HAEMACCEL

Active substance: POLYGELINE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Haemaccel

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Haemaccel contains 35g Polygeline as active ingredient in 1000ml.

3

PHARMACEUTICAL FORM
Solution for infusion

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
1. As a plasma volume substitute in the initial treatment of hypovolaemic
shock due to:
b) Haemorrhage (visible or concealed)
c) Burns. Peritonitis, pancreatitis, crush injuries
4. Fluid replacement in plasma exchange
5. Extra-corporeal circulation
6. Isolated organ perfusion
7. As a carrier solution for insulin

4.2

Posology and method of administration
Route of Administration: Intravenous infusion.
Haemaccel should be administered intravenously in a volume approximately
equal to the estimated blood loss.
See Section 6.6. for Instructions for Use/Handling.
Infusion rate:
The rate of infusion is determined by the condition of the patient. Normally,
500ml will be infused in not less than 60 minutes but, in emergencies,
Haemaccel can be rapidly infused. Losses of up to 25% of the blood volume
can be replaced by Haemaccel alone.
Hypovolaemic shock:

500-1,000ml Haemaccel should be infused intravenously initially. Up to
1,500ml blood loss can be replaced entirely by Haemaccel. For between
1,500ml and 4,000ml blood loss, fluid replacement should be with equal
volumes of Haemaccel and blood, given separately (see Pharmaceutical
Precautions). For losses over 4,000ml, the separate infusion should be in the
ratio of two parts blood to one part Haemaccel. The Haematocrit should not be
allowed to fall below 25%
Burns:
It is suggested that at least 1ml Haemaccel be infused per kg of body weight.
Multiplied by the % of body surface burned for each 24 hours for two days,
e.g. if a 70kg person has burns covering 10% of body surface, then the dosage
of Haemaccel should be at least 1 (ml) x 70 (kg) x 10 (%) = 700 ml/24 hours.
Additional crystalloid solutions should be given to cover the normal fluid loss,
i.e. about 2,000ml per 24 hours. In severe burns, additional protein and
vitamin therapy may be required. The volume of colloid and crystalloid given
should be varied according to the clinical response of the patient, the urine
volume, its specific gravity and
osmolality etc.
Plasma exchange:
Haemaccel should he given either alone or in combination with other
replacement fluids in a volume adequate to replace the plasma removed. Up to
2 litres have been given as sole replacement fluid.
4.3

Contraindications
Haemaccel is contra-indicated in patients with a known hypersensitivity to
constituents of the preparation and/or patients with existing anaphylactoid
reactions.

4.4

Special warnings and precautions for use
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 (e.g. 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 (e.g. allergic persons
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. Reactions caused by histamine release can beĀ· avoided by
the prophylactic use of H1 and H2 receptor antagonists.

Inappropriate rapid administration of Haemaccel, especially to normovolaemic
patients may cause the release of vasoactive substances. The exact mechanism
of this histamine release has not been clearly defined.
4.5
Interaction with other medicinal products and other forms of
interaction
Haemaccel contains calcium ions and caution should be observed in patients
being treated with cardiac glycosides.
Haemaccel may be mixed with other infusion solutions (e.g. saline, dextrose,
Ringer's solution etc.) or with heparinised blood. Sterility must be maintained.
Compatible water-soluble drugs may be infused in Haemaccel, e.g. insulin,
streptokinase etc. Any additive should be injected into the bottle through a
small hole located next to the pull-ring.
4.6 Pregnancy and lactation
Haemorrhage around the time of childbirth or blood loss during other obstetric
or gynaecological procedures may necessitate plasma volume replacement.
Haemaccel has been used for many years for the initial treatment in such cases
without apparent ill consequence. If plasma volume replacement is needed
during pregnancy, Haemaccel may be used if blood is not available.
4.7

Effects on ability to drive and use machines
Not applicable.

4.8

Undesirable effects
During or after the infusion of volume-expanding solutions, transient urticarial
skin reactions (wheats), hypotension, tachycardia, bradycardia,
nausea/vomiting, dyspnoea, increases in temperature and/or shivering may
occasionally occur.
Rare cases of severe hypersensitivity reactions including shock have been
observed. Treatment will depend on the nature: and severity of the reaction.
Mild reactions: Administer corticosteroids and antihistamines.
In the event of anaphylactic shock, the infusion should be discontinued and
adrenalin (5-10ml of 1:10,000 by slow i.v. injection or 0.5-1.0ml of 1:1,000 by
i.m./s.c. injection) should immediately be given. Administration of adrenalin
should be repeated every 15 minutes until improvement occurs. Circulatory
collapse requires volume replacement, preferably monitored by a central
venous pressure line. Large volumes of electrolyte solution may be necessary
because, in severe anaphylactic shock, plasma loss may constitute up to 40%
of the plasma volume. A slow i.v. injection of an H1 antagonist such as 1020mg chlorpheniramine may be given.

Histamine release has been shown to be a cause of anaphylactic side-effects
associated with infusions of Haemaccel.
These reactions may occur as a result of the cumulative effect of several
histamine-releasing drugs (e .g. anaesthetics, muscle relaxants. analgesics,
ganglia blockers and anticholinergic drugs).

Due to the 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.
The infusion of Haemaccel may result in a temporary increase in the
erythrocyte sedimentation rate.

4.9

Overdose
Not applicable.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Haemaccel is a gelatin derivative with a mean molecular weight of 30,000
Dalton. It is iso-oncotic with plasma and has a viscosity and pH similar to
plasma. It has very little pharmacological action and does not interfere with
cross matching or blood typing tests.

5.2 Pharmacokinetic properties
Haemaccel has a mean half-life of about 5 hours. About 74% is excreted via
the kidneys four days after administration. It is metabolised into smaller
peptides and amino acids by proteolytic enzymes.

5.3 Preclinical safety data
None.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Sodium Chloride, Ph.Eur.

8.5 g

Potassium Chloride, Ph,Eur.
Calcium Chloride, Ph,Eur.
Water for Injections, Ph. Ent'.

0.38 g
0.7 g
to 1.0 Litre

6.2

Incompatibilities
Citrated blood should NOT be mixed with Haemaccel since clotting of the
blood may occur due to the presence of calcium ions in Haemaccel. However,
citrated blood may be infused before or after Haemaccel provided that there is
adequate flushing of the infusion set.

6.3

Shelf life
2 years

6.4

Special precautions for storage
None.

6.5

Nature and contents of container
500 ml Polypropylene bottles.
Insocap (Polypropylene cap with elastomer liner)

6.6

Special precautions for disposal
In common with all intravenous infusion, Haemaccel should, if possible, be
warmed to body temperature before use. However, in emergencies, it may be
infused at ambient temperature. For technical reasons, there is a residual air
volume in the container. Thus, pressure infusions with the plastic infusion
boule must be carried out under controlled conditions only, as the risk of an air
embolism cannot be excluded.

7

MARKETING AUTHORISATION HOLDER
Piramal Healthcare UK Limited,
Whalton Road,
Morpeth,
Northumberland,
NE61 3YA.
United Kingdom

8

MARKETING AUTHORISATION NUMBER(S)
PL 29595/0001

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
12th January 2005

10

DATE OF REVISION OF THE TEXT
17/02/2012

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Source: Medicines and Healthcare Products Regulatory Agency

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