10% W/V GLUCOSE INTRAVENOUS INFUSION BP - Patient leaflet, side effects, dosage

10% w/v Glucose Intravenous Infusion BP

Glucose

In this leaflet:

• 1. What 10% w/v Glucose Intravenous Infusion BP is and what it is used for

• 2. Before you use 10% w/v Glucose Intravenous Infusion BP

• 3. How to use 10% w/v Glucose Intravenous Infusion BP

• 4. Possible side effects

• 5. How to store 10% w/v Glucose Intravenous Infusion BP

• 6. Further information

1. what 10% w/v glucose intravenous infusion bp is and what it is used for

10% w/v Glucose Intravenous Infusion BP is a solution containing glucose (also called grape sugar or dextrose) for administration in the form of a vein drip.

You may receive this medicine to provide you with carbohydrates and fluid when you are unable to eat and drink normally.

Other medicines may be added to 10% w/v Glucose Intravenous Infusion BP in order to deliver them to you.

2. before you use 10% w/v glucose intravenous infusion bp

YOU SHOULD NOT RECEIVE THIS MEDICINE

if you have any of the following:

• excessively high blood sugar level that needs more than 6 units of insulin per hour to be controlled
• poorly controlled or uncontrolled diabetes mellitus
• diabetic coma (a state of unconsciousness caused by extremely high blood sugar level)
• severely impaired blood circulation, i.e. states of shock and circulatory collapse
• bleeding within the skull or the spinal cord
• high levels of acidic substances in your blood
• untreated diabetes insipidus (a kidney disorder where you pass large amounts of urine)
• severe kidney failure without access to treatment with an artificial kidney
• too much water in your body tissues (hyperhydration)
• water in your lungs
• acute severe heart failure.

SPECIAL CARE WILL BE TAKEN WITH 10% W/V GLUCOSE INTRAVENOUS INFUSION BP

You should not normally receive this medicine after you suffered from stroke.

Your levels of blood sugar, fluids, electrolytes (especially potassium), and acid-base balance will be checked to make sure that these are correct before and during infusion. For this purpose blood samples may be taken from you.

Before you receive this medicine any existing disorders of your body’s fluid and salt content such as:

• – too low potassium concentration in your blood (hypokalaemia), – water deficiency and excess losses of salts have to be corrected.

Your doctor will exercise special caution if you have

• diabetes or any other disorder where your body cannot handle glucose properly
• any kind of impairment of your metabolism (e.g. after operations, injuries, some kinds of organ diseases)
• high blood volume
• abnormally high concentrated blood serum (high serum osmolarity)
• impairment of kidney or heart function.

3. how to use 10% w/v glucose intravenous infusion bp

The amount of 10% w/v Glucose Intravenous Infusion BP you will be given will be determined by your doctor, depending upon your condition. For an adult the maximum dose is 40 ml/kg bodyweight per day.

For children the dose will be determined according to the age and the body weight.

The medicine will be administered to you by infusion (a drip) through a small tube placed in one of your veins.

If you receive more 10% w/v Glucose Intravenous Infusion BP than you should

It is unlikely that this occurs because your doctor will determine your daily doses.

Overdose may result in too high levels of blood sugar, glucose losses in urine, unconsciousness due to extremely high blood sugar or too concentrated body fluids, excess fluid in the body, and abnormally high or low blood electrolyte levels.

If this occurs, your glucose infusion will be slowed down or stopped.

Your doctor will decide on any further treatment you may need.

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

B|BRAUN

____ 4. POSSIBLE SIDE EFFECTS

Like all medicines, 10% w/v Glucose Intravenous Infusion BP can cause side effects, although not everybody gets them.

The following side effects may occur:

Metabolism and nutrition disorders

When you are very undernourished and receive full doses of glucose from the very beginning of intravenous feeding, this could lead to decreases of blood potassium, magnesium and phosphate levels.

A decrease of blood potassium could also occur when you are receiving insulin together with glucose.

Stopping glucose administration suddenly and/or administration of insulin may cause your blood glucose level to drop especially if you have a reduced glucose tolerance.

Blood vessel disorders

Vein inflammation (thrombophlebitis) may be caused by solutions in which the concentration of dissolved substance is above a certain limit value. Added medication should be kept in mind in that respect.

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

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:. gov.uk/yellowcard

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

5. HOW TO STORE 10% W/V GLUCOSE INTRAVENOUS INFUSION BP

Keep out of the reach and sight of children.

Do not use 10% w/v Glucose Intravenous Infusion BP after the expiry date which is stated on the label and the outer carton. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions. Do not use 10% w/v Glucose Intravenous Infusion BP if you notice cloudiness or discoloration of the solution or if the container is damaged.

6. FURTHER INFORMATION

What 10% w/v Glucose Intravenous Infusion BP contains

The active substance is glucose

1000 ml of the solution contain 100 g of glucose (as glucose monohydrate)

The other ingredient is water for injections.

Caloric value: 1675 kJ/l = 400 kcal/l

Theoretical osmolarity: 555 mOsm/l

Titration acidity (to pH 7.4) < 1 mmol/l

pH 3.5 – 5.5

What 10% w/v Glucose Intravenous Infusion BP looks like and contents of the pack

10% w/v Glucose Intravenous Infusion BP is a sterile solution for infusion (administration by a vein drip).

It is a clear, colourless or slightly yellowish solution of glucose in water.

It is available in plastic (polyethylene) bottles containing 500 ml or 1000 ml.

Pack sizes: 10 × 500 ml, 10 × 1000 ml

Marketing Authorisation Holder

B. Braun Melsungen AG,

Carl-Braun-StraBe 1 Postal address:

34212 Melsungen, Germany 34209 Melsungen, Germany

Manufacturer

B. Braun Melsungen AG,

Carl-Braun-StraBe 1

34212 Melsungen, Germany

or

B. Braun Medical S.A.,

Carretera de Terrassa 121,

08191 Ru^ (Barcelona), Spain

This leaflet was last approved in 05/2015.

B|BRAUN

B. Braun Melsungen AG

34209 Melsungen, Germany

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24.06.15 08:16