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GLUCOSE INTRAVENOUS INFUSION BP 5% W/V

Active substance(s): GLUCOSE

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4/419027/0714

PACKAGE LEAFLET: INFORMATION FOR THE USER
B. Braun Melsungen AG · 34209 Melsungen, Germany

5 % w/v Glucose Intravenous Infusion BP
Solution for Infusion
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 any further questions, 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 5 % w/v Glucose Intravenous Infusion BP is and what it is used
for
2. What you need to know before you use 5 % w/v Glucose Intravenous
Infusion BP
3. How to use 5 % w/v Glucose Intravenous Infusion BP
4. Possible side effects
5. How to store 5 % w/v Glucose Intravenous Infusion BP
6. Contents of the pack and other information

1. What 5 % w/v Glucose Intravenous Infusion BP is
and what it is used for
5 % w/v Glucose Intravenous Infusion BP is a solution that contains glucose. It is used to dissolve or dilute medicines that are to be given to you
by infusion. 5 % w/v Glucose Intravenous Infusion BP will be given to you
in the form of a vein drip (that is, by intravenous infusion).

2. What you need to know before you use 5 % w/v
Glucose Intravenous Infusion BP
Do not use 5 % w/v Glucose Intravenous Infusion BP
You will not receive 5 % w/v Glucose Intravenous Infusion BP if you have:
• too high blood sugar level (hyperglycaemia) that needs more than 6
units of insulin per hour to be controlled
• high levels of acidic substances in your blood (metabolic acidosis)
You should not receive large amounts of this solution if you have:
• too much water in your body
• acute heart failure
• water in your lungs
5 % w/v Glucose Intravenous Infusion BP must not be used alone for the
treatment of fluid deficits, since it does not contain any salts (electrolytes).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using 5 % w/v Glucose
­Intravenous Infusion BP.
This medicine must not be used to treat fluid deficits without adequate
administration of salts (see also “Do not use 5 % w/v Glucose Intravenous
Infusion BP” above), since this may markedly reduce the salt concentration in your blood (in particular potassium and sodium). A lack of salts
can lead to problems with your heart and damage your brain. Especially
children, elderly patients and patients in poor general condition are at
risk.
Adequate supply of salts (in particular potassium and sodium) will be
­ensured.
Your levels of blood sugar, fluid, electrolytes (particularly potassium) and
acid-base balance will be checked to make sure that these are correct
­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 that your blood potassium level may decrease in this case.
Your doctor will consider very carefully whether this medicine is suitable
for you if you have:
• diabetes mellitus
• any kind of impairment of your glucose metabolism (e.g. after operations or injuries)
• impairment of kidney function.
You should not normally receive this medicine if you suffer or have recently suffered from stroke except your doctor considers it essential for
your recovery.

If you are also receiving blood transfusions these will be administered to
you through another tube.
Your doctor will consider the safety information of the medicine dissolved or diluted in 5 % w/v Glucose Intravenous Infusion BP.

Children
In children, the dose of 5 % w/v Glucose Intravenous Infusion BP should
be as low as possible (see also section 3).

Other medicines and 5 % w/v Glucose Intravenous Infusion BP
Tell your doctor if you are taking, have recently taken or might take any
other medicines.
Your doctor will consider that some medicines may influence glucose
metabolism.
The safety information of the medicine dissolved or diluted in 5 % w/v
Glucose Intravenous Infusion BP has to be taken into account.

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.

Driving and using machines
This medicine has no influence on the ability to drive and use machines.
The safety information of the medicine dissolved or diluted in 5 % w/v
Glucose Intravenous Infusion BP has to be taken into account.

3. How to use 5 % w/v Glucose Intravenous Infusion BP
This medicine is for intravenous use (that is, it is administered through a
cannula placed into a vein). It can be infused into peripheral veins. However, this possibility is limited by the nature of the medicine dissolved or
diluted in 5 % w/v Glucose Intravenous Infusion BP.
The amount of solution you receive depends on the concentration of the
medicine to be dissolved or diluted. The maximum doses stated below
will be considered.

Adults
Maximum daily dose
Up to 40 ml per kg body weight per day, corresponding to 2 g glucose per
kg body weight per day.
Maximum infusion rate
The maximum infusion rate is 5 ml per kg body weight per hour, corresponding to 250 mg glucose per kg body weight per hour.

Use in children
If 5 % w/v Glucose Intravenous Infusion BP is given to children, the dose
should be as low as possible. Salts have to be supplied as needed.
For adolescents from 15th year of life, the maximum amount is 40 ml
per kg body weight per day.

B|BRAUN
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2 Seiten
Lätus

GB___4
4/419027/0714
5 % w/v Glucose
Intravenous Infusion BP
EP – GIF
Standort Rubí
Font size: 9 pt.
G 080629

4/419027/0714

For children up to the 14th year of life the maximum daily amount
of this medicine will be determined according to the age and the body
weight:
Premature babies:
Newborns:
1st – 2nd year:
3rd – 5th year:
6th – 10th year:
11th – 14th year:

180 ml per kg body weight
150 ml per kg body weight
150 ml per kg body weight
120 ml per kg body weight
100 ml per kg body weight
80 ml per kg body weight

When determining the dose, the total daily fluid intake will be taken into
account, according to the following recommendations for children:
1st day of life:
2nd day of life:
3rd day of life:
4th day of life:
5th day of life:
6th day of life:
1st month, before stable growth:
1st month, with stable growth:
2nd to 12th month of life:
2nd year:
3rd – 5th year:
6th – 12th year:
13th – 18th year:

60 – 120 ml per kg body weight
80 – 120 ml per kg body weight
100 – 130 ml per kg body weight
120 – 150 ml per kg body weight
140 – 160 ml per kg body weight
140 – 180 ml per kg body weight
140 – 170 ml per kg body weight
140 – 160 ml per kg body weight
120 – 150 ml per kg body weight
80 – 120 ml per kg body weight
80 – 100 ml per kg body weight
60 – 80 ml per kg body weight
50 – 70 ml per kg body weight

If you receive more 5 % w/v Glucose Intravenous Infusion BP
than you should

It is unlikely that this occurs because your doctor will determine your
daily doses.
Glucose overdose may result in:
• too high levels of blood sugar,
• glucose losses in urine,
• abnormally high concentrated body fluids,
• impaired consciousness or unconsciousness due to extremely high
blood sugar levels or too concentrated body fluids
• fluid deficit.
Fluid overdose may result in excess fluid in the body with:
• increased skin tension,
• heaviness and swelling of legs (venous congestion),
• tissue swelling (possibly with water on the lungs or swelling of the
brain)
• abnormally high or low blood electrolyte levels
• disturbances of the acid-base balance.
In case of overdose you may feel sick or suffer from vomiting and spasms.
Further signs of overdose may develop depending on the medicine dissolved or diluted in 5 % w/v Glucose Intravenous Infusion BP.
If this occurs, the infusion will be slowed down or stopped.
Your doctor will decide on any further treatment you may need, e.g. administration of insulin, drugs to increase urine output (diuretics) or salts.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.

5. How to store 5 % w/v Glucose Intravenous Infusion BP
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.
After first opening: Containers once opened must be used immediately.
After admixture of additives: 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.
Do not use this medicine if the solution is not clear and colourless or
almost colourless or if the bottle or its closure are damaged.
This medicine does not require any special storage conditions

6. Other information and content of the pack
What 5 % w/v Glucose Intravenous Infusion BP contains
• The active substance is glucose monohydrate.
Per liter this medicine contains 55 g of glucose monohydrate,
­equivalent to 50 g of glucose.
• The other ingredient is water for injections.
Energy
837 kJ/l  200 kcal/l
Theoretical osmolarity
278 mOsm/l
ph
3.5 – 5.5

What 5 % w/v Glucose Intravenous Infusion BP looks like
and contents of the pack
5 % w/v Glucose Intravenous Infusion BP is a solution for infusion (for
administration by a vein drip).
It is a clear, colourless or almost colourless solution for infusion
It comes in:
• colourless plastic (polyethylene) bottles containing 50 ml, 100 ml,
250 ml, 500 ml or 1000 ml,
supplied in packs of: 20 × 50 ml, 20 × 100 ml
20 × 250 ml
10 × 500 ml
10 × 1000 ml
Not all pack sizes may be marketed.
For single use only.
Partially used containers must not be reconnected.
After first use, the container and any unused contents should be
­discarded.

Marketing Authorisation Holder and Manufacturer
B. Braun Melsungen AG
Carl-Braun-Straße 1
34212 Melsungen, Germany
Postal address
34209 Melsungen
Germany
Phone: +49-56 61-71-0
Fax: +49-56 61- 71-45 67

This leaflet was last revised in May 2014.

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.
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 the package 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.

B|BRAUN B. Braun Melsungen AG
34209 Melsungen
Germany

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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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