Haemaccel

Haemaccel

Manufacturer:

Sanofi-Aventis

Distributor:

DKSH
Full Prescribing Info
Contents
Polygeline.
Description
Each 1000 mL of infusion solution contains degraded bovine gelatin polypeptides cross-linked via urea bridges (equivalent of 6.3 g of nitrogen) 35 g. (See Tables 1 and 2.)
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Click on icon to see table/diagram/image
Haemaccel contains no preservative.
Action
Histochemical, radiochemical and histological studies have shown that Haemaccel is not stored in the RES. Disturbances of organ functions have not been observed even at high dosages.
In patients with intact renal function, polygeline is normally fully excreted 48 hrs after the end of the infusion. If, for example, in dialysis patients, the polygeline cannot be excreted adequately, it will be degraded by endogenous proteases.
Infusion of Haemaccel leads to haemodilution and thus lowers the viscosity of the blood. This can result in an improvement of the microcirculation.
Indications/Uses
Haemaccel is a plasma substitute for volume replacement used to correct or avert circulatory insufficiency due to plasma or blood volume deficiency, absolute (eg, resulting from bleeding) or relative (eg, resulting from a shift in a plasma volume between the circulatory compartments). Haemaccel is applied in the following areas:
Hypovolaemic shock; loss of blood and plasma (eg, due to trauma, burns, autologous blood or plasma donation before an operation); for filling the heart-lung machine.
Dosage/Direction for Use
The dosage and infusion speed are to be adjusted according to the individual situation and will depend inter alia on the usual circulatory parameters (eg, blood pressure).
The extent and duration of the effect achieved depend on the infusion volume, the infusion speed and the existing volume deficit.
For healthy adults, the following volumes are considered appropriate: Blood or plasma loss shock prophylaxis: 500-1500 mL; volume deficiency shock: Up to 2000 mL; in emergencies: Volume as required.
The blood pressure is the parameter of reference.
The dosage should be considered that the essential elements of the blood are maintained above their critical limit of dilution and that hypervolaemia and hyperhydration are avoided.
Generally, at the latest the administration of red cell concentrate or coagulation factors must be considered when the haematocrit falls <25% by volume.
Note that in the case of babies, infants and elderly persons, such patients have inadequate reserves of protein.
Administration: Haemaccel is a ready-for-use solution to be infused by the IV route. The speed and duration of the infusion depend on the needs of the patient.
The infusion speed is to be adjusted in accordance with the monitored blood pressure values. The drip rate can be calculated using the following formula:

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Example: 500 mL to be infused in 1 hr:

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In emergencies, it is possible to administer Haemaccel as a rapid infusion (eg, 500 mL in 5-15 min).
Reactions caused by histamine release can be avoided by the prophylactic use of H1- and H2-receptor antagonists (eg, dimetindene 0.1 mg/kg of body weight IV and cimetidine 0.5 mL/kg of body weight IV).
For technical reasons, there is residual air volume in the container. Thus, pressure infusions with the plastic infusion bottle must be carried out under controlled conditions only, as the risk of an air embolism cannot be excluded. For physiological reasons, Haemaccel should not be infused in the cold state, like all infusion solutions.
Infuse clear solutions only.
Contraindications
Known hypersensitivity to the constituents of Haemaccel.
Existing severe allergic reactions.
In the following cases, Haemaccel is indicated to a restricted extent only. If the physician considers the infusion necessary, it should be given taking special precautions:
All conditions in which an increase in intravascular volume and its consequences (eg, increased stroke volume, elevated blood pressure), or an increase in interstitial fluid volume or haemodilution could represent a special risk for the patient. Examples of such conditions are: Congestive heart failure, hypertension, oesophageal varices, pulmonary oedema, haemorrhagic diathesis, renal and post-renal anuria.
In all patients at an increased risk of histamine release (eg, persons with allergic/allergoid reactions and patients with a history of histamine response; also patients who in the previous 7 days have received a drug which releases histamine).
In the latter cases, Haemaccel may be given only after taking appropriate prophylactic steps (see Administration under Dosage & Administration).
Special Precautions
In patients with intact renal function, polygeline is normally fully excreted 48 hrs after the end of the infusion. If eg, in dialysis patients, the polygeline cannot be excreted adequately, it will be degraded by endogenous proteases. It should be used with caution in patients with cardiac insufficiency, fixed hypertension and cardiogenic shock.
Infusion of Haemaccel leads to haemodilution and thus lowers the viscosity of the blood. This can result in an improvement of microcirculation.
Haemaccel is non-immunogenic and therefore cannot induce antibody formation.
Haemaccel does not lead to any substance-specific impairment of coagulation. However, if relatively large amounts are infused, note that this will dilute the components of the coagulation system. Platelet function remains unaffected.
Blood grouping tests are not affected by polygeline.
Use in pregnancy & lactation: Use of Haemaccel in pregnant women and nursing mothers is not contraindicated. Generally, however, particular care should be exercised when fluid or volume replacements are administered during or immediately after pregnancy.
Use In Pregnancy & Lactation
Use of Haemaccel in pregnant women and nursing mothers is not contraindicated. Generally, however, particular care should be exercised when fluid or volume replacements are administered during or immediately after pregnancy.
Side Effects
If the patient develops the following side effects, the doctor or pharmacist must be informed.
During or after the infusion of plasma substitutes, transient skin reactions (urticaria, wheals), hypotension, tachycardia, bradycardia, nausea, vomiting, dyspnoea, increases in temperature and/or chills may occasionally occur.
Rare cases of severe hypersensitivity reactions reaching as far as life-threatening shock have been observed. Here, the treatment required depends on the nature and severity of the side effect.
If side effects occur, the infusion should be discontinued at once. If necessary, treatment should be given as follows:
Mild Reactions: Administer corticosteroids and antihistamines.
Severe Reactions: If appropriate, immediately inject catecholamines slowly IV, plus high doses of corticosteroids (slowly IV), volume replacement (eg, human albumin, Ringer's lactate solution), oxygen.
Histamine release has been shown to be the cause of anaphylactic side effects associated with infusions of Haemaccel.
Histamine-induced reactions can be encouraged by rapid infusion.
Furthermore, the previously described reactions may occur as a result of the cumulative effect of several histamine-releasing drugs (eg, anaesthetics, muscle relaxants, analgesics, ganglia blockers and anticholinergic drugs).
Drug Interactions
In the case of patients receiving cardiac glycosides, the synergistic effect of the calcium with Haemaccel should be taken into account.
Caution For Usage
Due to the raised calcium content of Haemaccel, the serum calcium concentrations may be found to be slightly elevated for a temporary period, especially when large amounts of Haemaccel are administered by rapid infusion. So far no reports have been received of cases involving clinical signs of hypercalcaemia resulting from an infusion of Haemaccel.
In case of simultaneous administration of Haemaccel and blood, anticoagulated with citrate, into separate venous accesses, no adverse reaction is to be expected; recalcification of the citrated blood due to the calcium ion content in Haemaccel can only occur when Haemaccel is mixed with it or if subsequent infusions are given using the same venous access.
Heparinized blood, however, can be mixed with Haemaccel.
Taking sterile precautions, Haemaccel can be mixed with the usual infusion solutions (saline, glucose, Ringer's solution, etc) as well as with cardiovascular drugs, corticosteroids, muscle relaxants, barbiturates, vitamins, streptokinase, urokinase, antibiotics of the penicillin series and cefotaxime, provided that these are soluble in water.
The infusion of Haemaccel may result in a temporary increase in the erythrocyte sedimentation rate.
Freezing and thawing do not result in a change in its physicochemical properties.
Once an infusion bottle has been opened, any unused contents are to be discarded.
Storage
Store at +2°C to +25°C. If Haemaccel is stored at above +25°C, the stated expiry date has to be reduced by 2 years.
ATC Classification
B05AA06 - gelatin agents ; Belongs to the class of blood substitutes and plasma protein fractions. Used as blood substitutes.
Presentation/Packing
Infusion 500 mL.
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