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MANNITOL INFUSION BP 20% AS POLYFUSOR M AND FREEFLEX

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Mannitol Infusion BP 20%, as Polyfusor M and freeflex

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Polyfusor M has the following composition:
Name
Mannitol

3

Specification Reference
BP

%w/v
20

PHARMACEUTICAL FORM
Intravenous fluid

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For use as an osmotic diuretic, alone or to supplement the action of other diuretics in
order to promote renal function, including the assisted elimination of drugs such as
aspirin and barbiturates.

4.2.

Posology and Method of Administration
Adults and Children
The volume, strength and rate of infusion of mannitol solutions given in
intravenous will depend upon the requirements of the patient and the
judgement of the physician. A dosage of 200g daily by intravenous infusion
should not be exceeded.
Elderly
Elderly patients are more susceptible to the adverse effects associated with
mannitol. This is due to diminished renal and cardiac reserves. Elderly
patients should therefore be given a test dose as described below for patients
with renal impairment.

Renal Impairment
Patients with impaired renal function should be given a test dose of 200 mg
per kilogrambody weight administered over five minutes and if 40 ml or more
of urine is produced in an hour, mannitol may then be given in therapeutic
doses.
For intravenous infusion

4.3.

Contra-indications
Mannitol is contraindicated in patients with abnormal capillary fragility,
pulmonary congestion or pulmonary oedema, intracranial bleeding, congestive
heart failure and renal failure unless a test dose has produced a diuretic
response.

4.4.

Special Warnings and Precautions for Use
Solutions of mannitol given in intravenous infusion should be administered
slowly and should not be mixed with blood in transfusion apparatus. All
patients given mannitol should be observed for signs of fluid and electrolyte
imbalance.
If renal flow is inadequate, water intoxication is likely in patients receiving
intravenous mannitol, therefore its use in oedematous conditions associated
with diminished cardiac reserve should only be considered if the advantages
outweigh the risks.
The label states:

4.5.

To retard crystallisation store at 20º-30º.
Carefully examine the solution for crystals immediately
before use. If necessary redissolve by raising the
temperature to 60º maintaining it at this temperature,
and shaking occasionally until the crystals have
redissolved.
Cool to blood heat before use.

Interactions with other Medicaments and other forms of Interaction
Mannitol may enhance tubocurarine-induced neuromuscular blockade.
Cyclosporin nephrotoxicity may be enhanced by the concurrent administration
of mannitol

4.6

Pregnancy and Lactation

The safety of mannitol infusion has not been established in pregnancy and it
should be used with caution.
The safety in lactation has not been assessed but its use in this period is not
considered to constitute a hazard.

4.7.

Effects on Ability to Drive and Use Machines

Not applicable

4.8.

Undesirable Effects

Rapid intravenous infusion of mannitol may produce headache, chills or chest pain. It
may also depress respiration by altering the acid base and electrolyte balance of the
body fluids.
Convulsions have been known in patients administered excessive doses of mannitol
solutions.
Other side effects reported may be associated with hypersensitivity reactions.

4.9.

Overdose

Treatment of overdosage with mannitol should be symptomatic and, particular,
directed at correction of fluid and electrolyte imbalance.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Mannitol is an osmotically active solute which is filtered at the glomerulus, and
produces a corresponding increase in urine volume.

5.2.

Pharmacokinetic Properties

N/A

5.3.

Preclinical Safety Data

None stated.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Water for Injections in bulk
Hydrochloric Acid
Sodium Hydroxide

6.2.

Incompatibilities
Mannitol should not be mixed with blood because of possible agglutination
and irreversible crenation.
Electrolyte solutions should not be added to mannitol infusions, since addition
is likely to salt out the mannitol.
Other drugs which are incompatible with mannitol solutions include;
corticotrophin, soluble barbiturates, noradrennaline, metaraminol,
suxamethonium and tetracyclines.

6.3.

Shelf Life
500 ml polyethylene container :
500 ml polyolefin bag:

6.4.

60 months
36 months

Special Precautions for Storage
Store at 20º to 30ºC.

6.5.

Nature and Contents of Container

Sealed semi-rigid, cylindrical neutral polythene (500ml) container with a ‘Twist-off
seal: at one end and a ring tab at the opposite end
Or a flexible 500ml polyolefin bag sealed in a polyolefin overwrap.

6.6.

Instruction for Use/Handling

Do not dilute before use.
Use standard sterile peritoneal dialysis equipment.

Or
Locate the corner tabs at the end of the bag. Grip the two tabs and pull the two halves
of the overwrap apart, releasing the bag onto a clean surface.
Setting up the solution:
Position the roller clamp of the giving-set to just below the drip chamber and close.
Hold the base of the giving set port firmly and grip the wings of the twist of tab.
Twist to remove the protective cover.
Still holding the base of the giving-set port push the set spike fully into the port to
ensure a leak proof connection.
Prime the set in accordance with the manufacturer’s instructions.

7

MARKETING AUTHORISATION HOLDER
Fresenius Kabi Limited
Cestrian Court
Eastgate Way
Manor Park
Runcorn
Cheshire
WA7 1NT

8

MARKETING AUTHORISATION NUMBER(S)
PL 08828/0023

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
25th April 1989 / 16th Jan 1995

10

DATE OF REVISION OF THE TEXT
June 2000

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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