Hospasol 167 Mmol/L Solution For Infusion

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Hospasol® 167 mmol/l Solution for infusion

Package Leaflet: Information for the user

Sodium hydrogen carbonate

Read all of this leaflet carefully before you start using this medicine.

• Keep this leaflet. You may need to read it again.

• If you have any further questions, ask your doctor or pharmacist.

• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. WHAT Hospasol® 167 MMoL/L Is AND WHAT It Is usED For

2. before you use hospasol® 167 mmol/l

3. how to use hospasol® 167 MMoL/L

4. possible side effects

5. how to store hospasol® 167 mmol/l

6. further information

1. WHAT hospasol® 167 MMoL/L is AND WHAT IT is usED For?

Hospasol® 167 mmol/l is used in hospitals or special centres during dialysis session to correct chemical imbalance of the blood which is caused by kidney failure.

It replaces bicarbonate (hydrogen carbonate), which is lost from the body during:

• Acetate-Free Biofiltration (AFB) or

• Acetate-Free Continuous Venous-Venous Haemofiltration (AFCVVH).

It also helps restore the body's bicarbonate levels, which becomes depleted when the kidneys are not working properly (renal failure).

2. before you are given hospasol® 167 mmol/l

You must not receive Hospasol® 167 mmol/l

• if a dialysis method with buffer supplementation is already used.

Take special care with Hospasol® 167 mmol/l

It is important to monitor the concentration of salts (electrolytes) in your blood and also the acid-base balance of your body. The composition of your blood will, therefore, be checked at regular intervals.

Special attention should be given to:

• the pH value of your blood. In case of high pH (alkalosis), Hospasol® 167 mmol/l shall not be used.

• the level of sodium in your blood if you have heart problem and/or renal failure. An overdose of sodium may lead to fluid retention within the body (hypervolemia) and particularly in the lungs (pulmonary oedema).

• your blood vessels as an inflammation associated with clot formation (thrombophlebitis) can be induced if the product is administered to a smaller (peripheral) vein.

• your blood level of proteins, amino acids and water-soluble vitamins, as significant losses can occur during dialysis.

using other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is because the concentration in your blood of some of these medicines may be reduced during treatment with Hospasol® 167 mmol/l. Your doctor will decide if any of the other medicines should be changed.

Pregnancy and breast-feeding

There are no adequate data from the use of Hospasol® 167 mmol/l in pregnant or breastfeeding women. Your doctor will decide whether you should be given Hospasol® 167 mmol/l if you are pregnant or breast-feeding.

3. how to use hospasol® 167 MMoL/L

Hospasol® 167 mmol/l is a product to be used in hospitals or special centres with dialysis machines. It shall be administered by medical professionals only.

The volume of Hospasol® 167 mmol/l, and therefore the dose used, will depend on your condition. The dose volume will be determined by the physician responsible for your treatment.

Do not use Hospasol® 167 mmol/l if the solution is cloudy or if the over wrap is damaged. All seals must be intact.

If you are given more Hospasol® 167 mmol/l than you should be given

Overdose may result in too low concentration of potassium (hypokalaemia) and/or glucose (hypoglycaemia) in the blood. If overdose occurs, administration of Hospasol® 167 mmol/l should immediately be discontinued and dialysis performed. Repeated blood-gas monitoring should be performed.

Your doctor will take the necessary corrective measures and adjust your dose.

If you have any further questions on the use of this product, please ask your doctor or your pharmacist.

4. possible side effects

Like all medicines, Hospasol® 167 mmol/l can cause side effects, although not everybody gets them.

There are some side effects which can be caused by the process of haemodialysis,

such as:

• feeling sick (nausea)

• being sick (vomiting)

• muscle cramps

• high blood pressure (hypertension)

• chills

• fever

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. how to store hospasol® 167 mmol/l

Keep out of the reach and sight of children.

Do not use Hospasol® 167 mmol/l after the expiry date which is stated on the label and the packaging. The expiry date refers to the last day of that month.

Do not store below +4°C.

Hospasol® 167 mmol/l can be disposed of via wastewater without harming the environment.

6. further information

What Hospasol® 167 mmol/l contains The active substance is:

1000 ml of solution contains:

Sodium hydrogen carbonate 14.0 g

Corresponding to

Sodium, Na+ 167 mmol/l

(167 mEq/l)

Hydrogen carbonate, HCO₃^- 167 mmol/l

(167 mEq/l)

Theoretical osmolarity: 334 mOsm/l

The other ingredients are:

• carbon dioxide (for pH adjustment)

• water for injections.

What Hospasol® 167 mmol/l looks like and contents of the pack

Hospasol® 167 mmol/l is presented in a one compartment bag. The solution is clear and colourless.

Each bag contains 3000 ml or 5000 ml solution for infusion. The bag is over wrapped with a transparent film.

Each box contains three bags of 3000 ml or two bags of 5000 ml and one package leaflet.

Marketing Authorisation Holder

Gambro Lundia AB, Magistratsvagen 16,

SE- 226 43 Lund, SWEDEN

Manufacturer

Gambro Dasco S.p.A. Sondalo Plant,

Via Stelvio 94, IT-23035 Sondalo (SO), ITALY

This leaflet was last approved in 11/2009.

Hospasol® 167 mmol/l Solution for infusion

the following information is intended for QK medical or healthcare professionals only

HOSPASOL® 167 mmol/l solution for infusion

The use of a buffer-free dialysis solution (which does not contain acetate or hydrogen carbonate) is essential. A dialysis solution 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.

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.

Hospasol® 167 mmol/l is injected into the venous return line or is injected into the extracorporeal circuit before (pre-dilution) or after the haemofilter (post-dilution).

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 INSTRUCTIONS FOR USE / HANDLING

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

Consult the instructions for use for the dialysis machine before you start the treatment with Hospasol® 167 mmol/l.

Do not remove unit from over wrap until ready for use.

Hospasol® 167 mmol/l should be used only if the solution is clear, free of particles and all seals intact.

Aseptic techniques must be used throughout the administration to the patient.

Before connection and after removing the cap of the bag connector (safelink), disinfectant should be applied to the interior of the safelink.

Prior to disconnection, it is recommended that the external surfaces of the line connector and the safelink should be disinfected.

The solution is for single use only. Discard any unused solution immediately after use.

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.