Presentation

A 3.5% straw-coloured infusion solution for plasma substitution in animals.

Composition and properties:

500 ml contains:

Degraded gelatin (polygeline) of average molecular weight 35,000 Dalton

 (equivalent to 3.15 g nitrogen)                                                      17.5 g

Sodium chloride                                                                              4.25 g

Potassium chloride                                                                          0.19 g

Calcium chloride                                                                             0.35 g

Sterile distilled water, pyrogen free to 500 ml

Isotonic equilibrium is made up by the polypeptides.

There are no preservatives.

Physico-chemical data:

Mean molecular weight                                                              c.a. 35,000

Viscosity ratio (+35^oC)                                                                     1.7‑1.8

Isoelectric point                                                                         pH 4.7±0.3

pH of infusion solution                                                                      7.3±0.3

Gel point                                                                                  below + 3^oC

Oncotic pressure (34^oC)                                                3.432 to 3.824 kPa

Uses

As a plasma volume substitute in horses, dogs and cats in cases of:

1.    Hypovolaemic shock due to:

       a) Blood loss after haemorrhage (visible or concealed) either due to accident or surgery.

       b) Plasma loss after burns, peritonitis or crush injuries.      

       c) Water and electrolyte loss from persistent vomiting and diarrhoea, diseases of the                       kidneys and adrenals, ileus, intestinal obstruction, diabetic coma.

2.     Neurogenic shock e.g. spinal injuries, severe head injuries, extreme pain.

3.     Shock prophylaxis during and/or following surgery.

4.     Haemorrhagic enteric shock in dogs.

5.    The use of the product as an irrigation fluid should be at the discretion of the veterinary          surgeon.

Dosage and administration

This product should be administered in a volume approximately equal to the estimated blood loss. Administration is by intravenous injection.  If this is not practicable, administration may be by intra-arterial infusion under pressure.

The amount required depends on the volume of intravascular fluid which has been lost, the speed with which the loss has taken place, and on the time which has elapsed since the onset of the first signs of shock.  In general the dose required is approximately equal to the calculated volume deficit.

Infusion rate: The rate at which the infusion should be given is determined by the patient's condition (clinical picture, arterial blood pressure, pulse rate, urinary output, central venous pressure, plasma electrolytes and blood picture).

Losses of up to 25% of the blood volume can be replaced by Haemaccel alone.

Hypovolaemic shock: Volume to be infused will depend on species and body weight.  For severe blood loss supplementary blood transfusion should also be considered.  The haematocrit should not be allowed to fall below 25%.

Burns: It is suggested that at least 1 ml Haemaccel be infused per kg body weight multiplied by the per cent of body surface burned, for each 24 hours for 2 days, e.g. if a 20 kg dog has burns covering 10% of body surface then the dosage of Haemaccel should be at least 1 (ml)x20 (kg) x 10(%) = 200 ml/24 hours.  Additional crystalloid solutions should be given to cover the normal fluid loss, i.e. about 500‑600 ml per 24 hours.  The volume of colloid and crystalloid given should be varied according to the clinical response of the patient.

After deciding the volume to be given and the time which the infusion is to take, the drip rate can be calculated from the following formula:

        required volume in ml                    =  number of drops in one minute

   4 x planned infusion time in hours        

e.g. 500 ml is to be infused in one hour.

   500     = 125 drops/minute.

   4x1

Plastic infusion bottle: It is advisable to disinfect the bottle top and then pull out the plastic ring.  A hole will be exposed  through which the piercing needle of an infusion set can be pushed.  There is no need to further disinfect the cap.

Contra-indications, warnings, etc.

1.         Use only the contents of unopened bottles.

2.         Solutions must be clear.

3.         Haemaccel may be mixed with other infusion solutions (e.g. saline, dextrose, Ringer's     solution, etc), or with heparinised blood.   Sterility must be maintained.

4.         Citrated blood should NOT be mixed with Haemaccel since the calcium ions present     in Haemaccel may cause recalcification.  However, citrated blood may be infused            immediately before or after Haemaccel.

5.         Haemaccel is not antigenic, but, as with all colloidal infusion solutions,    inappropriately rapid administration of Haemaccel, especially to normovolaemic           animals, may cause the release of vaso-active substances. 

            In the event of histamine release, the infusion should be discontinued and appropriate     action taken with antihistamines, etc. 

6.         Haemaccel contains calcium ions and caution should be observed in patients being         treated with cardiac glycosides.

7.         In common with all intravenous infusion solutions, Haemaccel should, if possible, be       warmed to body temperature before use.  However, in emergencies it may be infused      at ambient temperatures.

8.         Caution should be used in infusing Haemaccel in any patient likely to develop     circulatory overloading (e.g. severe congestive cardiac failure).

Withdrawal period:

Nil.

For animal treatment only. Keep out of reach and sight of children.

Pharmaceutical precautions

Do not store above 25^oC. Protect from light.

The product does not contain an antimicrobial preservative, therefore any fluid remaining in the bottle following withdrawal of the required dose should be discarded. Keep container in outer carton.

Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority.

Legal category

POM-V                       To be supplied only on veterinary prescription.

Package quantities

Available in 500 ml plastic bottles.

Further information

Haemaccel is of particular value as a volume replacement in the treatment of haemorrhagic and traumatic shock states (e.g. crush injuries, burns) as it promotes a demonstrable osmotic diuresis thereby protecting the kidneys.  It does not interfere with subsequent blood grouping and cross matching nor does it interfere with the coagulation system.  It is non-immunogenic and does not induce antibody formation.  Provided that sterility is maintained, compatible water soluble drugs may be infused in Haemaccel.  Any additive should be injected into the bottle through the small hole located next to the pull-ring.

Haemaccel will gel below 3^oC; however, warming will reverse this.  Freezing does not alter the physico-chemical characteristics in any way.

Marketing Authorisation number

Vm 01708/4421

Marketing Authorisation holder

Intervet UK Ltd.

Walton Manor

Walton

Milton Keynes

Bucks. MK7 7AJ

Date of text preparation: