Mannitol 50g/250ml (20%) infusion Viaflex bags

Country: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

Virkt innihaldsefni:

Mannitol

Fáanlegur frá:

20%) infusion Viaflex bags (Baxter Healthcare Ltd

ATC númer:

B05BC01

INN (Alþjóðlegt nafn):

Mannitol

Skammtar:

200mg/1ml

Lyfjaform:

Infusion

Stjórnsýsluleið:

Intravenous

Tegund:

No Controlled Drug Status

Gerð lyfseðils:

Valid as a prescribable product

Vörulýsing:

BNF: 02020500; GTIN: 5413760020235

Vara einkenni

OBJECT 1
MANNITOL INTRAVENOUS INFUSION EP 20% W/V
Summary of Product Characteristics Updated 02-Aug-2016 | Baxter
Healthcare Ltd
1. Name of the medicinal product
Mannitol Intravenous Infusion EP 20% w/v
2. Qualitative and quantitative composition
Mannitol EP 200.00gm
3. 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 Contraindications
1. Well-established anuria due to seve