150 mg / ml Infusion solution
mannitol
What Mannitol Baxter Viaflo is and what it is used for
Mannitol Baxter Viaflo is a solution that contains mannitol in water.
Mannitol Baxter Viaflo is used to:
- increase the amount of urine ( diuresis en) when the kidneys are not functioning satisfactorily.
- reduce the pressure in the skull caused by fluid accumulation in the brain ( edema ) or after a head injury.
- reduce the pressure in the eyes ( intraocular pressure ).
- treat certain types of poisoning or overdoses.
Mannitol contained in Mannitol Baxter Viaflo may also be approved for the treatment of other diseases not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What you need to know before you get Mannitol Baxter Viaflo
Do not use Mannitol Baxter Viaflo
- if you are allergic to mannitol.
- if you have a high concentration of salts in your blood.
- if you are severely dehydrated.
- if your kidneys can not produce urine.
- if you have a serious heart disease ( heart failure ).
- if you have an accumulation of fluid in your lungs ( edema ) due to heart failure .
- if you have an ongoing bleeding in the skull ( intracranial haemorrhage), or if you have recently suffered a serious head injury.
- if you do not respond adequately to the test dose given to you by your doctor or nurse (see section 3).
- if your kidney function deteriorates after starting treatment with mannitol.
Talk to a doctor if you are unsure if any of the examples above apply to you.
Warnings and cautions
Talk to your doctor before receiving Mannitol Baxter Viaflo
- if you have kidney disease or severe kidney function.
- if you are taking medicines that may be harmful to your kidneys (eg certain antibiotics or cancer medicines).
- if you are severely dehydrated (loss of fluid from the body for example due to vomiting, diarrhea, heavy sweating or certain medications). Symptoms include dry mouth and dizziness.
- if your doctor has informed you that you have low sodium (a salt) in your blood ( hyponatremia ).
- if you are allergic to mannitol (mannitol is found in nature and used in other medicines and you may therefore have developed sensitivity to mannitol without having received intravenous treatment with mannitol). In case of signs of hypersensitivity, treatment must be discontinued, see section 4.
If monitoring is needed, the doctor may perform tests to ensure that dose one is adequate. These tests may include:
- how well your heart, lungs and kidneys are working
- the amount of fluid you get
- the amount of urine produced
- blood pressure in the blood vessels that transport blood back to your heart (central venous pressure)
- the amount of salt, e.g. sodium and potassium in the blood and urine ( electrolytes )
- the acidity of the blood and urine ( acid-base balance one).
This infusion solution should not be given through the same needle as a blood transfusion. It can damage the red blood cells or cause them to clot.
Other medicines and Mannitol Baxter Viaflo
Tell your doctor or nurse if you are taking, have recently taken, or might take any other medicines.
It is known that the following medicines affect or are affected by Mannitol Baxter Viaflo. Tell your doctor if you are taking any of the following medicines:
- diuretics ( diuretics that increase urine output).
- cyclosporine (a drug that reduces the risk of organ rejection after transplantation).
- lithium (antipsychotic drug).
- aminoglycoside is (a type of antibiotic ).
- neuromuscular blocking drugs (drugs used in anesthesia to bring about muscle relaxation). These are monitored by an anesthesiologist.
- oral anticoagulants (blood thinners, such as warfarin ).
- digoxin (a heart medicine).
Mannitol Baxter Viaflo with food, drink and alcohol
You should consult your doctor about what you can eat or drink.
Pregnancy and Breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or nurse for advice before taking this medicine.
It is not known if mannitol can affect your unborn baby or your pregnancy. It is also not known if mannitol can be transmitted to your baby through breast milk. Your doctor will therefore give you Mannitol Baxter Viaflo during pregnancy or breastfeeding only if necessary.
Driving and using machines
There is no information on the effects of this medicine on the ability to drive or use other heavy machinery.
You are always responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
How to get Mannitol Baxter Viaflo
Your doctor will decide what dose you need and when it should be given to you. The doctor makes the decision based on age, weight, medical condition, and other treatments that are taking place at the same time.
Mannitol Baxter Viaflo is usually given through an infusion line via a vein. If your kidneys do not work satisfactorily, your doctor may first give you a small amount of the solution as a test dose. The amount of urine produced will then be measured. If the kidneys do not produce a large amount of urine in response to the test dose, you will receive another treatment.
Mannitol Baxter Viaflo can also be used for children and the elderly (over 65 years of age). Dose one will then be adjusted as needed.
Mannitol Baxter Viaflo should NOT be given to you if there are particles in the solution or if the packaging is damaged in any way.
If you take more Mannitol Baxter Viaflo then you should
If you take more Mannitol Baxter Viaflo than you should (Over-infusion) or if given too quickly, it may cause the following symptoms:
– too much fluid in the blood circulation ( hypervolemia ). Symptoms include swelling of the arms and legs (peripheral edema ), difficulty breathing ( pulmonary edema and dyspnoea ) and fluid in the abdomen ( ascites ), imbalance of salts in the body (electrolyte disturbances)
– your blood may become too acidic ( acidosis )
– headache
– nausea
shaking
– confusion
– fatigue
– cramps
– decreased level of consciousness ( stupor ) and unconsciousness ( coma )
– renal failure ( acute renal failure ).
If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor immediately. Infusion one will be discontinued and you will receive treatment depending on the symptoms.
If a medicine has been added to Mannitol Baxter Viaflo, you should also read the package leaflet for the added medicine for information on possible symptoms.
If you stop using Mannitol Baxter Viaflo
Your doctor will decide when to stop your infusion.
If you have any further questions on the use of this product, ask your doctor.
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 notice any of the following side effects. They can be a sign of a serious or even life-threatening allergic reaction called anaphylactic shock:
- difficulty breathing
- low blood pressure ( hypotension )
- swelling of the skin of the face and neck
- hives ( urticaria )
- rash
You will be given treatment depending on the symptoms.
Other side effects that you may get include:
- kidney damage, which may cause difficulty urinating or decreased or increased urine output
- blood in the urine
- heart failure
- high blood pressure
- rapid or irregular heartbeat (palpitations, arrhythmia )
- excess fluid in the lungs that causes shortness of breath
- coma , convulsions (seizures), confusion or fatigue (weakness) due to damage to the central nervous system
- swelling of the ankles, fingers or face due to accumulation of fluid in the body
- dehydration
- increased or decreased amount of potassium and / or sodium in the blood
- dry mouth , thirst
- nausea, vomiting
- feeling sick
- increased levels of acid in the blood (metabolic acidosis , see “If you have taken too much Mannitol Baxter Viaflo” in section 3)
- chest pain
- chills, fever
- an increased pressure in the skull (increased intracranial pressure ) which causes headaches, nausea, vomiting, back pain, blurred vision and other effects on vision e.g. difficulty moving the eyes ( ocular paresis)
- dizziness, headache
- fatigue and weakness ( asthenia )
- cramps
- dimsyn
- Runny nose
- skin necrosis (superficial tissue death)
- reactions due to administration techniques may include swelling, pain, itching , rash or redness at the infusion site or along the vein.
- leakage of the infusion solution into the surrounding tissue (extravasation). This may cause swelling and pain at the injection site. In severe cases, blood flow may decrease and surrounding tissue may be damaged (compartment syndrome).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects that are not mentioned in this information. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. Postal address
How to store Mannitol Baxter Viaflo
Store in a cold place.
Keep this medicine out of the sight and reach of children.
Do not remove the outer bag from Mannitol Baxter Viaflo until shortly before use.
Do not use this medicine after the expiry date which is stated on the bag after EXP: The expiration date is the last day of the specified month.
After opening with or without additives:
From a microbiological point of view, the solution should be used immediately. If the solution is not used immediately, the shelf life of the opened product and the conditions before use are the responsibility of the user.
Mannitol Baxter Viaflo must not be given to you if there are particles in the solution or if the packaging is damaged in any way.
Contents of the pack and other information
What Mannitol Baxter Viaflo contains
The active substance is mannitol.
The other ingredient is water for injections.
1000 ml solution contains 150 g mannitol.
What the medicine looks like and contents of the pack
Mannitol Baxter Viaflo is a clear solution without visible particles. It is supplied in plastic bags made of polyolefin/polyamide (Viaflo). Each bag has a sealed, protective outer bag made of plastic.
Bag sizes:
– 100 ml
– 250 ml
– 500 ml
The bags are packed in cartons. Each carton contains one of the following numbers:
– 50 bags with 100 ml
– 60 bags with 100 ml
– 30 bags with 250 ml
– 20 bags with 500 ml
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Baxter Medical AB
Box 63
SE-164 94 Kista
Tel: + 46 (0) 8 632 64 00
Manufacturer
Bieffe Medical SA
Ctra de Biescas-Senegüé
22666 Sabiñánigo (Huesca)
Spain
Baxter SA
Boulevard R. Branquart, 80
7860 Lessines
Belgium
Baxter Healthcare SA
Moneen Road
Castlebar – County Mayo
Ireland