OSMITROL Mannitol 100g/L injection AHB3026

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

mannitol, Quantity: 100 g/L

Tilgjengelig fra:

Baxter Healthcare Pty Ltd

INN (International Name):

Mannitol

Legemiddelform:

Injection, intravenous infusion

Sammensetning:

Excipient Ingredients: sodium hydroxide; hydrochloric acid; water for injections

Administreringsrute:

Intravenous

Enheter i pakken:

1000ml x 1

Resept typen:

Not scheduled. Not considered by committee

Indikasjoner:

Osmitrol Intravenous Infusion (Mannitol Intravenous Infusion, BP) can be used in: The promotion of diuresis in the prevention and/or treatment of the oliguric phase of acute renal failure before irreversible renal failure becomes established; The reduction of intraocular pressure when the pressure cannot be lowered by other means; The reduction of intracranial pressure and treatment of cerebral oedema by reducing brain mass and; Promoting the urinary excretion of toxic substances.

Produkt oppsummering:

Visual Identification: Clean colourless solution; Container Type: Bag; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Autorisasjon status:

Registered

Autorisasjon dato:

1991-09-30

Informasjon til brukeren

CONSUMER MEDICINE INFORMATION
OSMITROL INTRAVENOUS (IV) INFUSION
(MANNITOL IV INFUSION BP)
WHAT IS IN THIS LEAFLET?
This leaflet answers some common questions about the Osmitrol
Intravenous Infusion (Mannitol IV
Infusion BP). It does not contain all of the available information.
All medicines have risks and benefits.
Your doctor has weighed the risks of you using Osmitrol Intravenous
Infusion (Mannitol IV Infusion BP)
against the benefit they expect it will have for you.
It does not take the place of talking to your doctor or pharmacist. If
you have any concerns about having
this medicine, ask your doctor or pharmacist.
WHAT OSMITROL INTRAVENOUS INFUSION (MANNITOL IV INFUSION BP) IS USED
FOR?
The main ingredient in Osmitrol Intravenous Infusion (Mannitol IV
Infusion BP) is Mannitol. Osmitrol
Intravenous Infusion is used in the prevention and/or treatment of
kidney failure before irreversible
kidney failure becomes established, by promoting the urinary excretion
of toxic substances.
BEFORE YOU ARE GIVEN THE OSMITROL INTRAVENOUS INFUSION (MANNITOL IV
INFUSION BP)
_OSMITROL INTRAVENOUS INFUSION (MANNITOL IV INFUSION BP), SHOULD NOT
BE GIVEN TO YOU IF YOU HAVE: _
_ _
•
Sensitivity to mannitol
•
Severe kidney disease
•
Severe pulmonary disease
•
Active intracranial bleeding
•
Elevated intraocular pressure
•
Severe dehydration
•
Progressive kidney damage
•
Progressive heart failure
•
The expiry date printed on the pack is overdue
_YOU MUST TELL YOUR DOCTOR IF YOU: _
•
Have kidney disease
•
Have heart disease
•
Have any other illness
•
Are taking any prescription medicine or even non-prescription
medicines
•
Are pregnant
•
Are breast feeing
HOW OSMITROL INTRAVENOUS INFUSION (MANNITOL IV INFUSION BP) IS GIVEN?
_HOW MUCH IT IS GIVEN: _
Your doctor will decide how much Osmitrol Intravenous Infusion
(Mannitol IV Infusion BP), will be given
to you, which depends on your need and condition. The medicine is a
dripped Intravenous Infusion;
therefore it should be given by using special equipment and

Preparatomtale

OSMITROL INTRAVENOUS INFUSION (Mannitol)
Version 1.1
1 of 13
AUSTRALIAN PRODUCT INFORMATION –
OSMITROL (MANNITOL) INTRAVENOUS INFUSION
1
NAME OF THE MEDICINE
Mannitol.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Osmitrol Intravenous (IV) Infusion
(Mannitol IV Infusion,) is a sterile, nonpyrogenic solution
of Mannitol, in a single dose container for intravenous
administration.
IT CONTAINS NO
ANTIMICROBIAL AGENTS.
Mannitol is a six carbon sugar alcohol prepared commercially by the
reduction of glucose. Although virtually inert metabolically in
humans, it occurs naturally in
fruits and vegetables. Mannitol is an obligatory osmotic diuretic. The
pH is adjusted with
sodium hydroxide and hydrochloric acid. Composition, osmolality and pH
are shown in
Table 1.
TABLE 1: OSMITROL IV INFUSION PREPARATIONS
SIZE
COMPOSITION
(MANNITOL)
*OSMOLALITY
MOSMOL/KG
PH
10% Osmitrol (Mannitol)
IV Infusion
1000 mL
100 g/1000mL
596
5.5
(4.5 to 7.0)
20% Osmitrol (Mannitol)
IV Infusion
500 mL
100 g/500mL
1192
5.0
(4.5 to 7.0)
*An injection with an osmolality within the range of 250 to 350
mOsm/kg is considered to be isotonic.
Administration of substantially hypertonic solutions may cause vein
damage.
For the full list of excipients, see section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Solution for Intravenous Infusion.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Osmitrol IV Infusion can be used in:
•
the promotion of diuresis, in the prevention and/or treatment of the
oliguric phase of acute
renal failure before irreversible renal failure becomes established;
•
the reduction of elevated intraocular pressure when the pressure
cannot be lowered by other
means;
•
the reduction of intracranial pressure and treatment of cerebral
oedema by reducing brain
mass;
•
promoting the urinary excretion of toxic substances.
OSMITROL INTRAVENOUS INFUSION (Mannitol)
Version 1.1
2 of 13
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
Osmitrol (IV) Infusion should be administered only by intravenous
Infusion. The total dosage,
concentration,