4.5 mg / ml + 25 mg / ml solution for infusion ,
sodium chloride solution, glucose .
What Sodium Chloride-Glucos Baxter Viaflo is and what it is used for
Sodium Chloride-Glucose Baxter Viaflo is an aqueous solution of the following substances:
- sugar ( glucose )
- sodium chloride (salt)
Glucose is one of the body’s sources of energy. This infusion solution provides 100 kilocalories per liter. Sodium and chloride are chemical substances found in the blood.
Sodium Chloride-Glucose Baxter Viaflo is used:
- as a carbohydrate source (sugar)
- to restore fluid loss (dehydration) or salt loss (eg after heavy sweating or kidney disease)
- to treat you if the blood volume in your bloodstream is too small ( hypovolemia ).
What you need to know before you use Sodium Chloride-Glucos Baxter Viaflo
You can NOT get Sodium Chloride-Glucos Baxter Viaflo if you have any of the following conditions
- if you know you are allergic to the medicine
- too much fluid around the cells in your body ( extracellular hyperhydration)
- excessive blood volume in the bloodstream ( hypervolemia )
- too much fluid and sodium in the body (fluid and sodium retention)
- severe kidney disease that makes you urinate less than normal or not at all ( oliguria or anuria )
- inadequately treated heart failure which thus causes symptoms such as:- shortness of breath- swollen ankles
- abnormally high levels of sodium in the blood ( hypernatremia )
- abnormally high levels of chloride in the blood ( hyperchloremia )
- accumulation of fluid under the skin all over the body (general edema )
- liver disease that causes fluid retention in the abdomen (ascitic cirrhosis )
- inadequately treated diabetes , which means that your blood sugar level can rise above normal
- some form of glucose intolerance, eg in:- metabolic stress (when the body’s metabolism does not function satisfactorily, eg caused by a serious illness)- hyperosmolar coma (unconsciousness). This can happen if you have diabetes and do not receive adequate treatment.- much higher blood sugar level than normal ( significant hyperglycaemia )- abnormally high levels of lactic acid (hyperlactataemia).
Warnings and cautions
Tell your doctor if you have or have had any of the following conditions:
- conditions associated with sodium retention, fluid overload and edema , such asaldosteronism (a disease that produces high levels of a hormone called aldosterone ) associated with:- high blood pressure ( hypertension )- heart failure- impaired liver function or liver disease causing fluid accumulation in the abdomen (ascitic cirrhosis )impaired renal function- high blood pressure during pregnancy ( preeclampsia )
- intake of certain medicines (see below “Other medicines and Sodium Chloride-Glucos Baxter Viaflo”)
- a disease that causes the blood to become too alkaline ( metabolic alkalosis )
- muscle weakness and periodic paralysis due to low thyroid activity (thyrotoxic periodic paralysis)
- rapid loss of fluid from the body for example in case of vomiting or diarrhea
- long-term diet with low potassium intake
- allergy to maize (Sodium Chloride-Glucos Baxter Viaflo contains sugar obtained 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 Sodium Chloride-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 the fluid level in the brain, e.g. due to meningitis , cerebral haemorrhage or brain damage.
Infusion can cause:
- changes in salt concentrations in the blood (electrolyte disturbances)
- accumulation of fluid under the skin all over the body (general edema ), around the ankles (peripheral edema ) or in the lungs ( pulmonary edema ).
Your doctor will take blood and urine samples when the infusion is given to monitoring:
- the amount of salt e.g. sodium and chloride in your blood (plasma electrolytes)
- the amount of glucose (sugar).
Because Sodium Chloride-Glucose Baxter Viaflo contains sugar ( glucose ) it can cause high blood sugar (hyperglycemia). If this happens, the doctor can
- adjust the infusion rate
- give you insulin to lower your blood sugar
This is especially important if you:
- is diabetic
- have eaten poorly or drank too much alcohol for a long time
- recently had a stroke ( acute ichemic stroke ). High blood sugar levels can worsen the symptoms of a stroke and affect recovery.
- if you have had a head injury in the last 24 hours
Your doctor will consider if you are already receiving nutrition as an infusion (nutrition given in a tube into a vein). You may need extra nutrition during long-term treatment with Sodium Chloride-Glucose Baxter Viaflo. Your doctor should also monitor the level of potassium in your blood to prevent it from becoming too low ( hypokalaemia ).
Children
Special care should be taken when giving the solution to children, infants, and newborns (especially to premature and newborns with low birth weight). Children, infants, and newborns may have a poorer ability to take care of the chemicals in the solution.
Younger children have an increased risk of getting blood sugar levels that are either too high or too low and therefore need close monitoring during treatment to ensure that sugar levels are controlled. 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 infections, eye damage (prematurity retinopathy), intestinal wall inflammation, lung problems, prolonged hospital stays, and deaths.
Children are at greater risk of having or developing too low a sodium concentration in the blood ( hyponatremia ). Hyponatremia can lead to headaches, nausea, seizures, listlessness, coma, swelling of the brain (cerebral edema), and death. Acute hyponatremia encephalopathy is a serious complication, especially in children.
Your doctor is aware of this and will closely monitor the number of chemicals such as glucose (sugar), sodium, and chloride in your baby’s blood (plasma electrolytes).
Other medicines and Sodium Chloride-Glucos Baxter Viaflo
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
You must tell your doctor if you are taking:
- corticosteroids (anti-inflammatory drugs).
These medicines can cause the accumulation of water and sodium in the body, leading to swelling of the skin caused by fluid retention ( edema ) and high blood pressure.
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)
- medicines 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).
Other medicines that may or may not affect Baxter Viaflo Sodium Chloride-Glucose:
- lithium (used to treat psychiatric illness)
- insulin (used to treat diabetes )
- beta blockers (heart medicine).
Sodium chloride-Glucos Baxter Viaflo with food, drink and alcohol
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.
Sodium Chloride-Glucose Baxter Viaflo can be used during breastfeeding.
However, if another drug is added to Sodium Chloride-Glucose Baxter Viaflo during pregnancy and lactation, you should:
- consult your doctor
- read the package leaflet for the medicine to be added.
Driving and using machines
Sodium Chloride-Glucose Baxter Viaflo does not affect your ability to drive or use machines.
How to get Sodium Chloride-Glucos Baxter Viaflo
Sodium Chloride-Glucose Baxter Viaflo 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. This depends on your age, weight, general condition, and the purpose of the treatment. The amount given can also be affected by other concomitant treatments.
Sodium chloride-Glucose Baxter Viaflo should NOT be given to you if there are particles in the solution or if the packaging is damaged in any way.
Sodium chloride-Glucose Baxter Viaflo will be given via a plastic tube with a needle into a vein. Usually, a vein in the arm is used to give the infusion one. 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 amount of electrolyte is in the body (especially sodium levels 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 Sodium Chloride-Glucose Baxter Viaflo should NOT be given to you from a bag that is partially used.
If you take more Sodium Chloride-Glucos Baxter Viaflo than you should:
If you take too much Sodium Chloride-Glucose Baxter Viaflo (over-infusion) or if the solution is given too quickly, it may cause the following symptoms:
- high blood sugar levels ( hyperglycaemia ). Symptoms may include:
- dry mouth due to lack of fluid in the body’s tissues ( dehydration )
- thirst
- fatigue
- frequent urination due to increased urine production ( osmotic diuresis )
- dimsyn
- low levels of sodium in the blood ( hyponatremia ). Hyponatremia can lead to headache, nausea, seizures, listlessness, coma , swelling of the brain (cerebral edema) and death.
- accumulation of fluid in the body that causes swelling ( edema ).
If you get any of these symptoms, tell your doctor immediately. Infusion one will be discontinued and treatment depending on symptoms will be started.
If a medicine has been added to Sodium Chloride-Glucose 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 Sodium Chloride-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.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects may be related to Sodium Chloride-Glucose Baxter Viaflo. These include:
- hypersensitivity reaction , including a severe allergic reaction called anaphylaxis (possible symptoms in patients with maize allergy )
- high blood sugar levels in the blood ( hyperglycaemia )
- 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”).
The side effects may be related to the method of administration. These include:
- fever
- overindulge
- itching ( pruritus ) or rash
- 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.
If a drug is added to the infusion solution, the added drug can also cause side effects. The side effects depend on which drug is added. You can read about any symptoms in the package leaflet for the added medicine.
How to store Sodium Chloride-Glucos Baxter Viaflo
Keep this medicine out of the sight and reach of children.
Sodium Chloride-Glucose Baxter Viaflo has no special storage 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.
Sodium chloride-Glucose Baxter Viaflo 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:
- sugar ( glucose ): 25 g per liter
- sodium chloride: 4.5 g per liter
The only other ingredient is water for injections.
What the medicine looks like and contents of the pack
Sodium Chloride-Glucose 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:
- 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 SABoulevard René Branquart, 807860 LessinesBelgium | Bieffe Medital SabiñánigoCtra de Biescas-Senegüé22666 Sabiñánigo (Huesca)Spain |