150 mg / ml Infusion solution
mannitol
What Mannitol Fresenius Kabi is and what it is used f
Mannitol increases diuresis (urine production). Mannitol Fresenius Kabi is used to reduce the pressure and swelling in the brain and the pressure in the eye by removing excess fluid. Increased diuresis is also used to treat or prevent kidney failure.
What you need to know before using Mannitol Fresenius Kabi
Do not use Mannitol Fresenius Kabi
- you are allergic to mannitol or any of the other ingredients of this medicine (listed in section 6),
- you have severe heart failure ,
- you have anuria (the body does not produce enough urine),
- you are swollen due to a condition related to small blood vessels (capillary fragility) or membrane permeability (the regulation of the cells’ fluid balance),
- you have fluid in your lungs,
- you have bleeding in the brain (except during surgery ),
- you have a condition called hyperosmolar syndrome (caused by very high blood sugar levels),
- you are severely dehydrated
Warnings and cautions
Talk to your doctor or nurse before receiving Mannitol Fresenius Kabi
- you have a kidney disease,
- you have a heart disease ( heart failure ),
- you have electrolyte imbalance (low sodium levels),
- you get blood (see section Other medicines and Mannitol Fresenius Kabi ).
Other medicines and Mannitol Fresenius Kabi
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
- Cyclosporine (used after organ transplants or to treat rheumatoid arthritis , psoriasis or kidney disease) may increase the risk of adverse effects on the kidneys.
- Tobramycin ( antibiotics ) may increase the risk of harmful effects in the ears.
- Blood transfusion . Your doctor or nurse will make sure that blood is not administered via the same infusion set as Mannitol Fresenius Kabi, as this may cause the blood to clot.
- Lithium (used to treat, for example, manic episodes in bipolar disorder ). Mannitol can reduce the effect of lithium.
- Warfarin (so-called blood-thinning drugs). Mannitol may reduce its effect.
- Digoxin (used to treat heart rhythm disorders). In some cases, mannitol may increase the risk of harmful effects of digoxin .
Pregnancy and breastfeeding
Mannitol Fresenius Kabi should not be used during pregnancy or breastfeeding.
Driving and using machines
Mannitol Fresenius Kabi has no or negligible effect on the ability to drive and use machines.
Mannitol Fresenius Kabi contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per 500 ml, ie essentially ‘sodium-free’.
How to use Mannitol Fresenius Kabi
Mannitol Fresenius Kabi will be given to you by a doctor or nurse. It will be given to you as a drip into a vein ( infusion ). Your doctor will decide the right dose for you and when and how it should be given.
If you take more Mannitol Fresenius Kabi than you should
Mannitol Fresenius Kabi will be given by healthcare professionals, so it is unlikely that you will receive a higher dose than you should.
- An overdose can lead to disturbances in blood circulation and fluid imbalance. Initial symptoms include headache, nausea, vomiting and chills.
Tell your doctor or nurse immediately if you get any of these symptoms.
If you have any further questions on the use of this product, ask your doctor or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor or nurse immediately if you experience symptoms of a severe anaphylactic reaction, such as swelling of the face, tongue, or throat, difficulty swallowing, hives, and difficulty breathing. (Rare, may affect up to 1 in 1,000 people.)
Common (may affect up to 1 in 10 people)
- Electrolyte disturbances, too much or too little fluid in the body.
- Fast heart rate.
- Low or high blood pressure .
- Thrombophlebitis (blood clot and inflammation at the injection site).
Rare (may affect up to 1 in 1,000 people)
- Snuva.
- Allergic reactions such as hives .
- Dehydration.
- Cramps, headache, dizziness, increased pressure in the brain.
- Dimsyn.
- Cardiac arrhythmias.
- Pulmonary edema (accumulation of fluid in the lungs).
- Dry mouth , nausea, vomiting.
- Kidney damage, sudden inability to urinate, acute renal failure .
- Fever, fatigue, chills, thirst, chest pain, tissue damage (due to the drug accidentally ending up outside the vein), edema (accumulation of fluid).
Very rare (may affect up to 1 in 10,000 people)
- Heart failure .
How to store Mannitol Fresenius Kabi
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiration date is the last day of the specified month.
Store in a cold place. Do not freeze.
Do not use this medicine if the solution is not clear and colorless or if the container is damaged.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is mannitol. 1 ml contains 150 mg mannitol. 500 ml contains 75 g of mannitol.
- The other ingredients are water for injections and sodium hydroxide (for pH adjustment).
What the medicine looks like and contents of the pack
Mannitol Fresenius Kabi is a solution for infusion.
It is a clear, colorless, hypertonic, sterile, and pyrogen-free solution with an osmolality of about 930 mOsm / kg of water and a pH of about 6.
It is available in the following containers and pack sizes:
Plastic container, excel:
12 x 500 ml
Freeflex (polypropylene bag):
15 x 500 ml
20 x 500 ml
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Manufacturer
Fresenius Kabi Norge AS, Halden, Norway