Mannitol Intravenous Infusion BP 20% w/v Solution for Infusion

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Mannitol

Dostopno od:

Baxter Healthcare Limited

Koda artikla:

B05BC; B05BC01

INN (mednarodno ime):

Mannitol

Odmerek:

20 percent weight/volume

Farmacevtska oblika:

Solution for infusion

Tip zastaranja:

Product subject to prescription which may be renewed (B)

Terapevtsko območje:

Solutions producing osmotic diuresis; mannitol

Status dovoljenje:

Marketed

Datum dovoljenje:

1984-06-29

Navodilo za uporabo

PACKAGE LEAFLET: INFORMATION FOR THE USER
Mannitol Intravenous Infusion EP 20% w/v
Active substance: mannitol
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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
-
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.
Throughout this leaflet Mannitol Intravenous Infusion EP 20% w/v will
be called Mannitol 20% Infusion.
WHAT IS IN
THIS LEAFLET:
1.
What Mannitol 20% Infusion is and what it is used for
2.
What you need to know before
you are given Mannitol 20% Infusion
3.
How you will be given Mannitol 20% Infusion
4.
Possible side effects
5.
How Mannitol 20% Infusion is stored
6.
Contents of the pack and other information
1.
WHAT MANNITOL 20% INFUSION IS AND WHAT IT IS USED FOR
Mannitol 20% Infusion is a solution of mannitol in water. Mannitol is
an osmotic diuretic. Osmotic diuretics
act in the kidney to make it produce more urine. This will reduce the
amount of water in your body.
Mannitol 20% Infusion is given by infusion into a vein.
Mannitol 20% Infusion is used to:
-
produce an increase in your urine production (diuresis)
when your kidneys are not working properly
(acute kidney failure). This can help prevent your kidney disease
becoming more serious.
-
reduce the pressure within the skull caused by an accumulation of
liquid within the brain (oedema). This
is sometimes necessary following an injury to the head or before brain
surgery, when the natural
protective barrier between the blood vessels in your head and your
brain is intact.
-
reduce pressure in the eye (intraocular pressure). This may be
necessary during eye surgery, or during
attacks of glaucoma (a disease that causes eye pressure to rise).
-
treat certain types of poisoning or drug overdose. Mannitol helps the
kidney to remove these substances
from the blood. They are then e

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mannitol Intravenous Infusion BP 20% w/v Solution for Infusion.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Mannitol 200 g/l
Each ml contains 200 mg Mannitol
For a full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Solution for Infusion.
Clear, colourless solution, free from visible particles.
Osmolarity: 1098 mOsm/1 (approx)
pH: 4.5 -7.0
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Mannitol 20% 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 in a 24 hour period
(250 to 1000ml/day), with a dosage limit of 50g
mannitol (250ml) on any one occasion. In most instances adequate
response will be achieved at a dosage of 50g to
100g mannitol/day (250 to 500 ml/day) .
The normal infusion rate is 30 to 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 per hour,
with a maximum dose of 200 g/24h.
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