ISOPLEX 4% W/V SOLUTION FOR INFUSION

Active substance: SUCCINYLATED GELATIN

View full screen / Print PDF » Download PDF ⇩

Transcript
Patient Information Leaflet

Isoplex

4% w/v Solution for Infusion
(succinylated gelatin)

Read all of this leaflet carefully
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor or nurse.

Each container of Isoplex is designed to last only a few hours
at a time; most of the succinylated gelatin is passed out of the
body in less than 12 hours. For this reason, you may be given
more Isoplex when your doctor or nurse thinks this is
necessary. In time, your body will make up the blood or body
fluids that you have lost.
4. Possible Side Effects
Like all medicines Isoplex can cause side effects, although not
everybody gets them

In this leaflet:
1. What is Isoplex and what does it do?
2. Before being given Isoplex
3. How much Isoplex to use and for how long
4 Possible side effects
5. Storing Isoplex
6. Further Information

Rarely, (between 1 in 1,000 and 1 in 10,000 people), patients
may experience an allergic like reaction. Tell your doctor or
nurse immediately if you notice any of the following:

1. What is Isoplex and what does it do ?
Isoplex is a temporary plasma substitute solution containing
succinylated gelatin 4% w/v (Plasma is the fluid component of
blood in which the red cells and white cells are carried).
Isoplex is administered directly into a vein via a drip tube
(intravenous infusion).




You will be given Isoplex if you have lost blood or body fluids
because of bleeding, injury, surgery, burns or infection. It
takes time for your body to replace the blood or body fluids
that you have lost. Isoplex can help maintain the volume of
fluid in your blood vessels during that time. Isoplex is not
intended to provide nutrition nor replace blood components
such as red cells which carry oxygen or white cells which fight
infection; Isoplex can only replace lost fluid volume.



Isoplex can be used for the treatment of initial blood loss during
pregnancy.
2. Before being given Isoplex
Do not allow Isoplex to be given to you if you know that you
are allergic (hypersensitive) to succinylated gelatin
if you are suffering or have suffered from the following conditions,
please tell your doctor or nurse before being given Isoplex;
• Heart failure
• Kidney (renal) failure
• Liver disease
Please inform your doctor or nurse if you are taking, or have
recently taken, any other medicine, including those medicines
obtained without a prescription
Please ask your doctor or nurse for advice if you are pregnant
or breastfeeding.
3. How much Isoplex to use and for how long?
You will be given Isoplex via a drip tube inserted into a vein. It
is unlikely that you will ever have to use Isoplex yourself;
infusion fluids are mainly intended to be given by your doctor
or nurse.
Your doctor or nurse will work out how often you should have
Isoplex, and how much Isoplex should be used. The amount
given will depend upon your individual needs. You might also
be given other infusion fluids or products made from blood, or
a blood transfusion.
For infusion the usual dose rates are:
For Adults:
500 – 1500 ml/hour
For Children:
150 – 1500 ml/hour
For Elderly:
As Adults







Swelling of your face, mouth or throat
Changes in your breathing, e.g. fast breathing, difficulty
breathing out, wheezing
Changes in the way your heart beats, e.g. fast beating
Changes in your blood pressure, e.g. feeling dizzy or
faint, headache
Changes in your body temperature, e.g. chills, fever,
sweating.
Abnormal feelings in your skin, including itching, rash,
swelling or any other changes to your skin
Shaking of your arms and/or legs

If you suffer from any of these side effects, or any other
undesired effect, please inform your doctor or nurse
immediately.
5.







Storing Isoplex
Isoplex should not be used if:
the container shows any sign of leakage
the solution is cloudy.
the solution is NOT a clear pale yellow or straw colour
particles are visible within the container
the date of use is after the last day of the month of the expiry
date, which is stated on the infusion bag in the format
MM/YYYY

Please inform your doctor or nurse immediately if you believe that
any of the above situations have occurred.
6. Further Information
The active substance in Isoplex is succinylated gelatin (4%
w/v). 500ml and 1000 ml bags of Isoplex contain 20g and 40g
of succinylated gelatin respectively. The other ingredients are
sodium chloride, sodium lactate, potassium chloride,
magnesium chloride, sodium hydroxide, hydrochloric acid,
and water for injections.
Isoplex is a clear pale yellow or straw coloured solution for
infusion which is supplied in 500ml and 1000ml flexible plastic
containers (infusion bags).
The Marketing Authorisation Holder for Isoplex is Beacon
Pharmaceuticals Ltd., 85 High Street, Tunbridge Wells, TN1
1YG, UK
The manufacturer of Isoplex is Serumwerk Bernburg AG,
Hallesche Landstrasse 105b, Bernburg, 06406, Germany.
Leaflet prepared: March 2010
ISOPLEX is a Registered
Pharmaceuticals Ltd.

Trademark

of

Beacon

Expand view ⇕

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.

Hide
(web5)