Mannitol 50g/500ml (10%) infusion Viaflo bags

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Mannitol

Available from:

10%) infusion Viaflo bags (Baxter Healthcare Ltd

ATC code:

B05BC01

INN (International Name):

Mannitol

Dosage:

100mg/1ml

Pharmaceutical form:

Infusion

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02020500; GTIN: 5413760216140 55413760216145

Summary of Product characteristics

OBJECT 1
MANNITOL 10% SOLUTION FOR INFUSION BP
Summary of Product Characteristics Updated 28-Mar-2017 | Baxter
Healthcare Ltd
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:
• Promotion of diuresis in the prevention and/or treatment of the
oliguric phase of acute renal failure
before irreversible renal failure becomes established.
• Reduction of intracranial pressure and cerebral oedema, when
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, 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