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SODIUM CHLORIDE 0.45% W/V AND GLUCOSE 5% W/V IV INFUSION BP

Active substance(s): ANHYDROUS GLUCOSE / GLUCOSE MONOHYDRATE / SODIUM CHLORIDE / GLUCOSE MONOHYDRATE / SODIUM CHLORIDE

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84/445554/0714

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

Sodium Chloride 0.45% w/v
and Glucose 5 % w/v Intravenous Infusion BP
Sodium Chloride, Glucose
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 or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet.

What is in this leaflet:
1. What Sodium Chloride 4.5 mg/ml (0.45%) and Glucose 50 mg/ml
(5 %) is and what it is used for
2. What you need to know before you use Sodium Chloride 4.5 mg/ml
(0.45%) and Glucose 50 mg/ml (5 %)
3. How to use Sodium Chloride 4.5 mg/ml (0.45%) and Glucose
50 mg/ml (5 %)
4. Possible side effects
5. ­How to store Sodium Chloride 4.5 mg/ml (0.45%) and Glucose
50 mg/ml (5 %)
6. Contents of the pack and other information

Please note:
If this solution is used to dilute or dissolve medicines that are to be given
to you by a venous drip, your doctor will take into account the safety
information of the additive.

Other medicines and Sodium Chloride 4.5 mg/ml (0.45%)
and Glucose 50 mg/ml (5 %)
Tell your doctor if you are using, have recently used or might use any
other medicines.
Your doctor will adjust your dosage if you receive cortisone. Cortisone
may cause an accumulation of sodium and fluid in your body.

1. What Sodium Chloride 4.5 mg/ml (0.45%) and
­Glucose 50 mg/ml (5 %) is and what it is used for

Pregnancy and, breast-feeding and fertility

Sodium Chloride 4.5 mg/ml (0.45%) and Glucose 50 mg/ml (5 %) is a
infusion solution, which will be given to you as a venous infusion (drip)
by your doctor.
It will be given to you
• if you are dehydrated and lose water (hypertonic dehydration)
You are given this medicine to provide you partial with carbohydrates if
you are unable to eat and drink normally, especially if your energy needs
are high or if you need restriction of fluid intake.
This solution may also be used to dissolve or dilute medicines that are to
be given to you by a venous infusion (drip).

Pregnancy
Your doctor will decide carefully whether or not you should receive this
solution if you are pregnant.
Thus special care will be taken if you have a specific disorder that may
occur during pregnancy, called eclampsia, with the following symptoms:
high blood pressure, cramps, swelling.
Blood sugar levels will be checked regularly.

schwarz

Breast-feeding
This medicine can be given while you are breast feeding.

Format = 210 x 297 mm (A4)

2 Seiten

2. What you need to know before you use Chloride
4.5 mg/ml (0.45%) and Glucose 50 mg/ml (5 %)
Do not use Sodium Chloride 4.5 mg/ml (0.45%) and Glucose
50 mg/ml (5 %):
• if you are allergic to sodium chloride or glucose or any of the other
ingredients of this medicine (listed in section 6).
• if you have excessively high body fluid level (hyperhydration)
• if you have fluid and sodium deficit (hypotonic dehydration)
• Head trauma (first 24 hours)
• if you have abnormally high blood sugar level that only responds to
high insulin doses or intolerance to glucose

Warnings and precautions
This medicine must not be used to treat fluid deficits without adequate
administration of salts, since this may markedly reduce the salt concentration in your blood. A lack of salts can lead to problems with your heart
and damage your brain.
Special care should be taken if you have abnormally low level of sodium
or potassium in the blood. Then an adequate supply of salts (in particular
potassium and sodium) will be ensured.
In diabetic patients, the amount of infused glucose has to be taken into
account and insulin requirements may be modified.
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.
Your levels of blood sugar, electrolytes (especially potassium) and acidbase and water balance will be checked to make sure that these are correct before and during infusion.
After major operations or severe injuries (post-traumatic and post-­
operative conditions or in the presence of tissue oxygen deficiency, high
blood acidity or organ failure) you may not be able to metabolise glucose
properly (impaired glucose tolerance). Then your blood sugar level will be
regularly monitored.

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.

Driving and using machines
Sodium Chloride 4.5 mg/ml (0.45%) and Glucose 50 mg/ml (5 %) has no
influence on the ability to drive and use machines.

3. How to use Sodium Chloride 4.5 mg/ml (0.45%) and
Glucose 50 mg/ml (5 %)
Dosage
Adults
The amount of the medicine that you will be given will be determined
by your doctor and will depend on your age, weight, clinical and biological (acid-base-balance) condition and concomitant therapy. Thus your
individual requirements of fluid, electrolytes and energy will be taken
into account.
The normal maximum dosage for an adult is 40 ml/kg body weight/day.
The maximum infusion rate is 5 ml per kg body weight per hour.
Elderly patients
Basically the same dosage as for adults applies. But your doctor will
take caution if you are suffering from other diseases often seen with
­advanced age.
Other special patient groups
If you have an impaired glucose tolerance (e.g. after surgery, severe injury, organ failure, tissue oxygen deficiency etc.) the dosage should be
adjusted to keep the blood glucose level close to normal values.
In those cases your blood glucose level will be monitored while you receive this solution.

Use in children and adolescents
Children will receive a dosage dependent upon their age, weight and
clinical and biological (acid-base-balance) condition and concomitant
therapy. Thus the individual daily requirements of fluid and glucose of
your child will be taken into account.

B|BRAUN
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Lätus

GB___84
Sodium Chloride 0.45% w/v and
Glucose 5 % w/v
84/445554/0714
EP – GIF
Standort Melsungen + Rubí
Fpnt size: 9 pt.

G 080992

84/445554/0714

If you received more Sodium Chloride 4.5 mg/ml (0.45%)
and Glucose 50 mg/ml (5 %) than you should

6. Contents of the pack and other information

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

What Sodium Chloride 4.5 mg/ml (0.45%) and Glucose
50 mg/ml (5 %) contains

Symptoms
An overdose may lead to excess fluid in the body (hyperhydration), electrolyte imbalances (especially hypokalaemia and hyponatraemia), acidbase imbalances, and high blood sugar (hyperglycaemia).
Clinical symptoms of water intoxication may also occur, such as nausea,
vomiting, spasms.

The active substance are
sodium chloride and glucose.
1000 ml of the solution contain
Sodium chloride
4.5 g
Glucose monohydrate
55.0 g
equivalent to anhydrous glucose 50.00 g
Energy
835 kJ/l = 200 kcal/l
Theoretical osmolarity:
432 mOsm/l
Acidity (titration to pH 7.4):
< 0.5 mmol/l
pH:
3.5 – 5.5
The other ingredient is water for injections.

Treatment
The therapy to normalise your condition will be determined by your doctor. It may include stopping of the infusion, supervision of blood salt level
and administration of suitable medicines to treat the symptoms observed
(e.g. diuretics, insulin). In extreme situations you may also need dialysis.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
If the product is used as directed, no side effects are to be expected.
Yet if you get any side effects, talk to your doctor 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.

5. How to store Sodium Chloride 4.5 mg/ml (0.45%)
and Glucose 50 mg/ml (5 %)

What Chloride 4.5 mg/ml (0.45%) and Glucose 25 mg/ml
(2.5 %) looks like and contents of the pack
It is a clear, colourless up to faintly straw-coloured aqueous solution of
sodium chloride and glucose in water.
It is supplied in
• Polyethylene (LDPE) bottles, contents: 500 ml, 1000 ml
available in packs of 10 x 500 ml, 10 x 1000 ml

Marketing Authorisation Holder and Manufacturer
B. Braun Melsungen AG
Carl-Braun-Straße 1
34212 Melsungen
Germany
Postal address:
34209 Melsungen
Germany
Phone: +49-5661-71-0
Fax: +49-5661-71-4567

This leaflet was last revised in May 2014.

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
container and carton labels. The expiry date refers to the last day of that
month.
This medicinal product does not require any special storage conditions.
Only to be used if solution is clear and colourless up to faintly strawcoloured and the container and its closure are undamaged.
This medicine is for single use only. After use discard container and any
unused medicine.
Containers once opened must be used immediately and must not stored
for later use.
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.

The following information is intended for healthcare professionals only:
Method of administration:
The solution should not be administered through the same infusion equipment simultaneously, before or after an administration of blood because of
the possibility of pseudo-agglutination.
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.
In patients with chronic hypernatraemia, the serum sodium concentration should not be lowered faster than at a rate of 0.5 mmol×l-1×h-1.

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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