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MANNITOL INTRAVENOUS INFUSION EP 10% W/V

Active substance(s): MANNITOL

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Mannitol Intravenous Infusion EP 10% w/v

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Mannitol EP

3

100.00gm

PHARMACEUTICAL FORM
A sterile non-pyrogenic Intravenous Infusion for administration to human
beings.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
1. The promotion of diuresis in the prevention of and/or treatment of the
oliguric phase of acute renal failure before irreversible renal failure
becomes established.
2. The reduction of intracranial pressure and the treatment of cerebral
oedema.
3. The reduction of elevated intraocular pressure when the pressure cannot be
lowered by other means.
4. Promoting the urinary excretion of toxic substances such as aspirin and
barbiturates.

4.2.

Posology and Method of Administration
The dose range for adults is 50 to 200gm in a 24 hr period with a dosage limit
of 50gm on any one occasion. In most instances an adequate response will be
achieved at a dosage of approximately 100gm per 24hr period. The rate of
administration is usually adjusted to maintain a urine flow of at least 30-50ml
per hour.

The dosage requirements for patients 12 years of age and under have not been
established.
Treatment of oliguria: the usual dose is 100gm of Mannitol administered as a
15% w/v or 20% w/v solution.
Reduction of intraocular pressure: A dose of 1.5 to 2.0gm per kg of body
weight may be given, as a 15% w/v or 20% w/v solution, over a period as
short as 30 minutes in order to obtain a prompt and maximal effect. When
used preoperatively, the dose should be given 1-1.5 hours before surgery to
obtain the maximum effect. An infusion of 50 to 100gm of Mannitol may be
given during cardiovascular and other types of surgery as an aid in preventing
acute renal failure. The concentration and volume to be administered will
depend upon the fluid requirement of the patient.

4.3.

4.4.

Contra-Indications
1.

Well-established anuria due to severe renal disease.

2.

Severe pulmonary congestion or pulmonary oedema.

3.

Active intracranial bleeding except during craniotomy.

4.

Severe dehydration.

5.

Progressive renal damage or dysfunction after institution of mannitol therapy,
including increasing oliguria and azotaemla.

6.

Progressive heart failure or pulmonary congestion after institution of mannitol therapy.

7.

No response to the test dose.

Special Warnings and Special Precautions for Use
1.

Mannitol should be administered with caution to patients with severe impairment of
renal function.

2.

The obligatory diuretic response following rapid infusion of 15% w/v or 20% w/v
Mannitol Intravenous Infusion EP may further aggrevate pre-existing
haemoconcentration.

3.

Accumulation of Mannitol may result if urine output continues to decline during
administration and this may intensify existing or latent congestive heart failure.

4.

The cardiovascular status of the patient should be carefully evaluated before rapidly
administering Mannitol Intraenous Infusion EP since sudden expansion of the

extracellular fluid may lead to sudden congestive heart failure.
5.

During Mannitol Infusion the renal function must be closely monitored.

6.

By sustaining diuresis, Mannitol administration may obscure and intensify inadequate
hydration or hypovolaemia.

7,

Shift of sodium-free intracellular fluid into the extra cellular compartment following
mannitol infusion may lower serum sodium concentration and aggrevate pre-existing
hyponatraemia.

8.

Rapid infusion may be harmful. This hypertonic solution may cause vein damage.

4.5. Interactions with other Medicinal Products and other Forms of
Interaction
Mannitol Intravenous Infusion EP should not be administered simultaneously
with, before or after an administration of blood through the same infusion
equipment.

4.6.

Pregnancy and Lactation
The safe use of Mannitol has not been established with respect to adverse
effects upon foetal development.

4.7.

Effects on Ability to Drive and Use Machines
None stated.

4.8.

Undesirable Effects
Isolated cases of pulmonary congestion, fluid and electrolyte imbalance,
acidosis, dryness of mouth, thirst, marked diuresis, urinary retention, oedema,
headache, blurred vision, convulsions, nausea, vomiting, rhinitis, arm pain,
skin necrosis, chills, dizziness, urticaria, dehydration, hypotension,
tachycardia, fever and angina-like chest pains have been reported during or
following Mannitol Infusion.

4.9.

Overdose

None stated.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Not applicable.

5.2.

Pharmacokinetic Properties
Not applicable.

5.3.

Pre-clinical Safety Data
None

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Sodium hydroxide EP QS
Water for Injection EP to 1 litre

6.2.

Incompatibilities
Check additive compatibility before use.

6.3.

Shelf-Life
24 months for pack sizes 500ml and 1000ml from the date of manufacture
providing the unit has not been opened.

6.4.

Special Precautions for Storage

Storage between 20 - 30°C.

6.5.

Nature and Contents of Container
The solution is contained in a plastic Viaflex container. It contains either
500ml, or 1000ml of sterile solution. The container is sealed into a plastic
overpouch.

6.6.

Instruction for Use, Handling and Disposal
Do not use unless solution is clear and the container is undamaged. Any
contents of the product remaining after use should be discarded.

7

MARKETING AUTHORISATION HOLDER
Baxter Healthcare Limited,
Caxton Way,
Thetford,
Norfolk,
IP24 3SE.

8

MARKETING AUTHORISATION NUMBER(S)
PL

9

00116/5054R

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
18/12/1994.

10

DATE OF REVISION OF THE TEXT
21/08/1996.

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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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