1. Name Of The Medicinal Product
Isoplex 4% w/v Solution for Infusion
2. Qualitative And Quantitative Composition
Succinylated gelatin (Modified Fluid Gelatin) 4% w/v in Water for Injections, also containing electrolytes.
Electrolytes
Sodium ion (Na+) 145 mmol/litre
Chloride ion (Cl¯) 105 mmol/litre
Lactate ion 25 mmol/litre
Potassium ion (K+) 4 mmol/litre
Magnesium ion Mg2+) 0.9 mmol/litre
3. Pharmaceutical Form
Sterile non-pyrogenic solution for infusion.
A clear pale yellow or straw coloured solution contained within a flexible infusion bag.
Key Physico-chemical properties:
Weight average molecular weight (Mw) 30 000 Dalton
Number average molecular weight (Mn) 20 000 Dalton
pH 7.4 + 0.5
Osmolarity 284 mOsm/litre
4. Clinical Particulars
4.1 Therapeutic Indications
Isoplex is a colloidal plasma substitute indicated for the initial management of hypovolaemic shock caused by, for example, haemorrhage, acute trauma or surgery, burns, sepsis, peritonitis, pancreatitis or crush injury.
Isoplex may be used in the initial treatment of blood loss during pregnancy where plasma volume replacement is needed.
4.2 Posology And Method Of Administration
Isoplex is administered intravenously; the volume and rate of infusion will depend on the condition of the patient. The rate of administration can be increased by the application of pressure to the container or by adjusting the giving set pump. When given rapidly Isoplex should be warmed to no more than 37ºC if possible. In severe acute blood loss, Isoplex may be given rapidly (500 ml in 5 – 10 minutes) until signs of hypovolaemia are relieved. When large volumes are given, suitable monitoring should be used to ensure that an adequate haematocrit is maintained (the haematocrit should not be allowed to fall below 25%) and that dilutional effects upon coagulation are avoided. (Expert haematological advice should be sought, especially in cases of massive blood loss).
For massive fluid loss, Isoplex may be used concomitantly with blood, the rate and amount of which depends on the clinical condition of the patient. The haemodynamic status of the patient should be monitored.
If blood is to be given at the same time as Isoplex, it can be given through the same giving set since Isoplex has a negligible calcium content and therefore does not clot blood. Isoplex can also be used to reconstitute packed red cells.
4.3 Contraindications
Isoplex is contra-indicated in patients with a known hypersensitivity to succinylated gelatin.
Lactate containing solutions are contra-indicated in patients with liver disease.
4.4 Special Warnings And Precautions For Use
(i) Severe anaphylactic or anaphylactoid reactions have been reported following the intravenous administration of succinylated gelatin. These are rare, having an incidence of between 1 in 6,000 and 1 in 13,000 units. However, they may be more likely to occur if Isoplex is given rapidly to normovolaemic patients, and may be assumed to be more hazardous in patients with known allergic conditions such as asthma.
Treatment: The infusion of Isoplex should be stopped. Further treatment will depend on the severity of the reaction; administration of supplemental oxygen; an alternative infusion fluid; and the parenteral administration of adrenaline (e.g. for adults, 0.5 ml of a 1 in 1,000 solution intramuscularly, repeated every 5 minutes as necessary, or 5 ml of a 1 in 10,000 solution slowly intravenously), and an antihistamine (e.g. chlorpheniramine 10 – 20 mg slowly intravenously) should be considered.
(ii) Caution should be exercised in infusing Isoplex in any patient liable to develop circulatory overload (for example, congestive cardiac failure or renal failure with oliguria or anuria).
Treatment: The infusion of Isoplex should be stopped and the patient treated symptomatically. Electrolytes should be monitored. If necessary, a diuretic can be given to promote fluid loss. Decreased urinary output secondary to shock is not a contraindication unless there is no improvement in urine output after the initial dose of Isoplex.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
No interaction studies have been performed.
4.6 Pregnancy And Lactation
There is very little information available on the use of plasma substitutes in pregnant or lactating women. As with all drugs, the benefits and risks must be assessed.
Isoplex may be used in the initial treatment of blood loss during pregnancy where plasma volume replacement is needed.
4.7 Effects On Ability To Drive And Use Machines
Not applicable.
4.8 Undesirable Effects
The major undesirable effect risk associated with succinylated gelatin is that of a severe anaphylactic or anaphylactoid reaction, the occurrence and treatment of which is discussed in “4.4 Special warnings and precautions for use”.
A list of rare undesirable effects that have been associated with the administration of succinylated gelatin is given beneath;
Rare effects (>1 in 10,000 to <1 in 1,000)
Immune system disorders
Anaphylactic reaction
Anaphylactoid reaction
Nervous system disorders
Tremor
Cardiac disorders
Tachycardia
Vascular disorders
Hypotension
Hypertension
Respiratory, thoracic and mediastinal disorders
Wheezing
Dyspnoea
Hypoxia
Skin and subcutaneous disorders
Urticarial reactions
Sweating
General disorders and administration site reactions
Chills
Pyrexia
4.9 Overdose
As an overdose of Isoplex may give rise to circulatory overload and electrolyte imbalance (see Section 4.4 Special warnings and precautions for use).
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Pharmacotherapeutic group: Gelatin agents; ATC code B05A A 06
Isoplex is a colloidal plasma substitute. When used in the treatment of hypovolaemia Isoplex produces significant increases in blood volume, cardiac output, stroke volume, blood pressure, urinary output and oxygen delivery.
Isoplex promotes osmotic diuresis, thereby helping to protect the kidneys from the adverse effects of hypovolaemia.
5.2 Pharmacokinetic Properties
The half-life of Isoplex is about 4 hours, with the majority of the dose administered being eliminated by renal excretion within 24 hours.
5.3 Preclinical Safety Data
There are no preclinical data of relevance to the prescriber, which are additional to those already included in other sections of the SmPC.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Sodium chloride
Sodium lactate
Potassium chloride
Magnesium chloride
Sodium hydroxide/hydrochloric acid
Water for injection
Isoplex contains no preservatives.
6.2 Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Isoplex does not interfere with blood grouping or cross-matching.
6.3 Shelf Life
The shelf life for Isoplex 500 ml and 1,000 ml is 2 years
6.4 Special Precautions For Storage
Do not store above 25ºC. Do not freeze or refrigerate.
6.5 Nature And Contents Of Container
Isoplex is supplied in sterile flexible infusion bags (500 or 1,000 ml), which are overwrapped.
For 500 ml bags, each pack contains 10 units.
For 1,000 ml bags, each pack contains 6 units.
6.6 Special Precautions For Disposal And Other Handling
Do not use unless container is free of particles. Do not use if moisture is present between the container and the overwrap, or if the overwrap is damaged. Do not use if the container is not intact before breaking the seal. Check for leaks by squeezing the container before use. For single dose use only. Discard any unused solution immediately after initial use. Do not reconnect any partially used containers.
7. Marketing Authorisation Holder
Beacon Pharmaceutical Ltd
85 High Street
Tunbridge Wells
Kent
TN1 1YG
UK
8. Marketing Authorisation Number(S)
PL 18157/0244
9. Date Of First Authorisation/Renewal Of The Authorisation
09/06/2010
10. Date Of Revision Of The Text
09/06/2010
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