Mannitol 15% Baxter

LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE USER

Mannitol 15% Baxter, solution for infusion

Mannitol

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Mannitol 15% Baxter and what is it used for
• 2. Important information before using Mannitol 15% Baxter
• 3. How to use Mannitol 15% Baxter
• 4. Possible side effects
• 5. How to store Mannitol 15% Baxter
• 6. Contents of the package and other information

1. What is Mannitol 15% Baxter and what is it used for

Mannitol 15% Baxter is an aqueous solution of mannitol.
Mannitol 15% Baxter is used:

• to increase the amount of urine produced (diuresis) in patients with impaired kidney function;
• to reduce intracranial pressure caused by fluid accumulation in the brain (edema) or after a head injury;
• to reduce eye pressure (intraocular pressure);
• to treat certain types of poisoning or drug overdose.

2. Important information before using Mannitol 15% Baxter

Do not use Mannitol 15% Baxter:

• if the patient is allergic to mannitol;
• if the patient has increased salt levels in the body;
• if the patient has severe dehydration;
• if the patient's kidneys are not able to produce urine;
• if the patient has severe heart disease (heart failure);
• if the patient has excessive fluid accumulation in the lungs (pulmonary edema) associated with heart failure;
• if the patient has bleeding in the skull (active intracranial hemorrhage) or certain types of severe head injuries;
• if the patient's response to a test dose administered by a doctor or nurse is abnormal (see section 3);
• if the patient's kidneys gradually lose their function after starting mannitol administration.

In case of doubts about any of the above conditions, the patient should consult a doctor.

Warnings and precautions

Before starting treatment with Mannitol 15% Baxter, the patient should discuss it with their doctor

• if the patient has kidney disease or impaired kidney function;
• if the patient is taking medications that may be harmful to the kidneys (e.g., certain antibiotics or anticancer drugs);
• if the patient has severe dehydration (loss of water from the body, e.g., due to vomiting, diarrhea, excessive sweating, or use of certain medications). Symptoms include dry mouth and dizziness;
• if the doctor has informed the patient about low sodium levels in the blood (hyponatremia);
• if the patient is allergic to mannitol (since mannitol occurs naturally and is used in other medications, patients may be allergic without receiving intravenous mannitol treatment). The infusion must be discontinued if any signs of hypersensitivity occur, see section 4.

If control is necessary, the doctor may perform tests to confirm that the dose is correct. These tests may include:

• heart, lung, and kidney function;
• fluid intake;
• urine output;
• blood pressure in the veins that carry blood to the heart (central venous pressure);
• concentration of chemical substances in the blood and urine, such as sodium and potassium (electrolytes);
• blood and urine acidity (acid-base balance).

This solution must not be administered through the same needle as a blood transfusion. This can cause damage to red blood cells or their clumping.

Mannitol 15% Baxter and other medications

The patient should tell their doctor or nurse about all medications they are currently taking or have recently taken, as well as any medications they plan to take.
It is known that the following medications may interact with Mannitol 15% Baxter or be affected by it. The patient should inform their doctor if they are taking any of the following medications:

• diuretics (medications that increase urine production);
• cyclosporine (used to prevent transplant rejection);
• lithium (used to treat mental disorders);
• aminoglycosides (a type of antibiotic);
• depolarizing muscle relaxants (used during anesthesia and causing muscle paralysis). The administration of these medications will be controlled by an anesthesiologist;
• oral anticoagulants (blood thinners, e.g., warfarin);
• digoxin (a heart medication).

Using Mannitol 15% Baxter with food, drinks, and alcohol

The patient should ask their doctor what they can eat or drink.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or nurse before using this medication.
It is not known whether mannitol affects the unborn child or the course of pregnancy. It is also not known whether mannitol passes into breast milk. Therefore, in pregnant or breastfeeding women, the doctor will use Mannitol 15% Baxter only when clearly necessary.

Driving and using machines

Mannitol 15% Baxter does not affect the ability to drive or use machines.

3. How to use Mannitol 15% Baxter

The doctor will decide what dose to use and when to administer the medication. The doctor will make this decision based on the patient's age, weight, medical condition, and other medications the patient is taking.
Mannitol 15% Baxter is usually administered through a vein.
In patients with impaired kidney function, the doctor may administer a small amount of the solution as a test dose. Then, the amount of urine produced by the patient will be measured. If the kidneys do not produce the appropriate amount of urine in response to the test dose, the patient will receive different treatment.
Mannitol 15% Baxter can also be used in children and elderly patients (over 65 years). Depending on the needs, the doctor will adjust the dose of the medication.

DO NOT use Mannitol 15% Baxter if the solution contains visible particles or if the packaging is damaged in any way.

Using a higher dose of Mannitol 15% Baxter than recommended

If too much Mannitol 15% Baxter is used (overdose) or the medication is administered too quickly, the following symptoms may occur:

• excessive blood volume (hypervolemia). Symptoms include swelling of the hands and feet (peripheral edema), difficulty breathing (pulmonary edema and shortness of breath), fluid accumulation in the abdomen (ascites), and electrolyte imbalance;
• excessive blood acidity (acidosis);
• headache;
• feeling of nausea (nausea);
• chills;
• confusion;
• fatigue;
• seizures (convulsions);
• reduced consciousness (stupor) or loss of consciousness (coma);
• kidney failure (acute kidney failure). If the patient experiences any of these symptoms, they should immediately inform their doctor. The infusion will be discontinued, and treatment will be administered according to the symptoms.

If another medication has been added to Mannitol 15% Baxter, the patient should read the Patient Leaflet included with the added medication to learn about the list of possible symptoms.

Discontinuing Mannitol 15% Baxter

The doctor will decide when to discontinue the infusion.
If the patient has any questions about using this medication, they should consult their doctor.

4. Possible side effects

Like all medications, Mannitol 15% Baxter can cause side effects, although not everyone will experience them.
If any of the following side effects occur, the patient should immediately inform their doctor or nurse. These may be symptoms of a very severe or even life-threatening reaction (allergy) called anaphylactic shock:

• difficulty breathing;
• low blood pressure (hypotension);
• swelling of the skin on the face and throat;
• hives;
• skin rash. The treatment will depend on the symptoms.

Other side effects that may occur include:

• kidney damage, which can affect water excretion, or decrease or increase urine output;
• blood in the urine;
• heart failure;
• high blood pressure;
• rapid or irregular heartbeat (palpitations, arrhythmia);
• excessive fluid in the lungs causing shortness of breath;
• coma, seizures, feeling of fatigue (lethargy) due to damage to the central nervous system;
• swelling of the ankles, fingers, and face due to fluid retention;
• dehydration;
• increased or decreased levels of potassium and/or sodium in the blood;
• dry mouth, thirst;
• nausea, vomiting;
• malaise;
• increased blood acidity (metabolic acidosis, see section 3 "Using a higher dose of Mannitol 15% Baxter than recommended");
• chest pain;
• chills, fever;
• increased intracranial pressure (increased intracranial pressure) causing headaches, feeling of nausea (nausea), vomiting, back pain, blurred vision, and other vision changes, such as difficulty moving the eyeball (oculomotor paralysis);
• dizziness, headache;
• fatigue and weakness (asthenia);
• cramps;
• vision disturbances;
• runny nose;
• skin necrosis;
• reactions related to the infusion technique, which may include inflammation, pain, itching, rash, or redness at the infusion site or along the vein;
• leakage of the infusion solution into the tissue surrounding the vein (extravasation). This can cause burning and pain at the infusion site. In severe cases, blood flow will be reduced, and the tissue surrounding the vein will be damaged (compartment syndrome).

Reporting side effects

If the patient experiences any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the medication.

5. How to store Mannitol 15% Baxter

This product should not be stored in the refrigerator or frozen.
The medication should be stored out of sight and reach of children.
Do not remove Mannitol 15% Baxter from its outer protective packaging until use.
DO NOT use Mannitol 15% Baxter after the expiration date stated on the bag. The expiration date refers to the last day of the given month.
After opening, with or without added substances:
From a microbiological point of view, the product should be used immediately. If it is not used immediately, the user is responsible for the storage conditions before use.
Mannitol 15% Baxter should not be administered if the solution contains visible particles or if the packaging is damaged in any way.

6. Contents of the package and other information

What Mannitol 15% Baxter contains

The active substance is mannitol.
The only excipient is water for injections.
Each 1000 ml solution contains 150 grams of mannitol.

What Mannitol 15% Baxter looks like and what the package contains

Mannitol 15% Baxter is a clear solution, free from visible particles. It is available in polyolefin/polyamide plastic bags (Viaflo). Each bag is placed in a closed, protective, plastic outer packaging.
Package sizes:

• 100 ml
• 250 ml
• 500 ml

Bags are supplied in cardboard boxes. A cardboard box contains one of the following quantities:

• 50 bags of 100 ml
• 60 bags of 100 ml
• 30 bags of 250 ml
• 20 bags of 500 ml

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Baxter Polska Sp. z o.o.
ul. Kruczkowskiego 8
00-380 Warsaw
Manufacturer:
Baxter S.A.
Boulevard R. Branquart, 80
7860 Lessines
Belgium
Bieffe Medital S.A.
Ctra de Biescas-Senegüé
22666 Sabiñànigo (Huesca)
Spain
Vantive Manufacturing Limited
Moneen Road
Castlebar – County Mayo
Ireland
Date of last update of the leaflet:April 2025
Baxter and Viaflo are trademarks of Baxter International Inc.
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The following information is intended for healthcare professionals only:

Procedure and preparation

Use only when the solution is clear, free from visible particles or discoloration, and when the seal is not damaged. Administer immediately after connecting the infusion set, which contains a final filter on the line, due to the possibility of mannitol crystals precipitating.
Hypertonic mannitol solutions can cause vein damage. The osmolality of the solution should be considered.
Do not remove the bag from its outer protective packaging until use.
The inner bag ensures the sterility of the product.
Do not connect plastic containers in series. Such use could cause an air embolism caused by residual air from the first container before the fluid from the second container is administered.
The solution should be administered using a sterile and apyrogenic infusion set with a filter and using aseptic technique. The infusion equipment should be pre-filled with the solution to prevent air from entering the system.
Additional substances may be incompatible with Mannitol 15% Baxter.
Additional substances can be introduced into the solution before or during infusion through the self-sealing port for adding medication.
It is necessary to mix carefully and cautiously under aseptic conditions with each added substance. Solutions containing added substances should be used immediately, without storage.
Adding other medications or using incorrect infusion techniques can cause febrile reactions due to possible introduction of pyrogens. In case of an adverse reaction, the infusion should be discontinued immediately.

Mannitol solutions can crystallize at low temperatures. At higher concentrations, solutions have a greater tendency to crystallize. Before administration, the presence of crystals should be checked. If crystals are visible, they should be dissolved by warming the solution to 37°C, and

then gently mixing. The solution should not be heated in water or a microwave oven due to the risk of contamination or damage to the product. Before re-checking for crystals and use, cool the solution to room temperature or body temperature.
Discard after single use.
Discard any unused solution.
Do not reconnect partially used bags.

1. Opening

a.
Remove the Viaflo bag from its protective packaging immediately before use.
b.
Check the bag's integrity by squeezing it firmly. If the bag is damaged, discard the solution, as the contents may not be sterile.
c.
Check if the solution is clear and free from visible particles. If the solution is not clear or contains visible particles, discard it.

2. Preparation for administration

Use sterile materials during preparation and administration.
a.
Suspend the bag from the hanger.
b.
Remove the plastic cover from the transfer port at the bottom of the bag:

• grasp the smaller wing on the neck of the port with one hand,
• grasp the larger wing on the plug with the other hand and twist,
• the plug will come off. c. Prepare the infusion according to aseptic principles. d. Connect the infusion set. Read all the instructions provided with the infusion set regarding connection, filling, and administration of the solution.

3. Methods of adding other medications

Warning: Added medications may be incompatible (see below, section 5 "Incompatibilities with added medications").
Adding medications before administration
a.
Disinfect the medication addition port.
b.
Using a syringe with a needle from 19G (1.10 mm) to 22G (0.70 mm), insert the needle into the self-sealing medication addition port and inject.
c.
Mix the solution with the medication thoroughly. For preparations with high density, such as potassium chloride, gently tap the ports with the bag in an upright position and mix.
Warning: Do not store bags containing added medications.
Adding medications during administration
a.
Close the infusion set clamp.
b.
Disinfect the medication addition port.
c.
Using a syringe with a needle from 19G (1.10 mm) to 22G (0.70 mm), insert the needle into the self-sealing medication addition port and inject.
d.
Remove the bag from the infusion stand and/or turn it over with the ports facing up.
e.
Empty both ports by gently tapping the bag with the ports facing up.
f.
Mix the solution with the medication thoroughly.
g.
Hang the bag in its previous position, reopen the clamp, and continue the infusion.

4. Stability during use: Added substances

Before use, the chemical and physical stability of each added substance should be determined in the pH of the mannitol solution in the Viaflo bag.
From a microbiological point of view, the diluted product should be used immediately. If it is not used immediately, the user is responsible for the storage conditions before use.

5. Incompatibilities with added medications

Mannitol 15% Baxter should not be administered simultaneously, before, or after blood transfusion through the same infusion set due to the risk of pseudoagglutination.
Before adding another medication, its compatibility with the solution in the Viaflo bag should be evaluated.
The patient should read the instructions for use of the added medication.
Before adding the medication, its solubility and stability in water with a pH similar to that of the mannitol solution (4.5 to 7.0) should be checked. For example, cefepime, imipenem, cilastatin, and filgrastim are incompatible with mannitol solutions, but this list is not exhaustive.
Adding potassium or sodium chloride to Mannitol 15% Baxter may cause mannitol to precipitate.
Baxter and Viaflo are trademarks of Baxter International Inc.