Osmofundin 15% N Ecoflac Pl. solution for infusion, 10X250 ml

Information about Osmofundin 15% N infusion solution

Osmofundin 15% N is an infusion solution that contains the active ingredient mannitol.It is administered via a venous drip and is used to support kidney function by increasing urine flow, reducing pressure or fluid volume in the skull, and reducing 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 hypersensitive to mannitol, excrete unusually little urine, suffer from severe heart muscle weakness, have unregulated transfer of substances from the bloodstream into the brain tissue, have water in the lungs (pulmonary edema), are dehydrated or hyperhydrated, have unusually high concentrations of electrolytes in your body fluids and tissues, have bleeding in the cranial cavity or a blockage of the urinary tractown.

Take special care if you have had a transfusion of blood or fluid that has caused an increase in the amount of circulating blood, are passing unusually little or no urine, or have heart failure.Your doctor will monitor your heart and circulation before and during treatment, as well as the level of salts in your blood and your water and acid-base balance.

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

Application

The dosage is determined by your doctor and depends on your age, body weight and clinical condition.The usual maximum dose for an adult is 165 to 700 ml of Osmofundin 15% N per day, which is equivalent to 25 to 100 g of mannitol.Higher doses are possible if your doctor thinks it is necessary.For children and adolescents, the dosage is also determined by the doctor.

Osmofundin 15% N must not be administered through the same infusion system as blood.If you have been given more than you should, it may cause changes in the composition of your body fluids that need to be corrected.In severe cases, symptoms such as increased blood pressure, heart muscle weakness, drowsiness, confusion, impaired consciousness, nausea, vomiting, cramps, drop in blood pressure, rapid heartbeat, water in the lungs, swelling and kidney dysfunction may occur.

Side effects

Like all medicines, Osmofundin 15% N can cause side effects, although not everyone gets them.Possible side effects include sudden severe chest pain, seizures, muscle rigidity, acidosis, low blood sodium, high blood potassium, too much water in the body, allergic shock, volume overload, urinary retention, skin damage, arm pain, back pain, chills, dizziness, polyuria, nausea, vomiting, abdominal pain, pain or tenderness at the injection site, dry mouth, feeling thirsty, fever, headache, blurred vision and local allergic reactions.

Storage

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

More information

Osmofundin 15% N contains the active ingredient mannitol and the other ingredient water for injection purposes.The theoretical osmolarity is 825 mOsm/l, the titration acidity (from pH 7.4) is less than 0.2 mmol/l and the pH is between 4.5 and 7.0.The infusion solution is a clear, colorless aqueous solution available in glass bottles or polyethylene containers.

The pharmaceutical company is B. Braun Melsungen AG, Carl-Braun-Straße 1, 34212 Melsungen.The postal address is B. Braun Melsungen AG, 34209 Melsungen.The manufacturer can be either B. Braun Melsungen AG or B. Braun Medical S.A.be in Spain.