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HYPERHAES SOLUTION FOR INFUSION

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PATIENT INFORMATION LEAFTLET

HyperHAES ®
Solution for Infusion
• Read this entire 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 your pharmacist.
What HyperHAES® is and what it is used for
HyperHAES® is a solution for intravenous bolus dose or pressure infusion. It contains
hydroxyethyl starch which belongs to a group of medicines known as plasma volume
expanders. Plasma volume expanders work by increasing the fluid in your blood stream and
therefore helping to keep your blood pressure stable.
A litre of solution contains 60 grams per litre poly (O-2-hydroxyethyl) starch and 72 grams per
litre sodium chloride in water for injections. The solution may also contain small quantities of
either hydrochloric acid or sodium hydroxide, used to adjust the pH of the solution if necessary.
The solution is clear, colourless and free from particles. It is sterile and has a pH of 3.5 to 6.0.
It is contained in 250 ml flexible bags made of polyolefine (Freeflex®).
HyperHAES® is used for the treatment of severe low blood volume and shock.
The Marketing Authorisation holder is Fresenius Kabi Limited, Cestrian Court, Eastgate
Way, Manor Park, Runcorn. Cheshire. WA7 1NT. UK. The manufacturer are Fresenius Kabi
Deutschland GmbH, D-61346 Bad Homburg v.d.H., Germany and Fresenius Kabi France,
6, rue du Rempart, BP 611, 27400 Louviers Cedex, France.
Marketing Authorisation Number:
PL 08828 / 0157
Product Authorisation Number:
PA 566 / 027/ 001
Legal Category:

POM

HyperHAES®

Before
is used
Please inform your doctor if you:
Have any previous history of heart, kidney or liver trouble
Have any blood clotting abnormalities
Are dehydrated
Have abnormal levels of serum electrolytes (the ions dissolved in your blood), especially
sodium and chloride
• If you are pregnant
• If you have a known allergy to starch.
It is also important for the doctor to know if you are on any other medication or if you are
diabetic.

068 5691/01 UK






Administration to breast feeding mothers is not regarded as harmful. You should tell your doctor
if you are pregnant, if you think you are pregnant or if you are breast feeding. This product
should not be administered to pregnant women during labour.
How HyperHAES® is used
You will receive your medicine by a single intravenous bolus dose or pressure infusion.
The recommended dosage for the treatment of severe low blood volume and shock is
approximately 4 ml/kg body weight, which is equivalent to 250 ml for a 60 – 70 kg body weight
person. This will be given quickly, with the full dose administered within 2 to 5 minutes.
Tests may be carried out throughout your treatment to ensure that your blood pressure, fluid
balance and serum electrolytes (the ions dissolved in your blood) are controlled.
Immediately after treatment with HyperHAES® you will be given a standard volume therapy
medicine (e.g. electrolyte solution or colloid). The appropriate dose will decided upon by your
doctor based on your individual needs. Use in children has not been established.
Possible side effects
Like all medicines, HyperHAES® can have side effects. It is possible that HyperHAES® may
cause breathing difficulties, allergic reactions or problems with your heart.
Rarely, chills, decreased blood pressure, flushing of the face may occur. Skin rashes can occur
which may be blotchy, bumpy and itchy like nettle rash. In the event of such reactions the
infusion will be stopped and treatment given as appropriate.
Although not previously observed when administered as recommended, it is considered
possible that the increased serum osmolarity and sodium and/or chloride serum levels
following administration of HyperHAES® may cause undesirable effects in the brain (e.g.
bleeding) due to dehydration and shrinking of tissue. Redness or soreness of the vein where
your medicine has been given may also be possible.
Accidental overdosage with this infusion may result in hypernatremia (high levels of sodium ions
in your blood). If this condition arises, appropriate fluids will be given to compensate and a
diuretic may be administered to remove the excess fluid quickly if the doctor thinks it necessary.
If you notice any side effects not mentioned in this leaflet please inform your doctor, nurse or
pharmacist.
Storing HyperHAES®
The solution must not be used after the expiry date on the label. Do not freeze. Your doctor or
nurse will ensure that the solution is a clear to a slightly opalescent solution or colourless to
slightly yellow, free from any signs of product degradation and the container undamaged before
use. The solution should be used immediately after opening and any solution remaining after
treatment should be discarded. Do not reconnect partially used bags.
Expel air prior to pressure infusion.
Keep out of reach and sight of children.
The text of this leaflet was prepared / revised February 2007

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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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