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PLASMA VOLUME REDIBAG 6% SOLUTION FOR INFUSION

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PACKAGE LEAFLET: INFORMATION FOR THE USER

PLASMA VOLUME REDIBAG 6% solution for infusion

(Hydroxyethyl starch, sodium chloride, potassium chloride, calcium chloride dihydrate,
magnesium chloride hexahydrate, sodium acetate trihydrate)
Read all of this leaflet carefully before you start using this medicine.


Keep this leaflet. You may need to read it again.



If you have further questions, please ask your doctor or pharmacist.



If any of the side effects gets serious, or if you notice any side effects not
mentioned in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Plasma Volume Redibag is and what it is used for
2. Before you use Plasma Volume Redibag
3. How to use Plasma Volume Redibag
4. Possible side effects
5. How to store Plasma Volume Redibag
6. Further information

1. WHAT PLASMA VOLUME REDIBAG IS AND WHAT IT IS
USED FOR
Plasma Volume Redibag 6% Solution for Infusion contains a fluid which is given
directly into a vein and is used to replace blood lost from your body, for example
following an accident or other injury, in order to support your circulation.

Using other medicines:
Please inform your doctor if you are taking, or have recently taken, any medicines,
including medicines obtained without a prescription. It is particularly important to tell
your doctor about medicines which prevent clotting or thin the blood (e.g. heparin,
warfarin, anticoagulants, non-steroidal anti-inflamatory drugs and sodium valproate
(a medicine used to treat epilepsy)). This is because Plasma Volume Redibag can
also have an effect on blood clotting.

Pregnancy and breast-feeding
Ask your doctor for advice before taking any medicine if pregnant or breast feeding.
You will be given Plasma Volume Redibag only if your doctor considers it is essential
to treat your medical condition and the benefit to you outweighs any possible risk to
your unborn baby.
Patients receiving Plasma Volume Redibag are unlikely to be breast feeding but if you
are, ask your doctor for advice.

3. HOW TO USE PLASMA VOLUME REDIBAG
Your doctor will give you this product by infusion (drip) into a vein.
Your doctor will decide how much to give and this will depend on your individual
needs.

2. BEFORE YOU USE PLASMA VOLUME REDIBAG

If you have been given too much Plasma Volume Redibag

You should NOT be given Plasma Volume Redibag:

This could lead to too much fluid in your circulation. The infusion will be stopped
and you may be given medicines called diuretics to help you to get rid of the excess
water from your body.



If you are hypersensitive to hydroxyethyl starch or any of the other
ingredients in Plasma Volume Redibag (see section 6 of this leaflet for
further information)



If you have too much water in your body (hyperhydration), including fluid in
the lungs (pulmonary oedema)



If you have severe kidney failure with little or no passage of urine



If you have bleeding in the brain (intracranial bleeding)



The most common side-effects are on the body’s fluid and salt balance.

If you have severely reduced liver function



Thinning of the blood commonly affects the ability of the blood to clot.

If you have heart failure



Certain laboratory blood tests may be affected and give false results (e.g.
amylase, a test of pancreas function). Your doctor will be aware of this.



Sometimes itching of the skin (pruritus) occurs after receiving Plasma
Volume Redibag. This can start some weeks after the infusion and last for
several months.



Rarely, allergic (hypersensitivity) reactions to the infusion may occur which
can sometimes be serious. Your doctor will watch-out for these, and will
treat any such reaction appropriately.



Other products containing starch have caused liver problems when starch
has been given for a long period of time.




Special care will be taken with Plasma Volume Redibag:


If your blood level of chloride is too high (hyperchloraemia)



If your blood level of potassium is too high (hyperkalaemia)



If you have kidney problems. The dose of Plasma Volume Redibag may need
to be adjusted.



If you are severely dehydrated (lack of water in your body). You should
receive an infusion of fluids into a vein before you receive Plasma Volume
Redibag.

Like all medicines, Plasma Volume Redibag can cause side effects, though not
everybody gets them.

If your blood level of sodium is too high (hypernatraemia)



4. POSSIBLE SIDE EFFECTS



If you have a disease that requires a restricted sodium intake (e.g. heart
failure, fluid retention, high blood pressure, convulsions occurring in
pregnancy)



If you have liver problems



If you have a severe blood clotting disorder



In children

Your doctor will take special care to ensure the following:
Care will be taken to ensure you receive the correct amount of fluid from the Plasma
Volume Redibag in order to keep the correct balance of fluids and salts in your body,
especially if you:


Have liver problems or chronic liver disease,



Have kidney or heart problems



Have a blood clotting disorder such as haemophilia or Von Willebrand’s
disease
Care will also be taken to look-out for, and treat, any allergic reaction to this product.

If any of the side effects gets serious, or you notice any side effects not mentioned
in this leaflet, please tell your doctor.

5. HOW TO STORE PLASMA VOLUME REDIBAG
Do not freeze.
Keep out of reach and sight of children.
You should not be given Plasma Volume Redibag if there are particles floating in the
solution or if the bag is damaged in any way.
Use immediately after first opening.
Do not use Plasma Volume Redibag after the expiry date which is stated on the
carton and infusion bag. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will
help to protect the environment.
04-05-9576/01

6. FURTHER INFORMATION
What Plasma Volume Redibag contains:
1000 ml of Plasma Volume Redibag contains the active substances:
Poly(O-2-hydroxyethyl)starch (HES)
(Molar substitution
(Molecular weight
Sodium chloride
Potassium chloride
Calcium chloride dihydrate
Magnesium chloride hexahydrate
Sodium acetate trihydrate

60.0 g
0.42)
130,000 Da)
6.00 g
0.400 g
0.134 g
0.200 g
3.70 g

Electrolyte concentration:
Sodium
Potassium
Calcium
Magnesium
Chloride
Acetate

130 mmol/l
5.36 mmol/l
0.912 mmol/l
0.984 mmol/l
112 mmol/l
27.2 mmol/l

The other ingredients are water for injections and hydrochloric acid.

What Plasma Volume Redibag looks like and contents of the pack:
Plasma Volume Redibag is a clear, colourless solution.
It is available in 500 ml infusion bags. Each carton box contains 10 bags.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Baxter Healthcare Ltd., Caxton Way, Thetford, Norfolk, IP24 3SE, UK
Manufacturer:
Baxter S.A., Boulevard René Branquart 80, B-7860 Lessines, Belgium

This medicinal product is authorized in the Member States of the
EEA under the following names:
Austria
Belgium
Bulgaria
Czech Republic
Germany
Denmark
Estonia
Greece
Spain
Finland
France
Hungary
Ireland
Italy
Lithuania
Luxembourg
Latvia
Malta
The Netherlands
Norway
Poland
Portugal
Sweden
Slovenia
Slovak Republic
United Kingdom

PlasmaHES Redibag - Infusionslösung
PlasmaVolume Redibag, solution pour perfusion
PlasmaVolume Redibag
PlasmaVolume Redibag 6%, solution for infusion
PlasmaVolume Redibag, Infusionslösung
Hesra
PlasmaVolume solution for infusion
PlasmaVolume Redibag
PlasmaVolume Redibag, solución para perfusión
Hesra
PlasmaVolume Redibag Solution pour Perfusion
HesRa
Plasma Volume Redibag 6% Solution for Infusion
PlasmaVolume Redibag HES 130/0.42 6% in Ringer Acetate
Redibag Soluzione per infusione
PlasmaVolume solution for infusion
PlasmaVolume Redibag, solution pour perfusion
PlasmaVolume solution for infusion
Plasma Volume Redibag 6% Solution for Infusion
PlasmaVolume Redibag, oplossing voor infusie
Hesra
PlasmaVolume Redibag
PlasmaVolume Redibag
Hesra
PlasmaVolume Redibag 60 mg/ml raztopina za infundiranje
PlasmaVolume Redibag
Plasma Volume Redibag 6% Solution for Infusion

This leaflet was last approved in
Date of last revision: September 2008
Baxter and Redibag are trademarks of Baxter International Inc.

04-05-9576/01

PACKAGE LEAFLET: TECHNICAL INFORMATION

Plasma Volume Redibag 6% Solution for Infusion

(Hydroxyethyl starch, sodium chloride, potassium chloride, calcium chloride dihydrate,
magnesium chloride hexahydrate, sodium acetate trihydrate)
The following information is intended for medical or healthcare
professionals only:

Because of the possibility of allergic (anaphylactic/anaphylactoid) reactions,
appropriate monitoring of patients is necessary and treatment stopped in case of a
reaction.

Instructions for use, handling and disposal
Please read this information carefully before using Plasma Volume Redibag 6%
Solution for Infusion. Further information is contained in the Summary of Product
Characteristics.

General handling Information:


This medicinal product is intended for intravenous infusion only, with
sterile equipment using an aseptic technique.

Presentation: Each 1000 ml Plasma Volume Redibag 6% Solution for Infusion
contains 60 g Poly(O-2-hydroxyethyl) starch (HES) in a clear, colourless, aqueous
solution. Each Infusion bag contains 500 ml solution.



Each infusion bag is intended for single use only.



Discard any unused product.



Do not reconnect partially used bags.

Characteristics: Molar substitution 0.42; Average MW 130,000 Da;



Use only clear solutions and undamaged containers.



Use immediately after opening.



Parenteral drugs, such as Plasma Volume Redibag, should be visually
inspected for clarity, precipitate, particulate matter and leakage prior to
administration.



Do not use if the solution is cloudy, precipitated, contains visible particles
or if the seal is not intact.



Do not use Plasma Volume Redibag after the expiry date on the pack.



Do not freeze Plasma Volume Redibag.



Use Plasma Volume Redibag unvented.

Poly(O-2-hydroxyethyl) starch (HES)
Sodium chloride
Potassium chloride
Calcium chloride dihydrate
Magnesium chloride hexahydrate
Sodium acetate trihydrate
Electrolyte concentration:
Sodium
Potassium
Calcium
Magnesium
Chloride
Acetate
pH:
Theoretical osmolarity:

60.0 g
6.00 g
0.400 g
0.134 g
0.200 g
3.70 g
130 mmol/l
5.36 mmol/l
0.912 mmol/l
0.984 mmol/l
112 mmol/l
27.2 mmol/l
5.0 – 7.0
277 mOsmol/l (approx)

Before opening:


Check the composition and expiry date on Plasma Volume Redibag
(see table at the beginning of this leaflet for composition details).



Do not use the bag if it is damaged or past its expiry date.



Check that the Plasma Volume Redibag solution is clear. Do not use if the
solution is cloudy, precipitated or contains visible particles.

Dosage and Method of Administration:
HES must be administered intravenously. Total dosage, duration and rate of infusion
will depend upon the amount of blood lost, the haemodynamic status and general
clinical condition of the patient.
Dosage will need to be adjusted as necessary by monitoring the usual circulatory
parameters e.g. blood pressure.
Due to the risk of an anaphylactic reaction, the first 10 – 20 ml of Plasma Volume
Redibag solution should be infused slowly and with careful monitoring of the
patient.
The maximum daily dose in adults is 50 ml/kg.
The maximum infusion rate in adults is 20 ml/kg per hour although in life
threatening situations 500 ml can be infused by pressure infusion. Before pressure
infusion, complete venting of air from the infusion bag and infusion set must be
guaranteed.
The risk of circulatory overload by too rapid rate of infusion or inappropriately large
doses must be borne in mind. This is particularly important for patients at risk of
pulmonary and/or congestive heart failure.
Children: There is limited data concerning usage of HES solutions in children.
Administration to children should only be considered after careful benefit/risk
assessment. Please refer to the Summary of Product Characteristics.
Contraindications: Hyperhydration states, including pulmonary oedema and
congestive heart failure, renal failure with oliguria or anuria, intracranial bleeding,
known hypersensitivity to hydroxyethyl starch or any of the excipients and severely
impaired hepatic function.

To Open:


Remove the infusion bag from the overpouch just before use: Tear the
overpouch down the side at the slit and remove the infusion bag.



Immediately after removing the infusion bag from the overpouch, check
the bag for minute leaks by firmly squeezing the infusion bag. If leaks are
found, discard the product, because it may not be sterile.



Use immediately after removal from the overpouch and checking for leaks.

Preparation for Administration:


Suspend the infusion bag from the eyelet support.



Remove the cap from the infusion port.



Attach a non-vented administration set. Refer to complete directions
accompanying the set for connection, priming of the set and administration
of the solution.

After administration:


Discard any unused portion of the solution immediately after use.



Any unused product or waste material should be disposed of in accordance
with your own departmental guidelines.

Caution:

Warnings and Precautions related to the infusion of Plasma Volume Redibag:

Do not connect bags to each other. Such use could result in air embolism due to
residual air being drawn from the primary bag before the administration of the fluid
from the secondary bag is completed.

Please refer to the Summary of Product Characteristics for complete information on
the precautions, warnings and adverse events related to this product.

Compatibility of intravenous infusion:

Renal function (control of serum creatinine) must be monitored during treatment.
Particular caution should be exercised and the dosage adjusted as appropriate in
patients who have renal impairment and specific pathologies.
After infusion of HES, control of serum electrolytes and fluid balance is required.
Electrolytes must be given as necessary and in all patients adequate fluid supply is
essential.

Mixing with other drugs should be avoided because of the risk of microbial
contamination and incompatibility.
Unless compatibility has been proven, the medicinal product should always be
administered separately.
Mixing with solutions containing phosphate or carbonate could result in precipitation.
Baxter and Redibag are trademarks of Baxter International Inc.

04-05-9576/01

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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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