25 mg / ml solution for infusion, 50 mg / ml solution for infusion
glucose , sodium chloride, sodium acetate trihydrate glucose

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.

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

1. What Glucos Baxter buffered is and what it is used for

Glucos Baxter buffered is an aqueous solution containing the following substances:

  • sugar ( glucose )
  • sodium chloride
  • sodium acetate trihydrate

The infusion fluid is used in connection with surgery to supply fluid during the day of surgery and as a preventive treatment against, or treatment of, dehydration.

2. What you need to know before you get Glucos Baxter buffered

Glucos Baxter buffered should not be given:

  • if you are allergic to sodium acetate trihydrate, sodium chloride, glucose or any of the other ingredients of this medicine (listed in section 6).
  • if you have a high blood sugar level.

Warnings and cautions

Talk to your doctor or nurse before getting Glucos Baxter buffered if you have or have had any of the following conditions:

  • allergy to maize as Glucos Baxter buffered contains sugar obtained from maize, see section 4 “Possible side effects”
  • renal impairment
  • abnormally large amount of fluid in the body
  • any other condition in which the body retains too much sodium (salt), such as treatment with steroids (see also “Other drugs and Glucos Baxter buffered”)
  • disorders of blood pH
  • low levels of magnesium in the blood
  • low levels of calcium in the blood
  • head injury in the last 24 hours
  • 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 are suffering 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 “Other medicines and Glucos Baxter buffered”).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.
  • stroke due to a blood clot in the brain (ischemic stroke )
  • diabetes or impaired glucose tolerance, ie. that your blood sugar level rises a lot after you have eaten and does not go down as expected.

Your doctor will take samples for long-term treatment or if necessary to monitor:

  • fluid balance and the amount of salt ( electrolytes ) in the body
  • acidity in the blood and urine ( acid-base balance ).

Because Glucos Baxter buffered contains sugar ( glucose ), it can cause high blood sugar (hyperglycemia). It is especially important to keep in mind if you have diabetes. If you get too high blood sugar, your doctor may:

  • adjust the infusion rate
  • give you insulin to lower your blood sugar.

Children

Infusion of Glucos Baxter buffered should be given with special caution to children and should be closely monitored by a physician.

Contact a doctor or nurse immediately if your child develops headaches, nausea, seizures, lethargy, dizziness, or coma during treatment.

Other drugs and Glucos Baxter buffered

Tell your doctor or nurse if you have recently taken or might take any other medicines.

It is especially important that you tell your doctor if you are taking:

  • corticosteroids (used for inflammation )

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
  • 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 ).

Glucose Baxter buffer can affect the metabolism of certain drugs in the body, eg:

  • acetylsalicylic acid (used for pain and inflammation )
  • barbiturates (used for insomnia)
  • lithium (used for mental illness)
  • sympathomimetics , e.g. ephedrine and pseudoephedrine (used in cough medicine)
  • quinidine (for the treatment of disorders of the heart rhythm and against malaria )
  • dexamphetamine (used to treat ADHD ).

Glucos Baxter buffered with food and drink

You should ask your doctor 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. He or she will determine if you can be given Glucos Baxter buffered while you are pregnant or breastfeeding.

Driving and using machines

This medicine does not affect your ability to drive or use machines

3. How to get Glucos Baxter buffered

Glucos Baxter buffered is given to you by a doctor or nurse. Your doctor will decide how much you need and when to get it.

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

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 ).

If you get too much Glucos Baxter buffered

If you are given too much Glucos Baxter buffered (over-infused), or given too fast, the following symptoms may occur:

  • fluid retention, especially at the ankles (peripheral edema ), or in the lungs ( pulmonary edema ) due to excess water and / or sodium (salt)
  • high blood sugar ( hyperglycaemia )
  • blood becomes too acidic (hyperosmolarity)
  • increased urinary excretion ( osmotic diuresis )
  • fluid loss from the body ( dehydration )
  • abnormally low levels of potassium in the blood ( hypokalaemia ) and the blood becomes too alkaline ( metabolic alkalosis ). This can cause symptoms such as decreased bowel movements, constipation, muscle weakness and muscle cramps.

If any of these symptoms occur, tell your doctor or nurse immediately. Infusion one will be discontinued and you will receive treatment depending on the symptoms.

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

If you stop getting Glucos Baxter buffered

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.

If you have any of the following symptoms, tell your doctor or nurse immediately. They may be signs of a severe allergic reaction (occurs in an unknown number of users):

  • swelling of the face, tongue or throat
  • breathing difficulties
  • hives
  • drop in blood pressure
  • Low levels of sodium in the blood that may be caused by hospital treatment (hospitalized hyponatremia ) and related neurological condition ( 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”).

Other side effects are :

Common (may affect up to 1 in 10 people):

  • irritation or inflammation of the vein in which the solution is given ( phlebitis ). This can cause redness , pain or a burning sensation and swelling along the vein in which the solution is given.

Has been reported (occurs in an unknown number of users):

  • high levels of potassium in the blood, which can cause abnormal heart rhythm ( hyperkalemia )
  • high blood sugar levels ( hyperglycaemia )
  • burning sensation at the infusion site.

If a drug has been added to the infusion solution, this drug can also cause side effects. What these side effects depend on the drug 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 buffered

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

Do not store above 25 ° C.

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

6. Contents of the packaging and other information

Content declaration

Glucos Baxter 25 mg/ml buffered

The active substances are:

  • glucose (sugar): 25 g per liter
  • sodium chloride: 2.6 g per liter
  • sodium acetate trihydrate: 3.4 g per liter

Other ingredients are:

  • concentrated hydrochloric acid (for pH adjustment)
  • water for injections

Glucos Baxter 50 mg/ml buffered

The active substances are:

  • glucose (sugar): 50 g per liter
  • sodium chloride: 2.6 g per liter
  • sodium acetate trihydrate: 3.4 g per liter

Other ingredients are:

  • concentrated hydrochloric acid (for pH adjustment)
  • water for injections

What the medicine looks like and contents of the pack

Glucos Baxter buffered is a clear solution without visible particles.

Plastic container Clear-Flex:

500 ml

1000 ml

Plastic container Viaflo:

500 ml

1000 ml

20×500 ml

10×1000 ml

Marketing Authorization Holder and Manufacturer

Baxter Medical AB

Box 63

164 94 Kista

Manufacturer:

For products in Viaflo and Clear-Flex

Bieffe Medital SA

Ctra de Biescas-Senegüé,

22666 Sabiñánigo (Huesca)

Spain

For products in Viaflo

Baxter Healthcare Ltd

Caxton Way, Thetford,

Norfolk IP24 3SE

UK

For products in Clear-Flex

Bieffe Medital SpA

Via Nuova Provinciale,

23034 Grosotto (Sondrio)

Muhammad Nadeem

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