MANNITOL

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

MANNITOL

Dostopno od:

Baxter Healthcare Limited

Koda artikla:

B05BC01

INN (mednarodno ime):

MANNITOL

Odmerek:

10 Per Cent

Farmacevtska oblika:

Solution for Infusion

Tip zastaranja:

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

Terapevtsko območje:

mannitol

Status dovoljenje:

Marketed

Datum dovoljenje:

2007-09-14

Navodilo za uporabo

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 10% Infusion is and what it
is used for.
2.
What do you need to know before you are
given Mannitol 10% Infusion.
3.
How you will be given Mannitol 10%
Infusion.
4.
Possible side effects.
5.
How to store Mannitol 10% Infusion.
6.
Contents of the pack and other information.
1. What Mannitol 10% Infusion is
and what it is used for
Mannitol 10% Infusion is a solution of
mannitol in water.
Mannitol 10% Infusion is used to:
•
Produce an increase in your urine
production (a diuresis), when your kidneys
are not working properly, and to reduce
the amount of water in your body.
•
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 do you need to know
before you are given Mannitol
10% Infusion
Do not receive Mannitol 10%
Infusion if you are suffering from any
of the following conditions:
•
Allergy to mannitol (which is found
naturally in some fruit and vegetables
and may be added to some cosmetics,
food-stuffs and medicines, during
manufacturing). You may have developed
sensitivity to this substance, without
1a
SA-30-01-973
PACKAGE LEAFLET: INFORMATION FOR THE USER
Mannitol 10% Solution for infusion BP
Mannitol 10% Infusion
Active substance: mannitol
This medicine is called `Mannitol 10% Solution for Infusion BP´ but
will be referred to as
`Mannitol 10% Infusion´ thr

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mannitol 10% Solution for Infusion BP
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Mannitol:
100 g/l
Each ml contains 100 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 : 549 mOsm/l (approx)
pH : 4.5 – 7.0
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Mannitol 10% Solution for infusion is indicated for use as an osmotic
diuretic in the following situations:
1.
Promotion of diuresis in the prevention and/or treatment of the
oliguric phase of acute renal failure before
irreversible renal failure becomes established.
2.
Reduction of intracranial pressure and cerebral oedema, when
blood-barrier is intact.
3. Reduction of elevated intraocular pressure when it cannot be
lowered by other means
4. 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,
clinical and biological condition of the patient and concomitant
therapy.
Adults and adolescents:
_Acute renal failure_
The general dose range is 50 to 200 g mannitol (500 ml to 2000 ml/day)
in a 24 hour period, with a dosage limit of 50 g
(500ml mannitol) on any one occasion. In most instances, adequate
response will be achieved at a dosage of 50 to 100
g mannitol/day (500 ml to 1000 ml /day).
The rate of administration is usually adjusted to maintain a urine
flow of at least 30-50 ml/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/hour,
with a maximal dose of 200 g/24h.
_Use in patients with oliguria or renal impairment_
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