibrium).

5.2 Pharmacokinetic properties

Not relevant.

Preclinical safety data

Sodium and hydrogen carbonate are physiological components in animal and human plasma. Toxic effects are not expected at therapeutic doses.

6. PHARMACEUTICAL PARTICULARS 6.1 List of excipients

Water for injections, carbon dioxide (pH adjuster).

6.2 Incompatibilities

Hospasol 167 mmol/l must be administered alone without addition of any other medicinal products, in particular calcium or magnesium-containing solutions which could result in precipitation of calcium or magnesium carbonate.

6.3 Shelf life

1 year.

From a microbiological point of view, once opened, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.

6.4 Special precautions for storage

Do not store below 4°C.

6.5 Nature and contents of container

The container is made of Polyvinyl Chloride (PVC). It is a one compartment bag, overwrapped with a transparent overpouch made of multilayers copolymers. It is fitted with a safelink connector made of polycarbonate and polyvinyl chloride, to be attached to the infusion line.

One bag contains 3000 ml or 5000 ml.

Pack sizes: 3 x 3000 ml or 2 x 5000 ml in a box.

6.6 Special precautions for disposal

Hospasol 167 mmol/l is only intended for use with dialysis machines which have been specially designed to carry out Acetate-Free Biofiltration or Acetate-Free Continuous Veno-Venous Haemofiltration.

Consult the instructions for use for the dialysis machine before the use of Hospasol 167 mmol/l.

Do not remove unit from overwrap until ready for use.

Prior to preparing for administration, ensure that the solution is clear and practically free of particles and that all the seals are intact.

Aseptic techniques must be applied during connection / disconnection of the infusion line to the bag. It is recommended that, prior to disconnection, the external surfaces of the line/bag connector should be disinfected. After removing the safelink on the new bag, disinfectant should also be applied to the interior of the connector.

For single use only. Discard any unused solution immediately after use.

7. MARKETING AUTHORISATION HOLDER

Gambro Lundia AB Trading Hospal P.OBOX 10101 SE 220 10 Lund Sweden

8.    MARKETING AUTHORISATION NUMBER(S)

PL 17234/0016

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

19/09/2007

10    DATE OF REVISION OF THE TEXT

19/09/2007