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SODIUM GLYCEROPHOSPHATE 21.6% CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): SODIUM GLYCEROPHOSPHATE

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01-58-07-008E

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

1. What Sodium Glycerophosphate is and what it is used for

652

Sodium Glycerophosphate 21.6% concentrate for
solution for infusion
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.
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes
any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Sodium Glycerophosphate is and what it is used for
2. What you need to know before you use Sodium Glycerophosphate
3. How to use Sodium Glycerophosphate
4. Possible side effects
5. How to store Sodium Glycerophosphate
6. Contents of the pack and other information

1632

Sodium Glycerophosphate provides salts into your blood stream when you cannot eat normally.
Sodium Glycerophosphate is usually used as part of a balanced intravenous diet, together with proteins, fats, carbohydrates, and
vitamins.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant to are planning to have a baby, ask your doctor, pharmacist
or nurse for advise before using this medicine.

2. What you need to know before you use Sodium Glycerophosphate

Driving and using machines

Do not use Sodium Glycerophosphate

Sodium Glycerophosphate has no effect on the ability to drive or use machines.







if you are allergic to sodium glycerophosphate or any of the other ingredients of this medicine (listed in section 6).
if you are suffering from shock
if you are dehydrated (there is not enough water in the body)
if you have high levels of sodium, phosphate or potassium in your blood
if you have any problems with your kidneys

Sodium Glycerophosphate should be added to another solution before it is given to you. Your doctor, pharmacist or nurse will
make sure it is prepared correctly before you receive Sodium Glycerophosphate.
Warnings and precautions
You should not receive this medicine undiluted.

Talk to your doctor, pharmacist or nurse before using Sodium Glycerophosphate
- if you suffer from impaired liver function
Your doctor may want to do regular blood tests to check your condition.
Other medicines and Sodium Glycerophosphate

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Tell your doctor, pharmacist or nurse if you have been administered carbohydrate infusions or if you are taking, have recently taken or
might take any other medicines.

3. How to use Sodium Glycerophosphate
You will receive your medicine by infusion (IV drip).
Your doctor will decide on the correct dose for you to receive.
Dosage
Adults

The recommended daily dosage is 1020 ml Sodium Glycerophosphate, added to your infusion solution.
Sodium Glycerophosphate will usually be given every day until you can start eating again.
If you receive more Sodium Glycerophosphate than you should

It is very unlikely that you will receive more infusion than you should as your doctor or nurse will monitor you during the
treatment. However if you think that you have received too much Sodium Glycerophosphate inform your doctor or nurse as
soon as possible.
If you have any further questions on the use of this product, ask your doctor, pharmacist or nurse.

2016-10-28 09:12:31
MASTER ARTWORK/LABEL SPECIFICATION
Halden article number:
FYV 1963
Label spec. number:
01-58-07-008E
Code 128:
652
Pharmacode: 1632
Colour coding:
Black
Size:
360 x 84 mm folded to 120 x 48 mm
MS: 08.22.B
Prepared by: Sven-Erik Arneberg

4. Possible side effects

6. Contents of the pack and other information

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

What Sodium Glycerophosphate infusion contains

If you develop a rash or other allergic reactions (like itching, swollen lips or face or shortness of breath), please
inform your doctor, pharmacist or nurse.
No known undesirable effects have been reported with the use of Sodium Glycerophosphate.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet.
You can 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 Glycerophosphate
Keep out of the sight and reach of children.
Your doctor and hospital pharmacist are responsible for the correct storage, use and disposal of Sodium Glycerophosphate
infusion. Do not store above 25 ºC. Do not freeze.
Do not use this medicine after the expiry date which is stated on the carton and vial labels. The expiry date refers to the last
day of that month.
Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use.
These measures will help protect the environment.

01-58-07-008E

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1 millilitre of Sodium Glycerophosphate contains the following active ingredients:
306.1 mg Sodium glycerophosphate pentahydrate which is equivalent to 216 mg sodium glycerophosphate. This provides 1 mmol
phosphate and 2 mmol sodium per ml.
Sodium Glycerophosphate also contains hydrochloric acid and water for injections.
What Sodium Glycerophosphate looks like and contents of the pack

Sodium Glycerophosphate is a clear, colourless solution containing phosphate and sodium. It is available in plastic vials. Each vial
of Sodium Glycerophosphate contains 20 ml of the undiluted solution.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:

Fresenius Kabi Limited,
Cestrian Court
Eastgate Way
Manor Park
Runcorn
Cheshire
WA7 1NT, UK
Manufacturer:

Fresenius Kabi Norge AS
NO-1753 Halden
Norway
This leaflet was last revised in October 2016

2016-10-28 09:12:31

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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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