50 mg / ml solution for infusion
Active substances: glucose, sodium chloride, potassium chloride, magnesium chloride hexahydrate, sodium acetate trihydrate, and sodium gluconate
What Plasmalyte Glucose is and what it is used for
Plasmalyte Glucose is an aqueous solution of the following substances:
- sugar ( glucose )
- sodium chloride
- potassium chloride
- magnesium chloride hexahydrate
- sodium acetate trihydrate
- sodium gluconate
Glucose is one of the body’s energy sources. This infusion solution provides 220 kilocalories per liter.
Sodium, potassium, magnesium, chloride, acetate, and gluconate are chemical substances found in the blood.
Plasmalyte Glucose is used:
- to add liquid and carbohydrates (sugar) e.g. at:
- burns
- head injuries
- bone fracture ( fracture is)
- infection is
- peritoneal irritation ( inflammation inside the abdominal cavity)
- to deliver fluid during surgery
- in metabolic acidosis (when the blood becomes too acidic) which is not life-threatening
- lactic acidosis (a type of metabolic acidosis caused by the accumulation of lactic acid in the body). Lactic acid is mainly formed by the muscles and is removed by the liver.
Plasmalyte Glucose can be used:
- in adults, the elderly, and adolescents
- in infants and toddlers from 28 days to 23 months and children from 2 to 11 years.
What you need to know before you use Plasmalyte Glucose
Plasmalyte Glucose should NOT be given if you have any of the following conditions:
- abnormally high levels of chloride in the blood ( hyperchloremia )
- abnormally high levels of sodium in the blood ( hypernatremia )
- abnormally high levels of potassium in the blood (hyperkalemia)
- kidney failure
- heart block (very slow heartbeat)
- any condition in which the blood becomes too alkaline (metabolic or respiratory alkalosis )
- abnormally low levels of calcium in the blood (hypocalcemia)
- lack of acid secretion in the stomach (hypochlorhydria)
- treatment with potassium-sparing diuretics (diuretic tablets that cause an accumulation of potassium in the body) eg:
- amiloride
- potassium kanrenoate
- spironolactone
- triamterene
(the above medicines may be included in combination medicines)
- inadequately treated diabetes, which means that your blood sugar level can rise above normal
- some form of glucose intolerance, eg:
- metabolic stress (when the body’s metabolism does not function satisfactorily eg caused by serious illness)
- hyperosmolar coma (unconsciousness). This is a type of coma that can occur if you have diabetes and do not receive adequate treatment.
- higher blood sugar level than normal (hyperglycemia)
- abnormally high levels of lactate in the blood (hyperlactatemia)
- if you are allergic to glucose, sodium chloride, potassium chloride, magnesium chloride hexahydrate, sodium acetate trihydrate or sodium gluconate, or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Plasmalyte Glucose is a hyperosmotic (concentrated) solution. The doctor will take this into account when determining the dose.
Tell your doctor if you have or have had any of the following medical conditions.
- heart failure
- breathing difficulties (lung disease)
- renal failure
(special monitoring may be required for the above conditions) - high blood pressure ( hypertension )
- accumulation of fluid under the skin, especially at the ankles (peripheral edema )
- fluid accumulation in the lungs ( pulmonary edema )
- high blood pressure during pregnancy ( preeclampsia or eclampsia )
- aldosteronism (a disease that causes high levels of the hormone et alaldosterone )
- other conditions associated with sodium retention (when the body retains too much sodium ), such as treatment with steroids (see also below “Other medicines and Plasmalyte Glucose”)
- diabetes (your blood sugar levels will be closely monitored and your insulin treatment may need to be adjusted)
- any condition that causes you to probably have high levels of potassium in your blood ( hyperkalemia ), eg:
- kidney failure
- adrenal insufficiency (an adrenal disease that affects the hormones that regulate the body’s content of various chemical substances).
- acute dehydration (loss of fluid from the body eg due to vomiting or diarrhea)
- extensive tissue damage (which occurs, for example, in severe burns)
(in these cases, close monitoring of potassium levels in the blood is required)
- myasthenia gravis (a disease that causes gradually increasing muscle weakness)
- recovery after surgery
- head injury within the last 24 hours
- high pressure in the skull ( intracranial hypertension )
- a stroke due to a blockage in a blood vessel in the brain (ischemic stroke )
- if you have problems with the fluid level in your brain (for example due to meningitis, bleeding in the skull, or brain damage)
- if you have a disease that can cause high levels of vasopressin, a hormone that regulates fluid levels in the body, such as:
- an acute and serious illness or injury
- you have had surgery
- the 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:
- the amount of fluid in the body
- the amount of salt e.g. sodium and potassium in blood and urine ( plasma and urine electrolytes)
- the amount of sugar in the blood
- acid-base balance one in the body (acidity in the blood and urine).
Although Plasmalyte Glucose contains potassium , it is not sufficient to treat severe potassium loss (very low plasma levels).
Plasmalyte Glucose should not be given through the same needle as a blood transfusion. It can damage the red blood cells or cause them to clot.
Plasmalyte Glucose contains substances that can cause metabolic alkalosis (that the blood becomes too alkaline).
Because Plasmalyte Glucose contains sugar ( glucose ), it may cause high blood sugar (hyperglycemia). If this happens, your doctor may:
- adjust the infusion rate
- give you insulin to lower your blood sugar
This is especially important if you are diabetic.
With repeated treatment, your doctor will also give you other infusions to cover your body’s need for other substances and nutrients.
If a blood sample is taken to detect the presence of a fungus called Aspergillus, the test can detect Aspergillus even though you are not infected.
Children
Plasmalyte Glucose should be given special care to children.
Newborns, especially those born prematurely and with low birth weight, have an increased risk of getting low or high levels of blood sugar (hypo- or hyperglycemia), which can lead to complications.
Other medicines and Plasmalyte Glucose
Tell your doctor or nurse if you are taking, have recently taken, or might take any other medicines.
The following medicines should not be used while you are receiving an infusion of Plasmalyte Glucose:
- potassium-sparing diuretics (certain diuretics, eg amiloride, spironolactone , triamterene, potassium canrenoate)
(These medicines can be included in combination medicines. See also “Plasmalyte Glucose should NOT be given if you have any of the following conditions” at the beginning of this section).
The use of the following medicines is not recommended while you are receiving an infusion of Plasmalyte Glucose:
- ACE inhibitor (used to treat high blood pressure )
- angiotensin II receptor antagonists (used to treat high blood pressure )
- tacrolimus (used to prevent transplant rejection and to treat certain skin conditions)
- ciclosporin (used to prevent transplant rejection )
These drugs can increase the concentration of potassium in the blood which can be life-threatening. There is a greater risk of an increase in blood potassium levels if you have kidney disease.
Some medicines may increase the risk of side effects due to low sodium levels in the blood. These medicines may include:
- certain cancer drugs
- selective serotonin reuptake inhibitors (used to treat depression)
- antipsychotics
- opioid er
- medicines for pain and/or inflammation (also called non-steroidal anti-inflammatory drugs ( NSAIDs ))
- certain medicines for epilepsy
- oxytocin (a medicine used in women during pregnancy and during or after childbirth)
- diuretics.
Other medicines that can affect or be affected by Plasmalyte Glucose:
- corticosteroids (anti-inflammatory drugs)
- carbenoxolone (an anti-inflammatory drug used to treat stomach ulcers )
- muscle relaxants (eg tubocurarine, suxamethonone and vecuron). They are used in surgery under the supervision of an anesthesiologist.
- acetylcholine
- aminoglycoside is (a type of antibiotic )
- nifedipine (used to treat high blood pressure and chest pain)
- acidic drugs, including:
- salicylates used in the treatment of inflammation ( acetylsalicylic acid )
- sleeping pills ( barbiturates )
- lithium (for the treatment of mental illness
- basic medicines, including:
- sympathomimetics (stimulant drugs such as ephedrine and pseudoephedrine used in cough medicine)
- other stimulant drugs (eg dexamphetamine, fenfluramine).
Plasmalyte Glucose with food, drink, and alcohol
You should consult your doctor about what you can eat and 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.
Plasmalyte Glucose can be used if you are pregnant or breastfeeding. Your doctor will monitor the electrolyte levels and the amount of fluid in your body.
However, if another medicine is added to Plasmalyte Glucose you should:
- consult your doctor. Co-administration of a drug called oxytocin during childbirth may cause decreased sodium levels in the blood (increased risk of hyponatremia ).
- read the package leaflet for the added medicine
Driving and using machines
Consult a doctor or pharmacist 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.
How to get Plasmalyte Glucose
Plasmalyte Glucose is given to you by a doctor or nurse. Your doctor will decide how much you need and when it should be given to you. It depends on your age, weight, your general condition, and the purpose of the treatment. The amount you are given may also be affected by other concomitant treatments.
Plasmalyte Glucose must NOT be given to you if there are particles in the solution or if the packaging is damaged in any way.
Plasmalyte Glucose is usually given through a plastic tube with a needle into a vein. However, your doctor may use another method to give you the medicine.
Any remaining solution must be discarded. An infusion of Plasmalyte Glucose should NOT be given to you from a partially used bag.
If you take more Plasmalyte Glucose than you should
If you get too much Plasmalyte Glucose (over-infusion), or if it is given too fast, the following symptoms may occur:
- Excess fluid and/or sodium with the accumulation of fluid in tissue an ( edema ) that causes swelling
- stinging sensation in arms and legs ( paresthesias )
- muscle weakness
- inability to move (paralysis)
- irregular heartbeat ( arrhythmia )
- heart block (very slow heartbeat)
- cardiac arrest (heart stops beating; a life-threatening situation)
- confusion
- loss of tendon reflexes
- decreased breathing ( respiratory depression )
- nausea
- vomiting
- reddening of the skin
- thirst
- low blood pressure ( hypotension )
- somnolence
- slow heart rate ( bradycardia )
- coma (unconsciousness)
- acidification of the blood ( acidosis ) leading to fatigue, confusion, drowsiness, and increased breathing
- hypokalaemia (abnormally low levels of potassium in the blood) and metabolic alkalosis (when the blood becomes too alkaline) especially in patients with renal failure
- mood swings
- fatigue
- breathing difficulties
- muscle stiffness
- muscle twitching
- muscle contractions
- hyperosmolarity (blood becomes too concentrated)
- fluid loss from the body ( dehydration )
- high blood sugar (hyperglycemia)
- sugar in the urine (hyperglucosuria)
- increased urinary excretion ( osmotic diuresis ).
If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor immediately. Infusion one will be discontinued and you will receive treatment depending on the symptoms.
If a drug is added to Plasmalyte Glucose and an overdose occurs, the added drug can also cause symptoms. You can read about any symptoms in the package leaflet for the added medicine.
To stop using Plasmalyte Glucose
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 serious or even life-threatening allergic reaction ( hypersensitivity reaction ):
- swelling of the skin of the face, lips, and throat
- breathing difficulties
- rash
- redness ( erythema ).
Treatment will be given depending on the symptoms.
Other side effects are:
- reactions caused by the method of administration:
- fever
- infection at the infusion site
- local pain or reaction ( redness or swelling) at the infusion site
- irritation and inflammation of the vein in which infusion is given ( phlebitis ). It can cause redness, pain, or burning sensation as well as swelling along the vein in which the infusion is given.
- blood clot ( venous thrombosis ) forms at the infusion site and causes pain, swelling, or redness in the area of the clot
- leakage of the infusion fluid into the surrounding tissue (extravasation). It can damage tissue and cause scarring.
- excess fluid in the body ( hypervolemia )
- increased levels of potassium in the blood (hyperkalemia), which can cause abnormal heart rhythms
- high blood sugar (hyperglycemia)
- seizures (convulsions)
- hives ( urticaria )
- a severe allergic reaction that causes difficulty breathing or dizziness ( anaphylactic reaction )
- low blood pressure ( hypotension )
- a feeling of discomfort in the chest
- shortness of breath ( dyspnoea )
- hissing breathing
- hemorrhage
- increased blood flow locally in the body ( hyperemia )
- a feeling of weakness ( asthenia )
- cold sweats
- fever ( pyrexia )
- overindulge
- low sodium levels in the blood ( hyponatremia )
- swelling of the brain which can cause brain damage.
If a drug is added to the infusion solution, the added drug can also cause side effects. 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.
Other side effects have been observed with similar products
- Other signs of hypersensitivity, – infusion reactions: rapid heartbeat ( tachycardia ), palpitations, chest pain, increased respiratory rate, abnormal sensation, goosebumps, swelling of the arms and legs (peripheral edema ).
If you get any side effects, talk to your doctor or nurse. This also applies to any side effects not mentioned in this information.
How to store Plasmalyte Glucose
Keep this medicine out of the sight and reach of children.
Do not store above 30 ° C.
May not be given after the expiry date which is stated on the bag after EXP. The expiration date is the last day of the specified month.
This medicine must not be given to you if there are particles in the solution or if the packaging is damaged in any way.
Contents of the pack and other information
Content declaration
The active substances are:
- glucose (sugar): 55.00 g per liter
- sodium chloride: 5.26 g per liter
- potassium chloride: 0.37 g per liter
- magnesium chloride hexahydrate: 0.30 g per liter
- sodium acetate trihydrate: 3.68 g per liter
- sodium gluconate: 5.02 g per liter.
Other ingredients are:
- water for injections
- concentrated hydrochloric acid.
What the medicine looks like and the contents of the pack
Plasmalyte Glucose 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
- 250 ml
- 500 ml
- 1000 ml.
The bags are packed in cartons. Each carton contains one of the following numbers
- 30 bags of 250 ml
- 20 bags of 500 ml
- 10 bags with 1000 ml.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Manufacturer
Baxter SA
Boulevard René Branquart, 80
7860 Lessines
Belgium
Bieffe Medital Sabiñánigo
Ctra de Biescas, Senegüé
22666 Sabiñánigo (Huesca)
Spain