Active substances: glucose, sodium chloride, sodium acetate trihydrate, potassium chloride, magnesium chloride hexahydrate
What Glucose-Na-K Baxter 100 mg / ml is and what it is used for
Glucose -Na-K Baxter 100 mg/ml in an aqueous solution of the following substances:
- sugar ( glucose )
- sodium chloride
- sodium acetate trihydrate
- potassium chloride
- magnesium chloride hexahydrate
Glucose is one of the body’s energy sources. This infusion solution provides 400 kilocalories per liter. Sodium, potassium, magnesium, chloride, and acetate are chemical substances found in the blood.
Glucose -Na-K Baxter 100 mg/ml is used to add fluids and chemicals and to provide carbohydrates (sugar) if you cannot eat or drink normally.
What you need to know before you get Glucose-Na-K Baxter 100 mg / ml
Glucose-Na-K Baxter 100 mg / ml should NOT be given if you have any of the following conditions
- abnormally high levels of potassium in the blood ( hyperkalaemia )
- severe kidney problems (impaired renal function) with a decrease in the amount of urine excreted ( oliguria ) or no urine excretion at all ( anuria )
- impaired cardiac or pulmonary function (untreated or insufficiently treated cardiac or pulmonary failure)
- inadequately treated diabetes , which means that your blood sugar level can rise above normal
- any condition in which the body cannot utilize glucose (glucose intolerance).
- 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 levels ( hyperglycaemia )
- abnormally high levels of lactate in the blood (hyperlactataemia).
- if you are allergic to potassium chloride, sodium acetate trihydrate, sodium chloride, magnesium chloride hexahydrate, glucose or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Tell your doctor if you have or have had any of the following conditions
- allergy to maize as Glucose -Na-K Baxter 100 mg / ml contains sugar obtained from maize, see section ‘Possible side effects’
- heart failure , severe heart failure or other heart disease
- lung disease (lung weight)
- renal failure or renal impairment
- large amount of fluid in the body or fluid accumulation in the lungs or under the skin, especially when fluid accumulates under the skin, especially at the ankles
- high blood pressure
- high blood pressure during pregnancy ( preeclampsia or eclampsia )
- a disease that causes high levels of the hormone et aldosterone (aldosteronism)
- any other condition due to the body retaining too much sodium , such as treatment with steroids (see also “Other medicines and Glucose -Na-K Baxter 100 mg / ml”)
- any condition that makes you likely to have high levels of potassium in your blood, such as:
- kidney failure
- adrenal disease (adrenal insufficiency).
- rapid loss of fluid from the body e.g. due to vomiting or diarrhea
- severe burns or anything else that causes extensive tissue damage
- low levels of calcium in the blood
- a disease that causes gradually increasing muscle weakness ( myasthenia gravis )
- recently undergone surgery where you have received nerve and muscle blocking drugs (neuromuscular blocking) that are used in surgical procedures under the supervision of an anesthesiologist
- disorders of blood pH
- head injury during the last 24 hours – Glucose -Na-K Baxter 100 mg / ml should not be used
- high pressure in the skull
- stroke due to a blood clot in the brain (ischemic stroke )
- malnourished, or if you have been starving or eating very poorly for some time
- diabetes or impaired glucose tolerance
- if you have problems with the fluid level in the brain, e.g. due to meningitis , skull bleeding or brain damage
- if you have a disease that causes high levels of vasopressin , a hormone that regulates fluid levels in the body, such as:
- an acute and serious illness
- you have had surgery
- disease of the brain
- you are taking certain medicines.This can increase the risk of low sodium levels in the blood and can lead to headaches, nausea, seizures, fatigue, coma and swelling of the brain.
Your doctor will take blood and urine samples when the infusion is given to monitoring:
- fluid balance and the amount of chemical substances such as sodium , potassium and magnesium in the blood and urine ( plasma and urine electrolytes)
- acidity in the blood and urine ( acid-base balance )
Because Glucose -Na-K Baxter 100 mg/ml contains sugar ( glucose ), it may cause high blood sugar (hyperglycemia). This is especially important if you are diabetic.
If this happens, your doctor may:
- adjust the infusion rate
- give you insulin to lower your blood sugar
If long-term treatment with Glucose -Na-K Baxter 100 mg/ml is required, your doctor will also give you other types of infusion. These will cover the body’s needs for other chemical substances and nutrients.
Children
Infusion of Glucose -Na-K 100 mg/ml should be given with special caution to children and they should be closely monitored.
Newborns, especially those born prematurely and with low birth weight, have an increased risk of getting too low or too high a level of sugar in the blood when infusing glucose solutions. Low levels of sugar in newborns can cause prolonged seizures, coma, and brain damage. High levels of sugar have been associated with bleeding in the brain, late onset of bacterial and fungal infections, infection of the intestinal tract, effects on the eyes, lung problems, prolonged hospital stays, and deaths.
Children should be closely monitored. When normal regulation of the water content of the blood is disturbed due to increased secretion of antidiuretic hormone ( ADH ), infusion of fluid with a low concentration of sodium chloride can cause low levels of sodium in the blood ( hyponatremia ). It can lead to headaches, nausea, seizures, lethargy, coma, swelling of the brain, and death, therefore these symptoms are considered medical emergencies.
Other medicines and Glucose-Na-K Baxter 100 mg / ml
Tell your doctor or nurse if you have recently taken or might take any other medicines.
The use of the following medicines is not recommended when you receive Glucose -Na-K Baxter 100 mg/ml:
- neuromuscular blocking drugs (eg tubocurarine, suxamethonone and vecuron) which are used in surgery and under the supervision of an anesthetist.
Other drugs that can affect or be affected by Glucose -Na-K Baxter 100 mg/ml:
- anti-inflammatory drugs ( corticosteroids )
- anti-inflammatory drug to treat stomach ulcers (carbenoxolone)
- certain diuretics called potassium-sparing diuretics (eg amiloride, spironolactone , triamterene)
- ACE inhibitor (used to treat high blood pressure )
- angiotensin II receptor antagonists (used to treat high blood pressure )
- tacrolimus (used to prevent rejection of transplanted tissue and to treat certain skin conditions)
- ciclosporin (used to prevent transplantation of transplanted tissue )
- acidic drugs, eg:
- salicylate (used to treat inflammation ) ( acetylsalicylic acid )
- barbiturate (sleeping pills)
- lithium (used to treat mental illness)
- alkaline (basic) drugs, eg:
- sympathomimetic drugs (eg ephedrine and pseudoephedrine used in cough medicine)
- stimulant drugs (eg quinidine , dexamphetamine sulphate ( ADHD treatment) and fenfluramine hydrochloride (obesity treatment)).
Some medicines may increase the risk of side effects due to low levels of sodium in the blood. These medicines include:
- diuretics ( diuretics )
- medicines for pain and / or inflammation (also called non-steroidal anti-inflammatory drugs ( NSAIDs ))
- antipsychotics
- drugs to treat depression (selective serotonin reuptake inhibitors)
- drugs with morphine-like effects ( opioids )
- certain medicines for epilepsy ( antiepileptics )
- a hormone called oxytocin (causes the uterus to contract)
- certain anti-cancer drugs ( chemotherapy ).
Glucose-Na-K Baxter 100 mg / ml 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 for advice before taking this medicine. He or she will determine if you can be given Glucose -Na-K Baxter 100 mg/ml when you are pregnant or breastfeeding.
Driving and using machines
This medicine does not affect your ability to drive or use machines.
How to give Glucose-Na-K Baxter 100 mg / ml
Glucose -Na-K Baxter 100 mg/ml 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 and your general condition as well as other concomitant treatment. Your doctor can check the levels of salts ( electrolytes ) and sugar ( glucose ) in your blood.
Glucose -Na-K Baxter 100 mg/ml should NOT be given to you if there are particles in the solution or if the packaging is damaged in any way.
Glucose -Na-K Baxter 100 mg/ml is usually given to you through a plastic tube with a needle inserted 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.
Glucose -Na-K Baxter 100 mg/ml must NOT be given under the skin ( subcutaneously ).
The remaining solution must be discarded. An infusion of Glucose -Na-K Baxter 100 mg/ml should NOT be given to you from a partially used bag.
As the solution contains glucose, it should NOT be given through the same infusion equipment as whole blood ( blood transfusion ). It can damage the red blood cells or cause them to clot.
If you take more Glucose-Na-K Baxter 100 mg / ml than you should
If you get too much Glucose -Na-K Baxter 100 mg/ml (over-infusion), or if it is given too fast, the following symptoms may occur:
- excess water and / or sodium (salt) with fluid accumulation in the tissues ( edema ) that causes swelling
- high blood sugar ( hyperglycaemia )
- sugar in the urine ( glucosuria )
- stinging sensation in arms and legs ( paresthesia )
- muscle weakness
- inability to move (paralysis)
- irregular heartbeat ( cardiac arrhythmia )
- heart block (very slow pulse )
- cardiac arrest (heart stops beating; this is a life-threatening situation)
- confusion
- changed mood
- fatigue
- shortness of breath
- stiffness in muscles
- muscle twitching
- muscle spasms ( tetani )
- elevated levels of magnesium in the blood
If any of these symptoms occur, tell your doctor immediately. Infusion one will be discontinued and you will receive treatment depending on the symptoms.
If a medicine has been added to Glucose -Na-K Baxter 100 mg/ml and an overdose occur, this medicine may also cause symptoms. You can read about any symptoms in the package leaflet for the added medicine.
If you stop taking Glucose-Na-K Baxter 100 mg / ml
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.
The frequency of side effects can not be calculated from the available data (no known frequency).
If you have any of the following symptoms, tell your doctor or nurse immediately. They can be a sign of a serious or even life-threatening allergic (hypersensitivity) reaction.
- swelling of the skin of the face, lips and neck
- breathing difficulties
- rash
- redness ( erythema )
- Hypersensitivity reactions , including a severe allergic reaction called anaphylaxis , are possible symptoms in patients with corn allergy
Treatment will be given depending on the symptoms.
Other side effects are:
- side effects are caused by the method used to give the solution:
- fever
- infection at the infusion site
- local pain or reaction ( redness or swelling) at the infusion site
- 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
- a blood clot ( venous thrombosis ) is formed, sometimes followed by an inflammation . It causes pain, swelling or redness .
- leakage of infusion fluid into surrounding tissue (extravasation).
- high levels of potassium in the blood which can cause abnormal heart rhythm ( hyperkalemia )
- high blood sugar levels ( hyperglycaemia )
- accumulation of fluid in the body ( hypervolemia )
- disturbances of blood salt concentrations (electrolyte disturbances)
- cramps (seizures)
- low sodium levels in the blood ( hyponatremia )
- swelling of the brain which can cause brain damage (hyponatremic encephalopathy ).
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 Glucose-Na-K Baxter 100 mg / ml
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.
Glucose -Na-K Baxter 100 mg/ml must not be given to you 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 substances are:
- Glucose: 100 g per liter
- Sodium chloride: 1 g per liter
- Sodium acetate trihydrate: 3.13 g per liter
- Potassium chloride: 1.50 g per liter
- Magnesium chloride hexahydrate: 0.30 g per liter
Other ingredients are:
- concentrated hydrochloric acid
- water for injections
What the medicine looks like and contents of the pack
Glucose -Na-K Baxter 100 mg/ml 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.
The size of the bag is 1000 ml
The bags are delivered in cartons. Each carton contains 10 bags of 1000 ml
Marketing Authorisation Holder:
Baxter Medical AB
Box 63
SE-164 94 Kista
Manufacturer:
Bieffe Medital Sabiñánigo
Ctra de Biescas – Senegüe Sorripas
22666 Sabiñánigo (Huesca)
Spain