Document: Glukosel solution for infusion ENG PL change

• Glukosel solution for infusion PL
• Glukosel solution for infusion ENG PL

---

Package leaflet: Information for the user

Glukosel solution for infusion

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, pharmacist or nurse.

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

What is in this leaflet:

1. What Glukosel is and what it is used for

2. What you need to know before you use Glukosel

3. How to use Glukosel

4. Possible side effects

5 How to store Glukosel

6. Contents of the pack and further information

Glukosel is a solution that is given into your vein through a drip (intravenous infusion).

The solution is intended to provide the body with energy in the form of glucose and to provide salts in parenteral nutrition (nutrition is administered directly into the circulation), for example in situations when you are not able to eat or drink normally. The solution may also be administered after surgery to ensure intake of the basic amounts of fluid, energy and salts.

Glukosel may also be used as a supplement to enteral nutrition (nutrition is administered directly to the stomach or to the intestines e.g through a catheter).

It should be observed that this solution is only one component of parenteral nutrition. Total parenteral nutrition also includes amino acids, vitamins, fatty acids and trace elements.

Do not use Glukosel

:

• if you have abnormally high blood sugar levels that require high doses of insulin to remain in control

• if you have severe diabetes mellitus with complications up to loss of consciousness

• if you have severely disturbed kidney function with massive fluid loss (diabetes insipidus)

• if you have severe kidney failure not treated with dialysis (a treatment method in which the blood is filtered to artificially eliminate waste products and excess fluid from the body).

• if you have brain and spinal cord bleeding

• if you have delirium tremens (confusion caused by alcoholism that occurs at withdrawal of alcohol characterized by various symptoms, such as hallucinations, tremor, irritability, insomnia etc.), if accompanied by fluid deficiency

• if you have abnormally high blood levels of salts (especially potassium)

• if you have circulatory collapse (shock), oxygen deficiency in tissues

• if you have accumulation of acidic substances in the blood

• if you are allergic to active substances or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Administration of glucose solutions is not recommended if you have recently had a stroke. Talk to your doctor before using Glukosel if:

• you have diabetes mellitus

• you have carbohydrate intolerance

• your blood volume is too high

• you have impaired kidney or heart function.

If you have any of the above conditions, your doctor will consider particularly carefully whether this solution can be given to you.

You may need insulin for adequate control of your blood sugar levels. In such a case, also your blood potassium levels need to be monitored and corrected, if necessary, since insulin may affect your blood potassium levels.

Your doctor will take special care not to stop your infusion suddenly but only gradually, especially if you have diabetes or another disorder that leads to decreased ability to maintain normal blood sugar levels.

Normally, your blood sugar and serum electrolytes (salts in the blood), fluid and acid-base balance will be controlled. Your doctor decides how often these controls should be performed. This depends, among other things, on your condition and on how high doses you receive.

Children

Children may need additional carbohydrates and / or lipids to fully cover their energy requirements.

Other medicines and Glukosel

Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.

Please tell your doctor:

• If you are taking certain heart medicines, digitalis preparations (cardiac glycosides). There is a risk that the effect of digitalis preparations are potentiated after a sudden discontinuation of potassium, which may lead to digitalis intoxication.

• If you are taking certain types of diuretics (potassium-sparing diuretics) that reduce the excretion of potassium, since the levels of potassium in your blood may increase significantly above the normal levels. This may sometimes lead to serious cardiac arrhythmias. Therefore, your serum potassium levels will be carefully monitored during and after administration of Glukosel.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

There are no known risks with the treatment with this product during pregnancy or lactation when the treatment is carried out as indicated with a careful monitoring of blood tests (blood sugar, serum electrolytes, fluid and acid-base balance).

Driving and using machines

This medicine does not affect your ability to drive or use machines.

You doctor determines the right dose for you, depending on your age, body weight and condition.

If you also need blood transfusions, these will be administered to you through a separate line.

Adults:
The maximum daily dose is 40 ml per kg body weight and the infusion rate should not exceed 2.5 ml per kg body weight per hour.

Use in children:

For children over 2 years the same dosages as for adults may be applied.

Glukosel is not suitable for children under 2 years of age

In connection with the infusion, your blood sugar, fluid and salt levels as well as urine output will be controlled regularly. The doctor determines how often these should be checked, depending on your condition.

If you receive more Glukosel than you should

Since you receive Glukosel while you are monitored at the hospital, it is unlikely that you will receive too high amounts of the solution. However, should you accidentally receive too much of the solution or with too rapid an infusion rate, your doctor will know what measures to take. Symptoms of an overdose with Glukosel may include, for example, large amounts of urine, glucose in the urine, elevated blood sugar levels and/or disorders in the salt balance or the acid-base balance. In severe cases, an overdose may also lead to loss of consciousness and to effects on the liver.

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

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

Common (affecting 1 to 10 treated patients): concomitant inflammation and blood clots in a vein (thrombophlebitis).

Other side effects may be related to a particular treatment or to underlying disorders and may include:

Reporting of side effects

If you getany side effects, talk to your doctor, pharmacist or nurse.This includes any possible side effectsnot listed in this leaflet. You can also report side effects directly via the national reporting system listed in[To be completed nationally]. By reporting side effects you can help provide more information on the safety of this medicine.

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

Do not use this medicine after the expiry date which is stated on the labels of the container and the outer carton. The expiry date refers to the last day of that month.

Glukosel should only be used if the solution is clear and the container undamaged.

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

What Glukosel contains

1000 millilitres of the solution contain

Glucose monohydrate
(equivalent to glucose 100.0 g)	110.0	g
Sodium chloride	2.34	g
Potassium chloride	1.87	g
Magnesium chloride hexahydrate	0.51	g
Sodium dihydrogen phosphate dihydrate	1.56	g
Zinc acetate dihydrate	16.5	mg

Corresponding electrolyte concentrations are:
Sodium	50	mmol/l
Potassium	25	mmol/l
Magnesium	2.5	mmol/l
Zinc	0.075	mmol/l
Chloride	70	mmol/l
Dihydrogen phosphate	10	mmol/l
Acetate	0.15	mmol/l

Properties:

Caloric value: 1680 kJ/l (400 kcal/l)

Osmolarity 710 mOsm/l

pH approx. 3.5

Acidity, titration (to pH 7) approx. 8 mmol/l

What Glukosel looks like and contents of the pack

Glukosel is a solution for infusion, i.e. it is administered via a cannula or a small tube placed in a vein. It is a clear, colourless to slightly yellow solution.

Glukosel is available in plastic (colourless polyethylene) bottles containing 1000 ml.

Pack size: 10 plastic bottles.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

B. Braun Melsungen AG

Carl-Braun-Strasse 1

34212 Melsungen, Germany

Postal address:

B. Braun Melsungen AG
34209 Melsungen, Germany

Manufacturer

B. Braun Medical S.A.

Carreterra de Terrassa, 121

08191 Rubi (Barcelona), Spain

This leaflet was last approved in 20 February 2015

-----------------------------------------------------------------------------------------------------------------------------

The following information is intended for medical or healthcare professionals only:

Method of administration

Intravenous use. The solution can be infused into peripheral veins.

Incompatibilities

Only solutions and medicinal products known to be compatible with the product may be mixed.

Because of the risk for pseudoagglutination, this solution should not be administered through the same infusion line with blood. For the same reason, erythrocyte concentrates must not be suspended in this solution.

Special precautions for disposal and other handling

The solution is intended for single use. Any unused product in an opened container should be disposed of.

Only solutions that are clear and in undamaged containers should be used.

Shelf life after opening

The product should be administered immediately after the package has been connected to the infusion line.

Shelf life after reconstitution/dilution

Administration should be initiated immediately after reconstitution of the product.