PACKAGE LEAFLET: INFORMATION FOR THE USER

Glucose 5% in half strength Hartmann's, solution for infusion

Read all of this leaflet carefully before you are given 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 or pharmacist.

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

What is in this leaflet

1.    What Glucose 5% in half strength Hartmann's solution is and what it is used for

2.    What you need to know before you are given Glucose 5% in half strength Hartmann's solution

3.    How you are given Glucose 5% in half strength Hartmann's solution

4.    Possible side effects

5.    How Glucose 5% in half strength Hartmann's solution is stored

6.    Contents of the pack and other information

1. What Glucose 5% in half strength Hartmann's solution is and what it is used for

Glucose 5% in half strength Hartmann's solution is a clear solution of glucose and sodium lactate in water.

Glucose 5% in half strength Hartmann's solution is used for the treatment of dehydration with acidosis (acidic blood) when a low concentration of sodium is needed, e.g. for dehydrated children or increase of sodium in the blood.

2. What you need to know before you are given Glucose 5% in half strength Hartmann's solution

You should not receive Glucose 5% in half strength Hartmann's solution if you have:

•    a known allergy (hypersensitivity) to Glucose 5% in Half Strength Hartmann's Solution or any of the ingredients of Glucose 5% in Half Strength Hartmann's Solution mentioned in Section 6. If you development a rash or other allergic reactions (like itching, swollen lips or face or shortness of breath), please inform your doctor.

•    severe salt and water retention and hyperkalaemia (high potassium levels)

•    severe liver damage

•    a medical condition that means you cannot convert lactate to bicarbonate.

Your doctor will check these.

Warnings and precautions

Talk to your doctor or pharmacist before being given Glucose 5% in half strength Hartmann's solution if you have:

•    cardiac (heart) failure

•    hypertension (high blood pressure)

•    a kidney disorder

•    peripheral oedema (fluid under the skin)

•    pulmonary oedema (fluid in the lungs)

Your doctor or nurse will ensure the solution is clear and free from particles before use.

Other Medicines and Glucose 5% in half strength Hartmann's solution

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

The following drugs should not be mixed with Glucose 5% in half strength Hartmann's solution:

•    novobiocin, oxytetracycline, sulphadiazine sodium (antibiotics)

•    sodium bicarbonate (used to reduce acidity)

•    sodium calcium edetate (a preservative)

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 or pharmacist for advice before taking this medicine.

Driving and using machines

Glucose 5% in half strength Hartmann's solution has no effect on driving or using machines.

3.    How you are given Glucose 5% in half strength Hartmann's solution

Glucose 5% in half strength Hartmann's solution will be given to you in hospital by healthcare professionals. You will receive your medicine by infusion (IV drip).

Dosage

The amount and rate at which the infusion is given depends on your requirements. Your doctor will decide on the correct dose for you to receive.

4.    Possible side effects

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

The following side effects have been reported if the solution is given too quickly:

•    peripheral oedema (fluid under the skin)

•    convulsions

Thrombosis (the formation of a clot) may occur in the vein where the infusion is given.

The symptoms of thrombosis include:

•    pain, swelling and redness at the blood clot site.

•    an itchy rash at the clot site

•    warm skin around the clot

•    a mild fever

•    major veins that stand out from your skin.

Reporting of side effects

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

You can also report side effects directly via the Yellow Card Scheme at: w w w. m h ra. gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

5.    How Glucose 5% in half strength Hartmann's solution is stored

Keep out of the sight and reach of children.

Your doctor and hospital pharmacist are responsible for the correct storage, use and disposal of Glucose 5% in half strength Hartmann's solution. Glucose 5% in half strength Hartmann's solution should be stored between 2°C and 25°C.

The solutions must not be used after the expiry date shown on the label. The expiry date refers to the last day of that month.

Any solution remaining after treatment should be disposed of using the approved hospital procedures.

6.    Contents of the pack and other information

What Glucose 5% in half strength Hartmann's solution contains:

Glucose 5% in half strength Hartmann's solution is a solution of glucose and sodium lactate in water. The solution also contains sodium chloride 0.3%, potassium chloride 0.02%, calcium chloride dihydrate 0.014%, and small amounts of hydrochloric acid and sodium hydroxide.

What Glucose 5% in half strength Hartmann's solution looks like and contents of the pack.

The solution is clear and is contained in sealed plastic containers known as a Steriflex bag or a freeflex bag. The solutions are available in 500 ml and 1000 ml bags.

Marketing Authorisation Holder

Fresenius Kabi Limited Cestrian Court, Eastgate Way,

Manor Park, Runcorn,

Cheshire, WA7 1NT. UK.

Manufacturer:

Terumo BCT Limited Old Belfast Road, Millbrook,

Larne, Co. Antrim, BT40 2SH. UK.

This leaflet was last revised in September 2014.

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