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GLUCOSE INTRAVENOUS INFUSION BP 30% W/V

Active substance(s): GLUCOSE MONOHYDRATE

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40/12262587/0415

Package leaflet: Information for the patient
B. Braun Melsungen AG · 34209 Melsungen, Germany

Glucose monohydrate

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 further questions, please ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

What is in this leaflet
1. What Glucose Intravenous Infusion BP 30% w/v is and what it is used
for
2. What you need to know before you receive Glucose Intravenous Infusion BP 30% w/v
3. How to use Glucose Intravenous Infusion BP 30% w/v
4. Possible side effects
5. How to store Glucose Intravenous Infusion BP 30% w/v
6. Contents of the pack and other information

1. What Glucose Intravenous Infusion BP 30 % w/v is
and what it is used for
Glucose Intravenous Infusion BP 30% w/v is a solution that contains glucose for administration in the form of a vein drip (intravenous infusion).
You are given this medicine to provide you with carbohydrates if you are
unable to eat and drink normally.
You may also be given it in order to raise an abnormally low blood sugar
level.

giving this medicine to children in the first and second year of life, because a sudden stop of high infusion rates can lead to very low blood
sugar levels, especially in these children.

Other medicines and Glucose Intravenous Infusion BP 30% w/v
Tell your doctor if you are taking, have recently taken or might take any
other medicines.
Your doctor will take care only to add drugs or additives to the solution
that mix well with it.
This solution will not be infused together with, immediately before or
after blood through the same tubing.

2. What you need to know before you receive Glucose
Intravenous Infusion BP 30% w/v
You will not receive Glucose Intravenous Infusion BP 30% w/v

Driving and using machines

Warnings and precautions
Talk to your doctor or nurse before using Glucose Intravenous Infusion
BP 30% w/v.
Before you receive this medicine any existing disorders of your body’s
fluid and salt content such as:
• too low potassium or sodium level in your blood (hypokalaemia, hyponatraemia)
• water deficiency and excessive loss of salts
have to be corrected.
You should not normally receive this medicine if you suffer or have recently suffered from stroke or if your blood-brain barrier is damaged,
except if your doctor considers it essential for your recovery.
Your levels of blood sugar, fluids, electrolytes (particularly 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. If necessary, your blood sugar will be controlled by insulin administration.
Your doctor will consider very carefully whether this medicine is suitable
for you and take special care if you have:
• high blood volume
• any kind of impairment of your metabolism (e.g. after operations or
injuries, with too little oxygen in your tissues, or with some organ diseases) where your blood may become acidic
• abnormally high concentrated blood serum (high serum osmolarity)
• impairment of kidney or heart function.
Adequate supply of other nutrients, of salts (in particular potassium,
magnesium, phosphate) and vitamins (in particular vitamin B1) will be
ensured.

Children
Children will be monitored very carefully. Special care will be taken when

Lätus
130

GB_40
Glucose Intravenous Infusion
BP 30% w/v
40/12262587/0415
IL – GIF
Standort Melsungen

This medicine has no influence on the ability to drive and use machines.

Font size: 9 pt

3. How to use Glucose Intravenous Infusion BP 30% w/v

G 120259

The amount of Glucose Intravenous Infusion BP 30% w/v you will be
given will be determined by your doctor, depending upon your condition.

Method of administration
The solution will be administered to you through a small tube inserted
into a vein (by intravenous infusion).
During intravenous feeding you will also receive other foodstuffs like
amino acids for building up protein, fat emulsions, so-called essential
fatty acids, salts, vitamins and trace elements, as required.

If you receive more Glucose Intravenous Infusion BP 30%
w/v 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, abnormally high concentrated body fluids, fluid deficit, impaired
consciousness or unconsciousness due to extremely high blood sugar or
too concentrated body fluids, excess fluid in the body with increased
skin tension, venous congestion (heaviness and swelling of legs), tissue
swelling (possibly with water on the lungs or swelling of the brain) and
abnormally high or low blood electrolyte levels. Extreme overdosing may
also lead to accumulation of fat in the liver.
If this occurs, your glucose infusion will be slowed down or stopped.
Your doctor will decide on any further treatment you may need, e.g. administration of insulin, fluid or salts.
If you have any further questions on the use of this medicine, ask your
doctor, pharmacist or nurse.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
If this medicine is used according to the directions given, no side effects
are expected.
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet.

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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.
Pregnancy
Your doctor will decide carefully whether or not you should receive this
solution if you are pregnant. Your blood sugar will be checked when you
receive this medicine.
Breast-feeding
Your doctor will decide carefully whether or not you should receive this
solution if you are breast-feeding your child.

if you have
• too high blood sugar level (hyperglycaemia) that needs more than 6
units of insulin per hour to be controlled
• delirium tremens associated with severe fluid deficit
• severely impaired blood circulation, i.e. states of shock and circulatory
collapse
• high levels of acidic substances in your blood (acidosis)
• too much water in your body
• water in your lungs
• acute heart failure.

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Glucose Intravenous Infusion BP 30% w/v

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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: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Glucose Intravenous Infusion BP 30% w/v
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 bottle and carton labels. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not use this medicine if the solution is not clear and colourless or
slightly yellowish or if the bottle or its closure are damaged.

6. Contents of the pack and other information
What Glucose Intravenous Infusion BP 30% w/v contains
• The active substance is glucose monohydrate.
Per litre this medicine contains 330 g of glucose monohydrate, equivalent to 300 g of glucose.
• The other ingredients are hydrochloric acid and water for injections.
Energy
5025 kJ/l  1200 kcal/l
Theoretical osmolarity
1600 mOsm/l
Titration acidity (to pH 7.4) < 1 mmol/l
pH
3.5 - 5.5

What Glucose Intravenous Infusion BP 30% w/v looks like
and contents of the pack
Glucose Intravenous Infusion BP 30% w/v is a solution (for administration by a vein).
It is a clear, colourless or slightly yellowish solution of glucose monohydrate in water.
It comes in colourless plastic (polyethylene) bottles containing 500 ml,
supplied in packs of 10 × 500 ml.

Marketing Authorisation Holder
B. Braun Melsungen AG
Carl-Braun-Str. 1
34212 Melsungen, Germany
Postal address
34209 Melsungen, Germany
Tel.: +49-(0)-5661-71-0
Fax: +49-(0)-5661-71-4567

Manufacturer
B. Braun Melsungen AG
Carl-Braun-Str. 1
34212 Melsungen, Germany
or
B. Braun Medical S. A.
Carretera de Terrassa 121
08191 Rubí (Barcelona), Spain

This leaflet was last approved in 02/2015.

The following information is intended for healthcare professionals only:
Posology
The dosage of the solution depends on the patient’s individual glucose and fluid requirements.
Adults and adolescents from 15th year of life
The maximum daily dose is 20 ml per kg body weight (BW) per day, corresponding to 6 g of glucose per kg BW per day.
The maximum infusion rate is 0.83 ml per kg BW per hour, corresponding to 0.25 g of glucose per kg BW per hour.
Thus, for a patient weighing 70 kg the maximum infusion rate is approximately 58 ml per hour, resulting in a glucose intake of 17.5 g per hour.
Children
10% glucose solution is recommended for hypoglycaemia in children.
Use of 30% glucose solution
If higher strength solutions are deemed essential, the dose and rate of delivery should be determines by specialist in paediatric medicine or other appropriate discipline (e.g. intensive care; Accident and Emergency; parenteral nutrition) and will depend on age weight, clinical and metabolic condition
and concomitant therapy.
Monitoring
Careful monitoring is essential throughout treatment (see SmPC section 4.4 for details) and young children are particularly likely to develop hypoglycaemia if high glucose infusion rates are abruptly stopped (see below).
Elderly patients
Basically the same dosage as for adults applies, but caution should be exercised in patients suffering from further diseases such as cardiac insufficiency or renal insufficiency that increase in frequency with advancing age (see SmPC sections 4.3 and 4.4).
Patients with impaired glucose metabolism
If the oxidative metabolism of glucose is impaired (e.g. in the early post-operative or post-traumatic period or in the presence of hypoxia or organ failure), the dosage should be adjusted to keep the blood glucose level close to normal values. Close monitoring of blood glucose levels is recommended
in order to prevent hyperglycaemia. Impaired oxidative metabolism of glucose may lead to metabolic acidosis.
Discontinuation of therapy
Sudden discontinuation of high glucose infusion rates can lead to profound hypoglycaemia due to the high serum insulin concentrations. This applies
especially to children less than 2 years of age, patients with diabetes mellitus and other disease states associated with impaired glucose homeostasis.
The glucose infusion should be tapered off over 30 – 60 minutes and as a precaution it is recommended that on the first day of abrupt discontinuation
of parenteral nutrition every patient is monitored for hypoglycaemia for 30 minutes after the infusion is stopped.
Method of administration
• For central intravenous infusion only.
• This solution constitutes only one component of parenteral nutrition. In total parenteral nutrition, glucose infusions should always be combined with
adequate supply of amino acids, lipids, electrolytes, vitamins and trace elements (see also SmPC section 4.4 – Parenteral nutrition).
• In malnourished/depleted patients parenteral treatment should be instituted gradually (see SmPC section 4.4 – Parenteral nutrition).
Shelf life after first opening the container
Administration should commence immediately after connecting the container to the giving set or infusion equipment.
Shelf life after dilution
From a microbiological point of view, 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 and would normally not be longer than 24 hours at 2 to 8 °C, unless dilution has taken place in controlled and
validated aseptic conditions.
Incompatibilities
Because of its acid pH, the solution may be incompatible with other medicinal products.
Erythrocyte concentrates must not be suspended in glucose solutions because of the risk of pseudo-agglutination. See also SmPC section 4.4.

B|BRAUN B. Braun Melsungen AG

34209 Melsungen, Germany

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Reporting of side effects

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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