Infusion Solution

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.

– If you have any further questions, ask your doctor or nurse.

– If you get any side effects, talk to your doctor or nurse. This also applies to any side effects not mentioned in this information. See section 4.

This medicine is called Glucos Baxter Viaflo 50 mg/ml solution for infusion, but the rest of this leaflet will be called Glucos Baxter Viaflo.

In this leaflet you will find information about:
1. What Glucos Baxter Viaflo is and what it is used for
2. What you need to know before you get Glucos Baxter Viaflo
3. How to get Glucos Baxter Viaflo
4. Possible side effects
5. How to take Glucos Baxter Viaflo must be stored
6. Contents of the packaging and other information

What Glucos Baxter Viaflo is and what it is used for

  • Glucose Baxter Viaflo is a solution that contains sugar ( glucose ) in water.

Glucose is one of the body’s energy sources. This infusion solution provides 200 kilocalories per liter.

Glucos Baxter Viaflo is used:

  • as a source of fluid and carbohydrate ( glucose )
  • to dilute or administer other drugs that can be given as an infusion .

What you need to know before you get Glucos Baxter Viaflo

You can NOT get Glucos Baxter Viaflo if you have any of the following conditions

  • insufficiently treated diabetes , then your blood sugar level may rise above the normal (uncompensated diabetes )
  • some form of glucose intolerance, eg:
    • when the body’s metabolism does not function properly, e.g. due to serious illness (metabolic effects).
    • unconsciousness (hyperosmolar coma ). This is a type of coma that can occur if you have diabetes and do not receive adequate treatment.
    • higher than normal blood sugar level ( hyperglycaemia ).
    • abnormally high levels of lactic acid in the blood (hyperlactataemia).
    • intolerance (hypersensitivity) to glucose . It can occur in patients with allergies to corn.

If another medicine is added to your infusion solution, always read the package leaflet for that medicine. That way, you can check if that medicine is safe for you to use.

Warnings and cautions

Tell your doctor if you have or have had any of the following conditions.

  • fluid accumulation in the body (water poisoning).
  • diabetes or high levels of sugar in your blood ( hyperglycaemia ).
  • your kidneys are not working properly.
  • blood poisoning, trauma or shock .
  • low levels of salts ( sodium , potassium , phosphorus or magnesium ) in the blood.
  • head injury in the last 24 hours
  • stroke ( acute ischemic stroke ). High levels of sugar in your blood can aggravate the effects of a stroke and affect recovery.
  • disturbances in your metabolism due to starvation or because your diet does not contain the right composition of necessary nutrients (malnutrition).
  • low levels of thiamine ( vitamin B1) in your body. It can occur if you suffer from chronic alcoholism.
  • allergy to maize (Glucos Baxter Viaflo contains sugar made from maize).
  • if you have a disease that causes high levels of vasopressin , a hormone that regulates fluid levels in the body. You may have too much vasopressin in your body, e.g. if:- you had an acute and serious illness- you suffer from pain- you had surgery- you have infection , burn, brain disease- you have a disease that is linked to the heart, liver, kidneys or central nervous system- because you are taking certain medicines (see also below “Other medicines and Glucos Baxter Viaflo”).

This can increase the risk of low sodium levels in the blood and can lead to headaches, nausea, seizures, listlessness, coma, swelling of the brain, and death. Swelling of the brain increases the risk of death and brain damage. The following people are at higher risk of developing swelling of the brain:

  • children
  • women (especially of childbearing potential )
  • people who have problems with fluid levels in the brain, e.g. due to meningitis , cerebral haemorrhage or brain damage.

Your doctor will take blood and urine samples when the infusion is given to monitoring:

  • the amount of salt e.g. potassium in your blood (plasma electrolytes)
  • amount of sugar ( glucose )
  • the amount of fluid in your body (your fluid balance)
  • the acidity of your blood and urine (changes in acid-base balance one)

Because Glucos Baxter Viaflo contains sugar ( glucose ), it can cause high blood sugar. If this happens, your doctor may:

  • adjust the infusion rate
  • give you insulin to lower your blood sugar
  • give you extra potassium , if necessary

Glucose Baxter Viaflo should not be given through the same needle as a blood transfusion. It can damage the red blood cells or cause them to clot.

Your doctor will consider if you are already receiving nutrition as an infusion (nutrition given in a tube into a vein). During long-term treatment with Glucos Baxter Viaflo, you may need extra nutrition.

Children

Infusion of Glucos Baxter Viaflo should be given with special caution to children.

Children should receive Glucos Baxter Viaflo by a doctor or nurse. The amount should be determined by a doctor who specializes in the care of children. It depends on the child’s age, weight, and condition. If Glucos Baxter Viaflo is used to administer or dilute other medicines, or if other medicines are given at the same time, this may also affect dose one.

When infusing to children, the child’s doctor will take blood and urine samples to monitor the number of salts such as potassium in the blood (plasma electrolytes).

Newborns, especially those born prematurely and with low birth weight, have an increased risk of getting too low or too high a level of blood sugar (hypo- or hyperglycaemia ) and therefore need close monitoring during treatment with intravenous glucose-containing solutions to ensure adequate control of sugar levels and thus avoid any permanent damage. Low sugar levels in the newborn can cause prolonged seizures, coma, and brain damage. High sugar levels have been associated with cerebral hemorrhage, bacterial and fungal infection, eye damage (prematurity retinopathy), intestinal wall inflammation ( necrotizing enterocolitis), lung problems (bronchopulmonary dysplasia), prolonged hospital stay, and death.

When administered to a newborn baby, the infusion bag can be connected to an infusion pump, which enables the exact supply of the required amount of solution during the intended time interval. A doctor or nurse will monitor the pump for safe administration.

Children (including neonates and older children) who will Glucose Baxter Viaflo are at greater risk of low sodium levels in the blood (hypo-osmotic hyponatremia ) and a disease that affects the brain due to low levels of sodium in the plasma (hyponatremic encephalopathy ).

Other medicines and Glucos Baxter Viaflo

Tell your doctor or nurse if you have recently taken or might take any other medicines. Glucos Baxter Viaflo and other medicines taken at the same time can affect each other. You should not receive an infusion of Glucos Baxter Viaflo with certain hormones ( catecholamines ) including adrenaline or steroids, as they may increase your blood sugar levels.

Some medicines affect the hormone et vasopressin and may include:

  • diabetes medication (chloropropamide)
  • cholesterol drugs (clofibrate)
  • certain cancer drugs (vincristine, ifosfamide, cyclophosphamide)
  • selective serotonin reuptake inhibitors (used to treat depression)
  • antipsychotics or opioids (used to treat severe pain)
  • drugs that relieve pain and / or inflammation (non-steroidal anti-inflammatory drugs ( NSAIDs ))
  • drugs that mimic or enhance the effect of vasopressin such as desmopressin (used to treat increased thirst and urination), terlipressin (used to treat esophageal bleeding) and oxytocin (used to initiate labor)
  • antiepileptics (carbamazepine and oxcarbazepine)
  • diuretics ( diuretics ).

Glucos Baxter Viaflo with food and drink

You should consult your doctor about what you can eat or drink.

Pregnancy, breastfeeding and fertility

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.

Pregnancy

Glucos Baxter Viaflo can be used during pregnancy. Caution should be exercised when using glucose solutions during childbirth.

Fertility

There is insufficient information on the effect of Glucos Baxter Viaflo on fertility. No effect on fertility is expected.

Breast-feeding

There is insufficient information on the use of Glucos Baxter Viaflo during breastfeeding. However, no effect is expected during breastfeeding. Glucos Baxter Viaflo can be used during breastfeeding.

If another medicine is added to Glucos Baxter Viaflo, you should:

  • consult a doctor
  • read the package leaflet for the medicine to be added.

Driving and using machines

Ask your doctor or nurse for advice before driving or using machines.

You are 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.

3. How to get Glucos Baxter Viaflo

Glucos Baxter Viaflo is given to you by a doctor or nurse. Your doctor will decide how much you need and when to get it. This depends on your age, weight, general condition, the purpose of treatment, and whether the infusion solution is used to give or dilute another medicine. The amount given can also be affected by other concomitant treatments.

Glucos Baxter Viaflo should NOT be given to you if there are particles in the solution or if the packaging is damaged in any way.

Glucos Baxter Viaflo is usually given through a plastic tube with a needle into a vein. Usually, a vein is used in the arm to give one infusion, but your doctor may use another method to give you the medicine.

Glucose Baxter Viaflo should be given slowly to prevent the body from producing too much urine ( osmotic diuresis ).

Before and during infusion one, your doctor should check:

  • the amount of fluid in the body
  • the acidity of the blood and urine
  • the amount of electrolyte is in the body (especially sodium levels in patients with high vasopressin levels , or in patients using drugs that enhance the effect of vasopressin ).

Any remaining solution must be discarded. An infusion of Glucos Baxter Viaflo should NOT be given from a bag that is partially used.

If you take more Glucos Baxter Viaflo than you should:

If you take too much Glucos Baxter Viaflo (over-infusion) or if given too fast, it may cause the following symptoms:

  • accumulation of fluid that can cause swelling ( edema ) or water poisoning with lower than normal sodium levels in the blood ( hyponatremia )
  • increased urinary excretion ( osmotic diuresis )
  • blood becomes too concentrated (hyperosmolarity)
  • fluid loss from the body (dehydration)
  • high blood sugar ( hyperglycaemia )
  • sugar in the urine (hyperglucosuria)

If you get any of these side effects, talk to your doctor immediately. Infusion one will be discontinued and you will receive treatment depending on the symptoms.

If a medicine has been added to Glucos Baxter Viaflo and an overdose occurs, this medicine may also cause symptoms. You can read about any symptoms in the package leaflet for the added medicine.

If you stop taking Glucos 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 or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects that can occur are:

  • hypersensitivity reaction , including a severe allergic reaction called anaphylaxis (possible symptoms in patients with corn allergy ).
  • changes in blood salt concentrations (disturbance of electrolyte balance).
  • higher than normal blood sugar ( hyperglycaemia ).
  • fluid loss in the body (dehydration).
  • too much fluid in the blood vessels ( hypervolemia ).
  • increased urinary excretion ( polyuria ).
  • low levels of sodium in the blood that may be caused by hospital treatment (hospitalized hyponatremia ) and related neurological disease ( acute hyponatremic encephalopathy ). Hyponatremia can lead to permanent brain damage and death due to swelling of the brain (cerebral edema ) (see also section 2 “Warnings and precautions”).
  • reactions that may be caused by the administration technique:
    • infusion site reactions:
      • Irritation along the vein in which the solution is given, e.g. redness , pain, burning sensation and swelling.
      • Local pain or irritation ( redness or swelling at the infusion site).
      • Fever (fever reaction).
      • Infection at the infusion site.
      • Leakage of the infusion fluid to surrounding tissue (extravasation). This can damage tissue and cause scarring.
      • A blood clot ( venous thrombosis ) forms at the infusion site and causes pain, swelling or redness in the area of ​​the clot.

If a drug has been added to the infusion solution, the added drug can also cause side effects. What these side effects depend on the medicine that has been added. You can read about any symptoms in the package leaflet for the added medicine.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.

5. How to store Glucos Baxter Viaflo

Keep this medicine out of the sight and reach of children.

50 ml and 100 ml bags: Do not store above 30 ° C.

250 ml, 500 ml, and 1,000 ml bags: No special storage instructions.

Do not use this medicine after the expiry date which is stated on the sachet. The expiration date is the last day of the specified month.

Glucos Baxter Viaflo must not be given if there are particles in the solution or if the packaging is damaged in any way.

6. Contents of the packaging and other information

Content declaration

  • The active substance is sugar ( glucose ) 50 g / l.

The only other ingredients are water for injections.

What the medicine looks like and the contents of the pack

Gluco’s 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:

  • 50 ml
  • 100 ml
  • 250 ml
  • 500 ml
  • 1000 ml

The bags are packed in cartons. Each carton contains one of the following numbers:

  • 50 bags with 50 ml per carton
  • 75 bags with 50 ml per carton
  • 1 bag with 50 ml
  • 50 bags with 100 ml per carton
  • 60 bags with 100 ml per carton
  • 1 bag with 100 ml
  • 30 bags with 250 ml per carton
  • 1 bag with 250 ml
  • 20 bags of 500 ml per carton
  • 1 bag with 500 ml
  • 10 bags with 1000 ml per carton
  • 1 bag with 1000 ml

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Baxter Healthcare LtdCaxton WayThetfordNorfolkIP24 3SEUnited Kingdom Baxter SABoulevard René Branquart, 807860 LessinesBelgium
Baxter Healthcare SAMoneen RoadCastlebarCounty MayoIreland Bieffe Medital SACtra de Biescas-Senegüé22666 Sabiñánigo (Huesca)Spain
Bieffe Medital SPAVia Nuovo Proviencale23034 Grosotto (SO)Italy

Muhammad Nadeem

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