MANNITOL

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

MANNITOL

Available from:

Baxter Healthcare Limited

ATC code:

B05BC01

INN (International Name):

MANNITOL

Dosage:

15 %w/v

Pharmaceutical form:

Solution for Infusion

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

mannitol

Authorization status:

Not Marketed

Authorization date:

2010-04-09

Patient Information leaflet

1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE USER
MANNITOL 15% W/V SOLUTION FOR INFUSION
mannitol
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their
symptoms are the same as yours.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Mannitol 15% Infusion is and what it is used for
2.
What you need to know before you are given Mannitol 15% Infusion
3.
How you will be given Mannitol 15% Infusion
4.
Possible side effects
5.
How to store Mannitol 15% Infusion
6.
Contents of the pack and other information
1.
WHAT MANNITOL 15% INFUSION IS AND WHAT IT IS USED FOR
Mannitol 15% Infusion is a solution of mannitol in water.
Mannitol 15% Infusion is used to:
-
Produce an increase in your urine production (diuresis) when your
kidneys are not working properly
-
Reduce the pressure within the skull caused by an accumulation of
liquid within the brain (oedema) or
after a head injury
-
Reduce pressure in the eye (intraocular pressure)
-
Treat certain types of poisoning or drug overdose
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN MANNITOL 15% INFUSION
DO NOT RECEIVE MANNITOL 15% INFUSION
-
If you are allergic to mannitol.
-
If you have a high concentration of salts in your blood.
-
If you are severely dehydrated.
-
If your kidneys cannot produce urine.
-
If you have severe heart disease (heart failure).
-
if you have a build-up of fluid in the lungs (pulmonary oedema)
associated with heart failure
-
If you have bleeding inside the skull (active intracranial bleeding)
or if you have some type of recent,
severe head injury.
-
If you fail to respond to test dosing, which your doctor or nurse will
give you (see section 3

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mannitol 15%w/v solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Mannitol: 150 g/l
Each ml contains 150 mg mannitol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for Infusion
Clear, colourless solution, free from visible particles.
Osmolarity: 823 mOsm/l (approximately)
pH: 4.5- 7.0
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Mannitol 15% w/v solution for infusion is indicated for
use as an osmotic diuretic in the following situations:
Promotion of diuresis in the prevention and/or treatment of the
oliguric phase of acute renal failure before
irreversible oliguric renal failure becomes established.
Reduction of intracranial pressure and cerebral oedema, when the
blood-barrier is intact.
Reduction of elevated intraocular pressure when it cannot be lowered
by other means.
Promotion of elimination of renally excreted toxic substances in
poisoning.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
The choice of the specific mannitol concentration, dosage and rate of
administration depends on the age, weight and
clinical condition of the patient and concomitant therapy.
Adults and adolescents:
Acute renal failure
The general dose range for adults is 50 to 200 g mannitol (330 to 1320
ml) in a 24-hour period, with a dosage limit of
50 g mannitol (330 ml) on any one occasion. In most instances adequate
response will be achieved at a dosage of 50 to
100 g mannitol/day (330 to 660 ml). The rate of administration is
usually adjusted to maintain a urine flow of at least
30-50 ml per hour.
Only in emergency situations, the maximum infusion rate can be as high
as 200 mg/kg infused over 5 minutes (see also
test dose). After 5 minutes, the infusion rate should be readjusted to
maintain a urine flow of at least 30-50 ml per hour,
with a maximum dose of 200 g/24h.
_Use in patients with oliguria or renal impairment_
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