Haemaccel®
Haemaccel® a branded form of polygeline, is a commonly used Plasma Volume Expander since the last 50 years.
- About Polygeline
Prescription Information
- Abstract
- Composition and Description
- Contraindications
- Measures Of Precaution For Administration
- Interactions With Other Agents
- Interactions
- Dosage Instruction, Mode And Duration Of Administration
- Mode Of Administration
- Side Effects
- storage
- Additional Information
- Notes
Each 100 ml contains :
Polygeline Polypeptides of degraded gelatin, cross-linked via urea bridges 3.5g (equivalent to 0.63g of nitrogen)
Sodium Chloride Ph. Eur. 0.85g
Potassium Chloride Ph. Eur. 0.038g
Calcium Chloride Ph. Eur. 0.070g
Water for Injection Ph. Eur.q.s.
Electrolytes in m mol / litre : Na+ 145, K+ 5.1, Ca++ 6.25, Cl- 145
Mean molecular weight 30,000
Physico-Chemical Data
pH of the infusion solution 7.3 ±0.3
Gel point below +3°C
*determined using modern analytical techniques
Presentation
Infusion bottles of 500ml.
Substance Or Indication Category
Infusion solutions,volume replacement
Haemaccel is a plasma substitute for volume replacement used to correct or avert circulatory insufficiency due to plasma/blood volume deficiency, either absolute (e.g. resulting from bleeding) or relative (e.g. resulting from a shift in plasma volume between the circulatory compartments).
Haemaccel is applied in the following areas :
- Hypovolaemic shock
- Loss of blood and plasma (e.g.due to trauma, burns, autologous blood or plasma donation before an operation)
- For filling the heart-lung machine. In addition Haemaccel can be used as a carrier solution for various drugs.
Known hypersensitivity to constituents of the preparation. 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 (blood vessel) volume and its consequences (e.g. increased stroke volume, elevated blood pressure), or an increase in interstitial fluid volume or haemodilution could represent a particular risk for the patient.
Examples of such conditions are : congestive heart failure, hypertension, oesophageal varices, pulmonary oedema, haemorrhagic diathesis, renal and postrenal anuria. In all patients at an increased risk of histamine release (e.g. persons with allergic/allergoid reactions and patients with a history of histamine response).
In the latter cases Haemaccel may be given only after taking appropriate prophylactic steps (see Measures of precaution for administration). Use of the preparation 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.
Measures Of Precaution For Administration
For physiological reasons Haemaccel should not be infused in the cold state, like all infusion solutions. Infuse clear solutions only. Reactions caused by histamine release can be avoided by the prophylactic use of H1 and H2 receptor antagonists (e.g. Dimetinden 0.1mg/kg of body weight i.v. and Cimetidin 5mg/kg of body weight iv.).
For technical reasons there is a 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 can not be excluded. Expel air prior to infusion under pressure (“see mode of administration”).
Interactions With Other Agents
In the case of patients receiving cardiac glycosides, the synergistic effect of the calcium in Haemaccel should be taken into account.
Dosage Instruction, Mode And Duration Of Administration
Dosage,unless otherwise prescribed : Dosage and infusion rate are to be adjusted to the individual situation and are determined among other factors by the usual circulatory parameters (e.g. blood pressure).
The degree of efficacy and the duration of the effect achieved depend on the infusion volume, the infusion rate 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 above volumes may be even higher, provided that the essential elements of the blood are maintained above the 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 below 25% by volume. Note that in the case of babies, infants and elderly persons such patients have inadequate reserves of protein.
Haemaccel is a ready-for-use solution to be infused by the intravenous route. The rate 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 : e.g. : 500 ml to be infused in 1 hour :
500 = 125 drips per minute
4 x 1(h)
In emergencies it is possible to administer Haemaccel as a rapid infusion (e.g. 500 ml in 5 to15 min).
If infused under pressure expel air prior to infusion (see “measures of precaution for administration”)
Do not mix with citrated blood.
If you develop side-effects which are not mentioned in this package insert, please inform your doctor or pharmacist. 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. During administration of polygeline infusion under pressure, very rare cases of air embolism have been reported. If side effects occur the infusion should be discontinued at once. If necessary, treatment should be given as follows : Mild reactions : administer antihistamines. Severe reactions : if appropriate immediately inject catecholamines slowly i.v., plus high doses of corticosteroids slowly i.v., volume replacement, oxygen. Histamine release has been shown to be the cause of anaphylactoid side-effects associated with infusions of Haemaccel. Histamine-induced reactions can be encouraged by rapid infusion.
Furthermore, the above-described reactions may occur as a result of the cumulative effect of several histamine-releasing drugs (e.g. anaesthetics, muscle relaxants, analgetics, ganglia blockers and anticholinergic drugs).
Store below 25OC. (No refrigeration required).
Caution : Not to be used if the container is found leaking and / or solution is not clear.
Once an infusion bottle has been opened, any unused contents are to be discarded.
Store out of reach of children.
The preparation contains no preservative. Freezing and thawing do not result in a change in its physico-chemical properties. 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 hours 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 microcirculation. Administration of Haemaccel does not induce antibody formation. Haemaccel does not lead to a substance-specific impairment of coagulation or platelet function.
However, if large amounts are infused, haemodilutional effects on the coagulation potential occur. Blood-grouping tests are not affected by polygeline.
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.
Heparinised 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.
Pohan HT, Lie KC, Santoso WD, Eppy