infusion solution
What Plasmalyte is and what it is used for
Plasma surface is an aqueous solution of the following substances:
- sodium chloride
- potassium chloride
- magnesium chloride hexahydrate
- sodium acetate trihydrate
- sodium gluconate
Sodium, potassium, magnesium, chloride, acetate, and gluconate are chemical substances found in the blood.
Plasma surface is used:
- to supply liquid 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 case of shock caused by blood loss and any condition requiring rapid blood transfusion and/or fluid
- 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.
Plasma surface 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 using Plasmalyte
DO NOT use Plasmalyte if you have any of the following conditions:
- abnormally high levels of potassium in the blood (hyperkalemia)
- kidney failure
- heart block (very slow heartbeat)
- a condition in which the blood becomes too alkaline (metabolic or respiratory alkalosis )
- lack of acid secretion in the stomach (hypochlorhydria)
- if you are allergic to active substances or any of the other ingredients of this medicine (listed in section 6)
Warnings and cautions
Talk to your doctor or nurse before taking Plasmalyte if you have or have had any of the following 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”)
- if you have a disease or condition that causes high levels of vasopressin, a hormone that regulates the body’s fluid balance. 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 have had surgery
- you have an infection, burn, or brain disease
- you have a disease that is linked to the heart, liver, kidneys, or central nervous system
- you are taking certain medicines (see also below “Other medicines and Plasmalyte”). This can increase the risk of low sodium levels in the blood and can cause 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 balance in the brain, e.g. due to meningitis, skull bleeding, or brain damage.
- abnormally high levels of chloride in the blood ( hyperchloremia )
- abnormally high levels of sodium in the blood ( hypernatremia )
- abnormally low levels of calcium in the blood (hypocalcemia)
- 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.
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)
- acid-base balance one in the body (acidity in the blood and urine)
Although Plasmalyte contains potassium, it is not sufficient to treat severe potassium loss (very low plasma levels).
The plasma surface contains substances that can cause metabolic alkalosis (that the blood becomes too alkaline).
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.
Other medicines and Plasmalyte
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The use of the following medicines is not recommended while you are receiving an infusion of Plasmalyte:
- potassium-sparing diuretics (certain diuretics, eg amiloride, spironolactone, triamterene, potassium canrenoate).ACE inhibitor (used to treat high blood pressure )
- angiotensin II antagonist (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 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 similar to or enhancing 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).
Other medicines that can affect or be affected by Plasmalyte:
- 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 stimulants (eg dexamphetamine, fenfluramine)
Plasma surface with food and drink
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 for advice before using this medicine.
Plasma surface 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 drug is added to Plasmalyte, you should
- consult your doctor
- 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 use Plasmalyte
A playmate 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.
Plasma surface must NOT be given to you if there are particles in the solution or if the packaging is damaged in any way.
Plasma surface is usually given through a plastic tube with a needle into a vein. Usually,y a vein in the arm is used to give the infusion. However, your doctor may use another method to give you the medicine.
Before and during infusion, your doctor should check:
- the amount of fluid in the body
- the acidity of the blood and urine
- the number of electrolytes in the body (especially sodium in patients with high levels of vasopressin, or in patients using drugs that enhance the effect of vasopressin ).
Any remaining solution must be discarded. An infusion of Plasmalyte should NOT be given to you from a bag that is partially used.
If you take more Plasmalyte than you should
If you get too much Plasmalyte (over-infusion), or if 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 ) which leads 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
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 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 using Plasmalyte
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.
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 ar:
- reactions caused by the method of administration
- fever
- infection at the infusion site
- burning sensation
- 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,n 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,g 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 )
- seizures (convulsions)
- hives ( urticaria )a
- severe allergic reaction that causes difficulty breathing or dizziness ( anaphylactic reaction )
- fast heart rhythm (tachycardia)
- palpitation
- chest paina
- feeling of discomfort in the chest
- shortness of breath ( dyspnoea )
- increased respiratory rate
- hemorrhage
- increased blood flow locally in the body ( hyperemia )a
- feeling of weakness ( asthenia )
- abnormal feeling
- goosebumps
- swelling of the arms and legs (peripheral edema )
- fever ( pyrexia )
- low levels of sodium in the blood can be caused by the treatment given in a hospital hospital-acquired hyponatremia ) and a 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”).
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: low blood pressure ( hypotension )
- wheezing, cold sweats, chills
- elevated potassium value
How to store Plasmalyte
Keep this medicine out of the sight and reach of children.
No special temperature instructions.
Do not use this medicine after the expiry date which is stated on the bag after EXP. The expiration date is the last day of the specified month.
Do not use this medicine if you see 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
- 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
The other ingredients are
- water for injections
- sodium hydroxide
What the medicine looks like and the contents of the pack
The plasma surface is a clear solution without visible particles. It is supplied in plastic bags made ofpolyolefin/polyamidee (Viaflo). Each bag has a sealed, protective outer bag made of plastic.
Bag sizes are:
- 500 ml
- 1000 ml
The bags are packed in cartons. Each carton contains one of the following numbers
- 20 bags of 500 ml
- 10 bags with 1000 ml
Not all pack sizes may be marketed.
Marketing Authorisation Holder
| In Sweden: Baxter Medical ABBox 63164 96 Kista |
| Baxter SABoulevard René Branquart, 807860 LessinesBelgium | Bieffe Medital SACtra de Biescas-Senegüé22666 Sabiñánigo (Huesca)Spain |