Mannitol 5 %/000 ml Solution

Bladder irrigation during transurethral resection of the prostate in order to reduce haemolysis.

As required for irrigation. Not for intravenous administration. Not to be mixed with other products. If necessary, warm before use to dissolve crystals. Do not heat in excess of 66 u00b0C. Use administration set with a filter. For single use only. Discard unused portion. The use of aseptic technique is essential when irrigating solutions are used for the irrigation of body cavities, wound and urethral catheters. Do not use unless solution is clear, and the container is undamaged with the seal intact.

Special populations:

Cardiopulmonary and renal dysfunction
Use with caution in patients with severe cardiopulmonary or renal dysfunction. Since systemic absorption of large amounts of solution is possible in patients suffering from these conditions, cardiopulmonary or renal dysfunction may be altered substantially (see section 4.3).

Paediatric population
The safety and efficacy in children have not been established.

MANNITOL 5 % IRRIGATION SOLUTION FRESENIUS is contraindicated in patients with:

• hypersensitivity to mannitol or to any of the excipients listed in section 6.1
• pulmonary congestion or oedema
• intracranial bleeding (except during craniotomy)
• heart failure (in patients with diminished cardiac reserve, expansion of the extracellular fluid may lead to fulminating heart failure)
• metabolic oedema with abnormal capillary fragility, and
• renal failure.

MANNITOL 5 % IRRIGATION SOLUTION FRESENIUS should not be administered with whole blood.

Irrigation solutions should generally not be used in conditions in which systemic absorption may result. MANNITOL 5 % IRRIGATION SOLUTION FRESENIUS should be used with caution in patients with severe cardiopulmonary or renal dysfunction since systemic absorption of large amounts of solution may substantially alter cardiopulmonary or renal dysfunction.

All patients given MANNITOL 5 % IRRIGATION SOLUTION FRESENIUS should be carefully observed for signs of fluid and electrolyte imbalance and renal function should be monitored. Displaced catheters can lead to irritation or infiltration of unintended structures or cavities.

Irrigating fluids used during transurethral prostatectomy have been demonstrated to enter the systemic circulation in relatively large volumes. Any irrigation solution must be regarded as a systemic medicine.

CNS toxicity:
CNS toxicity manifested by, for example confusion, lethargy, coma, has been reported in patients treated with mannitol, in particular in the presence of impaired renal function. Fatal outcomes have been reported.

CNS toxicity may result from:

• high serum mannitol concentrations
• serum hyperosmolarity resulting in intracellular dehydration within the CNS
• hyponatraemia or other disturbances of electrolyte and acid/base balance secondary to mannitol administration.

At high concentrations, mannitol may cross the blood brain barrier and interfere with the ability of the brain to maintain the pH of the cerebrospinal fluid especially in the presence of acidosis.

In patients with pre-existing compromised blood brain barrier, the risk of increasing cerebral oedema (general or focal) associated with repeated or continued use of mannitol must be individually weighed against the expected benefits.

A rebound increase of intracranial pressure may occur several hours after the use of mannitol. Patients with compromised blood brain barrier are at increased risk.

Absorption of large amounts of fluids containing mannitol and the resultant osmotic diuresis may significantly affect cardiopulmonary and renal dynamics.

From a microbiological point of view, the product should be used immediately. Any unused portion should be discarded, due to the risk of bacterial growth or pyrogen formation.

MANNITOL 5 % IRRIGATION SOLUTION FRESENIUS should not be administered with whole blood.

Safety in pregnancy and lactation has not been established.

There is no information of the effects of MANNITOL 5 % IRRIGATION SOLUTION FRESENIUS on the ability to operate a vehicle or other heavy machinery.

Metabolism and nutrition disorders
Frequent: Fluid and electrolyte imbalance, circulatory overload and acidosis. The shift of fluid from the intracellular to extracellular compartment can cause tissue dehydration.

Skin and subcutaneous tissue disorders
Frequency unknown: Hypersensitivity reactions, oedema and skin necrosis.

See section 4.8. If adverse effects, overhydration, or solute overload occurs with the irrigation solution, it should be discontinued, the patient closely evaluated, and appropriate corrective therapy instituted if necessary. Treatment is symptomatic and supportive.