B. PACKAGE LEAFLET

Package leaflet: Information for the user

KIBOUsol potassium-free, solution for haemofiltration

Glucose monohydrate, Calcium chloride dihydrate, Magnesium chloride hexahydrate, Sodium hydrogen

carbonate, Sodium chloride

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

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

-    If you have any further questions, ask your doctor.

-    If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What KIBOUsol potassium-free solution for haemofiltration is and what it is used for

2.    What you need to know before you use KIBOUsol potassium-free solution for haemofiltration

3.    How to use KIBOUsol potassium-free solution for haemofiltration

4.    Possible side effects

5.    How to store KIBOUsol potassium-free solution for haemofiltration

6.    Contents of the pack and other information

1.    What KIBOUsol potassium-free solution for haemofiltration is and what it is used for

KIBOUsol potassium-free, solution for haemofiltration is prescribed to you if you have temporary or permanent kidney failure.

It purifies your blood of waste products; it corrects the acidity or alkalinity and the level of salts in your blood. As a replacement fluid in haemofiltration, it can also be used as a source of salts and water for hydration.

KIBOUsol potassium-free solution for haemofiltration are supplied in a non-PVC bag with two chambers. The two chambers are separated by a non-permanent seal. You will only receive KIBOUsol potassium-free solution for haemofiltration once the solutions of the two chambers are correctly mixed.

KIBOUsol potassium-free solution for haemofiltration must only be used by or under the direction of a doctor.

You must talk to a doctor if you do not feel better or if you feel worse

2.    What you need to know before you use KIBOUsol potassium-free solution for haemofiltration

Before starting the therapy, your doctor will ensure that you have a good access to your vein and artery. He will also ensure that you do not present a high risk of bleeding.

KIBOUsol solutions for haemofiltration are available in different potassium concentrations. Your blood levels of potassium will be monitored very closely to ensure that the most appropriate formulation of KIBOUsol solution for haemofiltration is used.

Do not use KIBOUsol potassium-free solution for haemofiltration:

-    if you are allergic to glucose monohydrate, calcium chloride dihydrate, magnesium chloride hexahydrate, sodium hydrogen carbonate, sodium chloride or any of the other ingredients of this medicine (listed in section 6).

-    do not have good access to the veins and/or arteries.

-    have an excessive risk of bleeding.

-    have a high level of bicarbonate in your blood.

-    have a potassium blood level too low, unless you are simultaneously receiving potassium supplementation.

-    have a clinical condition whereby the current acidity or alkalinity of your blood may worsen.

-    have kidney failure where waste products cannot be removed from the blood stream by haemofiltration

Warnings and precautions

Talk to your doctor before using KIBOUsol potassium-free solution for haemofiltration

KIBOUsol Potassium-free solution for haemofiltration can only be used by or under the direction of a

doctor who has experience with haemofiltration techniques.

Your doctor will:

-    check the tubing containing KIBOUsol Potassium-free solution for haemofiltration regularly. The bag and tubing will be immediately replaced if your doctor observes particles floating in the fluid.

-    measure the acidity, different salts and waste product levels in your blood.

-    ensure that their levels are correct and closely monitored during your treatment.

-    ensure that the fluid balance of your body is well maintained.

-    check your blood glucose very carefully especially if you are diabetic.

-    measure the potassium level in your blood regularly.

-    ensure, just before use, the content of the two chambers will be mixed. If your doctor infuses unmixed solution, your blood bicarbonate level may increase. This may cause side effects such as nausea, drowsiness, headache, abnormal heartbeat and difficulty of breathing.

Do not use in children and adolescents under the age of 18 as the efficacy and safety has not been

established. There is no data available.

Other medicines and KIBOUsol Potassium-free solution for haemofiltration

Inform your doctor if you are taking other medicines, even those not prescribed.

Taking KIBOUsol Potassium-free solution for haemofiltration may affect and interact with other medicines.

-    If you are diabetic your glucose level will be carefully measured. Your insulin dose will be adjusted as needed as this solution contains glucose.

-    If you use medicines for the heart known as cardiac glycosides you may need potassium supplements. Your doctor will monitor you closely during treatment.

Pregnancy and, breast-feeding

Tell your doctor if you are pregnant or breast-feeding. He will determine the benefits versus the risks of using KIBOUsol Potassium-freesolution for haemofiltration.

3.    How to use KIBOUsol Potassium-free solution for haemofiltration

The treatment by haemofiltration that you receive will depend upon your clinical diagnosis, physical examination, laboratory results and response to treatment.

Your doctor will determine the right formulation and amount of KIBOUsol Potassium-free solution for haemofiltration for your clinical condition and according to your body weight.

Your doctor will decide and adjust the flow rate and volume of the solution to be administered.

The amount of fluid required depends upon how KIBOUsol Potassium-free solution for haemofiltration is being used.

4.    Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You may experience possible side effects with KIBOUsol Potassium-free solution for haemofiltration, due to the solution or to the treatment. The potential undesirable effects that may occur are:

-    Reduction (hypovolaemia) or increase (hypervolaemia) in body fluid volume.

-    Reduction (hypotension) or increase (hypertension) in blood pressure.

-    Very low blood phosphate (hypophosphataemia).

-    Low blood glucose (hypoglycaemia).

-    Disturbance in the alkali level in your blood (alkalosis).

-    Feeling sick.

-    Vomiting.

-    Muscle cramps.

-    Bleeding disorder.

-    Infection.

-    Shortness of breath, irregular breathing (caused by air bubbles getting into the blood stream).

-    Disturbance in the different salt levels in your blood (e.g. disturbance in sodium, potassium, calcium in your blood).

-    Increase blood clotting.

Reporting of side effects

If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V*. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store KIBOUsol potassium-free solution for haemofiltration

Keep this medicine out of the sight and reach of children.

Do not store below +4°C

Do not use this medicine after the expiry date which is stated on the label and carton after ‘Exp.’

The expiry date refers to the last day of that month.

Your doctor will not use KIBOUsol potassium-free solution for haemofiltration if the solution is not clear or if the container is damaged.

Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What KIBOUsol potassium-free solution for haemofiltration contains

The active substances are:

BEFORE RECONSTITUTION:

Composition of the separate compartments	Per 1000 ml
Small compartment ml 500
Glucose monohydrate	11.000 g
Calcium chloride dihydrate	2.573 g
Magnesium chloride hexahydrate	1.017 g
Large compartment 4500ml

Sodium hydrogen carbonate	3.547 g
Sodium chloride	6.623 g

AFTER RECONSITUTION:

The 500 ml solution of the small compartment and the 4500 ml solution of the large comparments are mixed to give 5000 ml final reconsituted solution, whose composition is:

Composition of final solution	Per 1000 ml
Glucose monohydrate	1.100 g
Calcium chloride dihydrate	0.257 g
Magnesium chloride hexahydrate	0.102 g
Sodium hydrogen carbonate	3.192 g
Sodium chloride	5.961 g

The other ingredients are: hydrochloric acid, water for injection

What KIBOUsol potassium-free solution for haemofiltration looks like and contents of the pack

KIBOUsol potassium-free solution for haemofiltration is presented in a two-chamber bag. The smaller compartment (500 ml) contains the the acid solution, while the larger compartment (4500 ml) contains the basic solution.

The final reconstituted solution is obtained after breaking the internal seal and mixing both solutions.

The bag is overwrapped with a plastic film and packed in cardboard boxes.

Marketing Authorisation Holder and Manufacturer

Haemopharm Biofluids S.r.l.,

Via dell’Industria 6

23030 Tovo Di Sant’Agata (SO)

Italy

This leaflet was last revised in June 2016

5