INJECTIO 33 g/l + 3 g/l Solution

Contents of the leaflet

1. Leaflet accompanying the packaging: Information for the user
2. Injectio Glucosi 5% + Natrii Chlorati 0.9% 2:1 Viaflo
3. Solution for infusion
   1. Read the leaflet carefully before administering the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
4. What is Injectio Glucosi 5% + Natrii Chlorati 0.9% 2:1 Viaflo and what is it used for
5. Important information before administering Injectio Glucosi 5% + Natrii Chlorati 0.9% 2:1 Viaflo
   1. DO NOT administer Injectio Glucosi 5% + Natrii Chlorati 0.9% 2:1 Viaflo if the patient has any of the following conditions:
   2. Warnings and precautions
   3. Children
   4. Injectio Glucosi 5% + Natrii Chlorati 0.9% 2:1 Viaflo and other medicines
   5. Using Injectio Glucosi 5% + Natrii Chlorati 0.9% 2:1 Viaflo with food, drink, and alcohol
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
6. How Injectio Glucosi 5% + Natrii Chlorati 0.9% 2:1 Viaflo will be administered
   1. DO NOT administer Injectio Glucosi 5% + Natrii Chlorati 0.9% 2:1 Viaflo if it contains visible particles or if the packaging is damaged in any way.
   2. Using more than the recommended dose of Injectio Glucosi 5% + Natrii Chlorati 0.9% 2:1 Viaflo
   3. Stopping Injectio Glucosi 5% + Natrii Chlorati 0.9% 2:1 Viaflo
7. Possible side effects
   1. Reporting side effects
8. How to store Injectio Glucosi 5% + Natrii Chlorati 0.9% 2:1 Viaflo
9. Contents of the packaging and other information
   1. What Injectio Glucosi 5% + Natrii Chlorati 0.9% 2:1 Viaflo contains
   2. What Injectio Glucosi 5% + Natrii Chlorati 0.9% 2:1 Viaflo looks like and what the packaging contains
   3. Marketing authorization holder and manufacturer
   4. Information intended for healthcare professionals only:
   5. Procedure and preparation
10. Opening
11. Preparation for administration
12. Methods of adding additional medicines
13. Shelf life during use: Added medicines
14. Incompatibilities with added medicines

Leaflet accompanying the packaging: Information for the user

Injectio Glucosi 5% + Natrii Chlorati 0.9% 2:1 Viaflo

Solution for infusion

Active substances: sodium chloride, glucose.

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult a doctor or nurse.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, tell the doctor or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Injectio Glucosi 5% + Natrii Chlorati 0.9% 2:1 Viaflo and what is it used for
• 2. Important information before administering Injectio Glucosi 5% + Natrii Chlorati 0.9% 2:1 Viaflo
• 3. How Injectio Glucosi 5% + Natrii Chlorati 0.9% 2:1 Viaflo will be administered
• 4. Possible side effects
• 5. How to store Injectio Glucosi 5% + Natrii Chlorati 0.9% 2:1 Viaflo
• 6. Contents of the packaging and other information

1. What is Injectio Glucosi 5% + Natrii Chlorati 0.9% 2:1 Viaflo and what is it used for

Injectio Glucosi 5% + Natrii Chlorati 0.9% 2:1 Viaflo is a solution of the following substances in water:

• sugar (glucose);
• sodium chloride (salt). Glucose is one of the energy sources for the body. This infusion solution provides 132 kilocalories per liter. Sodium and chlorides are chemical substances found in the blood.

Injectio Glucosi 5% + Natrii Chlorati 0.9% 2:1 Viaflo is used:

• as a source of carbohydrates (sugar);
• to treat loss of water from the body (dehydration) and chemical compounds (e.g., due to excessive sweating, kidney disease);
• to treat too little blood volume in the blood vessels (hypovolemia).

2. Important information before administering Injectio Glucosi 5% + Natrii Chlorati 0.9% 2:1 Viaflo

DO NOT administer Injectio Glucosi 5% + Natrii Chlorati 0.9% 2:1 Viaflo if the patient has any of the following conditions:

• allergy to the medicine;
• too much fluid in the spaces around the body's cells (extracellular overhydration);
• blood volume in the blood vessels is greater than it should be (hypervolemia);
• there is more fluid and sodium in the body than normal (fluid and sodium retention);
• severe kidney function disorders, resulting in too little urine being produced or no urine being produced at all (oliguria or anuria);
• uncontrolled heart failure. This is heart failure that is not being properly treated and causes symptoms such as:
• shortness of breath;
• swelling of the ankles;
• sodium levels in the blood lower than normal (hyponatremia);
• chloride levels in the blood lower than normal (hypochloremia);
• fluid accumulation under the skin all over the body (generalized edema);
• liver disease causing fluid accumulation in the abdominal cavity (liver cirrhosis with ascites);
• poorly controlled diabetes, with blood sugar levels above normal (uncontrolled diabetes);
• other conditions of glucose intolerance, such as:
• metabolic stress (when the body's metabolism does not work properly, e.g., due to severe illness);
• hyperosmolar coma (a state of unconsciousness). This is a type of coma that can occur in diabetic patients who do not receive enough medication;
• very high blood sugar levels (significant hyperglycemia);
• higher than normal levels of lactate in the blood (hyperlactatemia).

Warnings and precautions

Tell the doctor if the patient has or has had any of the following conditions:

• conditions related to sodium retention, overhydration, and edema, such as:
• aldosteronism (a disease that causes high levels of the hormone aldosterone) associated with:
• high blood pressure (hypertension);
• heart failure;
• liver disease causing fluid accumulation in the abdominal cavity (liver cirrhosis with ascites);
• kidney function disorders;
• high blood pressure during pregnancy (pre-eclampsia);
• taking other medicines, see below "Injectio Glucosi 5% + Natrii Chlorati 0.9% 2:1 Viaflo and other medicines";
• a condition in which the blood becomes too alkaline (metabolic alkalosis);
• muscle weakness and periodic paralysis due to low thyroid activity (thyrotoxic periodic paralysis);
• rapid loss of water from the body, e.g., due to vomiting or diarrhea;
• a low-potassium diet for a long time;
• allergy, especially to corn (Injectio Glucosi 5% + Natrii Chlorati 0.9% 2:1 Viaflo contains sugar derived from corn);
• a condition that can cause high levels of vasopressin, a hormone that regulates the amount of fluid in the body. Too high a level of vasopressin in the body can be caused, for example:
• -sudden and severe illness;
• -pain;
• -surgery;
• -infections, burns, brain disease;
• -heart, liver, kidney, or central nervous system diseases;
• -taking certain medications (see also the section "Injectio Glucosi 5% + Natrii Chlorati 0.9% 2:1 Viaflo and other medicines"). This may increase the risk of low sodium levels in the blood and cause headache, nausea, seizures, drowsiness, coma, brain swelling, and death. Brain swelling increases the risk of death and brain damage. Patients at higher risk of brain swelling are:
• -children;
• -women (especially of childbearing age);
• -patients with problems with cerebrospinal fluid levels, e.g., due to meningitis, intracranial hemorrhage, or brain damage.

Infusion may cause:

• changes in the levels of chemical substances in the blood (electrolyte disturbances);
• fluid accumulation under the skin, all over the body (generalized edema), around the ankles (local edema), or in the lungs (pulmonary edema).

During administration of this infusion, the doctor will take blood and urine samples to examine:

• the amount of chemical substances, such as sodium and chlorides, in the blood (electrolytes in serum);
• the amount of sugar (glucose).

Because Injectio Glucosi 5% + Natrii Chlorati 0.9% 2:1 Viaflo contains sugar (glucose), it may cause an increase in blood sugar levels (hyperglycemia). In this situation, the doctor may:

• adjust the infusion rate;
• administer insulin to reduce blood sugar levels.

This is especially important:

• in diabetic patients;
• in patients who are malnourished or have been drinking large amounts of alcohol for a long time;
• if the patient has recently had a stroke (acute ischemic stroke). High blood sugar levels can worsen the effects of the stroke and disrupt the recovery process;
• in the case of a head injury within the last 24 hours.

The doctor will consider the use of parenteral nutrition (nutrition administered in the form of an intravenous infusion). During long-term therapy with Injectio Glucosi 5% + Natrii Chlorati 0.9% 2:1 Viaflo, additional nutrition may be necessary. The doctor should also monitor the potassium levels in the blood to prevent them from dropping below normal (hypokalemia).

Children

Particular caution should be exercised when using this solution in children, infants, and newborns (especially premature or low-birth-weight children). The bodies of children, infants, and newborns may not be able to cope with the substances contained in the solution. Younger children are more prone to developing too low or too high blood sugar levels and should be closely monitored during treatment to ensure proper blood sugar control. Low blood sugar levels in newborns can cause prolonged seizures, coma, and brain damage. High blood sugar levels are associated with brain hemorrhages, bacterial and fungal infections, vision damage (retinopathy of prematurity), gastrointestinal infections, lung disorders, prolonged hospital stay, and death. Children are at higher risk of developing low sodium levels in the blood (hyponatremia). Hyponatremia can cause headache, nausea, seizures, drowsiness, coma, brain swelling, and death. Acute encephalopathy with hyponatremia is a serious complication, especially in children. The doctor is aware of this and will monitor the levels of chemical substances, such as glucose (sugar), sodium, and chlorides, in the child's blood (electrolytes in serum).

Injectio Glucosi 5% + Natrii Chlorati 0.9% 2:1 Viaflo and other medicines

Tell the doctor or nurse about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. It is especially important to tell the doctor about:

• corticosteroids (anti-inflammatory medicines).

These medicines can cause sodium and water to accumulate in the body, leading to swelling of the tissue due to fluid accumulation under the skin (edema) or increased blood pressure (hypertension). Some medicines can affect the level of the vasopressin hormone. These include:

• -antidiabetic medicines (chlorpropamide)
• -cholesterol-lowering medicines (clofibrate)
• -some anticancer medicines (vincristine, ifosfamide, cyclophosphamide)
• -selective serotonin reuptake inhibitors (used to treat depression)
• -antipsychotic or opioid medicines used to relieve severe pain
• -pain-relieving and/or anti-inflammatory medicines (also known as NSAIDs)
• -medicines that mimic or enhance the action of vasopressin, such as desmopressin (used to treat increased thirst and urine production), terlipressin (used to treat bleeding from the esophagus), and oxytocin (used to induce labor)
• -antiepileptic medicines (carbamazepine and oxcarbazepine)
• -diuretics (diuretics).

Other medicines that may interact with or be affected by Injectio Glucosi 5% + Natrii Chlorati 0.9% 2:1 Viaflo:

• lithium (used to treat mental illnesses);
• insulin (used to treat diabetes);
• beta-blockers (used to treat heart conditions).

Using Injectio Glucosi 5% + Natrii Chlorati 0.9% 2:1 Viaflo with food, drink, and alcohol

Ask the doctor what the patient can eat or drink.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or nurse before using this medicine. Injectio Glucosi 5% + Natrii Chlorati 0.9% 2:1 Viaflo can be used during breastfeeding. Before adding any medicine to the infusion solution used during pregnancy or breastfeeding, the patient should:

• consult a doctor;
• read the leaflet accompanying the packaging of the medicine to be added.

Driving and using machines

Injectio Glucosi 5% + Natrii Chlorati 0.9% 2:1 Viaflo does not affect the ability to drive or use machines.

3. How Injectio Glucosi 5% + Natrii Chlorati 0.9% 2:1 Viaflo will be administered

Injectio Glucosi 5% + Natrii Chlorati 0.9% 2:1 Viaflo is administered by a doctor or nurse. The doctor will decide what dose of the medicine to use and when to administer it. This depends on the patient's age, weight, clinical condition, and reason for treatment. The amount of medicine administered may also depend on other medicines the patient is taking.

DO NOT administer Injectio Glucosi 5% + Natrii Chlorati 0.9% 2:1 Viaflo if it contains visible particles or if the packaging is damaged in any way.

The Injectio Glucosi 5% + Natrii Chlorati 0.9% 2:1 Viaflo infusion solution is usually administered through a plastic tube connected to a needle inserted into a vein. Typically, the solution is administered into a vein in the arm. However, the doctor may use a different method to administer the medicine to the patient. Before and during the infusion, the doctor will monitor:

• the amount of fluid in the body;
• the acidity of the blood and urine;
• the levels of electrolytes in the body (especially sodium, in patients with high levels of vasopressin or taking other medicines that increase the effect of vasopressin).

Any unused solution should be discarded. DO NOT administer Injectio Glucosi 5% + Natrii Chlorati 0.9% 2:1 Viaflo from a partially used bag.

Using more than the recommended dose of Injectio Glucosi 5% + Natrii Chlorati 0.9% 2:1 Viaflo

If too much Injectio Glucosi 5% + Natrii Chlorati 0.9% 2:1 Viaflo is administered (overdose) or administered too quickly, the following symptoms may occur:

• increased blood sugar levels (hyperglycemia). Symptoms include:
• dry mouth due to lack of water in the body tissues (dehydration);
• thirst;
• frequent urination due to increased urine production (osmotic diuresis);
• blurred vision;
• fatigue;
• low sodium levels in the blood (hyponatremia). Hyponatremia can cause headache, nausea, seizures, drowsiness, coma, brain swelling, and death;
• fluid accumulation in the body causing swelling (edema).

If the patient experiences any of these symptoms, they should immediately inform the doctor. The infusion will be stopped, and the doctor will provide treatment depending on the symptoms. If another medicine was added to Injectio Glucosi 5% + Natrii Chlorati 0.9% 2:1 Viaflo before the overdose symptoms occurred, it may also be the cause of these symptoms. The patient should read the leaflet accompanying the packaging of the added medicine to learn about the possible symptoms.

Stopping Injectio Glucosi 5% + Natrii Chlorati 0.9% 2:1 Viaflo

The doctor will decide when to stop the infusion. If the patient has any further doubts about using this medicine, they should consult a doctor or nurse.

4. Possible side effects

Like all medicines, Injectio Glucosi 5% + Natrii Chlorati 0.9% 2:1 Viaflo can cause side effects, although not everybody gets them. Side effects may be related to the medicine itself, Injectio Glucosi 5% + Natrii Chlorati 0.9% 2:1 Viaflo. These include:

• allergic reactions, including severe allergic reactions known as anaphylaxis (potential symptoms in patients allergic to corn);
• high blood sugar levels (hyperglycemia);
• low sodium levels in the blood, which may be related to hospital treatment (hospital hyponatremia) and associated neurological disorders (acute hyponatremic encephalopathy). Hyponatremia can lead to irreversible brain damage and death due to brain swelling (see also section 2 "Warnings and precautions").

Side effects may be related to the administration technique. These include:

• fever (febrile reaction);
• chills;
• itching (pruritus) or rash;
• local pain or reaction (pain or blisters at the infusion site);
• irritation and inflammation of the vein into which the solution is administered. This can cause redness, pain, swelling, or blisters along the vein into which the solution is administered.

If another medicine was added to the infusion solution, it may also cause side effects. These side effects will depend on the added medicine. The patient should read the leaflet accompanying the packaging of the added medicine to learn about the possible symptoms.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell the doctor or nurse. If any side effect occurs, the infusion must be stopped. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +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 medicine.

5. How to store Injectio Glucosi 5% + Natrii Chlorati 0.9% 2:1 Viaflo

Store the medicine out of sight and reach of children. Injectio Glucosi 5% + Natrii Chlorati 0.9% 2:1 Viaflo does not require special storage conditions. DO NOT use Injectio Glucosi 5% + Natrii Chlorati 0.9% 2:1 Viaflo after the expiry date stated on the bag, after "Expiry date". The expiry date refers to the last day of the given month. DO NOT use Injectio Glucosi 5% + Natrii Chlorati 0.9% 2:1 Viaflo if it contains visible particles or if the packaging is damaged in any way.

6. Contents of the packaging and other information

What Injectio Glucosi 5% + Natrii Chlorati 0.9% 2:1 Viaflo contains

The active substances of the medicine are:

• sugar (glucose): 33 g per liter
• sodium chloride: 3 g per liter

The only excipient is water for injections.

What Injectio Glucosi 5% + Natrii Chlorati 0.9% 2:1 Viaflo looks like and what the packaging contains

Injectio Glucosi 5% + Natrii Chlorati 0.9% 2:1 Viaflo 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, outer plastic packaging. The bag sizes are:

• 250 ml
• 500 ml
• 1000 ml

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

• 30 bags of 250 ml
• 20 bags of 500 ml
• 10 bags of 1000 ml
• 12 bags of 1000 ml

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder: Baxter Polska Sp. z o.o., ul. Kruczkowskiego 8, 00-380 Warsaw. Manufacturers: Baxter SA, Boulevard René Branquart, 80, 7860 Lessines, Belgium; Bieffe Medital S.A., Ctra de Biescas, Senegüé, 22666 Sabiñanigo (Huesca), Spain. Date of last revision of the leaflet:October 2023. Baxter and Viaflo are trademarks of Baxter International Inc.

Information intended for healthcare professionals only:

Procedure and preparation

Use only if the solution is clear and free from visible particles and the container is not damaged. Administer immediately after connecting the infusion set. Do not remove the bag from the 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 drawn in from the first container before the fluid from the second container is completely administered. Applying additional pressure on intravenous solutions in flexible plastic containers to increase the flow rate may cause an air embolism if the container is not completely emptied of air before administration. The use of intravenous administration sets with air vents, with the air vent valve in the open position, may cause an air embolism. Do not use intravenous administration sets with air vents, with the air vent valve in the open position, with flexible plastic containers. The solution should be administered using sterile equipment and following aseptic principles. The infusion set should be pre-filled with the solution to prevent air from entering the system. Additional medicines can be introduced into the solution before or during infusion, through the self-sealing port for adding medicines. When using another medicine, its tonicity should be confirmed before parenteral administration.

• From a physico-chemical point of view, the solution containing additional medicines should be used immediately, unless its physical and chemical stability has been established during use.
• From a microbiological point of view, the diluted product should be used immediately. If the solution is not used immediately, the user is responsible for the storage time and conditions, and the storage time should not exceed 24 hours at a temperature of 2 to 8°C, unless the solution was prepared in controlled and validated aseptic conditions.

Discard after single use. Discard any unused solution. Do not reconnect partially used bags.

1. Opening

a. Remove the Viaflo bag from the protective packaging immediately before use. b. By squeezing the inner bag tightly, check for leakage. If leakage is found, the solution must be discarded as it may not be sterile. c. Check if the solution is clear and free from visible particles. If the solution is not clear and contains visible particles, it must be discarded.

2. Preparation for administration

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

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

3. Methods of adding additional medicines

Warning: Added medicines may be incompatible (see below, section 5 "Incompatibilities with added medicines").Adding medicines before administrationa. Disinfect the site intended for adding the medicine. b. Using a syringe with a 19G (1.10 mm) to 22G (0.70 mm) needle, insert the needle into the self-sealing port for adding medicines and inject the medicine. c. Mix the solution with the medicine thoroughly. For medicines with high density, such as potassium chloride, gently tap the ports with the bag in an upright position and mix. Warning:storage of bags containing added medicines, see section 4 "Shelf life during use". Adding medicines during administrationa. Close the infusion set clamp. b. Disinfect the site intended for adding the medicine. c. Using a syringe with a 19G (1.10 mm) to 22G (0.70 mm) needle, insert the needle into the self-sealing port for adding medicines and inject the medicine. d. Remove the bag from the hanger and/or turn it upside down. e. Empty both ports by gently tapping the bag in an upright position. f. Mix the solution with the medicine thoroughly. g. Hang the bag in its previous position, reopen the clamp, and continue the infusion.

4. Shelf life during use: Added medicines

Before use, the chemical and physical stability of each added medicine should be established in the pH of the Injectio Glucosi 5% + Natrii Chlorati 0.9% 2:1 Viaflo solution in the Viaflo container. From a physico-chemical point of view, the solution containing additional medicines should be used immediately, unless its physical and chemical stability has been established during use. From a microbiological point of view, the diluted product should be used immediately. If the solution is not used immediately, the user is responsible for the storage time and conditions, and the storage time should not exceed 24 hours at a temperature of 2 to 8°C, unless the solution was prepared in controlled and validated aseptic conditions.

5. Incompatibilities with added medicines

As with all solutions for parenteral administration, the compatibility of added medicines with the solution in the Viaflo bag should always be checked before addition. The doctor is responsible for assessing the incompatibility of added medicines with Injectio Glucosi 5% + Natrii Chlorati 0.9% 2:1 Viaflo after checking for any change in color and/or the appearance of a precipitate, insoluble complexes, or crystals. Read the instructions for the added medicine. Before adding a medicine, its solubility and stability in water at the pH of the Injectio Glucosi 5% + Natrii Chlorati 0.9% 2:1 Viaflo solution (pH 3.5–6.5) should be checked. After adding a compatible medicine to Injectio Glucosi 5% + Natrii Chlorati 0.9% 2:1 Viaflo, the solution should be administered immediately, unless its chemical and physical stability has been established during use. For example, the following medicines are incompatible with Injectio Glucosi 5% + Natrii Chlorati 0.9% 2:1 Viaflo (the list is not exhaustive):

• ampicillin sodium
• mitomycin
• erythromycin lactobionate
• human insulin Due to the presence of glucose, Injectio Glucosi 5% + Natrii Chlorati 0.9% 2:1 Viaflo should not be administered through the same infusion set as whole blood, as this may cause hemolysis and agglutination. Medicines known to be incompatible should not be used.

Baxter and Viaflo are trademarks of Baxter International Inc.