Injectio glucosi 5 % + natrii chlorati 0,9 % 2:1 viaflo

Package leaflet: Information for the user

Injectio Glucosi 5 % + Natrii Chlorati 0,9 % 2:1 Viaflo
Infusion solution
Active substances: sodium chloride, glucose.
Please read all of this leaflet carefully before the medicine is administered, as it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:

1. What Injectio Glucosi 5 % + Natrii Chlorati 0,9 % 2:1 Viaflo is and what it is used for

2. Important information before administration of 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 pack and other information

7. What Injectio Glucosi 5 % + Natrii Chlorati 0,9 % 2:1 Viaflo is and what it is used for

Injectio Glucosi 5 % + Natrii Chlorati 0,9 % 2:1 Viaflo is a solution containing the following substances in water:

• sugar (glucose);
• sodium chloride (salt). Glucose is one of the body's sources of energy. This infusion solution provides 132 kilocalories per litre. Sodium and chlorides are chemical substances present 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 body water (dehydration) and chemical substances (e.g. due to excessive sweating, kidney diseases);
• to treat low blood volume in blood vessels (hypovolemia).

2. Important information before administration of Injectio Glucosi 5 % + Natrii Chlorati 0,9 % 2:1 Viaflo

DO NOT use Injectio Glucosi 5 % + Natrii Chlorati 0,9 % 2:1 Viaflo if the patient has any of the following conditions:

• hypersensitivity to the medicine;
• excess fluid in the spaces around body cells (extracellular overhydration);
• blood volume in blood vessels is higher than normal (hypervolemia);
• excess fluid and sodium in the body (fluid and sodium retention);
• severe kidney function disorders resulting in too little urine being produced or no urine at all (oliguria or anuria);
• uncompensated heart failure. This is heart failure that is not adequately treated and causes symptoms such as:
• shortness of breath;
• swelling around the ankles;
• blood sodium concentration lower than normal (hyponatremia);
• blood chloride concentration lower than normal (hypochloremia);
• accumulation of fluid under the skin throughout the body (generalized edema);
• liver disease causing accumulation of fluid in the abdominal cavity (liver cirrhosis with ascites);
• poorly controlled diabetes with blood sugar levels above normal (uncompensated diabetes);
• other conditions involving glucose intolerance, such as:
• metabolic stress (when metabolism in the body does not function properly, e.g. due to severe illness);
• hyperosmolar coma (unconscious state). This is a type of coma that may occur in patients with diabetes who are not receiving adequate medication;
• very high blood sugar levels (significant hyperglycemia);
• higher than normal blood lactate levels (hyperlactatemia).

Warnings and precautions
Tell your doctor if the patient has or has had any of the following conditions:

• conditions associated with sodium retention, overhydration and edema, such as:
• aldosteronism (a disease causing high levels of a hormone called aldosterone) associated with:
• high blood pressure (hypertension);
• heart failure;
• liver dysfunction or liver disease causing accumulation of fluid in the abdominal cavity (liver cirrhosis with ascites);
• kidney function disorders;
• increased 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 causing blood to become too alkaline (metabolic alkalosis);
• muscle weakness and periodic paralysis due to low thyroid activity (thyrotoxic periodic paralysis);
• rapid loss of body water, e.g. due to vomiting or diarrhea;
• long-term low-potassium diet;
• allergies, especially to corn (Injectio Glucosi 5 % + Natrii Chlorati 0,9 % 2:1 Viaflo contains sugar derived from corn);
• a condition that may cause high levels of vasopressin, a hormone regulating fluid levels in the body. Excess vasopressin in the body may be caused, for example, by:
• sudden and serious illness;
• pain;
• surgery;
• infections, burns, brain disease;
• diseases related to the heart, liver, kidneys or central nervous system;
• taking certain medicines (see also section "Injectio Glucosi 5 % + Natrii Chlorati 0,9 % 2:1 Viaflo and other medicines"). This may increase the risk of low blood sodium levels and cause headache, nausea, seizures, drowsiness, coma, brain edema and death. Brain edema increases the risk of death and brain damage. Patients at higher risk of brain edema include:
• children;
• women (especially of childbearing age);
• patients with problems related to cerebrospinal fluid levels, for example due to meningitis, intracranial hemorrhage or brain injury.

Infusion may cause:

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

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

• levels of chemical substances such as sodium and chlorides in the blood (plasma electrolytes);
• glucose (sugar) levels.

Because Injectio Glucosi 5 % + Natrii Chlorati 0,9 % 2:1 Viaflo contains sugar (glucose), it may cause increased blood glucose levels (hyperglycemia). In such cases, the doctor may:

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

This is particularly important:

• in patients with diabetes;
• in malnourished patients or those who have consumed large amounts of alcohol over a long period;
• if the patient has recently had a stroke (acute ischemic stroke). High blood glucose levels may worsen stroke outcomes and impair recovery;
• in patients with head injury within the last 24 hours.

The doctor will consider parenteral nutrition (nutrition delivered intravenously). During prolonged treatment with Injectio Glucosi 5 % + Natrii Chlorati 0,9 % 2:1 Viaflo, additional nutritional support may be necessary. The doctor should also monitor blood potassium levels to prevent them from falling below normal (hypokalemia).

Children
Extreme caution must be exercised when administering this solution to children, infants and newborns (especially premature infants or those with low birth weight). The bodies of children, infants and newborns may not be able to handle the substances contained in the solution. Younger children are more susceptible to abnormally low or high blood glucose levels and therefore require close monitoring during treatment to ensure proper glucose control. Low blood glucose in newborns may cause prolonged seizures, coma and brain damage. High blood glucose is associated with brain hemorrhage, bacterial and fungal infections, eye damage (retinopathy of prematurity), gastrointestinal infections, lung disorders, prolonged hospital stay and death. Children are at greater risk of developing low blood sodium levels (hyponatremia). Hyponatremia may cause headache, nausea, seizures, drowsiness, coma, brain edema and death. Acute encephalopathy with hyponatremia is a serious complication, particularly in children. The doctor is aware of this and will monitor levels of chemical substances such as glucose (sugar), sodium and chlorides in the child's blood (plasma electrolytes).

Injectio Glucosi 5 % + Natrii Chlorati 0,9 % 2:1 Viaflo and other medicines
Tell your 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 inform the doctor about the use of:

• corticosteroids (anti-inflammatory medicines).

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

• antidiabetic medicines (chlorpropamide);
• cholesterol-lowering medicines (clofibrate);
• certain anticancer medicines (vincristine, ifosfamide, cyclophosphamide);
• selective serotonin reuptake inhibitors (used to treat depression);
• antipsychotics or opioids used to relieve severe pain;
• painkillers and/or anti-inflammatory medicines (also known as NSAIDs);
• medicines that mimic or enhance the effect of vasopressin, such as desmopressin (used to treat excessive thirst and urine output), terlipressin (used to treat esophageal bleeding) and oxytocin (used to induce labour);
• antiepileptic medicines (carbamazepine and oxcarbazepine);
• diuretics (water tablets).

Other medicines that may interact with or be affected by Injectio Glucosi 5 % + Natrii Chlorati 0,9 % 2:1 Viaflo:

• lithium (used to treat psychiatric disorders);
• insulin (used to treat diabetes);
• beta-blockers (used in heart diseases).

Using Injectio Glucosi 5 % + Natrii Chlorati 0,9 % 2:1 Viaflo with food, drink and alcohol
Ask your doctor what the patient may eat or drink.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, thinks she may be pregnant or is planning to have a child, she should consult her doctor or nurse before using this medicine.
Injectio Glucosi 5 % + Natrii Chlorati 0,9 % 2:1 Viaflo may be used during breastfeeding.
Before adding any medicine to the infusion solution used during pregnancy or breastfeeding, you must:

• consult your doctor;
• read the Package Leaflet of the medicine to be added.

Driving and using machines
Injectio Glucosi 5 % + Natrii Chlorati 0,9 % 2:1 Viaflo has no effect on the ability to drive or operate machinery.

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 the dose and timing of administration. This depends on the patient's age, body weight, clinical condition and the reason for treatment. The amount of medicine given 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 container is damaged in any way.
The infusion solution Injectio Glucosi 5 % + Natrii Chlorati 0,9 % 2:1 Viaflo is usually administered through a plastic tube connected to a needle placed in a vein. Typically, the solution is administered into a vein in the arm. However, the doctor may use another method of administration for the patient.
Before and during infusion, the doctor will monitor:

• fluid levels in the body;
• blood and urine acidity;
• electrolyte levels in the body (especially sodium, in patients with high vasopressin levels 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.
Administration of a higher than recommended dose of Injectio Glucosi 5 % + Natrii Chlorati 0,9 % 2:1 Viaflo
If too large an amount of Injectio Glucosi 5 % + Natrii Chlorati 0,9 % 2:1 Viaflo is administered (overdose) or if it is administered too rapidly, the following symptoms may occur:

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

If any of these symptoms occur, inform the doctor immediately. 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 overdose symptoms occurred, that medicine may also be responsible for these symptoms. Read the Package Leaflet of the added medicine to review the list of possible side effects.
Stopping treatment with Injectio Glucosi 5 % + Natrii Chlorati 0,9 % 2:1 Viaflo
The doctor will decide when to stop the infusion.
If you have any further questions about the use of this medicine, ask your doctor or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Adverse effects may be related to the medicine itself, Injectio Glucosi 5% + Natrii Chlorati 0,9% 2:1 Viaflo. These include:

• hypersensitivity reactions, including severe allergic reactions known as anaphylaxis (potential symptoms in patients allergic to corn);
• high blood sugar levels (hyperglycaemia);
• low blood sodium levels, which may be associated with hospital treatment (hospital-acquired hyponatraemia) and related neurological disorders (acute hyponatraemic encephalopathy). Hyponatraemia may lead to irreversible brain damage and death due to cerebral oedema (see also section 2 "Warnings and precautions").

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

• fever (pyrogenic 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 may cause redness, pain, swelling or blisters along the course of the vein.

If another medicine has been added to the infusion solution, it may also cause adverse effects. These adverse effects will depend on the added medicine. Please read the package leaflet of the added medicine to become familiar with the list of possible symptoms.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or nurse. If any adverse effect occurs, the infusion must be stopped immediately.
Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to gather more information on the safety of the medicine.

5. How to store the medicinal product Injectio Glucosi 5% + Natrii Chlorati 0,9% 2:1 Viaflo

Keep this medicine out of the sight and reach of children.
No special storage conditions are required for the medicinal product Injectio Glucosi 5% + Natrii Chlorati 0,9% 2:1 Viaflo.
DO NOT use the medicinal product Injectio Glucosi 5% + Natrii Chlorati 0,9% 2:1 Viaflo after the expiry date stated on the bag under "Expiry date". The expiry date refers to the last day of the stated month.
Do not use the medicinal product Injectio Glucosi 5% + Natrii Chlorati 0,9% 2:1 Viaflo if it contains visible particles or if the container is damaged in any way.

6. Contents of the pack and other information

What Injectio Glucosi 5% + Natrii Chlorati 0,9% 2:1 Viaflo contains
The active substances are:

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

The only excipient is water for injections.

What Injectio Glucosi 5% + Natrii Chlorati 0,9% 2:1 Viaflo looks like and contents of the pack
Injectio Glucosi 5% + Natrii Chlorati 0,9% 2:1 Viaflo is a clear, particle-free solution. It is available in polyolefin/poliamide plastic bags (Viaflo).
Each bag is enclosed in a sealed protective outer plastic packaging.

Bag sizes:

• 250 ml
• 500 ml
• 1000 ml

The bags are supplied in cardboard boxes. Each 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 Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Baxter Polska Sp. z o.o.
ul. Kruczkowskiego 8
00-380 Warszawa
Poland

Manufacturers:
Baxter SA
Boulevard René Branquart, 80
7860 Lessines
Belgium
Bieffe Medital S.A.
Ctra de Biescas, Senegüé
22666 Sabiñanigo (Huesca)
Spain

Baxter and Viaflo are trademarks of Baxter International Inc.

Information intended exclusively for medical professionals:

Handling and Preparation
Use only if the solution is clear, free from visible particles, and the container is undamaged.
Administer immediately after connecting the infusion set.
Do not remove the bag from its outer protective packaging until ready for use.
The inner bag ensures product sterility.
Do not connect plastic containers in series. Such use could result in air embolism due to residual air being drawn from the first container before completion of infusion from the second container.
Applying additional pressure to intravenous solutions contained in flexible plastic containers in order to increase the flow rate may cause air embolism if all residual air has not been completely removed from the container prior to administration.
The use of vented intravenous administration sets with the air vent in the open position may lead to air embolism. Vented intravenous administration sets with the air vent open must not be used with flexible plastic containers.
The solution should be administered using sterile equipment and aseptic techniques. The infusion set must be pre-filled with the solution to prevent introduction of air into the system.
Additional medications may be added to the solution before or during infusion via the medication addition port.
When administering another drug, tonicity should be confirmed prior to parenteral administration.

• From a physico-chemical standpoint, the solution containing added medications should be used immediately unless physical and chemical stability during use has been established.
• From a microbiological standpoint, the solution containing added medications should be used immediately. If not used immediately, the responsibility for storage time and conditions lies with the user, and storage should generally not exceed 24 hours at 2 to 8°C, unless the addition of drugs was performed under controlled and validated aseptic conditions.

Discard after single use.
Discard any unused portion of the solution.
Do not re-enter partially used bags.

1. Opening

a. Remove the Viaflo bag from its protective packaging immediately before use.
b. Squeeze the inner bag firmly to check for leakage. If leakage is detected, discard the solution as it may not be sterile.
c. Check whether the solution is clear and free from insoluble particles. If the solution is not clear or contains insoluble particles, discard it.

2. Preparation for Administration

Use sterile materials during preparation and administration.
a. Hang the bag by the hanger loop.
b. Remove the plastic cover from the administration port located 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 cap with the other hand and twist;
• The cap will pop off.
  c. Prepare the infusion according to aseptic principles.
  d. Connect the administration set. Refer to all instructions provided with the set regarding connection, priming, and administration of the solution.

3. Methods of Adding Medications

Note: Added medications may be incompatible (see section 5 below, "Incompatibilities with added drugs").
Adding medications prior to administration
a. Disinfect the medication addition site.
b. Using a syringe with a 19G (1.10 mm) to 22G (0.70 mm) needle, insert the needle into the self-sealing medication addition port and inject the medication.
c. Mix the solution thoroughly with the medication. For high-density medications such as potassium chloride, gently tap the ports with the bag held upright (ports up) and mix well.
Note: Storage of bags containing added medications — see section 4, "Stability during use".
Adding medications during administration
a. Close the clamp on the administration set.
b. Disinfect the medication addition site.
c. Using a syringe with a 19G (1.10 mm) to 22G (0.70 mm) needle, insert the needle into the self-sealing medication addition port and inject the medication.
d. Remove the bag from the pole and (or) invert it with ports facing upward.
e. Empty both ports by gently tapping them while the bag is held with ports facing upward.
f. Mix the solution thoroughly with the medication.
g. Rehang the bag in its original position, reopen the clamp, and continue administration.

4. Stability During Use: Added Medications

Prior to use, the chemical and physical stability of each added medication must be established in the pH of the Injectio Glucosi 5% + Natrii Chlorati 0,9% 2:1 Viaflo solution within the Viaflo container.
From a physico-chemical standpoint, the solution containing added medications should be used immediately, unless physical and chemical stability during use has been established.
From a microbiological standpoint, the diluted product should be used immediately. If not used immediately, the responsibility for storage time and conditions lies with the user, and storage should generally not exceed 24 hours at 2 to 8°C, unless the solution was prepared under controlled and validated aseptic conditions.

5. Incompatibilities with Added Medications

As with all parenteral solutions, compatibility of any added medications with the solution in Viaflo-type bags must always be verified prior to addition.
The physician is responsible for assessing incompatibilities of added medications with Injectio Glucosi 5% + Natrii Chlorati 0,9% 2:1 Viaflo by checking for possible changes in color and/or formation of precipitate, insoluble complexes, or crystals. Refer to the instructions for use of the added medication.
Prior to adding a medication, its solubility and stability in water at the pH of Injectio Glucosi 5% + Natrii Chlorati 0,9% 2:1 Viaflo (pH 3.5–6.5) should be verified.
After adding a compatible medication to Injectio Glucosi 5% + Natrii Chlorati 0,9% 2:1 Viaflo, the solution should be administered immediately, unless chemical and physical stability during use has been established.
For example, the following medications are incompatible with Injectio Glucosi 5% + Natrii Chlorati 0,9% 2:1 Viaflo (list is not exhaustive ):

• sodium ampicillin
• 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 lead to hemolysis and agglutination. Do not use medications known to be incompatible.

Baxter and Viaflo are trademarks of Baxter International Inc.