ISOPLEX

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. NB No distinction between the recommended doses and dosage schedule for adults, children and the elderly is necessary as the rate of administration depends on the condition of the individual patient.

3 notably for hypersensitivity to galactose- α-1,3-galactose (alpha-Gal) and allergy to red meat and offal). . 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 Dysponoea Hypoxia Skin and subcutaneous disorders Urticarial reactions Sweating General disorders and administration site reactions Chills Pyrexia Reporting of suspected adverse reactions If you get any side effects, talk to your doctor or pharmacist.

This includes any possible side effects not listed on this leaflet. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

(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 administered. 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.

Due to possible cross-reactions involving the allergen galactose-alpha-1,3- galactose (alpha-Gal), the risk of sensitization and consequent anaphylactic reaction to gelatin- containing solutions could be highly increased in patients with history of allergy to red meat (mammal meat) and offal and/or tested positive for anti-alpha-Gal IgE antibodies.

3) Treatment: The infusion of Isoplex should be stopped. g. g. chlorpheniramine 10 – 20 mg slowly intravenously) should be considered. (i) Caution should be exercised in infusing Isoplex in any patient liable to develop circulatory overload (for example, severe congestive cardiac failure or renal failure with oliguria or anuria) since excessive volumes may give rise to circulatory overload and electrolyte imbalance.

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.

Important information about excipients Potassium:

This medicine contains 78 mg potassium per 500ml. To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.

Sodium:

Isoplex is contra-indicated in patients with a known hypersensitivity to succinylated gelatin. 4) Lactate containing solutions are contra-indicated in patients with liver disease.