Osmofundin 15% N Ecoflac Pl. solution for infusion, 10X100 ml

Information about Osmofundin 15% N infusion solution

Osmofundin 15% N is an infusion solution that contains the active ingredient mannitol.It is used to support kidney function by increasing urine flow, reducing pressure within the skull or intraocular pressure during an acute attack of glaucoma.No prescription is required for this product.

Important notes

Osmofundin 15% N must not be used if you are allergic to mannitol, have a low urine output, have severe heart failure, have pulmonary edema, are dehydrated or hyperhydrated, have unusually high electrolyte concentrations in your body fluids, have intracranial bleeding or have a urinary tract obstruction.Take special care if you have hypervolaemia, pass unusually little or no urine, have heart failure or are taking certain other medicines.

Tell your doctor or pharmacist about all the medicines you are taking, especially ciclosporin, heart medicines such as digoxin, lithium or other diuretics.Osmofundin 15% N may distort the results of blood tests for phosphate and ethylene glycol.

Application and dosage

Osmofundin 15% N is administered via a venous drip.The dosage is determined by your doctor and depends on your age, body weight and clinical condition.The usual maximum dose for adults is 165 to 700 ml per day, which corresponds to 25 to 100 g of mannitol.Higher doses may be given if your doctor thinks it is necessary.In children, the dosage is also determined by the doctor, making sure that the kidneys are functioning well.

Osmofundin 15% N must not be administered through the same infusion system as blood.If you have had an overdose, it may cause changes in the composition of your body fluids that need to be corrected.Possible symptoms of an overdose include increased blood pressure, heart muscle weakness, drowsiness, confusion, impaired consciousness, nausea, vomiting, convulsions, drop in blood pressure, rapid heartbeat, pulmonary edema, swelling and kidney dysfunction.

Side effects

Osmofundin 15% N may cause side effects that depend on the dose, your clinical condition and your salt and water balance.Possible serious side effects include sudden severe chest pain, seizures, muscle rigidity, acidosis, low sodium, high potassium, and too much water in the body.Other possible side effects include arm pain, back pain, chills, dizziness, polyuria, nausea, vomiting, abdominal pain, injection site pain, dry mouth, thirst, fever, headache, and blurred vision.

Storage

Keep Osmofundin 15% N out of the reach of children and do not use it after the expiry date stated on the container.Store at 20°C to 30°C as crystals may form at lower temperatures.Do not use the solution if you notice cloudiness, discoloration, particles, or leaks.The medicine is intended for single use only and any unused residue should be discarded.

Ingredients and pack sizes

Osmofundin 15% N contains the active ingredient mannitol and the other ingredient water for injection purposes.The theoretical osmolarity is 825 mOsm/l and the pH is between 4.5 and 7.0.The solution is available in glass bottles of 250 ml and in polyethylene containers of 100 ml, 250 ml or 500 ml.

Manufacturer

The pharmaceutical company is B. Braun Melsungen AG, Carl-Braun-Straße 1, 34212 Melsungen.The manufacturer can also be B. Braun Medical S.A.be in Spain.